0A4F4F9BD490A749D5437F821CF06DF1
Food and Drug Administration Amendments Act
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / criminal
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p.(None): the Secretary shall develop a standardized numerical identifier (which, to the extent practicable, shall be
p.(None): harmonized with international consensus standards for such an identifier) to be applied to a prescription
p.(None): drug at the point of manufacturing and repack- aging (in which case the numerical identifier shall be linked
p.(None): to the numerical identifier applied at the point of manufac- turing) at the package or pallet level,
p.(None): sufficient to facilitate the identification, validation, authentication, and tracking and tracing of the prescription
p.(None): drug.
p.(None): ‘‘(3) PROMISING TECHNOLOGIES.—The standards developed under this subsection shall address promising
p.(None): technologies, which may include—
p.(None): ‘‘(A) radio frequency identification technology; ‘‘(B) nanotechnology;
p.(None): ‘‘(C) encryption technologies; and
p.(None): ‘‘(D) other track-and-trace or authentication tech- nologies.
p.(None): ‘‘(4) INTERAGENCY COLLABORATION.—In carrying out this subsection, the Secretary shall consult with Federal
p.(None): health and security agencies, including—
p.(None): ‘‘(A) the Department of Justice;
p.(None): ‘‘(B) the Department of Homeland Security; ‘‘(C) the Department of Commerce; and
p.(None): ‘‘(D) other appropriate Federal and State agencies. ‘‘(c) INSPECTION AND ENFORCEMENT.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall expand and enhance the resources and facilities of agency components of
p.(None): the Food and Drug Administration involved with regulatory and criminal enforcement of this Act to secure the drug
p.(None): supply chain against counterfeit, diverted, subpotent, substandard, adulterated, mis- branded, or expired drugs
p.(None): including biological products and active pharmaceutical ingredients from domestic and foreign sources.
p.(None): ‘‘(2) ACTIVITIES.—The Secretary shall undertake enhanced and joint enforcement activities with other Federal
p.(None): and State agencies, and establish regional capacities for the validation of prescription drugs and the
p.(None): inspection of the prescription drug supply chain.
p.(None): ‘‘(d) DEFINITION.—In this section, the term ‘prescription drug’ means a drug subject to section 503(b)(1).’’.
p.(None): SEC. 914. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY ACTION.
p.(None): (a) IN GENERAL.—Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by
p.(None): section 901(a), is amended by adding at the end the following:
p.(None): ‘‘(q) PETITIONS AND CIVIL ACTIONS REGARDING APPROVAL OF
p.(None): CERTAIN APPLICATIONS.—
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p.(None): 121 STAT. 954 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): ‘‘(1) IN GENERAL.—
p.(None): ‘‘(A) DETERMINATION.—The Secretary shall not delay approval of a pending application submitted under sub-
p.(None): section (b)(2) or (j) because of any request to take any form of action relating to the application,
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Political / political affiliation
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p.(None): This Act may be cited as the ‘‘Food and Drug Administration Amendments Act of 2007’’.
p.(None): SEC. 2. TABLE OF CONTENTS.
p.(None): The table of contents for this Act is as follows:
p.(None): Sec. 1. Short title.
p.(None): Sec. 2. Table of contents.
p.(None): TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
p.(None): Sec. 101. Short title; references in title; finding. Sec. 102. Definitions.
p.(None): Sec. 103. Authority to assess and use drug fees.
p.(None): Sec. 104. Fees relating to advisory review of prescription-drug television adver- tising.
p.(None): Sec. 105. Reauthorization; reporting requirements. Sec. 106. Sunset dates.
p.(None): Sec. 107. Effective date. Sec. 108. Savings clause.
p.(None): Sec. 109. Technical amendment; conforming amendment.
p.(None): TITLE II—MEDICAL DEVICE USER FEE AMENDMENTS OF 2007
p.(None): Sec. 201. Short title; references in title; finding.
p.(None): Subtitle A—Fees Related to Medical Devices Sec. 211. Definitions.
p.(None): Sec. 212. Authority to assess and use device fees. Sec. 213. Reauthorization; reporting requirements. Sec. 214.
p.(None): Savings clause.
p.(None): Sec. 215. Additional authorization of appropriations for postmarket safety informa- tion.
p.(None): Sec. 216. Effective date. Sec. 217. Sunset clause.
p.(None): Subtitle B—Amendments Regarding Regulation of Medical Devices
p.(None): Sec. 221. Extension of authority for third party review of premarket notification. Sec. 222. Registration.
p.(None): Sec. 223. Filing of lists of drugs and devices manufactured, prepared, propagated, and compounded by
p.(None): registrants; statements; accompanying disclosures.
p.(None): Sec. 224. Electronic registration and listing.
p.(None): Sec. 225. Report by Government Accountability Office. Sec. 226. Unique device identification system.
p.(None): Sec. 227. Frequency of reporting for certain devices.
p.(None):
p.(None): Sept. 27, 2007
p.(None): [H.R. 3580]
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p.(None): Food and Drug Administration Amendments Act of 2007.
p.(None): 21 USC 301 note.
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p.(None): 121 STAT. 824 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): Sec. 228. Inspections by accredited persons.
p.(None): Sec. 229. Study of nosocomial infections relating to medical devices.
p.(None): Sec. 230. Report by the Food and Drug Administration regarding labeling informa- tion on the relationship between
p.(None): the use of indoor tanning devices and development of skin cancer or other skin damage.
p.(None): TITLE III—PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007
p.(None): Sec. 301. Short title.
p.(None): Sec. 302. Tracking pediatric device approvals.
p.(None): Sec. 303. Modification to humanitarian device exemption. Sec. 304. Encouraging pediatric medical device research.
p.(None): Sec. 305. Demonstration grants for improving pediatric device availability.
p.(None): Sec. 306. Amendments to office of pediatric therapeutics and pediatric advisory committee.
p.(None): Sec. 307. Postmarket surveillance.
p.(None): TITLE IV—PEDIATRIC RESEARCH EQUITY ACT OF 2007
p.(None): Sec. 401. Short title.
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p.(None): ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than
p.(None): January 15, 2012, the Secretary shall transmit to the Congress the revised recommendations under paragraph (4), a
p.(None): summary of the views and comments received under such paragraph, and any changes made to the
p.(None): recommendations in response to such views and comments.
p.(None): ‘‘(6) MINUTES OF NEGOTIATION MEETINGS.—
p.(None): ‘‘(A) PUBLIC AVAILABILITY.—Before presenting the rec- ommendations developed under paragraphs (1) through (5) to
p.(None): the Congress, the Secretary shall make publicly avail- able, on the public Web site of the Food and Drug
p.(None): Adminis- tration, minutes of all negotiation meetings conducted under this subsection between the Food and
p.(None): Drug Adminis- tration and the regulated industry.
p.(None): ‘‘(B) CONTENT.—The minutes described under subpara- graph (A) shall summarize any substantive proposal made
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p.(None): by any party to the negotiations as well as significant controversies or differences of opinion during
p.(None): the negotia- tions and their resolution.’’.
p.(None): SEC. 106. SUNSET DATES.
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p.(None): 21 USC 379g
p.(None): note.
p.(None): 21 USC 379h–2.
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p.(None): 21 USC 379g
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p.(None): Medical Device User Fee Amendments of 2007.
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p.(None): 21 USC 301 note.
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p.(None): 21 USC 379i
p.(None): note.
p.(None): (a) AUTHORIZATION.—The amendments made by sections 102, 103, and 104 cease to be effective October 1, 2012.
p.(None): (b) REPORTING REQUIREMENTS.—The amendment made by sec- tion 105 ceases to be effective January 31, 2013.
p.(None): SEC. 107. EFFECTIVE DATE.
p.(None): The amendments made by this title shall take effect on October 1, 2007, or the date of the enactment of this
p.(None): Act, whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food,
p.(None): Drug, and Cosmetic Act shall be assessed for all human drug applications received on or after October 1,
p.(None): 2007, regardless of the date of the enactment of this Act.
p.(None): SEC. 108. SAVINGS CLAUSE.
p.(None): Notwithstanding section 509 of the Prescription Drug User Fee Amendments of 2002 (21 U.S.C. 379g note),
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p.(None): ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than
p.(None): January 15, 2012, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a
p.(None): summary of the views and comments received under such paragraph, and any changes made to the
p.(None): recommendations in response to such views and comments.
p.(None): ‘‘(6) MINUTES OF NEGOTIATION MEETINGS.—
p.(None): ‘‘(A) PUBLIC AVAILABILITY.—Before presenting the rec- ommendations developed under paragraphs (1) through (5) to
p.(None): the Congress, the Secretary shall make publicly avail- able, on the public Web site of the Food and Drug
p.(None): Adminis- tration, minutes of all negotiation meetings conducted under this subsection between the Food and
p.(None): Drug Adminis- tration and the regulated industry.
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p.(None): Federal Register, publication.
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p.(None): Deadline.
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p.(None): 121 STAT. 852 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(B) CONTENT.—The minutes described under subpara- graph (A) shall summarize any substantive proposal made by any
p.(None): party to the negotiations as well as significant controversies or differences of opinion during the
p.(None): negotia- tions and their resolution.’’.
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p.(None): 21 USC 379i
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p.(None): 21 USC 379i
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p.(None): 21 USC 379i
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p.(None): SEC. 214. SAVINGS CLAUSE.
p.(None): Notwithstanding section 107 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250),
p.(None): and notwith- standing the amendments made by this subtitle, part 3 of sub- chapter C of chapter VII of
p.(None): the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the
p.(None): date of the enactment of this subtitle, shall continue to be in effect with respect to premarket
p.(None): applications, premarket reports, premarket notification submissions, and supplements (as defined in such part
p.(None): as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the
p.(None): Food and Drug Administration for filing with respect to assessing and collecting any fee required by such
p.(None): part for a fiscal year prior to fiscal year 2008.
p.(None): SEC. 215. ADDITIONAL AUTHORIZATION OF APPROPRIATIONS FOR POSTMARKET SAFETY INFORMATION.
p.(None): For the purpose of collecting, developing, reviewing, and evalu- ating postmarket safety information on medical
p.(None): devices, there are authorized to be appropriated to the Food and Drug Administration, in addition to the amounts
p.(None): authorized by other provisions of law for such purpose—
p.(None): (1) $7,100,000 for fiscal year 2008;
p.(None): (2) $7,455,000 for fiscal year 2009;
p.(None): (3) $7,827,750 for fiscal year 2010;
p.(None): (4) $8,219,138 for fiscal year 2011; and (5) $8,630,094 for fiscal year 2012.
p.(None): SEC. 216. EFFECTIVE DATE.
p.(None): The amendments made by this subtitle shall take effect on October 1, 2007, or the date of the enactment of
p.(None): this Act, whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal
p.(None): Food, Drug, and Cosmetic Act shall be assessed for all premarket applications, premarket reports, supplements,
p.(None): 30-day notices, and premarket notification submissions received on or after October 1, 2007, regardless of the
p.(None): date of the enactment of this Act.
p.(None): SEC. 217. SUNSET CLAUSE.
p.(None): The amendments made by this subtitle cease to be effective October 1, 2012, except that section 738A of
p.(None): the Federal Food, Drug, and Cosmetic Act (regarding annual performance and finan- cial reports) ceases to be
p.(None): effective January 31, 2013.
p.(None): Subtitle B—Amendments Regarding Regulation of Medical Devices
p.(None): SEC. 221. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF PREMARKET NOTIFICATION.
p.(None): Section 523(c) (21 U.S.C. 360m(c)) is amended by striking ‘‘2007’’ and inserting ‘‘2012’’.
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p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 853
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p.(None): SEC. 222. REGISTRATION.
p.(None): (a) ANNUAL REGISTRATION OF PRODUCERS OF DRUGS AND
p.(None): DEVICES.—Section 510(b) (21 U.S.C. 360(b)) is amended—
p.(None): (1) by striking ‘‘(b) On or before’’ and inserting ‘‘(b)(1) On or before’’;
p.(None): (2) by striking ‘‘or a device or devices’’; and
p.(None): (3) by adding at the end the following:
p.(None): ‘‘(2) During the period beginning on October 1 and ending on December 31 of each year, every person
p.(None): who owns or operates any establishment in any State engaged in the manufacture, preparation,
p.(None): propagation, compounding, or processing of a device or devices shall register with the Secretary his
p.(None): name, places of business, and all such establishments.’’.
p.(None): (b) REGISTRATION OF FOREIGN ESTABLISHMENTS.—Section 510(i)(1) (21 U.S.C. 360(i)(1)) is amended by
p.(None): striking ‘‘On or before December 31’’ and all that follows and inserting the following: ‘‘Any establishment
p.(None): within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a
p.(None): drug or device that is imported or offered for import into the United States shall, through electronic
p.(None): means in accordance with the criteria of the Secretary—
p.(None): ‘‘(A) upon first engaging in any such activity, immediately register with the Secretary the name and place of
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p.(None): may—
p.(None): ‘‘(1) adopt, alter, and use a corporate seal, which shall be judicially noticed;
p.(None): ‘‘(2) hire, promote, compensate, and discharge 1 or more officers, employees, and agents, as may be necessary,
p.(None): and define their duties;
p.(None): ‘‘(3) prescribe the manner in which—
p.(None): ‘‘(A) real or personal property of the Foundation is acquired, held, and transferred;
p.(None): ‘‘(B) general operations of the Foundation are to be conducted; and
p.(None): ‘‘(C) the privileges granted to the Board by law are exercised and enjoyed;
p.(None): ‘‘(4) with the consent of the applicable executive department or independent agency, use the information, services, and
p.(None): facili- ties of such department or agencies in carrying out this section; ‘‘(5) enter into contracts with public
p.(None): and private organiza- tions for the writing, editing, printing, and publishing of books
p.(None): and other material;
p.(None): ‘‘(6) hold, administer, invest, and spend any gift, devise, or bequest of real or personal property made to the
p.(None): Foundation under subsection (i);
p.(None): ‘‘(7) enter into such other contracts, leases, cooperative agreements, and other transactions as the Board
p.(None): considers appropriate to conduct the activities of the Foundation;
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p.(None): ‘‘(8) modify or consent to the modification of any contract or agreement to which it is a party or in
p.(None): which it has an interest under this subchapter;
p.(None): ‘‘(9) take such action as may be necessary to obtain patents and licenses for devices and procedures
p.(None): developed by the Foundation and its employees;
p.(None): ‘‘(10) sue and be sued in its corporate name, and complain and defend in courts of competent jurisdiction;
p.(None): ‘‘(11) appoint other groups of advisors as may be determined necessary to carry out the functions of the
p.(None): Foundation; and ‘‘(12) exercise other powers as set forth in this section, and such other incidental
p.(None): powers as are necessary to carry out its powers, duties, and functions in accordance with this
p.(None): subchapter.
p.(None): ‘‘(i) ACCEPTANCE OF FUNDS FROM OTHER SOURCES.—The Execu-
p.(None): tive Director may solicit and accept on behalf of the Foundation, any funds, gifts, grants, devises, or
p.(None): bequests of real or personal property made to the Foundation, including from private entities, for the
p.(None): purposes of carrying out the duties of the Foundation. ‘‘(j) SERVICE OF FEDERAL EMPLOYEES.—Federal
p.(None): Government employees may serve on committees advisory to the Foundation and otherwise cooperate with and
p.(None): assist the Foundation in carrying out its functions, so long as such employees do not direct or control
p.(None): Foundation activities.
p.(None): ‘‘(k) DETAIL OF GOVERNMENT EMPLOYEES; FELLOWSHIPS.—
p.(None): ‘‘(1) DETAIL FROM FEDERAL AGENCIES.—Federal Govern-
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p.(None): subjects (other than a small clin- ical trial to determine the feasibility of a device, or a clinical trial
p.(None): to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and
p.(None): ‘‘(II) a pediatric postmarket surveillance as required under section 522 of the Federal Food, Drug, and
p.(None): Cosmetic Act.
p.(None): ‘‘(iii) APPLICABLE DRUG CLINICAL TRIAL.—
p.(None): ‘‘(I) IN GENERAL.—The term ‘applicable drug clinical trial’ means a controlled clinical investiga- tion, other
p.(None): than a phase I clinical investigation, of a drug subject to section 505 of the Federal Food, Drug, and
p.(None): Cosmetic Act or to section 351 of this Act.
p.(None): ‘‘(II) CLINICAL INVESTIGATION.—For purposes
p.(None): of subclause (I), the term ‘clinical investigation’ has the meaning given that term in section 312.3 of title
p.(None): 21, Code of Federal Regulations (or any successor regulation).
p.(None): ‘‘(III) PHASE I.—For purposes of subclause (I), the term ‘phase I’ has the meaning given that term in section
p.(None): 312.21 of title 21, Code of Federal Regulations (or any successor regulation).
p.(None): ‘‘(iv) CLINICAL TRIAL INFORMATION.—The term ‘clin-
p.(None): ical trial information’ means, with respect to an applicable clinical trial, those data elements
p.(None): that the responsible party is required to submit under para- graph (2) or under paragraph (3).
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p.(None): ‘‘(v) COMPLETION DATE.—The term ‘completion date’ means, with respect to an applicable clinical trial, the
p.(None): date that the final subject was examined or received an intervention for the purposes of final collec-
p.(None): tion of data for the primary outcome, whether the clinical trial concluded according to the prespecified
p.(None): protocol or was terminated.
p.(None): ‘‘(vi) DEVICE.—The term ‘device’ means a device as defined in section 201(h) of the Federal Food, Drug, and
p.(None): Cosmetic Act.
p.(None): ‘‘(vii) DRUG.—The term ‘drug’ means a drug as defined in section 201(g) of the Federal Food, Drug, and
p.(None): Cosmetic Act or a biological product as defined in section 351 of this Act.
p.(None): ‘‘(viii) ONGOING.—The term ‘ongoing’ means, with respect to a clinical trial of a drug or a device and
p.(None): to a date, that—
p.(None): ‘‘(I) 1 or more patients is enrolled in the clin- ical trial; and
p.(None): ‘‘(II) the date is before the completion date of the clinical trial.
p.(None): ‘‘(ix) RESPONSIBLE PARTY.—The term ‘responsible party’, with respect to a clinical trial of a drug or
p.(None): device, means—
p.(None): ‘‘(I) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regula- tions (or any
p.(None): successor regulation)); or
p.(None): ‘‘(II) the principal investigator of such clinical trial if so designated by a sponsor, grantee, con- tractor,
p.(None): or awardee, so long as the principal inves- tigator is responsible for conducting the trial, has access to and control
p.(None): over the data from the clinical trial, has the right to publish the results of the trial, and has the ability
p.(None): to meet all of the require- ments under this subsection for the submission of clinical trial information.
p.(None): ‘‘(B) REQUIREMENT.—The Secretary shall develop a mechanism by which the responsible party for
p.(None): each applicable clinical trial shall submit the identity and con- tact information of such responsible party to
p.(None): the Secretary at the time of submission of clinical trial information under paragraph (2).
p.(None): ‘‘(2) EXPANSION OF CLINICAL TRIAL REGISTRY DATA BANK WITH RESPECT TO CLINICAL TRIAL INFORMATION.—
p.(None): ‘‘(A) IN GENERAL.—
p.(None): ‘‘(i) EXPANSION OF DATA BANK.—To enhance patient enrollment and provide a mechanism to track subse- quent
p.(None): progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accord-
p.(None): ance with this subsection, the clinical trials registry of the data bank described under subsection
p.(None): (i)(1) (referred to in this subsection as the ‘registry data bank’). The Director of NIH shall ensure that the
p.(None): reg- istry data bank is made publicly available through the Internet.
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p.(None): ‘‘(ii) CONTENT.—The clinical trial information required to be submitted under this paragraph for an
p.(None): applicable clinical trial shall include—
p.(None): ‘‘(I) descriptive information, including—
p.(None): ‘‘(aa) a brief title, intended for the lay public;
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p.(None): ‘‘(ff) study type;
p.(None): ‘‘(gg) the primary disease or condition being studied, or the focus of the study;
p.(None): ‘‘(hh) the intervention name and interven- tion type;
p.(None): ‘‘(ii) the study start date;
p.(None): ‘‘(jj) the expected completion date;
p.(None): ‘‘(kk) the target number of subjects; and ‘‘(ll) outcomes, including primary and sec-
p.(None): ondary outcome measures;
p.(None): ‘‘(II) recruitment information, including— ‘‘(aa) eligibility criteria;
p.(None): ‘‘(bb) gender;
p.(None): ‘‘(cc) age limits;
p.(None): ‘‘(dd) whether the trial accepts healthy vol- unteers;
p.(None): ‘‘(ee) overall recruitment status; ‘‘(ff) individual site status; and
p.(None): ‘‘(gg) in the case of an applicable drug clinical trial, if the drug is not approved under section 505 of the
p.(None): Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, specify whether or not
p.(None): there is expanded access to the drug under section 561 of the Federal Food, Drug, and Cosmetic Act for those
p.(None): who do not qualify for enrollment in the clinical trial and how to obtain informa- tion about such access;
p.(None): ‘‘(III) location and contact information, including—
p.(None): ‘‘(aa) the name of the sponsor;
p.(None): ‘‘(bb) the responsible party, by official title;
p.(None):
p.(None): and
p.(None): ‘‘(cc) the facility name and facility contact
p.(None): information (including the city, State, and zip code for each clinical trial location, or a toll- free number
p.(None): through which such location information may be accessed); and
p.(None): ‘‘(IV) administrative data (which the Secretary may make publicly available as necessary), including—
p.(None): ‘‘(aa) the unique protocol identification number;
p.(None): ‘‘(bb) other protocol identification num- bers, if any; and
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 907
p.(None):
p.(None):
p.(None): ‘‘(cc) the Food and Drug Administration IND/IDE protocol number and the record verification date.
p.(None): ‘‘(iii) MODIFICATIONS.—The Secretary may by regu- lation modify the requirements for clinical trial
p.(None): information under this paragraph, if the Secretary pro- vides a rationale for why such a modification improves and
p.(None): does not reduce such clinical trial information. ‘‘(B) FORMAT AND STRUCTURE.—
p.(None): ‘‘(i) SEARCHABLE CATEGORIES.—The Director of NIH shall ensure that the public may, in addition to
p.(None): keyword searching, search the entries in the registry data bank by 1 or more of the following criteria:
p.(None): ‘‘(I) The disease or condition being studied in the clinical trial, using Medical Subject Headers (MeSH)
p.(None): descriptors.
p.(None): ‘‘(II) The name of the intervention, including any drug or device being studied in the clinical trial.
p.(None): ‘‘(III) The location of the clinical trial.
p.(None): ‘‘(IV) The age group studied in the clinical trial, including pediatric subpopulations.
p.(None): ‘‘(V) The study phase of the clinical trial.
p.(None): ‘‘(VI) The sponsor of the clinical trial, which may be the National Institutes of Health or
p.(None): another Federal agency, a private industry source, or a university or other organization.
p.(None): ‘‘(VII) The recruitment status of the clinical trial.
p.(None): ‘‘(VIII) The National Clinical Trial number or other study identification for the clinical trial.
p.(None): ‘‘(ii) ADDITIONAL SEARCHABLE CATEGORY.—Not
p.(None): later than 18 months after the date of the enactment of the Food and Drug Administration Amendments Act
p.(None): of 2007, the Director of NIH shall ensure that the public may search the entries of the registry data bank by
p.(None): the safety issue, if any, being studied in the clinical trial as a primary or secondary outcome.
p.(None): ‘‘(iii) OTHER ELEMENTS.—The Director of NIH shall also ensure that the public may search the entries of the
p.(None): registry data bank by such other elements as the Director deems necessary on an ongoing basis. ‘‘(iv)
p.(None): FORMAT.—The Director of the NIH shall ensure that the registry data bank is easily used by
p.(None): the public, and that entries are easily compared.
p.(None): ‘‘(C) DATA SUBMISSION.—The responsible party for an applicable clinical trial, including an applicable drug
p.(None): clin- ical trial for a serious or life-threatening disease or condi- tion, that is initiated after, or is
p.(None): ongoing on the date that is 90 days after, the date of the enactment of the Food and Drug
p.(None): Administration Amendments Act of 2007, shall submit to the Director of NIH for inclusion in the registry
p.(None): data bank the clinical trial information described in of subparagraph (A)(ii) not later than the later
p.(None): of—
p.(None): ‘‘(i) 90 days after such date of enactment;
p.(None): ‘‘(ii) 21 days after the first patient is enrolled in such clinical trial; or
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None):
p.(None):
p.(None): 121 STAT. 908 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(iii) in the case of a clinical trial that is not for a serious or life-threatening disease or
p.(None): condition and that is ongoing on such date of enactment, 1 year after such date of enactment.
p.(None):
p.(None): Deadlines.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None): procedures for quality control, including using representative samples, with respect to completeness
p.(None): and content of clinical trial informa- tion under this subsection, to help ensure that data elements are not
p.(None): false or misleading and are non-promotional;
p.(None): ‘‘(IV) the appropriate timing and requirements for updates of clinical trial information, and whether and,
p.(None): if so, how such updates should be tracked;
p.(None): ‘‘(V) a statement to accompany the entry for an applicable clinical trial when the primary and secondary
p.(None): outcome measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the
p.(None): submission of such informa- tion in paragraph (2)(C); and
p.(None): ‘‘(VI) additions or modifications to the manner of reporting of the data elements established under subparagraph (C).
p.(None): ‘‘(vi) CONSIDERATION OF WORLD HEALTH ORGANIZA-
p.(None): TION DATA SET.—The Secretary shall consider the status of the consensus data elements set for reporting
p.(None): clinical trial results of the World Health Organization when issuing the regulations under this subparagraph. ‘‘(vii)
p.(None): PUBLIC MEETING.—The Secretary shall hold
p.(None): a public meeting no later than 18 months after the date of the enactment of the Food and Drug Adminis- tration
p.(None): Amendments Act of 2007 to provide an oppor- tunity for input from interested parties with regard to the
p.(None): regulations to be issued under this subpara- graph.
p.(None): ‘‘(E) SUBMISSION OF RESULTS INFORMATION.—
p.(None): ‘‘(i) IN GENERAL.—Except as provided in clauses (iii), (iv), (v), and (vi) the responsible party for an
p.(None): applicable clinical trial that is described in clause (ii) shall submit to the Director of NIH for
p.(None): inclusion in the registry and results data bank the clinical trial information described in subparagraph
p.(None): (C) not later than 1 year, or such other period as may be provided by regulation under subparagraph (D),
p.(None): after the earlier of—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 913
p.(None):
p.(None):
p.(None): ‘‘(I) the estimated completion date of the trial as described in paragraph (2)(A)(ii)(I)(jj)); or
p.(None): ‘‘(II) the actual date of completion.
p.(None): ‘‘(ii) CLINICAL TRIALS DESCRIBED.—An applicable clinical trial described in this clause is an applicable
p.(None): clinical trial subject to—
p.(None): ‘‘(I) paragraph (2)(C); and
p.(None): ‘‘(II)(aa) subparagraph (C); or
p.(None): ‘‘(bb) the regulations issued under subpara- graph (D).
p.(None): ‘‘(iii) DELAYED SUBMISSION OF RESULTS WITH CER-
p.(None): TIFICATION.—If the responsible party for an applicable clinical trial submits a certification that clause (iv)
p.(None): or (v) applies to such clinical trial, the responsible party shall submit to the Director of NIH for inclusion
p.(None): in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) as
p.(None): required under the applicable clause.
p.(None): ‘‘(iv) SEEKING INITIAL APPROVAL OF A DRUG OR
p.(None): DEVICE.—With respect to an applicable clinical trial that is completed before the drug is initially approved
p.(None): under section 505 of the Federal Food, Drug, and Cos- metic Act or initially licensed under section 351 of this
p.(None): Act, or the device is initially cleared under section 510(k) or initially approved under section 515 or 520(m) of the
p.(None): Federal Food, Drug, and Cosmetic Act, the responsible party shall submit to the Director of NIH for
p.(None): inclusion in the registry and results data bank the clinical trial information described in subpara-
p.(None): graphs (C) and (D) not later than 30 days after the drug or device is approved under such section
p.(None): 505, licensed under such section 351, cleared under such section 510(k), or approved under such section
p.(None): 515 or 520(m), as applicable.
p.(None): ‘‘(v) SEEKING APPROVAL OF A NEW USE FOR THE DRUG OR DEVICE.—
p.(None): ‘‘(I) IN GENERAL.—With respect to an applicable clinical trial where the manufacturer of the drug
p.(None): or device is the sponsor of an applicable clinical trial, and such manufacturer has filed, or will file
p.(None): within 1 year, an application seeking approval under section 505 of the Federal Food, Drug, and
p.(None): Cosmetic Act, licensing under section 351 of this Act, or clearance under section 510(k), or approval under
p.(None): section 515 or 520(m), of the Federal Food, Drug, and Cosmetic Act for the use studied in such clinical trial
p.(None): (which use is not included in the labeling of the approved drug or device), then the responsible party
p.(None): shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information
p.(None): described in subparagraphs (C) and (D) on the earlier of the date that is 30 days after the date— ‘‘(aa) the
p.(None): new use of the drug or device
p.(None): is approved under such section 505, licensed under such section 351, cleared under such
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None):
p.(None):
p.(None): 121 STAT. 914 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): section 510(k), or approved under such section 515 or 520(m);
p.(None): ‘‘(bb) the Secretary issues a letter, such as a complete response letter, not approving the submission or
p.(None): not clearing the submission, a not approvable letter, or a not substantially equivalent letter for the new use of
p.(None): the drug or device under such section 505, 351, 510(k), 515, or 520(m); or
p.(None): ‘‘(cc) except as provided in subclause (III), the application or premarket notification under such
p.(None): section 505, 351, 510(k), 515, or 520(m) is withdrawn without resubmission for no less than 210 days.
p.(None): ‘‘(II) REQUIREMENT THAT EACH CLINICAL TRIAL IN APPLICATION BE TREATED THE SAME.—If a manu-
p.(None): facturer makes a certification under clause (iii) that this clause applies with respect to a clinical
p.(None): trial, the manufacturer shall make such a certifi- cation with respect to each applicable clinical trial that is
p.(None): required to be submitted in an application or report for licensure, approval, or clearance (under section
p.(None): 351 of this Act or section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act, as
p.(None): applicable) of the use studied in the clinical trial.
p.(None): ‘‘(III) TWO-YEAR LIMITATION.—The responsible party shall submit to the Director of NIH for inclu- sion in the
p.(None): registry and results data bank the clinical trial information subject to subclause (I) on the date that is 2
p.(None): years after the date a certifi- cation under clause (iii) was made to the Director of NIH, if an action referred
p.(None): to in item (aa), (bb), or (cc) of subclause (I) has not occurred by such date.
p.(None): ‘‘(vi) EXTENSIONS.—The Director of NIH may pro- vide an extension of the deadline for submission of
p.(None): clinical trial information under clause (i) if the respon- sible party for the trial submits to the Director a
p.(None): written request that demonstrates good cause for the extension and provides an estimate of the date on
p.(None): which the information will be submitted. The Director of NIH may grant more than one such extension for a
p.(None): clinical trial.
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public information. Deadline.
p.(None): ‘‘(F) NOTICE TO DIRECTOR OF NIH.—The Commissioner of Food and Drugs shall notify the Director of
p.(None): NIH when there is an action described in subparagraph (E)(iv) or item (aa), (bb), or (cc) of subparagraph
p.(None): (E)(v)(I) with respect to an application or a report that includes a certification required under paragraph
p.(None): (5)(B) of such action not later than 30 days after such action.
p.(None): ‘‘(G) POSTING OF DATA.—The Director of NIH shall ensure that the clinical trial information described in sub-
p.(None): paragraphs (C) and (D) for an applicable clinical trial sub- mitted in accordance with this paragraph is posted
p.(None): publicly in the registry and results database not later than 30 days after such submission.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 915
p.(None):
p.(None):
p.(None): ‘‘(H) WAIVERS REGARDING CERTAIN CLINICAL TRIAL
p.(None): RESULTS.—The Secretary may waive any applicable requirements of this paragraph for an applicable
p.(None): clinical trial, upon a written request from the responsible party, if the Secretary determines that
p.(None): extraordinary cir- cumstances justify the waiver and that providing the waiver is consistent
p.(None): with the protection of public health, or in the interest of national security. Not later than 30 days
p.(None): after any part of a waiver is granted, the Secretary shall notify, in writing, the appropriate committees of
p.(None): Con- gress of the waiver and provide an explanation for why the waiver was granted.
p.(None): ‘‘(I) ADVERSE EVENTS.—
p.(None): ‘‘(i) REGULATIONS.—Not later than 18 months after the date of the enactment of the Food and Drug
p.(None): Administration Amendments Act of 2007, the Secretary shall by regulation determine the best method for including
p.(None): in the registry and results data bank appro- priate results information on serious adverse and fre- quent
p.(None): adverse events for drugs described in subpara- graph (C) in a manner and form that is useful and not
p.(None): misleading to patients, physicians, and scientists. ‘‘(ii) DEFAULT.—If the Secretary fails to issue the
p.(None): regulation required by clause (i) by the date that is
p.(None): 24 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007,
p.(None): clause (iii) shall take effect.
p.(None): ‘‘(iii) ADDITIONAL ELEMENTS.—Upon the application of clause (ii), the Secretary shall include in the registry and
p.(None): results data bank for drugs described in subpara- graph (C), in addition to the clinical trial information
p.(None): described in subparagraph (C), the following elements: ‘‘(I) SERIOUS ADVERSE EVENTS.—A table of
p.(None): anticipated and unanticipated serious adverse events grouped by organ system, with number and frequency of such
p.(None): event in each arm of the clinical trial.
p.(None): ‘‘(II) FREQUENT ADVERSE EVENTS.—A table of
p.(None): anticipated and unanticipated adverse events that are not included in the table described in subclause
p.(None): (I) that exceed a frequency of 5 percent within any arm of the clinical trial, grouped by organ system,
p.(None): with number and frequency of such event in each arm of the clinical trial.
p.(None): ‘‘(iv) POSTING OF OTHER INFORMATION.—In carrying
p.(None): out clause (iii), the Secretary shall, in consultation with experts in risk communication, post with the
p.(None): tables information to enhance patient understanding and to ensure such tables do not mislead patients or
p.(None): the lay public.
p.(None): ‘‘(v) RELATION TO SUBPARAGRAPH (C).—Clinical trial
p.(None): information included in the registry and results data bank pursuant to this subparagraph is deemed to be
p.(None): clinical trial information included in such data bank pursuant to subparagraph (C).
p.(None): ‘‘(4) ADDITIONAL SUBMISSIONS OF CLINICAL TRIAL INFORMA- TION.—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Notification.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Effective date.
p.(None):
p.(None):
p.(None): 121 STAT. 916 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(A) VOLUNTARY SUBMISSIONS.—A responsible party for a clinical trial that is not an applicable
p.(None): clinical trial, or that is an applicable clinical trial that is not subject to paragraph (2)(C), may
p.(None): submit complete clinical trial information described in paragraph (2) or paragraph (3) provided the
p.(None): responsible party submits clinical trial information for each applicable clinical trial that is required to be
p.(None): submitted under section 351 or under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug,
p.(None): and Cosmetic Act in an application or report for licensure, approval, or clearance of the drug or device
p.(None): for the use studied in the clinical trial.
p.(None): ‘‘(B) REQUIRED SUBMISSIONS.—
p.(None): ‘‘(i) IN GENERAL.—Notwithstanding paragraphs (2) and (3) and subparagraph (A), in any case in which the
p.(None): Secretary determines for a specific clinical trial described in clause (ii) that posting in the registry
p.(None): and results data bank of clinical trial information for such clinical trial is necessary to protect the
p.(None): public health—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None): ‘‘(I) the Secretary may require by notification that such information be submitted to the Sec- retary in
p.(None): accordance with paragraphs (2) and (3) except with regard to timing of submission;
p.(None): ‘‘(II) unless the responsible party submits a certification under paragraph (3)(E)(iii), such
p.(None): information shall be submitted not later than 30 days after the date specified by the Secretary in the
p.(None): notification; and
p.(None): ‘‘(III) failure to comply with the requirements under subclauses (I) and (II) shall be treated as a violation
p.(None): of the corresponding requirement of such paragraphs.
p.(None): ‘‘(ii) CLINICAL TRIALS DESCRIBED.—A clinical trial described in this clause is—
p.(None): ‘‘(I) an applicable clinical trial for a drug that is approved under section 505 of the Federal Food, Drug, and
p.(None): Cosmetic Act or licensed under section
p.(None): 351 of this Act or for a device that is cleared under section 510(k) of the Federal Food, Drug, and
p.(None): Cosmetic Act or approved under section 515 or section 520(m) of such Act, whose completion date is on
p.(None): or after the date 10 years before the date of the enactment of the Food and Drug Administration
p.(None): Amendments Act of 2007; or
p.(None): ‘‘(II) an applicable clinical trial that is described by both by paragraph (2)(C) and para-
p.(None): graph (3)(D)(ii)(II)).
p.(None): ‘‘(C) UPDATES TO CLINICAL TRIAL DATA BANK.—
p.(None): ‘‘(i) SUBMISSION OF UPDATES.—The responsible party for an applicable clinical trial shall submit to the
p.(None): Director of NIH for inclusion in the registry and results data bank updates to reflect changes to the
p.(None): clinical trial information submitted under paragraph (2). Such updates—
p.(None): ‘‘(I) shall be provided not less than once every
p.(None): 12 months, unless there were no changes to the
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 917
p.(None):
p.(None):
p.(None): clinical trial information during the preceding 12- month period;
p.(None): ‘‘(II) shall include identification of the dates of any such changes;
p.(None): ‘‘(III) not later than 30 days after the recruit- ment status of such clinical trial changes, shall include an
p.(None): update of the recruitment status; and ‘‘(IV) not later than 30 days after the comple- tion date of the clinical
p.(None): trial, shall include notifica- tion to the Director that such clinical trial is com-
p.(None): plete.
p.(None): ‘‘(ii) PUBLIC AVAILABILITY OF UPDATES.—The
p.(None): Director of NIH shall make updates submitted under clause (i) publicly available in the registry data bank.
p.(None): Except with regard to overall recruitment status, indi- vidual site status, location, and contact information,
p.(None): the Director of NIH shall ensure that updates to ele- ments required under subclauses (I) to (V) of paragraph
p.(None): (2)(A)(ii) do not result in the removal of any informa- tion from the original submissions or any
p.(None): preceding updates, and information in such databases is pre- sented in a manner that enables users to readily
p.(None): access each original element submission and to track the changes made by the updates. The Director of
p.(None): NIH shall provide a link from the table of primary and secondary outcomes required under paragraph (3)(C)(ii)
p.(None): to the tracked history required under this clause of the primary and secondary outcome measures sub-
p.(None): mitted under paragraph (2)(A)(ii)(I)(ll).
p.(None): ‘‘(5) COORDINATION AND COMPLIANCE.—
p.(None): ‘‘(A) CLINICAL TRIALS SUPPORTED BY GRANTS FROM FED- ERAL AGENCIES.—
p.(None): ‘‘(i) GRANTS FROM CERTAIN FEDERAL AGENCIES.—
p.(None): If an applicable clinical trial is funded in whole or in part by a grant from any agency of the Department of
p.(None): Health and Human Services, including the Food and Drug Administration, the National Institutes of Health,
p.(None): or the Agency for Healthcare Research and Quality, any grant or progress report forms required under such
p.(None): grant shall include a certification that the responsible party has made all required submissions to the
p.(None): Director of NIH under paragraphs (2) and (3). ‘‘(ii) VERIFICATION BY FEDERAL AGENCIES.—The
p.(None): heads of the agencies referred to in clause (i), as applicable, shall verify that the clinical trial
p.(None): informa- tion for each applicable clinical trial for which a grantee is the responsible party has
p.(None): been submitted under paragraphs (2) and (3) before releasing any remaining funding for a grant or funding
p.(None): for a future grant to such grantee.
p.(None): ‘‘(iii) NOTICE AND OPPORTUNITY TO REMEDY.—If the
p.(None): head of an agency referred to in clause (i), as applicable, verifies that a grantee has not
p.(None): submitted clinical trial information as described in clause (ii), such agency head shall provide notice to such
p.(None): grantee of such non-compliance and allow such grantee 30 days
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Certification.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 918 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): to correct such non-compliance and submit the required clinical trial information.
p.(None): ‘‘(iv) CONSULTATION WITH OTHER FEDERAL AGEN-
p.(None): CIES.—The Secretary shall—
p.(None): ‘‘(I) consult with other agencies that conduct research involving human subjects in accordance with any
p.(None): section of part 46 of title 45, Code of Federal Regulations (or any successor regulations), to determine if any
p.(None): such research is an applicable clinical trial; and
p.(None):
p.(None): Procedures.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None): PRODUCT, AND DEVICE SUBMISSIONS.—At the time of submis- sion of an application under section 505 of the
p.(None): Federal Food, Drug, and Cosmetic Act, section 515 of such Act, section 520(m) of such Act, or section
p.(None): 351 of this Act, or submission of a report under section 510(k) of such Act, such application or
p.(None): submission shall be accompanied by a certification that all applicable requirements of this subsection have
p.(None): been met. Where available, such certifi- cation shall include the appropriate National Clinical Trial control
p.(None): numbers.
p.(None): ‘‘(C) QUALITY CONTROL.—
p.(None): ‘‘(i) PILOT QUALITY CONTROL PROJECT.—Until the
p.(None): effective date of the regulations issued under para- graph (3)(D), the Secretary, acting through the Director of
p.(None): NIH and the Commissioner of Food and Drugs, shall conduct a pilot project to determine the optimal
p.(None): method of verification to help to ensure that the clinical trial information submitted under paragraph (3)(C) is
p.(None): non-promotional and is not false or misleading in any particular under subparagraph (D). The Secretary shall use the
p.(None): publicly available information described in paragraph (3)(A) and any other information available to the
p.(None): Secretary about applicable clinical trials to verify the accuracy of the clinical trial information submitted under
p.(None): paragraph (3)(C).
p.(None): ‘‘(ii) NOTICE OF COMPLIANCE.—If the Secretary determines that any clinical trial information was not
p.(None): submitted as required under this subsection, or was submitted but is false or misleading in any particular, the
p.(None): Secretary shall notify the responsible party and give such party an opportunity to remedy such non-
p.(None): compliance by submitting the required revised clinical trial information not later than 30 days after such
p.(None): notification.
p.(None): ‘‘(D) TRUTHFUL CLINICAL TRIAL INFORMATION.—
p.(None): ‘‘(i) IN GENERAL.—The clinical trial information submitted by a responsible party under this subsection shall not
p.(None): be false or misleading in any particular. ‘‘(ii) EFFECT.—Clause (i) shall not have the effect
p.(None): of—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 919
p.(None):
p.(None): ‘‘(I) requiring clinical trial information with respect to an applicable clinical trial to include
p.(None): information from any source other than such clin- ical trial involved; or
p.(None): ‘‘(II) requiring clinical trial information described in paragraph (3)(D) to be submitted for
p.(None): purposes of paragraph (3)(C).
p.(None): ‘‘(E) PUBLIC NOTICES.—
p.(None): ‘‘(i) NOTICE OF VIOLATIONS.—If the responsible party for an applicable clinical trial fails to submit
p.(None): clinical trial information for such clinical trial as required under paragraphs (2) or (3), the
p.(None): Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice—
p.(None): ‘‘(I) that the responsible party is not in compli- ance with this Act by—
p.(None): ‘‘(aa) failing to submit required clinical trial information; or
p.(None): ‘‘(bb) submitting false or misleading clin- ical trial information;
p.(None): ‘‘(II) of the penalties imposed for the violation, if any; and
p.(None): ‘‘(III) whether the responsible party has cor- rected the clinical trial information in the registry and results
p.(None): data bank.
p.(None): ‘‘(ii) NOTICE OF FAILURE TO SUBMIT PRIMARY AND
p.(None): SECONDARY OUTCOMES.—If the responsible party for an applicable clinical trial fails to submit the primary and
p.(None): secondary outcomes as required under section 2(A)(ii)(I)(ll), the Director of NIH shall include in
p.(None): the registry and results data bank entry for such clinical trial a notice that the responsible party is
p.(None): not in compliance by failing to register the primary and sec- ondary outcomes in accordance with this act, and
p.(None): that the primary and secondary outcomes were not publicly disclosed in the database before conducting the clinical
p.(None): trial.
p.(None): ‘‘(iii) FAILURE TO SUBMIT STATEMENT.—The notice
p.(None): under clause (i) for a violation described in clause (i)(I)(aa) shall include the following statement:
p.(None): ‘The entry for this clinical trial was not complete at the time of submission, as required by law. This
p.(None): may or may not have any bearing on the accuracy of the information in the entry.’.
p.(None): ‘‘(iv) SUBMISSION OF FALSE INFORMATION STATE-
p.(None): MENT.—The notice under clause (i) for a violation described in clause (i)(I)(bb) shall include the
p.(None): following statement: ‘The entry for this clinical trial was found to be false or misleading and therefore
p.(None): not in compli- ance with the law.’.
p.(None): ‘‘(v) NON-SUBMISSION OF STATEMENT.—The notice
p.(None): under clause (ii) for a violation described in clause
p.(None): (ii) shall include the following statement: ‘The entry for this clinical trial did not contain
p.(None): information on the primary and secondary outcomes at the time of submission, as required by law. This
p.(None): may or may not
p.(None):
p.(None):
p.(None): 121 STAT. 920 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): have any bearing on the accuracy of the information in the entry.’.
p.(None): ‘‘(vi) COMPLIANCE SEARCHES.—The Director of NIH shall provide that the public may easily search the registry
p.(None): and results data bank for entries that include notices required under this subparagraph.
...
p.(None): offices described in subsection (c)(2), determines that new safety or effectiveness information indicates that—
p.(None): ‘‘(i) an element under subsection (d) or (e) should be modified or included in the strategy; or
p.(None): ‘‘(ii) an element under subsection (f) should be modified or included in the strategy; or
p.(None):
p.(None): Deadline.
p.(None): ‘‘(D) within 15 days when ordered by the Secretary, in consultation with the offices described in
p.(None): subsection (c)(2), if the Secretary determines that there may be a cause for action by the Secretary
p.(None): under section 505(e). ‘‘(3) REQUIREMENTS FOR ASSESSMENTS.—An assessment
p.(None): under paragraph (1) or (2) of an approved risk evaluation and mitigation strategy for a drug shall include—
p.(None): ‘‘(A) with respect to any goal under subsection (f), an assessment of the extent to which the elements
p.(None): to assure safe use are meeting the goal or whether the goal or such elements should be modified;
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 933
p.(None):
p.(None):
p.(None): ‘‘(B) with respect to any postapproval study required under section 505(o) or otherwise undertaken
p.(None): by the responsible person to investigate a safety issue, the status of such study, including whether any difficulties
p.(None): completing the study have been encountered; and
p.(None): ‘‘(C) with respect to any postapproval clinical trial required under section 505(o) or otherwise
p.(None): undertaken by the responsible party to investigate a safety issue, the status of such clinical trial,
p.(None): including whether enrollment has begun, the number of participants enrolled, the expected completion
p.(None): date, whether any difficulties com- pleting the clinical trial have been encountered, and reg- istration
p.(None): information with respect to requirements under subsections (i) and (j) of section 402 of the Public
p.(None): Health Service Act.
p.(None): ‘‘(4) MODIFICATION.—A modification (whether an enhance- ment or a reduction) to the approved risk evaluation and
p.(None): mitiga- tion strategy for a drug may include the addition or modification of any element under subsection (d) or
p.(None): the addition, modifica- tion, or removal of any element under subsection (e) or (f), such as—
p.(None): ‘‘(A) modifying the timetable for assessments of the strategy as provided in subsection (d)(3), including to
p.(None): elimi- nate assessments; or
p.(None): ‘‘(B) adding, modifying, or removing an element to assure safe use under subsection (f).
p.(None): ‘‘(h) REVIEW OF PROPOSED STRATEGIES; REVIEW OF ASSESS-
p.(None): MENTS OF APPROVED STRATEGIES.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary, in consultation with the offices described in subsection (c)(2), shall
p.(None): promptly review each proposed risk evaluation and mitigation strategy for a drug submitted under subsection
...
p.(None): 503(b)(1) pre- sented directly to consumers in television or radio format and stating the name of the
p.(None): drug and its conditions of use, the major statement relating to side effects and contra- indications shall be
p.(None): presented in a clear, conspicuous, and neutral manner.’’.
p.(None):
p.(None): Deadline.
p.(None): 21 USC 352 note.
p.(None): (B) REGULATIONS TO DETERMINE CLEAR, CONSPICUOUS, AND NEUTRAL MANNER.—Not later than 30 months after the
p.(None): date of the enactment of the Food and Drug Administra- tion Amendments Act of 2007, the Secretary of Health and
p.(None): Human Services shall by regulation establish stand- ards for determining whether a major statement
p.(None): relating to side effects and contraindications of a drug, described in section 502(n) of the Federal Food,
p.(None): Drug, and Cosmetic Act (21 U.S.C. 352(n)) (as amended by subparagraph (A)) is presented in the manner
p.(None): required under such section.
p.(None): (4) CIVIL PENALTIES.—Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), as amended by
p.(None): section 801(b), is amended by adding at the end the following:
p.(None): ‘‘(g)(1) With respect to a person who is a holder of an approved application under section 505 for a drug
p.(None): subject to section 503(b) or under section 351 of the Public Health Service Act, any such person who
p.(None): disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or
p.(None): misleading shall be liable to the United States for a civil penalty in an amount not to exceed $250,000
p.(None): for the first such violation in any 3-year period, and not to exceed $500,000 for each subsequent
p.(None): violation in any 3-year period. No other civil monetary penalties in this Act (including the civil
p.(None): penalty in section 303(f)(4)) shall apply to a violation regarding direct-to-consumer advertising. For pur-
p.(None): poses of this paragraph: (A) Repeated dissemination of the same or similar advertisement prior to the
p.(None): receipt of the written notice referred to in paragraph (2) for such advertisements shall be consid- ered one
p.(None): violation. (B) On and after the date of the receipt of such a notice, all violations under this
p.(None): paragraph occurring in a single day shall be considered one violation. With respect to advertisements that
p.(None): appear in magazines or other publications that are published less frequently than daily, each issue date
p.(None): (whether weekly or monthly) shall be treated as a single day for the purpose of calculating the number of violations
p.(None): under this paragraph.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 941
p.(None):
p.(None):
p.(None): ‘‘(2) A civil penalty under paragraph (1) shall be assessed by the Secretary by an order made on the
p.(None): record after providing written notice to the person to be assessed a civil penalty and an opportunity
p.(None): for a hearing in accordance with this paragraph and section 554 of title 5, United States Code. If
p.(None): upon receipt of the written notice, the person to be assessed a civil penalty objects and requests a
p.(None): hearing, then in the course of any investiga- tion related to such hearing, the Secretary may issue subpoenas
p.(None): requiring the attendance and testimony of witnesses and the produc- tion of evidence that relates to the matter
p.(None): under investigation, including information pertaining to the factors described in para- graph (3).
p.(None): ‘‘(3) The Secretary, in determining the amount of the civil penalty under paragraph (1), shall take into
p.(None): account the nature, circumstances, extent, and gravity of the violation or violations, including the
p.(None): following factors:
p.(None): ‘‘(A) Whether the person submitted the advertisement or a similar advertisement for review under section 736A.
p.(None): ‘‘(B) Whether the person submitted the advertisement for review if required under section 503B.
p.(None): ‘‘(C) Whether, after submission of the advertisement as described in subparagraph (A) or (B), the person
p.(None): disseminated or caused another party to disseminate the advertisement before the end of the 45-day
p.(None): comment period.
p.(None): ‘‘(D) Whether the person incorporated any comments made by the Secretary with regard to the advertisement into
p.(None): the advertisement prior to its dissemination.
p.(None): ‘‘(E) Whether the person ceased distribution of the advertisement upon receipt of the written
p.(None): notice referred to in paragraph (2) for such advertisement.
p.(None): ‘‘(F) Whether the person had the advertisement reviewed by qualified medical, regulatory, and legal
p.(None): reviewers prior to its dissemination.
p.(None): ‘‘(G) Whether the violations were material.
p.(None): ‘‘(H) Whether the person who created the advertisement or caused the advertisement to be created acted
p.(None): in good faith. ‘‘(I) Whether the person who created the advertisement
p.(None): or caused the advertisement to be created has been assessed a civil penalty under this provision within
p.(None): the previous 1- year period.
p.(None): ‘‘(J) The scope and extent of any voluntary, subsequent remedial action by the person.
p.(None): ‘‘(K) Such other matters, as justice may require.
p.(None): ‘‘(4)(A) Subject to subparagraph (B), no person shall be required to pay a civil penalty under paragraph (1) if the
p.(None): person submitted the advertisement to the Secretary and disseminated or caused another party to disseminate
p.(None): such advertisement after incorporating each comment received from the Secretary.
p.(None): ‘‘(B) The Secretary may retract or modify any prior comments the Secretary has provided to an
p.(None): advertisement submitted to the Secretary based on new information or changed circumstances, so long as the
p.(None): Secretary provides written notice to the person of the new views of the Secretary on the advertisement and
p.(None): provides a reasonable time for modification or correction of the advertisement prior to seeking any civil penalty under
p.(None): paragraph (1).
p.(None): ‘‘(5) The Secretary may compromise, modify, or remit, with or without conditions, any civil penalty which
p.(None): may be assessed
p.(None): Public record. Notification.
p.(None):
p.(None):
p.(None): 121 STAT. 942 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): under paragraph (1). The amount of such penalty, when finally determined, or the amount charged upon in
p.(None): compromise, may be deducted from any sums owed by the United States to the person charged.
p.(None): ‘‘(6) Any person who requested, in accordance with paragraph (2), a hearing with respect to the
p.(None): assessment of a civil penalty and who is aggrieved by an order assessing a civil penalty, may file a
p.(None): petition for de novo judicial review of such order with the United States Court of Appeals for the District
p.(None): of Columbia Circuit or for any other circuit in which such person resides or transacts
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None): determination. The Secretary may issue guidance to describe the factors that will be used to deter- mine under
p.(None): this subparagraph whether a petition is sub- mitted with the primary purpose of delaying the approval of
p.(None): an application.
p.(None): ‘‘(F) FINAL AGENCY ACTION.—The Secretary shall take final agency action on a petition not later than 180
p.(None): days after the date on which the petition is submitted. The Secretary shall not extend such period for
p.(None): any reason, including—
p.(None): ‘‘(i) any determination made under subparagraph
p.(None): (A);
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 955
p.(None):
p.(None): ‘‘(ii) the submission of comments relating to the petition or supplemental information supplied by the
p.(None): petitioner; or
p.(None): ‘‘(iii) the consent of the petitioner.
p.(None): ‘‘(G) EXTENSION OF 30-MONTH PERIOD.—If the filing of
p.(None): an application resulted in first-applicant status under sub- section (j)(5)(D)(i)(IV) and approval of the
p.(None): application was delayed because of a petition, the 30-month period under such subsection is deemed to be
p.(None): extended by a period of time equal to the period beginning on the date on which the Secretary received the petition
p.(None): and ending on the date of final agency action on the petition (inclusive of such beginning and ending
p.(None): dates), without regard to whether the Secretary grants, in whole or in part, or denies, in whole or in
p.(None): part, the petition.
p.(None): ‘‘(H) CERTIFICATION.—The Secretary shall not consider a petition for review unless the party submitting such
p.(None): petition does so in written form and the subject document is signed and contains the following certification: ‘I
p.(None): certify that, to my best knowledge and belief: (a) this petition includes all information and views upon which
p.(None): the petition relies; (b) this petition includes representative data and/ or information known to the petitioner
p.(None): which are unfavor- able to the petition; and (c) I have taken reasonable steps to ensure that any representative data
p.(None): and/or information which are unfavorable to the petition were disclosed to me. I further certify that the
p.(None): information upon which I have based the action requested herein first became known to the party on whose behalf
p.(None): this petition is submitted on or about the following date: llllllllll. If I received or expect to
p.(None): receive payments, including cash and other forms of consideration, to file this information or its
p.(None): contents, I received or expect to receive those pay- ments from the following persons or
p.(None): organizations: lllllllllllll. I verify under penalty of per- jury that the foregoing is true and correct
p.(None): as of the date of the submission of this petition.’, with the date on which such information first became known
p.(None): to such party and the names of such persons or organizations inserted in the first and second blank space,
p.(None): respectively.
p.(None): ‘‘(I) VERIFICATION.—The Secretary shall not accept for review any supplemental information or comments on
p.(None): a petition unless the party submitting such information or comments does so in written form and the subject
p.(None): document is signed and contains the following verification: ‘I certify that, to my best knowledge and
p.(None): belief: (a) I have not intentionally delayed submission of this document or its contents; and (b) the
p.(None): information upon which I have based the action requested herein first became known to me on or about
p.(None): llllllllll. If I received or expect to receive payments, including cash and other forms of consideration,
p.(None): to file this information or its contents, I received or expect to receive those payments from the fol-
p.(None): lowing persons or organizations: lllll. I verify under penalty of perjury that the foregoing is true and
p.(None): correct as of the date of the submission of this petition.’, with the date on which such information
p.(None): first became known
p.(None):
p.(None):
p.(None): 121 STAT. 956 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): to the party and the names of such persons or organizations inserted in the first and second blank space,
p.(None): respectively. ‘‘(2) EXHAUSTION OF ADMINISTRATIVE REMEDIES.—
p.(None): ‘‘(A) FINAL AGENCY ACTION WITHIN 180 DAYS.—The Sec-
p.(None): retary shall be considered to have taken final agency action on a petition if—
p.(None): ‘‘(i) during the 180-day period referred to in para- graph (1)(F), the Secretary makes a final decision
p.(None): within the meaning of section 10.45(d) of title 21, Code of Federal Regulations (or any successor regulation); or
p.(None):
p.(None):
p.(None):
p.(None): Courts.
p.(None): ‘‘(ii) such period expires without the Secretary having made such a final decision.
p.(None): ‘‘(B) DISMISSAL OF CERTAIN CIVIL ACTIONS.—If a civil
p.(None): action is filed against the Secretary with respect to any issue raised in the petition before the Secretary
p.(None): has taken final agency action on the petition within the meaning of subparagraph (A), the court shall dismiss
p.(None): without preju- dice the action for failure to exhaust administrative rem- edies.
p.(None): ‘‘(C) ADMINISTRATIVE RECORD.—For purposes of judicial review related to the approval of an application for
p.(None): which a petition under paragraph (1) was submitted, the adminis- trative record regarding any issue raised by
p.(None): the petition shall include—
p.(None): ‘‘(i) the petition filed under paragraph (1) and any supplements and comments thereto;
p.(None): ‘‘(ii) the Secretary’s response to such petition, if issued; and
p.(None): ‘‘(iii) other information, as designated by the Sec- retary, related to the Secretary’s determinations
p.(None): regarding the issues raised in such petition, as long as the information was considered by the agency
...
p.(None): supplements are safe and properly labeled foods.
p.(None): (2) In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law
p.(None): 109–462) to establish a mandatory reporting system of serious adverse events for nonprescription drugs and
p.(None): dietary supple- ments sold and consumed in the United States.
p.(None): (3) The adverse event reporting system created under the Dietary Supplement and Nonprescription Drug
p.(None): Consumer Protection Act is intended to serve as an early warning system for potential public health issues
p.(None): associated with the use of these products.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 965
p.(None):
p.(None):
p.(None): (4) A reliable mechanism to track patterns of adulteration in food would support efforts by the Food and Drug
p.(None): Administra- tion to target limited inspection resources to protect the public health.
p.(None): (b) IN GENERAL.—Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is
p.(None): amended by adding at the end the following:
p.(None): ‘‘SEC. 417. REPORTABLE FOOD REGISTRY.
p.(None): ‘‘(a) DEFINITIONS.—In this section:
p.(None): ‘‘(1) RESPONSIBLE PARTY.—The term ‘responsible party’, with respect to an article of food, means a person
p.(None): that submits the registration under section 415(a) for a food facility that is required to register under
p.(None): section 415(a), at which such article of food is manufactured, processed, packed, or held. ‘‘(2)
p.(None): REPORTABLE FOOD.—The term ‘reportable food’ means
p.(None): an article of food (other than infant formula) for which there is a reasonable probability that the use
p.(None): of, or exposure to, such article of food will cause serious adverse health con- sequences or death to
p.(None): humans or animals.
p.(None): ‘‘(b) ESTABLISHMENT.—
p.(None): ‘‘(1) IN GENERAL.—Not later than 1 year after the date of the enactment of this section, the Secretary
p.(None): shall establish within the Food and Drug Administration a Reportable Food Registry to which instances of
p.(None): reportable food may be submitted by the Food and Drug Administration after receipt of reports under subsection
p.(None): (d), via an electronic portal, from—
p.(None): ‘‘(A) Federal, State, and local public health officials;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 350f.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): or
p.(None): ‘‘(B) responsible parties.
p.(None):
p.(None): ‘‘(2) REVIEW BY SECRETARY.—The Secretary shall promptly review and assess the information submitted under paragraph
p.(None): (1) for the purposes of identifying reportable food, submitting entries to the Reportable Food Registry, acting
p.(None): under subsection (c), and exercising other existing food safety authorities under this Act to protect the
p.(None): public health.
p.(None): ‘‘(c) ISSUANCE OF AN ALERT BY THE SECRETARY.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall issue, or cause to be issued, an alert or a notification with respect to
p.(None): a reportable food using information from the Reportable Food Registry as the Secretary deems necessary to
p.(None): protect the public health. ‘‘(2) EFFECT.—Paragraph (1) shall not affect the authority
p.(None): of the Secretary to issue an alert or a notification under any other provision of this Act.
p.(None): ‘‘(d) REPORTING AND NOTIFICATION.—
p.(None): ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), as soon as practicable, but in no case later
p.(None): than 24 hours after a responsible party determines that an article of food is a reportable food, the
p.(None): responsible party shall—
p.(None): ‘‘(A) submit a report to the Food and Drug Administra- tion through the electronic portal established under sub-
p.(None): section (b) that includes the data elements described in subsection (e) (except the elements described in
p.(None): paragraphs (8), (9), and (10) of such subsection); and
p.(None): ‘‘(B) investigate the cause of the adulteration if the adulteration of the article of food may have
p.(None): originated with the responsible party.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 966 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(2) NO REPORT REQUIRED.—A responsible party is not required to submit a report under paragraph (1) if—
p.(None): ‘‘(A) the adulteration originated with the responsible party;
p.(None): ‘‘(B) the responsible party detected the adulteration prior to any transfer to another person of such
p.(None): article of food; and
p.(None): ‘‘(C) the responsible party—
p.(None): ‘‘(i) corrected such adulteration; or
p.(None): ‘‘(ii) destroyed or caused the destruction of such article of food.
p.(None): ‘‘(3) REPORTS BY PUBLIC HEALTH OFFICIALS.—A Federal,
p.(None): State, or local public health official may submit a report about a reportable food to the Food and Drug Administration
p.(None): through the electronic portal established under subsection (b) that includes the data elements
p.(None): described in subsection (e) that the official is able to provide.
p.(None): ‘‘(4) REPORT NUMBER.—The Secretary shall ensure that, upon submission of a report under paragraph (1) or
p.(None): (3), a unique number is issued through the electronic portal estab- lished under subsection (b) to the
p.(None): person submitting such report, by which the Secretary is able to link reports about the reportable food
p.(None): submitted and amended under this sub- section and identify the supply chain for such reportable food.
p.(None): ‘‘(5) REVIEW.—The Secretary shall promptly review a report
p.(None): submitted under paragraph (1) or (3).
p.(None): ‘‘(6) RESPONSE TO REPORT SUBMITTED BY A RESPONSIBLE
p.(None): PARTY.—After consultation with the responsible party that sub- mitted a report under paragraph (1), the Secretary may
p.(None): require such responsible party to perform, as soon as practicable, but in no case later than a time
p.(None): specified by the Secretary, 1 or more of the following:
p.(None): ‘‘(A) Amend the report submitted by the responsible party under paragraph (1) to include the data
p.(None): element described in subsection (e)(9).
p.(None): ‘‘(B) Provide a notification—
p.(None): ‘‘(i) to the immediate previous source of the article of food, if the Secretary deems necessary;
p.(None): ‘‘(ii) to the immediate subsequent recipient of the article of food, if the Secretary deems necessary;
p.(None): and
p.(None): ‘‘(iii) that includes—
p.(None): ‘‘(I) the data elements described in subsection
p.(None): (e) that the Secretary deems necessary;
p.(None): ‘‘(II) the actions described under paragraph
p.(None): (7) that the recipient of the notification shall per- form, as required by the Secretary; and
p.(None): ‘‘(III) any other information that the Secretary may require.
p.(None): ‘‘(7) SUBSEQUENT REPORTS AND NOTIFICATIONS.—Except as
p.(None): provided in paragraph (8), the Secretary may require a respon- sible party to perform, as soon as practicable,
p.(None): but in no case later than a time specified by the Secretary, after the respon- sible party receives a
p.(None): notification under subparagraph (C) or paragraph (6)(B), 1 or more of the following:
p.(None): ‘‘(A) Submit a report to the Food and Drug Administra- tion through the electronic portal established under sub-
p.(None): section (b) that includes those data elements described
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 967
p.(None):
p.(None): in subsection (e) and other information that the Secretary deems necessary.
p.(None): ‘‘(B) Investigate the cause of the adulteration if the adulteration of the article of food may have
p.(None): originated with the responsible party.
p.(None): ‘‘(C) Provide a notification—
p.(None): ‘‘(i) to the immediate previous source of the article of food, if the Secretary deems necessary;
p.(None): ‘‘(ii) to the immediate subsequent recipient of the article of food, if the Secretary deems necessary;
p.(None): and
p.(None): ‘‘(iii) that includes—
p.(None): ‘‘(I) the data elements described in subsection
p.(None): (e) that the Secretary deems necessary;
p.(None): ‘‘(II) the actions described under this para- graph that the recipient of the notification shall perform,
p.(None): as required by the Secretary; and
p.(None): ‘‘(III) any other information that the Secretary may require.
p.(None): ‘‘(8) AMENDED REPORT.—If a responsible party receives a notification under paragraph (6)(B) or paragraph
p.(None): (7)(C) with respect to an article of food after the responsible party has submitted a report to the Food and
p.(None): Drug Administration under paragraph (1) with respect to such article of food—
p.(None): ‘‘(A) the responsible party is not required to submit an additional report or make a notification under
p.(None): para- graph (7); and
p.(None): ‘‘(B) the responsible party shall amend the report sub- mitted by the responsible party under paragraph (1) to
p.(None): include the data elements described in paragraph (9), and, with respect to both such notification and such
p.(None): report, paragraph (11) of subsection (e).
p.(None): ‘‘(e) DATA ELEMENTS.—The data elements described in this subsection are the following:
p.(None): ‘‘(1) The registration numbers of the responsible party under section 415(a)(3).
p.(None): ‘‘(2) The date on which an article of food was determined to be a reportable food.
p.(None): ‘‘(3) A description of the article of food including the quantity or amount.
p.(None): ‘‘(4) The extent and nature of the adulteration.
p.(None): ‘‘(5) If the adulteration of the article of food may have originated with the responsible party, the results
p.(None): of the inves- tigation required under paragraph (1)(B) or (7)(B) of subsection (d), as applicable and when known.
p.(None): ‘‘(6) The disposition of the article of food, when known. ‘‘(7) Product information typically found
p.(None): on packaging including product codes, use-by dates, and names of manufac- turers, packers, or distributors
p.(None): sufficient to identify the article
p.(None): of food.
p.(None): ‘‘(8) Contact information for the responsible party.
p.(None): ‘‘(9) The contact information for parties directly linked in the supply chain and notified under paragraph
p.(None): (6)(B) or (7)(C) of subsection (d), as applicable.
p.(None): ‘‘(10) The information required by the Secretary to be included in a notification provided by the
p.(None): responsible party involved under paragraph (6)(B) or (7)(C) of subsection (d) or required in a report under
p.(None): subsection (d)(7)(A).
p.(None):
p.(None):
p.(None): 121 STAT. 968 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(11) The unique number described in subsection (d)(4). ‘‘(f) COORDINATION OF FEDERAL, STATE, AND LOCAL
p.(None): EFFORTS.—
p.(None): ‘‘(1) DEPARTMENT OF AGRICULTURE.—In implementing this section, the Secretary shall—
p.(None): ‘‘(A) share information and coordinate regulatory efforts with the Department of Agriculture; and
p.(None): ‘‘(B) if the Secretary receives a report submitted about a food within the jurisdiction of the Department of
p.(None): Agri- culture, promptly provide such report to the Department of Agriculture.
p.(None): ‘‘(2) STATES AND LOCALITIES.—In implementing this section, the Secretary shall work with the State and local public
p.(None): health officials to share information and coordinate regulatory efforts, in order to—
p.(None): ‘‘(A) help to ensure coverage of the safety of the food supply chain, including those food establishments
p.(None): regulated by the States and localities that are not required to register under section 415; and
p.(None): ‘‘(B) reduce duplicative regulatory efforts.
p.(None): ‘‘(g) MAINTENANCE AND INSPECTION OF RECORDS.—The respon-
p.(None): sible party shall maintain records related to each report received, notification made, and report
p.(None): submitted to the Food and Drug Administration under this section for 2 years. A responsible party shall,
p.(None): at the request of the Secretary, permit inspection of such records as provided for section 414.
p.(None):
p.(None): Applicability.
p.(None): ‘‘(h) REQUEST FOR INFORMATION.—Except as provided by section 415(a)(4), section 552 of title 5, United States
p.(None): Code, shall apply to any request for information regarding a record in the Reportable Food Registry.
p.(None): ‘‘(i) SAFETY REPORT.—A report or notification under subsection
p.(None): (d) shall be considered to be a safety report under section 756 and may be accompanied by a statement,
p.(None): which shall be part of any report released for public disclosure, that denies that the report or the
p.(None): notification constitutes an admission that the product involved caused or contributed to a death, serious injury, or
p.(None): serious illness.
p.(None): ‘‘(j) ADMISSION.—A report or notification under this section shall not be considered an admission that the
p.(None): article of food involved is adulterated or caused or contributed to a death, serious injury, or serious
p.(None): illness.
p.(None): ‘‘(k) HOMELAND SECURITY NOTIFICATION.—If, after receiving a report under subsection (d), the Secretary
p.(None): believes such food may have been deliberately adulterated, the Secretary shall immediately notify the Secretary
p.(None): of Homeland Security. The Secretary shall make relevant information from the Reportable Food Registry avail- able
p.(None): to the Secretary of Homeland Security.’’.
p.(None): (c) DEFINITION.—Section 201(ff) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)) is amended by
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Searching for indicator political:
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p.(None): inserting at the end before the period ‘‘and such application shall include the certification required
p.(None): under section 402(j)(5)(B) of the Public Health Service Act (which shall not be consid- ered an element of such
p.(None): application)’’.
p.(None): (c) SURVEILLANCES.—Not later than 12 months after the date of the enactment of this Act, the
p.(None): Secretary of Health and Human
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Certification.
p.(None):
p.(None):
p.(None):
p.(None): Regulations.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 360j.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Guidance.
p.(None): 42 USC 282 note.
p.(None):
p.(None):
p.(None): 121 STAT. 922 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): Services shall issue guidance on how the requirements of section 402(j) of the Public Health Service
p.(None): Act, as added by this section, apply to a pediatric postmarket surveillance described in paragraph (1)(A)(ii)(II)
p.(None): of such section 402(j) that is not a clinical trial.
p.(None):
p.(None): 42 USC 282 note.
p.(None): (d) PREEMPTION.—
p.(None): (1) IN GENERAL.—Upon the expansion of the registry and results data bank under section 402(j)(3)(D) of the
p.(None): Public Health Service Act, as added by this section, no State or political subdivision of a State may
p.(None): establish or continue in effect any requirement for the registration of clinical trials or for the
p.(None): inclusion of information relating to the results of clinical trials in a database.
p.(None): (2) RULE OF CONSTRUCTION.—The fact of submission of clinical trial information, if submitted in compliance with
p.(None): sub- section (j) of section 402 of the Public Health Service Act (as amended by this section), that
p.(None): relates to a use of a drug or device not included in the official labeling of the approved drug or
p.(None): device shall not be construed by the Secretary of Health and Human Services or in any administrative or
p.(None): judicial proceeding, as evidence of a new intended use of the drug or device that is different from the
p.(None): intended use of the drug or device set forth in the official labeling of the drug or device. The availability of
p.(None): clinical trial information through the registry and results data bank under such subsection (j), if submitted
p.(None): in compliance with such subsection, shall not be considered as labeling, adulteration, or misbranding of the
p.(None): drug or device under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
p.(None):
p.(None): TITLE IX—ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS
p.(None): Subtitle A—Postmarket Studies and Surveillance
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Political / stateless persons
Searching for indicator nation:
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p.(None): amended by section 905, is amended by adding at the end the following:
p.(None): ‘‘(5) The Secretary shall—
p.(None): ‘‘(A) conduct regular, bi-weekly screening of the Adverse Event Reporting System database and post a quar-
p.(None): terly report on the Adverse Event Reporting System Web site of any new safety information or potential
p.(None): signal of a serious risk identified by Adverse Event Reporting System within the last quarter;
p.(None): ‘‘(B) report to Congress not later than 2 year after the date of the enactment of the Food and Drug
p.(None): Administra- tion Amendments Act of 2007 on procedures and processes of the Food and Drug Administration for
p.(None): addressing ongoing post market safety issues identified by the Office of Surveillance and Epidemiology
p.(None): and how recommenda- tions of the Office of Surveillance and Epidemiology are handled within the agency; and
p.(None): ‘‘(C) on an annual basis, review the entire backlog of postmarket safety commitments to determine
p.(None): which commitments require revision or should be eliminated, report to the Congress on these determinations, and
p.(None): assign start dates and estimated completion dates for such commitments.’’.
p.(None):
p.(None): TITLE X—FOOD SAFETY
p.(None):
p.(None):
p.(None): 21 USC 2101.
p.(None): SEC. 1001. FINDINGS.
p.(None): Congress finds that—
p.(None): (1) the safety and integrity of the United States food supply are vital to public health, to public confidence
p.(None): in the food supply, and to the success of the food sector of the Nation’s economy;
p.(None): (2) illnesses and deaths of individuals and companion ani- mals caused by contaminated food—
p.(None): (A) have contributed to a loss of public confidence in food safety; and
p.(None): (B) have caused significant economic losses to manufac- turers and producers not responsible for contaminated food
p.(None): items;
p.(None): (3) the task of preserving the safety of the food supply of the United States faces tremendous
p.(None): pressures with regard to—
p.(None): (A) emerging pathogens and other contaminants and the ability to detect all forms of contamination;
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 963
p.(None):
p.(None):
p.(None): (B) an increasing volume of imported food from a wide variety of countries; and
p.(None): (C) a shortage of adequate resources for monitoring and inspection;
p.(None): (4) according to the Economic Research Service of the Department of Agriculture, the United States is
p.(None): increasing the amount of food that it imports such that—
p.(None): (A) from 2003 to 2007, the value of food imports has increased from $45,600,000,000 to $64,000,000,000; and
p.(None): (B) imported food accounts for 13 percent of the average American diet including 31 percent of fruits, juices,
p.(None): and nuts, 9.5 percent of red meat, and 78.6 percent of fish and shellfish; and
p.(None): (5) the number of full-time equivalent Food and Drug Administration employees conducting inspections has
p.(None): decreased from 2003 to 2007.
p.(None): SEC. 1002. ENSURING THE SAFETY OF PET FOOD.
p.(None): (a) PROCESSING AND INGREDIENT STANDARDS.—Not later than 2 years after the date of the enactment of this
...
Health / Drug Usage
Searching for indicator drug:
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 823
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public Law 110–85 110th Congress
p.(None):
p.(None):
p.(None): An Act
p.(None):
p.(None): To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for
p.(None): prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug
p.(None): Administration with respect to the safety of drugs, and for other purposes.
p.(None): Be it enacted by the Senate and House of Representatives of the United States of America in Congress
p.(None): assembled,
p.(None): SECTION 1. SHORT TITLE.
p.(None): This Act may be cited as the ‘‘Food and Drug Administration Amendments Act of 2007’’.
p.(None): SEC. 2. TABLE OF CONTENTS.
p.(None): The table of contents for this Act is as follows:
p.(None): Sec. 1. Short title.
p.(None): Sec. 2. Table of contents.
p.(None): TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
p.(None): Sec. 101. Short title; references in title; finding. Sec. 102. Definitions.
p.(None): Sec. 103. Authority to assess and use drug fees.
p.(None): Sec. 104. Fees relating to advisory review of prescription-drug television adver- tising.
p.(None): Sec. 105. Reauthorization; reporting requirements. Sec. 106. Sunset dates.
p.(None): Sec. 107. Effective date. Sec. 108. Savings clause.
p.(None): Sec. 109. Technical amendment; conforming amendment.
p.(None): TITLE II—MEDICAL DEVICE USER FEE AMENDMENTS OF 2007
p.(None): Sec. 201. Short title; references in title; finding.
p.(None): Subtitle A—Fees Related to Medical Devices Sec. 211. Definitions.
p.(None): Sec. 212. Authority to assess and use device fees. Sec. 213. Reauthorization; reporting requirements. Sec. 214.
p.(None): Savings clause.
p.(None): Sec. 215. Additional authorization of appropriations for postmarket safety informa- tion.
p.(None): Sec. 216. Effective date. Sec. 217. Sunset clause.
p.(None): Subtitle B—Amendments Regarding Regulation of Medical Devices
p.(None): Sec. 221. Extension of authority for third party review of premarket notification. Sec. 222. Registration.
p.(None): Sec. 223. Filing of lists of drugs and devices manufactured, prepared, propagated, and compounded by
p.(None): registrants; statements; accompanying disclosures.
p.(None): Sec. 224. Electronic registration and listing.
p.(None): Sec. 225. Report by Government Accountability Office. Sec. 226. Unique device identification system.
p.(None): Sec. 227. Frequency of reporting for certain devices.
p.(None):
p.(None): Sept. 27, 2007
p.(None): [H.R. 3580]
p.(None):
p.(None):
p.(None): Food and Drug Administration Amendments Act of 2007.
p.(None): 21 USC 301 note.
p.(None):
p.(None):
p.(None): 121 STAT. 824 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): Sec. 228. Inspections by accredited persons.
p.(None): Sec. 229. Study of nosocomial infections relating to medical devices.
p.(None): Sec. 230. Report by the Food and Drug Administration regarding labeling informa- tion on the relationship between
p.(None): the use of indoor tanning devices and development of skin cancer or other skin damage.
p.(None): TITLE III—PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007
p.(None): Sec. 301. Short title.
p.(None): Sec. 302. Tracking pediatric device approvals.
p.(None): Sec. 303. Modification to humanitarian device exemption. Sec. 304. Encouraging pediatric medical device research.
p.(None): Sec. 305. Demonstration grants for improving pediatric device availability.
p.(None): Sec. 306. Amendments to office of pediatric therapeutics and pediatric advisory committee.
p.(None): Sec. 307. Postmarket surveillance.
p.(None): TITLE IV—PEDIATRIC RESEARCH EQUITY ACT OF 2007
p.(None): Sec. 401. Short title.
p.(None): Sec. 402. Reauthorization of Pediatric Research Equity Act. Sec. 403. Establishment of internal committee.
p.(None): Sec. 404. Government Accountability Office report.
p.(None): TITLE V—BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007
p.(None): Sec. 501. Short title.
p.(None): Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act. Sec. 503. Training of pediatric
p.(None): pharmacologists.
p.(None): TITLE VI—REAGAN-UDALL FOUNDATION
p.(None): Sec. 601. The Reagan-Udall Foundation for the Food and Drug Administration. Sec. 602. Office of the Chief
p.(None): Scientist.
p.(None): Sec. 603. Critical path public-private partnerships.
p.(None): TITLE VII—CONFLICTS OF INTEREST
p.(None): Sec. 701. Conflicts of interest.
p.(None): TITLE VIII—CLINICAL TRIAL DATABASES
p.(None): Sec. 801. Expanded clinical trial registry data bank.
p.(None): TITLE IX—ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS
p.(None): Subtitle A—Postmarket Studies and Surveillance
p.(None): Sec. 901. Postmarket studies and clinical trials regarding human drugs; risk eval- uation and mitigation
p.(None): strategies.
p.(None): Sec. 902. Enforcement.
p.(None): Sec. 903. No effect on withdrawal or suspension of approval. Sec. 904. Benefit-risk assessments.
p.(None): Sec. 905. Active postmarket risk identification and analysis.
p.(None): Sec. 906. Statement for inclusion in direct-to-consumer advertisements of drugs. Sec. 907. No effect on veterinary
p.(None): medicine.
p.(None): Sec. 908. Authorization of appropriations. Sec. 909. Effective date and applicability.
p.(None): Subtitle B—Other Provisions to Ensure Drug Safety and Surveillance Sec. 911. Clinical trial guidance for antibiotic
p.(None): drugs.
p.(None): Sec. 912. Prohibition against food to which drugs or biological products have been added.
p.(None): Sec. 913. Assuring pharmaceutical safety.
p.(None): Sec. 914. Citizen petitions and petitions for stay of agency action.
p.(None): Sec. 915. Postmarket drug safety information for patients and providers. Sec. 916. Action package for approval.
p.(None): Sec. 917. Risk communication.
p.(None): Sec. 918. Referral to advisory committee.
p.(None): Sec. 919. Response to the institute of medicine. Sec. 920. Database for authorized generic drugs.
p.(None): Sec. 921. Adverse drug reaction reports and postmarket safety.
p.(None): TITLE X—FOOD SAFETY
p.(None): Sec. 1001. Findings.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 825
p.(None):
p.(None):
p.(None): Sec. 1002. Ensuring the safety of pet food.
p.(None): Sec. 1003. Ensuring efficient and effective communications during a recall. Sec. 1004. State and Federal
p.(None): Cooperation.
p.(None): Sec. 1005. Reportable Food Registry.
p.(None): Sec. 1006. Enhanced aquaculture and seafood inspection.
p.(None): Sec. 1007. Consultation regarding genetically engineered seafood products. Sec. 1008. Sense of Congress.
p.(None): Sec. 1009. Annual report to Congress. Sec. 1010. Publication of annual reports. Sec. 1011. Rule of construction.
p.(None): TITLE XI—OTHER PROVISIONS
p.(None): Subtitle A—In General
p.(None): Sec. 1101. Policy on the review and clearance of scientific articles published by FDA employees.
p.(None): Sec. 1102. Priority review to encourage treatments for tropical diseases. Sec. 1103. Improving genetic test safety
p.(None): and quality.
p.(None): Sec. 1104. NIH Technical amendments. Sec. 1105. Severability clause.
p.(None): Subtitle B—Antibiotic Access and Innovation
p.(None): Sec. 1111. Identification of clinically susceptible concentrations of antimicrobials. Sec. 1112. Orphan antibiotic
p.(None): drugs.
p.(None): Sec. 1113. Exclusivity of certain drugs containing single enantiomers. Sec. 1114. Report.
p.(None):
p.(None): TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
p.(None): SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING.
p.(None): (a) SHORT TITLE.—This title may be cited as the ‘‘Prescription Drug User Fee Amendments of 2007’’.
p.(None): (b) REFERENCES IN TITLE.—Except as otherwise specified, amendments made by this title to a section
p.(None): or other provision of law are amendments to such section or other provision of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 301 et seq.).
p.(None): (c) FINDING.—The Congress finds that the fees authorized by the amendments made in this title will be
p.(None): dedicated toward expe- diting the drug development process and the process for the review of human drug
p.(None): applications, including postmarket drug safety activities, as set forth in the goals identified for
p.(None): purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the
p.(None): letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health,
p.(None): Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce
p.(None): of the House of Rep- resentatives, as set forth in the Congressional Record.
p.(None): SEC. 102. DEFINITIONS.
p.(None): Section 735 (21 U.S.C. 379g) is amended—
p.(None): (1) in the matter before paragraph (1), by striking ‘‘For purposes of this subchapter’’ and inserting
p.(None): ‘‘For purposes of this part’’;
p.(None): (2) in paragraph (1)—
p.(None): (A) in subparagraph (A), by striking ‘‘505(b)(1),’’ and inserting ‘‘505(b), or’’;
p.(None): (B) by striking subparagraph (B);
p.(None): (C) by redesignating subparagraph (C) as subpara- graph (B); and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Prescription Drug User Fee Amendments of 2007.
p.(None):
p.(None):
p.(None): 21 USC 301 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379g
p.(None): note.
p.(None):
p.(None):
p.(None): 121 STAT. 826 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): (D) in the matter following subparagraph (B), as so redesignated, by striking ‘‘subparagraph (C)’’ and
p.(None): inserting ‘‘subparagraph (B)’’;
p.(None): (3) in paragraph (3)(C)—
p.(None): (A) by striking ‘‘505(j)(7)(A)’’ and inserting ‘‘505(j)(7)(A) (not including the discontinued section of such
p.(None): list)’’; and
p.(None): (B) by inserting before the period ‘‘(not including the discontinued section of such list)’’;
p.(None): (4) in paragraph (4), by inserting before the period at the end the following: ‘‘(such as capsules, tablets,
p.(None): or lyophilized products before reconstitution)’’;
p.(None): (5) by amending paragraph (6)(F) to read as follows:
p.(None): ‘‘(F) Postmarket safety activities with respect to drugs approved under human drug applications or supplements,
p.(None): including the following activities:
p.(None): ‘‘(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse
p.(None): event reports.
p.(None): ‘‘(ii) Developing and using improved adverse-event data-collection systems, including information tech- nology
p.(None): systems.
p.(None): ‘‘(iii) Developing and using improved analytical tools to assess potential safety problems, including access
p.(None): to external data bases.
p.(None): ‘‘(iv) Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and
p.(None): labeling changes) and section 505(p) (relating to risk evaluation and mitigation strategies).
p.(None): ‘‘(v) Carrying out section 505(k)(5) (relating to adverse event reports and postmarket safety activi-
p.(None): ties).’’;
p.(None): (6) in paragraph (8)—
p.(None): (A) by striking ‘‘April of the preceding fiscal year’’ and inserting ‘‘October of the preceding fiscal
p.(None): year’’; and
p.(None): (B) by striking ‘‘April 1997’’ and inserting ‘‘October 1996’’;
p.(None): (7) by redesignating paragraph (9) as paragraph (11); and
p.(None): (8) by inserting after paragraph (8) the following para- graphs:
p.(None): ‘‘(9) The term ‘person’ includes an affiliate thereof.
p.(None): ‘‘(10) The term ‘active’, with respect to a commercial inves- tigational new drug application, means such an
p.(None): application to which information was submitted during the relevant period.’’.
p.(None): SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.
p.(None): (a) TYPES OF FEES.—Section 736(a) (21 U.S.C. 379h(a)) is amended—
p.(None): (1) in the matter preceding paragraph (1), by striking ‘‘2003’’ and inserting ‘‘2008’’;
p.(None): (2) in paragraph (1)—
p.(None): (A) in subparagraph (D)—
p.(None): (i) in the heading, by inserting ‘‘OR WITHDRAWN BEFORE FILING’’ after ‘‘REFUSED FOR FILING’’; and
p.(None): (ii) by inserting before the period at the end the following: ‘‘or withdrawn without a waiver
p.(None): before filing’’;
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 827
p.(None):
p.(None): (B) by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and
p.(None): (C) by inserting after subparagraph (D) the following: ‘‘(E) FEES FOR APPLICATIONS PREVIOUSLY REFUSED FOR
p.(None): FILING OR WITHDRAWN BEFORE FILING.—A human drug application or supplement that was submitted but was
p.(None): refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full
p.(None): fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived or
p.(None): reduced under sub-
p.(None): section (d).’’; and
p.(None): (3) in paragraph (2)—
p.(None): (A) in subparagraph (A), by striking ‘‘subparagraph (B)’’ and inserting ‘‘subparagraphs (B) and (C)’’; and
p.(None): (B) by adding at the end the following:
p.(None): ‘‘(C) SPECIAL RULES FOR POSITRON EMISSION TOMOG- RAPHY DRUGS.—
p.(None): ‘‘(i) IN GENERAL.—Except as provided in clause (ii), each person who is named as the applicant in an
p.(None): approved human drug application for a positron emission tomography drug shall be subject under
p.(None): subparagraph (A) to one-sixth of an annual establish- ment fee with respect to each such
p.(None): establishment identified in the application as producing positron emission tomography drugs under
p.(None): the approved application.
p.(None): ‘‘(ii) EXCEPTION FROM ANNUAL ESTABLISHMENT
p.(None): FEE.—Each person who is named as the applicant in an application described in clause (i) shall not be
p.(None): assessed an annual establishment fee for a fiscal year if the person certifies to the Secretary, at a time speci- fied
p.(None): by the Secretary and using procedures specified by the Secretary, that—
p.(None): ‘‘(I) the person is a not-for-profit medical center that has only 1 establishment for the production of positron
p.(None): emission tomography drugs; and
p.(None): ‘‘(II) at least 95 percent of the total number of doses of each positron emission tomography drug produced by
p.(None): such establishment during such fiscal year will be used within the medical center.
p.(None): ‘‘(iii) DEFINITION.—For purposes of this subpara- graph, the term ‘positron emission tomography drug’ has
p.(None): the meaning given to the term ‘compounded positron emission tomography drug’ in section 201(ii),
p.(None): except that paragraph (1)(B) of such section shall not apply.’’.
p.(None): (b) FEE REVENUE AMOUNTS.—Section 736(b) (21 U.S.C. 379h(b)) is amended to read as follows:
p.(None): ‘‘(b) FEE REVENUE AMOUNTS.—
p.(None): ‘‘(1) IN GENERAL.—For each of the fiscal years 2008 through 2012, fees under subsection (a) shall, except as
p.(None): provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under
p.(None): such subsection that is equal to the sum of—
p.(None): ‘‘(A) $392,783,000; and
p.(None):
p.(None):
p.(None): 121 STAT. 828 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(B) an amount equal to the modified workload adjust- ment factor for fiscal year 2007 (as determined under para-
p.(None): graph (3)).
p.(None): ‘‘(2) TYPES OF FEES.—Of the total revenue amount deter- mined for a fiscal year under paragraph (1)—
p.(None): ‘‘(A) one-third shall be derived from fees under sub- section (a)(1) (relating to human drug applications
p.(None): and supplements);
p.(None): ‘‘(B) one-third shall be derived from fees under sub- section (a)(2) (relating to prescription drug
p.(None): establishments); and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Applicability.
p.(None): ‘‘(C) one-third shall be derived from fees under sub- section (a)(3) (relating to prescription drug products).
p.(None): ‘‘(3) MODIFIED WORKLOAD ADJUSTMENT FACTOR FOR FISCAL
p.(None): YEAR 2007.—For purposes of paragraph (1)(B), the Secretary shall determine the modified workload
p.(None): adjustment factor by determining the dollar amount that results from applying the methodology that was in
p.(None): effect under subsection (c)(2) for fiscal year 2007 to the amount $354,893,000, except that, with respect to the
p.(None): portion of such determination that is based on the change in the total number of commercial
p.(None): investigational new drug applications, the Secretary shall count the number of such applications that were
p.(None): active during the most recent 12- month period for which data on such submissions is available.
p.(None): ‘‘(4) ADDITIONAL FEE REVENUES FOR DRUG SAFETY.—
p.(None): ‘‘(A) IN GENERAL.—For each of the fiscal years 2008 through 2012, paragraph (1)(A) shall be applied by
p.(None): sub- stituting the amount determined under subparagraph (B) for ‘$392,783,000’.
p.(None): ‘‘(B) AMOUNT DETERMINED.—For each of the fiscal years 2008 through 2012, the amount determined under this
p.(None): subparagraph is the sum of—
p.(None): ‘‘(i) $392,783,000; plus
p.(None): ‘‘(ii)(I) for fiscal year 2008, $25,000,000; ‘‘(II) for fiscal year 2009, $35,000,000; ‘‘(III) for fiscal year 2010,
p.(None): $45,000,000; ‘‘(IV) for fiscal year 2011, $55,000,000; and ‘‘(V) for fiscal year 2012, $65,000,000.’’.
p.(None): (c) ADJUSTMENTS TO FEES.—
p.(None): (1) INFLATION ADJUSTMENT.—Section 736(c)(1) (21 U.S.C. 379h(c)(1)) is amended—
p.(None): (A) in the matter preceding subparagraph (A), by striking ‘‘The revenues established in subsection
p.(None): (b)’’ and inserting ‘‘For fiscal year 2009 and subsequent fiscal years, the revenues established in subsection (b)’’;
p.(None): (B) in subparagraph (A), by striking ‘‘or’’ at the end;
p.(None): (C) in subparagraph (B), by striking the period at the end and inserting ‘‘, or’’;
p.(None): (D) by inserting after subparagraph (B) the following: ‘‘(C) the average annual change in the cost, per
p.(None): full- time equivalent position of the Food and Drug Administra- tion, of all personnel compensation and benefits paid
p.(None): with respect to such positions for the first 5 years of the pre-
p.(None): ceding 6 fiscal years.’’; and
p.(None): (E) in the matter following subparagraph (C) (as added by subparagraph (D)), by striking ‘‘fiscal year 2003’’
p.(None): and inserting ‘‘fiscal year 2008’’.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 829
p.(None):
p.(None):
p.(None): (2) WORKLOAD ADJUSTMENT.—Section 736(c)(2) (21 U.S.C. 379h(c)(2)) is amended—
p.(None): (A) in the matter preceding subparagraph (A), by striking ‘‘Beginning with fiscal year 2004,’’ and
p.(None): inserting ‘‘For fiscal year 2009 and subsequent fiscal years,’’;
p.(None): (B) in subparagraph (A), in the first sentence—
p.(None): (i) by striking ‘‘human drug applications,’’ and inserting ‘‘human drug applications (adjusted for
p.(None): changes in review activities, as described in the notice that the Secretary is required to publish in the Federal
p.(None): Register under this subparagraph),’’;
p.(None): (ii) by striking ‘‘commercial investigational new drug applications,’’; and
p.(None): (iii) by inserting before the period the following: ‘‘, and the change in the total number of active commer-
p.(None): cial investigational new drug applications (adjusted for changes in review activities, as so described) during the
p.(None): most recent 12-month period for which data on such submissions is available’’;
p.(None): (C) in subparagraph (B), by adding at the end the following: ‘‘Any adjustment for changes in review activities
p.(None): made in setting fees and revenue amounts for fiscal year 2009 may not result in the total workload
p.(None): adjustment being more than 2 percentage points higher than it would have been in the absence of the adjustment
p.(None): for changes in review activities.’’; and
p.(None): (D) by adding at the end the following:
p.(None): ‘‘(C) The Secretary shall contract with an independent accounting firm to study the adjustment for changes in
p.(None): review activities applied in setting fees and revenue amounts for fiscal year 2009 and to make
p.(None): recommendations, if warranted, for future changes in the methodology for calculating the adjustment.
p.(None): After review of the rec- ommendations, the Secretary shall, if warranted, make appropriate changes to
p.(None): the methodology, and the changes shall be effective for each of the fiscal years 2010 through 2012. The Secretary
p.(None): shall not make any adjustment for changes in review activities for any fiscal year after 2009 unless
p.(None): such study has been completed.’’.
p.(None): (3) RENT AND RENT-RELATED COST ADJUSTMENT.—Section 736(c) (21 U.S.C. 379h(c)) is amended—
p.(None): (A) by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), respectively; and
p.(None): (B) by inserting after paragraph (2) the following:
p.(None): ‘‘(3) RENT AND RENT-RELATED COST ADJUSTMENT.—For fiscal
p.(None): year 2010 and each subsequent fiscal year, the Secretary shall, before making adjustments under paragraphs
p.(None): (1) and (2), decrease the fee revenue amount established in subsection (b) if actual costs paid for
p.(None): rent and rent-related expenses for the preceding fiscal year are less than estimates made for such year
p.(None): in fiscal year 2006. Any reduction made under this para- graph shall not exceed the amount by which such costs
p.(None): fall below the estimates made in fiscal year 2006 for such fiscal year, and shall not exceed
p.(None): $11,721,000 for any fiscal year.’’.
p.(None): (4) FINAL YEAR ADJUSTMENT.—Paragraph (4) of section 736(c) (21 U.S.C. 379h(c)), as redesignated by paragraph
p.(None): (3)(A), is amended to read as follows:
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Contracts. Study.
p.(None):
p.(None):
p.(None):
p.(None): Effective date.
p.(None):
p.(None):
p.(None): 121 STAT. 830 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): ‘‘(4) FINAL YEAR ADJUSTMENT.—
p.(None): ‘‘(A) INCREASE IN FEES.—For fiscal year 2012, the Sec- retary may, in addition to adjustments under this para-
p.(None): graph and paragraphs (1), (2), and (3), further increase the fee revenues and fees established in
p.(None): subsection (b) if such an adjustment is necessary to provide for not more than 3 months of operating reserves of
p.(None): carryover user fees for the process for the review of human drug applica- tions for the first 3 months of
p.(None): fiscal year 2013. If such an adjustment is necessary, the rationale for the amount of the increase shall
p.(None): be contained in the annual notice establishing fee revenues and fees for fiscal year 2012. If the
p.(None): Secretary has carryover balances for such process in excess of 3 months of such operating reserves, the adjust-
p.(None): ment under this subparagraph shall not be made.
p.(None): ‘‘(B) DECREASE IN FEES.—
p.(None): ‘‘(i) IN GENERAL.—For fiscal year 2012, the Sec- retary may, in addition to adjustments under this para- graph
p.(None): and paragraphs (1), (2), and (3), decrease the fee revenues and fees established in subsection (b) by
p.(None): the amount determined in clause (ii), if, for fiscal year 2009 or 2010—
p.(None): ‘‘(I) the amount of the total appropriations for the Food and Drug Administration for such fiscal year
p.(None): (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of the total
p.(None): appropriations for the Food and Drug Administration for fiscal year 2008 (excluding the amount of fees
p.(None): appropriated for such fiscal year), adjusted as provided under paragraph (1); and
p.(None): ‘‘(II) the amount of the total appropriations expended for the process for the review of human drug applications
p.(None): at the Food and Drug Adminis- tration for such fiscal year (excluding the amount of fees appropriated for
p.(None): such fiscal year) exceeds the amount of appropriations expended for the process for the review of human drug
p.(None): applications at the Food and Drug Administration for fiscal year 2008 (excluding the amount of fees
p.(None): appro- priated for such fiscal year), adjusted as provided under paragraph (1).
p.(None): ‘‘(ii) AMOUNT OF DECREASE.—The amount deter- mined in this clause is the lesser of—
p.(None): ‘‘(I) the amount equal to the sum of the amounts that, for each of fiscal years 2009 and 2010,
p.(None): is the lesser of—
p.(None): ‘‘(aa) the excess amount described in clause (i)(II) for such fiscal year; or
p.(None): ‘‘(bb) the amount specified in subsection (b)(4)(B)(ii) for such fiscal year; or
p.(None): ‘‘(II) $65,000,000. ‘‘(iii) LIMITATIONS.—
p.(None): ‘‘(I) FISCAL YEAR CONDITION.—In making the
p.(None): determination under clause (ii), an amount described in subclause (I) of such clause for fiscal
p.(None): year 2009 or 2010 shall be taken into account
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 831
p.(None):
p.(None): only if subclauses (I) and (II) of clause (i) apply to such fiscal year.
p.(None): ‘‘(II) RELATION TO SUBPARAGRAPH (A).—The
p.(None): Secretary shall limit any decrease under this para- graph if such a limitation is necessary to provide for the
p.(None): 3 months of operating reserves described in subparagraph (A).’’.
p.(None): (5) LIMIT.—Paragraph (5) of section 736(c) (21 U.S.C. 379h(c)), as redesignated by paragraph (3)(A),
p.(None): is amended by striking ‘‘2002’’ and inserting ‘‘2007’’.
p.(None): (d) FEE WAIVER OR REDUCTION.—Section 736(d) (21 U.S.C. 379h(d)) is amended—
p.(None): (1) in paragraph (1), in the matter preceding subparagraph (A)—
p.(None): (A) by inserting after ‘‘The Secretary shall grant’’ the following: ‘‘to a person who is named as the
p.(None): applicant in a human drug application’’; and
p.(None): (B) by inserting ‘‘to that person’’ after ‘‘one or more fees assessed’’;
p.(None): (2) by redesignating paragraphs (2) and (3) as paragraphs
p.(None): (3) and (4), respectively;
p.(None): (3) by inserting after paragraph (1) the following:
p.(None): ‘‘(2) CONSIDERATIONS.—In determining whether to grant a waiver or reduction of a fee under paragraph (1), the
p.(None): Secretary shall consider only the circumstances and assets of the applicant involved and any
p.(None): affiliate of the applicant.’’; and
p.(None): (4) in paragraph (4) (as redesignated by paragraph (2)), in subparagraph (A), by inserting before the
p.(None): period the fol- lowing: ‘‘, and that does not have a drug product that has been approved under a human
p.(None): drug application and introduced or delivered for introduction into interstate commerce’’.
p.(None): (e) CREDITING AND AVAILABILITY OF FEES.—
p.(None): (1) AUTHORIZATION OF APPROPRIATIONS.—Section 736(g)(3) (21 U.S.C. 379h(g)(3)) is amended to read as follows:
p.(None): ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the
p.(None): fiscal years 2008 through 2012, there is authorized to be appro- priated for fees under this section an amount
p.(None): equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or
p.(None): otherwise affected under subsection
p.(None): (c) and paragraph (4) of this subsection.’’.
p.(None): (2) OFFSET.—Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is
p.(None): amended to read as follows:
p.(None): ‘‘(4) OFFSET.—If the sum of the cumulative amount of fees collected under this section for the fiscal years
p.(None): 2008 through 2010 and the amount of fees estimated to be collected under this section for fiscal year 2011
p.(None): exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2008 through 2011, the
p.(None): excess shall be credited to the appropriation account of the Food and Drug Administration as provided in
p.(None): paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be
p.(None): collected under this section pursuant to appropriation Acts for fiscal year 2012.’’.
p.(None): (f) EXEMPTION FOR ORPHAN DRUGS.—Section 736 (21 U.S.C. 379h) is further amended by adding at the end
p.(None): the following:
p.(None): ‘‘(k) ORPHAN DRUGS.—
p.(None):
p.(None):
p.(None): 121 STAT. 832 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(1) EXEMPTION.—A drug designated under section 526 for a rare disease or condition and approved under
p.(None): section 505 or under section 351 of the Public Health Service Act shall be exempt from product and
p.(None): establishment fees under this section, if the drug meets all of the following conditions:
p.(None): ‘‘(A) The drug meets the public health requirements contained in this Act as such requirements are
p.(None): applied to requests for waivers for product and establishment fees. ‘‘(B) The drug is owned or licensed and is
p.(None): marketed
p.(None): by a company that had less than $50,000,000 in gross worldwide revenue during the previous year.
p.(None): ‘‘(2) EVIDENCE OF QUALIFICATION.—An exemption under paragraph (1) applies with respect to a drug
p.(None): only if the applicant involved submits a certification that its gross annual revenues did not exceed
p.(None): $50,000,000 for the preceding 12 months before the exemption was requested.’’.
p.(None): (g) CONFORMING AMENDMENT.—Section 736(a) (21 U.S.C. 379h(a)) is amended in paragraphs (1)(A)(i),
p.(None): (1)(A)(ii), (2)(A), and (3)(A) by striking ‘‘(c)(4)’’ each place such term appears and inserting ‘‘(c)(5)’’.
p.(None): (h) TECHNICAL AMENDMENT.—
p.(None): (1) AMENDMENT.—Section 736(g)(1) (21 U.S.C. 379h(g)(1))
p.(None): is amended by striking the first sentence and inserting the following: ‘‘Fees authorized under subsection
p.(None): (a) shall be col- lected and available for obligation only to the extent and in the amount provided in
p.(None): advance in appropriations Acts. Such fees are authorized to remain available until expended.’’.
p.(None):
p.(None): 21 USC 379h
p.(None): note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379h–1.
p.(None):
p.(None):
p.(None): Effective date.
p.(None): (2) EFFECTIVE DATE.—Paragraph (1) shall take effect as if included in section 504 of the Prescription
p.(None): Drug User Fee Amendments of 2002 (Public Law 107–188; 116 Stat. 687).
p.(None): SEC. 104. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION- DRUG TELEVISION ADVERTISING.
p.(None): Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.) is amended by adding after section 736 the
p.(None): following:
p.(None): ‘‘SEC. 736A. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION- DRUG TELEVISION ADVERTISING.
p.(None): ‘‘(a) TYPES OF DIRECT-TO-CONSUMER TELEVISION ADVERTISE-
p.(None): MENT REVIEW FEES.—Beginning in fiscal year 2008, the Secretary shall assess and collect fees in
p.(None): accordance with this section as follows:
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines. Federal Register, publication.
p.(None): ‘‘(1) ADVISORY REVIEW FEE.—
p.(None): ‘‘(A) IN GENERAL.—With respect to a proposed direct- to-consumer television advertisement (referred to in
p.(None): this section as a ‘DTC advertisement’), each person that on or after October 1, 2007, submits such an
p.(None): advertisement for advisory review by the Secretary prior to its initial public dissemination shall, except
p.(None): as provided in subpara- graph (B), be subject to a fee established under subsection (c)(3).
p.(None): ‘‘(B) EXCEPTION FOR REQUIRED SUBMISSIONS.—A DTC
p.(None): advertisement that is required to be submitted to the Sec- retary prior to initial public dissemination is not
p.(None): subject to a fee under subparagraph (A) unless the sponsor des- ignates the submission as a submission for
p.(None): advisory review. ‘‘(C) NOTICE TO SECRETARY OF NUMBER OF
p.(None): ADVERTISEMENTS.—Not later than June 1 of each fiscal
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 833
p.(None):
p.(None):
p.(None): year, the Secretary shall publish a notice in the Federal Register requesting any person to notify the
p.(None): Secretary within 30 days of the number of DTC advertisements the person intends to submit for advisory
p.(None): review in the next fiscal year. Notwithstanding the preceding sentence, for fiscal year 2008, the Secretary
p.(None): shall publish such a notice in the Federal Register not later than 30 days after the date of the enactment of
p.(None): the Food and Drug Administration Amendments Act of 2007.
p.(None): ‘‘(D) PAYMENT.—
p.(None): ‘‘(i) IN GENERAL.—The fee required by subpara- graph (A) (referred to in this section as ‘an advisory
p.(None): review fee’) shall be due not later than October 1 of the fiscal year in which the DTC advertisement
p.(None): involved is intended to be submitted for advisory review, subject to subparagraph (F)(i). Notwithstanding
p.(None): the preceding sentence, the advisory review fee for any DTC advertisement that is intended to be sub-
p.(None): mitted for advisory review during fiscal year 2008 shall be due not later than 120 days after the date of
p.(None): the enactment of the Food and Drug Administration Amendments of 2007 or an earlier date as
p.(None): specified by the Secretary.
p.(None): ‘‘(ii) EFFECT OF SUBMISSION.—Notification of the Secretary under subparagraph (C) of the number of DTC
p.(None): advertisements a person intends to submit for advisory review is a legally binding commitment by that
p.(None): person to pay the annual advisory review fee for that number of submissions on or before October
p.(None): 1 of the fiscal year in which the advertisement is intended to be submitted. Notwithstanding the pre-
p.(None): ceding sentence, the commitment shall be a legally binding commitment by that person to pay the annual advisory
p.(None): review fee for that number of submissions for fiscal year 2008 by the date specified in clause (i).
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None):
p.(None): ‘‘(iii) NOTICE REGARDING CARRYOVER SUBMIS-
p.(None): SIONS.—In making a notification under subparagraph (C), the person involved shall in addition notify the
p.(None): Secretary if under subparagraph (F)(i) the person intends to submit a DTC advertisement for which the
p.(None): advisory review fee has already been paid. If the person does not so notify the Secretary, each DTC advertise-
p.(None): ment submitted by the person for advisory review in the fiscal year involved shall be subject to the advisory
p.(None): review fee.
p.(None): ‘‘(E) MODIFICATION OF ADVISORY REVIEW FEE.—
p.(None): ‘‘(i) LATE PAYMENT.—If a person has submitted a notification under subparagraph (C) with respect to a
p.(None): fiscal year and has not paid all advisory review fees due under subparagraph (D) not later than
p.(None): November 1 of such fiscal year (or, in the case of such a notification submitted with respect to
p.(None): fiscal year 2008, not later than 150 days after the date of the enactment of the Food and Drug Administration
p.(None): Amendments Act of 2007 or an earlier date specified by the Secretary), the fees shall be regarded as
p.(None): late
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Applicability.
p.(None):
p.(None):
p.(None): 121 STAT. 834 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): and an increase in the amount of fees applies in accord- ance with this clause, notwithstanding any other provi-
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None): sion of this section. For such person, all advisory review fees for such fiscal year shall be due and payable
p.(None): 20 days before any direct-to-consumer advertisement is submitted to the Secretary for advisory review, and each
p.(None): such fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to
p.(None): subsection (c)(3).
p.(None): ‘‘(ii) EXCEEDING IDENTIFIED NUMBER OF SUBMIS-
p.(None): SIONS.—If a person submits a number of DTC advertisements for advisory review in a fiscal year
p.(None): that exceeds the number identified by the person under subparagraph (C), an increase in the amount of fees
...
p.(None): advisory review submission to the next fiscal year. Resubmissions may be submitted without regard to the
p.(None): fiscal year of the initial advisory review submission. ‘‘(ii) NO REFUNDS.—Except as provided by sub- sections
p.(None): (d)(4) and (f), fees paid under this section
p.(None): shall not be refunded.
p.(None): ‘‘(iii) NO WAIVERS, EXEMPTIONS, OR REDUCTIONS.—
p.(None): The Secretary shall not grant a waiver, exemption, or reduction of any fees due or payable under this
p.(None): section.
p.(None): ‘‘(iv) RIGHT TO ADVISORY REVIEW NOT TRANSFER-
p.(None): ABLE.—The right to an advisory review under this paragraph is not transferable, except to a successor in
p.(None): interest.
p.(None): ‘‘(2) OPERATING RESERVE FEE.—
p.(None): ‘‘(A) IN GENERAL.—Each person that on or after October 1, 2007, is assessed an advisory review fee under paragraph
p.(None): (1) shall be subject to fee established under subsection (d)(2) (referred to in this section as an
p.(None): ‘operating reserve fee’) for the first fiscal year in which an advisory review fee is assessed to such
p.(None): person. The person is not subject to an operating reserve fee for any other fiscal year.
p.(None): ‘‘(B) PAYMENT.—Except as provided in subparagraph (C), the operating reserve fee shall be due no later than—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 835
p.(None):
p.(None):
p.(None): ‘‘(i) October 1 of the first fiscal year in which the person is required to pay an advisory review
p.(None): fee under paragraph (1); or
p.(None): ‘‘(ii) for fiscal year 2008, 120 days after the date of the enactment of the Food and Drug Administration
p.(None): Amendments Act of 2007 or an earlier date specified by the Secretary.
p.(None): ‘‘(C) LATE NOTICE OF SUBMISSION.—If, in the first fiscal year of a person’s participation in the program under this
p.(None): section, that person submits any DTC advertisements for advisory review that are in excess of the number
p.(None): identified by that person in response to the Federal Register notice described in subsection (a)(1)(C),
p.(None): that person shall pay an operating reserve fee for each of those advisory reviews equal to the advisory review fee
p.(None): for each submission estab- lished under paragraph (1)(E)(ii). Fees required by this subparagraph shall be in
p.(None): addition to any fees required by subparagraph (A). Fees under this subparagraph shall be due 20 days before
p.(None): any DTC advertisement is submitted by such person to the Secretary for advisory review.
p.(None): ‘‘(D) LATE PAYMENT.—
p.(None): ‘‘(i) IN GENERAL.—Notwithstanding subparagraph (B), and subject to clause (ii), an operating reserve fee
p.(None): shall be regarded as late if the person required to pay the fee has not paid the complete operating
p.(None): reserve fee by—
p.(None): ‘‘(I) for fiscal year 2008, 150 days after the date of the enactment of the Food and Drug
p.(None): Administration Amendments Act of 2007 or an earlier date specified by the Secretary; or
p.(None): ‘‘(II) in any subsequent year, November 1.
p.(None): ‘‘(ii) COMPLETE PAYMENT.—The complete operating reserve fee shall be due and payable 20 days before any DTC
p.(None): advertisement is submitted by such person to the Secretary for advisory review.
p.(None): ‘‘(iii) AMOUNT.—Notwithstanding any other provi- sion of this section, an operating reserve fee that is
p.(None): regarded as late under this subparagraph shall be equal to 150 percent of the operating reserve fee
p.(None): that otherwise would have applied pursuant to subsection (d).
p.(None): ‘‘(b) ADVISORY REVIEW FEE REVENUE AMOUNTS.—Fees under
p.(None): subsection (a)(1) shall be established to generate revenue amounts of $6,250,000 for each of fiscal years 2008 through
p.(None): 2012, as adjusted pursuant to subsections (c) and (g)(4).
p.(None): ‘‘(c) ADJUSTMENTS.—
p.(None): ‘‘(1) INFLATION ADJUSTMENT.—Beginning with fiscal year 2009, the revenues established in subsection
p.(None): (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to
p.(None): reflect the greater of—
p.(None): ‘‘(A) the total percentage change that occurred in the Consumer Price Index for all urban consumers (all
p.(None): items;
p.(None): U.S. city average), for the 12-month period ending June 30 preceding the fiscal year for which fees are being
p.(None): estab- lished;
p.(None): ‘‘(B) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): Deadlines.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Effective date. Notice.
p.(None): Federal Register, publication.
p.(None):
p.(None):
p.(None): 121 STAT. 836 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): with section 5332 of title 5, United States Code, as adjusted by any locality-based comparability payment pursuant
p.(None): to section 5304 of such title for Federal employees stationed in the District of Columbia; or
p.(None): ‘‘(C) the average annual change in the cost, per full- time equivalent position of the Food and Drug
p.(None): Administra- tion, of all personnel compensation and benefits paid with respect to such positions for the first 5
p.(None): fiscal years of the previous 6 fiscal years.
p.(None): The adjustment made each fiscal year by this subsection shall be added on a compounded basis to the sum of all
p.(None): adjustments made each fiscal year after fiscal year 2008 under this sub- section.
p.(None):
p.(None): Effective date.
