0A4F4F9BD490A749D5437F821CF06DF1
Food and Drug Administration Modernization 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 / political affiliation
Searching for indicator party:
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p.(None): at one general physical location consisting of one or more buildings all of which are within five miles
p.(None): of each other and at which one or more prescription drug products are manufactured in final dosage
p.(None): form.’’;
p.(None): (5) in paragraph (7)(A)—
p.(None): (A) by striking ‘‘employees under contract’’ and all that follows through ‘‘Administration,’’ the second
p.(None): time it occurs and inserting ‘‘contractors of the Food and Drug Administration,’’; and
p.(None): (B) by striking ‘‘and committees,’’ and inserting ‘‘and committees and to contracts with such contractors,’’;
p.(None): (6) in paragraph (8)—
p.(None): (A) in subparagraph (A)—
p.(None): (i) by striking ‘‘August of ’’ and inserting ‘‘April of ’’; and
p.(None): (ii) by striking ‘‘August 1992’’ and inserting ‘‘April 1997’’; and
p.(None): (B) in subparagraph (B)—
p.(None): (i) by striking ‘‘section 254(d)’’ and inserting ‘‘sec- tion 254(c)’’;
p.(None): (ii) by striking ‘‘1992’’ and inserting ‘‘1997’’; and
p.(None): (iii) by striking ‘‘102d Congress, 2d Session’’ and inserting ‘‘105th Congress, 1st Session’’; and
p.(None): (7) by adding at the end the following:
p.(None): ‘‘(9) The term ‘affiliate’ means a business entity that has a relationship with a second business entity
p.(None): if, directly or indirectly—
p.(None): ‘‘(A) one business entity controls, or has the power to control, the other business entity; or
p.(None): ‘‘(B) a third party controls, or has power to control, both of the business entities.’’.
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) by striking ‘‘Beginning in fiscal year 1993’’ and inserting ‘‘Beginning in fiscal year 1998’’;
p.(None): (2) in paragraph (1)—
p.(None): (A) by striking subparagraph (B) and inserting the following:
p.(None): ‘‘(B) PAYMENT.—The fee required by subparagraph (A) shall be due upon submission of the application or supple- ment.’’;
p.(None): (B) in subparagraph (D)—
p.(None):
p.(None):
p.(None): 111 STAT. 2300 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): (i) in the subparagraph heading, by striking ‘‘NOT ACCEPTED’’ and inserting ‘‘REFUSED’’;
p.(None): (ii) by striking ‘‘50 percent’’ and inserting ‘‘75 per- cent’’;
p.(None): (iii) by striking ‘‘subparagraph (B)(i)’’ and inserting ‘‘subparagraph (B)’’; and
p.(None): (iv) by striking ‘‘not accepted’’ and inserting ‘‘refused’’; and
p.(None): (C) by adding at the end the following:
p.(None): ‘‘(E) EXCEPTION FOR DESIGNATED ORPHAN DRUG OR
p.(None): INDICATION.—A human drug application for a prescription drug product that has been designated as a drug
p.(None): for a rare disease or condition pursuant to section 526 shall not be subject to a fee under
...
p.(None): submitted under paragraph (1), and does not include a similar or identical substance manufactured or prepared by a
p.(None): person other than the manufacturer identified in the notification.
p.(None): ‘‘(3)(A) The process in this subsection shall be utilized for authorizing the marketing of a food contact
p.(None): substance except where the Secretary determines that submission and review of a petition under subsection (b) is
p.(None): necessary to provide adequate assurance of safety, or where the Secretary and any manufacturer or supplier agree
p.(None): that such manufacturer or supplier may submit a petition under subsection (b).
p.(None): ‘‘(B) The Secretary is authorized to promulgate regulations to identify the circumstances in which a
p.(None): petition shall be filed under subsection (b), and shall consider criteria such as the probable consumption of such
p.(None): food contact substance and potential toxicity of the food contact substance in determining the
p.(None): circumstances in which a petition shall be filed under subsection (b).
p.(None): ‘‘(4) The Secretary shall keep confidential any information pro- vided in a notification under paragraph (1) for
p.(None): 120 days after receipt by the Secretary of the notification. After the expiration of such 120 days,
p.(None): the information shall be available to any interested party except for any matter in the
p.(None): notification that is a trade secret or confidential commercial information.
p.(None): ‘‘(5)(A)(i) Except as provided in clause (ii), the notification pro- gram established under this subsection shall
p.(None): not operate in any fiscal year unless—
p.(None): ‘‘(I) an appropriation equal to or exceeding the applicable amount under clause (iv) is made for such fiscal
p.(None): year for carry- ing out such program in such fiscal year; and
p.(None): ‘‘(II) the Secretary certifies that the amount appropriated for such fiscal year for the Center for Food Safety
p.(None): and Applied Nutrition of the Food and Drug Administration (exclusive of the appropriation referred to in
p.(None): subclause (I)) equals or exceeds the amount appropriated for the Center for fiscal year 1997, excluding any
p.(None): amount appropriated for new programs.
p.(None): ‘‘(ii) The Secretary shall, not later than April 1, 1999, begin accepting and reviewing notifications
p.(None): submitted under the notifica- tion program established under this subsection if—
p.(None): ‘‘(I) an appropriation equal to or exceeding the applicable amount under clause (iii) is made for the
p.(None): last six months of fiscal year 1999 for carrying out such program during such period; and
p.(None): ‘‘(II) the Secretary certifies that the amount appropriated for such period for the Center for Food
p.(None): Safety and Applied Nutrition of the Food and Drug Administration (exclusive of the appropriation referred to
p.(None): in subclause (I)) equals or exceeds an amount equivalent to one-half the amount appropriated for the Center
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Searching for indicator political:
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p.(None): ‘‘(5) Paragraphs (1) through (4) shall not apply with respect to products defined in section 201(ff).’’.
p.(None): SEC. 411. ENVIRONMENTAL IMPACT REVIEW.
p.(None): Chapter VII (21 U.S.C. 371 et seq.), as amended by section 407, is further amended by adding at the end the
p.(None): following:
p.(None):
p.(None): ‘‘SUBCHAPTER E—ENVIRONMENTAL IMPACT REVIEW
p.(None):
p.(None):
p.(None): ‘‘SEC. 746. ENVIRONMENTAL IMPACT.
p.(None): ‘‘Notwithstanding any other provision of law, an environmental impact statement prepared in accordance with the
p.(None): regulations pub- lished in part 25 of title 21, Code of Federal Regulations (as in effect on August 31,
p.(None): 1997) in connection with an action carried out under (or a recommendation or report relating to) this
p.(None): Act, shall be considered to meet the requirements for a detailed state- ment under section 102(2)(C) of the
p.(None): National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)).’’.
p.(None): SEC. 412. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND COSMETICS.
p.(None): (a) NONPRESCRIPTION DRUGS.—Chapter VII (21 U.S.C. 371 et seq.), as amended by section 411, is further
p.(None): amended by adding at the end the following:
p.(None): 21 USC 379o.
p.(None):
p.(None):
p.(None): 111 STAT. 2374 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘SUBCHAPTER F—NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND PREEMPTION FOR LABELING OR PACKAGING
p.(None): OF COS-
p.(None): METICS
p.(None):
p.(None): 21 USC 379r.
p.(None): ‘‘SEC. 751. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS.
p.(None): ‘‘(a) IN GENERAL.—Except as provided in subsection (b), (c)(1), (d), (e), or (f), no State or political
p.(None): subdivision of a State may establish or continue in effect any requirement—
p.(None): ‘‘(1) that relates to the regulation of a drug that is not subject to the requirements of section 503(b)(1)
p.(None): or 503(f)(1)(A); and
p.(None): ‘‘(2) that is different from or in addition to, or that is otherwise not identical with, a requirement
p.(None): under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair
p.(None): Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
p.(None): ‘‘(b) EXEMPTION.—
p.(None): ‘‘(1) IN GENERAL.—Upon application of a State or political subdivision thereof, the Secretary may by
p.(None): regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection
p.(None): (a), under such conditions as may be prescribed in such regulation, a State or political sub- division
p.(None): requirement that—
p.(None): ‘‘(A) protects an important public interest that would otherwise be unprotected, including the health and
p.(None): safety of children;
p.(None): ‘‘(B) would not cause any drug to be in violation of any applicable requirement or prohibition under
p.(None): Federal law; and
p.(None): ‘‘(C) would not unduly burden interstate commerce. ‘‘(2) TIMELY ACTION.—The Secretary shall make a decision
p.(None): on the exemption of a State or political subdivision requirement under paragraph (1) not later than 120 days
p.(None): after receiving the application of the State or political subdivision under paragraph (1).
p.(None): ‘‘(c) SCOPE.—
p.(None): ‘‘(1) IN GENERAL.—This section shall not apply to—
p.(None): ‘‘(A) any State or political subdivision requirement that relates to the practice of pharmacy; or
p.(None): ‘‘(B) any State or political subdivision requirement that a drug be dispensed only upon the prescription of a practi-
p.(None): tioner licensed by law to administer such drug.
p.(None): ‘‘(2) SAFETY OR EFFECTIVENESS.—For purposes of subsection (a), a requirement that relates to the regulation
p.(None): of a drug shall be deemed to include any requirement relating to public information or any other form of
p.(None): public communication relating to a warning of any kind for a drug.
p.(None): ‘‘(d) EXCEPTIONS.—
p.(None): ‘‘(1) IN GENERAL.—In the case of a drug described in sub- section (a)(1) that is not the subject of an
p.(None): application approved under section 505 or section 507 (as in effect on the day before the date of enactment of the
p.(None): Food and Drug Administration Modernization Act of 1997) or a final regulation promulgated by the Secretary
p.(None): establishing conditions under which the drug is generally recognized as safe and effective and not mis-
p.(None): branded, subsection (a) shall apply only with respect to a requirement of a State or political
p.(None): subdivision of a State that
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2375
p.(None):
p.(None): relates to the same subject as, but is different from or in addition to, or that is otherwise not identical
p.(None): with—
p.(None): ‘‘(A) a regulation in effect with respect to the drug pursuant to a statute described in subsection
p.(None): (a)(2); or ‘‘(B) any other requirement in effect with respect to
p.(None): the drug pursuant to an amendment to such a statute made on or after the date of enactment of the
p.(None): Food and Drug Administration Modernization Act of 1997.
p.(None): ‘‘(2) STATE INITIATIVES.—This section shall not apply to a State requirement adopted by a State
p.(None): public initiative or referendum enacted prior to September 1, 1997.
p.(None): ‘‘(e) NO EFFECT ON PRODUCT LIABILITY LAW.—Nothing in this
p.(None): section shall be construed to modify or otherwise affect any action or the liability of any person under the
p.(None): product liability law of any State.
p.(None): ‘‘(f) STATE ENFORCEMENT AUTHORITY.—Nothing in this section shall prevent a State or political subdivision
p.(None): thereof from enforcing, under any relevant civil or other enforcement authority, a require- ment that is identical to a
p.(None): requirement of this Act.’’.
p.(None): (b) INSPECTIONS.—Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended by striking ‘‘prescription drugs’’
p.(None): each place it appears and inserting ‘‘prescription drugs, nonprescription drugs intended for human use,’’.
p.(None): (c) MISBRANDING.—Subparagraph (1) of section 502(e) (21
p.(None): U.S.C. 352(e)(1)) is amended to read as follows:
p.(None): ‘‘(1)(A) If it is a drug, unless its label bears, to the exclusion of any other nonproprietary name (except
p.(None): the applicable systematic chemical name or the chemical formula)—
p.(None): ‘‘(i) the established name (as defined in subparagraph (3)) of the drug, if there is such a name;
p.(None): ‘‘(ii) the established name and quantity or, if determined to be appropriate by the Secretary, the
p.(None): proportion of each active ingredient, including the quantity, kind, and proportion of any alcohol, and
p.(None): also including whether active or not the established name and quantity or if determined to be appro-
p.(None): priate by the Secretary, the proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin,
p.(None): amidopyrine, anti- pyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digi- talis glucosides, mercury,
p.(None): ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such sub- stances,
p.(None): contained therein, except that the requirement for stating the quantity of the active ingredients, other
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p.(None): prescription drug the established name of such
p.(None): drug or ingredient, as the case may be, on such label (and on
p.(None):
p.(None):
p.(None): 111 STAT. 2376 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): any labeling on which a name for such drug or ingredient is used) shall be printed prominently and in type at
p.(None): least half as large as that used thereon for any proprietary name or designation for such drug or
p.(None): ingredient, except that to the extent that compliance with the requirements of subclause (ii) or (iii)
p.(None): of clause (A) or this clause is impracticable, exemptions shall be established by regulations promulgated by
p.(None): the Secretary.’’.
p.(None): (d) COSMETICS.—Subchapter F of chapter VII, as amended by subsection (a), is further amended by adding at the
p.(None): end the follow- ing:
p.(None):
p.(None): 21 USC 379s.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 393 note.
p.(None): ‘‘SEC. 752. PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS.
p.(None): ‘‘(a) IN GENERAL.—Except as provided in subsection (b), (d), or (e), no State or political subdivision
p.(None): of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic
p.(None): that is different from or in addition to, or that is otherwise not identical with, a requirement specifically
p.(None): applicable to a particular cosmetic or class of cosmetics under this Act, the Poison Prevention Packaging
p.(None): Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et
p.(None): seq.). ‘‘(b) EXEMPTION.—Upon application of a State or political sub- division thereof, the Secretary may
p.(None): by regulation, after notice and opportunity for written and oral presentation of views, exempt from
p.(None): subsection (a), under such conditions as may be prescribed in such regulation, a State or political
p.(None): subdivision requirement
p.(None): for labeling or packaging that—
p.(None): ‘‘(1) protects an important public interest that would other- wise be unprotected;
p.(None): ‘‘(2) would not cause a cosmetic to be in violation of any applicable requirement or prohibition under
p.(None): Federal law; and
p.(None): ‘‘(3) would not unduly burden interstate commerce.
p.(None): ‘‘(c) SCOPE.—For purposes of subsection (a), a reference to a State requirement that relates to the
p.(None): packaging or labeling of a cosmetic means any specific requirement relating to the same aspect of such
p.(None): cosmetic as a requirement specifically applicable to that particular cosmetic or class of cosmetics under
p.(None): this Act for packaging or labeling, including any State requirement relating to public information or any other
p.(None): form of public communication. ‘‘(d) NO EFFECT ON PRODUCT LIABILITY LAW.—Nothing in this
p.(None): section shall be construed to modify or otherwise affect any action or the liability of any person under the
p.(None): product liability law of any State.
p.(None): ‘‘(e) STATE INITIATIVE.—This section shall not apply to a State requirement adopted by a State public initiative
p.(None): or referendum enacted prior to September 1, 1997.’’.
p.(None): SEC. 413. FOOD AND DRUG ADMINISTRATION STUDY OF MERCURY COMPOUNDS IN DRUGS AND FOOD.
p.(None): (a) LIST AND ANALYSIS.—The Secretary of Health and Human Services shall, acting through the Food and Drug
p.(None): Administration—
p.(None): (1) compile a list of drugs and foods that contain inten- tionally introduced mercury compounds, and
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Health / Cognitive Impairment
Searching for indicator impairment:
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p.(None): change to the design of a device that affects safety or effectiveness, the Secretary shall approve such
p.(None): supplement if—
p.(None): ‘‘(I) nonclinical data demonstrate that the design modifica- tion creates the intended additional capacity,
p.(None): function, or performance of the device; and
p.(None): ‘‘(II) clinical data from the approved application and any supplement to the approved application provide
p.(None): a reasonable assurance of safety and effectiveness for the changed device. ‘‘(ii) The Secretary may
p.(None): require, when necessary, additional
p.(None): clinical data to evaluate the design modification of the device to provide a reasonable assurance of safety
p.(None): and effectiveness.’’.
p.(None): SEC. 206. PREMARKET NOTIFICATION.
p.(None): (a) SECTION 510.—Section 510 (21 U.S.C. 360) is amended—
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2339
p.(None):
p.(None):
p.(None): (1) in subsection (k), in the matter preceding paragraph (1), by adding after ‘‘report to the
p.(None): Secretary’’ the following: ‘‘or person who is accredited under section 523(a)’’; and
p.(None): (2) by adding at the end the following subsections:
p.(None): ‘‘(l) A report under subsection (k) is not required for a device intended for human use that is
p.(None): exempted from the requirements of this subsection under subsection (m) or is within a type that has been
p.(None): classified into class I under section 513. The exception established in the preceding sentence does not
p.(None): apply to any class I device that is intended for a use which is of substantial importance in preventing impairment
p.(None): of human health, or to any class I device that presents a potential unreasonable risk of illness or injury.
p.(None): ‘‘(m)(1) Not later than 60 days after the date of enactment
p.(None): of the Food and Drug Administration Modernization Act of 1997, the Secretary shall publish in the
p.(None): Federal Register a list of each type of class II device that does not require a report under sub-
p.(None): section (k) to provide reasonable assurance of safety and effective- ness. Each type of class II device
p.(None): identified by the Secretary as not requiring the report shall be exempt from the requirement to provide
p.(None): a report under subsection (k) as of the date of the publication of the list in the Federal Register.
p.(None): ‘‘(2) Beginning on the date that is 1 day after the date of the publication of a list under this
p.(None): subsection, the Secretary may exempt a class II device from the requirement to submit a report under
p.(None): subsection (k), upon the Secretary’s own initiative or a peti- tion of an interested person, if the Secretary
p.(None): determines that such report is not necessary to assure the safety and effectiveness of the device. The
p.(None): Secretary shall publish in the Federal Register notice of the intent of the Secretary to exempt the
p.(None): device, or of the petition, and provide a 30-day period for public comment. Within 120 days after the
p.(None): issuance of the notice in the Federal Register, the Secretary shall publish an order in the Federal
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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 105–115—NOV. 21, 1997
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): FOOD AND DRUG ADMINISTRATION MODERIZATION ACT OF 1997
p.(None):
p.(None):
p.(None): 111 STAT. 2296 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Public Law 105–115 105th Congress
p.(None):
p.(None):
p.(None): An Act
p.(None):
p.(None):
p.(None): Nov. 21, 1997
p.(None): To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service
p.(None): Act to improve the regulation of food, drugs, devices, and biological
p.(None): products,
p.(None):
p.(None): [S. 830]
p.(None):
p.(None):
p.(None): Food and Drug Administration Modernization Act of 1997.
p.(None): 21 USC 301 note.
p.(None): and for other purposes.
p.(None):
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; REFERENCES; TABLE OF CONTENTS.
p.(None): (a) SHORT TITLE.—This Act may be cited as the ‘‘Food and Drug Administration Modernization Act of 1997’’.
p.(None): (b) REFERENCES.—Except as otherwise specified, whenever in this Act an amendment or repeal is expressed
p.(None): in terms of an amendment to or a repeal of a section or other provision, the reference shall be
p.(None): considered to be made to that section or other provision of the Federal Food, Drug, and Cosmetic Act
p.(None): (21 U.S.C. 301 et seq.).
p.(None): (c) TABLE OF CONTENTS.—The table of contents for this Act is as follows:
p.(None): Sec. 1. Short title; references; table of contents. Sec. 2. Definitions.
p.(None): TITLE I—IMPROVING REGULATION OF DRUGS
p.(None): Subtitle A—Fees Relating to Drugs
p.(None): Sec. 101. Findings.
p.(None): Sec. 102. Definitions.
p.(None): Sec. 103. Authority to assess and use drug fees. Sec. 104. Annual reports.
p.(None): Sec. 105. Savings.
p.(None): Sec. 106. Effective date.
p.(None): Sec. 107. Termination of effectiveness.
p.(None): Subtitle B—Other Improvements Sec. 111. Pediatric studies of drugs.
p.(None): Sec. 112. Expediting study and approval of fast track drugs.
p.(None): Sec. 113. Information program on clinical trials for serious or life-threatening dis- eases.
p.(None): Sec. 114. Health care economic information. Sec. 115. Clinical investigations.
p.(None): Sec. 116. Manufacturing changes for drugs.
p.(None): Sec. 117. Streamlining clinical research on drugs. Sec. 118. Data requirements for drugs and biologics. Sec. 119.
p.(None): Content and review of applications.
p.(None): Sec. 120. Scientific advisory panels.
p.(None): Sec. 121. Positron emission tomography.
p.(None): Sec. 122. Requirements for radiopharmaceuticals. Sec. 123. Modernization of regulation.
p.(None): Sec. 124. Pilot and small scale manufacture. Sec. 125. Insulin and antibiotics.
p.(None): Sec. 126. Elimination of certain labeling requirements.
p.(None): Sec. 127. Application of Federal law to practice of pharmacy compounding.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2297
p.(None):
p.(None): Sec. 128. Reauthorization of clinical pharmacology program. Sec. 129. Regulations for sunscreen products.
p.(None): Sec. 130. Reports of postmarketing approval studies.
p.(None): Sec. 131. Notification of discontinuance of a life saving product.
p.(None): TITLE II—IMPROVING REGULATION OF DEVICES
p.(None): Sec. 201. Investigational device exemptions. Sec. 202. Special review for certain devices.
p.(None): Sec. 203. Expanding humanitarian use of devices. Sec. 204. Device standards.
p.(None): Sec. 205. Scope of review; collaborative determinations of device data requirements. Sec. 206. Premarket
p.(None): notification.
p.(None): Sec. 207. Evaluation of automatic class III designation. Sec. 208. Classification panels.
p.(None): Sec. 209. Certainty of review timeframes; collaborative review process.
p.(None): Sec. 210. Accreditation of persons for review of premarket notification reports. Sec. 211. Device tracking.
p.(None): Sec. 212. Postmarket surveillance. Sec. 213. Reports.
p.(None): Sec. 214. Practice of medicine.
p.(None): Sec. 215. Noninvasive blood glucose meter.
p.(None): Sec. 216. Use of data relating to premarket approval; product development protocol. Sec. 217. Clarification of
p.(None): the number of required clinical investigations for ap-
p.(None): proval.
p.(None): TITLE III—IMPROVING REGULATION OF FOOD
p.(None): Sec. 301. Flexibility for regulations regarding claims. Sec. 302. Petitions for claims.
p.(None): Sec. 303. Health claims for food products. Sec. 304. Nutrient content claims.
p.(None): Sec. 305. Referral statements. Sec. 306. Disclosure of irradiation. Sec. 307. Irradiation petition.
p.(None): Sec. 308. Glass and ceramic ware. Sec. 309. Food contact substances.
p.(None): TITLE IV—GENERAL PROVISIONS
p.(None): Sec. 401. Dissemination of information on new uses.
p.(None): Sec. 402. Expanded access to investigational therapies and diagnostics. Sec. 403. Approval of supplemental
p.(None): applications for approved products. Sec. 404. Dispute resolution.
p.(None): Sec. 405. Informal agency statements.
p.(None): Sec. 406. Food and Drug Administration mission and annual report. Sec. 407. Information system.
p.(None): Sec. 408. Education and training.
p.(None): Sec. 409. Centers for education and research on therapeutics.
p.(None): Sec. 410. Mutual recognition agreements and global harmonization. Sec. 411. Environmental impact review.
p.(None): Sec. 412. National uniformity for nonprescription drugs and cosmetics.
p.(None): Sec. 413. Food and Drug Administration study of mercury compounds in drugs and food.
p.(None): Sec. 414. Interagency collaboration. Sec. 415. Contracts for expert review. Sec. 416. Product classification.
p.(None): Sec. 417. Registration of foreign establishments. Sec. 418. Clarification of seizure authority.
p.(None): Sec. 419. Interstate commerce.
p.(None): Sec. 420. Safety report disclaimers.
p.(None): Sec. 421. Labeling and advertising regarding compliance with statutory require- ments.
p.(None): Sec. 422. Rule of construction.
p.(None): TITLE V—EFFECTIVE DATE
p.(None):
p.(None): Sec. 501. Effective date.
p.(None): SEC. 2. DEFINITIONS.
p.(None): In this Act, the terms ‘‘drug’’, ‘‘device’’, ‘‘food’’, and ‘‘dietary supplement’’ have the meaning given
p.(None): such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
p.(None):
p.(None): 21 USC 321 note.
p.(None):
p.(None):
p.(None): 111 STAT. 2298 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None): TITLE I—IMPROVING REGULATION OF DRUGS
p.(None): Subtitle A—Fees Relating to Drugs
p.(None):
p.(None):
p.(None): 21 USC 379g
p.(None): note.
p.(None): SEC. 101. FINDINGS.
p.(None): Congress finds that—
p.(None): (1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement
p.(None): of the public health so that patients may enjoy the benefits provided by these therapies to treat and
p.(None): prevent illness and disease;
p.(None): (2) the public health will be served by making additional funds available for the purpose of augmenting
p.(None): the resources of the Food and Drug Administration that are devoted to the process for review of human drug
p.(None): applications;
p.(None): (3) the provisions added by the Prescription Drug User Fee Act of 1992 have been successful in substantially
p.(None): reducing review times for human drug applications and should be—
p.(None): (A) reauthorized for an additional 5 years, with certain technical improvements; and
p.(None): (B) carried out by the Food and Drug Administration with new commitments to implement more ambitious and
p.(None): comprehensive improvements in regulatory processes of the Food and Drug Administration; and
p.(None): (4) the fees authorized by amendments made in this subtitle will be dedicated toward expediting the drug development
p.(None): proc- ess and the review of human drug applications as set forth in the goals identified, for purposes
p.(None): of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters
p.(None): from the Secretary of Health and Human Services to the chairman of the Committee on Commerce of the
p.(None): House of Representatives and the chairman of the Commit- tee on Labor and Human Resources of the Senate, as
p.(None): 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 second sentence of paragraph (1)—
p.(None): (A) by striking ‘‘Service Act, and’’ and inserting ‘‘Service Act,’’; and
p.(None): (B) by striking ‘‘September 1, 1992.’’ and inserting the following: ‘‘September 1, 1992, does not include
p.(None): an application for a licensure of a biological product for further manufacturing use only, and does not include
p.(None): an applica- tion or supplement submitted by a State or Federal Govern- ment entity for a drug that is not distributed
p.(None): commercially. Such term does include an application for licensure, as described in subparagraph (D), of a large
p.(None): volume biological product intended for single dose injection for intravenous use or infusion.’’;
p.(None): (2) in the second sentence of paragraph (3)—
p.(None): (A) by striking ‘‘Service Act, and’’ and inserting ‘‘Service Act,’’; and
p.(None): (B) by striking ‘‘September 1, 1992.’’ and inserting the following: ‘‘September 1, 1992, does not
p.(None): include a
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2299
p.(None):
p.(None): biological product that is licensed for further manufacturing use only, and does not include a drug that is not
p.(None): distributed commercially and is the subject of an application or supple- ment submitted by a State or Federal
p.(None): Government entity. Such term does include a large volume biological product intended for single dose
p.(None): injection for intravenous use or infusion.’’;
p.(None): (3) in paragraph (4), by striking ‘‘without’’ and inserting ‘‘without substantial’’;
p.(None): (4) by amending the first sentence of paragraph (5) to read as follows:
p.(None): ‘‘(5) The term ‘prescription drug establishment’ means a foreign or domestic place of business which is
p.(None): at one general physical location consisting of one or more buildings all of which are within five miles
p.(None): of each other and at which one or more prescription drug products are manufactured in final dosage
p.(None): form.’’;
p.(None): (5) in paragraph (7)(A)—
p.(None): (A) by striking ‘‘employees under contract’’ and all that follows through ‘‘Administration,’’ the second
p.(None): time it occurs and inserting ‘‘contractors of the Food and Drug Administration,’’; and
p.(None): (B) by striking ‘‘and committees,’’ and inserting ‘‘and committees and to contracts with such contractors,’’;
p.(None): (6) in paragraph (8)—
p.(None): (A) in subparagraph (A)—
p.(None): (i) by striking ‘‘August of ’’ and inserting ‘‘April of ’’; and
p.(None): (ii) by striking ‘‘August 1992’’ and inserting ‘‘April 1997’’; and
p.(None): (B) in subparagraph (B)—
p.(None): (i) by striking ‘‘section 254(d)’’ and inserting ‘‘sec- tion 254(c)’’;
p.(None): (ii) by striking ‘‘1992’’ and inserting ‘‘1997’’; and
p.(None): (iii) by striking ‘‘102d Congress, 2d Session’’ and inserting ‘‘105th Congress, 1st Session’’; and
p.(None): (7) by adding at the end the following:
p.(None): ‘‘(9) The term ‘affiliate’ means a business entity that has a relationship with a second business entity
p.(None): if, directly or indirectly—
p.(None): ‘‘(A) one business entity controls, or has the power to control, the other business entity; or
p.(None): ‘‘(B) a third party controls, or has power to control, both of the business entities.’’.
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) by striking ‘‘Beginning in fiscal year 1993’’ and inserting ‘‘Beginning in fiscal year 1998’’;
p.(None): (2) in paragraph (1)—
p.(None): (A) by striking subparagraph (B) and inserting the following:
p.(None): ‘‘(B) PAYMENT.—The fee required by subparagraph (A) shall be due upon submission of the application or supple- ment.’’;
p.(None): (B) in subparagraph (D)—
p.(None):
p.(None):
p.(None): 111 STAT. 2300 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): (i) in the subparagraph heading, by striking ‘‘NOT ACCEPTED’’ and inserting ‘‘REFUSED’’;
p.(None): (ii) by striking ‘‘50 percent’’ and inserting ‘‘75 per- cent’’;
p.(None): (iii) by striking ‘‘subparagraph (B)(i)’’ and inserting ‘‘subparagraph (B)’’; and
p.(None): (iv) by striking ‘‘not accepted’’ and inserting ‘‘refused’’; and
p.(None): (C) by adding at the end the following:
p.(None): ‘‘(E) EXCEPTION FOR DESIGNATED ORPHAN DRUG OR
p.(None): INDICATION.—A human drug application for a prescription drug product that has been designated as a drug
p.(None): for a rare disease or condition pursuant to section 526 shall not be subject to a fee under
p.(None): subparagraph (A), unless the human drug application includes an indication for other than a rare disease or
p.(None): condition. A supplement proposing to include a new indication for a rare disease or condition in a human drug
p.(None): application shall not be subject to a fee under subparagraph (A), if the drug has been des- ignated
p.(None): pursuant to section 526 as a drug for a rare disease or condition with regard to the indication proposed in such
p.(None): supplement.
p.(None): ‘‘(F) EXCEPTION FOR SUPPLEMENTS FOR PEDIATRIC
p.(None): INDICATIONS.—A supplement to a human drug application proposing to include a new indication for use in
p.(None): pediatric populations shall not be assessed a fee under subparagraph (A).
p.(None): ‘‘(G) REFUND OF FEE IF APPLICATION WITHDRAWN.—
p.(None): If an application or supplement is withdrawn after the application or supplement was filed, the Secretary
p.(None): may refund the fee or a portion of the fee if no substantial work was performed on the application or
p.(None): supplement after the application or supplement was filed. The Secretary shall have the sole discretion to
p.(None): refund a fee or a portion of the fee under this subparagraph. A determination by the Secretary
p.(None): concerning a refund under this paragraph shall not be reviewable.’’;
p.(None): (3) by striking paragraph (2) and inserting the following: ‘‘(2) PRESCRIPTION DRUG ESTABLISHMENT FEE.—
p.(None): ‘‘(A) IN GENERAL.—Except as provided in subparagraph (B), each person that—
p.(None): ‘‘(i) is named as the applicant in a human drug application; and
p.(None): ‘‘(ii) after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall
p.(None): be assessed an annual fee established in subsection
p.(None): (b) for each prescription drug establishment listed in its approved human drug application as an establishment
p.(None): that manufactures the prescription drug product named in the application. The annual establishment fee shall be
p.(None): assessed in each fiscal year in which the prescription drug product named in the application is assessed a fee
p.(None): under paragraph
p.(None): (3) unless the prescription drug establishment listed in the application does not engage in the
p.(None): manufacture of the prescription drug product during the fiscal year. The establishment fee shall be
p.(None): payable on or before January 31 of each year. Each such establishment shall be assessed
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2301
p.(None):
p.(None): only one fee per establishment, notwithstanding the num- ber of prescription drug products manufactured at
p.(None): the establishment. In the event an establishment is listed in a human drug application by more than one
p.(None): applicant, the establishment fee for the fiscal year shall be divided equally and assessed among the
p.(None): applicants whose prescrip- tion drug products are manufactured by the establishment during the fiscal year and
p.(None): assessed product fees under paragraph (3).
p.(None): ‘‘(B) EXCEPTION.—If, during the fiscal year, an applicant initiates or causes to be initiated the
p.(None): manufacture of a prescription drug product at an establishment listed in its human drug application—
p.(None): ‘‘(i) that did not manufacture the product in the previous fiscal year; and
p.(None): ‘‘(ii) for which the full establishment fee has been assessed in the fiscal year at a time before manufacture of the
p.(None): prescription drug product was begun;
p.(None): the applicant will not be assessed a share of the establish- ment fee for the fiscal year in which the
p.(None): manufacture of the product began.’’; and
p.(None): (4) in paragraph (3)—
p.(None): (A) in subparagraph (A)—
p.(None): (i) in clause (i), by striking ‘‘is listed’’ and inserting ‘‘has been submitted for listing’’; and
p.(None): (ii) by striking ‘‘Such fee shall be payable’’ and all that follows through ‘‘section 510.’’ and
p.(None): inserting the following: ‘‘Such fee shall be payable for the fiscal year in which the product is first submitted for
p.(None): listing under section 510, or is submitted for relisting under section 510 if the product has been
p.(None): withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be
p.(None): payable on or before January 31 of each year. Such fee shall be paid only once for each product for a
p.(None): fiscal year in which the fee is payable.’’; and
p.(None): (B) in subparagraph (B), by striking ‘‘505(j).’’ and inserting the following: ‘‘505(j), under
p.(None): an abbreviated application filed under section 507 (as in effect on the day before the date of
p.(None): enactment of the Food and Drug Administration Modernization Act of 1997), or under an abbreviated new
p.(None): drug application pursuant to regulations in effect prior to the implementation of the Drug Price
p.(None): Competition and Patent Term Restoration Act of 1984.’’.
p.(None): (b) FEE AMOUNTS.—Section 736(b) (21 U.S.C. 379h(b)) is amend- ed to read as follows:
p.(None): ‘‘(b) FEE AMOUNTS.—Except as provided in subsections (c), (d), (f), and (g), the fees required under subsection
p.(None): (a) shall be deter- mined and assessed as follows:
p.(None): ‘‘(1) APPLICATION AND SUPPLEMENT FEES.—
p.(None): ‘‘(A) FULL FEES.—The application fee under subsection (a)(1)(A)(i) shall be $250,704 in fiscal year 1998,
p.(None): $256,338 in each of fiscal years 1999 and 2000, $267,606 in fiscal year 2001, and $258,451 in fiscal year
p.(None): 2002.
p.(None): ‘‘(B) OTHER FEES.—The fee under subsection (a)(1)(A)(ii) shall be $125,352 in fiscal year 1998,
p.(None): $128,169
p.(None):
p.(None):
p.(None): 111 STAT. 2302 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): in each of fiscal years 1999 and 2000, $133,803 in fiscal year 2001, and $129,226 in fiscal year 2002.
p.(None): ‘‘(2) TOTAL FEE REVENUES FOR ESTABLISHMENT FEES.—The
p.(None): total fee revenues to be collected in establishment fees under subsection (a)(2) shall be $35,600,000
p.(None): in fiscal year 1998,
p.(None): $36,400,000 in each of fiscal years 1999 and 2000, $38,000,000 in fiscal year 2001, and $36,700,000 in fiscal year
p.(None): 2002.
p.(None): ‘‘(3) TOTAL FEE REVENUES FOR PRODUCT FEES.—The total
p.(None): fee revenues to be collected in product fees under subsection (a)(3) in a fiscal year shall be equal
p.(None): to the total fee revenues collected in establishment fees under subsection (a)(2) in that fiscal year.’’.
p.(None): (c) INCREASES AND ADJUSTMENTS.—Section 736(c) (21 U.S.C. 379h(c)) is amended—
p.(None): (1) in the subsection heading, by striking ‘‘INCREASES AND’’;
...
p.(None): and inserting the following: ‘‘September 30, 1997, adjust the establishment and product fees described in
p.(None): subsection (b) for the fiscal year in which the adjustment occurs so that the revenues collected from
p.(None): each of the categories of fees described in paragraphs
p.(None): (2) and (3) of subsection (b) shall be set to be equal to the revenues collected from the category of
p.(None): application and supple- ment fees described in paragraph (1) of subsection (b).’’; and
p.(None): (4) in paragraph (3), by striking ‘‘paragraph (2)’’ and insert- ing ‘‘this subsection’’.
p.(None): (d) FEE WAIVER OR REDUCTION.—Section 736(d) (21 U.S.C. 379h(d)) is amended—
p.(None): (1) by redesignating paragraphs (1), (2), (3), and (4) as subparagraphs (A), (B), (C), and (D), respectively
p.(None): and indenting appropriately;
p.(None): (2) by striking ‘‘The Secretary shall grant a’’ and all that follows through ‘‘finds that—’’ and inserting
p.(None): the following:
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall grant a waiver from or a reduction of one or more fees assessed under
p.(None): subsection
p.(None): (a) where the Secretary finds that—’’;
p.(None): (3) in subparagraph (C) (as so redesignated in paragraph (1)), by striking ‘‘, or’’ and inserting a comma;
p.(None): (4) in subparagraph (D) (as so redesignated in paragraph (1)), by striking the period and inserting ‘‘, or’’;
p.(None): (5) by inserting after subparagraph (D) (as so redesignated in paragraph (1)) the following:
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2303
p.(None):
p.(None): ‘‘(E) the applicant involved is a small business submit- ting its first human drug application to the Secretary
p.(None): for review.’’; and
p.(None): (6) by striking ‘‘In making the finding in paragraph (3),’’ and all that follows through ‘‘standard
p.(None): costs.’’ and inserting the following:
p.(None): ‘‘(2) USE OF STANDARD COSTS.—In making the finding in paragraph (1)(C), the Secretary may use standard costs.
p.(None): ‘‘(3) RULES RELATING TO SMALL BUSINESSES.—
p.(None): ‘‘(A) DEFINITION.—In paragraph (1)(E), the term ‘small business’ means an entity that has fewer than 500 employ- ees,
p.(None): including employees of affiliates.
p.(None): ‘‘(B) WAIVER OF APPLICATION FEE.—The Secretary shall waive under paragraph (1)(E) the application fee for the
p.(None): first human drug application that a small business or its affiliate submits to the Secretary for review. After
p.(None): a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay—
p.(None): ‘‘(i) application fees for all subsequent human drug applications submitted to the Secretary for review in the
p.(None): same manner as an entity that does not qualify as a small business; and
p.(None): ‘‘(ii) all supplement fees for all supplements to human drug applications submitted to the Secretary for
p.(None): review in the same manner as an entity that does not qualify as a small business.’’.
p.(None): (e) ASSESSMENT OF FEES.—Section 736(f)(1) (21 U.S.C. 379h(f)(1)) is amended—
p.(None): (1) by striking ‘‘fiscal year 1993’’ and inserting ‘‘fiscal year 1997’’; and
p.(None): (2) by striking ‘‘fiscal year 1992’’ and inserting ‘‘fiscal year 1997 (excluding the amount of fees appropriated for
p.(None): such fiscal year)’’.
p.(None): (f) CREDITING AND AVAILABILITY OF FEES.—Section 736(g) (21
p.(None): U.S.C. 379h(g)) is amended—
p.(None): (1) in paragraph (1), by adding at the end the following: ‘‘Such sums as may be necessary may be
p.(None): transferred from the Food and Drug Administration salaries and expenses appro- priation account without fiscal
p.(None): year limitation to such appro- priation account for salaries and expenses with such fiscal year limitation.
p.(None): The sums transferred shall be available solely for the process for the review of human drug applications.’’;
p.(None): (2) in paragraph (2)—
p.(None): (A) in subparagraph (A), by striking ‘‘Acts’’ and insert- ing ‘‘Acts, or otherwise made available for obligation,’’;
p.(None): and
p.(None): (B) in subparagraph (B), by striking ‘‘over such costs for fiscal year 1992’’ and inserting ‘‘over such costs,
p.(None): exclud- ing costs paid from fees collected under this section, for fiscal year 1997’’; and
p.(None): (3) by striking paragraph (3) and inserting the following: ‘‘(3) AUTHORIZATION OF
p.(None): APPROPRIATIONS.—There are authorized to be appropriated for fees under this section—
p.(None): ‘‘(A) $106,800,000 for fiscal year 1998; ‘‘(B) $109,200,000 for fiscal year 1999; ‘‘(C) $109,200,000 for fiscal year
p.(None): 2000;
p.(None): ‘‘(D) $114,000,000 for fiscal year 2001; and ‘‘(E) $110,100,000 for fiscal year 2002,
p.(None):
p.(None):
p.(None): 111 STAT. 2304 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): as adjusted to reflect adjustments in the total fee revenues made under this section and changes in the
p.(None): total amounts collected by application, supplement, establishment, and prod- uct fees.