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None): ‘‘(2) WORKLOAD ADJUSTMENT.—Beginning with fiscal year 2009, after the fee revenues established in
p.(None): subsection (b) are adjusted for a fiscal year for inflation in accordance with para- graph (1), the fee revenues
p.(None): shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary with
p.(None): respect to the submission of DTC advertisements for advisory review prior to initial dissemination. With
p.(None): respect to such adjustment:
p.(None): ‘‘(A) The adjustment shall be determined by the Sec- retary based upon the number of DTC advertisements
p.(None): identified pursuant to subsection (a)(1)(C) for the upcoming fiscal year, excluding allowable previously paid
p.(None): carry over submissions. The adjustment shall be determined by multi- plying the number of such advertisements
p.(None): projected for that fiscal year that exceeds 150 by $27,600 (adjusted each year beginning with fiscal year
p.(None): 2009 for inflation in accordance with paragraph (1)). The Secretary shall publish in the Federal Register
p.(None): the fee revenues and fees resulting from the adjustment and the supporting meth- odologies.
p.(None): ‘‘(B) Under no circumstances shall the adjustment result in fee revenues for a fiscal year that
p.(None): are less than the fee revenues established for the prior fiscal year.
p.(None): ‘‘(3) ANNUAL FEE SETTING FOR ADVISORY REVIEW.—
p.(None): ‘‘(A) IN GENERAL.—Not later than August 1 of each fiscal year (or, with respect to fiscal year 2008,
p.(None): not later than 90 days after the date of the enactment of the Food and Drug Administration Amendments
p.(None): Act of 2007), the Secretary shall establish for the next fiscal year the DTC advertisement advisory review
p.(None): fee under subsection (a)(1), based on the revenue amounts established under subsection (b), the adjustments provided
p.(None): under paragraphs (1) and (2), and the number of DTC advertisements identified pursuant to
p.(None): subsection (a)(1)(C), excluding allowable pre- viously-paid carry over submissions. The annual advisory
p.(None): review fee shall be established by dividing the fee revenue for a fiscal year (as adjusted pursuant to this
p.(None): subsection) by the number of DTC advertisements so identified, excluding allowable previously-paid carry
p.(None): over submissions under subsection (a)(1)(F)(i).
p.(None): ‘‘(B) FISCAL YEAR 2008 FEE LIMIT.—Notwithstanding subsection (b) and the adjustments pursuant to this sub-
p.(None): section, the fee established under subparagraph (A) for
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 837
p.(None):
p.(None):
p.(None): fiscal year 2008 may not be more than $83,000 per submis- sion for advisory review.
p.(None): ‘‘(C) ANNUAL FEE LIMIT.—Notwithstanding subsection
p.(None): (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for a
p.(None): fiscal year after fiscal year 2008 may not be more than 50 percent more than the fee established for
p.(None): the prior fiscal year. ‘‘(D) LIMIT.—The total amount of fees obligated for
p.(None): a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process
p.(None): for the advisory review of prescription drug advertising.
p.(None): ‘‘(d) OPERATING RESERVES.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall establish in the Food and Drug Administration salaries and expenses
p.(None): appropriation account without fiscal year limitation a Direct-to-Consumer Advisory Review Operating Reserve,
p.(None): of at least $6,250,000 in fiscal year 2008, to continue the program under this section in the event the
p.(None): fees collected in any subsequent fiscal year pursuant to subsection (a)(1) do not generate the fee
p.(None): revenue amount established for that fiscal year.
p.(None): ‘‘(2) FEE SETTING.—The Secretary shall establish the oper- ating reserve fee under subsection (a)(2)(A) for each
p.(None): person required to pay the fee by multiplying the number of DTC advertisements identified by that person
p.(None): pursuant to subsection (a)(1)(C) by the advisory review fee established pursuant to subsection (c)(3) for
p.(None): that fiscal year, except that in no case shall the operating reserve fee assessed be less than the oper- ating
p.(None): reserve fee assessed if the person had first participated in the program under this section in fiscal year
p.(None): 2008.
p.(None): ‘‘(3) USE OF OPERATING RESERVE.—The Secretary may use funds from the reserves only to the extent
p.(None): necessary in any fiscal year to make up the difference between the fee revenue amount established for
p.(None): that fiscal year under subsections (b) and (c) and the amount of fees actually collected for that fiscal year
p.(None): pursuant to subsection (a)(1), or to pay costs of ending the program under this section if it is
p.(None): terminated pursuant to subsection (f) or not reauthorized beyond fiscal year 2012. ‘‘(4) REFUND OF
p.(None): OPERATING RESERVES.—Within 120 days
p.(None): after the end of fiscal year 2012, or if the program under this section ends early pursuant to subsection
p.(None): (f), the Secretary, after setting aside sufficient operating reserve amounts to terminate the program
p.(None): under this section, shall refund all amounts remaining in the operating reserve on a pro rata basis to
p.(None): each person that paid an operating reserve fee assess- ment. In no event shall the refund to any person
p.(None): exceed the total amount of operating reserve fees paid by such person pursuant to subsection (a)(2).
p.(None): ‘‘(e) EFFECT OF FAILURE TO PAY FEES.—Notwithstanding any other requirement, a submission for advisory
p.(None): review of a DTC advertisement submitted by a person subject to fees under sub- section (a) shall be
p.(None): considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such
p.(None): person under this section have been paid.
p.(None): ‘‘(f) EFFECT OF INADEQUATE FUNDING OF PROGRAM.—
p.(None): ‘‘(1) INITIAL FUNDING.—If on November 1, 2007, or 120
p.(None): days after the date of the enactment of the Food and Drug Administration Amendments Act of 2007,
p.(None): whichever is later,
p.(None):
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p.(None): Deadline.
p.(None):
p.(None):
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p.(None): Effective date.
p.(None):
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p.(None): 121 STAT. 838 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): the Secretary has not received at least $11,250,000 in advisory review fees and operating reserve fees combined,
p.(None): the program under this section shall not commence and all collected fees shall be refunded.
p.(None):
p.(None): Effective date. Notification.
p.(None): ‘‘(2) LATER FISCAL YEARS.—Beginning in fiscal year 2009, if, on November 1 of the fiscal year, the
p.(None): combination of the operating reserves, annual fee revenues from that fiscal year, and unobligated fee
p.(None): revenues from prior fiscal years falls below
p.(None): $9,000,000, adjusted for inflation (as described in subsection (c)(1)), the program under this section
p.(None): shall terminate, and the Secretary shall notify all participants, retain any money from the unused
p.(None): advisory review fees and the operating reserves needed to terminate the program, and refund the
p.(None): remainder of the unused fees and operating reserves. To the extent required to terminate the program,
p.(None): the Secretary shall first use unobligated advisory review fee revenues from prior fiscal years, then the
p.(None): operating reserves, and finally, unused advisory review fees from the relevant fiscal year.
p.(None): ‘‘(g) CREDITING AND AVAILABILITY OF FEES.—
p.(None): ‘‘(1) IN GENERAL.—Fees authorized under subsection (a) shall be collected and available for obligation only to
p.(None): the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain
p.(None): available until expended. Such sums as may be necessary may be transferred from the Food and Drug
p.(None): Administration salaries and expenses appropria- tion account without fiscal year limitation to such appropriation
p.(None): account for salaries and expenses with such fiscal year limita- tion. The sums transferred shall be available
p.(None): solely for the process for the advisory review of prescription drug advertising.
p.(None): ‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.—
p.(None): ‘‘(A) IN GENERAL.—The fees authorized by this sec- tion—
p.(None): ‘‘(i) shall be retained in each fiscal year in an amount not to exceed the amount specified in appro-
p.(None): priation Acts, or otherwise made available for obliga- tion for such fiscal year; and
p.(None): ‘‘(ii) shall be available for obligation only if the amounts appropriated as budget authority for such
p.(None): fiscal year are sufficient to support a number of full- time equivalent review employees that is not
p.(None): fewer than the number of such employees supported in fiscal year 2007.
p.(None): ‘‘(B) REVIEW EMPLOYEES.—For purposes of subpara- graph (A)(ii), the term ‘full-time equivalent
p.(None): review employees’ means the total combined number of full-time equivalent employees in—
p.(None): ‘‘(i) the Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Commu- nications, Food
p.(None): and Drug Administration; and
p.(None): ‘‘(ii) the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling
p.(None): Branch, Food and Drug Administration.
p.(None): ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the
p.(None): fiscal years 2008 through 2012, there is authorized to be appro- priated for fees under this section an amount
p.(None): equal to the total revenue amount determined under subsection (b) for the
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 839
p.(None):
p.(None): fiscal year, as adjusted pursuant to subsection (c) and para- graph (4) of this subsection, plus amounts
p.(None): collected for the reserve fund under subsection (d).
p.(None): ‘‘(4) OFFSET.—Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees
p.(None): specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the
p.(None): Food and Drug Administra- tion as provided in paragraph (1), and shall be subtracted from the amount of
p.(None): fees that would otherwise be collected under this section pursuant to appropriation Acts for a subse-
p.(None): quent fiscal year.
p.(None): ‘‘(h) DEFINITIONS.—For purposes of this section:
p.(None): ‘‘(1) The term ‘advisory review’ means reviewing and pro- viding advisory comments on DTC advertisements
p.(None): regarding compliance of a proposed advertisement with the requirements of this Act prior to its initial public
p.(None): dissemination.
p.(None): ‘‘(2) The term ‘advisory review fee’ has the meaning indicated for such term in subsection (a)(1)(D).
p.(None): ‘‘(3) The term ‘carry over submission’ means a submission for an advisory review for which a fee was
p.(None): paid in one fiscal year that is submitted for review in the following fiscal year. ‘‘(4) The term
p.(None): ‘direct-to-consumer television advertisement’ means an advertisement for a prescription drug product (as
p.(None): defined in section 735(3)) intended to be displayed on any
p.(None): television channel for less than 3 minutes.
p.(None): ‘‘(5) The term ‘DTC advertisement’ has the meaning indicated for such term in subsection (a)(1)(A).
p.(None): ‘‘(6) The term ‘operating reserve fee’ has the meaning indicated for such term in subsection (a)(2)(A).
p.(None): ‘‘(7) The term ‘person’ includes an individual, partnership, corporation, and association, and any affiliate
p.(None): thereof or suc- cessor in interest.
p.(None): ‘‘(8) The term ‘process for the advisory review of prescrip- tion drug advertising’ means the activities
p.(None): necessary to review and provide advisory comments on DTC advertisements prior to public dissemination and,
p.(None): to the extent the Secretary has additional staff resources available under the program under this section
p.(None): that are not necessary for the advisory review of DTC advertisements, the activities necessary to review
p.(None): and provide advisory comments on other proposed advertisements and promotional material prior to public
p.(None): dissemination.
p.(None): ‘‘(9) The term ‘resources allocated for the process for the advisory review of prescription drug
p.(None): advertising’ means the expenses incurred in connection with the process for the advisory review of
p.(None): prescription drug advertising for—
p.(None): ‘‘(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Adminis-
p.(None): tration, advisory committees, and costs related to such officers, employees, and committees, and to contracts
p.(None): with such contractors;
p.(None): ‘‘(B) management of information, and the acquisition, maintenance, and repair of computer resources;
p.(None): ‘‘(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair
p.(None): of fix- tures, furniture, scientific equipment, and other necessary materials and supplies;
p.(None):
p.(None):
p.(None): 121 STAT. 840 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(D) collection of fees under this section and accounting for resources allocated for the advisory review of prescrip-
p.(None): tion drug advertising; and
p.(None): ‘‘(E) terminating the program under this section pursu- ant to subsection (f)(2) if that becomes necessary.
p.(None): ‘‘(10) The term ‘resubmission’ means a subsequent submis- sion for advisory review of a direct-to-consumer
p.(None): television advertisement that has been revised in response to the Sec- retary’s comments on an original
p.(None): submission. A resubmission may not introduce significant new concepts or creative themes into the television
p.(None): advertisement.
p.(None): ‘‘(11) The term ‘submission for advisory review’ means an original submission of a direct-to-consumer
p.(None): television advertise- ment for which the sponsor voluntarily requests advisory com- ments before the advertisement is
p.(None): publicly disseminated.’’.
p.(None): SEC. 105. REAUTHORIZATION; REPORTING REQUIREMENTS.
p.(None): Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.), as amended by section 104, is further
p.(None): amended by inserting after section 736A the following:
p.(None):
p.(None): 21 USC 379h–2.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Website.
p.(None): ‘‘SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS.
p.(None): ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal year 2008, not later than 120 days after the end of each
p.(None): fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the
p.(None): Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor,
p.(None): and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving
p.(None): the goals identified in the letters described in section 101(c) of the Food and Drug Administration
p.(None): Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug Administration
p.(None): for meeting the goals. The report for a fiscal year shall include informa- tion on all previous cohorts for
p.(None): which the Secretary has not given a complete response on all human drug applications and supple- ments in
p.(None): the cohort.
p.(None): ‘‘(b) FISCAL REPORT.—Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal
p.(None): year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on
p.(None): Energy and Commerce of the House of Rep- resentatives and the Committee on Health, Education, Labor, and
p.(None): Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal
p.(None): year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.
p.(None): ‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall make the reports required under subsections (a) and
p.(None): (b) available to the public on the Internet Web site of the Food and Drug Administra- tion.
p.(None): ‘‘(d) REAUTHORIZATION.—
p.(None): ‘‘(1) CONSULTATION.—In developing recommendations to present to the Congress with respect to the goals,
p.(None): and plans for meeting the goals, for the process for the review of human drug applications for the first 5
p.(None): fiscal years after fiscal year 2012, and for the reauthorization of this part for such fiscal years, the
p.(None): Secretary shall consult with—
p.(None): ‘‘(A) the Committee on Energy and Commerce of the House of Representatives;
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 841
p.(None):
p.(None):
p.(None): ‘‘(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
p.(None): ‘‘(C) scientific and academic experts; ‘‘(D) health care professionals;
p.(None): ‘‘(E) representatives of patient and consumer advocacy groups; and
p.(None): ‘‘(F) the regulated industry.
p.(None): ‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations with the regulated industry on the reauthorization of
p.(None): this part, the Secretary shall—
p.(None): ‘‘(A) publish a notice in the Federal Register requesting public input on the reauthorization;
p.(None): ‘‘(B) hold a public meeting at which the public may present its views on the reauthorization, including
p.(None): specific suggestions for changes to the goals referred to in sub- section (a);
p.(None): ‘‘(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting
p.(None): changes to this part; and
p.(None): ‘‘(D) publish the comments on the Food and Drug Administration’s Internet Web site.
p.(None): ‘‘(3) PERIODIC CONSULTATION.—Not less frequently than once every month during negotiations with the
p.(None): regulated industry, the Secretary shall hold discussions with representa- tives of patient and consumer advocacy
p.(None): groups to continue discussions of their views on the reauthorization and their suggestions for changes to
p.(None): this part as expressed under para- graph (2).
p.(None): ‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotia-
p.(None): tions with the regulated industry, the Secretary shall—
p.(None): ‘‘(A) present the recommendations developed under paragraph (1) to the Congressional committees
p.(None): specified in such paragraph;
p.(None): ‘‘(B) publish such recommendations in the Federal Reg- ister;
p.(None): ‘‘(C) provide for a period of 30 days for the public to provide written comments on such
p.(None): recommendations; ‘‘(D) hold a meeting at which the public may present
p.(None): its views on such recommendations; and
p.(None): ‘‘(E) after consideration of such public views and com- ments, revise such recommendations as necessary.
p.(None): ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than
p.(None): January 15, 2012, the Secretary shall transmit to the Congress the revised recommendations under paragraph (4), a
p.(None): summary of the views and comments received under such paragraph, and any changes made to the
p.(None): recommendations in response to such views and comments.
p.(None): ‘‘(6) MINUTES OF NEGOTIATION MEETINGS.—
p.(None): ‘‘(A) PUBLIC AVAILABILITY.—Before presenting the rec- ommendations developed under paragraphs (1) through (5) to
p.(None): the Congress, the Secretary shall make publicly avail- able, on the public Web site of the Food and Drug
p.(None): Adminis- tration, minutes of all negotiation meetings conducted under this subsection between the Food and
p.(None): Drug Adminis- tration and the regulated industry.
p.(None): ‘‘(B) CONTENT.—The minutes described under subpara- graph (A) shall summarize any substantive proposal made
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None):
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p.(None):
p.(None):
p.(None): Website.
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None):
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p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None): Website.
p.(None):
p.(None):
p.(None): 121 STAT. 842 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): by any party to the negotiations as well as significant controversies or differences of opinion during
p.(None): the negotia- tions and their resolution.’’.
p.(None): SEC. 106. SUNSET DATES.
p.(None):
p.(None): 21 USC 379g
p.(None): note.
p.(None): 21 USC 379h–2.
p.(None):
p.(None): 21 USC 379g
p.(None): note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379g
p.(None): note.
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None): Medical Device User Fee Amendments of 2007.
p.(None):
p.(None): 21 USC 301 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379i
p.(None): note.
p.(None): (a) AUTHORIZATION.—The amendments made by sections 102, 103, and 104 cease to be effective October 1, 2012.
p.(None): (b) REPORTING REQUIREMENTS.—The amendment made by sec- tion 105 ceases to be effective January 31, 2013.
p.(None): SEC. 107. EFFECTIVE DATE.
p.(None): The amendments made by this title shall take effect on October 1, 2007, or the date of the enactment of this
p.(None): Act, whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food,
p.(None): Drug, and Cosmetic Act shall be assessed for all human drug applications received on or after October 1,
p.(None): 2007, regardless of the date of the enactment of this Act.
p.(None): SEC. 108. SAVINGS CLAUSE.
p.(None): Notwithstanding section 509 of the Prescription Drug User Fee Amendments of 2002 (21 U.S.C. 379g note),
p.(None): and notwith- standing the amendments made by this title, part 2 of subchapter C of chapter VII of the
p.(None): Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of
p.(None): this title, shall continue to be in effect with respect to human drug applications and supplements (as
p.(None): defined in such part as of such day) that on or after October 1, 2002, but before October 1, 2007,
p.(None): were accepted by the Food and Drug Administration for filing with respect to assessing and collecting
p.(None): any fee required by such part for a fiscal year prior to fiscal year 2008.
p.(None): SEC. 109. TECHNICAL AMENDMENT; CONFORMING AMENDMENT.
p.(None): (a) Section 739 (21 U.S.C. 379j–11) is amended in the matter preceding paragraph (1) by striking
p.(None): ‘‘subchapter’’ and inserting ‘‘part’’.
p.(None): (b) Paragraph (11) of section 739 (21 U.S.C. 379j–11) is amended by striking ‘‘735(9)’’ and inserting ‘‘735(11)’’.
p.(None): TITLE II—MEDICAL DEVICE USER FEE AMENDMENTS OF 2007
p.(None): SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING.
p.(None): (a) SHORT TITLE.—This title may be cited as the ‘‘Medical Device User Fee Amendments of 2007’’.
p.(None): (b) REFERENCES IN TITLE.—Except as otherwise specified, amendments made by this title to a section
p.(None): or other provision of law are amendments to such section or other provision of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 301 et seq.).
p.(None): (c) FINDING.—The Congress finds that the fees authorized under the amendments made by this title will be dedicated
p.(None): toward expe- diting the process for the review of device applications and for assuring the safety and
p.(None): effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C
p.(None): of chapter VII of the Federal Food, Drug, and Cosmetic Act in the letters from the Secretary of Health
p.(None): and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pen- sions of the Senate and
p.(None): the Chairman of the Committee on Energy
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 843
p.(None):
p.(None): and Commerce of the House of Representatives, as set forth in the Congressional Record.
p.(None): Subtitle A—Fees Related to Medical Devices
p.(None):
p.(None):
p.(None): SEC. 211. DEFINITIONS.
p.(None): Section 737 is amended—
p.(None): (1) in the matter preceding paragraph (1), by striking ‘‘For purposes of this subchapter’’ and inserting ‘‘For
p.(None): purposes of this part’’;
p.(None): (2) by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (8), (9), (10), and (12), respectively;
p.(None): (3) by inserting after paragraph (4) the following:
p.(None): ‘‘(5) The term ‘30-day notice’ means a notice under section 515(d)(6) that is limited to a request to make
p.(None): modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness
p.(None): of the device.
p.(None): ‘‘(6) The term ‘request for classification information’ means a request made under section 513(g) for information
p.(None): respecting the class in which a device has been classified or the require- ments applicable to a device.
p.(None): ‘‘(7) The term ‘annual fee’, for periodic reporting concerning a class III device, means the annual fee associated with
p.(None): periodic reports required by a premarket application approval order.’’;
p.(None): (4) in paragraph (10), as so redesignated—
...
p.(None): may be paid at 50 percent of the fee that applies under sub- section (a)(2)(A)(viii), and as established
p.(None): under subsection (c)(1).’’.
p.(None): (f) EFFECT OF FAILURE TO PAY FEES.—Section 738(f) (21 U.S.C. 379j(f)) is amended to read as follows:
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): ‘‘(f) EFFECT OF FAILURE TO PAY FEES.—
p.(None): 121 STAT. 849
p.(None): ‘‘(1) NO ACCEPTANCE OF SUBMISSIONS.—A premarket
p.(None): application, premarket report, supplement, premarket notifica- tion submission, 30-day notice, request for
p.(None): classification information, or periodic reporting concerning a class III device submitted by a person subject to
p.(None): fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the
p.(None): Secretary until all fees owed by such person have been paid.
p.(None): ‘‘(2) NO REGISTRATION.—Registration information submitted under section 510 by an establishment subject to a
p.(None): registration fee shall be considered incomplete and shall not be accepted by the Secretary until the
p.(None): registration fee under subsection (a)(3) owed for the establishment has been paid. Until the fee is paid
p.(None): and the registration is complete, the establishment is deemed to have failed to register in accordance with section
p.(None): 510.’’.
p.(None): (g) CONDITIONS.—Section 738(g) (21 U.S.C. 379j(g)) is amended—
p.(None): (1) by striking paragraph (1) and inserting the following: ‘‘(1) PERFORMANCE GOALS; TERMINATION OF
p.(None): PROGRAM.— With respect to the amount that, under the salaries and expenses account of the Food
p.(None): and Drug Administration, is appropriated for a fiscal year for devices and radiological prod- ucts, fees may not
p.(None): be assessed under subsection (a) for the fiscal year, and the Secretary is not expected to meet any
p.(None): performance goals identified for the fiscal year, if—
p.(None): ‘‘(A) the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the
p.(None): fiscal year, is more than 1 percent less than $205,720,000 multi- plied by the adjustment factor applicable to
p.(None): such fiscal year; or
p.(None): ‘‘(B) fees were not assessed under subsection (a) for the previous fiscal year.’’; and
p.(None): (2) by amending paragraph (2) to read as follows:
p.(None): ‘‘(2) AUTHORITY.—If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year
p.(None): because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such
p.(None): fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket
p.(None): applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for
p.(None): classification information, periodic reporting concerning a class III device, and establishment registrations
p.(None): at any time in such fiscal year, notwithstanding the provisions of subsection
p.(None): (a) relating to the date fees are to be paid.’’.
p.(None): (h) CREDITING AND AVAILABILITY OF FEES.—
p.(None): (1) AUTHORIZATION OF APPROPRIATIONS.—Section 738(h)(3) (21 U.S.C. 379j(h)(3)) is amended to read as follows:
p.(None): ‘‘(3) AUTHORIZATIONS OF APPROPRIATIONS.—There are
p.(None): authorized to be appropriated for fees under this section— ‘‘(A) $48,431,000 for fiscal year 2008;
p.(None): ‘‘(B) $52,547,000 for fiscal year 2009; ‘‘(C) $57,014,000 for fiscal year 2010;
p.(None): ‘‘(D) $61,860,000 for fiscal year 2011; and ‘‘(E) $67,118,000 for fiscal year 2012.’’.
p.(None):
p.(None):
p.(None): 121 STAT. 850 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): (2) OFFSET.—Section 738(h)(4) (21 U.S.C. 379j(h)(3)) is
p.(None): amended to read as follows:
p.(None): ‘‘(4) OFFSET.—If the cumulative amount of fees collected during fiscal years 2008, 2009, and 2010, added to the
p.(None): amount estimated to be collected for fiscal year 2011, which estimate shall be based upon the amount of
p.(None): fees received by the Sec- retary through June 30, 2011, exceeds the amount of fees specified in
p.(None): aggregate in paragraph (3) for these four fiscal years, the aggregate amount in excess shall be credited
p.(None): to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be
p.(None): subtracted from the amount of fees that would otherwise be authorized to be collected under this section
p.(None): pursuant to appropriation Acts for fiscal year 2012.’’.
p.(None): SEC. 213. REAUTHORIZATION; REPORTING REQUIREMENTS.
p.(None): Part 3 of subchapter C of chapter VII is amended by inserting after section 738 the following:
p.(None):
p.(None): 21 USC 379j–1.
p.(None):
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p.(None): ‘‘SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS.
p.(None): ‘‘(a) REPORTS.—
p.(None): ‘‘(1) PERFORMANCE REPORT.—For fiscal years 2008 through 2012, not later than 120 days after the end of each
p.(None): fiscal year during which fees are collected under this part, the Sec- retary shall prepare and submit to
p.(None): the Committee on Health, Education, Labor, and Pensions of the Senate and the Com- mittee on Energy and
p.(None): Commerce of the House of Representa- tives, a report concerning the progress of the Food and Drug
p.(None): Administration in achieving the goals identified in the letters described in section 201(c) of the Food and
p.(None): Drug Administration Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug
p.(None): Administration for meeting the goals. The report for a fiscal year shall include information on all
p.(None): previous cohorts for which the Secretary has not given a complete response on all device premarket
p.(None): applications and reports, supplements, and premarket notifications in the cohort. ‘‘(2) FISCAL REPORT.—For fiscal
p.(None): years 2008 through 2012,
p.(None): not later than 120 days after the end of each fiscal year during which fees are collected under this part, the
p.(None): Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the
p.(None): Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the implementation
p.(None): of the authority for such fees during such fiscal year and the use, by the Food and Drug Administra- tion, of
p.(None): the fees collected during such fiscal year for which the report is made.
p.(None): ‘‘(3) PUBLIC AVAILABILITY.—The Secretary shall make the reports required under paragraphs (1) and (2)
p.(None): available to the public on the Internet Web site of the Food and Drug Administration.
p.(None): ‘‘(b) REAUTHORIZATION.—
p.(None): ‘‘(1) CONSULTATION.—In developing recommendations to present to Congress with respect to the goals, and
p.(None): plans for meeting the goals, for the process for the review of device applications for the first 5
p.(None): fiscal years after fiscal year 2012, and for the reauthorization of this part for such fiscal years, the
p.(None): Secretary shall consult with—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 851
p.(None):
p.(None):
p.(None): ‘‘(A) the Committee on Energy and Commerce of the House of Representatives;
p.(None): ‘‘(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
p.(None): ‘‘(C) scientific and academic experts; ‘‘(D) health care professionals;
p.(None): ‘‘(E) representatives of patient and consumer advocacy groups; and
p.(None): ‘‘(F) the regulated industry.
p.(None): ‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations with the regulated industry on the reauthorization of
p.(None): this part, the Secretary shall—
p.(None): ‘‘(A) publish a notice in the Federal Register requesting public input on the reauthorization;
p.(None): ‘‘(B) hold a public meeting at which the public may present its views on the reauthorization, including
p.(None): specific suggestions for changes to the goals referred to in sub- section (a)(1);
p.(None): ‘‘(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting
p.(None): changes to this part; and
p.(None): ‘‘(D) publish the comments on the Food and Drug Administration’s Internet Web site.
p.(None): ‘‘(3) PERIODIC CONSULTATION.—Not less frequently than once every month during negotiations with the
p.(None): regulated industry, the Secretary shall hold discussions with representa- tives of patient and consumer advocacy
p.(None): groups to continue discussions of their views on the reauthorization and their suggestions for changes to
p.(None): this part as expressed under para- graph (2).
p.(None): ‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotia-
p.(None): tions with the regulated industry, the Secretary shall—
p.(None): ‘‘(A) present the recommendations developed under paragraph (1) to the Congressional committees
p.(None): specified in such paragraph;
p.(None): ‘‘(B) publish such recommendations in the Federal Reg- ister;
p.(None): ‘‘(C) provide for a period of 30 days for the public to provide written comments on such
p.(None): recommendations; ‘‘(D) hold a meeting at which the public may present
p.(None): its views on such recommendations; and
p.(None): ‘‘(E) after consideration of such public views and com- ments, revise such recommendations as necessary.
p.(None): ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than
p.(None): January 15, 2012, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a
p.(None): summary of the views and comments received under such paragraph, and any changes made to the
p.(None): recommendations in response to such views and comments.
p.(None): ‘‘(6) MINUTES OF NEGOTIATION MEETINGS.—
p.(None): ‘‘(A) PUBLIC AVAILABILITY.—Before presenting the rec- ommendations developed under paragraphs (1) through (5) to
p.(None): the Congress, the Secretary shall make publicly avail- able, on the public Web site of the Food and Drug
p.(None): Adminis- tration, minutes of all negotiation meetings conducted under this subsection between the Food and
p.(None): Drug Adminis- tration and the regulated industry.
p.(None):
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p.(None): Federal Register, publication.
p.(None):
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p.(None):
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p.(None): Website.
p.(None):
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p.(None): Federal Register, publication.
p.(None):
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p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None): Website.
p.(None):
p.(None):
p.(None): 121 STAT. 852 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(B) CONTENT.—The minutes described under subpara- graph (A) shall summarize any substantive proposal made by any
p.(None): party to the negotiations as well as significant controversies or differences of opinion during the
p.(None): negotia- tions and their resolution.’’.
p.(None):
p.(None): 21 USC 379i
p.(None): note.
p.(None):
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p.(None):
p.(None): 21 USC 379i
p.(None): note.
p.(None):
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p.(None):
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p.(None): 21 USC 379i
p.(None): note.
p.(None): SEC. 214. SAVINGS CLAUSE.
p.(None): Notwithstanding section 107 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250),
p.(None): and notwith- standing the amendments made by this subtitle, part 3 of sub- chapter C of chapter VII of
p.(None): the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the
p.(None): date of the enactment of this subtitle, shall continue to be in effect with respect to premarket
p.(None): applications, premarket reports, premarket notification submissions, and supplements (as defined in such part
p.(None): as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the
p.(None): Food and Drug Administration for filing with respect to assessing and collecting any fee required by such
p.(None): part for a fiscal year prior to fiscal year 2008.
p.(None): SEC. 215. ADDITIONAL AUTHORIZATION OF APPROPRIATIONS FOR POSTMARKET SAFETY INFORMATION.
p.(None): For the purpose of collecting, developing, reviewing, and evalu- ating postmarket safety information on medical
p.(None): devices, there are authorized to be appropriated to the Food and Drug Administration, in addition to the amounts
p.(None): authorized by other provisions of law for such purpose—
p.(None): (1) $7,100,000 for fiscal year 2008;
p.(None): (2) $7,455,000 for fiscal year 2009;
p.(None): (3) $7,827,750 for fiscal year 2010;
p.(None): (4) $8,219,138 for fiscal year 2011; and (5) $8,630,094 for fiscal year 2012.
p.(None): SEC. 216. EFFECTIVE DATE.
p.(None): The amendments made by this subtitle shall take effect on October 1, 2007, or the date of the enactment of
p.(None): this Act, whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal
p.(None): Food, Drug, and Cosmetic Act shall be assessed for all premarket applications, premarket reports, supplements,
p.(None): 30-day notices, and premarket notification submissions received on or after October 1, 2007, regardless of the
p.(None): date of the enactment of this Act.
p.(None): SEC. 217. SUNSET CLAUSE.
p.(None): The amendments made by this subtitle cease to be effective October 1, 2012, except that section 738A of
p.(None): the Federal Food, Drug, and Cosmetic Act (regarding annual performance and finan- cial reports) ceases to be
p.(None): effective January 31, 2013.
p.(None): Subtitle B—Amendments Regarding Regulation of Medical Devices
p.(None): SEC. 221. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF PREMARKET NOTIFICATION.
p.(None): Section 523(c) (21 U.S.C. 360m(c)) is amended by striking ‘‘2007’’ and inserting ‘‘2012’’.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 853
p.(None):
p.(None):
p.(None): SEC. 222. REGISTRATION.
p.(None): (a) ANNUAL REGISTRATION OF PRODUCERS OF DRUGS AND
p.(None): DEVICES.—Section 510(b) (21 U.S.C. 360(b)) is amended—
p.(None): (1) by striking ‘‘(b) On or before’’ and inserting ‘‘(b)(1) On or before’’;
p.(None): (2) by striking ‘‘or a device or devices’’; and
p.(None): (3) by adding at the end the following:
p.(None): ‘‘(2) During the period beginning on October 1 and ending on December 31 of each year, every person
p.(None): who owns or operates any establishment in any State engaged in the manufacture, preparation,
p.(None): propagation, compounding, or processing of a device or devices shall register with the Secretary his
p.(None): name, places of business, and all such establishments.’’.
p.(None): (b) REGISTRATION OF FOREIGN ESTABLISHMENTS.—Section 510(i)(1) (21 U.S.C. 360(i)(1)) is amended by
p.(None): striking ‘‘On or before December 31’’ and all that follows and inserting the following: ‘‘Any establishment
p.(None): within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a
p.(None): drug or device that is imported or offered for import into the United States shall, through electronic
p.(None): means in accordance with the criteria of the Secretary—
p.(None): ‘‘(A) upon first engaging in any such activity, immediately register with the Secretary the name and place of
p.(None): business of the establishment, the name of the United States agent for the establishment, the name of each
p.(None): importer of such drug or device in the United States that is known to the establish- ment, and the name
p.(None): of each person who imports or offers for import such drug or device to the United States for purposes of
p.(None): importation; and
p.(None): ‘‘(B) each establishment subject to the requirements of subparagraph (A) shall thereafter—
p.(None): ‘‘(i) with respect to drugs, register with the Secretary on or before December 31 of each year; and
p.(None): ‘‘(ii) with respect to devices, register with the Secretary during the period beginning on October 1 and ending
p.(None): on December 31 of each year.’’.
p.(None): SEC. 223. FILING OF LISTS OF DRUGS AND DEVICES MANUFACTURED, PREPARED, PROPAGATED, AND COMPOUNDED BY REG-
p.(None): ISTRANTS; STATEMENTS; ACCOMPANYING DISCLOSURES.
p.(None): Section 510(j)(2) (21 U.S.C. 360(j)(2)) is amended, in the matter preceding subparagraph (A), by striking ‘‘Each
p.(None): person’’ and all that follows through ‘‘the following information:’’ and inserting ‘‘Each person who
p.(None): registers with the Secretary under this section shall report to the Secretary, with regard to drugs once
p.(None): during the month of June of each year and once during the month of December of each year, and with
p.(None): regard to devices once each year during the period beginning on October 1 and ending on December 31, the following
p.(None): information:’’.
p.(None): SEC. 224. ELECTRONIC REGISTRATION AND LISTING.
p.(None): Section 510(p) (21 U.S.C. 360(p)) is amended to read as follows: ‘‘(p) Registrations and listings under this
p.(None): section (including
p.(None): the submission of updated information) shall be submitted to the Secretary by electronic means unless the
p.(None): Secretary grants a request for waiver of such requirement because use of electronic means is not reasonable
p.(None): for the person requesting such waiver.’’.
p.(None):
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p.(None):
p.(None): Reports. Deadlines.
p.(None):
p.(None):
p.(None): 121 STAT. 854 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Study.
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p.(None): Federal Register, publication.
p.(None): SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE.
p.(None): (a) IN GENERAL.—The Comptroller General of the United States shall conduct a study on the appropriate use of
p.(None): the process under section 510(k) of the Federal Food, Drug, and Cosmetic Act as part of the device
p.(None): classification process to determine whether a new device is as safe and effective as a classified device.
p.(None): (b) CONSIDERATION.—In determining the effectiveness of the premarket notification and classification
p.(None): authority under section 510(k) and subsections (f) and (i) of section 513 of the Federal Food, Drug, and
p.(None): Cosmetic Act, the study under subsection (a) shall consider the Secretary of Health and Human Services’s evaluation of
p.(None): the respective intended uses and technologies of such devices, including the effectiveness of such
p.(None): Secretary’s comparative assess- ment of technological characteristics such as device materials, prin- ciples of
p.(None): operations, and power sources.
p.(None): (c) REPORT.—Not later than 1 year after the date of the enact- ment of this Act, the Comptroller General shall complete
p.(None): the study under subsection (a) and submit to the Congress a report on the results of such study.
p.(None): SEC. 226. UNIQUE DEVICE IDENTIFICATION SYSTEM.
p.(None): (a) IN GENERAL.—Section 519 (21 U.S.C. 360i) is amended—
p.(None): (1) by redesignating subsection (f) as subsection (g); and
p.(None): (2) by inserting after subsection (e) the following:
p.(None): ‘‘Unique Device Identification System
p.(None): ‘‘(f) The Secretary shall promulgate regulations establishing a unique device identification system for medical
p.(None): devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative
p.(None): placement or provides an exception for a particular device or type of device. The unique identifier
p.(None): shall adequately identify the device through distribution and use, and may include information on the lot or
p.(None): serial number.’’.
p.(None): (b) CONFORMING AMENDMENT.—Section 303 (21 U.S.C. 333) is amended—
p.(None): (1) by redesignating the subsection that follows subsection
p.(None): (e) as subsection (f); and
p.(None): (2) in paragraph (1)(B)(ii) of subsection (f), as so redesig- nated, by striking ‘‘519(f)’’ and inserting
p.(None): ‘‘519(g)’’.
p.(None): SEC. 227. FREQUENCY OF REPORTING FOR CERTAIN DEVICES.
...
p.(None): operator of an establishment elects to submit audit reports under this subparagraph, the owner or
p.(None): operator shall submit all such audit reports with respect to the establishment during the preceding 2-year
p.(None): periods.’’; and
p.(None): (6) in paragraph (10)(C)(iii), by striking ‘‘based’’ and inserting ‘‘base’’.
p.(None): SEC. 229. STUDY OF NOSOCOMIAL INFECTIONS RELATING TO MEDICAL DEVICES.
p.(None): (a) IN GENERAL.—The Comptroller General of the United States shall conduct a study on—
p.(None): (1) the number of nosocomial infections attributable to new and reused medical devices; and
p.(None): (2) the causes of such nosocomial infections, including the following:
p.(None): (A) Reprocessed single-use devices.
p.(None): (B) Handling of sterilized medical devices.
p.(None): (C) In-hospital sterilization of medical devices.
p.(None): (D) Health care professionals’ practices for patient examination and treatment.
p.(None): (E) Hospital-based policies and procedures for infection control and prevention.
p.(None): (F) Hospital-based practices for handling of medical waste.
p.(None): (G) Other causes.
p.(None): (b) REPORT.—Not later than 1 year after the date of the enact- ment of this Act, the Comptroller General shall complete
p.(None): the study under subsection (a) and submit to the Congress a report on the results of such study.
p.(None): (c) DEFINITION.—In this section, the term ‘‘nosocomial infection’’ means an infection that is acquired while an
p.(None): individual is a patient at a hospital and was neither present nor incubating in the patient prior to receiving services
p.(None): in the hospital.
p.(None): SEC. 230. REPORT BY THE FOOD AND DRUG ADMINISTRATION REGARDING LABELING INFORMATION ON THE RELATION-
p.(None): SHIP BETWEEN THE USE OF INDOOR TANNING DEVICES AND DEVELOPMENT OF SKIN CANCER OR OTHER SKIN DAMAGE.
p.(None): (a) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’),
p.(None): acting through the Commissioner of Food and Drugs, shall determine—
p.(None): (1) whether the labeling requirements for indoor tanning devices, including the positioning requirements,
p.(None): provide suffi- cient information to consumers regarding the risks that the use of such devices pose for
p.(None): the development of irreversible damage to the eyes and skin, including skin cancer; and
p.(None): (2)(A) whether modifying the warning label required on tanning beds to read, ‘‘Ultraviolet radiation can
p.(None): cause skin cancer’’, or any other additional warning, would communicate the risks of indoor tanning more
p.(None): effectively; or
p.(None): (B) whether there is no warning that would be capable of adequately communicating such risks.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 859
p.(None):
p.(None):
p.(None): (b) CONSUMER TESTING.—In making the determinations under subsection (a), the Secretary shall conduct
p.(None): appropriate consumer testing to determine consumer understanding of label warnings.
p.(None): (c) REPORT.—Not later than 1 year after the date of the enact- ment of this Act, the Secretary shall submit to
p.(None): the Congress a report that provides the determinations under subsection (a). In addition, the Secretary
p.(None): shall include in the report the measures being implemented by the Secretary to significantly reduce the
p.(None): risks associated with indoor tanning devices.
p.(None): TITLE III—PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007
p.(None): SEC. 301. SHORT TITLE.
p.(None): This title may be cited as the ‘‘Pediatric Medical Device Safety and Improvement Act of 2007’’.
p.(None): SEC. 302. TRACKING PEDIATRIC DEVICE APPROVALS.
p.(None): Chapter V of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 351 et seq.) is amended by inserting after section 515 the following:
p.(None): ‘‘SEC. 515A. PEDIATRIC USES OF DEVICES.
p.(None): ‘‘(a) NEW DEVICES.—
p.(None): ‘‘(1) IN GENERAL.—A person that submits to the Secretary an application under section 520(m), or an
p.(None): application (or supplement to an application) or a product development protocol under section 515, shall include
p.(None): in the application or protocol the information described in paragraph (2).
p.(None): ‘‘(2) REQUIRED INFORMATION.—The application or protocol described in paragraph (1) shall include, with
p.(None): respect to the device for which approval is sought and if readily available— ‘‘(A) a description of any
p.(None): pediatric subpopulations that
p.(None): suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and
p.(None): ‘‘(B) the number of affected pediatric patients.
p.(None): ‘‘(3) ANNUAL REPORT.—Not later than 18 months after the date of the enactment of this section, and annually thereafter,
p.(None): the Secretary shall submit to the Committee on Health, Edu- cation, Labor, and Pensions of the Senate
p.(None): and the Committee on Energy and Commerce of the House of Representatives a report that includes—
p.(None): ‘‘(A) the number of devices approved in the year pre- ceding the year in which the report is submitted, for
p.(None): which there is a pediatric subpopulation that suffers from the disease or condition that the device is
p.(None): intended to treat, diagnose, or cure;
p.(None): ‘‘(B) the number of devices approved in the year pre- ceding the year in which the report is
p.(None): submitted, labeled for use in pediatric patients;
p.(None): ‘‘(C) the number of pediatric devices approved in the year preceding the year in which the report is
p.(None): submitted, exempted from a fee pursuant to section 738(a)(2)(B)(v); and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Pediatric Medical Device Safety and Improvement Act of 2007.
p.(None):
p.(None): 21 USC 301 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 360e–1.
p.(None):
p.(None):
p.(None): 121 STAT. 860 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(D) the review time for each device described in sub- paragraphs (A), (B), and (C).
p.(None): ‘‘(b) DETERMINATION OF PEDIATRIC EFFECTIVENESS BASED ON SIMILAR COURSE OF DISEASE OR CONDITION
p.(None): OR SIMILAR EFFECT OF DEVICE ON ADULTS.—
p.(None): ‘‘(1) IN GENERAL.—If the course of the disease or condition and the effects of the device are sufficiently
p.(None): similar in adults and pediatric patients, the Secretary may conclude that adult data may be used to
p.(None): support a determination of a reasonable assurance of effectiveness in pediatric populations, as appro-
p.(None): priate.
p.(None): ‘‘(2) EXTRAPOLATION BETWEEN SUBPOPULATIONS.—A study
p.(None): may not be needed in each pediatric subpopulation if data from one subpopulation can be extrapolated to
p.(None): another sub- population.
p.(None): ‘‘(c) PEDIATRIC SUBPOPULATION.—For purposes of this section, the term ‘pediatric subpopulation’ has the
p.(None): meaning given the term in section 520(m)(6)(E)(ii).’’.
p.(None): SEC. 303. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION.
p.(None): (a) IN GENERAL.—Section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is amended—
p.(None): (1) in paragraph (3), by striking ‘‘No’’ and inserting ‘‘Except as provided in paragraph (6), no’’;
p.(None): (2) in paragraph (5)—
p.(None): (A) by inserting ‘‘, if the Secretary has reason to believe that the requirements of paragraph (6) are no longer met,’’
p.(None): after ‘‘public health’’; and
p.(None): (B) by adding at the end the following: ‘‘If the person granted an exemption under paragraph (2) fails
p.(None): to dem- onstrate continued compliance with the requirements of this subsection, the Secretary may suspend
p.(None): or withdraw the exemption from the effectiveness requirements of sec- tions 514 and 515 for a
p.(None): humanitarian device only after providing notice and an opportunity for an informal hearing.’’; and
p.(None): (3) by striking paragraph (6) and inserting after paragraph
p.(None): (5) the following new paragraphs:
p.(None): ‘‘(6)(A) Except as provided in subparagraph (D), the prohibition in paragraph (3) shall not apply with respect
p.(None): to a person granted an exemption under paragraph (2) if each of the following conditions apply:
p.(None): ‘‘(i)(I) The device with respect to which the exemption is granted is intended for the treatment or diagnosis
p.(None): of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such
p.(None): device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or
p.(None): condition occurs.
p.(None): ‘‘(II) The device was not previously approved under this subsection for the pediatric patients or the pediatric
p.(None): subpopula- tion described in subclause (I) prior to the date of the enactment of the Pediatric Medical Device
p.(None): Safety and Improvement Act of 2007.
...
p.(None): committee regarding whether the Secretary should take action under this Act in response to the report.
p.(None): ‘‘(8) The Secretary, acting through the Office of Pediatric Thera- peutics and the Center for Devices and
p.(None): Radiological Health, shall provide for an annual review by the Pediatric Advisory Committee
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Notification.
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Applicability.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Annual review.
p.(None):
p.(None):
p.(None): 121 STAT. 862 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): of all devices described in paragraph (6) to ensure that the exemp- tion under paragraph (2) remains appropriate
p.(None): for the pediatric populations for which it is granted.’’.
p.(None): (b) REPORT.—Not later than January 1, 2012, the Comptroller General of the United States shall submit to
p.(None): the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representa- tives a report on the impact of allowing persons granted an exemp- tion
p.(None): under section 520(m)(2) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C. 360j(m)(2)) with
p.(None): respect to a device to profit from such device pursuant to section 520(m)(6) of such Act (21
p.(None): U.S.C. 360j(m)(6)) (as amended by subsection (a)), including—
p.(None): (1) an assessment of whether such section 520(m)(6) (as amended by subsection (a)) has increased the
p.(None): availability of pediatric devices for conditions that occur in small numbers of children, including any
p.(None): increase or decrease in the number of—
p.(None): (A) exemptions granted under such section 520(m)(2) for pediatric devices; and
p.(None): (B) applications approved under section 515 of such Act (21 U.S.C. 360e) for devices intended to treat,
p.(None): diagnose, or cure conditions that occur in pediatric patients or for devices labeled for use in a pediatric
p.(None): population;
p.(None): (2) the conditions or diseases the pediatric devices were intended to treat or diagnose and the
p.(None): estimated size of the pediatric patient population for each condition or disease;
p.(None): (3) the costs of purchasing pediatric devices, based on a representative sampling of children’s hospitals;
p.(None): (4) the extent to which the costs of such devices are covered by health insurance;
p.(None): (5) the impact, if any, of allowing profit on access to such devices for patients;
p.(None): (6) the profits made by manufacturers for each device that receives an exemption;
p.(None): (7) an estimate of the extent of the use of the pediatric devices by both adults and pediatric populations
p.(None): for a condition or disease other than the condition or disease on the label of such devices;
p.(None): (8) recommendations of the Comptroller General of the United States regarding the effectiveness of
p.(None): such section 520(m)(6) (as amended by subsection (a)) and whether any modifications to such section
p.(None): 520(m)(6) (as amended by sub- section (a)) should be made;
p.(None): (9) existing obstacles to pediatric device development; and
p.(None): (10) an evaluation of the demonstration grants described in section 305, which shall include an evaluation of
p.(None): the number of pediatric medical devices—
p.(None): (A) that have been or are being studied in children;
p.(None):
p.(None): and
p.(None): (B) that have been submitted to the Food and Drug
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): 21 USC 360j
p.(None): note.
p.(None): Administration for approval, clearance, or review under such section 520(m) (as amended by this Act) and
p.(None): any regulatory actions taken.
p.(None): (c) GUIDANCE.—Not later than 180 days after the date of the enactment of this Act, the Commissioner of
p.(None): Food and Drugs shall issue guidance for institutional review committees on how to evaluate requests
p.(None): for approval for devices for which a humanitarian
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 863
p.(None):
p.(None):
p.(None): device exemption under section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) has been
p.(None): granted.
p.(None): SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH.
p.(None): (a) CONTACT POINT FOR AVAILABLE FUNDING.—Section 402(b) of the Public Health Service Act (42 U.S.C.
p.(None): 282(b)) is amended—
p.(None): (1) in paragraph (21), by striking ‘‘and’’ after the semicolon at the end;
p.(None): (2) in paragraph (22), by striking the period at the end and inserting ‘‘; and’’; and
p.(None): (3) by inserting after paragraph (22) the following:
p.(None): ‘‘(23) shall designate a contact point or office to help innovators and physicians identify sources
p.(None): of funding available for pediatric medical device development.’’.
p.(None): (b) PLAN FOR PEDIATRIC MEDICAL DEVICE RESEARCH.—
p.(None): (1) IN GENERAL.—Not later than 180 days after the date of the enactment of this Act, the Secretary of
p.(None): Health and Human Services, acting through the Commissioner of Food and Drugs, the Director of the
p.(None): National Institutes of Health, and the Director of the Agency for Healthcare Research and Quality, shall
p.(None): submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on
p.(None): Energy and Commerce of the House of Representatives a plan for expanding pediatric medical device research and
p.(None): develop- ment. In developing such plan, the Secretary of Health and Human Services shall consult with
p.(None): individuals and organiza- tions with appropriate expertise in pediatric medical devices.
p.(None): (2) CONTENTS.—The plan under paragraph (1) shall include—
p.(None): (A) the current status of federally funded pediatric medical device research;
p.(None): (B) any gaps in such research, which may include a survey of pediatric medical providers regarding unmet
p.(None): pediatric medical device needs, as needed; and
p.(None): (C) a research agenda for improving pediatric medical device development and Food and Drug Administration
p.(None): clearance or approval of pediatric medical devices, and for evaluating the short- and long-term safety and
p.(None): effective- ness of pediatric medical devices.
p.(None): SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE AVAILABILITY.
p.(None): (a) IN GENERAL.—
p.(None): (1) REQUEST FOR PROPOSALS.—Not later than 90 days after the date of the enactment of this Act, the
p.(None): Secretary of Health and Human Services shall issue a request for proposals for 1 or more grants or
p.(None): contracts to nonprofit consortia for dem- onstration projects to promote pediatric device development.
p.(None): (2) DETERMINATION ON GRANTS OR CONTRACTS.—Not later than 180 days after the date the Secretary of Health
p.(None): and Human Services issues a request for proposals under paragraph (1), the Secretary shall make a determination
p.(None): on the grants or contracts under this section.
p.(None): (b) APPLICATION.—A nonprofit consortium that desires to receive a grant or contract under this
p.(None): section shall submit an application to the Secretary of Health and Human Services at such time, in such
p.(None): manner, and containing such information as the Secretary may require.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 282 note. Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 864 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): (c) USE OF FUNDS.—A nonprofit consortium that receives a grant or contract under this section shall facilitate
p.(None): the development, production, and distribution of pediatric medical devices by—
p.(None): (1) encouraging innovation and connecting qualified individuals with pediatric device ideas with
p.(None): potential manufac- turers;
p.(None): (2) mentoring and managing pediatric device projects through the development process, including product
p.(None): identifica- tion, prototype design, device development, and marketing;
p.(None): (3) connecting innovators and physicians to existing Federal and non-Federal resources, including resources from
p.(None): the Food and Drug Administration, the National Institutes of Health, the Small Business Administration, the
p.(None): Department of Energy, the Department of Education, the National Science Foundation, the Department of Veterans Affairs,
p.(None): the Agency for Healthcare Research and Quality, and the National Institute of Standards and Technology;
p.(None): (4) assessing the scientific and medical merit of proposed pediatric device projects; and
p.(None): (5) providing assistance and advice as needed on business development, personnel training, prototype
p.(None): development, postmarket needs, and other activities consistent with the pur- poses of this section.
p.(None): (d) COORDINATION.—
p.(None): (1) NATIONAL INSTITUTES OF HEALTH.—Each consortium that receives a grant or contract under this section
p.(None): shall—
p.(None): (A) coordinate with the National Institutes of Health’s pediatric device contact point or office, designated
p.(None): under section 402(b)(23) of the Public Health Service Act, as added by section 304(a) of this Act; and
p.(None): (B) provide to the National Institutes of Health any identified pediatric device needs that the consortium
p.(None): lacks sufficient capacity to address or those needs in which the consortium has been unable to stimulate
p.(None): manufacturer interest.
p.(None): (2) FOOD AND DRUG ADMINISTRATION.—Each consortium that receives a grant or contract under this section shall
p.(None): coordi- nate with the Commissioner of Food and Drugs and device companies to facilitate the application for
p.(None): approval or clearance of devices labeled for pediatric use.
p.(None):
p.(None): Reports.
p.(None): (3) EFFECTIVENESS AND OUTCOMES.—Each consortium that
p.(None): receives a grant or contract under this section shall annually report to the Secretary of Health and
p.(None): Human Services on the status of pediatric device development, production, and distribution that has been
p.(None): facilitated by the consortium.
p.(None): (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.(None): $6,000,000 for each of fiscal years 2008 through 2012.
p.(None): SEC. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND PEDIATRIC ADVISORY COMMITTEE.
p.(None): (a) OFFICE OF PEDIATRIC THERAPEUTICS.—Section 6(b) of the Best Pharmaceuticals for Children Act (21
p.(None): U.S.C. 393a(b)) is amended by inserting ‘‘, including increasing pediatric access to medical devices’’
p.(None): after ‘‘pediatric issues’’.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 865
p.(None):
p.(None): (b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C.
p.(None): 284m note) is amended—
p.(None): (1) in subsection (a), by inserting ‘‘(including drugs and biological products) and medical devices’’
p.(None): after ‘‘therapeutics’’; and
p.(None): (2) in subsection (b)—
p.(None): (A) in paragraph (1), by inserting ‘‘(including drugs and biological products) and medical devices’’ after
p.(None): ‘‘thera- peutics’’; and
p.(None): (B) in paragraph (2)—
p.(None): (i) in subparagraph (A), by striking ‘‘and 505B’’ and inserting ‘‘505B, 510(k), 515, and 520(m)’’;
p.(None): (ii) by striking subparagraph (B) and inserting the following:
p.(None): ‘‘(B) identification of research priorities related to therapeutics (including drugs and biological
p.(None): products) and medical devices for pediatric populations and the need for additional diagnostics and treatments
p.(None): for specific pediatric diseases or conditions;’’; and
p.(None): (iii) in subparagraph (C), by inserting ‘‘(including drugs and biological products) and medical devices’’
p.(None): after ‘‘therapeutics’’.
p.(None): SEC. 307. POSTMARKET SURVEILLANCE.
p.(None): Section 522 of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 360l) is amended—
p.(None): (1) by amending the section heading and designation to read as follows:
p.(None): ‘‘SEC. 522. POSTMARKET SURVEILLANCE.’’;
p.(None): (2) by striking subsection (a) and inserting the following: ‘‘(a) POSTMARKET SURVEILLANCE.—
p.(None): ‘‘(1) IN GENERAL.—
p.(None): ‘‘(A) CONDUCT.—The Secretary may by order require a manufacturer to conduct postmarket surveillance for any
p.(None): device of the manufacturer that is a class II or class III device—
p.(None): ‘‘(i) the failure of which would be reasonably likely to have serious adverse health consequences;
p.(None): ‘‘(ii) that is expected to have significant use in pediatric populations; or
p.(None): ‘‘(iii) that is intended to be—
p.(None): ‘‘(I) implanted in the human body for more than 1 year; or
p.(None): ‘‘(II) a life-sustaining or life-supporting device used outside a device user facility.
p.(None): ‘‘(B) CONDITION.—The Secretary may order a postmarket surveillance under subparagraph (A) as a
p.(None): condi- tion to approval or clearance of a device described in subparagraph (A)(ii).
p.(None): ‘‘(2) RULE OF CONSTRUCTION.—The provisions of paragraph
p.(None): (1) shall have no effect on authorities otherwise provided under the Act or regulations issued under this Act.’’; and
p.(None): (3) in subsection (b)—
p.(None): (A) by striking ‘‘(b) SURVEILLANCE APPROVAL.—Each’’ and inserting the following:
p.(None): ‘‘(b) SURVEILLANCE APPROVAL.—
p.(None):
p.(None):
p.(None): 121 STAT. 866 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): ‘‘(1) IN GENERAL.—Each’’;
p.(None): (B) by striking ‘‘The Secretary, in consultation’’ and inserting ‘‘Except as provided in paragraph (2),
p.(None): the Sec- retary, in consultation’’;
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Pediatric Research Equity Act of 2007.
p.(None):
p.(None): 21 USC 301 note.
p.(None): (D) by adding at the end the following:
p.(None): ‘‘(2) LONGER SURVEILLANCE FOR PEDIATRIC DEVICES.—The
p.(None): Secretary may by order require a prospective surveillance period of more than 36 months with
p.(None): respect to a device that is expected to have significant use in pediatric populations if such period of
p.(None): more than 36 months is necessary in order to assess the impact of the device on growth and development, or the
p.(None): effects of growth, development, activity level, or other factors on the safety or efficacy of the device.
p.(None): ‘‘(c) DISPUTE RESOLUTION.—A manufacturer may request review under section 562 of any order or condition
p.(None): requiring postmarket surveillance under this section. During the pendency of such review, the device subject to such a
p.(None): postmarket surveillance order or condi- tion shall not, because of noncompliance with such order or condi-
p.(None): tion, be deemed in violation of section 301(q)(1)(C), adulterated under section 501(f)(1), misbranded under
p.(None): section 502(t)(3), or in violation of, as applicable, section 510(k) or section 515, unless deemed
p.(None): necessary to protect the public health.’’.
p.(None):
p.(None): TITLE IV—PEDIATRIC RESEARCH EQUITY ACT OF 2007
p.(None): SEC. 401. SHORT TITLE.
p.(None): This title may be cited as the ‘‘Pediatric Research Equity Act of 2007’’.
p.(None): SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQUITY ACT.
p.(None): (a) IN GENERAL.—Section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amended to
p.(None): read as follows:
p.(None): ‘‘SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL PRODUCTS.
p.(None): ‘‘(a) NEW DRUGS AND BIOLOGICAL PRODUCTS.—
p.(None): ‘‘(1) IN GENERAL.—A person that submits, on or after the date of the enactment of the Pediatric
p.(None): Research Equity Act of 2007, an application (or supplement to an application)— ‘‘(A) under section 505
p.(None): for a new active ingredient,
p.(None): new indication, new dosage form, new dosing regimen, or new route of administration, or
p.(None): ‘‘(B) under section 351 of the Public Health Service Act (42 U.S.C. 262) for a new active ingredient, new
p.(None): indica- tion, new dosage form, new dosing regimen, or new route of administration,
p.(None): shall submit with the application the assessments described in paragraph (2).
p.(None): ‘‘(2) ASSESSMENTS.—
p.(None): ‘‘(A) IN GENERAL.—The assessments referred to in para- graph (1) shall contain data, gathered using appropriate
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 867
p.(None):
p.(None): formulations for each age group for which the assessment is required, that are adequate—
p.(None): ‘‘(i) to assess the safety and effectiveness of the drug or the biological product for the claimed
p.(None): indica- tions in all relevant pediatric subpopulations; and
p.(None): ‘‘(ii) to support dosing and administration for each pediatric subpopulation for which the drug or the
p.(None): biological product is safe and effective.
p.(None): ‘‘(B) SIMILAR COURSE OF DISEASE OR SIMILAR EFFECT OF DRUG OR BIOLOGICAL PRODUCT.—
p.(None): ‘‘(i) IN GENERAL.—If the course of the disease and the effects of the drug are sufficiently similar in adults and
p.(None): pediatric patients, the Secretary may conclude that pediatric effectiveness can be extrapolated from
p.(None): adequate and well-controlled studies in adults, usually supplemented with other information obtained in pedi- atric
p.(None): patients, such as pharmacokinetic studies.
p.(None): ‘‘(ii) EXTRAPOLATION BETWEEN AGE GROUPS.—A
p.(None): study may not be needed in each pediatric age group if data from one age group can be extrapolated to
p.(None): another age group.
p.(None): ‘‘(iii) INFORMATION ON EXTRAPOLATION.—A brief
p.(None): documentation of the scientific data supporting the conclusion under clauses (i) and (ii) shall be
p.(None): included in any pertinent reviews for the application under sec- tion 505 of this Act or section 351 of the Public
p.(None): Health Service Act (42 U.S.C. 262).
p.(None): ‘‘(3) DEFERRAL.—
p.(None): ‘‘(A) IN GENERAL.—On the initiative of the Secretary or at the request of the applicant, the Secretary may
p.(None): defer submission of some or all assessments required under para- graph (1) until a specified date after approval
p.(None): of the drug or issuance of the license for a biological product if—
p.(None): ‘‘(i) the Secretary finds that—
p.(None): ‘‘(I) the drug or biological product is ready for approval for use in adults before pediatric studies are
p.(None): complete;
p.(None): ‘‘(II) pediatric studies should be delayed until additional safety or effectiveness data have been
p.(None): collected; or
p.(None): ‘‘(III) there is another appropriate reason for deferral; and
p.(None): ‘‘(ii) the applicant submits to the Secretary—
p.(None): ‘‘(I) certification of the grounds for deferring the assessments;
p.(None): ‘‘(II) a description of the planned or ongoing studies;
p.(None): ‘‘(III) evidence that the studies are being con- ducted or will be conducted with due diligence and at the
p.(None): earliest possible time; and
p.(None): ‘‘(IV) a timeline for the completion of such studies.
p.(None): ‘‘(B) ANNUAL REVIEW.—
p.(None): ‘‘(i) IN GENERAL.—On an annual basis following the approval of a deferral under subparagraph (A), the
p.(None): applicant shall submit to the Secretary the fol- lowing information:
p.(None):
p.(None):
p.(None): 121 STAT. 868 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(I) Information detailing the progress made in conducting pediatric studies.
p.(None): ‘‘(II) If no progress has been made in con- ducting such studies, evidence and documentation that such
p.(None): studies will be conducted with due dili- gence and at the earliest possible time.
p.(None):
p.(None): Website.
p.(None): ‘‘(ii) PUBLIC AVAILABILITY.—The information sub- mitted through the annual review under clause (i) shall
p.(None): promptly be made available to the public in an easily accessible manner, including through the Web site
p.(None): of the Food and Drug Administration.
p.(None): ‘‘(4) WAIVERS.—
p.(None): ‘‘(A) FULL WAIVER.—On the initiative of the Secretary or at the request of an applicant, the Secretary shall
p.(None): grant a full waiver, as appropriate, of the requirement to submit assessments for a drug or biological product
p.(None): under this subsection if the applicant certifies and the Secretary finds that—
p.(None): ‘‘(i) necessary studies are impossible or highly impracticable (because, for example, the number of
p.(None): patients is so small or the patients are geographically dispersed);
p.(None): ‘‘(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or
p.(None): unsafe in all pediatric age groups; or
p.(None): ‘‘(iii) the drug or biological product—
p.(None): ‘‘(I) does not represent a meaningful thera- peutic benefit over existing therapies for pediatric patients; and
p.(None): ‘‘(II) is not likely to be used in a substantial number of pediatric patients.
p.(None): ‘‘(B) PARTIAL WAIVER.—On the initiative of the Sec- retary or at the request of an applicant, the
p.(None): Secretary shall grant a partial waiver, as appropriate, of the require- ment to submit assessments for a drug or
p.(None): biological product under this subsection with respect to a specific pediatric age group if the applicant
p.(None): certifies and the Secretary finds that—
p.(None): ‘‘(i) necessary studies are impossible or highly impracticable (because, for example, the number of
p.(None): patients in that age group is so small or patients in that age group are geographically dispersed);
p.(None): ‘‘(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or
p.(None): unsafe in that age group;
p.(None): ‘‘(iii) the drug or biological product—
p.(None): ‘‘(I) does not represent a meaningful thera- peutic benefit over existing therapies for pediatric patients in
p.(None): that age group; and
p.(None): ‘‘(II) is not likely to be used by a substantial number of pediatric patients in that age group; or
p.(None): ‘‘(iv) the applicant can demonstrate that reasonable attempts to produce a pediatric formulation necessary for that age
p.(None): group have failed.
p.(None): ‘‘(C) PEDIATRIC FORMULATION NOT POSSIBLE.—If a
p.(None): waiver is granted on the ground that it is not possible
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 869
p.(None):
p.(None):
p.(None): to develop a pediatric formulation, the waiver shall cover only the pediatric groups requiring that
p.(None): formulation. An applicant seeking either a full or partial waiver shall submit to the Secretary
p.(None): documentation detailing why a pediatric formulation cannot be developed and, if the waiver is granted, the
p.(None): applicant’s submission shall promptly be made available to the public in an easily accessible manner, including
p.(None): through posting on the Web site of the Food and Drug Administration.
p.(None): ‘‘(D) LABELING REQUIREMENT.—If the Secretary grants a full or partial waiver because there is evidence
p.(None): that a drug or biological product would be ineffective or unsafe in pediatric populations, the information shall be
p.(None): included in the labeling for the drug or biological product.
p.(None): ‘‘(b) MARKETED DRUGS AND BIOLOGICAL PRODUCTS.—
p.(None): ‘‘(1) IN GENERAL.—After providing notice in the form of a letter (that, for a drug approved under section
p.(None): 505, references a declined written request under section 505A for a labeled indication which written
p.(None): request is not referred under section 505A(n)(1)(A) to the Foundation of the National Institutes of Health
p.(None): for the pediatric studies), the Secretary may (by order in the form of a letter) require the sponsor
p.(None): or holder of an approved application for a drug under section 505 or the holder of a license for a biological
p.(None): product under section 351 of the Public Health Service Act to submit by a specified date the assessments
p.(None): described in subsection (a)(2), if the Secretary finds that—
p.(None): ‘‘(A)(i) the drug or biological product is used for a substantial number of pediatric patients for the
p.(None): labeled indications; and
p.(None): ‘‘(ii) adequate pediatric labeling could confer a benefit on pediatric patients;
p.(None): ‘‘(B) there is reason to believe that the drug or biological product would represent a
p.(None): meaningful thera- peutic benefit over existing therapies for pediatric patients for 1 or more of the claimed
p.(None): indications; or
p.(None): ‘‘(C) the absence of adequate pediatric labeling could pose a risk to pediatric patients.
p.(None): ‘‘(2) WAIVERS.—
p.(None): ‘‘(A) FULL WAIVER.—At the request of an applicant, the Secretary shall grant a full waiver, as
p.(None): appropriate, of the requirement to submit assessments under this sub- section if the applicant certifies
p.(None): and the Secretary finds that—
p.(None):
p.(None): Public information. Website.
p.(None): ‘‘(i) necessary studies are impossible or highly impracticable (because, for example, the number of
p.(None): patients in that age group is so small or patients in that age group are geographically dispersed); or
p.(None): ‘‘(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or
p.(None): unsafe in all pediatric age groups.
p.(None): ‘‘(B) PARTIAL WAIVER.—At the request of an applicant, the Secretary shall grant a partial waiver, as appropriate, of
p.(None): the requirement to submit assessments under this sub- section with respect to a specific pediatric age
p.(None): group if the applicant certifies and the Secretary finds that—
p.(None):
p.(None):
p.(None): 121 STAT. 870 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(i) necessary studies are impossible or highly impracticable (because, for example, the number of
p.(None): patients in that age group is so small or patients in that age group are geographically dispersed);
p.(None): ‘‘(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or
p.(None): unsafe in that age group;
p.(None): ‘‘(iii)(I) the drug or biological product—
p.(None): ‘‘(aa) does not represent a meaningful thera- peutic benefit over existing therapies for pediatric patients in
p.(None): that age group; and
p.(None): ‘‘(bb) is not likely to be used in a substantial number of pediatric patients in that age group; and
p.(None): ‘‘(II) the absence of adequate labeling could not pose significant risks to pediatric patients; or
p.(None): ‘‘(iv) the applicant can demonstrate that reasonable attempts to produce a pediatric formulation necessary for that age
p.(None): group have failed.
p.(None): ‘‘(C) PEDIATRIC FORMULATION NOT POSSIBLE.—If a
p.(None): waiver is granted on the ground that it is not possible to develop a pediatric formulation, the waiver
p.(None): shall cover
p.(None):
p.(None): Public information. Website.
p.(None): only the pediatric groups requiring that formulation. An applicant seeking either a full or partial
p.(None): waiver shall submit to the Secretary documentation detailing why a pediatric formulation cannot be developed
p.(None): and, if the waiver is granted, the applicant’s submission shall promptly be made available to the public in an
p.(None): easily accessible manner, including through posting on the Web site of the Food and Drug Administration.
p.(None): ‘‘(D) LABELING REQUIREMENT.—If the Secretary grants a full or partial waiver because there is evidence
p.(None): that a drug or biological product would be ineffective or unsafe in pediatric populations, the information shall be
p.(None): included in the labeling for the drug or biological product.
p.(None): ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection alters or amends section 301(j) of this Act or
p.(None): section 552 of title 5 or section 1905 of title 18, United States Code.
p.(None): ‘‘(c) MEANINGFUL THERAPEUTIC BENEFIT.—For the purposes of paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of
p.(None): subsection (a) and para-
p.(None): graphs (1)(B) and (2)(B)(iii)(I)(aa) of subsection (b), a drug or biological product shall be
p.(None): considered to represent a meaningful therapeutic benefit over existing therapies if the Secretary deter-
p.(None): mines that—
p.(None): ‘‘(1) if approved, the drug or biological product could rep- resent an improvement in the treatment,
p.(None): diagnosis, or preven- tion of a disease, compared with marketed products adequately labeled for that use in the
p.(None): relevant pediatric population; or ‘‘(2) the drug or biological product is in a class of products
p.(None): or for an indication for which there is a need for additional options.
p.(None): ‘‘(d) SUBMISSION OF ASSESSMENTS.—If a person fails to submit an assessment described in subsection
p.(None): (a)(2), or a request for approval of a pediatric formulation described in subsection (a) or (b), in
p.(None): accordance with applicable provisions of subsections (a) and (b)—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 871
p.(None):
p.(None):
p.(None): ‘‘(1) the drug or biological product that is the subject of the assessment or request may be considered
p.(None): misbranded solely because of that failure and subject to relevant enforcement action (except that the drug
p.(None): or biological product shall not be subject to action under section 303); but
p.(None): ‘‘(2) the failure to submit the assessment or request shall not be the basis for a proceeding—
p.(None): ‘‘(A) to withdraw approval for a drug under section 505(e); or
p.(None): ‘‘(B) to revoke the license for a biological product under section 351 of the Public Health Service Act.
p.(None): ‘‘(e) MEETINGS.—Before and during the investigational process for a new drug or biological product, the
p.(None): Secretary shall meet at appropriate times with the sponsor of the new drug or biological product to discuss—
p.(None): ‘‘(1) information that the sponsor submits on plans and timelines for pediatric studies; or
p.(None): ‘‘(2) any planned request by the sponsor for waiver or deferral of pediatric studies.
p.(None): ‘‘(f) REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS,
p.(None): AND WAIVERS.—
p.(None): ‘‘(1) REVIEW.—Beginning not later than 30 days after the date of the enactment of the Pediatric Research
p.(None): Equity Act of 2007, the Secretary shall utilize the internal committee estab- lished under section 505C to provide
p.(None): consultation to reviewing divisions on all pediatric plans and assessments prior to approval of an
p.(None): application or supplement for which a pediatric assessment is required under this section and all deferral and waiver
p.(None): requests granted pursuant to this section.
p.(None): ‘‘(2) ACTIVITY BY COMMITTEE.—The committee referred to in paragraph (1) may operate using appropriate
p.(None): members of such committee and need not convene all members of the com- mittee.
p.(None): ‘‘(3) DOCUMENTATION OF COMMITTEE ACTION.—For each
p.(None): drug or biological product, the committee referred to in para- graph (1) shall document, for each
p.(None): activity described in para- graph (4) or (5), which members of the committee participated in such activity.
p.(None): ‘‘(4) REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS,
p.(None): AND WAIVERS.—Consultation on pediatric plans and assess- ments by the committee referred to in paragraph (1)
p.(None): pursuant to this section shall occur prior to approval of an application or supplement for which a
p.(None): pediatric assessment is required under this section. The committee shall review all requests for deferrals
p.(None): and waivers from the requirement to submit a pediatric assessment granted under this section and shall pro- vide
p.(None): recommendations as needed to reviewing divisions, including with respect to whether such a
p.(None): supplement, when submitted, shall be considered for priority review.
p.(None): ‘‘(5) RETROSPECTIVE REVIEW OF PEDIATRIC ASSESSMENTS,
p.(None): DEFERRALS, AND WAIVERS.—Not later than 1 year after the date of the enactment of the Pediatric Research
p.(None): Equity Act of 2007, the committee referred to in paragraph (1) shall con- duct a retrospective review
p.(None): and analysis of a representative sample of assessments submitted and deferrals and waivers approved under
p.(None): this section since the enactment of the Pediatric Research Equity Act of 2003. Such review shall include an
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 872 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): analysis of the quality and consistency of pediatric information in pediatric assessments and the appropriateness
p.(None): of waivers
p.(None):
p.(None): Recommen- dations.
p.(None):
p.(None):
p.(None):
p.(None): Public information. Website.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): and deferrals granted. Based on such review, the Secretary shall issue recommendations to the review
p.(None): divisions for improvements and initiate guidance to industry related to the scope of pediatric studies
p.(None): required under this section.
p.(None): ‘‘(6) TRACKING OF ASSESSMENTS AND LABELING CHANGES.—
p.(None): The Secretary, in consultation with the committee referred to in paragraph (1), shall track and make
p.(None): available to the public in an easily accessible manner, including through posting on the Web site of the Food and
p.(None): Drug Administration—
p.(None): ‘‘(A) the number of assessments conducted under this section;
p.(None): ‘‘(B) the specific drugs and biological products and their uses assessed under this section;
p.(None): ‘‘(C) the types of assessments conducted under this section, including trial design, the number of
p.(None): pediatric patients studied, and the number of centers and countries involved;
p.(None): ‘‘(D) the total number of deferrals requested and granted under this section and, if granted, the
p.(None): reasons for such deferrals, the timeline for completion, and the number completed and pending by the
p.(None): specified date, as outlined in subsection (a)(3);
p.(None): ‘‘(E) the number of waivers requested and granted under this section and, if granted, the reasons for
p.(None): the waivers;
p.(None): ‘‘(F) the number of pediatric formulations developed and the number of pediatric formulations not
p.(None): developed and the reasons any such formulation was not developed; ‘‘(G) the labeling changes made as a
p.(None): result of assess-
p.(None): ments conducted under this section;
p.(None): ‘‘(H) an annual summary of labeling changes made as a result of assessments conducted under this section
p.(None): for distribution pursuant to subsection (h)(2);
p.(None): ‘‘(I) an annual summary of information submitted pursuant to subsection (a)(3)(B); and
p.(None): ‘‘(J) the number of times the committee referred to in paragraph (1) made a recommendation to the Secretary
p.(None): under paragraph (4) regarding priority review, the number of times the Secretary followed or did not follow
p.(None): such a recommendation, and, if not followed, the reasons why such a recommendation was not followed.
p.(None): ‘‘(g) LABELING CHANGES.—
p.(None): ‘‘(1) DISPUTE RESOLUTION.—
p.(None): ‘‘(A) REQUEST FOR LABELING CHANGE AND FAILURE TO
p.(None): AGREE.—If, on or after the date of the enactment of the Pediatric Research Equity Act of 2007, the
p.(None): Commissioner determines that a sponsor and the Commissioner have been unable to reach agreement on
p.(None): appropriate changes to the labeling for the drug that is the subject of the application or supplement,
p.(None): not later than 180 days after the date of the submission of the application or supple- ment—
p.(None): ‘‘(i) the Commissioner shall request that the sponsor of the application make any labeling change
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 873
p.(None):
p.(None): that the Commissioner determines to be appropriate; and
p.(None):
p.(None): ‘‘(ii) if the sponsor does not agree within 30 days after the Commissioner’s request to make a labeling
p.(None): change requested by the Commissioner, the Commis- sioner shall refer the matter to the Pediatric Advisory
p.(None): Committee.
p.(None): ‘‘(B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.—
p.(None): Not later than 90 days after receiving a referral under subparagraph (A)(ii), the Pediatric Advisory
p.(None): Committee shall—
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None): ‘‘(i) review the pediatric study reports; and
p.(None): ‘‘(ii) make a recommendation to the Commissioner concerning appropriate labeling changes, if any.
p.(None): ‘‘(C) CONSIDERATION OF RECOMMENDATIONS.—The
p.(None): Commissioner shall consider the recommendations of the Pediatric Advisory Committee and, if appropriate, not
p.(None): later than 30 days after receiving the recommendation, make a request to the sponsor of the application
p.(None): or supplement to make any labeling changes that the Commissioner deter- mines to be appropriate.
p.(None): ‘‘(D) MISBRANDING.—If the sponsor of the application or supplement, within 30 days after receiving a
p.(None): request under subparagraph (C), does not agree to make a labeling change requested by the Commissioner, the
p.(None): Commissioner may deem the drug that is the subject of the application or supplement to be misbranded.
p.(None): ‘‘(E) NO EFFECT ON AUTHORITY.—Nothing in this sub- section limits the authority of the United States to
p.(None): bring an enforcement action under this Act when a drug lacks appropriate pediatric labeling. Neither course of
p.(None): action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence)
p.(None): shall preclude, delay, or serve as the basis to stay the other course of action.
p.(None): ‘‘(2) OTHER LABELING CHANGES.—If, on or after the date of the enactment of the Pediatric Research Equity
p.(None): Act of 2007, the Secretary makes a determination that a pediatric assess- ment conducted under this section
p.(None): does or does not demonstrate that the drug that is the subject of such assessment is safe and effective
p.(None): in pediatric populations or subpopulations, including whether such assessment results are inconclusive,
p.(None): the Secretary shall order the label of such product to include information about the results of the
p.(None): assessment and a state- ment of the Secretary’s determination.
p.(None): ‘‘(h) DISSEMINATION OF PEDIATRIC INFORMATION.—
p.(None): ‘‘(1) IN GENERAL.—Not later than 210 days after the date of submission of a pediatric assessment under
p.(None): this section, the Secretary shall make available to the public in an easily accessible manner the medical,
p.(None): statistical, and clinical pharma- cology reviews of such pediatric assessments, and shall post such
p.(None): assessments on the Web site of the Food and Drug Administration.
p.(None): ‘‘(2) DISSEMINATION OF INFORMATION REGARDING LABELING
p.(None): CHANGES.—Beginning on the date of the enactment of the Pedi- atric Research Equity Act of 2007, the Secretary
p.(None): shall require that the sponsors of the assessments that result in labeling
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Public information. Website.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Effective date.
p.(None):
p.(None):
p.(None): 121 STAT. 874 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): changes that are reflected in the annual summary developed pursuant to subsection (f)(6)(H) distribute
p.(None): such information to physicians and other health care providers.
p.(None): ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection shall alter or amend section 301(j) of this Act
p.(None): or section 552 of title 5 or section 1905 of title 18, United States Code.
p.(None): ‘‘(i) ADVERSE EVENT REPORTING.—
p.(None):
p.(None): Effective date.
p.(None): ‘‘(1) REPORTING IN YEAR ONE.—Beginning on the date of the enactment of the Pediatric Research Equity
p.(None): Act of 2007, during the one-year period beginning on the date a labeling change is made pursuant to
p.(None): subsection (g), the Secretary shall ensure that all adverse event reports that have been received for such
p.(None): drug (regardless of when such report was received) are referred to the Office of Pediatric Therapeutics.
p.(None): In consid- ering such reports, the Director of such Office shall provide for the review of such reports
p.(None): by the Pediatric Advisory Com- mittee, including obtaining any recommendations of such com- mittee regarding
p.(None): whether the Secretary should take action under this Act in response to such reports.
p.(None): ‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Following the one-
p.(None): year period described in paragraph (1), the Secretary shall, as appropriate, refer to the Office of
p.(None): Pediatric Therapeutics all pediatric adverse event reports for a drug for which a pediatric study was
p.(None): conducted under this section. In considering such reports, the Director of such Office may provide for the
p.(None): review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of such
p.(None): Committee regarding whether the Secretary should take action in response to such reports.
p.(None): ‘‘(3) EFFECT.—The requirements of this subsection shall supplement, not supplant, other review of such
p.(None): adverse event reports by the Secretary.
p.(None): ‘‘(j) SCOPE OF AUTHORITY.—Nothing in this section provides to the Secretary any authority to require
p.(None): a pediatric assessment of any drug or biological product, or any assessment regarding other populations or
p.(None): uses of a drug or biological product, other than the pediatric assessments described in this section.
p.(None): ‘‘(k) ORPHAN DRUGS.—Unless the Secretary requires otherwise by regulation, this section does not apply to any drug for
p.(None): an indica- tion for which orphan designation has been granted under section 526.
p.(None):
p.(None):
p.(None): Deadline. Contracts. Reports.
p.(None): ‘‘(l) INSTITUTE OF MEDICINE STUDY.—
p.(None): ‘‘(1) IN GENERAL.—Not later than three years after the date of the enactment of the Pediatric Research
p.(None): Equity Act of 2007, the Secretary shall contract with the Institute of Medi- cine to conduct a study and report
p.(None): to Congress regarding the pediatric studies conducted pursuant to this section or precursor regulations since 1997
p.(None): and labeling changes made as a result of such studies.
p.(None): ‘‘(2) CONTENT OF STUDY.—The study under paragraph (1) shall review and assess the use of extrapolation
p.(None): for pediatric subpopulations, the use of alternative endpoints for pediatric populations, neonatal assessment
p.(None): tools, the number and type of pediatric adverse events, and ethical issues in pediatric clin- ical trials.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 875
p.(None):
p.(None):
p.(None): ‘‘(3) REPRESENTATIVE SAMPLE.—The Institute of Medicine may devise an appropriate mechanism to review a
p.(None): representa- tive sample of studies conducted pursuant to this section from each review division within the Center
p.(None): for Drug Evaluation and Research in order to make the requested assessment.
p.(None): ‘‘(m) INTEGRATION WITH OTHER PEDIATRIC STUDIES.—The
p.(None): authority under this section shall remain in effect so long as an application subject to this section
p.(None): may be accepted for filing by the Secretary on or before the date specified in section 505A(q).’’.
p.(None): (b) APPLICABILITY.—
p.(None): (1) IN GENERAL.—Notwithstanding subsection (h) of section 505B of the Federal Food, Drug and Cosmetic Act, as in effect
p.(None): on the day before the date of the enactment of this Act, a pending assessment, including a deferred
p.(None): assessment, required under such section 505B shall be deemed to have been required under section 505B of the
p.(None): Federal Food, Drug and Cosmetic Act as in effect on or after the date of the enactment of this Act.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355c
p.(None): note.
p.(None):
p.(None): (2) CERTAIN ASSESSMENTS AND WAIVER REQUESTS.—An assessment pending on or after the date that is
p.(None): 1 year prior to the date of the enactment of this Act shall be subject to the tracking and disclosure
p.(None): requirements established under such section 505B, as in effect on or after such date of enact- ment,
p.(None): except that any such assessments submitted or waivers of such assessments requested before such date of
p.(None): enactment shall not be subject to subsections (a)(4)(C), (b)(2)(C), (f)(6)(F), and (h) of such section 505B.
p.(None): SEC. 403. ESTABLISHMENT OF INTERNAL COMMITTEE.
p.(None): Chapter V of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 351 et seq.) is amended by inserting after section 505B the following:
p.(None): ‘‘SEC. 505C. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, AND WAIVERS.
p.(None): ‘‘The Secretary shall establish an internal committee within the Food and Drug Administration to carry
p.(None): out the activities as described in sections 505A(f) and 505B(f). Such internal committee shall include employees of
p.(None): the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of
p.(None): Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, and the
p.(None): appropriate expertise per- taining to the pediatric product under review, such as expertise in child and
p.(None): adolescent psychiatry, and other individuals designated by the Secretary.’’.
p.(None): SEC. 404. GOVERNMENT ACCOUNTABILITY OFFICE REPORT.
p.(None): Not later than January 1, 2011, the Comptroller General of the United States, in consultation with the
p.(None): Secretary of Health and Human Services, shall submit to the Congress a report that addresses the
p.(None): effectiveness of sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and
p.(None): section 409I of the Public Health Service Act (42 U.S.C. 284m) in ensuring that medicines used by children are
p.(None): tested and properly labeled. Such report shall include—
p.(None): (1) the number and importance of drugs and biological products for children that are being tested as a
p.(None): result of the amendments made by this title and title V and the importance
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Establishment. 21 USC 355d.
p.(None):
p.(None):
p.(None): 121 STAT. 876 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): for children, health care providers, parents, and others of labeling changes made as a result of such
p.(None): testing;
p.(None): (2) the number and importance of drugs and biological products for children that are not being tested
p.(None): for their use notwithstanding the provisions of this title and title V and possible reasons for the lack of
p.(None): testing;
p.(None): (3) the number of drugs and biological products for which testing is being done and labeling changes
p.(None): required, including the date labeling changes are made and which labeling changes required the use of the dispute
p.(None): resolution process established pursuant to the amendments made by this title, together with a description of the
p.(None): outcomes of such process, including a description of the disputes and the recommendations of the Pediatric
p.(None): Advisory Committee;
p.(None): (4) any recommendations for modifications to the programs established under sections 505A and 505B of the Federal Food,
p.(None): Drug, and Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public Health Service Act (42 U.S.C.
p.(None): 284m) that the Secretary determines to be appropriate, including a detailed rationale for each recommendation;
p.(None): and
p.(None): (5)(A) the efforts made by the Secretary to increase the number of studies conducted in the neonate
p.(None): population; and
p.(None): (B) the results of those efforts, including efforts made to encourage the conduct of appropriate studies
p.(None): in neonates by companies with products that have sufficient safety and other information to make the
p.(None): conduct of the studies ethical and safe.
p.(None):
p.(None):
p.(None): Best Pharmaceuticals for Children Act of 2007.
p.(None): 21 USC 301 note.
p.(None): TITLE V—BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007
p.(None): SEC. 501. SHORT TITLE.
p.(None): This title may be cited as the ‘‘Best Pharmaceuticals for Chil- dren Act of 2007’’.
p.(None): SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHIL- DREN ACT.
p.(None): (a) PEDIATRIC STUDIES OF DRUGS.—
p.(None): (1) IN GENERAL.—Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended to read
p.(None): as follows:
p.(None): ‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
p.(None): ‘‘(a) DEFINITIONS.—As used in this section, the term ‘pediatric studies’ or ‘studies’ means at least one
p.(None): clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic studies) in pediatric age
p.(None): groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the
p.(None): discretion of the Secretary, may include preclinical studies.
p.(None): ‘‘(b) MARKET EXCLUSIVITY FOR NEW DRUGS.—
p.(None): ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), if, prior to approval of an application that is
p.(None): submitted under section 505(b)(1), the Secretary determines that information relating to the use of a new
p.(None): drug in the pediatric population may produce health benefits in that population, the Secretary makes a
p.(None): written request for pediatric studies (which shall
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 877
p.(None):
p.(None): include a timeframe for completing such studies), the applicant agrees to the request, such studies are completed using
p.(None): appro- priate formulations for each age group for which the study is requested within any such timeframe, and
p.(None): the reports thereof are submitted and accepted in accordance with subsection (d)(3)—
p.(None): ‘‘(A)(i)(I) the period referred to in subsection (c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii) of such
p.(None): section, is deemed to be five years and six months rather than five years, and the references in
p.(None): subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and
p.(None): one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively;
p.(None): or
p.(None): ‘‘(II) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(E) of such section, and in
p.(None): clauses (iii) and (iv) of subsection (j)(5)(F) of such section, is deemed to be three years and six months
p.(None): rather than three years; and
p.(None): ‘‘(ii) if the drug is designated under section 526 for a rare disease or condition, the period referred to in
p.(None): section 527(a) is deemed to be seven years and six months rather than seven years; and
p.(None): ‘‘(B)(i) if the drug is the subject of—
p.(None): ‘‘(I) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii)
p.(None): or (j)(2)(A)(vii)(II) of section 505 and for which pediatric studies were submitted prior to the
p.(None): expiration of the patent (including any patent extensions); or
p.(None): ‘‘(II) a listed patent for which a certification has been submitted under subsections (b)(2)(A)(iii)
p.(None): or (j)(2)(A)(vii)(III) of section 505,
p.(None): the period during which an application may not be approved under section 505(c)(3) or section
p.(None): 505(j)(5)(B) shall be extended by a period of six months after the date the patent expires (including
p.(None): any patent extensions); or
p.(None): ‘‘(ii) if the drug is the subject of a listed patent for which a certification has been submitted under
p.(None): subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation
p.(None): resulting from the certifi- cation the court determines that the patent is valid and would be infringed,
p.(None): the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B)
p.(None): shall be extended by a period of six months after the date the patent expires (including any patent
p.(None): extensions).
p.(None): ‘‘(2) EXCEPTION.—The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the
p.(None): determination made under subsection (d)(3) is made later than 9 months prior to the expiration of such period.
p.(None): ‘‘(c) MARKET EXCLUSIVITY FOR ALREADY-MARKETED DRUGS.—
p.(None): ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), if the Secretary determines that information
p.(None): relating to the use of an approved drug in the pediatric population may produce health benefits in
p.(None): that population and makes a written request to the holder of an approved application under section
p.(None):
p.(None):
p.(None): 121 STAT. 878 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): 505(b)(1) for pediatric studies (which shall include a timeframe for completing such studies), the holder agrees
p.(None): to the request, such studies are completed using appropriate formulations for each age group for which
p.(None): the study is requested within any such timeframe, and the reports thereof are submitted and accepted in
p.(None): accordance with subsection (d)(3)—
p.(None): ‘‘(A)(i)(I) the period referred to in subsection (c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii) of such
p.(None): section, is deemed to be five years and six months rather than five years, and the references in
p.(None): subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and
p.(None): one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively;
p.(None): or
p.(None): ‘‘(II) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(D) of such section, and in
p.(None): clauses (iii) and (iv) of subsection (j)(5)(F) of such section, is deemed to be three years and six months
p.(None): rather than three years; and
p.(None): ‘‘(ii) if the drug is designated under section 526 for a rare disease or condition, the period referred to in
p.(None): section 527(a) is deemed to be seven years and six months rather than seven years; and
p.(None): ‘‘(B)(i) if the drug is the subject of—
p.(None): ‘‘(I) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii)
p.(None): or (j)(2)(A)(vii)(II) of section 505 and for which pediatric studies were submitted prior to the
p.(None): expiration of the patent (including any patent extensions); or
p.(None): ‘‘(II) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iii)
p.(None): or (j)(2)(A)(vii)(III) of section 505,
p.(None): the period during which an application may not be approved under section 505(c)(3) or section
p.(None): 505(j)(5)(B)(ii) shall be extended by a period of six months after the date the patent expires (including
p.(None): any patent extensions); or
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(ii) if the drug is the subject of a listed patent for which a certification has been submitted under
p.(None): subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation
p.(None): resulting from the certifi- cation the court determines that the patent is valid and would be infringed,
p.(None): the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B)
p.(None): shall be extended by a period of six months after the date the patent expires (including any patent
p.(None): extensions).
p.(None): ‘‘(2) EXCEPTION.—The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the
p.(None): determination made under subsection (d)(3) is made later than 9 months prior to the expiration of such period.
p.(None): ‘‘(d) CONDUCT OF PEDIATRIC STUDIES.— ‘‘(1) REQUEST FOR STUDIES.—
p.(None): ‘‘(A) IN GENERAL.—The Secretary may, after consulta- tion with the sponsor of an application for an
p.(None): investiga- tional new drug under section 505(i), the sponsor of an application for a new drug under
p.(None): section 505(b)(1), or the
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 879
p.(None):
p.(None):
p.(None): holder of an approved application for a drug under section 505(b)(1), issue to the sponsor or holder a written
p.(None): request for the conduct of pediatric studies for such drug. In issuing such request, the Secretary shall take
p.(None): into account ade- quate representation of children of ethnic and racial minori- ties. Such request to conduct
p.(None): pediatric studies shall be in writing and shall include a timeframe for such studies and a request to the
p.(None): sponsor or holder to propose pediatric labeling resulting from such studies.
p.(None): ‘‘(B) SINGLE WRITTEN REQUEST.—A single written request—
p.(None): ‘‘(i) may relate to more than one use of a drug;
p.(None):
p.(None):
p.(None): Minorities.
p.(None):
p.(None):
p.(None): Timeframe.
p.(None):
p.(None): and
p.(None): ‘‘(ii) may include uses that are both approved and
p.(None):
p.(None): unapproved.
p.(None): ‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUDIES.— ‘‘(A) REQUEST AND RESPONSE.—
p.(None): ‘‘(i) IN GENERAL.—If the Secretary makes a written request for pediatric studies (including neonates, as
p.(None): appropriate) under subsection (b) or (c), the applicant or holder, not later than 180 days after
p.(None): receiving the written request, shall respond to the Secretary as to the intention of the applicant or
p.(None): holder to act on the request by—
p.(None): ‘‘(I) indicating when the pediatric studies will be initiated, if the applicant or holder agrees to the
p.(None): request; or
p.(None): ‘‘(II) indicating that the applicant or holder does not agree to the request and stating the rea- sons for
p.(None): declining the request.
p.(None): ‘‘(ii) DISAGREE WITH REQUEST.—If, on or after the date of the enactment of the Best Pharmaceuticals for
p.(None): Children Act of 2007, the applicant or holder does not agree to the request on the grounds that it
p.(None): is not possible to develop the appropriate pediatric formu- lation, the applicant or holder shall submit to the
p.(None): Secretary the reasons such pediatric formulation cannot be developed.
p.(None): ‘‘(B) ADVERSE EVENT REPORTS.—An applicant or holder that, on or after the date of the enactment of the Best
p.(None): Pharmaceuticals for Children Act of 2007, agrees to the request for such studies shall provide the
p.(None): Secretary, at the same time as the submission of the reports of such studies, with all postmarket
p.(None): adverse event reports regarding the drug that is the subject of such studies and are available prior to
p.(None): submission of such reports.
p.(None): ‘‘(3) MEETING THE STUDIES REQUIREMENT.—Not later than
p.(None): 180 days after the submission of the reports of the studies, the Secretary shall accept or reject such
p.(None): reports and so notify the sponsor or holder. The Secretary’s only responsibility in accepting or rejecting
p.(None): the reports shall be to determine, within the 180-day period, whether the studies fairly respond to the
p.(None): written request, have been conducted in accordance with com- monly accepted scientific principles and
p.(None): protocols, and have been reported in accordance with the requirements of the Sec- retary for filing.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Notification.
p.(None):
p.(None):
p.(None): 121 STAT. 880 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(4) EFFECT OF SUBSECTION.—Nothing in this subsection alters or amends section 301(j) of this Act or
p.(None): section 552 of title 5 or section 1905 of title 18, United States Code.
p.(None): ‘‘(e) NOTICE OF DETERMINATIONS ON STUDIES REQUIREMENT.—
p.(None):
p.(None): Publication.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Records.
p.(None):
p.(None):
p.(None): Publication.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public information. Website.
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall publish a notice of any determination, made on or after the date
p.(None): of the enact- ment of the Best Pharmaceuticals for Children Act of 2007, that the requirements of
p.(None): subsection (d) have been met and that submissions and approvals under subsection (b)(2) or (j) of section
p.(None): 505 for a drug will be subject to the provisions of this section. Such notice shall be published not
p.(None): later than
p.(None): 30 days after the date of the Secretary’s determination regarding market exclusivity and shall
p.(None): include a copy of the written request made under subsection (b) or (c).
p.(None): ‘‘(2) IDENTIFICATION OF CERTAIN DRUGS.—The Secretary
p.(None): shall publish a notice identifying any drug for which, on or after the date of the enactment of the
p.(None): Best Pharmaceuticals for Children Act of 2007, a pediatric formulation was developed, studied, and found to be
p.(None): safe and effective in the pediatric population (or specified subpopulation) if the pediatric formula- tion for
p.(None): such drug is not introduced onto the market within one year after the date that the Secretary publishes the
p.(None): notice described in paragraph (1). Such notice identifying such drug shall be published not later than 30
p.(None): days after the date of the expiration of such one year period.
p.(None): ‘‘(f) INTERNAL REVIEW OF WRITTEN REQUESTS AND PEDIATRIC STUDIES.—
p.(None): ‘‘(1) INTERNAL REVIEW.—The Secretary shall utilize the internal review committee established under section
p.(None): 505C to review all written requests issued on or after the date of the enactment of the Best
p.(None): Pharmaceuticals for Children Act of 2007, in accordance with paragraph (2).
p.(None): ‘‘(2) REVIEW OF WRITTEN REQUESTS.—The committee
p.(None): referred to in paragraph (1) shall review all written requests issued pursuant to this section prior to being
p.(None): issued.
p.(None): ‘‘(3) REVIEW OF PEDIATRIC STUDIES.—The committee
p.(None): referred to in paragraph (1) may review studies conducted pursuant to this section to make a
p.(None): recommendation to the Secretary whether to accept or reject such reports under sub- section (d)(3).
p.(None): ‘‘(4) ACTIVITY BY COMMITTEE.—The committee referred to in paragraph (1) may operate using appropriate
p.(None): members of such committee and need not convene all members of the com- mittee.
p.(None): ‘‘(5) DOCUMENTATION OF COMMITTEE ACTION.—For each
p.(None): drug, the committee referred to in paragraph (1) shall docu- ment, for each activity described in paragraph
p.(None): (2) or (3), which members of the committee participated in such activity.
p.(None): ‘‘(6) TRACKING PEDIATRIC STUDIES AND LABELING
p.(None): CHANGES.—The Secretary, in consultation with the committee referred to in paragraph (1), shall track and
p.(None): make available to the public, in an easily accessible manner, including through posting on the Web site of the Food
p.(None): and Drug Administration— ‘‘(A) the number of studies conducted under this section
p.(None): and under section 409I of the Public Health Service Act; ‘‘(B) the specific drugs and drug uses, including
p.(None): labeled and off-labeled indications, studied under such sections;
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 881
p.(None):
p.(None):
p.(None): ‘‘(C) the types of studies conducted under such sections, including trial design, the number of pediatric
p.(None): patients studied, and the number of centers and countries involved; ‘‘(D) the number of pediatric formulations
p.(None): developed and the number of pediatric formulations not developed and the reasons such formulations were
p.(None): not developed; ‘‘(E) the labeling changes made as a result of studies
p.(None): conducted under such sections;
p.(None): ‘‘(F) an annual summary of labeling changes made as a result of studies conducted under such sections
p.(None): for distribution pursuant to subsection (k)(2); and
p.(None): ‘‘(G) information regarding reports submitted on or after the date of the enactment of the Best Pharmaceuticals
p.(None): for Children Act of 2007.
p.(None): ‘‘(g) LIMITATIONS.—Notwithstanding subsection (c)(2), a drug to which the six-month period under subsection (b)
p.(None): or (c) has already been applied—
p.(None): ‘‘(1) may receive an additional six-month period under sub- section (c)(1)(A)(i)(II) for a supplemental application if
p.(None): all other requirements under this section are satisfied, except that such drug may not receive any additional
p.(None): such period under sub- section (c)(1)(B); and
p.(None): ‘‘(2) may not receive any additional such period under subsection (c)(1)(A)(ii).
p.(None): ‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH REQUIREMENTS.—
p.(None): Notwithstanding any other provision of law, if any pediatric study is required by a provision of law (including
p.(None): a regulation) other than this section and such study meets the completeness, timeliness, and other requirements of
p.(None): this section, such study shall be deemed to satisfy the requirement for market exclusivity pursuant to this
p.(None): section.
p.(None): ‘‘(i) LABELING CHANGES.—
p.(None): ‘‘(1) PRIORITY STATUS FOR PEDIATRIC APPLICATIONS AND
p.(None): SUPPLEMENTS.—Any application or supplement to an applica- tion under section 505 proposing a labeling change as a
p.(None): result of any pediatric study conducted pursuant to this section— ‘‘(A) shall be considered to be a
p.(None): priority application
p.(None): or supplement; and
p.(None): ‘‘(B) shall be subject to the performance goals estab- lished by the Commissioner for priority drugs.
p.(None): ‘‘(2) DISPUTE RESOLUTION.—
p.(None): ‘‘(A) REQUEST FOR LABELING CHANGE AND FAILURE TO
p.(None): AGREE.—If, on or after the date of the enactment of the Best Pharmaceuticals for Children Act of
p.(None): 2007, the Commissioner determines that the sponsor and the Commissioner have been unable to reach
p.(None): agreement on appropriate changes to the labeling for the drug that is the subject of the application,
p.(None): not later than 180 days after the date of submission of the application—
p.(None): ‘‘(i) the Commissioner shall request that the sponsor of the application make any labeling change
p.(None): that the Commissioner determines to be appropriate; and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None): ‘‘(ii) if the sponsor of the application does not agree within 30 days after the Commissioner’s request to
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 882 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): make a labeling change requested by the Commis- sioner, the Commissioner shall refer the matter to the
p.(None): Pediatric Advisory Committee.
p.(None): ‘‘(B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.—
p.(None):
p.(None): Deadline.
p.(None): Not later than 90 days after receiving a referral under subparagraph (A)(ii), the Pediatric Advisory
p.(None): Committee shall—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Public information.
p.(None): ‘‘(i) review the pediatric study reports; and
p.(None): ‘‘(ii) make a recommendation to the Commissioner concerning appropriate labeling changes, if any.
p.(None): ‘‘(C) CONSIDERATION OF RECOMMENDATIONS.—The
p.(None): Commissioner shall consider the recommendations of the Pediatric Advisory Committee and, if appropriate, not
p.(None): later than 30 days after receiving the recommendation, make a request to the sponsor of the application
p.(None): to make any labeling change that the Commissioner determines to be appropriate.
p.(None): ‘‘(D) MISBRANDING.—If the sponsor of the application, within 30 days after receiving a request under
p.(None): subpara- graph (C), does not agree to make a labeling change requested by the Commissioner, the
p.(None): Commissioner may deem the drug that is the subject of the application to be misbranded.
p.(None): ‘‘(E) NO EFFECT ON AUTHORITY.—Nothing in this sub- section limits the authority of the United States to
p.(None): bring an enforcement action under this Act when a drug lacks appropriate pediatric labeling. Neither course of
p.(None): action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence)
p.(None): shall preclude, delay, or serve as the basis to stay the other course of action.
p.(None): ‘‘(j) OTHER LABELING CHANGES.—If, on or after the date of the enactment of the Best Pharmaceuticals
p.(None): for Children Act of 2007, the Secretary determines that a pediatric study conducted under this section
p.(None): does or does not demonstrate that the drug that is the subject of the study is safe and effective,
p.(None): including whether such study results are inconclusive, in pediatric populations or subpopulations, the Secretary
p.(None): shall order the labeling of such product to include information about the results of the study and a
p.(None): statement of the Secretary’s determination.
p.(None): ‘‘(k) DISSEMINATION OF PEDIATRIC INFORMATION.—
p.(None): ‘‘(1) IN GENERAL.—Not later than 210 days after the date of submission of a report on a pediatric study under
p.(None): this section, the Secretary shall make available to the public the medical, statistical, and clinical
p.(None): pharmacology reviews of pediatric studies conducted under subsection (b) or (c).
p.(None): ‘‘(2) DISSEMINATION OF INFORMATION REGARDING LABELING
p.(None): CHANGES.—Beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the
p.(None): Secretary shall include as a requirement of a written request that the sponsors of the studies that result in labeling
p.(None): changes that are reflected in the annual summary developed pursuant to subsection (f)(3)(F) distribute,
p.(None): at least annually (or more frequently if the Secretary determines that it would be beneficial to the
p.(None): public health), such information to physicians and other health care providers.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 883
p.(None):
p.(None):
p.(None): ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection alters or amends section 301(j) of this Act or
p.(None): section 552 of title 5 or section 1905 of title 18, United States Code.
p.(None): ‘‘(l) ADVERSE EVENT REPORTING.—
p.(None): ‘‘(1) REPORTING IN YEAR ONE.—Beginning on the date of the enactment of the Best Pharmaceuticals for
p.(None): Children Act of 2007, during the one-year period beginning on the date a labeling change is approved
p.(None): pursuant to subsection (i), the Secretary shall ensure that all adverse event reports that have been received for
p.(None): such drug (regardless of when such report was received) are referred to the Office of Pediatric Thera-
p.(None): peutics established under section 6 of the Best Pharmaceuticals for Children Act (Public Law 107–109). In
p.(None): considering the reports, the Director of such Office shall provide for the review of the reports by the Pediatric
p.(None): Advisory Committee, including obtaining any recommendations of such Committee regarding whether the
p.(None): Secretary should take action under this Act in response to such reports.
p.(None): ‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Following the one-
p.(None): year period described in paragraph (1), the Secretary shall, as appropriate, refer to the Office of
p.(None): Pediatric Therapeutics all pediatric adverse event reports for a drug for which a pediatric study was
p.(None): conducted under this section. In considering such reports, the Director of such Office may provide for the
p.(None): review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of such
p.(None): Committee regarding whether the Secretary should take action in response to such reports.
p.(None): ‘‘(3) EFFECT.—The requirements of this subsection shall supplement, not supplant, other review of such
p.(None): adverse event reports by the Secretary.
p.(None): ‘‘(m) CLARIFICATION OF INTERACTION OF MARKET EXCLUSIVITY UNDER THIS SECTION AND MARKET EXCLUSIVITY AWARDED
p.(None): TO AN APPLICANT FOR APPROVAL OF A DRUG UNDER SECTION 505(j).—
p.(None): If a 180-day period under section 505(j)(5)(B)(iv) overlaps with a 6-month exclusivity period under
p.(None): this section, so that the applicant for approval of a drug under section 505(j) entitled to the
p.(None): 180-day period under that section loses a portion of the 180- day period to which the applicant is
p.(None): entitled for the drug, the 180-day period shall be extended from—
p.(None): ‘‘(1) the date on which the 180-day period would have expired by the number of days of the overlap,
p.(None): if the 180- day period would, but for the application of this subsection, expire after the 6-month
p.(None): exclusivity period; or
p.(None): ‘‘(2) the date on which the 6-month exclusivity period expires, by the number of days of the overlap
p.(None): if the 180- day period would, but for the application of this subsection, expire during the six-month
p.(None): exclusivity period.
p.(None): ‘‘(n) REFERRAL IF PEDIATRIC STUDIES NOT COMPLETED.—
p.(None): ‘‘(1) IN GENERAL.—Beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007,
p.(None): if pedi- atric studies of a drug have not been completed under sub- section (d) and if the Secretary,
p.(None): through the committee estab- lished under section 505C, determines that there is a continuing need for information
p.(None): relating to the use of the drug in the pediatric population (including neonates, as appropriate), the
p.(None): Secretary shall carry out the following:
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Effective date.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Effective date.
p.(None):
p.(None):
p.(None): 121 STAT. 884 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(A) For a drug for which a listed patent has not expired, make a determination regarding whether
p.(None): an assessment shall be required to be submitted under section
p.(None):
p.(None): Deadline. Certification.
p.(None): 505B(b). Prior to making such a determination, the Sec- retary may not take more than 30 days to certify
p.(None): whether the Foundation for the National Institutes of Health has sufficient funding at the time of such
p.(None): certification to initiate and fund all of the studies in the written request in their entirety within the
p.(None): timeframes specified within the written request. Only if the Secretary makes such certification in the
p.(None): affirmative, the Secretary shall refer all pediatric studies in the written request to the Foundation for
p.(None): the National Institutes of Health for the conduct of such studies, and such Foundation shall fund
p.(None): such studies. If no certification has been made at the end of the 30-day period, or if the Secretary
p.(None): certifies that funds are not sufficient to initiate and fund all the studies in their entirety, the
p.(None): Secretary shall consider whether assessments shall be required under section 505B(b) for such drug. ‘‘(B) For
p.(None): a drug that has no listed patents or has
p.(None): 1 or more listed patents that have expired, the Secretary shall refer the drug for inclusion on the
p.(None): list established under section 409I of the Public Health Service Act for the conduct of studies.
p.(None): ‘‘(2) PUBLIC NOTICE.—The Secretary shall give the public notice of a decision under paragraph (1)(A) not
p.(None): to require an assessment under section 505B and the basis for such decision. ‘‘(3) EFFECT OF SUBSECTION.—Nothing
p.(None): in this subsection alters or amends section 301(j) of this Act or section 552 of
p.(None): title 5 or section 1905 of title 18, United States Code.
p.(None): ‘‘(o) PROMPT APPROVAL OF DRUGS UNDER SECTION 505(j) WHEN PEDIATRIC INFORMATION IS ADDED TO LABELING.—
p.(None): ‘‘(1) GENERAL RULE.—A drug for which an application has been submitted or approved under section 505(j)
p.(None): shall not be considered ineligible for approval under that section or mis- branded under section 502 on
p.(None): the basis that the labeling of the drug omits a pediatric indication or any other aspect of labeling
p.(None): pertaining to pediatric use when the omitted indication or other aspect is protected by patent or by
p.(None): exclusivity under clause (iii) or (iv) of section 505(j)(5)(F).
p.(None): ‘‘(2) LABELING.—Notwithstanding clauses (iii) and (iv) of section 505(j)(5)(F), the Secretary may require that
p.(None): the labeling of a drug approved under section 505(j) that omits a pediatric indication or other aspect of
p.(None): labeling as described in paragraph
p.(None): (1) include—
p.(None): ‘‘(A) a statement that, because of marketing exclusivity for a manufacturer—
p.(None): ‘‘(i) the drug is not labeled for pediatric use; or ‘‘(ii) in the case of a drug for which there is
p.(None): an additional pediatric use not referred to in paragraph (1), the drug is not labeled for the pediatric use
p.(None): under
p.(None): paragraph (1); and
p.(None): ‘‘(B) a statement of any appropriate pediatric contra- indications, warnings, or precautions that the
p.(None): Secretary considers necessary.
p.(None): ‘‘(3) PRESERVATION OF PEDIATRIC EXCLUSIVITY AND OTHER
p.(None): PROVISIONS.—This subsection does not affect—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 885
p.(None):
p.(None):
p.(None): ‘‘(A) the availability or scope of exclusivity under this section;
p.(None): ‘‘(B) the availability or scope of exclusivity under sec- tion 505 for pediatric formulations;
p.(None): ‘‘(C) the question of the eligibility for approval of any application under section 505(j) that omits any
p.(None): other condi- tions of approval entitled to exclusivity under clause (iii) or (iv) of section 505(j)(5)(F); or
p.(None): ‘‘(D) except as expressly provided in paragraphs (1) and (2), the operation of section 505.
p.(None): ‘‘(p) INSTITUTE OF MEDICINE STUDY.—Not later than 3 years after the date of the enactment of the Best
p.(None): Pharmaceuticals for Children Act of 2007, the Secretary shall enter into a contract with the Institute
p.(None): of Medicine to conduct a study and report to Congress regarding the written requests made and the
p.(None): studies conducted pursuant to this section. The Institute of Medicine may devise an appropriate mechanism to
p.(None): review a representative sample of requests made and studies conducted pursuant to this section in order to
p.(None): conduct such study. Such study shall—
p.(None): ‘‘(1) review such representative written requests issued by the Secretary since 1997 under subsections (b) and (c);
p.(None): ‘‘(2) review and assess such representative pediatric studies conducted under subsections (b) and (c) since 1997 and
p.(None): labeling changes made as a result of such studies;
p.(None): ‘‘(3) review the use of extrapolation for pediatric subpopula- tions, the use of alternative endpoints for pediatric
p.(None): populations, neonatal assessment tools, and ethical issues in pediatric clin- ical trials;
p.(None): ‘‘(4) review and assess the pediatric studies of biological products as required under subsections (a)
p.(None): and (b) of section 505B; and
p.(None): ‘‘(5) make recommendations regarding appropriate incen- tives for encouraging pediatric studies of biologics.
p.(None): ‘‘(q) SUNSET.—A drug may not receive any 6-month period under subsection (b) or (c) unless—
p.(None): ‘‘(1) on or before October 1, 2012, the Secretary makes a written request for pediatric studies of the drug;
p.(None): ‘‘(2) on or before October 1, 2012, an application for the drug is accepted for filing under section 505(b);
p.(None): and
p.(None): ‘‘(3) all requirements of this section are met.’’.
p.(None): (2) APPLICABILITY.—
p.(None): (A) IN GENERAL.—The amendment made by this sub- section shall apply to written requests under section 505A of
p.(None): the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) issued on or after the date of the enactment
p.(None): of this Act.
p.(None): (B) CERTAIN WRITTEN REQUESTS.—A written request issued under section 505A of the Federal Food, Drug, and
p.(None): Cosmetic Act, as in effect on the day before the date of the enactment of this Act, which has been
p.(None): accepted and for which no determination under subsection (d)(2) of such section has been made before such date of
p.(None): enactment, shall be subject to such section 505A, except that such written requests shall be subject to
p.(None): subsections (d)(2)(A)(ii), (e)(1) and (2), (f), (i)(2)(A), (j), (k)(1), (l)(1), and (n) of section 505A of
p.(None): the Federal Food, Drug, and Cosmetic Act, as
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Contracts. Reports.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Deadline.
p.(None):
p.(None): 21 USC 355a
p.(None): note.
p.(None):
p.(None):
p.(None): 121 STAT. 886 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): in effect on or after the date of the enactment of this Act.
p.(None): (b) PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.—Section 409I of the Public Health Service Act (42 U.S.C. 284m)
p.(None): is amended to read as follows:
p.(None): ‘‘SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.
p.(None): ‘‘(a) LIST OF PRIORITY ISSUES IN PEDIATRIC THERAPEUTICS.—
p.(None):
p.(None): Deadline. Publication.
p.(None): ‘‘(1) IN GENERAL.—Not later than one year after the date of the enactment of the Best Pharmaceuticals
p.(None): for Children Act of 2007, the Secretary, acting through the Director of the National Institutes of Health
p.(None): and in consultation with the Commissioner of Food and Drugs and experts in pediatric research, shall
p.(None): develop and publish a priority list of needs in pediatric therapeutics, including drugs or indications
p.(None): that require study. The list shall be revised every three years. ‘‘(2) CONSIDERATION OF AVAILABLE
p.(None): INFORMATION.—In devel-
p.(None): oping and prioritizing the list under paragraph (1), the Sec- retary shall consider—
p.(None): ‘‘(A) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic
p.(None): deter- minants of drug response, metabolism of drugs and bio- logics in children, and pediatric clinical
p.(None): trials;
p.(None): ‘‘(B) particular pediatric diseases, disorders or condi- tions where more complete knowledge and testing of
p.(None): thera- peutics, including drugs and biologics, may be beneficial in pediatric populations; and
p.(None): ‘‘(C) the adequacy of necessary infrastructure to con- duct pediatric pharmacological research, including
p.(None): research networks and trained pediatric investigators.
p.(None): ‘‘(b) PEDIATRIC STUDIES AND RESEARCH.—The Secretary, acting through the National Institutes of Health, shall
p.(None): award funds to entities that have the expertise to conduct pediatric clinical trials or other research
p.(None): (including qualified universities, hospitals, labora- tories, contract research organizations, practice groups,
p.(None): federally funded programs such as pediatric pharmacology research units, other public or private
p.(None): institutions, or individuals) to enable the entities to conduct the drug studies or other research on the issues
p.(None): described in subsection (a). The Secretary may use contracts, grants, or other appropriate funding mechanisms to
p.(None): award funds under this subsection.
p.(None): ‘‘(c) PROCESS FOR PROPOSED PEDIATRIC STUDY REQUESTS AND
p.(None): LABELING CHANGES.—
p.(None): ‘‘(1) SUBMISSION OF PROPOSED PEDIATRIC STUDY REQUEST.—
p.(None): The Director of the National Institutes of Health shall, as appropriate, submit proposed pediatric
p.(None): study requests for consideration by the Commissioner of Food and Drugs for pedi- atric studies of a specific
p.(None): pediatric indication identified under subsection (a). Such a proposed pediatric study request shall be made
p.(None): in a manner equivalent to a written request made under subsection (b) or (c) of section 505A of the
p.(None): Federal Food, Drug, and Cosmetic Act, including with respect to the information provided on the pediatric
p.(None): studies to be conducted pursuant to the request. The Director of the National Institutes of Health may submit a
p.(None): proposed pediatric study request for a drug for which—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 887
p.(None):
p.(None):
p.(None): ‘‘(A)(i) there is an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic
p.(None): Act; or ‘‘(ii) there is a submitted application that could be
p.(None): approved under the criteria of such section; and
p.(None): ‘‘(B) there is no patent protection or market exclusivity protection for at least one form of the drug under
p.(None): the Federal Food, Drug, and Cosmetic Act; and
p.(None): ‘‘(C) additional studies are needed to assess the safety and effectiveness of the use of the drug in the
p.(None): pediatric population.
p.(None): ‘‘(2) WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICA- TIONS FOR DRUGS LACKING EXCLUSIVITY.—The
p.(None): Commissioner
p.(None): of Food and Drugs, in consultation with the Director of the National Institutes of Health, may issue a
p.(None): written request based on the proposed pediatric study request for the indication or indications submitted pursuant to
p.(None): paragraph (1) (which shall include a timeframe for negotiations for an agreement) for pediatric studies
p.(None): concerning a drug identified under subsection
p.(None): (a) to all holders of an approved application for the drug under section 505 of the Federal Food, Drug, and Cosmetic
p.(None): Act. Such a written request shall be made in a manner equivalent to the manner in which a written
p.(None): request is made under sub- section (b) or (c) of section 505A of such Act, including with respect to
p.(None): information provided on the pediatric studies to be conducted pursuant to the request and using
p.(None): appropriate formulations for each age group for which the study is requested.
p.(None): ‘‘(3) REQUESTS FOR PROPOSALS.—If the Commissioner of Food and Drugs does not receive a response to a written
p.(None): request issued under paragraph (2) not later than 30 days after the date on which a request was issued,
p.(None): the Secretary, acting through the Director of the National Institutes of Health and in consultation with
p.(None): the Commissioner of Food and Drugs, shall publish a request for proposals to conduct the pediatric
p.(None): studies described in the written request in accordance with subsection (b).
p.(None): ‘‘(4) DISQUALIFICATION.—A holder that receives a first right of refusal shall not be entitled to respond to
p.(None): a request for proposals under paragraph (3).
p.(None): ‘‘(5) CONTRACTS, GRANTS, OR OTHER FUNDING MECHA-
p.(None): NISMS.—A contract, grant, or other funding may be awarded under this section only if a proposal is
p.(None): submitted to the Sec- retary in such form and manner, and containing such agree- ments, assurances, and
p.(None): information as the Secretary determines to be necessary to carry out this section.
p.(None): ‘‘(6) REPORTING OF STUDIES.—
p.(None): ‘‘(A) IN GENERAL.—On completion of a pediatric study in accordance with an award under this section, a
p.(None): report concerning the study shall be submitted to the Director of the National Institutes of Health and the
p.(None): Commissioner of Food and Drugs. The report shall include all data gen- erated in connection with the
p.(None): study, including a written request if issued.
p.(None): ‘‘(B) AVAILABILITY OF REPORTS.—Each report submitted under subparagraph (A) shall be considered to be in the
p.(None): public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act) and shall be assigned
p.(None): a
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Publication.
p.(None):
p.(None):
p.(None): 121 STAT. 888 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): docket number by the Commissioner of Food and Drugs. An interested person may submit written comments
p.(None): con- cerning such pediatric studies to the Commissioner of Food and Drugs, and the written comments shall become
p.(None): part of the docket file with respect to each of the drugs.
p.(None): ‘‘(C) ACTION BY COMMISSIONER.—The Commissioner of Food and Drugs shall take appropriate action in
p.(None): response to the reports submitted under subparagraph (A) in accord- ance with paragraph (7).
p.(None): ‘‘(7) REQUESTS FOR LABELING CHANGE.—During the 180-
p.(None): day period after the date on which a report is submitted under paragraph (6)(A), the Commissioner of Food and Drugs
p.(None): shall— ‘‘(A) review the report and such other data as are available concerning the safe and effective use in
p.(None): the pedi-
p.(None): atric population of the drug studied;
p.(None): ‘‘(B) negotiate with the holders of approved applications for the drug studied for any labeling changes that
p.(None): the Commissioner of Food and Drugs determines to be appro- priate and requests the holders to make; and
p.(None): ‘‘(C)(i) place in the public docket file a copy of the report and of any requested labeling changes; and
p.(None):
p.(None): Federal Register, publication.
p.(None): Website.
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(ii) publish in the Federal Register and through a posting on the Web site of the Food and Drug Administra-
p.(None): tion a summary of the report and a copy of any requested labeling changes.
p.(None): ‘‘(8) DISPUTE RESOLUTION.—
p.(None): ‘‘(A) REFERRAL TO PEDIATRIC ADVISORY COMMITTEE.—
p.(None): If, not later than the end of the 180-day period specified in paragraph (7), the holder of an approved
p.(None): application for the drug involved does not agree to any labeling change requested by the Commissioner of Food
p.(None): and Drugs under that paragraph, the Commissioner of Food and Drugs shall refer the request to the Pediatric
p.(None): Advisory Committee. ‘‘(B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.—
p.(None): Not later than 90 days after receiving a referral under subparagraph (A), the Pediatric Advisory
p.(None): Committee shall—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Recommen- dations.
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(i) review the available information on the safe and effective use of the drug in the pediatric popu-
p.(None): lation, including study reports submitted under this section; and
p.(None): ‘‘(ii) make a recommendation to the Commissioner of Food and Drugs as to appropriate labeling changes, if any.
p.(None): ‘‘(9) FDA DETERMINATION.—Not later than 30 days after receiving a recommendation from the Pediatric Advisory
p.(None): Com- mittee under paragraph (8)(B)(ii) with respect to a drug, the Commissioner of Food and Drugs
p.(None): shall consider the rec- ommendation and, if appropriate, make a request to the holders of approved applications
p.(None): for the drug to make any labeling change that the Commissioner of Food and Drugs determines to be
p.(None): appropriate.
p.(None): ‘‘(10) FAILURE TO AGREE.—If a holder of an approved application for a drug, within 30 days after
p.(None): receiving a request to make a labeling change under paragraph (9), does not agree to make a requested labeling
p.(None): change, the Commissioner of
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 889
p.(None):
p.(None):
p.(None): Food and Drugs may deem the drug to be misbranded under the Federal Food, Drug, and Cosmetic Act.
p.(None): ‘‘(11) NO EFFECT ON AUTHORITY.—Nothing in this sub- section limits the authority of the United States to
p.(None): bring an enforcement action under the Federal Food, Drug, and Cosmetic Act when a drug lacks appropriate
p.(None): pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement
p.(None): action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the other
p.(None): course of action.
p.(None): ‘‘(d) DISSEMINATION OF PEDIATRIC INFORMATION.—Not later
p.(None): than one year after the date of the enactment of the Best Pharma- ceuticals for Children Act of 2007, the
p.(None): Secretary, acting through the Director of the National Institutes of Health, shall study the feasibility of
p.(None): establishing a compilation of information on pediatric drug use and report the findings to Congress.
p.(None): ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—
p.(None): ‘‘(1) IN GENERAL.—There are authorized to be appropriated to carry out this section—
p.(None): ‘‘(A) $200,000,000 for fiscal year 2008; and
p.(None): ‘‘(B) such sums as are necessary for each of the four succeeding fiscal years.
p.(None): ‘‘(2) AVAILABILITY.—Any amount appropriated under para- graph (1) shall remain available to carry out this section
p.(None): until expended.’’.
p.(None): (c) FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.— Section 499(c)(1)(C) of the Public Health Service
p.(None): Act (42 U.S.C. 290b(c)(1)(C)) is amended by striking ‘‘and studies listed by the Secretary pursuant to
p.(None): section 409I(a)(1)(A) of this Act and referred under section 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic Act
p.(None): (21 U.S.C. 355(a)(d)(4)(C)’ ’’ and inserting ‘‘and studies for which the Secretary issues a certification in the
p.(None): affirmative under section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act’’.
p.(None): (d) CONTINUATION OF OPERATION OF COMMITTEE.—Section 14 of the Best Pharmaceuticals for Children Act (42
p.(None): U.S.C. 284m note) is amended by adding at the end the following new subsection: ‘‘(d) CONTINUATION OF OPERATION
p.(None): OF COMMITTEE.—Notwith- standing section 14 of the Federal Advisory Committee Act, the advisory committee
p.(None): shall continue to operate during the five-year period beginning on the date of the enactment of the Best Pharma-
p.(None): ceuticals for Children Act of 2007.’’.
p.(None): (e) PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY COMMITTEE.—Section 15 of the Best
p.(None): Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended—
p.(None): (1) in subsection (a)—
p.(None): (A) in paragraph (1)—
p.(None): (i) in subparagraph (B), by striking ‘‘and’’ after the semicolon;
p.(None): (ii) in subparagraph (C), by striking the period at the end and inserting ‘‘; and’’; and
p.(None): (iii) by adding at the end the following new subparagraph:
p.(None): ‘‘(D) provide recommendations to the internal review committee created under section 505B(f) of the
p.(None): Federal Food, Drug, and Cosmetic Act regarding the implementa- tion of amendments to sections 505A and
p.(None): 505B of the
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Reports.
p.(None):
p.(None):
p.(None): 121 STAT. 890 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): Federal Food, Drug, and Cosmetic Act with respect to the treatment of pediatric cancers.’’; and
p.(None): (B) by adding at the end the following new paragraph: ‘‘(3) CONTINUATION OF OPERATION OF SUBCOMMITTEE.—Not-
p.(None): withstanding section 14 of the Federal Advisory Committee Act, the Subcommittee shall continue to operate
p.(None): during the five-year period beginning on the date of the enactment of
p.(None): the Best Pharmaceuticals for Children Act of 2007.’’; and
p.(None): (2) in subsection (d), by striking ‘‘2003’’ and inserting ‘‘2009’’.
p.(None): (f) EFFECTIVE DATE AND LIMITATION FOR RULE RELATING TO TOLL-FREE NUMBER FOR ADVERSE EVENTS ON LABELING
p.(None): FOR HUMAN DRUG PRODUCTS.—
p.(None): (1) IN GENERAL.—Notwithstanding subchapter II of chapter 5, and chapter 7, of title 5, United States Code
p.(None): (commonly known as the ‘‘Administrative Procedure Act’’) and any other provision of law, the proposed rule
p.(None): issued by the Commissioner of Food and Drugs entitled ‘‘Toll-Free Number for Reporting Adverse Events on
p.(None): Labeling for Human Drug Products,’’ 69 Fed. Reg. 21778, (April 22, 2004) shall take effect on January 1,
p.(None): 2008, unless such Commissioner issues the final rule before such date.
p.(None): (2) LIMITATION.—The proposed rule that takes effect under subsection (a), or the final rule described under
p.(None): subsection (a), shall, notwithstanding section 17(a) of the Best Pharma- ceuticals for Children Act (21
p.(None): U.S.C. 355b(a)), not apply to a drug—
p.(None): (A) for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
p.(None): (B) that is not described under section 503(b)(1) of such Act (21 U.S.C. 353(b)(1)); and
p.(None): (C) the packaging of which includes a toll-free number through which consumers can report complaints to the
p.(None): manufacturer or distributor of the drug.
p.(None): SEC. 503. TRAINING OF PEDIATRIC PHARMACOLOGISTS.
p.(None): (a) INVESTMENT IN TOMORROW’S PEDIATRIC RESEARCHERS.—Sec- tion 452G(2) of the Public Health Service Act (42
p.(None): U.S.C. 285g– 10(2)) is amended by adding before the period at the end the following: ‘‘, including
p.(None): pediatric pharmacological research’’.
p.(None): (b) PEDIATRIC RESEARCH LOAN REPAYMENT PROGRAM.—Section 487F(a)(1) of the Public Health Service Act (42 U.S.C.
p.(None): 288–6(a)(1)) is amended by inserting ‘‘including pediatric pharmacological research,’’ after ‘‘pediatric
p.(None): research,’’.
p.(None):
p.(None): TITLE VI—REAGAN-UDALL FOUNDATION
p.(None): SEC. 601. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION.
p.(None): (a) IN GENERAL.—Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is
p.(None): amended by adding at the end the following:
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘Subchapter I—Reagan-Udall Foundation for the Food and Drug Administration
p.(None): 121 STAT. 891
p.(None):
p.(None): ‘‘SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION.
p.(None): ‘‘(a) IN GENERAL.—A nonprofit corporation to be known as the Reagan-Udall Foundation for the Food and Drug
p.(None): Administration (referred to in this subchapter as the ‘Foundation’) shall be estab- lished in accordance
p.(None): with this section. The Foundation shall be headed by an Executive Director, appointed by the members of
p.(None): the Board of Directors under subsection (e). The Foundation shall not be an agency or instrumentality of
p.(None): the United States Govern- ment.
p.(None): ‘‘(b) PURPOSE OF FOUNDATION.—The purpose of the Foundation is to advance the mission of the Food and
p.(None): Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development,
p.(None): accelerate innovation, and enhance product safety.
p.(None): ‘‘(c) DUTIES OF THE FOUNDATION.—The Foundation shall—
p.(None): ‘‘(1) taking into consideration the Critical Path reports and priorities published by the Food and Drug
p.(None): Administration, identify unmet needs in the development, manufacture, and evaluation of the safety and
p.(None): effectiveness, including post- approval, of devices, including diagnostics, biologics, and drugs, and the safety
p.(None): of food, food ingredients, and cosmetics, and including the incorporation of more sensitive and predictive
p.(None): tools and devices to measure safety;
p.(None): ‘‘(2) establish goals and priorities in order to meet the unmet needs identified in paragraph (1);
p.(None): ‘‘(3) in consultation with the Secretary, identify existing and proposed Federal intramural and extramural
p.(None): research and development programs relating to the goals and priorities estab- lished under paragraph (2),
p.(None): coordinate Foundation activities with such programs, and minimize Foundation duplication of existing efforts;
p.(None): ‘‘(4) award grants to, or enter into contracts, memoranda of understanding, or cooperative agreements
p.(None): with, scientists and entities, which may include the Food and Drug Administra- tion, university consortia,
p.(None): public-private partnerships, institu- tions of higher education, entities described in section 501(c)(3) of the
p.(None): Internal Revenue Code (and exempt from tax under section 501(a) of such Code), and industry, to
p.(None): efficiently and effectively advance the goals and priorities established under paragraph (2);
p.(None): ‘‘(5) recruit meeting participants and hold or sponsor (in whole or in part) meetings as appropriate to
p.(None): further the goals and priorities established under paragraph (2);
p.(None): ‘‘(6) release and publish information and data and, to the extent practicable, license, distribute, and
p.(None): release material, re- agents, and techniques to maximize, promote, and coordinate the availability of such
p.(None): material, reagents, and techniques for use by the Food and Drug Administration, nonprofit organiza- tions, and
p.(None): academic and industrial researchers to further the goals and priorities established under paragraph (2);
p.(None): ‘‘(7) ensure that—
p.(None): ‘‘(A) action is taken as necessary to obtain patents for inventions developed by the Foundation or with
p.(None): funds from the Foundation;
p.(None): 21 USC 379dd.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Grants. Contracts. Memorandums.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Publication.
p.(None):
p.(None):
p.(None): 121 STAT. 892 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(B) action is taken as necessary to enable the licensing of inventions developed by the Foundation or with
p.(None): funds from the Foundation; and
p.(None): ‘‘(C) executed licenses, memoranda of understanding, material transfer agreements, contracts, and other such
p.(None): instruments, promote, to the maximum extent practicable, the broadest conversion to commercial and noncommercial
p.(None): applications of licensed and patented inventions of the Foundation to further the goals and priorities
p.(None): established under paragraph (2);
p.(None): ‘‘(8) provide objective clinical and scientific information to the Food and Drug Administration and, upon
p.(None): request, to other Federal agencies to assist in agency determinations of how to ensure that regulatory
p.(None): policy accommodates scientific advances and meets the agency’s public health mission;
p.(None): ‘‘(9) conduct annual assessments of the unmet needs identi- fied in paragraph (1); and
p.(None): ‘‘(10) carry out such other activities consistent with the purposes of the Foundation as the Board
p.(None): determines appro- priate.
p.(None): ‘‘(d) BOARD OF DIRECTORS.— ‘‘(1) ESTABLISHMENT.—
p.(None): ‘‘(A) IN GENERAL.—The Foundation shall have a Board of Directors (referred to in this subchapter as the ‘Board’),
p.(None): which shall be composed of ex officio and appointed mem- bers in accordance with this subsection. All appointed mem-
p.(None): bers of the Board shall be voting members.
p.(None): ‘‘(B) EX OFFICIO MEMBERS.—The ex officio members of the Board shall be the following individuals or
p.(None): their designees:
p.(None): ‘‘(i) The Commissioner.
p.(None): ‘‘(ii) The Director of the National Institutes of Health.
p.(None): ‘‘(iii) The Director of the Centers for Disease Con- trol and Prevention.
p.(None): ‘‘(iv) The Director of the Agency for Healthcare Research and Quality.
p.(None): ‘‘(C) APPOINTED MEMBERS.—
p.(None): ‘‘(i) IN GENERAL.—The ex officio members of the Board under subparagraph (B) shall, by majority vote, appoint
p.(None): to the Board 14 individuals, of which 9 shall be from a list of candidates to be provided by the
p.(None): National Academy of Sciences and 5 shall be from lists of candidates provided by patient and consumer
p.(None): advocacy groups, professional scientific and medical societies, and industry trade organizations. Of such
p.(None): appointed members—
...
p.(None): of donated funds;
p.(None): ‘‘(iv) establish policies that would subject all employees, fellows, and trainees of the Foundation
p.(None): to the conflict of interest standards under section 208 of title 18, United States Code;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None):
p.(None):
p.(None): 121 STAT. 894 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(v) establish licensing, distribution, and publica- tion policies that support the widest and least restric-
p.(None): tive use by the public of information and inventions developed by the Foundation or with Foundation funds to
p.(None): carry out the duties described in paragraphs (6) and (7) of subsection (c), and may include charging
p.(None): cost-based fees for published material produced by the Foundation;
p.(None): ‘‘(vi) specify principles for the review of proposals and awarding of grants and contracts that include
p.(None): peer review and that are consistent with those of the Foundation for the National Institutes of Health,
p.(None): to the extent determined practicable and appropriate by the Board;
p.(None): ‘‘(vii) specify a cap on administrative expenses for recipients of a grant, contract, or cooperative agree- ment
p.(None): from the Foundation;
p.(None): ‘‘(viii) establish policies for the execution of memo- randa of understanding and cooperative agreements between
p.(None): the Foundation and other entities, including the Food and Drug Administration;
p.(None): ‘‘(ix) establish policies for funding training fellow- ships, whether at the Foundation, academic or sci-
p.(None): entific institutions, or the Food and Drug Administra- tion, for scientists, doctors, and other professionals who are
p.(None): not employees of regulated industry, to foster greater understanding of and expertise in new sci-
p.(None): entific tools, diagnostics, manufacturing techniques, and potential barriers to translating basic
p.(None): research into clinical and regulatory practice;
p.(None): ‘‘(x) specify a process for annual Board review of the operations of the Foundation; and
p.(None): ‘‘(xi) establish specific duties of the Executive Director;
p.(None): ‘‘(B) prioritize and provide overall direction to the activities of the Foundation;
p.(None): ‘‘(C) evaluate the performance of the Executive Director; and
p.(None): ‘‘(D) carry out any other necessary activities regarding the functioning of the Foundation.
p.(None): ‘‘(3) TERMS AND VACANCIES.—
p.(None): ‘‘(A) TERM.—The term of office of each member of the Board appointed under paragraph (1)(C) shall be 4
p.(None): years, except that the terms of offices for the initial appointed members of the Board shall expire on
p.(None): a staggered basis as determined by the ex officio members.
p.(None): ‘‘(B) VACANCY.—Any vacancy in the membership of the Board—
p.(None): ‘‘(i) shall not affect the power of the remaining members to execute the duties of the Board; and
p.(None): ‘‘(ii) shall be filled by appointment by the appointed members described in paragraph (1)(C) by majority vote.
p.(None): ‘‘(C) PARTIAL TERM.—If a member of the Board does not serve the full term applicable under subparagraph (A),
p.(None): the individual appointed under subparagraph (B) to fill
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 895
p.(None):
...
p.(None): purposes of carrying out the duties of the Foundation. ‘‘(j) SERVICE OF FEDERAL EMPLOYEES.—Federal
p.(None): Government employees may serve on committees advisory to the Foundation and otherwise cooperate with and
p.(None): assist the Foundation in carrying out its functions, so long as such employees do not direct or control
p.(None): Foundation activities.
p.(None): ‘‘(k) DETAIL OF GOVERNMENT EMPLOYEES; FELLOWSHIPS.—
p.(None): ‘‘(1) DETAIL FROM FEDERAL AGENCIES.—Federal Govern-
p.(None): ment employees may be detailed from Federal agencies with or without reimbursement to those agencies to the
p.(None): Foundation at any time, and such detail shall be without interruption or loss of civil service status or
p.(None): privilege. Each such employee shall abide by the statutory, regulatory, ethical, and procedural standards
p.(None): applicable to the employees of the agency from which such employee is detailed and those of the Foundation.
p.(None): ‘‘(2) VOLUNTARY SERVICE; ACCEPTANCE OF FEDERAL EMPLOYEES.—
p.(None): ‘‘(A) FOUNDATION.—The Executive Director of the Foundation may accept the services of employees
p.(None): detailed from Federal agencies with or without reimbursement to those agencies.
p.(None): ‘‘(B) FOOD AND DRUG ADMINISTRATION.—The Commis-
p.(None): sioner may accept the uncompensated services of Founda- tion fellows or trainees. Such services shall be
p.(None): considered to be undertaking an activity under contract with the Sec- retary as described in section 708.
p.(None): ‘‘(l) ANNUAL REPORTS.—
p.(None): ‘‘(1) REPORTS TO FOUNDATION.—Any recipient of a grant, contract, fellowship, memorandum of
p.(None): understanding, or cooperative agreement from the Foundation under this section shall submit to the Foundation a
p.(None): report on an annual basis for the duration of such grant, contract, fellowship, memo- randum of
p.(None): understanding, or cooperative agreement, that describes the activities carried out under such grant, contract,
p.(None): fellowship, memorandum of understanding, or cooperative agreement.
p.(None): ‘‘(2) REPORT TO CONGRESS AND THE FDA.—Beginning with
p.(None): fiscal year 2009, the Executive Director shall submit to Con- gress and the Commissioner an annual report
p.(None): that—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 897
p.(None):
p.(None):
p.(None): ‘‘(A) describes the activities of the Foundation and the progress of the Foundation in furthering the
p.(None): goals and priorities established under subsection (c)(2), including the practical impact of the Foundation on regulated
p.(None): product development;
p.(None): ‘‘(B) provides a specific accounting of the source and use of all funds used by the Foundation to
p.(None): carry out such activities; and
p.(None): ‘‘(C) provides information on how the results of Founda- tion activities could be incorporated into the
p.(None): regulatory and product review activities of the Food and Drug Administration.
p.(None): ‘‘(m) SEPARATION OF FUNDS.—The Executive Director shall ensure that the funds received from the
p.(None): Treasury are held in separate accounts from funds received from entities under sub- section (i).
p.(None): ‘‘(n) FUNDING.—From amounts appropriated to the Food and Drug Administration for each fiscal year, the
p.(None): Commissioner shall transfer not less than $500,000 and not more than $1,250,000, to the Foundation to carry
p.(None): out subsections (a), (b), and (d) through (m).’’.
p.(None): (b) OTHER FOUNDATION PROVISIONS.—Chapter VII of the Fed- eral Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 371 et seq.) (as amended by subsection (a)) is amended by adding at the end the following:
p.(None): ‘‘SEC. 771. LOCATION OF FOUNDATION.
p.(None): ‘‘The Foundation shall, if practicable, be located not more than 20 miles from the District of Columbia.
p.(None): ‘‘SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.
p.(None): ‘‘(a) IN GENERAL.—The Commissioner shall receive and assess the report submitted to the Commissioner by the
p.(None): Executive Director of the Foundation under section 770(l)(2).
p.(None): ‘‘(b) REPORT TO CONGRESS.—Beginning with fiscal year 2009, the Commissioner shall submit to Congress
p.(None): an annual report summarizing the incorporation of the information provided by the Foundation in the
p.(None): report described under section 770(l)(2) and by other recipients of grants, contracts, memoranda of
p.(None): under- standing, or cooperative agreements into regulatory and product review activities of the Food and Drug
p.(None): Administration.
p.(None): ‘‘(c) EXTRAMURAL GRANTS.—The provisions of this subchapter and section 566 shall have no effect on any grant,
p.(None): contract, memo- randum of understanding, or cooperative agreement between the Food and Drug Administration
p.(None): and any other entity entered into before, on, or after the date of the enactment of this subchapter.’’.
p.(None): (c) CONFORMING AMENDMENT.—Section 742(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379l(b))
p.(None): is amended by adding at the end the following: ‘‘Any such fellowships and training programs under this section or
p.(None): under section 770(d)(2)(A)(ix) may include provision by such scientists and physicians of services on a
p.(None): voluntary and uncompensated basis, as the Secretary determines appropriate. Such scientists and physicians shall
p.(None): be subject to all legal and ethical requirements otherwise applicable to officers or employees of the
p.(None): Department of Health and Human Services.’’.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379dd–1.
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379dd–2.
p.(None):
p.(None):
p.(None): 121 STAT. 898 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 399a.
p.(None): SEC. 602. OFFICE OF THE CHIEF SCIENTIST.
p.(None): Chapter IX of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 391 et seq.) is amended by adding at the end the following:
p.(None): ‘‘SEC. 910. OFFICE OF THE CHIEF SCIENTIST.
p.(None): ‘‘(a) ESTABLISHMENT; APPOINTMENT.—The Secretary shall estab- lish within the Office of the Commissioner an
p.(None): office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to
p.(None): lead such Office.
p.(None): ‘‘(b) DUTIES OF THE OFFICE.—The Office of the Chief Scientist shall—
p.(None): ‘‘(1) oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the
p.(None): Food and Drug Administration;
p.(None): ‘‘(2) track and, to the extent necessary, coordinate intra- mural research awards made by each center of the
p.(None): Administra- tion or science-based office within the Office of the Commis- sioner, and ensure that there
p.(None): is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug
p.(None): Administration;
p.(None): ‘‘(3) develop and advocate for a budget to support intra- mural research;
p.(None): ‘‘(4) develop a peer review process by which intramural research can be evaluated;
p.(None): ‘‘(5) identify and solicit intramural research proposals from across the Food and Drug Administration through an
p.(None): advisory board composed of employees of the Administration that shall include—
p.(None): ‘‘(A) representatives of each of the centers and the science-based offices within the Office of the
p.(None): Commissioner; and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC
p.(None): 360bbb–5.
p.(None): ‘‘(B) experts on trial design, epidemiology, demo- graphics, pharmacovigilance, basic science, and
p.(None): public health; and
p.(None): ‘‘(6) develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed
p.(None): for premarket review.’’.
p.(None): SEC. 603. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
p.(None): Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is
p.(None): amended by adding at the end the following:
p.(None): ‘‘SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
p.(None): ‘‘(a) ESTABLISHMENT.—The Secretary, acting through the Commissioner of Food and Drugs, may enter
p.(None): into collaborative agreements, to be known as Critical Path Public-Private Partner- ships, with one or
p.(None): more eligible entities to implement the Critical Path Initiative of the Food and Drug Administration by
p.(None): developing innovative, collaborative projects in research, education, and out- reach for the purpose of
p.(None): fostering medical product innovation, enabling the acceleration of medical product development, manufac- turing,
p.(None): and translational therapeutics, and enhancing medical product safety.
p.(None): ‘‘(b) ELIGIBLE ENTITY.—In this section, the term ‘eligible entity’ means an entity that meets each of the following:
p.(None): ‘‘(1) The entity is—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 899
p.(None):
p.(None): ‘‘(A) an institution of higher education (as such term is defined in section 101 of the Higher
p.(None): Education Act of 1965) or a consortium of such institutions; or
p.(None): ‘‘(B) an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt
p.(None): from tax under section 501(a) of such Code.
p.(None): ‘‘(2) The entity has experienced personnel and clinical and other technical expertise in the biomedical sciences, which
p.(None): may include graduate training programs in areas relevant to prior- ities of the Critical Path Initiative.
p.(None): ‘‘(3) The entity demonstrates to the Secretary’s satisfaction that the entity is capable of—
p.(None): ‘‘(A) developing and critically evaluating tools, methods, and processes—
p.(None): ‘‘(i) to increase efficiency, predictability, and productivity of medical product development; and
p.(None): ‘‘(ii) to more accurately identify the benefits and risks of new and existing medical products;
p.(None): ‘‘(B) establishing partnerships, consortia, and collabora- tions with health care practitioners and other
p.(None): providers of health care goods or services; pharmacists; pharmacy benefit managers and purchasers;
p.(None): health maintenance organizations and other managed health care organiza- tions; health care insurers;
p.(None): government agencies; patients and consumers; manufacturers of prescription drugs, biological products,
p.(None): diagnostic technologies, and devices; and academic scientists; and
p.(None): ‘‘(C) securing funding for the projects of a Critical Path Public-Private Partnership from Federal and
p.(None): non- federal governmental sources, foundations, and private individuals.
p.(None): ‘‘(c) FUNDING.—The Secretary may not enter into a collaborative agreement under subsection (a) unless the
p.(None): eligible entity involved provides an assurance that the entity will not accept funding for a Critical
p.(None): Path Public-Private Partnership project from any organization that manufactures or distributes products
p.(None): regulated by the Food and Drug Administration unless the entity provides assurances in its agreement with the
p.(None): Food and Drug Administration that the results of the Critical Path Public-Private Partnership project will not
p.(None): be influenced by any source of funding.
p.(None): ‘‘(d) ANNUAL REPORT.—Not later than 18 months after the date of the enactment of this section, and
p.(None): annually thereafter, the Secretary, in collaboration with the parties to each Critical Path Public-Private
p.(None): Partnership, shall submit a report to the Com- mittee on Health, Education, Labor, and Pensions of the Senate
p.(None): and the Committee on Energy and Commerce of the House of Representatives—
p.(None): ‘‘(1) reviewing the operations and activities of the Partner- ships in the previous year; and
p.(None): ‘‘(2) addressing such other issues relating to this section as the Secretary determines to be appropriate.
p.(None): ‘‘(e) DEFINITION.—In this section, the term ‘medical product’ includes a drug, a biological product as
p.(None): defined in section 351 of the Public Health Service Act, a device, and any combination of such products.
p.(None): ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.(None): $5,000,000 for fiscal
p.(None):
p.(None):
p.(None): 121 STAT. 900 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): year 2008 and such sums as may be necessary for each of fiscal years 2009 through 2012.’’.
p.(None): TITLE VII—CONFLICTS OF INTEREST
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379d–1.
p.(None): SEC. 701. CONFLICTS OF INTEREST.
p.(None): (a) IN GENERAL.—Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371
p.(None): et seq.) is amended by inserting at the end the following:
p.(None): ‘‘SEC. 712. CONFLICTS OF INTEREST.
p.(None): ‘‘(a) DEFINITIONS.—For purposes of this section:
p.(None): ‘‘(1) ADVISORY COMMITTEE.—The term ‘advisory committee’ means an advisory committee under the Federal Advisory Com-
p.(None): mittee Act that provides advice or recommendations to the Secretary regarding activities of the Food and Drug
p.(None): Administra- tion.
p.(None): ‘‘(2) FINANCIAL INTEREST.—The term ‘financial interest’ means a financial interest under section 208(a)
p.(None): of title 18, United States Code.
p.(None): ‘‘(b) APPOINTMENTS TO ADVISORY COMMITTEES.— ‘‘(1) RECRUITMENT.—
p.(None): ‘‘(A) IN GENERAL.—The Secretary shall—
p.(None): ‘‘(i) develop and implement strategies on effective outreach to potential members of advisory committees at
p.(None): universities, colleges, other academic research cen- ters, professional and medical societies, and patient
p.(None): and consumer groups;
p.(None): ‘‘(ii) seek input from professional medical and sci- entific societies to determine the most effective
p.(None): informational and recruitment activities; and
p.(None): ‘‘(iii) take into account the advisory committees with the greatest number of vacancies.
p.(None): ‘‘(B) RECRUITMENT ACTIVITIES.—The recruitment activi- ties under subparagraph (A) may include—
p.(None): ‘‘(i) advertising the process for becoming an advisory committee member at medical and scientific
p.(None): society conferences;
p.(None): ‘‘(ii) making widely available, including by using existing electronic communications channels, the con-
p.(None): tact information for the Food and Drug Administration point of contact regarding advisory committee nomina- tions; and
p.(None): ‘‘(iii) developing a method through which an entity receiving funding from the National Institutes of
p.(None): Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Preven-
p.(None): tion, or the Veterans Health Administration can iden- tify a person who the Food and Drug Administration can
p.(None): contact regarding the nomination of individuals to serve on advisory committees.
p.(None): ‘‘(2) EVALUATION AND CRITERIA.—When considering a term appointment to an advisory committee, the Secretary shall
p.(None): review the expertise of the individual and the financial disclo- sure report filed by the individual pursuant to
p.(None): the Ethics in Government Act of 1978 for each individual under consideration
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 901
p.(None):
p.(None): for the appointment, so as to reduce the likelihood that an appointed individual will later require a written
p.(None): determination as referred to in section 208(b)(1) of title 18, United States Code, a written certification
p.(None): as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in
p.(None): subsection (c)(2) of this section for service on the committee at a meeting of the committee.
p.(None): ‘‘(c) DISCLOSURES; PROHIBITIONS ON PARTICIPATION; WAIVERS.— ‘‘(1) DISCLOSURE OF FINANCIAL INTEREST.—Prior
p.(None): to a
p.(None): meeting of an advisory committee regarding a ‘particular matter’ (as that term is used in section 208 of
p.(None): title 18, United States Code), each member of the committee who is a full- time Government employee or
p.(None): special Government employee shall disclose to the Secretary financial interests in accordance with subsection (b) of
p.(None): such section 208.
p.(None): ‘‘(2) PROHIBITIONS AND WAIVERS ON PARTICIPATION.—
p.(None): ‘‘(A) IN GENERAL.—Except as provided under subpara- graph (B), a member of an advisory committee may not
p.(None): participate with respect to a particular matter considered in an advisory committee meeting if such
p.(None): member (or an immediate family member of such member) has a financial interest that could be affected by the
p.(None): advice given to the Secretary with respect to such matter, excluding interests exempted in regulations issued
p.(None): by the Director of the Office of Government Ethics as too remote or inconsequential to affect the integrity
p.(None): of the services of the Government officers or employees to which such regulations apply.
p.(None): ‘‘(B) WAIVER.—If the Secretary determines it necessary to afford the advisory committee essential expertise, the
p.(None): Secretary may grant a waiver of the prohibition in subpara- graph (A) to permit a member described in such
p.(None): subpara- graph to—
p.(None): ‘‘(i) participate as a non-voting member with respect to a particular matter considered in a com-
p.(None): mittee meeting; or
p.(None): ‘‘(ii) participate as a voting member with respect to a particular matter considered in a
p.(None): committee meeting.
p.(None): ‘‘(C) LIMITATION ON WAIVERS AND OTHER EXCEPTIONS.—
p.(None): ‘‘(i) DEFINITION.—For purposes of this subpara- graph, the term ‘exception’ means each of the following with
p.(None): respect to members of advisory committees:
p.(None): ‘‘(I) A waiver under section 505(n)(4) (as in effect on the day before the date of the enactment of the Food and
p.(None): Drug Administration Amendments Act of 2007).
p.(None): ‘‘(II) A written determination under section 208(b) of title 18, United States Code.
p.(None): ‘‘(III) A written certification under section 208(b)(3) of such title.
p.(None): ‘‘(ii) DETERMINATION OF TOTAL NUMBER OF MEM- BERS SLOTS AND MEMBER EXCEPTIONS DURING FISCAL
p.(None): YEAR 2007.—The Secretary shall determine—
p.(None): ‘‘(I)(aa) for each meeting held by any advisory committee during fiscal year 2007, the number of members who
p.(None): participated in the meeting; and
p.(None):
p.(None):
p.(None): 121 STAT. 902 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(bb) the sum of the respective numbers deter- mined under item (aa) (referred to in this subpara- graph as the
p.(None): ‘‘total number of 2007 meeting slots’’); and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Applicability. Website.
p.(None): ‘‘(II)(aa) for each meeting held by any advisory committee during fiscal year 2007, the number of members who
p.(None): received an exception for the meeting; and
p.(None): ‘‘(bb) the sum of the respective numbers deter- mined under item (aa) (referred to in this subpara- graph as the
p.(None): ‘‘total number of 2007 meeting excep- tions’’).
p.(None): ‘‘(iii) DETERMINATION OF PERCENTAGE REGARDING EXCEPTIONS DURING FISCAL YEAR 2007.—The Secretary
p.(None): shall determine the percentage constituted by—
p.(None): ‘‘(I) the total number of 2007 meeting excep- tions; divided by
p.(None): ‘‘(II) the total number of 2007 meeting slots. ‘‘(iv) LIMITATION FOR FISCAL YEARS 2008 THROUGH
p.(None): 2012.—The number of exceptions at the Food and Drug Administration for members of advisory committees for a fiscal
p.(None): year may not exceed the following:
p.(None): ‘‘(I) For fiscal year 2008, 95 percent of the percentage determined under clause (iii) (referred to in
p.(None): this clause as the ‘‘base percentage’’).
p.(None): ‘‘(II) For fiscal year 2009, 90 percent of the base percentage.
p.(None): ‘‘(III) For fiscal year 2010, 85 percent of the base percentage.
p.(None): ‘‘(IV) For fiscal year 2011, 80 percent of the base percentage.
p.(None): ‘‘(V) For fiscal year 2012, 75 percent of the base percentage.
p.(None): ‘‘(v) ALLOCATION OF EXCEPTIONS.—The exceptions authorized under clause (iv) for a fiscal year may be
p.(None): allocated within the centers or other organizational units of the Food and Drug Administration as deter-
p.(None): mined appropriate by the Secretary.
p.(None): ‘‘(3) DISCLOSURE OF WAIVER.—Notwithstanding section 107(a)(2) of the Ethics in Government Act (5 U.S.C.
p.(None): App.), the following shall apply:
p.(None): ‘‘(A) 15 OR MORE DAYS IN ADVANCE.—As soon as prac-
p.(None): ticable, but (except as provided in subparagraph (B)) not later than 15 days prior to a meeting of an
p.(None): advisory com- mittee to which a written determination as referred to in section 208(b)(1) of title 18, United
p.(None): States Code, a writ- ten certification as referred to in section 208(b)(3) of title 18, United States Code,
p.(None): or a waiver as referred to in paragraph (2)(B) applies, the Secretary shall disclose (other than information
p.(None): exempted from disclosure under section
p.(None): 552 of title 5, United States Code, and section 552a of title 5, United States Code (popularly
p.(None): known as the Freedom of Information Act and the Privacy Act of 1974, respectively)) on the Internet
p.(None): Web site of the Food and Drug Administration—
p.(None): ‘‘(i) the type, nature, and magnitude of the finan- cial interests of the advisory committee member to
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 903
p.(None):
p.(None): which such determination, certification, or waiver applies; and
p.(None): ‘‘(ii) the reasons of the Secretary for such deter- mination, certification, or waiver.
p.(None): ‘‘(B) LESS THAN 30 DAYS IN ADVANCE.—In the case
p.(None): of a financial interest that becomes known to the Secretary less than 30 days prior to a meeting of an
p.(None): advisory com- mittee to which a written determination as referred to in section 208(b)(1) of title 18, United
p.(None): States Code, a writ- ten certification as referred to in section 208(b)(3) of title 18, United States Code,
p.(None): or a waiver as referred to in paragraph (2)(B) applies, the Secretary shall disclose (other than information
p.(None): exempted from disclosure under section
p.(None): 552 of title 5, United States Code, and section 552a of title 5, United States Code) on the Internet
p.(None): Web site of the Food and Drug Administration, the information described in clauses (i) and (ii) of
p.(None): subparagraph (A) as soon as practicable after the Secretary makes such deter- mination, certification, or
p.(None): waiver, but in no case later than the date of such meeting.
p.(None): ‘‘(d) PUBLIC RECORD.—The Secretary shall ensure that the public record and transcript of each meeting of
p.(None): an advisory com- mittee includes the disclosure required under subsection (c)(3) (other than information exempted
p.(None): from disclosure under section 552 of title 5, United States Code, and section 552a of title 5, United
p.(None): States Code).
p.(None): ‘‘(e) ANNUAL REPORT.—Not later than February 1 of each year, the Secretary shall submit to the Committee on
p.(None): Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on
p.(None): Appropriations and the Com- mittee on Energy and Commerce of the House of Representatives a report that
p.(None): describes—
p.(None): ‘‘(1) with respect to the fiscal year that ended on September
p.(None): 30 of the previous year, the number of vacancies on each advisory committee, the number of nominees received
p.(None): for each committee, and the number of such nominees willing to serve; ‘‘(2) with respect to such year, the
p.(None): aggregate number of disclosures required under subsection (c)(3) for each meeting of each advisory
p.(None): committee and the percentage of individuals to whom such disclosures did not apply who served on such
p.(None): committee for each such meeting;
p.(None): ‘‘(3) with respect to such year, the number of times the disclosures required under subsection (c)(3)
p.(None): occurred under subparagraph (B) of such subsection; and
p.(None): ‘‘(4) how the Secretary plans to reduce the number of vacancies reported under paragraph (1) during the
p.(None): fiscal year following such year, and mechanisms to encourage the nomina- tion of individuals for service on
p.(None): an advisory committee, including those who are classified by the Food and Drug Administration as
p.(None): academicians or practitioners.
p.(None): ‘‘(f) PERIODIC REVIEW OF GUIDANCE.—Not less than once every 5 years, the Secretary shall review guidance of
p.(None): the Food and Drug Administration regarding conflict of interest waiver determinations with respect to advisory
p.(None): committees and update such guidance as necessary.’’.
p.(None): (b) CONFORMING AMENDMENTS.—Section 505(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(n))
p.(None): is amended by—
p.(None):
p.(None):
p.(None): 121 STAT. 904 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): (1) striking paragraph (4); and
p.(None): (2) redesignating paragraphs (5), (6), (7), and (8) as para- graphs (4), (5), (6), and (7), respectively.
p.(None):
p.(None): 21 USC 355 note.
p.(None): (c) EFFECTIVE DATE.—The amendments made by this section shall take effect on October 1, 2007.
p.(None): TITLE VIII—CLINICAL TRIAL DATABASES
p.(None): SEC. 801. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.
p.(None): (a) IN GENERAL.—Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended by—
p.(None): (1) redesignating subsections (j) and (k) as subsections
p.(None): (k) and (l), respectively; and
p.(None): (2) inserting after subsection (i) the following:
p.(None): ‘‘(j) EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.— ‘‘(1) DEFINITIONS; REQUIREMENT.—
p.(None): ‘‘(A) DEFINITIONS.—In this subsection:
p.(None): ‘‘(i) APPLICABLE CLINICAL TRIAL.—The term
p.(None): ‘applicable clinical trial’ means an applicable device clinical trial or an applicable drug clinical trial.
p.(None): ‘‘(ii) APPLICABLE DEVICE CLINICAL TRIAL.—The term
p.(None): ‘applicable device clinical trial’ means—
p.(None): ‘‘(I) a prospective clinical study of health out- comes comparing an intervention with a device subject
p.(None): to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act against a control in human
p.(None): subjects (other than a small clin- ical trial to determine the feasibility of a device, or a clinical trial
p.(None): to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and
p.(None): ‘‘(II) a pediatric postmarket surveillance as required under section 522 of the Federal Food, Drug, and
p.(None): Cosmetic Act.
p.(None): ‘‘(iii) APPLICABLE DRUG CLINICAL TRIAL.—
p.(None): ‘‘(I) IN GENERAL.—The term ‘applicable drug clinical trial’ means a controlled clinical investiga- tion, other
p.(None): than a phase I clinical investigation, of a drug subject to section 505 of the Federal Food, Drug, and
p.(None): Cosmetic Act or to section 351 of this Act.
p.(None): ‘‘(II) CLINICAL INVESTIGATION.—For purposes
p.(None): of subclause (I), the term ‘clinical investigation’ has the meaning given that term in section 312.3 of title
p.(None): 21, Code of Federal Regulations (or any successor regulation).
p.(None): ‘‘(III) PHASE I.—For purposes of subclause (I), the term ‘phase I’ has the meaning given that term in section
p.(None): 312.21 of title 21, Code of Federal Regulations (or any successor regulation).
p.(None): ‘‘(iv) CLINICAL TRIAL INFORMATION.—The term ‘clin-
p.(None): ical trial information’ means, with respect to an applicable clinical trial, those data elements
p.(None): that the responsible party is required to submit under para- graph (2) or under paragraph (3).
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 905
p.(None):
p.(None):
p.(None): ‘‘(v) COMPLETION DATE.—The term ‘completion date’ means, with respect to an applicable clinical trial, the
p.(None): date that the final subject was examined or received an intervention for the purposes of final collec-
p.(None): tion of data for the primary outcome, whether the clinical trial concluded according to the prespecified
p.(None): protocol or was terminated.
p.(None): ‘‘(vi) DEVICE.—The term ‘device’ means a device as defined in section 201(h) of the Federal Food, Drug, and
p.(None): Cosmetic Act.
p.(None): ‘‘(vii) DRUG.—The term ‘drug’ means a drug as defined in section 201(g) of the Federal Food, Drug, and
p.(None): Cosmetic Act or a biological product as defined in section 351 of this Act.
p.(None): ‘‘(viii) ONGOING.—The term ‘ongoing’ means, with respect to a clinical trial of a drug or a device and
p.(None): to a date, that—
p.(None): ‘‘(I) 1 or more patients is enrolled in the clin- ical trial; and
p.(None): ‘‘(II) the date is before the completion date of the clinical trial.
p.(None): ‘‘(ix) RESPONSIBLE PARTY.—The term ‘responsible party’, with respect to a clinical trial of a drug or
p.(None): device, means—
p.(None): ‘‘(I) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regula- tions (or any
p.(None): successor regulation)); or
p.(None): ‘‘(II) the principal investigator of such clinical trial if so designated by a sponsor, grantee, con- tractor,
p.(None): or awardee, so long as the principal inves- tigator is responsible for conducting the trial, has access to and control
p.(None): over the data from the clinical trial, has the right to publish the results of the trial, and has the ability
p.(None): to meet all of the require- ments under this subsection for the submission of clinical trial information.
p.(None): ‘‘(B) REQUIREMENT.—The Secretary shall develop a mechanism by which the responsible party for
p.(None): each applicable clinical trial shall submit the identity and con- tact information of such responsible party to
p.(None): the Secretary at the time of submission of clinical trial information under paragraph (2).
p.(None): ‘‘(2) EXPANSION OF CLINICAL TRIAL REGISTRY DATA BANK WITH RESPECT TO CLINICAL TRIAL INFORMATION.—
p.(None): ‘‘(A) IN GENERAL.—
p.(None): ‘‘(i) EXPANSION OF DATA BANK.—To enhance patient enrollment and provide a mechanism to track subse- quent
p.(None): progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accord-
p.(None): ance with this subsection, the clinical trials registry of the data bank described under subsection
p.(None): (i)(1) (referred to in this subsection as the ‘registry data bank’). The Director of NIH shall ensure that the
p.(None): reg- istry data bank is made publicly available through the Internet.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public information. Internet.
p.(None):
p.(None):
p.(None): 121 STAT. 906 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(ii) CONTENT.—The clinical trial information required to be submitted under this paragraph for an
p.(None): applicable clinical trial shall include—
p.(None): ‘‘(I) descriptive information, including—
p.(None): ‘‘(aa) a brief title, intended for the lay public;
p.(None): ‘‘(bb) a brief summary, intended for the lay public;
p.(None): ‘‘(cc) the primary purpose; ‘‘(dd) the study design;
p.(None): ‘‘(ee) for an applicable drug clinical trial, the study phase;
p.(None): ‘‘(ff) study type;
p.(None): ‘‘(gg) the primary disease or condition being studied, or the focus of the study;
p.(None): ‘‘(hh) the intervention name and interven- tion type;
p.(None): ‘‘(ii) the study start date;
p.(None): ‘‘(jj) the expected completion date;
p.(None): ‘‘(kk) the target number of subjects; and ‘‘(ll) outcomes, including primary and sec-
p.(None): ondary outcome measures;
p.(None): ‘‘(II) recruitment information, including— ‘‘(aa) eligibility criteria;
p.(None): ‘‘(bb) gender;
p.(None): ‘‘(cc) age limits;
p.(None): ‘‘(dd) whether the trial accepts healthy vol- unteers;
p.(None): ‘‘(ee) overall recruitment status; ‘‘(ff) individual site status; and
p.(None): ‘‘(gg) in the case of an applicable drug clinical trial, if the drug is not approved under section 505 of the
p.(None): Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, specify whether or not
p.(None): there is expanded access to the drug under section 561 of the Federal Food, Drug, and Cosmetic Act for those
p.(None): who do not qualify for enrollment in the clinical trial and how to obtain informa- tion about such access;
p.(None): ‘‘(III) location and contact information, including—
p.(None): ‘‘(aa) the name of the sponsor;
p.(None): ‘‘(bb) the responsible party, by official title;
p.(None):
p.(None): and
p.(None): ‘‘(cc) the facility name and facility contact
p.(None): information (including the city, State, and zip code for each clinical trial location, or a toll- free number
p.(None): through which such location information may be accessed); and
p.(None): ‘‘(IV) administrative data (which the Secretary may make publicly available as necessary), including—
p.(None): ‘‘(aa) the unique protocol identification number;
p.(None): ‘‘(bb) other protocol identification num- bers, if any; and
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 907
p.(None):
p.(None):
p.(None): ‘‘(cc) the Food and Drug Administration IND/IDE protocol number and the record verification date.
p.(None): ‘‘(iii) MODIFICATIONS.—The Secretary may by regu- lation modify the requirements for clinical trial
p.(None): information under this paragraph, if the Secretary pro- vides a rationale for why such a modification improves and
p.(None): does not reduce such clinical trial information. ‘‘(B) FORMAT AND STRUCTURE.—
p.(None): ‘‘(i) SEARCHABLE CATEGORIES.—The Director of NIH shall ensure that the public may, in addition to
p.(None): keyword searching, search the entries in the registry data bank by 1 or more of the following criteria:
p.(None): ‘‘(I) The disease or condition being studied in the clinical trial, using Medical Subject Headers (MeSH)
p.(None): descriptors.
p.(None): ‘‘(II) The name of the intervention, including any drug or device being studied in the clinical trial.
p.(None): ‘‘(III) The location of the clinical trial.
p.(None): ‘‘(IV) The age group studied in the clinical trial, including pediatric subpopulations.
p.(None): ‘‘(V) The study phase of the clinical trial.
p.(None): ‘‘(VI) The sponsor of the clinical trial, which may be the National Institutes of Health or
p.(None): another Federal agency, a private industry source, or a university or other organization.
p.(None): ‘‘(VII) The recruitment status of the clinical trial.
p.(None): ‘‘(VIII) The National Clinical Trial number or other study identification for the clinical trial.
p.(None): ‘‘(ii) ADDITIONAL SEARCHABLE CATEGORY.—Not
p.(None): later than 18 months after the date of the enactment of the Food and Drug Administration Amendments Act
p.(None): of 2007, the Director of NIH shall ensure that the public may search the entries of the registry data bank by
p.(None): the safety issue, if any, being studied in the clinical trial as a primary or secondary outcome.
p.(None): ‘‘(iii) OTHER ELEMENTS.—The Director of NIH shall also ensure that the public may search the entries of the
p.(None): registry data bank by such other elements as the Director deems necessary on an ongoing basis. ‘‘(iv)
p.(None): FORMAT.—The Director of the NIH shall ensure that the registry data bank is easily used by
p.(None): the public, and that entries are easily compared.
p.(None): ‘‘(C) DATA SUBMISSION.—The responsible party for an applicable clinical trial, including an applicable drug
p.(None): clin- ical trial for a serious or life-threatening disease or condi- tion, that is initiated after, or is
p.(None): ongoing on the date that is 90 days after, the date of the enactment of the Food and Drug
p.(None): Administration Amendments Act of 2007, shall submit to the Director of NIH for inclusion in the registry
p.(None): data bank the clinical trial information described in of subparagraph (A)(ii) not later than the later
p.(None): of—
p.(None): ‘‘(i) 90 days after such date of enactment;
p.(None): ‘‘(ii) 21 days after the first patient is enrolled in such clinical trial; or
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None):
p.(None):
p.(None): 121 STAT. 908 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(iii) in the case of a clinical trial that is not for a serious or life-threatening disease or
p.(None): condition and that is ongoing on such date of enactment, 1 year after such date of enactment.
p.(None):
p.(None): Deadlines.
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None): Deadlines.
p.(None): ‘‘(D) POSTING OF DATA.—
p.(None): ‘‘(i) APPLICABLE DRUG CLINICAL TRIAL.—The
p.(None): Director of NIH shall ensure that clinical trial informa- tion for an applicable drug clinical trial submitted
p.(None): in accordance with this paragraph is posted in the reg- istry data bank not later than 30 days after
p.(None): such submission.
p.(None): ‘‘(ii) APPLICABLE DEVICE CLINICAL TRIAL.—The
p.(None): Director of NIH shall ensure that clinical trial informa- tion for an applicable device clinical trial submitted
p.(None): in accordance with this paragraph is posted publicly in the registry data bank—
p.(None): ‘‘(I) not earlier than the date of clearance under section 510(k) of the Federal Food, Drug, and
p.(None): Cosmetic Act, or approval under section 515 or 520(m) of such Act, as applicable, for a device that was
p.(None): not previously cleared or approved, and not later than 30 days after such date; or
p.(None): ‘‘(II) for a device that was previously cleared or approved, not later than 30 days after the clin- ical trial
p.(None): information under paragraph (3)(C) is required to be posted by the Secretary.
p.(None): ‘‘(3) EXPANSION OF REGISTRY DATA BANK TO INCLUDE RESULTS OF CLINICAL TRIALS.—
p.(None): ‘‘(A) LINKING REGISTRY DATA BANK TO EXISTING RESULTS.—
p.(None): ‘‘(i) IN GENERAL.—Beginning not later than 90 days after the date of the enactment of the Food and Drug Administration
p.(None): Amendments Act of 2007, for those clinical trials that form the primary basis of an efficacy claim or are
p.(None): conducted after the drug involved is approved or after the device involved is cleared or approved,
p.(None): the Secretary shall ensure that the registry data bank includes links to results information as described in
p.(None): clause (ii) for such clinical trial—
p.(None): ‘‘(I) not earlier than 30 days after the date of the approval of the drug involved or clearance or
p.(None): approval of the device involved; or
p.(None): ‘‘(II) not later than 30 days after the results information described in clause (ii) becomes pub- licly
p.(None): available.
p.(None): ‘‘(ii) REQUIRED INFORMATION.—
p.(None): ‘‘(I) FDA INFORMATION.—The Secretary shall ensure that the registry data bank includes links to the
p.(None): following information:
p.(None): ‘‘(aa) If an advisory committee considered at a meeting an applicable clinical trial, any posted Food and
p.(None): Drug Administration sum- mary document regarding such applicable clin- ical trial.
p.(None): ‘‘(bb) If an applicable drug clinical trial was conducted under section 505A or 505B of the Federal
p.(None): Food, Drug, and Cosmetic Act,
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 909
p.(None):
p.(None):
p.(None): a link to the posted Food and Drug Adminis- tration assessment of the results of such trial. ‘‘(cc) Food and
p.(None): Drug Administration public health advisories regarding the drug or device that is the subject of the applicable
p.(None): clinical
p.(None): trial, if any.
p.(None): ‘‘(dd) For an applicable drug clinical trial, the Food and Drug Administration action package for approval
p.(None): document required under section 505(l)(2) of the Federal Food, Drug, and Cosmetic Act.
p.(None): ‘‘(ee) For an applicable device clinical trial, in the case of a premarket application under section 515 of
p.(None): the Federal Food, Drug, and Cosmetic Act, the detailed summary of information respecting the
p.(None): safety and effectiveness of the device required under sec- tion 520(h)(1) of such Act, or, in the case
p.(None): of a report under section 510(k) of such Act, the section 510(k) summary of the safety and effectiveness
p.(None): data required under section 807.95(d) of title 21, Code of Federal Regula- tions (or any successor
p.(None): regulation).
p.(None): ‘‘(II) NIH INFORMATION.—The Secretary shall ensure that the registry data bank includes links to the
p.(None): following information:
p.(None): ‘‘(aa) Medline citations to any publications focused on the results of an applicable clinical trial.
p.(None): ‘‘(bb) The entry for the drug that is the subject of an applicable drug clinical trial in the National
p.(None): Library of Medicine database of structured product labels, if available.
p.(None): ‘‘(iii) RESULTS FOR EXISTING DATA BANK ENTRIES.—
p.(None): The Secretary may include the links described in clause
p.(None): (ii) for data bank entries for clinical trials submitted to the data bank prior to enactment of the
p.(None): Food and Drug Administration Amendments Act of 2007, as available.
p.(None): ‘‘(B) INCLUSION OF RESULTS.—The Secretary, acting through the Director of NIH, shall—
p.(None): ‘‘(i) expand the registry data bank to include the results of applicable clinical trials (referred to in
p.(None): this subsection as the ‘registry and results data bank’); ‘‘(ii) ensure that such results are made
p.(None): publicly
p.(None): available through the Internet;
p.(None): ‘‘(iii) post publicly a glossary for the lay public explaining technical terms related to the results of
p.(None): clinical trials; and
p.(None): ‘‘(iv) in consultation with experts on risk commu- nication, provide information with the information
p.(None): included under subparagraph (C) in the registry and results data bank to help ensure that such information does
p.(None): not mislead the patients or the public.
p.(None): ‘‘(C) BASIC RESULTS.—Not later than 1 year after the date of the enactment of the Food and Drug Administration
p.(None): Amendments Act of 2007, the Secretary shall include in
p.(None):
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p.(None):
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p.(None):
p.(None):
p.(None):
p.(None): Public information. Internet.
p.(None):
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p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 910 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): the registry and results data bank the following elements for drugs that are approved under section 505 of the
p.(None): Fed- eral Food, Drug, and Cosmetic Act or licensed under section 351 of this Act and devices that are cleared under
p.(None): section 510(k) of the Federal Food, Drug, and Cosmetic Act or approved under section 515 or 520(m) of such
p.(None): Act:
p.(None): ‘‘(i) DEMOGRAPHIC AND BASELINE CHARACTERISTICS
p.(None): OF PATIENT SAMPLE.—A table of the demographic and baseline data collected overall and for each arm of
p.(None): the clinical trial to describe the patients who partici- pated in the clinical trial, including the
p.(None): number of patients who dropped out of the clinical trial and the number of patients excluded from the
p.(None): analysis, if any. ‘‘(ii) PRIMARY AND SECONDARY OUTCOMES.—The
p.(None): primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for
p.(None): each of the primary and secondary outcome meas- ures for each arm of the clinical trial, including the
p.(None): results of scientifically appropriate tests of the statis- tical significance of such outcome measures.
p.(None): ‘‘(iii) POINT OF CONTACT.—A point of contact for scientific information about the clinical trial results.
p.(None): ‘‘(iv) CERTAIN AGREEMENTS.—Whether there exists
p.(None): an agreement (other than an agreement solely to comply with applicable provisions of law protecting
p.(None): the privacy of participants) between the sponsor or its agent and the principal investigator (unless the
p.(None): sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal
p.(None): investigator, after the completion date of the trial, to discuss the results of the trial at a scientific
p.(None): meeting or any other public or private forum, or to publish in a scientific or academic journal
p.(None): information con- cerning the results of the trial.
p.(None): ‘‘(D) EXPANDED REGISTRY AND RESULTS DATA BANK.—
p.(None):
p.(None): Deadline.
p.(None): ‘‘(i) EXPANSION BY RULEMAKING.—To provide more complete results information and to enhance patient access to
p.(None): and understanding of the results of clinical trials, not later than 3 years after the date of the
p.(None): enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall by regu- lation
p.(None): expand the registry and results data bank as provided under this subparagraph.
p.(None): ‘‘(ii) CLINICAL TRIALS.—
p.(None): ‘‘(I) APPROVED PRODUCTS.—The regulations under this subparagraph shall require the inclu- sion of the
p.(None): results information described in clause
p.(None): (iii) for—
p.(None): ‘‘(aa) each applicable drug clinical trial for a drug that is approved under section 505 of the Federal Food,
p.(None): Drug, and Cosmetic Act or licensed under section 351 of this Act; and ‘‘(bb) each applicable device clinical
p.(None): trial
p.(None): for a device that is cleared under section 510(k) of the Federal Food, Drug, and Cos- metic Act
p.(None): or approved under section 515 or 520(m) of such Act.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 911
p.(None):
p.(None):
p.(None): ‘‘(II) UNAPPROVED PRODUCTS.—The regulations under this subparagraph shall establish whether or not the results
p.(None): information described in clause
p.(None): (iii) shall be required for—
p.(None): ‘‘(aa) an applicable drug clinical trial for a drug that is not approved under section 505 of the Federal
p.(None): Food, Drug, and Cosmetic Act and not licensed under section 351 of this Act (whether approval or licensure
p.(None): was sought or not); and
p.(None): ‘‘(bb) an applicable device clinical trial for a device that is not cleared under section 510(k) of the
p.(None): Federal Food, Drug, and Cos- metic Act and not approved under section 515 or section 520(m) of such Act
p.(None): (whether clear- ance or approval was sought or not).
p.(None): ‘‘(iii) REQUIRED ELEMENTS.—The regulations under this subparagraph shall require, in addition to the elements
p.(None): described in subparagraph (C), information within each of the following categories:
p.(None): ‘‘(I) A summary of the clinical trial and its results that is written in non-technical, under- standable
p.(None): language for patients, if the Secretary determines that such types of summary can be included without being
p.(None): misleading or promotional. ‘‘(II) A summary of the clinical trial and its results that is technical in nature,
p.(None): if the Secretary determines that such types of summary can be included without being misleading or promotional.
p.(None): ‘‘(III) The full protocol or such information
p.(None): on the protocol for the trial as may be necessary to help to evaluate the results of the trial.
p.(None): ‘‘(IV) Such other categories as the Secretary determines appropriate.
p.(None): ‘‘(iv) RESULTS SUBMISSION.—The results informa- tion described in clause (iii) shall be submitted to the
p.(None): Director of NIH for inclusion in the registry and results data bank as provided by subparagraph (E), except that
p.(None): the Secretary shall by regulation determine—
p.(None): ‘‘(I) whether the 1-year period for submission of clinical trial information described in subpara- graph
p.(None): (E)(i) should be increased from 1 year to a period not to exceed 18 months;
p.(None): ‘‘(II) whether the clinical trial information described in clause (iii) should be required to be
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(III) considering the experience under the pilot quality control project described in paragraph (5)(C),
p.(None): procedures for quality control, including using representative samples, with respect to completeness
p.(None): and content of clinical trial informa- tion under this subsection, to help ensure that data elements are not
p.(None): false or misleading and are non-promotional;
p.(None): ‘‘(IV) the appropriate timing and requirements for updates of clinical trial information, and whether and,
p.(None): if so, how such updates should be tracked;
p.(None): ‘‘(V) a statement to accompany the entry for an applicable clinical trial when the primary and secondary
p.(None): outcome measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the
p.(None): submission of such informa- tion in paragraph (2)(C); and
p.(None): ‘‘(VI) additions or modifications to the manner of reporting of the data elements established under subparagraph (C).
p.(None): ‘‘(vi) CONSIDERATION OF WORLD HEALTH ORGANIZA-
p.(None): TION DATA SET.—The Secretary shall consider the status of the consensus data elements set for reporting
p.(None): clinical trial results of the World Health Organization when issuing the regulations under this subparagraph. ‘‘(vii)
p.(None): PUBLIC MEETING.—The Secretary shall hold
p.(None): a public meeting no later than 18 months after the date of the enactment of the Food and Drug Adminis- tration
p.(None): Amendments Act of 2007 to provide an oppor- tunity for input from interested parties with regard to the
p.(None): regulations to be issued under this subpara- graph.
p.(None): ‘‘(E) SUBMISSION OF RESULTS INFORMATION.—
p.(None): ‘‘(i) IN GENERAL.—Except as provided in clauses (iii), (iv), (v), and (vi) the responsible party for an
p.(None): applicable clinical trial that is described in clause (ii) shall submit to the Director of NIH for
p.(None): inclusion in the registry and results data bank the clinical trial information described in subparagraph
p.(None): (C) not later than 1 year, or such other period as may be provided by regulation under subparagraph (D),
p.(None): after the earlier of—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 913
p.(None):
p.(None):
p.(None): ‘‘(I) the estimated completion date of the trial as described in paragraph (2)(A)(ii)(I)(jj)); or
p.(None): ‘‘(II) the actual date of completion.
p.(None): ‘‘(ii) CLINICAL TRIALS DESCRIBED.—An applicable clinical trial described in this clause is an applicable
p.(None): clinical trial subject to—
p.(None): ‘‘(I) paragraph (2)(C); and
p.(None): ‘‘(II)(aa) subparagraph (C); or
p.(None): ‘‘(bb) the regulations issued under subpara- graph (D).
p.(None): ‘‘(iii) DELAYED SUBMISSION OF RESULTS WITH CER-
p.(None): TIFICATION.—If the responsible party for an applicable clinical trial submits a certification that clause (iv)
p.(None): or (v) applies to such clinical trial, the responsible party shall submit to the Director of NIH for inclusion
p.(None): in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) as
p.(None): required under the applicable clause.
p.(None): ‘‘(iv) SEEKING INITIAL APPROVAL OF A DRUG OR
p.(None): DEVICE.—With respect to an applicable clinical trial that is completed before the drug is initially approved
p.(None): under section 505 of the Federal Food, Drug, and Cos- metic Act or initially licensed under section 351 of this
p.(None): Act, or the device is initially cleared under section 510(k) or initially approved under section 515 or 520(m) of the
p.(None): Federal Food, Drug, and Cosmetic Act, the responsible party shall submit to the Director of NIH for
p.(None): inclusion in the registry and results data bank the clinical trial information described in subpara-
p.(None): graphs (C) and (D) not later than 30 days after the drug or device is approved under such section
p.(None): 505, licensed under such section 351, cleared under such section 510(k), or approved under such section
p.(None): 515 or 520(m), as applicable.
p.(None): ‘‘(v) SEEKING APPROVAL OF A NEW USE FOR THE DRUG OR DEVICE.—
p.(None): ‘‘(I) IN GENERAL.—With respect to an applicable clinical trial where the manufacturer of the drug
p.(None): or device is the sponsor of an applicable clinical trial, and such manufacturer has filed, or will file
p.(None): within 1 year, an application seeking approval under section 505 of the Federal Food, Drug, and
p.(None): Cosmetic Act, licensing under section 351 of this Act, or clearance under section 510(k), or approval under
p.(None): section 515 or 520(m), of the Federal Food, Drug, and Cosmetic Act for the use studied in such clinical trial
p.(None): (which use is not included in the labeling of the approved drug or device), then the responsible party
p.(None): shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information
p.(None): described in subparagraphs (C) and (D) on the earlier of the date that is 30 days after the date— ‘‘(aa) the
p.(None): new use of the drug or device
p.(None): is approved under such section 505, licensed under such section 351, cleared under such
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None):
p.(None):
p.(None): 121 STAT. 914 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): section 510(k), or approved under such section 515 or 520(m);
p.(None): ‘‘(bb) the Secretary issues a letter, such as a complete response letter, not approving the submission or
p.(None): not clearing the submission, a not approvable letter, or a not substantially equivalent letter for the new use of
p.(None): the drug or device under such section 505, 351, 510(k), 515, or 520(m); or
p.(None): ‘‘(cc) except as provided in subclause (III), the application or premarket notification under such
p.(None): section 505, 351, 510(k), 515, or 520(m) is withdrawn without resubmission for no less than 210 days.
p.(None): ‘‘(II) REQUIREMENT THAT EACH CLINICAL TRIAL IN APPLICATION BE TREATED THE SAME.—If a manu-
p.(None): facturer makes a certification under clause (iii) that this clause applies with respect to a clinical
p.(None): trial, the manufacturer shall make such a certifi- cation with respect to each applicable clinical trial that is
p.(None): required to be submitted in an application or report for licensure, approval, or clearance (under section
p.(None): 351 of this Act or section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act, as
p.(None): applicable) of the use studied in the clinical trial.
p.(None): ‘‘(III) TWO-YEAR LIMITATION.—The responsible party shall submit to the Director of NIH for inclu- sion in the
p.(None): registry and results data bank the clinical trial information subject to subclause (I) on the date that is 2
p.(None): years after the date a certifi- cation under clause (iii) was made to the Director of NIH, if an action referred
p.(None): to in item (aa), (bb), or (cc) of subclause (I) has not occurred by such date.
p.(None): ‘‘(vi) EXTENSIONS.—The Director of NIH may pro- vide an extension of the deadline for submission of
p.(None): clinical trial information under clause (i) if the respon- sible party for the trial submits to the Director a
p.(None): written request that demonstrates good cause for the extension and provides an estimate of the date on
p.(None): which the information will be submitted. The Director of NIH may grant more than one such extension for a
p.(None): clinical trial.
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public information. Deadline.
p.(None): ‘‘(F) NOTICE TO DIRECTOR OF NIH.—The Commissioner of Food and Drugs shall notify the Director of
p.(None): NIH when there is an action described in subparagraph (E)(iv) or item (aa), (bb), or (cc) of subparagraph
p.(None): (E)(v)(I) with respect to an application or a report that includes a certification required under paragraph
p.(None): (5)(B) of such action not later than 30 days after such action.
p.(None): ‘‘(G) POSTING OF DATA.—The Director of NIH shall ensure that the clinical trial information described in sub-
p.(None): paragraphs (C) and (D) for an applicable clinical trial sub- mitted in accordance with this paragraph is posted
p.(None): publicly in the registry and results database not later than 30 days after such submission.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 915
p.(None):
p.(None):
p.(None): ‘‘(H) WAIVERS REGARDING CERTAIN CLINICAL TRIAL
p.(None): RESULTS.—The Secretary may waive any applicable requirements of this paragraph for an applicable
p.(None): clinical trial, upon a written request from the responsible party, if the Secretary determines that
p.(None): extraordinary cir- cumstances justify the waiver and that providing the waiver is consistent
p.(None): with the protection of public health, or in the interest of national security. Not later than 30 days
p.(None): after any part of a waiver is granted, the Secretary shall notify, in writing, the appropriate committees of
p.(None): Con- gress of the waiver and provide an explanation for why the waiver was granted.
p.(None): ‘‘(I) ADVERSE EVENTS.—
p.(None): ‘‘(i) REGULATIONS.—Not later than 18 months after the date of the enactment of the Food and Drug
p.(None): Administration Amendments Act of 2007, the Secretary shall by regulation determine the best method for including
p.(None): in the registry and results data bank appro- priate results information on serious adverse and fre- quent
p.(None): adverse events for drugs described in subpara- graph (C) in a manner and form that is useful and not
p.(None): misleading to patients, physicians, and scientists. ‘‘(ii) DEFAULT.—If the Secretary fails to issue the
p.(None): regulation required by clause (i) by the date that is
p.(None): 24 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007,
p.(None): clause (iii) shall take effect.
p.(None): ‘‘(iii) ADDITIONAL ELEMENTS.—Upon the application of clause (ii), the Secretary shall include in the registry and
p.(None): results data bank for drugs described in subpara- graph (C), in addition to the clinical trial information
p.(None): described in subparagraph (C), the following elements: ‘‘(I) SERIOUS ADVERSE EVENTS.—A table of
p.(None): anticipated and unanticipated serious adverse events grouped by organ system, with number and frequency of such
p.(None): event in each arm of the clinical trial.
p.(None): ‘‘(II) FREQUENT ADVERSE EVENTS.—A table of
p.(None): anticipated and unanticipated adverse events that are not included in the table described in subclause
p.(None): (I) that exceed a frequency of 5 percent within any arm of the clinical trial, grouped by organ system,
p.(None): with number and frequency of such event in each arm of the clinical trial.
p.(None): ‘‘(iv) POSTING OF OTHER INFORMATION.—In carrying
p.(None): out clause (iii), the Secretary shall, in consultation with experts in risk communication, post with the
p.(None): tables information to enhance patient understanding and to ensure such tables do not mislead patients or
p.(None): the lay public.
p.(None): ‘‘(v) RELATION TO SUBPARAGRAPH (C).—Clinical trial
p.(None): information included in the registry and results data bank pursuant to this subparagraph is deemed to be
p.(None): clinical trial information included in such data bank pursuant to subparagraph (C).
p.(None): ‘‘(4) ADDITIONAL SUBMISSIONS OF CLINICAL TRIAL INFORMA- TION.—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Notification.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Effective date.
p.(None):
p.(None):
p.(None): 121 STAT. 916 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(A) VOLUNTARY SUBMISSIONS.—A responsible party for a clinical trial that is not an applicable
p.(None): clinical trial, or that is an applicable clinical trial that is not subject to paragraph (2)(C), may
p.(None): submit complete clinical trial information described in paragraph (2) or paragraph (3) provided the
p.(None): responsible party submits clinical trial information for each applicable clinical trial that is required to be
p.(None): submitted under section 351 or under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug,
p.(None): and Cosmetic Act in an application or report for licensure, approval, or clearance of the drug or device
p.(None): for the use studied in the clinical trial.
p.(None): ‘‘(B) REQUIRED SUBMISSIONS.—
p.(None): ‘‘(i) IN GENERAL.—Notwithstanding paragraphs (2) and (3) and subparagraph (A), in any case in which the
p.(None): Secretary determines for a specific clinical trial described in clause (ii) that posting in the registry
p.(None): and results data bank of clinical trial information for such clinical trial is necessary to protect the
p.(None): public health—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None): ‘‘(I) the Secretary may require by notification that such information be submitted to the Sec- retary in
p.(None): accordance with paragraphs (2) and (3) except with regard to timing of submission;
p.(None): ‘‘(II) unless the responsible party submits a certification under paragraph (3)(E)(iii), such
p.(None): information shall be submitted not later than 30 days after the date specified by the Secretary in the
p.(None): notification; and
p.(None): ‘‘(III) failure to comply with the requirements under subclauses (I) and (II) shall be treated as a violation
p.(None): of the corresponding requirement of such paragraphs.
p.(None): ‘‘(ii) CLINICAL TRIALS DESCRIBED.—A clinical trial described in this clause is—
p.(None): ‘‘(I) an applicable clinical trial for a drug that is approved under section 505 of the Federal Food, Drug, and
p.(None): Cosmetic Act or licensed under section
p.(None): 351 of this Act or for a device that is cleared under section 510(k) of the Federal Food, Drug, and
p.(None): Cosmetic Act or approved under section 515 or section 520(m) of such Act, whose completion date is on
p.(None): or after the date 10 years before the date of the enactment of the Food and Drug Administration
p.(None): Amendments Act of 2007; or
p.(None): ‘‘(II) an applicable clinical trial that is described by both by paragraph (2)(C) and para-
p.(None): graph (3)(D)(ii)(II)).
p.(None): ‘‘(C) UPDATES TO CLINICAL TRIAL DATA BANK.—
p.(None): ‘‘(i) SUBMISSION OF UPDATES.—The responsible party for an applicable clinical trial shall submit to the
p.(None): Director of NIH for inclusion in the registry and results data bank updates to reflect changes to the
p.(None): clinical trial information submitted under paragraph (2). Such updates—
p.(None): ‘‘(I) shall be provided not less than once every
p.(None): 12 months, unless there were no changes to the
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 917
p.(None):
p.(None):
p.(None): clinical trial information during the preceding 12- month period;
p.(None): ‘‘(II) shall include identification of the dates of any such changes;
p.(None): ‘‘(III) not later than 30 days after the recruit- ment status of such clinical trial changes, shall include an
p.(None): update of the recruitment status; and ‘‘(IV) not later than 30 days after the comple- tion date of the clinical
p.(None): trial, shall include notifica- tion to the Director that such clinical trial is com-
p.(None): plete.
p.(None): ‘‘(ii) PUBLIC AVAILABILITY OF UPDATES.—The
p.(None): Director of NIH shall make updates submitted under clause (i) publicly available in the registry data bank.
p.(None): Except with regard to overall recruitment status, indi- vidual site status, location, and contact information,
p.(None): the Director of NIH shall ensure that updates to ele- ments required under subclauses (I) to (V) of paragraph
p.(None): (2)(A)(ii) do not result in the removal of any informa- tion from the original submissions or any
p.(None): preceding updates, and information in such databases is pre- sented in a manner that enables users to readily
p.(None): access each original element submission and to track the changes made by the updates. The Director of
p.(None): NIH shall provide a link from the table of primary and secondary outcomes required under paragraph (3)(C)(ii)
p.(None): to the tracked history required under this clause of the primary and secondary outcome measures sub-
p.(None): mitted under paragraph (2)(A)(ii)(I)(ll).
p.(None): ‘‘(5) COORDINATION AND COMPLIANCE.—
p.(None): ‘‘(A) CLINICAL TRIALS SUPPORTED BY GRANTS FROM FED- ERAL AGENCIES.—
p.(None): ‘‘(i) GRANTS FROM CERTAIN FEDERAL AGENCIES.—
p.(None): If an applicable clinical trial is funded in whole or in part by a grant from any agency of the Department of
p.(None): Health and Human Services, including the Food and Drug Administration, the National Institutes of Health,
p.(None): or the Agency for Healthcare Research and Quality, any grant or progress report forms required under such
p.(None): grant shall include a certification that the responsible party has made all required submissions to the
p.(None): Director of NIH under paragraphs (2) and (3). ‘‘(ii) VERIFICATION BY FEDERAL AGENCIES.—The
p.(None): heads of the agencies referred to in clause (i), as applicable, shall verify that the clinical trial
p.(None): informa- tion for each applicable clinical trial for which a grantee is the responsible party has
p.(None): been submitted under paragraphs (2) and (3) before releasing any remaining funding for a grant or funding
p.(None): for a future grant to such grantee.
p.(None): ‘‘(iii) NOTICE AND OPPORTUNITY TO REMEDY.—If the
p.(None): head of an agency referred to in clause (i), as applicable, verifies that a grantee has not
p.(None): submitted clinical trial information as described in clause (ii), such agency head shall provide notice to such
p.(None): grantee of such non-compliance and allow such grantee 30 days
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Certification.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 918 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): to correct such non-compliance and submit the required clinical trial information.
p.(None): ‘‘(iv) CONSULTATION WITH OTHER FEDERAL AGEN-
p.(None): CIES.—The Secretary shall—
p.(None): ‘‘(I) consult with other agencies that conduct research involving human subjects in accordance with any
p.(None): section of part 46 of title 45, Code of Federal Regulations (or any successor regulations), to determine if any
p.(None): such research is an applicable clinical trial; and
p.(None):
p.(None): Procedures.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(II) develop with such agencies procedures comparable to those described in clauses (i), (ii), and (iii)
p.(None): to ensure that clinical trial information for such applicable clinical trial is submitted under paragraphs (2)
p.(None): and (3).
p.(None): ‘‘(B) CERTIFICATION TO ACCOMPANY DRUG, BIOLOGICAL
p.(None): PRODUCT, AND DEVICE SUBMISSIONS.—At the time of submis- sion of an application under section 505 of the
p.(None): Federal Food, Drug, and Cosmetic Act, section 515 of such Act, section 520(m) of such Act, or section
p.(None): 351 of this Act, or submission of a report under section 510(k) of such Act, such application or
p.(None): submission shall be accompanied by a certification that all applicable requirements of this subsection have
p.(None): been met. Where available, such certifi- cation shall include the appropriate National Clinical Trial control
p.(None): numbers.
p.(None): ‘‘(C) QUALITY CONTROL.—
p.(None): ‘‘(i) PILOT QUALITY CONTROL PROJECT.—Until the
p.(None): effective date of the regulations issued under para- graph (3)(D), the Secretary, acting through the Director of
p.(None): NIH and the Commissioner of Food and Drugs, shall conduct a pilot project to determine the optimal
p.(None): method of verification to help to ensure that the clinical trial information submitted under paragraph (3)(C) is
p.(None): non-promotional and is not false or misleading in any particular under subparagraph (D). The Secretary shall use the
p.(None): publicly available information described in paragraph (3)(A) and any other information available to the
p.(None): Secretary about applicable clinical trials to verify the accuracy of the clinical trial information submitted under
p.(None): paragraph (3)(C).
p.(None): ‘‘(ii) NOTICE OF COMPLIANCE.—If the Secretary determines that any clinical trial information was not
p.(None): submitted as required under this subsection, or was submitted but is false or misleading in any particular, the
p.(None): Secretary shall notify the responsible party and give such party an opportunity to remedy such non-
...
p.(None): information on the primary and secondary outcomes at the time of submission, as required by law. This
p.(None): may or may not
p.(None):
p.(None):
p.(None): 121 STAT. 920 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): have any bearing on the accuracy of the information in the entry.’.
p.(None): ‘‘(vi) COMPLIANCE SEARCHES.—The Director of NIH shall provide that the public may easily search the registry
p.(None): and results data bank for entries that include notices required under this subparagraph.
p.(None): ‘‘(6) LIMITATION ON DISCLOSURE OF CLINICAL TRIAL INFORMATION.—
p.(None): ‘‘(A) IN GENERAL.—Nothing in this subsection (or under section 552 of title 5, United States Code) shall
p.(None): require the Secretary to publicly disclose, by any means other than the registry and results data
p.(None): bank, information described in subparagraph (B).
p.(None): ‘‘(B) INFORMATION DESCRIBED.—Information described in this subparagraph is—
p.(None): ‘‘(i) information submitted to the Director of NIH under this subsection, or information of the same gen- eral
p.(None): nature as (or integrally associated with) the information so submitted; and
p.(None): ‘‘(ii) information not otherwise publicly available, including because it is protected from disclosure under
p.(None): section 552 of title 5, United States Code.
p.(None): ‘‘(7) AUTHORIZATION OF APPROPRIATIONS.—There are
p.(None): authorized to be appropriated to carry out this subsection
p.(None): $10,000,000 for each fiscal year.’’.
p.(None): (b) CONFORMING AMENDMENTS.—
p.(None): (1) PROHIBITED ACTS.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by
p.(None): adding at the end the following:
p.(None): ‘‘(jj)(1) The failure to submit the certification required by section 402(j)(5)(B) of the Public Health Service Act, or
p.(None): knowingly submit- ting a false certification under such section.
p.(None): ‘‘(2) The failure to submit clinical trial information required under subsection (j) of section 402 of
p.(None): the Public Health Service Act.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Penalties.
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(3) The submission of clinical trial information under sub- section (j) of section 402 of the Public
p.(None): Health Service Act that is false or misleading in any particular under paragraph (5)(D) of such subsection
p.(None): (j).’’.
p.(None): (2) CIVIL MONEY PENALTIES.—Subsection (f) of section 303 of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 333), as redesignated by section 226, is amended—
p.(None): (A) by redesignating paragraphs (3), (4), and (5) as paragraphs (5), (6), and (7), respectively;
p.(None): (B) by inserting after paragraph (2) the following: ‘‘(3)(A) Any person who violates section 301(jj) shall be subject
p.(None): to a civil monetary penalty of not more than $10,000 for all viola- tions adjudicated in a single
p.(None): proceeding.
p.(None): ‘‘(B) If a violation of section 301(jj) is not corrected within the 30-day period following notification
p.(None): under section 402(j)(5)(C)(ii), the person shall, in addition to any penalty under subparagraph (A), be
p.(None): subject to a civil monetary penalty of not more than $10,000 for each day of the violation after such period
p.(None): until the violation is corrected.’’;
p.(None): (C) in paragraph (2)(C), by striking ‘‘paragraph (3)(A)’’ and inserting ‘‘paragraph (5)(A)’’;
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 921
p.(None):
p.(None):
p.(None): (D) in paragraph (5), as so redesignated, by striking ‘‘paragraph (1) or (2)’’ each place it appears
p.(None): and inserting ‘‘paragraph (1), (2), or (3)’’;
p.(None): (E) in paragraph (6), as so redesignated, by striking ‘‘paragraph (3)(A)’’ and inserting ‘‘paragraph
p.(None): (5)(A)’’; and
p.(None): (F) in paragraph (7), as so redesignated, by striking ‘‘paragraph (4)’’ each place it appears and inserting
p.(None): ‘‘para- graph (6)’’.
p.(None): (3) NEW DRUGS AND DEVICES.—
p.(None): (A) INVESTIGATIONAL NEW DRUGS.—Section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is
p.(None): amended in paragraph (4), by adding at the end the following: ‘‘The Secretary shall update such
p.(None): regulations to require inclusion in the informed consent documents and process a statement that clinical
p.(None): trial information for such clinical investigation has been or will be submitted for inclusion in the
p.(None): registry data bank pursuant to sub- section (j) of section 402 of the Public Health Service Act.’’.
p.(None): (B) NEW DRUG APPLICATIONS.—Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b))
p.(None): is amended by adding at the end the following:
p.(None): ‘‘(6) An application submitted under this subsection shall be accompanied by the certification required
p.(None): under section 402(j)(5)(B) of the Public Health Service Act. Such certification shall not be considered an element of
p.(None): such application.’’.
p.(None): (C) DEVICE REPORTS UNDER SECTION 510(k).—Section 510(k) of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 360(k)) is amended by adding at the end the fol- lowing:
p.(None): ‘‘A notification submitted under this subsection that contains clin- ical trial data for an applicable
p.(None): device clinical trial (as defined in section 402(j)(1) of the Public Health Service Act) shall be accom- panied by
p.(None): the certification required under section 402(j)(5)(B) of such Act. Such certification shall not be
p.(None): considered an element of such notification.’’.
p.(None): (D) DEVICE PREMARKET APPROVAL APPLICATION.—Sec- tion 515(c)(1) of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 360e(c)(1)) is amended—
p.(None): (i) in subparagraph (F), by striking ‘‘; and’’ and inserting a semicolon;
p.(None): (ii) by redesignating subparagraph (G) as subpara- graph (H); and
p.(None): (iii) by inserting after subparagraph (F) the fol- lowing:
p.(None): ‘‘(G) the certification required under section 402(j)(5)(B) of the Public Health Service Act (which shall not be
p.(None): consid- ered an element of such application); and’’.
p.(None): (E) HUMANITARIAN DEVICE EXEMPTION.—Section 520(m)(2) of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 360e(c)) is amended in the first sentence in the matter following subparagraph (C), by
p.(None): inserting at the end before the period ‘‘and such application shall include the certification required
p.(None): under section 402(j)(5)(B) of the Public Health Service Act (which shall not be consid- ered an element of such
p.(None): application)’’.
p.(None): (c) SURVEILLANCES.—Not later than 12 months after the date of the enactment of this Act, the
p.(None): Secretary of Health and Human
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Certification.
p.(None):
p.(None):
p.(None):
p.(None): Regulations.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 360j.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Guidance.
p.(None): 42 USC 282 note.
p.(None):
p.(None):
p.(None): 121 STAT. 922 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): Services shall issue guidance on how the requirements of section 402(j) of the Public Health Service
p.(None): Act, as added by this section, apply to a pediatric postmarket surveillance described in paragraph (1)(A)(ii)(II)
p.(None): of such section 402(j) that is not a clinical trial.
p.(None):
p.(None): 42 USC 282 note.
p.(None): (d) PREEMPTION.—
p.(None): (1) IN GENERAL.—Upon the expansion of the registry and results data bank under section 402(j)(3)(D) of the
p.(None): Public Health Service Act, as added by this section, no State or political subdivision of a State may
p.(None): establish or continue in effect any requirement for the registration of clinical trials or for the
p.(None): inclusion of information relating to the results of clinical trials in a database.
p.(None): (2) RULE OF CONSTRUCTION.—The fact of submission of clinical trial information, if submitted in compliance with
p.(None): sub- section (j) of section 402 of the Public Health Service Act (as amended by this section), that
p.(None): relates to a use of a drug or device not included in the official labeling of the approved drug or
p.(None): device shall not be construed by the Secretary of Health and Human Services or in any administrative or
p.(None): judicial proceeding, as evidence of a new intended use of the drug or device that is different from the
p.(None): intended use of the drug or device set forth in the official labeling of the drug or device. The availability of
p.(None): clinical trial information through the registry and results data bank under such subsection (j), if submitted
p.(None): in compliance with such subsection, shall not be considered as labeling, adulteration, or misbranding of the
p.(None): drug or device under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
p.(None):
p.(None): TITLE IX—ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS
p.(None): Subtitle A—Postmarket Studies and Surveillance
p.(None): SEC. 901. POSTMARKET STUDIES AND CLINICAL TRIALS REGARDING HUMAN DRUGS; RISK EVALUATION AND
p.(None): MITIGATION STRATEGIES.
p.(None): (a) IN GENERAL.—Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by
p.(None): adding at the end the following subsections:
p.(None): ‘‘(o) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING.—
p.(None): ‘‘(1) IN GENERAL.—A responsible person may not introduce or deliver for introduction into interstate commerce
p.(None): the new drug involved if the person is in violation of a requirement established under paragraph (3) or
p.(None): (4) with respect to the drug.
p.(None): ‘‘(2) DEFINITIONS.—For purposes of this subsection:
p.(None): ‘‘(A) RESPONSIBLE PERSON.—The term ‘responsible per- son’ means a person who—
p.(None): ‘‘(i) has submitted to the Secretary a covered application that is pending; or
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 923
p.(None):
p.(None): ‘‘(ii) is the holder of an approved covered applica- tion.
p.(None): ‘‘(B) COVERED APPLICATION.—The term ‘covered application’ means—
p.(None): ‘‘(i) an application under subsection (b) for a drug that is subject to section 503(b); and
p.(None): ‘‘(ii) an application under section 351 of the Public Health Service Act.
p.(None): ‘‘(C) NEW SAFETY INFORMATION; SERIOUS RISK.—The
p.(None): terms ‘new safety information’, ‘serious risk’, and ‘signal of a serious risk’ have the meanings given
p.(None): such terms in section 505–1(b).
p.(None): ‘‘(3) STUDIES AND CLINICAL TRIALS.—
p.(None): ‘‘(A) IN GENERAL.—For any or all of the purposes speci- fied in subparagraph (B), the Secretary may, subject to
p.(None): subparagraph (D), require a responsible person for a drug to conduct a postapproval study or studies of the
p.(None): drug, or a postapproval clinical trial or trials of the drug, on the basis of scientific data deemed
p.(None): appropriate by the Sec- retary, including information regarding chemically-related or pharmacologically-related
p.(None): drugs.
p.(None): ‘‘(B) PURPOSES OF STUDY OR CLINICAL TRIAL.—The pur-
p.(None): poses referred to in this subparagraph with respect to a postapproval study or postapproval clinical
p.(None): trial are the following:
p.(None): ‘‘(i) To assess a known serious risk related to the use of the drug involved.
p.(None): ‘‘(ii) To assess signals of serious risk related to the use of the drug.
p.(None): ‘‘(iii) To identify an unexpected serious risk when available data indicates the potential for a serious
p.(None): risk.
p.(None): ‘‘(C) ESTABLISHMENT OF REQUIREMENT AFTER APPROVAL
p.(None): OF COVERED APPLICATION.—The Secretary may require a postapproval study or studies or postapproval clinical
p.(None): trial or trials for a drug for which an approved covered applica- tion is in effect as of the date on which
p.(None): the Secretary seeks to establish such requirement only if the Secretary becomes aware of new safety
p.(None): information.
p.(None): ‘‘(D) DETERMINATION BY SECRETARY.—
p.(None): ‘‘(i) POSTAPPROVAL STUDIES.—The Secretary may not require the responsible person to conduct a study
p.(None): under this paragraph, unless the Secretary makes a determination that the reports under subsection (k)(1) and
p.(None): the active postmarket risk identification and anal- ysis system as available under subsection (k)(3) will not
p.(None): be sufficient to meet the purposes set forth in subparagraph (B).
p.(None): ‘‘(ii) POSTAPPROVAL CLINICAL TRIALS.—The Sec-
p.(None): retary may not require the responsible person to con- duct a clinical trial under this paragraph, unless
p.(None): the Secretary makes a determination that a postapproval study or studies will not be sufficient to meet
p.(None): the purposes set forth in subparagraph (B).
p.(None): ‘‘(E) NOTIFICATION; TIMETABLES; PERIODIC REPORTS.—
p.(None): ‘‘(i) NOTIFICATION.—The Secretary shall notify the responsible person regarding a requirement under this
p.(None):
p.(None):
p.(None): 121 STAT. 924 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): paragraph to conduct a postapproval study or clinical trial by the target dates for communication of feedback
p.(None): from the review team to the responsible person regarding proposed labeling and postmarketing study
p.(None): commitments as set forth in the letters described in section 101(c) of the Food and Drug Administration
p.(None): Amendments Act of 2007.
p.(None): ‘‘(ii) TIMETABLE; PERIODIC REPORTS.—For each
p.(None): study or clinical trial required to be conducted under this paragraph, the Secretary shall require that
p.(None): the responsible person submit a timetable for completion of the study or clinical trial. With respect to
p.(None): each study required to be conducted under this paragraph or otherwise undertaken by the responsible person
p.(None): to investigate a safety issue, the Secretary shall require the responsible person to periodically report
p.(None): to the Secretary on the status of such study including whether any difficulties in completing the
p.(None): study have been encountered. With respect to each clinical trial required to be conducted under this
p.(None): paragraph or otherwise undertaken by the responsible person to investigate a safety issue, the Secretary
p.(None): shall require the responsible person to periodically report to the Secretary on the status of such clinical
p.(None): trial including whether enrollment has begun, the number of partici- pants enrolled, the expected completion date,
p.(None): whether any difficulties completing the clinical trial have been encountered, and registration information with respect
p.(None): to the requirements under section 402(j) of the Public Health Service Act. If the responsible person
p.(None): fails to comply with such timetable or violates any other requirement of this subparagraph, the
p.(None): responsible per- son shall be considered in violation of this subsection, unless the responsible person demonstrates
p.(None): good cause for such noncompliance or such other violation. The Secretary shall determine what constitutes good
p.(None): cause under the preceding sentence.
p.(None): ‘‘(F) DISPUTE RESOLUTION.—The responsible person may appeal a requirement to conduct a study or
p.(None): clinical trial under this paragraph using dispute resolution proce- dures established by the Secretary in
p.(None): regulation and guid- ance.
p.(None):
p.(None): Deadlines. Notification.
p.(None): ‘‘(4) SAFETY LABELING CHANGES REQUESTED BY SEC- RETARY.—
p.(None): ‘‘(A) NEW SAFETY INFORMATION.—If the Secretary
p.(None): becomes aware of new safety information that the Secretary believes should be included in the labeling of the
p.(None): drug, the Secretary shall promptly notify the responsible person or, if the same drug approved under section
p.(None): 505(b) is not currently marketed, the holder of an approved application under 505(j).
p.(None): ‘‘(B) RESPONSE TO NOTIFICATION.—Following notifica- tion pursuant to subparagraph (A), the responsible person
p.(None): or the holder of the approved application under section 505(j) shall within 30 days—
p.(None): ‘‘(i) submit a supplement proposing changes to the approved labeling to reflect the new safety information,
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 925
p.(None):
p.(None):
p.(None): including changes to boxed warnings, contraindica- tions, warnings, precautions, or adverse reactions;
p.(None): or ‘‘(ii) notify the Secretary that the responsible per-
p.(None): son or the holder of the approved application under section 505(j) does not believe a labeling change
p.(None): is warranted and submit a statement detailing the rea- sons why such a change is not warranted.
p.(None): ‘‘(C) REVIEW.—Upon receipt of such supplement, the Secretary shall promptly review and act upon such supple-
p.(None): ment. If the Secretary disagrees with the proposed changes in the supplement or with the statement setting
p.(None): forth the reasons why no labeling change is necessary, the Sec- retary shall initiate discussions to
p.(None): reach agreement on whether the labeling for the drug should be modified to reflect the new safety
p.(None): information, and if so, the contents of such labeling changes.
p.(None): ‘‘(D) DISCUSSIONS.—Such discussions shall not extend for more than 30 days after the response to the notification
p.(None): under subparagraph (B), unless the Secretary determines an extension of such discussion period is warranted.
p.(None): ‘‘(E) ORDER.—Within 15 days of the conclusion of the discussions under subparagraph (D), the Secretary
p.(None): may issue an order directing the responsible person or the holder of the approved application under section
p.(None): 505(j) to make such a labeling change as the Secretary deems appropriate to address the new safety information.
p.(None): Within 15 days of such an order, the responsible person or the holder of the approved application
p.(None): under section 505(j) shall submit a supplement containing the labeling change.
p.(None): ‘‘(F) DISPUTE RESOLUTION.—Within 5 days of receiving an order under subparagraph (E), the responsible person
p.(None): or the holder of the approved application under section 505(j) may appeal using dispute resolution
p.(None): procedures established by the Secretary in regulation and guidance. ‘‘(G) VIOLATION.—If the responsible
p.(None): person or the holder of the approved application under section 505(j) has not submitted a supplement
p.(None): within 15 days of the date of such order under subparagraph (E), and there is no appeal or dispute
p.(None): resolution proceeding pending, the responsible person or holder shall be considered to be in violation of
p.(None): this subsection. If at the conclusion of any dispute resolution procedures the Secretary determines
p.(None): that a supplement must be submitted and such a supple- ment is not submitted within 15 days of the
p.(None): date of that determination, the responsible person or holder shall be
p.(None): in violation of this subsection.
p.(None): ‘‘(H) PUBLIC HEALTH THREAT.—Notwithstanding sub- paragraphs (A) through (F), if the Secretary concludes that such
p.(None): a labeling change is necessary to protect the public health, the Secretary may accelerate the timelines in such
p.(None): subparagraphs.
p.(None): ‘‘(I) RULE OF CONSTRUCTION.—This paragraph shall not be construed to affect the responsibility of the
p.(None): responsible person or the holder of the approved application under section 505(j) to maintain its label
p.(None): in accordance with existing requirements, including subpart B of part 201
p.(None):
p.(None):
p.(None): Notification.
p.(None):
p.(None):
p.(None): 121 STAT. 926 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): and sections 314.70 and 601.12 of title 21, Code of Federal Regulations (or any successor regulations).
p.(None): ‘‘(5) NON-DELEGATION.—Determinations by the Secretary under this subsection for a drug shall be made by
p.(None): individuals at or above the level of individuals empowered to approve a drug (such as division directors
p.(None): within the Center for Drug Evaluation and Research).
p.(None): ‘‘(p) RISK EVALUATION AND MITIGATION STRATEGY.—
p.(None): ‘‘(1) IN GENERAL.—A person may not introduce or deliver for introduction into interstate commerce a new drug
p.(None): if—
p.(None): ‘‘(A)(i) the application for such drug is approved under subsection (b) or (j) and is subject to section
p.(None): 503(b); or ‘‘(ii) the application for such drug is approved under
p.(None): section 351 of the Public Health Service Act; and
p.(None): ‘‘(B) a risk evaluation and mitigation strategy is required under section 505–1 with respect to
p.(None): the drug and the person fails to maintain compliance with the requirements of the approved
p.(None): strategy or with other requirements under section 505–1, including requirements regarding assessments of approved
p.(None): strategies.
p.(None): ‘‘(2) CERTAIN POSTMARKET STUDIES.—The failure to conduct a postmarket study under section 506, subpart
p.(None): H of part 314, or subpart E of part 601 of title 21, Code of Federal Regulations (or any successor regulations),
p.(None): is deemed to be a violation of paragraph (1).’’.
p.(None): (b) REQUIREMENTS REGARDING STRATEGIES.—Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 351 et seq.) is amended by inserting after section 505 the following section:
p.(None):
p.(None): 21 USC 355–1.
p.(None): ‘‘SEC. 505–1. RISK EVALUATION AND MITIGATION STRATEGIES.
p.(None): ‘‘(a) SUBMISSION OF PROPOSED STRATEGY.—
p.(None): ‘‘(1) INITIAL APPROVAL.—If the Secretary, in consultation with the office responsible for reviewing the
p.(None): drug and the office responsible for postapproval safety with respect to the drug, determines that a risk
p.(None): evaluation and mitigation strategy is necessary to ensure that the benefits of the drug outweigh the risks
p.(None): of the drug, and informs the person who submits such application of such determination, then such person shall
p.(None): submit to the Secretary as part of such application a proposed risk evaluation and mitigation strategy. In making
p.(None): such a determination, the Secretary shall consider the following fac- tors:
p.(None): ‘‘(A) The estimated size of the population likely to use the drug involved.
p.(None): ‘‘(B) The seriousness of the disease or condition that is to be treated with the drug.
p.(None): ‘‘(C) The expected benefit of the drug with respect to such disease or condition.
p.(None): ‘‘(D) The expected or actual duration of treatment with the drug.
p.(None): ‘‘(E) The seriousness of any known or potential adverse events that may be related to the drug and the background
p.(None): incidence of such events in the population likely to use the drug.
p.(None): ‘‘(F) Whether the drug is a new molecular entity. ‘‘(2) POSTAPPROVAL REQUIREMENT.—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 927
p.(None):
p.(None):
p.(None): ‘‘(A) IN GENERAL.—If the Secretary has approved a covered application (including an application
p.(None): approved before the effective date of this section) and did not when approving the application require a
p.(None): risk evaluation and mitigation strategy under paragraph (1), the Secretary, in consultation with the
p.(None): offices described in paragraph (1), may subsequently require such a strategy for the drug involved (including when
p.(None): acting on a supplemental applica- tion seeking approval of a new indication for use of the drug) if the
p.(None): Secretary becomes aware of new safety informa- tion and makes a determination that such a strategy is
p.(None): necessary to ensure that the benefits of the drug outweigh the risks of the drug.
p.(None): ‘‘(B) SUBMISSION OF PROPOSED STRATEGY.—Not later
p.(None): than 120 days after the Secretary notifies the holder of an approved covered application that the
p.(None): Secretary has made a determination under subparagraph (A) with respect to the drug involved, or within such other
p.(None): reasonable time as the Secretary requires to protect the public health, the holder shall submit to the
p.(None): Secretary a proposed risk evalua- tion and mitigation strategy.
p.(None): ‘‘(3) ABBREVIATED NEW DRUG APPLICATIONS.—The applica-
p.(None): bility of this section to an application under section 505(j) is subject to subsection (i).
p.(None): ‘‘(4) NON-DELEGATION.—Determinations by the Secretary under this subsection for a drug shall be made by
p.(None): individuals at or above the level of individuals empowered to approve a drug (such as division directors
p.(None): within the Center for Drug Evaluation and Research).
p.(None): ‘‘(b) DEFINITIONS.—For purposes of this section:
p.(None): ‘‘(1) ADVERSE DRUG EXPERIENCE.—The term ‘adverse drug experience’ means any adverse event associated with
p.(None): the use of a drug in humans, whether or not considered drug related, including—
p.(None): ‘‘(A) an adverse event occurring in the course of the use of the drug in professional practice;
p.(None): ‘‘(B) an adverse event occurring from an overdose of the drug, whether accidental or intentional;
p.(None): ‘‘(C) an adverse event occurring from abuse of the drug;
p.(None): ‘‘(D) an adverse event occurring from withdrawal of the drug; and
p.(None): ‘‘(E) any failure of expected pharmacological action of the drug.
p.(None): ‘‘(2) COVERED APPLICATION.—The term ‘covered application’ means an application referred to in section 505(p)(1)(A).
p.(None): ‘‘(3) NEW SAFETY INFORMATION.—The term ‘new safety information’, with respect to a drug, means information
p.(None): derived from a clinical trial, an adverse event report, a postapproval study (including a study under
p.(None): section 505(o)(3)), or peer- reviewed biomedical literature; data derived from the postmarket
p.(None): risk identification and analysis system under sec- tion 505(k); or other scientific data deemed
p.(None): appropriate by the Secretary about—
p.(None): ‘‘(A) a serious risk or an unexpected serious risk associ- ated with use of the drug that the Secretary has
p.(None): become aware of (that may be based on a new analysis of existing
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Notification.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Applicability.
p.(None):
p.(None):
p.(None): 121 STAT. 928 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): information) since the drug was approved, since the risk evaluation and mitigation strategy was required,
p.(None): or since the last assessment of the approved risk evaluation and mitigation strategy for the drug; or
p.(None): ‘‘(B) the effectiveness of the approved risk evaluation and mitigation strategy for the drug obtained
p.(None): since the last assessment of such strategy.
p.(None): ‘‘(4) SERIOUS ADVERSE DRUG EXPERIENCE.—The term
p.(None): ‘serious adverse drug experience’ is an adverse drug experience that—
p.(None): ‘‘(A) results in—
p.(None): ‘‘(i) death;
p.(None): ‘‘(ii) an adverse drug experience that places the patient at immediate risk of death from the adverse
p.(None): drug experience as it occurred (not including an adverse drug experience that might have caused death had
p.(None): it occurred in a more severe form);
p.(None): ‘‘(iii) inpatient hospitalization or prolongation of existing hospitalization;
p.(None): ‘‘(iv) a persistent or significant incapacity or substantial disruption of the ability to conduct normal
p.(None): life functions; or
p.(None): ‘‘(v) a congenital anomaly or birth defect; or
p.(None): ‘‘(B) based on appropriate medical judgment, may jeop- ardize the patient and may require a medical or
p.(None): surgical intervention to prevent an outcome described under subparagraph (A).
p.(None): ‘‘(5) SERIOUS RISK.—The term ‘serious risk’ means a risk of a serious adverse drug experience.
p.(None): ‘‘(6) SIGNAL OF A SERIOUS RISK.—The term ‘signal of a serious risk’ means information related to a
p.(None): serious adverse drug experience associated with use of a drug and derived from—
p.(None): ‘‘(A) a clinical trial;
p.(None): ‘‘(B) adverse event reports;
p.(None): ‘‘(C) a postapproval study, including a study under section 505(o)(3);
p.(None): ‘‘(D) peer-reviewed biomedical literature;
p.(None): ‘‘(E) data derived from the postmarket risk identifica- tion and analysis system under section 505(k)(4); or
p.(None): ‘‘(F) other scientific data deemed appropriate by the Secretary.
p.(None): ‘‘(7) RESPONSIBLE PERSON.—The term ‘responsible person’ means the person submitting a covered application or the
p.(None): holder of the approved such application.
p.(None): ‘‘(8) UNEXPECTED SERIOUS RISK.—The term ‘unexpected serious risk’ means a serious adverse drug
p.(None): experience that is not listed in the labeling of a drug, or that may be sympto- matically and pathophysiologically
p.(None): related to an adverse drug experience identified in the labeling, but differs from such adverse drug
p.(None): experience because of greater severity, specificity, or prevalence.
p.(None): ‘‘(c) CONTENTS.—A proposed risk evaluation and mitigation strategy under subsection (a) shall—
p.(None): ‘‘(1) include the timetable required under subsection (d);
p.(None): and
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 929
p.(None):
p.(None):
p.(None): ‘‘(2) to the extent required by the Secretary, in consultation with the office responsible for reviewing the
p.(None): drug and the office responsible for postapproval safety with respect to the drug, include additional
p.(None): elements described in subsections (e) and (f).
p.(None): ‘‘(d) MINIMAL STRATEGY.—For purposes of subsection (c)(1), the risk evaluation and mitigation strategy for a
p.(None): drug shall require a timetable for submission of assessments of the strategy that— ‘‘(1) includes an
p.(None): assessment, by the date that is 18 months
p.(None): after the strategy is initially approved;
p.(None): ‘‘(2) includes an assessment by the date that is 3 years after the strategy is initially approved;
p.(None): ‘‘(3) includes an assessment in the seventh year after the strategy is so approved; and
p.(None): ‘‘(4) subject to paragraphs (1), (2), and (3)—
p.(None): ‘‘(A) is at a frequency specified in the strategy;
p.(None): ‘‘(B) is increased or reduced in frequency as necessary as provided for in subsection (g)(4)(A); and
p.(None): ‘‘(C) is eliminated after the 3-year period described in paragraph (1) if the Secretary determines that
p.(None): serious risks of the drug have been adequately identified and assessed and are being adequately managed.
p.(None): ‘‘(e) ADDITIONAL POTENTIAL ELEMENTS OF STRATEGY.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary, in consultation with the offices described in subsection (c)(2), may under such
p.(None): subsection require that the risk evaluation and mitigation strategy for a drug include 1 or more of the
p.(None): additional elements described in this subsection if the Secretary makes the determination required with
p.(None): respect to each element involved.
p.(None): ‘‘(2) MEDICATION GUIDE; PATIENT PACKAGE INSERT.—The
p.(None): risk evaluation and mitigation strategy for a drug may require that, as applicable, the responsible person develop for
p.(None): distribu- tion to each patient when the drug is dispensed—
p.(None): ‘‘(A) a Medication Guide, as provided for under part 208 of title 21, Code of Federal Regulations (or
p.(None): any suc- cessor regulations); and
p.(None): ‘‘(B) a patient package insert, if the Secretary deter- mines that such insert may help mitigate a
p.(None): serious risk of the drug.
p.(None): ‘‘(3) COMMUNICATION PLAN.—The risk evaluation and miti- gation strategy for a drug may require that the
p.(None): responsible person conduct a communication plan to health care providers, if, with respect to such drug, the
p.(None): Secretary determines that such plan may support implementation of an element of the strategy (including
p.(None): under this paragraph). Such plan may include—
p.(None): ‘‘(A) sending letters to health care providers;
p.(None): ‘‘(B) disseminating information about the elements of the risk evaluation and mitigation strategy to
p.(None): encourage implementation by health care providers of components that apply to such health care providers,
p.(None): or to explain certain safety protocols (such as medical monitoring by periodic laboratory tests); or
p.(None): ‘‘(C) disseminating information to health care providers through professional societies about any serious risks
p.(None): of the drug and any protocol to assure safe use.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None):
p.(None):
p.(None): 121 STAT. 930 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(f) PROVIDING SAFE ACCESS FOR PATIENTS TO DRUGS WITH KNOWN SERIOUS RISKS THAT WOULD
p.(None): OTHERWISE BE UNAVAIL-
p.(None): ABLE.—
p.(None): ‘‘(1) ALLOWING SAFE ACCESS TO DRUGS WITH KNOWN SERIOUS
p.(None): RISKS.—The Secretary, in consultation with the offices described in subsection (c)(2), may require that the risk
p.(None): evaluation and mitigation strategy for a drug include such elements as are necessary to assure safe use of
p.(None): the drug, because of its inherent toxicity or potential harmfulness, if the Secretary determines that—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(A) the drug, which has been shown to be effective, but is associated with a serious adverse drug
p.(None): experience, can be approved only if, or would be withdrawn unless, such elements are required as part of
p.(None): such strategy to mitigate a specific serious risk listed in the labeling of the drug; and
p.(None): ‘‘(B) for a drug initially approved without elements to assure safe use, other elements under subsections
p.(None): (c), (d), and (e) are not sufficient to mitigate such serious risk.
p.(None): ‘‘(2) ASSURING ACCESS AND MINIMIZING BURDEN.—Such ele-
p.(None): ments to assure safe use under paragraph (1) shall—
p.(None): ‘‘(A) be commensurate with the specific serious risk listed in the labeling of the drug;
p.(None): ‘‘(B) within 30 days of the date on which any element under paragraph (1) is imposed, be posted publicly by
p.(None): the Secretary with an explanation of how such elements will mitigate the observed safety risk;
p.(None): ‘‘(C) considering such risk, not be unduly burdensome on patient access to the drug, considering in
p.(None): particular— ‘‘(i) patients with serious or life-threatening dis-
p.(None): eases or conditions; and
p.(None): ‘‘(ii) patients who have difficulty accessing health care (such as patients in rural or medically under-
p.(None): served areas); and
p.(None): ‘‘(D) to the extent practicable, so as to minimize the burden on the health care delivery system—
p.(None): ‘‘(i) conform with elements to assure safe use for other drugs with similar, serious risks; and
p.(None): ‘‘(ii) be designed to be compatible with established distribution, procurement, and dispensing systems for drugs.