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 authorized to be collected under this section pursuant to appropriation Acts
p.(None): for a subsequent fiscal year.’’.
p.(None): (g) REQUIREMENT FOR WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, AND REFUNDS.—Section 736 (21
p.(None): U.S.C. 379h) is amended—
p.(None): (1) by redesignating subsection (i) as subsection (j); and
p.(None): (2) by inserting after subsection (h) the following:
p.(None): ‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, AND
p.(None): REFUNDS.—To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any
p.(None): fee collected in accord- ance with subsection (a), a person shall submit to the Secretary a written request
p.(None): for such waiver, reduction, or refund not later than 180 days after such fee is due.’’.
p.(None):
p.(None): 21 USC 379h
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): 21 USC 379g
p.(None): note.
p.(None): (h) SPECIAL RULE FOR WAIVERS AND REFUNDS.—Any requests for waivers or refunds for fees assessed under
p.(None): section 736 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 379h) prior to the date of enactment
p.(None): of this Act shall be submitted in writing to the Secretary of Health and Human Services within 1 year
p.(None): after the date of enactment of this Act. Any requests for waivers or refunds pertaining to a fee for
p.(None): a human drug application or supplement accepted for filing prior to October 1, 1997 or to a product or
p.(None): establishment fee required by such Act for a fiscal year prior to fiscal year 1998, shall be evaluated
p.(None): according to the terms of the Prescription Drug User Fee Act of 1992 (as in effect on September 30, 1997)
p.(None): and part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (as in effect on
p.(None): September 30, 1997). The term ‘‘person’’ in such Acts shall continue to include an affiliate thereof.
p.(None): SEC. 104. ANNUAL REPORTS.
p.(None): (a) PERFORMANCE REPORT.—Beginning with fiscal year 1998, not later than 60 days after the end of each
p.(None): fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal
p.(None): Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of Health and Human Services shall prepare
p.(None): and submit to the Committee on Commerce of the House of Rep- resentatives and the Committee on Labor
p.(None): and Human Resources of the Senate a report concerning the progress of the Food and Drug Administration in
p.(None): achieving the goals identified in the letters described in section 101(4) during such fiscal year and the
p.(None): future plans of the Food and Drug Administration for meeting the goals.
p.(None): (b) FISCAL REPORT.—Beginning with fiscal year 1998, not later than 120 days after the end of each fiscal year
p.(None): during which fees are collected under the part described in subsection (a), the Secretary of Health and
p.(None): Human Services shall prepare and submit to the Committee on Commerce of the House of Representatives and the
p.(None): Committee on Labor and Human Resources of the Senate
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2305
p.(None):
p.(None):
p.(None): a report on the implementation of the authority for such fees during such fiscal year and the use, by the
p.(None): Food and Drug Adminis- tration, of the fees collected during such fiscal year for which the report is made.
p.(None): SEC. 105. SAVINGS.
p.(None): Notwithstanding section 105 of the Prescription Drug User Fee Act of 1992, the Secretary shall retain the
p.(None): authority to assess and collect any fee required by part 2 of subchapter C of chapter VII of the Federal
p.(None): Food, Drug, and Cosmetic Act for a human drug application or supplement accepted for filing prior to October 1,
p.(None): 1997, and to assess and collect any product or establishment fee required by such Act for a fiscal
p.(None): year prior to fiscal year 1998.
p.(None): SEC. 106. EFFECTIVE DATE.
p.(None): The amendments made by this subtitle shall take effect October 1, 1997.
p.(None): SEC. 107. TERMINATION OF EFFECTIVENESS.
p.(None): The amendments made by sections 102 and 103 cease to be effective October 1, 2002, and section 104
p.(None): ceases to be effective 120 days after such date.
p.(None): Subtitle B—Other Improvements
p.(None): SEC. 111. PEDIATRIC STUDIES OF DRUGS.
p.(None): Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 505 the following:
p.(None): ‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
p.(None): ‘‘(a) MARKET EXCLUSIVITY FOR NEW DRUGS.—If, prior to
p.(None): approval of an application that is submitted under section 505(b)(1), the Secretary determines that information
p.(None): relating to the use of a new drug in the pediatric population may produce health benefits in that population, the
p.(None): Secretary makes a written request for pedi- atric studies (which shall include a timeframe for completing such
p.(None): studies), and such studies are completed within any such timeframe and the reports thereof submitted in
p.(None): accordance with subsection (d)(2) or accepted in accordance with subsection (d)(3)—
p.(None): ‘‘(1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of section 505, and in subsection
p.(None): (j)(4)(D)(ii) of such section, is deemed to be five years and six months rather than five years, and
p.(None): the references in subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of such section to four years, to forty-eight
p.(None): months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and
p.(None): eight years, respectively; or
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): 21 USC 379g
p.(None): note.
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): 21 USC 355a.
p.(None): ‘‘(ii) the period referred to in clauses (iii) and (iv) of sub- section (c)(3)(D) of such section, and
p.(None): in clauses (iii) and (iv) of subsection (j)(4)(D) of such section, is deemed to be three years and six
p.(None): months rather than three years; and
p.(None): ‘‘(B) if the drug is designated under section 526 for a rare disease or condition, the period referred
p.(None): to in section 527(a) is deemed to be seven years and six months rather than seven years; and
p.(None): ‘‘(2)(A) if the drug is the subject of—
p.(None):
p.(None):
p.(None): 111 STAT. 2306 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘(i) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or
p.(None): (j)(2)(A)(vii)(II) of section 505 and for which pediatric studies were submit- ted prior to the expiration of the
p.(None): 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) or
p.(None): (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 505(j)(4)(B)
p.(None): shall be extended by a period of six months after the date the patent expires (including any patent
p.(None): extensions); or
p.(None): ‘‘(B) 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 infringe- ment litigation
p.(None): resulting from the certification the court deter- mines that the patent is valid and would be infringed, the
p.(None): period during which an application may not be approved under section 505(c)(3) or section 505(j)(4)(B) shall be
p.(None): extended by a period of six months after the date the patent expires (includ- ing any patent extensions).
p.(None): ‘‘(b) SECRETARY TO DEVELOP LIST OF DRUGS FOR WHICH ADDI-
p.(None): TIONAL PEDIATRIC INFORMATION MAY BE BENEFICIAL.—Not later
p.(None): than 180 days after the date of enactment of the Food and Drug Administration Modernization Act of 1997,
p.(None): the Secretary, after con- sultation with experts in pediatric research shall develop, prioritize, and publish an
p.(None): initial list of approved drugs for which additional pediatric information may produce health benefits in
p.(None): the pediatric population. The Secretary shall annually update the list.
p.(None): ‘‘(c) MARKET EXCLUSIVITY FOR ALREADY-MARKETED DRUGS.—
p.(None): If the Secretary makes a written request to the holder of an approved application under section
p.(None): 505(b)(1) for pediatric studies (which shall include a timeframe for completing such studies)
p.(None): concerning a drug identified in the list described in subsection (b), the holder agrees to the request,
p.(None): the studies are completed within any such timeframe, and the reports thereof are submitted in accordance
p.(None): with subsection (d)(2) or accepted in accordance with subsection (d)(3)—
p.(None): ‘‘(1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of section 505, and in subsection
p.(None): (j)(4)(D)(ii) of such section, is deemed to be five years and six months rather than five years, and
p.(None): the references in subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of such section to four years, to forty-eight
p.(None): months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and
p.(None): eight years, respectively; or
p.(None): ‘‘(ii) the period referred to in clauses (iii) and (iv) of sub- section (c)(3)(D) of such section, and
p.(None): in clauses (iii) and (iv) of subsection (j)(4)(D) of such section, is deemed to be three years and six
p.(None): months rather than three years; and
p.(None): ‘‘(B) if the drug is designated under section 526 for a rare disease or condition, the period referred
p.(None): to in section 527(a) is deemed to be seven years and six months rather than seven years; and
p.(None): ‘‘(2)(A) 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) or
p.(None): (j)(2)(A)(vii)(II)
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2307
p.(None):
p.(None): of section 505 and for which pediatric studies were submit- ted prior to the expiration of the patent
p.(None): (including any patent extensions); or
p.(None): ‘‘(ii) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iii) or
p.(None): (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 505(j)(4)(B)
p.(None): shall be extended by a period of six months after the date the patent expires (including any patent
p.(None): extensions); or
p.(None): ‘‘(B) 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 infringe- ment litigation
p.(None): resulting from the certification the court deter- mines that the patent is valid and would be infringed, the
p.(None): period during which an application may not be approved under section 505(c)(3) or section 505(j)(4)(B) shall be
p.(None): extended by a period of six months after the date the patent expires (includ- ing any patent extensions).
p.(None): ‘‘(d) CONDUCT OF PEDIATRIC STUDIES.—
p.(None): ‘‘(1) AGREEMENT FOR STUDIES.—The Secretary may, pursu- ant to a written request from the Secretary under
p.(None): subsection
p.(None): (a) or (c), after consultation with—
p.(None): ‘‘(A) the sponsor of an application for an investigational new drug under section 505(i);
p.(None): ‘‘(B) the sponsor of an application for a new drug under section 505(b)(1); or
p.(None): ‘‘(C) the holder of an approved application for a drug under section 505(b)(1),
p.(None): agree with the sponsor or holder for the conduct of pediatric studies for such drug. Such agreement
p.(None): shall be in writing and shall include a timeframe for such studies.
p.(None): ‘‘(2) WRITTEN PROTOCOLS TO MEET THE STUDIES REQUIRE-
p.(None): MENT.—If the sponsor or holder and the Secretary agree upon written protocols for the studies, the
p.(None): studies requirement of subsection (a) or (c) is satisfied upon the completion of the studies and
p.(None): submission of the reports thereof in accordance with the original written request and the written
p.(None): agreement referred to in paragraph (1). Not later than 60 days after the submission of the report of the
p.(None): studies, the Secretary shall determine if such studies were or were not conducted in accord- ance with the original
p.(None): written request and the written agree- ment and reported in accordance with the requirements of the
p.(None): Secretary for filing and so notify the sponsor or holder. ‘‘(3) OTHER METHODS TO MEET THE STUDIES
p.(None): REQUIREMENT.—
p.(None): If the sponsor or holder and the Secretary have not agreed in writing on the protocols for the studies, the
p.(None): studies require- ment of subsection (a) or (c) is satisfied when such studies have been completed and the
p.(None): reports accepted by the Secretary. Not later than 90 days after the submission of the reports of the studies,
p.(None): the Secretary shall accept or reject such reports and so notify the sponsor or holder. The Secretary’s only respon-
p.(None): sibility in accepting or rejecting the reports shall be to deter- mine, within the 90 days, whether the
p.(None): studies fairly respond to the written request, have been conducted in accordance with commonly accepted
p.(None): scientific principles and protocols, and
p.(None):
p.(None):
p.(None): 111 STAT. 2308 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): have been reported in accordance with the requirements of the Secretary for filing.
p.(None): ‘‘(e) DELAY OF EFFECTIVE DATE FOR CERTAIN APPLICATION.—
p.(None): If the Secretary determines that the acceptance or approval of an application under section 505(b)(2) or
p.(None): 505(j) for a new drug may occur after submission of reports of pediatric studies under this section,
p.(None): which were submitted prior to the expiration of the patent (including any patent extension) or the
p.(None): applicable period under clauses (ii) through (iv) of section 505(c)(3)(D) or clauses
p.(None): (ii) through (iv) of section 505(j)(4)(D), but before the Secretary has determined whether the
p.(None): requirements of subsection (d) have been satisfied, the Secretary shall delay the acceptance or approval under
p.(None): section 505(b)(2) or 505(j) until the determination under subsection (d) is made, but any such delay
p.(None): shall not exceed 90 days. In the event that requirements of this section are satisfied, the applicable
p.(None): six-month period under subsection (a) or (c) shall be deemed to have been running during the period of delay.
p.(None): ‘‘(f) NOTICE OF DETERMINATIONS ON STUDIES REQUIREMENT.—
p.(None): The Secretary shall publish a notice of any determination that the requirements of subsection (d) have been
p.(None): met and that submis- sions and approvals under subsection (b)(2) or (j) of section 505 for a drug will be
p.(None): subject to the provisions of this section.
p.(None): ‘‘(g) 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 in which a drug is anticipated to be used. ‘‘(h) LIMITATIONS.—A drug to which the six-month period
p.(None): under
p.(None): subsection (a) or (b) has already been applied—
p.(None): ‘‘(1) may receive an additional six-month period under sub- section (c)(1)(A)(ii) for a supplemental application
p.(None): if all other requirements under this section are satisfied, except that such a drug may not receive any
p.(None): additional such period under sub- section (c)(2); and
p.(None): ‘‘(2) may not receive any additional such period under subsection (c)(1)(B).
p.(None): ‘‘(i) RELATIONSHIP TO REGULATIONS.—Notwithstanding any other provision of law, if any pediatric study
p.(None): is required pursuant to regulations promulgated by the Secretary and such study meets the completeness, timeliness,
p.(None): and other requirements of this section, such study shall be deemed to satisfy the requirement for market
p.(None): exclusivity pursuant to this section.
p.(None): ‘‘(j) SUNSET.—A drug may not receive any six-month period under subsection (a) or (c) unless the
p.(None): application for the drug under section 505(b)(1) is submitted on or before January 1, 2002. After January 1,
p.(None): 2002, a drug shall receive a six-month period under subsection (c) if—
p.(None): ‘‘(1) the drug was in commercial distribution as of the date of enactment of the Food and Drug
p.(None): Administration Mod- ernization Act of 1997;
p.(None): ‘‘(2) the drug was included by the Secretary on the list under subsection (b) as of January 1, 2002;
p.(None): ‘‘(3) the Secretary determines that there is a continuing need for information relating to the use of
p.(None): the drug in the pediatric population and that the drug may provide health benefits in that population; and
p.(None): ‘‘(4) all requirements of this section are met.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2309
p.(None):
p.(None):
p.(None): ‘‘(k) REPORT.—The Secretary shall conduct a study and report to Congress not later than January 1, 2001, based
p.(None): on the experience under the program established under this section. The study and report shall examine all
p.(None): relevant issues, including—
p.(None): ‘‘(1) the effectiveness of the program in improving informa- tion about important pediatric uses for approved drugs;
p.(None): ‘‘(2) the adequacy of the incentive provided under this section;
p.(None): ‘‘(3) the economic impact of the program on taxpayers and consumers, including the impact of the lack of lower cost
p.(None): generic drugs on patients, including on lower income patients; and ‘‘(4) any suggestions for modification
p.(None): that the Secretary
p.(None): determines to be appropriate.’’.
p.(None): SEC. 112. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS.
p.(None): (a) IN GENERAL.—Chapter V (21 U.S.C. 351 et seq.), as amended by section 125, is amended by inserting before
p.(None): section 508 the following:
p.(None): ‘‘SEC. 506. FAST TRACK PRODUCTS.
p.(None): ‘‘(a) DESIGNATION OF DRUG AS A FAST TRACK PRODUCT.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall, at the request of the sponsor of a new drug, facilitate the
p.(None): development and expedite the review of such drug if it is intended for the treatment of a serious or
p.(None): life-threatening condition and it dem- onstrates the potential to address unmet medical needs for such a
p.(None): condition. (In this section, such a drug is referred to as a ‘fast track product’.)
p.(None): ‘‘(2) REQUEST FOR DESIGNATION.—The sponsor of a new drug may request the Secretary to designate the
p.(None): drug as a fast track product. A request for the designation may be made concurrently with, or at any time
p.(None): after, submission of an application for the investigation of the drug under section 505(i) or section 351(a)(3) of
p.(None): the Public Health Service Act.
p.(None): ‘‘(3) DESIGNATION.—Within 60 calendar days after the receipt of a request under paragraph (2), the
p.(None): Secretary shall determine whether the drug that is the subject of the request meets the criteria
p.(None): described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall
p.(None): designate the drug as a fast track product and shall take such actions as are appropriate to expedite
p.(None): the development and review of the application for approval of such product. ‘‘(b) APPROVAL OF APPLICATION
p.(None): FOR A FAST TRACK PRODUCT.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary may approve an applica- tion for approval of a fast track product under
p.(None): section 505(c) or section 351 of the Public Health Service Act upon a deter- mination that the product
p.(None): has an effect on a clinical endpoint or on a surrogate endpoint that is reasonably likely to predict
p.(None): clinical benefit.
p.(None): ‘‘(2) LIMITATION.—Approval of a fast track product under this subsection may be subject to the requirements—
p.(None): ‘‘(A) that the sponsor conduct appropriate post-approval studies to validate the surrogate endpoint or otherwise
p.(None): confirm the effect on the clinical endpoint; and
p.(None): ‘‘(B) that the sponsor submit copies of all promotional materials related to the fast track product
p.(None): during the preapproval review period and, following approval and for such period thereafter as the
p.(None): Secretary determines 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): 21 USC 356.
p.(None):
p.(None):
p.(None): 111 STAT. 2310 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): appropriate, at least 30 days prior to dissemination of the materials.
p.(None): ‘‘(3) EXPEDITED WITHDRAWAL OF APPROVAL.—The Secretary
p.(None): may withdraw approval of a fast track product using expedited procedures (as prescribed by the Secretary in regulations
p.(None): which shall include an opportunity for an informal hearing) if—
p.(None): ‘‘(A) the sponsor fails to conduct any required post- approval study of the fast track drug with due
p.(None): diligence; ‘‘(B) a post-approval study of the fast track product
p.(None): fails to verify clinical benefit of the product;
p.(None): ‘‘(C) other evidence demonstrates that the fast track product is not safe or effective under the
p.(None): conditions of use; or
p.(None): ‘‘(D) the sponsor disseminates false or misleading pro- motional materials with respect to the product.
p.(None): ‘‘(c) REVIEW OF INCOMPLETE APPLICATIONS FOR APPROVAL OF A FAST TRACK PRODUCT.—
p.(None): ‘‘(1) IN GENERAL.—If the Secretary determines, after preliminary evaluation of clinical data submitted
p.(None): by the spon- sor, that a fast track product may be effective, the Secretary shall evaluate for filing, and
p.(None): may commence review of portions of, an application for the approval of the product before the sponsor
p.(None): submits a complete application. The Secretary shall commence such review only if the applicant—
p.(None): ‘‘(A) provides a schedule for submission of information necessary to make the application complete; and
p.(None): ‘‘(B) pays any fee that may be required 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): 21 USC 356 note.
p.(None): 736.
p.(None): ‘‘(2) EXCEPTION.—Any time period for review of human drug applications that has been agreed to by the
p.(None): Secretary and that has been set forth in goals identified in letters of the Secretary (relating to the use
p.(None): of fees collected under section 736 to expedite the drug development process and the review of human drug
p.(None): applications) shall not apply to an application submitted under paragraph (1) until the date on which
p.(None): the application is complete.
p.(None): ‘‘(d) AWARENESS EFFORTS.—The Secretary shall—
p.(None): ‘‘(1) develop and disseminate to physicians, patient organizations, pharmaceutical and
p.(None): biotechnology companies, and other appropriate persons a description of the provisions of this section
p.(None): applicable to fast track products; and
p.(None): ‘‘(2) establish a program to encourage the development of surrogate endpoints that are reasonably likely
p.(None): to predict clinical benefit for serious or life-threatening conditions for which there exist significant unmet
p.(None): medical needs.’’.
p.(None): (b) GUIDANCE.—Within 1 year after the date of enactment of this Act, the Secretary of Health and Human
p.(None): Services shall issue guidance for fast track products (as defined in section 506(a)(1) of the Federal Food, Drug,
p.(None): and Cosmetic Act) that describes the policies and procedures that pertain to section 506 of such Act.
p.(None): SEC. 113. INFORMATION PROGRAM ON CLINICAL TRIALS FOR SERI- OUS OR LIFE-THREATENING DISEASES.
p.(None): (a) IN GENERAL.—Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended—
p.(None): (1) by redesignating subsections (j) and (k) as subsections
p.(None): (k) and (l), respectively; and
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997
p.(None): (2) by inserting after subsection (i) the following:
p.(None): 111 STAT. 2311
p.(None):
p.(None): ‘‘(j)(1)(A) The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a
p.(None): data bank of information on clinical trials for drugs for serious or life-threatening diseases and
p.(None): conditions (in this subsection referred to as the ‘data bank’). The activities of the data bank shall be
p.(None): integrated and coordinated with related activities of other agencies of the Department of Health and Human Services,
p.(None): and to the extent practicable, coordinated with other data banks containing similar information.
p.(None): ‘‘(B) The Secretary shall establish the data bank after consulta- tion with the Commissioner of Food and Drugs,
p.(None): the directors of the appropriate agencies of the National Institutes of Health (including the
p.(None): National Library of Medicine), and the Director of the Centers for Disease Control and Prevention.
p.(None): ‘‘(2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the
p.(None): information described in such paragraph. The Secretary shall disseminate such information through
p.(None): information systems, which shall include toll-free telephone communications, available to individuals with
p.(None): serious or life- threatening diseases and conditions, to other members of the public, to health care providers, and
p.(None): to researchers.
p.(None): ‘‘(3) The data bank shall include the following:
p.(None): ‘‘(A) A registry of clinical trials (whether federally or pri- vately funded) of experimental treatments
p.(None): for serious or life- threatening diseases and conditions under regulations promul- gated pursuant to section
p.(None): 505(i) of the Federal Food, Drug, and Cosmetic Act, which provides a description of the purpose of each
p.(None): experimental drug, either with the consent of the proto- col sponsor, or when a trial to test effectiveness begins.
p.(None): Informa- tion provided shall consist of eligibility criteria for participation in the clinical trials, a description of
p.(None): the location of trial sites, and a point of contact for those wanting to enroll in the trial, and shall
p.(None): be in a form that can be readily understood by members of the public. Such information shall be
p.(None): forwarded to the data bank by the sponsor of the trial not later than 21 days after the approval of the
p.(None): protocol.
p.(None): ‘‘(B) Information pertaining to experimental treatments for serious or life-threatening diseases and conditions
p.(None): that may be available—
p.(None): ‘‘(i) under a treatment investigational new drug application that has been submitted to the Secretary under
p.(None): section 561(c) of the Federal Food, Drug, and Cosmetic Act; or
p.(None): ‘‘(ii) as a Group C cancer drug (as defined by the National Cancer Institute).
p.(None): The data bank may also include information pertaining to the results of clinical trials of such treatments,
p.(None): with the consent of the sponsor, including information concerning potential toxicities or adverse effects
p.(None): associated with the use or adminis- tration of such experimental treatments.
p.(None): ‘‘(4) The data bank shall not include information relating to an investigation if the sponsor has provided a
p.(None): detailed certification to the Secretary that disclosure of such information would substan- tially interfere with the
p.(None): timely enrollment of subjects in the inves- tigation, unless the Secretary, after the receipt of the certification,
p.(None): provides the sponsor with a detailed written determination that
p.(None): Establishment.
p.(None):
p.(None):
p.(None): 111 STAT. 2312 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): such disclosure would not substantially interfere with such enroll- ment.
p.(None):
p.(None): Appropriation authorization.
p.(None):
p.(None):
p.(None): 42 USC 282 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):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 352 note.
p.(None): ‘‘(5) For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as
p.(None): may be necessary. Fees collected under section 736 of the Federal Food, Drug, and Cosmetic Act shall not
p.(None): be used in carrying out this subsection.’’.
p.(None): (b) COLLABORATION AND REPORT.—
p.(None): (1) IN GENERAL.—The Secretary of Health and Human Services, the Director of the National Institutes of
p.(None): Health, and the Commissioner of Food and Drugs shall collaborate to determine the feasibility of including
p.(None): device investigations within the scope of the data bank under section 402(j) of the Public Health Service
p.(None): Act.
p.(None): (2) REPORT.—Not later than two years after the date of enactment of this section, the Secretary of Health and
p.(None): Human Services shall prepare and submit to the Committee on Labor and Human Resources of the Senate and
p.(None): the Committee on Commerce of the House of Representatives a report—
p.(None): (A) of the public health need, if any, for inclusion of device investigations within the scope of the
p.(None): data bank under section 402(j) of the Public Health Service Act;
p.(None): (B) on the adverse impact, if any, on device innovation and research in the United States if information
p.(None): relating to such device investigations is required to be publicly disclosed; and
p.(None): (C) on such other issues relating to such section 402(j) as the Secretary determines to be appropriate.
p.(None): SEC. 114. HEALTH CARE ECONOMIC INFORMATION.
p.(None): (a) IN GENERAL.—Section 502(a) (21 U.S.C. 352(a)) is amended by adding at the end the following: ‘‘Health care economic
p.(None): informa- tion provided to a formulary committee, or other similar entity, in the course of the committee or
p.(None): the entity carrying out its respon- sibilities for the selection of drugs for managed care or other similar
p.(None): organizations, shall not be considered to be false or misleading under this paragraph if the health
p.(None): care economic information directly relates to an indication approved under section 505 or under section
p.(None): 351(a) of the Public Health Service Act for such drug and is based on competent and reliable scientific
p.(None): evidence. The requirements set forth in section 505(a) or in section 351(a) of the Public Health Service
p.(None): Act shall not apply to health care economic information provided to such a committee or entity in
p.(None): accordance with this paragraph. Information that is relevant to the substantiation of the health care
p.(None): economic information pre- sented pursuant to this paragraph shall be made available to the Secretary upon
p.(None): request. In this paragraph, the term ‘health care economic information’ means any analysis that identifies,
p.(None): measures, or compares the economic consequences, including the costs of the represented health outcomes, of
p.(None): the use of a drug to the use of another drug, to another health care intervention, or to no interven- tion.’’.
p.(None): (b) STUDY AND REPORT.—The Comptroller General of the United States shall conduct a study of the implementation of the
p.(None): provisions added by the amendment made by subsection (a). Not later than
p.(None): 4 years and 6 months after the date of enactment of this Act, the Comptroller General of the United
p.(None): States shall prepare and submit to Congress a report containing the findings of the study.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2313
p.(None):
p.(None):
p.(None): SEC. 115. CLINICAL INVESTIGATIONS.
p.(None): (a) CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL INVESTIGATIONS FOR APPROVAL.—Section 505(d) (21
p.(None): U.S.C. 355(d)) is amended by adding at the end the following: ‘‘If the Secretary determines, based
p.(None): on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence
p.(None): (obtained prior to or after such investigation) are sufficient to establish effectiveness, the Secretary
p.(None): may consider such data and evidence to constitute substantial evidence for purposes of the preceding
p.(None): sentence.’’.
p.(None): (b) WOMEN AND MINORITIES.—Section 505(b)(1) (21 U.S.C. 355(b)(1)) is amended by adding at the end
p.(None): the following: ‘‘The Secretary shall, in consultation with the Director of the National Institutes of Health
p.(None): and with representatives of the drug manufac- turing industry, review and develop guidance, as appropriate, on
p.(None): the inclusion of women and minorities in clinical trials required by clause (A).’’.
p.(None): SEC. 116. MANUFACTURING CHANGES FOR DRUGS.
p.(None): (a) IN GENERAL.—Chapter V, as amended by section 112, is amended by inserting after section 506 the following
p.(None): section:
p.(None): ‘‘SEC. 506A. MANUFACTURING CHANGES.
p.(None): ‘‘(a) IN GENERAL.—With respect to a drug for which there is in effect an approved application under
p.(None): section 505 or 512 or a license under section 351 of the Public Health Service Act, a change from the
p.(None): manufacturing process approved pursuant to such application or license may be made, and the drug as made
p.(None): with the change may be distributed, if—
p.(None): ‘‘(1) the holder of the approved application or license (referred to in this section as a
p.(None): ‘holder’) has validated the effects of the change in accordance with subsection (b); and ‘‘(2)(A) in the
p.(None): case of a major manufacturing change, the holder has complied with the requirements of subsection (c);
p.(None): 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): 21 USC 356a.
p.(None): ‘‘(B) in the case of a change that is not a major manufactur- ing change, the holder complies with the
p.(None): applicable require- ments of subsection (d).
p.(None): ‘‘(b) VALIDATION OF EFFECTS OF CHANGES.—For purposes of
p.(None): subsection (a)(1), a drug made with a manufacturing change (whether a major manufacturing change
p.(None): or otherwise) may be distributed only if, before distribution of the drug as so made, the holder involved
p.(None): validates the effects of the change on the iden- tity, strength, quality, purity, and potency of the drug as the iden-
p.(None): tity, strength, quality, purity, and potency may relate to the safety or effectiveness of the drug.
p.(None): ‘‘(c) MAJOR MANUFACTURING CHANGES.—
p.(None): ‘‘(1) REQUIREMENT OF SUPPLEMENTAL APPLICATION.—For
p.(None): purposes of subsection (a)(2)(A), a drug made with a major manufacturing change may be distributed only
p.(None): if, before the distribution of the drug as so made, the holder involved submits to the Secretary a supplemental
p.(None): application for such change and the Secretary approves the application. The application shall contain such
p.(None): information as the Secretary determines to be appropriate, and shall include the information developed under
p.(None): subsection (b) by the holder in validating the effects of the change.
p.(None):
p.(None):
p.(None): 111 STAT. 2314 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None): ‘‘(2) CHANGES QUALIFYING AS MAJOR CHANGES.—For pur-
p.(None): poses of subsection (a)(2)(A), a major manufacturing change is a manufacturing change that is determined by the
p.(None): Secretary to have substantial potential to adversely affect the identity, strength, quality, purity, or
p.(None): potency of the drug as they may relate to the safety or effectiveness of a drug. Such a change
p.(None): includes a change that—
p.(None): ‘‘(A) is made in the qualitative or quantitative formula- tion of the drug involved or in the specifications
p.(None): in the approved application or license referred to in subsection
p.(None): (a) for the drug (unless exempted by the Secretary by regulation or guidance from the requirements of
p.(None): this sub- section);
p.(None): ‘‘(B) is determined by the Secretary by regulation or guidance to require completion of an appropriate
p.(None): clinical study demonstrating equivalence of the drug to the drug as manufactured without the change; or
p.(None): ‘‘(C) is another type of change determined by the Sec- retary by regulation or guidance to have a substantial
p.(None): potential to adversely affect the safety or effectiveness of the drug.
p.(None): ‘‘(d) OTHER MANUFACTURING CHANGES.—
p.(None): ‘‘(1) IN GENERAL.—For purposes of subsection (a)(2)(B), the Secretary may regulate drugs made with
p.(None): manufacturing changes that are not major manufacturing changes as follows: ‘‘(A) The Secretary may in accordance with
p.(None): paragraph
p.(None): (2) authorize holders to distribute such drugs without submitting a supplemental application for
p.(None): such changes. ‘‘(B) The Secretary may in accordance with paragraph
p.(None): (3) require that, prior to the distribution of such drugs, holders submit to the Secretary supplemental
p.(None): applications for such changes.
p.(None): ‘‘(C) The Secretary may establish categories of such changes and designate categories to which
p.(None): subparagraph
p.(None): (A) applies and categories to which subparagraph (B) applies.
p.(None): ‘‘(2) CHANGES NOT REQUIRING SUPPLEMENTAL APPLICA- TION.—
p.(None): ‘‘(A) SUBMISSION OF REPORT.—A holder making a manufacturing change to which paragraph (1)(A) applies
p.(None): shall submit to the Secretary a report on the change, which shall contain such information as the
p.(None): Secretary determines to be appropriate, and which shall include the information developed under subsection (b) by
p.(None): the holder in validating the effects of the change. The report shall be submitted by such date as the
p.(None): Secretary may specify. ‘‘(B) AUTHORITY REGARDING ANNUAL REPORTS.—In the
p.(None): case of a holder that during a single year makes more than one manufacturing change to which paragraph (1)(A)
p.(None): applies, the Secretary may in carrying out subparagraph
p.(None): (A) authorize the holder to comply with such subparagraph by submitting a single report for the year that
p.(None): provides the information required in such subparagraph for all the changes made by the holder during the year.
p.(None): ‘‘(3) CHANGES REQUIRING SUPPLEMENTAL APPLICATION.— ‘‘(A) SUBMISSION OF SUPPLEMENTAL APPLICATION.—The
p.(None): supplemental application required under paragraph (1)(B)
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2315
p.(None):
p.(None):
p.(None): for a manufacturing change shall contain such information as the Secretary determines to be appropriate, which shall
p.(None): include the information developed under subsection (b) by the holder in validating the effects of the change.
p.(None): ‘‘(B) AUTHORITY FOR DISTRIBUTION.—In the case of a
p.(None): manufacturing change to which paragraph (1)(B) applies: ‘‘(i) The holder involved may commence distribu-
p.(None): tion of the drug involved 30 days after the Secretary receives the supplemental application under such para-
p.(None): graph, unless the Secretary notifies the holder within such 30-day period that prior approval of the
p.(None): applica- tion is required before distribution may be commenced. ‘‘(ii) The Secretary may designate a category of
p.(None): such changes for the purpose of providing that, in the case of a change that is in such category, the
p.(None): holder involved may commence distribution of the drug involved upon the receipt by the Secretary of a supple-
p.(None): mental application for the change.
p.(None): ‘‘(iii) If the Secretary disapproves the supplemental application, the Secretary may order the manufacturer to cease
p.(None): the distribution of the drugs that have been made with the manufacturing change.’’.
p.(None): (b) TRANSITION RULE.—The amendment made by subsection
p.(None): (a) takes effect upon the effective date of regulations promulgated by the Secretary of Health and Human
p.(None): Services to implement such amendment, or upon the expiration of the 24-month period beginning on the
p.(None): date of the enactment of this Act, whichever occurs first.
p.(None): SEC. 117. STREAMLINING CLINICAL RESEARCH ON DRUGS.
p.(None): Section 505(i) (21 U.S.C. 355(i)) is amended—
p.(None): (1) by redesignating paragraphs (1) through (3) as subpara- graphs (A) through (C), respectively;
p.(None): (2) by inserting ‘‘(1)’’ after ‘‘(i)’’;
p.(None): (3) by striking the last two sentences; and
p.(None): (4) by inserting after paragraph (1) (as designated by para- graph (2) of this section) the following new paragraphs:
p.(None): ‘‘(2) Subject to paragraph (3), a clinical investigation of a new drug may begin 30 days after the
p.(None): Secretary has received from the manufacturer or sponsor of the investigation a submission containing such
p.(None): information about the drug and the clinical inves- tigation, including—
p.(None): ‘‘(A) information on design of the investigation and ade- quate reports of basic information, certified
p.(None): by the applicant to be accurate reports, necessary to assess the safety of the drug for use in clinical
p.(None): investigation; and
p.(None): ‘‘(B) adequate information on the chemistry and manufac- turing of the drug, controls available for the drug,
p.(None): and primary data tabulations from animal or human studies.
p.(None): ‘‘(3)(A) At any time, the Secretary may prohibit the sponsor of an investigation from conducting the
p.(None): investigation (referred to in this paragraph as a ‘clinical hold’) if the Secretary makes a determination
p.(None): described in subparagraph (B). The Secretary shall specify the basis for the clinical hold, including the
p.(None): specific informa- tion available to the Secretary which served as the basis for such clinical hold, and
p.(None): confirm such determination in writing.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 356a
p.(None): note.
p.(None):
p.(None):
p.(None): 111 STAT. 2316 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘(B) For purposes of subparagraph (A), a determination described in this subparagraph with respect
p.(None): to a clinical hold is 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):
p.(None):
p.(None):
p.(None):
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): ‘‘(i) the drug involved represents an unreasonable risk to the safety of the persons who are the
p.(None): subjects of the clinical investigation, taking into account the qualifications of the clini- cal investigators,
p.(None): information about the drug, the design of the clinical investigation, the condition for which the drug is
p.(None): to be investigated, and the health status of the subjects involved; or
p.(None): ‘‘(ii) the clinical hold should be issued for such other reasons as the Secretary may by regulation establish
p.(None): (including reasons established by regulation before the date of the enactment of the Food and Drug
p.(None): Administration Modernization Act of 1997).