p.(None): ‘‘(3) ELEMENTS TO ASSURE SAFE USE.—The elements to
p.(None): assure safe use under paragraph (1) shall include 1 or more goals to mitigate a specific serious risk
p.(None): listed in the labeling of the drug and, to mitigate such risk, may require that— ‘‘(A) health care
p.(None): providers who prescribe the drug have particular training or experience, or are specially certified (the
p.(None): opportunity to obtain such training or certification with respect to the drug shall be available to any
p.(None): willing provider from a frontier area in a widely available training
p.(None): or certification method (including an on-line course or via mail) as approved by the Secretary at
p.(None): reasonable cost to the provider);
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 931
p.(None):
p.(None):
p.(None): ‘‘(B) pharmacies, practitioners, or health care settings that dispense the drug are specially certified
p.(None): (the oppor- tunity to obtain such certification shall be available to any willing provider from a frontier
p.(None): area);
p.(None): ‘‘(C) the drug be dispensed to patients only in certain health care settings, such as hospitals;
p.(None): ‘‘(D) the drug be dispensed to patients with evidence or other documentation of safe-use conditions, such as
p.(None): lab- oratory test results;
p.(None): ‘‘(E) each patient using the drug be subject to certain monitoring; or
p.(None): ‘‘(F) each patient using the drug be enrolled in a reg- istry.
p.(None): ‘‘(4) IMPLEMENTATION SYSTEM.—The elements to assure safe use under paragraph (1) that are described in
p.(None): subparagraphs (B), (C), and (D) of paragraph (3) may include a system through which the applicant is able to take
p.(None): reasonable steps to—
p.(None): ‘‘(A) monitor and evaluate implementation of such ele- ments by health care providers, pharmacists, and other
p.(None): parties in the health care system who are responsible for implementing such elements; and
p.(None): ‘‘(B) work to improve implementation of such elements by such persons.
p.(None): ‘‘(5) EVALUATION OF ELEMENTS TO ASSURE SAFE USE.—The
p.(None): Secretary, through the Drug Safety and Risk Management Advisory Committee (or successor committee) of the
p.(None): Food and Drug Administration, shall—
p.(None): ‘‘(A) seek input from patients, physicians, pharmacists, and other health care providers about how elements to
p.(None): assure safe use under this subsection for 1 or more drugs may be standardized so as not to be—
p.(None): ‘‘(i) unduly burdensome on patient access to the drug; and
p.(None): ‘‘(ii) to the extent practicable, minimize the burden on the health care delivery system;
p.(None): ‘‘(B) at least annually, evaluate, for 1 or more drugs, the elements to assure safe use of such drug
p.(None): to assess whether the elements—
p.(None): ‘‘(i) assure safe use of the drug;
p.(None): ‘‘(ii) are not unduly burdensome on patient access to the drug; and
p.(None): ‘‘(iii) to the extent practicable, minimize the burden on the health care delivery system; and
p.(None): ‘‘(C) considering such input and evaluations—
p.(None): ‘‘(i) issue or modify agency guidance about how to implement the requirements of this subsection; and ‘‘(ii)
p.(None): modify elements under this subsection for 1
p.(None): or more drugs as appropriate.
p.(None): ‘‘(6) ADDITIONAL MECHANISMS TO ASSURE ACCESS.—The
p.(None): mechanisms under section 561 to provide for expanded access for patients with serious or life-threatening
p.(None): diseases or condi- tions may be used to provide access for patients with a serious or life-threatening disease or
p.(None): condition, the treatment of which is not an approved use for the drug, to a drug that is subject to
p.(None): elements to assure safe use under this subsection. The Sec- retary shall promulgate regulations for how a
p.(None): physician may provide the drug under the mechanisms of section 561.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Regulations.
p.(None):
p.(None):
p.(None): 121 STAT. 932 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): ‘‘(7) WAIVER IN PUBLIC HEALTH EMERGENCIES.—The Sec-
p.(None): retary may waive any requirement of this subsection during the period described in section 319(a) of the
p.(None): Public Health Service Act with respect to a qualified countermeasure described under section
p.(None): 319F–1(a)(2) of such Act, to which a requirement under this subsection has been applied, if the Secretary
p.(None): has—
p.(None): ‘‘(A) declared a public health emergency under such section 319; and
p.(None): ‘‘(B) determined that such waiver is required to miti- gate the effects of, or reduce the severity of,
p.(None): such public health emergency.
p.(None): ‘‘(8) LIMITATION.—No holder of an approved covered application shall use any element to assure safe
p.(None): use required by the Secretary under this subsection to block or delay approval of an application
p.(None): under section 505(b)(2) or (j) or to prevent application of such element under subsection (i)(1)(B) to a drug
p.(None): that is the subject of an abbreviated new drug application.
p.(None): ‘‘(g) ASSESSMENT AND MODIFICATION OF APPROVED STRATEGY.—
p.(None): ‘‘(1) VOLUNTARY ASSESSMENTS.—After the approval of a risk evaluation and mitigation strategy under
p.(None): subsection (a), the responsible person involved may, subject to paragraph (2), submit to the Secretary an assessment
p.(None): of, and propose a modi- fication to, the approved strategy for the drug involved at any time.
p.(None): ‘‘(2) REQUIRED ASSESSMENTS.—A responsible person shall, subject to paragraph (5), submit an assessment of,
p.(None): and may propose a modification to, the approved risk evaluation and mitigation strategy for a drug—
p.(None): ‘‘(A) when submitting a supplemental application for a new indication for use under section 505(b) or
p.(None): under section 351 of the Public Health Service Act, unless the drug is not subject to section 503(b) and the
p.(None): risk evaluation and mitigation strategy for the drug includes only the timetable under subsection (d);
p.(None): ‘‘(B) when required by the strategy, as provided for in such timetable under subsection (d);
p.(None): ‘‘(C) within a time period to be determined by the Secretary, if the Secretary, in consultation with the
p.(None): offices described in subsection (c)(2), determines that new safety or effectiveness information indicates that—
p.(None): ‘‘(i) an element under subsection (d) or (e) should be modified or included in the strategy; or
p.(None): ‘‘(ii) an element under subsection (f) should be modified or included in the strategy; or
p.(None):
p.(None): Deadline.
p.(None): ‘‘(D) within 15 days when ordered by the Secretary, in consultation with the offices described in
p.(None): subsection (c)(2), if the Secretary determines that there may be a cause for action by the Secretary
p.(None): under section 505(e). ‘‘(3) REQUIREMENTS FOR ASSESSMENTS.—An assessment
p.(None): under paragraph (1) or (2) of an approved risk evaluation and mitigation strategy for a drug shall include—
p.(None): ‘‘(A) with respect to any goal under subsection (f), an assessment of the extent to which the elements
p.(None): to assure safe use are meeting the goal or whether the goal or such elements should be modified;
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 933
p.(None):
p.(None):
p.(None): ‘‘(B) with respect to any postapproval study required under section 505(o) or otherwise undertaken
p.(None): by the responsible person to investigate a safety issue, the status of such study, including whether any difficulties
p.(None): completing the study have been encountered; and
p.(None): ‘‘(C) with respect to any postapproval clinical trial required under section 505(o) or otherwise
p.(None): undertaken by the responsible party to investigate a safety issue, the status of such clinical trial,
p.(None): including whether enrollment has begun, the number of participants enrolled, the expected completion
p.(None): date, whether any difficulties com- pleting the clinical trial have been encountered, and reg- istration
p.(None): information with respect to requirements under subsections (i) and (j) of section 402 of the Public
p.(None): Health Service Act.
p.(None): ‘‘(4) MODIFICATION.—A modification (whether an enhance- ment or a reduction) to the approved risk evaluation and
p.(None): mitiga- tion strategy for a drug may include the addition or modification of any element under subsection (d) or
p.(None): the addition, modifica- tion, or removal of any element under subsection (e) or (f), such as—
p.(None): ‘‘(A) modifying the timetable for assessments of the strategy as provided in subsection (d)(3), including to
p.(None): elimi- nate assessments; or
p.(None): ‘‘(B) adding, modifying, or removing an element to assure safe use under subsection (f).
p.(None): ‘‘(h) REVIEW OF PROPOSED STRATEGIES; REVIEW OF ASSESS-
p.(None): MENTS OF APPROVED STRATEGIES.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary, in consultation with the offices described in subsection (c)(2), shall
p.(None): promptly review each proposed risk evaluation and mitigation strategy for a drug submitted under subsection
p.(None): (a) and each assessment of an approved risk evaluation and mitigation strategy for a drug submitted under
p.(None): subsection (g).
p.(None): ‘‘(2) DISCUSSION.—The Secretary, in consultation with the offices described in subsection (c)(2), shall
p.(None): initiate discussions with the responsible person for purposes of this subsection to determine a strategy
p.(None): not later than 60 days after any such assessment is submitted or, in the case of an assessment sub- mitted under
p.(None): subsection (g)(2)(D), not later than 30 days after such assessment is submitted.
p.(None): ‘‘(3) ACTION.—
p.(None): ‘‘(A) IN GENERAL.—Unless the dispute resolution process described under paragraph (4) or (5) applies,
p.(None): the Secretary, in consultation with the offices described in sub- section (c)(2), shall describe any required
p.(None): risk evaluation and mitigation strategy for a drug, or any modification to any required strategy—
p.(None): ‘‘(i) as part of the action letter on the application, when a proposed strategy is submitted under sub- section
p.(None): (a) or a modification to the strategy is proposed as part of an assessment of the strategy submitted under
p.(None): subsection (g)(1); or
p.(None): ‘‘(ii) in an order issued not later than 90 days after the date discussions of such modification begin
p.(None): under paragraph (2), when a modification to the strategy is proposed as part of an assessment of
p.(None): the
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 934 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): strategy submitted under subsection (g)(1) or under any of subparagraphs (B) through (D) of subsection
p.(None): (g)(2).
p.(None): ‘‘(B) INACTION.—An approved risk evaluation and miti- gation strategy shall remain in effect until the
p.(None): Secretary acts, if the Secretary fails to act as provided under subpara- graph (A).
p.(None): ‘‘(C) PUBLIC AVAILABILITY.—Any action letter described in subparagraph (A)(i) or order described in subparagraph
p.(None): (A)(ii) shall be made publicly available.
p.(None): ‘‘(4) DISPUTE RESOLUTION AT INITIAL APPROVAL.—If a pro-
p.(None): posed risk evaluation and mitigation strategy is submitted under subsection (a)(1) in an application for
p.(None): initial approval of a drug and there is a dispute about the strategy, the respon- sible person shall use the
p.(None): major dispute resolution procedures as set forth in the letters described in section 101(c) of the Food
p.(None): and Drug Administration Amendments Act of 2007.
p.(None): ‘‘(5) DISPUTE RESOLUTION IN ALL OTHER CASES.—
p.(None):
p.(None): Deadlines.
p.(None): ‘‘(A) REQUEST FOR REVIEW.—
p.(None): ‘‘(i) IN GENERAL.—Not earlier than 15 days, and not later than 35 days, after discussions under para-
p.(None): graph (2) have begun, the responsible person may request in writing that a dispute about the strategy be
p.(None): reviewed by the Drug Safety Oversight Board under subsection (j), except that the determination of the Secretary
p.(None): to require a risk evaluation and mitigation strategy is not subject to review under this paragraph. The
p.(None): preceding sentence does not prohibit review under this paragraph of the particular elements of such a strategy.
p.(None): ‘‘(ii) SCHEDULING.—Upon receipt of a request under clause (i), the Secretary shall schedule the dispute involved
p.(None): for review under subparagraph (B) and, not later than 5 business days of scheduling the dispute for
p.(None): review, shall publish by posting on the Internet or otherwise a notice that the dispute will be reviewed by the
p.(None): Drug Safety Oversight Board.
p.(None): ‘‘(B) SCHEDULING REVIEW.—If a responsible person requests review under subparagraph (A), the Secretary—
p.(None): ‘‘(i) shall schedule the dispute for review at 1 of
p.(None): the next 2 regular meetings of the Drug Safety Over- sight Board, whichever meeting date is more prac-
p.(None): ticable; or
p.(None): ‘‘(ii) may convene a special meeting of the Drug Safety Oversight Board to review the matter more
p.(None): promptly, including to meet an action deadline on an application (including a supplemental application).
p.(None): ‘‘(C) AGREEMENT AFTER DISCUSSION OR ADMINISTRATIVE APPEALS.—
p.(None): ‘‘(i) FURTHER DISCUSSION OR ADMINISTRATIVE
p.(None): APPEALS.—A request for review under subparagraph
p.(None): (A) shall not preclude further discussions to reach agreement on the risk evaluation and mitigation
p.(None): strategy, and such a request shall not preclude the use of administrative appeals within the Food and
p.(None): Drug Administration to reach agreement on the strategy, including appeals as described in the
p.(None): letters
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 935
p.(None):
p.(None):
p.(None): described in section 101(c) of the Food and Drug Administration Amendments Act of 2007 for procedural
p.(None): or scientific matters involving the review of human drug applications and supplemental applications that
p.(None): cannot be resolved at the divisional level. At the time a review has been scheduled under subparagraph (B) and
p.(None): notice of such review has been posted, the respon- sible person shall either withdraw the request under
p.(None): subparagraph (A) or terminate the use of such adminis- trative appeals.
p.(None): ‘‘(ii) AGREEMENT TERMINATES DISPUTE RESOLU-
p.(None): TION.—At any time before a decision and order is issued under subparagraph (G) , the Secretary (in consultation with
p.(None): the offices described in subsection (c)(2)) and the responsible person may reach an agreement on the risk
p.(None): evaluation and mitigation strategy through further discussion or administrative appeals, terminating the dispute
p.(None): resolution process, and the Secretary shall issue an action letter or order, as appropriate, that
p.(None): describes the strategy.
p.(None): ‘‘(D) MEETING OF THE BOARD.—At a meeting of the Drug Safety Oversight Board described in subparagraph
p.(None): (B), the Board shall—
p.(None): ‘‘(i) hear from both parties via written or oral presentation; and
p.(None): ‘‘(ii) review the dispute.
p.(None): ‘‘(E) RECORD OF PROCEEDINGS.—The Secretary shall ensure that the proceedings of any such meeting
p.(None): are recorded, transcribed, and made public within 90 days of the meeting. The Secretary shall redact the
p.(None): transcript to protect any trade secrets and other information that is exempted from disclosure under
p.(None): section 552 of title 5, United States Code, or section 552a of title 5, United States Code.
p.(None): ‘‘(F) RECOMMENDATION OF THE BOARD.—Not later than
p.(None): 5 days after any such meeting, the Drug Safety Oversight Board shall provide a written recommendation on resolving the
p.(None): dispute to the Secretary. Not later than 5 days after the Board provides such written recommendation to
p.(None): the Secretary, the Secretary shall make the recommendation available to the public.
p.(None): ‘‘(G) ACTION BY THE SECRETARY.—
p.(None): ‘‘(i) ACTION LETTER.—With respect to a proposal or assessment referred to in paragraph (1), the Sec-
p.(None): retary shall issue an action letter that resolves the dispute not later than the later of—
p.(None): ‘‘(I) the action deadline for the action letter on the application; or
p.(None): ‘‘(II) 7 days after receiving the recommenda- tion of the Drug Safety Oversight Board.
p.(None): ‘‘(ii) ORDER.—With respect to an assessment of an approved risk evaluation and mitigation strategy under
p.(None): subsection (g)(1) or under any of subparagraphs
p.(None): (B) through (D) of subsection (g)(2), the Secretary shall issue an order, which shall be made public,
p.(None): that resolves the dispute not later than 7 days after
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public information. Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines. Public information.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None):
p.(None):
p.(None): 121 STAT. 936 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): receiving the recommendation of the Drug Safety Over- sight Board.
p.(None): ‘‘(H) INACTION.—An approved risk evaluation and miti- gation strategy shall remain in effect until the
p.(None): Secretary acts, if the Secretary fails to act as provided for under subparagraph (G).
p.(None): ‘‘(I) EFFECT ON ACTION DEADLINE.—With respect to a proposal or assessment referred to in paragraph (1),
p.(None): the Secretary shall be considered to have met the action dead- line for the action letter on the application if the
p.(None): responsible person requests the dispute resolution process described in this paragraph and if the Secretary—
p.(None): ‘‘(i) has initiated the discussions described under paragraph (2) not less than 60 days before such action
p.(None): deadline; and
p.(None): ‘‘(ii) has complied with the timing requirements of scheduling review by the Drug Safety Oversight Board,
p.(None): providing a written recommendation, and issuing an action letter under subparagraphs (B), (F), and (G),
p.(None): respectively.
p.(None): ‘‘(J) DISQUALIFICATION.—No individual who is an employee of the Food and Drug Administration and who
p.(None): reviews a drug or who participated in an administrative appeal under subparagraph (C)(i) with respect to such
p.(None): drug may serve on the Drug Safety Oversight Board at a meeting under subparagraph (D) to review a dispute about
p.(None): the risk evaluation and mitigation strategy for such drug.
p.(None): ‘‘(K) ADDITIONAL EXPERTISE.—The Drug Safety Over-
p.(None): sight Board may add members with relevant expertise from the Food and Drug Administration, including the
p.(None): Office of Pediatrics, the Office of Women’s Health, or the Office of Rare Diseases, or from other Federal
p.(None): public health or health care agencies, for a meeting under subparagraph
p.(None): (D) of the Drug Safety Oversight Board.
p.(None): ‘‘(6) USE OF ADVISORY COMMITTEES.—The Secretary may
p.(None): convene a meeting of 1 or more advisory committees of the Food and Drug Administration to—
p.(None): ‘‘(A) review a concern about the safety of a drug or class of drugs, including before an assessment of
p.(None): the risk evaluation and mitigation strategy or strategies of such drug or drugs is required to be
p.(None): submitted under any of subparagraphs (B) through (D) of subsection (g)(2);
p.(None): ‘‘(B) review the risk evaluation and mitigation strategy or strategies of a drug or group of drugs; or
p.(None): ‘‘(C) review a dispute under paragraph (4) or (5). ‘‘(7) PROCESS FOR ADDRESSING DRUG CLASS EFFECTS.—
p.(None): ‘‘(A) IN GENERAL.—When a concern about a serious risk of a drug may be related to the pharmacological class of
p.(None): the drug, the Secretary, in consultation with the offices described in subsection (c)(2), may defer assessments
p.(None): of the approved risk evaluation and mitigation strategies for such drugs until the Secretary has convened
p.(None): 1 or more public meetings to consider possible responses to such con- cern.
p.(None): ‘‘(B) NOTICE.—If the Secretary defers an assessment under subparagraph (A), the Secretary shall—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 937
p.(None):
p.(None):
p.(None): ‘‘(i) give notice of the deferral to the holder of the approved covered application not later than 5 days
p.(None): after the deferral;
p.(None): ‘‘(ii) publish the deferral in the Federal Register;
p.(None): and
p.(None): ‘‘(iii) give notice to the public of any public meetings to be convened under subparagraph
p.(None): (A), including a description of the deferral.
p.(None): ‘‘(C) PUBLIC MEETINGS.—Such public meetings may include—
p.(None): ‘‘(i) 1 or more meetings of the responsible person for such drugs;
p.(None): ‘‘(ii) 1 or more meetings of 1 or more advisory committees of the Food and Drug Administration, as
p.(None): provided for under paragraph (6); or
p.(None): ‘‘(iii) 1 or more workshops of scientific experts and other stakeholders.
p.(None): ‘‘(D) ACTION.—After considering the discussions from any meetings under subparagraph (A), the Secretary may— ‘‘(i)
p.(None): announce in the Federal Register a planned regulatory action, including a modification to each risk evaluation
p.(None): and mitigation strategy, for drugs in the
p.(None): pharmacological class;
p.(None): ‘‘(ii) seek public comment about such action; and ‘‘(iii) after seeking such comment, issue an order
p.(None): addressing such regulatory action.
p.(None): ‘‘(8) INTERNATIONAL COORDINATION.—The Secretary, in con-
p.(None): sultation with the offices described in subsection (c)(2), may coordinate the timetable for submission of
p.(None): assessments under subsection (d), or a study or clinical trial under section 505(o)(3), with efforts to identify
p.(None): and assess the serious risks of such drug by the marketing authorities of other countries whose drug
p.(None): approval and risk management processes the Secretary deems comparable to the drug approval and risk management
p.(None): processes of the United States. If the Secretary takes action to coordinate such timetable, the Secretary
p.(None): shall give notice to the responsible person.
p.(None): ‘‘(9) EFFECT.—Use of the processes described in paragraphs
p.(None): (7) and (8) shall not be the sole source of delay of action on an application or a supplement to an
p.(None): application for a drug.
p.(None): ‘‘(i) ABBREVIATED NEW DRUG APPLICATIONS.—
p.(None): ‘‘(1) IN GENERAL.—A drug that is the subject of an abbre- viated new drug application under section
p.(None): 505(j) is subject to only the following elements of the risk evaluation and mitiga- tion strategy required under
p.(None): subsection (a) for the applicable listed drug:
p.(None): ‘‘(A) A Medication Guide or patient package insert, if required under subsection (e) for the applicable
p.(None): listed drug.
p.(None): ‘‘(B) Elements to assure safe use, if required under subsection (f) for the listed drug. A drug that is the
p.(None): subject of an abbreviated new drug application and the listed drug shall use a single, shared system under
p.(None): subsection (f). The Secretary may waive the requirement under the pre- ceding sentence for a drug that is the
p.(None): subject of an abbre- viated new drug application, and permit the applicant to
p.(None): Deadline.
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None): Public information.
p.(None):
p.(None):
p.(None): 121 STAT. 938 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): use a different, comparable aspect of the elements to assure safe use, if the Secretary determines that—
p.(None): ‘‘(i) the burden of creating a single, shared system outweighs the benefit of a single, system, taking into
p.(None): consideration the impact on health care providers, patients, the applicant for the abbreviated new
p.(None): drug application, and the holder of the reference drug product; or
p.(None): ‘‘(ii) an aspect of the elements to assure safe use for the applicable listed drug is claimed by a
p.(None): patent that has not expired or is a method or process that, as a trade secret, is entitled to
p.(None): protection, and the applicant for the abbreviated new drug application cer- tifies that it has sought a license
p.(None): for use of an aspect of the elements to assure safe use for the applicable listed drug and that it was
p.(None): unable to obtain a license.
p.(None): A certification under clause (ii) shall include a description of the efforts made by the applicant for the
p.(None): abbreviated new drug application to obtain a license. In a case described in clause (ii), the Secretary may seek
p.(None): to negotiate a vol- untary agreement with the owner of the patent, method, or process for a license
p.(None): under which the applicant for such abbreviated new drug application may use an aspect of the elements to assure
p.(None): safe use, if required under sub- section (f) for the applicable listed drug, that is claimed by a patent
p.(None): that has not expired or is a method or process that as a trade secret is entitled to protection.
p.(None): ‘‘(2) ACTION BY SECRETARY.—For an applicable listed drug for which a drug is approved under section
p.(None): 505(j), the Sec- retary—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Establishment.
p.(None): ‘‘(A) shall undertake any communication plan to health care providers required under subsection (e)(3) for the
p.(None): applicable listed drug; and
p.(None): ‘‘(B) shall inform the responsible person for the drug that is so approved if the risk evaluation and
p.(None): mitigation strategy for the applicable listed drug is modified.
p.(None): ‘‘(j) DRUG SAFETY OVERSIGHT BOARD.—
p.(None): ‘‘(1) IN GENERAL.—There is established a Drug Safety Over- sight Board.
p.(None): ‘‘(2) COMPOSITION; MEETINGS.—The Drug Safety Oversight Board shall—
p.(None): ‘‘(A) be composed of scientists and health care practi- tioners appointed by the Secretary, each of whom
p.(None): is an employee of the Federal Government;
p.(None): ‘‘(B) include representatives from offices throughout the Food and Drug Administration, including the
p.(None): offices responsible for postapproval safety of drugs;
p.(None): ‘‘(C) include at least 1 representative each from the National Institutes of Health and the Department of
p.(None): Health and Human Services (other than the Food and Drug Administration);
p.(None): ‘‘(D) include such representatives as the Secretary shall designate from other appropriate agencies that wish to
p.(None): provide representatives; and
p.(None): ‘‘(E) meet at least monthly to provide oversight and advice to the Secretary on the management of
p.(None): important drug safety issues.’’.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 939
p.(None):
p.(None):
p.(None): (c) REGULATION OF BIOLOGICAL PRODUCTS.—Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended—
p.(None): (1) in subsection (a)(2), by adding at the end the following: ‘‘(D) POSTMARKET STUDIES AND CLINICAL TRIALS;
p.(None): LABELING; RISK EVALUATION AND MITIGATION STRATEGY.—A person that sub- mits an application for a license under
p.(None): this paragraph is subject to sections 505(o), 505(p), and 505–1 of the Federal Food, Drug,
p.(None): and Cosmetic Act.’’; and
p.(None): (2) in subsection (j), by inserting ‘‘, including the require- ments under sections 505(o), 505(p), and
p.(None): 505–1 of such Act,’’ after ‘‘, and Cosmetic Act’’.
p.(None): (d) ADVERTISEMENTS OF DRUGS.—The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), as amended by section
p.(None): 801(b), is amended—
p.(None): (1) in section 301 (21 U.S.C. 331), by adding at the end the following:
p.(None): ‘‘(kk) The dissemination of a television advertisement without complying with section 503B.’’; and
p.(None): (2) by inserting after section 503A the following:
p.(None): ‘‘SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS.
p.(None): ‘‘(a) IN GENERAL.—The Secretary may require the submission of any television advertisement for a drug
p.(None): (including any script, story board, rough, or a completed video production of the television advertisement) to the
p.(None): Secretary for review under this section not later than 45 days before dissemination of the television advertise-
p.(None): ment.
p.(None): ‘‘(b) REVIEW.—In conducting a review of a television advertise- ment under this section, the Secretary may make
p.(None): recommendations with respect to information included in the label of the drug—
p.(None): ‘‘(1) on changes that are—
p.(None): ‘‘(A) necessary to protect the consumer good and well- being; or
p.(None): ‘‘(B) consistent with prescribing information for the product under review; and
p.(None): ‘‘(2) if appropriate and if information exists, on statements for inclusion in the advertisement to address the
p.(None): specific effi- cacy of the drug as it relates to specific population groups, including elderly
p.(None): populations, children, and racial and ethnic minorities.
p.(None): ‘‘(c) NO AUTHORITY TO REQUIRE CHANGES.—Except as provided by subsection (e), this section does not
p.(None): authorize the Secretary to make or direct changes in any material submitted pursuant to subsection (a).
p.(None): ‘‘(d) ELDERLY POPULATIONS, CHILDREN, RACIALLY AND ETH-
p.(None): NICALLY DIVERSE COMMUNITIES.—In formulating recommendations under subsection (b), the Secretary shall take
p.(None): into consideration the impact of the advertised drug on elderly populations, children, and racially and ethnically
p.(None): diverse communities.
p.(None): ‘‘(e) SPECIFIC DISCLOSURES.—
p.(None): ‘‘(1) SERIOUS RISK; SAFETY PROTOCOL.—In conducting a
p.(None): review of a television advertisement under this section, if the Secretary determines that the
p.(None): advertisement would be false or misleading without a specific disclosure about a serious risk listed in
p.(None): the labeling of the drug involved, the Secretary may require inclusion of such disclosure in the advertisement.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 353b.
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 940 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(2) DATE OF APPROVAL.—In conducting a review of a tele- vision advertisement under this section, the Secretary
p.(None): may require the advertisement to include, for a period not to exceed 2 years from the date of the approval of the drug
p.(None): under section 505 or section 351 of the Public Health Service Act, a specific disclosure of such date of
p.(None): approval if the Secretary determines that the advertisement would otherwise be false or misleading. ‘‘(f) RULE OF
p.(None): CONSTRUCTION.—Nothing in this section may be
p.(None): construed as having any effect on requirements under section 502(n) or on the authority of the Secretary under section
p.(None): 314.550, 314.640, 601.45, or 601.94 of title 21, Code of Federal Regulations (or suc- cessor
p.(None): regulations).’’.
p.(None): (3) DIRECT-TO-CONSUMER ADVERTISEMENTS.—
p.(None): (A) IN GENERAL.—Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended
p.(None): by adding at the end the following: ‘‘In the case of an advertisement for a drug subject to section
p.(None): 503(b)(1) pre- sented directly to consumers in television or radio format and stating the name of the
p.(None): drug and its conditions of use, the major statement relating to side effects and contra- indications shall be
p.(None): presented in a clear, conspicuous, and neutral manner.’’.
p.(None):
p.(None): Deadline.
p.(None): 21 USC 352 note.
p.(None): (B) REGULATIONS TO DETERMINE CLEAR, CONSPICUOUS, AND NEUTRAL MANNER.—Not later than 30 months after the
p.(None): date of the enactment of the Food and Drug Administra- tion Amendments Act of 2007, the Secretary of Health and
p.(None): Human Services shall by regulation establish stand- ards for determining whether a major statement
p.(None): relating to side effects and contraindications of a drug, described in section 502(n) of the Federal Food,
p.(None): Drug, and Cosmetic Act (21 U.S.C. 352(n)) (as amended by subparagraph (A)) is presented in the manner
p.(None): required under such section.
p.(None): (4) CIVIL PENALTIES.—Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), as amended by
p.(None): section 801(b), is amended by adding at the end the following:
p.(None): ‘‘(g)(1) With respect to a person who is a holder of an approved application under section 505 for a drug
p.(None): subject to section 503(b) or under section 351 of the Public Health Service Act, any such person who
p.(None): disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or
p.(None): misleading shall be liable to the United States for a civil penalty in an amount not to exceed $250,000
p.(None): for the first such violation in any 3-year period, and not to exceed $500,000 for each subsequent
p.(None): violation in any 3-year period. No other civil monetary penalties in this Act (including the civil
p.(None): penalty in section 303(f)(4)) shall apply to a violation regarding direct-to-consumer advertising. For pur-
p.(None): poses of this paragraph: (A) Repeated dissemination of the same or similar advertisement prior to the
p.(None): receipt of the written notice referred to in paragraph (2) for such advertisements shall be consid- ered one
p.(None): violation. (B) On and after the date of the receipt of such a notice, all violations under this
p.(None): paragraph occurring in a single day shall be considered one violation. With respect to advertisements that
p.(None): appear in magazines or other publications that are published less frequently than daily, each issue date
p.(None): (whether weekly or monthly) shall be treated as a single day for the purpose of calculating the number of violations
p.(None): under this paragraph.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 941
p.(None):
p.(None):
p.(None): ‘‘(2) A civil penalty under paragraph (1) shall be assessed by the Secretary by an order made on the
...
p.(None): shall not be subject to review.’’.
p.(None): (5) REPORT ON DIRECT-TO-CONSUMER ADVERTISING.—Not later than 24 months after the date of the enactment
p.(None): of this Act, the Secretary of Health and Human Services shall report to the Congress on direct-to-consumer
p.(None): advertising and its ability to communicate to subsets of the general population, including elderly populations,
p.(None): children, and racial and ethnic minority communities. The Secretary shall utilize the Advisory Com- mittee
p.(None): on Risk Communication established under this Act to advise the Secretary with respect to such report. The
p.(None): Advisory Committee shall study direct-to-consumer advertising as it relates to increased access to health
p.(None): information and decreased health disparities for these populations. The report required by this paragraph
p.(None): shall recommend effective ways to present and disseminate information to these populations. Such report shall
p.(None): also make recommendations regarding impediments to the participation of elderly populations, children,
p.(None): racially and ethnically diverse communities, and medically underserved populations in clinical drug
p.(None): trials and shall recommend best practice approaches for increasing the inclusion of such subsets of the general
p.(None): population. The Secretary of Health and Human Services shall submit the report under this paragraph to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representatives.
p.(None): (6) RULEMAKING.—Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is
p.(None): amended by striking ‘‘the procedure specified in section 701(e) of this Act’’ and inserting ‘‘section
p.(None): 701(a)’’.
p.(None): (e) RULE OF CONSTRUCTION REGARDING PEDIATRIC STUDIES.— This title and the amendments made by this title
p.(None): may not be
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 943
p.(None):
p.(None): construed as affecting the authority of the Secretary of Health and Human Services to request pediatric
p.(None): studies under section 505A of the Federal Food, Drug, and Cosmetic Act or to require such studies under
p.(None): section 505B of such Act.
p.(None): SEC. 902. ENFORCEMENT.
p.(None): (a) MISBRANDING.—Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding
p.(None): at the end the following:
p.(None): ‘‘(y) If it is a drug subject to an approved risk evaluation and mitigation strategy pursuant to section
p.(None): 505(p) and the respon- sible person (as such term is used in section 505–1) fails to comply with a requirement of such
p.(None): strategy provided for under subsection (d), (e), or (f) of section 505–1.
p.(None): ‘‘(z) If it is a drug, and the responsible person (as such term is used in section 505(o)) is in violation
p.(None): of a requirement established under paragraph (3) (relating to postmarket studies and clinical trials) or
p.(None): paragraph (4) (relating to labeling) of section 505(o) with respect to such drug.’’.
p.(None): (b) CIVIL PENALTIES.—Section 303(f) of the Federal Food, Drug, and Cosmetic Act, as amended by section 801(b),
p.(None): is amended—
p.(None): (1) by inserting after paragraph (3), as added by section 801(b)(2), the following:
p.(None): ‘‘(4)(A) Any responsible person (as such term is used in section 505–1) that violates a requirement of section
p.(None): 505(o), 505(p), or 505–1 shall be subject to a civil monetary penalty of—
p.(None): ‘‘(i) not more than $250,000 per violation, and not to exceed
p.(None): $1,000,000 for all such violations adjudicated in a single pro- ceeding; or
p.(None): ‘‘(ii) in the case of a violation that continues after the Secretary provides written notice to the
p.(None): responsible person, the responsible person shall be subject to a civil monetary penalty of $250,000 for
p.(None): the first 30-day period (or any portion thereof) that the responsible person continues to be in violation, and
p.(None): such amount shall double for every 30-day period thereafter that the violation continues, not to exceed
p.(None): $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such viola- tions adjudicated in a single
p.(None): proceeding.
p.(None): ‘‘(B) In determining the amount of a civil penalty under subparagraph (A)(ii), the Secretary
p.(None): shall take into consideration whether the responsible person is making efforts toward correcting the violation of
p.(None): the requirement of section 505(o), 505(p), or 505– 1 for which the responsible person is subject to such civil
p.(None): penalty.’’; and
p.(None): (2) in paragraph (5), as redesignated by section 801(b)(2)(A), by striking ‘‘paragraph (1), (2), or (3)’’ each
p.(None): place it appears and inserting ‘‘paragraph (1), (2), (3), or (4)’’.
p.(None): SEC. 903. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.
p.(None): Section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) is amended by adding at
p.(None): the end the following: ‘‘The Secretary may withdraw the approval of an application sub- mitted under this
p.(None): section, or suspend the approval of such an application, as provided under this subsection, without first
p.(None): ordering the applicant to submit an assessment of the approved risk evalua- tion and mitigation strategy for
p.(None): the drug under section 505– 1(g)(2)(D).’’.
p.(None):
p.(None):
p.(None): 121 STAT. 944 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None):
p.(None): Deadline. Reports.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Committee.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Procedures.
p.(None): SEC. 904. BENEFIT-RISK ASSESSMENTS.
p.(None): Not later than 1 year after the date of the enactment of this Act, the Commissioner of Food and Drugs
p.(None): shall submit to the Congress a report on how best to communicate to the public the risks and benefits of
p.(None): new drugs and the role of the risk evaluation and mitigation strategy in assessing such risks and benefits. As
p.(None): part of such study, the Commissioner may consider the possibility of including in the labeling
p.(None): and any direct-to-consumer advertisements of a newly approved drug or indication a unique symbol
p.(None): indicating the newly approved status of the drug or indica- tion for a period after approval.
p.(None): SEC. 905. ACTIVE POSTMARKET RISK IDENTIFICATION AND ANALYSIS.
p.(None): (a) IN GENERAL.—Subsection (k) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 355) is amended by adding at the end the following:
p.(None): ‘‘(3) ACTIVE POSTMARKET RISK IDENTIFICATION.—
p.(None): ‘‘(A) DEFINITION.—In this paragraph, the term ‘data’ refers to information with respect to a drug approved under
p.(None): this section or under section 351 of the Public Health Service Act, including claims data, patient
p.(None): survey data, standardized analytic files that allow for the pooling and analysis of data from disparate
p.(None): data environments, and any other data deemed appropriate by the Secretary.
p.(None): ‘‘(B) DEVELOPMENT OF POSTMARKET RISK IDENTIFICA-
p.(None): TION AND ANALYSIS METHODS.—The Secretary shall, not later than 2 years after the date of the
p.(None): enactment of the Food and Drug Administration Amendments Act of 2007, in collaboration with public,
p.(None): academic, and private entities—
p.(None): ‘‘(i) develop methods to obtain access to disparate data sources including the data sources specified in
p.(None): subparagraph (C);
p.(None): ‘‘(ii) develop validated methods for the establish- ment of a postmarket risk identification and analysis
p.(None): system to link and analyze safety data from multiple sources, with the goals of including, in aggregate—
p.(None): ‘‘(I) at least 25,000,000 patients by July 1,
p.(None): 2010; and
p.(None): ‘‘(II) at least 100,000,000 patients by July 1, 2012; and
p.(None): ‘‘(iii) convene a committee of experts, including individuals who are recognized in the field of protecting data
p.(None): privacy and security, to make recommendations to the Secretary on the development of tools and
p.(None): methods for the ethical and scientific uses for, and communication of, postmarketing data specified under
p.(None): subparagraph (C), including recommendations on the development of effective research methods for the study of drug
p.(None): safety questions.
p.(None): ‘‘(C) ESTABLISHMENT OF THE POSTMARKET RISK IDENTI- FICATION AND ANALYSIS SYSTEM.—
p.(None): ‘‘(i) IN GENERAL.—The Secretary shall, not later than 1 year after the development of the risk identifica- tion
p.(None): and analysis methods under subparagraph (B), establish and maintain procedures—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 945
p.(None):
p.(None):
p.(None): ‘‘(I) for risk identification and analysis based on electronic health data, in compliance with the
p.(None): regulations promulgated under section 264(c) of the Health Insurance Portability and Account- ability
p.(None): Act of 1996, and in a manner that does not disclose individually identifiable health information in
p.(None): violation of paragraph (4)(B);
p.(None): ‘‘(II) for the reporting (in a standardized form) of data on all serious adverse drug experiences (as defined
p.(None): in section 505–1(b)) submitted to the Secretary under paragraph (1), and those adverse events submitted by
p.(None): patients, providers, and drug sponsors, when appropriate;
p.(None): ‘‘(III) to provide for active adverse event surveillance using the following data sources, as
p.(None): available:
p.(None): ‘‘(aa) Federal health-related electronic data (such as data from the Medicare program and the health
p.(None): systems of the Department of Veterans Affairs);
p.(None): ‘‘(bb) private sector health-related elec- tronic data (such as pharmaceutical purchase data and health
p.(None): insurance claims data); and ‘‘(cc) other data as the Secretary deems necessary to create a robust system to
p.(None): identify adverse events and potential drug safety sig-
p.(None): nals;
p.(None): ‘‘(IV) to identify certain trends and patterns with respect to data accessed by the system;
p.(None): ‘‘(V) to provide regular reports to the Secretary concerning adverse event trends, adverse event patterns,
p.(None): incidence and prevalence of adverse events, and other information the Secretary deter- mines appropriate,
p.(None): which may include data on comparative national adverse event trends; and ‘‘(VI) to enable the program to
p.(None): export data
p.(None): in a form appropriate for further aggregation, statistical analysis, and reporting.
p.(None): ‘‘(ii) TIMELINESS OF REPORTING.—The procedures established under clause (i) shall ensure that such data are
p.(None): accessed, analyzed, and reported in a timely, routine, and systematic manner, taking into consider- ation the
p.(None): need for data completeness, coding, cleansing, and standardized analysis and transmission.
p.(None): ‘‘(iii) PRIVATE SECTOR RESOURCES.—To ensure the establishment of the active postmarket risk identifica- tion and
p.(None): analysis system under this subsection not later than 1 year after the development of the risk
p.(None): identification and analysis methods under subpara- graph (B), as required under clause (i), the Secretary
p.(None): may, on a temporary or permanent basis, implement systems or products developed by private entities.
p.(None): ‘‘(iv) COMPLEMENTARY APPROACHES.—To the extent
p.(None): the active postmarket risk identification and analysis system under this subsection is not sufficient to gather
p.(None): data and information relevant to a priority drug safety question, the Secretary shall develop, support, and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Reports.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 946 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): participate in complementary approaches to gather and analyze such data and information, including—
p.(None): ‘‘(I) approaches that are complementary with respect to assessing the safety of use of a drug in domestic
p.(None): populations not included, or underrep- resented, in the trials used to approve the drug (such as older
p.(None): people, people with comorbidities, pregnant women, or children); and
p.(None): ‘‘(II) existing approaches such as the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink or
p.(None): successor databases.
p.(None): ‘‘(v) AUTHORITY FOR CONTRACTS.—The Secretary
p.(None): may enter into contracts with public and private enti- ties to fulfill the requirements of this subparagraph.
p.(None): ‘‘(4) ADVANCED ANALYSIS OF DRUG SAFETY DATA.—
p.(None): ‘‘(A) PURPOSE.—The Secretary shall establish collabora- tions with public, academic, and private entities, which
p.(None): may include the Centers for Education and Research on Therapeutics under section 912 of the Public Health
p.(None): Service Act, to provide for advanced analysis of drug safety data described in paragraph (3)(C) and other
p.(None): information that is publicly available or is provided by the Secretary, in order to—
p.(None): ‘‘(i) improve the quality and efficiency of postmarket drug safety risk-benefit analysis;
p.(None): ‘‘(ii) provide the Secretary with routine access to outside expertise to study advanced drug safety ques-
p.(None): tions; and
p.(None): ‘‘(iii) enhance the ability of the Secretary to make timely assessments based on drug safety data.
p.(None): ‘‘(B) PRIVACY.—Such analysis shall not disclose individ- ually identifiable health information when presenting such
p.(None): drug safety signals and trends or when responding to inquiries regarding such drug safety signals and
p.(None): trends. ‘‘(C) PUBLIC PROCESS FOR PRIORITY QUESTIONS.—At
p.(None): least biannually, the Secretary shall seek recommendations from the Drug Safety and Risk Management Advisory Com-
p.(None): mittee (or any successor committee) and from other advisory committees, as appropriate, to the Food and
p.(None): Drug Administration on—
p.(None): ‘‘(i) priority drug safety questions; and
p.(None): ‘‘(ii) mechanisms for answering such questions, including through—
p.(None): ‘‘(I) active risk identification under paragraph (3); and
p.(None): ‘‘(II) when such risk identification is not suffi- cient, postapproval studies and clinical trials under subsection
p.(None): (o)(3).
p.(None): ‘‘(D) PROCEDURES FOR THE DEVELOPMENT OF DRUG SAFETY COLLABORATIONS.—
p.(None):
p.(None): Deadline.
p.(None): ‘‘(i) IN GENERAL.—Not later than 180 days after the date of the establishment of the active postmarket risk
p.(None): identification and analysis system under this sub- section, the Secretary shall establish and implement
p.(None): procedures under which the Secretary may routinely contract with one or more qualified entities to—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 947
p.(None):
p.(None):
p.(None): ‘‘(I) classify, analyze, or aggregate data described in paragraph (3)(C) and information that is
p.(None): publicly available or is provided by the Sec- retary;
p.(None): ‘‘(II) allow for prompt investigation of priority drug safety questions, including—
p.(None): ‘‘(aa) unresolved safety questions for drugs or classes of drugs; and
p.(None): ‘‘(bb) for a newly-approved drugs, safety signals from clinical trials used to approve the drug and other
p.(None): preapproval trials; rare, serious drug side effects; and the safety of use in domestic populations not
p.(None): included, or underrepresented, in the trials used to approve the drug (such as older people, people with
p.(None): comorbidities, pregnant women, or children); ‘‘(III) perform advanced research and analysis
p.(None): on identified drug safety risks;
p.(None): ‘‘(IV) focus postapproval studies and clinical trials under subsection (o)(3) more effectively on cases for
p.(None): which reports under paragraph (1) and other safety signal detection is not sufficient to resolve whether
p.(None): there is an elevated risk of a serious adverse event associated with the use of a drug; and
p.(None): ‘‘(V) carry out other activities as the Secretary deems necessary to carry out the purposes of this paragraph.
p.(None): ‘‘(ii) REQUEST FOR SPECIFIC METHODOLOGY.—The
p.(None): procedures described in clause (i) shall permit the Sec- retary to request that a specific methodology be used
p.(None): by the qualified entity. The qualified entity shall work with the Secretary to finalize the methodology to be
p.(None): used.
p.(None): ‘‘(E) USE OF ANALYSES.—The Secretary shall provide the analyses described in this paragraph, including
p.(None): the methods and results of such analyses, about a drug to the sponsor or sponsors of such drug.
p.(None): ‘‘(F) QUALIFIED ENTITIES.—
p.(None): ‘‘(i) IN GENERAL.—The Secretary shall enter into contracts with a sufficient number of qualified entities to
p.(None): develop and provide information to the Secretary in a timely manner.
p.(None): ‘‘(ii) QUALIFICATION.—The Secretary shall enter into a contract with an entity under clause (i) only
p.(None): if the Secretary determines that the entity has a significant presence in the United States and has one
p.(None): or more of the following qualifications:
p.(None): ‘‘(I) The research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete
p.(None): the activities under this paragraph, including the capability and expertise to provide the Secretary
p.(None): de-identified data consistent with the requirements of this subsection.
p.(None): ‘‘(II) An information technology infrastructure in place to support electronic data and operational standards to
p.(None): provide security for such data.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Contracts.
p.(None):
p.(None):
p.(None): 121 STAT. 948 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(III) Experience with, and expertise on, the development of drug safety and effectiveness research
p.(None): using electronic population data.
p.(None): ‘‘(IV) An understanding of drug development or risk/benefit balancing in a clinical setting.
p.(None): ‘‘(V) Other expertise which the Secretary deems necessary to fulfill the activities under this paragraph.
p.(None): ‘‘(G) CONTRACT REQUIREMENTS.—Each contract with a qualified entity under subparagraph (F)(i) shall contain
p.(None): the following requirements:
p.(None): ‘‘(i) ENSURING PRIVACY.—The qualified entity shall ensure that the entity will not use data under this
p.(None): subsection in a manner that—
p.(None): ‘‘(I) violates the regulations promulgated under section 264(c) of the Health Insurance Portability and
p.(None): Accountability Act of 1996;
p.(None): ‘‘(II) violates sections 552 or 552a of title 5, United States Code, with regard to the privacy of
p.(None): individually-identifiable beneficiary health information; or
p.(None): ‘‘(III) discloses individually identifiable health information when presenting drug safety signals and trends
p.(None): or when responding to inquiries regarding drug safety signals and trends.
p.(None): Nothing in this clause prohibits lawful disclosure for other purposes.
p.(None): ‘‘(ii) COMPONENT OF ANOTHER ORGANIZATION.—If
p.(None): a qualified entity is a component of another organiza- tion—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Applicability.
p.(None): ‘‘(I) the qualified entity shall establish appro- priate security measures to maintain the confiden- tiality and
p.(None): privacy of such data; and
p.(None): ‘‘(II) the entity shall not make an unauthorized disclosure of such data to the other components of the
p.(None): organization in breach of such confidentiality and privacy requirement.
p.(None): ‘‘(iii) TERMINATION OR NONRENEWAL.—If a contract with a qualified entity under this subparagraph is terminated
p.(None): or not renewed, the following requirements shall apply:
p.(None): ‘‘(I) CONFIDENTIALITY AND PRIVACY PROTEC-
p.(None): TIONS.—The entity shall continue to comply with the confidentiality and privacy requirements under this
p.(None): paragraph with respect to all data disclosed to the entity.
p.(None): ‘‘(II) DISPOSITION OF DATA.—The entity shall return any data disclosed to such entity under this
p.(None): subsection to which it would not otherwise have access or, if returning the data is not prac- ticable,
p.(None): destroy the data.
p.(None): ‘‘(H) COMPETITIVE PROCEDURES.—The Secretary shall use competitive procedures (as defined in section 4(5)
p.(None): of the Federal Procurement Policy Act) to enter into contracts under subparagraph (G).
p.(None): ‘‘(I) REVIEW OF CONTRACT IN THE EVENT OF A MERGER
p.(None): OR ACQUISITION.—The Secretary shall review the contract
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 949
p.(None):
p.(None):
p.(None): with a qualified entity under this paragraph in the event of a merger or acquisition of the entity in
p.(None): order to ensure that the requirements under this paragraph will continue to be met.
p.(None): ‘‘(J) COORDINATION.—In carrying out this paragraph, the Secretary shall provide for appropriate communications to
p.(None): the public, scientific, public health, and medical commu- nities, and other key stakeholders, and to the extent prac-
p.(None): ticable shall coordinate with the activities of private enti- ties, professional associations, or other
p.(None): entities that may have sources of drug safety data.’’.
p.(None): (b) RULE OF CONSTRUCTION.—Nothing in this section or the amendment made by this section shall be
p.(None): construed to prohibit the lawful disclosure or use of data or information by an entity other than as
p.(None): described in paragraph (4)(B) or (4)(G) of section 505(k) of the Federal Food, Drug, and Cosmetic Act,
p.(None): as added by subsection (a).
p.(None): (c) REPORT TO CONGRESS.—Not later than 4 years after the date of the enactment of this Act, the
p.(None): Secretary shall report to the Congress on the ways in which the Secretary has used the active postmarket
p.(None): risk identification and analysis system described in paragraphs (3) and (4) of section 505(k) of the Federal
p.(None): Food, Drug, and Cosmetic Act, as added by subsection (a), to identify specific drug safety signals and to
p.(None): better understand the outcomes associated with drugs marketed in the United States.
p.(None): (d) AUTHORIZATION OF APPROPRIATIONS.—To carry out activities under the amendment made by this section for which
p.(None): funds are made available under section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 379h), there are authorized to be appro- priated to carry out the amendment made by this section, in addi- tion
p.(None): to such funds, $25,000,000 for each of fiscal years 2008 through 2012.
p.(None): (e) GAO REPORT.—Not later than 18 months after the date of the enactment of this Act, the Comptroller General
p.(None): of the United States shall evaluate data privacy, confidentiality, and security issues relating to accessing,
p.(None): transmitting, and maintaining data for the active postmarket risk identification and analysis system
p.(None): described in paragraphs (3) and (4) of section 505(k) of the Federal Food, Drug, and Cosmetic Act, as added by
p.(None): subsection (a), and make recommendations to the Committee on Energy and Commerce of the House of Representatives
p.(None): and the Committee on Health, Education, Labor and Pensions of the Senate, and any other
p.(None): congressional committees of relevant jurisdiction, regarding the need for any additional legislative or
p.(None): regulatory actions to ensure privacy, confidentiality, and security of this data or otherwise address
p.(None): privacy, confidentiality, and security issues to ensure the effective operation of such active postmarket
p.(None): identification and anal- ysis system.
p.(None): SEC. 906. STATEMENT FOR INCLUSION IN DIRECT-TO-CONSUMER ADVERTISEMENTS OF DRUGS.
p.(None): (a) PUBLISHED DIRECT-TO-CONSUMER ADVERTISEMENTS.—Sec- tion 502(n) of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 352), as amended by section 901(d)(6), is further amended by inserting ‘‘and in the case
p.(None): of published direct-to-consumer advertisements the following statement printed in conspicuous text: ‘You are
p.(None): encouraged to report negative side effects of prescription
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355 note.
p.(None):
p.(None):
p.(None): 121 STAT. 950 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800- FDA-1088.’,’’ after ‘‘section 701(a),’’.
p.(None):
p.(None): 21 USC 352 note. Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Reports.
p.(None):
p.(None):
p.(None): 21 USC 355 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 331 note.
p.(None): (b) STUDY.—
p.(None): (1) IN GENERAL.—In the case of direct-to-consumer tele- vision advertisements, the Secretary of Health and
p.(None): Human Services, in consultation with the Advisory Committee on Risk Communication under section 567 of the
p.(None): Federal Food, Drug, and Cosmetic Act (as added by section 917), shall, not later than 6 months after
p.(None): the date of the enactment of this Act, conduct a study to determine if the statement in section 502(n) of such
p.(None): Act (as added by subsection (a)) required with respect to published direct-to-consumer advertisements is
p.(None): appropriate for inclusion in such television advertisements.
p.(None): (2) CONTENT.—As part of the study under paragraph (1), such Secretary shall consider whether the
p.(None): information in the statement described in paragraph (1) would detract from the presentation of risk
p.(None): information in a direct-to-consumer tele- vision advertisement. If such Secretary determines the inclusion of such
p.(None): statement is appropriate in direct-to-consumer tele- vision advertisements, such Secretary shall issue
p.(None): regulations requiring the implementation of such statement in direct-to- consumer television advertisements,
p.(None): including determining a reasonable length of time for displaying the statement in such advertisements. The
p.(None): Secretary shall report to the appropriate committees of Congress the findings of such study and any plans
p.(None): to issue regulations under this paragraph.
p.(None): SEC. 907. NO EFFECT ON VETERINARY MEDICINE.
p.(None): This subtitle, and the amendments made by this subtitle, shall have no effect on the use of drugs approved
p.(None): under section 505 of the Federal Food, Drug, and Cosmetic Act by, or on the lawful written or oral order
p.(None): of, a licensed veterinarian within the context of a veterinarian-client-patient relationship, as provided for
p.(None): under section 512(a)(5) of such Act.
p.(None): SEC. 908. AUTHORIZATION OF APPROPRIATIONS.
p.(None): (a) IN GENERAL.—For carrying out this subtitle and the amend- ments made by this subtitle, there is authorized to be
p.(None): appropriated
p.(None): $25,000,000 for each of fiscal years 2008 through 2012.
p.(None): (b) RELATION TO OTHER FUNDING.—The authorization of appro- priations under subsection (a) is in addition to any
p.(None): other funds available for carrying out this subtitle and the amendments made by this subtitle.
p.(None): SEC. 909. EFFECTIVE DATE AND APPLICABILITY.
p.(None): (a) EFFECTIVE DATE.—This subtitle takes effect 180 days after the date of the enactment of this Act.
p.(None): (b) DRUGS DEEMED TO HAVE RISK EVALUATION AND MITIGATION STRATEGIES.—
p.(None): (1) IN GENERAL.—A drug that was approved before the effective date of this Act is, in accordance with
p.(None): paragraph (2), deemed to have in effect an approved risk evaluation and mitigation strategy under section
p.(None): 505–1 of the Federal Food, Drug, and Cosmetic Act (as added by section 901) (referred to in this
p.(None): section as the ‘‘Act’’) if there are in effect on the effective date of this Act elements to assure safe use—
p.(None): (A) required under section 314.520 or section 601.42 of title 21, Code of Federal Regulations; or
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 951
p.(None):
p.(None):
p.(None): (B) otherwise agreed to by the applicant and the Sec- retary for such drug.
p.(None): (2) ELEMENTS OF STRATEGY; ENFORCEMENT.—The approved risk evaluation and mitigation strategy in effect for a
p.(None): drug under paragraph (1)—
p.(None): (A) is deemed to consist of the timetable required under section 505–1(d) and any additional elements under sub-
p.(None): sections (e) and (f) of such section in effect for such drug on the effective date of this Act; and
p.(None): (B) is subject to enforcement by the Secretary to the same extent as any other risk evaluation and
p.(None): mitigation strategy under section 505–1 of the Act, except that sections 303(f)(4) and 502(y) and (z) of the Act (as
p.(None): added by section 902) shall not apply to such strategy before the Secretary has completed review of, and acted
p.(None): on, the first assessment of such strategy under such section 505–1.
p.(None): (3) SUBMISSION.—Not later than 180 days after the effective date of this Act, the holder of an approved
p.(None): application for which a risk evaluation and mitigation strategy is deemed to be in effect under paragraph (1)
p.(None): shall submit to the Secretary a proposed risk evaluation and mitigation strategy. Such pro- posed strategy is
p.(None): subject to section 505–1 of the Act as if included in such application at the time of submission of
p.(None): the application to the Secretary.
p.(None): Subtitle B—Other Provisions to Ensure Drug Safety and Surveillance
p.(None): SEC. 911. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.
p.(None): Chapter V of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 351 et seq.) is amended by inserting after section 510 the following:
p.(None): ‘‘SEC. 511. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.
p.(None): ‘‘(a) IN GENERAL.—Not later than 1 year after the date of the enactment of this section, the Secretary
p.(None): shall issue guidance for the conduct of clinical trials with respect to antibiotic drugs, including
p.(None): antimicrobials to treat acute bacterial sinusitis, acute bacterial otitis media, and acute bacterial
p.(None): exacerbation of chronic bronchitis. Such guidance shall indicate the appropriate models and valid surrogate
p.(None): markers.
p.(None): ‘‘(b) REVIEW.—Not later than 5 years after the date of the enactment of this section, the Secretary
p.(None): shall review and update the guidance described under subsection (a) to reflect developments in scientific and
p.(None): medical information and technology.’’.
p.(None): SEC. 912. PROHIBITION AGAINST FOOD TO WHICH DRUGS OR BIOLOGICAL PRODUCTS HAVE BEEN ADDED.
p.(None): (a) PROHIBITION.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by
p.(None): section 901(d), is amended by adding at the end the following:
p.(None): ‘‘(ll) The introduction or delivery for introduction into interstate commerce of any food to which has been
p.(None): added a drug approved under section 505, a biological product licensed under section 351 of the Public
p.(None): Health Service Act, or a drug or a biological product for which substantial clinical investigations have
p.(None): been instituted
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None): 21 USC 360a.
p.(None):
p.(None):
p.(None): 121 STAT. 952 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): and for which the existence of such investigations has been made public, unless—
p.(None): ‘‘(1) such drug or such biological product was marketed in food before any approval of the drug under
p.(None): section 505, before licensure of the biological product under such section 351, and before any substantial
p.(None): clinical investigations involving the drug or the biological product have been instituted;
p.(None): ‘‘(2) the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, approving
p.(None): the use of such drug or such biological product in the food;
p.(None): ‘‘(3) the use of the drug or the biological product in the food is to enhance the safety of the food
p.(None): to which the drug or the biological product is added or applied and not to have independent biological
p.(None): or therapeutic effects on humans, and the use is in conformity with—
p.(None): ‘‘(A) a regulation issued under section 409 prescribing conditions of safe use in food;
p.(None): ‘‘(B) a regulation listing or affirming conditions under which the use of the drug or the biological
p.(None): product in food is generally recognized as safe;
p.(None): ‘‘(C) the conditions of use identified in a notification to the Secretary of a claim of exemption from the
p.(None): premarket approval requirements for food additives based on the noti- fier’s determination that the use of
p.(None): the drug or the biological product in food is generally recognized as safe, provided that the Secretary
p.(None): has not questioned the general recognition of safety determination in a letter to the noti- fier;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 334.
p.(None):
p.(None): 21 USC 381.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355e.
p.(None): Standards.
p.(None): ‘‘(D) a food contact substance notification that is effec- tive under section 409(h); or
p.(None): ‘‘(E) such drug or biological product had been marketed for smoking cessation prior to the date of the
p.(None): enactment of the Food and Drug Administration Amendments Act of 2007; or
p.(None): ‘‘(4) the drug is a new animal drug whose use is not unsafe under section 512.’’.
p.(None): (b) CONFORMING CHANGES.—The Federal Food, Drug, and Cos- metic Act (21 U.S.C. 301 et seq.) is amended—
p.(None): (1) in section 304(a)(1), by striking ‘‘section 404 or 505’’ and inserting ‘‘section 301(ll), 404, or 505’’;
p.(None): and
p.(None): (2) in section 801(a), by striking ‘‘is adulterated, mis- branded, or in violation of section
p.(None): 505,’’ and inserting ‘‘is adulterated, misbranded, or in violation of section 505, or prohibited from
p.(None): introduction or delivery for introduction into interstate commerce under section 301(ll),’’.
p.(None): SEC. 913. ASSURING PHARMACEUTICAL SAFETY.
p.(None): Chapter V of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 351 et seq.), as amended in section 403, is amended by inserting after section 505C the following:
p.(None): ‘‘SEC. 505D. PHARMACEUTICAL SECURITY.
p.(None): ‘‘(a) IN GENERAL.—The Secretary shall develop standards and identify and validate effective technologies
p.(None): for the purpose of securing the drug supply chain against counterfeit, diverted, sub- potent,
p.(None): substandard, adulterated, misbranded, or expired drugs.
p.(None): ‘‘(b) STANDARDS DEVELOPMENT.—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 953
p.(None):
p.(None):
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall, in consultation with the agencies specified in paragraph (4), manufacturers,
p.(None): distribu- tors, pharmacies, and other supply chain stakeholders, prioritize and develop standards
p.(None): for the identification, valida- tion, authentication, and tracking and tracing of prescription drugs.
p.(None): ‘‘(2) STANDARDIZED NUMERAL IDENTIFIER.—Not later than
p.(None): 30 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007,
p.(None): the Secretary shall develop a standardized numerical identifier (which, to the extent practicable, shall be
p.(None): harmonized with international consensus standards for such an identifier) to be applied to a prescription
p.(None): drug at the point of manufacturing and repack- aging (in which case the numerical identifier shall be linked
p.(None): to the numerical identifier applied at the point of manufac- turing) at the package or pallet level,
p.(None): sufficient to facilitate the identification, validation, authentication, and tracking and tracing of the prescription
p.(None): drug.
p.(None): ‘‘(3) PROMISING TECHNOLOGIES.—The standards developed under this subsection shall address promising
p.(None): technologies, which may include—
p.(None): ‘‘(A) radio frequency identification technology; ‘‘(B) nanotechnology;
p.(None): ‘‘(C) encryption technologies; and
p.(None): ‘‘(D) other track-and-trace or authentication tech- nologies.
p.(None): ‘‘(4) INTERAGENCY COLLABORATION.—In carrying out this subsection, the Secretary shall consult with Federal
p.(None): health and security agencies, including—
p.(None): ‘‘(A) the Department of Justice;
p.(None): ‘‘(B) the Department of Homeland Security; ‘‘(C) the Department of Commerce; and
p.(None): ‘‘(D) other appropriate Federal and State agencies. ‘‘(c) INSPECTION AND ENFORCEMENT.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall expand and enhance the resources and facilities of agency components of
p.(None): the Food and Drug Administration involved with regulatory and criminal enforcement of this Act to secure the drug
p.(None): supply chain against counterfeit, diverted, subpotent, substandard, adulterated, mis- branded, or expired drugs
p.(None): including biological products and active pharmaceutical ingredients from domestic and foreign sources.
p.(None): ‘‘(2) ACTIVITIES.—The Secretary shall undertake enhanced and joint enforcement activities with other Federal
p.(None): and State agencies, and establish regional capacities for the validation of prescription drugs and the
p.(None): inspection of the prescription drug supply chain.
p.(None): ‘‘(d) DEFINITION.—In this section, the term ‘prescription drug’ means a drug subject to section 503(b)(1).’’.
p.(None): SEC. 914. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY ACTION.
p.(None): (a) IN GENERAL.—Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by
p.(None): section 901(a), is amended by adding at the end the following:
p.(None): ‘‘(q) PETITIONS AND CIVIL ACTIONS REGARDING APPROVAL OF
p.(None): CERTAIN APPLICATIONS.—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 954 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): ‘‘(1) IN GENERAL.—
p.(None): ‘‘(A) DETERMINATION.—The Secretary shall not delay approval of a pending application submitted under sub-
p.(None): section (b)(2) or (j) because of any request to take any form of action relating to the application,
p.(None): either before or during consideration of the request, unless—
p.(None): ‘‘(i) the request is in writing and is a petition submitted to the Secretary pursuant to section 10.30
p.(None): or 10.35 of title 21, Code of Federal Regulations (or any successor regulations); and
p.(None): ‘‘(ii) the Secretary determines, upon reviewing the petition, that a delay is necessary to protect the public health.
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(B) NOTIFICATION.—If the Secretary determines under
p.(None): subparagraph (A) that a delay is necessary with respect to an application, the Secretary shall
...
p.(None): TIONS.—The Secretary shall annually submit to the Congress a report that specifies—
p.(None): ‘‘(A) the number of applications that were approved during the preceding 12-month period;
p.(None): ‘‘(B) the number of such applications whose effective dates were delayed by petitions referred to in
p.(None): paragraph
p.(None): (1) during such period;
p.(None): ‘‘(C) the number of days by which such applications were so delayed; and
p.(None): ‘‘(D) the number of such petitions that were submitted during such period.
p.(None): ‘‘(4) EXCEPTIONS.—This subsection does not apply to—
p.(None): ‘‘(A) a petition that relates solely to the timing of the approval of an application pursuant to
p.(None): subsection (j)(5)(B)(iv); or
p.(None): ‘‘(B) a petition that is made by the sponsor of an application and that seeks only to have the Secretary take
p.(None): or refrain from taking any form of action with respect to that application.
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): ‘‘(5) DEFINITIONS.—
p.(None): 121 STAT. 957
p.(None):
p.(None): ‘‘(A) APPLICATION.—For purposes of this subsection, the term ‘application’ means an application submitted under
p.(None): subsection (b)(2) or (j).
p.(None): ‘‘(B) PETITION.—For purposes of this subsection, other than paragraph (1)(A)(i), the term ‘petition’
p.(None): means a request described in paragraph (1)(A)(i).’’.
p.(None): (b) REPORT.—Not later than 1 year after the date of the enact- ment of this Act, the Secretary of Health and
p.(None): Human Services shall submit a report to the Congress on ways to encourage the early submission of
p.(None): petitions under section 505(q), as added by subsection (a).
p.(None): SEC. 915. POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND PROVIDERS.
p.(None): Section 505 of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 355), as amended by section 914(a), is amended by adding at the end the following:
p.(None): ‘‘(r) POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND PROVIDERS.—
p.(None): ‘‘(1) ESTABLISHMENT.—Not later than 1 year after the date of the enactment of the Food and Drug Administration
p.(None): Amend- ments Act of 2007, the Secretary shall improve the transparency of information about drugs and allow patients
p.(None): and health care providers better access to information about drugs by devel- oping and maintaining an Internet
p.(None): Web site that—
p.(None): ‘‘(A) provides links to drug safety information listed in paragraph (2) for prescription drugs that are
p.(None): approved under this section or licensed under section 351 of the Public Health Service Act; and
p.(None): ‘‘(B) improves communication of drug safety informa- tion to patients and providers.
p.(None): ‘‘(2) INTERNET WEB SITE.—The Secretary shall carry out paragraph (1) by—
p.(None): ‘‘(A) developing and maintaining an accessible, consoli- dated Internet Web site with easily searchable drug safety
p.(None): information, including the information found on United States Government Internet Web sites, such as the United
p.(None): States National Library of Medicine’s Daily Med and Medline Plus Web sites, in addition to other
p.(None): such Web sites maintained by the Secretary;
p.(None): ‘‘(B) ensuring that the information provided on the Internet Web site is comprehensive and includes, when
p.(None): available and appropriate—
p.(None): ‘‘(i) patient labeling and patient packaging inserts; ‘‘(ii) a link to a list of each drug, whether approved under
p.(None): this section or licensed under such section 351, for which a Medication Guide, as provided for under
p.(None): part 208 of title 21, Code of Federal Regulations (or
p.(None): any successor regulations), is required;
p.(None): ‘‘(iii) a link to the registry and results data bank provided for under subsections (i) and (j) of
p.(None): section 402 of the Public Health Service Act;
p.(None): ‘‘(iv) the most recent safety information and alerts issued by the Food and Drug Administration for drugs approved by
p.(None): the Secretary under this section, such as product recalls, warning letters, and import alerts;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Website.
p.(None):
p.(None):
p.(None): 121 STAT. 958 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(v) publicly available information about imple- mented RiskMAPs and risk evaluation and mitigation strategies
p.(None): under subsection (o);
p.(None): ‘‘(vi) guidance documents and regulations related to drug safety; and
p.(None): ‘‘(vii) other material determined appropriate by the Secretary;
p.(None): ‘‘(C) providing access to summaries of the assessed and aggregated data collected from the active surveillance
p.(None): infrastructure under subsection (k)(3) to provide informa- tion of known and serious side-effects for
p.(None): drugs approved under this section or licensed under such section 351;
p.(None):
p.(None): Reports.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Reports.
p.(None): ‘‘(D) preparing, by 18 months after approval of a drug or after use of the drug by 10,000 individuals,
p.(None): whichever is later, a summary analysis of the adverse drug reaction reports received for the drug,
p.(None): including identification of any new risks not previously identified, potential new risks, or known risks reported in
p.(None): unusual number;
p.(None): ‘‘(E) enabling patients, providers, and drug sponsors to submit adverse event reports through the Internet Web
p.(None): site;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(F) providing educational materials for patients and providers about the appropriate means of
p.(None): disposing of expired, damaged, or unusable medications; and
p.(None): ‘‘(G) supporting initiatives that the Secretary deter- mines to be useful to fulfill the purposes of the
p.(None): Internet Web site.
p.(None): ‘‘(3) POSTING OF DRUG LABELING.—The Secretary shall post on the Internet Web site established under
p.(None): paragraph (1) the approved professional labeling and any required patient labeling of a drug approved
p.(None): under this section or licensed under such section 351 not later than 21 days after the date the drug
p.(None): is approved or licensed, including in a supplemental application with respect to a labeling change.
p.(None): ‘‘(4) PRIVATE SECTOR RESOURCES.—To ensure development of the Internet Web site by the date
p.(None): described in paragraph (1), the Secretary may, on a temporary or permanent basis, implement systems or
p.(None): products developed by private entities. ‘‘(5) AUTHORITY FOR CONTRACTS.—The Secretary may enter into
p.(None): contracts with public and private entities to fulfill the
p.(None): requirements of this subsection.
p.(None): ‘‘(6) REVIEW.—The Advisory Committee on Risk Commu- nication under section 567 shall, on a regular basis,
p.(None): perform a comprehensive review and evaluation of the types of risk communication information provided on
p.(None): the Internet Web site established under paragraph (1) and, through other means, shall identify, clarify,
p.(None): and define the purposes and types of information available to facilitate the efficient flow of informa- tion to
p.(None): patients and providers, and shall recommend ways for the Food and Drug Administration to work with
p.(None): outside entities to help facilitate the dispensing of risk communication information to patients and providers.’’.
p.(None): SEC. 916. ACTION PACKAGE FOR APPROVAL.
p.(None): Section 505(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(l)) is amended by—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 959
p.(None):
p.(None):
p.(None): (1) redesignating paragraphs (1), (2), (3), (4), and (5) as subparagraphs (A), (B), (C), (D), and (E),
p.(None): respectively;
p.(None): (2) striking ‘‘(l) Safety and’’ and inserting ‘‘(l)(1) Safety and’’; and
p.(None): (3) adding at the end the following: ‘‘(2) ACTION PACKAGE FOR APPROVAL.—
p.(None): ‘‘(A) ACTION PACKAGE.—The Secretary shall publish the action package for approval of an application under
p.(None): subsection
p.(None): (b) or section 351 of the Public Health Service Act on the Internet Web site of the Food and Drug
p.(None): Administration—
p.(None): ‘‘(i) not later than 30 days after the date of approval of such application for a drug no
p.(None): active ingredient (including any ester or salt of the active ingredient) of which has been approved in
p.(None): any other application under this section or section 351 of the Public Health Service Act; and
p.(None): ‘‘(ii) not later than 30 days after the third request for such action package for approval received under
p.(None): section
p.(None): 552 of title 5, United States Code, for any other drug. ‘‘(B) IMMEDIATE PUBLICATION OF SUMMARY
p.(None): REVIEW.—Not- withstanding subparagraph (A), the Secretary shall publish, on the Internet Web site of the Food and
p.(None): Drug Administration, the materials described in subparagraph (C)(iv) not later than 48 hours after the date of
p.(None): approval of the drug, except where
p.(None): such materials require redaction by the Secretary.
p.(None): ‘‘(C) CONTENTS.—An action package for approval of an application under subparagraph (A) shall be dated
p.(None): and shall include the following:
p.(None): ‘‘(i) Documents generated by the Food and Drug Administration related to review of the application.
p.(None): ‘‘(ii) Documents pertaining to the format and content of the application generated during drug development.
p.(None): ‘‘(iii) Labeling submitted by the applicant.
p.(None): ‘‘(iv) A summary review that documents conclusions from all reviewing disciplines about the drug, noting
p.(None): any critical issues and disagreements with the applicant and within the review team and how they were
p.(None): resolved, rec- ommendations for action, and an explanation of any non- concurrence with review conclusions.
p.(None): ‘‘(v) The Division Director and Office Director’s decision document which includes—
p.(None): ‘‘(I) a brief statement of concurrence with the sum- mary review;
p.(None): ‘‘(II) a separate review or addendum to the review if disagreeing with the summary review; and
p.(None): ‘‘(III) a separate review or addendum to the review to add further analysis.
p.(None): ‘‘(vi) Identification by name of each officer or employee of the Food and Drug Administration who—
p.(None): ‘‘(I) participated in the decision to approve the application; and
p.(None): ‘‘(II) consents to have his or her name included in the package.
p.(None): ‘‘(D) REVIEW.—A scientific review of an application is considered the work of the reviewer and
p.(None): shall not be altered by management or the reviewer once final.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Publication. Website.
p.(None): Deadlines.
p.(None):
p.(None):
p.(None): 121 STAT. 960 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(E) CONFIDENTIAL INFORMATION.—This paragraph does not authorize the disclosure of any trade secret,
p.(None): confidential commercial or financial information, or other matter listed in section 552(b) of title 5, United
p.(None): States Code.’’.
p.(None): SEC. 917. RISK COMMUNICATION.
p.(None): Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.), as
p.(None): amended by section 603, is amended by adding at the end the following:
p.(None):
p.(None): 21 USC
p.(None): 360bbb–6. Establishment.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355.
p.(None): ‘‘SEC. 567. RISK COMMUNICATION.
p.(None): ‘‘(a) ADVISORY COMMITTEE ON RISK COMMUNICATION.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall establish an advisory committee to be known as the ‘Advisory Committee on
p.(None): Risk Communication’ (referred to in this section as the ‘Committee’). ‘‘(2) DUTIES OF COMMITTEE.—The Committee
p.(None): shall advise
p.(None): the Commissioner on methods to effectively communicate risks associated with the products regulated by the Food
p.(None): and Drug Administration.
p.(None): ‘‘(3) MEMBERS.—The Secretary shall ensure that the Com- mittee is composed of experts on risk communication,
p.(None): experts on the risks described in subsection (b), and representatives of patient, consumer, and health
p.(None): professional organizations. ‘‘(4) PERMANENCE OF COMMITTEE.—Section 14 of the Fed-
p.(None): eral Advisory Committee Act shall not apply to the Committee established under this subsection.
p.(None): ‘‘(b) PARTNERSHIPS FOR RISK COMMUNICATION.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall partner with profes- sional medical societies, medical schools, academic medical
p.(None): cen- ters, and other stakeholders to develop robust and multi-faceted systems for communication to health
p.(None): care providers about emerging postmarket drug risks.
p.(None): ‘‘(2) PARTNERSHIPS.—The systems developed under para- graph (1) shall—
p.(None): ‘‘(A) account for the diversity among physicians in terms of practice, willingness to adopt technology, and med-
p.(None): ical specialty; and
p.(None): ‘‘(B) include the use of existing communication chan- nels, including electronic communications, in place
p.(None): at the Food and Drug Administration.’’.
p.(None): SEC. 918. REFERRAL TO ADVISORY COMMITTEE.
p.(None): Section 505 of the Federal Food, Drug, and Cosmetic Act, as amended by section 915, is further amended
p.(None): by adding at the end the following:
p.(None): ‘‘(s) REFERRAL TO ADVISORY COMMITTEE.—Prior to the approval of a drug no active ingredient (including
p.(None): any ester or salt of the active ingredient) of which has been approved in any other applica- tion under this
p.(None): section or section 351 of the Public Health Service Act, the Secretary shall—
p.(None): ‘‘(1) refer such drug to a Food and Drug Administration advisory committee for review at a meeting of
p.(None): such advisory committee; or
p.(None): ‘‘(2) if the Secretary does not refer such a drug to a Food and Drug Administration advisory
p.(None): committee prior to the approval of the drug, provide in the action letter on the applica- tion for the drug a
p.(None): summary of the reasons why the Secretary
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 961
p.(None):
p.(None):
p.(None): did not refer the drug to an advisory committee prior to approval.’’.
p.(None): SEC. 919. RESPONSE TO THE INSTITUTE OF MEDICINE.
p.(None): (a) IN GENERAL.—Not later than 1 year after the date of the enactment of this title, the Secretary shall
p.(None): issue a report responding to the 2006 report of the Institute of Medicine entitled ‘‘The Future of Drug
p.(None): Safety—Promoting and Protecting the Health of the Public’’.
p.(None): (b) CONTENT OF REPORT.—The report issued by the Secretary under subsection (a) shall include—
p.(None): (1) an update on the implementation by the Food and Drug Administration of its plan to respond to the
p.(None): Institute of Medicine report described under such subsection; and
p.(None): (2) an assessment of how the Food and Drug Administra- tion has implemented—
p.(None): (A) the recommendations described in such Institute of Medicine report; and
p.(None): (B) the requirement under section 505–1(c)(2) of the Federal Food, Drug, and Cosmetic Act (as added by
p.(None): this title), that the appropriate office responsible for reviewing a drug and the office responsible for
p.(None): postapproval safety with respect to the drug work together to assess, imple- ment, and ensure compliance
p.(None): with the requirements of such section 505–1.
p.(None): SEC. 920. DATABASE FOR AUTHORIZED GENERIC DRUGS.
p.(None): Section 505 of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 355), as amended by section 918, is further amended by adding at the end the following:
p.(None): ‘‘(t) DATABASE FOR AUTHORIZED GENERIC DRUGS.— ‘‘(1) IN GENERAL.—
p.(None): ‘‘(A) PUBLICATION.—The Commissioner shall—
p.(None): ‘‘(i) not later than 9 months after the date of the enactment of the Food and Drug Administration
p.(None): Amendments Act of 2007, publish a complete list on the Internet Web site of the Food and Drug Adminis-
p.(None): tration of all authorized generic drugs (including drug trade name, brand company manufacturer, and the date the
p.(None): authorized generic drug entered the market); and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Reports.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None): ‘‘(ii) update the list quarterly to include each authorized generic drug included in an annual
p.(None): report submitted to the Secretary by the sponsor of a listed drug during the preceding 3-month period.
p.(None): ‘‘(B) NOTIFICATION.—The Commissioner shall notify relevant Federal agencies, including the Centers for Medi-
p.(None): care & Medicaid Services and the Federal Trade Commis- sion, when the Commissioner first publishes the informa-
p.(None): tion described in subparagraph (A) that the information has been published and that the information
p.(None): will be updated quarterly.
p.(None): ‘‘(2) INCLUSION.—The Commissioner shall include in the list described in paragraph (1) each authorized
p.(None): generic drug included in an annual report submitted to the Secretary by the sponsor of a listed drug after
p.(None): January 1, 1999.
p.(None): ‘‘(3) AUTHORIZED GENERIC DRUG.—In this section, the term ‘authorized generic drug’ means a listed drug (as that
p.(None): term is used in subsection (j)) that—
p.(None):
p.(None):
p.(None): 121 STAT. 962 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): ‘‘(A) has been approved under subsection (c); and
p.(None): ‘‘(B) is marketed, sold, or distributed directly or indirectly to retail class of trade under a different
p.(None): labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar
p.(None): packaging for use in institutions), product code, labeler code, trade name, or trade mark than the listed
p.(None): drug.’’.
p.(None): SEC. 921. ADVERSE DRUG REACTION REPORTS AND POSTMARKET SAFETY.
p.(None): Subsection (k) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as
p.(None): amended by section 905, is amended by adding at the end the following:
p.(None): ‘‘(5) The Secretary shall—
p.(None): ‘‘(A) conduct regular, bi-weekly screening of the Adverse Event Reporting System database and post a quar-
p.(None): terly report on the Adverse Event Reporting System Web site of any new safety information or potential
p.(None): signal of a serious risk identified by Adverse Event Reporting System within the last quarter;
p.(None): ‘‘(B) report to Congress not later than 2 year after the date of the enactment of the Food and Drug
p.(None): Administra- tion Amendments Act of 2007 on procedures and processes of the Food and Drug Administration for
p.(None): addressing ongoing post market safety issues identified by the Office of Surveillance and Epidemiology
p.(None): and how recommenda- tions of the Office of Surveillance and Epidemiology are handled within the agency; and
p.(None): ‘‘(C) on an annual basis, review the entire backlog of postmarket safety commitments to determine
p.(None): which commitments require revision or should be eliminated, report to the Congress on these determinations, and
p.(None): assign start dates and estimated completion dates for such commitments.’’.
p.(None):
p.(None): TITLE X—FOOD SAFETY
p.(None):
p.(None):
p.(None): 21 USC 2101.
p.(None): SEC. 1001. FINDINGS.
p.(None): Congress finds that—
p.(None): (1) the safety and integrity of the United States food supply are vital to public health, to public confidence
p.(None): in the food supply, and to the success of the food sector of the Nation’s economy;
p.(None): (2) illnesses and deaths of individuals and companion ani- mals caused by contaminated food—
p.(None): (A) have contributed to a loss of public confidence in food safety; and
p.(None): (B) have caused significant economic losses to manufac- turers and producers not responsible for contaminated food
p.(None): items;
p.(None): (3) the task of preserving the safety of the food supply of the United States faces tremendous
p.(None): pressures with regard to—
p.(None): (A) emerging pathogens and other contaminants and the ability to detect all forms of contamination;
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 963
p.(None):
p.(None):
p.(None): (B) an increasing volume of imported food from a wide variety of countries; and
p.(None): (C) a shortage of adequate resources for monitoring and inspection;
p.(None): (4) according to the Economic Research Service of the Department of Agriculture, the United States is
p.(None): increasing the amount of food that it imports such that—
p.(None): (A) from 2003 to 2007, the value of food imports has increased from $45,600,000,000 to $64,000,000,000; and
p.(None): (B) imported food accounts for 13 percent of the average American diet including 31 percent of fruits, juices,
p.(None): and nuts, 9.5 percent of red meat, and 78.6 percent of fish and shellfish; and
p.(None): (5) the number of full-time equivalent Food and Drug Administration employees conducting inspections has
p.(None): decreased from 2003 to 2007.
p.(None): SEC. 1002. ENSURING THE SAFETY OF PET FOOD.
p.(None): (a) PROCESSING AND INGREDIENT STANDARDS.—Not later than 2 years after the date of the enactment of this
p.(None): Act, the Secretary of Health and Human Services (referred to in this title as the ‘‘Secretary’’), in
p.(None): consultation with the Association of American Feed Control Officials and other relevant stakeholder groups,
p.(None): including veterinary medical associations, animal health organizations, and pet food manufacturers, shall by
p.(None): regulation establish—
p.(None): (1) ingredient standards and definitions with respect to pet food;
p.(None): (2) processing standards for pet food; and
p.(None): (3) updated standards for the labeling of pet food that include nutritional and ingredient information.
p.(None): (b) EARLY WARNING SURVEILLANCE SYSTEMS AND NOTIFICATION DURING PET FOOD RECALLS.—Not later than 1 year after the
p.(None): date of the enactment of this Act, the Secretary shall establish an early warning and surveillance
p.(None): system to identify adulteration of the pet food supply and outbreaks of illness associated with pet food.
p.(None): In establishing such system, the Secretary shall—
p.(None): (1) consider using surveillance and monitoring mechanisms similar to, or in coordination with, those used to monitor
p.(None): human or animal health, such as the Foodborne Diseases Active Surveillance Network (FoodNet) and
p.(None): PulseNet of the Centers for Disease Control and Prevention, the Food Emergency Response Network of
p.(None): the Food and Drug Administration and the Department of Agriculture, and the National Animal Health Laboratory
p.(None): Network of the Department of Agriculture;
p.(None): (2) consult with relevant professional associations and pri- vate sector veterinary hospitals;
p.(None): (3) work with the National Companion Animal Surveillance Program, the Health Alert Network, or other
p.(None): notification net- works as appropriate to inform veterinarians and relevant stakeholders during any recall of
p.(None): pet food; and
p.(None): (4) use such information and conduct such other activities as the Secretary deems appropriate.
p.(None): SEC. 1003. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS DURING A RECALL.
p.(None): The Secretary shall, during an ongoing recall of human or pet food regulated by the Secretary—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2102.
p.(None): Deadline. Regulations.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2103.
p.(None):
p.(None):
p.(None): 121 STAT. 964 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): (1) work with companies, relevant professional associations, and other organizations to collect and aggregate
p.(None): information pertaining to the recall;
p.(None): (2) use existing networks of communication, including elec- tronic forms of information dissemination, to
p.(None): enhance the quality and speed of communication with the public; and
p.(None):
p.(None): Website.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2104.
p.(None): (3) post information regarding recalled human and pet foods on the Internet Web site of the Food and Drug
p.(None): Adminis- tration in a single location, which shall include a searchable database of recalled human foods
p.(None): and a searchable database of recalled pet foods, that is easily accessed and understood by the public.
p.(None): SEC. 1004. STATE AND FEDERAL COOPERATION.
p.(None): (a) IN GENERAL.—The Secretary shall work with the States in undertaking activities and programs that
p.(None): assist in improving the safety of food, including fresh and processed produce, so that State food safety
p.(None): programs and activities conducted by the Secretary function in a coordinated and cost-effective manner. With the
p.(None): assist- ance provided under subsection (b), the Secretary shall encourage States to—
p.(None): (1) establish, continue, or strengthen State food safety pro- grams, especially with respect to the
p.(None): regulation of retail commercial food establishments; and
p.(None): (2) establish procedures and requirements for ensuring that processed produce under the jurisdiction of State
p.(None): food safety programs is not unsafe for human consumption.
p.(None): (b) ASSISTANCE.—The Secretary may provide to a State, for planning, developing, and implementing such a
p.(None): food safety pro- gram—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 350f
p.(None): note.
p.(None): (1) advisory assistance;
p.(None): (2) technical assistance, training, and laboratory assistance (including necessary materials and equipment); and
p.(None): (3) financial and other assistance.
p.(None): (c) SERVICE AGREEMENTS.—The Secretary may, under an agree- ment entered into with a Federal, State, or local
p.(None): agency, use, on a reimbursable basis or otherwise, the personnel, services, and facilities of the agency to
p.(None): carry out the responsibilities of the agency under this section. An agreement entered into with a State agency under
p.(None): this subsection may provide for training of State employees.
p.(None): SEC. 1005. REPORTABLE FOOD REGISTRY.
p.(None): (a) FINDINGS.—Congress makes the following findings:
p.(None): (1) In 1994, Congress passed the Dietary Supplement Health and Education Act of 1994 (Public Law
p.(None): 103–417) to provide the Food and Drug Administration the legal framework which is intended to ensure that dietary
p.(None): supplements are safe and properly labeled foods.
p.(None): (2) In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law
p.(None): 109–462) to establish a mandatory reporting system of serious adverse events for nonprescription drugs and
p.(None): dietary supple- ments sold and consumed in the United States.
p.(None): (3) The adverse event reporting system created under the Dietary Supplement and Nonprescription Drug
p.(None): Consumer Protection Act is intended to serve as an early warning system for potential public health issues
p.(None): associated with the use of these products.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 965
p.(None):
p.(None):
p.(None): (4) A reliable mechanism to track patterns of adulteration in food would support efforts by the Food and Drug
p.(None): Administra- tion to target limited inspection resources to protect the public health.
p.(None): (b) IN GENERAL.—Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is
p.(None): amended by adding at the end the following:
p.(None): ‘‘SEC. 417. REPORTABLE FOOD REGISTRY.
p.(None): ‘‘(a) DEFINITIONS.—In this section:
p.(None): ‘‘(1) RESPONSIBLE PARTY.—The term ‘responsible party’, with respect to an article of food, means a person
p.(None): that submits the registration under section 415(a) for a food facility that is required to register under
p.(None): section 415(a), at which such article of food is manufactured, processed, packed, or held. ‘‘(2)
p.(None): REPORTABLE FOOD.—The term ‘reportable food’ means
p.(None): an article of food (other than infant formula) for which there is a reasonable probability that the use
p.(None): of, or exposure to, such article of food will cause serious adverse health con- sequences or death to
p.(None): humans or animals.
p.(None): ‘‘(b) ESTABLISHMENT.—
p.(None): ‘‘(1) IN GENERAL.—Not later than 1 year after the date of the enactment of this section, the Secretary
p.(None): shall establish within the Food and Drug Administration a Reportable Food Registry to which instances of
p.(None): reportable food may be submitted by the Food and Drug Administration after receipt of reports under subsection
p.(None): (d), via an electronic portal, from—
p.(None): ‘‘(A) Federal, State, and local public health officials;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 350f.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): or
p.(None): ‘‘(B) responsible parties.
p.(None):
p.(None): ‘‘(2) REVIEW BY SECRETARY.—The Secretary shall promptly review and assess the information submitted under paragraph
p.(None): (1) for the purposes of identifying reportable food, submitting entries to the Reportable Food Registry, acting
p.(None): under subsection (c), and exercising other existing food safety authorities under this Act to protect the
p.(None): public health.
p.(None): ‘‘(c) ISSUANCE OF AN ALERT BY THE SECRETARY.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall issue, or cause to be issued, an alert or a notification with respect to
p.(None): a reportable food using information from the Reportable Food Registry as the Secretary deems necessary to
p.(None): protect the public health. ‘‘(2) EFFECT.—Paragraph (1) shall not affect the authority
p.(None): of the Secretary to issue an alert or a notification under any other provision of this Act.
p.(None): ‘‘(d) REPORTING AND NOTIFICATION.—
p.(None): ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), as soon as practicable, but in no case later
p.(None): than 24 hours after a responsible party determines that an article of food is a reportable food, the
p.(None): responsible party shall—
p.(None): ‘‘(A) submit a report to the Food and Drug Administra- tion through the electronic portal established under sub-
p.(None): section (b) that includes the data elements described in subsection (e) (except the elements described in
p.(None): paragraphs (8), (9), and (10) of such subsection); and
p.(None): ‘‘(B) investigate the cause of the adulteration if the adulteration of the article of food may have
p.(None): originated with the responsible party.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 966 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(2) NO REPORT REQUIRED.—A responsible party is not required to submit a report under paragraph (1) if—
p.(None): ‘‘(A) the adulteration originated with the responsible party;
p.(None): ‘‘(B) the responsible party detected the adulteration prior to any transfer to another person of such
p.(None): article of food; and
p.(None): ‘‘(C) the responsible party—
p.(None): ‘‘(i) corrected such adulteration; or
p.(None): ‘‘(ii) destroyed or caused the destruction of such article of food.
p.(None): ‘‘(3) REPORTS BY PUBLIC HEALTH OFFICIALS.—A Federal,
p.(None): State, or local public health official may submit a report about a reportable food to the Food and Drug Administration
p.(None): through the electronic portal established under subsection (b) that includes the data elements
p.(None): described in subsection (e) that the official is able to provide.
p.(None): ‘‘(4) REPORT NUMBER.—The Secretary shall ensure that, upon submission of a report under paragraph (1) or
p.(None): (3), a unique number is issued through the electronic portal estab- lished under subsection (b) to the
p.(None): person submitting such report, by which the Secretary is able to link reports about the reportable food
p.(None): submitted and amended under this sub- section and identify the supply chain for such reportable food.
p.(None): ‘‘(5) REVIEW.—The Secretary shall promptly review a report
p.(None): submitted under paragraph (1) or (3).
p.(None): ‘‘(6) RESPONSE TO REPORT SUBMITTED BY A RESPONSIBLE
p.(None): PARTY.—After consultation with the responsible party that sub- mitted a report under paragraph (1), the Secretary may
p.(None): require such responsible party to perform, as soon as practicable, but in no case later than a time
p.(None): specified by the Secretary, 1 or more of the following:
p.(None): ‘‘(A) Amend the report submitted by the responsible party under paragraph (1) to include the data
p.(None): element described in subsection (e)(9).
p.(None): ‘‘(B) Provide a notification—
p.(None): ‘‘(i) to the immediate previous source of the article of food, if the Secretary deems necessary;
p.(None): ‘‘(ii) to the immediate subsequent recipient of the article of food, if the Secretary deems necessary;
p.(None): and
p.(None): ‘‘(iii) that includes—
p.(None): ‘‘(I) the data elements described in subsection
p.(None): (e) that the Secretary deems necessary;
p.(None): ‘‘(II) the actions described under paragraph
p.(None): (7) that the recipient of the notification shall per- form, as required by the Secretary; and
p.(None): ‘‘(III) any other information that the Secretary may require.
p.(None): ‘‘(7) SUBSEQUENT REPORTS AND NOTIFICATIONS.—Except as
p.(None): provided in paragraph (8), the Secretary may require a respon- sible party to perform, as soon as practicable,
p.(None): but in no case later than a time specified by the Secretary, after the respon- sible party receives a
p.(None): notification under subparagraph (C) or paragraph (6)(B), 1 or more of the following:
p.(None): ‘‘(A) Submit a report to the Food and Drug Administra- tion through the electronic portal established under sub-
p.(None): section (b) that includes those data elements described
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 967
p.(None):
p.(None): in subsection (e) and other information that the Secretary deems necessary.
p.(None): ‘‘(B) Investigate the cause of the adulteration if the adulteration of the article of food may have
p.(None): originated with the responsible party.
p.(None): ‘‘(C) Provide a notification—
p.(None): ‘‘(i) to the immediate previous source of the article of food, if the Secretary deems necessary;
p.(None): ‘‘(ii) to the immediate subsequent recipient of the article of food, if the Secretary deems necessary;
p.(None): and
p.(None): ‘‘(iii) that includes—
p.(None): ‘‘(I) the data elements described in subsection
p.(None): (e) that the Secretary deems necessary;
p.(None): ‘‘(II) the actions described under this para- graph that the recipient of the notification shall perform,
p.(None): as required by the Secretary; and
p.(None): ‘‘(III) any other information that the Secretary may require.
p.(None): ‘‘(8) AMENDED REPORT.—If a responsible party receives a notification under paragraph (6)(B) or paragraph
p.(None): (7)(C) with respect to an article of food after the responsible party has submitted a report to the Food and
p.(None): Drug Administration under paragraph (1) with respect to such article of food—
p.(None): ‘‘(A) the responsible party is not required to submit an additional report or make a notification under
p.(None): para- graph (7); and
p.(None): ‘‘(B) the responsible party shall amend the report sub- mitted by the responsible party under paragraph (1) to
p.(None): include the data elements described in paragraph (9), and, with respect to both such notification and such
p.(None): report, paragraph (11) of subsection (e).
p.(None): ‘‘(e) DATA ELEMENTS.—The data elements described in this subsection are the following:
p.(None): ‘‘(1) The registration numbers of the responsible party under section 415(a)(3).
p.(None): ‘‘(2) The date on which an article of food was determined to be a reportable food.
p.(None): ‘‘(3) A description of the article of food including the quantity or amount.
p.(None): ‘‘(4) The extent and nature of the adulteration.
p.(None): ‘‘(5) If the adulteration of the article of food may have originated with the responsible party, the results
p.(None): of the inves- tigation required under paragraph (1)(B) or (7)(B) of subsection (d), as applicable and when known.
p.(None): ‘‘(6) The disposition of the article of food, when known. ‘‘(7) Product information typically found
p.(None): on packaging including product codes, use-by dates, and names of manufac- turers, packers, or distributors
p.(None): sufficient to identify the article
p.(None): of food.
...
p.(None): (6)(B) or (7)(C) of subsection (d), as applicable.
p.(None): ‘‘(10) The information required by the Secretary to be included in a notification provided by the
p.(None): responsible party involved under paragraph (6)(B) or (7)(C) of subsection (d) or required in a report under
p.(None): subsection (d)(7)(A).
p.(None):
p.(None):
p.(None): 121 STAT. 968 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(11) The unique number described in subsection (d)(4). ‘‘(f) COORDINATION OF FEDERAL, STATE, AND LOCAL
p.(None): EFFORTS.—
p.(None): ‘‘(1) DEPARTMENT OF AGRICULTURE.—In implementing this section, the Secretary shall—
p.(None): ‘‘(A) share information and coordinate regulatory efforts with the Department of Agriculture; and
p.(None): ‘‘(B) if the Secretary receives a report submitted about a food within the jurisdiction of the Department of
p.(None): Agri- culture, promptly provide such report to the Department of Agriculture.
p.(None): ‘‘(2) STATES AND LOCALITIES.—In implementing this section, the Secretary shall work with the State and local public
p.(None): health officials to share information and coordinate regulatory efforts, in order to—
p.(None): ‘‘(A) help to ensure coverage of the safety of the food supply chain, including those food establishments
p.(None): regulated by the States and localities that are not required to register under section 415; and
p.(None): ‘‘(B) reduce duplicative regulatory efforts.
p.(None): ‘‘(g) MAINTENANCE AND INSPECTION OF RECORDS.—The respon-
p.(None): sible party shall maintain records related to each report received, notification made, and report
p.(None): submitted to the Food and Drug Administration under this section for 2 years. A responsible party shall,
p.(None): at the request of the Secretary, permit inspection of such records as provided for section 414.
p.(None):
p.(None): Applicability.
p.(None): ‘‘(h) REQUEST FOR INFORMATION.—Except as provided by section 415(a)(4), section 552 of title 5, United States
p.(None): Code, shall apply to any request for information regarding a record in the Reportable Food Registry.
p.(None): ‘‘(i) SAFETY REPORT.—A report or notification under subsection
p.(None): (d) shall be considered to be a safety report under section 756 and may be accompanied by a statement,
p.(None): which shall be part of any report released for public disclosure, that denies that the report or the
p.(None): notification constitutes an admission that the product involved caused or contributed to a death, serious injury, or
p.(None): serious illness.
p.(None): ‘‘(j) ADMISSION.—A report or notification under this section shall not be considered an admission that the
p.(None): article of food involved is adulterated or caused or contributed to a death, serious injury, or serious
p.(None): illness.
p.(None): ‘‘(k) HOMELAND SECURITY NOTIFICATION.—If, after receiving a report under subsection (d), the Secretary
p.(None): believes such food may have been deliberately adulterated, the Secretary shall immediately notify the Secretary
p.(None): of Homeland Security. The Secretary shall make relevant information from the Reportable Food Registry avail- able
p.(None): to the Secretary of Homeland Security.’’.
p.(None): (c) DEFINITION.—Section 201(ff) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)) is amended by
p.(None): striking ‘‘section 201(g)’’ and inserting ‘‘sections 201(g) and 417’’.
p.(None): (d) PROHIBITED ACTS.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by
p.(None): section 912, is further amended—
p.(None): (1) in subsection (e), by—
p.(None): (A) striking ‘‘414,’’ and inserting ‘‘414, 417(g),’’; and
p.(None): (B) striking ‘‘414(b)’’ and inserting ‘‘414(b), 417’’; and
p.(None): (2) by adding at the end the following:
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 969
p.(None):
p.(None):
p.(None): ‘‘(mm) The failure to submit a report or provide a notification required under section 417(d).
p.(None): ‘‘(nn) The falsification of a report or notification required under section 417(d).’’.
p.(None): (e) EFFECTIVE DATE.—The requirements of section 417(d) of the Federal Food, Drug, and Cosmetic Act, as added by
p.(None): subsection (a), shall become effective 1 year after the date of the enactment of this Act.
p.(None): (f) GUIDANCE.—Not later than 9 months after the date of the enactment of this Act, the Secretary shall
p.(None): issue a guidance to industry about submitting reports to the electronic portal estab- lished under section
p.(None): 417 of the Federal Food, Drug, and Cosmetic Act (as added by this section) and providing notifications
p.(None): to other persons in the supply chain of an article of food under such section 417.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 350f
p.(None): note.
p.(None):
p.(None):
p.(None): Deadline.
p.(None): 21 USC 350f
p.(None): note.
p.(None):
p.(None): (g) EFFECT.—Nothing in this title, or an amendment made by this title, shall be construed to alter the
p.(None): jurisdiction between the Secretaries of Agriculture and of Health and Human Services, under applicable
p.(None): statutes and regulations.
p.(None): SEC. 1006. ENHANCED AQUACULTURE AND SEAFOOD INSPECTION.
p.(None): (a) FINDINGS.—Congress finds the following:
p.(None): (1) In 2007, there has been an overwhelming increase in the volume of aquaculture and seafood that has
p.(None): been found to contain substances that are not approved for use in food in the United States.
p.(None): (2) As of May 2007, inspection programs are not able to satisfactorily accomplish the goals of ensuring
p.(None): the food safety of the United States.
p.(None): (3) To protect the health and safety of consumers in the United States, the ability of the Secretary to
p.(None): perform inspection functions must be enhanced.
p.(None): (b) HEIGHTENED INSPECTIONS.—The Secretary is authorized to enhance, as necessary, the inspection regime of the
p.(None): Food and Drug Administration for aquaculture and seafood, consistent with obliga- tions of the United States under
p.(None): international agreements and United States law.
p.(None): (c) REPORT TO CONGRESS.—Not later than 180 days after the date of the enactment of this Act, the
p.(None): Secretary shall submit to Congress a report that—
p.(None): (1) describes the specifics of the aquaculture and seafood inspection program;
p.(None): (2) describes the feasibility of developing a traceability system for all catfish and seafood products, both
p.(None): domestic and imported, for the purpose of identifying the processing plant of origin of such products; and
p.(None): (3) provides for an assessment of the risks associated with particular contaminants and banned substances.
p.(None): (d) PARTNERSHIPS WITH STATES.—Upon the request by any State, the Secretary may enter into partnership
p.(None): agreements, as soon as practicable after the request is made, to implement inspec- tion programs to Federal
p.(None): standards regarding the importation of aquaculture and seafood.
p.(None): SEC. 1007. CONSULTATION REGARDING GENETICALLY ENGINEERED SEAFOOD PRODUCTS.
p.(None): The Commissioner of Food and Drugs shall consult with the Assistant Administrator of the National Marine
p.(None): Fisheries Service
p.(None): 21 USC 2110
p.(None): note.
p.(None):
p.(None):
p.(None): 21 USC 2105.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Reports.
p.(None): 21 USC 2106.
p.(None):
p.(None):
p.(None): 121 STAT. 970 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): of the National Oceanic and Atmospheric Administration to produce a report on any environmental risks associated
p.(None): with genetically engineered seafood products, including the impact on wild fish stocks.
p.(None):
p.(None): 21 USC 2107.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2108.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2109.
p.(None): Website.
p.(None): SEC. 1008. SENSE OF CONGRESS.
p.(None): It is the sense of Congress that—
p.(None): (1) it is vital for Congress to provide the Food and Drug Administration with additional resources,
p.(None): authorities, and direction with respect to ensuring the safety of the food supply of the United States;
p.(None): (2) additional inspectors are required to improve the Food and Drug Administration’s ability to safeguard the food
p.(None): supply of the United States;
p.(None): (3) because of the increasing volume of international trade in food products the Secretary should make it a
p.(None): priority to enter into agreements with the trading partners of the United States with respect to food safety; and
p.(None): (4) Congress should work to develop a comprehensive response to the issue of food safety.
p.(None): SEC. 1009. ANNUAL REPORT TO CONGRESS.
p.(None): The Secretary shall, on an annual basis, submit to the Com- mittee on Health, Education, Labor, and
p.(None): Pensions and the Com- mittee on Appropriations of the Senate and the Committee on Energy and Commerce
p.(None): and the Committee on Appropriations of the House of Representatives a report that includes, with respect
p.(None): to the preceding 1-year period—
p.(None): (1) the number and amount of food products regulated by the Food and Drug Administration imported into the
p.(None): United States, aggregated by country and type of food;
p.(None): (2) a listing of the number of Food and Drug Administration inspectors of imported food products referenced in
p.(None): paragraph
p.(None): (1) and the number of Food and Drug Administration inspec- tions performed on such products; and
p.(None): (3) aggregated data on the findings of such inspections, including data related to violations of the Federal
p.(None): Food, Drug, and Cosmetic Act (21 U.S.C. 201 et seq.), and enforcement actions used to follow-up on such
p.(None): findings and violations.
p.(None): SEC. 1010. PUBLICATION OF ANNUAL REPORTS.
p.(None): (a) IN GENERAL.—The Commissioner of Food and Drugs shall annually submit to Congress and publish on the
p.(None): Internet Web site of the Food and Drug Administration, a report concerning the results of the
p.(None): Administration’s pesticide residue monitoring program, that includes—
p.(None): (1) information and analysis similar to that contained in the report entitled ‘‘Food and Drug
p.(None): Administration Pesticide Program Residue Monitoring 2003’’ as released in June of 2005;
p.(None): (2) based on an analysis of previous samples, an identifica- tion of products or countries (for imports) that
p.(None): require special attention and additional study based on a comparison with equivalent products manufactured,
p.(None): distributed, or sold in the United States (including details on the plans for such additional studies), including
p.(None): in the initial report (and subsequent reports as determined necessary) the results and analysis of the Gin-
p.(None): seng Dietary Supplements Special Survey as described on page
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 971
p.(None):
p.(None):
p.(None): 13 of the report entitled ‘‘Food and Drug Administration Pes- ticide Program Residue Monitoring 2003’’;
p.(None): (3) information on the relative number of interstate and imported shipments of each tested commodity that
p.(None): were sam- pled, including recommendations on whether sampling is statis- tically significant, provides confidence
p.(None): intervals or other related statistical information, and whether the number of samples should be increased and
p.(None): the details of any plans to provide for such increase; and
p.(None): (4) a description of whether certain commodities are being improperly imported as another commodity, including a
p.(None): descrip- tion of additional steps that are being planned to prevent such smuggling.
p.(None): (b) INITIAL REPORTS.—Annual reports under subsection (a) for fiscal years 2004 through 2006 may be
p.(None): combined into a single report, by not later than June 1, 2008, for purposes of publication under
p.(None): subsection (a). Thereafter such reports shall be completed by June 1 of each year for the data
p.(None): collected for the year that was 2-years prior to the year in which the report is published.
p.(None): (c) MEMORANDUM OF UNDERSTANDING.—The Commissioner of Food and Drugs, the Administrator of the Food Safety and
p.(None): Inspec- tion Service, the Department of Commerce, and the head of the Agricultural Marketing Service shall
p.(None): enter into a memorandum of understanding to permit inclusion of data in the reports under subsection (a)
p.(None): relating to testing carried out by the Food Safety and Inspection Service and the Agricultural Marketing
p.(None): Service on meat, poultry, eggs, and certain raw agricultural products, respec- tively.
p.(None): SEC. 1011. RULE OF CONSTRUCTION.
p.(None): Nothing in this title (or an amendment made by this title) shall be construed to affect—
p.(None): (1) the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (Public
p.(None): Law 103–417); or
p.(None): (2) the adverse event reporting system for dietary supple- ments created under the Dietary Supplement and
p.(None): Nonprescrip- tion Drug Consumer Protection Act (Public Law 109–462).
p.(None): TITLE XI—OTHER PROVISIONS
p.(None): Subtitle A—In General
p.(None): SEC. 1101. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC ARTICLES PUBLISHED BY FDA EMPLOYEES.
p.(None): Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.), as
p.(None): amended by section 701, is further amended by adding at the end the following:
p.(None): ‘‘SEC. 713. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC ARTICLES PUBLISHED BY FDA EMPLOYEES.
p.(None): ‘‘(a) DEFINITION.—In this section, the term ‘article’ means a paper, poster, abstract, book, book chapter,
p.(None): or other published writing.
p.(None): ‘‘(b) POLICIES.—The Secretary, through the Commissioner of Food and Drugs, shall establish and make
p.(None): publicly available clear
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2110.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379d–2.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public information.
p.(None):
p.(None):
p.(None): 121 STAT. 972 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): written policies to implement this section and govern the timely submission, review, clearance, and disclaimer
p.(None): requirements for arti- cles.
p.(None): ‘‘(c) TIMING OF SUBMISSION FOR REVIEW.—If an officer or
p.(None): employee, including a Staff Fellow and a contractor who performs staff work, of the Food and Drug
p.(None): Administration is directed by the policies established under subsection (b) to submit an article to the
p.(None): supervisor of such officer or employee, or to some other official of the Food and Drug Administration, for
p.(None): review and clear- ance before such officer or employee may seek to publish or present such an article at a
p.(None): conference, such officer or employee shall submit such article for such review and clearance not less
p.(None): than 30 days before submitting the article for publication or presentation. ‘‘(d) TIMING FOR REVIEW AND
p.(None): CLEARANCE.—The supervisor or other reviewing official shall review such article and provide written
p.(None): clearance, or written clearance on the condition of specified changes being made, to such officer or employee
p.(None): not later than 30 days after such officer or employee submitted such article for review. ‘‘(e) NON-TIMELY
p.(None): REVIEW.—If, 31 days after such submission under subsection (c), the supervisor or other reviewing
p.(None): official has not cleared or has not reviewed such article and provided written clearance, such officer or
p.(None): employee may consider such article not to have been cleared and may submit the article for publication
p.(None): or presentation with an appropriate disclaimer as specified in the
p.(None): policies established under subsection (b).
p.(None): ‘‘(f) EFFECT.—Nothing in this section shall be construed as affecting any restrictions on such publication
p.(None): or presentation pro- vided by other provisions of law.’’.
p.(None): SEC. 1102. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROP- ICAL DISEASES.
p.(None): Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is
p.(None): amended by adding at the end the following:
p.(None):
p.(None): 21 USC 360n.
p.(None): ‘‘SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROP- ICAL DISEASES.
p.(None): ‘‘(a) DEFINITIONS.—In this section:
p.(None): ‘‘(1) PRIORITY REVIEW.—The term ‘priority review’, with respect to a human drug application as defined in
p.(None): section 735(1), means review and action by the Secretary on such application not later than 6 months
p.(None): after receipt by the Sec- retary of such application, as described in the Manual of Policies and Procedures of the
p.(None): Food and Drug Administration and goals identified in the letters described in section 101(c) of the Food and Drug
p.(None): Administration Amendments Act of 2007.
p.(None): ‘‘(2) PRIORITY REVIEW VOUCHER.—The term ‘priority review voucher’ means a voucher issued by the Secretary to the
p.(None): sponsor of a tropical disease product application that entitles the holder of such voucher to priority review of
p.(None): a single human drug application submitted under section 505(b)(1) or section 351 of the Public Health
p.(None): Service Act after the date of approval of the tropical disease product application.
p.(None): ‘‘(3) TROPICAL DISEASE.—The term ‘tropical disease’ means any of the following:
p.(None): ‘‘(A) Tuberculosis. ‘‘(B) Malaria.
p.(None): ‘‘(C) Blinding trachoma.
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(D) Buruli Ulcer. ‘‘(E) Cholera.
p.(None): ‘‘(F) Dengue/dengue haemorrhagic fever. ‘‘(G) Dracunculiasis (guinea-worm disease). ‘‘(H) Fascioliasis.
p.(None): ‘‘(I) Human African trypanosomiasis. ‘‘(J) Leishmaniasis.
p.(None): ‘‘(K) Leprosy.
p.(None): ‘‘(L) Lymphatic filariasis. ‘‘(M) Onchocerciasis.
p.(None): ‘‘(N) Schistosomiasis.
p.(None): ‘‘(O) Soil transmitted helmithiasis. ‘‘(P) Yaws.
p.(None): 121 STAT. 973
p.(None): ‘‘(Q) Any other infectious disease for which there is no significant market in developed nations and
p.(None): that dis- proportionately affects poor and marginalized populations, designated by regulation by the Secretary.
p.(None): ‘‘(4) TROPICAL DISEASE PRODUCT APPLICATION.—The term
p.(None): ‘tropical disease product application’ means an application that—
p.(None): ‘‘(A) is a human drug application as defined in section 735(1)—
p.(None): ‘‘(i) for prevention or treatment of a tropical dis- ease; and
p.(None): ‘‘(ii) the Secretary deems eligible for priority review;
p.(None): ‘‘(B) is approved after the date of the enactment of the Food and Drug Administration Amendments Act of
p.(None): 2007, by the Secretary for use in the prevention, detection, or treatment of a tropical disease; and
p.(None): ‘‘(C) is for a human drug, no active ingredient (including any ester or salt of the active
p.(None): ingredient) of which has been approved in any other application under section 505(b)(1) or section 351 of the
p.(None): Public Health Service Act.
p.(None): ‘‘(b) PRIORITY REVIEW VOUCHER.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall award a priority review voucher to the sponsor of a tropical
p.(None): disease product application upon approval by the Secretary of such tropical disease product application.
p.(None): ‘‘(2) TRANSFERABILITY.—The sponsor of a tropical disease product that receives a priority review voucher under
p.(None): this sec- tion may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug
p.(None): for which an application under section 505(b)(1) or section 351 of the Public Health Service Act will be
p.(None): submitted after the date of the approval of the tropical disease product application.
p.(None): ‘‘(3) LIMITATION.—
p.(None): ‘‘(A) NO AWARD FOR PRIOR APPROVED APPLICATION.—
p.(None): A sponsor of a tropical disease product may not receive a priority review voucher under this section if the
p.(None): tropical disease product application was submitted to the Secretary prior to the date of the enactment of this section.
p.(None): ‘‘(B) ONE-YEAR WAITING PERIOD.—The Secretary shall issue a priority review voucher to the sponsor of a tropical
p.(None): disease product no earlier than the date that is 1 year
p.(None):
p.(None):
p.(None): 121 STAT. 974 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): after the date of the enactment of the Food and Drug Administration Amendments Act of 2007.
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Contracts. Study.
p.(None): ‘‘(4) NOTIFICATION.—The sponsor of a human drug applica- tion shall notify the Secretary not later than 365
p.(None): days prior to submission of the human drug application that is the subject of a priority review voucher of an intent
p.(None): to submit the human drug application, including the date on which the sponsor intends to submit the
p.(None): application. Such notification shall be a legally binding commitment to pay for the user fee to be
p.(None): assessed in accordance with this section.
p.(None): ‘‘(c) PRIORITY REVIEW USER FEE.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall establish a user fee program under which a sponsor of a human drug
p.(None): application that is the subject of a priority review voucher shall pay to the Secretary a fee determined
p.(None): under paragraph (2). Such fee shall be in addition to any fee required to be submitted by the sponsor
p.(None): under chapter VII.
p.(None): ‘‘(2) FEE AMOUNT.—The amount of the priority review user fee shall be determined each fiscal year by the
p.(None): Secretary and based on the average cost incurred by the agency in the review of a human drug application subject
p.(None): to priority review in the previous fiscal year.
p.(None): ‘‘(3) ANNUAL FEE SETTING.—The Secretary shall establish, before the beginning of each fiscal year
p.(None): beginning after Sep- tember 30, 2007, for that fiscal year, the amount of the priority review user fee.
p.(None): ‘‘(4) PAYMENT.—
p.(None): ‘‘(A) IN GENERAL.—The priority review user fee required by this subsection shall be due upon the submis-
p.(None): sion of a human drug application under section 505(b)(1) or section 351 of the Public Health Services Act for
p.(None): which the priority review voucher is used.
p.(None): ‘‘(B) COMPLETE APPLICATION.—An application described under subparagraph (A) for which the sponsor requests the
p.(None): use of a priority review voucher shall be considered incomplete if the fee required by this subsection
p.(None): and all other applicable user fees are not paid in accordance with the Secretary’s procedures for paying such fees.
p.(None): ‘‘(C) NO WAIVERS, EXEMPTIONS, REDUCTIONS, OR
p.(None): REFUNDS.—The Secretary may not grant a waiver, exemp- tion, reduction, or refund of any fees due and payable
p.(None): under this section.
p.(None): ‘‘(5) OFFSETTING COLLECTIONS.—Fees collected pursuant to this subsection for any fiscal year—
p.(None): ‘‘(A) shall be deposited and credited as offsetting collec- tions to the account providing appropriations to the
p.(None): Food and Drug Administration; and
p.(None): ‘‘(B) shall not be collected for any fiscal year except to the extent provided in advance in
p.(None): appropriation Acts.’’.
p.(None): SEC. 1103. IMPROVING GENETIC TEST SAFETY AND QUALITY.
p.(None): (a) REPORT.—If the Secretary’s Advisory Committee on Genetics, Health, and Society does not
p.(None): complete and submit the Regulatory Oversight of Genetic/Genomic Testing Report & Action Recommendations to
p.(None): the Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’) by July
p.(None): of 2008, the Secretary shall enter into a contract with the Institute of
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 975
p.(None):
p.(None):
p.(None): Medicine to conduct a study to assess the overall safety and quality of genetic tests and prepare a report that
p.(None): includes recommendations to improve Federal oversight and regulation of genetic tests. Such study shall take
p.(None): into consideration relevant reports by the Sec- retary’s Advisory Committee on Genetics, Health, and
p.(None): Society and other groups and shall be completed not later than 1 year after the date on which the Secretary
p.(None): entered into such contract.
p.(None): (b) RULE OF CONSTRUCTION.—Nothing in this section shall be construed as requiring Federal efforts with
p.(None): respect to regulatory oversight of genetic tests to cease or be limited or delayed pending completion of the
p.(None): report by the Secretary’s Advisory Committee on Genetics, Health, and Society or the Institute of Medicine.
p.(None): SEC. 1104. NIH TECHNICAL AMENDMENTS.
p.(None): The Public Health Service Act (42 U.S.C. 201 et seq.) is amended—
p.(None): (1) in section 319C–2(j)(3)(B), by striking ‘‘section 319C– 1(h)’’ and inserting ‘‘section 319C–1(i)’’;
p.(None): (2) in section 402(b)(4), by inserting ‘‘minority and other’’ after ‘‘reducing’’;
p.(None): (3) in section 403(a)(4)(C)(iv)(III), by inserting ‘‘and postdoctoral training funded through research
p.(None): grants’’ before the semicolon;
p.(None): (4) by designating the second section 403C (relating to the drug diethylstilbestrol) as section 403D; and
p.(None): (5) in section 403C(a)—
p.(None): (A) in the matter preceding paragraph (1)—
p.(None): (i) by inserting ‘‘graduate students supported by the National Institutes of Health’’ after ‘‘with respect
p.(None): to’’; and
p.(None): (ii) by deleting ‘‘each degree-granting program’’;
p.(None): (B) in paragraph (1), by inserting ‘‘such’’ after ‘‘percent- age of’’; and
p.(None): (C) in paragraph (2), by inserting ‘‘(not including any leaves of absence)’’ after ‘‘average time’’.
p.(None): SEC. 1105. SEVERABILITY CLAUSE.
p.(None): If any provision of this Act, an amendment made this Act, or the application of such provision or
p.(None): amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the
p.(None): amendments made by this Act, and the application of the provisions of such to any person or
p.(None): circumstances shall not be affected thereby.
p.(None): Subtitle B—Antibiotic Access and Innovation
p.(None): SEC. 1111. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE CON- CENTRATIONS OF ANTIMICROBIALS.
p.(None): (a) DEFINITION.—In this section, the term ‘‘clinically susceptible concentrations’’ means specific values which
p.(None): characterize bacteria as clinically susceptible, intermediate, or resistant to the drug (or drugs) tested.
p.(None): (b) IDENTIFICATION.—The Secretary of Health and Human Serv- ices (referred to in this section as the
p.(None): ‘‘Secretary’’), through the Commissioner of Food and Drugs, shall identify (where such
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 247d–3b.
p.(None):
p.(None): 42 USC 282.
p.(None):
p.(None): 42 USC 283.
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 283a–3.
p.(None): 42 USC 283a–2.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 301 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 247d–5a.
p.(None):
p.(None):
p.(None): 121 STAT. 976 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): information is reasonably available) and periodically update clini- cally susceptible concentrations.
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Appropriation authorization.
p.(None): (c) PUBLIC AVAILABILITY.—The Secretary, through the Commis- sioner of Food and Drugs, shall make such
p.(None): clinically susceptible concentrations publicly available, such as by posting on the Internet, not later than 30
p.(None): days after the date of identification and any update under this section.
p.(None): (d) EFFECT.—Nothing in this section shall be construed to restrict, in any manner, the prescribing of
p.(None): antibiotics by physicians, or to limit the practice of medicine, including for diseases such as Lyme and
p.(None): tick-borne diseases.
p.(None): SEC. 1112. ORPHAN ANTIBIOTIC DRUGS.
p.(None): (a) PUBLIC MEETING.—The Commissioner of Food and Drugs shall convene a public meeting regarding which
p.(None): serious and life threatening infectious diseases, such as diseases due to gram-nega- tive bacteria and other diseases
p.(None): due to antibiotic-resistant bacteria, potentially qualify for available grants and contracts under section 5(a) of the
p.(None): Orphan Drug Act (21 U.S.C. 360ee(a)) or other incentives for development.
p.(None): (b) GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF ORPHAN DRUGS.—Section 5(c) of the Orphan Drug Act (21
p.(None): U.S.C. 360ee(c)) is amended to read as follows:
p.(None): ‘‘(c) For grants and contracts under subsection (a), there is authorized to be appropriated $30,000,000
p.(None): for each of fiscal years 2008 through 2012.’’.
p.(None): SEC. 1113. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
p.(None): Section 505 of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 355), as amended by section 920, is further amended by adding at the end the following:
p.(None): ‘‘(u) CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.—
p.(None): ‘‘(1) IN GENERAL.—For purposes of subsections (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is submitted
p.(None): under subsection
p.(None): (b) for a non-racemic drug containing as an active ingredient (including any ester or salt of the
p.(None): active ingredient) a single enantiomer that is contained in a racemic drug approved in another application
p.(None): under subsection (b), the applicant may, in the application for such non-racemic drug, elect to have the
p.(None): single enantiomer not be considered the same active ingre- dient as that contained in the approved racemic
p.(None): drug, if— ‘‘(A)(i) the single enantiomer has not been previously
p.(None): approved except in the approved racemic drug; and
p.(None): ‘‘(ii) the application submitted under subsection (b) for such non-racemic drug—
p.(None): ‘‘(I) includes full reports of new clinical investiga- tions (other than bioavailability studies)—
p.(None): ‘‘(aa) necessary for the approval of the applica- tion under subsections (c) and (d); and
p.(None): ‘‘(bb) conducted or sponsored by the applicant;
p.(None): and
p.(None): ‘‘(II) does not rely on any investigations that are part of an application submitted under subsection
p.(None): (b) for approval of the approved racemic drug; and
p.(None): ‘‘(B) the application submitted under subsection (b) for such non-racemic drug is not submitted for
p.(None): approval of a condition of use—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 977
p.(None):
p.(None):
p.(None): ‘‘(i) in a therapeutic category in which the approved racemic drug has been approved; or
p.(None): ‘‘(ii) for which any other enantiomer of the racemic drug has been approved.
p.(None): ‘‘(2) LIMITATION.—
p.(None): ‘‘(A) NO APPROVAL IN CERTAIN THERAPEUTIC CAT-
p.(None): EGORIES.—Until the date that is 10 years after the date of approval of a non-racemic drug described in
p.(None): paragraph
p.(None): (1) and with respect to which the applicant has made the election provided for by such paragraph, the
p.(None): Secretary shall not approve such non-racemic drug for any condition of use in the therapeutic category in which
p.(None): the racemic drug has been approved.
p.(None): ‘‘(B) LABELING.—If applicable, the labeling of a non- racemic drug described in paragraph (1) and with
p.(None): respect to which the applicant has made the election provided for by such paragraph shall include a
p.(None): statement that the non-racemic drug is not approved, and has not been shown to be safe and effective, for any
p.(None): condition of use of the racemic drug.
p.(None): ‘‘(3) DEFINITION.—
p.(None): ‘‘(A) IN GENERAL.—For purposes of this subsection, the term ‘therapeutic category’ means a therapeutic category
p.(None): identified in the list developed by the United States Pharmacopeia pursuant to section
p.(None): 1860D–4(b)(3)(C)(ii) of the Social Security Act and as in effect on the date of the enactment of this
p.(None): subsection.
p.(None): ‘‘(B) PUBLICATION BY SECRETARY.—The Secretary shall publish the list described in subparagraph (A) and may
p.(None): amend such list by regulation.
p.(None): ‘‘(4) AVAILABILITY.—The election referred to in paragraph
p.(None): (1) may be made only in an application that is submitted to the Secretary after the date of the
p.(None): enactment of this sub- section and before October 1, 2012.’’.
p.(None): SEC. 1114. REPORT.
p.(None): Not later than January 1, 2012, the Comptroller General of the United States shall submit a report to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce
p.(None): of the House of Representatives that examines whether and how this subtitle has—
p.(None): (1) encouraged the development of new antibiotics and other drugs; and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 978 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): (2) prevented or delayed timely generic drug entry into the market.
p.(None): Approved September 27, 2007.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): LEGISLATIVE HISTORY—H.R. 3580:
p.(None): CONGRESSIONAL RECORD, Vol. 153 (2007):
p.(None): Sept. 19, considered and passed House. Sept. 20, considered and passed Senate.
...
Searching for indicator substance:
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p.(None): to which the drug or the biological product is added or applied and not to have independent biological
p.(None): or therapeutic effects on humans, and the use is in conformity with—
p.(None): ‘‘(A) a regulation issued under section 409 prescribing conditions of safe use in food;
p.(None): ‘‘(B) a regulation listing or affirming conditions under which the use of the drug or the biological
p.(None): product in food is generally recognized as safe;
p.(None): ‘‘(C) the conditions of use identified in a notification to the Secretary of a claim of exemption from the
p.(None): premarket approval requirements for food additives based on the noti- fier’s determination that the use of
p.(None): the drug or the biological product in food is generally recognized as safe, provided that the Secretary
p.(None): has not questioned the general recognition of safety determination in a letter to the noti- fier;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 334.
p.(None):
p.(None): 21 USC 381.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355e.
p.(None): Standards.
p.(None): ‘‘(D) a food contact substance notification that is effec- tive under section 409(h); or
p.(None): ‘‘(E) such drug or biological product had been marketed for smoking cessation prior to the date of the
p.(None): enactment of the Food and Drug Administration Amendments Act of 2007; or
p.(None): ‘‘(4) the drug is a new animal drug whose use is not unsafe under section 512.’’.
p.(None): (b) CONFORMING CHANGES.—The Federal Food, Drug, and Cos- metic Act (21 U.S.C. 301 et seq.) is amended—
p.(None): (1) in section 304(a)(1), by striking ‘‘section 404 or 505’’ and inserting ‘‘section 301(ll), 404, or 505’’;
p.(None): and
p.(None): (2) in section 801(a), by striking ‘‘is adulterated, mis- branded, or in violation of section
p.(None): 505,’’ and inserting ‘‘is adulterated, misbranded, or in violation of section 505, or prohibited from
p.(None): introduction or delivery for introduction into interstate commerce under section 301(ll),’’.
p.(None): SEC. 913. ASSURING PHARMACEUTICAL SAFETY.
p.(None): Chapter V of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 351 et seq.), as amended in section 403, is amended by inserting after section 505C the following:
p.(None): ‘‘SEC. 505D. PHARMACEUTICAL SECURITY.
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None): review the expertise of the individual and the financial disclo- sure report filed by the individual pursuant to
p.(None): the Ethics in Government Act of 1978 for each individual under consideration
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 901
p.(None):
p.(None): for the appointment, so as to reduce the likelihood that an appointed individual will later require a written
p.(None): determination as referred to in section 208(b)(1) of title 18, United States Code, a written certification
p.(None): as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in
p.(None): subsection (c)(2) of this section for service on the committee at a meeting of the committee.
p.(None): ‘‘(c) DISCLOSURES; PROHIBITIONS ON PARTICIPATION; WAIVERS.— ‘‘(1) DISCLOSURE OF FINANCIAL INTEREST.—Prior
p.(None): to a
p.(None): meeting of an advisory committee regarding a ‘particular matter’ (as that term is used in section 208 of
p.(None): title 18, United States Code), each member of the committee who is a full- time Government employee or
p.(None): special Government employee shall disclose to the Secretary financial interests in accordance with subsection (b) of
p.(None): such section 208.
p.(None): ‘‘(2) PROHIBITIONS AND WAIVERS ON PARTICIPATION.—
p.(None): ‘‘(A) IN GENERAL.—Except as provided under subpara- graph (B), a member of an advisory committee may not
p.(None): participate with respect to a particular matter considered in an advisory committee meeting if such
p.(None): member (or an immediate family member of such member) has a financial interest that could be affected by the
p.(None): advice given to the Secretary with respect to such matter, excluding interests exempted in regulations issued
p.(None): by the Director of the Office of Government Ethics as too remote or inconsequential to affect the integrity
p.(None): of the services of the Government officers or employees to which such regulations apply.
p.(None): ‘‘(B) WAIVER.—If the Secretary determines it necessary to afford the advisory committee essential expertise, the
p.(None): Secretary may grant a waiver of the prohibition in subpara- graph (A) to permit a member described in such
p.(None): subpara- graph to—
p.(None): ‘‘(i) participate as a non-voting member with respect to a particular matter considered in a com-
p.(None): mittee meeting; or
p.(None): ‘‘(ii) participate as a voting member with respect to a particular matter considered in a
p.(None): committee meeting.
p.(None): ‘‘(C) LIMITATION ON WAIVERS AND OTHER EXCEPTIONS.—
p.(None): ‘‘(i) DEFINITION.—For purposes of this subpara- graph, the term ‘exception’ means each of the following with
p.(None): respect to members of advisory committees:
p.(None): ‘‘(I) A waiver under section 505(n)(4) (as in effect on the day before the date of the enactment of the Food and
p.(None): Drug Administration Amendments Act of 2007).
p.(None): ‘‘(II) A written determination under section 208(b) of title 18, United States Code.
p.(None): ‘‘(III) A written certification under section 208(b)(3) of such title.
p.(None): ‘‘(ii) DETERMINATION OF TOTAL NUMBER OF MEM- BERS SLOTS AND MEMBER EXCEPTIONS DURING FISCAL
...
Health / Physically Disabled
Searching for indicator illness:
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p.(None): increasing the amount of food that it imports such that—
p.(None): (A) from 2003 to 2007, the value of food imports has increased from $45,600,000,000 to $64,000,000,000; and
p.(None): (B) imported food accounts for 13 percent of the average American diet including 31 percent of fruits, juices,
p.(None): and nuts, 9.5 percent of red meat, and 78.6 percent of fish and shellfish; and
p.(None): (5) the number of full-time equivalent Food and Drug Administration employees conducting inspections has
p.(None): decreased from 2003 to 2007.
p.(None): SEC. 1002. ENSURING THE SAFETY OF PET FOOD.
p.(None): (a) PROCESSING AND INGREDIENT STANDARDS.—Not later than 2 years after the date of the enactment of this
p.(None): Act, the Secretary of Health and Human Services (referred to in this title as the ‘‘Secretary’’), in
p.(None): consultation with the Association of American Feed Control Officials and other relevant stakeholder groups,
p.(None): including veterinary medical associations, animal health organizations, and pet food manufacturers, shall by
p.(None): regulation establish—
p.(None): (1) ingredient standards and definitions with respect to pet food;
p.(None): (2) processing standards for pet food; and
p.(None): (3) updated standards for the labeling of pet food that include nutritional and ingredient information.
p.(None): (b) EARLY WARNING SURVEILLANCE SYSTEMS AND NOTIFICATION DURING PET FOOD RECALLS.—Not later than 1 year after the
p.(None): date of the enactment of this Act, the Secretary shall establish an early warning and surveillance
p.(None): system to identify adulteration of the pet food supply and outbreaks of illness associated with pet food.
p.(None): In establishing such system, the Secretary shall—
p.(None): (1) consider using surveillance and monitoring mechanisms similar to, or in coordination with, those used to monitor
p.(None): human or animal health, such as the Foodborne Diseases Active Surveillance Network (FoodNet) and
p.(None): PulseNet of the Centers for Disease Control and Prevention, the Food Emergency Response Network of
p.(None): the Food and Drug Administration and the Department of Agriculture, and the National Animal Health Laboratory
p.(None): Network of the Department of Agriculture;
p.(None): (2) consult with relevant professional associations and pri- vate sector veterinary hospitals;
p.(None): (3) work with the National Companion Animal Surveillance Program, the Health Alert Network, or other
p.(None): notification net- works as appropriate to inform veterinarians and relevant stakeholders during any recall of
p.(None): pet food; and
p.(None): (4) use such information and conduct such other activities as the Secretary deems appropriate.
p.(None): SEC. 1003. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS DURING A RECALL.
p.(None): The Secretary shall, during an ongoing recall of human or pet food regulated by the Secretary—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2102.
p.(None): Deadline. Regulations.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None): ‘‘(2) STATES AND LOCALITIES.—In implementing this section, the Secretary shall work with the State and local public
p.(None): health officials to share information and coordinate regulatory efforts, in order to—
p.(None): ‘‘(A) help to ensure coverage of the safety of the food supply chain, including those food establishments
p.(None): regulated by the States and localities that are not required to register under section 415; and
p.(None): ‘‘(B) reduce duplicative regulatory efforts.
p.(None): ‘‘(g) MAINTENANCE AND INSPECTION OF RECORDS.—The respon-
p.(None): sible party shall maintain records related to each report received, notification made, and report
p.(None): submitted to the Food and Drug Administration under this section for 2 years. A responsible party shall,
p.(None): at the request of the Secretary, permit inspection of such records as provided for section 414.
p.(None):
p.(None): Applicability.
p.(None): ‘‘(h) REQUEST FOR INFORMATION.—Except as provided by section 415(a)(4), section 552 of title 5, United States
p.(None): Code, shall apply to any request for information regarding a record in the Reportable Food Registry.
p.(None): ‘‘(i) SAFETY REPORT.—A report or notification under subsection
p.(None): (d) shall be considered to be a safety report under section 756 and may be accompanied by a statement,
p.(None): which shall be part of any report released for public disclosure, that denies that the report or the
p.(None): notification constitutes an admission that the product involved caused or contributed to a death, serious injury, or
p.(None): serious illness.
p.(None): ‘‘(j) ADMISSION.—A report or notification under this section shall not be considered an admission that the
p.(None): article of food involved is adulterated or caused or contributed to a death, serious injury, or serious
p.(None): illness.
p.(None): ‘‘(k) HOMELAND SECURITY NOTIFICATION.—If, after receiving a report under subsection (d), the Secretary
p.(None): believes such food may have been deliberately adulterated, the Secretary shall immediately notify the Secretary
p.(None): of Homeland Security. The Secretary shall make relevant information from the Reportable Food Registry avail- able
p.(None): to the Secretary of Homeland Security.’’.
p.(None): (c) DEFINITION.—Section 201(ff) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)) is amended by
p.(None): striking ‘‘section 201(g)’’ and inserting ‘‘sections 201(g) and 417’’.
p.(None): (d) PROHIBITED ACTS.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by
p.(None): section 912, is further amended—
p.(None): (1) in subsection (e), by—
p.(None): (A) striking ‘‘414,’’ and inserting ‘‘414, 417(g),’’; and
p.(None): (B) striking ‘‘414(b)’’ and inserting ‘‘414(b), 417’’; and
p.(None): (2) by adding at the end the following:
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 969
p.(None):
p.(None):
p.(None): ‘‘(mm) The failure to submit a report or provide a notification required under section 417(d).
p.(None): ‘‘(nn) The falsification of a report or notification required under section 417(d).’’.
p.(None): (e) EFFECTIVE DATE.—The requirements of section 417(d) of the Federal Food, Drug, and Cosmetic Act, as added by
p.(None): subsection (a), shall become effective 1 year after the date of the enactment of this Act.
p.(None): (f) GUIDANCE.—Not later than 9 months after the date of the enactment of this Act, the Secretary shall
...
Health / Pregnant
Searching for indicator pregnant:
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p.(None): identification and analysis methods under subpara- graph (B), as required under clause (i), the Secretary
p.(None): may, on a temporary or permanent basis, implement systems or products developed by private entities.
p.(None): ‘‘(iv) COMPLEMENTARY APPROACHES.—To the extent
p.(None): the active postmarket risk identification and analysis system under this subsection is not sufficient to gather
p.(None): data and information relevant to a priority drug safety question, the Secretary shall develop, support, and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Reports.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 946 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): participate in complementary approaches to gather and analyze such data and information, including—
p.(None): ‘‘(I) approaches that are complementary with respect to assessing the safety of use of a drug in domestic
p.(None): populations not included, or underrep- resented, in the trials used to approve the drug (such as older
p.(None): people, people with comorbidities, pregnant women, or children); and
p.(None): ‘‘(II) existing approaches such as the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink or
p.(None): successor databases.
p.(None): ‘‘(v) AUTHORITY FOR CONTRACTS.—The Secretary
p.(None): may enter into contracts with public and private enti- ties to fulfill the requirements of this subparagraph.
p.(None): ‘‘(4) ADVANCED ANALYSIS OF DRUG SAFETY DATA.—
p.(None): ‘‘(A) PURPOSE.—The Secretary shall establish collabora- tions with public, academic, and private entities, which
p.(None): may include the Centers for Education and Research on Therapeutics under section 912 of the Public Health
p.(None): Service Act, to provide for advanced analysis of drug safety data described in paragraph (3)(C) and other
p.(None): information that is publicly available or is provided by the Secretary, in order to—
p.(None): ‘‘(i) improve the quality and efficiency of postmarket drug safety risk-benefit analysis;
p.(None): ‘‘(ii) provide the Secretary with routine access to outside expertise to study advanced drug safety ques-
p.(None): tions; and
p.(None): ‘‘(iii) enhance the ability of the Secretary to make timely assessments based on drug safety data.
...
p.(None): (o)(3).
p.(None): ‘‘(D) PROCEDURES FOR THE DEVELOPMENT OF DRUG SAFETY COLLABORATIONS.—
p.(None):
p.(None): Deadline.
p.(None): ‘‘(i) IN GENERAL.—Not later than 180 days after the date of the establishment of the active postmarket risk
p.(None): identification and analysis system under this sub- section, the Secretary shall establish and implement
p.(None): procedures under which the Secretary may routinely contract with one or more qualified entities to—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 947
p.(None):
p.(None):
p.(None): ‘‘(I) classify, analyze, or aggregate data described in paragraph (3)(C) and information that is
p.(None): publicly available or is provided by the Sec- retary;
p.(None): ‘‘(II) allow for prompt investigation of priority drug safety questions, including—
p.(None): ‘‘(aa) unresolved safety questions for drugs or classes of drugs; and
p.(None): ‘‘(bb) for a newly-approved drugs, safety signals from clinical trials used to approve the drug and other
p.(None): preapproval trials; rare, serious drug side effects; and the safety of use in domestic populations not
p.(None): included, or underrepresented, in the trials used to approve the drug (such as older people, people with
p.(None): comorbidities, pregnant women, or children); ‘‘(III) perform advanced research and analysis
p.(None): on identified drug safety risks;
p.(None): ‘‘(IV) focus postapproval studies and clinical trials under subsection (o)(3) more effectively on cases for
p.(None): which reports under paragraph (1) and other safety signal detection is not sufficient to resolve whether
p.(None): there is an elevated risk of a serious adverse event associated with the use of a drug; and
p.(None): ‘‘(V) carry out other activities as the Secretary deems necessary to carry out the purposes of this paragraph.
p.(None): ‘‘(ii) REQUEST FOR SPECIFIC METHODOLOGY.—The
p.(None): procedures described in clause (i) shall permit the Sec- retary to request that a specific methodology be used
p.(None): by the qualified entity. The qualified entity shall work with the Secretary to finalize the methodology to be
p.(None): used.
p.(None): ‘‘(E) USE OF ANALYSES.—The Secretary shall provide the analyses described in this paragraph, including
p.(None): the methods and results of such analyses, about a drug to the sponsor or sponsors of such drug.
p.(None): ‘‘(F) QUALIFIED ENTITIES.—
p.(None): ‘‘(i) IN GENERAL.—The Secretary shall enter into contracts with a sufficient number of qualified entities to
p.(None): develop and provide information to the Secretary in a timely manner.
...
Health / patients in emergency situations
Searching for indicator emergencies:
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p.(None): modify elements under this subsection for 1
p.(None): or more drugs as appropriate.
p.(None): ‘‘(6) ADDITIONAL MECHANISMS TO ASSURE ACCESS.—The
p.(None): mechanisms under section 561 to provide for expanded access for patients with serious or life-threatening
p.(None): diseases or condi- tions may be used to provide access for patients with a serious or life-threatening disease or
p.(None): condition, the treatment of which is not an approved use for the drug, to a drug that is subject to
p.(None): elements to assure safe use under this subsection. The Sec- retary shall promulgate regulations for how a
p.(None): physician may provide the drug under the mechanisms of section 561.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Regulations.
p.(None):
p.(None):
p.(None): 121 STAT. 932 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): ‘‘(7) WAIVER IN PUBLIC HEALTH EMERGENCIES.—The Sec-
p.(None): retary may waive any requirement of this subsection during the period described in section 319(a) of the
p.(None): Public Health Service Act with respect to a qualified countermeasure described under section
p.(None): 319F–1(a)(2) of such Act, to which a requirement under this subsection has been applied, if the Secretary
p.(None): has—
p.(None): ‘‘(A) declared a public health emergency under such section 319; and
p.(None): ‘‘(B) determined that such waiver is required to miti- gate the effects of, or reduce the severity of,
p.(None): such public health emergency.
p.(None): ‘‘(8) LIMITATION.—No holder of an approved covered application shall use any element to assure safe
p.(None): use required by the Secretary under this subsection to block or delay approval of an application
p.(None): under section 505(b)(2) or (j) or to prevent application of such element under subsection (i)(1)(B) to a drug
p.(None): that is the subject of an abbreviated new drug application.
p.(None): ‘‘(g) ASSESSMENT AND MODIFICATION OF APPROVED STRATEGY.—
p.(None): ‘‘(1) VOLUNTARY ASSESSMENTS.—After the approval of a risk evaluation and mitigation strategy under
p.(None): subsection (a), the responsible person involved may, subject to paragraph (2), submit to the Secretary an assessment
p.(None): of, and propose a modi- fication to, the approved strategy for the drug involved at any time.
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): Sec. 915. Postmarket drug safety information for patients and providers. Sec. 916. Action package for approval.
p.(None): Sec. 917. Risk communication.
p.(None): Sec. 918. Referral to advisory committee.
p.(None): Sec. 919. Response to the institute of medicine. Sec. 920. Database for authorized generic drugs.
p.(None): Sec. 921. Adverse drug reaction reports and postmarket safety.
p.(None): TITLE X—FOOD SAFETY
p.(None): Sec. 1001. Findings.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 825
p.(None):
p.(None):
p.(None): Sec. 1002. Ensuring the safety of pet food.
p.(None): Sec. 1003. Ensuring efficient and effective communications during a recall. Sec. 1004. State and Federal
p.(None): Cooperation.
p.(None): Sec. 1005. Reportable Food Registry.
p.(None): Sec. 1006. Enhanced aquaculture and seafood inspection.
p.(None): Sec. 1007. Consultation regarding genetically engineered seafood products. Sec. 1008. Sense of Congress.
p.(None): Sec. 1009. Annual report to Congress. Sec. 1010. Publication of annual reports. Sec. 1011. Rule of construction.
p.(None): TITLE XI—OTHER PROVISIONS
p.(None): Subtitle A—In General
p.(None): Sec. 1101. Policy on the review and clearance of scientific articles published by FDA employees.
p.(None): Sec. 1102. Priority review to encourage treatments for tropical diseases. Sec. 1103. Improving genetic test safety
p.(None): and quality.
p.(None): Sec. 1104. NIH Technical amendments. Sec. 1105. Severability clause.
p.(None): Subtitle B—Antibiotic Access and Innovation
p.(None): Sec. 1111. Identification of clinically susceptible concentrations of antimicrobials. Sec. 1112. Orphan antibiotic
p.(None): drugs.
p.(None): Sec. 1113. Exclusivity of certain drugs containing single enantiomers. Sec. 1114. Report.
p.(None):
p.(None): TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
p.(None): SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING.
p.(None): (a) SHORT TITLE.—This title may be cited as the ‘‘Prescription Drug User Fee Amendments of 2007’’.
p.(None): (b) REFERENCES IN TITLE.—Except as otherwise specified, amendments made by this title to a section
p.(None): or other provision of law are amendments to such section or other provision of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 301 et seq.).
p.(None): (c) FINDING.—The Congress finds that the fees authorized by the amendments made in this title will be
p.(None): dedicated toward expe- diting the drug development process and the process for the review of human drug
p.(None): applications, including postmarket drug safety activities, as set forth in the goals identified for
p.(None): purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the
...
p.(None): Prescription Drug User Fee Amendments of 2007.
p.(None):
p.(None):
p.(None): 21 USC 301 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379g
p.(None): note.
p.(None):
p.(None):
p.(None): 121 STAT. 826 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): (D) in the matter following subparagraph (B), as so redesignated, by striking ‘‘subparagraph (C)’’ and
p.(None): inserting ‘‘subparagraph (B)’’;
p.(None): (3) in paragraph (3)(C)—
p.(None): (A) by striking ‘‘505(j)(7)(A)’’ and inserting ‘‘505(j)(7)(A) (not including the discontinued section of such
p.(None): list)’’; and
p.(None): (B) by inserting before the period ‘‘(not including the discontinued section of such list)’’;
p.(None): (4) in paragraph (4), by inserting before the period at the end the following: ‘‘(such as capsules, tablets,
p.(None): or lyophilized products before reconstitution)’’;
p.(None): (5) by amending paragraph (6)(F) to read as follows:
p.(None): ‘‘(F) Postmarket safety activities with respect to drugs approved under human drug applications or supplements,
p.(None): including the following activities:
p.(None): ‘‘(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse
p.(None): event reports.
p.(None): ‘‘(ii) Developing and using improved adverse-event data-collection systems, including information tech- nology
p.(None): systems.
p.(None): ‘‘(iii) Developing and using improved analytical tools to assess potential safety problems, including access
p.(None): to external data bases.
p.(None): ‘‘(iv) Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and
p.(None): labeling changes) and section 505(p) (relating to risk evaluation and mitigation strategies).
p.(None): ‘‘(v) Carrying out section 505(k)(5) (relating to adverse event reports and postmarket safety activi-
p.(None): ties).’’;
p.(None): (6) in paragraph (8)—
p.(None): (A) by striking ‘‘April of the preceding fiscal year’’ and inserting ‘‘October of the preceding fiscal
p.(None): year’’; and
p.(None): (B) by striking ‘‘April 1997’’ and inserting ‘‘October 1996’’;
p.(None): (7) by redesignating paragraph (9) as paragraph (11); and
p.(None): (8) by inserting after paragraph (8) the following para- graphs:
p.(None): ‘‘(9) The term ‘person’ includes an affiliate thereof.
p.(None): ‘‘(10) The term ‘active’, with respect to a commercial inves- tigational new drug application, means such an
p.(None): application to which information was submitted during the relevant period.’’.
p.(None): SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.
p.(None): (a) TYPES OF FEES.—Section 736(a) (21 U.S.C. 379h(a)) is amended—
p.(None): (1) in the matter preceding paragraph (1), by striking ‘‘2003’’ and inserting ‘‘2008’’;
p.(None): (2) in paragraph (1)—
p.(None): (A) in subparagraph (D)—
p.(None): (i) in the heading, by inserting ‘‘OR WITHDRAWN BEFORE FILING’’ after ‘‘REFUSED FOR FILING’’; and
p.(None): (ii) by inserting before the period at the end the following: ‘‘or withdrawn without a waiver
p.(None): before filing’’;
...
p.(None): Commerce of the House of Representa- tives a report on the impact of allowing persons granted an exemp- tion
p.(None): under section 520(m)(2) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C. 360j(m)(2)) with
p.(None): respect to a device to profit from such device pursuant to section 520(m)(6) of such Act (21
p.(None): U.S.C. 360j(m)(6)) (as amended by subsection (a)), including—
p.(None): (1) an assessment of whether such section 520(m)(6) (as amended by subsection (a)) has increased the
p.(None): availability of pediatric devices for conditions that occur in small numbers of children, including any
p.(None): increase or decrease in the number of—
p.(None): (A) exemptions granted under such section 520(m)(2) for pediatric devices; and
p.(None): (B) applications approved under section 515 of such Act (21 U.S.C. 360e) for devices intended to treat,
p.(None): diagnose, or cure conditions that occur in pediatric patients or for devices labeled for use in a pediatric
p.(None): population;
p.(None): (2) the conditions or diseases the pediatric devices were intended to treat or diagnose and the
p.(None): estimated size of the pediatric patient population for each condition or disease;
p.(None): (3) the costs of purchasing pediatric devices, based on a representative sampling of children’s hospitals;
p.(None): (4) the extent to which the costs of such devices are covered by health insurance;
p.(None): (5) the impact, if any, of allowing profit on access to such devices for patients;
p.(None): (6) the profits made by manufacturers for each device that receives an exemption;
p.(None): (7) an estimate of the extent of the use of the pediatric devices by both adults and pediatric populations
p.(None): for a condition or disease other than the condition or disease on the label of such devices;
p.(None): (8) recommendations of the Comptroller General of the United States regarding the effectiveness of
p.(None): such section 520(m)(6) (as amended by subsection (a)) and whether any modifications to such section
p.(None): 520(m)(6) (as amended by sub- section (a)) should be made;
p.(None): (9) existing obstacles to pediatric device development; and
p.(None): (10) an evaluation of the demonstration grants described in section 305, which shall include an evaluation of
p.(None): the number of pediatric medical devices—
p.(None): (A) that have been or are being studied in children;
p.(None):
p.(None): and
p.(None): (B) that have been submitted to the Food and Drug
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): 21 USC 360j
p.(None): note.
p.(None): Administration for approval, clearance, or review under such section 520(m) (as amended by this Act) and
p.(None): any regulatory actions taken.
p.(None): (c) GUIDANCE.—Not later than 180 days after the date of the enactment of this Act, the Commissioner of
p.(None): Food and Drugs shall issue guidance for institutional review committees on how to evaluate requests
p.(None): for approval for devices for which a humanitarian
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 863
p.(None):
p.(None):
...
p.(None): under section 402(b)(23) of the Public Health Service Act, as added by section 304(a) of this Act; and
p.(None): (B) provide to the National Institutes of Health any identified pediatric device needs that the consortium
p.(None): lacks sufficient capacity to address or those needs in which the consortium has been unable to stimulate
p.(None): manufacturer interest.
p.(None): (2) FOOD AND DRUG ADMINISTRATION.—Each consortium that receives a grant or contract under this section shall
p.(None): coordi- nate with the Commissioner of Food and Drugs and device companies to facilitate the application for
p.(None): approval or clearance of devices labeled for pediatric use.
p.(None):
p.(None): Reports.
p.(None): (3) EFFECTIVENESS AND OUTCOMES.—Each consortium that
p.(None): receives a grant or contract under this section shall annually report to the Secretary of Health and
p.(None): Human Services on the status of pediatric device development, production, and distribution that has been
p.(None): facilitated by the consortium.
p.(None): (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.(None): $6,000,000 for each of fiscal years 2008 through 2012.
p.(None): SEC. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND PEDIATRIC ADVISORY COMMITTEE.
p.(None): (a) OFFICE OF PEDIATRIC THERAPEUTICS.—Section 6(b) of the Best Pharmaceuticals for Children Act (21
p.(None): U.S.C. 393a(b)) is amended by inserting ‘‘, including increasing pediatric access to medical devices’’
p.(None): after ‘‘pediatric issues’’.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 865
p.(None):
p.(None): (b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C.
p.(None): 284m note) is amended—
p.(None): (1) in subsection (a), by inserting ‘‘(including drugs and biological products) and medical devices’’
p.(None): after ‘‘therapeutics’’; and
p.(None): (2) in subsection (b)—
p.(None): (A) in paragraph (1), by inserting ‘‘(including drugs and biological products) and medical devices’’ after
p.(None): ‘‘thera- peutics’’; and
p.(None): (B) in paragraph (2)—
p.(None): (i) in subparagraph (A), by striking ‘‘and 505B’’ and inserting ‘‘505B, 510(k), 515, and 520(m)’’;
p.(None): (ii) by striking subparagraph (B) and inserting the following:
p.(None): ‘‘(B) identification of research priorities related to therapeutics (including drugs and biological
p.(None): products) and medical devices for pediatric populations and the need for additional diagnostics and treatments
p.(None): for specific pediatric diseases or conditions;’’; and
p.(None): (iii) in subparagraph (C), by inserting ‘‘(including drugs and biological products) and medical devices’’
p.(None): after ‘‘therapeutics’’.
p.(None): SEC. 307. POSTMARKET SURVEILLANCE.
p.(None): Section 522 of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 360l) is amended—
p.(None): (1) by amending the section heading and designation to read as follows:
p.(None): ‘‘SEC. 522. POSTMARKET SURVEILLANCE.’’;
p.(None): (2) by striking subsection (a) and inserting the following: ‘‘(a) POSTMARKET SURVEILLANCE.—
...
p.(None): protocol or was terminated.
p.(None): ‘‘(vi) DEVICE.—The term ‘device’ means a device as defined in section 201(h) of the Federal Food, Drug, and
p.(None): Cosmetic Act.
p.(None): ‘‘(vii) DRUG.—The term ‘drug’ means a drug as defined in section 201(g) of the Federal Food, Drug, and
p.(None): Cosmetic Act or a biological product as defined in section 351 of this Act.
p.(None): ‘‘(viii) ONGOING.—The term ‘ongoing’ means, with respect to a clinical trial of a drug or a device and
p.(None): to a date, that—
p.(None): ‘‘(I) 1 or more patients is enrolled in the clin- ical trial; and
p.(None): ‘‘(II) the date is before the completion date of the clinical trial.
p.(None): ‘‘(ix) RESPONSIBLE PARTY.—The term ‘responsible party’, with respect to a clinical trial of a drug or
p.(None): device, means—
p.(None): ‘‘(I) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regula- tions (or any
p.(None): successor regulation)); or
p.(None): ‘‘(II) the principal investigator of such clinical trial if so designated by a sponsor, grantee, con- tractor,
p.(None): or awardee, so long as the principal inves- tigator is responsible for conducting the trial, has access to and control
p.(None): over the data from the clinical trial, has the right to publish the results of the trial, and has the ability
p.(None): to meet all of the require- ments under this subsection for the submission of clinical trial information.
p.(None): ‘‘(B) REQUIREMENT.—The Secretary shall develop a mechanism by which the responsible party for
p.(None): each applicable clinical trial shall submit the identity and con- tact information of such responsible party to
p.(None): the Secretary at the time of submission of clinical trial information under paragraph (2).
p.(None): ‘‘(2) EXPANSION OF CLINICAL TRIAL REGISTRY DATA BANK WITH RESPECT TO CLINICAL TRIAL INFORMATION.—
p.(None): ‘‘(A) IN GENERAL.—
p.(None): ‘‘(i) EXPANSION OF DATA BANK.—To enhance patient enrollment and provide a mechanism to track subse- quent
p.(None): progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accord-
p.(None): ance with this subsection, the clinical trials registry of the data bank described under subsection
p.(None): (i)(1) (referred to in this subsection as the ‘registry data bank’). The Director of NIH shall ensure that the
p.(None): reg- istry data bank is made publicly available through the Internet.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None):
p.(None): ‘‘(ii) CONTENT.—The clinical trial information required to be submitted under this paragraph for an
p.(None): applicable clinical trial shall include—
p.(None): ‘‘(I) descriptive information, including—
p.(None): ‘‘(aa) a brief title, intended for the lay public;
p.(None): ‘‘(bb) a brief summary, intended for the lay public;
p.(None): ‘‘(cc) the primary purpose; ‘‘(dd) the study design;
p.(None): ‘‘(ee) for an applicable drug clinical trial, the study phase;
p.(None): ‘‘(ff) study type;
p.(None): ‘‘(gg) the primary disease or condition being studied, or the focus of the study;
p.(None): ‘‘(hh) the intervention name and interven- tion type;
p.(None): ‘‘(ii) the study start date;
p.(None): ‘‘(jj) the expected completion date;
p.(None): ‘‘(kk) the target number of subjects; and ‘‘(ll) outcomes, including primary and sec-
p.(None): ondary outcome measures;
p.(None): ‘‘(II) recruitment information, including— ‘‘(aa) eligibility criteria;
p.(None): ‘‘(bb) gender;
p.(None): ‘‘(cc) age limits;
p.(None): ‘‘(dd) whether the trial accepts healthy vol- unteers;
p.(None): ‘‘(ee) overall recruitment status; ‘‘(ff) individual site status; and
p.(None): ‘‘(gg) in the case of an applicable drug clinical trial, if the drug is not approved under section 505 of the
p.(None): Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, specify whether or not
p.(None): there is expanded access to the drug under section 561 of the Federal Food, Drug, and Cosmetic Act for those
p.(None): who do not qualify for enrollment in the clinical trial and how to obtain informa- tion about such access;
p.(None): ‘‘(III) location and contact information, including—
p.(None): ‘‘(aa) the name of the sponsor;
p.(None): ‘‘(bb) the responsible party, by official title;
p.(None):
p.(None): and
p.(None): ‘‘(cc) the facility name and facility contact
p.(None): information (including the city, State, and zip code for each clinical trial location, or a toll- free number
p.(None): through which such location information may be accessed); and
p.(None): ‘‘(IV) administrative data (which the Secretary may make publicly available as necessary), including—
p.(None): ‘‘(aa) the unique protocol identification number;
p.(None): ‘‘(bb) other protocol identification num- bers, if any; and
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 907
p.(None):
p.(None):
p.(None): ‘‘(cc) the Food and Drug Administration IND/IDE protocol number and the record verification date.
p.(None): ‘‘(iii) MODIFICATIONS.—The Secretary may by regu- lation modify the requirements for clinical trial
p.(None): information under this paragraph, if the Secretary pro- vides a rationale for why such a modification improves and
p.(None): does not reduce such clinical trial information. ‘‘(B) FORMAT AND STRUCTURE.—
p.(None): ‘‘(i) SEARCHABLE CATEGORIES.—The Director of NIH shall ensure that the public may, in addition to
p.(None): keyword searching, search the entries in the registry data bank by 1 or more of the following criteria:
p.(None): ‘‘(I) The disease or condition being studied in the clinical trial, using Medical Subject Headers (MeSH)
p.(None): descriptors.
...
p.(None): the clinical trial to describe the patients who partici- pated in the clinical trial, including the
p.(None): number of patients who dropped out of the clinical trial and the number of patients excluded from the
p.(None): analysis, if any. ‘‘(ii) PRIMARY AND SECONDARY OUTCOMES.—The
p.(None): primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for
p.(None): each of the primary and secondary outcome meas- ures for each arm of the clinical trial, including the
p.(None): results of scientifically appropriate tests of the statis- tical significance of such outcome measures.
p.(None): ‘‘(iii) POINT OF CONTACT.—A point of contact for scientific information about the clinical trial results.
p.(None): ‘‘(iv) CERTAIN AGREEMENTS.—Whether there exists
p.(None): an agreement (other than an agreement solely to comply with applicable provisions of law protecting
p.(None): the privacy of participants) between the sponsor or its agent and the principal investigator (unless the
p.(None): sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal
p.(None): investigator, after the completion date of the trial, to discuss the results of the trial at a scientific
p.(None): meeting or any other public or private forum, or to publish in a scientific or academic journal
p.(None): information con- cerning the results of the trial.
p.(None): ‘‘(D) EXPANDED REGISTRY AND RESULTS DATA BANK.—
p.(None):
p.(None): Deadline.
p.(None): ‘‘(i) EXPANSION BY RULEMAKING.—To provide more complete results information and to enhance patient access to
p.(None): and understanding of the results of clinical trials, not later than 3 years after the date of the
p.(None): enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall by regu- lation
p.(None): expand the registry and results data bank as provided under this subparagraph.
p.(None): ‘‘(ii) CLINICAL TRIALS.—
p.(None): ‘‘(I) APPROVED PRODUCTS.—The regulations under this subparagraph shall require the inclu- sion of the
p.(None): results information described in clause
p.(None): (iii) for—
p.(None): ‘‘(aa) each applicable drug clinical trial for a drug that is approved under section 505 of the Federal Food,
p.(None): Drug, and Cosmetic Act or licensed under section 351 of this Act; and ‘‘(bb) each applicable device clinical
p.(None): trial
p.(None): for a device that is cleared under section 510(k) of the Federal Food, Drug, and Cos- metic Act
p.(None): or approved under section 515 or 520(m) of such Act.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 911
p.(None):
p.(None):
p.(None): ‘‘(II) UNAPPROVED PRODUCTS.—The regulations under this subparagraph shall establish whether or not the results
p.(None): information described in clause
p.(None): (iii) shall be required for—
p.(None): ‘‘(aa) an applicable drug clinical trial for a drug that is not approved under section 505 of the Federal
...
p.(None): ‘‘(i) SUBMISSION OF UPDATES.—The responsible party for an applicable clinical trial shall submit to the
p.(None): Director of NIH for inclusion in the registry and results data bank updates to reflect changes to the
p.(None): clinical trial information submitted under paragraph (2). Such updates—
p.(None): ‘‘(I) shall be provided not less than once every
p.(None): 12 months, unless there were no changes to the
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 917
p.(None):
p.(None):
p.(None): clinical trial information during the preceding 12- month period;
p.(None): ‘‘(II) shall include identification of the dates of any such changes;
p.(None): ‘‘(III) not later than 30 days after the recruit- ment status of such clinical trial changes, shall include an
p.(None): update of the recruitment status; and ‘‘(IV) not later than 30 days after the comple- tion date of the clinical
p.(None): trial, shall include notifica- tion to the Director that such clinical trial is com-
p.(None): plete.
p.(None): ‘‘(ii) PUBLIC AVAILABILITY OF UPDATES.—The
p.(None): Director of NIH shall make updates submitted under clause (i) publicly available in the registry data bank.
p.(None): Except with regard to overall recruitment status, indi- vidual site status, location, and contact information,
p.(None): the Director of NIH shall ensure that updates to ele- ments required under subclauses (I) to (V) of paragraph
p.(None): (2)(A)(ii) do not result in the removal of any informa- tion from the original submissions or any
p.(None): preceding updates, and information in such databases is pre- sented in a manner that enables users to readily
p.(None): access each original element submission and to track the changes made by the updates. The Director of
p.(None): NIH shall provide a link from the table of primary and secondary outcomes required under paragraph (3)(C)(ii)
p.(None): to the tracked history required under this clause of the primary and secondary outcome measures sub-
p.(None): mitted under paragraph (2)(A)(ii)(I)(ll).
p.(None): ‘‘(5) COORDINATION AND COMPLIANCE.—
p.(None): ‘‘(A) CLINICAL TRIALS SUPPORTED BY GRANTS FROM FED- ERAL AGENCIES.—
p.(None): ‘‘(i) GRANTS FROM CERTAIN FEDERAL AGENCIES.—
p.(None): If an applicable clinical trial is funded in whole or in part by a grant from any agency of the Department of
p.(None): Health and Human Services, including the Food and Drug Administration, the National Institutes of Health,
p.(None): or the Agency for Healthcare Research and Quality, any grant or progress report forms required under such
p.(None): grant shall include a certification that the responsible party has made all required submissions to the
p.(None): Director of NIH under paragraphs (2) and (3). ‘‘(ii) VERIFICATION BY FEDERAL AGENCIES.—The
p.(None): heads of the agencies referred to in clause (i), as applicable, shall verify that the clinical trial
p.(None): informa- tion for each applicable clinical trial for which a grantee is the responsible party has
p.(None): been submitted under paragraphs (2) and (3) before releasing any remaining funding for a grant or funding
p.(None): for a future grant to such grantee.
p.(None): ‘‘(iii) NOTICE AND OPPORTUNITY TO REMEDY.—If the
...
p.(None): any suc- cessor regulations); and
p.(None): ‘‘(B) a patient package insert, if the Secretary deter- mines that such insert may help mitigate a
p.(None): serious risk of the drug.
p.(None): ‘‘(3) COMMUNICATION PLAN.—The risk evaluation and miti- gation strategy for a drug may require that the
p.(None): responsible person conduct a communication plan to health care providers, if, with respect to such drug, the
p.(None): Secretary determines that such plan may support implementation of an element of the strategy (including
p.(None): under this paragraph). Such plan may include—
p.(None): ‘‘(A) sending letters to health care providers;
p.(None): ‘‘(B) disseminating information about the elements of the risk evaluation and mitigation strategy to
p.(None): encourage implementation by health care providers of components that apply to such health care providers,
p.(None): or to explain certain safety protocols (such as medical monitoring by periodic laboratory tests); or
p.(None): ‘‘(C) disseminating information to health care providers through professional societies about any serious risks
p.(None): of the drug and any protocol to assure safe use.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None):
p.(None):
p.(None): 121 STAT. 930 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(f) PROVIDING SAFE ACCESS FOR PATIENTS TO DRUGS WITH KNOWN SERIOUS RISKS THAT WOULD
p.(None): OTHERWISE BE UNAVAIL-
p.(None): ABLE.—
p.(None): ‘‘(1) ALLOWING SAFE ACCESS TO DRUGS WITH KNOWN SERIOUS
p.(None): RISKS.—The Secretary, in consultation with the offices described in subsection (c)(2), may require that the risk
p.(None): evaluation and mitigation strategy for a drug include such elements as are necessary to assure safe use of
p.(None): the drug, because of its inherent toxicity or potential harmfulness, if the Secretary determines that—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(A) the drug, which has been shown to be effective, but is associated with a serious adverse drug
p.(None): experience, can be approved only if, or would be withdrawn unless, such elements are required as part of
p.(None): such strategy to mitigate a specific serious risk listed in the labeling of the drug; and
p.(None): ‘‘(B) for a drug initially approved without elements to assure safe use, other elements under subsections
p.(None): (c), (d), and (e) are not sufficient to mitigate such serious risk.
p.(None): ‘‘(2) ASSURING ACCESS AND MINIMIZING BURDEN.—Such ele-
p.(None): ments to assure safe use under paragraph (1) shall—
p.(None): ‘‘(A) be commensurate with the specific serious risk listed in the labeling of the drug;
p.(None): ‘‘(B) within 30 days of the date on which any element under paragraph (1) is imposed, be posted publicly by
p.(None): the Secretary with an explanation of how such elements will mitigate the observed safety risk;
p.(None): ‘‘(C) considering such risk, not be unduly burdensome on patient access to the drug, considering in
p.(None): particular— ‘‘(i) patients with serious or life-threatening dis-
p.(None): eases or conditions; and
p.(None): ‘‘(ii) patients who have difficulty accessing health care (such as patients in rural or medically under-
p.(None): served areas); and
p.(None): ‘‘(D) to the extent practicable, so as to minimize the burden on the health care delivery system—
p.(None): ‘‘(i) conform with elements to assure safe use for other drugs with similar, serious risks; and
p.(None): ‘‘(ii) be designed to be compatible with established distribution, procurement, and dispensing systems for drugs.
p.(None): ‘‘(3) ELEMENTS TO ASSURE SAFE USE.—The elements to
p.(None): assure safe use under paragraph (1) shall include 1 or more goals to mitigate a specific serious risk
p.(None): listed in the labeling of the drug and, to mitigate such risk, may require that— ‘‘(A) health care
p.(None): providers who prescribe the drug have particular training or experience, or are specially certified (the
p.(None): opportunity to obtain such training or certification with respect to the drug shall be available to any
p.(None): willing provider from a frontier area in a widely available training
p.(None): or certification method (including an on-line course or via mail) as approved by the Secretary at
p.(None): reasonable cost to the provider);
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 931
p.(None):
p.(None):
...
p.(None): ‘‘(D) the drug be dispensed to patients with evidence or other documentation of safe-use conditions, such as
p.(None): lab- oratory test results;
p.(None): ‘‘(E) each patient using the drug be subject to certain monitoring; or
p.(None): ‘‘(F) each patient using the drug be enrolled in a reg- istry.
p.(None): ‘‘(4) IMPLEMENTATION SYSTEM.—The elements to assure safe use under paragraph (1) that are described in
p.(None): subparagraphs (B), (C), and (D) of paragraph (3) may include a system through which the applicant is able to take
p.(None): reasonable steps to—
p.(None): ‘‘(A) monitor and evaluate implementation of such ele- ments by health care providers, pharmacists, and other
p.(None): parties in the health care system who are responsible for implementing such elements; and
p.(None): ‘‘(B) work to improve implementation of such elements by such persons.
p.(None): ‘‘(5) EVALUATION OF ELEMENTS TO ASSURE SAFE USE.—The
p.(None): Secretary, through the Drug Safety and Risk Management Advisory Committee (or successor committee) of the
p.(None): Food and Drug Administration, shall—
p.(None): ‘‘(A) seek input from patients, physicians, pharmacists, and other health care providers about how elements to
p.(None): assure safe use under this subsection for 1 or more drugs may be standardized so as not to be—
p.(None): ‘‘(i) unduly burdensome on patient access to the drug; and
p.(None): ‘‘(ii) to the extent practicable, minimize the burden on the health care delivery system;
p.(None): ‘‘(B) at least annually, evaluate, for 1 or more drugs, the elements to assure safe use of such drug
p.(None): to assess whether the elements—
p.(None): ‘‘(i) assure safe use of the drug;
p.(None): ‘‘(ii) are not unduly burdensome on patient access to the drug; and
p.(None): ‘‘(iii) to the extent practicable, minimize the burden on the health care delivery system; and
p.(None): ‘‘(C) considering such input and evaluations—
p.(None): ‘‘(i) issue or modify agency guidance about how to implement the requirements of this subsection; and ‘‘(ii)
p.(None): modify elements under this subsection for 1
p.(None): or more drugs as appropriate.
p.(None): ‘‘(6) ADDITIONAL MECHANISMS TO ASSURE ACCESS.—The
p.(None): mechanisms under section 561 to provide for expanded access for patients with serious or life-threatening
p.(None): diseases or condi- tions may be used to provide access for patients with a serious or life-threatening disease or
p.(None): condition, the treatment of which is not an approved use for the drug, to a drug that is subject to
p.(None): elements to assure safe use under this subsection. The Sec- retary shall promulgate regulations for how a
p.(None): physician may provide the drug under the mechanisms of section 561.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Regulations.
p.(None):
p.(None):
p.(None): 121 STAT. 932 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): ‘‘(7) WAIVER IN PUBLIC HEALTH EMERGENCIES.—The Sec-
p.(None): retary may waive any requirement of this subsection during the period described in section 319(a) of the
p.(None): Public Health Service Act with respect to a qualified countermeasure described under section
p.(None): 319F–1(a)(2) of such Act, to which a requirement under this subsection has been applied, if the Secretary
p.(None): has—
p.(None): ‘‘(A) declared a public health emergency under such section 319; and
...
p.(None): judicial review of the order in accordance with paragraph (6), or
p.(None): ‘‘(B) after a court in an action brought under paragraph
p.(None): (6) has entered a final judgment in favor of the Secretary, the Attorney General of the United States shall
p.(None): recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of
p.(None): the 60-day period referred to in paragraph
p.(None): (6) or the date of such final judgment, as the case may be) in an action brought in any appropriate
p.(None): district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty
p.(None): shall not be subject to review.’’.
p.(None): (5) REPORT ON DIRECT-TO-CONSUMER ADVERTISING.—Not later than 24 months after the date of the enactment
p.(None): of this Act, the Secretary of Health and Human Services shall report to the Congress on direct-to-consumer
p.(None): advertising and its ability to communicate to subsets of the general population, including elderly populations,
p.(None): children, and racial and ethnic minority communities. The Secretary shall utilize the Advisory Com- mittee
p.(None): on Risk Communication established under this Act to advise the Secretary with respect to such report. The
p.(None): Advisory Committee shall study direct-to-consumer advertising as it relates to increased access to health
p.(None): information and decreased health disparities for these populations. The report required by this paragraph
p.(None): shall recommend effective ways to present and disseminate information to these populations. Such report shall
p.(None): also make recommendations regarding impediments to the participation of elderly populations, children,
p.(None): racially and ethnically diverse communities, and medically underserved populations in clinical drug
p.(None): trials and shall recommend best practice approaches for increasing the inclusion of such subsets of the general
p.(None): population. The Secretary of Health and Human Services shall submit the report under this paragraph to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representatives.
p.(None): (6) RULEMAKING.—Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is
p.(None): amended by striking ‘‘the procedure specified in section 701(e) of this Act’’ and inserting ‘‘section
p.(None): 701(a)’’.
p.(None): (e) RULE OF CONSTRUCTION REGARDING PEDIATRIC STUDIES.— This title and the amendments made by this title
p.(None): may not be
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 943
p.(None):
p.(None): construed as affecting the authority of the Secretary of Health and Human Services to request pediatric
...
p.(None): and any direct-to-consumer advertisements of a newly approved drug or indication a unique symbol
p.(None): indicating the newly approved status of the drug or indica- tion for a period after approval.
p.(None): SEC. 905. ACTIVE POSTMARKET RISK IDENTIFICATION AND ANALYSIS.
p.(None): (a) IN GENERAL.—Subsection (k) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 355) is amended by adding at the end the following:
p.(None): ‘‘(3) ACTIVE POSTMARKET RISK IDENTIFICATION.—
p.(None): ‘‘(A) DEFINITION.—In this paragraph, the term ‘data’ refers to information with respect to a drug approved under
p.(None): this section or under section 351 of the Public Health Service Act, including claims data, patient
p.(None): survey data, standardized analytic files that allow for the pooling and analysis of data from disparate
p.(None): data environments, and any other data deemed appropriate by the Secretary.
p.(None): ‘‘(B) DEVELOPMENT OF POSTMARKET RISK IDENTIFICA-
p.(None): TION AND ANALYSIS METHODS.—The Secretary shall, not later than 2 years after the date of the
p.(None): enactment of the Food and Drug Administration Amendments Act of 2007, in collaboration with public,
p.(None): academic, and private entities—
p.(None): ‘‘(i) develop methods to obtain access to disparate data sources including the data sources specified in
p.(None): subparagraph (C);
p.(None): ‘‘(ii) develop validated methods for the establish- ment of a postmarket risk identification and analysis
p.(None): system to link and analyze safety data from multiple sources, with the goals of including, in aggregate—
p.(None): ‘‘(I) at least 25,000,000 patients by July 1,
p.(None): 2010; and
p.(None): ‘‘(II) at least 100,000,000 patients by July 1, 2012; and
p.(None): ‘‘(iii) convene a committee of experts, including individuals who are recognized in the field of protecting data
p.(None): privacy and security, to make recommendations to the Secretary on the development of tools and
p.(None): methods for the ethical and scientific uses for, and communication of, postmarketing data specified under
p.(None): subparagraph (C), including recommendations on the development of effective research methods for the study of drug
p.(None): safety questions.
p.(None): ‘‘(C) ESTABLISHMENT OF THE POSTMARKET RISK IDENTI- FICATION AND ANALYSIS SYSTEM.—
p.(None): ‘‘(i) IN GENERAL.—The Secretary shall, not later than 1 year after the development of the risk identifica- tion
p.(None): and analysis methods under subparagraph (B), establish and maintain procedures—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 945
p.(None):
p.(None):
p.(None): ‘‘(I) for risk identification and analysis based on electronic health data, in compliance with the
...
p.(None): populations not included, or underrep- resented, in the trials used to approve the drug (such as older
p.(None): people, people with comorbidities, pregnant women, or children); and
p.(None): ‘‘(II) existing approaches such as the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink or
p.(None): successor databases.
p.(None): ‘‘(v) AUTHORITY FOR CONTRACTS.—The Secretary
p.(None): may enter into contracts with public and private enti- ties to fulfill the requirements of this subparagraph.
p.(None): ‘‘(4) ADVANCED ANALYSIS OF DRUG SAFETY DATA.—
p.(None): ‘‘(A) PURPOSE.—The Secretary shall establish collabora- tions with public, academic, and private entities, which
p.(None): may include the Centers for Education and Research on Therapeutics under section 912 of the Public Health
p.(None): Service Act, to provide for advanced analysis of drug safety data described in paragraph (3)(C) and other
p.(None): information that is publicly available or is provided by the Secretary, in order to—
p.(None): ‘‘(i) improve the quality and efficiency of postmarket drug safety risk-benefit analysis;
p.(None): ‘‘(ii) provide the Secretary with routine access to outside expertise to study advanced drug safety ques-
p.(None): tions; and
p.(None): ‘‘(iii) enhance the ability of the Secretary to make timely assessments based on drug safety data.
p.(None): ‘‘(B) PRIVACY.—Such analysis shall not disclose individ- ually identifiable health information when presenting such
p.(None): drug safety signals and trends or when responding to inquiries regarding such drug safety signals and
p.(None): trends. ‘‘(C) PUBLIC PROCESS FOR PRIORITY QUESTIONS.—At
p.(None): least biannually, the Secretary shall seek recommendations from the Drug Safety and Risk Management Advisory Com-
p.(None): mittee (or any successor committee) and from other advisory committees, as appropriate, to the Food and
p.(None): Drug Administration on—
p.(None): ‘‘(i) priority drug safety questions; and
p.(None): ‘‘(ii) mechanisms for answering such questions, including through—
p.(None): ‘‘(I) active risk identification under paragraph (3); and
p.(None): ‘‘(II) when such risk identification is not suffi- cient, postapproval studies and clinical trials under subsection
p.(None): (o)(3).
p.(None): ‘‘(D) PROCEDURES FOR THE DEVELOPMENT OF DRUG SAFETY COLLABORATIONS.—
p.(None):
p.(None): Deadline.
...
p.(None): ‘‘(II) violates sections 552 or 552a of title 5, United States Code, with regard to the privacy of
p.(None): individually-identifiable beneficiary health information; or
p.(None): ‘‘(III) discloses individually identifiable health information when presenting drug safety signals and trends
p.(None): or when responding to inquiries regarding drug safety signals and trends.
p.(None): Nothing in this clause prohibits lawful disclosure for other purposes.
p.(None): ‘‘(ii) COMPONENT OF ANOTHER ORGANIZATION.—If
p.(None): a qualified entity is a component of another organiza- tion—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Applicability.
p.(None): ‘‘(I) the qualified entity shall establish appro- priate security measures to maintain the confiden- tiality and
p.(None): privacy of such data; and
p.(None): ‘‘(II) the entity shall not make an unauthorized disclosure of such data to the other components of the
p.(None): organization in breach of such confidentiality and privacy requirement.
p.(None): ‘‘(iii) TERMINATION OR NONRENEWAL.—If a contract with a qualified entity under this subparagraph is terminated
p.(None): or not renewed, the following requirements shall apply:
p.(None): ‘‘(I) CONFIDENTIALITY AND PRIVACY PROTEC-
p.(None): TIONS.—The entity shall continue to comply with the confidentiality and privacy requirements under this
p.(None): paragraph with respect to all data disclosed to the entity.
p.(None): ‘‘(II) DISPOSITION OF DATA.—The entity shall return any data disclosed to such entity under this
p.(None): subsection to which it would not otherwise have access or, if returning the data is not prac- ticable,
p.(None): destroy the data.
p.(None): ‘‘(H) COMPETITIVE PROCEDURES.—The Secretary shall use competitive procedures (as defined in section 4(5)
p.(None): of the Federal Procurement Policy Act) to enter into contracts under subparagraph (G).
p.(None): ‘‘(I) REVIEW OF CONTRACT IN THE EVENT OF A MERGER
p.(None): OR ACQUISITION.—The Secretary shall review the contract
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 949
p.(None):
p.(None):
p.(None): with a qualified entity under this paragraph in the event of a merger or acquisition of the entity in
p.(None): order to ensure that the requirements under this paragraph will continue to be met.
p.(None): ‘‘(J) COORDINATION.—In carrying out this paragraph, the Secretary shall provide for appropriate communications to
p.(None): the public, scientific, public health, and medical commu- nities, and other key stakeholders, and to the extent prac-
p.(None): ticable shall coordinate with the activities of private enti- ties, professional associations, or other
p.(None): entities that may have sources of drug safety data.’’.
p.(None): (b) RULE OF CONSTRUCTION.—Nothing in this section or the amendment made by this section shall be
p.(None): construed to prohibit the lawful disclosure or use of data or information by an entity other than as
p.(None): described in paragraph (4)(B) or (4)(G) of section 505(k) of the Federal Food, Drug, and Cosmetic Act,
p.(None): as added by subsection (a).
p.(None): (c) REPORT TO CONGRESS.—Not later than 4 years after the date of the enactment of this Act, the
...
p.(None): or refrain from taking any form of action with respect to that application.
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): ‘‘(5) DEFINITIONS.—
p.(None): 121 STAT. 957
p.(None):
p.(None): ‘‘(A) APPLICATION.—For purposes of this subsection, the term ‘application’ means an application submitted under
p.(None): subsection (b)(2) or (j).
p.(None): ‘‘(B) PETITION.—For purposes of this subsection, other than paragraph (1)(A)(i), the term ‘petition’
p.(None): means a request described in paragraph (1)(A)(i).’’.
p.(None): (b) REPORT.—Not later than 1 year after the date of the enact- ment of this Act, the Secretary of Health and
p.(None): Human Services shall submit a report to the Congress on ways to encourage the early submission of
p.(None): petitions under section 505(q), as added by subsection (a).
p.(None): SEC. 915. POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND PROVIDERS.
p.(None): Section 505 of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 355), as amended by section 914(a), is amended by adding at the end the following:
p.(None): ‘‘(r) POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND PROVIDERS.—
p.(None): ‘‘(1) ESTABLISHMENT.—Not later than 1 year after the date of the enactment of the Food and Drug Administration
p.(None): Amend- ments Act of 2007, the Secretary shall improve the transparency of information about drugs and allow patients
p.(None): and health care providers better access to information about drugs by devel- oping and maintaining an Internet
p.(None): Web site that—
p.(None): ‘‘(A) provides links to drug safety information listed in paragraph (2) for prescription drugs that are
p.(None): approved under this section or licensed under section 351 of the Public Health Service Act; and
p.(None): ‘‘(B) improves communication of drug safety informa- tion to patients and providers.
p.(None): ‘‘(2) INTERNET WEB SITE.—The Secretary shall carry out paragraph (1) by—
p.(None): ‘‘(A) developing and maintaining an accessible, consoli- dated Internet Web site with easily searchable drug safety
p.(None): information, including the information found on United States Government Internet Web sites, such as the United
p.(None): States National Library of Medicine’s Daily Med and Medline Plus Web sites, in addition to other
p.(None): such Web sites maintained by the Secretary;
p.(None): ‘‘(B) ensuring that the information provided on the Internet Web site is comprehensive and includes, when
p.(None): available and appropriate—
p.(None): ‘‘(i) patient labeling and patient packaging inserts; ‘‘(ii) a link to a list of each drug, whether approved under
p.(None): this section or licensed under such section 351, for which a Medication Guide, as provided for under
p.(None): part 208 of title 21, Code of Federal Regulations (or
p.(None): any successor regulations), is required;
p.(None): ‘‘(iii) a link to the registry and results data bank provided for under subsections (i) and (j) of
p.(None): section 402 of the Public Health Service Act;
p.(None): ‘‘(iv) the most recent safety information and alerts issued by the Food and Drug Administration for drugs approved by
p.(None): the Secretary under this section, such as product recalls, warning letters, and import alerts;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Website.
p.(None):
p.(None):
p.(None): 121 STAT. 958 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(v) publicly available information about imple- mented RiskMAPs and risk evaluation and mitigation strategies
p.(None): under subsection (o);
p.(None): ‘‘(vi) guidance documents and regulations related to drug safety; and
p.(None): ‘‘(vii) other material determined appropriate by the Secretary;
p.(None): ‘‘(C) providing access to summaries of the assessed and aggregated data collected from the active surveillance
p.(None): infrastructure under subsection (k)(3) to provide informa- tion of known and serious side-effects for
p.(None): drugs approved under this section or licensed under such section 351;
p.(None):
p.(None): Reports.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Reports.
p.(None): ‘‘(D) preparing, by 18 months after approval of a drug or after use of the drug by 10,000 individuals,
p.(None): whichever is later, a summary analysis of the adverse drug reaction reports received for the drug,
p.(None): including identification of any new risks not previously identified, potential new risks, or known risks reported in
p.(None): unusual number;
p.(None): ‘‘(E) enabling patients, providers, and drug sponsors to submit adverse event reports through the Internet Web
p.(None): site;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(F) providing educational materials for patients and providers about the appropriate means of
p.(None): disposing of expired, damaged, or unusable medications; and
p.(None): ‘‘(G) supporting initiatives that the Secretary deter- mines to be useful to fulfill the purposes of the
p.(None): Internet Web site.
p.(None): ‘‘(3) POSTING OF DRUG LABELING.—The Secretary shall post on the Internet Web site established under
...
p.(None): SEC. 1104. NIH TECHNICAL AMENDMENTS.
p.(None): The Public Health Service Act (42 U.S.C. 201 et seq.) is amended—
p.(None): (1) in section 319C–2(j)(3)(B), by striking ‘‘section 319C– 1(h)’’ and inserting ‘‘section 319C–1(i)’’;
p.(None): (2) in section 402(b)(4), by inserting ‘‘minority and other’’ after ‘‘reducing’’;
p.(None): (3) in section 403(a)(4)(C)(iv)(III), by inserting ‘‘and postdoctoral training funded through research
p.(None): grants’’ before the semicolon;
p.(None): (4) by designating the second section 403C (relating to the drug diethylstilbestrol) as section 403D; and
p.(None): (5) in section 403C(a)—
p.(None): (A) in the matter preceding paragraph (1)—
p.(None): (i) by inserting ‘‘graduate students supported by the National Institutes of Health’’ after ‘‘with respect
p.(None): to’’; and
p.(None): (ii) by deleting ‘‘each degree-granting program’’;
p.(None): (B) in paragraph (1), by inserting ‘‘such’’ after ‘‘percent- age of’’; and
p.(None): (C) in paragraph (2), by inserting ‘‘(not including any leaves of absence)’’ after ‘‘average time’’.
p.(None): SEC. 1105. SEVERABILITY CLAUSE.
p.(None): If any provision of this Act, an amendment made this Act, or the application of such provision or
p.(None): amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the
p.(None): amendments made by this Act, and the application of the provisions of such to any person or
p.(None): circumstances shall not be affected thereby.
p.(None): Subtitle B—Antibiotic Access and Innovation
p.(None): SEC. 1111. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE CON- CENTRATIONS OF ANTIMICROBIALS.
p.(None): (a) DEFINITION.—In this section, the term ‘‘clinically susceptible concentrations’’ means specific values which
p.(None): characterize bacteria as clinically susceptible, intermediate, or resistant to the drug (or drugs) tested.
p.(None): (b) IDENTIFICATION.—The Secretary of Health and Human Serv- ices (referred to in this section as the
p.(None): ‘‘Secretary’’), through the Commissioner of Food and Drugs, shall identify (where such
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 247d–3b.
p.(None):
p.(None): 42 USC 282.
p.(None):
p.(None): 42 USC 283.
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 283a–3.
p.(None): 42 USC 283a–2.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 301 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 247d–5a.
p.(None):
p.(None):
p.(None): 121 STAT. 976 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): information is reasonably available) and periodically update clini- cally susceptible concentrations.
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Appropriation authorization.
p.(None): (c) PUBLIC AVAILABILITY.—The Secretary, through the Commis- sioner of Food and Drugs, shall make such
...
Social / Age
Searching for indicator age:
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p.(None): be based on the following fee amounts:
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Fee Type
p.(None): Fiscal Year 2008
p.(None): Fiscal Year 2009
p.(None): Fiscal Year 2010
p.(None): Fiscal Year 2011
p.(None): Fiscal Year 2012
p.(None): Premarket Application .... $185,000 $200,725 $217,787 $236,298 $256,384
p.(None): ................
p.(None): Establishment Registra-
p.(None): tion ................................ $1,706 $1,851 $2,008 $2,179 $2,364.’’.
p.(None):
p.(None): (c) ANNUAL FEE SETTING.—
p.(None): (1) IN GENERAL.—Section 738(c) (21 U.S.C. 379j(c)(1)) is amended—
p.(None): (A) in the subsection heading, by striking ‘‘Annual Fee Setting’’ and inserting ‘‘ANNUAL FEE SETTING’’;
p.(None): and
p.(None): (B) in paragraph (1), by striking the last sentence.
p.(None):
p.(None):
p.(None): 121 STAT. 846 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): (2) ADJUSTMENT OF ANNUAL ESTABLISHMENT FEE.—Section 738(c) (21 U.S.C. 379j(c)), as amended by paragraph
p.(None): (1), is further amended—
p.(None): (A) by redesignating paragraphs (2) and (3) as para- graphs (3) and (4), respectively;
p.(None): (B) by inserting after paragraph (1) the following: ‘‘(2) ADJUSTMENT.—
p.(None): ‘‘(A) IN GENERAL.—When setting fees for fiscal year 2010, the Secretary may increase the fee under subsection
p.(None): (a)(3)(A) (applicable to establishments subject to registra- tion) only if the Secretary estimates that
p.(None): the number of establishments submitting fees for fiscal year 2009 is fewer than 12,250. The percentage increase shall
p.(None): be the percent- age by which the estimate of establishments submitting fees in fiscal year 2009 is fewer
p.(None): than 12,750, but in no case may the percentage increase be more than 8.5 percent over that specified in
p.(None): subsection (b) for fiscal year 2010. If the Secretary makes any adjustment to the fee under subsection
p.(None): (a)(3)(A) for fiscal year 2010, then such fee for fiscal years 2011 and 2012 shall be adjusted so that
p.(None): such fee for fiscal year 2011 is equal to the adjusted fee for fiscal year 2010 increased by 8.5
p.(None): percent, and such fee for fiscal year 2012 is equal to the adjusted fee for fiscal year 2011 increased by
p.(None): 8.5 percent.
p.(None):
p.(None): Federal Register, publication.
p.(None): ‘‘(B) PUBLICATION.—For any adjustment made under
p.(None): subparagraph (A), the Secretary shall publish in the Fed- eral Register the Secretary’s determination to
p.(None): make the adjustment and the rationale for the determination.’’; and
p.(None): (C) in paragraph (4), as redesignated by this para- graph, in subparagraph (A)—
p.(None): (i) by striking ‘‘For fiscal years 2006 and 2007, the Secretary’’ and inserting ‘‘The Secretary’’; and
p.(None): (ii) by striking ‘‘for the first month of fiscal year 2008’’ and inserting ‘‘for the first month of
p.(None): the next fiscal year’’.
p.(None): (d) SMALL BUSINESSES; FEE WAIVER AND FEE REDUCTION REGARDING PREMARKET APPROVAL.—
p.(None): (1) IN GENERAL.—Section 738(d)(1) (21 U.S.C. 379j(d)(1))
p.(None): is amended—
p.(None): (A) by striking ‘‘, partners, and parent firms’’; and
p.(None): (B) by striking ‘‘clauses (i) through (vi) of subsection (a)(2)(A)’’ and inserting ‘‘clauses (i) through (v)
...
p.(None): distribution number exceed the number identified in paragraph (2)(A).
p.(None): ‘‘(iii) Such person immediately notifies the Secretary if the number of such devices distributed during
p.(None): any calendar year exceeds the annual distribution number referred to in clause (ii).
p.(None): ‘‘(iv) The request for such exemption is submitted on or before October 1, 2012.
p.(None): ‘‘(B) The Secretary may inspect the records relating to the number of devices distributed during any calendar
p.(None): year of a person granted an exemption under paragraph (2) for which the prohibition in paragraph (3) does not apply.
p.(None): ‘‘(C) A person may petition the Secretary to modify the annual distribution number specified by the Secretary under
p.(None): subparagraph (A)(ii) with respect to a device if additional information on the number of individuals
p.(None): affected by the disease or condition arises, and the Secretary may modify such number but in no case
p.(None): shall the annual distribution number exceed the number identified in paragraph (2)(A).
p.(None): ‘‘(D) If a person notifies the Secretary, or the Secretary deter- mines through an inspection under
p.(None): subparagraph (B), that the number of devices distributed during any calendar year exceeds the annual
p.(None): distribution number, as required under subparagraph (A)(iii), and modified under subparagraph (C), if
p.(None): applicable, then the prohibition in paragraph (3) shall apply with respect to such person for such device
p.(None): for any sales of such device after such notification.
p.(None): ‘‘(E)(i) In this subsection, the term ‘pediatric patients’ means patients who are 21 years of age or
p.(None): younger at the time of the diagnosis or treatment.
p.(None): ‘‘(ii) In this subsection, the term ‘pediatric subpopulation’ means 1 of the following populations:
p.(None): ‘‘(I) Neonates.
p.(None): ‘‘(II) Infants.
p.(None): ‘‘(III) Children. ‘‘(IV) Adolescents.
p.(None): ‘‘(7) The Secretary shall refer any report of an adverse event regarding a device for which the
p.(None): prohibition under paragraph (3) does not apply pursuant to paragraph (6)(A) that the Secretary receives to
p.(None): the Office of Pediatric Therapeutics, established under section 6 of the Best Pharmaceuticals for
p.(None): Children Act (Public Law 107–109). In considering the report, the Director of the Office of Pediatric Therapeutics,
p.(None): in consultation with experts in the Center for Devices and Radiological Health, shall provide for periodic
p.(None): review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such
p.(None): committee regarding whether the Secretary should take action under this Act in response to the report.
p.(None): ‘‘(8) The Secretary, acting through the Office of Pediatric Thera- peutics and the Center for Devices and
p.(None): Radiological Health, shall provide for an annual review by the Pediatric Advisory Committee
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Notification.
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Applicability.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None): necessary to protect the public health.’’.
p.(None):
p.(None): TITLE IV—PEDIATRIC RESEARCH EQUITY ACT OF 2007
p.(None): SEC. 401. SHORT TITLE.
p.(None): This title may be cited as the ‘‘Pediatric Research Equity Act of 2007’’.
p.(None): SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQUITY ACT.
p.(None): (a) IN GENERAL.—Section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amended to
p.(None): read as follows:
p.(None): ‘‘SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL PRODUCTS.
p.(None): ‘‘(a) NEW DRUGS AND BIOLOGICAL PRODUCTS.—
p.(None): ‘‘(1) IN GENERAL.—A person that submits, on or after the date of the enactment of the Pediatric
p.(None): Research Equity Act of 2007, an application (or supplement to an application)— ‘‘(A) under section 505
p.(None): for a new active ingredient,
p.(None): new indication, new dosage form, new dosing regimen, or new route of administration, or
p.(None): ‘‘(B) under section 351 of the Public Health Service Act (42 U.S.C. 262) for a new active ingredient, new
p.(None): indica- tion, new dosage form, new dosing regimen, or new route of administration,
p.(None): shall submit with the application the assessments described in paragraph (2).
p.(None): ‘‘(2) ASSESSMENTS.—
p.(None): ‘‘(A) IN GENERAL.—The assessments referred to in para- graph (1) shall contain data, gathered using appropriate
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 867
p.(None):
p.(None): formulations for each age group for which the assessment is required, that are adequate—
p.(None): ‘‘(i) to assess the safety and effectiveness of the drug or the biological product for the claimed
p.(None): indica- tions in all relevant pediatric subpopulations; and
p.(None): ‘‘(ii) to support dosing and administration for each pediatric subpopulation for which the drug or the
p.(None): biological product is safe and effective.
p.(None): ‘‘(B) SIMILAR COURSE OF DISEASE OR SIMILAR EFFECT OF DRUG OR BIOLOGICAL PRODUCT.—
p.(None): ‘‘(i) IN GENERAL.—If the course of the disease and the effects of the drug are sufficiently similar in adults and
p.(None): pediatric patients, the Secretary may conclude that pediatric effectiveness can be extrapolated from
p.(None): adequate and well-controlled studies in adults, usually supplemented with other information obtained in pedi- atric
p.(None): patients, such as pharmacokinetic studies.
p.(None): ‘‘(ii) EXTRAPOLATION BETWEEN AGE GROUPS.—A
p.(None): study may not be needed in each pediatric age group if data from one age group can be extrapolated to
p.(None): another age group.
p.(None): ‘‘(iii) INFORMATION ON EXTRAPOLATION.—A brief
p.(None): documentation of the scientific data supporting the conclusion under clauses (i) and (ii) shall be
p.(None): included in any pertinent reviews for the application under sec- tion 505 of this Act or section 351 of the Public
p.(None): Health Service Act (42 U.S.C. 262).
p.(None): ‘‘(3) DEFERRAL.—
p.(None): ‘‘(A) IN GENERAL.—On the initiative of the Secretary or at the request of the applicant, the Secretary may
p.(None): defer submission of some or all assessments required under para- graph (1) until a specified date after approval
p.(None): of the drug or issuance of the license for a biological product if—
p.(None): ‘‘(i) the Secretary finds that—
p.(None): ‘‘(I) the drug or biological product is ready for approval for use in adults before pediatric studies are
p.(None): complete;
p.(None): ‘‘(II) pediatric studies should be delayed until additional safety or effectiveness data have been
p.(None): collected; or
p.(None): ‘‘(III) there is another appropriate reason for deferral; and
p.(None): ‘‘(ii) the applicant submits to the Secretary—
p.(None): ‘‘(I) certification of the grounds for deferring the assessments;
p.(None): ‘‘(II) a description of the planned or ongoing studies;
p.(None): ‘‘(III) evidence that the studies are being con- ducted or will be conducted with due diligence and at the
p.(None): earliest possible time; and
p.(None): ‘‘(IV) a timeline for the completion of such studies.
p.(None): ‘‘(B) ANNUAL REVIEW.—
p.(None): ‘‘(i) IN GENERAL.—On an annual basis following the approval of a deferral under subparagraph (A), the
p.(None): applicant shall submit to the Secretary the fol- lowing information:
p.(None):
p.(None):
p.(None): 121 STAT. 868 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(I) Information detailing the progress made in conducting pediatric studies.
p.(None): ‘‘(II) If no progress has been made in con- ducting such studies, evidence and documentation that such
p.(None): studies will be conducted with due dili- gence and at the earliest possible time.
p.(None):
p.(None): Website.
p.(None): ‘‘(ii) PUBLIC AVAILABILITY.—The information sub- mitted through the annual review under clause (i) shall
p.(None): promptly be made available to the public in an easily accessible manner, including through the Web site
p.(None): of the Food and Drug Administration.
p.(None): ‘‘(4) WAIVERS.—
p.(None): ‘‘(A) FULL WAIVER.—On the initiative of the Secretary or at the request of an applicant, the Secretary shall
p.(None): grant a full waiver, as appropriate, of the requirement to submit assessments for a drug or biological product
p.(None): under this subsection if the applicant certifies and the Secretary finds that—
p.(None): ‘‘(i) necessary studies are impossible or highly impracticable (because, for example, the number of
p.(None): patients is so small or the patients are geographically dispersed);
p.(None): ‘‘(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or
p.(None): unsafe in all pediatric age groups; or
p.(None): ‘‘(iii) the drug or biological product—
p.(None): ‘‘(I) does not represent a meaningful thera- peutic benefit over existing therapies for pediatric patients; and
p.(None): ‘‘(II) is not likely to be used in a substantial number of pediatric patients.
p.(None): ‘‘(B) PARTIAL WAIVER.—On the initiative of the Sec- retary or at the request of an applicant, the
p.(None): Secretary shall grant a partial waiver, as appropriate, of the require- ment to submit assessments for a drug or
p.(None): biological product under this subsection with respect to a specific pediatric age group if the applicant
p.(None): certifies and the Secretary finds that—
p.(None): ‘‘(i) necessary studies are impossible or highly impracticable (because, for example, the number of
p.(None): patients in that age group is so small or patients in that age group are geographically dispersed);
p.(None): ‘‘(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or
p.(None): unsafe in that age group;
p.(None): ‘‘(iii) the drug or biological product—
p.(None): ‘‘(I) does not represent a meaningful thera- peutic benefit over existing therapies for pediatric patients in
p.(None): that age group; and
p.(None): ‘‘(II) is not likely to be used by a substantial number of pediatric patients in that age group; or
p.(None): ‘‘(iv) the applicant can demonstrate that reasonable attempts to produce a pediatric formulation necessary for that age
p.(None): group have failed.
p.(None): ‘‘(C) PEDIATRIC FORMULATION NOT POSSIBLE.—If a
p.(None): waiver is granted on the ground that it is not possible
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 869
p.(None):
p.(None):
p.(None): to develop a pediatric formulation, the waiver shall cover only the pediatric groups requiring that
p.(None): formulation. An applicant seeking either a full or partial waiver shall submit to the Secretary
p.(None): documentation detailing why a pediatric formulation cannot be developed and, if the waiver is granted, the
p.(None): applicant’s submission shall promptly be made available to the public in an easily accessible manner, including
p.(None): through posting on the Web site of the Food and Drug Administration.
p.(None): ‘‘(D) LABELING REQUIREMENT.—If the Secretary grants a full or partial waiver because there is evidence
p.(None): that a drug or biological product would be ineffective or unsafe in pediatric populations, the information shall be
p.(None): included in the labeling for the drug or biological product.
p.(None): ‘‘(b) MARKETED DRUGS AND BIOLOGICAL PRODUCTS.—
p.(None): ‘‘(1) IN GENERAL.—After providing notice in the form of a letter (that, for a drug approved under section
p.(None): 505, references a declined written request under section 505A for a labeled indication which written
p.(None): request is not referred under section 505A(n)(1)(A) to the Foundation of the National Institutes of Health
p.(None): for the pediatric studies), the Secretary may (by order in the form of a letter) require the sponsor
p.(None): or holder of an approved application for a drug under section 505 or the holder of a license for a biological
p.(None): product under section 351 of the Public Health Service Act to submit by a specified date the assessments
p.(None): described in subsection (a)(2), if the Secretary finds that—
p.(None): ‘‘(A)(i) the drug or biological product is used for a substantial number of pediatric patients for the
p.(None): labeled indications; and
p.(None): ‘‘(ii) adequate pediatric labeling could confer a benefit on pediatric patients;
p.(None): ‘‘(B) there is reason to believe that the drug or biological product would represent a
p.(None): meaningful thera- peutic benefit over existing therapies for pediatric patients for 1 or more of the claimed
p.(None): indications; or
p.(None): ‘‘(C) the absence of adequate pediatric labeling could pose a risk to pediatric patients.
p.(None): ‘‘(2) WAIVERS.—
p.(None): ‘‘(A) FULL WAIVER.—At the request of an applicant, the Secretary shall grant a full waiver, as
p.(None): appropriate, of the requirement to submit assessments under this sub- section if the applicant certifies
p.(None): and the Secretary finds that—
p.(None):
p.(None): Public information. Website.
p.(None): ‘‘(i) necessary studies are impossible or highly impracticable (because, for example, the number of
p.(None): patients in that age group is so small or patients in that age group are geographically dispersed); or
p.(None): ‘‘(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or
p.(None): unsafe in all pediatric age groups.
p.(None): ‘‘(B) PARTIAL WAIVER.—At the request of an applicant, the Secretary shall grant a partial waiver, as appropriate, of
p.(None): the requirement to submit assessments under this sub- section with respect to a specific pediatric age
p.(None): group if the applicant certifies and the Secretary finds that—
p.(None):
p.(None):
p.(None): 121 STAT. 870 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(i) necessary studies are impossible or highly impracticable (because, for example, the number of
p.(None): patients in that age group is so small or patients in that age group are geographically dispersed);
p.(None): ‘‘(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or
p.(None): unsafe in that age group;
p.(None): ‘‘(iii)(I) the drug or biological product—
p.(None): ‘‘(aa) does not represent a meaningful thera- peutic benefit over existing therapies for pediatric patients in
p.(None): that age group; and
p.(None): ‘‘(bb) is not likely to be used in a substantial number of pediatric patients in that age group; and
p.(None): ‘‘(II) the absence of adequate labeling could not pose significant risks to pediatric patients; or
p.(None): ‘‘(iv) the applicant can demonstrate that reasonable attempts to produce a pediatric formulation necessary for that age
p.(None): group have failed.
p.(None): ‘‘(C) PEDIATRIC FORMULATION NOT POSSIBLE.—If a
p.(None): waiver is granted on the ground that it is not possible to develop a pediatric formulation, the waiver
p.(None): shall cover
p.(None):
p.(None): Public information. Website.
p.(None): only the pediatric groups requiring that formulation. An applicant seeking either a full or partial
p.(None): waiver shall submit to the Secretary documentation detailing why a pediatric formulation cannot be developed
p.(None): and, if the waiver is granted, the applicant’s submission shall promptly be made available to the public in an
p.(None): easily accessible manner, including through posting on the Web site of the Food and Drug Administration.
p.(None): ‘‘(D) LABELING REQUIREMENT.—If the Secretary grants a full or partial waiver because there is evidence
p.(None): that a drug or biological product would be ineffective or unsafe in pediatric populations, the information shall be
p.(None): included in the labeling for the drug or biological product.
p.(None): ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection alters or amends section 301(j) of this Act or
p.(None): section 552 of title 5 or section 1905 of title 18, United States Code.
p.(None): ‘‘(c) MEANINGFUL THERAPEUTIC BENEFIT.—For the purposes of paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of
p.(None): subsection (a) and para-
p.(None): graphs (1)(B) and (2)(B)(iii)(I)(aa) of subsection (b), a drug or biological product shall be
...
p.(None): 284m) that the Secretary determines to be appropriate, including a detailed rationale for each recommendation;
p.(None): and
p.(None): (5)(A) the efforts made by the Secretary to increase the number of studies conducted in the neonate
p.(None): population; and
p.(None): (B) the results of those efforts, including efforts made to encourage the conduct of appropriate studies
p.(None): in neonates by companies with products that have sufficient safety and other information to make the
p.(None): conduct of the studies ethical and safe.
p.(None):
p.(None):
p.(None): Best Pharmaceuticals for Children Act of 2007.
p.(None): 21 USC 301 note.
p.(None): TITLE V—BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007
p.(None): SEC. 501. SHORT TITLE.
p.(None): This title may be cited as the ‘‘Best Pharmaceuticals for Chil- dren Act of 2007’’.
p.(None): SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHIL- DREN ACT.
p.(None): (a) PEDIATRIC STUDIES OF DRUGS.—
p.(None): (1) IN GENERAL.—Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended to read
p.(None): as follows:
p.(None): ‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
p.(None): ‘‘(a) DEFINITIONS.—As used in this section, the term ‘pediatric studies’ or ‘studies’ means at least one
p.(None): clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic studies) in pediatric age
p.(None): groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the
p.(None): discretion of the Secretary, may include preclinical studies.
p.(None): ‘‘(b) MARKET EXCLUSIVITY FOR NEW DRUGS.—
p.(None): ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), if, prior to approval of an application that is
p.(None): submitted under section 505(b)(1), the Secretary determines that information relating to the use of a new
p.(None): drug in the pediatric population may produce health benefits in that population, the Secretary makes a
p.(None): written request for pediatric studies (which shall
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 877
p.(None):
p.(None): include a timeframe for completing such studies), the applicant agrees to the request, such studies are completed using
p.(None): appro- priate formulations for each age group for which the study is requested within any such timeframe, and
p.(None): the reports thereof are submitted and accepted in accordance with subsection (d)(3)—
p.(None): ‘‘(A)(i)(I) the period referred to in subsection (c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii) of such
p.(None): section, is deemed to be five years and six months rather than five years, and the references in
p.(None): subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and
p.(None): one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively;
p.(None): or
p.(None): ‘‘(II) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(E) of such section, and in
p.(None): clauses (iii) and (iv) of subsection (j)(5)(F) of such section, is deemed to be three years and six months
p.(None): rather than three years; and
p.(None): ‘‘(ii) if the drug is designated under section 526 for a rare disease or condition, the period referred to in
p.(None): section 527(a) is deemed to be seven years and six months rather than seven years; and
p.(None): ‘‘(B)(i) if the drug is the subject of—
p.(None): ‘‘(I) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii)
p.(None): or (j)(2)(A)(vii)(II) of section 505 and for which pediatric studies were submitted prior to the
p.(None): expiration of the patent (including any patent extensions); or
p.(None): ‘‘(II) a listed patent for which a certification has been submitted under subsections (b)(2)(A)(iii)
p.(None): or (j)(2)(A)(vii)(III) of section 505,
...
p.(None): any patent extensions); or
p.(None): ‘‘(ii) if the drug is the subject of a listed patent for which a certification has been submitted under
p.(None): subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation
p.(None): resulting from the certifi- cation the court determines that the patent is valid and would be infringed,
p.(None): the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B)
p.(None): shall be extended by a period of six months after the date the patent expires (including any patent
p.(None): extensions).
p.(None): ‘‘(2) EXCEPTION.—The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the
p.(None): determination made under subsection (d)(3) is made later than 9 months prior to the expiration of such period.
p.(None): ‘‘(c) MARKET EXCLUSIVITY FOR ALREADY-MARKETED DRUGS.—
p.(None): ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), if the Secretary determines that information
p.(None): relating to the use of an approved drug in the pediatric population may produce health benefits in
p.(None): that population and makes a written request to the holder of an approved application under section
p.(None):
p.(None):
p.(None): 121 STAT. 878 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): 505(b)(1) for pediatric studies (which shall include a timeframe for completing such studies), the holder agrees
p.(None): to the request, such studies are completed using appropriate formulations for each age group for which
p.(None): the study is requested within any such timeframe, and the reports thereof are submitted and accepted in
p.(None): accordance with subsection (d)(3)—
p.(None): ‘‘(A)(i)(I) the period referred to in subsection (c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii) of such
p.(None): section, is deemed to be five years and six months rather than five years, and the references in
p.(None): subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and
p.(None): one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively;
p.(None): or
p.(None): ‘‘(II) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(D) of such section, and in
p.(None): clauses (iii) and (iv) of subsection (j)(5)(F) of such section, is deemed to be three years and six months
p.(None): rather than three years; and
p.(None): ‘‘(ii) if the drug is designated under section 526 for a rare disease or condition, the period referred to in
p.(None): section 527(a) is deemed to be seven years and six months rather than seven years; and
p.(None): ‘‘(B)(i) if the drug is the subject of—
p.(None): ‘‘(I) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii)
p.(None): or (j)(2)(A)(vii)(II) of section 505 and for which pediatric studies were submitted prior to the
p.(None): expiration of the patent (including any patent extensions); or
p.(None): ‘‘(II) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iii)
p.(None): or (j)(2)(A)(vii)(III) of section 505,
...
p.(None): the Federal Food, Drug, and Cosmetic Act; and
p.(None): ‘‘(C) additional studies are needed to assess the safety and effectiveness of the use of the drug in the
p.(None): pediatric population.
p.(None): ‘‘(2) WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICA- TIONS FOR DRUGS LACKING EXCLUSIVITY.—The
p.(None): Commissioner
p.(None): of Food and Drugs, in consultation with the Director of the National Institutes of Health, may issue a
p.(None): written request based on the proposed pediatric study request for the indication or indications submitted pursuant to
p.(None): paragraph (1) (which shall include a timeframe for negotiations for an agreement) for pediatric studies
p.(None): concerning a drug identified under subsection
p.(None): (a) to all holders of an approved application for the drug under section 505 of the Federal Food, Drug, and Cosmetic
p.(None): Act. Such a written request shall be made in a manner equivalent to the manner in which a written
p.(None): request is made under sub- section (b) or (c) of section 505A of such Act, including with respect to
p.(None): information provided on the pediatric studies to be conducted pursuant to the request and using
p.(None): appropriate formulations for each age group for which the study is requested.
p.(None): ‘‘(3) REQUESTS FOR PROPOSALS.—If the Commissioner of Food and Drugs does not receive a response to a written
p.(None): request issued under paragraph (2) not later than 30 days after the date on which a request was issued,
p.(None): the Secretary, acting through the Director of the National Institutes of Health and in consultation with
p.(None): the Commissioner of Food and Drugs, shall publish a request for proposals to conduct the pediatric
p.(None): studies described in the written request in accordance with subsection (b).
p.(None): ‘‘(4) DISQUALIFICATION.—A holder that receives a first right of refusal shall not be entitled to respond to
p.(None): a request for proposals under paragraph (3).
p.(None): ‘‘(5) CONTRACTS, GRANTS, OR OTHER FUNDING MECHA-
p.(None): NISMS.—A contract, grant, or other funding may be awarded under this section only if a proposal is
p.(None): submitted to the Sec- retary in such form and manner, and containing such agree- ments, assurances, and
p.(None): information as the Secretary determines to be necessary to carry out this section.
p.(None): ‘‘(6) REPORTING OF STUDIES.—
p.(None): ‘‘(A) IN GENERAL.—On completion of a pediatric study in accordance with an award under this section, a
p.(None): report concerning the study shall be submitted to the Director of the National Institutes of Health and the
p.(None): Commissioner of Food and Drugs. The report shall include all data gen- erated in connection with the
p.(None): study, including a written request if issued.
p.(None): ‘‘(B) AVAILABILITY OF REPORTS.—Each report submitted under subparagraph (A) shall be considered to be in the
...
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p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public information. Internet.
p.(None):
p.(None):
p.(None): 121 STAT. 906 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(ii) CONTENT.—The clinical trial information required to be submitted under this paragraph for an
p.(None): applicable clinical trial shall include—
p.(None): ‘‘(I) descriptive information, including—
p.(None): ‘‘(aa) a brief title, intended for the lay public;
p.(None): ‘‘(bb) a brief summary, intended for the lay public;
p.(None): ‘‘(cc) the primary purpose; ‘‘(dd) the study design;
p.(None): ‘‘(ee) for an applicable drug clinical trial, the study phase;
p.(None): ‘‘(ff) study type;
p.(None): ‘‘(gg) the primary disease or condition being studied, or the focus of the study;
p.(None): ‘‘(hh) the intervention name and interven- tion type;
p.(None): ‘‘(ii) the study start date;
p.(None): ‘‘(jj) the expected completion date;
p.(None): ‘‘(kk) the target number of subjects; and ‘‘(ll) outcomes, including primary and sec-
p.(None): ondary outcome measures;
p.(None): ‘‘(II) recruitment information, including— ‘‘(aa) eligibility criteria;
p.(None): ‘‘(bb) gender;
p.(None): ‘‘(cc) age limits;
p.(None): ‘‘(dd) whether the trial accepts healthy vol- unteers;
p.(None): ‘‘(ee) overall recruitment status; ‘‘(ff) individual site status; and
p.(None): ‘‘(gg) in the case of an applicable drug clinical trial, if the drug is not approved under section 505 of the
p.(None): Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, specify whether or not
p.(None): there is expanded access to the drug under section 561 of the Federal Food, Drug, and Cosmetic Act for those
p.(None): who do not qualify for enrollment in the clinical trial and how to obtain informa- tion about such access;
p.(None): ‘‘(III) location and contact information, including—
p.(None): ‘‘(aa) the name of the sponsor;
p.(None): ‘‘(bb) the responsible party, by official title;
p.(None):
p.(None): and
p.(None): ‘‘(cc) the facility name and facility contact
p.(None): information (including the city, State, and zip code for each clinical trial location, or a toll- free number
p.(None): through which such location information may be accessed); and
p.(None): ‘‘(IV) administrative data (which the Secretary may make publicly available as necessary), including—
p.(None): ‘‘(aa) the unique protocol identification number;
p.(None): ‘‘(bb) other protocol identification num- bers, if any; and
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 907
p.(None):
p.(None):
p.(None): ‘‘(cc) the Food and Drug Administration IND/IDE protocol number and the record verification date.
p.(None): ‘‘(iii) MODIFICATIONS.—The Secretary may by regu- lation modify the requirements for clinical trial
p.(None): information under this paragraph, if the Secretary pro- vides a rationale for why such a modification improves and
p.(None): does not reduce such clinical trial information. ‘‘(B) FORMAT AND STRUCTURE.—
p.(None): ‘‘(i) SEARCHABLE CATEGORIES.—The Director of NIH shall ensure that the public may, in addition to
p.(None): keyword searching, search the entries in the registry data bank by 1 or more of the following criteria:
p.(None): ‘‘(I) The disease or condition being studied in the clinical trial, using Medical Subject Headers (MeSH)
p.(None): descriptors.
p.(None): ‘‘(II) The name of the intervention, including any drug or device being studied in the clinical trial.
p.(None): ‘‘(III) The location of the clinical trial.
p.(None): ‘‘(IV) The age group studied in the clinical trial, including pediatric subpopulations.
p.(None): ‘‘(V) The study phase of the clinical trial.
p.(None): ‘‘(VI) The sponsor of the clinical trial, which may be the National Institutes of Health or
p.(None): another Federal agency, a private industry source, or a university or other organization.
p.(None): ‘‘(VII) The recruitment status of the clinical trial.
p.(None): ‘‘(VIII) The National Clinical Trial number or other study identification for the clinical trial.
p.(None): ‘‘(ii) ADDITIONAL SEARCHABLE CATEGORY.—Not
p.(None): later than 18 months after the date of the enactment of the Food and Drug Administration Amendments Act
p.(None): of 2007, the Director of NIH shall ensure that the public may search the entries of the registry data bank by
p.(None): the safety issue, if any, being studied in the clinical trial as a primary or secondary outcome.
p.(None): ‘‘(iii) OTHER ELEMENTS.—The Director of NIH shall also ensure that the public may search the entries of the
p.(None): registry data bank by such other elements as the Director deems necessary on an ongoing basis. ‘‘(iv)
p.(None): FORMAT.—The Director of the NIH shall ensure that the registry data bank is easily used by
p.(None): the public, and that entries are easily compared.
p.(None): ‘‘(C) DATA SUBMISSION.—The responsible party for an applicable clinical trial, including an applicable drug
p.(None): clin- ical trial for a serious or life-threatening disease or condi- tion, that is initiated after, or is
...
p.(None): into consideration relevant reports by the Sec- retary’s Advisory Committee on Genetics, Health, and
p.(None): Society and other groups and shall be completed not later than 1 year after the date on which the Secretary
p.(None): entered into such contract.
p.(None): (b) RULE OF CONSTRUCTION.—Nothing in this section shall be construed as requiring Federal efforts with
p.(None): respect to regulatory oversight of genetic tests to cease or be limited or delayed pending completion of the
p.(None): report by the Secretary’s Advisory Committee on Genetics, Health, and Society or the Institute of Medicine.
p.(None): SEC. 1104. NIH TECHNICAL AMENDMENTS.
p.(None): The Public Health Service Act (42 U.S.C. 201 et seq.) is amended—
p.(None): (1) in section 319C–2(j)(3)(B), by striking ‘‘section 319C– 1(h)’’ and inserting ‘‘section 319C–1(i)’’;
p.(None): (2) in section 402(b)(4), by inserting ‘‘minority and other’’ after ‘‘reducing’’;
p.(None): (3) in section 403(a)(4)(C)(iv)(III), by inserting ‘‘and postdoctoral training funded through research
p.(None): grants’’ before the semicolon;
p.(None): (4) by designating the second section 403C (relating to the drug diethylstilbestrol) as section 403D; and
p.(None): (5) in section 403C(a)—
p.(None): (A) in the matter preceding paragraph (1)—
p.(None): (i) by inserting ‘‘graduate students supported by the National Institutes of Health’’ after ‘‘with respect
p.(None): to’’; and
p.(None): (ii) by deleting ‘‘each degree-granting program’’;
p.(None): (B) in paragraph (1), by inserting ‘‘such’’ after ‘‘percent- age of’’; and
p.(None): (C) in paragraph (2), by inserting ‘‘(not including any leaves of absence)’’ after ‘‘average time’’.
p.(None): SEC. 1105. SEVERABILITY CLAUSE.
p.(None): If any provision of this Act, an amendment made this Act, or the application of such provision or
p.(None): amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the
p.(None): amendments made by this Act, and the application of the provisions of such to any person or
p.(None): circumstances shall not be affected thereby.
p.(None): Subtitle B—Antibiotic Access and Innovation
p.(None): SEC. 1111. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE CON- CENTRATIONS OF ANTIMICROBIALS.
p.(None): (a) DEFINITION.—In this section, the term ‘‘clinically susceptible concentrations’’ means specific values which
p.(None): characterize bacteria as clinically susceptible, intermediate, or resistant to the drug (or drugs) tested.
p.(None): (b) IDENTIFICATION.—The Secretary of Health and Human Serv- ices (referred to in this section as the
p.(None): ‘‘Secretary’’), through the Commissioner of Food and Drugs, shall identify (where such
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 247d–3b.
p.(None):
p.(None): 42 USC 282.
p.(None):
p.(None): 42 USC 283.
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 283a–3.
p.(None): 42 USC 283a–2.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 301 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None): (2) CERTAIN ASSESSMENTS AND WAIVER REQUESTS.—An assessment pending on or after the date that is
p.(None): 1 year prior to the date of the enactment of this Act shall be subject to the tracking and disclosure
p.(None): requirements established under such section 505B, as in effect on or after such date of enact- ment,
p.(None): except that any such assessments submitted or waivers of such assessments requested before such date of
p.(None): enactment shall not be subject to subsections (a)(4)(C), (b)(2)(C), (f)(6)(F), and (h) of such section 505B.
p.(None): SEC. 403. ESTABLISHMENT OF INTERNAL COMMITTEE.
p.(None): Chapter V of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 351 et seq.) is amended by inserting after section 505B the following:
p.(None): ‘‘SEC. 505C. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, AND WAIVERS.
p.(None): ‘‘The Secretary shall establish an internal committee within the Food and Drug Administration to carry
p.(None): out the activities as described in sections 505A(f) and 505B(f). Such internal committee shall include employees of
p.(None): the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of
p.(None): Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, and the
p.(None): appropriate expertise per- taining to the pediatric product under review, such as expertise in child and
p.(None): adolescent psychiatry, and other individuals designated by the Secretary.’’.
p.(None): SEC. 404. GOVERNMENT ACCOUNTABILITY OFFICE REPORT.
p.(None): Not later than January 1, 2011, the Comptroller General of the United States, in consultation with the
p.(None): Secretary of Health and Human Services, shall submit to the Congress a report that addresses the
p.(None): effectiveness of sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and
p.(None): section 409I of the Public Health Service Act (42 U.S.C. 284m) in ensuring that medicines used by children are
p.(None): tested and properly labeled. Such report shall include—
p.(None): (1) the number and importance of drugs and biological products for children that are being tested as a
p.(None): result of the amendments made by this title and title V and the importance
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Establishment. 21 USC 355d.
p.(None):
p.(None):
p.(None): 121 STAT. 876 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): for children, health care providers, parents, and others of labeling changes made as a result of such
p.(None): testing;
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p.(None): Sec. 224. Electronic registration and listing.
p.(None): Sec. 225. Report by Government Accountability Office. Sec. 226. Unique device identification system.
p.(None): Sec. 227. Frequency of reporting for certain devices.
p.(None):
p.(None): Sept. 27, 2007
p.(None): [H.R. 3580]
p.(None):
p.(None):
p.(None): Food and Drug Administration Amendments Act of 2007.
p.(None): 21 USC 301 note.
p.(None):
p.(None):
p.(None): 121 STAT. 824 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): Sec. 228. Inspections by accredited persons.
p.(None): Sec. 229. Study of nosocomial infections relating to medical devices.
p.(None): Sec. 230. Report by the Food and Drug Administration regarding labeling informa- tion on the relationship between
p.(None): the use of indoor tanning devices and development of skin cancer or other skin damage.
p.(None): TITLE III—PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007
p.(None): Sec. 301. Short title.
p.(None): Sec. 302. Tracking pediatric device approvals.
p.(None): Sec. 303. Modification to humanitarian device exemption. Sec. 304. Encouraging pediatric medical device research.
p.(None): Sec. 305. Demonstration grants for improving pediatric device availability.
p.(None): Sec. 306. Amendments to office of pediatric therapeutics and pediatric advisory committee.
p.(None): Sec. 307. Postmarket surveillance.
p.(None): TITLE IV—PEDIATRIC RESEARCH EQUITY ACT OF 2007
p.(None): Sec. 401. Short title.
p.(None): Sec. 402. Reauthorization of Pediatric Research Equity Act. Sec. 403. Establishment of internal committee.
p.(None): Sec. 404. Government Accountability Office report.
p.(None): TITLE V—BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007
p.(None): Sec. 501. Short title.
p.(None): Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act. Sec. 503. Training of pediatric
p.(None): pharmacologists.
p.(None): TITLE VI—REAGAN-UDALL FOUNDATION
p.(None): Sec. 601. The Reagan-Udall Foundation for the Food and Drug Administration. Sec. 602. Office of the Chief
p.(None): Scientist.
p.(None): Sec. 603. Critical path public-private partnerships.
p.(None): TITLE VII—CONFLICTS OF INTEREST
p.(None): Sec. 701. Conflicts of interest.
p.(None): TITLE VIII—CLINICAL TRIAL DATABASES
p.(None): Sec. 801. Expanded clinical trial registry data bank.
p.(None): TITLE IX—ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS
p.(None): Subtitle A—Postmarket Studies and Surveillance
p.(None): Sec. 901. Postmarket studies and clinical trials regarding human drugs; risk eval- uation and mitigation
p.(None): strategies.
p.(None): Sec. 902. Enforcement.
p.(None): Sec. 903. No effect on withdrawal or suspension of approval. Sec. 904. Benefit-risk assessments.
p.(None): Sec. 905. Active postmarket risk identification and analysis.
p.(None): Sec. 906. Statement for inclusion in direct-to-consumer advertisements of drugs. Sec. 907. No effect on veterinary
p.(None): medicine.
p.(None): Sec. 908. Authorization of appropriations. Sec. 909. Effective date and applicability.
p.(None): Subtitle B—Other Provisions to Ensure Drug Safety and Surveillance Sec. 911. Clinical trial guidance for antibiotic
p.(None): drugs.
p.(None): Sec. 912. Prohibition against food to which drugs or biological products have been added.
p.(None): Sec. 913. Assuring pharmaceutical safety.
p.(None): Sec. 914. Citizen petitions and petitions for stay of agency action.
...
p.(None): ‘‘(iv) The request for such exemption is submitted on or before October 1, 2012.
p.(None): ‘‘(B) The Secretary may inspect the records relating to the number of devices distributed during any calendar
p.(None): year of a person granted an exemption under paragraph (2) for which the prohibition in paragraph (3) does not apply.
p.(None): ‘‘(C) A person may petition the Secretary to modify the annual distribution number specified by the Secretary under
p.(None): subparagraph (A)(ii) with respect to a device if additional information on the number of individuals
p.(None): affected by the disease or condition arises, and the Secretary may modify such number but in no case
p.(None): shall the annual distribution number exceed the number identified in paragraph (2)(A).
p.(None): ‘‘(D) If a person notifies the Secretary, or the Secretary deter- mines through an inspection under
p.(None): subparagraph (B), that the number of devices distributed during any calendar year exceeds the annual
p.(None): distribution number, as required under subparagraph (A)(iii), and modified under subparagraph (C), if
p.(None): applicable, then the prohibition in paragraph (3) shall apply with respect to such person for such device
p.(None): for any sales of such device after such notification.
p.(None): ‘‘(E)(i) In this subsection, the term ‘pediatric patients’ means patients who are 21 years of age or
p.(None): younger at the time of the diagnosis or treatment.
p.(None): ‘‘(ii) In this subsection, the term ‘pediatric subpopulation’ means 1 of the following populations:
p.(None): ‘‘(I) Neonates.
p.(None): ‘‘(II) Infants.
p.(None): ‘‘(III) Children. ‘‘(IV) Adolescents.
p.(None): ‘‘(7) The Secretary shall refer any report of an adverse event regarding a device for which the
p.(None): prohibition under paragraph (3) does not apply pursuant to paragraph (6)(A) that the Secretary receives to
p.(None): the Office of Pediatric Therapeutics, established under section 6 of the Best Pharmaceuticals for
p.(None): Children Act (Public Law 107–109). In considering the report, the Director of the Office of Pediatric Therapeutics,
p.(None): in consultation with experts in the Center for Devices and Radiological Health, shall provide for periodic
p.(None): review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such
p.(None): committee regarding whether the Secretary should take action under this Act in response to the report.
p.(None): ‘‘(8) The Secretary, acting through the Office of Pediatric Thera- peutics and the Center for Devices and
p.(None): Radiological Health, shall provide for an annual review by the Pediatric Advisory Committee
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Notification.