p.(None): ‘‘(C) Any written request to the Secretary from the sponsor of an investigation that a clinical hold be
p.(None): removed shall receive a decision, in writing and specifying the reasons therefor, within 30 days after
p.(None): receipt of such request. Any such request shall include sufficient information to support the removal of such
p.(None): clinical hold. ‘‘(4) Regulations under paragraph (1) shall provide that such exemption shall be conditioned
p.(None): upon the manufacturer, or the spon- sor of the investigation, requiring that experts using such drugs for
p.(None): investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom
p.(None): such drugs, or any controls used in connection therewith, are being adminis- tered, or their
p.(None): representatives, that such drugs are being used for investigational purposes and will obtain the consent
p.(None): of such human beings or their representatives, except where it is not fea- sible or it is contrary to
p.(None): the best interests of such human beings. Nothing in this subsection shall be construed to require any clinical
p.(None): investigator to submit directly to the Secretary reports on the
p.(None): investigational use of drugs.’’.
p.(None): SEC. 118. DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS.
p.(None): Within 12 months after the date of enactment of this Act, the Secretary of Health and Human Services,
p.(None): acting through the Commissioner of Food and Drugs, shall issue guidance that describes when
p.(None): abbreviated study reports may be submitted, in lieu of full reports, with a new drug application under
p.(None): section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and with a biologics
p.(None): license application under section 351 of the Public Health Service Act (42 U.S.C. 262) for certain types
p.(None): of studies. Such guidance shall describe the kinds of studies for which abbreviated reports are
p.(None): appropriate and the appropriate abbreviated report formats.
p.(None): SEC. 119. CONTENT AND REVIEW OF APPLICATIONS.
p.(None): (a) SECTION 505(b).—Section 505(b) (21 U.S.C. 355(b)) is amend- ed by adding at the end the following:
p.(None): ‘‘(4)(A) The Secretary shall issue guidance for the individuals who review applications submitted under
p.(None): paragraph (1) or under section 351 of the Public Health Service Act, which shall relate to promptness in
p.(None): conducting the review, technical excellence, lack of bias and conflict of interest, and knowledge of
p.(None): regulatory and scientific standards, and which shall apply equally to all individuals who review such applications.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2317
p.(None):
p.(None): ‘‘(B) The Secretary shall meet with a sponsor of an investigation or an applicant for approval for a drug under
p.(None): this subsection or section 351 of the Public Health Service Act if the sponsor or applicant makes a
p.(None): reasonable written request for a meeting for the purpose of reaching agreement on the design and size of clinical
p.(None): trials intended to form the primary basis of an effectiveness claim. The sponsor or applicant shall provide
p.(None): information necessary for discussion and agreement on the design and size of the clinical trials. Minutes
p.(None): of any such meeting shall be prepared by the Sec- retary and made available to the sponsor or applicant upon
p.(None): request. ‘‘(C) Any agreement regarding the parameters of the design and size of clinical trials of a
p.(None): new drug under this paragraph that is reached between the Secretary and a sponsor or applicant shall be
p.(None): reduced to writing and made part of the administrative record by the Secretary. Such agreement shall not
p.(None): be changed
p.(None): after the testing begins, except—
p.(None): ‘‘(i) with the written agreement of the sponsor or applicant;
p.(None): or
p.(None): ‘‘(ii) pursuant to a decision, made in accordance with
p.(None): subparagraph (D) by the director of the reviewing division, that a substantial scientific issue essential
p.(None): to determining the safety or effectiveness of the drug has been identified after the testing has begun.
p.(None): ‘‘(D) A decision under subparagraph (C)(ii) by the director shall be in writing and the Secretary shall provide
p.(None): to the sponsor or applicant an opportunity for a meeting at which the director and the sponsor or
p.(None): applicant will be present and at which the director will document the scientific issue involved.
p.(None): ‘‘(E) The written decisions of the reviewing division shall be binding upon, and may not directly or
p.(None): indirectly be changed by, the field or compliance division personnel unless such field or compliance
p.(None): division personnel demonstrate to the reviewing division why such decision should be modified.
p.(None): ‘‘(F) No action by the reviewing division may be delayed because of the unavailability of information from or action by
p.(None): field personnel unless the reviewing division determines that a delay is necessary to assure the marketing of a safe
p.(None): and effective drug.
p.(None): ‘‘(G) For purposes of this paragraph, the reviewing division is the division responsible for the review
p.(None): of an application for approval of a drug under this subsection or section 351 of the Public Health
p.(None): Service Act (including all scientific and medical mat- ters, chemistry, manufacturing, and controls).’’.
p.(None): (b) SECTION 505(j).—
p.(None): (1) AMENDMENT.—Section 505(j) (21 U.S.C 355(j)) is amend- ed—
p.(None): (A) by redesignating paragraphs (3) through (8) as paragraphs (4) through (9), respectively; and
p.(None): (B) by adding after paragraph (2) the following:
p.(None): ‘‘(3)(A) The Secretary shall issue guidance for the individuals who review applications submitted under
p.(None): paragraph (1), which shall relate to promptness in conducting the review, technical excellence, lack of bias and
p.(None): conflict of interest, and knowledge of regulatory and scientific standards, and which shall apply equally
p.(None): to all individuals who review such applications.
p.(None): ‘‘(B) The Secretary shall meet with a sponsor of an investigation or an applicant for approval for a drug under
p.(None): this subsection if the sponsor or applicant makes a reasonable written request for
p.(None):
p.(None):
p.(None): 111 STAT. 2318 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): a meeting for the purpose of reaching agreement on the design and size of bioavailability and
p.(None): bioequivalence studies needed for approval of such application. The sponsor or applicant shall provide information
p.(None): necessary for discussion and agreement on the design and size of such studies. Minutes of any such
p.(None): meeting shall be prepared by the Secretary and made available to the sponsor or applicant.
p.(None): ‘‘(C) Any agreement regarding the parameters of design and size of bioavailability and bioequivalence
p.(None): studies of a drug under this paragraph that is reached between the Secretary and a sponsor or applicant shall be
p.(None): reduced to writing and made part of the administrative record by the Secretary. Such agreement shall
p.(None): not be changed after the testing begins, except—
p.(None): ‘‘(i) with the written agreement of the sponsor or applicant;
p.(None): or
p.(None): ‘‘(ii) pursuant to a decision, made in accordance with
p.(None): subparagraph (D) by the director of the reviewing division, that a substantial scientific issue essential
p.(None): to determining the safety or effectiveness of the drug has been identified after the testing has begun.
p.(None): ‘‘(D) A decision under subparagraph (C)(ii) by the director shall be in writing and the Secretary shall provide
p.(None): to the sponsor or applicant an opportunity for a meeting at which the director and the sponsor or
p.(None): applicant will be present and at which the director will document the scientific issue involved.
p.(None): ‘‘(E) The written decisions of the reviewing division shall be binding upon, and may not directly or
p.(None): indirectly be changed by, the field or compliance office personnel unless such field or compli- ance office
p.(None): personnel demonstrate to the reviewing division why such decision should be modified.
p.(None): ‘‘(F) No action by the reviewing division may be delayed because of the unavailability of information from or action by
p.(None): field personnel unless the reviewing division determines that a delay is necessary to assure the marketing of a safe
p.(None): and effective drug.
p.(None): ‘‘(G) For purposes of this paragraph, the reviewing division is the division responsible for the review
p.(None): of an application for approval of a drug under this subsection (including scientific mat- ters, chemistry,
p.(None): manufacturing, and controls).’’.
p.(None): (2) CONFORMING AMENDMENTS.—Section 505(j) (21 U.S.C. 355(j)), as amended by paragraph (1), is further
p.(None): amended—
p.(None): (A) in paragraph (2)(A)(i), by striking ‘‘(6)’’ and insert- ing ‘‘(7)’’;
p.(None): (B) in paragraph (4) (as redesignated in paragraph (1)), by striking ‘‘(4)’’ and inserting ‘‘(5)’’;
p.(None): (C) in paragraph (4)(I) (as redesignated in paragraph (1)), by striking ‘‘(5)’’ and inserting ‘‘(6)’’; and
p.(None): (D) in paragraph (7)(C) (as redesignated in paragraph (1)), by striking ‘‘(5)’’ each place it occurs and
p.(None): inserting ‘‘(6)’’.
p.(None): SEC. 120. SCIENTIFIC ADVISORY PANELS.
p.(None): Section 505 (21 U.S.C. 355) is amended by adding at the end the following:
p.(None): ‘‘(n)(1) For the purpose of providing expert scientific advice and recommendations to the Secretary
p.(None): regarding a clinical inves- tigation of a drug or the approval for marketing of a drug under section
p.(None): 505 or section 351 of the Public Health Service Act, the
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2319
p.(None):
p.(None): Secretary shall establish panels of experts or use panels of experts established before the date of enactment of
p.(None): the Food and Drug Administration Modernization Act of 1997, or both.
p.(None): ‘‘(2) The Secretary may delegate the appointment and oversight authority granted under section 904 to a director
p.(None): of a center or successor entity within the Food and Drug Administration.
p.(None): ‘‘(3) The Secretary shall make appointments to each panel established under paragraph (1) so that each
p.(None): panel shall consist of—
p.(None): ‘‘(A) members who are qualified by training and experience to evaluate the safety and effectiveness of the
p.(None): drugs to be referred to the panel and who, to the extent feasible, possess skill and experience in the
p.(None): development, manufacture, or utili- zation of such drugs;
p.(None): ‘‘(B) members with diverse expertise in such fields as clini- cal and administrative medicine, pharmacy,
p.(None): pharmacology, pharmacoeconomics, biological and physical sciences, and other related professions;
p.(None): ‘‘(C) a representative of consumer interests, and a rep- resentative of interests of the drug
p.(None): manufacturing industry not directly affected by the matter to be brought before the panel; and
p.(None): ‘‘(D) two or more members who are specialists or have other expertise in the particular disease or condition
p.(None): for which the drug under review is proposed to be indicated.
p.(None): Scientific, trade, and consumer organizations shall be afforded an opportunity to nominate individuals for
p.(None): appointment to the panels. No individual who is in the regular full-time employ of the United States and engaged in
p.(None): the administration of this Act may be a voting member of any panel. The Secretary shall designate one
p.(None): of the members of each panel to serve as chairman thereof.
p.(None): ‘‘(4) Each member of a panel shall publicly disclose all conflicts of interest that member may have with the work to be
p.(None): undertaken by the panel. No member of a panel may vote on any matter where the member or the immediate
p.(None): family of such member could gain financially from the advice given to the Secretary. The Sec- retary
p.(None): may grant a waiver of any conflict of interest requirement upon public disclosure of such conflict of
p.(None): interest if such waiver is necessary to afford the panel essential expertise, except that the Secretary
p.(None): may not grant a waiver for a member of a panel when the member’s own scientific work is involved.
p.(None): ‘‘(5) The Secretary shall, as appropriate, provide education and training to each new panel member before such member
p.(None): participates in a panel’s activities, including education regarding requirements under this Act and related
p.(None): regulations of the Secretary, and the administrative processes and procedures related to panel meetings. ‘‘(6)
p.(None): Panel members (other than officers or employees of the United States), while attending meetings or conferences
p.(None): of a panel or otherwise engaged in its business, shall be entitled to receive compensation for each day
p.(None): so engaged, including traveltime, at rates to be fixed by the Secretary, but not to exceed the daily
p.(None): equivalent of the rate in effect for positions classified above grade GS–15 of the General Schedule.
p.(None): While serving away from their homes or regular places of business, panel members may be allowed travel expenses
p.(None): (including per diem in lieu of subsistence) as author- ized by section 5703 of title 5, United States Code,
p.(None): for persons
p.(None): in the Government service employed intermittently.
p.(None):
p.(None):
p.(None): 111 STAT. 2320 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘(7) The Secretary shall ensure that scientific advisory panels meet regularly and at appropriate
p.(None): intervals so that any matter to be reviewed by such a panel can be presented to the panel not more
p.(None): than 60 days after the matter is ready for such review. Meetings of the panel may be held using electronic
p.(None): communication to convene the meetings.
p.(None): ‘‘(8) Within 90 days after a scientific advisory panel makes recommendations on any matter under its
p.(None): review, the Food and Drug Administration official responsible for the matter shall review the conclusions and
p.(None): recommendations of the panel, and notify the affected persons of the final decision on the matter, or
p.(None): of the reasons that no such decision has been reached. Each such final decision shall be documented
p.(None): including the rationale for the deci- sion.’’.
p.(None): SEC. 121. POSITRON EMISSION TOMOGRAPHY.
p.(None): (a) REGULATION OF COMPOUNDED POSITRON EMISSION TOMOG- RAPHY DRUGS.—Section 201 (21 U.S.C. 321) is amended by
p.(None): adding at the end the following:
p.(None): ‘‘(ii) The term ‘compounded positron emission tomography drug’—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 351 note.
p.(None): ‘‘(1) means a drug that—
p.(None): ‘‘(A) exhibits spontaneous disintegration of unstable nuclei by the emission of positrons and is used for
p.(None): the purpose of providing dual photon positron emission tomo- graphic diagnostic images; and
p.(None): ‘‘(B) has been compounded by or on the order of a practitioner who is licensed by a State to compound
p.(None): or order compounding for a drug described in subparagraph (A), and is compounded in accordance with that
p.(None): State’s law, for a patient or for research, teaching, or quality control; and
p.(None): ‘‘(2) includes any nonradioactive reagent, reagent kit, ingredient, nuclide generator, accelerator, target
p.(None): material, elec- tronic synthesizer, or other apparatus or computer program to be used in the preparation of such
p.(None): a drug.’’.
p.(None): (b) ADULTERATION.—
p.(None): (1) IN GENERAL.—Section 501(a) (21 U.S.C. 351(a)) is amended by striking ‘‘; or (3)’’ and
p.(None): inserting the following: ‘‘; or (C) if it is a compounded positron emission tomography drug and the
p.(None): methods used in, or the facilities and controls used for, its compounding, processing, packing, or
p.(None): holding do not conform to or are not operated or administered in conformity with the positron emission tomography
p.(None): compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug
p.(None): meets the requirements of this Act as to safety and has the identity and strength, and meets the
p.(None): quality and purity characteristics, that it purports or is represented to possess; or (3)’’.
p.(None): (2) SUNSET.—Section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall
p.(None): not apply
p.(None): 4 years after the date of enactment of this Act or 2 years after the date on which the Secretary of
p.(None): Health and Human Services establishes the requirements described in subsection (c)(1)(B), whichever is later.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2321
p.(None):
p.(None):
p.(None): (c) REQUIREMENTS FOR REVIEW OF APPROVAL PROCEDURES AND CURRENT GOOD MANUFACTURING PRACTICES FOR
p.(None): POSITRON EMIS- SION TOMOGRAPHY.—
p.(None): (1) PROCEDURES AND REQUIREMENTS.—
p.(None): (A) IN GENERAL.—In order to take account of the special characteristics of positron emission tomography drugs and the
p.(None): special techniques and processes required to produce these drugs, not later than 2 years after the date of enact-
p.(None): ment of this Act, the Secretary of Health and Human Services shall establish—
p.(None): (i) appropriate procedures for the approval of positron emission tomography drugs pursuant to sec-
p.(None): tion 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
p.(None): (ii) appropriate current good manufacturing prac- tice requirements for such drugs.
p.(None): (B) CONSIDERATIONS AND CONSULTATION.—In establish- ing the procedures and requirements required by subpara- graph (A),
p.(None): the Secretary of Health and Human Services shall take due account of any relevant differences between
p.(None): not-for-profit institutions that compound the drugs for their patients and commercial manufacturers of the drugs. Prior
p.(None): to establishing the procedures and requirements, the Sec- retary of Health and Human Services shall
p.(None): consult with patient advocacy groups, professional associations, manu- facturers, and physicians and
p.(None): scientists licensed to make or use positron emission tomography drugs.
p.(None): (2) SUBMISSION OF NEW DRUG APPLICATIONS AND ABBRE- VIATED NEW DRUG APPLICATIONS.—
p.(None): (A) IN GENERAL.—Except as provided in subparagraph (B), the Secretary of Health and Human Services shall not
p.(None): require the submission of new drug applications or abbreviated new drug applications under subsection (b)
p.(None): or (j) of section 505 (21 U.S.C. 355), for compounded positron emission tomography drugs that
p.(None): are not adulter- ated drugs described in section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21
p.(None): U.S.C. 351(a)(2)(C)) (as amended by subsection (b)), for a period of 4 years after the date of enactment
p.(None): of this Act, or for 2 years after the date on which the Secretary establishes procedures and
p.(None): requirements under paragraph (1), whichever is longer.
p.(None): (B) EXCEPTION.—Nothing in this Act shall prohibit the voluntary submission of such applications or the review of
p.(None): such applications by the Secretary of Health and Human Services. Nothing in this Act shall constitute an exemption for
p.(None): a positron emission tomography drug from the require- ments of regulations issued under section 505(i) of the
p.(None): Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)).
p.(None): (d) REVOCATION OF CERTAIN INCONSISTENT DOCUMENTS.— Within 30 days after the date of enactment of this
p.(None): Act, the Secretary of Health and Human Services shall publish in the Federal Register a notice terminating the
p.(None): application of the following notices and rule:
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):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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): (1) A notice entitled ‘‘Regulation of Positron Emission Tomography Radiopharmaceutical Drug Products;
p.(None): Guidance; Public Workshop’’, published in the Federal Register on Feb- ruary 27, 1995, 60 Fed. Reg. 10594.
p.(None):
p.(None):
p.(None): 111 STAT. 2322 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): (2) A notice entitled ‘‘Draft Guideline on the Manufacture of Positron Emission Tomography
p.(None): Radiopharmaceutical Drug Products; Availability’’, published in the Federal Register on February 27, 1995, 60
p.(None): Fed. Reg. 10593.
p.(None): (3) A final rule entitled ‘‘Current Good Manufacturing Prac- tice for Finished Pharmaceuticals; Positron Emission
p.(None): Tomog- raphy’’, published in the Federal Register on April 22, 1997,
p.(None): 62 Fed. Reg. 19493 (codified at part 211 of title 21, Code of Federal Regulations).
p.(None):
p.(None): 21 USC 355 note.
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355 note.
p.(None): (e) DEFINITION.—As used in this section, the term ‘‘compounded positron emission tomography drug’’ has the
p.(None): meaning given the term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
p.(None): SEC. 122. REQUIREMENTS FOR RADIOPHARMACEUTICALS.
p.(None): (a) REQUIREMENTS.—
p.(None): (1) REGULATIONS.—
p.(None): (A) PROPOSED REGULATIONS.—Not later than 180 days after the date of enactment of this Act, the Secretary of
p.(None): Health and Human Services, after consultation with patient advocacy groups, associations, physicians
p.(None): licensed to use radiopharmaceuticals, and the regulated industry, shall issue proposed regulations governing
p.(None): the approval of radiopharmaceuticals. The regulations shall provide that the determination of the safety and
p.(None): effectiveness of such a radiopharmaceutical under section 505 of the Federal Food, Drug, and Cosmetic Act
p.(None): (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262) shall include consideration
p.(None): of the proposed use of the radiopharmaceutical in the practice of medicine, the
p.(None): pharmacological and toxicological activity of the radiopharmaceutical (including any carrier
p.(None): or ligand component of the radiopharmaceutical), and the estimated absorbed radiation dose of the
p.(None): radiopharmaceutical.
p.(None): (B) FINAL REGULATIONS.—Not later than 18 months after the date of enactment of this Act, the Secretary shall
p.(None): promulgate final regulations governing the approval of the radiopharmaceuticals.
p.(None): (2) SPECIAL RULE.—In the case of a radiopharmaceutical, the indications for which such radiopharmaceutical is
p.(None): approved for marketing may, in appropriate cases, refer to manifestations of disease (such as biochemical,
p.(None): physiological, anatomic, or pathological processes) common to, or present in, one or more disease states.
p.(None): (b) DEFINITION.—In this section, the term ‘‘radiopharma- ceutical’’ means—
p.(None): (1) an article—
p.(None): (A) that is intended for use in the diagnosis or monitor- ing of a disease or a manifestation of a disease in humans;
p.(None): and
p.(None): (B) that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or
p.(None): photons; or
p.(None): (2) any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation
p.(None): of any such article.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2323
p.(None):
p.(None): SEC. 123. MODERNIZATION OF REGULATION.
p.(None): (a) LICENSES.—
...
p.(None): mark.’’.
p.(None):
p.(None):
p.(None): 111 STAT. 2324 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): (c) INSPECTION.—Section 351(c) of the Public Health Service Act (42 U.S.C. 262(c)) is amended by striking
p.(None): ‘‘virus, serum,’’ and all that follows and inserting ‘‘biological product.’’.
p.(None): (d) DEFINITION; APPLICATION.—Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended by adding
p.(None): at the end the following:
p.(None): ‘‘(i) In this section, the term ‘biological product’ means a virus, therapeutic serum, toxin, antitoxin, vaccine,
p.(None): blood, blood component or derivative, allergenic product, or analogous product, or arsphen- amine or derivative of
p.(None): arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a
p.(None): disease or condition of human beings.’’.
p.(None): (e) CONFORMING AMENDMENT.—Section 503(g)(4) (21 U.S.C. 353(g)(4)) is amended—
p.(None): (1) in subparagraph (A)—
p.(None): (A) by striking ‘‘section 351(a)’’ and inserting ‘‘section 351(i)’’; and
p.(None): (B) by striking ‘‘262(a)’’ and inserting ‘‘262(i)’’; and
p.(None): (2) in subparagraph (B)(iii), by striking ‘‘product or establishment license under subsection (a) or
p.(None): (d)’’ and inserting ‘‘biologics license application under subsection (a)’’.
p.(None):
p.(None): 21 USC 355 note.
p.(None): (f) SPECIAL RULE.—The Secretary of Health and Human Serv- ices shall take measures to minimize differences in
p.(None): the review and approval of products required to have approved biologics license applications under section 351 of
p.(None): the Public Health Service Act (42 U.S.C. 262) and products required to have approved new drug
p.(None): applications under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)).
p.(None): (g) APPLICATION OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.—Section 351 of the Public Health
p.(None): Service Act (42 U.S.C. 262), as amended by subsection (d), is further amended by adding at the end the
p.(None): following:
p.(None): ‘‘(j) The Federal Food, Drug, and Cosmetic Act applies to a biological product subject to regulation
p.(None): under this section, except that a product for which a license has been approved under sub- section (a)
p.(None): shall not be required to have an approved application under section 505 of such Act.’’.
p.(None): (h) EXAMINATIONS AND PROCEDURES.—Paragraph (3) of section 353(d) of the Public Health Service Act (42 U.S.C.
p.(None): 263a(d)) is amended to read as follows:
p.(None): ‘‘(3) EXAMINATIONS AND PROCEDURES.—The examinations
p.(None): and procedures identified in paragraph (2) are laboratory examinations and procedures that have been
p.(None): approved by the Food and Drug Administration for home use or that, as deter- mined by the Secretary, are simple
p.(None): laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that—
p.(None): ‘‘(A) employ methodologies that are so simple and accurate as to render the likelihood of
p.(None): erroneous results by the user negligible, or
p.(None): ‘‘(B) the Secretary has determined pose no unreason- able risk of harm to the patient if performed
p.(None): incorrectly.’’.
p.(None): SEC. 124. PILOT AND SMALL SCALE MANUFACTURE.
p.(None): (a) HUMAN DRUGS.—Section 505(c) (21 U.S.C. 355(c)) is amend- ed by adding at the end the following:
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2325
p.(None):
p.(None): ‘‘(4) A drug manufactured in a pilot or other small facility may be used to demonstrate the safety and
p.(None): effectiveness of the drug and to obtain approval for the drug prior to manufacture of the drug in a
p.(None): larger facility, unless the Secretary makes a determination that a full scale production facility is
p.(None): necessary to ensure the safety or effectiveness of the drug.’’.
p.(None): (b) ANIMAL DRUGS.—Section 512(c) (21 U.S.C. 360b(c)) is amended by adding at the end the following:
p.(None): ‘‘(4) A drug manufactured in a pilot or other small facility may be used to demonstrate the safety and
p.(None): effectiveness of the drug and to obtain approval for the drug prior to manufacture of the drug in a
p.(None): larger facility, unless the Secretary makes a determination that a full scale production facility is
p.(None): necessary to ensure the safety or effectiveness of the drug.’’.
p.(None): SEC. 125. INSULIN AND ANTIBIOTICS.
p.(None): (a) CERTIFICATION OF DRUGS CONTAINING INSULIN.—
p.(None): (1) AMENDMENT.—Section 506 (21 U.S.C. 356), as in effect before the date of the enactment of this Act, is repealed.
p.(None): (2) CONFORMING AMENDMENTS.—
p.(None): (A) Section 301(j) (21 U.S.C. 331(j)) is amended by striking ‘‘506, 507,’’.
p.(None): (B) Subsection (k) of section 502 (21 U.S.C. 352) is repealed.
p.(None): (C) Sections 301(i)(1), 510(j)(1)(A), and 510(j)(1)(D) (21
p.(None): U.S.C. 331(i)(1), 360(j)(1)(A), 360(j)(1)(D)) are each amended by striking ‘‘, 506, 507,’’.
p.(None): (D) Section 801(d)(1) (21 U.S.C. 381(d)(1)) is amended by inserting after ‘‘503(b)’’ the following: ‘‘or
p.(None): composed wholly or partly of insulin’’.
p.(None): (E) Section 8126(h)(2) of title 38, United States Code, is amended by inserting ‘‘or’’ at the end of
p.(None): subparagraph (B), by striking ‘‘; or’’ at the end of subparagraph (C) and inserting a period, and by
p.(None): striking subparagraph (D).
p.(None): (b) CERTIFICATION OF ANTIBIOTICS.—
p.(None): (1) AMENDMENT.—Section 507 (21 U.S.C. 357) is repealed.
p.(None): (2) CONFORMING AMENDMENTS.—
p.(None): (A) Section 201(aa) (21 U.S.C. 321(aa)) is amended by striking out ‘‘or 507’’, section 201(dd) (21 U.S.C.
p.(None): 321(dd)) is amended by striking ‘‘507,’’, and section 201(ff)(3)(A) (21 U.S.C. 321(ff)(3)(A)) is amended by
p.(None): striking ‘‘, certified as an antibiotic under section 507,’’.
p.(None): (B) Section 301(e) (21 U.S.C. 331(e)) is amended by striking ‘‘507(d) or (g),’’.
p.(None): (C) Section 306(d)(4)(B)(ii) (21 U.S.C. 335a(d)(4)(B)(ii))
p.(None): is amended by striking ‘‘or 507’’.
p.(None): (D) Section 502 (21 U.S.C. 352) is amended by striking subsection (l).
p.(None): (E) Section 520(l) (21 U.S.C. 360j(l)) is amended by striking paragraph (4) and by striking ‘‘or Antibiotic
p.(None): Drugs’’ in the subsection heading.
p.(None): (F) Section 525(a) (21 U.S.C. 360aa(a)) is amended by inserting ‘‘or’’ at the end of paragraph (1), by
p.(None): striking paragraph (2), and by redesignating paragraph (3) as para- graph (2).
p.(None):
p.(None):
p.(None): 111 STAT. 2326 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): (G) Section 525(a) (21 U.S.C. 360aa(a)) is amended by striking ‘‘, certification of such drug for such
p.(None): disease or condition under section 507,’’.
p.(None): (H) Section 526(a)(1) (21 U.S.C. 360bb) is amended by striking ‘‘the submission of an application for
p.(None): certifi- cation of the drug under section 507,’’, by inserting ‘‘or’’ at the end of subparagraph (A), by
p.(None): striking subparagraph (B), and by redesignating subparagraph (C) as subpara- graph (B).
p.(None): (I) Section 526(b) (21 U.S.C. 360bb(b)) is amended—
p.(None): (i) in paragraph (1), by striking ‘‘, a certificate was issued for the drug under section 507,’’; and
p.(None): (ii) in paragraph (2) by striking ‘‘, a certificate has not been issued for the drug under section
p.(None): 507,’’ and by striking ‘‘, approval of an application for certifi- cation under section 507,’’.
p.(None): (J) Section 527(a) (21 U.S.C. 360cc(a)) is amended by inserting ‘‘or’’ at the end of paragraph (1), by
p.(None): striking paragraph (2), by redesignating paragraph (3) as paragraph (2), and by striking ‘‘, issue another
p.(None): certification under section 507,’’.
p.(None): (K) Section 527(b) (21 U.S.C. 360cc(b)) is amended by striking ‘‘, if a certification is issued under
p.(None): section 507 for such a drug,’’, ‘‘, of the issuance of the certification under section 507,’’, ‘‘, issue another
p.(None): certification under section 507,’’, ‘‘, of such certification,’’, ‘‘, of the certifi- cation,’’, and ‘‘,
p.(None): issuance of other certifications,’’.
p.(None): (L) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended by striking ‘‘, section 507 (d) or (g),’’.
p.(None): (M) Section 735(1) (21 U.S.C. 379g(1)(C)) is amended by inserting ‘‘or’’ at the end of subparagraph (B), by
p.(None): striking subparagraph (C), and by redesignating subparagraph (D) as subparagraph (C).
p.(None): (N) Subparagraphs (A)(ii) and (B) of sections 5(b)(1) of the Orphan Drug Act (21 U.S.C.
p.(None): 360ee(b)(1)(A), 360ee(b)(1)(B)) are each amended by striking ‘‘or 507’’.
p.(None): (O) Section 45C(b)(2)(A)(ii)(II) of the Internal Revenue
p.(None):
p.(None): 26 USC 45C.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355 note.
p.(None): Code of 1986 is amended by striking ‘‘or 507’’.
p.(None): (P) Section 156(f)(4)(B) of title 35, United States Code, is amended by striking ‘‘507,’’ each place it occurs.
p.(None): (c) EXPORTATION.—Section 802 (21 U.S.C. 382) is amended by adding at the end the following:
p.(None): ‘‘(i) Insulin and antibiotic drugs may be exported without regard to the requirements in this section if the
p.(None): insulin and antibiotic drugs meet the requirements of section 801(e)(1).’’.
p.(None): (d) TRANSITION.—
p.(None): (1) IN GENERAL.—An application that was approved by the Secretary of Health and Human Services before
p.(None): the date of the enactment of this Act for the marketing of an antibiotic drug under section 507 of the Federal Food,
p.(None): Drug, and Cosmetic Act (21 U.S.C. 357), as in effect on the day before the date of the enactment of
p.(None): this Act, shall, on and after such date of enactment, be considered to be an application that was
p.(None): submitted and filed under section 505(b) of such Act (21 U.S.C. 355(b)) and approved for safety and effectiveness under
p.(None): section
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2327
p.(None):
p.(None): 505(c) of such Act (21 U.S.C. 355(c)), except that if such applica- tion for marketing was in the form of an
p.(None): abbreviated applica- tion, the application shall be considered to have been filed and approved under section
p.(None): 505(j) of such Act (21 U.S.C. 355(j)).
p.(None): (2) EXCEPTION.—The following subsections of section 505 (21 U.S.C. 355) shall not apply to any application for
p.(None): marketing in which the drug that is the subject of the application contains an antibiotic drug and the antibiotic
p.(None): drug was the subject of any application for marketing received by the Secretary of Health and Human
p.(None): Services under section 507 of such Act (21 U.S.C. 357) before the date of the enactment of this Act:
p.(None): (A)(i) Subsections (c)(2), (d)(6), (e)(4), (j)(2)(A)(vii),
p.(None): (j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), and (j)(4)(D); and
p.(None): (ii) The third and fourth sentences of subsection (b)(1) (regarding the filing and publication of patent information);
p.(None): and
p.(None): (B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and (c)(3) if the investigations relied upon by the
p.(None): applicant for approval of the application were not conducted by or for the applicant and for which the
p.(None): applicant has not obtained a right of reference or use from the person by or for whom the investigations
p.(None): were conducted.
p.(None): (3) PUBLICATION.—For purposes of this section, the Sec- retary is authorized to make available to the public the
p.(None): estab- lished name of each antibiotic drug that was the subject of any application for marketing received
p.(None): by the Secretary for Health and Human Services under section 507 of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 357) before the date of enactment of this Act.
p.(None): (e) DEFINITION.—Section 201 (21 U.S.C. 321), as amended by section 121(a)(1), is further amended by
p.(None): adding at the end the following:
p.(None): ‘‘(jj) The term ‘antibiotic drug’ means any drug (except drugs for use in animals other than humans)
p.(None): composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chlor- amphenicol,
p.(None): bacitracin, or any other drug intended for human use containing any quantity of any chemical substance
p.(None): which is pro- duced by a micro-organism and which has the capacity to inhibit or destroy micro-organisms in
p.(None): dilute solution (including a chemically synthesized equivalent of any such substance) or any derivative
p.(None): thereof.’’.
p.(None): SEC. 126. ELIMINATION OF CERTAIN LABELING REQUIREMENTS.
p.(None): (a) PRESCRIPTION DRUGS.—Section 503(b)(4) (21 U.S.C. 353(b)(4)) is amended to read as follows:
p.(None): ‘‘(4)(A) A drug that is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to
p.(None): dispensing the label of the drug fails to bear, at a minimum, the symbol ‘Rx only’. ‘‘(B) A drug to
p.(None): which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing
p.(None): the label of the drug bears the symbol described in subparagraph (A).’’.
p.(None): (b) MISBRANDED DRUG.—Section 502(d) (21 U.S.C. 352(d)) is repealed.
p.(None): (c) CONFORMING AMENDMENTS.—
p.(None): (1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended—
p.(None): (A) by striking subparagraph (A); and
p.(None):
p.(None):
p.(None): 111 STAT. 2328 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): (B) by redesignating subparagraphs (B) and (C) as subparagraphs (A) and (B), respectively.
p.(None): (2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by striking ‘‘section 502(d) and’’.
p.(None): (3) Section 102(9)(A) of the Controlled Substances Act (21
p.(None): U.S.C. 802(9)(A)) is amended—
p.(None): (A) in clause (i), by striking ‘‘(i)’’; and
p.(None): (B) by striking ‘‘(ii)’’ and all that follows.
p.(None): SEC. 127. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHAR- MACY COMPOUNDING.
p.(None): (a) AMENDMENT.—Chapter V is amended by inserting after section 503 (21 U.S.C. 353) the following:
p.(None):
p.(None): 21 USC 353a.
p.(None): ‘‘SEC. 503A. PHARMACY COMPOUNDING.
p.(None): ‘‘(a) IN GENERAL.—Sections 501(a)(2)(B), 502(f)(1), and 505 shall not apply to a drug product if the drug
p.(None): product is compounded for an identified individual patient based on the unsolicited receipt of a valid prescription
p.(None): order or a notation, approved by the prescrib- ing practitioner, on the prescription order that a compounded prod- uct
p.(None): is necessary for the identified patient, if the drug product meets the requirements of this section, and
p.(None): if the compounding—
p.(None): ‘‘(1) is by—
p.(None): ‘‘(A) a licensed pharmacist in a State licensed pharmacy or a Federal facility, or
p.(None): ‘‘(B) a licensed physician,
p.(None): on the prescription order for such individual patient made by a licensed physician or other licensed
p.(None): practitioner authorized by State law to prescribe drugs; or
p.(None): ‘‘(2)(A) is by a licensed pharmacist or licensed physician in limited quantities before the receipt of a
p.(None): valid prescription order for such individual patient; and
p.(None): ‘‘(B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription
p.(None): orders for the compounding of the drug product, which orders have been generated solely within an
p.(None): established relationship between— ‘‘(i) the licensed pharmacist or licensed physician; and
p.(None): ‘‘(ii)(I) such individual patient for whom the prescrip- tion order will be provided; or
p.(None): ‘‘(II) the physician or other licensed practitioner who will write such prescription order.
p.(None): ‘‘(b) COMPOUNDED DRUG.—
p.(None): ‘‘(1) LICENSED PHARMACIST AND LICENSED PHYSICIAN.—A
p.(None): drug product may be compounded under subsection (a) if the licensed pharmacist or licensed physician—
p.(None): ‘‘(A) compounds the drug product using bulk drug sub- stances, as defined in regulations of the Secretary published at
p.(None): section 207.3(a)(4) of title 21 of the Code of Federal Regulations—
p.(None): ‘‘(i) that—
p.(None): ‘‘(I) comply with the standards of an applicable United States Pharmacopoeia or National For- mulary
p.(None): monograph, if a monograph exists, and the United States Pharmacopoeia chapter on phar- macy compounding;
p.(None): ‘‘(II) if such a monograph does not exist, are drug substances that are components of drugs
p.(None): approved by the Secretary; or
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2329
p.(None):
p.(None): ‘‘(III) if such a monograph does not exist and the drug substance is not a component of a drug
p.(None): approved by the Secretary, that appear on a list developed by the Secretary through regulations issued by
p.(None): the Secretary under subsection (d);
p.(None): ‘‘(ii) that are manufactured by an establishment that is registered under section 510 (including a foreign
p.(None): establishment that is registered under section 510(i)); and
p.(None): ‘‘(iii) that are accompanied by valid certificates of analysis for each bulk drug substance;
p.(None): ‘‘(B) compounds the drug product using ingredients (other than bulk drug substances) that comply with the
p.(None): standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph
p.(None): exists, and the United States Pharmacopoeia chapter on pharmacy compounding;
p.(None): ‘‘(C) does not compound a drug product that appears on a list published by the Secretary in the Federal
p.(None): Register of drug products that have been withdrawn or removed from the market because such drug products or
p.(None): components of such drug products have been found to be unsafe or not effective; and
p.(None): ‘‘(D) does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug
p.(None): products that are essentially copies of a commercially available drug product.
p.(None): ‘‘(2) DEFINITION.—For purposes of paragraph (1)(D), the term ‘essentially a copy of a commercially available drug
p.(None): prod- uct’ does not include a drug product in which there is a change, made for an identified individual patient,
p.(None): which produces for that patient a significant difference, as determined by the prescribing practitioner,
p.(None): between the compounded drug and the comparable commercially available drug product.
p.(None): ‘‘(3) DRUG PRODUCT.—A drug product may be compounded under subsection (a) only if—
p.(None): ‘‘(A) such drug product is not a drug product identified by the Secretary by regulation as a drug product that
p.(None): presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the
p.(None): safety or effectiveness of that drug product; and
p.(None): ‘‘(B) such drug product is compounded in a State— ‘‘(i) that has entered into a memorandum of under- standing
p.(None): with the Secretary which addresses the dis- tribution of inordinate amounts of compounded drug products
p.(None): interstate and provides for appropriate inves- tigation by a State agency of complaints relating to compounded
p.(None): drug products distributed outside such
p.(None): State; or
p.(None): ‘‘(ii) that has not entered into the memorandum of understanding described in clause (i) and the
p.(None): licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be
p.(None): distributed) compounded drug products out of the State in which they are compounded in quantities that do not
p.(None): exceed
p.(None): 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician.
p.(None):
p.(None):
p.(None): 111 STAT. 2330 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): The Secretary shall, in consultation with the National Associa- tion of Boards of Pharmacy, develop a standard
p.(None): memorandum of understanding for use by the States in complying with subparagraph (B)(i).