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Applicability.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Annual review.
p.(None):
p.(None):
p.(None): 121 STAT. 862 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): of all devices described in paragraph (6) to ensure that the exemp- tion under paragraph (2) remains appropriate
p.(None): for the pediatric populations for which it is granted.’’.
p.(None): (b) REPORT.—Not later than January 1, 2012, the Comptroller General of the United States shall submit to
p.(None): the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representa- tives a report on the impact of allowing persons granted an exemp- tion
p.(None): under section 520(m)(2) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C. 360j(m)(2)) with
p.(None): respect to a device to profit from such device pursuant to section 520(m)(6) of such Act (21
p.(None): U.S.C. 360j(m)(6)) (as amended by subsection (a)), including—
p.(None): (1) an assessment of whether such section 520(m)(6) (as amended by subsection (a)) has increased the
p.(None): availability of pediatric devices for conditions that occur in small numbers of children, including any
p.(None): increase or decrease in the number of—
p.(None): (A) exemptions granted under such section 520(m)(2) for pediatric devices; and
p.(None): (B) applications approved under section 515 of such Act (21 U.S.C. 360e) for devices intended to treat,
p.(None): diagnose, or cure conditions that occur in pediatric patients or for devices labeled for use in a pediatric
p.(None): population;
p.(None): (2) the conditions or diseases the pediatric devices were intended to treat or diagnose and the
p.(None): estimated size of the pediatric patient population for each condition or disease;
p.(None): (3) the costs of purchasing pediatric devices, based on a representative sampling of children’s hospitals;
p.(None): (4) the extent to which the costs of such devices are covered by health insurance;
p.(None): (5) the impact, if any, of allowing profit on access to such devices for patients;
p.(None): (6) the profits made by manufacturers for each device that receives an exemption;
p.(None): (7) an estimate of the extent of the use of the pediatric devices by both adults and pediatric populations
p.(None): for a condition or disease other than the condition or disease on the label of such devices;
p.(None): (8) recommendations of the Comptroller General of the United States regarding the effectiveness of
p.(None): such section 520(m)(6) (as amended by subsection (a)) and whether any modifications to such section
p.(None): 520(m)(6) (as amended by sub- section (a)) should be made;
p.(None): (9) existing obstacles to pediatric device development; and
p.(None): (10) an evaluation of the demonstration grants described in section 305, which shall include an evaluation of
p.(None): the number of pediatric medical devices—
p.(None): (A) that have been or are being studied in children;
p.(None):
p.(None): and
p.(None): (B) that have been submitted to the Food and Drug
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): 21 USC 360j
p.(None): note.
p.(None): Administration for approval, clearance, or review under such section 520(m) (as amended by this Act) and
p.(None): any regulatory actions taken.
p.(None): (c) GUIDANCE.—Not later than 180 days after the date of the enactment of this Act, the Commissioner of
p.(None): Food and Drugs shall issue guidance for institutional review committees on how to evaluate requests
p.(None): for approval for devices for which a humanitarian
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 863
p.(None):
p.(None):
p.(None): device exemption under section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) has been
p.(None): granted.
p.(None): SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH.
p.(None): (a) CONTACT POINT FOR AVAILABLE FUNDING.—Section 402(b) of the Public Health Service Act (42 U.S.C.
p.(None): 282(b)) is amended—
p.(None): (1) in paragraph (21), by striking ‘‘and’’ after the semicolon at the end;
p.(None): (2) in paragraph (22), by striking the period at the end and inserting ‘‘; and’’; and
p.(None): (3) by inserting after paragraph (22) the following:
p.(None): ‘‘(23) shall designate a contact point or office to help innovators and physicians identify sources
p.(None): of funding available for pediatric medical device development.’’.
p.(None): (b) PLAN FOR PEDIATRIC MEDICAL DEVICE RESEARCH.—
p.(None): (1) IN GENERAL.—Not later than 180 days after the date of the enactment of this Act, the Secretary of
...
p.(None): shall—
p.(None): (A) coordinate with the National Institutes of Health’s pediatric device contact point or office, designated
p.(None): under section 402(b)(23) of the Public Health Service Act, as added by section 304(a) of this Act; and
p.(None): (B) provide to the National Institutes of Health any identified pediatric device needs that the consortium
p.(None): lacks sufficient capacity to address or those needs in which the consortium has been unable to stimulate
p.(None): manufacturer interest.
p.(None): (2) FOOD AND DRUG ADMINISTRATION.—Each consortium that receives a grant or contract under this section shall
p.(None): coordi- nate with the Commissioner of Food and Drugs and device companies to facilitate the application for
p.(None): approval or clearance of devices labeled for pediatric use.
p.(None):
p.(None): Reports.
p.(None): (3) EFFECTIVENESS AND OUTCOMES.—Each consortium that
p.(None): receives a grant or contract under this section shall annually report to the Secretary of Health and
p.(None): Human Services on the status of pediatric device development, production, and distribution that has been
p.(None): facilitated by the consortium.
p.(None): (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.(None): $6,000,000 for each of fiscal years 2008 through 2012.
p.(None): SEC. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND PEDIATRIC ADVISORY COMMITTEE.
p.(None): (a) OFFICE OF PEDIATRIC THERAPEUTICS.—Section 6(b) of the Best Pharmaceuticals for Children Act (21
p.(None): U.S.C. 393a(b)) is amended by inserting ‘‘, including increasing pediatric access to medical devices’’
p.(None): after ‘‘pediatric issues’’.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 865
p.(None):
p.(None): (b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C.
p.(None): 284m note) is amended—
p.(None): (1) in subsection (a), by inserting ‘‘(including drugs and biological products) and medical devices’’
p.(None): after ‘‘therapeutics’’; and
p.(None): (2) in subsection (b)—
p.(None): (A) in paragraph (1), by inserting ‘‘(including drugs and biological products) and medical devices’’ after
p.(None): ‘‘thera- peutics’’; and
p.(None): (B) in paragraph (2)—
p.(None): (i) in subparagraph (A), by striking ‘‘and 505B’’ and inserting ‘‘505B, 510(k), 515, and 520(m)’’;
p.(None): (ii) by striking subparagraph (B) and inserting the following:
p.(None): ‘‘(B) identification of research priorities related to therapeutics (including drugs and biological
p.(None): products) and medical devices for pediatric populations and the need for additional diagnostics and treatments
p.(None): for specific pediatric diseases or conditions;’’; and
p.(None): (iii) in subparagraph (C), by inserting ‘‘(including drugs and biological products) and medical devices’’
p.(None): after ‘‘therapeutics’’.
p.(None): SEC. 307. POSTMARKET SURVEILLANCE.
p.(None): Section 522 of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 360l) is amended—
p.(None): (1) by amending the section heading and designation to read as follows:
p.(None): ‘‘SEC. 522. POSTMARKET SURVEILLANCE.’’;
p.(None): (2) by striking subsection (a) and inserting the following: ‘‘(a) POSTMARKET SURVEILLANCE.—
p.(None): ‘‘(1) IN GENERAL.—
p.(None): ‘‘(A) CONDUCT.—The Secretary may by order require a manufacturer to conduct postmarket surveillance for any
p.(None): device of the manufacturer that is a class II or class III device—
p.(None): ‘‘(i) the failure of which would be reasonably likely to have serious adverse health consequences;
...
p.(None): U.S.C. 351 et seq.) is amended by inserting after section 505B the following:
p.(None): ‘‘SEC. 505C. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, AND WAIVERS.
p.(None): ‘‘The Secretary shall establish an internal committee within the Food and Drug Administration to carry
p.(None): out the activities as described in sections 505A(f) and 505B(f). Such internal committee shall include employees of
p.(None): the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of
p.(None): Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, and the
p.(None): appropriate expertise per- taining to the pediatric product under review, such as expertise in child and
p.(None): adolescent psychiatry, and other individuals designated by the Secretary.’’.
p.(None): SEC. 404. GOVERNMENT ACCOUNTABILITY OFFICE REPORT.
p.(None): Not later than January 1, 2011, the Comptroller General of the United States, in consultation with the
p.(None): Secretary of Health and Human Services, shall submit to the Congress a report that addresses the
p.(None): effectiveness of sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and
p.(None): section 409I of the Public Health Service Act (42 U.S.C. 284m) in ensuring that medicines used by children are
p.(None): tested and properly labeled. Such report shall include—
p.(None): (1) the number and importance of drugs and biological products for children that are being tested as a
p.(None): result of the amendments made by this title and title V and the importance
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Establishment. 21 USC 355d.
p.(None):
p.(None):
p.(None): 121 STAT. 876 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): for children, health care providers, parents, and others of labeling changes made as a result of such
p.(None): testing;
p.(None): (2) the number and importance of drugs and biological products for children that are not being tested
p.(None): for their use notwithstanding the provisions of this title and title V and possible reasons for the lack of
p.(None): testing;
p.(None): (3) the number of drugs and biological products for which testing is being done and labeling changes
p.(None): required, including the date labeling changes are made and which labeling changes required the use of the dispute
p.(None): resolution process established pursuant to the amendments made by this title, together with a description of the
p.(None): outcomes of such process, including a description of the disputes and the recommendations of the Pediatric
p.(None): Advisory Committee;
p.(None): (4) any recommendations for modifications to the programs established under sections 505A and 505B of the Federal Food,
p.(None): Drug, and Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public Health Service Act (42 U.S.C.
p.(None): 284m) that the Secretary determines to be appropriate, including a detailed rationale for each recommendation;
p.(None): and
p.(None): (5)(A) the efforts made by the Secretary to increase the number of studies conducted in the neonate
p.(None): population; and
p.(None): (B) the results of those efforts, including efforts made to encourage the conduct of appropriate studies
p.(None): in neonates by companies with products that have sufficient safety and other information to make the
p.(None): conduct of the studies ethical and safe.
p.(None):
p.(None):
p.(None): Best Pharmaceuticals for Children Act of 2007.
p.(None): 21 USC 301 note.
p.(None): TITLE V—BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007
p.(None): SEC. 501. SHORT TITLE.
p.(None): This title may be cited as the ‘‘Best Pharmaceuticals for Chil- dren Act of 2007’’.
p.(None): SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHIL- DREN ACT.
p.(None): (a) PEDIATRIC STUDIES OF DRUGS.—
p.(None): (1) IN GENERAL.—Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended to read
p.(None): as follows:
p.(None): ‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
p.(None): ‘‘(a) DEFINITIONS.—As used in this section, the term ‘pediatric studies’ or ‘studies’ means at least one
p.(None): clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic studies) in pediatric age
p.(None): groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the
p.(None): discretion of the Secretary, may include preclinical studies.
p.(None): ‘‘(b) MARKET EXCLUSIVITY FOR NEW DRUGS.—
p.(None): ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), if, prior to approval of an application that is
p.(None): submitted under section 505(b)(1), the Secretary determines that information relating to the use of a new
p.(None): drug in the pediatric population may produce health benefits in that population, the Secretary makes a
p.(None): written request for pediatric studies (which shall
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 877
p.(None):
...
p.(None): subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation
p.(None): resulting from the certifi- cation the court determines that the patent is valid and would be infringed,
p.(None): the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B)
p.(None): shall be extended by a period of six months after the date the patent expires (including any patent
p.(None): extensions).
p.(None): ‘‘(2) EXCEPTION.—The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the
p.(None): determination made under subsection (d)(3) is made later than 9 months prior to the expiration of such period.
p.(None): ‘‘(d) CONDUCT OF PEDIATRIC STUDIES.— ‘‘(1) REQUEST FOR STUDIES.—
p.(None): ‘‘(A) IN GENERAL.—The Secretary may, after consulta- tion with the sponsor of an application for an
p.(None): investiga- tional new drug under section 505(i), the sponsor of an application for a new drug under
p.(None): section 505(b)(1), or the
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 879
p.(None):
p.(None):
p.(None): holder of an approved application for a drug under section 505(b)(1), issue to the sponsor or holder a written
p.(None): request for the conduct of pediatric studies for such drug. In issuing such request, the Secretary shall take
p.(None): into account ade- quate representation of children of ethnic and racial minori- ties. Such request to conduct
p.(None): pediatric studies shall be in writing and shall include a timeframe for such studies and a request to the
p.(None): sponsor or holder to propose pediatric labeling resulting from such studies.
p.(None): ‘‘(B) SINGLE WRITTEN REQUEST.—A single written request—
p.(None): ‘‘(i) may relate to more than one use of a drug;
p.(None):
p.(None):
p.(None): Minorities.
p.(None):
p.(None):
p.(None): Timeframe.
p.(None):
p.(None): and
p.(None): ‘‘(ii) may include uses that are both approved and
p.(None):
p.(None): unapproved.
p.(None): ‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUDIES.— ‘‘(A) REQUEST AND RESPONSE.—
p.(None): ‘‘(i) IN GENERAL.—If the Secretary makes a written request for pediatric studies (including neonates, as
p.(None): appropriate) under subsection (b) or (c), the applicant or holder, not later than 180 days after
p.(None): receiving the written request, shall respond to the Secretary as to the intention of the applicant or
p.(None): holder to act on the request by—
p.(None): ‘‘(I) indicating when the pediatric studies will be initiated, if the applicant or holder agrees to the
p.(None): request; or
p.(None): ‘‘(II) indicating that the applicant or holder does not agree to the request and stating the rea- sons for
p.(None): declining the request.
p.(None): ‘‘(ii) DISAGREE WITH REQUEST.—If, on or after the date of the enactment of the Best Pharmaceuticals for
p.(None): Children Act of 2007, the applicant or holder does not agree to the request on the grounds that it
p.(None): is not possible to develop the appropriate pediatric formu- lation, the applicant or holder shall submit to the
p.(None): Secretary the reasons such pediatric formulation cannot be developed.
p.(None): ‘‘(B) ADVERSE EVENT REPORTS.—An applicant or holder that, on or after the date of the enactment of the Best
p.(None): Pharmaceuticals for Children Act of 2007, agrees to the request for such studies shall provide the
p.(None): Secretary, at the same time as the submission of the reports of such studies, with all postmarket
p.(None): adverse event reports regarding the drug that is the subject of such studies and are available prior to
p.(None): submission of such reports.
p.(None): ‘‘(3) MEETING THE STUDIES REQUIREMENT.—Not later than
p.(None): 180 days after the submission of the reports of the studies, the Secretary shall accept or reject such
p.(None): reports and so notify the sponsor or holder. The Secretary’s only responsibility in accepting or rejecting
p.(None): the reports shall be to determine, within the 180-day period, whether the studies fairly respond to the
p.(None): written request, have been conducted in accordance with com- monly accepted scientific principles and
p.(None): protocols, and have been reported in accordance with the requirements of the Sec- retary for filing.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Notification.
p.(None):
p.(None):
p.(None): 121 STAT. 880 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(4) EFFECT OF SUBSECTION.—Nothing in this subsection alters or amends section 301(j) of this Act or
p.(None): section 552 of title 5 or section 1905 of title 18, United States Code.
p.(None): ‘‘(e) NOTICE OF DETERMINATIONS ON STUDIES REQUIREMENT.—
p.(None):
p.(None): Publication.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Records.
p.(None):
p.(None):
p.(None): Publication.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public information. Website.
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall publish a notice of any determination, made on or after the date
p.(None): of the enact- ment of the Best Pharmaceuticals for Children Act of 2007, that the requirements of
p.(None): subsection (d) have been met and that submissions and approvals under subsection (b)(2) or (j) of section
p.(None): 505 for a drug will be subject to the provisions of this section. Such notice shall be published not
p.(None): later than
p.(None): 30 days after the date of the Secretary’s determination regarding market exclusivity and shall
p.(None): include a copy of the written request made under subsection (b) or (c).
p.(None): ‘‘(2) IDENTIFICATION OF CERTAIN DRUGS.—The Secretary
p.(None): shall publish a notice identifying any drug for which, on or after the date of the enactment of the
p.(None): Best Pharmaceuticals for Children Act of 2007, a pediatric formulation was developed, studied, and found to be
p.(None): safe and effective in the pediatric population (or specified subpopulation) if the pediatric formula- tion for
p.(None): such drug is not introduced onto the market within one year after the date that the Secretary publishes the
p.(None): notice described in paragraph (1). Such notice identifying such drug shall be published not later than 30
p.(None): days after the date of the expiration of such one year period.
p.(None): ‘‘(f) INTERNAL REVIEW OF WRITTEN REQUESTS AND PEDIATRIC STUDIES.—
p.(None): ‘‘(1) INTERNAL REVIEW.—The Secretary shall utilize the internal review committee established under section
p.(None): 505C to review all written requests issued on or after the date of the enactment of the Best
p.(None): Pharmaceuticals for Children Act of 2007, in accordance with paragraph (2).
p.(None): ‘‘(2) REVIEW OF WRITTEN REQUESTS.—The committee
p.(None): referred to in paragraph (1) shall review all written requests issued pursuant to this section prior to being
p.(None): issued.
p.(None): ‘‘(3) REVIEW OF PEDIATRIC STUDIES.—The committee
p.(None): referred to in paragraph (1) may review studies conducted pursuant to this section to make a
p.(None): recommendation to the Secretary whether to accept or reject such reports under sub- section (d)(3).
p.(None): ‘‘(4) ACTIVITY BY COMMITTEE.—The committee referred to in paragraph (1) may operate using appropriate
p.(None): members of such committee and need not convene all members of the com- mittee.
p.(None): ‘‘(5) DOCUMENTATION OF COMMITTEE ACTION.—For each
p.(None): drug, the committee referred to in paragraph (1) shall docu- ment, for each activity described in paragraph
p.(None): (2) or (3), which members of the committee participated in such activity.
p.(None): ‘‘(6) TRACKING PEDIATRIC STUDIES AND LABELING
p.(None): CHANGES.—The Secretary, in consultation with the committee referred to in paragraph (1), shall track and
p.(None): make available to the public, in an easily accessible manner, including through posting on the Web site of the Food
p.(None): and Drug Administration— ‘‘(A) the number of studies conducted under this section
p.(None): and under section 409I of the Public Health Service Act; ‘‘(B) the specific drugs and drug uses, including
p.(None): labeled and off-labeled indications, studied under such sections;
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 881
p.(None):
p.(None):
p.(None): ‘‘(C) the types of studies conducted under such sections, including trial design, the number of pediatric
p.(None): patients studied, and the number of centers and countries involved; ‘‘(D) the number of pediatric formulations
p.(None): developed and the number of pediatric formulations not developed and the reasons such formulations were
p.(None): not developed; ‘‘(E) the labeling changes made as a result of studies
p.(None): conducted under such sections;
p.(None): ‘‘(F) an annual summary of labeling changes made as a result of studies conducted under such sections
p.(None): for distribution pursuant to subsection (k)(2); and
p.(None): ‘‘(G) information regarding reports submitted on or after the date of the enactment of the Best Pharmaceuticals
p.(None): for Children Act of 2007.
p.(None): ‘‘(g) LIMITATIONS.—Notwithstanding subsection (c)(2), a drug to which the six-month period under subsection (b)
p.(None): or (c) has already been applied—
p.(None): ‘‘(1) may receive an additional six-month period under sub- section (c)(1)(A)(i)(II) for a supplemental application if
p.(None): all other requirements under this section are satisfied, except that such drug may not receive any additional
p.(None): such period under sub- section (c)(1)(B); and
p.(None): ‘‘(2) may not receive any additional such period under subsection (c)(1)(A)(ii).
p.(None): ‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH REQUIREMENTS.—
p.(None): Notwithstanding any other provision of law, if any pediatric study is required by a provision of law (including
p.(None): a regulation) other than this section and such study meets the completeness, timeliness, and other requirements of
p.(None): this section, such study shall be deemed to satisfy the requirement for market exclusivity pursuant to this
p.(None): section.
p.(None): ‘‘(i) LABELING CHANGES.—
p.(None): ‘‘(1) PRIORITY STATUS FOR PEDIATRIC APPLICATIONS AND
p.(None): SUPPLEMENTS.—Any application or supplement to an applica- tion under section 505 proposing a labeling change as a
p.(None): result of any pediatric study conducted pursuant to this section— ‘‘(A) shall be considered to be a
p.(None): priority application
p.(None): or supplement; and
p.(None): ‘‘(B) shall be subject to the performance goals estab- lished by the Commissioner for priority drugs.
p.(None): ‘‘(2) DISPUTE RESOLUTION.—
p.(None): ‘‘(A) REQUEST FOR LABELING CHANGE AND FAILURE TO
p.(None): AGREE.—If, on or after the date of the enactment of the Best Pharmaceuticals for Children Act of
p.(None): 2007, the Commissioner determines that the sponsor and the Commissioner have been unable to reach
p.(None): agreement on appropriate changes to the labeling for the drug that is the subject of the application,
p.(None): not later than 180 days after the date of submission of the application—
p.(None): ‘‘(i) the Commissioner shall request that the sponsor of the application make any labeling change
p.(None): that the Commissioner determines to be appropriate; and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None): ‘‘(ii) if the sponsor of the application does not agree within 30 days after the Commissioner’s request to
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 882 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): make a labeling change requested by the Commis- sioner, the Commissioner shall refer the matter to the
p.(None): Pediatric Advisory Committee.
p.(None): ‘‘(B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.—
p.(None):
p.(None): Deadline.
p.(None): Not later than 90 days after receiving a referral under subparagraph (A)(ii), the Pediatric Advisory
p.(None): Committee shall—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Public information.
p.(None): ‘‘(i) review the pediatric study reports; and
p.(None): ‘‘(ii) make a recommendation to the Commissioner concerning appropriate labeling changes, if any.
p.(None): ‘‘(C) CONSIDERATION OF RECOMMENDATIONS.—The
p.(None): Commissioner shall consider the recommendations of the Pediatric Advisory Committee and, if appropriate, not
p.(None): later than 30 days after receiving the recommendation, make a request to the sponsor of the application
p.(None): to make any labeling change that the Commissioner determines to be appropriate.
p.(None): ‘‘(D) MISBRANDING.—If the sponsor of the application, within 30 days after receiving a request under
p.(None): subpara- graph (C), does not agree to make a labeling change requested by the Commissioner, the
p.(None): Commissioner may deem the drug that is the subject of the application to be misbranded.
p.(None): ‘‘(E) NO EFFECT ON AUTHORITY.—Nothing in this sub- section limits the authority of the United States to
p.(None): bring an enforcement action under this Act when a drug lacks appropriate pediatric labeling. Neither course of
p.(None): action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence)
p.(None): shall preclude, delay, or serve as the basis to stay the other course of action.
p.(None): ‘‘(j) OTHER LABELING CHANGES.—If, on or after the date of the enactment of the Best Pharmaceuticals
p.(None): for Children Act of 2007, the Secretary determines that a pediatric study conducted under this section
p.(None): does or does not demonstrate that the drug that is the subject of the study is safe and effective,
p.(None): including whether such study results are inconclusive, in pediatric populations or subpopulations, the Secretary
p.(None): shall order the labeling of such product to include information about the results of the study and a
p.(None): statement of the Secretary’s determination.
p.(None): ‘‘(k) DISSEMINATION OF PEDIATRIC INFORMATION.—
p.(None): ‘‘(1) IN GENERAL.—Not later than 210 days after the date of submission of a report on a pediatric study under
p.(None): this section, the Secretary shall make available to the public the medical, statistical, and clinical
p.(None): pharmacology reviews of pediatric studies conducted under subsection (b) or (c).
p.(None): ‘‘(2) DISSEMINATION OF INFORMATION REGARDING LABELING
p.(None): CHANGES.—Beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the
p.(None): Secretary shall include as a requirement of a written request that the sponsors of the studies that result in labeling
p.(None): changes that are reflected in the annual summary developed pursuant to subsection (f)(3)(F) distribute,
p.(None): at least annually (or more frequently if the Secretary determines that it would be beneficial to the
p.(None): public health), such information to physicians and other health care providers.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 883
p.(None):
p.(None):
p.(None): ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection alters or amends section 301(j) of this Act or
p.(None): section 552 of title 5 or section 1905 of title 18, United States Code.
p.(None): ‘‘(l) ADVERSE EVENT REPORTING.—
p.(None): ‘‘(1) REPORTING IN YEAR ONE.—Beginning on the date of the enactment of the Best Pharmaceuticals for
p.(None): Children Act of 2007, during the one-year period beginning on the date a labeling change is approved
p.(None): pursuant to subsection (i), the Secretary shall ensure that all adverse event reports that have been received for
p.(None): such drug (regardless of when such report was received) are referred to the Office of Pediatric Thera-
p.(None): peutics established under section 6 of the Best Pharmaceuticals for Children Act (Public Law 107–109). In
p.(None): considering the reports, the Director of such Office shall provide for the review of the reports by the Pediatric
p.(None): Advisory Committee, including obtaining any recommendations of such Committee regarding whether the
p.(None): Secretary should take action under this Act in response to such reports.
p.(None): ‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Following the one-
p.(None): year period described in paragraph (1), the Secretary shall, as appropriate, refer to the Office of
p.(None): Pediatric Therapeutics all pediatric adverse event reports for a drug for which a pediatric study was
p.(None): conducted under this section. In considering such reports, the Director of such Office may provide for the
p.(None): review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of such
p.(None): Committee regarding whether the Secretary should take action in response to such reports.
p.(None): ‘‘(3) EFFECT.—The requirements of this subsection shall supplement, not supplant, other review of such
p.(None): adverse event reports by the Secretary.
p.(None): ‘‘(m) CLARIFICATION OF INTERACTION OF MARKET EXCLUSIVITY UNDER THIS SECTION AND MARKET EXCLUSIVITY AWARDED
p.(None): TO AN APPLICANT FOR APPROVAL OF A DRUG UNDER SECTION 505(j).—
p.(None): If a 180-day period under section 505(j)(5)(B)(iv) overlaps with a 6-month exclusivity period under
p.(None): this section, so that the applicant for approval of a drug under section 505(j) entitled to the
p.(None): 180-day period under that section loses a portion of the 180- day period to which the applicant is
p.(None): entitled for the drug, the 180-day period shall be extended from—
p.(None): ‘‘(1) the date on which the 180-day period would have expired by the number of days of the overlap,
p.(None): if the 180- day period would, but for the application of this subsection, expire after the 6-month
p.(None): exclusivity period; or
p.(None): ‘‘(2) the date on which the 6-month exclusivity period expires, by the number of days of the overlap
p.(None): if the 180- day period would, but for the application of this subsection, expire during the six-month
p.(None): exclusivity period.
p.(None): ‘‘(n) REFERRAL IF PEDIATRIC STUDIES NOT COMPLETED.—
p.(None): ‘‘(1) IN GENERAL.—Beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007,
p.(None): if pedi- atric studies of a drug have not been completed under sub- section (d) and if the Secretary,
p.(None): through the committee estab- lished under section 505C, determines that there is a continuing need for information
p.(None): relating to the use of the drug in the pediatric population (including neonates, as appropriate), the
p.(None): Secretary shall carry out the following:
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Effective date.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Effective date.
p.(None):
p.(None):
p.(None): 121 STAT. 884 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(A) For a drug for which a listed patent has not expired, make a determination regarding whether
p.(None): an assessment shall be required to be submitted under section
p.(None):
p.(None): Deadline. Certification.
p.(None): 505B(b). Prior to making such a determination, the Sec- retary may not take more than 30 days to certify
p.(None): whether the Foundation for the National Institutes of Health has sufficient funding at the time of such
...
p.(None): labeling as described in paragraph
p.(None): (1) include—
p.(None): ‘‘(A) a statement that, because of marketing exclusivity for a manufacturer—
p.(None): ‘‘(i) the drug is not labeled for pediatric use; or ‘‘(ii) in the case of a drug for which there is
p.(None): an additional pediatric use not referred to in paragraph (1), the drug is not labeled for the pediatric use
p.(None): under
p.(None): paragraph (1); and
p.(None): ‘‘(B) a statement of any appropriate pediatric contra- indications, warnings, or precautions that the
p.(None): Secretary considers necessary.
p.(None): ‘‘(3) PRESERVATION OF PEDIATRIC EXCLUSIVITY AND OTHER
p.(None): PROVISIONS.—This subsection does not affect—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 885
p.(None):
p.(None):
p.(None): ‘‘(A) the availability or scope of exclusivity under this section;
p.(None): ‘‘(B) the availability or scope of exclusivity under sec- tion 505 for pediatric formulations;
p.(None): ‘‘(C) the question of the eligibility for approval of any application under section 505(j) that omits any
p.(None): other condi- tions of approval entitled to exclusivity under clause (iii) or (iv) of section 505(j)(5)(F); or
p.(None): ‘‘(D) except as expressly provided in paragraphs (1) and (2), the operation of section 505.
p.(None): ‘‘(p) INSTITUTE OF MEDICINE STUDY.—Not later than 3 years after the date of the enactment of the Best
p.(None): Pharmaceuticals for Children Act of 2007, the Secretary shall enter into a contract with the Institute
p.(None): of Medicine to conduct a study and report to Congress regarding the written requests made and the
p.(None): studies conducted pursuant to this section. The Institute of Medicine may devise an appropriate mechanism to
p.(None): review a representative sample of requests made and studies conducted pursuant to this section in order to
p.(None): conduct such study. Such study shall—
p.(None): ‘‘(1) review such representative written requests issued by the Secretary since 1997 under subsections (b) and (c);
p.(None): ‘‘(2) review and assess such representative pediatric studies conducted under subsections (b) and (c) since 1997 and
p.(None): labeling changes made as a result of such studies;
p.(None): ‘‘(3) review the use of extrapolation for pediatric subpopula- tions, the use of alternative endpoints for pediatric
p.(None): populations, neonatal assessment tools, and ethical issues in pediatric clin- ical trials;
p.(None): ‘‘(4) review and assess the pediatric studies of biological products as required under subsections (a)
p.(None): and (b) of section 505B; and
p.(None): ‘‘(5) make recommendations regarding appropriate incen- tives for encouraging pediatric studies of biologics.
p.(None): ‘‘(q) SUNSET.—A drug may not receive any 6-month period under subsection (b) or (c) unless—
p.(None): ‘‘(1) on or before October 1, 2012, the Secretary makes a written request for pediatric studies of the drug;
p.(None): ‘‘(2) on or before October 1, 2012, an application for the drug is accepted for filing under section 505(b);
p.(None): and
...
p.(None): Cosmetic Act, as in effect on the day before the date of the enactment of this Act, which has been
p.(None): accepted and for which no determination under subsection (d)(2) of such section has been made before such date of
p.(None): enactment, shall be subject to such section 505A, except that such written requests shall be subject to
p.(None): subsections (d)(2)(A)(ii), (e)(1) and (2), (f), (i)(2)(A), (j), (k)(1), (l)(1), and (n) of section 505A of
p.(None): the Federal Food, Drug, and Cosmetic Act, as
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Contracts. Reports.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Deadline.
p.(None):
p.(None): 21 USC 355a
p.(None): note.
p.(None):
p.(None):
p.(None): 121 STAT. 886 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): in effect on or after the date of the enactment of this Act.
p.(None): (b) PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.—Section 409I of the Public Health Service Act (42 U.S.C. 284m)
p.(None): is amended to read as follows:
p.(None): ‘‘SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.
p.(None): ‘‘(a) LIST OF PRIORITY ISSUES IN PEDIATRIC THERAPEUTICS.—
p.(None):
p.(None): Deadline. Publication.
p.(None): ‘‘(1) IN GENERAL.—Not later than one year after the date of the enactment of the Best Pharmaceuticals
p.(None): for Children Act of 2007, the Secretary, acting through the Director of the National Institutes of Health
p.(None): and in consultation with the Commissioner of Food and Drugs and experts in pediatric research, shall
p.(None): develop and publish a priority list of needs in pediatric therapeutics, including drugs or indications
p.(None): that require study. The list shall be revised every three years. ‘‘(2) CONSIDERATION OF AVAILABLE
p.(None): INFORMATION.—In devel-
p.(None): oping and prioritizing the list under paragraph (1), the Sec- retary shall consider—
p.(None): ‘‘(A) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic
p.(None): deter- minants of drug response, metabolism of drugs and bio- logics in children, and pediatric clinical
p.(None): trials;
p.(None): ‘‘(B) particular pediatric diseases, disorders or condi- tions where more complete knowledge and testing of
p.(None): thera- peutics, including drugs and biologics, may be beneficial in pediatric populations; and
p.(None): ‘‘(C) the adequacy of necessary infrastructure to con- duct pediatric pharmacological research, including
p.(None): research networks and trained pediatric investigators.
p.(None): ‘‘(b) PEDIATRIC STUDIES AND RESEARCH.—The Secretary, acting through the National Institutes of Health, shall
p.(None): award funds to entities that have the expertise to conduct pediatric clinical trials or other research
p.(None): (including qualified universities, hospitals, labora- tories, contract research organizations, practice groups,
p.(None): federally funded programs such as pediatric pharmacology research units, other public or private
p.(None): institutions, or individuals) to enable the entities to conduct the drug studies or other research on the issues
p.(None): described in subsection (a). The Secretary may use contracts, grants, or other appropriate funding mechanisms to
p.(None): award funds under this subsection.
p.(None): ‘‘(c) PROCESS FOR PROPOSED PEDIATRIC STUDY REQUESTS AND
p.(None): LABELING CHANGES.—
p.(None): ‘‘(1) SUBMISSION OF PROPOSED PEDIATRIC STUDY REQUEST.—
p.(None): The Director of the National Institutes of Health shall, as appropriate, submit proposed pediatric
p.(None): study requests for consideration by the Commissioner of Food and Drugs for pedi- atric studies of a specific
p.(None): pediatric indication identified under subsection (a). Such a proposed pediatric study request shall be made
...
p.(None): for the drug to make any labeling change that the Commissioner of Food and Drugs determines to be
p.(None): appropriate.
p.(None): ‘‘(10) FAILURE TO AGREE.—If a holder of an approved application for a drug, within 30 days after
p.(None): receiving a request to make a labeling change under paragraph (9), does not agree to make a requested labeling
p.(None): change, the Commissioner of
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 889
p.(None):
p.(None):
p.(None): Food and Drugs may deem the drug to be misbranded under the Federal Food, Drug, and Cosmetic Act.
p.(None): ‘‘(11) NO EFFECT ON AUTHORITY.—Nothing in this sub- section limits the authority of the United States to
p.(None): bring an enforcement action under the Federal Food, Drug, and Cosmetic Act when a drug lacks appropriate
p.(None): pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement
p.(None): action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the other
p.(None): course of action.
p.(None): ‘‘(d) DISSEMINATION OF PEDIATRIC INFORMATION.—Not later
p.(None): than one year after the date of the enactment of the Best Pharma- ceuticals for Children Act of 2007, the
p.(None): Secretary, acting through the Director of the National Institutes of Health, shall study the feasibility of
p.(None): establishing a compilation of information on pediatric drug use and report the findings to Congress.
p.(None): ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—
p.(None): ‘‘(1) IN GENERAL.—There are authorized to be appropriated to carry out this section—
p.(None): ‘‘(A) $200,000,000 for fiscal year 2008; and
p.(None): ‘‘(B) such sums as are necessary for each of the four succeeding fiscal years.
p.(None): ‘‘(2) AVAILABILITY.—Any amount appropriated under para- graph (1) shall remain available to carry out this section
p.(None): until expended.’’.
p.(None): (c) FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.— Section 499(c)(1)(C) of the Public Health Service
p.(None): Act (42 U.S.C. 290b(c)(1)(C)) is amended by striking ‘‘and studies listed by the Secretary pursuant to
p.(None): section 409I(a)(1)(A) of this Act and referred under section 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic Act
p.(None): (21 U.S.C. 355(a)(d)(4)(C)’ ’’ and inserting ‘‘and studies for which the Secretary issues a certification in the
p.(None): affirmative under section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act’’.
p.(None): (d) CONTINUATION OF OPERATION OF COMMITTEE.—Section 14 of the Best Pharmaceuticals for Children Act (42
p.(None): U.S.C. 284m note) is amended by adding at the end the following new subsection: ‘‘(d) CONTINUATION OF OPERATION
p.(None): OF COMMITTEE.—Notwith- standing section 14 of the Federal Advisory Committee Act, the advisory committee
p.(None): shall continue to operate during the five-year period beginning on the date of the enactment of the Best Pharma-
p.(None): ceuticals for Children Act of 2007.’’.
p.(None): (e) PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY COMMITTEE.—Section 15 of the Best
p.(None): Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended—
p.(None): (1) in subsection (a)—
p.(None): (A) in paragraph (1)—
p.(None): (i) in subparagraph (B), by striking ‘‘and’’ after the semicolon;
p.(None): (ii) in subparagraph (C), by striking the period at the end and inserting ‘‘; and’’; and
p.(None): (iii) by adding at the end the following new subparagraph:
p.(None): ‘‘(D) provide recommendations to the internal review committee created under section 505B(f) of the
p.(None): Federal Food, Drug, and Cosmetic Act regarding the implementa- tion of amendments to sections 505A and
p.(None): 505B of the
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Reports.
p.(None):
p.(None):
p.(None): 121 STAT. 890 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): Federal Food, Drug, and Cosmetic Act with respect to the treatment of pediatric cancers.’’; and
p.(None): (B) by adding at the end the following new paragraph: ‘‘(3) CONTINUATION OF OPERATION OF SUBCOMMITTEE.—Not-
p.(None): withstanding section 14 of the Federal Advisory Committee Act, the Subcommittee shall continue to operate
p.(None): during the five-year period beginning on the date of the enactment of
p.(None): the Best Pharmaceuticals for Children Act of 2007.’’; and
p.(None): (2) in subsection (d), by striking ‘‘2003’’ and inserting ‘‘2009’’.
p.(None): (f) EFFECTIVE DATE AND LIMITATION FOR RULE RELATING TO TOLL-FREE NUMBER FOR ADVERSE EVENTS ON LABELING
p.(None): FOR HUMAN DRUG PRODUCTS.—
p.(None): (1) IN GENERAL.—Notwithstanding subchapter II of chapter 5, and chapter 7, of title 5, United States Code
p.(None): (commonly known as the ‘‘Administrative Procedure Act’’) and any other provision of law, the proposed rule
p.(None): issued by the Commissioner of Food and Drugs entitled ‘‘Toll-Free Number for Reporting Adverse Events on
p.(None): Labeling for Human Drug Products,’’ 69 Fed. Reg. 21778, (April 22, 2004) shall take effect on January 1,
p.(None): 2008, unless such Commissioner issues the final rule before such date.
p.(None): (2) LIMITATION.—The proposed rule that takes effect under subsection (a), or the final rule described under
p.(None): subsection (a), shall, notwithstanding section 17(a) of the Best Pharma- ceuticals for Children Act (21
p.(None): U.S.C. 355b(a)), not apply to a drug—
p.(None): (A) for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
p.(None): (B) that is not described under section 503(b)(1) of such Act (21 U.S.C. 353(b)(1)); and
p.(None): (C) the packaging of which includes a toll-free number through which consumers can report complaints to the
p.(None): manufacturer or distributor of the drug.
p.(None): SEC. 503. TRAINING OF PEDIATRIC PHARMACOLOGISTS.
p.(None): (a) INVESTMENT IN TOMORROW’S PEDIATRIC RESEARCHERS.—Sec- tion 452G(2) of the Public Health Service Act (42
p.(None): U.S.C. 285g– 10(2)) is amended by adding before the period at the end the following: ‘‘, including
p.(None): pediatric pharmacological research’’.
p.(None): (b) PEDIATRIC RESEARCH LOAN REPAYMENT PROGRAM.—Section 487F(a)(1) of the Public Health Service Act (42 U.S.C.
p.(None): 288–6(a)(1)) is amended by inserting ‘‘including pediatric pharmacological research,’’ after ‘‘pediatric
p.(None): research,’’.
p.(None):
p.(None): TITLE VI—REAGAN-UDALL FOUNDATION
p.(None): SEC. 601. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION.
p.(None): (a) IN GENERAL.—Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is
p.(None): amended by adding at the end the following:
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘Subchapter I—Reagan-Udall Foundation for the Food and Drug Administration
...
p.(None): 801(b), is amended—
p.(None): (1) in section 301 (21 U.S.C. 331), by adding at the end the following:
p.(None): ‘‘(kk) The dissemination of a television advertisement without complying with section 503B.’’; and
p.(None): (2) by inserting after section 503A the following:
p.(None): ‘‘SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS.
p.(None): ‘‘(a) IN GENERAL.—The Secretary may require the submission of any television advertisement for a drug
p.(None): (including any script, story board, rough, or a completed video production of the television advertisement) to the
p.(None): Secretary for review under this section not later than 45 days before dissemination of the television advertise-
p.(None): ment.
p.(None): ‘‘(b) REVIEW.—In conducting a review of a television advertise- ment under this section, the Secretary may make
p.(None): recommendations with respect to information included in the label of the drug—
p.(None): ‘‘(1) on changes that are—
p.(None): ‘‘(A) necessary to protect the consumer good and well- being; or
p.(None): ‘‘(B) consistent with prescribing information for the product under review; and
p.(None): ‘‘(2) if appropriate and if information exists, on statements for inclusion in the advertisement to address the
p.(None): specific effi- cacy of the drug as it relates to specific population groups, including elderly
p.(None): populations, children, and racial and ethnic minorities.
p.(None): ‘‘(c) NO AUTHORITY TO REQUIRE CHANGES.—Except as provided by subsection (e), this section does not
p.(None): authorize the Secretary to make or direct changes in any material submitted pursuant to subsection (a).
p.(None): ‘‘(d) ELDERLY POPULATIONS, CHILDREN, RACIALLY AND ETH-
p.(None): NICALLY DIVERSE COMMUNITIES.—In formulating recommendations under subsection (b), the Secretary shall take
p.(None): into consideration the impact of the advertised drug on elderly populations, children, and racially and ethnically
p.(None): diverse communities.
p.(None): ‘‘(e) SPECIFIC DISCLOSURES.—
p.(None): ‘‘(1) SERIOUS RISK; SAFETY PROTOCOL.—In conducting a
p.(None): review of a television advertisement under this section, if the Secretary determines that the
p.(None): advertisement would be false or misleading without a specific disclosure about a serious risk listed in
p.(None): the labeling of the drug involved, the Secretary may require inclusion of such disclosure in the advertisement.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 353b.
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 940 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(2) DATE OF APPROVAL.—In conducting a review of a tele- vision advertisement under this section, the Secretary
p.(None): may require the advertisement to include, for a period not to exceed 2 years from the date of the approval of the drug
p.(None): under section 505 or section 351 of the Public Health Service Act, a specific disclosure of such date of
p.(None): approval if the Secretary determines that the advertisement would otherwise be false or misleading. ‘‘(f) RULE OF
p.(None): CONSTRUCTION.—Nothing in this section may be
p.(None): construed as having any effect on requirements under section 502(n) or on the authority of the Secretary under section
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355a
p.(None): note.
p.(None): business. Such a petition may only be filed within the 60-day period beginning on the date the order
p.(None): making such assessments was issued.
p.(None): ‘‘(7) If any person fails to pay an assessment of a civil penalty under paragraph (1)—
p.(None): ‘‘(A) after the order making the assessment becomes final, and if such person does not file a petition for
p.(None): judicial review of the order in accordance with paragraph (6), or
p.(None): ‘‘(B) after a court in an action brought under paragraph
p.(None): (6) has entered a final judgment in favor of the Secretary, the Attorney General of the United States shall
p.(None): recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of
p.(None): the 60-day period referred to in paragraph
p.(None): (6) or the date of such final judgment, as the case may be) in an action brought in any appropriate
p.(None): district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty
p.(None): shall not be subject to review.’’.
p.(None): (5) REPORT ON DIRECT-TO-CONSUMER ADVERTISING.—Not later than 24 months after the date of the enactment
p.(None): of this Act, the Secretary of Health and Human Services shall report to the Congress on direct-to-consumer
p.(None): advertising and its ability to communicate to subsets of the general population, including elderly populations,
p.(None): children, and racial and ethnic minority communities. The Secretary shall utilize the Advisory Com- mittee
p.(None): on Risk Communication established under this Act to advise the Secretary with respect to such report. The
p.(None): Advisory Committee shall study direct-to-consumer advertising as it relates to increased access to health
p.(None): information and decreased health disparities for these populations. The report required by this paragraph
p.(None): shall recommend effective ways to present and disseminate information to these populations. Such report shall
p.(None): also make recommendations regarding impediments to the participation of elderly populations, children,
p.(None): racially and ethnically diverse communities, and medically underserved populations in clinical drug
p.(None): trials and shall recommend best practice approaches for increasing the inclusion of such subsets of the general
p.(None): population. The Secretary of Health and Human Services shall submit the report under this paragraph to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representatives.
p.(None): (6) RULEMAKING.—Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is
p.(None): amended by striking ‘‘the procedure specified in section 701(e) of this Act’’ and inserting ‘‘section
p.(None): 701(a)’’.
p.(None): (e) RULE OF CONSTRUCTION REGARDING PEDIATRIC STUDIES.— This title and the amendments made by this title
p.(None): may not be
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 943
p.(None):
p.(None): construed as affecting the authority of the Secretary of Health and Human Services to request pediatric
p.(None): studies under section 505A of the Federal Food, Drug, and Cosmetic Act or to require such studies under
p.(None): section 505B of such Act.
p.(None): SEC. 902. ENFORCEMENT.
p.(None): (a) MISBRANDING.—Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding
p.(None): at the end the following:
...
p.(None): may, on a temporary or permanent basis, implement systems or products developed by private entities.
p.(None): ‘‘(iv) COMPLEMENTARY APPROACHES.—To the extent
p.(None): the active postmarket risk identification and analysis system under this subsection is not sufficient to gather
p.(None): data and information relevant to a priority drug safety question, the Secretary shall develop, support, and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Reports.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 946 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): participate in complementary approaches to gather and analyze such data and information, including—
p.(None): ‘‘(I) approaches that are complementary with respect to assessing the safety of use of a drug in domestic
p.(None): populations not included, or underrep- resented, in the trials used to approve the drug (such as older
p.(None): people, people with comorbidities, pregnant women, or children); and
p.(None): ‘‘(II) existing approaches such as the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink or
p.(None): successor databases.
p.(None): ‘‘(v) AUTHORITY FOR CONTRACTS.—The Secretary
p.(None): may enter into contracts with public and private enti- ties to fulfill the requirements of this subparagraph.
p.(None): ‘‘(4) ADVANCED ANALYSIS OF DRUG SAFETY DATA.—
p.(None): ‘‘(A) PURPOSE.—The Secretary shall establish collabora- tions with public, academic, and private entities, which
p.(None): may include the Centers for Education and Research on Therapeutics under section 912 of the Public Health
p.(None): Service Act, to provide for advanced analysis of drug safety data described in paragraph (3)(C) and other
p.(None): information that is publicly available or is provided by the Secretary, in order to—
p.(None): ‘‘(i) improve the quality and efficiency of postmarket drug safety risk-benefit analysis;
p.(None): ‘‘(ii) provide the Secretary with routine access to outside expertise to study advanced drug safety ques-
p.(None): tions; and
p.(None): ‘‘(iii) enhance the ability of the Secretary to make timely assessments based on drug safety data.
p.(None): ‘‘(B) PRIVACY.—Such analysis shall not disclose individ- ually identifiable health information when presenting such
...
p.(None): (o)(3).
p.(None): ‘‘(D) PROCEDURES FOR THE DEVELOPMENT OF DRUG SAFETY COLLABORATIONS.—
p.(None):
p.(None): Deadline.
p.(None): ‘‘(i) IN GENERAL.—Not later than 180 days after the date of the establishment of the active postmarket risk
p.(None): identification and analysis system under this sub- section, the Secretary shall establish and implement
p.(None): procedures under which the Secretary may routinely contract with one or more qualified entities to—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 947
p.(None):
p.(None):
p.(None): ‘‘(I) classify, analyze, or aggregate data described in paragraph (3)(C) and information that is
p.(None): publicly available or is provided by the Sec- retary;
p.(None): ‘‘(II) allow for prompt investigation of priority drug safety questions, including—
p.(None): ‘‘(aa) unresolved safety questions for drugs or classes of drugs; and
p.(None): ‘‘(bb) for a newly-approved drugs, safety signals from clinical trials used to approve the drug and other
p.(None): preapproval trials; rare, serious drug side effects; and the safety of use in domestic populations not
p.(None): included, or underrepresented, in the trials used to approve the drug (such as older people, people with
p.(None): comorbidities, pregnant women, or children); ‘‘(III) perform advanced research and analysis
p.(None): on identified drug safety risks;
p.(None): ‘‘(IV) focus postapproval studies and clinical trials under subsection (o)(3) more effectively on cases for
p.(None): which reports under paragraph (1) and other safety signal detection is not sufficient to resolve whether
p.(None): there is an elevated risk of a serious adverse event associated with the use of a drug; and
p.(None): ‘‘(V) carry out other activities as the Secretary deems necessary to carry out the purposes of this paragraph.
p.(None): ‘‘(ii) REQUEST FOR SPECIFIC METHODOLOGY.—The
p.(None): procedures described in clause (i) shall permit the Sec- retary to request that a specific methodology be used
p.(None): by the qualified entity. The qualified entity shall work with the Secretary to finalize the methodology to be
p.(None): used.
p.(None): ‘‘(E) USE OF ANALYSES.—The Secretary shall provide the analyses described in this paragraph, including
p.(None): the methods and results of such analyses, about a drug to the sponsor or sponsors of such drug.
p.(None): ‘‘(F) QUALIFIED ENTITIES.—
p.(None): ‘‘(i) IN GENERAL.—The Secretary shall enter into contracts with a sufficient number of qualified entities to
p.(None): develop and provide information to the Secretary in a timely manner.
p.(None): ‘‘(ii) QUALIFICATION.—The Secretary shall enter into a contract with an entity under clause (i) only
p.(None): if the Secretary determines that the entity has a significant presence in the United States and has one
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.(None): (d) ADVERTISEMENTS OF DRUGS.—The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), as amended by section
p.(None): 801(b), is amended—
p.(None): (1) in section 301 (21 U.S.C. 331), by adding at the end the following:
p.(None): ‘‘(kk) The dissemination of a television advertisement without complying with section 503B.’’; and
p.(None): (2) by inserting after section 503A the following:
p.(None): ‘‘SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS.
p.(None): ‘‘(a) IN GENERAL.—The Secretary may require the submission of any television advertisement for a drug
p.(None): (including any script, story board, rough, or a completed video production of the television advertisement) to the
p.(None): Secretary for review under this section not later than 45 days before dissemination of the television advertise-
p.(None): ment.
p.(None): ‘‘(b) REVIEW.—In conducting a review of a television advertise- ment under this section, the Secretary may make
p.(None): recommendations with respect to information included in the label of the drug—
p.(None): ‘‘(1) on changes that are—
p.(None): ‘‘(A) necessary to protect the consumer good and well- being; or
p.(None): ‘‘(B) consistent with prescribing information for the product under review; and
p.(None): ‘‘(2) if appropriate and if information exists, on statements for inclusion in the advertisement to address the
p.(None): specific effi- cacy of the drug as it relates to specific population groups, including elderly
p.(None): populations, children, and racial and ethnic minorities.
p.(None): ‘‘(c) NO AUTHORITY TO REQUIRE CHANGES.—Except as provided by subsection (e), this section does not
p.(None): authorize the Secretary to make or direct changes in any material submitted pursuant to subsection (a).
p.(None): ‘‘(d) ELDERLY POPULATIONS, CHILDREN, RACIALLY AND ETH-
p.(None): NICALLY DIVERSE COMMUNITIES.—In formulating recommendations under subsection (b), the Secretary shall take
p.(None): into consideration the impact of the advertised drug on elderly populations, children, and racially and ethnically
p.(None): diverse communities.
p.(None): ‘‘(e) SPECIFIC DISCLOSURES.—
p.(None): ‘‘(1) SERIOUS RISK; SAFETY PROTOCOL.—In conducting a
p.(None): review of a television advertisement under this section, if the Secretary determines that the
p.(None): advertisement would be false or misleading without a specific disclosure about a serious risk listed in
p.(None): the labeling of the drug involved, the Secretary may require inclusion of such disclosure in the advertisement.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 353b.
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 940 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(2) DATE OF APPROVAL.—In conducting a review of a tele- vision advertisement under this section, the Secretary
p.(None): may require the advertisement to include, for a period not to exceed 2 years from the date of the approval of the drug
p.(None): under section 505 or section 351 of the Public Health Service Act, a specific disclosure of such date of
p.(None): approval if the Secretary determines that the advertisement would otherwise be false or misleading. ‘‘(f) RULE OF
p.(None): CONSTRUCTION.—Nothing in this section may be
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355a
p.(None): note.
p.(None): business. Such a petition may only be filed within the 60-day period beginning on the date the order
p.(None): making such assessments was issued.
p.(None): ‘‘(7) If any person fails to pay an assessment of a civil penalty under paragraph (1)—
p.(None): ‘‘(A) after the order making the assessment becomes final, and if such person does not file a petition for
p.(None): judicial review of the order in accordance with paragraph (6), or
p.(None): ‘‘(B) after a court in an action brought under paragraph
p.(None): (6) has entered a final judgment in favor of the Secretary, the Attorney General of the United States shall
p.(None): recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of
p.(None): the 60-day period referred to in paragraph
p.(None): (6) or the date of such final judgment, as the case may be) in an action brought in any appropriate
p.(None): district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty
p.(None): shall not be subject to review.’’.
p.(None): (5) REPORT ON DIRECT-TO-CONSUMER ADVERTISING.—Not later than 24 months after the date of the enactment
p.(None): of this Act, the Secretary of Health and Human Services shall report to the Congress on direct-to-consumer
p.(None): advertising and its ability to communicate to subsets of the general population, including elderly populations,
p.(None): children, and racial and ethnic minority communities. The Secretary shall utilize the Advisory Com- mittee
p.(None): on Risk Communication established under this Act to advise the Secretary with respect to such report. The
p.(None): Advisory Committee shall study direct-to-consumer advertising as it relates to increased access to health
p.(None): information and decreased health disparities for these populations. The report required by this paragraph
p.(None): shall recommend effective ways to present and disseminate information to these populations. Such report shall
p.(None): also make recommendations regarding impediments to the participation of elderly populations, children,
p.(None): racially and ethnically diverse communities, and medically underserved populations in clinical drug
p.(None): trials and shall recommend best practice approaches for increasing the inclusion of such subsets of the general
p.(None): population. The Secretary of Health and Human Services shall submit the report under this paragraph to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representatives.
p.(None): (6) RULEMAKING.—Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is
p.(None): amended by striking ‘‘the procedure specified in section 701(e) of this Act’’ and inserting ‘‘section
p.(None): 701(a)’’.
p.(None): (e) RULE OF CONSTRUCTION REGARDING PEDIATRIC STUDIES.— This title and the amendments made by this title
p.(None): may not be
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 943
p.(None):
p.(None): construed as affecting the authority of the Secretary of Health and Human Services to request pediatric
p.(None): studies under section 505A of the Federal Food, Drug, and Cosmetic Act or to require such studies under
p.(None): section 505B of such Act.
p.(None): SEC. 902. ENFORCEMENT.
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.(None): subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation
p.(None): resulting from the certifi- cation the court determines that the patent is valid and would be infringed,
p.(None): the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B)
p.(None): shall be extended by a period of six months after the date the patent expires (including any patent
p.(None): extensions).
p.(None): ‘‘(2) EXCEPTION.—The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the
p.(None): determination made under subsection (d)(3) is made later than 9 months prior to the expiration of such period.
p.(None): ‘‘(d) CONDUCT OF PEDIATRIC STUDIES.— ‘‘(1) REQUEST FOR STUDIES.—
p.(None): ‘‘(A) IN GENERAL.—The Secretary may, after consulta- tion with the sponsor of an application for an
p.(None): investiga- tional new drug under section 505(i), the sponsor of an application for a new drug under
p.(None): section 505(b)(1), or the
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 879
p.(None):
p.(None):
p.(None): holder of an approved application for a drug under section 505(b)(1), issue to the sponsor or holder a written
p.(None): request for the conduct of pediatric studies for such drug. In issuing such request, the Secretary shall take
p.(None): into account ade- quate representation of children of ethnic and racial minori- ties. Such request to conduct
p.(None): pediatric studies shall be in writing and shall include a timeframe for such studies and a request to the
p.(None): sponsor or holder to propose pediatric labeling resulting from such studies.
p.(None): ‘‘(B) SINGLE WRITTEN REQUEST.—A single written request—
p.(None): ‘‘(i) may relate to more than one use of a drug;
p.(None):
p.(None):
p.(None): Minorities.
p.(None):
p.(None):
p.(None): Timeframe.
p.(None):
p.(None): and
p.(None): ‘‘(ii) may include uses that are both approved and
p.(None):
p.(None): unapproved.
p.(None): ‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUDIES.— ‘‘(A) REQUEST AND RESPONSE.—
p.(None): ‘‘(i) IN GENERAL.—If the Secretary makes a written request for pediatric studies (including neonates, as
p.(None): appropriate) under subsection (b) or (c), the applicant or holder, not later than 180 days after
p.(None): receiving the written request, shall respond to the Secretary as to the intention of the applicant or
p.(None): holder to act on the request by—
p.(None): ‘‘(I) indicating when the pediatric studies will be initiated, if the applicant or holder agrees to the
p.(None): request; or
p.(None): ‘‘(II) indicating that the applicant or holder does not agree to the request and stating the rea- sons for
p.(None): declining the request.
p.(None): ‘‘(ii) DISAGREE WITH REQUEST.—If, on or after the date of the enactment of the Best Pharmaceuticals for
...
p.(None): 801(b), is amended—
p.(None): (1) in section 301 (21 U.S.C. 331), by adding at the end the following:
p.(None): ‘‘(kk) The dissemination of a television advertisement without complying with section 503B.’’; and
p.(None): (2) by inserting after section 503A the following:
p.(None): ‘‘SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS.
p.(None): ‘‘(a) IN GENERAL.—The Secretary may require the submission of any television advertisement for a drug
p.(None): (including any script, story board, rough, or a completed video production of the television advertisement) to the
p.(None): Secretary for review under this section not later than 45 days before dissemination of the television advertise-
p.(None): ment.
p.(None): ‘‘(b) REVIEW.—In conducting a review of a television advertise- ment under this section, the Secretary may make
p.(None): recommendations with respect to information included in the label of the drug—
p.(None): ‘‘(1) on changes that are—
p.(None): ‘‘(A) necessary to protect the consumer good and well- being; or
p.(None): ‘‘(B) consistent with prescribing information for the product under review; and
p.(None): ‘‘(2) if appropriate and if information exists, on statements for inclusion in the advertisement to address the
p.(None): specific effi- cacy of the drug as it relates to specific population groups, including elderly
p.(None): populations, children, and racial and ethnic minorities.
p.(None): ‘‘(c) NO AUTHORITY TO REQUIRE CHANGES.—Except as provided by subsection (e), this section does not
p.(None): authorize the Secretary to make or direct changes in any material submitted pursuant to subsection (a).
p.(None): ‘‘(d) ELDERLY POPULATIONS, CHILDREN, RACIALLY AND ETH-
p.(None): NICALLY DIVERSE COMMUNITIES.—In formulating recommendations under subsection (b), the Secretary shall take
p.(None): into consideration the impact of the advertised drug on elderly populations, children, and racially and ethnically
p.(None): diverse communities.
p.(None): ‘‘(e) SPECIFIC DISCLOSURES.—
p.(None): ‘‘(1) SERIOUS RISK; SAFETY PROTOCOL.—In conducting a
p.(None): review of a television advertisement under this section, if the Secretary determines that the
p.(None): advertisement would be false or misleading without a specific disclosure about a serious risk listed in
p.(None): the labeling of the drug involved, the Secretary may require inclusion of such disclosure in the advertisement.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 353b.
p.(None): Deadline.
p.(None):
p.(None):
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355a
p.(None): note.
p.(None): business. Such a petition may only be filed within the 60-day period beginning on the date the order
p.(None): making such assessments was issued.
p.(None): ‘‘(7) If any person fails to pay an assessment of a civil penalty under paragraph (1)—
p.(None): ‘‘(A) after the order making the assessment becomes final, and if such person does not file a petition for
p.(None): judicial review of the order in accordance with paragraph (6), or
p.(None): ‘‘(B) after a court in an action brought under paragraph
p.(None): (6) has entered a final judgment in favor of the Secretary, the Attorney General of the United States shall
p.(None): recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of
p.(None): the 60-day period referred to in paragraph
p.(None): (6) or the date of such final judgment, as the case may be) in an action brought in any appropriate
p.(None): district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty
p.(None): shall not be subject to review.’’.
p.(None): (5) REPORT ON DIRECT-TO-CONSUMER ADVERTISING.—Not later than 24 months after the date of the enactment
p.(None): of this Act, the Secretary of Health and Human Services shall report to the Congress on direct-to-consumer
p.(None): advertising and its ability to communicate to subsets of the general population, including elderly populations,
p.(None): children, and racial and ethnic minority communities. The Secretary shall utilize the Advisory Com- mittee
p.(None): on Risk Communication established under this Act to advise the Secretary with respect to such report. The
p.(None): Advisory Committee shall study direct-to-consumer advertising as it relates to increased access to health
p.(None): information and decreased health disparities for these populations. The report required by this paragraph
p.(None): shall recommend effective ways to present and disseminate information to these populations. Such report shall
p.(None): also make recommendations regarding impediments to the participation of elderly populations, children,
p.(None): racially and ethnically diverse communities, and medically underserved populations in clinical drug
p.(None): trials and shall recommend best practice approaches for increasing the inclusion of such subsets of the general
p.(None): population. The Secretary of Health and Human Services shall submit the report under this paragraph to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representatives.
p.(None): (6) RULEMAKING.—Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is
...
Social / Fetus/Neonate
Searching for indicator neonate:
(return to top)
p.(None):
p.(None):
p.(None):
p.(None): Establishment. 21 USC 355d.
p.(None):
p.(None):
p.(None): 121 STAT. 876 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): for children, health care providers, parents, and others of labeling changes made as a result of such
p.(None): testing;
p.(None): (2) the number and importance of drugs and biological products for children that are not being tested
p.(None): for their use notwithstanding the provisions of this title and title V and possible reasons for the lack of
p.(None): testing;
p.(None): (3) the number of drugs and biological products for which testing is being done and labeling changes
p.(None): required, including the date labeling changes are made and which labeling changes required the use of the dispute
p.(None): resolution process established pursuant to the amendments made by this title, together with a description of the
p.(None): outcomes of such process, including a description of the disputes and the recommendations of the Pediatric
p.(None): Advisory Committee;
p.(None): (4) any recommendations for modifications to the programs established under sections 505A and 505B of the Federal Food,
p.(None): Drug, and Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public Health Service Act (42 U.S.C.
p.(None): 284m) that the Secretary determines to be appropriate, including a detailed rationale for each recommendation;
p.(None): and
p.(None): (5)(A) the efforts made by the Secretary to increase the number of studies conducted in the neonate
p.(None): population; and
p.(None): (B) the results of those efforts, including efforts made to encourage the conduct of appropriate studies
p.(None): in neonates by companies with products that have sufficient safety and other information to make the
p.(None): conduct of the studies ethical and safe.
p.(None):
p.(None):
p.(None): Best Pharmaceuticals for Children Act of 2007.
p.(None): 21 USC 301 note.
p.(None): TITLE V—BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007
p.(None): SEC. 501. SHORT TITLE.
p.(None): This title may be cited as the ‘‘Best Pharmaceuticals for Chil- dren Act of 2007’’.
p.(None): SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHIL- DREN ACT.
p.(None): (a) PEDIATRIC STUDIES OF DRUGS.—
p.(None): (1) IN GENERAL.—Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended to read
p.(None): as follows:
p.(None): ‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
p.(None): ‘‘(a) DEFINITIONS.—As used in this section, the term ‘pediatric studies’ or ‘studies’ means at least one
p.(None): clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic studies) in pediatric age
p.(None): groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the
p.(None): discretion of the Secretary, may include preclinical studies.
...
Searching for indicator neonates:
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p.(None): any calendar year exceeds the annual distribution number referred to in clause (ii).
p.(None): ‘‘(iv) The request for such exemption is submitted on or before October 1, 2012.
p.(None): ‘‘(B) The Secretary may inspect the records relating to the number of devices distributed during any calendar
p.(None): year of a person granted an exemption under paragraph (2) for which the prohibition in paragraph (3) does not apply.
p.(None): ‘‘(C) A person may petition the Secretary to modify the annual distribution number specified by the Secretary under
p.(None): subparagraph (A)(ii) with respect to a device if additional information on the number of individuals
p.(None): affected by the disease or condition arises, and the Secretary may modify such number but in no case
p.(None): shall the annual distribution number exceed the number identified in paragraph (2)(A).
p.(None): ‘‘(D) If a person notifies the Secretary, or the Secretary deter- mines through an inspection under
p.(None): subparagraph (B), that the number of devices distributed during any calendar year exceeds the annual
p.(None): distribution number, as required under subparagraph (A)(iii), and modified under subparagraph (C), if
p.(None): applicable, then the prohibition in paragraph (3) shall apply with respect to such person for such device
p.(None): for any sales of such device after such notification.
p.(None): ‘‘(E)(i) In this subsection, the term ‘pediatric patients’ means patients who are 21 years of age or
p.(None): younger at the time of the diagnosis or treatment.
p.(None): ‘‘(ii) In this subsection, the term ‘pediatric subpopulation’ means 1 of the following populations:
p.(None): ‘‘(I) Neonates.
p.(None): ‘‘(II) Infants.
p.(None): ‘‘(III) Children. ‘‘(IV) Adolescents.
p.(None): ‘‘(7) The Secretary shall refer any report of an adverse event regarding a device for which the
p.(None): prohibition under paragraph (3) does not apply pursuant to paragraph (6)(A) that the Secretary receives to
p.(None): the Office of Pediatric Therapeutics, established under section 6 of the Best Pharmaceuticals for
p.(None): Children Act (Public Law 107–109). In considering the report, the Director of the Office of Pediatric Therapeutics,
p.(None): in consultation with experts in the Center for Devices and Radiological Health, shall provide for periodic
p.(None): review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such
p.(None): committee regarding whether the Secretary should take action under this Act in response to the report.
p.(None): ‘‘(8) The Secretary, acting through the Office of Pediatric Thera- peutics and the Center for Devices and
p.(None): Radiological Health, shall provide for an annual review by the Pediatric Advisory Committee
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Notification.
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Applicability.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Annual review.
p.(None):
...
p.(None): testing;
p.(None): (2) the number and importance of drugs and biological products for children that are not being tested
p.(None): for their use notwithstanding the provisions of this title and title V and possible reasons for the lack of
p.(None): testing;
p.(None): (3) the number of drugs and biological products for which testing is being done and labeling changes
p.(None): required, including the date labeling changes are made and which labeling changes required the use of the dispute
p.(None): resolution process established pursuant to the amendments made by this title, together with a description of the
p.(None): outcomes of such process, including a description of the disputes and the recommendations of the Pediatric
p.(None): Advisory Committee;
p.(None): (4) any recommendations for modifications to the programs established under sections 505A and 505B of the Federal Food,
p.(None): Drug, and Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public Health Service Act (42 U.S.C.
p.(None): 284m) that the Secretary determines to be appropriate, including a detailed rationale for each recommendation;
p.(None): and
p.(None): (5)(A) the efforts made by the Secretary to increase the number of studies conducted in the neonate
p.(None): population; and
p.(None): (B) the results of those efforts, including efforts made to encourage the conduct of appropriate studies
p.(None): in neonates by companies with products that have sufficient safety and other information to make the
p.(None): conduct of the studies ethical and safe.
p.(None):
p.(None):
p.(None): Best Pharmaceuticals for Children Act of 2007.
p.(None): 21 USC 301 note.
p.(None): TITLE V—BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007
p.(None): SEC. 501. SHORT TITLE.
p.(None): This title may be cited as the ‘‘Best Pharmaceuticals for Chil- dren Act of 2007’’.
p.(None): SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHIL- DREN ACT.
p.(None): (a) PEDIATRIC STUDIES OF DRUGS.—
p.(None): (1) IN GENERAL.—Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended to read
p.(None): as follows:
p.(None): ‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
p.(None): ‘‘(a) DEFINITIONS.—As used in this section, the term ‘pediatric studies’ or ‘studies’ means at least one
p.(None): clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic studies) in pediatric age
p.(None): groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the
p.(None): discretion of the Secretary, may include preclinical studies.
p.(None): ‘‘(b) MARKET EXCLUSIVITY FOR NEW DRUGS.—
p.(None): ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), if, prior to approval of an application that is
p.(None): submitted under section 505(b)(1), the Secretary determines that information relating to the use of a new
p.(None): drug in the pediatric population may produce health benefits in that population, the Secretary makes a
p.(None): written request for pediatric studies (which shall
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 877
p.(None):
p.(None): include a timeframe for completing such studies), the applicant agrees to the request, such studies are completed using
p.(None): appro- priate formulations for each age group for which the study is requested within any such timeframe, and
p.(None): the reports thereof are submitted and accepted in accordance with subsection (d)(3)—
p.(None): ‘‘(A)(i)(I) the period referred to in subsection (c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii) of such
p.(None): section, is deemed to be five years and six months rather than five years, and the references in
p.(None): subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and
p.(None): one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively;
p.(None): or
...
p.(None): section 505(b)(1), or the
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 879
p.(None):
p.(None):
p.(None): holder of an approved application for a drug under section 505(b)(1), issue to the sponsor or holder a written
p.(None): request for the conduct of pediatric studies for such drug. In issuing such request, the Secretary shall take
p.(None): into account ade- quate representation of children of ethnic and racial minori- ties. Such request to conduct
p.(None): pediatric studies shall be in writing and shall include a timeframe for such studies and a request to the
p.(None): sponsor or holder to propose pediatric labeling resulting from such studies.
p.(None): ‘‘(B) SINGLE WRITTEN REQUEST.—A single written request—
p.(None): ‘‘(i) may relate to more than one use of a drug;
p.(None):
p.(None):
p.(None): Minorities.
p.(None):
p.(None):
p.(None): Timeframe.
p.(None):
p.(None): and
p.(None): ‘‘(ii) may include uses that are both approved and
p.(None):
p.(None): unapproved.
p.(None): ‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUDIES.— ‘‘(A) REQUEST AND RESPONSE.—
p.(None): ‘‘(i) IN GENERAL.—If the Secretary makes a written request for pediatric studies (including neonates, as
p.(None): appropriate) under subsection (b) or (c), the applicant or holder, not later than 180 days after
p.(None): receiving the written request, shall respond to the Secretary as to the intention of the applicant or
p.(None): holder to act on the request by—
p.(None): ‘‘(I) indicating when the pediatric studies will be initiated, if the applicant or holder agrees to the
p.(None): request; or
p.(None): ‘‘(II) indicating that the applicant or holder does not agree to the request and stating the rea- sons for
p.(None): declining the request.
p.(None): ‘‘(ii) DISAGREE WITH REQUEST.—If, on or after the date of the enactment of the Best Pharmaceuticals for
p.(None): Children Act of 2007, the applicant or holder does not agree to the request on the grounds that it
p.(None): is not possible to develop the appropriate pediatric formu- lation, the applicant or holder shall submit to the
p.(None): Secretary the reasons such pediatric formulation cannot be developed.
p.(None): ‘‘(B) ADVERSE EVENT REPORTS.—An applicant or holder that, on or after the date of the enactment of the Best
p.(None): Pharmaceuticals for Children Act of 2007, agrees to the request for such studies shall provide the
p.(None): Secretary, at the same time as the submission of the reports of such studies, with all postmarket
p.(None): adverse event reports regarding the drug that is the subject of such studies and are available prior to
p.(None): submission of such reports.
p.(None): ‘‘(3) MEETING THE STUDIES REQUIREMENT.—Not later than
...
p.(None): If a 180-day period under section 505(j)(5)(B)(iv) overlaps with a 6-month exclusivity period under
p.(None): this section, so that the applicant for approval of a drug under section 505(j) entitled to the
p.(None): 180-day period under that section loses a portion of the 180- day period to which the applicant is
p.(None): entitled for the drug, the 180-day period shall be extended from—
p.(None): ‘‘(1) the date on which the 180-day period would have expired by the number of days of the overlap,
p.(None): if the 180- day period would, but for the application of this subsection, expire after the 6-month
p.(None): exclusivity period; or
p.(None): ‘‘(2) the date on which the 6-month exclusivity period expires, by the number of days of the overlap
p.(None): if the 180- day period would, but for the application of this subsection, expire during the six-month
p.(None): exclusivity period.
p.(None): ‘‘(n) REFERRAL IF PEDIATRIC STUDIES NOT COMPLETED.—
p.(None): ‘‘(1) IN GENERAL.—Beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007,
p.(None): if pedi- atric studies of a drug have not been completed under sub- section (d) and if the Secretary,
p.(None): through the committee estab- lished under section 505C, determines that there is a continuing need for information
p.(None): relating to the use of the drug in the pediatric population (including neonates, as appropriate), the
p.(None): Secretary shall carry out the following:
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Effective date.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Effective date.
p.(None):
p.(None):
p.(None): 121 STAT. 884 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(A) For a drug for which a listed patent has not expired, make a determination regarding whether
p.(None): an assessment shall be required to be submitted under section
p.(None):
p.(None): Deadline. Certification.
p.(None): 505B(b). Prior to making such a determination, the Sec- retary may not take more than 30 days to certify
p.(None): whether the Foundation for the National Institutes of Health has sufficient funding at the time of such
p.(None): certification to initiate and fund all of the studies in the written request in their entirety within the
p.(None): timeframes specified within the written request. Only if the Secretary makes such certification in the
p.(None): affirmative, the Secretary shall refer all pediatric studies in the written request to the Foundation for
p.(None): the National Institutes of Health for the conduct of such studies, and such Foundation shall fund
p.(None): such studies. If no certification has been made at the end of the 30-day period, or if the Secretary
...
Social / Infant
Searching for indicator infant:
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p.(None): dietary supple- ments sold and consumed in the United States.
p.(None): (3) The adverse event reporting system created under the Dietary Supplement and Nonprescription Drug
p.(None): Consumer Protection Act is intended to serve as an early warning system for potential public health issues
p.(None): associated with the use of these products.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 965
p.(None):
p.(None):
p.(None): (4) A reliable mechanism to track patterns of adulteration in food would support efforts by the Food and Drug
p.(None): Administra- tion to target limited inspection resources to protect the public health.
p.(None): (b) IN GENERAL.—Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is
p.(None): amended by adding at the end the following:
p.(None): ‘‘SEC. 417. REPORTABLE FOOD REGISTRY.
p.(None): ‘‘(a) DEFINITIONS.—In this section:
p.(None): ‘‘(1) RESPONSIBLE PARTY.—The term ‘responsible party’, with respect to an article of food, means a person
p.(None): that submits the registration under section 415(a) for a food facility that is required to register under
p.(None): section 415(a), at which such article of food is manufactured, processed, packed, or held. ‘‘(2)
p.(None): REPORTABLE FOOD.—The term ‘reportable food’ means
p.(None): an article of food (other than infant formula) for which there is a reasonable probability that the use
p.(None): of, or exposure to, such article of food will cause serious adverse health con- sequences or death to
p.(None): humans or animals.
p.(None): ‘‘(b) ESTABLISHMENT.—
p.(None): ‘‘(1) IN GENERAL.—Not later than 1 year after the date of the enactment of this section, the Secretary
p.(None): shall establish within the Food and Drug Administration a Reportable Food Registry to which instances of
p.(None): reportable food may be submitted by the Food and Drug Administration after receipt of reports under subsection
p.(None): (d), via an electronic portal, from—
p.(None): ‘‘(A) Federal, State, and local public health officials;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 350f.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): or
p.(None): ‘‘(B) responsible parties.
p.(None):
p.(None): ‘‘(2) REVIEW BY SECRETARY.—The Secretary shall promptly review and assess the information submitted under paragraph
p.(None): (1) for the purposes of identifying reportable food, submitting entries to the Reportable Food Registry, acting
p.(None): under subsection (c), and exercising other existing food safety authorities under this Act to protect the
p.(None): public health.
p.(None): ‘‘(c) ISSUANCE OF AN ALERT BY THE SECRETARY.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall issue, or cause to be issued, an alert or a notification with respect to
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): trial
p.(None): for a device that is cleared under section 510(k) of the Federal Food, Drug, and Cos- metic Act
p.(None): or approved under section 515 or 520(m) of such Act.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 911
p.(None):
p.(None):
p.(None): ‘‘(II) UNAPPROVED PRODUCTS.—The regulations under this subparagraph shall establish whether or not the results
p.(None): information described in clause
p.(None): (iii) shall be required for—
p.(None): ‘‘(aa) an applicable drug clinical trial for a drug that is not approved under section 505 of the Federal
p.(None): Food, Drug, and Cosmetic Act and not licensed under section 351 of this Act (whether approval or licensure
p.(None): was sought or not); and
p.(None): ‘‘(bb) an applicable device clinical trial for a device that is not cleared under section 510(k) of the
p.(None): Federal Food, Drug, and Cos- metic Act and not approved under section 515 or section 520(m) of such Act
p.(None): (whether clear- ance or approval was sought or not).
p.(None): ‘‘(iii) REQUIRED ELEMENTS.—The regulations under this subparagraph shall require, in addition to the elements
p.(None): described in subparagraph (C), information within each of the following categories:
p.(None): ‘‘(I) A summary of the clinical trial and its results that is written in non-technical, under- standable
p.(None): language for patients, if the Secretary determines that such types of summary can be included without being
p.(None): misleading or promotional. ‘‘(II) A summary of the clinical trial and its results that is technical in nature,
p.(None): if the Secretary determines that such types of summary can be included without being misleading or promotional.
p.(None): ‘‘(III) The full protocol or such information
p.(None): on the protocol for the trial as may be necessary to help to evaluate the results of the trial.
p.(None): ‘‘(IV) Such other categories as the Secretary determines appropriate.
p.(None): ‘‘(iv) RESULTS SUBMISSION.—The results informa- tion described in clause (iii) shall be submitted to the
p.(None): Director of NIH for inclusion in the registry and results data bank as provided by subparagraph (E), except that
p.(None): the Secretary shall by regulation determine—
p.(None): ‘‘(I) whether the 1-year period for submission of clinical trial information described in subpara- graph
p.(None): (E)(i) should be increased from 1 year to a period not to exceed 18 months;
p.(None): ‘‘(II) whether the clinical trial information described in clause (iii) should be required to be
p.(None): submitted for an applicable clinical trial for which the clinical trial information described in subpara- graph (C) is
p.(None): submitted to the registry and results data bank before the effective date of the regula- tions issued under
p.(None): this subparagraph; and
p.(None): ‘‘(III) in the case when the clinical trial information described in clause (iii) is required to
p.(None): be submitted for the applicable clinical trials described in clause (ii)(II), the date by which such clinical
p.(None): trial information shall be required to be submitted, taking into account—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Regulations.
p.(None):
p.(None):
p.(None): 121 STAT. 912 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(aa) the certification process under subparagraph (E)(iii) when approval, licen- sure, or
p.(None): clearance is sought; and
p.(None): ‘‘(bb) whether there should be a delay of submission when approval, licensure, or clear- ance will not be
p.(None): sought.
p.(None): ‘‘(v) ADDITIONAL PROVISIONS.—The regulations under this subparagraph shall also establish—
p.(None): ‘‘(I) a standard format for the submission of clinical trial information under this paragraph to the
p.(None): registry and results data bank;
p.(None): ‘‘(II) additional information on clinical trials and results that is written in nontechnical, under- standable
p.(None): language for patients;
p.(None):
p.(None): Procedures.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(III) considering the experience under the pilot quality control project described in paragraph (5)(C),
p.(None): procedures for quality control, including using representative samples, with respect to completeness
p.(None): and content of clinical trial informa- tion under this subsection, to help ensure that data elements are not
p.(None): false or misleading and are non-promotional;
p.(None): ‘‘(IV) the appropriate timing and requirements for updates of clinical trial information, and whether and,
p.(None): if so, how such updates should be tracked;
p.(None): ‘‘(V) a statement to accompany the entry for an applicable clinical trial when the primary and secondary
p.(None): outcome measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the
p.(None): submission of such informa- tion in paragraph (2)(C); and
p.(None): ‘‘(VI) additions or modifications to the manner of reporting of the data elements established under subparagraph (C).
p.(None): ‘‘(vi) CONSIDERATION OF WORLD HEALTH ORGANIZA-
p.(None): TION DATA SET.—The Secretary shall consider the status of the consensus data elements set for reporting
p.(None): clinical trial results of the World Health Organization when issuing the regulations under this subparagraph. ‘‘(vii)
p.(None): PUBLIC MEETING.—The Secretary shall hold
...
Social / Marital Status
Searching for indicator single:
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p.(None): Sec. 919. Response to the institute of medicine. Sec. 920. Database for authorized generic drugs.
p.(None): Sec. 921. Adverse drug reaction reports and postmarket safety.
p.(None): TITLE X—FOOD SAFETY
p.(None): Sec. 1001. Findings.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 825
p.(None):
p.(None):
p.(None): Sec. 1002. Ensuring the safety of pet food.
p.(None): Sec. 1003. Ensuring efficient and effective communications during a recall. Sec. 1004. State and Federal
p.(None): Cooperation.
p.(None): Sec. 1005. Reportable Food Registry.
p.(None): Sec. 1006. Enhanced aquaculture and seafood inspection.
p.(None): Sec. 1007. Consultation regarding genetically engineered seafood products. Sec. 1008. Sense of Congress.
p.(None): Sec. 1009. Annual report to Congress. Sec. 1010. Publication of annual reports. Sec. 1011. Rule of construction.
p.(None): TITLE XI—OTHER PROVISIONS
p.(None): Subtitle A—In General
p.(None): Sec. 1101. Policy on the review and clearance of scientific articles published by FDA employees.
p.(None): Sec. 1102. Priority review to encourage treatments for tropical diseases. Sec. 1103. Improving genetic test safety
p.(None): and quality.
p.(None): Sec. 1104. NIH Technical amendments. Sec. 1105. Severability clause.
p.(None): Subtitle B—Antibiotic Access and Innovation
p.(None): Sec. 1111. Identification of clinically susceptible concentrations of antimicrobials. Sec. 1112. Orphan antibiotic
p.(None): drugs.
p.(None): Sec. 1113. Exclusivity of certain drugs containing single enantiomers. Sec. 1114. Report.
p.(None):
p.(None): TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
p.(None): SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING.
p.(None): (a) SHORT TITLE.—This title may be cited as the ‘‘Prescription Drug User Fee Amendments of 2007’’.
p.(None): (b) REFERENCES IN TITLE.—Except as otherwise specified, amendments made by this title to a section
p.(None): or other provision of law are amendments to such section or other provision of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 301 et seq.).
p.(None): (c) FINDING.—The Congress finds that the fees authorized by the amendments made in this title will be
p.(None): dedicated toward expe- diting the drug development process and the process for the review of human drug
p.(None): applications, including postmarket drug safety activities, as set forth in the goals identified for
p.(None): purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the
p.(None): letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health,
p.(None): Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce
p.(None): of the House of Rep- resentatives, as set forth in the Congressional Record.
p.(None): SEC. 102. DEFINITIONS.
...
p.(None): ‘‘(5) The term ‘30-day notice’ means a notice under section 515(d)(6) that is limited to a request to make
p.(None): modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness
p.(None): of the device.
p.(None): ‘‘(6) The term ‘request for classification information’ means a request made under section 513(g) for information
p.(None): respecting the class in which a device has been classified or the require- ments applicable to a device.
p.(None): ‘‘(7) The term ‘annual fee’, for periodic reporting concerning a class III device, means the annual fee associated with
p.(None): periodic reports required by a premarket application approval order.’’;
p.(None): (4) in paragraph (10), as so redesignated—
p.(None): (A) by striking ‘‘April of the preceding fiscal year’’ and inserting ‘‘October of the preceding fiscal
p.(None): year’’; and
p.(None): (B) by striking ‘‘April 2002’’ and inserting ‘‘October 2001’’;
p.(None): (5) by inserting after paragraph (10), as so amended, the following:
p.(None): ‘‘(11) The term ‘person’ includes an affiliate thereof.’’; and
p.(None): (6) by inserting after paragraph (12), as so redesignated, the following:
p.(None): ‘‘(13) The term ‘establishment subject to a registration fee’ means an establishment that is required to
p.(None): register with the Secretary under section 510 and is one of the following types of establishments:
p.(None): ‘‘(A) MANUFACTURER.—An establishment that makes by any means any article that is a device, including an
p.(None): establishment that sterilizes or otherwise makes such article for or on behalf of a specification
p.(None): developer or any other person.
p.(None): ‘‘(B) SINGLE-USE DEVICE REPROCESSOR.—An establish-
p.(None): ment that, within the meaning of section 201(ll)(2)(A), per- forms additional processing and manufacturing
p.(None): operations on a single-use device that has previously been used on a patient.
p.(None): ‘‘(C) SPECIFICATION DEVELOPER.—An establishment that develops specifications for a device that is distributed
p.(None): under the establishment’s name but which performs no manufacturing, including an establishment that, in
p.(None): addi- tion to developing specifications, also arranges for the manufacturing of devices labeled with
p.(None): another establish- ment’s name by a contract manufacturer.’’.
p.(None):
p.(None):
p.(None): 21 USC 379i.
p.(None):
p.(None):
p.(None): 121 STAT. 844 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): SEC. 212. AUTHORITY TO ASSESS AND USE DEVICE FEES.
p.(None): (a) TYPES OF FEES.—
p.(None): (1) IN GENERAL.—Section 738(a) (21 U.S.C. 379j(a)) is amended—
p.(None): (A) in paragraph (1), by striking ‘‘Beginning on the date of the enactment of the Medical Device User
p.(None): Fee and Modernization Act of 2002’’ and inserting ‘‘Beginning in fiscal year 2008’’; and
p.(None): (B) by amending the designation and heading of para- graph (2) to read as follows:
p.(None): ‘‘(2) PREMARKET APPLICATION, PREMARKET REPORT, SUPPLE- MENT, AND SUBMISSION FEE, AND ANNUAL FEE FOR
p.(None): PERIODIC REPORTING CONCERNING A CLASS III DEVICE.—’’.
p.(None): (2) FEE AMOUNTS.—Section 738(a)(2)(A) (21 U.S.C. 379j(a)(2)(A)) is amended—
p.(None): (A) in clause (iii), by striking ‘‘a fee equal to the fee that applies’’ and inserting ‘‘a fee equal
p.(None): to 75 percent of the fee that applies’’;
p.(None): (B) in clause (iv), by striking ‘‘21.5 percent’’ and inserting ‘‘15 percent’’;
p.(None): (C) in clause (v), by striking ‘‘7.2 percent’’ and inserting ‘‘7 percent’’;
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Notification.
p.(None):
p.(None):
p.(None):
p.(None): Applicability.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Records.
p.(None):
p.(None):
p.(None):
p.(None): Reports.
p.(None):
p.(None):
p.(None): 121 STAT. 858 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None):
p.(None): Audits.
p.(None): ‘‘(F) For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions
p.(None): of reports of audits assessing conformance with appropriate quality systems standards set by the International
p.(None): Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or
p.(None): operator of an establishment elects to submit audit reports under this subparagraph, the owner or
p.(None): operator shall submit all such audit reports with respect to the establishment during the preceding 2-year
p.(None): periods.’’; and
p.(None): (6) in paragraph (10)(C)(iii), by striking ‘‘based’’ and inserting ‘‘base’’.
p.(None): SEC. 229. STUDY OF NOSOCOMIAL INFECTIONS RELATING TO MEDICAL DEVICES.
p.(None): (a) IN GENERAL.—The Comptroller General of the United States shall conduct a study on—
p.(None): (1) the number of nosocomial infections attributable to new and reused medical devices; and
p.(None): (2) the causes of such nosocomial infections, including the following:
p.(None): (A) Reprocessed single-use devices.
p.(None): (B) Handling of sterilized medical devices.
p.(None): (C) In-hospital sterilization of medical devices.
p.(None): (D) Health care professionals’ practices for patient examination and treatment.
p.(None): (E) Hospital-based policies and procedures for infection control and prevention.
p.(None): (F) Hospital-based practices for handling of medical waste.
p.(None): (G) Other causes.
p.(None): (b) REPORT.—Not later than 1 year after the date of the enact- ment of this Act, the Comptroller General shall complete
p.(None): the study under subsection (a) and submit to the Congress a report on the results of such study.
p.(None): (c) DEFINITION.—In this section, the term ‘‘nosocomial infection’’ means an infection that is acquired while an
p.(None): individual is a patient at a hospital and was neither present nor incubating in the patient prior to receiving services
p.(None): in the hospital.
p.(None): SEC. 230. REPORT BY THE FOOD AND DRUG ADMINISTRATION REGARDING LABELING INFORMATION ON THE RELATION-
p.(None): SHIP BETWEEN THE USE OF INDOOR TANNING DEVICES AND DEVELOPMENT OF SKIN CANCER OR OTHER SKIN DAMAGE.
p.(None): (a) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’),
p.(None): acting through the Commissioner of Food and Drugs, shall determine—
p.(None): (1) whether the labeling requirements for indoor tanning devices, including the positioning requirements,
p.(None): provide suffi- cient information to consumers regarding the risks that the use of such devices pose for
p.(None): the development of irreversible damage to the eyes and skin, including skin cancer; and
...
p.(None): extensions).
p.(None): ‘‘(2) EXCEPTION.—The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the
p.(None): determination made under subsection (d)(3) is made later than 9 months prior to the expiration of such period.
p.(None): ‘‘(d) CONDUCT OF PEDIATRIC STUDIES.— ‘‘(1) REQUEST FOR STUDIES.—
p.(None): ‘‘(A) IN GENERAL.—The Secretary may, after consulta- tion with the sponsor of an application for an
p.(None): investiga- tional new drug under section 505(i), the sponsor of an application for a new drug under
p.(None): section 505(b)(1), or the
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 879
p.(None):
p.(None):
p.(None): holder of an approved application for a drug under section 505(b)(1), issue to the sponsor or holder a written
p.(None): request for the conduct of pediatric studies for such drug. In issuing such request, the Secretary shall take
p.(None): into account ade- quate representation of children of ethnic and racial minori- ties. Such request to conduct
p.(None): pediatric studies shall be in writing and shall include a timeframe for such studies and a request to the
p.(None): sponsor or holder to propose pediatric labeling resulting from such studies.
p.(None): ‘‘(B) SINGLE WRITTEN REQUEST.—A single written request—
p.(None): ‘‘(i) may relate to more than one use of a drug;
p.(None):
p.(None):
p.(None): Minorities.
p.(None):
p.(None):
p.(None): Timeframe.
p.(None):
p.(None): and
p.(None): ‘‘(ii) may include uses that are both approved and
p.(None):
p.(None): unapproved.
p.(None): ‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUDIES.— ‘‘(A) REQUEST AND RESPONSE.—
p.(None): ‘‘(i) IN GENERAL.—If the Secretary makes a written request for pediatric studies (including neonates, as
p.(None): appropriate) under subsection (b) or (c), the applicant or holder, not later than 180 days after
p.(None): receiving the written request, shall respond to the Secretary as to the intention of the applicant or
p.(None): holder to act on the request by—
p.(None): ‘‘(I) indicating when the pediatric studies will be initiated, if the applicant or holder agrees to the
p.(None): request; or
p.(None): ‘‘(II) indicating that the applicant or holder does not agree to the request and stating the rea- sons for
p.(None): declining the request.
p.(None): ‘‘(ii) DISAGREE WITH REQUEST.—If, on or after the date of the enactment of the Best Pharmaceuticals for
p.(None): Children Act of 2007, the applicant or holder does not agree to the request on the grounds that it
p.(None): is not possible to develop the appropriate pediatric formu- lation, the applicant or holder shall submit to the
p.(None): Secretary the reasons such pediatric formulation cannot be developed.
p.(None): ‘‘(B) ADVERSE EVENT REPORTS.—An applicant or holder that, on or after the date of the enactment of the Best
...
p.(None): authorized to be appropriated to carry out this subsection
p.(None): $10,000,000 for each fiscal year.’’.
p.(None): (b) CONFORMING AMENDMENTS.—
p.(None): (1) PROHIBITED ACTS.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by
p.(None): adding at the end the following:
p.(None): ‘‘(jj)(1) The failure to submit the certification required by section 402(j)(5)(B) of the Public Health Service Act, or
p.(None): knowingly submit- ting a false certification under such section.
p.(None): ‘‘(2) The failure to submit clinical trial information required under subsection (j) of section 402 of
p.(None): the Public Health Service Act.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Penalties.
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(3) The submission of clinical trial information under sub- section (j) of section 402 of the Public
p.(None): Health Service Act that is false or misleading in any particular under paragraph (5)(D) of such subsection
p.(None): (j).’’.
p.(None): (2) CIVIL MONEY PENALTIES.—Subsection (f) of section 303 of the Federal Food, Drug, and Cosmetic
p.(None): Act (21 U.S.C. 333), as redesignated by section 226, is amended—
p.(None): (A) by redesignating paragraphs (3), (4), and (5) as paragraphs (5), (6), and (7), respectively;
p.(None): (B) by inserting after paragraph (2) the following: ‘‘(3)(A) Any person who violates section 301(jj) shall be subject
p.(None): to a civil monetary penalty of not more than $10,000 for all viola- tions adjudicated in a single
p.(None): proceeding.
p.(None): ‘‘(B) If a violation of section 301(jj) is not corrected within the 30-day period following notification
p.(None): under section 402(j)(5)(C)(ii), the person shall, in addition to any penalty under subparagraph (A), be
p.(None): subject to a civil monetary penalty of not more than $10,000 for each day of the violation after such period
p.(None): until the violation is corrected.’’;
p.(None): (C) in paragraph (2)(C), by striking ‘‘paragraph (3)(A)’’ and inserting ‘‘paragraph (5)(A)’’;
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 921
p.(None):
p.(None):
p.(None): (D) in paragraph (5), as so redesignated, by striking ‘‘paragraph (1) or (2)’’ each place it appears
p.(None): and inserting ‘‘paragraph (1), (2), or (3)’’;
p.(None): (E) in paragraph (6), as so redesignated, by striking ‘‘paragraph (3)(A)’’ and inserting ‘‘paragraph
p.(None): (5)(A)’’; and
p.(None): (F) in paragraph (7), as so redesignated, by striking ‘‘paragraph (4)’’ each place it appears and inserting
p.(None): ‘‘para- graph (6)’’.
p.(None): (3) NEW DRUGS AND DEVICES.—
p.(None): (A) INVESTIGATIONAL NEW DRUGS.—Section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is
p.(None): amended in paragraph (4), by adding at the end the following: ‘‘The Secretary shall update such
p.(None): regulations to require inclusion in the informed consent documents and process a statement that clinical
p.(None): trial information for such clinical investigation has been or will be submitted for inclusion in the
p.(None): registry data bank pursuant to sub- section (j) of section 402 of the Public Health Service Act.’’.
...
p.(None): processes of the United States. If the Secretary takes action to coordinate such timetable, the Secretary
p.(None): shall give notice to the responsible person.
p.(None): ‘‘(9) EFFECT.—Use of the processes described in paragraphs
p.(None): (7) and (8) shall not be the sole source of delay of action on an application or a supplement to an
p.(None): application for a drug.
p.(None): ‘‘(i) ABBREVIATED NEW DRUG APPLICATIONS.—
p.(None): ‘‘(1) IN GENERAL.—A drug that is the subject of an abbre- viated new drug application under section
p.(None): 505(j) is subject to only the following elements of the risk evaluation and mitiga- tion strategy required under
p.(None): subsection (a) for the applicable listed drug:
p.(None): ‘‘(A) A Medication Guide or patient package insert, if required under subsection (e) for the applicable
p.(None): listed drug.
p.(None): ‘‘(B) Elements to assure safe use, if required under subsection (f) for the listed drug. A drug that is the
p.(None): subject of an abbreviated new drug application and the listed drug shall use a single, shared system under
p.(None): subsection (f). The Secretary may waive the requirement under the pre- ceding sentence for a drug that is the
p.(None): subject of an abbre- viated new drug application, and permit the applicant to
p.(None): Deadline.
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None): Public information.
p.(None):
p.(None):
p.(None): 121 STAT. 938 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): use a different, comparable aspect of the elements to assure safe use, if the Secretary determines that—
p.(None): ‘‘(i) the burden of creating a single, shared system outweighs the benefit of a single, system, taking into
p.(None): consideration the impact on health care providers, patients, the applicant for the abbreviated new
p.(None): drug application, and the holder of the reference drug product; or
p.(None): ‘‘(ii) an aspect of the elements to assure safe use for the applicable listed drug is claimed by a
p.(None): patent that has not expired or is a method or process that, as a trade secret, is entitled to
p.(None): protection, and the applicant for the abbreviated new drug application cer- tifies that it has sought a license
p.(None): for use of an aspect of the elements to assure safe use for the applicable listed drug and that it was
p.(None): unable to obtain a license.
p.(None): A certification under clause (ii) shall include a description of the efforts made by the applicant for the
p.(None): abbreviated new drug application to obtain a license. In a case described in clause (ii), the Secretary may seek
p.(None): to negotiate a vol- untary agreement with the owner of the patent, method, or process for a license
p.(None): under which the applicant for such abbreviated new drug application may use an aspect of the elements to assure
p.(None): safe use, if required under sub- section (f) for the applicable listed drug, that is claimed by a patent
...
p.(None): Drug, and Cosmetic Act (21 U.S.C. 352(n)) (as amended by subparagraph (A)) is presented in the manner
p.(None): required under such section.
p.(None): (4) CIVIL PENALTIES.—Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), as amended by
p.(None): section 801(b), is amended by adding at the end the following:
p.(None): ‘‘(g)(1) With respect to a person who is a holder of an approved application under section 505 for a drug
p.(None): subject to section 503(b) or under section 351 of the Public Health Service Act, any such person who
p.(None): disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or
p.(None): misleading shall be liable to the United States for a civil penalty in an amount not to exceed $250,000
p.(None): for the first such violation in any 3-year period, and not to exceed $500,000 for each subsequent
p.(None): violation in any 3-year period. No other civil monetary penalties in this Act (including the civil
p.(None): penalty in section 303(f)(4)) shall apply to a violation regarding direct-to-consumer advertising. For pur-
p.(None): poses of this paragraph: (A) Repeated dissemination of the same or similar advertisement prior to the
p.(None): receipt of the written notice referred to in paragraph (2) for such advertisements shall be consid- ered one
p.(None): violation. (B) On and after the date of the receipt of such a notice, all violations under this
p.(None): paragraph occurring in a single day shall be considered one violation. With respect to advertisements that
p.(None): appear in magazines or other publications that are published less frequently than daily, each issue date
p.(None): (whether weekly or monthly) shall be treated as a single day for the purpose of calculating the number of violations
p.(None): under this paragraph.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 941
p.(None):
p.(None):
p.(None): ‘‘(2) A civil penalty under paragraph (1) shall be assessed by the Secretary by an order made on the
p.(None): record after providing written notice to the person to be assessed a civil penalty and an opportunity
p.(None): for a hearing in accordance with this paragraph and section 554 of title 5, United States Code. If
p.(None): upon receipt of the written notice, the person to be assessed a civil penalty objects and requests a
p.(None): hearing, then in the course of any investiga- tion related to such hearing, the Secretary may issue subpoenas
p.(None): requiring the attendance and testimony of witnesses and the produc- tion of evidence that relates to the matter
p.(None): under investigation, including information pertaining to the factors described in para- graph (3).
p.(None): ‘‘(3) The Secretary, in determining the amount of the civil penalty under paragraph (1), shall take into
p.(None): account the nature, circumstances, extent, and gravity of the violation or violations, including the
p.(None): following factors:
p.(None): ‘‘(A) Whether the person submitted the advertisement or a similar advertisement for review under section 736A.
p.(None): ‘‘(B) Whether the person submitted the advertisement for review if required under section 503B.
p.(None): ‘‘(C) Whether, after submission of the advertisement as described in subparagraph (A) or (B), the person
p.(None): disseminated or caused another party to disseminate the advertisement before the end of the 45-day
p.(None): comment period.
...
p.(None): section 505B of such Act.
p.(None): SEC. 902. ENFORCEMENT.
p.(None): (a) MISBRANDING.—Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding
p.(None): at the end the following:
p.(None): ‘‘(y) If it is a drug subject to an approved risk evaluation and mitigation strategy pursuant to section
p.(None): 505(p) and the respon- sible person (as such term is used in section 505–1) fails to comply with a requirement of such
p.(None): strategy provided for under subsection (d), (e), or (f) of section 505–1.
p.(None): ‘‘(z) If it is a drug, and the responsible person (as such term is used in section 505(o)) is in violation
p.(None): of a requirement established under paragraph (3) (relating to postmarket studies and clinical trials) or
p.(None): paragraph (4) (relating to labeling) of section 505(o) with respect to such drug.’’.
p.(None): (b) CIVIL PENALTIES.—Section 303(f) of the Federal Food, Drug, and Cosmetic Act, as amended by section 801(b),
p.(None): is amended—
p.(None): (1) by inserting after paragraph (3), as added by section 801(b)(2), the following:
p.(None): ‘‘(4)(A) Any responsible person (as such term is used in section 505–1) that violates a requirement of section
p.(None): 505(o), 505(p), or 505–1 shall be subject to a civil monetary penalty of—
p.(None): ‘‘(i) not more than $250,000 per violation, and not to exceed
p.(None): $1,000,000 for all such violations adjudicated in a single pro- ceeding; or
p.(None): ‘‘(ii) in the case of a violation that continues after the Secretary provides written notice to the
p.(None): responsible person, the responsible person shall be subject to a civil monetary penalty of $250,000 for
p.(None): the first 30-day period (or any portion thereof) that the responsible person continues to be in violation, and
p.(None): such amount shall double for every 30-day period thereafter that the violation continues, not to exceed
p.(None): $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such viola- tions adjudicated in a single
p.(None): proceeding.
p.(None): ‘‘(B) In determining the amount of a civil penalty under subparagraph (A)(ii), the Secretary
p.(None): shall take into consideration whether the responsible person is making efforts toward correcting the violation of
p.(None): the requirement of section 505(o), 505(p), or 505– 1 for which the responsible person is subject to such civil
p.(None): penalty.’’; and
p.(None): (2) in paragraph (5), as redesignated by section 801(b)(2)(A), by striking ‘‘paragraph (1), (2), or (3)’’ each
p.(None): place it appears and inserting ‘‘paragraph (1), (2), (3), or (4)’’.
p.(None): SEC. 903. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.
p.(None): Section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) is amended by adding at
p.(None): the end the following: ‘‘The Secretary may withdraw the approval of an application sub- mitted under this
p.(None): section, or suspend the approval of such an application, as provided under this subsection, without first
p.(None): ordering the applicant to submit an assessment of the approved risk evalua- tion and mitigation strategy for
p.(None): the drug under section 505– 1(g)(2)(D).’’.
p.(None):
p.(None):
p.(None): 121 STAT. 944 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None):
p.(None): Deadline. Reports.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None): pet food; and
p.(None): (4) use such information and conduct such other activities as the Secretary deems appropriate.
p.(None): SEC. 1003. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS DURING A RECALL.
p.(None): The Secretary shall, during an ongoing recall of human or pet food regulated by the Secretary—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2102.
p.(None): Deadline. Regulations.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2103.
p.(None):
p.(None):
p.(None): 121 STAT. 964 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): (1) work with companies, relevant professional associations, and other organizations to collect and aggregate
p.(None): information pertaining to the recall;
p.(None): (2) use existing networks of communication, including elec- tronic forms of information dissemination, to
p.(None): enhance the quality and speed of communication with the public; and
p.(None):
p.(None): Website.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2104.
p.(None): (3) post information regarding recalled human and pet foods on the Internet Web site of the Food and Drug
p.(None): Adminis- tration in a single location, which shall include a searchable database of recalled human foods
p.(None): and a searchable database of recalled pet foods, that is easily accessed and understood by the public.
p.(None): SEC. 1004. STATE AND FEDERAL COOPERATION.
p.(None): (a) IN GENERAL.—The Secretary shall work with the States in undertaking activities and programs that
p.(None): assist in improving the safety of food, including fresh and processed produce, so that State food safety
p.(None): programs and activities conducted by the Secretary function in a coordinated and cost-effective manner. With the
p.(None): assist- ance provided under subsection (b), the Secretary shall encourage States to—
p.(None): (1) establish, continue, or strengthen State food safety pro- grams, especially with respect to the
p.(None): regulation of retail commercial food establishments; and
p.(None): (2) establish procedures and requirements for ensuring that processed produce under the jurisdiction of State
p.(None): food safety programs is not unsafe for human consumption.
p.(None): (b) ASSISTANCE.—The Secretary may provide to a State, for planning, developing, and implementing such a
p.(None): food safety pro- gram—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 350f
p.(None): note.
p.(None): (1) advisory assistance;
p.(None): (2) technical assistance, training, and laboratory assistance (including necessary materials and equipment); and
p.(None): (3) financial and other assistance.
p.(None): (c) SERVICE AGREEMENTS.—The Secretary may, under an agree- ment entered into with a Federal, State, or local
...
p.(None): Administration Pesticide Program Residue Monitoring 2003’’ as released in June of 2005;
p.(None): (2) based on an analysis of previous samples, an identifica- tion of products or countries (for imports) that
p.(None): require special attention and additional study based on a comparison with equivalent products manufactured,
p.(None): distributed, or sold in the United States (including details on the plans for such additional studies), including
p.(None): in the initial report (and subsequent reports as determined necessary) the results and analysis of the Gin-
p.(None): seng Dietary Supplements Special Survey as described on page
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 971
p.(None):
p.(None):
p.(None): 13 of the report entitled ‘‘Food and Drug Administration Pes- ticide Program Residue Monitoring 2003’’;
p.(None): (3) information on the relative number of interstate and imported shipments of each tested commodity that
p.(None): were sam- pled, including recommendations on whether sampling is statis- tically significant, provides confidence
p.(None): intervals or other related statistical information, and whether the number of samples should be increased and
p.(None): the details of any plans to provide for such increase; and
p.(None): (4) a description of whether certain commodities are being improperly imported as another commodity, including a
p.(None): descrip- tion of additional steps that are being planned to prevent such smuggling.
p.(None): (b) INITIAL REPORTS.—Annual reports under subsection (a) for fiscal years 2004 through 2006 may be
p.(None): combined into a single report, by not later than June 1, 2008, for purposes of publication under
p.(None): subsection (a). Thereafter such reports shall be completed by June 1 of each year for the data
p.(None): collected for the year that was 2-years prior to the year in which the report is published.
p.(None): (c) MEMORANDUM OF UNDERSTANDING.—The Commissioner of Food and Drugs, the Administrator of the Food Safety and
p.(None): Inspec- tion Service, the Department of Commerce, and the head of the Agricultural Marketing Service shall
p.(None): enter into a memorandum of understanding to permit inclusion of data in the reports under subsection (a)
p.(None): relating to testing carried out by the Food Safety and Inspection Service and the Agricultural Marketing
p.(None): Service on meat, poultry, eggs, and certain raw agricultural products, respec- tively.
p.(None): SEC. 1011. RULE OF CONSTRUCTION.
p.(None): Nothing in this title (or an amendment made by this title) shall be construed to affect—
p.(None): (1) the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (Public
p.(None): Law 103–417); or
p.(None): (2) the adverse event reporting system for dietary supple- ments created under the Dietary Supplement and
p.(None): Nonprescrip- tion Drug Consumer Protection Act (Public Law 109–462).
p.(None): TITLE XI—OTHER PROVISIONS
p.(None): Subtitle A—In General
p.(None): SEC. 1101. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC ARTICLES PUBLISHED BY FDA EMPLOYEES.
...
p.(None): or presentation with an appropriate disclaimer as specified in the
p.(None): policies established under subsection (b).
p.(None): ‘‘(f) EFFECT.—Nothing in this section shall be construed as affecting any restrictions on such publication
p.(None): or presentation pro- vided by other provisions of law.’’.
p.(None): SEC. 1102. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROP- ICAL DISEASES.
p.(None): Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is
p.(None): amended by adding at the end the following:
p.(None):
p.(None): 21 USC 360n.
p.(None): ‘‘SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROP- ICAL DISEASES.
p.(None): ‘‘(a) DEFINITIONS.—In this section:
p.(None): ‘‘(1) PRIORITY REVIEW.—The term ‘priority review’, with respect to a human drug application as defined in
p.(None): section 735(1), means review and action by the Secretary on such application not later than 6 months
p.(None): after receipt by the Sec- retary of such application, as described in the Manual of Policies and Procedures of the
p.(None): Food and Drug Administration and goals identified in the letters described in section 101(c) of the Food and Drug
p.(None): Administration Amendments Act of 2007.
p.(None): ‘‘(2) PRIORITY REVIEW VOUCHER.—The term ‘priority review voucher’ means a voucher issued by the Secretary to the
p.(None): sponsor of a tropical disease product application that entitles the holder of such voucher to priority review of
p.(None): a single human drug application submitted under section 505(b)(1) or section 351 of the Public Health
p.(None): Service Act after the date of approval of the tropical disease product application.
p.(None): ‘‘(3) TROPICAL DISEASE.—The term ‘tropical disease’ means any of the following:
p.(None): ‘‘(A) Tuberculosis. ‘‘(B) Malaria.
p.(None): ‘‘(C) Blinding trachoma.
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(D) Buruli Ulcer. ‘‘(E) Cholera.
p.(None): ‘‘(F) Dengue/dengue haemorrhagic fever. ‘‘(G) Dracunculiasis (guinea-worm disease). ‘‘(H) Fascioliasis.
p.(None): ‘‘(I) Human African trypanosomiasis. ‘‘(J) Leishmaniasis.
p.(None): ‘‘(K) Leprosy.
p.(None): ‘‘(L) Lymphatic filariasis. ‘‘(M) Onchocerciasis.
p.(None): ‘‘(N) Schistosomiasis.
p.(None): ‘‘(O) Soil transmitted helmithiasis. ‘‘(P) Yaws.
p.(None): 121 STAT. 973
p.(None): ‘‘(Q) Any other infectious disease for which there is no significant market in developed nations and
p.(None): that dis- proportionately affects poor and marginalized populations, designated by regulation by the Secretary.
p.(None): ‘‘(4) TROPICAL DISEASE PRODUCT APPLICATION.—The term
p.(None): ‘tropical disease product application’ means an application that—
p.(None): ‘‘(A) is a human drug application as defined in section 735(1)—
p.(None): ‘‘(i) for prevention or treatment of a tropical dis- ease; and
p.(None): ‘‘(ii) the Secretary deems eligible for priority review;
p.(None): ‘‘(B) is approved after the date of the enactment of the Food and Drug Administration Amendments Act of
...
p.(None): clinically susceptible concentrations publicly available, such as by posting on the Internet, not later than 30
p.(None): days after the date of identification and any update under this section.
p.(None): (d) EFFECT.—Nothing in this section shall be construed to restrict, in any manner, the prescribing of
p.(None): antibiotics by physicians, or to limit the practice of medicine, including for diseases such as Lyme and
p.(None): tick-borne diseases.
p.(None): SEC. 1112. ORPHAN ANTIBIOTIC DRUGS.
p.(None): (a) PUBLIC MEETING.—The Commissioner of Food and Drugs shall convene a public meeting regarding which
p.(None): serious and life threatening infectious diseases, such as diseases due to gram-nega- tive bacteria and other diseases
p.(None): due to antibiotic-resistant bacteria, potentially qualify for available grants and contracts under section 5(a) of the
p.(None): Orphan Drug Act (21 U.S.C. 360ee(a)) or other incentives for development.
p.(None): (b) GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF ORPHAN DRUGS.—Section 5(c) of the Orphan Drug Act (21
p.(None): U.S.C. 360ee(c)) is amended to read as follows:
p.(None): ‘‘(c) For grants and contracts under subsection (a), there is authorized to be appropriated $30,000,000
p.(None): for each of fiscal years 2008 through 2012.’’.
p.(None): SEC. 1113. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
p.(None): Section 505 of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 355), as amended by section 920, is further amended by adding at the end the following:
p.(None): ‘‘(u) CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.—
p.(None): ‘‘(1) IN GENERAL.—For purposes of subsections (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is submitted
p.(None): under subsection
p.(None): (b) for a non-racemic drug containing as an active ingredient (including any ester or salt of the
p.(None): active ingredient) a single enantiomer that is contained in a racemic drug approved in another application
p.(None): under subsection (b), the applicant may, in the application for such non-racemic drug, elect to have the
p.(None): single enantiomer not be considered the same active ingre- dient as that contained in the approved racemic
p.(None): drug, if— ‘‘(A)(i) the single enantiomer has not been previously
p.(None): approved except in the approved racemic drug; and
p.(None): ‘‘(ii) the application submitted under subsection (b) for such non-racemic drug—
p.(None): ‘‘(I) includes full reports of new clinical investiga- tions (other than bioavailability studies)—
p.(None): ‘‘(aa) necessary for the approval of the applica- tion under subsections (c) and (d); and
p.(None): ‘‘(bb) conducted or sponsored by the applicant;
p.(None): and
p.(None): ‘‘(II) does not rely on any investigations that are part of an application submitted under subsection
p.(None): (b) for approval of the approved racemic drug; and
p.(None): ‘‘(B) the application submitted under subsection (b) for such non-racemic drug is not submitted for
p.(None): approval of a condition of use—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 977
p.(None):
p.(None):
p.(None): ‘‘(i) in a therapeutic category in which the approved racemic drug has been approved; or
p.(None): ‘‘(ii) for which any other enantiomer of the racemic drug has been approved.
p.(None): ‘‘(2) LIMITATION.—
p.(None): ‘‘(A) NO APPROVAL IN CERTAIN THERAPEUTIC CAT-
p.(None): EGORIES.—Until the date that is 10 years after the date of approval of a non-racemic drug described in
p.(None): paragraph
p.(None): (1) and with respect to which the applicant has made the election provided for by such paragraph, the
...
Social / Police Officer
Searching for indicator officer:
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p.(None): (iv) by striking the last sentence and inserting ‘‘If no tax forms are submitted for any affiliate, the
p.(None): applicant shall certify that the applicant has no affili- ates.’’; and
p.(None): (v) by adding at the end the following:
p.(None): ‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE UNITED STATES INTERNAL REVENUE SERVICE.—In the
p.(None): case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of
p.(None): its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a
p.(None): signed certification, in such form as the Secretary may direct through a notice published in the Federal
p.(None): Register, that the applicant or affiliate meets the cri- teria for a small business and a
p.(None): certification, in English, from the national taxing authority of the country in which the applicant or, if
p.(None): applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official
p.(None): seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the
p.(None): most recent year in both the local currency of such country and in United States dollars, the exchange rate
p.(None): used in converting such local currency to dollars, and the dates during which these receipts or sales
p.(None): were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or
p.(None): by its chief financial officer that the applicant has submitted certifications for all of its affiliates,
p.(None): or that the applicant has no affiliates.’’.
p.(None): (3) REDUCED FEES.—Section 738(d)(2)(C) (21 U.S.C. 379j(d)(2)(C)) is amended to read as follows:
p.(None): ‘‘(C) REDUCED FEES.—Where the Secretary finds that the applicant involved meets the definition under subpara-
p.(None): graph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of—
p.(None): ‘‘(i) 25 percent of the fee established under such subsection for a premarket application, a premarket
p.(None): report, a supplement, or periodic reporting concerning a class III device; and
p.(None): ‘‘(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classifica-
p.(None): tion information.’’.
p.(None): (e) SMALL BUSINESSES; FEE REDUCTION REGARDING PREMARKET NOTIFICATION SUBMISSIONS.—
p.(None): (1) IN GENERAL.—Section 738(e)(1) (21 U.S.C. 379j(e)(1))
p.(None): is amended—
p.(None): (A) by striking ‘‘2004’’ and inserting ‘‘2008’’; and
p.(None): (B) by striking ‘‘(a)(2)(A)(vii)’’ and inserting ‘‘(a)(2)(A)(viii)’’.
p.(None): (2) RULES RELATING TO PREMARKET NOTIFICATION SUBMIS- SIONS.—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Certification. Federal Register, publication.
p.(None):
p.(None):
p.(None): 121 STAT. 848 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): (A) DEFINITION.—Section 738(e)(2)(A) (21 U.S.C. 379j(e)(2)(A)) is amended by striking ‘‘, partners, and
p.(None): parent firms’’.
p.(None): (B) EVIDENCE OF QUALIFICATION.—Section 738(e)(2)(B) (21 U.S.C. 379j(e)(2)(B)) is amended—
...
p.(None): applicant shall certify that the applicant has no affili- ates.’’; and
p.(None): (v) by adding at the end the following:
p.(None): ‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE
p.(None):
p.(None): Certification. Federal Register, publication.
p.(None): UNITED STATES INTERNAL REVENUE SERVICE.—In the
p.(None): case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of
p.(None): its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a
p.(None): signed certification, in such form as the Secretary may direct through a notice published in the Federal
p.(None): Register, that the applicant or affiliate meets the cri- teria for a small business and a
p.(None): certification, in English, from the national taxing authority of the country in which the applicant or, if
p.(None): applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official
p.(None): seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the
p.(None): most recent year in both the local currency of such country and in United States dollars, the exchange rate
p.(None): used in converting such local currency to dollars, and the dates during which these receipts or sales
p.(None): were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or
p.(None): by its chief financial officer that the applicant has submitted certifications for all of its affiliates,
p.(None): or that the applicant has no affiliates.’’.
p.(None): (3) REDUCED FEES.—Section 738(e)(2)(C) (21 U.S.C. 379j(e)(2)(C)) is amended to read as follows:
p.(None): ‘‘(C) REDUCED FEES.—For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the
p.(None): applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission
p.(None): may be paid at 50 percent of the fee that applies under sub- section (a)(2)(A)(viii), and as established
p.(None): under subsection (c)(1).’’.
p.(None): (f) EFFECT OF FAILURE TO PAY FEES.—Section 738(f) (21 U.S.C. 379j(f)) is amended to read as follows:
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): ‘‘(f) EFFECT OF FAILURE TO PAY FEES.—
p.(None): 121 STAT. 849
p.(None): ‘‘(1) NO ACCEPTANCE OF SUBMISSIONS.—A premarket
p.(None): application, premarket report, supplement, premarket notifica- tion submission, 30-day notice, request for
p.(None): classification information, or periodic reporting concerning a class III device submitted by a person subject to
p.(None): fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the
p.(None): Secretary until all fees owed by such person have been paid.
p.(None): ‘‘(2) NO REGISTRATION.—Registration information submitted under section 510 by an establishment subject to a
p.(None): registration fee shall be considered incomplete and shall not be accepted by the Secretary until the
p.(None): registration fee under subsection (a)(3) owed for the establishment has been paid. Until the fee is paid
...
p.(None): Drug Administration, the materials described in subparagraph (C)(iv) not later than 48 hours after the date of
p.(None): approval of the drug, except where
p.(None): such materials require redaction by the Secretary.
p.(None): ‘‘(C) CONTENTS.—An action package for approval of an application under subparagraph (A) shall be dated
p.(None): and shall include the following:
p.(None): ‘‘(i) Documents generated by the Food and Drug Administration related to review of the application.
p.(None): ‘‘(ii) Documents pertaining to the format and content of the application generated during drug development.
p.(None): ‘‘(iii) Labeling submitted by the applicant.
p.(None): ‘‘(iv) A summary review that documents conclusions from all reviewing disciplines about the drug, noting
p.(None): any critical issues and disagreements with the applicant and within the review team and how they were
p.(None): resolved, rec- ommendations for action, and an explanation of any non- concurrence with review conclusions.
p.(None): ‘‘(v) The Division Director and Office Director’s decision document which includes—
p.(None): ‘‘(I) a brief statement of concurrence with the sum- mary review;
p.(None): ‘‘(II) a separate review or addendum to the review if disagreeing with the summary review; and
p.(None): ‘‘(III) a separate review or addendum to the review to add further analysis.
p.(None): ‘‘(vi) Identification by name of each officer or employee of the Food and Drug Administration who—
p.(None): ‘‘(I) participated in the decision to approve the application; and
p.(None): ‘‘(II) consents to have his or her name included in the package.
p.(None): ‘‘(D) REVIEW.—A scientific review of an application is considered the work of the reviewer and
p.(None): shall not be altered by management or the reviewer once final.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Publication. Website.
p.(None): Deadlines.
p.(None):
p.(None):
p.(None): 121 STAT. 960 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(E) CONFIDENTIAL INFORMATION.—This paragraph does not authorize the disclosure of any trade secret,
p.(None): confidential commercial or financial information, or other matter listed in section 552(b) of title 5, United
p.(None): States Code.’’.
p.(None): SEC. 917. RISK COMMUNICATION.
p.(None): Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.), as
p.(None): amended by section 603, is amended by adding at the end the following:
p.(None):
p.(None): 21 USC
p.(None): 360bbb–6. Establishment.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355.
p.(None): ‘‘SEC. 567. RISK COMMUNICATION.
...
p.(None): Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.), as
p.(None): amended by section 701, is further amended by adding at the end the following:
p.(None): ‘‘SEC. 713. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC ARTICLES PUBLISHED BY FDA EMPLOYEES.
p.(None): ‘‘(a) DEFINITION.—In this section, the term ‘article’ means a paper, poster, abstract, book, book chapter,
p.(None): or other published writing.
p.(None): ‘‘(b) POLICIES.—The Secretary, through the Commissioner of Food and Drugs, shall establish and make
p.(None): publicly available clear
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2110.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379d–2.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public information.
p.(None):
p.(None):
p.(None): 121 STAT. 972 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): written policies to implement this section and govern the timely submission, review, clearance, and disclaimer
p.(None): requirements for arti- cles.
p.(None): ‘‘(c) TIMING OF SUBMISSION FOR REVIEW.—If an officer or
p.(None): employee, including a Staff Fellow and a contractor who performs staff work, of the Food and Drug
p.(None): Administration is directed by the policies established under subsection (b) to submit an article to the
p.(None): supervisor of such officer or employee, or to some other official of the Food and Drug Administration, for
p.(None): review and clear- ance before such officer or employee may seek to publish or present such an article at a
p.(None): conference, such officer or employee shall submit such article for such review and clearance not less
p.(None): than 30 days before submitting the article for publication or presentation. ‘‘(d) TIMING FOR REVIEW AND
p.(None): CLEARANCE.—The supervisor or other reviewing official shall review such article and provide written
p.(None): clearance, or written clearance on the condition of specified changes being made, to such officer or employee
p.(None): not later than 30 days after such officer or employee submitted such article for review. ‘‘(e) NON-TIMELY
p.(None): REVIEW.—If, 31 days after such submission under subsection (c), the supervisor or other reviewing
p.(None): official has not cleared or has not reviewed such article and provided written clearance, such officer or
p.(None): employee may consider such article not to have been cleared and may submit the article for publication
p.(None): or presentation with an appropriate disclaimer as specified in the
p.(None): policies established under subsection (b).
p.(None): ‘‘(f) EFFECT.—Nothing in this section shall be construed as affecting any restrictions on such publication
p.(None): or presentation pro- vided by other provisions of law.’’.
p.(None): SEC. 1102. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROP- ICAL DISEASES.
p.(None): Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is
p.(None): amended by adding at the end the following:
p.(None):
p.(None): 21 USC 360n.
p.(None): ‘‘SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROP- ICAL DISEASES.
p.(None): ‘‘(a) DEFINITIONS.—In this section:
p.(None): ‘‘(1) PRIORITY REVIEW.—The term ‘priority review’, with respect to a human drug application as defined in
p.(None): section 735(1), means review and action by the Secretary on such application not later than 6 months
p.(None): after receipt by the Sec- retary of such application, as described in the Manual of Policies and Procedures of the
p.(None): Food and Drug Administration and goals identified in the letters described in section 101(c) of the Food and Drug
p.(None): Administration Amendments Act of 2007.
p.(None): ‘‘(2) PRIORITY REVIEW VOUCHER.—The term ‘priority review voucher’ means a voucher issued by the Secretary to the
p.(None): sponsor of a tropical disease product application that entitles the holder of such voucher to priority review of
...
Social / Property Ownership
Searching for indicator property:
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p.(None): ‘‘(e) INCORPORATION.—The ex officio members of the Board shall serve as incorporators and shall take whatever
p.(None): actions necessary to incorporate the Foundation.
p.(None): ‘‘(f) NONPROFIT STATUS.—In carrying out subsection (b), the Board shall establish such policies and bylaws
p.(None): under subsection (d), and the Executive Director shall carry out such activities under subsection (g), as may be
p.(None): necessary to ensure that the Foundation maintains status as an organization that—
p.(None): ‘‘(1) is described in subsection (c)(3) of section 501 of the Internal Revenue Code of 1986; and
p.(None): ‘‘(2) is, under subsection (a) of such section, exempt from taxation.
p.(None): ‘‘(g) EXECUTIVE DIRECTOR.—
p.(None): ‘‘(1) IN GENERAL.—The Board shall appoint an Executive Director who shall serve at the pleasure of the
p.(None): Board. The Executive Director shall be responsible for the day-to-day oper- ations of the Foundation and shall
p.(None): have such specific duties and responsibilities as the Board shall prescribe.
p.(None): ‘‘(2) COMPENSATION.—The compensation of the Executive Director shall be fixed by the Board but shall not
p.(None): be greater than the compensation of the Commissioner.
p.(None): ‘‘(h) ADMINISTRATIVE POWERS.—In carrying out this subchapter, the Board, acting through the Executive Director,
p.(None): may—
p.(None): ‘‘(1) adopt, alter, and use a corporate seal, which shall be judicially noticed;
p.(None): ‘‘(2) hire, promote, compensate, and discharge 1 or more officers, employees, and agents, as may be necessary,
p.(None): and define their duties;
p.(None): ‘‘(3) prescribe the manner in which—
p.(None): ‘‘(A) real or personal property of the Foundation is acquired, held, and transferred;
p.(None): ‘‘(B) general operations of the Foundation are to be conducted; and
p.(None): ‘‘(C) the privileges granted to the Board by law are exercised and enjoyed;
p.(None): ‘‘(4) with the consent of the applicable executive department or independent agency, use the information, services, and
p.(None): facili- ties of such department or agencies in carrying out this section; ‘‘(5) enter into contracts with public
p.(None): and private organiza- tions for the writing, editing, printing, and publishing of books
p.(None): and other material;
p.(None): ‘‘(6) hold, administer, invest, and spend any gift, devise, or bequest of real or personal property made to the
p.(None): Foundation under subsection (i);
p.(None): ‘‘(7) enter into such other contracts, leases, cooperative agreements, and other transactions as the Board
p.(None): considers appropriate to conduct the activities of the Foundation;
p.(None):
p.(None):
p.(None): 121 STAT. 896 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(8) modify or consent to the modification of any contract or agreement to which it is a party or in
p.(None): which it has an interest under this subchapter;
p.(None): ‘‘(9) take such action as may be necessary to obtain patents and licenses for devices and procedures
p.(None): developed by the Foundation and its employees;
p.(None): ‘‘(10) sue and be sued in its corporate name, and complain and defend in courts of competent jurisdiction;
p.(None): ‘‘(11) appoint other groups of advisors as may be determined necessary to carry out the functions of the
p.(None): Foundation; and ‘‘(12) exercise other powers as set forth in this section, and such other incidental
p.(None): powers as are necessary to carry out its powers, duties, and functions in accordance with this
p.(None): subchapter.
p.(None): ‘‘(i) ACCEPTANCE OF FUNDS FROM OTHER SOURCES.—The Execu-
p.(None): tive Director may solicit and accept on behalf of the Foundation, any funds, gifts, grants, devises, or
p.(None): bequests of real or personal property made to the Foundation, including from private entities, for the
p.(None): purposes of carrying out the duties of the Foundation. ‘‘(j) SERVICE OF FEDERAL EMPLOYEES.—Federal
p.(None): Government employees may serve on committees advisory to the Foundation and otherwise cooperate with and
p.(None): assist the Foundation in carrying out its functions, so long as such employees do not direct or control
p.(None): Foundation activities.
p.(None): ‘‘(k) DETAIL OF GOVERNMENT EMPLOYEES; FELLOWSHIPS.—
p.(None): ‘‘(1) DETAIL FROM FEDERAL AGENCIES.—Federal Govern-
p.(None): ment employees may be detailed from Federal agencies with or without reimbursement to those agencies to the
p.(None): Foundation at any time, and such detail shall be without interruption or loss of civil service status or
p.(None): privilege. Each such employee shall abide by the statutory, regulatory, ethical, and procedural standards
p.(None): applicable to the employees of the agency from which such employee is detailed and those of the Foundation.
p.(None): ‘‘(2) VOLUNTARY SERVICE; ACCEPTANCE OF FEDERAL EMPLOYEES.—
p.(None): ‘‘(A) FOUNDATION.—The Executive Director of the Foundation may accept the services of employees
p.(None): detailed from Federal agencies with or without reimbursement to those agencies.
...
Social / Racial Minority
Searching for indicator minority:
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p.(None): note.
p.(None): business. Such a petition may only be filed within the 60-day period beginning on the date the order
p.(None): making such assessments was issued.
p.(None): ‘‘(7) If any person fails to pay an assessment of a civil penalty under paragraph (1)—
p.(None): ‘‘(A) after the order making the assessment becomes final, and if such person does not file a petition for
p.(None): judicial review of the order in accordance with paragraph (6), or
p.(None): ‘‘(B) after a court in an action brought under paragraph
p.(None): (6) has entered a final judgment in favor of the Secretary, the Attorney General of the United States shall
p.(None): recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of
p.(None): the 60-day period referred to in paragraph
p.(None): (6) or the date of such final judgment, as the case may be) in an action brought in any appropriate
p.(None): district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty
p.(None): shall not be subject to review.’’.
p.(None): (5) REPORT ON DIRECT-TO-CONSUMER ADVERTISING.—Not later than 24 months after the date of the enactment
p.(None): of this Act, the Secretary of Health and Human Services shall report to the Congress on direct-to-consumer
p.(None): advertising and its ability to communicate to subsets of the general population, including elderly populations,
p.(None): children, and racial and ethnic minority communities. The Secretary shall utilize the Advisory Com- mittee
p.(None): on Risk Communication established under this Act to advise the Secretary with respect to such report. The
p.(None): Advisory Committee shall study direct-to-consumer advertising as it relates to increased access to health
p.(None): information and decreased health disparities for these populations. The report required by this paragraph
p.(None): shall recommend effective ways to present and disseminate information to these populations. Such report shall
p.(None): also make recommendations regarding impediments to the participation of elderly populations, children,
p.(None): racially and ethnically diverse communities, and medically underserved populations in clinical drug
p.(None): trials and shall recommend best practice approaches for increasing the inclusion of such subsets of the general
p.(None): population. The Secretary of Health and Human Services shall submit the report under this paragraph to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representatives.
p.(None): (6) RULEMAKING.—Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is
p.(None): amended by striking ‘‘the procedure specified in section 701(e) of this Act’’ and inserting ‘‘section
p.(None): 701(a)’’.
...
p.(None): (a) REPORT.—If the Secretary’s Advisory Committee on Genetics, Health, and Society does not
p.(None): complete and submit the Regulatory Oversight of Genetic/Genomic Testing Report & Action Recommendations to
p.(None): the Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’) by July
p.(None): of 2008, the Secretary shall enter into a contract with the Institute of
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 975
p.(None):
p.(None):
p.(None): Medicine to conduct a study to assess the overall safety and quality of genetic tests and prepare a report that
p.(None): includes recommendations to improve Federal oversight and regulation of genetic tests. Such study shall take
p.(None): into consideration relevant reports by the Sec- retary’s Advisory Committee on Genetics, Health, and
p.(None): Society and other groups and shall be completed not later than 1 year after the date on which the Secretary
p.(None): entered into such contract.
p.(None): (b) RULE OF CONSTRUCTION.—Nothing in this section shall be construed as requiring Federal efforts with
p.(None): respect to regulatory oversight of genetic tests to cease or be limited or delayed pending completion of the
p.(None): report by the Secretary’s Advisory Committee on Genetics, Health, and Society or the Institute of Medicine.
p.(None): SEC. 1104. NIH TECHNICAL AMENDMENTS.
p.(None): The Public Health Service Act (42 U.S.C. 201 et seq.) is amended—
p.(None): (1) in section 319C–2(j)(3)(B), by striking ‘‘section 319C– 1(h)’’ and inserting ‘‘section 319C–1(i)’’;
p.(None): (2) in section 402(b)(4), by inserting ‘‘minority and other’’ after ‘‘reducing’’;
p.(None): (3) in section 403(a)(4)(C)(iv)(III), by inserting ‘‘and postdoctoral training funded through research
p.(None): grants’’ before the semicolon;
p.(None): (4) by designating the second section 403C (relating to the drug diethylstilbestrol) as section 403D; and
p.(None): (5) in section 403C(a)—
p.(None): (A) in the matter preceding paragraph (1)—
p.(None): (i) by inserting ‘‘graduate students supported by the National Institutes of Health’’ after ‘‘with respect
p.(None): to’’; and
p.(None): (ii) by deleting ‘‘each degree-granting program’’;
p.(None): (B) in paragraph (1), by inserting ‘‘such’’ after ‘‘percent- age of’’; and
p.(None): (C) in paragraph (2), by inserting ‘‘(not including any leaves of absence)’’ after ‘‘average time’’.
p.(None): SEC. 1105. SEVERABILITY CLAUSE.
p.(None): If any provision of this Act, an amendment made this Act, or the application of such provision or
p.(None): amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the
p.(None): amendments made by this Act, and the application of the provisions of such to any person or
p.(None): circumstances shall not be affected thereby.
p.(None): Subtitle B—Antibiotic Access and Innovation
p.(None): SEC. 1111. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE CON- CENTRATIONS OF ANTIMICROBIALS.
p.(None): (a) DEFINITION.—In this section, the term ‘‘clinically susceptible concentrations’’ means specific values which
p.(None): characterize bacteria as clinically susceptible, intermediate, or resistant to the drug (or drugs) tested.
...
Searching for indicator racial:
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p.(None): resulting from the certifi- cation the court determines that the patent is valid and would be infringed,
p.(None): the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B)
p.(None): shall be extended by a period of six months after the date the patent expires (including any patent
p.(None): extensions).
p.(None): ‘‘(2) EXCEPTION.—The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the
p.(None): determination made under subsection (d)(3) is made later than 9 months prior to the expiration of such period.
p.(None): ‘‘(d) CONDUCT OF PEDIATRIC STUDIES.— ‘‘(1) REQUEST FOR STUDIES.—
p.(None): ‘‘(A) IN GENERAL.—The Secretary may, after consulta- tion with the sponsor of an application for an
p.(None): investiga- tional new drug under section 505(i), the sponsor of an application for a new drug under
p.(None): section 505(b)(1), or the
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 879
p.(None):
p.(None):
p.(None): holder of an approved application for a drug under section 505(b)(1), issue to the sponsor or holder a written
p.(None): request for the conduct of pediatric studies for such drug. In issuing such request, the Secretary shall take
p.(None): into account ade- quate representation of children of ethnic and racial minori- ties. Such request to conduct
p.(None): pediatric studies shall be in writing and shall include a timeframe for such studies and a request to the
p.(None): sponsor or holder to propose pediatric labeling resulting from such studies.
p.(None): ‘‘(B) SINGLE WRITTEN REQUEST.—A single written request—
p.(None): ‘‘(i) may relate to more than one use of a drug;
p.(None):
p.(None):
p.(None): Minorities.
p.(None):
p.(None):
p.(None): Timeframe.
p.(None):
p.(None): and
p.(None): ‘‘(ii) may include uses that are both approved and
p.(None):
p.(None): unapproved.
p.(None): ‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUDIES.— ‘‘(A) REQUEST AND RESPONSE.—
p.(None): ‘‘(i) IN GENERAL.—If the Secretary makes a written request for pediatric studies (including neonates, as
p.(None): appropriate) under subsection (b) or (c), the applicant or holder, not later than 180 days after
p.(None): receiving the written request, shall respond to the Secretary as to the intention of the applicant or
p.(None): holder to act on the request by—
p.(None): ‘‘(I) indicating when the pediatric studies will be initiated, if the applicant or holder agrees to the
p.(None): request; or
p.(None): ‘‘(II) indicating that the applicant or holder does not agree to the request and stating the rea- sons for
p.(None): declining the request.
p.(None): ‘‘(ii) DISAGREE WITH REQUEST.—If, on or after the date of the enactment of the Best Pharmaceuticals for
...
p.(None): 801(b), is amended—
p.(None): (1) in section 301 (21 U.S.C. 331), by adding at the end the following:
p.(None): ‘‘(kk) The dissemination of a television advertisement without complying with section 503B.’’; and
p.(None): (2) by inserting after section 503A the following:
p.(None): ‘‘SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS.
p.(None): ‘‘(a) IN GENERAL.—The Secretary may require the submission of any television advertisement for a drug
p.(None): (including any script, story board, rough, or a completed video production of the television advertisement) to the
p.(None): Secretary for review under this section not later than 45 days before dissemination of the television advertise-
p.(None): ment.
p.(None): ‘‘(b) REVIEW.—In conducting a review of a television advertise- ment under this section, the Secretary may make
p.(None): recommendations with respect to information included in the label of the drug—
p.(None): ‘‘(1) on changes that are—
p.(None): ‘‘(A) necessary to protect the consumer good and well- being; or
p.(None): ‘‘(B) consistent with prescribing information for the product under review; and
p.(None): ‘‘(2) if appropriate and if information exists, on statements for inclusion in the advertisement to address the
p.(None): specific effi- cacy of the drug as it relates to specific population groups, including elderly
p.(None): populations, children, and racial and ethnic minorities.
p.(None): ‘‘(c) NO AUTHORITY TO REQUIRE CHANGES.—Except as provided by subsection (e), this section does not
p.(None): authorize the Secretary to make or direct changes in any material submitted pursuant to subsection (a).
p.(None): ‘‘(d) ELDERLY POPULATIONS, CHILDREN, RACIALLY AND ETH-
p.(None): NICALLY DIVERSE COMMUNITIES.—In formulating recommendations under subsection (b), the Secretary shall take
p.(None): into consideration the impact of the advertised drug on elderly populations, children, and racially and ethnically
p.(None): diverse communities.
p.(None): ‘‘(e) SPECIFIC DISCLOSURES.—
p.(None): ‘‘(1) SERIOUS RISK; SAFETY PROTOCOL.—In conducting a
p.(None): review of a television advertisement under this section, if the Secretary determines that the
p.(None): advertisement would be false or misleading without a specific disclosure about a serious risk listed in
p.(None): the labeling of the drug involved, the Secretary may require inclusion of such disclosure in the advertisement.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 353b.
p.(None): Deadline.
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355a
p.(None): note.
p.(None): business. Such a petition may only be filed within the 60-day period beginning on the date the order
p.(None): making such assessments was issued.
p.(None): ‘‘(7) If any person fails to pay an assessment of a civil penalty under paragraph (1)—
p.(None): ‘‘(A) after the order making the assessment becomes final, and if such person does not file a petition for
p.(None): judicial review of the order in accordance with paragraph (6), or
p.(None): ‘‘(B) after a court in an action brought under paragraph
p.(None): (6) has entered a final judgment in favor of the Secretary, the Attorney General of the United States shall
p.(None): recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of
p.(None): the 60-day period referred to in paragraph
p.(None): (6) or the date of such final judgment, as the case may be) in an action brought in any appropriate
p.(None): district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty
p.(None): shall not be subject to review.’’.
p.(None): (5) REPORT ON DIRECT-TO-CONSUMER ADVERTISING.—Not later than 24 months after the date of the enactment
p.(None): of this Act, the Secretary of Health and Human Services shall report to the Congress on direct-to-consumer
p.(None): advertising and its ability to communicate to subsets of the general population, including elderly populations,
p.(None): children, and racial and ethnic minority communities. The Secretary shall utilize the Advisory Com- mittee
p.(None): on Risk Communication established under this Act to advise the Secretary with respect to such report. The
p.(None): Advisory Committee shall study direct-to-consumer advertising as it relates to increased access to health
p.(None): information and decreased health disparities for these populations. The report required by this paragraph
p.(None): shall recommend effective ways to present and disseminate information to these populations. Such report shall
p.(None): also make recommendations regarding impediments to the participation of elderly populations, children,
p.(None): racially and ethnically diverse communities, and medically underserved populations in clinical drug
p.(None): trials and shall recommend best practice approaches for increasing the inclusion of such subsets of the general
p.(None): population. The Secretary of Health and Human Services shall submit the report under this paragraph to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representatives.
...
Social / Religion
Searching for indicator faith:
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p.(None): requiring the attendance and testimony of witnesses and the produc- tion of evidence that relates to the matter
p.(None): under investigation, including information pertaining to the factors described in para- graph (3).
p.(None): ‘‘(3) The Secretary, in determining the amount of the civil penalty under paragraph (1), shall take into
p.(None): account the nature, circumstances, extent, and gravity of the violation or violations, including the
p.(None): following factors:
p.(None): ‘‘(A) Whether the person submitted the advertisement or a similar advertisement for review under section 736A.
p.(None): ‘‘(B) Whether the person submitted the advertisement for review if required under section 503B.
p.(None): ‘‘(C) Whether, after submission of the advertisement as described in subparagraph (A) or (B), the person
p.(None): disseminated or caused another party to disseminate the advertisement before the end of the 45-day
p.(None): comment period.
p.(None): ‘‘(D) Whether the person incorporated any comments made by the Secretary with regard to the advertisement into
p.(None): the advertisement prior to its dissemination.
p.(None): ‘‘(E) Whether the person ceased distribution of the advertisement upon receipt of the written
p.(None): notice referred to in paragraph (2) for such advertisement.
p.(None): ‘‘(F) Whether the person had the advertisement reviewed by qualified medical, regulatory, and legal
p.(None): reviewers prior to its dissemination.
p.(None): ‘‘(G) Whether the violations were material.
p.(None): ‘‘(H) Whether the person who created the advertisement or caused the advertisement to be created acted
p.(None): in good faith. ‘‘(I) Whether the person who created the advertisement
p.(None): or caused the advertisement to be created has been assessed a civil penalty under this provision within
p.(None): the previous 1- year period.
p.(None): ‘‘(J) The scope and extent of any voluntary, subsequent remedial action by the person.
p.(None): ‘‘(K) Such other matters, as justice may require.
p.(None): ‘‘(4)(A) Subject to subparagraph (B), no person shall be required to pay a civil penalty under paragraph (1) if the
p.(None): person submitted the advertisement to the Secretary and disseminated or caused another party to disseminate
p.(None): such advertisement after incorporating each comment received from the Secretary.
p.(None): ‘‘(B) The Secretary may retract or modify any prior comments the Secretary has provided to an
p.(None): advertisement submitted to the Secretary based on new information or changed circumstances, so long as the
p.(None): Secretary provides written notice to the person of the new views of the Secretary on the advertisement and
p.(None): provides a reasonable time for modification or correction of the advertisement prior to seeking any civil penalty under
p.(None): paragraph (1).
p.(None): ‘‘(5) The Secretary may compromise, modify, or remit, with or without conditions, any civil penalty which
p.(None): may be assessed
p.(None): Public record. Notification.
p.(None):
p.(None):
p.(None): 121 STAT. 942 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): under paragraph (1). The amount of such penalty, when finally determined, or the amount charged upon in
p.(None): compromise, may be deducted from any sums owed by the United States to the person charged.
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Searching for indicator belief:
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p.(None): an application.
p.(None): ‘‘(F) FINAL AGENCY ACTION.—The Secretary shall take final agency action on a petition not later than 180
p.(None): days after the date on which the petition is submitted. The Secretary shall not extend such period for
p.(None): any reason, including—
p.(None): ‘‘(i) any determination made under subparagraph
p.(None): (A);
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 955
p.(None):
p.(None): ‘‘(ii) the submission of comments relating to the petition or supplemental information supplied by the
p.(None): petitioner; or
p.(None): ‘‘(iii) the consent of the petitioner.
p.(None): ‘‘(G) EXTENSION OF 30-MONTH PERIOD.—If the filing of
p.(None): an application resulted in first-applicant status under sub- section (j)(5)(D)(i)(IV) and approval of the
p.(None): application was delayed because of a petition, the 30-month period under such subsection is deemed to be
p.(None): extended by a period of time equal to the period beginning on the date on which the Secretary received the petition
p.(None): and ending on the date of final agency action on the petition (inclusive of such beginning and ending
p.(None): dates), without regard to whether the Secretary grants, in whole or in part, or denies, in whole or in
p.(None): part, the petition.
p.(None): ‘‘(H) CERTIFICATION.—The Secretary shall not consider a petition for review unless the party submitting such
p.(None): petition does so in written form and the subject document is signed and contains the following certification: ‘I
p.(None): certify that, to my best knowledge and belief: (a) this petition includes all information and views upon which
p.(None): the petition relies; (b) this petition includes representative data and/ or information known to the petitioner
p.(None): which are unfavor- able to the petition; and (c) I have taken reasonable steps to ensure that any representative data
p.(None): and/or information which are unfavorable to the petition were disclosed to me. I further certify that the
p.(None): information upon which I have based the action requested herein first became known to the party on whose behalf
p.(None): this petition is submitted on or about the following date: llllllllll. If I received or expect to
p.(None): receive payments, including cash and other forms of consideration, to file this information or its
p.(None): contents, I received or expect to receive those pay- ments from the following persons or
p.(None): organizations: lllllllllllll. I verify under penalty of per- jury that the foregoing is true and correct
p.(None): as of the date of the submission of this petition.’, with the date on which such information first became known
p.(None): to such party and the names of such persons or organizations inserted in the first and second blank space,
p.(None): respectively.
p.(None): ‘‘(I) VERIFICATION.—The Secretary shall not accept for review any supplemental information or comments on
p.(None): a petition unless the party submitting such information or comments does so in written form and the subject
p.(None): document is signed and contains the following verification: ‘I certify that, to my best knowledge and
p.(None): belief: (a) I have not intentionally delayed submission of this document or its contents; and (b) the
p.(None): information upon which I have based the action requested herein first became known to me on or about
p.(None): llllllllll. If I received or expect to receive payments, including cash and other forms of consideration,
p.(None): to file this information or its contents, I received or expect to receive those payments from the fol-
p.(None): lowing persons or organizations: lllll. I verify under penalty of perjury that the foregoing is true and
p.(None): correct as of the date of the submission of this petition.’, with the date on which such information
p.(None): first became known
p.(None):
p.(None):
p.(None): 121 STAT. 956 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): to the party and the names of such persons or organizations inserted in the first and second blank space,
p.(None): respectively. ‘‘(2) EXHAUSTION OF ADMINISTRATIVE REMEDIES.—
p.(None): ‘‘(A) FINAL AGENCY ACTION WITHIN 180 DAYS.—The Sec-
p.(None): retary shall be considered to have taken final agency action on a petition if—
p.(None): ‘‘(i) during the 180-day period referred to in para- graph (1)(F), the Secretary makes a final decision
p.(None): within the meaning of section 10.45(d) of title 21, Code of Federal Regulations (or any successor regulation); or
p.(None):
p.(None):
p.(None):
p.(None): Courts.
p.(None): ‘‘(ii) such period expires without the Secretary having made such a final decision.
p.(None): ‘‘(B) DISMISSAL OF CERTAIN CIVIL ACTIONS.—If a civil
p.(None): action is filed against the Secretary with respect to any issue raised in the petition before the Secretary
...
Social / Threat of Stigma
Searching for indicator threat:
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p.(None): ‘‘(E) ORDER.—Within 15 days of the conclusion of the discussions under subparagraph (D), the Secretary
p.(None): may issue an order directing the responsible person or the holder of the approved application under section
p.(None): 505(j) to make such a labeling change as the Secretary deems appropriate to address the new safety information.
p.(None): Within 15 days of such an order, the responsible person or the holder of the approved application
p.(None): under section 505(j) shall submit a supplement containing the labeling change.
p.(None): ‘‘(F) DISPUTE RESOLUTION.—Within 5 days of receiving an order under subparagraph (E), the responsible person
p.(None): or the holder of the approved application under section 505(j) may appeal using dispute resolution
p.(None): procedures established by the Secretary in regulation and guidance. ‘‘(G) VIOLATION.—If the responsible
p.(None): person or the holder of the approved application under section 505(j) has not submitted a supplement
p.(None): within 15 days of the date of such order under subparagraph (E), and there is no appeal or dispute
p.(None): resolution proceeding pending, the responsible person or holder shall be considered to be in violation of
p.(None): this subsection. If at the conclusion of any dispute resolution procedures the Secretary determines
p.(None): that a supplement must be submitted and such a supple- ment is not submitted within 15 days of the
p.(None): date of that determination, the responsible person or holder shall be
p.(None): in violation of this subsection.
p.(None): ‘‘(H) PUBLIC HEALTH THREAT.—Notwithstanding sub- paragraphs (A) through (F), if the Secretary concludes that such
p.(None): a labeling change is necessary to protect the public health, the Secretary may accelerate the timelines in such
p.(None): subparagraphs.
p.(None): ‘‘(I) RULE OF CONSTRUCTION.—This paragraph shall not be construed to affect the responsibility of the
p.(None): responsible person or the holder of the approved application under section 505(j) to maintain its label
p.(None): in accordance with existing requirements, including subpart B of part 201
p.(None):
p.(None):
p.(None): Notification.
p.(None):
p.(None):
p.(None): 121 STAT. 926 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): and sections 314.70 and 601.12 of title 21, Code of Federal Regulations (or any successor regulations).
p.(None): ‘‘(5) NON-DELEGATION.—Determinations by the Secretary under this subsection for a drug shall be made by
p.(None): individuals at or above the level of individuals empowered to approve a drug (such as division directors
p.(None): within the Center for Drug Evaluation and Research).
p.(None): ‘‘(p) RISK EVALUATION AND MITIGATION STRATEGY.—
p.(None): ‘‘(1) IN GENERAL.—A person may not introduce or deliver for introduction into interstate commerce a new drug
p.(None): if—
p.(None): ‘‘(A)(i) the application for such drug is approved under subsection (b) or (j) and is subject to section
...
Social / Victim of Abuse
Searching for indicator abuse:
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p.(None): Secretary a proposed risk evalua- tion and mitigation strategy.
p.(None): ‘‘(3) ABBREVIATED NEW DRUG APPLICATIONS.—The applica-
p.(None): bility of this section to an application under section 505(j) is subject to subsection (i).
p.(None): ‘‘(4) NON-DELEGATION.—Determinations by the Secretary under this subsection for a drug shall be made by
p.(None): individuals at or above the level of individuals empowered to approve a drug (such as division directors
p.(None): within the Center for Drug Evaluation and Research).
p.(None): ‘‘(b) DEFINITIONS.—For purposes of this section:
p.(None): ‘‘(1) ADVERSE DRUG EXPERIENCE.—The term ‘adverse drug experience’ means any adverse event associated with
p.(None): the use of a drug in humans, whether or not considered drug related, including—
p.(None): ‘‘(A) an adverse event occurring in the course of the use of the drug in professional practice;
p.(None): ‘‘(B) an adverse event occurring from an overdose of the drug, whether accidental or intentional;
p.(None): ‘‘(C) an adverse event occurring from abuse of the drug;
p.(None): ‘‘(D) an adverse event occurring from withdrawal of the drug; and
p.(None): ‘‘(E) any failure of expected pharmacological action of the drug.
p.(None): ‘‘(2) COVERED APPLICATION.—The term ‘covered application’ means an application referred to in section 505(p)(1)(A).
p.(None): ‘‘(3) NEW SAFETY INFORMATION.—The term ‘new safety information’, with respect to a drug, means information
p.(None): derived from a clinical trial, an adverse event report, a postapproval study (including a study under
p.(None): section 505(o)(3)), or peer- reviewed biomedical literature; data derived from the postmarket
p.(None): risk identification and analysis system under sec- tion 505(k); or other scientific data deemed
p.(None): appropriate by the Secretary about—
p.(None): ‘‘(A) a serious risk or an unexpected serious risk associ- ated with use of the drug that the Secretary has
p.(None): become aware of (that may be based on a new analysis of existing
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Notification.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Applicability.
p.(None):
p.(None):
p.(None): 121 STAT. 928 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
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Social / Women
Searching for indicator women:
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p.(None): the Secretary shall be considered to have met the action dead- line for the action letter on the application if the
p.(None): responsible person requests the dispute resolution process described in this paragraph and if the Secretary—
p.(None): ‘‘(i) has initiated the discussions described under paragraph (2) not less than 60 days before such action
p.(None): deadline; and
p.(None): ‘‘(ii) has complied with the timing requirements of scheduling review by the Drug Safety Oversight Board,
p.(None): providing a written recommendation, and issuing an action letter under subparagraphs (B), (F), and (G),
p.(None): respectively.
p.(None): ‘‘(J) DISQUALIFICATION.—No individual who is an employee of the Food and Drug Administration and who
p.(None): reviews a drug or who participated in an administrative appeal under subparagraph (C)(i) with respect to such
p.(None): drug may serve on the Drug Safety Oversight Board at a meeting under subparagraph (D) to review a dispute about
p.(None): the risk evaluation and mitigation strategy for such drug.
p.(None): ‘‘(K) ADDITIONAL EXPERTISE.—The Drug Safety Over-
p.(None): sight Board may add members with relevant expertise from the Food and Drug Administration, including the
p.(None): Office of Pediatrics, the Office of Women’s Health, or the Office of Rare Diseases, or from other Federal
p.(None): public health or health care agencies, for a meeting under subparagraph
p.(None): (D) of the Drug Safety Oversight Board.
p.(None): ‘‘(6) USE OF ADVISORY COMMITTEES.—The Secretary may
p.(None): convene a meeting of 1 or more advisory committees of the Food and Drug Administration to—
p.(None): ‘‘(A) review a concern about the safety of a drug or class of drugs, including before an assessment of
p.(None): the risk evaluation and mitigation strategy or strategies of such drug or drugs is required to be
p.(None): submitted under any of subparagraphs (B) through (D) of subsection (g)(2);
p.(None): ‘‘(B) review the risk evaluation and mitigation strategy or strategies of a drug or group of drugs; or
p.(None): ‘‘(C) review a dispute under paragraph (4) or (5). ‘‘(7) PROCESS FOR ADDRESSING DRUG CLASS EFFECTS.—
p.(None): ‘‘(A) IN GENERAL.—When a concern about a serious risk of a drug may be related to the pharmacological class of
p.(None): the drug, the Secretary, in consultation with the offices described in subsection (c)(2), may defer assessments
...
p.(None): identification and analysis methods under subpara- graph (B), as required under clause (i), the Secretary
p.(None): may, on a temporary or permanent basis, implement systems or products developed by private entities.
p.(None): ‘‘(iv) COMPLEMENTARY APPROACHES.—To the extent
p.(None): the active postmarket risk identification and analysis system under this subsection is not sufficient to gather
p.(None): data and information relevant to a priority drug safety question, the Secretary shall develop, support, and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Reports.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 946 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): participate in complementary approaches to gather and analyze such data and information, including—
p.(None): ‘‘(I) approaches that are complementary with respect to assessing the safety of use of a drug in domestic
p.(None): populations not included, or underrep- resented, in the trials used to approve the drug (such as older
p.(None): people, people with comorbidities, pregnant women, or children); and
p.(None): ‘‘(II) existing approaches such as the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink or
p.(None): successor databases.
p.(None): ‘‘(v) AUTHORITY FOR CONTRACTS.—The Secretary
p.(None): may enter into contracts with public and private enti- ties to fulfill the requirements of this subparagraph.
p.(None): ‘‘(4) ADVANCED ANALYSIS OF DRUG SAFETY DATA.—
p.(None): ‘‘(A) PURPOSE.—The Secretary shall establish collabora- tions with public, academic, and private entities, which
p.(None): may include the Centers for Education and Research on Therapeutics under section 912 of the Public Health
p.(None): Service Act, to provide for advanced analysis of drug safety data described in paragraph (3)(C) and other
p.(None): information that is publicly available or is provided by the Secretary, in order to—
p.(None): ‘‘(i) improve the quality and efficiency of postmarket drug safety risk-benefit analysis;
p.(None): ‘‘(ii) provide the Secretary with routine access to outside expertise to study advanced drug safety ques-
p.(None): tions; and
p.(None): ‘‘(iii) enhance the ability of the Secretary to make timely assessments based on drug safety data.
...
p.(None): (o)(3).
p.(None): ‘‘(D) PROCEDURES FOR THE DEVELOPMENT OF DRUG SAFETY COLLABORATIONS.—
p.(None):
p.(None): Deadline.
p.(None): ‘‘(i) IN GENERAL.—Not later than 180 days after the date of the establishment of the active postmarket risk
p.(None): identification and analysis system under this sub- section, the Secretary shall establish and implement
p.(None): procedures under which the Secretary may routinely contract with one or more qualified entities to—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 947
p.(None):
p.(None):
p.(None): ‘‘(I) classify, analyze, or aggregate data described in paragraph (3)(C) and information that is
p.(None): publicly available or is provided by the Sec- retary;
p.(None): ‘‘(II) allow for prompt investigation of priority drug safety questions, including—
p.(None): ‘‘(aa) unresolved safety questions for drugs or classes of drugs; and
p.(None): ‘‘(bb) for a newly-approved drugs, safety signals from clinical trials used to approve the drug and other
p.(None): preapproval trials; rare, serious drug side effects; and the safety of use in domestic populations not
p.(None): included, or underrepresented, in the trials used to approve the drug (such as older people, people with
p.(None): comorbidities, pregnant women, or children); ‘‘(III) perform advanced research and analysis
p.(None): on identified drug safety risks;
p.(None): ‘‘(IV) focus postapproval studies and clinical trials under subsection (o)(3) more effectively on cases for
p.(None): which reports under paragraph (1) and other safety signal detection is not sufficient to resolve whether
p.(None): there is an elevated risk of a serious adverse event associated with the use of a drug; and
p.(None): ‘‘(V) carry out other activities as the Secretary deems necessary to carry out the purposes of this paragraph.
p.(None): ‘‘(ii) REQUEST FOR SPECIFIC METHODOLOGY.—The
p.(None): procedures described in clause (i) shall permit the Sec- retary to request that a specific methodology be used
p.(None): by the qualified entity. The qualified entity shall work with the Secretary to finalize the methodology to be
p.(None): used.
p.(None): ‘‘(E) USE OF ANALYSES.—The Secretary shall provide the analyses described in this paragraph, including
p.(None): the methods and results of such analyses, about a drug to the sponsor or sponsors of such drug.
p.(None): ‘‘(F) QUALIFIED ENTITIES.—
p.(None): ‘‘(i) IN GENERAL.—The Secretary shall enter into contracts with a sufficient number of qualified entities to
p.(None): develop and provide information to the Secretary in a timely manner.
p.(None): ‘‘(ii) QUALIFICATION.—The Secretary shall enter into a contract with an entity under clause (i) only
...
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p.(None): drugs.
p.(None): Sec. 1113. Exclusivity of certain drugs containing single enantiomers. Sec. 1114. Report.
p.(None):
p.(None): TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
p.(None): SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING.
p.(None): (a) SHORT TITLE.—This title may be cited as the ‘‘Prescription Drug User Fee Amendments of 2007’’.
p.(None): (b) REFERENCES IN TITLE.—Except as otherwise specified, amendments made by this title to a section
p.(None): or other provision of law are amendments to such section or other provision of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 301 et seq.).
p.(None): (c) FINDING.—The Congress finds that the fees authorized by the amendments made in this title will be
p.(None): dedicated toward expe- diting the drug development process and the process for the review of human drug
p.(None): applications, including postmarket drug safety activities, as set forth in the goals identified for
p.(None): purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the
p.(None): letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health,
p.(None): Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce
p.(None): of the House of Rep- resentatives, as set forth in the Congressional Record.
p.(None): SEC. 102. DEFINITIONS.
p.(None): Section 735 (21 U.S.C. 379g) is amended—
p.(None): (1) in the matter before paragraph (1), by striking ‘‘For purposes of this subchapter’’ and inserting
p.(None): ‘‘For purposes of this part’’;
p.(None): (2) in paragraph (1)—
p.(None): (A) in subparagraph (A), by striking ‘‘505(b)(1),’’ and inserting ‘‘505(b), or’’;
p.(None): (B) by striking subparagraph (B);
p.(None): (C) by redesignating subparagraph (C) as subpara- graph (B); and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Prescription Drug User Fee Amendments of 2007.
p.(None):
p.(None):
p.(None): 21 USC 301 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379g
p.(None): note.
p.(None):
p.(None):
p.(None): 121 STAT. 826 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): (D) in the matter following subparagraph (B), as so redesignated, by striking ‘‘subparagraph (C)’’ and
p.(None): inserting ‘‘subparagraph (B)’’;
p.(None): (3) in paragraph (3)(C)—
p.(None): (A) by striking ‘‘505(j)(7)(A)’’ and inserting ‘‘505(j)(7)(A) (not including the discontinued section of such
p.(None): list)’’; and
p.(None): (B) by inserting before the period ‘‘(not including the discontinued section of such list)’’;
p.(None): (4) in paragraph (4), by inserting before the period at the end the following: ‘‘(such as capsules, tablets,
...
p.(None): tion drug advertising; and
p.(None): ‘‘(E) terminating the program under this section pursu- ant to subsection (f)(2) if that becomes necessary.
p.(None): ‘‘(10) The term ‘resubmission’ means a subsequent submis- sion for advisory review of a direct-to-consumer
p.(None): television advertisement that has been revised in response to the Sec- retary’s comments on an original
p.(None): submission. A resubmission may not introduce significant new concepts or creative themes into the television
p.(None): advertisement.
p.(None): ‘‘(11) The term ‘submission for advisory review’ means an original submission of a direct-to-consumer
p.(None): television advertise- ment for which the sponsor voluntarily requests advisory com- ments before the advertisement is
p.(None): publicly disseminated.’’.
p.(None): SEC. 105. REAUTHORIZATION; REPORTING REQUIREMENTS.
p.(None): Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.), as amended by section 104, is further
p.(None): amended by inserting after section 736A the following:
p.(None):
p.(None): 21 USC 379h–2.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Website.
p.(None): ‘‘SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS.
p.(None): ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal year 2008, not later than 120 days after the end of each
p.(None): fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the
p.(None): Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor,
p.(None): and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving
p.(None): the goals identified in the letters described in section 101(c) of the Food and Drug Administration
p.(None): Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug Administration
p.(None): for meeting the goals. The report for a fiscal year shall include informa- tion on all previous cohorts for
p.(None): which the Secretary has not given a complete response on all human drug applications and supple- ments in
p.(None): the cohort.
p.(None): ‘‘(b) FISCAL REPORT.—Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal
p.(None): year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on
p.(None): Energy and Commerce of the House of Rep- resentatives and the Committee on Health, Education, Labor, and
p.(None): Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal
p.(None): year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.
p.(None): ‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall make the reports required under subsections (a) and
p.(None): (b) available to the public on the Internet Web site of the Food and Drug Administra- tion.
p.(None): ‘‘(d) REAUTHORIZATION.—
p.(None): ‘‘(1) CONSULTATION.—In developing recommendations to present to the Congress with respect to the goals,
p.(None): and plans for meeting the goals, for the process for the review of human drug applications for the first 5
p.(None): fiscal years after fiscal year 2012, and for the reauthorization of this part for such fiscal years, the
p.(None): Secretary shall consult with—
p.(None): ‘‘(A) the Committee on Energy and Commerce of the House of Representatives;
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 841
p.(None):
p.(None):
p.(None): ‘‘(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
p.(None): ‘‘(C) scientific and academic experts; ‘‘(D) health care professionals;
p.(None): ‘‘(E) representatives of patient and consumer advocacy groups; and
p.(None): ‘‘(F) the regulated industry.
p.(None): ‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations with the regulated industry on the reauthorization of
p.(None): this part, the Secretary shall—
p.(None): ‘‘(A) publish a notice in the Federal Register requesting public input on the reauthorization;
p.(None): ‘‘(B) hold a public meeting at which the public may present its views on the reauthorization, including
p.(None): specific suggestions for changes to the goals referred to in sub- section (a);
p.(None): ‘‘(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting
p.(None): changes to this part; and
p.(None): ‘‘(D) publish the comments on the Food and Drug Administration’s Internet Web site.
p.(None): ‘‘(3) PERIODIC CONSULTATION.—Not less frequently than once every month during negotiations with the
p.(None): regulated industry, the Secretary shall hold discussions with representa- tives of patient and consumer advocacy
p.(None): groups to continue discussions of their views on the reauthorization and their suggestions for changes to
p.(None): this part as expressed under para- graph (2).
p.(None): ‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotia-
p.(None): tions with the regulated industry, the Secretary shall—
p.(None): ‘‘(A) present the recommendations developed under paragraph (1) to the Congressional committees
p.(None): specified in such paragraph;
p.(None): ‘‘(B) publish such recommendations in the Federal Reg- ister;
...
p.(None): were accepted by the Food and Drug Administration for filing with respect to assessing and collecting
p.(None): any fee required by such part for a fiscal year prior to fiscal year 2008.
p.(None): SEC. 109. TECHNICAL AMENDMENT; CONFORMING AMENDMENT.
p.(None): (a) Section 739 (21 U.S.C. 379j–11) is amended in the matter preceding paragraph (1) by striking
p.(None): ‘‘subchapter’’ and inserting ‘‘part’’.
p.(None): (b) Paragraph (11) of section 739 (21 U.S.C. 379j–11) is amended by striking ‘‘735(9)’’ and inserting ‘‘735(11)’’.
p.(None): TITLE II—MEDICAL DEVICE USER FEE AMENDMENTS OF 2007
p.(None): SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING.
p.(None): (a) SHORT TITLE.—This title may be cited as the ‘‘Medical Device User Fee Amendments of 2007’’.
p.(None): (b) REFERENCES IN TITLE.—Except as otherwise specified, amendments made by this title to a section
p.(None): or other provision of law are amendments to such section or other provision of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 301 et seq.).
p.(None): (c) FINDING.—The Congress finds that the fees authorized under the amendments made by this title will be dedicated
p.(None): toward expe- diting the process for the review of device applications and for assuring the safety and
p.(None): effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C
p.(None): of chapter VII of the Federal Food, Drug, and Cosmetic Act in the letters from the Secretary of Health
p.(None): and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pen- sions of the Senate and
p.(None): the Chairman of the Committee on Energy
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 843
p.(None):
p.(None): and Commerce of the House of Representatives, as set forth in the Congressional Record.
p.(None): Subtitle A—Fees Related to Medical Devices
p.(None):
p.(None):
p.(None): SEC. 211. DEFINITIONS.
p.(None): Section 737 is amended—
p.(None): (1) in the matter preceding paragraph (1), by striking ‘‘For purposes of this subchapter’’ and inserting ‘‘For
p.(None): purposes of this part’’;
p.(None): (2) by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (8), (9), (10), and (12), respectively;
p.(None): (3) by inserting after paragraph (4) the following:
p.(None): ‘‘(5) The term ‘30-day notice’ means a notice under section 515(d)(6) that is limited to a request to make
p.(None): modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness
p.(None): of the device.
p.(None): ‘‘(6) The term ‘request for classification information’ means a request made under section 513(g) for information
p.(None): respecting the class in which a device has been classified or the require- ments applicable to a device.
p.(None): ‘‘(7) The term ‘annual fee’, for periodic reporting concerning a class III device, means the annual fee associated with
p.(None): periodic reports required by a premarket application approval order.’’;
p.(None): (4) in paragraph (10), as so redesignated—
p.(None): (A) by striking ‘‘April of the preceding fiscal year’’ and inserting ‘‘October of the preceding fiscal
p.(None): year’’; and
p.(None): (B) by striking ‘‘April 2002’’ and inserting ‘‘October 2001’’;
p.(None): (5) by inserting after paragraph (10), as so amended, the following:
...
p.(None): amended to read as follows:
p.(None): ‘‘(4) OFFSET.—If the cumulative amount of fees collected during fiscal years 2008, 2009, and 2010, added to the
p.(None): amount estimated to be collected for fiscal year 2011, which estimate shall be based upon the amount of
p.(None): fees received by the Sec- retary through June 30, 2011, exceeds the amount of fees specified in
p.(None): aggregate in paragraph (3) for these four fiscal years, the aggregate amount in excess shall be credited
p.(None): to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be
p.(None): subtracted from the amount of fees that would otherwise be authorized to be collected under this section
p.(None): pursuant to appropriation Acts for fiscal year 2012.’’.
p.(None): SEC. 213. REAUTHORIZATION; REPORTING REQUIREMENTS.
p.(None): Part 3 of subchapter C of chapter VII is amended by inserting after section 738 the following:
p.(None):
p.(None): 21 USC 379j–1.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Website.
p.(None): ‘‘SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS.
p.(None): ‘‘(a) REPORTS.—
p.(None): ‘‘(1) PERFORMANCE REPORT.—For fiscal years 2008 through 2012, not later than 120 days after the end of each
p.(None): fiscal year during which fees are collected under this part, the Sec- retary shall prepare and submit to
p.(None): the Committee on Health, Education, Labor, and Pensions of the Senate and the Com- mittee on Energy and
p.(None): Commerce of the House of Representa- tives, a report concerning the progress of the Food and Drug
p.(None): Administration in achieving the goals identified in the letters described in section 201(c) of the Food and
p.(None): Drug Administration Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug
p.(None): Administration for meeting the goals. The report for a fiscal year shall include information on all
p.(None): previous cohorts for which the Secretary has not given a complete response on all device premarket
p.(None): applications and reports, supplements, and premarket notifications in the cohort. ‘‘(2) FISCAL REPORT.—For fiscal
p.(None): years 2008 through 2012,
p.(None): not later than 120 days after the end of each fiscal year during which fees are collected under this part, the
p.(None): Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the
p.(None): Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the implementation
p.(None): of the authority for such fees during such fiscal year and the use, by the Food and Drug Administra- tion, of
p.(None): the fees collected during such fiscal year for which the report is made.
p.(None): ‘‘(3) PUBLIC AVAILABILITY.—The Secretary shall make the reports required under paragraphs (1) and (2)
p.(None): available to the public on the Internet Web site of the Food and Drug Administration.
p.(None): ‘‘(b) REAUTHORIZATION.—
p.(None): ‘‘(1) CONSULTATION.—In developing recommendations to present to Congress with respect to the goals, and
p.(None): plans for meeting the goals, for the process for the review of device applications for the first 5
p.(None): fiscal years after fiscal year 2012, and for the reauthorization of this part for such fiscal years, the
p.(None): Secretary shall consult with—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 851
p.(None):
p.(None):
p.(None): ‘‘(A) the Committee on Energy and Commerce of the House of Representatives;
p.(None): ‘‘(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
p.(None): ‘‘(C) scientific and academic experts; ‘‘(D) health care professionals;
p.(None): ‘‘(E) representatives of patient and consumer advocacy groups; and
p.(None): ‘‘(F) the regulated industry.
p.(None): ‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations with the regulated industry on the reauthorization of
p.(None): this part, the Secretary shall—
p.(None): ‘‘(A) publish a notice in the Federal Register requesting public input on the reauthorization;
p.(None): ‘‘(B) hold a public meeting at which the public may present its views on the reauthorization, including
p.(None): specific suggestions for changes to the goals referred to in sub- section (a)(1);
p.(None): ‘‘(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting
p.(None): changes to this part; and
p.(None): ‘‘(D) publish the comments on the Food and Drug Administration’s Internet Web site.
p.(None): ‘‘(3) PERIODIC CONSULTATION.—Not less frequently than once every month during negotiations with the
p.(None): regulated industry, the Secretary shall hold discussions with representa- tives of patient and consumer advocacy
p.(None): groups to continue discussions of their views on the reauthorization and their suggestions for changes to
p.(None): this part as expressed under para- graph (2).
p.(None): ‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotia-
p.(None): tions with the regulated industry, the Secretary shall—
p.(None): ‘‘(A) present the recommendations developed under paragraph (1) to the Congressional committees
p.(None): specified in such paragraph;
p.(None): ‘‘(B) publish such recommendations in the Federal Reg- ister;
...
p.(None): in consultation with experts in the Center for Devices and Radiological Health, shall provide for periodic
p.(None): review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such
p.(None): committee regarding whether the Secretary should take action under this Act in response to the report.
p.(None): ‘‘(8) The Secretary, acting through the Office of Pediatric Thera- peutics and the Center for Devices and
p.(None): Radiological Health, shall provide for an annual review by the Pediatric Advisory Committee
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Notification.
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Applicability.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Annual review.
p.(None):
p.(None):
p.(None): 121 STAT. 862 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): of all devices described in paragraph (6) to ensure that the exemp- tion under paragraph (2) remains appropriate
p.(None): for the pediatric populations for which it is granted.’’.
p.(None): (b) REPORT.—Not later than January 1, 2012, the Comptroller General of the United States shall submit to
p.(None): the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representa- tives a report on the impact of allowing persons granted an exemp- tion
p.(None): under section 520(m)(2) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C. 360j(m)(2)) with
p.(None): respect to a device to profit from such device pursuant to section 520(m)(6) of such Act (21
p.(None): U.S.C. 360j(m)(6)) (as amended by subsection (a)), including—
p.(None): (1) an assessment of whether such section 520(m)(6) (as amended by subsection (a)) has increased the
p.(None): availability of pediatric devices for conditions that occur in small numbers of children, including any
p.(None): increase or decrease in the number of—
p.(None): (A) exemptions granted under such section 520(m)(2) for pediatric devices; and
p.(None): (B) applications approved under section 515 of such Act (21 U.S.C. 360e) for devices intended to treat,
p.(None): diagnose, or cure conditions that occur in pediatric patients or for devices labeled for use in a pediatric
p.(None): population;
p.(None): (2) the conditions or diseases the pediatric devices were intended to treat or diagnose and the
p.(None): estimated size of the pediatric patient population for each condition or disease;
p.(None): (3) the costs of purchasing pediatric devices, based on a representative sampling of children’s hospitals;
p.(None): (4) the extent to which the costs of such devices are covered by health insurance;
p.(None): (5) the impact, if any, of allowing profit on access to such devices for patients;
...
p.(None): any regulatory actions taken.
p.(None): (c) GUIDANCE.—Not later than 180 days after the date of the enactment of this Act, the Commissioner of
p.(None): Food and Drugs shall issue guidance for institutional review committees on how to evaluate requests
p.(None): for approval for devices for which a humanitarian
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 863
p.(None):
p.(None):
p.(None): device exemption under section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) has been
p.(None): granted.
p.(None): SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH.
p.(None): (a) CONTACT POINT FOR AVAILABLE FUNDING.—Section 402(b) of the Public Health Service Act (42 U.S.C.
p.(None): 282(b)) is amended—
p.(None): (1) in paragraph (21), by striking ‘‘and’’ after the semicolon at the end;
p.(None): (2) in paragraph (22), by striking the period at the end and inserting ‘‘; and’’; and
p.(None): (3) by inserting after paragraph (22) the following:
p.(None): ‘‘(23) shall designate a contact point or office to help innovators and physicians identify sources
p.(None): of funding available for pediatric medical device development.’’.
p.(None): (b) PLAN FOR PEDIATRIC MEDICAL DEVICE RESEARCH.—
p.(None): (1) IN GENERAL.—Not later than 180 days after the date of the enactment of this Act, the Secretary of
p.(None): Health and Human Services, acting through the Commissioner of Food and Drugs, the Director of the
p.(None): National Institutes of Health, and the Director of the Agency for Healthcare Research and Quality, shall
p.(None): submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on
p.(None): Energy and Commerce of the House of Representatives a plan for expanding pediatric medical device research and
p.(None): develop- ment. In developing such plan, the Secretary of Health and Human Services shall consult with
p.(None): individuals and organiza- tions with appropriate expertise in pediatric medical devices.
p.(None): (2) CONTENTS.—The plan under paragraph (1) shall include—
p.(None): (A) the current status of federally funded pediatric medical device research;
p.(None): (B) any gaps in such research, which may include a survey of pediatric medical providers regarding unmet
p.(None): pediatric medical device needs, as needed; and
p.(None): (C) a research agenda for improving pediatric medical device development and Food and Drug Administration
p.(None): clearance or approval of pediatric medical devices, and for evaluating the short- and long-term safety and
p.(None): effective- ness of pediatric medical devices.
p.(None): SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE AVAILABILITY.
p.(None): (a) IN GENERAL.—
p.(None): (1) REQUEST FOR PROPOSALS.—Not later than 90 days after the date of the enactment of this Act, the
p.(None): Secretary of Health and Human Services shall issue a request for proposals for 1 or more grants or
p.(None): contracts to nonprofit consortia for dem- onstration projects to promote pediatric device development.
p.(None): (2) DETERMINATION ON GRANTS OR CONTRACTS.—Not later than 180 days after the date the Secretary of Health
...
p.(None): (b) APPLICATION.—A nonprofit consortium that desires to receive a grant or contract under this
p.(None): section shall submit an application to the Secretary of Health and Human Services at such time, in such
p.(None): manner, and containing such information as the Secretary may require.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 282 note. Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 864 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): (c) USE OF FUNDS.—A nonprofit consortium that receives a grant or contract under this section shall facilitate
p.(None): the development, production, and distribution of pediatric medical devices by—
p.(None): (1) encouraging innovation and connecting qualified individuals with pediatric device ideas with
p.(None): potential manufac- turers;
p.(None): (2) mentoring and managing pediatric device projects through the development process, including product
p.(None): identifica- tion, prototype design, device development, and marketing;
p.(None): (3) connecting innovators and physicians to existing Federal and non-Federal resources, including resources from
p.(None): the Food and Drug Administration, the National Institutes of Health, the Small Business Administration, the
p.(None): Department of Energy, the Department of Education, the National Science Foundation, the Department of Veterans Affairs,
p.(None): the Agency for Healthcare Research and Quality, and the National Institute of Standards and Technology;
p.(None): (4) assessing the scientific and medical merit of proposed pediatric device projects; and
p.(None): (5) providing assistance and advice as needed on business development, personnel training, prototype
p.(None): development, postmarket needs, and other activities consistent with the pur- poses of this section.
p.(None): (d) COORDINATION.—
p.(None): (1) NATIONAL INSTITUTES OF HEALTH.—Each consortium that receives a grant or contract under this section
p.(None): shall—
p.(None): (A) coordinate with the National Institutes of Health’s pediatric device contact point or office, designated
p.(None): under section 402(b)(23) of the Public Health Service Act, as added by section 304(a) of this Act; and
p.(None): (B) provide to the National Institutes of Health any identified pediatric device needs that the consortium
p.(None): lacks sufficient capacity to address or those needs in which the consortium has been unable to stimulate
p.(None): manufacturer interest.
p.(None): (2) FOOD AND DRUG ADMINISTRATION.—Each consortium that receives a grant or contract under this section shall
p.(None): coordi- nate with the Commissioner of Food and Drugs and device companies to facilitate the application for
p.(None): approval or clearance of devices labeled for pediatric use.
p.(None):
p.(None): Reports.
p.(None): (3) EFFECTIVENESS AND OUTCOMES.—Each consortium that
p.(None): receives a grant or contract under this section shall annually report to the Secretary of Health and
...
p.(None): Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development,
p.(None): accelerate innovation, and enhance product safety.
p.(None): ‘‘(c) DUTIES OF THE FOUNDATION.—The Foundation shall—
p.(None): ‘‘(1) taking into consideration the Critical Path reports and priorities published by the Food and Drug
p.(None): Administration, identify unmet needs in the development, manufacture, and evaluation of the safety and
p.(None): effectiveness, including post- approval, of devices, including diagnostics, biologics, and drugs, and the safety
p.(None): of food, food ingredients, and cosmetics, and including the incorporation of more sensitive and predictive
p.(None): tools and devices to measure safety;
p.(None): ‘‘(2) establish goals and priorities in order to meet the unmet needs identified in paragraph (1);
p.(None): ‘‘(3) in consultation with the Secretary, identify existing and proposed Federal intramural and extramural
p.(None): research and development programs relating to the goals and priorities estab- lished under paragraph (2),
p.(None): coordinate Foundation activities with such programs, and minimize Foundation duplication of existing efforts;
p.(None): ‘‘(4) award grants to, or enter into contracts, memoranda of understanding, or cooperative agreements
p.(None): with, scientists and entities, which may include the Food and Drug Administra- tion, university consortia,
p.(None): public-private partnerships, institu- tions of higher education, entities described in section 501(c)(3) of the
p.(None): Internal Revenue Code (and exempt from tax under section 501(a) of such Code), and industry, to
p.(None): efficiently and effectively advance the goals and priorities established under paragraph (2);
p.(None): ‘‘(5) recruit meeting participants and hold or sponsor (in whole or in part) meetings as appropriate to
p.(None): further the goals and priorities established under paragraph (2);
p.(None): ‘‘(6) release and publish information and data and, to the extent practicable, license, distribute, and
p.(None): release material, re- agents, and techniques to maximize, promote, and coordinate the availability of such
p.(None): material, reagents, and techniques for use by the Food and Drug Administration, nonprofit organiza- tions, and
p.(None): academic and industrial researchers to further the goals and priorities established under paragraph (2);
p.(None): ‘‘(7) ensure that—
p.(None): ‘‘(A) action is taken as necessary to obtain patents for inventions developed by the Foundation or with
p.(None): funds from the Foundation;
p.(None): 21 USC 379dd.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Grants. Contracts. Memorandums.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Publication.
p.(None):
p.(None):
p.(None): 121 STAT. 892 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
...
p.(None): advisory board composed of employees of the Administration that shall include—
p.(None): ‘‘(A) representatives of each of the centers and the science-based offices within the Office of the
p.(None): Commissioner; and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC
p.(None): 360bbb–5.
p.(None): ‘‘(B) experts on trial design, epidemiology, demo- graphics, pharmacovigilance, basic science, and
p.(None): public health; and
p.(None): ‘‘(6) develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed
p.(None): for premarket review.’’.
p.(None): SEC. 603. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
p.(None): Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is
p.(None): amended by adding at the end the following:
p.(None): ‘‘SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
p.(None): ‘‘(a) ESTABLISHMENT.—The Secretary, acting through the Commissioner of Food and Drugs, may enter
p.(None): into collaborative agreements, to be known as Critical Path Public-Private Partner- ships, with one or
p.(None): more eligible entities to implement the Critical Path Initiative of the Food and Drug Administration by
p.(None): developing innovative, collaborative projects in research, education, and out- reach for the purpose of
p.(None): fostering medical product innovation, enabling the acceleration of medical product development, manufac- turing,
p.(None): and translational therapeutics, and enhancing medical product safety.
p.(None): ‘‘(b) ELIGIBLE ENTITY.—In this section, the term ‘eligible entity’ means an entity that meets each of the following:
p.(None): ‘‘(1) The entity is—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 899
p.(None):
p.(None): ‘‘(A) an institution of higher education (as such term is defined in section 101 of the Higher
p.(None): Education Act of 1965) or a consortium of such institutions; or
p.(None): ‘‘(B) an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt
p.(None): from tax under section 501(a) of such Code.
p.(None): ‘‘(2) The entity has experienced personnel and clinical and other technical expertise in the biomedical sciences, which
p.(None): may include graduate training programs in areas relevant to prior- ities of the Critical Path Initiative.
p.(None): ‘‘(3) The entity demonstrates to the Secretary’s satisfaction that the entity is capable of—
p.(None): ‘‘(A) developing and critically evaluating tools, methods, and processes—
p.(None): ‘‘(i) to increase efficiency, predictability, and productivity of medical product development; and
p.(None): ‘‘(ii) to more accurately identify the benefits and risks of new and existing medical products;
p.(None): ‘‘(B) establishing partnerships, consortia, and collabora- tions with health care practitioners and other
p.(None): providers of health care goods or services; pharmacists; pharmacy benefit managers and purchasers;
p.(None): health maintenance organizations and other managed health care organiza- tions; health care insurers;
p.(None): government agencies; patients and consumers; manufacturers of prescription drugs, biological products,
p.(None): diagnostic technologies, and devices; and academic scientists; and
p.(None): ‘‘(C) securing funding for the projects of a Critical Path Public-Private Partnership from Federal and
p.(None): non- federal governmental sources, foundations, and private individuals.
p.(None): ‘‘(c) FUNDING.—The Secretary may not enter into a collaborative agreement under subsection (a) unless the
p.(None): eligible entity involved provides an assurance that the entity will not accept funding for a Critical
p.(None): Path Public-Private Partnership project from any organization that manufactures or distributes products
p.(None): regulated by the Food and Drug Administration unless the entity provides assurances in its agreement with the
p.(None): Food and Drug Administration that the results of the Critical Path Public-Private Partnership project will not
p.(None): be influenced by any source of funding.
p.(None): ‘‘(d) ANNUAL REPORT.—Not later than 18 months after the date of the enactment of this section, and
p.(None): annually thereafter, the Secretary, in collaboration with the parties to each Critical Path Public-Private
p.(None): Partnership, shall submit a report to the Com- mittee on Health, Education, Labor, and Pensions of the Senate
p.(None): and the Committee on Energy and Commerce of the House of Representatives—
p.(None): ‘‘(1) reviewing the operations and activities of the Partner- ships in the previous year; and
p.(None): ‘‘(2) addressing such other issues relating to this section as the Secretary determines to be appropriate.
p.(None): ‘‘(e) DEFINITION.—In this section, the term ‘medical product’ includes a drug, a biological product as
p.(None): defined in section 351 of the Public Health Service Act, a device, and any combination of such products.
p.(None): ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.(None): $5,000,000 for fiscal
p.(None):
p.(None):
p.(None): 121 STAT. 900 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): year 2008 and such sums as may be necessary for each of fiscal years 2009 through 2012.’’.
p.(None): TITLE VII—CONFLICTS OF INTEREST
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379d–1.
p.(None): SEC. 701. CONFLICTS OF INTEREST.
p.(None): (a) IN GENERAL.—Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371
p.(None): et seq.) is amended by inserting at the end the following:
p.(None): ‘‘SEC. 712. CONFLICTS OF INTEREST.
p.(None): ‘‘(a) DEFINITIONS.—For purposes of this section:
p.(None): ‘‘(1) ADVISORY COMMITTEE.—The term ‘advisory committee’ means an advisory committee under the Federal Advisory Com-
p.(None): mittee Act that provides advice or recommendations to the Secretary regarding activities of the Food and Drug
...
p.(None): ‘‘(ii) the reasons of the Secretary for such deter- mination, certification, or waiver.
p.(None): ‘‘(B) LESS THAN 30 DAYS IN ADVANCE.—In the case
p.(None): of a financial interest that becomes known to the Secretary less than 30 days prior to a meeting of an
p.(None): advisory com- mittee to which a written determination as referred to in section 208(b)(1) of title 18, United
p.(None): States Code, a writ- ten certification as referred to in section 208(b)(3) of title 18, United States Code,
p.(None): or a waiver as referred to in paragraph (2)(B) applies, the Secretary shall disclose (other than information
p.(None): exempted from disclosure under section
p.(None): 552 of title 5, United States Code, and section 552a of title 5, United States Code) on the Internet
p.(None): Web site of the Food and Drug Administration, the information described in clauses (i) and (ii) of
p.(None): subparagraph (A) as soon as practicable after the Secretary makes such deter- mination, certification, or
p.(None): waiver, but in no case later than the date of such meeting.
p.(None): ‘‘(d) PUBLIC RECORD.—The Secretary shall ensure that the public record and transcript of each meeting of
p.(None): an advisory com- mittee includes the disclosure required under subsection (c)(3) (other than information exempted
p.(None): from disclosure under section 552 of title 5, United States Code, and section 552a of title 5, United
p.(None): States Code).
p.(None): ‘‘(e) ANNUAL REPORT.—Not later than February 1 of each year, the Secretary shall submit to the Committee on
p.(None): Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on
p.(None): Appropriations and the Com- mittee on Energy and Commerce of the House of Representatives a report that
p.(None): describes—
p.(None): ‘‘(1) with respect to the fiscal year that ended on September
p.(None): 30 of the previous year, the number of vacancies on each advisory committee, the number of nominees received
p.(None): for each committee, and the number of such nominees willing to serve; ‘‘(2) with respect to such year, the
p.(None): aggregate number of disclosures required under subsection (c)(3) for each meeting of each advisory
p.(None): committee and the percentage of individuals to whom such disclosures did not apply who served on such
p.(None): committee for each such meeting;
p.(None): ‘‘(3) with respect to such year, the number of times the disclosures required under subsection (c)(3)
p.(None): occurred under subparagraph (B) of such subsection; and
p.(None): ‘‘(4) how the Secretary plans to reduce the number of vacancies reported under paragraph (1) during the
p.(None): fiscal year following such year, and mechanisms to encourage the nomina- tion of individuals for service on
p.(None): an advisory committee, including those who are classified by the Food and Drug Administration as
p.(None): academicians or practitioners.
p.(None): ‘‘(f) PERIODIC REVIEW OF GUIDANCE.—Not less than once every 5 years, the Secretary shall review guidance of
p.(None): the Food and Drug Administration regarding conflict of interest waiver determinations with respect to advisory
p.(None): committees and update such guidance as necessary.’’.
...
p.(None): advertising and its ability to communicate to subsets of the general population, including elderly populations,
p.(None): children, and racial and ethnic minority communities. The Secretary shall utilize the Advisory Com- mittee
p.(None): on Risk Communication established under this Act to advise the Secretary with respect to such report. The
p.(None): Advisory Committee shall study direct-to-consumer advertising as it relates to increased access to health
p.(None): information and decreased health disparities for these populations. The report required by this paragraph
p.(None): shall recommend effective ways to present and disseminate information to these populations. Such report shall
p.(None): also make recommendations regarding impediments to the participation of elderly populations, children,
p.(None): racially and ethnically diverse communities, and medically underserved populations in clinical drug
p.(None): trials and shall recommend best practice approaches for increasing the inclusion of such subsets of the general
p.(None): population. The Secretary of Health and Human Services shall submit the report under this paragraph to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representatives.
p.(None): (6) RULEMAKING.—Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is
p.(None): amended by striking ‘‘the procedure specified in section 701(e) of this Act’’ and inserting ‘‘section
p.(None): 701(a)’’.
p.(None): (e) RULE OF CONSTRUCTION REGARDING PEDIATRIC STUDIES.— This title and the amendments made by this title
p.(None): may not be
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 943
p.(None):
p.(None): construed as affecting the authority of the Secretary of Health and Human Services to request pediatric
p.(None): studies under section 505A of the Federal Food, Drug, and Cosmetic Act or to require such studies under
p.(None): section 505B of such Act.
p.(None): SEC. 902. ENFORCEMENT.
p.(None): (a) MISBRANDING.—Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding
p.(None): at the end the following:
p.(None): ‘‘(y) If it is a drug subject to an approved risk evaluation and mitigation strategy pursuant to section
p.(None): 505(p) and the respon- sible person (as such term is used in section 505–1) fails to comply with a requirement of such
p.(None): strategy provided for under subsection (d), (e), or (f) of section 505–1.
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Reports.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 946 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): participate in complementary approaches to gather and analyze such data and information, including—
p.(None): ‘‘(I) approaches that are complementary with respect to assessing the safety of use of a drug in domestic
p.(None): populations not included, or underrep- resented, in the trials used to approve the drug (such as older
p.(None): people, people with comorbidities, pregnant women, or children); and
p.(None): ‘‘(II) existing approaches such as the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink or
p.(None): successor databases.
p.(None): ‘‘(v) AUTHORITY FOR CONTRACTS.—The Secretary
p.(None): may enter into contracts with public and private enti- ties to fulfill the requirements of this subparagraph.
p.(None): ‘‘(4) ADVANCED ANALYSIS OF DRUG SAFETY DATA.—
p.(None): ‘‘(A) PURPOSE.—The Secretary shall establish collabora- tions with public, academic, and private entities, which
p.(None): may include the Centers for Education and Research on Therapeutics under section 912 of the Public Health
p.(None): Service Act, to provide for advanced analysis of drug safety data described in paragraph (3)(C) and other
p.(None): information that is publicly available or is provided by the Secretary, in order to—
p.(None): ‘‘(i) improve the quality and efficiency of postmarket drug safety risk-benefit analysis;
p.(None): ‘‘(ii) provide the Secretary with routine access to outside expertise to study advanced drug safety ques-
p.(None): tions; and
p.(None): ‘‘(iii) enhance the ability of the Secretary to make timely assessments based on drug safety data.
p.(None): ‘‘(B) PRIVACY.—Such analysis shall not disclose individ- ually identifiable health information when presenting such
p.(None): drug safety signals and trends or when responding to inquiries regarding such drug safety signals and
p.(None): trends. ‘‘(C) PUBLIC PROCESS FOR PRIORITY QUESTIONS.—At
p.(None): least biannually, the Secretary shall seek recommendations from the Drug Safety and Risk Management Advisory Com-
p.(None): mittee (or any successor committee) and from other advisory committees, as appropriate, to the Food and
p.(None): Drug Administration on—
...
p.(None): risk identification and analysis system described in paragraphs (3) and (4) of section 505(k) of the Federal
p.(None): Food, Drug, and Cosmetic Act, as added by subsection (a), to identify specific drug safety signals and to
p.(None): better understand the outcomes associated with drugs marketed in the United States.
p.(None): (d) AUTHORIZATION OF APPROPRIATIONS.—To carry out activities under the amendment made by this section for which
p.(None): funds are made available under section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.(None): 379h), there are authorized to be appro- priated to carry out the amendment made by this section, in addi- tion
p.(None): to such funds, $25,000,000 for each of fiscal years 2008 through 2012.
p.(None): (e) GAO REPORT.—Not later than 18 months after the date of the enactment of this Act, the Comptroller General
p.(None): of the United States shall evaluate data privacy, confidentiality, and security issues relating to accessing,
p.(None): transmitting, and maintaining data for the active postmarket risk identification and analysis system
p.(None): described in paragraphs (3) and (4) of section 505(k) of the Federal Food, Drug, and Cosmetic Act, as added by
p.(None): subsection (a), and make recommendations to the Committee on Energy and Commerce of the House of Representatives
p.(None): and the Committee on Health, Education, Labor and Pensions of the Senate, and any other
p.(None): congressional committees of relevant jurisdiction, regarding the need for any additional legislative or
p.(None): regulatory actions to ensure privacy, confidentiality, and security of this data or otherwise address
p.(None): privacy, confidentiality, and security issues to ensure the effective operation of such active postmarket
p.(None): identification and anal- ysis system.
p.(None): SEC. 906. STATEMENT FOR INCLUSION IN DIRECT-TO-CONSUMER ADVERTISEMENTS OF DRUGS.
p.(None): (a) PUBLISHED DIRECT-TO-CONSUMER ADVERTISEMENTS.—Sec- tion 502(n) of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 352), as amended by section 901(d)(6), is further amended by inserting ‘‘and in the case
p.(None): of published direct-to-consumer advertisements the following statement printed in conspicuous text: ‘You are
p.(None): encouraged to report negative side effects of prescription
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355 note.
p.(None):
p.(None):
p.(None): 121 STAT. 950 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800- FDA-1088.’,’’ after ‘‘section 701(a),’’.
p.(None):
p.(None): 21 USC 352 note. Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Reports.
p.(None):
p.(None):
p.(None): 21 USC 355 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None): assist- ance provided under subsection (b), the Secretary shall encourage States to—
p.(None): (1) establish, continue, or strengthen State food safety pro- grams, especially with respect to the
p.(None): regulation of retail commercial food establishments; and
p.(None): (2) establish procedures and requirements for ensuring that processed produce under the jurisdiction of State
p.(None): food safety programs is not unsafe for human consumption.
p.(None): (b) ASSISTANCE.—The Secretary may provide to a State, for planning, developing, and implementing such a
p.(None): food safety pro- gram—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 350f
p.(None): note.
p.(None): (1) advisory assistance;
p.(None): (2) technical assistance, training, and laboratory assistance (including necessary materials and equipment); and
p.(None): (3) financial and other assistance.
p.(None): (c) SERVICE AGREEMENTS.—The Secretary may, under an agree- ment entered into with a Federal, State, or local
p.(None): agency, use, on a reimbursable basis or otherwise, the personnel, services, and facilities of the agency to
p.(None): carry out the responsibilities of the agency under this section. An agreement entered into with a State agency under
p.(None): this subsection may provide for training of State employees.
p.(None): SEC. 1005. REPORTABLE FOOD REGISTRY.
p.(None): (a) FINDINGS.—Congress makes the following findings:
p.(None): (1) In 1994, Congress passed the Dietary Supplement Health and Education Act of 1994 (Public Law
p.(None): 103–417) to provide the Food and Drug Administration the legal framework which is intended to ensure that dietary
p.(None): supplements are safe and properly labeled foods.
p.(None): (2) In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law
p.(None): 109–462) to establish a mandatory reporting system of serious adverse events for nonprescription drugs and
p.(None): dietary supple- ments sold and consumed in the United States.
p.(None): (3) The adverse event reporting system created under the Dietary Supplement and Nonprescription Drug
p.(None): Consumer Protection Act is intended to serve as an early warning system for potential public health issues
p.(None): associated with the use of these products.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 965
p.(None):
p.(None):
p.(None): (4) A reliable mechanism to track patterns of adulteration in food would support efforts by the Food and Drug
p.(None): Administra- tion to target limited inspection resources to protect the public health.
p.(None): (b) IN GENERAL.—Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is
p.(None): amended by adding at the end the following:
p.(None): ‘‘SEC. 417. REPORTABLE FOOD REGISTRY.
p.(None): ‘‘(a) DEFINITIONS.—In this section:
...
p.(None):
p.(None): of the National Oceanic and Atmospheric Administration to produce a report on any environmental risks associated
p.(None): with genetically engineered seafood products, including the impact on wild fish stocks.
p.(None):
p.(None): 21 USC 2107.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2108.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2109.
p.(None): Website.
p.(None): SEC. 1008. SENSE OF CONGRESS.
p.(None): It is the sense of Congress that—
p.(None): (1) it is vital for Congress to provide the Food and Drug Administration with additional resources,
p.(None): authorities, and direction with respect to ensuring the safety of the food supply of the United States;
p.(None): (2) additional inspectors are required to improve the Food and Drug Administration’s ability to safeguard the food
p.(None): supply of the United States;
p.(None): (3) because of the increasing volume of international trade in food products the Secretary should make it a
p.(None): priority to enter into agreements with the trading partners of the United States with respect to food safety; and
p.(None): (4) Congress should work to develop a comprehensive response to the issue of food safety.
p.(None): SEC. 1009. ANNUAL REPORT TO CONGRESS.
p.(None): The Secretary shall, on an annual basis, submit to the Com- mittee on Health, Education, Labor, and
p.(None): Pensions and the Com- mittee on Appropriations of the Senate and the Committee on Energy and Commerce
p.(None): and the Committee on Appropriations of the House of Representatives a report that includes, with respect
p.(None): to the preceding 1-year period—
p.(None): (1) the number and amount of food products regulated by the Food and Drug Administration imported into the
p.(None): United States, aggregated by country and type of food;
p.(None): (2) a listing of the number of Food and Drug Administration inspectors of imported food products referenced in
p.(None): paragraph
p.(None): (1) and the number of Food and Drug Administration inspec- tions performed on such products; and
p.(None): (3) aggregated data on the findings of such inspections, including data related to violations of the Federal
p.(None): Food, Drug, and Cosmetic Act (21 U.S.C. 201 et seq.), and enforcement actions used to follow-up on such
p.(None): findings and violations.
p.(None): SEC. 1010. PUBLICATION OF ANNUAL REPORTS.
p.(None): (a) IN GENERAL.—The Commissioner of Food and Drugs shall annually submit to Congress and publish on the
p.(None): Internet Web site of the Food and Drug Administration, a report concerning the results of the
p.(None): Administration’s pesticide residue monitoring program, that includes—
p.(None): (1) information and analysis similar to that contained in the report entitled ‘‘Food and Drug
...
p.(None): intervals or other related statistical information, and whether the number of samples should be increased and
p.(None): the details of any plans to provide for such increase; and
p.(None): (4) a description of whether certain commodities are being improperly imported as another commodity, including a
p.(None): descrip- tion of additional steps that are being planned to prevent such smuggling.
p.(None): (b) INITIAL REPORTS.—Annual reports under subsection (a) for fiscal years 2004 through 2006 may be
p.(None): combined into a single report, by not later than June 1, 2008, for purposes of publication under
p.(None): subsection (a). Thereafter such reports shall be completed by June 1 of each year for the data
p.(None): collected for the year that was 2-years prior to the year in which the report is published.
p.(None): (c) MEMORANDUM OF UNDERSTANDING.—The Commissioner of Food and Drugs, the Administrator of the Food Safety and
p.(None): Inspec- tion Service, the Department of Commerce, and the head of the Agricultural Marketing Service shall
p.(None): enter into a memorandum of understanding to permit inclusion of data in the reports under subsection (a)
p.(None): relating to testing carried out by the Food Safety and Inspection Service and the Agricultural Marketing
p.(None): Service on meat, poultry, eggs, and certain raw agricultural products, respec- tively.
p.(None): SEC. 1011. RULE OF CONSTRUCTION.
p.(None): Nothing in this title (or an amendment made by this title) shall be construed to affect—
p.(None): (1) the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (Public
p.(None): Law 103–417); or
p.(None): (2) the adverse event reporting system for dietary supple- ments created under the Dietary Supplement and
p.(None): Nonprescrip- tion Drug Consumer Protection Act (Public Law 109–462).
p.(None): TITLE XI—OTHER PROVISIONS
p.(None): Subtitle A—In General
p.(None): SEC. 1101. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC ARTICLES PUBLISHED BY FDA EMPLOYEES.
p.(None): Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.), as
p.(None): amended by section 701, is further amended by adding at the end the following:
p.(None): ‘‘SEC. 713. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC ARTICLES PUBLISHED BY FDA EMPLOYEES.
p.(None): ‘‘(a) DEFINITION.—In this section, the term ‘article’ means a paper, poster, abstract, book, book chapter,
p.(None): or other published writing.
p.(None): ‘‘(b) POLICIES.—The Secretary, through the Commissioner of Food and Drugs, shall establish and make
p.(None): publicly available clear
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2110.
p.(None):
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p.(None):
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p.(None): the racemic drug has been approved.
p.(None): ‘‘(B) LABELING.—If applicable, the labeling of a non- racemic drug described in paragraph (1) and with
p.(None): respect to which the applicant has made the election provided for by such paragraph shall include a
p.(None): statement that the non-racemic drug is not approved, and has not been shown to be safe and effective, for any
p.(None): condition of use of the racemic drug.
p.(None): ‘‘(3) DEFINITION.—
p.(None): ‘‘(A) IN GENERAL.—For purposes of this subsection, the term ‘therapeutic category’ means a therapeutic category
p.(None): identified in the list developed by the United States Pharmacopeia pursuant to section
p.(None): 1860D–4(b)(3)(C)(ii) of the Social Security Act and as in effect on the date of the enactment of this
p.(None): subsection.
p.(None): ‘‘(B) PUBLICATION BY SECRETARY.—The Secretary shall publish the list described in subparagraph (A) and may
p.(None): amend such list by regulation.
p.(None): ‘‘(4) AVAILABILITY.—The election referred to in paragraph
p.(None): (1) may be made only in an application that is submitted to the Secretary after the date of the
p.(None): enactment of this sub- section and before October 1, 2012.’’.
p.(None): SEC. 1114. REPORT.
p.(None): Not later than January 1, 2012, the Comptroller General of the United States shall submit a report to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce
p.(None): of the House of Representatives that examines whether and how this subtitle has—
p.(None): (1) encouraged the development of new antibiotics and other drugs; and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 978 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): (2) prevented or delayed timely generic drug entry into the market.
p.(None): Approved September 27, 2007.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): LEGISLATIVE HISTORY—H.R. 3580:
p.(None): CONGRESSIONAL RECORD, Vol. 153 (2007):
p.(None): Sept. 19, considered and passed House. Sept. 20, considered and passed Senate.
...
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p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 845
p.(None):
p.(None): under section 515(c)(4) that is withdrawn before a second portion is submitted and before a first action
p.(None): on the first portion.
p.(None): ‘‘(v) LATER WITHDRAWN MODULAR APPLICATIONS.—
p.(None): If an application submitted under section 515(c)(4) is withdrawn after a second or subsequent portion is
p.(None): submitted but before any first action, the Secretary may return a portion of the fee. The amount of refund, if
p.(None): any, shall be based on the level of effort already expended on the review of the portions submitted.
p.(None): ‘‘(vi) SOLE DISCRETION TO REFUND.—The Secretary
p.(None): shall have sole discretion to refund a fee or portion of the fee under clause (iii) or (v). A
p.(None): determination by the Secretary concerning a refund under clause
p.(None): (iii) or (v) shall not be reviewable.’’.
p.(None): (5) ANNUAL ESTABLISHMENT REGISTRATION FEE.—Section 738(a) (21 U.S.C. 379j(a)) is amended by adding after
p.(None): paragraph
p.(None): (2) the following:
p.(None): ‘‘(3) ANNUAL ESTABLISHMENT REGISTRATION FEE.—
p.(None): ‘‘(A) IN GENERAL.—Except as provided in subparagraph (B), each establishment subject to a registration fee
p.(None): shall be subject to a fee for each initial or annual registration under section 510 beginning with its
p.(None): registration for fiscal year 2008.
p.(None): ‘‘(B) EXCEPTION.—No fee shall be required under subparagraph (A) for an establishment operated by a State
p.(None): or Federal governmental entity or an Indian tribe (as defined in the Indian Self Determination and
p.(None): Educational Assistance Act), unless a device manufactured by the establishment is to be distributed
p.(None): commercially.
p.(None): ‘‘(C) PAYMENT.—The fee required under subparagraph
p.(None): (A) shall be due once each fiscal year, upon the initial registration of the establishment or upon the
p.(None): annual reg- istration under section 510.’’.
p.(None): (b) FEE AMOUNTS.—Section 738(b) (21 U.S.C. 379j(b)) is amended to read as follows:
p.(None): ‘‘(b) FEE AMOUNTS.—Except as provided in subsections (c), (d), (e), and (h) the fees under subsection (a) shall
p.(None): be based on the following fee amounts:
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Fee Type
p.(None): Fiscal Year 2008
p.(None): Fiscal Year 2009
p.(None): Fiscal Year 2010
p.(None): Fiscal Year 2011
p.(None): Fiscal Year 2012
p.(None): Premarket Application .... $185,000 $200,725 $217,787 $236,298 $256,384
p.(None): ................
p.(None): Establishment Registra-
p.(None): tion ................................ $1,706 $1,851 $2,008 $2,179 $2,364.’’.
p.(None):
p.(None): (c) ANNUAL FEE SETTING.—
p.(None): (1) IN GENERAL.—Section 738(c) (21 U.S.C. 379j(c)(1)) is amended—
p.(None): (A) in the subsection heading, by striking ‘‘Annual Fee Setting’’ and inserting ‘‘ANNUAL FEE SETTING’’;
p.(None): and
p.(None): (B) in paragraph (1), by striking the last sentence.
p.(None):
p.(None):
p.(None): 121 STAT. 846 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): (2) ADJUSTMENT OF ANNUAL ESTABLISHMENT FEE.—Section 738(c) (21 U.S.C. 379j(c)), as amended by paragraph
p.(None): (1), is further amended—
p.(None): (A) by redesignating paragraphs (2) and (3) as para- graphs (3) and (4), respectively;
...
p.(None):
p.(None): ‘‘(v) publicly available information about imple- mented RiskMAPs and risk evaluation and mitigation strategies
p.(None): under subsection (o);
p.(None): ‘‘(vi) guidance documents and regulations related to drug safety; and
p.(None): ‘‘(vii) other material determined appropriate by the Secretary;
p.(None): ‘‘(C) providing access to summaries of the assessed and aggregated data collected from the active surveillance
p.(None): infrastructure under subsection (k)(3) to provide informa- tion of known and serious side-effects for
p.(None): drugs approved under this section or licensed under such section 351;
p.(None):
p.(None): Reports.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Reports.
p.(None): ‘‘(D) preparing, by 18 months after approval of a drug or after use of the drug by 10,000 individuals,
p.(None): whichever is later, a summary analysis of the adverse drug reaction reports received for the drug,
p.(None): including identification of any new risks not previously identified, potential new risks, or known risks reported in
p.(None): unusual number;
p.(None): ‘‘(E) enabling patients, providers, and drug sponsors to submit adverse event reports through the Internet Web
p.(None): site;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(F) providing educational materials for patients and providers about the appropriate means of
p.(None): disposing of expired, damaged, or unusable medications; and
p.(None): ‘‘(G) supporting initiatives that the Secretary deter- mines to be useful to fulfill the purposes of the
p.(None): Internet Web site.
p.(None): ‘‘(3) POSTING OF DRUG LABELING.—The Secretary shall post on the Internet Web site established under
p.(None): paragraph (1) the approved professional labeling and any required patient labeling of a drug approved
p.(None): under this section or licensed under such section 351 not later than 21 days after the date the drug
p.(None): is approved or licensed, including in a supplemental application with respect to a labeling change.
p.(None): ‘‘(4) PRIVATE SECTOR RESOURCES.—To ensure development of the Internet Web site by the date
p.(None): described in paragraph (1), the Secretary may, on a temporary or permanent basis, implement systems or
p.(None): products developed by private entities. ‘‘(5) AUTHORITY FOR CONTRACTS.—The Secretary may enter into
p.(None): contracts with public and private entities to fulfill the
p.(None): requirements of this subsection.
p.(None): ‘‘(6) REVIEW.—The Advisory Committee on Risk Commu- nication under section 567 shall, on a regular basis,
p.(None): perform a comprehensive review and evaluation of the types of risk communication information provided on
...
Social / employees
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p.(None): drugs.
p.(None): Sec. 912. Prohibition against food to which drugs or biological products have been added.
p.(None): Sec. 913. Assuring pharmaceutical safety.
p.(None): Sec. 914. Citizen petitions and petitions for stay of agency action.
p.(None): Sec. 915. Postmarket drug safety information for patients and providers. Sec. 916. Action package for approval.
p.(None): Sec. 917. Risk communication.
p.(None): Sec. 918. Referral to advisory committee.
p.(None): Sec. 919. Response to the institute of medicine. Sec. 920. Database for authorized generic drugs.
p.(None): Sec. 921. Adverse drug reaction reports and postmarket safety.
p.(None): TITLE X—FOOD SAFETY
p.(None): Sec. 1001. Findings.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 825
p.(None):
p.(None):
p.(None): Sec. 1002. Ensuring the safety of pet food.
p.(None): Sec. 1003. Ensuring efficient and effective communications during a recall. Sec. 1004. State and Federal
p.(None): Cooperation.
p.(None): Sec. 1005. Reportable Food Registry.
p.(None): Sec. 1006. Enhanced aquaculture and seafood inspection.
p.(None): Sec. 1007. Consultation regarding genetically engineered seafood products. Sec. 1008. Sense of Congress.
p.(None): Sec. 1009. Annual report to Congress. Sec. 1010. Publication of annual reports. Sec. 1011. Rule of construction.
p.(None): TITLE XI—OTHER PROVISIONS
p.(None): Subtitle A—In General
p.(None): Sec. 1101. Policy on the review and clearance of scientific articles published by FDA employees.
p.(None): Sec. 1102. Priority review to encourage treatments for tropical diseases. Sec. 1103. Improving genetic test safety
p.(None): and quality.
p.(None): Sec. 1104. NIH Technical amendments. Sec. 1105. Severability clause.
p.(None): Subtitle B—Antibiotic Access and Innovation
p.(None): Sec. 1111. Identification of clinically susceptible concentrations of antimicrobials. Sec. 1112. Orphan antibiotic
p.(None): drugs.
p.(None): Sec. 1113. Exclusivity of certain drugs containing single enantiomers. Sec. 1114. Report.
p.(None):
p.(None): TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
p.(None): SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING.
p.(None): (a) SHORT TITLE.—This title may be cited as the ‘‘Prescription Drug User Fee Amendments of 2007’’.
p.(None): (b) REFERENCES IN TITLE.—Except as otherwise specified, amendments made by this title to a section
p.(None): or other provision of law are amendments to such section or other provision of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 301 et seq.).
p.(None): (c) FINDING.—The Congress finds that the fees authorized by the amendments made in this title will be
p.(None): dedicated toward expe- diting the drug development process and the process for the review of human drug
...
p.(None): subsection (a)(1) shall be established to generate revenue amounts of $6,250,000 for each of fiscal years 2008 through
p.(None): 2012, as adjusted pursuant to subsections (c) and (g)(4).
p.(None): ‘‘(c) ADJUSTMENTS.—
p.(None): ‘‘(1) INFLATION ADJUSTMENT.—Beginning with fiscal year 2009, the revenues established in subsection
p.(None): (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to
p.(None): reflect the greater of—
p.(None): ‘‘(A) the total percentage change that occurred in the Consumer Price Index for all urban consumers (all
p.(None): items;
p.(None): U.S. city average), for the 12-month period ending June 30 preceding the fiscal year for which fees are being
p.(None): estab- lished;
p.(None): ‘‘(B) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): Deadlines.
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None): Effective date. Notice.
p.(None): Federal Register, publication.
p.(None):
p.(None):
p.(None): 121 STAT. 836 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): with section 5332 of title 5, United States Code, as adjusted by any locality-based comparability payment pursuant
p.(None): to section 5304 of such title for Federal employees stationed in the District of Columbia; or
p.(None): ‘‘(C) the average annual change in the cost, per full- time equivalent position of the Food and Drug
p.(None): Administra- tion, of all personnel compensation and benefits paid with respect to such positions for the first 5
p.(None): fiscal years of the previous 6 fiscal years.
p.(None): The adjustment made each fiscal year by this subsection shall be added on a compounded basis to the sum of all
p.(None): adjustments made each fiscal year after fiscal year 2008 under this sub- section.
p.(None):
p.(None): Effective date.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadlines.
p.(None): ‘‘(2) WORKLOAD ADJUSTMENT.—Beginning with fiscal year 2009, after the fee revenues established in
p.(None): subsection (b) are adjusted for a fiscal year for inflation in accordance with para- graph (1), the fee revenues
p.(None): shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary with
p.(None): respect to the submission of DTC advertisements for advisory review prior to initial dissemination. With
p.(None): respect to such adjustment:
p.(None): ‘‘(A) The adjustment shall be determined by the Sec- retary based upon the number of DTC advertisements
p.(None): identified pursuant to subsection (a)(1)(C) for the upcoming fiscal year, excluding allowable previously paid
p.(None): carry over submissions. The adjustment shall be determined by multi- plying the number of such advertisements
...
p.(None): remainder of the unused fees and operating reserves. To the extent required to terminate the program,
p.(None): the Secretary shall first use unobligated advisory review fee revenues from prior fiscal years, then the
p.(None): operating reserves, and finally, unused advisory review fees from the relevant fiscal year.
p.(None): ‘‘(g) CREDITING AND AVAILABILITY OF FEES.—
p.(None): ‘‘(1) IN GENERAL.—Fees authorized under subsection (a) shall be collected and available for obligation only to
p.(None): the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain
p.(None): available until expended. Such sums as may be necessary may be transferred from the Food and Drug
p.(None): Administration salaries and expenses appropria- tion account without fiscal year limitation to such appropriation
p.(None): account for salaries and expenses with such fiscal year limita- tion. The sums transferred shall be available
p.(None): solely for the process for the advisory review of prescription drug advertising.
p.(None): ‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.—
p.(None): ‘‘(A) IN GENERAL.—The fees authorized by this sec- tion—
p.(None): ‘‘(i) shall be retained in each fiscal year in an amount not to exceed the amount specified in appro-
p.(None): priation Acts, or otherwise made available for obliga- tion for such fiscal year; and
p.(None): ‘‘(ii) shall be available for obligation only if the amounts appropriated as budget authority for such
p.(None): fiscal year are sufficient to support a number of full- time equivalent review employees that is not
p.(None): fewer than the number of such employees supported in fiscal year 2007.
p.(None): ‘‘(B) REVIEW EMPLOYEES.—For purposes of subpara- graph (A)(ii), the term ‘full-time equivalent
p.(None): review employees’ means the total combined number of full-time equivalent employees in—
p.(None): ‘‘(i) the Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Commu- nications, Food
p.(None): and Drug Administration; and
p.(None): ‘‘(ii) the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling
p.(None): Branch, Food and Drug Administration.
p.(None): ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the
p.(None): fiscal years 2008 through 2012, there is authorized to be appro- priated for fees under this section an amount
p.(None): equal to the total revenue amount determined under subsection (b) for the
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 839
p.(None):
p.(None): fiscal year, as adjusted pursuant to subsection (c) and para- graph (4) of this subsection, plus amounts
p.(None): collected for the reserve fund under subsection (d).
p.(None): ‘‘(4) OFFSET.—Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees
p.(None): specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the
p.(None): Food and Drug Administra- tion as provided in paragraph (1), and shall be subtracted from the amount of
p.(None): fees that would otherwise be collected under this section pursuant to appropriation Acts for a subse-
p.(None): quent fiscal year.
p.(None): ‘‘(h) DEFINITIONS.—For purposes of this section:
...
p.(None): ‘direct-to-consumer television advertisement’ means an advertisement for a prescription drug product (as
p.(None): defined in section 735(3)) intended to be displayed on any
p.(None): television channel for less than 3 minutes.
p.(None): ‘‘(5) The term ‘DTC advertisement’ has the meaning indicated for such term in subsection (a)(1)(A).
p.(None): ‘‘(6) The term ‘operating reserve fee’ has the meaning indicated for such term in subsection (a)(2)(A).
p.(None): ‘‘(7) The term ‘person’ includes an individual, partnership, corporation, and association, and any affiliate
p.(None): thereof or suc- cessor in interest.
p.(None): ‘‘(8) The term ‘process for the advisory review of prescrip- tion drug advertising’ means the activities
p.(None): necessary to review and provide advisory comments on DTC advertisements prior to public dissemination and,
p.(None): to the extent the Secretary has additional staff resources available under the program under this section
p.(None): that are not necessary for the advisory review of DTC advertisements, the activities necessary to review
p.(None): and provide advisory comments on other proposed advertisements and promotional material prior to public
p.(None): dissemination.
p.(None): ‘‘(9) The term ‘resources allocated for the process for the advisory review of prescription drug
p.(None): advertising’ means the expenses incurred in connection with the process for the advisory review of
p.(None): prescription drug advertising for—
p.(None): ‘‘(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Adminis-
p.(None): tration, advisory committees, and costs related to such officers, employees, and committees, and to contracts
p.(None): with such contractors;
p.(None): ‘‘(B) management of information, and the acquisition, maintenance, and repair of computer resources;
p.(None): ‘‘(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair
p.(None): of fix- tures, furniture, scientific equipment, and other necessary materials and supplies;
p.(None):
p.(None):
p.(None): 121 STAT. 840 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(D) collection of fees under this section and accounting for resources allocated for the advisory review of prescrip-
p.(None): tion drug advertising; and
p.(None): ‘‘(E) terminating the program under this section pursu- ant to subsection (f)(2) if that becomes necessary.
p.(None): ‘‘(10) The term ‘resubmission’ means a subsequent submis- sion for advisory review of a direct-to-consumer
p.(None): television advertisement that has been revised in response to the Sec- retary’s comments on an original
p.(None): submission. A resubmission may not introduce significant new concepts or creative themes into the television
p.(None): advertisement.
p.(None): ‘‘(11) The term ‘submission for advisory review’ means an original submission of a direct-to-consumer
p.(None): television advertise- ment for which the sponsor voluntarily requests advisory com- ments before the advertisement is
p.(None): publicly disseminated.’’.
p.(None): SEC. 105. REAUTHORIZATION; REPORTING REQUIREMENTS.
p.(None): Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.), as amended by section 104, is further
p.(None): amended by inserting after section 736A the following:
p.(None):
p.(None): 21 USC 379h–2.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None): assessment, required under such section 505B shall be deemed to have been required under section 505B of the
p.(None): Federal Food, Drug and Cosmetic Act as in effect on or after the date of the enactment of this Act.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355c
p.(None): note.
p.(None):
p.(None): (2) CERTAIN ASSESSMENTS AND WAIVER REQUESTS.—An assessment pending on or after the date that is
p.(None): 1 year prior to the date of the enactment of this Act shall be subject to the tracking and disclosure
p.(None): requirements established under such section 505B, as in effect on or after such date of enact- ment,
p.(None): except that any such assessments submitted or waivers of such assessments requested before such date of
p.(None): enactment shall not be subject to subsections (a)(4)(C), (b)(2)(C), (f)(6)(F), and (h) of such section 505B.
p.(None): SEC. 403. ESTABLISHMENT OF INTERNAL COMMITTEE.
p.(None): Chapter V of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 351 et seq.) is amended by inserting after section 505B the following:
p.(None): ‘‘SEC. 505C. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, AND WAIVERS.
p.(None): ‘‘The Secretary shall establish an internal committee within the Food and Drug Administration to carry
p.(None): out the activities as described in sections 505A(f) and 505B(f). Such internal committee shall include employees of
p.(None): the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of
p.(None): Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, and the
p.(None): appropriate expertise per- taining to the pediatric product under review, such as expertise in child and
p.(None): adolescent psychiatry, and other individuals designated by the Secretary.’’.
p.(None): SEC. 404. GOVERNMENT ACCOUNTABILITY OFFICE REPORT.
p.(None): Not later than January 1, 2011, the Comptroller General of the United States, in consultation with the
p.(None): Secretary of Health and Human Services, shall submit to the Congress a report that addresses the
p.(None): effectiveness of sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and
p.(None): section 409I of the Public Health Service Act (42 U.S.C. 284m) in ensuring that medicines used by children are
p.(None): tested and properly labeled. Such report shall include—
p.(None): (1) the number and importance of drugs and biological products for children that are being tested as a
p.(None): result of the amendments made by this title and title V and the importance
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Establishment. 21 USC 355d.
p.(None):
p.(None):
p.(None): 121 STAT. 876 PUBLIC LAW 110–85—SEPT. 27, 2007
...
p.(None): ‘‘(iv) The Director of the Agency for Healthcare Research and Quality.
p.(None): ‘‘(C) APPOINTED MEMBERS.—
p.(None): ‘‘(i) IN GENERAL.—The ex officio members of the Board under subparagraph (B) shall, by majority vote, appoint
p.(None): to the Board 14 individuals, of which 9 shall be from a list of candidates to be provided by the
p.(None): National Academy of Sciences and 5 shall be from lists of candidates provided by patient and consumer
p.(None): advocacy groups, professional scientific and medical societies, and industry trade organizations. Of such
p.(None): appointed members—
p.(None): ‘‘(I) 4 shall be representatives of the general pharmaceutical, device, food, cosmetic, and bio- technology
p.(None): industries;
p.(None): ‘‘(II) 3 shall be representatives of academic research organizations;
p.(None): ‘‘(III) 2 shall be representatives of patient or consumer advocacy organizations;
p.(None): ‘‘(IV) 1 shall be a representative of health care providers; and
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 893
p.(None):
p.(None):
p.(None): ‘‘(V) 4 shall be at-large members with expertise or experience relevant to the purpose of the Foundation.
p.(None): ‘‘(ii) REQUIREMENTS.—
p.(None): ‘‘(I) EXPERTISE.—The ex officio members shall ensure the Board membership includes individuals with expertise in
p.(None): areas including the sciences of developing, manufacturing, and evaluating the safety and effectiveness
p.(None): of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and
p.(None): cosmetics.
p.(None): ‘‘(II) FEDERAL EMPLOYEES.—No employee of the Federal Government shall be appointed as a member of
p.(None): the Board under this subparagraph or under paragraph (3)(B).
p.(None): ‘‘(D) INITIAL MEETING.—
p.(None): ‘‘(i) IN GENERAL.—Not later than 30 days after the date of the enactment of this subchapter, the Sec- retary
p.(None): shall convene a meeting of the ex officio mem- bers of the Board to—
p.(None): ‘‘(I) incorporate the Foundation; and
p.(None): ‘‘(II) appoint the members of the Board in accordance with subparagraph (C).
p.(None): ‘‘(ii) SERVICE OF EX OFFICIO MEMBERS.—Upon the
p.(None): appointment of the members of the Board under clause (i)(II)—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None): ‘‘(I) the terms of service of the Director of the Centers for Disease Control and Prevention and of the
p.(None): Director of the Agency for Healthcare Research and Quality as ex officio members of the Board shall
p.(None): terminate; and
p.(None): ‘‘(II) the Commissioner and the Director of the National Institutes of Health shall continue to serve as
p.(None): ex officio members of the Board, but shall be nonvoting members.
p.(None): ‘‘(iii) CHAIR.—The ex officio members of the Board under subparagraph (B) shall designate an appointed member of
p.(None): the Board to serve as the Chair of the Board.
p.(None): ‘‘(2) DUTIES OF BOARD.—The Board shall—
p.(None): ‘‘(A) establish bylaws for the Foundation that—
p.(None): ‘‘(i) are published in the Federal Register and available for public comment;
p.(None): ‘‘(ii) establish policies for the selection of the offi- cers, employees, agents, and contractors of the
p.(None): Founda- tion;
p.(None): ‘‘(iii) establish policies, including ethical standards, for the acceptance, solicitation, and disposition of dona-
p.(None): tions and grants to the Foundation and for the disposi- tion of the assets of the Foundation, including appro-
p.(None): priate limits on the ability of donors to designate, by stipulation or restriction, the use or recipient
p.(None): of donated funds;
p.(None): ‘‘(iv) establish policies that would subject all employees, fellows, and trainees of the Foundation
p.(None): to the conflict of interest standards under section 208 of title 18, United States Code;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None):
p.(None):
p.(None): 121 STAT. 894 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(v) establish licensing, distribution, and publica- tion policies that support the widest and least restric-
p.(None): tive use by the public of information and inventions developed by the Foundation or with Foundation funds to
p.(None): carry out the duties described in paragraphs (6) and (7) of subsection (c), and may include charging
p.(None): cost-based fees for published material produced by the Foundation;
p.(None): ‘‘(vi) specify principles for the review of proposals and awarding of grants and contracts that include
p.(None): peer review and that are consistent with those of the Foundation for the National Institutes of Health,
p.(None): to the extent determined practicable and appropriate by the Board;
p.(None): ‘‘(vii) specify a cap on administrative expenses for recipients of a grant, contract, or cooperative agree- ment
p.(None): from the Foundation;
p.(None): ‘‘(viii) establish policies for the execution of memo- randa of understanding and cooperative agreements between
p.(None): the Foundation and other entities, including the Food and Drug Administration;
p.(None): ‘‘(ix) establish policies for funding training fellow- ships, whether at the Foundation, academic or sci-
p.(None): entific institutions, or the Food and Drug Administra- tion, for scientists, doctors, and other professionals who are
p.(None): not employees of regulated industry, to foster greater understanding of and expertise in new sci-
p.(None): entific tools, diagnostics, manufacturing techniques, and potential barriers to translating basic
p.(None): research into clinical and regulatory practice;
p.(None): ‘‘(x) specify a process for annual Board review of the operations of the Foundation; and
p.(None): ‘‘(xi) establish specific duties of the Executive Director;
p.(None): ‘‘(B) prioritize and provide overall direction to the activities of the Foundation;
p.(None): ‘‘(C) evaluate the performance of the Executive Director; and
p.(None): ‘‘(D) carry out any other necessary activities regarding the functioning of the Foundation.
p.(None): ‘‘(3) TERMS AND VACANCIES.—
p.(None): ‘‘(A) TERM.—The term of office of each member of the Board appointed under paragraph (1)(C) shall be 4
p.(None): years, except that the terms of offices for the initial appointed members of the Board shall expire on
p.(None): a staggered basis as determined by the ex officio members.
p.(None): ‘‘(B) VACANCY.—Any vacancy in the membership of the Board—
p.(None): ‘‘(i) shall not affect the power of the remaining members to execute the duties of the Board; and
p.(None): ‘‘(ii) shall be filled by appointment by the appointed members described in paragraph (1)(C) by majority vote.
p.(None): ‘‘(C) PARTIAL TERM.—If a member of the Board does not serve the full term applicable under subparagraph (A),
p.(None): the individual appointed under subparagraph (B) to fill
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 895
p.(None):
p.(None): the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.