p.(None): ‘‘(c) ADVERTISING AND PROMOTION.—A drug may be compounded under subsection (a) only if the pharmacy, licensed
p.(None): pharmacist, or licensed physician does not advertise or promote the compounding of any particular drug, class of drug,
p.(None): or type of drug. The pharmacy, licensed pharmacist, or licensed physician may advertise and pro- mote the
p.(None): compounding service provided by the licensed pharmacist or licensed physician.
p.(None): ‘‘(d) REGULATIONS.—
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall issue regulations to implement this section. Before issuing regulations to
p.(None): imple- ment subsections (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A), the Sec- retary shall convene and consult an
p.(None): advisory committee on compounding unless the Secretary determines that the issuance of such regulations before
p.(None): consultation is necessary to protect the public health. The advisory committee shall include rep-
p.(None): resentatives from the National Association of Boards of Phar- macy, the United States Pharmacopoeia, pharmacy,
p.(None): physician, and consumer organizations, and other experts selected by the Secretary.
p.(None): ‘‘(2) LIMITING COMPOUNDING.—The Secretary, in consulta-
p.(None): tion with the United States Pharmacopoeia Convention, Incor- porated, shall promulgate regulations identifying
p.(None): drug sub- stances that may be used in compounding under subsection (b)(1)(A)(i)(III) for which a monograph
p.(None): does not exist or which are not components of drug products approved by the Secretary. The Secretary shall
p.(None): include in the regulation the criteria for such substances, which shall include historical use, reports in
p.(None): peer reviewed medical literature, or other criteria the Sec- retary may identify.
p.(None): ‘‘(e) APPLICATION.—This section shall not apply to—
p.(None): ‘‘(1) compounded positron emission tomography drugs as defined in section 201(ii); or
p.(None): ‘‘(2) radiopharmaceuticals.
p.(None): ‘‘(f) DEFINITION.—As used in this section, the term ‘compounding’ does not include mixing,
p.(None): reconstituting, or other such acts that are performed in accordance with directions contained in approved
p.(None): labeling provided by the product’s manufacturer and other manufacturer directions consistent with that
p.(None): labeling.’’.
p.(None):
p.(None): 21 USC 353a
p.(None): note.
p.(None): (b) EFFECTIVE DATE.—Section 503A of the Federal Food, Drug, and Cosmetic Act, added by subsection (a), shall
p.(None): take effect upon the expiration of the 1-year period beginning on the date of the enactment of this Act.
p.(None): SEC. 128. REAUTHORIZATION OF CLINICAL PHARMACOLOGY PRO- GRAM.
p.(None): Section 2 of Public Law 102–222 (105 Stat. 1677) is amended—
p.(None): (1) in subsection (a), by striking ‘‘a grant’’ and all that follows through ‘‘Such grant’’ and
p.(None): inserting the following: ‘‘grants for a pilot program for the training of individuals in clinical
p.(None): pharmacology at appropriate medical schools. Such grants’’; and
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2331
p.(None):
p.(None):
p.(None): (2) in subsection (b), by striking ‘‘to carry out this section’’ and inserting ‘‘, and for fiscal years
p.(None): 1998 through 2002
p.(None): $3,000,000 for each fiscal year, to carry out this section’’.
p.(None): SEC. 129. REGULATIONS FOR SUNSCREEN PRODUCTS.
p.(None): Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services
p.(None): shall issue regula- tions for over-the-counter sunscreen products for the prevention or treatment of sunburn.
p.(None): SEC. 130. REPORTS OF POSTMARKETING APPROVAL STUDIES.
p.(None): (a) IN GENERAL.—Chapter V, as amended by section 116, is further amended by inserting after section 506A
p.(None): the following:
p.(None): ‘‘SEC. 506B. REPORTS OF POSTMARKETING STUDIES.
p.(None): ‘‘(a) SUBMISSION.—
p.(None): ‘‘(1) IN GENERAL.—A sponsor of a drug that has entered into an agreement with the Secretary
p.(None): to conduct a postmarketing study of a drug shall submit to the Secretary, within 1 year after the
p.(None): approval of such drug and annually thereafter until the study is completed or terminated, a report of the
p.(None): progress of the study or the reasons for the failure of the sponsor to conduct the study. The report shall be
p.(None): submit- ted in such form as is prescribed by the Secretary in regulations issued by the Secretary.
p.(None): ‘‘(2) AGREEMENTS PRIOR TO EFFECTIVE DATE.—Any agree-
p.(None): ment entered into between the Secretary and a sponsor of a drug, prior to the date of enactment of
p.(None): the Food and Drug Administration Modernization Act of 1997, to conduct a postmarketing study of a
p.(None): drug shall be subject to the require- ments of paragraph (1). An initial report for such an agreement shall be
p.(None): submitted within 6 months after the date of the issu- ance of the regulations under paragraph (1).
p.(None): ‘‘(b) CONSIDERATION OF INFORMATION AS PUBLIC INFORMA-
p.(None): TION.—Any information pertaining to a report described in sub- section (a) shall be considered to be
p.(None): public information to the extent that the information is necessary—
p.(None): ‘‘(1) to identify the sponsor; and
p.(None): ‘‘(2) to establish the status of a study described in sub- section (a) and the reasons, if any, for
p.(None): any failure to carry out the study.
p.(None): ‘‘(c) STATUS OF STUDIES AND REPORTS.—The Secretary shall annually develop and publish in the Federal
p.(None): Register a report that provides information on the status of the postmarketing studies—
p.(None): ‘‘(1) that sponsors have entered into agreements to conduct;
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 393 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 356b.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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): and
p.(None): ‘‘(2) for which reports have been submitted under sub-
p.(None):
p.(None): section (a)(1).’’.
p.(None): (b) REPORT TO CONGRESSIONAL COMMITTEES.—Not later than October 1, 2001, the Secretary shall prepare and
p.(None): submit to the Committee on Labor and Human Resources of the Senate and the Committee on Commerce of the
p.(None): House of Representatives a report containing—
p.(None): (1) a summary of the reports submitted under section 506B of the Federal Food, Drug, and Cosmetic Act;
p.(None): (2) an evaluation of—
p.(None):
p.(None): 21 USC 356b
p.(None): note.
p.(None):
p.(None):
p.(None): 111 STAT. 2332 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): (A) the performance of the sponsors referred to in such section in fulfilling the agreements with
p.(None): respect to the conduct of postmarketing studies described in such section of such Act; and
p.(None): (B) the timeliness of the Secretary’s review of the postmarketing studies; and
p.(None): (3) any legislative recommendations respecting the postmarketing studies.
p.(None): SEC. 131. NOTIFICATION OF DISCONTINUANCE OF A LIFE SAVING PRODUCT.
p.(None): (a) IN GENERAL.—Chapter V, as amended by section 130, is further amended by inserting after section 506B
p.(None): the following:
p.(None):
p.(None): 21 USC 356c.
p.(None): ‘‘SEC. 506C. DISCONTINUANCE OF A LIFE SAVING PRODUCT.
p.(None): ‘‘(a) IN GENERAL.—A manufacturer that is the sole manufac- turer of a drug—
p.(None): ‘‘(1) that is—
p.(None): ‘‘(A) life-supporting; ‘‘(B) life-sustaining; or
p.(None): ‘‘(C) intended for use in the prevention of a debilitating disease or condition;
p.(None): ‘‘(2) for which an application has been approved under section 505(b) or 505(j); and
p.(None): ‘‘(3) that is not a product that was originally derived from human tissue and was replaced by a recombinant
p.(None): product, shall notify the Secretary of a discontinuance of the manufacture of the drug at least 6 months prior
p.(None): to the date of the discontinuance. ‘‘(b) REDUCTION IN NOTIFICATION PERIOD.—The notification
p.(None): period required under subsection (a) for a manufacturer may be reduced if the manufacturer certifies to
p.(None): the Secretary that good cause exists for the reduction, such as a situation in which— ‘‘(1) a public
p.(None): health problem may result from continuation
p.(None): of the manufacturing for the 6-month period;
p.(None): ‘‘(2) a biomaterials shortage prevents the continuation of the manufacturing for the 6-month period;
p.(None): ‘‘(3) a liability problem may exist for the manufacturer if the manufacturing is continued for the 6-month
p.(None): period;
p.(None): ‘‘(4) continuation of the manufacturing for the 6-month period may cause substantial economic hardship for the
p.(None): manu- facturer;
p.(None): ‘‘(5) the manufacturer has filed for bankruptcy under chap- ter 7 or 11 of title 11, United States Code; or
p.(None): ‘‘(6) the manufacturer can continue the distribution of the drug involved for 6 months.
p.(None): ‘‘(c) DISTRIBUTION.—To the maximum extent practicable, the Secretary shall distribute information on the
p.(None): discontinuation of the drugs described in subsection (a) to appropriate physician and patient
p.(None): organizations.’’.
p.(None): TITLE II—IMPROVING REGULATION OF DEVICES
p.(None): SEC. 201. INVESTIGATIONAL DEVICE EXEMPTIONS.
p.(None): (a) IN GENERAL.—Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end the following:
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2333
p.(None):
p.(None): ‘‘(6)(A) Not later than 1 year after the date of the enactment of the Food and Drug Administration
p.(None): Modernization Act of 1997, the Secretary shall by regulation establish, with respect to a device for which an
p.(None): exemption under this subsection is in effect, procedures and conditions that, without requiring an additional
p.(None): approval of an application for an exemption or the approval of a supplement to such an application, permit—
p.(None): ‘‘(i) developmental changes in the device (including manu- facturing changes) that do not constitute a
p.(None): significant change in design or in basic principles of operation and that are made in response to information
p.(None): gathered during the course of an investigation; and
p.(None): ‘‘(ii) changes or modifications to clinical protocols that do not affect—
p.(None): ‘‘(I) the validity of data or information resulting from the completion of an approved protocol, or the
p.(None): relationship of likely patient risk to benefit relied upon to approve a protocol;
p.(None): ‘‘(II) the scientific soundness of an investigational plan submitted under paragraph (3)(A); or
p.(None): ‘‘(III) the rights, safety, or welfare of the human sub- jects involved in the investigation.
p.(None): ‘‘(B) Regulations under subparagraph (A) shall provide that a change or modification described in such
p.(None): subparagraph may be made if—
p.(None): ‘‘(i) the sponsor of the investigation determines, on the basis of credible information (as defined by the
p.(None): Secretary) that the applicable conditions under subparagraph (A) are met; and ‘‘(ii) the sponsor submits to the
p.(None): Secretary, not later than
p.(None): 5 days after making the change or modification, a notice of the change or modification.
...
p.(None): device can be found substantially equivalent to a legally marketed device, the director of the
p.(None): organizational unit responsible for regulating devices (in this subparagraph referred to as the
p.(None): ‘Director’) may require a statement in labeling that provides appropriate information regarding a use of the
p.(None): device not identified in the proposed labeling if, after providing an oppor- tunity for consultation with the person
p.(None): who submitted such report, the Director determines and states in writing—
p.(None): ‘‘(I) that there is a reasonable likelihood that the device will be used for an intended use not identified in
p.(None): the proposed labeling for the device; and
p.(None): ‘‘(II) that such use could cause harm. ‘‘(ii) Such determination shall—
p.(None): ‘‘(I) be provided to the person who submitted the report within 10 days from the date of the notification of
p.(None): the Director’s concerns regarding the proposed labeling;
p.(None): ‘‘(II) specify the limitations on the use of the device not included in the proposed labeling; and
p.(None): ‘‘(III) find the device substantially equivalent if the require- ments of subparagraph (A) are met and if the
p.(None): labeling for such device conforms to the limitations specified in subclause (II).
p.(None): ‘‘(iii) The responsibilities of the Director under this subpara- graph may not be delegated.
p.(None):
p.(None):
p.(None): 111 STAT. 2338 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘(iv) This subparagraph has no legal effect after the expiration of the five-year period beginning on the date
p.(None): of the enactment of the Food and Drug Administration Modernization Act of 1997.’’.
p.(None): (c) SECTION 515(d).—Section 515(d) (21 U.S.C. 360e(d)) is amended—
p.(None): (1) in paragraph (1)(A), by adding after and below clause
p.(None): (ii) the following:
p.(None): ‘‘In making the determination whether to approve or deny the application, the Secretary shall rely
p.(None): on the conditions of use included in the proposed labeling as the basis for determining whether or
p.(None): not there is a reasonable assurance of safety and effectiveness, if the proposed labeling is neither
p.(None): false nor mislead- ing. In determining whether or not such labeling is false or mislead- ing, the Secretary shall
p.(None): fairly evaluate all material facts pertinent to the proposed labeling.’’; and
p.(None): (2) by adding after paragraph (5) (as added by section 202(2)) the following:
p.(None): ‘‘(6)(A)(i) A supplemental application shall be required for any change to a device subject to an
p.(None): approved application under this subsection that affects safety or effectiveness, unless such change is a
p.(None): modification in a manufacturing procedure or method of manu- facturing and the holder of the approved
p.(None): application submits a written notice to the Secretary that describes in detail the change, summarizes the data or
p.(None): information supporting the change, and informs the Secretary that the change has been made under the
p.(None): requirements of section 520(f).
p.(None): ‘‘(ii) The holder of an approved application who submits a notice under clause (i) with respect to a
p.(None): manufacturing change of a device may distribute the device 30 days after the date on which the Secretary
...
p.(None): ‘‘(II) clinical data from the approved application and any supplement to the approved application provide
p.(None): a reasonable assurance of safety and effectiveness for the changed device. ‘‘(ii) The Secretary may
p.(None): require, when necessary, additional
p.(None): clinical data to evaluate the design modification of the device to provide a reasonable assurance of safety
p.(None): and effectiveness.’’.
p.(None): SEC. 206. PREMARKET NOTIFICATION.
p.(None): (a) SECTION 510.—Section 510 (21 U.S.C. 360) is amended—
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2339
p.(None):
p.(None):
p.(None): (1) in subsection (k), in the matter preceding paragraph (1), by adding after ‘‘report to the
p.(None): Secretary’’ the following: ‘‘or person who is accredited under section 523(a)’’; and
p.(None): (2) by adding at the end the following subsections:
p.(None): ‘‘(l) A report under subsection (k) is not required for a device intended for human use that is
p.(None): exempted from the requirements of this subsection under subsection (m) or is within a type that has been
p.(None): classified into class I under section 513. The exception established in the preceding sentence does not
p.(None): apply to any class I device that is intended for a use which is of substantial importance in preventing impairment
p.(None): of human health, or to any class I device that presents a potential unreasonable risk of illness or injury.
p.(None): ‘‘(m)(1) Not later than 60 days after the date of enactment
p.(None): of the Food and Drug Administration Modernization Act of 1997, the Secretary shall publish in the
p.(None): Federal Register a list of each type of class II device that does not require a report under sub-
p.(None): section (k) to provide reasonable assurance of safety and effective- ness. Each type of class II device
p.(None): identified by the Secretary as not requiring the report shall be exempt from the requirement to provide
p.(None): a report under subsection (k) as of the date of the publication of the list in the Federal Register.
p.(None): ‘‘(2) Beginning on the date that is 1 day after the date of the publication of a list under this
p.(None): subsection, the Secretary may exempt a class II device from the requirement to submit a report under
p.(None): subsection (k), upon the Secretary’s own initiative or a peti- tion of an interested person, if the Secretary
p.(None): determines that such report is not necessary to assure the safety and effectiveness of the device. The
p.(None): Secretary shall publish in the Federal Register notice of the intent of the Secretary to exempt the
p.(None): device, or of the petition, and provide a 30-day period for public comment. Within 120 days after the
p.(None): issuance of the notice in the Federal Register, the Secretary shall publish an order in the Federal
p.(None): Reg- ister that sets forth the final determination of the Secretary regard- ing the exemption of the device that was
p.(None): the subject of the notice. If the Secretary fails to respond to a petition within 180 days of receiving it,
p.(None): the petition shall be deemed to be granted.’’.
p.(None): (b) SECTION 513(f).—Section 513(f) (21 U.S.C. 360c(f)) is amend- ed by adding at the end the following:
p.(None): ‘‘(5) The Secretary may not withhold a determination of the initial classification of a device under
p.(None): paragraph (1) because of a failure to comply with any provision of this Act unrelated to a substantial
p.(None): equivalence decision, including a finding that the facility in which the device is manufactured is not
p.(None): in compliance with good manufacturing requirements as set forth in regulations of the Secretary under
p.(None): section 520(f) (other than a finding that there is a substantial likelihood that the failure to comply
p.(None): with such regulations will potentially present a serious risk to human health).’’.
p.(None): (c) SECTION 513(i).—Section 513(i)(1) (21 U.S.C. 360c(i)), as
p.(None): amended by section 205(b), is amended—
p.(None): (1) in subparagraph (A)(ii)—
p.(None): (A) in subclause (I), by striking ‘‘clinical data’’ and inserting ‘‘appropriate clinical or scientific
p.(None): data’’ and by inserting ‘‘or a person accredited under section 523’’ after ‘‘Secretary’’; and
p.(None): (B) in subclause (II), by striking ‘‘efficacy’’ and inserting ‘‘effectiveness’’; 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): Federal Register, publication.
p.(None):
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): Federal Register, publication.
p.(None):
p.(None):
p.(None): 111 STAT. 2340 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None): (2) by adding at the end the following:
p.(None): ‘‘(F) Not later than 270 days after the date of the enactment of the Food and Drug Administration
p.(None): Modernization Act of 1997, the Secretary shall issue guidance specifying the general principles that the Secretary
p.(None): will consider in determining when a specific intended use of a device is not reasonably included within a
p.(None): general use of such device for purposes of a determination of substantial equivalence under subsection (f) or
p.(None): section 520(l).’’.
p.(None): SEC. 207. EVALUATION OF AUTOMATIC CLASS III DESIGNATION.
p.(None): Section 513(f) (21 U.S.C. 360c(f)), as amended by section 206(b), is amended—
p.(None): (1) in paragraph (1)—
p.(None): (A) in subparagraph (B), by striking ‘‘paragraph (2)’’ and inserting ‘‘paragraph (3)’’; and
p.(None): (B) in the last sentence, by striking ‘‘paragraph (2)’’ and inserting ‘‘paragraph (2) or (3)’’;
p.(None): (2) by redesignating paragraphs (2) and (3) as paragraphs
p.(None): (3) and (4), respectively; and
p.(None): (3) by inserting after paragraph (1) the following:
p.(None): ‘‘(2)(A) Any person who submits a report under section 510(k) for a type of device that has not been
p.(None): previously classified under this Act, and that is classified into class III under paragraph (1), may
p.(None): request, within 30 days after receiving written notice of such a classification, the Secretary to
p.(None): classify the device under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1). The person
p.(None): may, in the request, recommend to the Secretary a classification for the device. Any such request shall
p.(None): describe the device and provide detailed information and reasons for the recommended classification.
p.(None): ‘‘(B)(i) Not later than 60 days after the date of the submission of the request under subparagraph (A), the
...
p.(None): later than 100 days after the receipt of an application that has been filed as complete under subsection (c), to
p.(None): discuss the review status of the application.
p.(None): ‘‘(ii) The Secretary shall, in writing and prior to the meeting, provide to the applicant a description
p.(None): of any deficiencies in the application that, at that point, have been identified by the Secretary based on an
p.(None): interim review of the entire application and identify the information that is required to correct those
p.(None): deficiencies.
p.(None): ‘‘(iii) The Secretary shall notify the applicant promptly of— ‘‘(I) any additional deficiency identified
p.(None): in the application,
p.(None): or
p.(None): ‘‘(II) any additional information required to achieve comple-
p.(None): tion of the review and final action on the application,
p.(None): that was not described as a deficiency in the written description provided by the Secretary under clause
p.(None): (ii).
p.(None): ‘‘(B) The Secretary and the applicant may, by mutual consent, establish a different schedule for a meeting
p.(None): required under this paragraph.
p.(None):
p.(None):
p.(None): 111 STAT. 2342 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 360m.
p.(None): SEC. 210. ACCREDITATION OF PERSONS FOR REVIEW OF PREMARKET NOTIFICATION REPORTS.
p.(None): (a) IN GENERAL.—Subchapter A of chapter V is amended by adding at the end the following:
p.(None): ‘‘SEC. 523. ACCREDITED PERSONS.
p.(None): ‘‘(a) IN GENERAL.—
p.(None): ‘‘(1) REVIEW AND CLASSIFICATION OF DEVICES.—Not later
p.(None): than 1 year after the date of the enactment of the Food and Drug Administration Modernization Act of 1997,
p.(None): the Secretary shall, subject to paragraph (3), accredit persons for the purpose of reviewing reports submitted under
p.(None): section 510(k) and making recommendations to the Secretary regarding the initial classi- fication of devices
p.(None): under section 513(f)(1).
p.(None): ‘‘(2) REQUIREMENTS REGARDING REVIEW.—
p.(None): ‘‘(A) IN GENERAL.—In making a recommendation to the Secretary under paragraph (1), an accredited person
p.(None): shall notify the Secretary in writing of the reasons for the recommendation.
p.(None): ‘‘(B) TIME PERIOD FOR REVIEW.—Not later than 30 days after the date on which the Secretary is notified under
p.(None): subparagraph (A) by an accredited person with respect to a recommendation of an initial classification of a
p.(None): device, the Secretary shall make a determination with respect to the initial classification.
p.(None): ‘‘(C) SPECIAL RULE.—The Secretary may change the initial classification under section 513(f)(1) that is
p.(None): rec- ommended under paragraph (1) by an accredited person, and in such case shall provide to such
p.(None): person, and the person who submitted the report under section 510(k) for the device, a statement
p.(None): explaining in detail the reasons for the change.
p.(None): ‘‘(3) CERTAIN DEVICES.—
p.(None): ‘‘(A) IN GENERAL.—An accredited person may not be used to perform a review of—
p.(None): ‘‘(i) a class III device;
p.(None): ‘‘(ii) a class II device which is intended to be perma- nently implantable or life sustaining or life supporting; or
p.(None): ‘‘(iii) a class II device which requires clinical data in the report submitted under section 510(k) for the
p.(None): device, except that the number of class II devices to which the Secretary applies this clause for a
p.(None): year, less the number of such reports to which clauses (i) and (ii) apply, may not exceed 6 percent of the
p.(None): number that is equal to the total number of reports submitted to the Secretary under such section for such year less
p.(None): the number of such reports to which such clauses apply for such year.
p.(None): ‘‘(B) ADJUSTMENT.—In determining for a year the ratio described in subparagraph (A)(iii), the Secretary shall
p.(None): not include in the numerator class III devices that the Sec- retary reclassified into class II, and the
p.(None): Secretary shall include in the denominator class II devices for which reports under section
p.(None): 510(k) were not required to be submitted by reason of the operation of section 510(m).
p.(None): ‘‘(b) ACCREDITATION.—
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2343
p.(None):
p.(None):
p.(None): ‘‘(1) PROGRAMS.—The Secretary shall provide for such accreditation through programs administered by
p.(None): the Food and Drug Administration, other government agencies, or by other qualified nongovernment
p.(None): organizations.
p.(None): ‘‘(2) ACCREDITATION.—
p.(None): ‘‘(A) IN GENERAL.—Not later than 180 days after the date of the enactment of the Food and Drug Administration
p.(None): Modernization Act of 1997, the Secretary shall establish and publish in the Federal Register criteria to
p.(None): accredit or deny accreditation to persons who request to perform the duties specified in subsection (a).
p.(None): The Secretary shall respond to a request for accreditation within 60 days of the receipt of the request. The
p.(None): accreditation of such person shall specify the particular activities under subsection (a) for which such person
p.(None): is accredited.
p.(None): ‘‘(B) WITHDRAWAL OF ACCREDITATION.—The Secretary
p.(None): may suspend or withdraw accreditation of any person accredited under this paragraph, after providing
p.(None): notice and an opportunity for an informal hearing, when such person is substantially not in compliance with the
p.(None): requirements of this section or poses a threat to public health or fails to act in a manner that is
p.(None): consistent with the purposes of this section.
p.(None): ‘‘(C) PERFORMANCE AUDITING.—To ensure that persons accredited under this section will continue to meet the
p.(None): standards of accreditation, the Secretary shall—
p.(None): ‘‘(i) make onsite visits on a periodic basis to each accredited person to audit the performance of such
p.(None): person; and
p.(None): ‘‘(ii) take such additional measures as the Sec- retary determines to be appropriate.
p.(None): ‘‘(D) ANNUAL REPORT.—The Secretary shall include in the annual report required under section 903(g) the names of
p.(None): all accredited persons and the particular activities under subsection (a) for which each such person is
p.(None): accredited and the name of each accredited person whose accreditation has been withdrawn during the year.
...
p.(None): whichever occurs first.’’.
p.(None): (b) RECORDKEEPING.—Section 704 (21 U.S.C. 374) is amended by adding at the end the following:
p.(None): ‘‘(f)(1) A person accredited under section 523 to review reports made under section 510(k) and make
p.(None): recommendations of initial classifications of devices to the Secretary shall maintain records documenting
p.(None): the training qualifications of the person and the employees of the person, the procedures used by
p.(None): the person for handling confidential information, the compensation arrangements made by the person, and the
p.(None): procedures used by the person to identify and avoid conflicts of interest. Upon the request of an
p.(None): officer or employee designated by the Secretary, the person shall permit the officer or employee, at all
p.(None): reasonable times, to have access to, to copy, and to verify, the records.
p.(None): ‘‘(2) Within 15 days after the receipt of a written request from the Secretary to a person accredited
p.(None): under section 523 for copies of records described in paragraph (1), the person shall produce the
p.(None): copies of the records at the place designated by the Secretary.’’.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2345
p.(None):
p.(None):
p.(None): (c) CONFORMING AMENDMENT.—Section 301 (21 U.S.C. 331), as amended by section 204(b), is amended by
p.(None): adding at the end the following:
p.(None): ‘‘(y) In the case of a drug, device, or food—
p.(None): ‘‘(1) the submission of a report or recommendation by a person accredited under section 523 that is false or
p.(None): misleading in any material respect;
p.(None): ‘‘(2) the disclosure by a person accredited under section 523 of confidential commercial information or any
p.(None): trade secret without the express written consent of the person who submit- ted such information or secret to such
p.(None): person; or
p.(None): ‘‘(3) the receipt by a person accredited under section 523 of a bribe in any form or the doing of
p.(None): any corrupt act by such person associated with a responsibility delegated to such person under this Act.’’.
p.(None): (d) REPORTS ON PROGRAM OF ACCREDITATION.—
p.(None): (1) COMPTROLLER GENERAL.—
p.(None): (A) IMPLEMENTATION OF PROGRAM.—Not later than 5 years after the date of the enactment of this Act, the
p.(None): Comptroller General of the United States shall submit to the Committee on Commerce of the House of Representa-
p.(None): tives and the Committee on Labor and Human Resources of the Senate a report describing the extent to
p.(None): which the program of accreditation required by the amendment made by subsection (a) has been implemented.
p.(None): (B) EVALUATION OF PROGRAM.—Not later than 6 months prior to the date on which, pursuant to subsection
p.(None): (c) of section 523 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the authority
p.(None): provided under subsection (a) of such section will terminate, the Comptroller General shall submit to the
p.(None): Committee on Commerce of the House of Representatives and the Committee on Labor and Human
p.(None): Resources of the Senate a report describing the use of accredited persons under such section 523,
p.(None): including an evaluation of the extent to which such use assisted the Secretary in carrying out the
p.(None): duties of the Secretary under such Act with respect to devices, and the extent to which such use
p.(None): promoted actions which are contrary to the purposes of such Act.
p.(None): (2) INCLUSION OF CERTAIN DEVICES WITHIN PROGRAM.—Not later than 3 years after the date of the enactment
p.(None): of this Act, the Secretary of Health and Human Services shall submit to the Committee on Commerce of the House of
p.(None): Representatives and the Committee on Labor and Human Resources of the Senate a report providing a
p.(None): determination by the Secretary of whether, in the program of accreditation established pursu- ant to the
p.(None): amendment made by subsection (a), the limitation established in clause (iii) of section 523(a)(3)(A) of the
p.(None): Federal Food, Drug, and Cosmetic Act (relating to class II devices for which clinical data are required
p.(None): in reports under section 510(k)) should be removed.
p.(None): SEC. 211. DEVICE TRACKING.
p.(None): Effective 90 days after the date of the enactment of this Act, section 519(e) (21 U.S.C. 360i(e)) is
p.(None): 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): 21 USC 360m
p.(None): note.
p.(None):
p.(None):
p.(None): 111 STAT. 2346 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None): ‘‘Device Tracking
p.(None): ‘‘(e)(1) The Secretary may by order require a manufacturer to adopt a method of tracking a class II or
p.(None): class III device— ‘‘(A) the failure of which would be reasonably likely to
p.(None): have serious adverse health consequences; or ‘‘(B) which is—
p.(None): ‘‘(i) intended to be implanted in the human body for more than one year, or
p.(None): ‘‘(ii) a life sustaining or life supporting device used outside a device user facility.
p.(None): ‘‘(2) Any patient receiving a device subject to tracking under paragraph (1) may refuse to release, or refuse
p.(None): permission to release, the patient’s name, address, social security number, or other identi- fying information for the
p.(None): purpose of tracking.’’.
p.(None): SEC. 212. POSTMARKET SURVEILLANCE.
p.(None): Effective 90 days after the date of the enactment of this Act, section 522 (21 U.S.C. 360l) is amended to
p.(None): read as follows:
p.(None): ‘‘POSTMARKET SURVEILLANCE
p.(None): ‘‘SEC. 522. (a) IN GENERAL.—The Secretary may by order require a manufacturer to conduct postmarket
...
p.(None): (iii) by striking the matter after and below clause (iv); and
p.(None): (B) in paragraph (2)—
p.(None): (i) in subparagraph (A), by inserting ‘‘or’’ after the comma at the end;
p.(None): (ii) in subparagraph (B), by striking ‘‘, or’’ at the end and inserting a period; and
p.(None): (iii) by striking subparagraph (C).
p.(None): (2) SENTINEL SYSTEM.—Section 519(b) (21 U.S.C. 360i(b)) is amended—
p.(None): (A) by redesignating paragraph (5) as paragraph (6);
p.(None):
p.(None): and
p.(None): (B) by inserting after paragraph (4) the following para-
p.(None): graph:
p.(None): ‘‘(5) With respect to device user facilities:
p.(None): ‘‘(A) The Secretary shall by regulation plan and implement a program under which the Secretary limits user
p.(None): reporting
p.(None):
p.(None):
p.(None): 111 STAT. 2348 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): under paragraphs (1) through (4) to a subset of user facilities that constitutes a representative profile
p.(None): of user reports for device deaths and serious illnesses or serious injuries.
p.(None): ‘‘(B) During the period of planning the program under subparagraph (A), paragraphs (1) through (4) continue to
p.(None): apply. ‘‘(C) During the period in which the Secretary is providing
p.(None): for a transition to the full implementation of the program, paragraphs (1) through (4) apply except to
p.(None): the extent that the Secretary determines otherwise.
p.(None): ‘‘(D) On and after the date on which the program is fully implemented, paragraphs (1) through (4) do
p.(None): not apply to a user facility unless the facility is included in the subset referred to in subparagraph (A).
p.(None): ‘‘(E) Not later than 2 years after the date of the enactment of the Food and Drug Administration Modernization
p.(None): Act of 1997, the Secretary shall submit to the Committee on Com- merce of the House of Representatives,
p.(None): and to the Committee on Labor and Human Resources of the Senate, a report describ- ing the plan developed by
p.(None): the Secretary under subparagraph
p.(None): (A) and the progress that has been made toward the implementation of the plan.’’.
p.(None): SEC. 214. PRACTICE OF MEDICINE.
p.(None): Chapter IX is amended by adding at the end the following:
p.(None):
p.(None): 21 USC 396.
p.(None): ‘‘SEC. 906. PRACTICE OF MEDICINE.
p.(None): ‘‘Nothing in this Act shall be construed to limit or interfere with the authority of a health care
p.(None): practitioner to prescribe or administer any legally marketed device to a patient for any condi- tion or disease
p.(None): within a legitimate health care practitioner-patient relationship. This section shall not limit any existing
p.(None): authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the
p.(None): labeling, of a device that are part of a determination of substantial equivalence, established as a condi- tion
p.(None): of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the
p.(None): promotion of unapproved uses of legally marketed devices.’’.
p.(None): SEC. 215. NONINVASIVE BLOOD GLUCOSE METER.
p.(None): (a) FINDINGS.—The Congress finds that—
p.(None): (1) diabetes and its complications are a leading cause of death by disease in America;
p.(None): (2) diabetes affects approximately 16,000,000 Americans and another 650,000 will be diagnosed in 1997;
p.(None): (3) the total health care-related costs of diabetes total nearly $100,000,000,000 per year;
p.(None): (4) diabetes is a disease that is managed and controlled on a daily basis by the patient;
p.(None): (5) the failure to properly control and manage diabetes results in costly and often fatal complications
p.(None): including but not limited to blindness, coronary artery disease, and kidney failure;
p.(None): (6) blood testing devices are a critical tool for the control and management of diabetes, and existing blood
p.(None): testing devices require repeated piercing of the skin;
p.(None): (7) the pain associated with existing blood testing devices creates a disincentive for people with
p.(None): diabetes to test blood glucose levels, particularly children;
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2349
p.(None):
p.(None): (8) a safe and effective noninvasive blood glucose meter would likely improve control and management of
p.(None): diabetes by increasing the number of tests conducted by people with diabetes, particularly children;
p.(None): and
p.(None): (9) the Food and Drug Administration is responsible for reviewing all applications for new medical devices in
p.(None): the United States.
p.(None): (b) SENSE OF CONGRESS.—It is the sense of the Congress that the availability of a safe, effective,
p.(None): noninvasive blood glucose meter would greatly enhance the health and well-being of all people with diabetes across
p.(None): America and the world.
p.(None): SEC. 216. USE OF DATA RELATING TO PREMARKET APPROVAL; PROD- UCT DEVELOPMENT PROTOCOL.
p.(None): (a) USE OF DATA RELATING TO PREMARKET APPROVAL.—
p.(None): (1) IN GENERAL.—Section 520(h)(4) (21 U.S.C. 360j(h)(4))
p.(None): is amended to read as follows:
p.(None): ‘‘(4)(A) Any information contained in an application for pre- market approval filed with the Secretary pursuant
p.(None): to section 515(c) (including information from clinical and preclinical tests or studies that demonstrate the safety
p.(None): and effectiveness of a device, but excluding descriptions of methods of manufacture and product com- position and
p.(None): other trade secrets) shall be available, 6 years after the application has been approved by the
p.(None): Secretary, for use by the Secretary in—
p.(None): ‘‘(i) approving another device;
p.(None): ‘‘(ii) determining whether a product development protocol has been completed, under section 515 for another
p.(None): device;
p.(None): ‘‘(iii) establishing a performance standard or special control under this Act; or
p.(None): ‘‘(iv) classifying or reclassifying another device under sec- tion 513 and subsection (l)(2).
p.(None): ‘‘(B) The publicly available detailed summaries of information respecting the safety and effectiveness of
p.(None): devices required by para- graph (1)(A) shall be available for use by the Secretary as the evidentiary basis
p.(None): for the agency actions described in subparagraph (A).’’.
...
p.(None): Secretary makes a determina- tion that the food contains a nutrient at a level that increases to persons in
p.(None): the general population the risk of a disease or health- related condition that is diet related, the label or
p.(None): labeling of such food shall contain, prominently and in immediate proximity to such claim, the following
p.(None): statement: ‘See nutrition information for ll content.’ The blank shall identify the nutrient associated with the
p.(None): increased disease or health-related condition risk. In making the determination described in this clause,
p.(None): the Secretary shall take into account the significance of the food in the total daily diet.’’.
p.(None): SEC. 306. DISCLOSURE OF IRRADIATION.
p.(None): Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting after section 403B the following:
p.(None): ‘‘DISCLOSURE
p.(None): ‘‘SEC. 403C. (a) No provision of section 201(n), 403(a), or 409 shall be construed to require on the
p.(None): label or labeling of a food a separate radiation disclosure statement that is more prominent than the
p.(None): declaration of ingredients required by section 403(i)(2). ‘‘(b) In this section, the term ‘radiation
p.(None): disclosure statement’ means a written statement that discloses that a food has been
p.(None): intentionally subject to radiation.’’.
p.(None): SEC. 307. IRRADIATION PETITION.
p.(None): Not later than 60 days following the date of the enactment of this Act, the Secretary of Health and
p.(None): Human Services shall make a final determination on any petition pending with the Food and Drug Administration that
p.(None): would permit the irradiation of red meat under section 409(b)(1) of the Federal Food, Drug, and Cos-
p.(None): metic Act. If the Secretary does not make such determination, the Secretary shall, not later than 60
p.(None): days following the date of the enactment of this Act, provide the Committee on Commerce of the House of
p.(None): Representatives and the Committee on Labor and Human Resources of the Senate an explanation of the
p.(None): process followed by the Food and Drug Administration in reviewing the petition referred to in paragraph
p.(None): (1) and the reasons action on the petition was delayed.
p.(None): SEC. 308. GLASS AND CERAMIC WARE.
p.(None): (a) IN GENERAL.—The Secretary may not implement any requirement which would ban, as an unapproved
p.(None): food additive, lead and cadmium based enamel in the lip and rim area of glass and ceramic ware before
p.(None): the expiration of one year after the date such requirement is published.
p.(None): (b) LEAD AND CADMIUM BASED ENAMEL.—Unless the Secretary determines, based on available data, that lead and cadmium
p.(None): based enamel on glass and ceramic ware—
p.(None): (1) which has less than 60 millimeters of decorating area below the external rim, and
p.(None): (2) which is not, by design, representation, or custom of usage intended for use by children,
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 343–3.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 348 note.
p.(None):
p.(None):
p.(None): 111 STAT. 2354 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): is unsafe, the Secretary shall not take any action before January 1, 2003, to ban lead and cadmium
...
p.(None): that such manufacturer or supplier may submit a petition under subsection (b).
p.(None): ‘‘(B) The Secretary is authorized to promulgate regulations to identify the circumstances in which a
p.(None): petition shall be filed under subsection (b), and shall consider criteria such as the probable consumption of such
p.(None): food contact substance and potential toxicity of the food contact substance in determining the
p.(None): circumstances in which a petition shall be filed under subsection (b).
p.(None): ‘‘(4) The Secretary shall keep confidential any information pro- vided in a notification under paragraph (1) for
p.(None): 120 days after receipt by the Secretary of the notification. After the expiration of such 120 days,
p.(None): the information shall be available to any interested party except for any matter in the
p.(None): notification that is a trade secret or confidential commercial information.
p.(None): ‘‘(5)(A)(i) Except as provided in clause (ii), the notification pro- gram established under this subsection shall
p.(None): not operate in any fiscal year unless—
p.(None): ‘‘(I) an appropriation equal to or exceeding the applicable amount under clause (iv) is made for such fiscal
p.(None): year for carry- ing out such program in such fiscal year; and
p.(None): ‘‘(II) the Secretary certifies that the amount appropriated for such fiscal year for the Center for Food Safety
p.(None): and Applied Nutrition of the Food and Drug Administration (exclusive of the appropriation referred to in
p.(None): subclause (I)) equals or exceeds the amount appropriated for the Center for fiscal year 1997, excluding any
p.(None): amount appropriated for new programs.
p.(None): ‘‘(ii) The Secretary shall, not later than April 1, 1999, begin accepting and reviewing notifications
p.(None): submitted under the notifica- tion program established under this subsection if—
p.(None): ‘‘(I) an appropriation equal to or exceeding the applicable amount under clause (iii) is made for the
p.(None): last six months of fiscal year 1999 for carrying out such program during such period; and
p.(None): ‘‘(II) the Secretary certifies that the amount appropriated for such period for the Center for Food
p.(None): Safety and Applied Nutrition of the Food and Drug Administration (exclusive of the appropriation referred to
p.(None): in subclause (I)) equals or exceeds an amount equivalent to one-half the amount appropriated for the Center
p.(None): for fiscal year 1997, excluding any amount appropriated for new programs.
p.(None):
p.(None):
p.(None): 111 STAT. 2356 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘(iii) For the last six months of fiscal year 1999, the applicable amount under this clause is $1,500,000, or
p.(None): the amount specified in the budget request of the President for the six-month period involved for
p.(None): carrying out the notification program in fiscal year 1999, whichever is less.
p.(None): ‘‘(iv) For fiscal year 2000 and subsequent fiscal years, the applicable amount under this clause is
p.(None): $3,000,000, or the amount specified in the budget request of the President for the fiscal year involved
p.(None): for carrying out the notification program under this sub- section, whichever is less.
p.(None): ‘‘(B) For purposes of carrying out the notification program under this subsection, there are authorized to be
p.(None): appropriated such sums as may be necessary for each of the fiscal years 1999 through fiscal year 2003,
p.(None): except that such authorization of appropriations is not effective for a fiscal year for any amount that
p.(None): is less than the applicable amount under clause (iii) or (iv) of subparagraph (A), whichever is applicable.
p.(None): ‘‘(C) Not later than April 1 of fiscal year 1998 and February
p.(None): 1 of each subsequent fiscal year, the Secretary shall submit a report to the Committees on
p.(None): Appropriations of the House of Rep- resentatives and the Senate, the Committee on Commerce of the House
...
p.(None): component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is
p.(None): not intended to have any technical effect in such food.’’;
p.(None): (3) in subsection (i), as so redesignated by paragraph (1), by adding at the end the following: ‘‘The
p.(None): Secretary shall by regulation prescribe the procedure by which the Secretary may deem a notification under
p.(None): subsection (h) to no longer be effec- tive.’’; and
p.(None): (4) in subsection (j), as so redesignated by paragraph (1), by striking ‘‘subsections (b) to (h)’’ and
p.(None): inserting ‘‘subsections
p.(None): (b) to (i)’’.
p.(None): TITLE IV—GENERAL PROVISIONS
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 360aaa.
p.(None): SEC. 401. DISSEMINATION OF INFORMATION ON NEW USES.
p.(None): (a) IN GENERAL.—Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after subchapter C the following:
p.(None): ‘‘SUBCHAPTER D—DISSEMINATION OF TREATMENT INFORMATION
p.(None): ‘‘SEC. 551. REQUIREMENTS FOR DISSEMINATION OF TREATMENT INFORMATION ON DRUGS OR DEVICES.
p.(None): ‘‘(a) IN GENERAL.—Notwithstanding sections 301(d), 502(f), and 505, and section 351 of the Public Health
p.(None): Service Act (42 U.S.C. 262), a manufacturer may disseminate to—
p.(None): ‘‘(1) a health care practitioner; ‘‘(2) a pharmacy benefit manager; ‘‘(3) a health insurance issuer; ‘‘(4) a group
p.(None): health plan; or
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997
p.(None): ‘‘(5) a Federal or State governmental agency;
p.(None): 111 STAT. 2357
p.(None): written information concerning the safety, effectiveness, or benefit of a use not described in the approved
p.(None): labeling of a drug or device if the manufacturer meets the requirements of subsection (b).
p.(None): ‘‘(b) SPECIFIC REQUIREMENTS.—A manufacturer may dissemi- nate information under subsection (a) on a new use only
p.(None): if—
p.(None): ‘‘(1)(A) in the case of a drug, there is in effect for the drug an application filed under subsection
p.(None): (b) or (j) of section 505 or a biologics license issued under section 351 of the Public Health Service Act; or
p.(None): ‘‘(B) in the case of a device, the device is being commercially distributed in accordance with a regulation under
p.(None): subsection
p.(None): (d) or (e) of section 513, an order under subsection (f) of such section, or the approval of an
p.(None): application under section 515; ‘‘(2) the information meets the requirements of section 552;
p.(None): ‘‘(3) the information to be disseminated is not derived from clinical research conducted by another manufacturer
p.(None): or if it was derived from research conducted by another manufacturer, the manufacturer disseminating the
p.(None): information has the permission of such other manufacturer to make the dissemina- tion;
p.(None): ‘‘(4) the manufacturer has, 60 days before such dissemina- tion, submitted to the Secretary—
p.(None): ‘‘(A) a copy of the information to be disseminated;
p.(None):
p.(None): and
p.(None): ‘‘(B) any clinical trial information the manufacturer
p.(None): has relating to the safety or effectiveness of the new use, any reports of clinical experience pertinent
p.(None): to the safety of the new use, and a summary of such information;
p.(None): ‘‘(5) the manufacturer has complied with the requirements of section 554 (relating to a supplemental
p.(None): application for such use);
p.(None): ‘‘(6) the manufacturer includes along with the information to be disseminated under this subsection—
p.(None): ‘‘(A) a prominently displayed statement that discloses— ‘‘(i) that the information concerns a use of a drug
p.(None): or device that has not been approved or cleared by the Food and Drug Administration;
p.(None): ‘‘(ii) if applicable, that the information is being disseminated at the expense of the manufacturer;
p.(None): ‘‘(iii) if applicable, the name of any authors of the information who are employees of, consultants to,
p.(None): or have received compensation from, the manufacturer, or who have a significant financial interest in the
p.(None): manufacturer;
p.(None): ‘‘(iv) the official labeling for the drug or device and all updates with respect to the labeling;
p.(None): ‘‘(v) if applicable, a statement that there are prod- ucts or treatments that have been approved or cleared for the use
p.(None): that is the subject of the information being disseminated pursuant to subsection (a)(1); and
p.(None): ‘‘(vi) the identification of any person that has pro- vided funding for the conduct of a study relating to the
p.(None): new use of a drug or device for which such informa- tion is being disseminated; and
p.(None): ‘‘(B) a bibliography of other articles from a scientific reference publication or scientific or medical
p.(None): journal that
p.(None):
p.(None):
p.(None): 111 STAT. 2358 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): have been previously published about the use of the drug or device covered by the information
p.(None): disseminated (unless the information already includes such bibliography).
p.(None): ‘‘(c) ADDITIONAL INFORMATION.—If the Secretary determines, after providing notice of such determination and
p.(None): an opportunity for a meeting with respect to such determination, that the informa- tion submitted by a
p.(None): manufacturer under subsection (b)(3)(B), with respect to the use of a drug or device for which the
p.(None): manufacturer intends to disseminate information, fails to provide data, analyses, or other written matter that is
p.(None): objective and balanced, the Secretary may require the manufacturer to disseminate—
p.(None): ‘‘(1) additional objective and scientifically sound informa- tion that pertains to the safety or
p.(None): effectiveness of the use and is necessary to provide objectivity and balance, including any information
p.(None): that the manufacturer has submitted to the Secretary or, where appropriate, a summary of such information or any
p.(None): other information that the Secretary has authority to make available to the public; and
p.(None): ‘‘(2) an objective statement of the Secretary, based on data or other scientifically sound information available
p.(None): to the Sec- retary, that bears on the safety or effectiveness of the new use of the drug or device.
p.(None):
p.(None): 21 USC
p.(None): 360aaa–1.
p.(None): ‘‘SEC. 552. INFORMATION AUTHORIZED TO BE DISSEMINATED.
p.(None): ‘‘(a) AUTHORIZED INFORMATION.—A manufacturer may dissemi- nate information under section 551 on a new use only if the
p.(None): informa- tion—
p.(None): ‘‘(1) is in the form of an unabridged—
p.(None): ‘‘(A) reprint or copy of an article, peer-reviewed by experts qualified by scientific training or
p.(None): experience to evaluate the safety or effectiveness of the drug or device involved, which was published in
p.(None): a scientific or medical journal (as defined in section 556(5)), which is about a clinical investigation
p.(None): with respect to the drug or device, and which would be considered to be scientifically sound by such
p.(None): experts; or
p.(None): ‘‘(B) reference publication, described in subsection (b), that includes information about a clinical
p.(None): investigation with respect to the drug or device that would be considered to be scientifically sound by
p.(None): experts qualified by scientific training or experience to evaluate the safety or effectiveness of the drug or
p.(None): device that is the subject of such a clinical investigation; and
p.(None): ‘‘(2) is not false or misleading and would not pose a signifi- cant risk to the public health.
p.(None): ‘‘(b) REFERENCE PUBLICATION.—A reference publication referred to in subsection (a)(1)(B) is a publication that—
p.(None): ‘‘(1) has not been written, edited, excerpted, or published specifically for, or at the request of, a
p.(None): manufacturer of a drug or device;
p.(None): ‘‘(2) has not been edited or significantly influenced by such a manufacturer;
p.(None): ‘‘(3) is not solely distributed through such a manufacturer but is generally available in bookstores or
p.(None): other distribution channels where medical textbooks are sold;
p.(None): ‘‘(4) does not focus on any particular drug or device of a manufacturer that disseminates information
p.(None): under section
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2359
p.(None):
p.(None):
p.(None): 551 and does not have a primary focus on new uses of drugs or devices that are marketed or under
p.(None): investigation by a manu- facturer supporting the dissemination of information; and
p.(None): ‘‘(5) presents materials that are not false or misleading.
p.(None): ‘‘SEC. 553. ESTABLISHMENT OF LIST OF ARTICLES AND PUBLICA- TIONS DISSEMINATED AND LIST OF PROVIDERS
p.(None): THAT RECEIVED ARTICLES AND REFERENCE PUBLICATIONS.
p.(None): ‘‘(a) IN GENERAL.—A manufacturer may disseminate informa- tion under section 551 on a new use only if
p.(None): the manufacturer prepares and submits to the Secretary biannually—
p.(None): ‘‘(1) a list containing the titles of the articles and reference publications relating to the new use of drugs
p.(None): or devices that were disseminated by the manufacturer to a person described in section 551(a) for the
p.(None): 6-month period preceding the date on which the manufacturer submits the list to the Secretary; and
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC
p.(None): 360aaa–2.
p.(None):
p.(None): ‘‘(2) a list that identifies the categories of providers (as described in section 551(a)) that received
p.(None): the articles and ref- erence publications for the 6-month period described in para- graph (1).
p.(None): ‘‘(b) RECORDS.—A manufacturer that disseminates information under section 551 shall keep records that may
p.(None): be used by the manufacturer when, pursuant to section 555, such manufacturer is required to take
...
p.(None): ‘‘(3) EXTENSION OF TIME REGARDING PLANNED STUDIES.—
p.(None): The period of 36 months authorized in paragraph (1)(A)(ii) for the completion of studies may be extended by the
p.(None): Secretary if—
p.(None): ‘‘(A) the Secretary determines that the studies needed to submit such an application cannot be completed and
p.(None): submitted within 36 months; or
p.(None): ‘‘(B) the manufacturer involved submits to the Sec- retary a written request for the extension and the Secretary
p.(None): determines that the manufacturer has acted with due dili- gence to conduct the studies in a timely manner,
p.(None): except that an extension under this subparagraph may not be provided for more than 24 additional months.
p.(None): ‘‘(d) EXEMPTION FROM REQUIREMENT OF SUPPLEMENTAL APPLICATION.—
p.(None): ‘‘(1) IN GENERAL.—For purposes of subsection (a)(2), a manufacturer may disseminate information on a
p.(None): new use if— ‘‘(A) the manufacturer has submitted to the Secretary
p.(None): an application for an exemption from meeting the require- ment of subsection (a)(1); and
p.(None): ‘‘(B)(i) the Secretary has approved the application in accordance with paragraph (2); or
p.(None): ‘‘(ii) the application is deemed under paragraph (3)(A) to have been approved (unless such approval is
p.(None): terminated pursuant to paragraph (3)(B)).
p.(None): ‘‘(2) CONDITIONS FOR APPROVAL.—The Secretary may approve an application under paragraph (1) for an
p.(None): exemption if the Secretary makes a determination described in subpara- graph (A) or (B), as follows:
p.(None): ‘‘(A) The Secretary makes a determination that, for reasons defined by the Secretary, it would be economically
p.(None): prohibitive with respect to such drug or device for the manufacturer to incur the costs necessary for
p.(None): the submis- sion of a supplemental application. In making such deter- mination, the Secretary shall
p.(None): consider (in addition to any other considerations the Secretary finds appropriate)—
p.(None): ‘‘(i) the lack of the availability under law of any period during which the manufacturer would have
p.(None): exclusive marketing rights with respect to the new use involved; and
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2361
p.(None):
p.(None):
p.(None): ‘‘(ii) the size of the population expected to benefit from approval of the supplemental application.
p.(None): ‘‘(B) The Secretary makes a determination that, for reasons defined by the Secretary, it would be
p.(None): unethical to conduct the studies necessary for the supplemental application. In making such
p.(None): determination, the Secretary shall consider (in addition to any other considerations the Secretary finds
p.(None): appropriate) whether the new use involved is the standard of medical care for a health condition. ‘‘(3) TIME
p.(None): FOR CONSIDERATION OF APPLICATION; DEEMED
p.(None): APPROVAL.—
p.(None): ‘‘(A) IN GENERAL.—The Secretary shall approve or deny an application under paragraph (1) for an exemption not
p.(None): later than 60 days after the receipt of the application. If the Secretary does not comply with the
p.(None): preceding sen- tence, the application is deemed to be approved.
p.(None): ‘‘(B) TERMINATION OF DEEMED APPROVAL.—If pursuant
p.(None): to a deemed approval under subparagraph (A) a manufac- turer disseminates written information under section 551
...
p.(None): involved to cease disseminating the information. A manufacturer shall comply with an order under the
p.(None): preceding sentence not later than 60 days after the receipt of the order.
p.(None): ‘‘(c) CORRECTIVE ACTIONS BY MANUFACTURERS.—
p.(None): ‘‘(1) IN GENERAL.—In any case in which under this section the Secretary orders a manufacturer to cease
p.(None): disseminating information, the Secretary may order the manufacturer to take action to correct the information that
p.(None): has been disseminated, except as provided in paragraph (2).
p.(None): ‘‘(2) TERMINATION OF DEEMED APPROVAL OF EXEMPTION REGARDING SUPPLEMENTAL APPLICATIONS.—In the case
p.(None): of an
p.(None): order under subsection (b)(3) to cease disseminating informa- tion, the Secretary may not order the
p.(None): manufacturer involved to take action to correct the information that has been dissemi- nated unless the
p.(None): Secretary determines that the new use described in the information would pose a significant risk to
p.(None): the public health.
p.(None): ‘‘SEC. 556. DEFINITIONS.
p.(None): ‘‘For purposes of this subchapter:
p.(None): ‘‘(1) The term ‘health care practitioner’ means a physician, or other individual who is a provider of health
p.(None): care, who is licensed under the law of a State to prescribe drugs or devices.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2363
p.(None):
p.(None):
p.(None): ‘‘(2) The terms ‘health insurance issuer’ and ‘group health plan’ have the meaning given such terms
p.(None): under section 2791 of the Public Health Service Act.
p.(None): ‘‘(3) The term ‘manufacturer’ means a person who manufac- tures a drug or device, or who is licensed by such
p.(None): person to distribute or market the drug or device.
p.(None): ‘‘(4) The term ‘new use’—
p.(None): ‘‘(A) with respect to a drug, means a use that is not included in the labeling of the approved drug; and
p.(None): ‘‘(B) with respect to a device, means a use that is not included in the labeling for the approved or
p.(None): cleared device.
p.(None): ‘‘(5) The term ‘scientific or medical journal’ means a sci- entific or medical publication—
p.(None): ‘‘(A) that is published by an organization— ‘‘(i) that has an editorial board;
p.(None): ‘‘(ii) that utilizes experts, who have demonstrated expertise in the subject of an article under review
p.(None): by the organization and who are independent of the organization, to review and objectively select,
p.(None): reject, or provide comments about proposed articles; and
p.(None): ‘‘(iii) that has a publicly stated policy, to which the organization adheres, of full disclosure of any con-
p.(None): flict of interest or biases for all authors or contributors involved with the journal or organization;
p.(None): ‘‘(B) whose articles are peer-reviewed and published in accordance with the regular peer-review procedures
p.(None): of the organization;
p.(None): ‘‘(C) that is generally recognized to be of national scope and reputation;
p.(None): ‘‘(D) that is indexed in the Index Medicus of the National Library of Medicine of the National
p.(None): Institutes of Health; and
p.(None): ‘‘(E) that is not in the form of a special supplement that has been funded in whole or in part by
p.(None): one or more manufacturers.
p.(None): ‘‘SEC. 557. RULES OF CONSTRUCTION.
p.(None): ‘‘(a) UNSOLICITED REQUEST.—Nothing in section 551 shall be construed as prohibiting a manufacturer
p.(None): from disseminating information in response to an unsolicited request from a health care practitioner.
p.(None): ‘‘(b) DISSEMINATION OF INFORMATION ON DRUGS OR DEVICES
p.(None): NOT EVIDENCE OF INTENDED USE.—Notwithstanding subsection (a), (f), or (o) of section 502, or any other provision
p.(None): of law, the dissemina- tion of information relating to a new use of a drug or device, in accordance with
p.(None): section 551, shall not be construed by the Secretary as evidence of a new intended use of the drug or
p.(None): device that is different from the intended use of the drug or device set forth in the official labeling of
p.(None): the drug or device. Such dissemina- tion shall not be considered by the Secretary as labeling, adultera- tion, or
p.(None): misbranding of the drug or device.
p.(None): ‘‘(c) PATENT PROTECTION.—Nothing in section 551 shall affect patent rights in any manner.
p.(None): ‘‘(d) AUTHORIZATION FOR DISSEMINATION OF ARTICLES AND FEES
p.(None): FOR REPRINTS OF ARTICLES.—Nothing in section 551 shall be con- strued as prohibiting an entity that
p.(None): publishes a scientific journal
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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): 360aaa–6.
p.(None):
p.(None):
p.(None): 111 STAT. 2364 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): (as defined in section 556(5)) from requiring authorization from the entity to disseminate an article
p.(None): published by such entity or charging fees for the purchase of reprints of published articles from such
p.(None): entity.’’.
p.(None): (b) PROHIBITED ACT.—Section 301 (21 U.S.C. 331), as amended by section 210, is amended by adding at the end
p.(None): the following: ‘‘(z) The dissemination of information in violation of section
p.(None): 551.’’.
p.(None):
p.(None): 21 USC 360aaa
p.(None): note.
p.(None):
p.(None):
p.(None): 21 USC 360aaa
p.(None): note.
p.(None):
p.(None):
p.(None): 21 USC 360aaa
p.(None): note.
p.(None):
p.(None):
p.(None): 21 USC 360aaa
p.(None): note.
p.(None): (c) REGULATIONS.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and
p.(None): Human Services shall promulgate regulations to implement the amendments made by this section.
p.(None): (d) EFFECTIVE DATE.—The amendments made by this section shall take effect 1 year after the date of
p.(None): enactment of this Act, or upon the Secretary’s issuance of final regulations pursuant to subsection (c),
p.(None): whichever is sooner.
p.(None): (e) SUNSET.—The amendments made by this section cease to be effective September 30, 2006, or 7 years
p.(None): after the date on which the Secretary promulgates the regulations described in sub- section (c), whichever is later.
p.(None): (f) STUDIES AND REPORTS.—
p.(None): (1) GENERAL ACCOUNTING OFFICE.—
p.(None): (A) IN GENERAL.—The Comptroller General of the United States shall conduct a study to
p.(None): determine the impact of subchapter D of chapter V of the Federal Food, Drug, and Cosmetic Act, as
p.(None): added by this section, on the resources of the Department of Health and Human Serv- ices.
p.(None): (B) REPORT.—Not later than January 1, 2002, the Comptroller General of the United States shall prepare
p.(None): and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Commerce of
p.(None): the House of Representatives a report of the results of the study.
p.(None): (2) DEPARTMENT OF HEALTH AND HUMAN SERVICES.—
p.(None): (A) IN GENERAL.—In order to assist Congress in deter- mining whether the provisions of such subchapter should be
p.(None): extended beyond the termination date specified in sub- section (e), the Secretary of Health and Human Services
p.(None): shall, in accordance with subparagraph (B), arrange for the conduct of a study of the scientific issues
p.(None): raised as a result of the enactment of such subchapter including issues relating to—
p.(None): (i) the effectiveness of such subchapter with respect to the provision of useful scientific information
p.(None): to health care practitioners;
p.(None): (ii) the quality of the information being dissemi- nated pursuant to the provisions of such subchapter;
p.(None): (iii) the quality and usefulness of the information provided, in accordance with such subchapter, by the
p.(None): Secretary or by the manufacturer at the request of the Secretary; and
p.(None): (iv) the impact of such subchapter on research in the area of new uses, indications, or dosages,
p.(None): particularly the impact on pediatric indications and rare diseases.
p.(None): (3) PROCEDURE FOR STUDY.—
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2365
p.(None):
p.(None):
...
p.(None): of the Senate, the Committee on Commerce of the House of Rep- resentatives, and the Secretary a report of the
p.(None): results of the study required by paragraph (2). The Secretary, after the receipt of the report, shall make the
p.(None): report avail- able to the public.
p.(None): SEC. 402. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES AND DIAGNOSTICS.
p.(None): Chapter V (21 U.S.C. 351 et seq.), as amended in section 401, is further amended by adding at the end the
p.(None): following:
p.(None): ‘‘SUBCHAPTER E—GENERAL PROVISIONS RELATING TO DRUGS AND
p.(None): DEVICES
p.(None): ‘‘SEC. 561. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS.
p.(None): ‘‘(a) EMERGENCY SITUATIONS.—The Secretary may, under appro- priate conditions determined by the Secretary,
p.(None): authorize the ship- ment of investigational drugs or investigational devices for the diagnosis, monitoring,
p.(None): or treatment of a serious disease or condition in emergency situations.
p.(None): ‘‘(b) INDIVIDUAL PATIENT ACCESS TO INVESTIGATIONAL PROD-
p.(None): UCTS INTENDED FOR SERIOUS DISEASES.—Any person, acting
p.(None): through a physician licensed in accordance with State law, may request from a manufacturer or distributor, and
p.(None): any manufacturer or distributor may, after complying with the provisions of this subsection, provide to
p.(None): such physician an investigational drug or investigational device for the diagnosis, monitoring, or
p.(None): treatment of a serious disease or condition if—
p.(None): ‘‘(1) the licensed physician determines that the person has no comparable or satisfactory alternative therapy
p.(None): available to diagnose, monitor, or treat the disease or condition involved, and that the probable risk to the
p.(None): person from the investigational drug or investigational device is not greater than the probable risk from the disease
p.(None): or condition;
p.(None): ‘‘(2) the Secretary determines that there is sufficient evi- dence of safety and effectiveness to support
p.(None): the use of the investigational drug or investigational device in the case described in paragraph (1);
p.(None): ‘‘(3) the Secretary determines that provision of the inves- tigational drug or investigational device will not
p.(None): interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval;
p.(None): 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): 21 USC 360bbb.
p.(None):
p.(None):
p.(None): 111 STAT. 2366 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘(4) the sponsor, or clinical investigator, of the investiga- tional drug or investigational device
p.(None): submits to the Secretary a clinical protocol consistent with the provisions of section 505(i) or 520(g),
p.(None): including any regulations promulgated under section 505(i) or 520(g), describing the use of the investigational
p.(None): drug or investigational device in a single patient or a small group of patients.
p.(None): ‘‘(c) TREATMENT INVESTIGATIONAL NEW DRUG APPLICATIONS AND
p.(None): TREATMENT INVESTIGATIONAL DEVICE EXEMPTIONS.—Upon submis-
p.(None): sion by a sponsor or a physician of a protocol intended to provide widespread access to an
p.(None): investigational drug or investigational device for eligible patients (referred to in this subsection as an
p.(None): ‘expanded access protocol’), the Secretary shall permit such inves- tigational drug or investigational
p.(None): device to be made available for expanded access under a treatment investigational new drug
p.(None): application or treatment investigational device exemption if the Secretary determines that—
p.(None): ‘‘(1) under the treatment investigational new drug applica- tion or treatment investigational device exemption,
p.(None): the inves- tigational drug or investigational device is intended for use in the diagnosis, monitoring, or
p.(None): treatment of a serious or imme- diately life-threatening disease or condition;
p.(None): ‘‘(2) there is no comparable or satisfactory alternative ther- apy available to diagnose, monitor, or treat that stage
p.(None): of disease or condition in the population of patients to which the investiga- tional drug or investigational device is
p.(None): intended to be adminis- tered;
p.(None): ‘‘(3)(A) the investigational drug or investigational device is under investigation in a controlled clinical
p.(None): trial for the use described in paragraph (1) under an investigational drug application in effect
p.(None): under section 505(i) or investigational device exemption in effect under section 520(g); or
p.(None): ‘‘(B) all clinical trials necessary for approval of that use of the investigational drug or investigational
p.(None): device have been completed;
p.(None): ‘‘(4) the sponsor of the controlled clinical trials is actively pursuing marketing approval of the
p.(None): investigational drug or investigational device for the use described in paragraph (1) with due diligence;
p.(None): ‘‘(5) in the case of an investigational drug or investigational device described in paragraph (3)(A), the provision of
p.(None): the inves- tigational drug or investigational device will not interfere with the enrollment of patients in ongoing
p.(None): clinical investigations under section 505(i) or 520(g);
p.(None): ‘‘(6) in the case of serious diseases, there is sufficient evi- dence of safety and effectiveness to
p.(None): support the use described in paragraph (1); and
p.(None): ‘‘(7) in the case of immediately life-threatening diseases, the available scientific evidence, taken as a
p.(None): whole, provides a reasonable basis to conclude that the investigational drug or investigational device may
p.(None): be effective for its intended use and would not expose patients to an unreasonable and signifi- cant risk of
p.(None): illness or injury.
p.(None): A protocol submitted under this subsection shall be subject to the provisions of section 505(i) or
p.(None): 520(g), including regulations promulgated under section 505(i) or 520(g). The Secretary may inform national,
p.(None): State, and local medical associations and societies,
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2367
p.(None):
p.(None):
p.(None): voluntary health associations, and other appropriate persons about the availability of an investigational drug or
p.(None): investigational device under expanded access protocols submitted under this subsection. The information
p.(None): provided by the Secretary, in accordance with the preceding sentence, shall be the same type of information that
p.(None): is required by section 402(j)(3) of the Public Health Service Act. ‘‘(d) TERMINATION.—The Secretary
p.(None): may, at any time, with respect to a sponsor, physician, manufacturer, or distributor described in
p.(None): this section, terminate expanded access provided under this section for an investigational drug or
p.(None): investigational device
p.(None): if the requirements under this section are no longer met.
p.(None): ‘‘(e) DEFINITIONS.—In this section, the terms ‘investigational drug’, ‘investigational device’, ‘treatment
p.(None): investigational new drug application’, and ‘treatment investigational device exemption’ shall have the meanings
p.(None): given the terms in regulations prescribed by the Secretary.’’.
p.(None): SEC. 403. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED PRODUCTS.
p.(None): (a) STANDARDS.—Not later than 180 days after the date of enactment of this Act, the Secretary of Health and
p.(None): Human Services shall publish in the Federal Register standards for the prompt review of supplemental
p.(None): applications submitted for approved articles under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
p.(None): seq.) or section 351 of the Public Health Service Act (42 U.S.C. 262).
p.(None): (b) GUIDANCE TO INDUSTRY.—Not later than 180 days after the date of enactment of this Act, the
p.(None): Secretary shall issue final guidances to clarify the requirements for, and facilitate the submis- sion of data to
p.(None): support, the approval of supplemental applications for the approved articles described in subsection (a). The
p.(None): guidances shall—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 371 note.
p.(None): (1) clarify circumstances in which published matter may be the basis for approval of a supplemental application;
p.(None): (2) specify data requirements that will avoid duplication of previously submitted data by recognizing the
p.(None): availability of data previously submitted in support of an original applica- tion; and
p.(None): (3) define supplemental applications that are eligible for priority review.
p.(None): (c) RESPONSIBILITIES OF CENTERS.—The Secretary shall des- ignate an individual in each center within the
p.(None): Food and Drug Administration (except the Center for Food Safety and Applied Nutrition) to be responsible for—
p.(None): (1) encouraging the prompt review of supplemental applica- tions for approved articles; and
p.(None): (2) working with sponsors to facilitate the development and submission of data to support supplemental
p.(None): applications.
p.(None): (d) COLLABORATION.—The Secretary shall implement programs and policies that will foster collaboration between
p.(None): the Food and Drug Administration, the National Institutes of Health, professional medical and scientific societies,
p.(None): and other persons, to identify pub- lished and unpublished studies that may support a supplemental application,
p.(None): and to encourage sponsors to make supplemental applications or conduct further research in support
p.(None): of a supple- mental application based, in whole or in part, on such studies.
p.(None):
p.(None):
p.(None): 111 STAT. 2368 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC
p.(None): 360bbb–1. Regulations.
p.(None): SEC. 404. DISPUTE RESOLUTION.
p.(None): Subchapter E of chapter V, as added by section 402, is amended by adding at the end the following:
p.(None): ‘‘SEC. 562. DISPUTE RESOLUTION.
p.(None): ‘‘If, regarding an obligation concerning drugs or devices under this Act or section 351 of the Public
p.(None): Health Service Act, there is a scientific controversy between the Secretary and a person who is a sponsor,
p.(None): applicant, or manufacturer and no specific provi- sion of the Act involved, including a regulation promulgated under
p.(None): such Act, provides a right of review of the matter in controversy, the Secretary shall, by regulation,
p.(None): establish a procedure under which such sponsor, applicant, or manufacturer may request a review of such
p.(None): controversy, including a review by an appropriate scientific advisory panel described in section 505(n) or an
p.(None): advisory committee described in section 515(g)(2)(B). Any such review shall take place in a timely manner.
p.(None): The Secretary shall promulgate such regulations within 1 year after the date of the enactment of the Food
p.(None): and Drug Administration Modernization Act of 1997.’’.
p.(None): SEC. 405. INFORMAL AGENCY STATEMENTS.
p.(None): Section 701 (21 U.S.C. 371) is amended by adding at the end the following:
p.(None): ‘‘(h)(1)(A) The Secretary shall develop guidance documents with public participation and ensure that information
p.(None): identifying the existence of such documents and the documents themselves are made available to the public both
p.(None): in written form and, as feasible, through electronic means. Such documents shall not create or confer any rights for
p.(None): or on any person, although they present the views of the Secretary on matters under the jurisdiction of
p.(None): the Food and Drug Administration.
p.(None): ‘‘(B) Although guidance documents shall not be binding on the Secretary, the Secretary shall ensure that
p.(None): employees of the Food and Drug Administration do not deviate from such guidances without appropriate justification
p.(None): and supervisory concurrence. The Secretary shall provide training to employees in how to develop and use
p.(None): guidance documents and shall monitor the development and issuance of such documents.
p.(None): ‘‘(C) For guidance documents that set forth initial interpreta- tions of a statute or regulation, changes in
p.(None): interpretation or policy that are of more than a minor nature, complex scientific issues, or highly
p.(None): controversial issues, the Secretary shall ensure public participation prior to implementation of guidance
p.(None): documents, unless the Secretary determines that such prior public participation is not feasible or
p.(None): appropriate. In such cases, the Secretary shall pro- vide for public comment upon implementation and take
p.(None): such com- ment into account.
p.(None): ‘‘(D) For guidance documents that set forth existing practices or minor changes in policy, the Secretary
p.(None): shall provide for public comment upon implementation.
p.(None): ‘‘(2) In developing guidance documents, the Secretary shall ensure uniform nomenclature for such documents
p.(None): and uniform internal procedures for approval of such documents. The Secretary shall ensure that guidance documents
p.(None): and revisions of such docu- ments are properly dated and indicate the nonbinding nature of the documents.
p.(None): The Secretary shall periodically review all guidance documents and, where appropriate, revise such documents.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2369
p.(None):
p.(None):
p.(None): ‘‘(3) The Secretary, acting through the Commissioner, shall maintain electronically and update and publish
p.(None): periodically in the Federal Register a list of guidance documents. All such documents shall be made available to the
p.(None): public.
p.(None): ‘‘(4) The Secretary shall ensure that an effective appeals mecha- nism is in place to address complaints that
p.(None): the Food and Drug Administration is not developing and using guidance documents in accordance with this
p.(None): subsection.
p.(None): ‘‘(5) Not later than July 1, 2000, the Secretary after evaluating the effectiveness of the Good Guidance
p.(None): Practices document, pub- lished in the Federal Register at 62 Fed. Reg. 8961, shall promul- gate a
p.(None): regulation consistent with this subsection specifying the policies and procedures of the Food and Drug
p.(None): Administration for the development, issuance, and use of guidance documents.’’.
p.(None): SEC. 406. FOOD AND DRUG ADMINISTRATION MISSION AND ANNUAL REPORT.
p.(None): (a) MISSION.—Section 903 (21 U.S.C. 393) is amended—
p.(None): (1) by redesignating subsections (b) and (c) as subsections
p.(None): (d) and (e), respectively; and
p.(None): (2) by inserting after subsection (a) the following: ‘‘(b) MISSION.—The Administration shall—
p.(None): ‘‘(1) promote the public health by promptly and efficiently reviewing clinical research and taking
p.(None): appropriate action on the marketing of regulated products in a timely manner;
p.(None): ‘‘(2) with respect to such products, protect the public health by ensuring that—
p.(None): ‘‘(A) foods are safe, wholesome, sanitary, and properly labeled;
p.(None): ‘‘(B) human and veterinary drugs are safe and effective; ‘‘(C) there is reasonable assurance of the safety and
p.(None): effectiveness of devices intended for human use;
p.(None): ‘‘(D) cosmetics are safe and properly labeled; and
p.(None): ‘‘(E) public health and safety are protected from elec- tronic product radiation;
p.(None): ‘‘(3) participate through appropriate processes with rep- resentatives of other countries to reduce the burden of
p.(None): regula- tion, harmonize regulatory requirements, and achieve appro- priate reciprocal arrangements; and
p.(None): ‘‘(4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in
p.(None): consultation with experts in science, medicine, and public health, and in coopera- tion with consumers, users,
p.(None): manufacturers, importers, packers, distributors, and retailers of regulated products.’’.
p.(None): (b) ANNUAL REPORT.—Section 903 (21 U.S.C. 393), as amended by subsection (a), is further amended by adding at
p.(None): the end the following:
p.(None): ‘‘(f) AGENCY PLAN FOR STATUTORY COMPLIANCE.—
p.(None): ‘‘(1) IN GENERAL.—Not later than 1 year after the date of enactment of the Food and Drug Administration
p.(None): Moderniza- tion Act of 1997, the Secretary, after consultation with appro- priate scientific and academic
p.(None): experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated
p.(None): industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with
p.(None): each of the obligations of the Secretary under this Act. The
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):
p.(None):
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): 111 STAT. 2370 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): Secretary shall review the plan biannually and shall revise the plan as necessary, in consultation with such
p.(None): persons.
p.(None): ‘‘(2) OBJECTIVES OF AGENCY PLAN.—The plan required by paragraph (1) shall establish objectives and
p.(None): mechanisms to achieve such objectives, including objectives related to—
p.(None): ‘‘(A) maximizing the availability and clarity of informa- tion about the process for review of
p.(None): applications and submissions (including petitions, notifications, and any other similar forms of request)
p.(None): made under this Act;
p.(None): ‘‘(B) maximizing the availability and clarity of informa- tion for consumers and patients concerning new
p.(None): products; ‘‘(C) implementing inspection and postmarket monitor-
p.(None): ing provisions of this Act;
p.(None): ‘‘(D) ensuring access to the scientific and technical expertise needed by the Secretary to meet
p.(None): obligations described in paragraph (1);
p.(None): ‘‘(E) establishing mechanisms, by July 1, 1999, for meeting the time periods specified in this Act for the
p.(None): review of all applications and submissions described in subpara- graph (A) and submitted after the date
p.(None): of enactment of the Food and Drug Administration Modernization Act of 1997; and
p.(None): ‘‘(F) eliminating backlogs in the review of applications and submissions described in subparagraph (A), by January 1,
p.(None): 2000.
p.(None):
p.(None): Federal Register, publication.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 379k.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379k
p.(None): note.
p.(None): ‘‘(g) ANNUAL REPORT.—The Secretary shall annually prepare and publish in the Federal Register and solicit
p.(None): public comment on a report that—
p.(None): ‘‘(1) provides detailed statistical information on the performance of the Secretary under the plan
p.(None): described in sub- section (f);
p.(None): ‘‘(2) compares such performance of the Secretary with the objectives of the plan and with the statutory
p.(None): obligations of the Secretary; and
p.(None): ‘‘(3) identifies any regulatory policy that has a significant negative impact on compliance with any
p.(None): objective of the plan or any statutory obligation and sets forth any proposed revision to any such regulatory
p.(None): policy.’’.
p.(None): SEC. 407. INFORMATION SYSTEM.
p.(None): (a) AMENDMENT.—Chapter VII (21 U.S.C. 371 et seq.) is amend- ed by adding at the end the following:
p.(None):
p.(None): ‘‘SUBCHAPTER D—INFORMATION AND EDUCATION
p.(None):
p.(None): ‘‘SEC. 741. INFORMATION SYSTEM.
p.(None): ‘‘The Secretary shall establish and maintain an information system to track the status and progress of
p.(None): each application or submission (including a petition, notification, or other similar form of request) submitted to
p.(None): the Food and Drug Administration request- ing agency action.’’.
p.(None): (b) REPORT.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human
p.(None): Services shall submit a report to the Committee on Labor and Human Resources of the Senate and the Committee on
p.(None): Commerce of the House of Representatives on the status of the system to be established under
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2371
p.(None):
p.(None):
p.(None): the amendment made by subsection (a), including the projected costs of the system and concerns about
p.(None): confidentiality.
p.(None): SEC. 408. EDUCATION AND TRAINING.
p.(None): (a) FOOD AND DRUG ADMINISTRATION.—Chapter VII (21 U.S.C.
p.(None): 371 et seq.), as amended by section 407, is further amended by adding at the end the following section:
p.(None): ‘‘SEC. 742. EDUCATION.
p.(None): ‘‘(a) IN GENERAL.—The Secretary shall conduct training and education programs for the employees of
p.(None): the Food and Drug Administration relating to the regulatory responsibilities and poli- cies established by
p.(None): this Act, including programs for—
p.(None): ‘‘(1) scientific training;
p.(None): ‘‘(2) training to improve the skill of officers and employees authorized to conduct inspections under section 704;
p.(None): ‘‘(3) training to achieve product specialization in such inspections; and
p.(None): ‘‘(4) training in administrative process and procedure and integrity issues.
p.(None): ‘‘(b) INTRAMURAL FELLOWSHIPS AND OTHER TRAINING PRO-
p.(None): GRAMS.—The Secretary, acting through the Commissioner, may, through fellowships and other training programs,
p.(None): conduct and sup- port intramural research training for predoctoral and postdoctoral scientists and
p.(None): physicians.’’.
p.(None): (b) CENTERS FOR DISEASE CONTROL AND PREVENTION.—
p.(None): (1) IN GENERAL.—Part B of title III of the Public Health Service Act is amended by inserting after
p.(None): section 317F (42
p.(None): U.S.C. 247b–7) the following:
p.(None): ‘‘SEC. 317G. FELLOWSHIP AND TRAINING PROGRAMS.
p.(None): ‘‘The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall
p.(None): establish fellowship and training programs to be conducted by such Centers to train individ- uals to develop
p.(None): skills in epidemiology, surveillance, laboratory analysis, and other disease detection and prevention methods.
p.(None): Such programs shall be designed to enable health professionals and health personnel trained under such programs
p.(None): to work, after receiv- ing such training, in local, State, national, and international efforts toward the prevention
...