...
p.(None): members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the
p.(None): duties of the Board, as set forth in the bylaws issued by the Board.
p.(None): ‘‘(e) INCORPORATION.—The ex officio members of the Board shall serve as incorporators and shall take whatever
p.(None): actions necessary to incorporate the Foundation.
p.(None): ‘‘(f) NONPROFIT STATUS.—In carrying out subsection (b), the Board shall establish such policies and bylaws
p.(None): under subsection (d), and the Executive Director shall carry out such activities under subsection (g), as may be
p.(None): necessary to ensure that the Foundation maintains status as an organization that—
p.(None): ‘‘(1) is described in subsection (c)(3) of section 501 of the Internal Revenue Code of 1986; and
p.(None): ‘‘(2) is, under subsection (a) of such section, exempt from taxation.
p.(None): ‘‘(g) EXECUTIVE DIRECTOR.—
p.(None): ‘‘(1) IN GENERAL.—The Board shall appoint an Executive Director who shall serve at the pleasure of the
p.(None): Board. The Executive Director shall be responsible for the day-to-day oper- ations of the Foundation and shall
p.(None): have such specific duties and responsibilities as the Board shall prescribe.
p.(None): ‘‘(2) COMPENSATION.—The compensation of the Executive Director shall be fixed by the Board but shall not
p.(None): be greater than the compensation of the Commissioner.
p.(None): ‘‘(h) ADMINISTRATIVE POWERS.—In carrying out this subchapter, the Board, acting through the Executive Director,
p.(None): may—
p.(None): ‘‘(1) adopt, alter, and use a corporate seal, which shall be judicially noticed;
p.(None): ‘‘(2) hire, promote, compensate, and discharge 1 or more officers, employees, and agents, as may be necessary,
p.(None): and define their duties;
p.(None): ‘‘(3) prescribe the manner in which—
p.(None): ‘‘(A) real or personal property of the Foundation is acquired, held, and transferred;
p.(None): ‘‘(B) general operations of the Foundation are to be conducted; and
p.(None): ‘‘(C) the privileges granted to the Board by law are exercised and enjoyed;
p.(None): ‘‘(4) with the consent of the applicable executive department or independent agency, use the information, services, and
p.(None): facili- ties of such department or agencies in carrying out this section; ‘‘(5) enter into contracts with public
p.(None): and private organiza- tions for the writing, editing, printing, and publishing of books
p.(None): and other material;
p.(None): ‘‘(6) hold, administer, invest, and spend any gift, devise, or bequest of real or personal property made to the
p.(None): Foundation under subsection (i);
p.(None): ‘‘(7) enter into such other contracts, leases, cooperative agreements, and other transactions as the Board
p.(None): considers appropriate to conduct the activities of the Foundation;
p.(None):
p.(None):
p.(None): 121 STAT. 896 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(8) modify or consent to the modification of any contract or agreement to which it is a party or in
p.(None): which it has an interest under this subchapter;
p.(None): ‘‘(9) take such action as may be necessary to obtain patents and licenses for devices and procedures
p.(None): developed by the Foundation and its employees;
p.(None): ‘‘(10) sue and be sued in its corporate name, and complain and defend in courts of competent jurisdiction;
p.(None): ‘‘(11) appoint other groups of advisors as may be determined necessary to carry out the functions of the
p.(None): Foundation; and ‘‘(12) exercise other powers as set forth in this section, and such other incidental
p.(None): powers as are necessary to carry out its powers, duties, and functions in accordance with this
p.(None): subchapter.
p.(None): ‘‘(i) ACCEPTANCE OF FUNDS FROM OTHER SOURCES.—The Execu-
p.(None): tive Director may solicit and accept on behalf of the Foundation, any funds, gifts, grants, devises, or
p.(None): bequests of real or personal property made to the Foundation, including from private entities, for the
p.(None): purposes of carrying out the duties of the Foundation. ‘‘(j) SERVICE OF FEDERAL EMPLOYEES.—Federal
p.(None): Government employees may serve on committees advisory to the Foundation and otherwise cooperate with and
p.(None): assist the Foundation in carrying out its functions, so long as such employees do not direct or control
p.(None): Foundation activities.
p.(None): ‘‘(k) DETAIL OF GOVERNMENT EMPLOYEES; FELLOWSHIPS.—
p.(None): ‘‘(1) DETAIL FROM FEDERAL AGENCIES.—Federal Govern-
p.(None): ment employees may be detailed from Federal agencies with or without reimbursement to those agencies to the
p.(None): Foundation at any time, and such detail shall be without interruption or loss of civil service status or
p.(None): privilege. Each such employee shall abide by the statutory, regulatory, ethical, and procedural standards
p.(None): applicable to the employees of the agency from which such employee is detailed and those of the Foundation.
p.(None): ‘‘(2) VOLUNTARY SERVICE; ACCEPTANCE OF FEDERAL EMPLOYEES.—
p.(None): ‘‘(A) FOUNDATION.—The Executive Director of the Foundation may accept the services of employees
p.(None): detailed from Federal agencies with or without reimbursement to those agencies.
p.(None): ‘‘(B) FOOD AND DRUG ADMINISTRATION.—The Commis-
p.(None): sioner may accept the uncompensated services of Founda- tion fellows or trainees. Such services shall be
p.(None): considered to be undertaking an activity under contract with the Sec- retary as described in section 708.
p.(None): ‘‘(l) ANNUAL REPORTS.—
p.(None): ‘‘(1) REPORTS TO FOUNDATION.—Any recipient of a grant, contract, fellowship, memorandum of
p.(None): understanding, or cooperative agreement from the Foundation under this section shall submit to the Foundation a
p.(None): report on an annual basis for the duration of such grant, contract, fellowship, memo- randum of
p.(None): understanding, or cooperative agreement, that describes the activities carried out under such grant, contract,
p.(None): fellowship, memorandum of understanding, or cooperative agreement.
p.(None): ‘‘(2) REPORT TO CONGRESS AND THE FDA.—Beginning with
p.(None): fiscal year 2009, the Executive Director shall submit to Con- gress and the Commissioner an annual report
p.(None): that—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 897
p.(None):
p.(None):
p.(None): ‘‘(A) describes the activities of the Foundation and the progress of the Foundation in furthering the
p.(None): goals and priorities established under subsection (c)(2), including the practical impact of the Foundation on regulated
p.(None): product development;
p.(None): ‘‘(B) provides a specific accounting of the source and use of all funds used by the Foundation to
p.(None): carry out such activities; and
...
p.(None): Executive Director of the Foundation under section 770(l)(2).
p.(None): ‘‘(b) REPORT TO CONGRESS.—Beginning with fiscal year 2009, the Commissioner shall submit to Congress
p.(None): an annual report summarizing the incorporation of the information provided by the Foundation in the
p.(None): report described under section 770(l)(2) and by other recipients of grants, contracts, memoranda of
p.(None): under- standing, or cooperative agreements into regulatory and product review activities of the Food and Drug
p.(None): Administration.
p.(None): ‘‘(c) EXTRAMURAL GRANTS.—The provisions of this subchapter and section 566 shall have no effect on any grant,
p.(None): contract, memo- randum of understanding, or cooperative agreement between the Food and Drug Administration
p.(None): and any other entity entered into before, on, or after the date of the enactment of this subchapter.’’.
p.(None): (c) CONFORMING AMENDMENT.—Section 742(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379l(b))
p.(None): is amended by adding at the end the following: ‘‘Any such fellowships and training programs under this section or
p.(None): under section 770(d)(2)(A)(ix) may include provision by such scientists and physicians of services on a
p.(None): voluntary and uncompensated basis, as the Secretary determines appropriate. Such scientists and physicians shall
p.(None): be subject to all legal and ethical requirements otherwise applicable to officers or employees of the
p.(None): Department of Health and Human Services.’’.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379dd–1.
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379dd–2.
p.(None):
p.(None):
p.(None): 121 STAT. 898 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 399a.
p.(None): SEC. 602. OFFICE OF THE CHIEF SCIENTIST.
p.(None): Chapter IX of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 391 et seq.) is amended by adding at the end the following:
p.(None): ‘‘SEC. 910. OFFICE OF THE CHIEF SCIENTIST.
p.(None): ‘‘(a) ESTABLISHMENT; APPOINTMENT.—The Secretary shall estab- lish within the Office of the Commissioner an
p.(None): office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to
p.(None): lead such Office.
p.(None): ‘‘(b) DUTIES OF THE OFFICE.—The Office of the Chief Scientist shall—
p.(None): ‘‘(1) oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the
p.(None): Food and Drug Administration;
p.(None): ‘‘(2) track and, to the extent necessary, coordinate intra- mural research awards made by each center of the
p.(None): Administra- tion or science-based office within the Office of the Commis- sioner, and ensure that there
p.(None): is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug
p.(None): Administration;
p.(None): ‘‘(3) develop and advocate for a budget to support intra- mural research;
p.(None): ‘‘(4) develop a peer review process by which intramural research can be evaluated;
p.(None): ‘‘(5) identify and solicit intramural research proposals from across the Food and Drug Administration through an
p.(None): advisory board composed of employees of the Administration that shall include—
p.(None): ‘‘(A) representatives of each of the centers and the science-based offices within the Office of the
p.(None): Commissioner; and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC
p.(None): 360bbb–5.
p.(None): ‘‘(B) experts on trial design, epidemiology, demo- graphics, pharmacovigilance, basic science, and
p.(None): public health; and
p.(None): ‘‘(6) develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed
p.(None): for premarket review.’’.
p.(None): SEC. 603. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
p.(None): Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is
p.(None): amended by adding at the end the following:
p.(None): ‘‘SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
p.(None): ‘‘(a) ESTABLISHMENT.—The Secretary, acting through the Commissioner of Food and Drugs, may enter
p.(None): into collaborative agreements, to be known as Critical Path Public-Private Partner- ships, with one or
p.(None): more eligible entities to implement the Critical Path Initiative of the Food and Drug Administration by
p.(None): developing innovative, collaborative projects in research, education, and out- reach for the purpose of
p.(None): fostering medical product innovation, enabling the acceleration of medical product development, manufac- turing,
p.(None): and translational therapeutics, and enhancing medical product safety.
...
p.(None): determination as referred to in section 208(b)(1) of title 18, United States Code, a written certification
p.(None): as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in
p.(None): subsection (c)(2) of this section for service on the committee at a meeting of the committee.
p.(None): ‘‘(c) DISCLOSURES; PROHIBITIONS ON PARTICIPATION; WAIVERS.— ‘‘(1) DISCLOSURE OF FINANCIAL INTEREST.—Prior
p.(None): to a
p.(None): meeting of an advisory committee regarding a ‘particular matter’ (as that term is used in section 208 of
p.(None): title 18, United States Code), each member of the committee who is a full- time Government employee or
p.(None): special Government employee shall disclose to the Secretary financial interests in accordance with subsection (b) of
p.(None): such section 208.
p.(None): ‘‘(2) PROHIBITIONS AND WAIVERS ON PARTICIPATION.—
p.(None): ‘‘(A) IN GENERAL.—Except as provided under subpara- graph (B), a member of an advisory committee may not
p.(None): participate with respect to a particular matter considered in an advisory committee meeting if such
p.(None): member (or an immediate family member of such member) has a financial interest that could be affected by the
p.(None): advice given to the Secretary with respect to such matter, excluding interests exempted in regulations issued
p.(None): by the Director of the Office of Government Ethics as too remote or inconsequential to affect the integrity
p.(None): of the services of the Government officers or employees to which such regulations apply.
p.(None): ‘‘(B) WAIVER.—If the Secretary determines it necessary to afford the advisory committee essential expertise, the
p.(None): Secretary may grant a waiver of the prohibition in subpara- graph (A) to permit a member described in such
p.(None): subpara- graph to—
p.(None): ‘‘(i) participate as a non-voting member with respect to a particular matter considered in a com-
p.(None): mittee meeting; or
p.(None): ‘‘(ii) participate as a voting member with respect to a particular matter considered in a
p.(None): committee meeting.
p.(None): ‘‘(C) LIMITATION ON WAIVERS AND OTHER EXCEPTIONS.—
p.(None): ‘‘(i) DEFINITION.—For purposes of this subpara- graph, the term ‘exception’ means each of the following with
p.(None): respect to members of advisory committees:
p.(None): ‘‘(I) A waiver under section 505(n)(4) (as in effect on the day before the date of the enactment of the Food and
p.(None): Drug Administration Amendments Act of 2007).
p.(None): ‘‘(II) A written determination under section 208(b) of title 18, United States Code.
p.(None): ‘‘(III) A written certification under section 208(b)(3) of such title.
p.(None): ‘‘(ii) DETERMINATION OF TOTAL NUMBER OF MEM- BERS SLOTS AND MEMBER EXCEPTIONS DURING FISCAL
p.(None): YEAR 2007.—The Secretary shall determine—
p.(None): ‘‘(I)(aa) for each meeting held by any advisory committee during fiscal year 2007, the number of members who
p.(None): participated in the meeting; and
p.(None):
p.(None):
p.(None): 121 STAT. 902 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(bb) the sum of the respective numbers deter- mined under item (aa) (referred to in this subpara- graph as the
p.(None): ‘‘total number of 2007 meeting slots’’); and
...
p.(None): (1) the safety and integrity of the United States food supply are vital to public health, to public confidence
p.(None): in the food supply, and to the success of the food sector of the Nation’s economy;
p.(None): (2) illnesses and deaths of individuals and companion ani- mals caused by contaminated food—
p.(None): (A) have contributed to a loss of public confidence in food safety; and
p.(None): (B) have caused significant economic losses to manufac- turers and producers not responsible for contaminated food
p.(None): items;
p.(None): (3) the task of preserving the safety of the food supply of the United States faces tremendous
p.(None): pressures with regard to—
p.(None): (A) emerging pathogens and other contaminants and the ability to detect all forms of contamination;
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 963
p.(None):
p.(None):
p.(None): (B) an increasing volume of imported food from a wide variety of countries; and
p.(None): (C) a shortage of adequate resources for monitoring and inspection;
p.(None): (4) according to the Economic Research Service of the Department of Agriculture, the United States is
p.(None): increasing the amount of food that it imports such that—
p.(None): (A) from 2003 to 2007, the value of food imports has increased from $45,600,000,000 to $64,000,000,000; and
p.(None): (B) imported food accounts for 13 percent of the average American diet including 31 percent of fruits, juices,
p.(None): and nuts, 9.5 percent of red meat, and 78.6 percent of fish and shellfish; and
p.(None): (5) the number of full-time equivalent Food and Drug Administration employees conducting inspections has
p.(None): decreased from 2003 to 2007.
p.(None): SEC. 1002. ENSURING THE SAFETY OF PET FOOD.
p.(None): (a) PROCESSING AND INGREDIENT STANDARDS.—Not later than 2 years after the date of the enactment of this
p.(None): Act, the Secretary of Health and Human Services (referred to in this title as the ‘‘Secretary’’), in
p.(None): consultation with the Association of American Feed Control Officials and other relevant stakeholder groups,
p.(None): including veterinary medical associations, animal health organizations, and pet food manufacturers, shall by
p.(None): regulation establish—
p.(None): (1) ingredient standards and definitions with respect to pet food;
p.(None): (2) processing standards for pet food; and
p.(None): (3) updated standards for the labeling of pet food that include nutritional and ingredient information.
p.(None): (b) EARLY WARNING SURVEILLANCE SYSTEMS AND NOTIFICATION DURING PET FOOD RECALLS.—Not later than 1 year after the
p.(None): date of the enactment of this Act, the Secretary shall establish an early warning and surveillance
p.(None): system to identify adulteration of the pet food supply and outbreaks of illness associated with pet food.
p.(None): In establishing such system, the Secretary shall—
p.(None): (1) consider using surveillance and monitoring mechanisms similar to, or in coordination with, those used to monitor
p.(None): human or animal health, such as the Foodborne Diseases Active Surveillance Network (FoodNet) and
p.(None): PulseNet of the Centers for Disease Control and Prevention, the Food Emergency Response Network of
...
p.(None): (a) IN GENERAL.—The Secretary shall work with the States in undertaking activities and programs that
p.(None): assist in improving the safety of food, including fresh and processed produce, so that State food safety
p.(None): programs and activities conducted by the Secretary function in a coordinated and cost-effective manner. With the
p.(None): assist- ance provided under subsection (b), the Secretary shall encourage States to—
p.(None): (1) establish, continue, or strengthen State food safety pro- grams, especially with respect to the
p.(None): regulation of retail commercial food establishments; and
p.(None): (2) establish procedures and requirements for ensuring that processed produce under the jurisdiction of State
p.(None): food safety programs is not unsafe for human consumption.
p.(None): (b) ASSISTANCE.—The Secretary may provide to a State, for planning, developing, and implementing such a
p.(None): food safety pro- gram—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 350f
p.(None): note.
p.(None): (1) advisory assistance;
p.(None): (2) technical assistance, training, and laboratory assistance (including necessary materials and equipment); and
p.(None): (3) financial and other assistance.
p.(None): (c) SERVICE AGREEMENTS.—The Secretary may, under an agree- ment entered into with a Federal, State, or local
p.(None): agency, use, on a reimbursable basis or otherwise, the personnel, services, and facilities of the agency to
p.(None): carry out the responsibilities of the agency under this section. An agreement entered into with a State agency under
p.(None): this subsection may provide for training of State employees.
p.(None): SEC. 1005. REPORTABLE FOOD REGISTRY.
p.(None): (a) FINDINGS.—Congress makes the following findings:
p.(None): (1) In 1994, Congress passed the Dietary Supplement Health and Education Act of 1994 (Public Law
p.(None): 103–417) to provide the Food and Drug Administration the legal framework which is intended to ensure that dietary
p.(None): supplements are safe and properly labeled foods.
p.(None): (2) In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law
p.(None): 109–462) to establish a mandatory reporting system of serious adverse events for nonprescription drugs and
p.(None): dietary supple- ments sold and consumed in the United States.
p.(None): (3) The adverse event reporting system created under the Dietary Supplement and Nonprescription Drug
p.(None): Consumer Protection Act is intended to serve as an early warning system for potential public health issues
p.(None): associated with the use of these products.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 965
p.(None):
p.(None):
p.(None): (4) A reliable mechanism to track patterns of adulteration in food would support efforts by the Food and Drug
p.(None): Administra- tion to target limited inspection resources to protect the public health.
...
p.(None): combined into a single report, by not later than June 1, 2008, for purposes of publication under
p.(None): subsection (a). Thereafter such reports shall be completed by June 1 of each year for the data
p.(None): collected for the year that was 2-years prior to the year in which the report is published.
p.(None): (c) MEMORANDUM OF UNDERSTANDING.—The Commissioner of Food and Drugs, the Administrator of the Food Safety and
p.(None): Inspec- tion Service, the Department of Commerce, and the head of the Agricultural Marketing Service shall
p.(None): enter into a memorandum of understanding to permit inclusion of data in the reports under subsection (a)
p.(None): relating to testing carried out by the Food Safety and Inspection Service and the Agricultural Marketing
p.(None): Service on meat, poultry, eggs, and certain raw agricultural products, respec- tively.
p.(None): SEC. 1011. RULE OF CONSTRUCTION.
p.(None): Nothing in this title (or an amendment made by this title) shall be construed to affect—
p.(None): (1) the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (Public
p.(None): Law 103–417); or
p.(None): (2) the adverse event reporting system for dietary supple- ments created under the Dietary Supplement and
p.(None): Nonprescrip- tion Drug Consumer Protection Act (Public Law 109–462).
p.(None): TITLE XI—OTHER PROVISIONS
p.(None): Subtitle A—In General
p.(None): SEC. 1101. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC ARTICLES PUBLISHED BY FDA EMPLOYEES.
p.(None): Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.), as
p.(None): amended by section 701, is further amended by adding at the end the following:
p.(None): ‘‘SEC. 713. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC ARTICLES PUBLISHED BY FDA EMPLOYEES.
p.(None): ‘‘(a) DEFINITION.—In this section, the term ‘article’ means a paper, poster, abstract, book, book chapter,
p.(None): or other published writing.
p.(None): ‘‘(b) POLICIES.—The Secretary, through the Commissioner of Food and Drugs, shall establish and make
p.(None): publicly available clear
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2110.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379d–2.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public information.
p.(None):
p.(None):
p.(None): 121 STAT. 972 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): written policies to implement this section and govern the timely submission, review, clearance, and disclaimer
p.(None): requirements for arti- cles.
p.(None): ‘‘(c) TIMING OF SUBMISSION FOR REVIEW.—If an officer or
p.(None): employee, including a Staff Fellow and a contractor who performs staff work, of the Food and Drug
p.(None): Administration is directed by the policies established under subsection (b) to submit an article to the
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public information. Internet.
p.(None):
p.(None):
p.(None): 121 STAT. 906 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(ii) CONTENT.—The clinical trial information required to be submitted under this paragraph for an
p.(None): applicable clinical trial shall include—
p.(None): ‘‘(I) descriptive information, including—
p.(None): ‘‘(aa) a brief title, intended for the lay public;
p.(None): ‘‘(bb) a brief summary, intended for the lay public;
p.(None): ‘‘(cc) the primary purpose; ‘‘(dd) the study design;
p.(None): ‘‘(ee) for an applicable drug clinical trial, the study phase;
p.(None): ‘‘(ff) study type;
p.(None): ‘‘(gg) the primary disease or condition being studied, or the focus of the study;
p.(None): ‘‘(hh) the intervention name and interven- tion type;
p.(None): ‘‘(ii) the study start date;
p.(None): ‘‘(jj) the expected completion date;
p.(None): ‘‘(kk) the target number of subjects; and ‘‘(ll) outcomes, including primary and sec-
p.(None): ondary outcome measures;
p.(None): ‘‘(II) recruitment information, including— ‘‘(aa) eligibility criteria;
p.(None): ‘‘(bb) gender;
p.(None): ‘‘(cc) age limits;
p.(None): ‘‘(dd) whether the trial accepts healthy vol- unteers;
p.(None): ‘‘(ee) overall recruitment status; ‘‘(ff) individual site status; and
p.(None): ‘‘(gg) in the case of an applicable drug clinical trial, if the drug is not approved under section 505 of the
p.(None): Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, specify whether or not
p.(None): there is expanded access to the drug under section 561 of the Federal Food, Drug, and Cosmetic Act for those
p.(None): who do not qualify for enrollment in the clinical trial and how to obtain informa- tion about such access;
p.(None): ‘‘(III) location and contact information, including—
p.(None): ‘‘(aa) the name of the sponsor;
p.(None): ‘‘(bb) the responsible party, by official title;
p.(None):
p.(None): and
p.(None): ‘‘(cc) the facility name and facility contact
p.(None): information (including the city, State, and zip code for each clinical trial location, or a toll- free number
p.(None): through which such location information may be accessed); and
p.(None): ‘‘(IV) administrative data (which the Secretary may make publicly available as necessary), including—
p.(None): ‘‘(aa) the unique protocol identification number;
p.(None): ‘‘(bb) other protocol identification num- bers, if any; and
p.(None):
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p.(None): Sec. 917. Risk communication.
p.(None): Sec. 918. Referral to advisory committee.
p.(None): Sec. 919. Response to the institute of medicine. Sec. 920. Database for authorized generic drugs.
p.(None): Sec. 921. Adverse drug reaction reports and postmarket safety.
p.(None): TITLE X—FOOD SAFETY
p.(None): Sec. 1001. Findings.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 825
p.(None):
p.(None):
p.(None): Sec. 1002. Ensuring the safety of pet food.
p.(None): Sec. 1003. Ensuring efficient and effective communications during a recall. Sec. 1004. State and Federal
p.(None): Cooperation.
p.(None): Sec. 1005. Reportable Food Registry.
p.(None): Sec. 1006. Enhanced aquaculture and seafood inspection.
p.(None): Sec. 1007. Consultation regarding genetically engineered seafood products. Sec. 1008. Sense of Congress.
p.(None): Sec. 1009. Annual report to Congress. Sec. 1010. Publication of annual reports. Sec. 1011. Rule of construction.
p.(None): TITLE XI—OTHER PROVISIONS
p.(None): Subtitle A—In General
p.(None): Sec. 1101. Policy on the review and clearance of scientific articles published by FDA employees.
p.(None): Sec. 1102. Priority review to encourage treatments for tropical diseases. Sec. 1103. Improving genetic test safety
p.(None): and quality.
p.(None): Sec. 1104. NIH Technical amendments. Sec. 1105. Severability clause.
p.(None): Subtitle B—Antibiotic Access and Innovation
p.(None): Sec. 1111. Identification of clinically susceptible concentrations of antimicrobials. Sec. 1112. Orphan antibiotic
p.(None): drugs.
p.(None): Sec. 1113. Exclusivity of certain drugs containing single enantiomers. Sec. 1114. Report.
p.(None):
p.(None): TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
p.(None): SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING.
p.(None): (a) SHORT TITLE.—This title may be cited as the ‘‘Prescription Drug User Fee Amendments of 2007’’.
p.(None): (b) REFERENCES IN TITLE.—Except as otherwise specified, amendments made by this title to a section
p.(None): or other provision of law are amendments to such section or other provision of the Federal Food, Drug,
p.(None): and Cosmetic Act (21 U.S.C. 301 et seq.).
p.(None): (c) FINDING.—The Congress finds that the fees authorized by the amendments made in this title will be
p.(None): dedicated toward expe- diting the drug development process and the process for the review of human drug
p.(None): applications, including postmarket drug safety activities, as set forth in the goals identified for
p.(None): purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the
p.(None): letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health,
...
p.(None): period the fol- lowing: ‘‘, and that does not have a drug product that has been approved under a human
p.(None): drug application and introduced or delivered for introduction into interstate commerce’’.
p.(None): (e) CREDITING AND AVAILABILITY OF FEES.—
p.(None): (1) AUTHORIZATION OF APPROPRIATIONS.—Section 736(g)(3) (21 U.S.C. 379h(g)(3)) is amended to read as follows:
p.(None): ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the
p.(None): fiscal years 2008 through 2012, there is authorized to be appro- priated for fees under this section an amount
p.(None): equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or
p.(None): otherwise affected under subsection
p.(None): (c) and paragraph (4) of this subsection.’’.
p.(None): (2) OFFSET.—Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is
p.(None): amended to read as follows:
p.(None): ‘‘(4) OFFSET.—If the sum of the cumulative amount of fees collected under this section for the fiscal years
p.(None): 2008 through 2010 and the amount of fees estimated to be collected under this section for fiscal year 2011
p.(None): exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2008 through 2011, the
p.(None): excess shall be credited to the appropriation account of the Food and Drug Administration as provided in
p.(None): paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be
p.(None): collected under this section pursuant to appropriation Acts for fiscal year 2012.’’.
p.(None): (f) EXEMPTION FOR ORPHAN DRUGS.—Section 736 (21 U.S.C. 379h) is further amended by adding at the end
p.(None): the following:
p.(None): ‘‘(k) ORPHAN DRUGS.—
p.(None):
p.(None):
p.(None): 121 STAT. 832 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(1) EXEMPTION.—A drug designated under section 526 for a rare disease or condition and approved under
p.(None): section 505 or under section 351 of the Public Health Service Act shall be exempt from product and
p.(None): establishment fees under this section, if the drug meets all of the following conditions:
p.(None): ‘‘(A) The drug meets the public health requirements contained in this Act as such requirements are
p.(None): applied to requests for waivers for product and establishment fees. ‘‘(B) The drug is owned or licensed and is
p.(None): marketed
p.(None): by a company that had less than $50,000,000 in gross worldwide revenue during the previous year.
p.(None): ‘‘(2) EVIDENCE OF QUALIFICATION.—An exemption under paragraph (1) applies with respect to a drug
p.(None): only if the applicant involved submits a certification that its gross annual revenues did not exceed
p.(None): $50,000,000 for the preceding 12 months before the exemption was requested.’’.
p.(None): (g) CONFORMING AMENDMENT.—Section 736(a) (21 U.S.C. 379h(a)) is amended in paragraphs (1)(A)(i),
p.(None): (1)(A)(ii), (2)(A), and (3)(A) by striking ‘‘(c)(4)’’ each place such term appears and inserting ‘‘(c)(5)’’.
p.(None): (h) TECHNICAL AMENDMENT.—
p.(None): (1) AMENDMENT.—Section 736(g)(1) (21 U.S.C. 379h(g)(1))
...
p.(None): In consid- ering such reports, the Director of such Office shall provide for the review of such reports
p.(None): by the Pediatric Advisory Com- mittee, including obtaining any recommendations of such com- mittee regarding
p.(None): whether the Secretary should take action under this Act in response to such reports.
p.(None): ‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Following the one-
p.(None): year period described in paragraph (1), the Secretary shall, as appropriate, refer to the Office of
p.(None): Pediatric Therapeutics all pediatric adverse event reports for a drug for which a pediatric study was
p.(None): conducted under this section. In considering such reports, the Director of such Office may provide for the
p.(None): review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of such
p.(None): Committee regarding whether the Secretary should take action in response to such reports.
p.(None): ‘‘(3) EFFECT.—The requirements of this subsection shall supplement, not supplant, other review of such
p.(None): adverse event reports by the Secretary.
p.(None): ‘‘(j) SCOPE OF AUTHORITY.—Nothing in this section provides to the Secretary any authority to require
p.(None): a pediatric assessment of any drug or biological product, or any assessment regarding other populations or
p.(None): uses of a drug or biological product, other than the pediatric assessments described in this section.
p.(None): ‘‘(k) ORPHAN DRUGS.—Unless the Secretary requires otherwise by regulation, this section does not apply to any drug for
p.(None): an indica- tion for which orphan designation has been granted under section 526.
p.(None):
p.(None):
p.(None): Deadline. Contracts. Reports.
p.(None): ‘‘(l) INSTITUTE OF MEDICINE STUDY.—
p.(None): ‘‘(1) IN GENERAL.—Not later than three years after the date of the enactment of the Pediatric Research
p.(None): Equity Act of 2007, the Secretary shall contract with the Institute of Medi- cine to conduct a study and report
p.(None): to Congress regarding the pediatric studies conducted pursuant to this section or precursor regulations since 1997
p.(None): and labeling changes made as a result of such studies.
p.(None): ‘‘(2) CONTENT OF STUDY.—The study under paragraph (1) shall review and assess the use of extrapolation
p.(None): for pediatric subpopulations, the use of alternative endpoints for pediatric populations, neonatal assessment
p.(None): tools, the number and type of pediatric adverse events, and ethical issues in pediatric clin- ical trials.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 875
p.(None):
p.(None):
p.(None): ‘‘(3) REPRESENTATIVE SAMPLE.—The Institute of Medicine may devise an appropriate mechanism to review a
p.(None): representa- tive sample of studies conducted pursuant to this section from each review division within the Center
p.(None): for Drug Evaluation and Research in order to make the requested assessment.
p.(None): ‘‘(m) INTEGRATION WITH OTHER PEDIATRIC STUDIES.—The
p.(None): authority under this section shall remain in effect so long as an application subject to this section
p.(None): may be accepted for filing by the Secretary on or before the date specified in section 505A(q).’’.
p.(None): (b) APPLICABILITY.—
...
p.(None): ‘‘Secretary’’), through the Commissioner of Food and Drugs, shall identify (where such
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 247d–3b.
p.(None):
p.(None): 42 USC 282.
p.(None):
p.(None): 42 USC 283.
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 283a–3.
p.(None): 42 USC 283a–2.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 301 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 247d–5a.
p.(None):
p.(None):
p.(None): 121 STAT. 976 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): information is reasonably available) and periodically update clini- cally susceptible concentrations.
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Appropriation authorization.
p.(None): (c) PUBLIC AVAILABILITY.—The Secretary, through the Commis- sioner of Food and Drugs, shall make such
p.(None): clinically susceptible concentrations publicly available, such as by posting on the Internet, not later than 30
p.(None): days after the date of identification and any update under this section.
p.(None): (d) EFFECT.—Nothing in this section shall be construed to restrict, in any manner, the prescribing of
p.(None): antibiotics by physicians, or to limit the practice of medicine, including for diseases such as Lyme and
p.(None): tick-borne diseases.
p.(None): SEC. 1112. ORPHAN ANTIBIOTIC DRUGS.
p.(None): (a) PUBLIC MEETING.—The Commissioner of Food and Drugs shall convene a public meeting regarding which
p.(None): serious and life threatening infectious diseases, such as diseases due to gram-nega- tive bacteria and other diseases
p.(None): due to antibiotic-resistant bacteria, potentially qualify for available grants and contracts under section 5(a) of the
p.(None): Orphan Drug Act (21 U.S.C. 360ee(a)) or other incentives for development.
p.(None): (b) GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF ORPHAN DRUGS.—Section 5(c) of the Orphan Drug Act (21
p.(None): U.S.C. 360ee(c)) is amended to read as follows:
p.(None): ‘‘(c) For grants and contracts under subsection (a), there is authorized to be appropriated $30,000,000
p.(None): for each of fiscal years 2008 through 2012.’’.
p.(None): SEC. 1113. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
p.(None): Section 505 of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 355), as amended by section 920, is further amended by adding at the end the following:
p.(None): ‘‘(u) CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.—
p.(None): ‘‘(1) IN GENERAL.—For purposes of subsections (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is submitted
p.(None): under subsection
p.(None): (b) for a non-racemic drug containing as an active ingredient (including any ester or salt of the
p.(None): active ingredient) a single enantiomer that is contained in a racemic drug approved in another application
p.(None): under subsection (b), the applicant may, in the application for such non-racemic drug, elect to have the
p.(None): single enantiomer not be considered the same active ingre- dient as that contained in the approved racemic
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p.(None): be the percent- age by which the estimate of establishments submitting fees in fiscal year 2009 is fewer
p.(None): than 12,750, but in no case may the percentage increase be more than 8.5 percent over that specified in
p.(None): subsection (b) for fiscal year 2010. If the Secretary makes any adjustment to the fee under subsection
p.(None): (a)(3)(A) for fiscal year 2010, then such fee for fiscal years 2011 and 2012 shall be adjusted so that
p.(None): such fee for fiscal year 2011 is equal to the adjusted fee for fiscal year 2010 increased by 8.5
p.(None): percent, and such fee for fiscal year 2012 is equal to the adjusted fee for fiscal year 2011 increased by
p.(None): 8.5 percent.
p.(None):
p.(None): Federal Register, publication.
p.(None): ‘‘(B) PUBLICATION.—For any adjustment made under
p.(None): subparagraph (A), the Secretary shall publish in the Fed- eral Register the Secretary’s determination to
p.(None): make the adjustment and the rationale for the determination.’’; and
p.(None): (C) in paragraph (4), as redesignated by this para- graph, in subparagraph (A)—
p.(None): (i) by striking ‘‘For fiscal years 2006 and 2007, the Secretary’’ and inserting ‘‘The Secretary’’; and
p.(None): (ii) by striking ‘‘for the first month of fiscal year 2008’’ and inserting ‘‘for the first month of
p.(None): the next fiscal year’’.
p.(None): (d) SMALL BUSINESSES; FEE WAIVER AND FEE REDUCTION REGARDING PREMARKET APPROVAL.—
p.(None): (1) IN GENERAL.—Section 738(d)(1) (21 U.S.C. 379j(d)(1))
p.(None): is amended—
p.(None): (A) by striking ‘‘, partners, and parent firms’’; and
p.(None): (B) by striking ‘‘clauses (i) through (vi) of subsection (a)(2)(A)’’ and inserting ‘‘clauses (i) through (v)
p.(None): and clauses (vii), (ix), and (x) of subsection (a)(2)(A)’’.
p.(None): (2) RULES RELATING TO PREMARKET APPROVAL FEES.—
p.(None): (A) DEFINITION.—Section 738(d)(2)(A) (21 U.S.C. 379j(d)(2)(A)) is amended by striking ‘‘,
p.(None): partners, and parent firms’’.
p.(None): (B) EVIDENCE OF QUALIFICATION.—Section 738(d)(2)(B) (21 U.S.C. 379j(d)(2)(B)) is amended—
p.(None): (i) by striking ‘‘(B) EVIDENCE OF QUALIFICATION.— An applicant’’ and inserting the following:
p.(None): ‘‘(B) EVIDENCE OF QUALIFICATION.—
p.(None): ‘‘(i) IN GENERAL.—An applicant’’;
p.(None): (ii) by striking ‘‘The applicant shall support its claim’’ and inserting the following:
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 847
p.(None):
p.(None):
p.(None): ‘‘(ii) FIRMS SUBMITTING TAX RETURNS TO THE UNITED STATES INTERNAL REVENUE SERVICE.—The
p.(None): applicant shall support its claim’’;
p.(None): (iii) by striking ‘‘, partners, and parent firms’’ each place it appears;
p.(None): (iv) by striking the last sentence and inserting ‘‘If no tax forms are submitted for any affiliate, the
p.(None): applicant shall certify that the applicant has no affili- ates.’’; and
p.(None): (v) by adding at the end the following:
p.(None): ‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE UNITED STATES INTERNAL REVENUE SERVICE.—In the
p.(None): case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of
p.(None): its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a
p.(None): signed certification, in such form as the Secretary may direct through a notice published in the Federal
p.(None): Register, that the applicant or affiliate meets the cri- teria for a small business and a
p.(None): certification, in English, from the national taxing authority of the country in which the applicant or, if
p.(None): applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official
p.(None): seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the
p.(None): most recent year in both the local currency of such country and in United States dollars, the exchange rate
p.(None): used in converting such local currency to dollars, and the dates during which these receipts or sales
p.(None): were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or
p.(None): by its chief financial officer that the applicant has submitted certifications for all of its affiliates,
p.(None): or that the applicant has no affiliates.’’.
p.(None): (3) REDUCED FEES.—Section 738(d)(2)(C) (21 U.S.C. 379j(d)(2)(C)) is amended to read as follows:
p.(None): ‘‘(C) REDUCED FEES.—Where the Secretary finds that the applicant involved meets the definition under subpara-
p.(None): graph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of—
p.(None): ‘‘(i) 25 percent of the fee established under such subsection for a premarket application, a premarket
p.(None): report, a supplement, or periodic reporting concerning a class III device; and
p.(None): ‘‘(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classifica-
p.(None): tion information.’’.
p.(None): (e) SMALL BUSINESSES; FEE REDUCTION REGARDING PREMARKET NOTIFICATION SUBMISSIONS.—
p.(None): (1) IN GENERAL.—Section 738(e)(1) (21 U.S.C. 379j(e)(1))
p.(None): is amended—
p.(None): (A) by striking ‘‘2004’’ and inserting ‘‘2008’’; and
p.(None): (B) by striking ‘‘(a)(2)(A)(vii)’’ and inserting ‘‘(a)(2)(A)(viii)’’.
p.(None): (2) RULES RELATING TO PREMARKET NOTIFICATION SUBMIS- SIONS.—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Certification. Federal Register, publication.
p.(None):
p.(None):
p.(None): 121 STAT. 848 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): (A) DEFINITION.—Section 738(e)(2)(A) (21 U.S.C. 379j(e)(2)(A)) is amended by striking ‘‘, partners, and
p.(None): parent firms’’.
p.(None): (B) EVIDENCE OF QUALIFICATION.—Section 738(e)(2)(B) (21 U.S.C. 379j(e)(2)(B)) is amended—
p.(None): (i) by striking ‘‘(B) EVIDENCE OF QUALIFICATION.— An applicant’’ and inserting the following:
p.(None): ‘‘(B) EVIDENCE OF QUALIFICATION.—
p.(None): ‘‘(i) IN GENERAL.—An applicant’’;
p.(None): (ii) by striking ‘‘The applicant shall support its claim’’ and inserting the following:
p.(None): ‘‘(ii) FIRMS SUBMITTING TAX RETURNS TO THE UNITED STATES INTERNAL REVENUE SERVICE.—The
p.(None): applicant shall support its claim’’;
p.(None): (iii) by striking ‘‘, partners, and parent firms’’ each place it appears;
p.(None): (iv) by striking the last sentence and inserting ‘‘If no tax forms are submitted for any affiliate, the
p.(None): applicant shall certify that the applicant has no affili- ates.’’; and
p.(None): (v) by adding at the end the following:
p.(None): ‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE
p.(None):
p.(None): Certification. Federal Register, publication.
p.(None): UNITED STATES INTERNAL REVENUE SERVICE.—In the
p.(None): case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of
p.(None): its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a
p.(None): signed certification, in such form as the Secretary may direct through a notice published in the Federal
p.(None): Register, that the applicant or affiliate meets the cri- teria for a small business and a
p.(None): certification, in English, from the national taxing authority of the country in which the applicant or, if
p.(None): applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official
p.(None): seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the
p.(None): most recent year in both the local currency of such country and in United States dollars, the exchange rate
p.(None): used in converting such local currency to dollars, and the dates during which these receipts or sales
p.(None): were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or
...
Searching for indicator parents:
(return to top)
p.(None): Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, and the
p.(None): appropriate expertise per- taining to the pediatric product under review, such as expertise in child and
p.(None): adolescent psychiatry, and other individuals designated by the Secretary.’’.
p.(None): SEC. 404. GOVERNMENT ACCOUNTABILITY OFFICE REPORT.
p.(None): Not later than January 1, 2011, the Comptroller General of the United States, in consultation with the
p.(None): Secretary of Health and Human Services, shall submit to the Congress a report that addresses the
p.(None): effectiveness of sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and
p.(None): section 409I of the Public Health Service Act (42 U.S.C. 284m) in ensuring that medicines used by children are
p.(None): tested and properly labeled. Such report shall include—
p.(None): (1) the number and importance of drugs and biological products for children that are being tested as a
p.(None): result of the amendments made by this title and title V and the importance
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Establishment. 21 USC 355d.
p.(None):
p.(None):
p.(None): 121 STAT. 876 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): for children, health care providers, parents, and others of labeling changes made as a result of such
p.(None): testing;
p.(None): (2) the number and importance of drugs and biological products for children that are not being tested
p.(None): for their use notwithstanding the provisions of this title and title V and possible reasons for the lack of
p.(None): testing;
p.(None): (3) the number of drugs and biological products for which testing is being done and labeling changes
p.(None): required, including the date labeling changes are made and which labeling changes required the use of the dispute
p.(None): resolution process established pursuant to the amendments made by this title, together with a description of the
p.(None): outcomes of such process, including a description of the disputes and the recommendations of the Pediatric
p.(None): Advisory Committee;
p.(None): (4) any recommendations for modifications to the programs established under sections 505A and 505B of the Federal Food,
p.(None): Drug, and Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public Health Service Act (42 U.S.C.
p.(None): 284m) that the Secretary determines to be appropriate, including a detailed rationale for each recommendation;
p.(None): and
p.(None): (5)(A) the efforts made by the Secretary to increase the number of studies conducted in the neonate
p.(None): population; and
p.(None): (B) the results of those efforts, including efforts made to encourage the conduct of appropriate studies
p.(None): in neonates by companies with products that have sufficient safety and other information to make the
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): summary of the views and comments received under such paragraph, and any changes made to the
p.(None): recommendations in response to such views and comments.
p.(None): ‘‘(6) MINUTES OF NEGOTIATION MEETINGS.—
p.(None): ‘‘(A) PUBLIC AVAILABILITY.—Before presenting the rec- ommendations developed under paragraphs (1) through (5) to
p.(None): the Congress, the Secretary shall make publicly avail- able, on the public Web site of the Food and Drug
p.(None): Adminis- tration, minutes of all negotiation meetings conducted under this subsection between the Food and
p.(None): Drug Adminis- tration and the regulated industry.
p.(None): ‘‘(B) CONTENT.—The minutes described under subpara- graph (A) shall summarize any substantive proposal made
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Website.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Website.
p.(None):
p.(None):
p.(None): 121 STAT. 842 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): by any party to the negotiations as well as significant controversies or differences of opinion during
p.(None): the negotia- tions and their resolution.’’.
p.(None): SEC. 106. SUNSET DATES.
p.(None):
p.(None): 21 USC 379g
p.(None): note.
p.(None): 21 USC 379h–2.
p.(None):
p.(None): 21 USC 379g
p.(None): note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379g
p.(None): note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Medical Device User Fee Amendments of 2007.
p.(None):
p.(None): 21 USC 301 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379i
p.(None): note.
p.(None): (a) AUTHORIZATION.—The amendments made by sections 102, 103, and 104 cease to be effective October 1, 2012.
p.(None): (b) REPORTING REQUIREMENTS.—The amendment made by sec- tion 105 ceases to be effective January 31, 2013.
p.(None): SEC. 107. EFFECTIVE DATE.
p.(None): The amendments made by this title shall take effect on October 1, 2007, or the date of the enactment of this
p.(None): Act, whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food,
p.(None): Drug, and Cosmetic Act shall be assessed for all human drug applications received on or after October 1,
p.(None): 2007, regardless of the date of the enactment of this Act.
p.(None): SEC. 108. SAVINGS CLAUSE.
p.(None): Notwithstanding section 509 of the Prescription Drug User Fee Amendments of 2002 (21 U.S.C. 379g note),
p.(None): and notwith- standing the amendments made by this title, part 2 of subchapter C of chapter VII of the
...
p.(None): summary of the views and comments received under such paragraph, and any changes made to the
p.(None): recommendations in response to such views and comments.
p.(None): ‘‘(6) MINUTES OF NEGOTIATION MEETINGS.—
p.(None): ‘‘(A) PUBLIC AVAILABILITY.—Before presenting the rec- ommendations developed under paragraphs (1) through (5) to
p.(None): the Congress, the Secretary shall make publicly avail- able, on the public Web site of the Food and Drug
p.(None): Adminis- tration, minutes of all negotiation meetings conducted under this subsection between the Food and
p.(None): Drug Adminis- tration and the regulated industry.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Website.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Website.
p.(None):
p.(None):
p.(None): 121 STAT. 852 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(B) CONTENT.—The minutes described under subpara- graph (A) shall summarize any substantive proposal made by any
p.(None): party to the negotiations as well as significant controversies or differences of opinion during the
p.(None): negotia- tions and their resolution.’’.
p.(None):
p.(None): 21 USC 379i
p.(None): note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379i
p.(None): note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379i
p.(None): note.
p.(None): SEC. 214. SAVINGS CLAUSE.
p.(None): Notwithstanding section 107 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250),
p.(None): and notwith- standing the amendments made by this subtitle, part 3 of sub- chapter C of chapter VII of
p.(None): the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the
p.(None): date of the enactment of this subtitle, shall continue to be in effect with respect to premarket
p.(None): applications, premarket reports, premarket notification submissions, and supplements (as defined in such part
p.(None): as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the
p.(None): Food and Drug Administration for filing with respect to assessing and collecting any fee required by such
p.(None): part for a fiscal year prior to fiscal year 2008.
p.(None): SEC. 215. ADDITIONAL AUTHORIZATION OF APPROPRIATIONS FOR POSTMARKET SAFETY INFORMATION.
...
Economic / Economic/Poverty
Searching for indicator poor:
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p.(None): after receipt by the Sec- retary of such application, as described in the Manual of Policies and Procedures of the
p.(None): Food and Drug Administration and goals identified in the letters described in section 101(c) of the Food and Drug
p.(None): Administration Amendments Act of 2007.
p.(None): ‘‘(2) PRIORITY REVIEW VOUCHER.—The term ‘priority review voucher’ means a voucher issued by the Secretary to the
p.(None): sponsor of a tropical disease product application that entitles the holder of such voucher to priority review of
p.(None): a single human drug application submitted under section 505(b)(1) or section 351 of the Public Health
p.(None): Service Act after the date of approval of the tropical disease product application.
p.(None): ‘‘(3) TROPICAL DISEASE.—The term ‘tropical disease’ means any of the following:
p.(None): ‘‘(A) Tuberculosis. ‘‘(B) Malaria.
p.(None): ‘‘(C) Blinding trachoma.
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(D) Buruli Ulcer. ‘‘(E) Cholera.
p.(None): ‘‘(F) Dengue/dengue haemorrhagic fever. ‘‘(G) Dracunculiasis (guinea-worm disease). ‘‘(H) Fascioliasis.
p.(None): ‘‘(I) Human African trypanosomiasis. ‘‘(J) Leishmaniasis.
p.(None): ‘‘(K) Leprosy.
p.(None): ‘‘(L) Lymphatic filariasis. ‘‘(M) Onchocerciasis.
p.(None): ‘‘(N) Schistosomiasis.
p.(None): ‘‘(O) Soil transmitted helmithiasis. ‘‘(P) Yaws.
p.(None): 121 STAT. 973
p.(None): ‘‘(Q) Any other infectious disease for which there is no significant market in developed nations and
p.(None): that dis- proportionately affects poor and marginalized populations, designated by regulation by the Secretary.
p.(None): ‘‘(4) TROPICAL DISEASE PRODUCT APPLICATION.—The term
p.(None): ‘tropical disease product application’ means an application that—
p.(None): ‘‘(A) is a human drug application as defined in section 735(1)—
p.(None): ‘‘(i) for prevention or treatment of a tropical dis- ease; and
p.(None): ‘‘(ii) the Secretary deems eligible for priority review;
p.(None): ‘‘(B) is approved after the date of the enactment of the Food and Drug Administration Amendments Act of
p.(None): 2007, by the Secretary for use in the prevention, detection, or treatment of a tropical disease; and
p.(None): ‘‘(C) is for a human drug, no active ingredient (including any ester or salt of the active
p.(None): ingredient) of which has been approved in any other application under section 505(b)(1) or section 351 of the
p.(None): Public Health Service Act.
p.(None): ‘‘(b) PRIORITY REVIEW VOUCHER.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall award a priority review voucher to the sponsor of a tropical
p.(None): disease product application upon approval by the Secretary of such tropical disease product application.
p.(None): ‘‘(2) TRANSFERABILITY.—The sponsor of a tropical disease product that receives a priority review voucher under
p.(None): this sec- tion may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug
p.(None): for which an application under section 505(b)(1) or section 351 of the Public Health Service Act will be
...
General/Other / Incapacitated
Searching for indicator incapacity:
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p.(None):
p.(None): information) since the drug was approved, since the risk evaluation and mitigation strategy was required,
p.(None): or since the last assessment of the approved risk evaluation and mitigation strategy for the drug; or
p.(None): ‘‘(B) the effectiveness of the approved risk evaluation and mitigation strategy for the drug obtained
p.(None): since the last assessment of such strategy.
p.(None): ‘‘(4) SERIOUS ADVERSE DRUG EXPERIENCE.—The term
p.(None): ‘serious adverse drug experience’ is an adverse drug experience that—
p.(None): ‘‘(A) results in—
p.(None): ‘‘(i) death;
p.(None): ‘‘(ii) an adverse drug experience that places the patient at immediate risk of death from the adverse
p.(None): drug experience as it occurred (not including an adverse drug experience that might have caused death had
p.(None): it occurred in a more severe form);
p.(None): ‘‘(iii) inpatient hospitalization or prolongation of existing hospitalization;
p.(None): ‘‘(iv) a persistent or significant incapacity or substantial disruption of the ability to conduct normal
p.(None): life functions; or
p.(None): ‘‘(v) a congenital anomaly or birth defect; or
p.(None): ‘‘(B) based on appropriate medical judgment, may jeop- ardize the patient and may require a medical or
p.(None): surgical intervention to prevent an outcome described under subparagraph (A).
p.(None): ‘‘(5) SERIOUS RISK.—The term ‘serious risk’ means a risk of a serious adverse drug experience.
p.(None): ‘‘(6) SIGNAL OF A SERIOUS RISK.—The term ‘signal of a serious risk’ means information related to a
p.(None): serious adverse drug experience associated with use of a drug and derived from—
p.(None): ‘‘(A) a clinical trial;
p.(None): ‘‘(B) adverse event reports;
p.(None): ‘‘(C) a postapproval study, including a study under section 505(o)(3);
p.(None): ‘‘(D) peer-reviewed biomedical literature;
p.(None): ‘‘(E) data derived from the postmarket risk identifica- tion and analysis system under section 505(k)(4); or
p.(None): ‘‘(F) other scientific data deemed appropriate by the Secretary.
p.(None): ‘‘(7) RESPONSIBLE PERSON.—The term ‘responsible person’ means the person submitting a covered application or the
p.(None): holder of the approved such application.
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None): condition, the treatment of which is not an approved use for the drug, to a drug that is subject to
p.(None): elements to assure safe use under this subsection. The Sec- retary shall promulgate regulations for how a
p.(None): physician may provide the drug under the mechanisms of section 561.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Regulations.
p.(None):
p.(None):
p.(None): 121 STAT. 932 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): ‘‘(7) WAIVER IN PUBLIC HEALTH EMERGENCIES.—The Sec-
p.(None): retary may waive any requirement of this subsection during the period described in section 319(a) of the
p.(None): Public Health Service Act with respect to a qualified countermeasure described under section
p.(None): 319F–1(a)(2) of such Act, to which a requirement under this subsection has been applied, if the Secretary
p.(None): has—
p.(None): ‘‘(A) declared a public health emergency under such section 319; and
p.(None): ‘‘(B) determined that such waiver is required to miti- gate the effects of, or reduce the severity of,
p.(None): such public health emergency.
p.(None): ‘‘(8) LIMITATION.—No holder of an approved covered application shall use any element to assure safe
p.(None): use required by the Secretary under this subsection to block or delay approval of an application
p.(None): under section 505(b)(2) or (j) or to prevent application of such element under subsection (i)(1)(B) to a drug
p.(None): that is the subject of an abbreviated new drug application.
p.(None): ‘‘(g) ASSESSMENT AND MODIFICATION OF APPROVED STRATEGY.—
p.(None): ‘‘(1) VOLUNTARY ASSESSMENTS.—After the approval of a risk evaluation and mitigation strategy under
p.(None): subsection (a), the responsible person involved may, subject to paragraph (2), submit to the Secretary an assessment
p.(None): of, and propose a modi- fication to, the approved strategy for the drug involved at any time.
p.(None): ‘‘(2) REQUIRED ASSESSMENTS.—A responsible person shall, subject to paragraph (5), submit an assessment of,
p.(None): and may propose a modification to, the approved risk evaluation and mitigation strategy for a drug—
p.(None): ‘‘(A) when submitting a supplemental application for a new indication for use under section 505(b) or
p.(None): under section 351 of the Public Health Service Act, unless the drug is not subject to section 503(b) and the
...
p.(None): decreased from 2003 to 2007.
p.(None): SEC. 1002. ENSURING THE SAFETY OF PET FOOD.
p.(None): (a) PROCESSING AND INGREDIENT STANDARDS.—Not later than 2 years after the date of the enactment of this
p.(None): Act, the Secretary of Health and Human Services (referred to in this title as the ‘‘Secretary’’), in
p.(None): consultation with the Association of American Feed Control Officials and other relevant stakeholder groups,
p.(None): including veterinary medical associations, animal health organizations, and pet food manufacturers, shall by
p.(None): regulation establish—
p.(None): (1) ingredient standards and definitions with respect to pet food;
p.(None): (2) processing standards for pet food; and
p.(None): (3) updated standards for the labeling of pet food that include nutritional and ingredient information.
p.(None): (b) EARLY WARNING SURVEILLANCE SYSTEMS AND NOTIFICATION DURING PET FOOD RECALLS.—Not later than 1 year after the
p.(None): date of the enactment of this Act, the Secretary shall establish an early warning and surveillance
p.(None): system to identify adulteration of the pet food supply and outbreaks of illness associated with pet food.
p.(None): In establishing such system, the Secretary shall—
p.(None): (1) consider using surveillance and monitoring mechanisms similar to, or in coordination with, those used to monitor
p.(None): human or animal health, such as the Foodborne Diseases Active Surveillance Network (FoodNet) and
p.(None): PulseNet of the Centers for Disease Control and Prevention, the Food Emergency Response Network of
p.(None): the Food and Drug Administration and the Department of Agriculture, and the National Animal Health Laboratory
p.(None): Network of the Department of Agriculture;
p.(None): (2) consult with relevant professional associations and pri- vate sector veterinary hospitals;
p.(None): (3) work with the National Companion Animal Surveillance Program, the Health Alert Network, or other
p.(None): notification net- works as appropriate to inform veterinarians and relevant stakeholders during any recall of
p.(None): pet food; and
p.(None): (4) use such information and conduct such other activities as the Secretary deems appropriate.
p.(None): SEC. 1003. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS DURING A RECALL.
p.(None): The Secretary shall, during an ongoing recall of human or pet food regulated by the Secretary—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2102.
p.(None): Deadline. Regulations.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 2103.
p.(None):
p.(None):
p.(None): 121 STAT. 964 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): (1) work with companies, relevant professional associations, and other organizations to collect and aggregate
p.(None): information pertaining to the recall;
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 823
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public Law 110–85 110th Congress
p.(None):
p.(None):
p.(None): An Act
p.(None):
p.(None): To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for
p.(None): prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug
p.(None): Administration with respect to the safety of drugs, and for other purposes.
p.(None): Be it enacted by the Senate and House of Representatives of the United States of America in Congress
p.(None): assembled,
p.(None): SECTION 1. SHORT TITLE.
p.(None): This Act may be cited as the ‘‘Food and Drug Administration Amendments Act of 2007’’.
p.(None): SEC. 2. TABLE OF CONTENTS.
p.(None): The table of contents for this Act is as follows:
p.(None): Sec. 1. Short title.
p.(None): Sec. 2. Table of contents.
p.(None): TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
p.(None): Sec. 101. Short title; references in title; finding. Sec. 102. Definitions.
p.(None): Sec. 103. Authority to assess and use drug fees.
p.(None): Sec. 104. Fees relating to advisory review of prescription-drug television adver- tising.
p.(None): Sec. 105. Reauthorization; reporting requirements. Sec. 106. Sunset dates.
p.(None): Sec. 107. Effective date. Sec. 108. Savings clause.
p.(None): Sec. 109. Technical amendment; conforming amendment.
p.(None): TITLE II—MEDICAL DEVICE USER FEE AMENDMENTS OF 2007
p.(None): Sec. 201. Short title; references in title; finding.
p.(None): Subtitle A—Fees Related to Medical Devices Sec. 211. Definitions.
p.(None): Sec. 212. Authority to assess and use device fees. Sec. 213. Reauthorization; reporting requirements. Sec. 214.
p.(None): Savings clause.
p.(None): Sec. 215. Additional authorization of appropriations for postmarket safety informa- tion.
p.(None): Sec. 216. Effective date. Sec. 217. Sunset clause.
p.(None): Subtitle B—Amendments Regarding Regulation of Medical Devices
p.(None): Sec. 221. Extension of authority for third party review of premarket notification. Sec. 222. Registration.
p.(None): Sec. 223. Filing of lists of drugs and devices manufactured, prepared, propagated, and compounded by
p.(None): registrants; statements; accompanying disclosures.
p.(None): Sec. 224. Electronic registration and listing.
p.(None): Sec. 225. Report by Government Accountability Office. Sec. 226. Unique device identification system.
p.(None): Sec. 227. Frequency of reporting for certain devices.
p.(None):
p.(None): Sept. 27, 2007
p.(None): [H.R. 3580]
p.(None):
p.(None):
p.(None): Food and Drug Administration Amendments Act of 2007.
p.(None): 21 USC 301 note.
p.(None):
p.(None):
p.(None): 121 STAT. 824 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): Sec. 228. Inspections by accredited persons.
p.(None): Sec. 229. Study of nosocomial infections relating to medical devices.
p.(None): Sec. 230. Report by the Food and Drug Administration regarding labeling informa- tion on the relationship between
p.(None): the use of indoor tanning devices and development of skin cancer or other skin damage.
p.(None): TITLE III—PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007
p.(None): Sec. 301. Short title.
p.(None): Sec. 302. Tracking pediatric device approvals.
p.(None): Sec. 303. Modification to humanitarian device exemption. Sec. 304. Encouraging pediatric medical device research.
p.(None): Sec. 305. Demonstration grants for improving pediatric device availability.
p.(None): Sec. 306. Amendments to office of pediatric therapeutics and pediatric advisory committee.
p.(None): Sec. 307. Postmarket surveillance.
p.(None): TITLE IV—PEDIATRIC RESEARCH EQUITY ACT OF 2007
...
p.(None): event reports.
p.(None): ‘‘(ii) Developing and using improved adverse-event data-collection systems, including information tech- nology
p.(None): systems.
p.(None): ‘‘(iii) Developing and using improved analytical tools to assess potential safety problems, including access
p.(None): to external data bases.
p.(None): ‘‘(iv) Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and
p.(None): labeling changes) and section 505(p) (relating to risk evaluation and mitigation strategies).
p.(None): ‘‘(v) Carrying out section 505(k)(5) (relating to adverse event reports and postmarket safety activi-
p.(None): ties).’’;
p.(None): (6) in paragraph (8)—
p.(None): (A) by striking ‘‘April of the preceding fiscal year’’ and inserting ‘‘October of the preceding fiscal
p.(None): year’’; and
p.(None): (B) by striking ‘‘April 1997’’ and inserting ‘‘October 1996’’;
p.(None): (7) by redesignating paragraph (9) as paragraph (11); and
p.(None): (8) by inserting after paragraph (8) the following para- graphs:
p.(None): ‘‘(9) The term ‘person’ includes an affiliate thereof.
p.(None): ‘‘(10) The term ‘active’, with respect to a commercial inves- tigational new drug application, means such an
p.(None): application to which information was submitted during the relevant period.’’.
p.(None): SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.
p.(None): (a) TYPES OF FEES.—Section 736(a) (21 U.S.C. 379h(a)) is amended—
p.(None): (1) in the matter preceding paragraph (1), by striking ‘‘2003’’ and inserting ‘‘2008’’;
p.(None): (2) in paragraph (1)—
p.(None): (A) in subparagraph (D)—
p.(None): (i) in the heading, by inserting ‘‘OR WITHDRAWN BEFORE FILING’’ after ‘‘REFUSED FOR FILING’’; and
p.(None): (ii) by inserting before the period at the end the following: ‘‘or withdrawn without a waiver
p.(None): before filing’’;
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 827
p.(None):
p.(None): (B) by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and
p.(None): (C) by inserting after subparagraph (D) the following: ‘‘(E) FEES FOR APPLICATIONS PREVIOUSLY REFUSED FOR
p.(None): FILING OR WITHDRAWN BEFORE FILING.—A human drug application or supplement that was submitted but was
p.(None): refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full
p.(None): fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived or
p.(None): reduced under sub-
p.(None): section (d).’’; and
p.(None): (3) in paragraph (2)—
p.(None): (A) in subparagraph (A), by striking ‘‘subparagraph (B)’’ and inserting ‘‘subparagraphs (B) and (C)’’; and
p.(None): (B) by adding at the end the following:
p.(None): ‘‘(C) SPECIAL RULES FOR POSITRON EMISSION TOMOG- RAPHY DRUGS.—
p.(None): ‘‘(i) IN GENERAL.—Except as provided in clause (ii), each person who is named as the applicant in an
...
p.(None): advisory review fees and the operating reserves needed to terminate the program, and refund the
p.(None): remainder of the unused fees and operating reserves. To the extent required to terminate the program,
p.(None): the Secretary shall first use unobligated advisory review fee revenues from prior fiscal years, then the
p.(None): operating reserves, and finally, unused advisory review fees from the relevant fiscal year.
p.(None): ‘‘(g) CREDITING AND AVAILABILITY OF FEES.—
p.(None): ‘‘(1) IN GENERAL.—Fees authorized under subsection (a) shall be collected and available for obligation only to
p.(None): the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain
p.(None): available until expended. Such sums as may be necessary may be transferred from the Food and Drug
p.(None): Administration salaries and expenses appropria- tion account without fiscal year limitation to such appropriation
p.(None): account for salaries and expenses with such fiscal year limita- tion. The sums transferred shall be available
p.(None): solely for the process for the advisory review of prescription drug advertising.
p.(None): ‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.—
p.(None): ‘‘(A) IN GENERAL.—The fees authorized by this sec- tion—
p.(None): ‘‘(i) shall be retained in each fiscal year in an amount not to exceed the amount specified in appro-
p.(None): priation Acts, or otherwise made available for obliga- tion for such fiscal year; and
p.(None): ‘‘(ii) shall be available for obligation only if the amounts appropriated as budget authority for such
p.(None): fiscal year are sufficient to support a number of full- time equivalent review employees that is not
p.(None): fewer than the number of such employees supported in fiscal year 2007.
p.(None): ‘‘(B) REVIEW EMPLOYEES.—For purposes of subpara- graph (A)(ii), the term ‘full-time equivalent
p.(None): review employees’ means the total combined number of full-time equivalent employees in—
p.(None): ‘‘(i) the Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Commu- nications, Food
p.(None): and Drug Administration; and
p.(None): ‘‘(ii) the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling
p.(None): Branch, Food and Drug Administration.
p.(None): ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the
p.(None): fiscal years 2008 through 2012, there is authorized to be appro- priated for fees under this section an amount
p.(None): equal to the total revenue amount determined under subsection (b) for the
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 839
p.(None):
p.(None): fiscal year, as adjusted pursuant to subsection (c) and para- graph (4) of this subsection, plus amounts
p.(None): collected for the reserve fund under subsection (d).
...
p.(None): ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal year 2008, not later than 120 days after the end of each
p.(None): fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the
p.(None): Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor,
p.(None): and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving
p.(None): the goals identified in the letters described in section 101(c) of the Food and Drug Administration
p.(None): Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug Administration
p.(None): for meeting the goals. The report for a fiscal year shall include informa- tion on all previous cohorts for
p.(None): which the Secretary has not given a complete response on all human drug applications and supple- ments in
p.(None): the cohort.
p.(None): ‘‘(b) FISCAL REPORT.—Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal
p.(None): year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on
p.(None): Energy and Commerce of the House of Rep- resentatives and the Committee on Health, Education, Labor, and
p.(None): Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal
p.(None): year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.
p.(None): ‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall make the reports required under subsections (a) and
p.(None): (b) available to the public on the Internet Web site of the Food and Drug Administra- tion.
p.(None): ‘‘(d) REAUTHORIZATION.—
p.(None): ‘‘(1) CONSULTATION.—In developing recommendations to present to the Congress with respect to the goals,
p.(None): and plans for meeting the goals, for the process for the review of human drug applications for the first 5
p.(None): fiscal years after fiscal year 2012, and for the reauthorization of this part for such fiscal years, the
p.(None): Secretary shall consult with—
p.(None): ‘‘(A) the Committee on Energy and Commerce of the House of Representatives;
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 841
p.(None):
p.(None):
p.(None): ‘‘(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
p.(None): ‘‘(C) scientific and academic experts; ‘‘(D) health care professionals;
p.(None): ‘‘(E) representatives of patient and consumer advocacy groups; and
p.(None): ‘‘(F) the regulated industry.
p.(None): ‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations with the regulated industry on the reauthorization of
p.(None): this part, the Secretary shall—
p.(None): ‘‘(A) publish a notice in the Federal Register requesting public input on the reauthorization;
...
p.(None): (5) by inserting after paragraph (10), as so amended, the following:
p.(None): ‘‘(11) The term ‘person’ includes an affiliate thereof.’’; and
p.(None): (6) by inserting after paragraph (12), as so redesignated, the following:
p.(None): ‘‘(13) The term ‘establishment subject to a registration fee’ means an establishment that is required to
p.(None): register with the Secretary under section 510 and is one of the following types of establishments:
p.(None): ‘‘(A) MANUFACTURER.—An establishment that makes by any means any article that is a device, including an
p.(None): establishment that sterilizes or otherwise makes such article for or on behalf of a specification
p.(None): developer or any other person.
p.(None): ‘‘(B) SINGLE-USE DEVICE REPROCESSOR.—An establish-
p.(None): ment that, within the meaning of section 201(ll)(2)(A), per- forms additional processing and manufacturing
p.(None): operations on a single-use device that has previously been used on a patient.
p.(None): ‘‘(C) SPECIFICATION DEVELOPER.—An establishment that develops specifications for a device that is distributed
p.(None): under the establishment’s name but which performs no manufacturing, including an establishment that, in
p.(None): addi- tion to developing specifications, also arranges for the manufacturing of devices labeled with
p.(None): another establish- ment’s name by a contract manufacturer.’’.
p.(None):
p.(None):
p.(None): 21 USC 379i.
p.(None):
p.(None):
p.(None): 121 STAT. 844 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): SEC. 212. AUTHORITY TO ASSESS AND USE DEVICE FEES.
p.(None): (a) TYPES OF FEES.—
p.(None): (1) IN GENERAL.—Section 738(a) (21 U.S.C. 379j(a)) is amended—
p.(None): (A) in paragraph (1), by striking ‘‘Beginning on the date of the enactment of the Medical Device User
p.(None): Fee and Modernization Act of 2002’’ and inserting ‘‘Beginning in fiscal year 2008’’; and
p.(None): (B) by amending the designation and heading of para- graph (2) to read as follows:
p.(None): ‘‘(2) PREMARKET APPLICATION, PREMARKET REPORT, SUPPLE- MENT, AND SUBMISSION FEE, AND ANNUAL FEE FOR
p.(None): PERIODIC REPORTING CONCERNING A CLASS III DEVICE.—’’.
p.(None): (2) FEE AMOUNTS.—Section 738(a)(2)(A) (21 U.S.C. 379j(a)(2)(A)) is amended—
p.(None): (A) in clause (iii), by striking ‘‘a fee equal to the fee that applies’’ and inserting ‘‘a fee equal
p.(None): to 75 percent of the fee that applies’’;
p.(None): (B) in clause (iv), by striking ‘‘21.5 percent’’ and inserting ‘‘15 percent’’;
p.(None): (C) in clause (v), by striking ‘‘7.2 percent’’ and inserting ‘‘7 percent’’;
p.(None): (D) by redesignating clauses (vi) and (vii) as clauses
p.(None): (vii) and (viii), respectively;
p.(None): (E) by inserting after clause (v) the following:
p.(None): ‘‘(vi) For a 30-day notice, a fee equal to 1.6 percent of the fee that applies under clause (i).’’;
p.(None): (F) in clause (viii), as so redesignated—
p.(None): (i) by striking ‘‘1.42 percent’’ and inserting ‘‘1.84 percent’’; and
p.(None): (ii) by striking ‘‘, subject to any adjustment under subsection (e)(2)(C)(ii)’’; and
p.(None): (G) by inserting after such clause (viii) the following: ‘‘(ix) For a request for classification
p.(None): information,
p.(None): a fee equal to 1.35 percent of the fee that applies under clause (i).
...
p.(None): (B) EVIDENCE OF QUALIFICATION.—Section 738(d)(2)(B) (21 U.S.C. 379j(d)(2)(B)) is amended—
p.(None): (i) by striking ‘‘(B) EVIDENCE OF QUALIFICATION.— An applicant’’ and inserting the following:
p.(None): ‘‘(B) EVIDENCE OF QUALIFICATION.—
p.(None): ‘‘(i) IN GENERAL.—An applicant’’;
p.(None): (ii) by striking ‘‘The applicant shall support its claim’’ and inserting the following:
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 847
p.(None):
p.(None):
p.(None): ‘‘(ii) FIRMS SUBMITTING TAX RETURNS TO THE UNITED STATES INTERNAL REVENUE SERVICE.—The
p.(None): applicant shall support its claim’’;
p.(None): (iii) by striking ‘‘, partners, and parent firms’’ each place it appears;
p.(None): (iv) by striking the last sentence and inserting ‘‘If no tax forms are submitted for any affiliate, the
p.(None): applicant shall certify that the applicant has no affili- ates.’’; and
p.(None): (v) by adding at the end the following:
p.(None): ‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE UNITED STATES INTERNAL REVENUE SERVICE.—In the
p.(None): case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of
p.(None): its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a
p.(None): signed certification, in such form as the Secretary may direct through a notice published in the Federal
p.(None): Register, that the applicant or affiliate meets the cri- teria for a small business and a
p.(None): certification, in English, from the national taxing authority of the country in which the applicant or, if
p.(None): applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official
p.(None): seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the
p.(None): most recent year in both the local currency of such country and in United States dollars, the exchange rate
p.(None): used in converting such local currency to dollars, and the dates during which these receipts or sales
p.(None): were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or
p.(None): by its chief financial officer that the applicant has submitted certifications for all of its affiliates,
p.(None): or that the applicant has no affiliates.’’.
p.(None): (3) REDUCED FEES.—Section 738(d)(2)(C) (21 U.S.C. 379j(d)(2)(C)) is amended to read as follows:
p.(None): ‘‘(C) REDUCED FEES.—Where the Secretary finds that the applicant involved meets the definition under subpara-
p.(None): graph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of—
p.(None): ‘‘(i) 25 percent of the fee established under such subsection for a premarket application, a premarket
p.(None): report, a supplement, or periodic reporting concerning a class III device; and
p.(None): ‘‘(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classifica-
p.(None): tion information.’’.
p.(None): (e) SMALL BUSINESSES; FEE REDUCTION REGARDING PREMARKET NOTIFICATION SUBMISSIONS.—
p.(None): (1) IN GENERAL.—Section 738(e)(1) (21 U.S.C. 379j(e)(1))
p.(None): is amended—
p.(None): (A) by striking ‘‘2004’’ and inserting ‘‘2008’’; and
p.(None): (B) by striking ‘‘(a)(2)(A)(vii)’’ and inserting ‘‘(a)(2)(A)(viii)’’.
p.(None): (2) RULES RELATING TO PREMARKET NOTIFICATION SUBMIS- SIONS.—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None): parent firms’’.
p.(None): (B) EVIDENCE OF QUALIFICATION.—Section 738(e)(2)(B) (21 U.S.C. 379j(e)(2)(B)) is amended—
p.(None): (i) by striking ‘‘(B) EVIDENCE OF QUALIFICATION.— An applicant’’ and inserting the following:
p.(None): ‘‘(B) EVIDENCE OF QUALIFICATION.—
p.(None): ‘‘(i) IN GENERAL.—An applicant’’;
p.(None): (ii) by striking ‘‘The applicant shall support its claim’’ and inserting the following:
p.(None): ‘‘(ii) FIRMS SUBMITTING TAX RETURNS TO THE UNITED STATES INTERNAL REVENUE SERVICE.—The
p.(None): applicant shall support its claim’’;
p.(None): (iii) by striking ‘‘, partners, and parent firms’’ each place it appears;
p.(None): (iv) by striking the last sentence and inserting ‘‘If no tax forms are submitted for any affiliate, the
p.(None): applicant shall certify that the applicant has no affili- ates.’’; and
p.(None): (v) by adding at the end the following:
p.(None): ‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE
p.(None):
p.(None): Certification. Federal Register, publication.
p.(None): UNITED STATES INTERNAL REVENUE SERVICE.—In the
p.(None): case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of
p.(None): its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a
p.(None): signed certification, in such form as the Secretary may direct through a notice published in the Federal
p.(None): Register, that the applicant or affiliate meets the cri- teria for a small business and a
p.(None): certification, in English, from the national taxing authority of the country in which the applicant or, if
p.(None): applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official
p.(None): seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the
p.(None): most recent year in both the local currency of such country and in United States dollars, the exchange rate
p.(None): used in converting such local currency to dollars, and the dates during which these receipts or sales
p.(None): were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or
p.(None): by its chief financial officer that the applicant has submitted certifications for all of its affiliates,
p.(None): or that the applicant has no affiliates.’’.
p.(None): (3) REDUCED FEES.—Section 738(e)(2)(C) (21 U.S.C. 379j(e)(2)(C)) is amended to read as follows:
p.(None): ‘‘(C) REDUCED FEES.—For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the
p.(None): applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission
p.(None): may be paid at 50 percent of the fee that applies under sub- section (a)(2)(A)(viii), and as established
p.(None): under subsection (c)(1).’’.
p.(None): (f) EFFECT OF FAILURE TO PAY FEES.—Section 738(f) (21 U.S.C. 379j(f)) is amended to read as follows:
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): ‘‘(f) EFFECT OF FAILURE TO PAY FEES.—
p.(None): 121 STAT. 849
p.(None): ‘‘(1) NO ACCEPTANCE OF SUBMISSIONS.—A premarket
p.(None): application, premarket report, supplement, premarket notifica- tion submission, 30-day notice, request for
p.(None): classification information, or periodic reporting concerning a class III device submitted by a person subject to
p.(None): fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the
p.(None): Secretary until all fees owed by such person have been paid.
p.(None): ‘‘(2) NO REGISTRATION.—Registration information submitted under section 510 by an establishment subject to a
p.(None): registration fee shall be considered incomplete and shall not be accepted by the Secretary until the
p.(None): registration fee under subsection (a)(3) owed for the establishment has been paid. Until the fee is paid
p.(None): and the registration is complete, the establishment is deemed to have failed to register in accordance with section
p.(None): 510.’’.
p.(None): (g) CONDITIONS.—Section 738(g) (21 U.S.C. 379j(g)) is amended—
p.(None): (1) by striking paragraph (1) and inserting the following: ‘‘(1) PERFORMANCE GOALS; TERMINATION OF
p.(None): PROGRAM.— With respect to the amount that, under the salaries and expenses account of the Food
p.(None): and Drug Administration, is appropriated for a fiscal year for devices and radiological prod- ucts, fees may not
p.(None): be assessed under subsection (a) for the fiscal year, and the Secretary is not expected to meet any
p.(None): performance goals identified for the fiscal year, if—
p.(None): ‘‘(A) the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the
p.(None): fiscal year, is more than 1 percent less than $205,720,000 multi- plied by the adjustment factor applicable to
p.(None): such fiscal year; or
p.(None): ‘‘(B) fees were not assessed under subsection (a) for the previous fiscal year.’’; and
p.(None): (2) by amending paragraph (2) to read as follows:
p.(None): ‘‘(2) AUTHORITY.—If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year
p.(None): because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such
p.(None): fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket
p.(None): applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for
p.(None): classification information, periodic reporting concerning a class III device, and establishment registrations
p.(None): at any time in such fiscal year, notwithstanding the provisions of subsection
p.(None): (a) relating to the date fees are to be paid.’’.
p.(None): (h) CREDITING AND AVAILABILITY OF FEES.—
p.(None): (1) AUTHORIZATION OF APPROPRIATIONS.—Section 738(h)(3) (21 U.S.C. 379j(h)(3)) is amended to read as follows:
p.(None): ‘‘(3) AUTHORIZATIONS OF APPROPRIATIONS.—There are
p.(None): authorized to be appropriated for fees under this section— ‘‘(A) $48,431,000 for fiscal year 2008;
p.(None): ‘‘(B) $52,547,000 for fiscal year 2009; ‘‘(C) $57,014,000 for fiscal year 2010;
p.(None): ‘‘(D) $61,860,000 for fiscal year 2011; and ‘‘(E) $67,118,000 for fiscal year 2012.’’.
p.(None):
p.(None):
p.(None): 121 STAT. 850 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None): (2) OFFSET.—Section 738(h)(4) (21 U.S.C. 379j(h)(3)) is
p.(None): amended to read as follows:
p.(None): ‘‘(4) OFFSET.—If the cumulative amount of fees collected during fiscal years 2008, 2009, and 2010, added to the
p.(None): amount estimated to be collected for fiscal year 2011, which estimate shall be based upon the amount of
p.(None): fees received by the Sec- retary through June 30, 2011, exceeds the amount of fees specified in
...
p.(None): ‘‘(a) REPORTS.—
p.(None): ‘‘(1) PERFORMANCE REPORT.—For fiscal years 2008 through 2012, not later than 120 days after the end of each
p.(None): fiscal year during which fees are collected under this part, the Sec- retary shall prepare and submit to
p.(None): the Committee on Health, Education, Labor, and Pensions of the Senate and the Com- mittee on Energy and
p.(None): Commerce of the House of Representa- tives, a report concerning the progress of the Food and Drug
p.(None): Administration in achieving the goals identified in the letters described in section 201(c) of the Food and
p.(None): Drug Administration Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug
p.(None): Administration for meeting the goals. The report for a fiscal year shall include information on all
p.(None): previous cohorts for which the Secretary has not given a complete response on all device premarket
p.(None): applications and reports, supplements, and premarket notifications in the cohort. ‘‘(2) FISCAL REPORT.—For fiscal
p.(None): years 2008 through 2012,
p.(None): not later than 120 days after the end of each fiscal year during which fees are collected under this part, the
p.(None): Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the
p.(None): Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the implementation
p.(None): of the authority for such fees during such fiscal year and the use, by the Food and Drug Administra- tion, of
p.(None): the fees collected during such fiscal year for which the report is made.
p.(None): ‘‘(3) PUBLIC AVAILABILITY.—The Secretary shall make the reports required under paragraphs (1) and (2)
p.(None): available to the public on the Internet Web site of the Food and Drug Administration.
p.(None): ‘‘(b) REAUTHORIZATION.—
p.(None): ‘‘(1) CONSULTATION.—In developing recommendations to present to Congress with respect to the goals, and
p.(None): plans for meeting the goals, for the process for the review of device applications for the first 5
p.(None): fiscal years after fiscal year 2012, and for the reauthorization of this part for such fiscal years, the
p.(None): Secretary shall consult with—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 851
p.(None):
p.(None):
p.(None): ‘‘(A) the Committee on Energy and Commerce of the House of Representatives;
p.(None): ‘‘(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
p.(None): ‘‘(C) scientific and academic experts; ‘‘(D) health care professionals;
p.(None): ‘‘(E) representatives of patient and consumer advocacy groups; and
p.(None): ‘‘(F) the regulated industry.
p.(None): ‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations with the regulated industry on the reauthorization of
p.(None): this part, the Secretary shall—
p.(None): ‘‘(A) publish a notice in the Federal Register requesting public input on the reauthorization;
...
p.(None): For the purpose of collecting, developing, reviewing, and evalu- ating postmarket safety information on medical
p.(None): devices, there are authorized to be appropriated to the Food and Drug Administration, in addition to the amounts
p.(None): authorized by other provisions of law for such purpose—
p.(None): (1) $7,100,000 for fiscal year 2008;
p.(None): (2) $7,455,000 for fiscal year 2009;
p.(None): (3) $7,827,750 for fiscal year 2010;
p.(None): (4) $8,219,138 for fiscal year 2011; and (5) $8,630,094 for fiscal year 2012.
p.(None): SEC. 216. EFFECTIVE DATE.
p.(None): The amendments made by this subtitle shall take effect on October 1, 2007, or the date of the enactment of
p.(None): this Act, whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal
p.(None): Food, Drug, and Cosmetic Act shall be assessed for all premarket applications, premarket reports, supplements,
p.(None): 30-day notices, and premarket notification submissions received on or after October 1, 2007, regardless of the
p.(None): date of the enactment of this Act.
p.(None): SEC. 217. SUNSET CLAUSE.
p.(None): The amendments made by this subtitle cease to be effective October 1, 2012, except that section 738A of
p.(None): the Federal Food, Drug, and Cosmetic Act (regarding annual performance and finan- cial reports) ceases to be
p.(None): effective January 31, 2013.
p.(None): Subtitle B—Amendments Regarding Regulation of Medical Devices
p.(None): SEC. 221. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF PREMARKET NOTIFICATION.
p.(None): Section 523(c) (21 U.S.C. 360m(c)) is amended by striking ‘‘2007’’ and inserting ‘‘2012’’.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 853
p.(None):
p.(None):
p.(None): SEC. 222. REGISTRATION.
p.(None): (a) ANNUAL REGISTRATION OF PRODUCERS OF DRUGS AND
p.(None): DEVICES.—Section 510(b) (21 U.S.C. 360(b)) is amended—
p.(None): (1) by striking ‘‘(b) On or before’’ and inserting ‘‘(b)(1) On or before’’;
p.(None): (2) by striking ‘‘or a device or devices’’; and
p.(None): (3) by adding at the end the following:
p.(None): ‘‘(2) During the period beginning on October 1 and ending on December 31 of each year, every person
p.(None): who owns or operates any establishment in any State engaged in the manufacture, preparation,
p.(None): propagation, compounding, or processing of a device or devices shall register with the Secretary his
p.(None): name, places of business, and all such establishments.’’.
p.(None): (b) REGISTRATION OF FOREIGN ESTABLISHMENTS.—Section 510(i)(1) (21 U.S.C. 360(i)(1)) is amended by
p.(None): striking ‘‘On or before December 31’’ and all that follows and inserting the following: ‘‘Any establishment
p.(None): within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a
p.(None): drug or device that is imported or offered for import into the United States shall, through electronic
p.(None): means in accordance with the criteria of the Secretary—
p.(None): ‘‘(A) upon first engaging in any such activity, immediately register with the Secretary the name and place of
...
p.(None): for the person requesting such waiver.’’.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Reports. Deadlines.
p.(None):
p.(None):
p.(None): 121 STAT. 854 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Study.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Regulations.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None): SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE.
p.(None): (a) IN GENERAL.—The Comptroller General of the United States shall conduct a study on the appropriate use of
p.(None): the process under section 510(k) of the Federal Food, Drug, and Cosmetic Act as part of the device
p.(None): classification process to determine whether a new device is as safe and effective as a classified device.
p.(None): (b) CONSIDERATION.—In determining the effectiveness of the premarket notification and classification
p.(None): authority under section 510(k) and subsections (f) and (i) of section 513 of the Federal Food, Drug, and
p.(None): Cosmetic Act, the study under subsection (a) shall consider the Secretary of Health and Human Services’s evaluation of
p.(None): the respective intended uses and technologies of such devices, including the effectiveness of such
p.(None): Secretary’s comparative assess- ment of technological characteristics such as device materials, prin- ciples of
p.(None): operations, and power sources.
p.(None): (c) REPORT.—Not later than 1 year after the date of the enact- ment of this Act, the Comptroller General shall complete
p.(None): the study under subsection (a) and submit to the Congress a report on the results of such study.
p.(None): SEC. 226. UNIQUE DEVICE IDENTIFICATION SYSTEM.
p.(None): (a) IN GENERAL.—Section 519 (21 U.S.C. 360i) is amended—
p.(None): (1) by redesignating subsection (f) as subsection (g); and
p.(None): (2) by inserting after subsection (e) the following:
p.(None): ‘‘Unique Device Identification System
p.(None): ‘‘(f) The Secretary shall promulgate regulations establishing a unique device identification system for medical
p.(None): devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative
p.(None): placement or provides an exception for a particular device or type of device. The unique identifier
p.(None): shall adequately identify the device through distribution and use, and may include information on the lot or
p.(None): serial number.’’.
p.(None): (b) CONFORMING AMENDMENT.—Section 303 (21 U.S.C. 333) is amended—
p.(None): (1) by redesignating the subsection that follows subsection
p.(None): (e) as subsection (f); and
...
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 873
p.(None):
p.(None): that the Commissioner determines to be appropriate; and
p.(None):
p.(None): ‘‘(ii) if the sponsor does not agree within 30 days after the Commissioner’s request to make a labeling
p.(None): change requested by the Commissioner, the Commis- sioner shall refer the matter to the Pediatric Advisory
p.(None): Committee.
p.(None): ‘‘(B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.—
p.(None): Not later than 90 days after receiving a referral under subparagraph (A)(ii), the Pediatric Advisory
p.(None): Committee shall—
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None): ‘‘(i) review the pediatric study reports; and
p.(None): ‘‘(ii) make a recommendation to the Commissioner concerning appropriate labeling changes, if any.
p.(None): ‘‘(C) CONSIDERATION OF RECOMMENDATIONS.—The
p.(None): Commissioner shall consider the recommendations of the Pediatric Advisory Committee and, if appropriate, not
p.(None): later than 30 days after receiving the recommendation, make a request to the sponsor of the application
p.(None): or supplement to make any labeling changes that the Commissioner deter- mines to be appropriate.
p.(None): ‘‘(D) MISBRANDING.—If the sponsor of the application or supplement, within 30 days after receiving a
p.(None): request under subparagraph (C), does not agree to make a labeling change requested by the Commissioner, the
p.(None): Commissioner may deem the drug that is the subject of the application or supplement to be misbranded.
p.(None): ‘‘(E) NO EFFECT ON AUTHORITY.—Nothing in this sub- section limits the authority of the United States to
p.(None): bring an enforcement action under this Act when a drug lacks appropriate pediatric labeling. Neither course of
p.(None): action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence)
p.(None): shall preclude, delay, or serve as the basis to stay the other course of action.
p.(None): ‘‘(2) OTHER LABELING CHANGES.—If, on or after the date of the enactment of the Pediatric Research Equity
p.(None): Act of 2007, the Secretary makes a determination that a pediatric assess- ment conducted under this section
p.(None): does or does not demonstrate that the drug that is the subject of such assessment is safe and effective
p.(None): in pediatric populations or subpopulations, including whether such assessment results are inconclusive,
p.(None): the Secretary shall order the label of such product to include information about the results of the
p.(None): assessment and a state- ment of the Secretary’s determination.
p.(None): ‘‘(h) DISSEMINATION OF PEDIATRIC INFORMATION.—
p.(None): ‘‘(1) IN GENERAL.—Not later than 210 days after the date of submission of a pediatric assessment under
p.(None): this section, the Secretary shall make available to the public in an easily accessible manner the medical,
p.(None): statistical, and clinical pharma- cology reviews of such pediatric assessments, and shall post such
p.(None): assessments on the Web site of the Food and Drug Administration.
p.(None): ‘‘(2) DISSEMINATION OF INFORMATION REGARDING LABELING
...
p.(None):
p.(None): Effective date.
p.(None): ‘‘(1) REPORTING IN YEAR ONE.—Beginning on the date of the enactment of the Pediatric Research Equity
p.(None): Act of 2007, during the one-year period beginning on the date a labeling change is made pursuant to
p.(None): subsection (g), the Secretary shall ensure that all adverse event reports that have been received for such
p.(None): drug (regardless of when such report was received) are referred to the Office of Pediatric Therapeutics.
p.(None): In consid- ering such reports, the Director of such Office shall provide for the review of such reports
p.(None): by the Pediatric Advisory Com- mittee, including obtaining any recommendations of such com- mittee regarding
p.(None): whether the Secretary should take action under this Act in response to such reports.
p.(None): ‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Following the one-
p.(None): year period described in paragraph (1), the Secretary shall, as appropriate, refer to the Office of
p.(None): Pediatric Therapeutics all pediatric adverse event reports for a drug for which a pediatric study was
p.(None): conducted under this section. In considering such reports, the Director of such Office may provide for the
p.(None): review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of such
p.(None): Committee regarding whether the Secretary should take action in response to such reports.
p.(None): ‘‘(3) EFFECT.—The requirements of this subsection shall supplement, not supplant, other review of such
p.(None): adverse event reports by the Secretary.
p.(None): ‘‘(j) SCOPE OF AUTHORITY.—Nothing in this section provides to the Secretary any authority to require
p.(None): a pediatric assessment of any drug or biological product, or any assessment regarding other populations or
p.(None): uses of a drug or biological product, other than the pediatric assessments described in this section.
p.(None): ‘‘(k) ORPHAN DRUGS.—Unless the Secretary requires otherwise by regulation, this section does not apply to any drug for
p.(None): an indica- tion for which orphan designation has been granted under section 526.
p.(None):
p.(None):
p.(None): Deadline. Contracts. Reports.
p.(None): ‘‘(l) INSTITUTE OF MEDICINE STUDY.—
p.(None): ‘‘(1) IN GENERAL.—Not later than three years after the date of the enactment of the Pediatric Research
p.(None): Equity Act of 2007, the Secretary shall contract with the Institute of Medi- cine to conduct a study and report
p.(None): to Congress regarding the pediatric studies conducted pursuant to this section or precursor regulations since 1997
p.(None): and labeling changes made as a result of such studies.
p.(None): ‘‘(2) CONTENT OF STUDY.—The study under paragraph (1) shall review and assess the use of extrapolation
p.(None): for pediatric subpopulations, the use of alternative endpoints for pediatric populations, neonatal assessment
p.(None): tools, the number and type of pediatric adverse events, and ethical issues in pediatric clin- ical trials.
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 875
p.(None):
p.(None):
p.(None): ‘‘(3) REPRESENTATIVE SAMPLE.—The Institute of Medicine may devise an appropriate mechanism to review a
p.(None): representa- tive sample of studies conducted pursuant to this section from each review division within the Center
p.(None): for Drug Evaluation and Research in order to make the requested assessment.
p.(None): ‘‘(m) INTEGRATION WITH OTHER PEDIATRIC STUDIES.—The
p.(None): authority under this section shall remain in effect so long as an application subject to this section
p.(None): may be accepted for filing by the Secretary on or before the date specified in section 505A(q).’’.
p.(None): (b) APPLICABILITY.—
p.(None): (1) IN GENERAL.—Notwithstanding subsection (h) of section 505B of the Federal Food, Drug and Cosmetic Act, as in effect
p.(None): on the day before the date of the enactment of this Act, a pending assessment, including a deferred
p.(None): assessment, required under such section 505B shall be deemed to have been required under section 505B of the
p.(None): Federal Food, Drug and Cosmetic Act as in effect on or after the date of the enactment of this Act.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355c
p.(None): note.
p.(None):
p.(None): (2) CERTAIN ASSESSMENTS AND WAIVER REQUESTS.—An assessment pending on or after the date that is
p.(None): 1 year prior to the date of the enactment of this Act shall be subject to the tracking and disclosure
p.(None): requirements established under such section 505B, as in effect on or after such date of enact- ment,
p.(None): except that any such assessments submitted or waivers of such assessments requested before such date of
p.(None): enactment shall not be subject to subsections (a)(4)(C), (b)(2)(C), (f)(6)(F), and (h) of such section 505B.
p.(None): SEC. 403. ESTABLISHMENT OF INTERNAL COMMITTEE.
p.(None): Chapter V of the Federal Food, Drug, and Cosmetic Act (21
...
p.(None): Pediatric Advisory Committee.
p.(None): ‘‘(B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.—
p.(None):
p.(None): Deadline.
p.(None): Not later than 90 days after receiving a referral under subparagraph (A)(ii), the Pediatric Advisory
p.(None): Committee shall—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline. Public information.
p.(None): ‘‘(i) review the pediatric study reports; and
p.(None): ‘‘(ii) make a recommendation to the Commissioner concerning appropriate labeling changes, if any.
p.(None): ‘‘(C) CONSIDERATION OF RECOMMENDATIONS.—The
p.(None): Commissioner shall consider the recommendations of the Pediatric Advisory Committee and, if appropriate, not
p.(None): later than 30 days after receiving the recommendation, make a request to the sponsor of the application
p.(None): to make any labeling change that the Commissioner determines to be appropriate.
p.(None): ‘‘(D) MISBRANDING.—If the sponsor of the application, within 30 days after receiving a request under
p.(None): subpara- graph (C), does not agree to make a labeling change requested by the Commissioner, the
p.(None): Commissioner may deem the drug that is the subject of the application to be misbranded.
p.(None): ‘‘(E) NO EFFECT ON AUTHORITY.—Nothing in this sub- section limits the authority of the United States to
p.(None): bring an enforcement action under this Act when a drug lacks appropriate pediatric labeling. Neither course of
p.(None): action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence)
p.(None): shall preclude, delay, or serve as the basis to stay the other course of action.
p.(None): ‘‘(j) OTHER LABELING CHANGES.—If, on or after the date of the enactment of the Best Pharmaceuticals
p.(None): for Children Act of 2007, the Secretary determines that a pediatric study conducted under this section
p.(None): does or does not demonstrate that the drug that is the subject of the study is safe and effective,
p.(None): including whether such study results are inconclusive, in pediatric populations or subpopulations, the Secretary
p.(None): shall order the labeling of such product to include information about the results of the study and a
p.(None): statement of the Secretary’s determination.
p.(None): ‘‘(k) DISSEMINATION OF PEDIATRIC INFORMATION.—
p.(None): ‘‘(1) IN GENERAL.—Not later than 210 days after the date of submission of a report on a pediatric study under
p.(None): this section, the Secretary shall make available to the public the medical, statistical, and clinical
p.(None): pharmacology reviews of pediatric studies conducted under subsection (b) or (c).
p.(None): ‘‘(2) DISSEMINATION OF INFORMATION REGARDING LABELING
p.(None): CHANGES.—Beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the
...
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(i) review the available information on the safe and effective use of the drug in the pediatric popu-
p.(None): lation, including study reports submitted under this section; and
p.(None): ‘‘(ii) make a recommendation to the Commissioner of Food and Drugs as to appropriate labeling changes, if any.
p.(None): ‘‘(9) FDA DETERMINATION.—Not later than 30 days after receiving a recommendation from the Pediatric Advisory
p.(None): Com- mittee under paragraph (8)(B)(ii) with respect to a drug, the Commissioner of Food and Drugs
p.(None): shall consider the rec- ommendation and, if appropriate, make a request to the holders of approved applications
p.(None): for the drug to make any labeling change that the Commissioner of Food and Drugs determines to be
p.(None): appropriate.
p.(None): ‘‘(10) FAILURE TO AGREE.—If a holder of an approved application for a drug, within 30 days after
p.(None): receiving a request to make a labeling change under paragraph (9), does not agree to make a requested labeling
p.(None): change, the Commissioner of
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 889
p.(None):
p.(None):
p.(None): Food and Drugs may deem the drug to be misbranded under the Federal Food, Drug, and Cosmetic Act.
p.(None): ‘‘(11) NO EFFECT ON AUTHORITY.—Nothing in this sub- section limits the authority of the United States to
p.(None): bring an enforcement action under the Federal Food, Drug, and Cosmetic Act when a drug lacks appropriate
p.(None): pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement
p.(None): action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the other
p.(None): course of action.
p.(None): ‘‘(d) DISSEMINATION OF PEDIATRIC INFORMATION.—Not later
p.(None): than one year after the date of the enactment of the Best Pharma- ceuticals for Children Act of 2007, the
p.(None): Secretary, acting through the Director of the National Institutes of Health, shall study the feasibility of
p.(None): establishing a compilation of information on pediatric drug use and report the findings to Congress.
p.(None): ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—
p.(None): ‘‘(1) IN GENERAL.—There are authorized to be appropriated to carry out this section—
p.(None): ‘‘(A) $200,000,000 for fiscal year 2008; and
p.(None): ‘‘(B) such sums as are necessary for each of the four succeeding fiscal years.
p.(None): ‘‘(2) AVAILABILITY.—Any amount appropriated under para- graph (1) shall remain available to carry out this section
p.(None): until expended.’’.
p.(None): (c) FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.— Section 499(c)(1)(C) of the Public Health Service
p.(None): Act (42 U.S.C. 290b(c)(1)(C)) is amended by striking ‘‘and studies listed by the Secretary pursuant to
...
p.(None): ‘‘(kk) The dissemination of a television advertisement without complying with section 503B.’’; and
p.(None): (2) by inserting after section 503A the following:
p.(None): ‘‘SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS.
p.(None): ‘‘(a) IN GENERAL.—The Secretary may require the submission of any television advertisement for a drug
p.(None): (including any script, story board, rough, or a completed video production of the television advertisement) to the
p.(None): Secretary for review under this section not later than 45 days before dissemination of the television advertise-
p.(None): ment.
p.(None): ‘‘(b) REVIEW.—In conducting a review of a television advertise- ment under this section, the Secretary may make
p.(None): recommendations with respect to information included in the label of the drug—
p.(None): ‘‘(1) on changes that are—
p.(None): ‘‘(A) necessary to protect the consumer good and well- being; or
p.(None): ‘‘(B) consistent with prescribing information for the product under review; and
p.(None): ‘‘(2) if appropriate and if information exists, on statements for inclusion in the advertisement to address the
p.(None): specific effi- cacy of the drug as it relates to specific population groups, including elderly
p.(None): populations, children, and racial and ethnic minorities.
p.(None): ‘‘(c) NO AUTHORITY TO REQUIRE CHANGES.—Except as provided by subsection (e), this section does not
p.(None): authorize the Secretary to make or direct changes in any material submitted pursuant to subsection (a).
p.(None): ‘‘(d) ELDERLY POPULATIONS, CHILDREN, RACIALLY AND ETH-
p.(None): NICALLY DIVERSE COMMUNITIES.—In formulating recommendations under subsection (b), the Secretary shall take
p.(None): into consideration the impact of the advertised drug on elderly populations, children, and racially and ethnically
p.(None): diverse communities.
p.(None): ‘‘(e) SPECIFIC DISCLOSURES.—
p.(None): ‘‘(1) SERIOUS RISK; SAFETY PROTOCOL.—In conducting a
p.(None): review of a television advertisement under this section, if the Secretary determines that the
p.(None): advertisement would be false or misleading without a specific disclosure about a serious risk listed in
p.(None): the labeling of the drug involved, the Secretary may require inclusion of such disclosure in the advertisement.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 353b.
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 940 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(2) DATE OF APPROVAL.—In conducting a review of a tele- vision advertisement under this section, the Secretary
p.(None): may require the advertisement to include, for a period not to exceed 2 years from the date of the approval of the drug
p.(None): under section 505 or section 351 of the Public Health Service Act, a specific disclosure of such date of
p.(None): approval if the Secretary determines that the advertisement would otherwise be false or misleading. ‘‘(f) RULE OF
p.(None): CONSTRUCTION.—Nothing in this section may be
p.(None): construed as having any effect on requirements under section 502(n) or on the authority of the Secretary under section
p.(None): 314.550, 314.640, 601.45, or 601.94 of title 21, Code of Federal Regulations (or suc- cessor
p.(None): regulations).’’.
p.(None): (3) DIRECT-TO-CONSUMER ADVERTISEMENTS.—
p.(None): (A) IN GENERAL.—Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended
p.(None): by adding at the end the following: ‘‘In the case of an advertisement for a drug subject to section
p.(None): 503(b)(1) pre- sented directly to consumers in television or radio format and stating the name of the
p.(None): drug and its conditions of use, the major statement relating to side effects and contra- indications shall be
p.(None): presented in a clear, conspicuous, and neutral manner.’’.
p.(None):
p.(None): Deadline.
p.(None): 21 USC 352 note.
p.(None): (B) REGULATIONS TO DETERMINE CLEAR, CONSPICUOUS, AND NEUTRAL MANNER.—Not later than 30 months after the
p.(None): date of the enactment of the Food and Drug Administra- tion Amendments Act of 2007, the Secretary of Health and
p.(None): Human Services shall by regulation establish stand- ards for determining whether a major statement
p.(None): relating to side effects and contraindications of a drug, described in section 502(n) of the Federal Food,
p.(None): Drug, and Cosmetic Act (21 U.S.C. 352(n)) (as amended by subparagraph (A)) is presented in the manner
p.(None): required under such section.
...
p.(None): information and decreased health disparities for these populations. The report required by this paragraph
p.(None): shall recommend effective ways to present and disseminate information to these populations. Such report shall
p.(None): also make recommendations regarding impediments to the participation of elderly populations, children,
p.(None): racially and ethnically diverse communities, and medically underserved populations in clinical drug
p.(None): trials and shall recommend best practice approaches for increasing the inclusion of such subsets of the general
p.(None): population. The Secretary of Health and Human Services shall submit the report under this paragraph to the
p.(None): Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.(None): Commerce of the House of Representatives.
p.(None): (6) RULEMAKING.—Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is
p.(None): amended by striking ‘‘the procedure specified in section 701(e) of this Act’’ and inserting ‘‘section
p.(None): 701(a)’’.
p.(None): (e) RULE OF CONSTRUCTION REGARDING PEDIATRIC STUDIES.— This title and the amendments made by this title
p.(None): may not be
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 943
p.(None):
p.(None): construed as affecting the authority of the Secretary of Health and Human Services to request pediatric
p.(None): studies under section 505A of the Federal Food, Drug, and Cosmetic Act or to require such studies under
p.(None): section 505B of such Act.
p.(None): SEC. 902. ENFORCEMENT.
p.(None): (a) MISBRANDING.—Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding
p.(None): at the end the following:
p.(None): ‘‘(y) If it is a drug subject to an approved risk evaluation and mitigation strategy pursuant to section
p.(None): 505(p) and the respon- sible person (as such term is used in section 505–1) fails to comply with a requirement of such
p.(None): strategy provided for under subsection (d), (e), or (f) of section 505–1.
p.(None): ‘‘(z) If it is a drug, and the responsible person (as such term is used in section 505(o)) is in violation
p.(None): of a requirement established under paragraph (3) (relating to postmarket studies and clinical trials) or
p.(None): paragraph (4) (relating to labeling) of section 505(o) with respect to such drug.’’.
p.(None): (b) CIVIL PENALTIES.—Section 303(f) of the Federal Food, Drug, and Cosmetic Act, as amended by section 801(b),
p.(None): is amended—
p.(None): (1) by inserting after paragraph (3), as added by section 801(b)(2), the following:
p.(None): ‘‘(4)(A) Any responsible person (as such term is used in section 505–1) that violates a requirement of section
...
p.(None): the active postmarket risk identification and analysis system under this subsection is not sufficient to gather
p.(None): data and information relevant to a priority drug safety question, the Secretary shall develop, support, and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Reports.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 946 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): participate in complementary approaches to gather and analyze such data and information, including—
p.(None): ‘‘(I) approaches that are complementary with respect to assessing the safety of use of a drug in domestic
p.(None): populations not included, or underrep- resented, in the trials used to approve the drug (such as older
p.(None): people, people with comorbidities, pregnant women, or children); and
p.(None): ‘‘(II) existing approaches such as the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink or
p.(None): successor databases.
p.(None): ‘‘(v) AUTHORITY FOR CONTRACTS.—The Secretary
p.(None): may enter into contracts with public and private enti- ties to fulfill the requirements of this subparagraph.
p.(None): ‘‘(4) ADVANCED ANALYSIS OF DRUG SAFETY DATA.—
p.(None): ‘‘(A) PURPOSE.—The Secretary shall establish collabora- tions with public, academic, and private entities, which
p.(None): may include the Centers for Education and Research on Therapeutics under section 912 of the Public Health
p.(None): Service Act, to provide for advanced analysis of drug safety data described in paragraph (3)(C) and other
p.(None): information that is publicly available or is provided by the Secretary, in order to—
p.(None): ‘‘(i) improve the quality and efficiency of postmarket drug safety risk-benefit analysis;
p.(None): ‘‘(ii) provide the Secretary with routine access to outside expertise to study advanced drug safety ques-
p.(None): tions; and
p.(None): ‘‘(iii) enhance the ability of the Secretary to make timely assessments based on drug safety data.
p.(None): ‘‘(B) PRIVACY.—Such analysis shall not disclose individ- ually identifiable health information when presenting such
p.(None): drug safety signals and trends or when responding to inquiries regarding such drug safety signals and
...
p.(None): including identification of any new risks not previously identified, potential new risks, or known risks reported in
p.(None): unusual number;
p.(None): ‘‘(E) enabling patients, providers, and drug sponsors to submit adverse event reports through the Internet Web
p.(None): site;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): ‘‘(F) providing educational materials for patients and providers about the appropriate means of
p.(None): disposing of expired, damaged, or unusable medications; and
p.(None): ‘‘(G) supporting initiatives that the Secretary deter- mines to be useful to fulfill the purposes of the
p.(None): Internet Web site.
p.(None): ‘‘(3) POSTING OF DRUG LABELING.—The Secretary shall post on the Internet Web site established under
p.(None): paragraph (1) the approved professional labeling and any required patient labeling of a drug approved
p.(None): under this section or licensed under such section 351 not later than 21 days after the date the drug
p.(None): is approved or licensed, including in a supplemental application with respect to a labeling change.
p.(None): ‘‘(4) PRIVATE SECTOR RESOURCES.—To ensure development of the Internet Web site by the date
p.(None): described in paragraph (1), the Secretary may, on a temporary or permanent basis, implement systems or
p.(None): products developed by private entities. ‘‘(5) AUTHORITY FOR CONTRACTS.—The Secretary may enter into
p.(None): contracts with public and private entities to fulfill the
p.(None): requirements of this subsection.
p.(None): ‘‘(6) REVIEW.—The Advisory Committee on Risk Commu- nication under section 567 shall, on a regular basis,
p.(None): perform a comprehensive review and evaluation of the types of risk communication information provided on
p.(None): the Internet Web site established under paragraph (1) and, through other means, shall identify, clarify,
p.(None): and define the purposes and types of information available to facilitate the efficient flow of informa- tion to
p.(None): patients and providers, and shall recommend ways for the Food and Drug Administration to work with
p.(None): outside entities to help facilitate the dispensing of risk communication information to patients and providers.’’.
p.(None): SEC. 916. ACTION PACKAGE FOR APPROVAL.
p.(None): Section 505(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(l)) is amended by—
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 959
p.(None):
p.(None):
p.(None): (1) redesignating paragraphs (1), (2), (3), (4), and (5) as subparagraphs (A), (B), (C), (D), and (E),
p.(None): respectively;
p.(None): (2) striking ‘‘(l) Safety and’’ and inserting ‘‘(l)(1) Safety and’’; and
p.(None): (3) adding at the end the following: ‘‘(2) ACTION PACKAGE FOR APPROVAL.—
p.(None): ‘‘(A) ACTION PACKAGE.—The Secretary shall publish the action package for approval of an application under
...
p.(None): ‘‘(1) IN GENERAL.—Not later than 1 year after the date of the enactment of this section, the Secretary
p.(None): shall establish within the Food and Drug Administration a Reportable Food Registry to which instances of
p.(None): reportable food may be submitted by the Food and Drug Administration after receipt of reports under subsection
p.(None): (d), via an electronic portal, from—
p.(None): ‘‘(A) Federal, State, and local public health officials;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 350f.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None): or
p.(None): ‘‘(B) responsible parties.
p.(None):
p.(None): ‘‘(2) REVIEW BY SECRETARY.—The Secretary shall promptly review and assess the information submitted under paragraph
p.(None): (1) for the purposes of identifying reportable food, submitting entries to the Reportable Food Registry, acting
p.(None): under subsection (c), and exercising other existing food safety authorities under this Act to protect the
p.(None): public health.
p.(None): ‘‘(c) ISSUANCE OF AN ALERT BY THE SECRETARY.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall issue, or cause to be issued, an alert or a notification with respect to
p.(None): a reportable food using information from the Reportable Food Registry as the Secretary deems necessary to
p.(None): protect the public health. ‘‘(2) EFFECT.—Paragraph (1) shall not affect the authority
p.(None): of the Secretary to issue an alert or a notification under any other provision of this Act.
p.(None): ‘‘(d) REPORTING AND NOTIFICATION.—
p.(None): ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), as soon as practicable, but in no case later
p.(None): than 24 hours after a responsible party determines that an article of food is a reportable food, the
p.(None): responsible party shall—
p.(None): ‘‘(A) submit a report to the Food and Drug Administra- tion through the electronic portal established under sub-
p.(None): section (b) that includes the data elements described in subsection (e) (except the elements described in
p.(None): paragraphs (8), (9), and (10) of such subsection); and
p.(None): ‘‘(B) investigate the cause of the adulteration if the adulteration of the article of food may have
p.(None): originated with the responsible party.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Deadline.
p.(None):
p.(None):
p.(None): 121 STAT. 966 PUBLIC LAW 110–85—SEPT. 27, 2007
p.(None):
p.(None): ‘‘(2) NO REPORT REQUIRED.—A responsible party is not required to submit a report under paragraph (1) if—
p.(None): ‘‘(A) the adulteration originated with the responsible party;
...
Orphaned Trigger Words
p.(None): placement or provides an exception for a particular device or type of device. The unique identifier
p.(None): shall adequately identify the device through distribution and use, and may include information on the lot or
p.(None): serial number.’’.
p.(None): (b) CONFORMING AMENDMENT.—Section 303 (21 U.S.C. 333) is amended—
p.(None): (1) by redesignating the subsection that follows subsection
p.(None): (e) as subsection (f); and
p.(None): (2) in paragraph (1)(B)(ii) of subsection (f), as so redesig- nated, by striking ‘‘519(f)’’ and inserting
p.(None): ‘‘519(g)’’.
p.(None): SEC. 227. FREQUENCY OF REPORTING FOR CERTAIN DEVICES.
p.(None): Subparagraph (B) of section 519(a)(1) (21 U.S.C. 360i(a)(1)) is amended by striking ‘‘were to recur;’’ and
p.(None): inserting the following: ‘‘were to recur, which report under this subparagraph—
p.(None): ‘‘(i) shall be submitted in accordance with part 803 of title 21, Code of Federal Regulations (or suc-
p.(None): cessor regulations), unless the Secretary grants an exemption or variance from, or an alternative to, a
p.(None): requirement under such regulations pursuant to sec- tion 803.19 of such part, if the device involved is—
p.(None): ‘‘(I) a class III device;
p.(None): ‘‘(II) a class II device that is permanently implantable, is life supporting, or is life sustaining; or
p.(None): ‘‘(III) a type of device which the Secretary has, by notice published in the Federal Register or letter
p.(None): to the person who is the manufacturer
p.(None):
p.(None):
p.(None): PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 855
p.(None):
p.(None):
p.(None): or importer of the device, indicated should be sub- ject to such part 803 in order to protect the public health;
p.(None): ‘‘(ii) shall, if the device is not subject to clause (i), be submitted in accordance with criteria established
p.(None): by the Secretary for reports made pursuant to this clause, which criteria shall require the reports to
p.(None): be in summary form and made on a quarterly basis; or ‘‘(iii) shall, if the device is imported into the United
p.(None): States and for which part 803 of title 21, Code of Federal Regulations (or successor regulations) requires an
p.(None): importer to submit a report to the manufacturer, be submitted by the importer to the manufacturer in
p.(None): accordance with part 803 of title 21, Code of Federal
p.(None): Regulations (or successor regulations)’’.
p.(None): SEC. 228. INSPECTIONS BY ACCREDITED PERSONS.
p.(None): Section 704(g) (21 U.S.C. 374(g)) is amended—
p.(None): (1) in paragraph (1), by striking ‘‘Not later than one year after the date of the enactment of this
p.(None): subsection, the Secretary’’ and inserting ‘‘The Secretary’’;
p.(None): (2) in paragraph (2), by—
p.(None): (A) striking ‘‘Not later than 180 days after the date of enactment of this subsection, the
p.(None): Secretary’’ and inserting ‘‘The Secretary’’; and
p.(None): (B) striking the fifth sentence;
p.(None): (3) in paragraph (3), by adding at the end the following: ‘‘(F) Such person shall notify the Secretary
p.(None): of any with- drawal, suspension, restriction, or expiration of certificate of conformance with the quality
p.(None): systems standard referred to in paragraph (7) for any device establishment that such person inspects under this
p.(None): subsection not later than 30 days after
p.(None): such withdrawal, suspension, restriction, or expiration.
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| belief | Religion |
| child | Child |
| children | Child |
| criminal | criminal |
| drug | Drug Usage |
| education | education |
| educational | education |
| elderly | Elderly |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| employees | employees |
| ethnic | Ethnicity |
| faith | Religion |
| family | Motherhood/Family |
| gender | gender |
| illness | Physically Disabled |
| incapacity | Incapacitated |
| infant | Infant |
| language | Linguistic Proficiency |
| minority | Racial Minority |
| nation | stateless persons |
| neonate | Fetus/Neonate |
| neonates | Fetus/Neonate |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| orphan | orphan |
| parent | parents |
| parents | parents |
| party | political affiliation |
| political | political affiliation |
| poor | Economic/Poverty |
| pregnant | Pregnant |
| property | Property Ownership |
| racial | Racial Minority |
| single | Marital Status |
| substance | Drug Usage |
| threat | Threat of Stigma |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| belief | ['faith'] |
| child | ['children'] |
| children | ['child'] |
| drug | ['substance'] |
| education | ['educational'] |
| educational | ['education'] |
| faith | ['belief'] |
| minority | ['racial'] |
| neonate | ['neonates'] |
| neonates | ['neonate'] |
| parent | ['parents'] |
| parents | ['parent'] |
| party | ['political'] |
| political | ['party'] |
| racial | ['minority'] |
| substance | ['drug'] |
Trigger Words
capacity
consent
developing
ethics
justice
protect
protection
risk
sensitive
Applicable Type / Vulnerability / Indicator Overlay for this Input