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997
p.(None): (3) by inserting after clause (ii) the following:
p.(None): 111 STAT. 2373
p.(None): ‘‘(iii) ensure that such regulation conforms, to the extent practicable, with internationally recognized
p.(None): standards defining quality systems, or parts of the standards, for medical devices.’’.
p.(None): (b) HARMONIZATION EFFORTS.—Section 803 (21 U.S.C. 383) is amended by adding at the end the following:
p.(None): ‘‘(c)(1) The Secretary shall support the Office of the United States Trade Representative, in consultation
p.(None): with the Secretary of Commerce, in meetings with representatives of other countries to discuss methods and
p.(None): approaches to reduce the burden of regula- tion and harmonize regulatory requirements if the Secretary deter- mines
p.(None): that such harmonization continues consumer protections consistent with the purposes of this Act.
p.(None): ‘‘(2) The Secretary shall support the Office of the United States Trade Representative, in consultation with the
p.(None): Secretary of Com- merce, in efforts to move toward the acceptance of mutual recogni- tion agreements relating to the
p.(None): regulation of drugs, biological prod- ucts, devices, foods, food additives, and color additives, and the
p.(None): regulation of good manufacturing practices, between the European Union and the United States.
p.(None): ‘‘(3) The Secretary shall regularly participate in meetings with representatives of other foreign governments to
p.(None): discuss and reach agreement on methods and approaches to harmonize regulatory requirements.
p.(None): ‘‘(4) The Secretary shall, not later than 180 days after the date of enactment of the Food and Drug
p.(None): Administration Moderniza- tion Act of 1997, make public a plan that establishes a framework for achieving mutual
p.(None): recognition of good manufacturing practices inspections.
p.(None): ‘‘(5) Paragraphs (1) through (4) shall not apply with respect to products defined in section 201(ff).’’.
p.(None): SEC. 411. ENVIRONMENTAL IMPACT REVIEW.
p.(None): Chapter VII (21 U.S.C. 371 et seq.), as amended by section 407, is further amended by adding at the end the
p.(None): following:
p.(None):
p.(None): ‘‘SUBCHAPTER E—ENVIRONMENTAL IMPACT REVIEW
p.(None):
p.(None):
p.(None): ‘‘SEC. 746. ENVIRONMENTAL IMPACT.
p.(None): ‘‘Notwithstanding any other provision of law, an environmental impact statement prepared in accordance with the
p.(None): regulations pub- lished in part 25 of title 21, Code of Federal Regulations (as in effect on August 31,
p.(None): 1997) in connection with an action carried out under (or a recommendation or report relating to) this
p.(None): Act, shall be considered to meet the requirements for a detailed state- ment under section 102(2)(C) of the
p.(None): National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)).’’.
p.(None): SEC. 412. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND COSMETICS.
p.(None): (a) NONPRESCRIPTION DRUGS.—Chapter VII (21 U.S.C. 371 et seq.), as amended by section 411, is further
p.(None): amended by adding at the end the following:
p.(None): 21 USC 379o.
p.(None):
p.(None):
p.(None): 111 STAT. 2374 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘SUBCHAPTER F—NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND PREEMPTION FOR LABELING OR PACKAGING
p.(None): OF COS-
p.(None): METICS
p.(None):
p.(None): 21 USC 379r.
p.(None): ‘‘SEC. 751. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS.
p.(None): ‘‘(a) IN GENERAL.—Except as provided in subsection (b), (c)(1), (d), (e), or (f), no State or political
p.(None): subdivision of a State may establish or continue in effect any requirement—
p.(None): ‘‘(1) that relates to the regulation of a drug that is not subject to the requirements of section 503(b)(1)
p.(None): or 503(f)(1)(A); and
p.(None): ‘‘(2) that is different from or in addition to, or that is otherwise not identical with, a requirement
p.(None): under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair
p.(None): Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
p.(None): ‘‘(b) EXEMPTION.—
p.(None): ‘‘(1) IN GENERAL.—Upon application of a State or political subdivision thereof, the Secretary may by
p.(None): regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection
p.(None): (a), under such conditions as may be prescribed in such regulation, a State or political sub- division
p.(None): requirement that—
p.(None): ‘‘(A) protects an important public interest that would otherwise be unprotected, including the health and
p.(None): safety of children;
p.(None): ‘‘(B) would not cause any drug to be in violation of any applicable requirement or prohibition under
p.(None): Federal law; and
p.(None): ‘‘(C) would not unduly burden interstate commerce. ‘‘(2) TIMELY ACTION.—The Secretary shall make a decision
p.(None): on the exemption of a State or political subdivision requirement under paragraph (1) not later than 120 days
p.(None): after receiving the application of the State or political subdivision under paragraph (1).
p.(None): ‘‘(c) SCOPE.—
p.(None): ‘‘(1) IN GENERAL.—This section shall not apply to—
p.(None): ‘‘(A) any State or political subdivision requirement that relates to the practice of pharmacy; or
p.(None): ‘‘(B) any State or political subdivision requirement that a drug be dispensed only upon the prescription of a practi-
p.(None): tioner licensed by law to administer such drug.
p.(None): ‘‘(2) SAFETY OR EFFECTIVENESS.—For purposes of subsection (a), a requirement that relates to the regulation
p.(None): of a drug shall be deemed to include any requirement relating to public information or any other form of
p.(None): public communication relating to a warning of any kind for a drug.
p.(None): ‘‘(d) EXCEPTIONS.—
p.(None): ‘‘(1) IN GENERAL.—In the case of a drug described in sub- section (a)(1) that is not the subject of an
p.(None): application approved under section 505 or section 507 (as in effect on the day before the date of enactment of the
p.(None): Food and Drug Administration Modernization Act of 1997) or a final regulation promulgated by the Secretary
p.(None): establishing conditions under which the drug is generally recognized as safe and effective and not mis-
p.(None): branded, subsection (a) shall apply only with respect to a requirement of a State or political
p.(None): subdivision of a State that
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2375
p.(None):
p.(None): relates to the same subject as, but is different from or in addition to, or that is otherwise not identical
p.(None): with—
p.(None): ‘‘(A) a regulation in effect with respect to the drug pursuant to a statute described in subsection
p.(None): (a)(2); or ‘‘(B) any other requirement in effect with respect to
p.(None): the drug pursuant to an amendment to such a statute made on or after the date of enactment of the
p.(None): Food and Drug Administration Modernization Act of 1997.
p.(None): ‘‘(2) STATE INITIATIVES.—This section shall not apply to a State requirement adopted by a State
p.(None): public initiative or referendum enacted prior to September 1, 1997.
p.(None): ‘‘(e) NO EFFECT ON PRODUCT LIABILITY LAW.—Nothing in this
p.(None): section shall be construed to modify or otherwise affect any action or the liability of any person under the
p.(None): product liability law of any State.
p.(None): ‘‘(f) STATE ENFORCEMENT AUTHORITY.—Nothing in this section shall prevent a State or political subdivision
p.(None): thereof from enforcing, under any relevant civil or other enforcement authority, a require- ment that is identical to a
p.(None): requirement of this Act.’’.
p.(None): (b) INSPECTIONS.—Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended by striking ‘‘prescription drugs’’
p.(None): each place it appears and inserting ‘‘prescription drugs, nonprescription drugs intended for human use,’’.
p.(None): (c) MISBRANDING.—Subparagraph (1) of section 502(e) (21
p.(None): U.S.C. 352(e)(1)) is amended to read as follows:
p.(None): ‘‘(1)(A) If it is a drug, unless its label bears, to the exclusion of any other nonproprietary name (except
p.(None): the applicable systematic chemical name or the chemical formula)—
p.(None): ‘‘(i) the established name (as defined in subparagraph (3)) of the drug, if there is such a name;
p.(None): ‘‘(ii) the established name and quantity or, if determined to be appropriate by the Secretary, the
p.(None): proportion of each active ingredient, including the quantity, kind, and proportion of any alcohol, and
p.(None): also including whether active or not the established name and quantity or if determined to be appro-
p.(None): priate by the Secretary, the proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin,
p.(None): amidopyrine, anti- pyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digi- talis glucosides, mercury,
p.(None): ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such sub- stances,
p.(None): contained therein, except that the requirement for stating the quantity of the active ingredients, other
p.(None): than the quantity of those specifically named in this subclause, shall not apply to nonprescription drugs
p.(None): not intended for human use; and
p.(None): ‘‘(iii) the established name of each inactive ingredient listed in alphabetical order on the outside container
p.(None): of the retail package and, if determined to be appropriate by the Secretary, on the immediate container, as
p.(None): prescribed in regulation promul- gated by the Secretary, except that nothing in this subclause shall be
p.(None): deemed to require that any trade secret be divulged, and except that the requirements of this subclause with
p.(None): respect to alphabetical order shall apply only to nonprescription drugs that are not also cosmetics and that
p.(None): this subclause shall not apply to nonprescription drugs not intended for human use. ‘‘(B) For any
p.(None): prescription drug the established name of such
p.(None): drug or ingredient, as the case may be, on such label (and on
p.(None):
p.(None):
p.(None): 111 STAT. 2376 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): any labeling on which a name for such drug or ingredient is used) shall be printed prominently and in type at
p.(None): least half as large as that used thereon for any proprietary name or designation for such drug or
p.(None): ingredient, except that to the extent that compliance with the requirements of subclause (ii) or (iii)
p.(None): of clause (A) or this clause is impracticable, exemptions shall be established by regulations promulgated by
p.(None): the Secretary.’’.
p.(None): (d) COSMETICS.—Subchapter F of chapter VII, as amended by subsection (a), is further amended by adding at the
p.(None): end the follow- ing:
p.(None):
p.(None): 21 USC 379s.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 393 note.
p.(None): ‘‘SEC. 752. PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS.
p.(None): ‘‘(a) IN GENERAL.—Except as provided in subsection (b), (d), or (e), no State or political subdivision
p.(None): of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic
p.(None): that is different from or in addition to, or that is otherwise not identical with, a requirement specifically
p.(None): applicable to a particular cosmetic or class of cosmetics under this Act, the Poison Prevention Packaging
p.(None): Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et
p.(None): seq.). ‘‘(b) EXEMPTION.—Upon application of a State or political sub- division thereof, the Secretary may
p.(None): by regulation, after notice and opportunity for written and oral presentation of views, exempt from
p.(None): subsection (a), under such conditions as may be prescribed in such regulation, a State or political
p.(None): subdivision requirement
p.(None): for labeling or packaging that—
p.(None): ‘‘(1) protects an important public interest that would other- wise be unprotected;
p.(None): ‘‘(2) would not cause a cosmetic to be in violation of any applicable requirement or prohibition under
p.(None): Federal law; and
p.(None): ‘‘(3) would not unduly burden interstate commerce.
p.(None): ‘‘(c) SCOPE.—For purposes of subsection (a), a reference to a State requirement that relates to the
p.(None): packaging or labeling of a cosmetic means any specific requirement relating to the same aspect of such
p.(None): cosmetic as a requirement specifically applicable to that particular cosmetic or class of cosmetics under
p.(None): this Act for packaging or labeling, including any State requirement relating to public information or any other
p.(None): form of public communication. ‘‘(d) NO EFFECT ON PRODUCT LIABILITY LAW.—Nothing in this
p.(None): section shall be construed to modify or otherwise affect any action or the liability of any person under the
p.(None): product liability law of any State.
p.(None): ‘‘(e) STATE INITIATIVE.—This section shall not apply to a State requirement adopted by a State public initiative
p.(None): or referendum enacted prior to September 1, 1997.’’.
p.(None): SEC. 413. FOOD AND DRUG ADMINISTRATION STUDY OF MERCURY COMPOUNDS IN DRUGS AND FOOD.
p.(None): (a) LIST AND ANALYSIS.—The Secretary of Health and Human Services shall, acting through the Food and Drug
p.(None): Administration—
p.(None): (1) compile a list of drugs and foods that contain inten- tionally introduced mercury compounds, and
p.(None): (2) provide a quantitative and qualitative analysis of the mercury compounds in the list under paragraph (1).
p.(None): The Secretary shall compile the list required by paragraph (1) within 2 years after the date of
p.(None): enactment of the Food and Drug Administration Modernization Act of 1997 and shall provide the
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2377
p.(None):
p.(None):
p.(None): analysis required by paragraph (2) within 2 years after such date of enactment.
p.(None): (b) STUDY.—The Secretary of Health and Human Services, act- ing through the Food and Drug Administration, shall
p.(None): conduct a study of the effect on humans of the use of mercury compounds in nasal sprays. Such study
p.(None): shall include data from other studies that have been made of such use.
p.(None): (c) STUDY OF MERCURY SALES.—
p.(None): (1) STUDY.—The Secretary of Health and Human Services, acting through the Food and Drug Administration and subject to
p.(None): appropriations, shall conduct, or shall contract with the Institute of Medicine of the National Academy
p.(None): of Sciences to conduct, a study of the effect on humans of the use of elemental, organic, or inorganic mercury
p.(None): when offered for sale as a drug or dietary supplement. Such study shall, among other things, evaluate—
p.(None): (A) the scope of mercury use as a drug or dietary supplement; and
p.(None): (B) the adverse effects on health of children and other sensitive populations resulting from exposure to, or
p.(None): inges- tion or inhalation of, mercury when so used.
p.(None): In conducting such study, the Secretary shall consult with the Administrator of the Environmental Protection
p.(None): Agency, the Chair of the Consumer Product Safety Commission, and the Administrator of the Agency for Toxic
p.(None): Substances and Disease Registry, and, to the extent the Secretary believes necessary or appropriate, with any
p.(None): other Federal or private entity.
p.(None): (2) REGULATIONS.—If, in the opinion of the Secretary, the use of elemental, organic, or inorganic mercury
p.(None): offered for sale as a drug or dietary supplement poses a threat to human health, the Secretary shall promulgate
p.(None): regulations restricting the sale of mercury intended for such use. At a minimum, such regulations shall
p.(None): be designed to protect the health of children and other sensitive populations from adverse effects
p.(None): resulting from exposure to, or ingestion or inhalation of, mer- cury. Such regulations, to the
p.(None): extent feasible, should not unnecessarily interfere with the availability of mercury for use in religious
p.(None): ceremonies.
p.(None): SEC. 414. INTERAGENCY COLLABORATION.
p.(None): Section 903 (21 U.S.C. 393), as amended by section 406, is further amended by inserting after subsection
p.(None): (b) the following: ‘‘(c) INTERAGENCY COLLABORATION.—The Secretary shall imple- ment programs and
p.(None): policies that will foster collaboration between the Administration, the National Institutes of Health, and
p.(None): other science-based Federal agencies, to enhance the scientific and tech- nical expertise available to the
p.(None): Secretary in the conduct of the duties of the Secretary with respect to the development, clinical
p.(None): investigation, evaluation, and postmarket monitoring of emerging medical therapies, including
p.(None): complementary therapies, and
p.(None): advances in nutrition and food science.’’.
p.(None): SEC. 415. CONTRACTS FOR EXPERT REVIEW.
...
p.(None): notification, and any other similar form of request) made under this Act for the approval or
p.(None): classification of an article or made under section 351(a) of the Public Health Serv- ice Act (42 U.S.C. 262(a))
p.(None): with respect to a biological product. Any such contract shall be subject to the requirements of section 708
p.(None): relating to the confidentiality of information.
p.(None): ‘‘(2) INCREASED EFFICIENCY AND EXPERTISE THROUGH CON-
p.(None): TRACTS.—The Secretary may use the authority granted in para- graph (1) whenever the Secretary determines that
p.(None): use of a contract described in paragraph (1) will improve the timeliness of the review of an application or
p.(None): submission described in paragraph (1), unless using such authority would reduce the quality, or unduly
p.(None): increase the cost, of such review. The Sec- retary may use such authority whenever the Secretary deter-
p.(None): mines that use of such a contract will improve the quality of the review of an application or
p.(None): submission described in paragraph (1), unless using such authority would unduly increase the cost of
p.(None): such review. Such improvement in timeli- ness or quality may include providing the Secretary increased
p.(None): scientific or technical expertise that is necessary to review or evaluate new therapies and technologies.
p.(None): ‘‘(b) REVIEW OF EXPERT REVIEW.—
p.(None): ‘‘(1) IN GENERAL.—Subject to paragraph (2), the official of the Food and Drug Administration responsible for
p.(None): any matter for which expert review is used pursuant to subsection (a) shall review the recommendations
p.(None): of the organization or individual who conducted the expert review and shall make a final decision
p.(None): regarding the matter in a timely manner. ‘‘(2) LIMITATION.—A final decision by the Secretary on any such
p.(None): application or submission shall be made within the applicable prescribed time period for review of
p.(None): the matter as set forth in this Act or in the Public Health Service Act (42
p.(None): U.S.C. 201 et seq.).’’.
p.(None): SEC. 416. PRODUCT CLASSIFICATION.
p.(None): Subchapter E of chapter V, as amended by section 404, is further amended by adding at the end the following:
p.(None):
p.(None): 21 USC
p.(None): 360bbb–2.
p.(None): ‘‘SEC. 563. CLASSIFICATION OF PRODUCTS.
p.(None): ‘‘(a) REQUEST.—A person who submits an application or submis- sion (including a petition, notification, and any
p.(None): other similar form of request) under this Act for a product, may submit a request to the Secretary
p.(None): respecting the classification of the product as a drug, biological product, device, or a combination product
p.(None): subject to section 503(g) or respecting the component of the Food and Drug Administration that will
p.(None): regulate the product. In submitting the request, the person shall recommend a classification for the
p.(None): product, or a component to regulate the product, as appropriate. ‘‘(b) STATEMENT.—Not later than 60 days
p.(None): after the receipt of
p.(None): the request described in subsection (a), the Secretary shall deter- mine the classification of the
p.(None): product under subsection (a), or the component of the Food and Drug Administration that will regulate the
p.(None): product, and shall provide to the person a written statement
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2379
p.(None):
p.(None):
p.(None): that identifies such classification or such component, and the rea- sons for such determination. The
p.(None): Secretary may not modify such statement except with the written consent of the person, or for public
p.(None): health reasons based on scientific evidence.
p.(None): ‘‘(c) INACTION OF SECRETARY.—If the Secretary does not provide the statement within the 60-day period
p.(None): described in subsection (b), the recommendation made by the person under subsection (a) shall be
p.(None): considered to be a final determination by the Secretary of such classification of the product, or the
p.(None): component of the Food and Drug Administration that will regulate the product, as applicable, and
p.(None): may not be modified by the Secretary except with the written consent of the person, or for public
p.(None): health reasons based on scientific evidence.’’.
p.(None): SEC. 417. REGISTRATION OF FOREIGN ESTABLISHMENTS.
p.(None): Section 510(i) (21 U.S.C. 360(i)) is amended to read as follows: ‘‘(i)(1) Any establishment within any foreign
p.(None): country engaged
p.(None): in the manufacture, preparation, propagation, compounding, or processing of a drug or a device that
p.(None): is imported or offered for import into the United States shall register with the Secretary the name and
p.(None): place of business of the establishment and the name of the United States agent for the establishment.
p.(None): ‘‘(2) The establishment shall also provide the information required by subsection (j).
p.(None): ‘‘(3) The Secretary is authorized to enter into cooperative arrangements with officials of foreign
p.(None): countries to ensure that ade- quate and effective means are available for purposes of determining, from time to
p.(None): time, whether drugs or devices manufactured, pre- pared, propagated, compounded, or processed by an
p.(None): establishment described in paragraph (1), if imported or offered for import into the United States, shall be
p.(None): refused admission on any of the grounds set forth in section 801(a).’’.
p.(None): SEC. 418. CLARIFICATION OF SEIZURE AUTHORITY.
p.(None): Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended—
p.(None): (1) in the fifth sentence, by striking ‘‘paragraphs (1) and
p.(None): (2) of section 801(e)’’ and inserting ‘‘subparagraphs (A) and
p.(None): (B) of section 801(e)(1)’’; and
p.(None): (2) by inserting after the fifth sentence the following: ‘‘Any person seeking to export an imported article
p.(None): pursuant to any of the provisions of this subsection shall establish that the article was intended for
p.(None): export at the time the article entered commerce.’’.
p.(None): SEC. 419. INTERSTATE COMMERCE.
p.(None): Section 709 (21 U.S.C. 379a) is amended by striking ‘‘a device’’ and inserting ‘‘a device, food, drug, or cosmetic’’.
p.(None): SEC. 420. SAFETY REPORT DISCLAIMERS.
p.(None): Chapter VII (21 U.S.C. 371 et seq.), as amended by section 412, is further amended by adding at the end the
p.(None): following:
p.(None): ‘‘SUBCHAPTER G—SAFETY REPORTS
p.(None): ‘‘SEC. 756. SAFETY REPORT DISCLAIMERS.
p.(None): ‘‘With respect to any entity that submits or is required to submit a safety report or other information
p.(None): in connection with the safety of a product (including a product that is a food, drug,
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 379v.
p.(None):
p.(None):
p.(None): 111 STAT. 2380 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): device, dietary supplement, or cosmetic) under this Act (and any release by the Secretary of that report or
p.(None): information), such report or information shall not be construed to reflect necessarily a conclu- sion by the entity
p.(None): or the Secretary that the report or information constitutes an admission that the product involved
p.(None): malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death,
p.(None): serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or informa- tion
p.(None): submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed
p.(None): to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.’’.
p.(None): SEC. 421. LABELING AND ADVERTISING REGARDING COMPLIANCE WITH STATUTORY REQUIREMENTS.
p.(None):
p.(None):
p.(None): (l).
p.(None): Section 301 (21 U.S.C. 331) is amended by striking paragraph
p.(None):
p.(None): 21 USC 321 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 321 note.
p.(None): SEC. 422. RULE OF CONSTRUCTION.
p.(None): Nothing in this Act or the amendments made by this Act shall be construed to affect the question of
p.(None): whether the Secretary of Health and Human Services has any authority to regulate any tobacco product,
p.(None): tobacco ingredient, or tobacco additive. Such authority, if any, shall be exercised under the Federal Food,
p.(None): Drug, and Cosmetic Act as in effect on the day before the date of the enactment of this Act.
p.(None): TITLE V—EFFECTIVE DATE
p.(None): SEC. 501. EFFECTIVE DATE.
p.(None): Except as otherwise provided in this Act, this Act and the amendments made by this Act, other than the
p.(None): provisions of and the amendments made by sections 111, 121, 125, and 307, shall take effect 90 days after
p.(None): the date of enactment of this Act.
p.(None): Approved November 21, 1997.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): LEGISLATIVE HISTORY—S. 830 (H.R. 1411):
p.(None): HOUSE REPORTS: Nos. 105–310, accompanying H.R. 1411 (Comm. on Commerce) and 105–399 (Comm. of Conference).
p.(None): SENATE REPORTS: No. 105–43 (Comm. on Labor and Human Resources). CONGRESSIONAL RECORD, Vol. 143 (1997):
p.(None): Sept. 11, 16, 18, 19, 23, 24, considered and passed Senate.
p.(None): Oct. 7, considered and passed House, amended, in lieu of H.R. 1411. Nov. 9, Senate and House agreed to conference
p.(None): report.
p.(None): WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 33 (1997):
p.(None): Nov. 21, Presidential remarks.
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p.(None): applicant for approval of the application were not conducted by or for the applicant and for which the
p.(None): applicant has not obtained a right of reference or use from the person by or for whom the investigations
p.(None): were conducted.
p.(None): (3) PUBLICATION.—For purposes of this section, the Sec- retary is authorized to make available to the public the
p.(None): estab- lished name of each antibiotic drug that was the subject of any application for marketing received
p.(None): by the Secretary for Health and Human Services under section 507 of the Federal Food, Drug, and
p.(None): Cosmetic Act (21 U.S.C. 357) before the date of enactment of this Act.
p.(None): (e) DEFINITION.—Section 201 (21 U.S.C. 321), as amended by section 121(a)(1), is further amended by
p.(None): adding at the end the following:
p.(None): ‘‘(jj) The term ‘antibiotic drug’ means any drug (except drugs for use in animals other than humans)
p.(None): composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chlor- amphenicol,
p.(None): bacitracin, or any other drug intended for human use containing any quantity of any chemical substance
p.(None): which is pro- duced by a micro-organism and which has the capacity to inhibit or destroy micro-organisms in
p.(None): dilute solution (including a chemically synthesized equivalent of any such substance) or any derivative
p.(None): thereof.’’.
p.(None): SEC. 126. ELIMINATION OF CERTAIN LABELING REQUIREMENTS.
p.(None): (a) PRESCRIPTION DRUGS.—Section 503(b)(4) (21 U.S.C. 353(b)(4)) is amended to read as follows:
p.(None): ‘‘(4)(A) A drug that is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to
p.(None): dispensing the label of the drug fails to bear, at a minimum, the symbol ‘Rx only’. ‘‘(B) A drug to
p.(None): which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing
p.(None): the label of the drug bears the symbol described in subparagraph (A).’’.
p.(None): (b) MISBRANDED DRUG.—Section 502(d) (21 U.S.C. 352(d)) is repealed.
p.(None): (c) CONFORMING AMENDMENTS.—
p.(None): (1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended—
p.(None): (A) by striking subparagraph (A); and
p.(None):
p.(None):
p.(None): 111 STAT. 2328 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): (B) by redesignating subparagraphs (B) and (C) as subparagraphs (A) and (B), respectively.
p.(None): (2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by striking ‘‘section 502(d) and’’.
p.(None): (3) Section 102(9)(A) of the Controlled Substances Act (21
p.(None): U.S.C. 802(9)(A)) is amended—
...
p.(None): ‘‘(II) the physician or other licensed practitioner who will write such prescription order.
p.(None): ‘‘(b) COMPOUNDED DRUG.—
p.(None): ‘‘(1) LICENSED PHARMACIST AND LICENSED PHYSICIAN.—A
p.(None): drug product may be compounded under subsection (a) if the licensed pharmacist or licensed physician—
p.(None): ‘‘(A) compounds the drug product using bulk drug sub- stances, as defined in regulations of the Secretary published at
p.(None): section 207.3(a)(4) of title 21 of the Code of Federal Regulations—
p.(None): ‘‘(i) that—
p.(None): ‘‘(I) comply with the standards of an applicable United States Pharmacopoeia or National For- mulary
p.(None): monograph, if a monograph exists, and the United States Pharmacopoeia chapter on phar- macy compounding;
p.(None): ‘‘(II) if such a monograph does not exist, are drug substances that are components of drugs
p.(None): approved by the Secretary; or
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2329
p.(None):
p.(None): ‘‘(III) if such a monograph does not exist and the drug substance is not a component of a drug
p.(None): approved by the Secretary, that appear on a list developed by the Secretary through regulations issued by
p.(None): the Secretary under subsection (d);
p.(None): ‘‘(ii) that are manufactured by an establishment that is registered under section 510 (including a foreign
p.(None): establishment that is registered under section 510(i)); and
p.(None): ‘‘(iii) that are accompanied by valid certificates of analysis for each bulk drug substance;
p.(None): ‘‘(B) compounds the drug product using ingredients (other than bulk drug substances) that comply with the
p.(None): standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph
p.(None): exists, and the United States Pharmacopoeia chapter on pharmacy compounding;
p.(None): ‘‘(C) does not compound a drug product that appears on a list published by the Secretary in the Federal
p.(None): Register of drug products that have been withdrawn or removed from the market because such drug products or
p.(None): components of such drug products have been found to be unsafe or not effective; and
p.(None): ‘‘(D) does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug
p.(None): products that are essentially copies of a commercially available drug product.
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 343–3.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 348 note.
p.(None):
p.(None):
p.(None): 111 STAT. 2354 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): is unsafe, the Secretary shall not take any action before January 1, 2003, to ban lead and cadmium
p.(None): based enamel on such glass and ceramic ware. Any action taken after January 1, 2003, to ban such enamel
p.(None): on such glass and ceramic ware as an unapproved food additive shall be taken by regulation and such regulation
p.(None): shall provide that such products shall not be removed from the market before 1 year after publication of the
p.(None): final regulation.
p.(None): SEC. 309. FOOD CONTACT SUBSTANCES.
p.(None): (a) FOOD CONTACT SUBSTANCES.—Section 409(a) (21 U.S.C. 348(a)) is amended—
p.(None): (1) in paragraph (1)—
p.(None): (A) by striking ‘‘subsection (i)’’ and inserting ‘‘sub- section (j)’’; and
p.(None): (B) by striking at the end ‘‘or’’;
p.(None): (2) by striking the period at the end of paragraph (2) and inserting ‘‘; or’’;
p.(None): (3) by inserting after paragraph (2) the following:
p.(None): ‘‘(3) in the case of a food additive as defined in this Act that is a food contact substance, there is—
p.(None): ‘‘(A) in effect, and such substance and the use of such substance are in conformity with, a regulation issued under
p.(None): this section prescribing the conditions under which such additive may be safely used; or
p.(None): ‘‘(B) a notification submitted under subsection (h) that is effective.’’; and
p.(None): (4) by striking the matter following paragraph (3) (as added by paragraph (3)) and inserting the following flush
p.(None): sentence: ‘‘While such a regulation relating to a food additive, or such a notification under subsection
p.(None): (h)(1) relating to a food additive that is a food contact substance, is in effect, and has not been revoked
p.(None): pursuant to subsection (i), a food shall not, by reason of bearing or containing such a food additive in
p.(None): accordance with the regulation or notification, be considered adulterated under section 402(a)(1).’’.
p.(None): (b) NOTIFICATION FOR FOOD CONTACT SUBSTANCES.—Section 409 (21 U.S.C. 348), as amended by subsection (a), is
p.(None): further amend- ed—
p.(None): (1) by redesignating subsections (h) and (i), as subsections
p.(None): (i) and (j), respectively;
p.(None): (2) by inserting after subsection (g) the following:
p.(None): ‘‘Notification Relating to a Food Contact Substance
p.(None): ‘‘(h)(1) Subject to such regulations as may be promulgated under paragraph (3), a manufacturer or
p.(None): supplier of a food contact substance may, at least 120 days prior to the introduction or deliv- ery for
p.(None): introduction into interstate commerce of the food contact substance, notify the Secretary of the identity
p.(None): and intended use of the food contact substance, and of the determination of the manufacturer or supplier
p.(None): that the intended use of such food contact substance is safe under the standard described in subsection
p.(None): (c)(3)(A). The notification shall contain the information that forms the basis of the determination and
p.(None): all information required to be submitted by regulations promulgated by the Secretary.
p.(None): ‘‘(2)(A) A notification submitted under paragraph (1) shall become effective 120 days after the date of
p.(None): receipt by the Secretary and the food contact substance may be introduced or delivered for introduction into
p.(None): interstate commerce, unless the Secretary
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2355
p.(None):
p.(None): makes a determination within the 120-day period that, based on the data and information before the
p.(None): Secretary, such use of the food contact substance has not been shown to be safe under the standard
p.(None): described in subsection (c)(3)(A), and informs the manufac- turer or supplier of such determination.
p.(None): ‘‘(B) A decision by the Secretary to object to a notification shall constitute final agency action subject to
p.(None): judicial review.
p.(None): ‘‘(C) In this paragraph, the term ‘food contact substance’ means the substance that is the subject of a notification
p.(None): submitted under paragraph (1), and does not include a similar or identical substance manufactured or prepared by a
p.(None): person other than the manufacturer identified in the notification.
p.(None): ‘‘(3)(A) The process in this subsection shall be utilized for authorizing the marketing of a food contact
p.(None): substance except where the Secretary determines that submission and review of a petition under subsection (b) is
p.(None): necessary to provide adequate assurance of safety, or where the Secretary and any manufacturer or supplier agree
p.(None): that such manufacturer or supplier may submit a petition under subsection (b).
p.(None): ‘‘(B) The Secretary is authorized to promulgate regulations to identify the circumstances in which a
p.(None): petition shall be filed under subsection (b), and shall consider criteria such as the probable consumption of such
p.(None): food contact substance and potential toxicity of the food contact substance in determining the
p.(None): circumstances in which a petition shall be filed under subsection (b).
p.(None): ‘‘(4) The Secretary shall keep confidential any information pro- vided in a notification under paragraph (1) for
p.(None): 120 days after receipt by the Secretary of the notification. After the expiration of such 120 days,
p.(None): the information shall be available to any interested party except for any matter in the
p.(None): notification that is a trade secret or confidential commercial information.
p.(None): ‘‘(5)(A)(i) Except as provided in clause (ii), the notification pro- gram established under this subsection shall
p.(None): not operate in any fiscal year unless—
p.(None): ‘‘(I) an appropriation equal to or exceeding the applicable amount under clause (iv) is made for such fiscal
p.(None): year for carry- ing out such program in such fiscal year; and
p.(None): ‘‘(II) the Secretary certifies that the amount appropriated for such fiscal year for the Center for Food Safety
p.(None): and Applied Nutrition of the Food and Drug Administration (exclusive of the appropriation referred to in
p.(None): subclause (I)) equals or exceeds the amount appropriated for the Center for fiscal year 1997, excluding any
p.(None): amount appropriated for new programs.
p.(None): ‘‘(ii) The Secretary shall, not later than April 1, 1999, begin accepting and reviewing notifications
p.(None): submitted under the notifica- tion program established under this subsection if—
p.(None): ‘‘(I) an appropriation equal to or exceeding the applicable amount under clause (iii) is made for the
...
p.(None):
p.(None): ‘‘(iii) For the last six months of fiscal year 1999, the applicable amount under this clause is $1,500,000, or
p.(None): the amount specified in the budget request of the President for the six-month period involved for
p.(None): carrying out the notification program in fiscal year 1999, whichever is less.
p.(None): ‘‘(iv) For fiscal year 2000 and subsequent fiscal years, the applicable amount under this clause is
p.(None): $3,000,000, or the amount specified in the budget request of the President for the fiscal year involved
p.(None): for carrying out the notification program under this sub- section, whichever is less.
p.(None): ‘‘(B) For purposes of carrying out the notification program under this subsection, there are authorized to be
p.(None): appropriated such sums as may be necessary for each of the fiscal years 1999 through fiscal year 2003,
p.(None): except that such authorization of appropriations is not effective for a fiscal year for any amount that
p.(None): is less than the applicable amount under clause (iii) or (iv) of subparagraph (A), whichever is applicable.
p.(None): ‘‘(C) Not later than April 1 of fiscal year 1998 and February
p.(None): 1 of each subsequent fiscal year, the Secretary shall submit a report to the Committees on
p.(None): Appropriations of the House of Rep- resentatives and the Senate, the Committee on Commerce of the House
p.(None): of Representatives, and the Committee on Labor and Human Resources of the Senate that provides an estimate of the
p.(None): Secretary of the costs of carrying out the notification program established under this subsection for the next
p.(None): fiscal year.
p.(None): ‘‘(6) In this section, the term ‘food contact substance’ means any substance intended for use as a
p.(None): component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is
p.(None): not intended to have any technical effect in such food.’’;
p.(None): (3) in subsection (i), as so redesignated by paragraph (1), by adding at the end the following: ‘‘The
p.(None): Secretary shall by regulation prescribe the procedure by which the Secretary may deem a notification under
p.(None): subsection (h) to no longer be effec- tive.’’; and
p.(None): (4) in subsection (j), as so redesignated by paragraph (1), by striking ‘‘subsections (b) to (h)’’ and
p.(None): inserting ‘‘subsections
p.(None): (b) to (i)’’.
p.(None): TITLE IV—GENERAL PROVISIONS
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 360aaa.
p.(None): SEC. 401. DISSEMINATION OF INFORMATION ON NEW USES.
p.(None): (a) IN GENERAL.—Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after subchapter C the following:
p.(None): ‘‘SUBCHAPTER D—DISSEMINATION OF TREATMENT INFORMATION
p.(None): ‘‘SEC. 551. REQUIREMENTS FOR DISSEMINATION OF TREATMENT INFORMATION ON DRUGS OR DEVICES.
p.(None): ‘‘(a) IN GENERAL.—Notwithstanding sections 301(d), 502(f), and 505, and section 351 of the Public Health
p.(None): Service Act (42 U.S.C. 262), a manufacturer may disseminate to—
p.(None): ‘‘(1) a health care practitioner; ‘‘(2) a pharmacy benefit manager; ‘‘(3) a health insurance issuer; ‘‘(4) a group
p.(None): health plan; or
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997
p.(None): ‘‘(5) a Federal or State governmental agency;
p.(None): 111 STAT. 2357
p.(None): written information concerning the safety, effectiveness, or benefit of a use not described in the approved
...
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p.(None): Human Services shall make a final determination on any petition pending with the Food and Drug Administration that
p.(None): would permit the irradiation of red meat under section 409(b)(1) of the Federal Food, Drug, and Cos-
p.(None): metic Act. If the Secretary does not make such determination, the Secretary shall, not later than 60
p.(None): days following the date of the enactment of this Act, provide the Committee on Commerce of the House of
p.(None): Representatives and the Committee on Labor and Human Resources of the Senate an explanation of the
p.(None): process followed by the Food and Drug Administration in reviewing the petition referred to in paragraph
p.(None): (1) and the reasons action on the petition was delayed.
p.(None): SEC. 308. GLASS AND CERAMIC WARE.
p.(None): (a) IN GENERAL.—The Secretary may not implement any requirement which would ban, as an unapproved
p.(None): food additive, lead and cadmium based enamel in the lip and rim area of glass and ceramic ware before
p.(None): the expiration of one year after the date such requirement is published.
p.(None): (b) LEAD AND CADMIUM BASED ENAMEL.—Unless the Secretary determines, based on available data, that lead and cadmium
p.(None): based enamel on glass and ceramic ware—
p.(None): (1) which has less than 60 millimeters of decorating area below the external rim, and
p.(None): (2) which is not, by design, representation, or custom of usage intended for use by children,
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 343–3.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 348 note.
p.(None):
p.(None):
p.(None): 111 STAT. 2354 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): is unsafe, the Secretary shall not take any action before January 1, 2003, to ban lead and cadmium
p.(None): based enamel on such glass and ceramic ware. Any action taken after January 1, 2003, to ban such enamel
p.(None): on such glass and ceramic ware as an unapproved food additive shall be taken by regulation and such regulation
p.(None): shall provide that such products shall not be removed from the market before 1 year after publication of the
p.(None): final regulation.
p.(None): SEC. 309. FOOD CONTACT SUBSTANCES.
p.(None): (a) FOOD CONTACT SUBSTANCES.—Section 409(a) (21 U.S.C. 348(a)) is amended—
p.(None): (1) in paragraph (1)—
p.(None): (A) by striking ‘‘subsection (i)’’ and inserting ‘‘sub- section (j)’’; and
p.(None): (B) by striking at the end ‘‘or’’;
p.(None): (2) by striking the period at the end of paragraph (2) and inserting ‘‘; or’’;
p.(None): (3) by inserting after paragraph (2) the following:
...
Health / Motherhood/Family
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p.(None): panel shall consist of—
p.(None): ‘‘(A) members who are qualified by training and experience to evaluate the safety and effectiveness of the
p.(None): drugs to be referred to the panel and who, to the extent feasible, possess skill and experience in the
p.(None): development, manufacture, or utili- zation of such drugs;
p.(None): ‘‘(B) members with diverse expertise in such fields as clini- cal and administrative medicine, pharmacy,
p.(None): pharmacology, pharmacoeconomics, biological and physical sciences, and other related professions;
p.(None): ‘‘(C) a representative of consumer interests, and a rep- resentative of interests of the drug
p.(None): manufacturing industry not directly affected by the matter to be brought before the panel; and
p.(None): ‘‘(D) two or more members who are specialists or have other expertise in the particular disease or condition
p.(None): for which the drug under review is proposed to be indicated.
p.(None): Scientific, trade, and consumer organizations shall be afforded an opportunity to nominate individuals for
p.(None): appointment to the panels. No individual who is in the regular full-time employ of the United States and engaged in
p.(None): the administration of this Act may be a voting member of any panel. The Secretary shall designate one
p.(None): of the members of each panel to serve as chairman thereof.
p.(None): ‘‘(4) Each member of a panel shall publicly disclose all conflicts of interest that member may have with the work to be
p.(None): undertaken by the panel. No member of a panel may vote on any matter where the member or the immediate
p.(None): family of such member could gain financially from the advice given to the Secretary. The Sec- retary
p.(None): may grant a waiver of any conflict of interest requirement upon public disclosure of such conflict of
p.(None): interest if such waiver is necessary to afford the panel essential expertise, except that the Secretary
p.(None): may not grant a waiver for a member of a panel when the member’s own scientific work is involved.
p.(None): ‘‘(5) The Secretary shall, as appropriate, provide education and training to each new panel member before such member
p.(None): participates in a panel’s activities, including education regarding requirements under this Act and related
p.(None): regulations of the Secretary, and the administrative processes and procedures related to panel meetings. ‘‘(6)
p.(None): Panel members (other than officers or employees of the United States), while attending meetings or conferences
p.(None): of a panel or otherwise engaged in its business, shall be entitled to receive compensation for each day
p.(None): so engaged, including traveltime, at rates to be fixed by the Secretary, but not to exceed the daily
p.(None): equivalent of the rate in effect for positions classified above grade GS–15 of the General Schedule.
p.(None): While serving away from their homes or regular places of business, panel members may be allowed travel expenses
p.(None): (including per diem in lieu of subsistence) as author- ized by section 5703 of title 5, United States Code,
p.(None): for persons
p.(None): in the Government service employed intermittently.
p.(None):
p.(None):
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p.(None): Sec. 412. National uniformity for nonprescription drugs and cosmetics.
p.(None): Sec. 413. Food and Drug Administration study of mercury compounds in drugs and food.
p.(None): Sec. 414. Interagency collaboration. Sec. 415. Contracts for expert review. Sec. 416. Product classification.
p.(None): Sec. 417. Registration of foreign establishments. Sec. 418. Clarification of seizure authority.
p.(None): Sec. 419. Interstate commerce.
p.(None): Sec. 420. Safety report disclaimers.
p.(None): Sec. 421. Labeling and advertising regarding compliance with statutory require- ments.
p.(None): Sec. 422. Rule of construction.
p.(None): TITLE V—EFFECTIVE DATE
p.(None):
p.(None): Sec. 501. Effective date.
p.(None): SEC. 2. DEFINITIONS.
p.(None): In this Act, the terms ‘‘drug’’, ‘‘device’’, ‘‘food’’, and ‘‘dietary supplement’’ have the meaning given
p.(None): such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
p.(None):
p.(None): 21 USC 321 note.
p.(None):
p.(None):
p.(None): 111 STAT. 2298 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None): TITLE I—IMPROVING REGULATION OF DRUGS
p.(None): Subtitle A—Fees Relating to Drugs
p.(None):
p.(None):
p.(None): 21 USC 379g
p.(None): note.
p.(None): SEC. 101. FINDINGS.
p.(None): Congress finds that—
p.(None): (1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement
p.(None): of the public health so that patients may enjoy the benefits provided by these therapies to treat and
p.(None): prevent illness and disease;
p.(None): (2) the public health will be served by making additional funds available for the purpose of augmenting
p.(None): the resources of the Food and Drug Administration that are devoted to the process for review of human drug
p.(None): applications;
p.(None): (3) the provisions added by the Prescription Drug User Fee Act of 1992 have been successful in substantially
p.(None): reducing review times for human drug applications and should be—
p.(None): (A) reauthorized for an additional 5 years, with certain technical improvements; and
p.(None): (B) carried out by the Food and Drug Administration with new commitments to implement more ambitious and
p.(None): comprehensive improvements in regulatory processes of the Food and Drug Administration; and
p.(None): (4) the fees authorized by amendments made in this subtitle will be dedicated toward expediting the drug development
p.(None): proc- ess and the review of human drug applications as set forth in the goals identified, for purposes
p.(None): of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters
p.(None): from the Secretary of Health and Human Services to the chairman of the Committee on Commerce of the
...
p.(None): function, or performance of the device; and
p.(None): ‘‘(II) clinical data from the approved application and any supplement to the approved application provide
p.(None): a reasonable assurance of safety and effectiveness for the changed device. ‘‘(ii) The Secretary may
p.(None): require, when necessary, additional
p.(None): clinical data to evaluate the design modification of the device to provide a reasonable assurance of safety
p.(None): and effectiveness.’’.
p.(None): SEC. 206. PREMARKET NOTIFICATION.
p.(None): (a) SECTION 510.—Section 510 (21 U.S.C. 360) is amended—
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2339
p.(None):
p.(None):
p.(None): (1) in subsection (k), in the matter preceding paragraph (1), by adding after ‘‘report to the
p.(None): Secretary’’ the following: ‘‘or person who is accredited under section 523(a)’’; and
p.(None): (2) by adding at the end the following subsections:
p.(None): ‘‘(l) A report under subsection (k) is not required for a device intended for human use that is
p.(None): exempted from the requirements of this subsection under subsection (m) or is within a type that has been
p.(None): classified into class I under section 513. The exception established in the preceding sentence does not
p.(None): apply to any class I device that is intended for a use which is of substantial importance in preventing impairment
p.(None): of human health, or to any class I device that presents a potential unreasonable risk of illness or injury.
p.(None): ‘‘(m)(1) Not later than 60 days after the date of enactment
p.(None): of the Food and Drug Administration Modernization Act of 1997, the Secretary shall publish in the
p.(None): Federal Register a list of each type of class II device that does not require a report under sub-
p.(None): section (k) to provide reasonable assurance of safety and effective- ness. Each type of class II device
p.(None): identified by the Secretary as not requiring the report shall be exempt from the requirement to provide
p.(None): a report under subsection (k) as of the date of the publication of the list in the Federal Register.
p.(None): ‘‘(2) Beginning on the date that is 1 day after the date of the publication of a list under this
p.(None): subsection, the Secretary may exempt a class II device from the requirement to submit a report under
p.(None): subsection (k), upon the Secretary’s own initiative or a peti- tion of an interested person, if the Secretary
p.(None): determines that such report is not necessary to assure the safety and effectiveness of the device. The
p.(None): Secretary shall publish in the Federal Register notice of the intent of the Secretary to exempt the
p.(None): device, or of the petition, and provide a 30-day period for public comment. Within 120 days after the
p.(None): issuance of the notice in the Federal Register, the Secretary shall publish an order in the Federal
p.(None): Reg- ister that sets forth the final determination of the Secretary regard- ing the exemption of the device that was
p.(None): the subject of the notice. If the Secretary fails to respond to a petition within 180 days of receiving it,
...
p.(None): under section 505(i) or investigational device exemption in effect under section 520(g); or
p.(None): ‘‘(B) all clinical trials necessary for approval of that use of the investigational drug or investigational
p.(None): device have been completed;
p.(None): ‘‘(4) the sponsor of the controlled clinical trials is actively pursuing marketing approval of the
p.(None): investigational drug or investigational device for the use described in paragraph (1) with due diligence;
p.(None): ‘‘(5) in the case of an investigational drug or investigational device described in paragraph (3)(A), the provision of
p.(None): the inves- tigational drug or investigational device will not interfere with the enrollment of patients in ongoing
p.(None): clinical investigations under section 505(i) or 520(g);
p.(None): ‘‘(6) in the case of serious diseases, there is sufficient evi- dence of safety and effectiveness to
p.(None): support the use described in paragraph (1); and
p.(None): ‘‘(7) in the case of immediately life-threatening diseases, the available scientific evidence, taken as a
p.(None): whole, provides a reasonable basis to conclude that the investigational drug or investigational device may
p.(None): be effective for its intended use and would not expose patients to an unreasonable and signifi- cant risk of
p.(None): illness or injury.
p.(None): A protocol submitted under this subsection shall be subject to the provisions of section 505(i) or
p.(None): 520(g), including regulations promulgated under section 505(i) or 520(g). The Secretary may inform national,
p.(None): State, and local medical associations and societies,
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2367
p.(None):
p.(None):
p.(None): voluntary health associations, and other appropriate persons about the availability of an investigational drug or
p.(None): investigational device under expanded access protocols submitted under this subsection. The information
p.(None): provided by the Secretary, in accordance with the preceding sentence, shall be the same type of information that
p.(None): is required by section 402(j)(3) of the Public Health Service Act. ‘‘(d) TERMINATION.—The Secretary
p.(None): may, at any time, with respect to a sponsor, physician, manufacturer, or distributor described in
p.(None): this section, terminate expanded access provided under this section for an investigational drug or
p.(None): investigational device
p.(None): if the requirements under this section are no longer met.
p.(None): ‘‘(e) DEFINITIONS.—In this section, the terms ‘investigational drug’, ‘investigational device’, ‘treatment
p.(None): investigational new drug application’, and ‘treatment investigational device exemption’ shall have the meanings
...
p.(None): SEC. 420. SAFETY REPORT DISCLAIMERS.
p.(None): Chapter VII (21 U.S.C. 371 et seq.), as amended by section 412, is further amended by adding at the end the
p.(None): following:
p.(None): ‘‘SUBCHAPTER G—SAFETY REPORTS
p.(None): ‘‘SEC. 756. SAFETY REPORT DISCLAIMERS.
p.(None): ‘‘With respect to any entity that submits or is required to submit a safety report or other information
p.(None): in connection with the safety of a product (including a product that is a food, drug,
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None): 21 USC 379v.
p.(None):
p.(None):
p.(None): 111 STAT. 2380 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): device, dietary supplement, or cosmetic) under this Act (and any release by the Secretary of that report or
p.(None): information), such report or information shall not be construed to reflect necessarily a conclu- sion by the entity
p.(None): or the Secretary that the report or information constitutes an admission that the product involved
p.(None): malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death,
p.(None): serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or informa- tion
p.(None): submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed
p.(None): to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.’’.
p.(None): SEC. 421. LABELING AND ADVERTISING REGARDING COMPLIANCE WITH STATUTORY REQUIREMENTS.
p.(None):
p.(None):
p.(None): (l).
p.(None): Section 301 (21 U.S.C. 331) is amended by striking paragraph
p.(None):
p.(None): 21 USC 321 note.
p.(None):
p.(None):
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p.(None):
p.(None): 21 USC 321 note.
p.(None): SEC. 422. RULE OF CONSTRUCTION.
p.(None): Nothing in this Act or the amendments made by this Act shall be construed to affect the question of
p.(None): whether the Secretary of Health and Human Services has any authority to regulate any tobacco product,
p.(None): tobacco ingredient, or tobacco additive. Such authority, if any, shall be exercised under the Federal Food,
p.(None): Drug, and Cosmetic Act as in effect on the day before the date of the enactment of this Act.
p.(None): TITLE V—EFFECTIVE DATE
p.(None): SEC. 501. EFFECTIVE DATE.
p.(None): Except as otherwise provided in this Act, this Act and the amendments made by this Act, other than the
p.(None): provisions of and the amendments made by sections 111, 121, 125, and 307, shall take effect 90 days after
p.(None): the date of enactment of this Act.
p.(None): Approved November 21, 1997.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): LEGISLATIVE HISTORY—S. 830 (H.R. 1411):
p.(None): HOUSE REPORTS: Nos. 105–310, accompanying H.R. 1411 (Comm. on Commerce) and 105–399 (Comm. of Conference).
p.(None): SENATE REPORTS: No. 105–43 (Comm. on Labor and Human Resources). CONGRESSIONAL RECORD, Vol. 143 (1997):
...
Social / Access to Social Goods
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p.(None): Sec. 130. Reports of postmarketing approval studies.
p.(None): Sec. 131. Notification of discontinuance of a life saving product.
p.(None): TITLE II—IMPROVING REGULATION OF DEVICES
p.(None): Sec. 201. Investigational device exemptions. Sec. 202. Special review for certain devices.
p.(None): Sec. 203. Expanding humanitarian use of devices. Sec. 204. Device standards.
p.(None): Sec. 205. Scope of review; collaborative determinations of device data requirements. Sec. 206. Premarket
p.(None): notification.
p.(None): Sec. 207. Evaluation of automatic class III designation. Sec. 208. Classification panels.
p.(None): Sec. 209. Certainty of review timeframes; collaborative review process.
p.(None): Sec. 210. Accreditation of persons for review of premarket notification reports. Sec. 211. Device tracking.
p.(None): Sec. 212. Postmarket surveillance. Sec. 213. Reports.
p.(None): Sec. 214. Practice of medicine.
p.(None): Sec. 215. Noninvasive blood glucose meter.
p.(None): Sec. 216. Use of data relating to premarket approval; product development protocol. Sec. 217. Clarification of
p.(None): the number of required clinical investigations for ap-
p.(None): proval.
p.(None): TITLE III—IMPROVING REGULATION OF FOOD
p.(None): Sec. 301. Flexibility for regulations regarding claims. Sec. 302. Petitions for claims.
p.(None): Sec. 303. Health claims for food products. Sec. 304. Nutrient content claims.
p.(None): Sec. 305. Referral statements. Sec. 306. Disclosure of irradiation. Sec. 307. Irradiation petition.
p.(None): Sec. 308. Glass and ceramic ware. Sec. 309. Food contact substances.
p.(None): TITLE IV—GENERAL PROVISIONS
p.(None): Sec. 401. Dissemination of information on new uses.
p.(None): Sec. 402. Expanded access to investigational therapies and diagnostics. Sec. 403. Approval of supplemental
p.(None): applications for approved products. Sec. 404. Dispute resolution.
p.(None): Sec. 405. Informal agency statements.
p.(None): Sec. 406. Food and Drug Administration mission and annual report. Sec. 407. Information system.
p.(None): Sec. 408. Education and training.
p.(None): Sec. 409. Centers for education and research on therapeutics.
p.(None): Sec. 410. Mutual recognition agreements and global harmonization. Sec. 411. Environmental impact review.
p.(None): Sec. 412. National uniformity for nonprescription drugs and cosmetics.
p.(None): Sec. 413. Food and Drug Administration study of mercury compounds in drugs and food.
p.(None): Sec. 414. Interagency collaboration. Sec. 415. Contracts for expert review. Sec. 416. Product classification.
p.(None): Sec. 417. Registration of foreign establishments. Sec. 418. Clarification of seizure authority.
p.(None): Sec. 419. Interstate commerce.
p.(None): Sec. 420. Safety report disclaimers.
p.(None): Sec. 421. Labeling and advertising regarding compliance with statutory require- ments.
p.(None): Sec. 422. Rule of construction.
p.(None): TITLE V—EFFECTIVE DATE
p.(None):
p.(None): Sec. 501. Effective date.
p.(None): SEC. 2. DEFINITIONS.
p.(None): In this Act, the terms ‘‘drug’’, ‘‘device’’, ‘‘food’’, and ‘‘dietary supplement’’ have the meaning given
...
p.(None): may, in the request, recommend to the Secretary a classification for the device. Any such request shall
p.(None): describe the device and provide detailed information and reasons for the recommended classification.
p.(None): ‘‘(B)(i) Not later than 60 days after the date of the submission of the request under subparagraph (A), the
p.(None): Secretary shall by written order classify the device involved. Such classification shall be the initial
p.(None): classification of the device for purposes of paragraph
p.(None): (1) and any device classified under this paragraph shall be a predi- cate device for determining substantial
p.(None): equivalence under para- graph (1).
p.(None): ‘‘(ii) A device that remains in class III under this subparagraph shall be deemed to be adulterated within the
p.(None): meaning of section 501(f)(1)(B) until approved under section 515 or exempted from such approval under section
p.(None): 520(g).
p.(None):
p.(None): Federal Register, publication.
p.(None): ‘‘(C) Within 30 days after the issuance of an order classifying a device under this paragraph, the Secretary
p.(None): shall publish a notice in the Federal Register announcing such classification.’’.
p.(None): SEC. 208. CLASSIFICATION PANELS.
p.(None): Section 513(b) (21 U.S.C. 360c(b)) is amended by adding at the end the following:
p.(None): ‘‘(5) Classification panels covering each type of device shall be scheduled to meet at such times as
p.(None): may be appropriate for the Secretary to meet applicable statutory deadlines.
p.(None): ‘‘(6)(A) Any person whose device is specifically the subject of review by a classification panel shall have—
p.(None): ‘‘(i) the same access to data and information submitted to a classification panel (except for data and
p.(None): information that are not available for public disclosure under section 552 of title 5, United States Code) as
p.(None): the Secretary;
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2341
p.(None):
p.(None): ‘‘(ii) the opportunity to submit, for review by a classification panel, information that is based on the data
p.(None): or information provided in the application submitted under section 515 by the person, which information
p.(None): shall be submitted to the Sec- retary for prompt transmittal to the classification panel; and ‘‘(iii) the
p.(None): same opportunity as the Secretary to participate
p.(None): in meetings of the panel.
p.(None): ‘‘(B) Any meetings of a classification panel shall provide ade- quate time for initial presentations and for
p.(None): response to any differing views by persons whose devices are specifically the subject of a classification
p.(None): panel review, and shall encourage free and open participation by all interested persons.
p.(None): ‘‘(7) After receiving from a classification panel the conclusions and recommendations of the panel on a
p.(None): matter that the panel has reviewed, the Secretary shall review the conclusions and rec- ommendations, shall
p.(None): make a final decision on the matter in accord- ance with section 515(d)(2), and shall notify the affected
p.(None): persons of the decision in writing and, if the decision differs from the conclusions and recommendations
p.(None): of the panel, shall include the reasons for the difference.
p.(None): ‘‘(8) A classification panel under this subsection shall not be subject to the annual chartering and
...
p.(None): ‘‘(c) DURATION.—The authority provided by this section termi- nates—
p.(None): ‘‘(1) 5 years after the date on which the Secretary notifies Congress that at least 2 persons accredited under
p.(None): subsection
p.(None): (b) are available to review at least 60 percent of the submissions under section 510(k), or
p.(None): ‘‘(2) 4 years after the date on which the Secretary notifies Congress that the Secretary has made a
p.(None): determination described in paragraph (2)(B) of subsection (a) for at least
p.(None): 35 percent of the devices that are subject to review under paragraph (1) of such subsection,
p.(None): whichever occurs first.’’.
p.(None): (b) RECORDKEEPING.—Section 704 (21 U.S.C. 374) is amended by adding at the end the following:
p.(None): ‘‘(f)(1) A person accredited under section 523 to review reports made under section 510(k) and make
p.(None): recommendations of initial classifications of devices to the Secretary shall maintain records documenting
p.(None): the training qualifications of the person and the employees of the person, the procedures used by
p.(None): the person for handling confidential information, the compensation arrangements made by the person, and the
p.(None): procedures used by the person to identify and avoid conflicts of interest. Upon the request of an
p.(None): officer or employee designated by the Secretary, the person shall permit the officer or employee, at all
p.(None): reasonable times, to have access to, to copy, and to verify, the records.
p.(None): ‘‘(2) Within 15 days after the receipt of a written request from the Secretary to a person accredited
p.(None): under section 523 for copies of records described in paragraph (1), the person shall produce the
p.(None): copies of the records at the place designated by the Secretary.’’.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2345
p.(None):
p.(None):
p.(None): (c) CONFORMING AMENDMENT.—Section 301 (21 U.S.C. 331), as amended by section 204(b), is amended by
p.(None): adding at the end the following:
p.(None): ‘‘(y) In the case of a drug, device, or food—
p.(None): ‘‘(1) the submission of a report or recommendation by a person accredited under section 523 that is false or
p.(None): misleading in any material respect;
p.(None): ‘‘(2) the disclosure by a person accredited under section 523 of confidential commercial information or any
p.(None): trade secret without the express written consent of the person who submit- ted such information or secret to such
p.(None): person; or
p.(None): ‘‘(3) the receipt by a person accredited under section 523 of a bribe in any form or the doing of
p.(None): any corrupt act by such person associated with a responsibility delegated to such person under this Act.’’.
p.(None): (d) REPORTS ON PROGRAM OF ACCREDITATION.—
p.(None): (1) COMPTROLLER GENERAL.—
p.(None): (A) IMPLEMENTATION OF PROGRAM.—Not later than 5 years after the date of the enactment of this Act, the
p.(None): Comptroller General of the United States shall submit to the Committee on Commerce of the House of Representa-
...
p.(None): (iii) the quality and usefulness of the information provided, in accordance with such subchapter, by the
p.(None): Secretary or by the manufacturer at the request of the Secretary; and
p.(None): (iv) the impact of such subchapter on research in the area of new uses, indications, or dosages,
p.(None): particularly the impact on pediatric indications and rare diseases.
p.(None): (3) PROCEDURE FOR STUDY.—
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2365
p.(None):
p.(None):
p.(None): (A) IN GENERAL.—The Secretary shall request the Institute of Medicine of the National Academy of
p.(None): Sciences to conduct the study required by paragraph (2), and to prepare and submit the report required
p.(None): by subparagraph (B), under an arrangement by which the actual expenses incurred by the Institute of
p.(None): Medicine in conducting the study and preparing the report will be paid by the Sec- retary. If the
p.(None): Institute of Medicine is unwilling to conduct the study under such an arrangement, the Comptroller General of
p.(None): the United States shall conduct such study.
p.(None): (B) REPORT.—Not later than September 30, 2005, the Institute of Medicine or the Comptroller General of
p.(None): the United States, as appropriate, shall prepare and submit to the Committee on Labor and Human Resources
p.(None): of the Senate, the Committee on Commerce of the House of Rep- resentatives, and the Secretary a report of the
p.(None): results of the study required by paragraph (2). The Secretary, after the receipt of the report, shall make the
p.(None): report avail- able to the public.
p.(None): SEC. 402. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES AND DIAGNOSTICS.
p.(None): Chapter V (21 U.S.C. 351 et seq.), as amended in section 401, is further amended by adding at the end the
p.(None): following:
p.(None): ‘‘SUBCHAPTER E—GENERAL PROVISIONS RELATING TO DRUGS AND
p.(None): DEVICES
p.(None): ‘‘SEC. 561. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS.
p.(None): ‘‘(a) EMERGENCY SITUATIONS.—The Secretary may, under appro- priate conditions determined by the Secretary,
p.(None): authorize the ship- ment of investigational drugs or investigational devices for the diagnosis, monitoring,
p.(None): or treatment of a serious disease or condition in emergency situations.
p.(None): ‘‘(b) INDIVIDUAL PATIENT ACCESS TO INVESTIGATIONAL PROD-
p.(None): UCTS INTENDED FOR SERIOUS DISEASES.—Any person, acting
p.(None): through a physician licensed in accordance with State law, may request from a manufacturer or distributor, and
p.(None): any manufacturer or distributor may, after complying with the provisions of this subsection, provide to
p.(None): such physician an investigational drug or investigational device for the diagnosis, monitoring, or
p.(None): treatment of a serious disease or condition if—
p.(None): ‘‘(1) the licensed physician determines that the person has no comparable or satisfactory alternative therapy
p.(None): available to diagnose, monitor, or treat the disease or condition involved, and that the probable risk to the
p.(None): person from the investigational drug or investigational device is not greater than the probable risk from the disease
p.(None): or condition;
p.(None): ‘‘(2) the Secretary determines that there is sufficient evi- dence of safety and effectiveness to support
p.(None): the use of the investigational drug or investigational device in the case described in paragraph (1);
p.(None): ‘‘(3) the Secretary determines that provision of the inves- tigational drug or investigational device will not
p.(None): interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval;
p.(None): and
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None): 21 USC 360bbb.
p.(None):
p.(None):
p.(None): 111 STAT. 2366 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘(4) the sponsor, or clinical investigator, of the investiga- tional drug or investigational device
p.(None): submits to the Secretary a clinical protocol consistent with the provisions of section 505(i) or 520(g),
p.(None): including any regulations promulgated under section 505(i) or 520(g), describing the use of the investigational
p.(None): drug or investigational device in a single patient or a small group of patients.
p.(None): ‘‘(c) TREATMENT INVESTIGATIONAL NEW DRUG APPLICATIONS AND
p.(None): TREATMENT INVESTIGATIONAL DEVICE EXEMPTIONS.—Upon submis-
p.(None): sion by a sponsor or a physician of a protocol intended to provide widespread access to an
p.(None): investigational drug or investigational device for eligible patients (referred to in this subsection as an
p.(None): ‘expanded access protocol’), the Secretary shall permit such inves- tigational drug or investigational
p.(None): device to be made available for expanded access under a treatment investigational new drug
p.(None): application or treatment investigational device exemption if the Secretary determines that—
p.(None): ‘‘(1) under the treatment investigational new drug applica- tion or treatment investigational device exemption,
p.(None): the inves- tigational drug or investigational device is intended for use in the diagnosis, monitoring, or
p.(None): treatment of a serious or imme- diately life-threatening disease or condition;
p.(None): ‘‘(2) there is no comparable or satisfactory alternative ther- apy available to diagnose, monitor, or treat that stage
p.(None): of disease or condition in the population of patients to which the investiga- tional drug or investigational device is
p.(None): intended to be adminis- tered;
p.(None): ‘‘(3)(A) the investigational drug or investigational device is under investigation in a controlled clinical
p.(None): trial for the use described in paragraph (1) under an investigational drug application in effect
p.(None): under section 505(i) or investigational device exemption in effect under section 520(g); or
p.(None): ‘‘(B) all clinical trials necessary for approval of that use of the investigational drug or investigational
p.(None): device have been completed;
p.(None): ‘‘(4) the sponsor of the controlled clinical trials is actively pursuing marketing approval of the
...
p.(None): ‘‘(5) in the case of an investigational drug or investigational device described in paragraph (3)(A), the provision of
p.(None): the inves- tigational drug or investigational device will not interfere with the enrollment of patients in ongoing
p.(None): clinical investigations under section 505(i) or 520(g);
p.(None): ‘‘(6) in the case of serious diseases, there is sufficient evi- dence of safety and effectiveness to
p.(None): support the use described in paragraph (1); and
p.(None): ‘‘(7) in the case of immediately life-threatening diseases, the available scientific evidence, taken as a
p.(None): whole, provides a reasonable basis to conclude that the investigational drug or investigational device may
p.(None): be effective for its intended use and would not expose patients to an unreasonable and signifi- cant risk of
p.(None): illness or injury.
p.(None): A protocol submitted under this subsection shall be subject to the provisions of section 505(i) or
p.(None): 520(g), including regulations promulgated under section 505(i) or 520(g). The Secretary may inform national,
p.(None): State, and local medical associations and societies,
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2367
p.(None):
p.(None):
p.(None): voluntary health associations, and other appropriate persons about the availability of an investigational drug or
p.(None): investigational device under expanded access protocols submitted under this subsection. The information
p.(None): provided by the Secretary, in accordance with the preceding sentence, shall be the same type of information that
p.(None): is required by section 402(j)(3) of the Public Health Service Act. ‘‘(d) TERMINATION.—The Secretary
p.(None): may, at any time, with respect to a sponsor, physician, manufacturer, or distributor described in
p.(None): this section, terminate expanded access provided under this section for an investigational drug or
p.(None): investigational device
p.(None): if the requirements under this section are no longer met.
p.(None): ‘‘(e) DEFINITIONS.—In this section, the terms ‘investigational drug’, ‘investigational device’, ‘treatment
p.(None): investigational new drug application’, and ‘treatment investigational device exemption’ shall have the meanings
p.(None): given the terms in regulations prescribed by the Secretary.’’.
p.(None): SEC. 403. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED PRODUCTS.
p.(None): (a) STANDARDS.—Not later than 180 days after the date of enactment of this Act, the Secretary of Health and
p.(None): Human Services shall publish in the Federal Register standards for the prompt review of supplemental
p.(None): applications submitted for approved articles under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
p.(None): seq.) or section 351 of the Public Health Service Act (42 U.S.C. 262).
p.(None): (b) GUIDANCE TO INDUSTRY.—Not later than 180 days after the date of enactment of this Act, the
p.(None): Secretary shall issue final guidances to clarify the requirements for, and facilitate the submis- sion of data to
p.(None): support, the approval of supplemental applications for the approved articles described in subsection (a). The
p.(None): guidances shall—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 371 note.
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p.(None): industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with
p.(None): each of the obligations of the Secretary under this Act. The
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):
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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):
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): 111 STAT. 2370 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): Secretary shall review the plan biannually and shall revise the plan as necessary, in consultation with such
p.(None): persons.
p.(None): ‘‘(2) OBJECTIVES OF AGENCY PLAN.—The plan required by paragraph (1) shall establish objectives and
p.(None): mechanisms to achieve such objectives, including objectives related to—
p.(None): ‘‘(A) maximizing the availability and clarity of informa- tion about the process for review of
p.(None): applications and submissions (including petitions, notifications, and any other similar forms of request)
p.(None): made under this Act;
p.(None): ‘‘(B) maximizing the availability and clarity of informa- tion for consumers and patients concerning new
p.(None): products; ‘‘(C) implementing inspection and postmarket monitor-
p.(None): ing provisions of this Act;
p.(None): ‘‘(D) ensuring access to the scientific and technical expertise needed by the Secretary to meet
p.(None): obligations described in paragraph (1);
p.(None): ‘‘(E) establishing mechanisms, by July 1, 1999, for meeting the time periods specified in this Act for the
p.(None): review of all applications and submissions described in subpara- graph (A) and submitted after the date
p.(None): of enactment of the Food and Drug Administration Modernization Act of 1997; and
p.(None): ‘‘(F) eliminating backlogs in the review of applications and submissions described in subparagraph (A), by January 1,
p.(None): 2000.
p.(None):
p.(None): Federal Register, publication.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 379k.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379k
p.(None): note.
p.(None): ‘‘(g) ANNUAL REPORT.—The Secretary shall annually prepare and publish in the Federal Register and solicit
p.(None): public comment on a report that—
p.(None): ‘‘(1) provides detailed statistical information on the performance of the Secretary under the plan
p.(None): described in sub- section (f);
p.(None): ‘‘(2) compares such performance of the Secretary with the objectives of the plan and with the statutory
p.(None): obligations of the Secretary; and
p.(None): ‘‘(3) identifies any regulatory policy that has a significant negative impact on compliance with any
p.(None): objective of the plan or any statutory obligation and sets forth any proposed revision to any such regulatory
p.(None): policy.’’.
p.(None): SEC. 407. INFORMATION SYSTEM.
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p.(None): If the Secretary determines that the acceptance or approval of an application under section 505(b)(2) or
p.(None): 505(j) for a new drug may occur after submission of reports of pediatric studies under this section,
p.(None): which were submitted prior to the expiration of the patent (including any patent extension) or the
p.(None): applicable period under clauses (ii) through (iv) of section 505(c)(3)(D) or clauses
p.(None): (ii) through (iv) of section 505(j)(4)(D), but before the Secretary has determined whether the
p.(None): requirements of subsection (d) have been satisfied, the Secretary shall delay the acceptance or approval under
p.(None): section 505(b)(2) or 505(j) until the determination under subsection (d) is made, but any such delay
p.(None): shall not exceed 90 days. In the event that requirements of this section are satisfied, the applicable
p.(None): six-month period under subsection (a) or (c) shall be deemed to have been running during the period of delay.
p.(None): ‘‘(f) NOTICE OF DETERMINATIONS ON STUDIES REQUIREMENT.—
p.(None): The Secretary shall publish a notice of any determination that the requirements of subsection (d) have been
p.(None): met and that submis- sions and approvals under subsection (b)(2) or (j) of section 505 for a drug will be
p.(None): subject to the provisions of this section.
p.(None): ‘‘(g) 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 in which a drug is anticipated to be used. ‘‘(h) LIMITATIONS.—A drug to which the six-month period
p.(None): under
p.(None): subsection (a) or (b) has already been applied—
p.(None): ‘‘(1) may receive an additional six-month period under sub- section (c)(1)(A)(ii) for a supplemental application
p.(None): if all other requirements under this section are satisfied, except that such a drug may not receive any
p.(None): additional such period under sub- section (c)(2); and
p.(None): ‘‘(2) may not receive any additional such period under subsection (c)(1)(B).
p.(None): ‘‘(i) RELATIONSHIP TO REGULATIONS.—Notwithstanding any other provision of law, if any pediatric study
p.(None): is required pursuant to regulations promulgated by the Secretary and such study meets the completeness, timeliness,
p.(None): and other requirements of this section, such study shall be deemed to satisfy the requirement for market
p.(None): exclusivity pursuant to this section.
p.(None): ‘‘(j) SUNSET.—A drug may not receive any six-month period under subsection (a) or (c) unless the
p.(None): application for the drug under section 505(b)(1) is submitted on or before January 1, 2002. After January 1,
p.(None): 2002, a drug shall receive a six-month period under subsection (c) if—
p.(None): ‘‘(1) the drug was in commercial distribution as of the date of enactment of the Food and Drug
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p.(None): within a legitimate health care practitioner-patient relationship. This section shall not limit any existing
p.(None): authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the
p.(None): labeling, of a device that are part of a determination of substantial equivalence, established as a condi- tion
p.(None): of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the
p.(None): promotion of unapproved uses of legally marketed devices.’’.
p.(None): SEC. 215. NONINVASIVE BLOOD GLUCOSE METER.
p.(None): (a) FINDINGS.—The Congress finds that—
p.(None): (1) diabetes and its complications are a leading cause of death by disease in America;
p.(None): (2) diabetes affects approximately 16,000,000 Americans and another 650,000 will be diagnosed in 1997;
p.(None): (3) the total health care-related costs of diabetes total nearly $100,000,000,000 per year;
p.(None): (4) diabetes is a disease that is managed and controlled on a daily basis by the patient;
p.(None): (5) the failure to properly control and manage diabetes results in costly and often fatal complications
p.(None): including but not limited to blindness, coronary artery disease, and kidney failure;
p.(None): (6) blood testing devices are a critical tool for the control and management of diabetes, and existing blood
p.(None): testing devices require repeated piercing of the skin;
p.(None): (7) the pain associated with existing blood testing devices creates a disincentive for people with
p.(None): diabetes to test blood glucose levels, particularly children;
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2349
p.(None):
p.(None): (8) a safe and effective noninvasive blood glucose meter would likely improve control and management of
p.(None): diabetes by increasing the number of tests conducted by people with diabetes, particularly children;
p.(None): and
p.(None): (9) the Food and Drug Administration is responsible for reviewing all applications for new medical devices in
p.(None): the United States.
p.(None): (b) SENSE OF CONGRESS.—It is the sense of the Congress that the availability of a safe, effective,
p.(None): noninvasive blood glucose meter would greatly enhance the health and well-being of all people with diabetes across
p.(None): America and the world.
p.(None): SEC. 216. USE OF DATA RELATING TO PREMARKET APPROVAL; PROD- UCT DEVELOPMENT PROTOCOL.
p.(None): (a) USE OF DATA RELATING TO PREMARKET APPROVAL.—
p.(None): (1) IN GENERAL.—Section 520(h)(4) (21 U.S.C. 360j(h)(4))
p.(None): is amended to read as follows:
p.(None): ‘‘(4)(A) Any information contained in an application for pre- market approval filed with the Secretary pursuant
p.(None): to section 515(c) (including information from clinical and preclinical tests or studies that demonstrate the safety
p.(None): and effectiveness of a device, but excluding descriptions of methods of manufacture and product com- position and
p.(None): other trade secrets) shall be available, 6 years after the application has been approved by the
p.(None): Secretary, for use by the Secretary in—
p.(None): ‘‘(i) approving another device;
p.(None): ‘‘(ii) determining whether a product development protocol has been completed, under section 515 for another
p.(None): device;
p.(None): ‘‘(iii) establishing a performance standard or special control under this Act; or
p.(None): ‘‘(iv) classifying or reclassifying another device under sec- tion 513 and subsection (l)(2).
p.(None): ‘‘(B) The publicly available detailed summaries of information respecting the safety and effectiveness of
...
p.(None): Human Services shall make a final determination on any petition pending with the Food and Drug Administration that
p.(None): would permit the irradiation of red meat under section 409(b)(1) of the Federal Food, Drug, and Cos-
p.(None): metic Act. If the Secretary does not make such determination, the Secretary shall, not later than 60
p.(None): days following the date of the enactment of this Act, provide the Committee on Commerce of the House of
p.(None): Representatives and the Committee on Labor and Human Resources of the Senate an explanation of the
p.(None): process followed by the Food and Drug Administration in reviewing the petition referred to in paragraph
p.(None): (1) and the reasons action on the petition was delayed.
p.(None): SEC. 308. GLASS AND CERAMIC WARE.
p.(None): (a) IN GENERAL.—The Secretary may not implement any requirement which would ban, as an unapproved
p.(None): food additive, lead and cadmium based enamel in the lip and rim area of glass and ceramic ware before
p.(None): the expiration of one year after the date such requirement is published.
p.(None): (b) LEAD AND CADMIUM BASED ENAMEL.—Unless the Secretary determines, based on available data, that lead and cadmium
p.(None): based enamel on glass and ceramic ware—
p.(None): (1) which has less than 60 millimeters of decorating area below the external rim, and
p.(None): (2) which is not, by design, representation, or custom of usage intended for use by children,
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 343–3.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 348 note.
p.(None):
p.(None):
p.(None): 111 STAT. 2354 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): is unsafe, the Secretary shall not take any action before January 1, 2003, to ban lead and cadmium
p.(None): based enamel on such glass and ceramic ware. Any action taken after January 1, 2003, to ban such enamel
p.(None): on such glass and ceramic ware as an unapproved food additive shall be taken by regulation and such regulation
p.(None): shall provide that such products shall not be removed from the market before 1 year after publication of the
p.(None): final regulation.
p.(None): SEC. 309. FOOD CONTACT SUBSTANCES.
p.(None): (a) FOOD CONTACT SUBSTANCES.—Section 409(a) (21 U.S.C. 348(a)) is amended—
p.(None): (1) in paragraph (1)—
p.(None): (A) by striking ‘‘subsection (i)’’ and inserting ‘‘sub- section (j)’’; and
p.(None): (B) by striking at the end ‘‘or’’;
p.(None): (2) by striking the period at the end of paragraph (2) and inserting ‘‘; or’’;
p.(None): (3) by inserting after paragraph (2) the following:
p.(None): ‘‘(3) in the case of a food additive as defined in this Act that is a food contact substance, there is—
...
p.(None):
p.(None): 111 STAT. 2374 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘SUBCHAPTER F—NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND PREEMPTION FOR LABELING OR PACKAGING
p.(None): OF COS-
p.(None): METICS
p.(None):
p.(None): 21 USC 379r.
p.(None): ‘‘SEC. 751. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS.
p.(None): ‘‘(a) IN GENERAL.—Except as provided in subsection (b), (c)(1), (d), (e), or (f), no State or political
p.(None): subdivision of a State may establish or continue in effect any requirement—
p.(None): ‘‘(1) that relates to the regulation of a drug that is not subject to the requirements of section 503(b)(1)
p.(None): or 503(f)(1)(A); and
p.(None): ‘‘(2) that is different from or in addition to, or that is otherwise not identical with, a requirement
p.(None): under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair
p.(None): Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
p.(None): ‘‘(b) EXEMPTION.—
p.(None): ‘‘(1) IN GENERAL.—Upon application of a State or political subdivision thereof, the Secretary may by
p.(None): regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection
p.(None): (a), under such conditions as may be prescribed in such regulation, a State or political sub- division
p.(None): requirement that—
p.(None): ‘‘(A) protects an important public interest that would otherwise be unprotected, including the health and
p.(None): safety of children;
p.(None): ‘‘(B) would not cause any drug to be in violation of any applicable requirement or prohibition under
p.(None): Federal law; and
p.(None): ‘‘(C) would not unduly burden interstate commerce. ‘‘(2) TIMELY ACTION.—The Secretary shall make a decision
p.(None): on the exemption of a State or political subdivision requirement under paragraph (1) not later than 120 days
p.(None): after receiving the application of the State or political subdivision under paragraph (1).
p.(None): ‘‘(c) SCOPE.—
p.(None): ‘‘(1) IN GENERAL.—This section shall not apply to—
p.(None): ‘‘(A) any State or political subdivision requirement that relates to the practice of pharmacy; or
p.(None): ‘‘(B) any State or political subdivision requirement that a drug be dispensed only upon the prescription of a practi-
p.(None): tioner licensed by law to administer such drug.
p.(None): ‘‘(2) SAFETY OR EFFECTIVENESS.—For purposes of subsection (a), a requirement that relates to the regulation
p.(None): of a drug shall be deemed to include any requirement relating to public information or any other form of
p.(None): public communication relating to a warning of any kind for a drug.
p.(None): ‘‘(d) EXCEPTIONS.—
...
p.(None): (2) provide a quantitative and qualitative analysis of the mercury compounds in the list under paragraph (1).
p.(None): The Secretary shall compile the list required by paragraph (1) within 2 years after the date of
p.(None): enactment of the Food and Drug Administration Modernization Act of 1997 and shall provide the
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2377
p.(None):
p.(None):
p.(None): analysis required by paragraph (2) within 2 years after such date of enactment.
p.(None): (b) STUDY.—The Secretary of Health and Human Services, act- ing through the Food and Drug Administration, shall
p.(None): conduct a study of the effect on humans of the use of mercury compounds in nasal sprays. Such study
p.(None): shall include data from other studies that have been made of such use.
p.(None): (c) STUDY OF MERCURY SALES.—
p.(None): (1) STUDY.—The Secretary of Health and Human Services, acting through the Food and Drug Administration and subject to
p.(None): appropriations, shall conduct, or shall contract with the Institute of Medicine of the National Academy
p.(None): of Sciences to conduct, a study of the effect on humans of the use of elemental, organic, or inorganic mercury
p.(None): when offered for sale as a drug or dietary supplement. Such study shall, among other things, evaluate—
p.(None): (A) the scope of mercury use as a drug or dietary supplement; and
p.(None): (B) the adverse effects on health of children and other sensitive populations resulting from exposure to, or
p.(None): inges- tion or inhalation of, mercury when so used.
p.(None): In conducting such study, the Secretary shall consult with the Administrator of the Environmental Protection
p.(None): Agency, the Chair of the Consumer Product Safety Commission, and the Administrator of the Agency for Toxic
p.(None): Substances and Disease Registry, and, to the extent the Secretary believes necessary or appropriate, with any
p.(None): other Federal or private entity.
p.(None): (2) REGULATIONS.—If, in the opinion of the Secretary, the use of elemental, organic, or inorganic mercury
p.(None): offered for sale as a drug or dietary supplement poses a threat to human health, the Secretary shall promulgate
p.(None): regulations restricting the sale of mercury intended for such use. At a minimum, such regulations shall
p.(None): be designed to protect the health of children and other sensitive populations from adverse effects
p.(None): resulting from exposure to, or ingestion or inhalation of, mer- cury. Such regulations, to the
p.(None): extent feasible, should not unnecessarily interfere with the availability of mercury for use in religious
p.(None): ceremonies.
p.(None): SEC. 414. INTERAGENCY COLLABORATION.
p.(None): Section 903 (21 U.S.C. 393), as amended by section 406, is further amended by inserting after subsection
p.(None): (b) the following: ‘‘(c) INTERAGENCY COLLABORATION.—The Secretary shall imple- ment programs and
p.(None): policies that will foster collaboration between the Administration, the National Institutes of Health, and
p.(None): other science-based Federal agencies, to enhance the scientific and tech- nical expertise available to the
p.(None): Secretary in the conduct of the duties of the Secretary with respect to the development, clinical
p.(None): investigation, evaluation, and postmarket monitoring of emerging medical therapies, including
p.(None): complementary therapies, and
p.(None): advances in nutrition and food science.’’.
p.(None): SEC. 415. CONTRACTS FOR EXPERT REVIEW.
p.(None): Chapter IX (21 U.S.C. 391 et seq.), as amended by section 214, is further amended by adding at the end the
p.(None): following:
p.(None): ‘‘SEC. 907. CONTRACTS FOR EXPERT REVIEW.
p.(None): ‘‘(a) IN GENERAL.—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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): comprehensive improvements in regulatory processes of the Food and Drug Administration; and
p.(None): (4) the fees authorized by amendments made in this subtitle will be dedicated toward expediting the drug development
p.(None): proc- ess and the review of human drug applications as set forth in the goals identified, for purposes
p.(None): of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters
p.(None): from the Secretary of Health and Human Services to the chairman of the Committee on Commerce of the
p.(None): House of Representatives and the chairman of the Commit- tee on Labor and Human Resources of the Senate, as
p.(None): 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 second sentence of paragraph (1)—
p.(None): (A) by striking ‘‘Service Act, and’’ and inserting ‘‘Service Act,’’; and
p.(None): (B) by striking ‘‘September 1, 1992.’’ and inserting the following: ‘‘September 1, 1992, does not include
p.(None): an application for a licensure of a biological product for further manufacturing use only, and does not include
p.(None): an applica- tion or supplement submitted by a State or Federal Govern- ment entity for a drug that is not distributed
p.(None): commercially. Such term does include an application for licensure, as described in subparagraph (D), of a large
p.(None): volume biological product intended for single dose injection for intravenous use or infusion.’’;
p.(None): (2) in the second sentence of paragraph (3)—
p.(None): (A) by striking ‘‘Service Act, and’’ and inserting ‘‘Service Act,’’; and
p.(None): (B) by striking ‘‘September 1, 1992.’’ and inserting the following: ‘‘September 1, 1992, does not
p.(None): include a
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2299
p.(None):
p.(None): biological product that is licensed for further manufacturing use only, and does not include a drug that is not
p.(None): distributed commercially and is the subject of an application or supple- ment submitted by a State or Federal
p.(None): Government entity. Such term does include a large volume biological product intended for single dose
p.(None): injection for intravenous use or infusion.’’;
p.(None): (3) in paragraph (4), by striking ‘‘without’’ and inserting ‘‘without substantial’’;
p.(None): (4) by amending the first sentence of paragraph (5) to read as follows:
p.(None): ‘‘(5) The term ‘prescription drug establishment’ means a foreign or domestic place of business which is
p.(None): at one general physical location consisting of one or more buildings all of which are within five miles
p.(None): of each other and at which one or more prescription drug products are manufactured in final dosage
p.(None): form.’’;
p.(None): (5) in paragraph (7)(A)—
p.(None): (A) by striking ‘‘employees under contract’’ and all that follows through ‘‘Administration,’’ the second
p.(None): time it occurs and inserting ‘‘contractors of the Food and Drug Administration,’’; and
p.(None): (B) by striking ‘‘and committees,’’ and inserting ‘‘and committees and to contracts with such contractors,’’;
p.(None): (6) in paragraph (8)—
p.(None): (A) in subparagraph (A)—
p.(None): (i) by striking ‘‘August of ’’ and inserting ‘‘April of ’’; and
p.(None): (ii) by striking ‘‘August 1992’’ and inserting ‘‘April 1997’’; and
p.(None): (B) in subparagraph (B)—
p.(None): (i) by striking ‘‘section 254(d)’’ and inserting ‘‘sec- tion 254(c)’’;
p.(None): (ii) by striking ‘‘1992’’ and inserting ‘‘1997’’; and
p.(None): (iii) by striking ‘‘102d Congress, 2d Session’’ and inserting ‘‘105th Congress, 1st Session’’; and
p.(None): (7) by adding at the end the following:
...
p.(None): potential to adversely affect the safety or effectiveness of the drug.
p.(None): ‘‘(d) OTHER MANUFACTURING CHANGES.—
p.(None): ‘‘(1) IN GENERAL.—For purposes of subsection (a)(2)(B), the Secretary may regulate drugs made with
p.(None): manufacturing changes that are not major manufacturing changes as follows: ‘‘(A) The Secretary may in accordance with
p.(None): paragraph
p.(None): (2) authorize holders to distribute such drugs without submitting a supplemental application for
p.(None): such changes. ‘‘(B) The Secretary may in accordance with paragraph
p.(None): (3) require that, prior to the distribution of such drugs, holders submit to the Secretary supplemental
p.(None): applications for such changes.
p.(None): ‘‘(C) The Secretary may establish categories of such changes and designate categories to which
p.(None): subparagraph
p.(None): (A) applies and categories to which subparagraph (B) applies.
p.(None): ‘‘(2) CHANGES NOT REQUIRING SUPPLEMENTAL APPLICA- TION.—
p.(None): ‘‘(A) SUBMISSION OF REPORT.—A holder making a manufacturing change to which paragraph (1)(A) applies
p.(None): shall submit to the Secretary a report on the change, which shall contain such information as the
p.(None): Secretary determines to be appropriate, and which shall include the information developed under subsection (b) by
p.(None): the holder in validating the effects of the change. The report shall be submitted by such date as the
p.(None): Secretary may specify. ‘‘(B) AUTHORITY REGARDING ANNUAL REPORTS.—In the
p.(None): case of a holder that during a single year makes more than one manufacturing change to which paragraph (1)(A)
p.(None): applies, the Secretary may in carrying out subparagraph
p.(None): (A) authorize the holder to comply with such subparagraph by submitting a single report for the year that
p.(None): provides the information required in such subparagraph for all the changes made by the holder during the year.
p.(None): ‘‘(3) CHANGES REQUIRING SUPPLEMENTAL APPLICATION.— ‘‘(A) SUBMISSION OF SUPPLEMENTAL APPLICATION.—The
p.(None): supplemental application required under paragraph (1)(B)
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2315
p.(None):
p.(None):
p.(None): for a manufacturing change shall contain such information as the Secretary determines to be appropriate, which shall
p.(None): include the information developed under subsection (b) by the holder in validating the effects of the change.
p.(None): ‘‘(B) AUTHORITY FOR DISTRIBUTION.—In the case of a
p.(None): manufacturing change to which paragraph (1)(B) applies: ‘‘(i) The holder involved may commence distribu-
p.(None): tion of the drug involved 30 days after the Secretary receives the supplemental application under such para-
p.(None): graph, unless the Secretary notifies the holder within such 30-day period that prior approval of the
p.(None): applica- tion is required before distribution may be commenced. ‘‘(ii) The Secretary may designate a category of
p.(None): such changes for the purpose of providing that, in the case of a change that is in such category, the
p.(None): holder involved may commence distribution of the drug involved upon the receipt by the Secretary of a supple-
p.(None): mental application for the change.
p.(None): ‘‘(iii) If the Secretary disapproves the supplemental application, the Secretary may order the manufacturer to cease
...
p.(None): person from the investigational drug or investigational device is not greater than the probable risk from the disease
p.(None): or condition;
p.(None): ‘‘(2) the Secretary determines that there is sufficient evi- dence of safety and effectiveness to support
p.(None): the use of the investigational drug or investigational device in the case described in paragraph (1);
p.(None): ‘‘(3) the Secretary determines that provision of the inves- tigational drug or investigational device will not
p.(None): interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval;
p.(None): 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): 21 USC 360bbb.
p.(None):
p.(None):
p.(None): 111 STAT. 2366 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘(4) the sponsor, or clinical investigator, of the investiga- tional drug or investigational device
p.(None): submits to the Secretary a clinical protocol consistent with the provisions of section 505(i) or 520(g),
p.(None): including any regulations promulgated under section 505(i) or 520(g), describing the use of the investigational
p.(None): drug or investigational device in a single patient or a small group of patients.
p.(None): ‘‘(c) TREATMENT INVESTIGATIONAL NEW DRUG APPLICATIONS AND
p.(None): TREATMENT INVESTIGATIONAL DEVICE EXEMPTIONS.—Upon submis-
p.(None): sion by a sponsor or a physician of a protocol intended to provide widespread access to an
p.(None): investigational drug or investigational device for eligible patients (referred to in this subsection as an
p.(None): ‘expanded access protocol’), the Secretary shall permit such inves- tigational drug or investigational
p.(None): device to be made available for expanded access under a treatment investigational new drug
p.(None): application or treatment investigational device exemption if the Secretary determines that—
p.(None): ‘‘(1) under the treatment investigational new drug applica- tion or treatment investigational device exemption,
p.(None): the inves- tigational drug or investigational device is intended for use in the diagnosis, monitoring, or
p.(None): treatment of a serious or imme- diately life-threatening disease or condition;
p.(None): ‘‘(2) there is no comparable or satisfactory alternative ther- apy available to diagnose, monitor, or treat that stage
p.(None): of disease or condition in the population of patients to which the investiga- tional drug or investigational device is
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p.(None): ‘‘(3) QUALIFICATIONS.—An accredited person shall, at a minimum, meet the following requirements:
p.(None): ‘‘(A) Such person may not be an employee of the Fed- eral Government.
p.(None): ‘‘(B) Such person shall be an independent organization which is not owned or controlled by a manufacturer,
p.(None): sup- plier, or vendor of devices and which has no organizational, material, or financial affiliation with such a
p.(None): manufacturer, supplier, or vendor.
p.(None): ‘‘(C) Such person shall be a legally constituted entity permitted to conduct the activities for
p.(None): which it seeks accreditation.
p.(None): ‘‘(D) Such person shall not engage in the design, manu- facture, promotion, or sale of devices.
p.(None): ‘‘(E) The operations of such person shall be in accord- ance with generally accepted professional and ethical
p.(None): busi- ness practices and shall agree in writing that as a minimum it will—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None): ‘‘(i) certify that reported information accurately reflects data reviewed;
p.(None):
p.(None):
p.(None): 111 STAT. 2344 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘(ii) limit work to that for which competence and capacity are available;
p.(None): ‘‘(iii) treat information received, records, reports, and recommendations as proprietary information;
p.(None): ‘‘(iv) promptly respond and attempt to resolve com- plaints regarding its activities for which it is accred-
p.(None): ited; and
p.(None): ‘‘(v) protect against the use, in carrying out sub- section (a) with respect to a device, of any
p.(None): officer or employee of the person who has a financial conflict of interest regarding the device, and
p.(None): annually make available to the public disclosures of the extent to which the person, and the officers
p.(None): and employees of the person, have maintained compliance with require- ments under this clause relating to
p.(None): financial conflicts of interest.
p.(None): ‘‘(4) SELECTION OF ACCREDITED PERSONS.—The Secretary
p.(None): shall provide each person who chooses to use an accredited person to receive a section 510(k) report a
p.(None): panel of at least two or more accredited persons from which the regulated person may select one for a specific
p.(None): regulatory function.
p.(None): ‘‘(5) COMPENSATION OF ACCREDITED PERSONS.—Compensa-
p.(None): tion for an accredited person shall be determined by agreement between the accredited person and the person who
p.(None): engages the services of the accredited person, and shall be paid by the person who engages such services.
p.(None): ‘‘(c) DURATION.—The authority provided by this section termi- nates—
p.(None): ‘‘(1) 5 years after the date on which the Secretary notifies Congress that at least 2 persons accredited under
p.(None): subsection
p.(None): (b) are available to review at least 60 percent of the submissions under section 510(k), or
p.(None): ‘‘(2) 4 years after the date on which the Secretary notifies Congress that the Secretary has made a
p.(None): determination described in paragraph (2)(B) of subsection (a) for at least
p.(None): 35 percent of the devices that are subject to review under paragraph (1) of such subsection,
p.(None): whichever occurs first.’’.
p.(None): (b) RECORDKEEPING.—Section 704 (21 U.S.C. 374) is amended by adding at the end the following:
p.(None): ‘‘(f)(1) A person accredited under section 523 to review reports made under section 510(k) and make
p.(None): recommendations of initial classifications of devices to the Secretary shall maintain records documenting
p.(None): the training qualifications of the person and the employees of the person, the procedures used by
p.(None): the person for handling confidential information, the compensation arrangements made by the person, and the
p.(None): procedures used by the person to identify and avoid conflicts of interest. Upon the request of an
p.(None): officer or employee designated by the Secretary, the person shall permit the officer or employee, at all
p.(None): reasonable times, to have access to, to copy, and to verify, the records.
p.(None): ‘‘(2) Within 15 days after the receipt of a written request from the Secretary to a person accredited
p.(None): under section 523 for copies of records described in paragraph (1), the person shall produce the
p.(None): copies of the records at the place designated by the Secretary.’’.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2345
p.(None):
p.(None):
p.(None): (c) CONFORMING AMENDMENT.—Section 301 (21 U.S.C. 331), as amended by section 204(b), is amended by
p.(None): adding at the end the following:
p.(None): ‘‘(y) In the case of a drug, device, or food—
p.(None): ‘‘(1) the submission of a report or recommendation by a person accredited under section 523 that is false or
p.(None): misleading in any material respect;
p.(None): ‘‘(2) the disclosure by a person accredited under section 523 of confidential commercial information or any
p.(None): trade secret without the express written consent of the person who submit- ted such information or secret to such
p.(None): person; or
p.(None): ‘‘(3) the receipt by a person accredited under section 523 of a bribe in any form or the doing of
p.(None): any corrupt act by such person associated with a responsibility delegated to such person under this Act.’’.
p.(None): (d) REPORTS ON PROGRAM OF ACCREDITATION.—
p.(None): (1) COMPTROLLER GENERAL.—
p.(None): (A) IMPLEMENTATION OF PROGRAM.—Not later than 5 years after the date of the enactment of this Act, the
...
Social / Property Ownership
Searching for indicator home:
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p.(None):
p.(None): 21 USC 355 note.
p.(None): (f) SPECIAL RULE.—The Secretary of Health and Human Serv- ices shall take measures to minimize differences in
p.(None): the review and approval of products required to have approved biologics license applications under section 351 of
p.(None): the Public Health Service Act (42 U.S.C. 262) and products required to have approved new drug
p.(None): applications under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)).
p.(None): (g) APPLICATION OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.—Section 351 of the Public Health
p.(None): Service Act (42 U.S.C. 262), as amended by subsection (d), is further amended by adding at the end the
p.(None): following:
p.(None): ‘‘(j) The Federal Food, Drug, and Cosmetic Act applies to a biological product subject to regulation
p.(None): under this section, except that a product for which a license has been approved under sub- section (a)
p.(None): shall not be required to have an approved application under section 505 of such Act.’’.
p.(None): (h) EXAMINATIONS AND PROCEDURES.—Paragraph (3) of section 353(d) of the Public Health Service Act (42 U.S.C.
p.(None): 263a(d)) is amended to read as follows:
p.(None): ‘‘(3) EXAMINATIONS AND PROCEDURES.—The examinations
p.(None): and procedures identified in paragraph (2) are laboratory examinations and procedures that have been
p.(None): approved by the Food and Drug Administration for home use or that, as deter- mined by the Secretary, are simple
p.(None): laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that—
p.(None): ‘‘(A) employ methodologies that are so simple and accurate as to render the likelihood of
p.(None): erroneous results by the user negligible, or
p.(None): ‘‘(B) the Secretary has determined pose no unreason- able risk of harm to the patient if performed
p.(None): incorrectly.’’.
p.(None): SEC. 124. PILOT AND SMALL SCALE MANUFACTURE.
p.(None): (a) HUMAN DRUGS.—Section 505(c) (21 U.S.C. 355(c)) is amend- ed by adding at the end the following:
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2325
p.(None):
p.(None): ‘‘(4) A drug manufactured in a pilot or other small facility may be used to demonstrate the safety and
p.(None): effectiveness of the drug and to obtain approval for the drug prior to manufacture of the drug in a
p.(None): larger facility, unless the Secretary makes a determination that a full scale production facility is
p.(None): necessary to ensure the safety or effectiveness of the drug.’’.
p.(None): (b) ANIMAL DRUGS.—Section 512(c) (21 U.S.C. 360b(c)) is amended by adding at the end the following:
...
Social / Religion
Searching for indicator religious:
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p.(None): (B) the adverse effects on health of children and other sensitive populations resulting from exposure to, or
p.(None): inges- tion or inhalation of, mercury when so used.
p.(None): In conducting such study, the Secretary shall consult with the Administrator of the Environmental Protection
p.(None): Agency, the Chair of the Consumer Product Safety Commission, and the Administrator of the Agency for Toxic
p.(None): Substances and Disease Registry, and, to the extent the Secretary believes necessary or appropriate, with any
p.(None): other Federal or private entity.
p.(None): (2) REGULATIONS.—If, in the opinion of the Secretary, the use of elemental, organic, or inorganic mercury
p.(None): offered for sale as a drug or dietary supplement poses a threat to human health, the Secretary shall promulgate
p.(None): regulations restricting the sale of mercury intended for such use. At a minimum, such regulations shall
p.(None): be designed to protect the health of children and other sensitive populations from adverse effects
p.(None): resulting from exposure to, or ingestion or inhalation of, mer- cury. Such regulations, to the
p.(None): extent feasible, should not unnecessarily interfere with the availability of mercury for use in religious
p.(None): ceremonies.
p.(None): SEC. 414. INTERAGENCY COLLABORATION.
p.(None): Section 903 (21 U.S.C. 393), as amended by section 406, is further amended by inserting after subsection
p.(None): (b) the following: ‘‘(c) INTERAGENCY COLLABORATION.—The Secretary shall imple- ment programs and
p.(None): policies that will foster collaboration between the Administration, the National Institutes of Health, and
p.(None): other science-based Federal agencies, to enhance the scientific and tech- nical expertise available to the
p.(None): Secretary in the conduct of the duties of the Secretary with respect to the development, clinical
p.(None): investigation, evaluation, and postmarket monitoring of emerging medical therapies, including
p.(None): complementary therapies, and
p.(None): advances in nutrition and food science.’’.
p.(None): SEC. 415. CONTRACTS FOR EXPERT REVIEW.
p.(None): Chapter IX (21 U.S.C. 391 et seq.), as amended by section 214, is further amended by adding at the end the
p.(None): following:
p.(None): ‘‘SEC. 907. CONTRACTS FOR EXPERT REVIEW.
p.(None): ‘‘(a) IN GENERAL.—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 397.
p.(None):
p.(None):
p.(None): 111 STAT. 2378 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
...
Social / Threat of Stigma
Searching for indicator threat:
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p.(None): Secretary shall include in the denominator class II devices for which reports under section
p.(None): 510(k) were not required to be submitted by reason of the operation of section 510(m).
p.(None): ‘‘(b) ACCREDITATION.—
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2343
p.(None):
p.(None):
p.(None): ‘‘(1) PROGRAMS.—The Secretary shall provide for such accreditation through programs administered by
p.(None): the Food and Drug Administration, other government agencies, or by other qualified nongovernment
p.(None): organizations.
p.(None): ‘‘(2) ACCREDITATION.—
p.(None): ‘‘(A) IN GENERAL.—Not later than 180 days after the date of the enactment of the Food and Drug Administration
p.(None): Modernization Act of 1997, the Secretary shall establish and publish in the Federal Register criteria to
p.(None): accredit or deny accreditation to persons who request to perform the duties specified in subsection (a).
p.(None): The Secretary shall respond to a request for accreditation within 60 days of the receipt of the request. The
p.(None): accreditation of such person shall specify the particular activities under subsection (a) for which such person
p.(None): is accredited.
p.(None): ‘‘(B) WITHDRAWAL OF ACCREDITATION.—The Secretary
p.(None): may suspend or withdraw accreditation of any person accredited under this paragraph, after providing
p.(None): notice and an opportunity for an informal hearing, when such person is substantially not in compliance with the
p.(None): requirements of this section or poses a threat to public health or fails to act in a manner that is
p.(None): consistent with the purposes of this section.
p.(None): ‘‘(C) PERFORMANCE AUDITING.—To ensure that persons accredited under this section will continue to meet the
p.(None): standards of accreditation, the Secretary shall—
p.(None): ‘‘(i) make onsite visits on a periodic basis to each accredited person to audit the performance of such
p.(None): person; and
p.(None): ‘‘(ii) take such additional measures as the Sec- retary determines to be appropriate.
p.(None): ‘‘(D) ANNUAL REPORT.—The Secretary shall include in the annual report required under section 903(g) the names of
p.(None): all accredited persons and the particular activities under subsection (a) for which each such person is
p.(None): accredited and the name of each accredited person whose accreditation has been withdrawn during the year.
p.(None): ‘‘(3) QUALIFICATIONS.—An accredited person shall, at a minimum, meet the following requirements:
p.(None): ‘‘(A) Such person may not be an employee of the Fed- eral Government.
p.(None): ‘‘(B) Such person shall be an independent organization which is not owned or controlled by a manufacturer,
p.(None): sup- plier, or vendor of devices and which has no organizational, material, or financial affiliation with such a
p.(None): manufacturer, supplier, or vendor.
p.(None): ‘‘(C) Such person shall be a legally constituted entity permitted to conduct the activities for
p.(None): which it seeks accreditation.
p.(None): ‘‘(D) Such person shall not engage in the design, manu- facture, promotion, or sale of devices.
p.(None): ‘‘(E) The operations of such person shall be in accord- ance with generally accepted professional and ethical
p.(None): busi- ness practices and shall agree in writing that as a minimum it will—
p.(None):
p.(None):
p.(None):
...
p.(None): (c) STUDY OF MERCURY SALES.—
p.(None): (1) STUDY.—The Secretary of Health and Human Services, acting through the Food and Drug Administration and subject to
p.(None): appropriations, shall conduct, or shall contract with the Institute of Medicine of the National Academy
p.(None): of Sciences to conduct, a study of the effect on humans of the use of elemental, organic, or inorganic mercury
p.(None): when offered for sale as a drug or dietary supplement. Such study shall, among other things, evaluate—
p.(None): (A) the scope of mercury use as a drug or dietary supplement; and
p.(None): (B) the adverse effects on health of children and other sensitive populations resulting from exposure to, or
p.(None): inges- tion or inhalation of, mercury when so used.
p.(None): In conducting such study, the Secretary shall consult with the Administrator of the Environmental Protection
p.(None): Agency, the Chair of the Consumer Product Safety Commission, and the Administrator of the Agency for Toxic
p.(None): Substances and Disease Registry, and, to the extent the Secretary believes necessary or appropriate, with any
p.(None): other Federal or private entity.
p.(None): (2) REGULATIONS.—If, in the opinion of the Secretary, the use of elemental, organic, or inorganic mercury
p.(None): offered for sale as a drug or dietary supplement poses a threat to human health, the Secretary shall promulgate
p.(None): regulations restricting the sale of mercury intended for such use. At a minimum, such regulations shall
p.(None): be designed to protect the health of children and other sensitive populations from adverse effects
p.(None): resulting from exposure to, or ingestion or inhalation of, mer- cury. Such regulations, to the
p.(None): extent feasible, should not unnecessarily interfere with the availability of mercury for use in religious
p.(None): ceremonies.
p.(None): SEC. 414. INTERAGENCY COLLABORATION.
p.(None): Section 903 (21 U.S.C. 393), as amended by section 406, is further amended by inserting after subsection
p.(None): (b) the following: ‘‘(c) INTERAGENCY COLLABORATION.—The Secretary shall imple- ment programs and
p.(None): policies that will foster collaboration between the Administration, the National Institutes of Health, and
p.(None): other science-based Federal agencies, to enhance the scientific and tech- nical expertise available to the
p.(None): Secretary in the conduct of the duties of the Secretary with respect to the development, clinical
p.(None): investigation, evaluation, and postmarket monitoring of emerging medical therapies, including
p.(None): complementary therapies, and
p.(None): advances in nutrition and food science.’’.
p.(None): SEC. 415. CONTRACTS FOR EXPERT REVIEW.
p.(None): Chapter IX (21 U.S.C. 391 et seq.), as amended by section 214, is further amended by adding at the end the
p.(None): following:
p.(None): ‘‘SEC. 907. CONTRACTS FOR EXPERT REVIEW.
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Social / Trade Union Membership
Searching for indicator union:
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p.(None): SEC. 410. MUTUAL RECOGNITION AGREEMENTS AND GLOBAL HARMONIZATION.
p.(None): (a) GOOD MANUFACTURING PRACTICE REQUIREMENTS.—Section 520(f)(1)(B) (21 U.S.C. 360j(f)(1)(B)) is amended—
p.(None): (1) in clause (i), by striking ‘‘, and’’ at the end and inserting a semicolon;
p.(None): (2) in clause (ii), by striking the period and inserting ‘‘; and’’; and
p.(None):
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997
p.(None): (3) by inserting after clause (ii) the following:
p.(None): 111 STAT. 2373
p.(None): ‘‘(iii) ensure that such regulation conforms, to the extent practicable, with internationally recognized
p.(None): standards defining quality systems, or parts of the standards, for medical devices.’’.
p.(None): (b) HARMONIZATION EFFORTS.—Section 803 (21 U.S.C. 383) is amended by adding at the end the following:
p.(None): ‘‘(c)(1) The Secretary shall support the Office of the United States Trade Representative, in consultation
p.(None): with the Secretary of Commerce, in meetings with representatives of other countries to discuss methods and
p.(None): approaches to reduce the burden of regula- tion and harmonize regulatory requirements if the Secretary deter- mines
p.(None): that such harmonization continues consumer protections consistent with the purposes of this Act.
p.(None): ‘‘(2) The Secretary shall support the Office of the United States Trade Representative, in consultation with the
p.(None): Secretary of Com- merce, in efforts to move toward the acceptance of mutual recogni- tion agreements relating to the
p.(None): regulation of drugs, biological prod- ucts, devices, foods, food additives, and color additives, and the
p.(None): regulation of good manufacturing practices, between the European Union and the United States.
p.(None): ‘‘(3) The Secretary shall regularly participate in meetings with representatives of other foreign governments to
p.(None): discuss and reach agreement on methods and approaches to harmonize regulatory requirements.
p.(None): ‘‘(4) The Secretary shall, not later than 180 days after the date of enactment of the Food and Drug
p.(None): Administration Moderniza- tion Act of 1997, make public a plan that establishes a framework for achieving mutual
p.(None): recognition of good manufacturing practices inspections.
p.(None): ‘‘(5) Paragraphs (1) through (4) shall not apply with respect to products defined in section 201(ff).’’.
p.(None): SEC. 411. ENVIRONMENTAL IMPACT REVIEW.
p.(None): Chapter VII (21 U.S.C. 371 et seq.), as amended by section 407, is further amended by adding at the end the
p.(None): following:
p.(None):
p.(None): ‘‘SUBCHAPTER E—ENVIRONMENTAL IMPACT REVIEW
p.(None):
p.(None):
p.(None): ‘‘SEC. 746. ENVIRONMENTAL IMPACT.
p.(None): ‘‘Notwithstanding any other provision of law, an environmental impact statement prepared in accordance with the
p.(None): regulations pub- lished in part 25 of title 21, Code of Federal Regulations (as in effect on August 31,
p.(None): 1997) in connection with an action carried out under (or a recommendation or report relating to) this
p.(None): Act, shall be considered to meet the requirements for a detailed state- ment under section 102(2)(C) of the
p.(None): National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)).’’.
p.(None): SEC. 412. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND COSMETICS.
p.(None): (a) NONPRESCRIPTION DRUGS.—Chapter VII (21 U.S.C. 371 et seq.), as amended by section 411, is further
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Social / Women
Searching for indicator women:
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p.(None): request. In this paragraph, the term ‘health care economic information’ means any analysis that identifies,
p.(None): measures, or compares the economic consequences, including the costs of the represented health outcomes, of
p.(None): the use of a drug to the use of another drug, to another health care intervention, or to no interven- tion.’’.
p.(None): (b) STUDY AND REPORT.—The Comptroller General of the United States shall conduct a study of the implementation of the
p.(None): provisions added by the amendment made by subsection (a). Not later than
p.(None): 4 years and 6 months after the date of enactment of this Act, the Comptroller General of the United
p.(None): States shall prepare and submit to Congress a report containing the findings of the study.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2313
p.(None):
p.(None):
p.(None): SEC. 115. CLINICAL INVESTIGATIONS.
p.(None): (a) CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL INVESTIGATIONS FOR APPROVAL.—Section 505(d) (21
p.(None): U.S.C. 355(d)) is amended by adding at the end the following: ‘‘If the Secretary determines, based
p.(None): on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence
p.(None): (obtained prior to or after such investigation) are sufficient to establish effectiveness, the Secretary
p.(None): may consider such data and evidence to constitute substantial evidence for purposes of the preceding
p.(None): sentence.’’.
p.(None): (b) WOMEN AND MINORITIES.—Section 505(b)(1) (21 U.S.C. 355(b)(1)) is amended by adding at the end
p.(None): the following: ‘‘The Secretary shall, in consultation with the Director of the National Institutes of Health
p.(None): and with representatives of the drug manufac- turing industry, review and develop guidance, as appropriate, on
p.(None): the inclusion of women and minorities in clinical trials required by clause (A).’’.
p.(None): SEC. 116. MANUFACTURING CHANGES FOR DRUGS.
p.(None): (a) IN GENERAL.—Chapter V, as amended by section 112, is amended by inserting after section 506 the following
p.(None): section:
p.(None): ‘‘SEC. 506A. MANUFACTURING CHANGES.
p.(None): ‘‘(a) IN GENERAL.—With respect to a drug for which there is in effect an approved application under
p.(None): section 505 or 512 or a license under section 351 of the Public Health Service Act, a change from the
p.(None): manufacturing process approved pursuant to such application or license may be made, and the drug as made
p.(None): with the change may be distributed, if—
p.(None): ‘‘(1) the holder of the approved application or license (referred to in this section as a
p.(None): ‘holder’) has validated the effects of the change in accordance with subsection (b); and ‘‘(2)(A) in the
p.(None): case of a major manufacturing change, the holder has complied with the requirements of subsection (c);
p.(None): 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): 21 USC 356a.
p.(None): ‘‘(B) in the case of a change that is not a major manufactur- ing change, the holder complies with the
p.(None): applicable require- ments of subsection (d).
p.(None): ‘‘(b) VALIDATION OF EFFECTS OF CHANGES.—For purposes of
p.(None): subsection (a)(1), a drug made with a manufacturing change (whether a major manufacturing change
...
Social / Youth/Minors
Searching for indicator minor:
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p.(None): the data, the notification shall include the data. The Secretary shall by regulation establish the scope
p.(None): of the responsibilities of manufacturers under this paragraph, including such limits on the
p.(None): responsibilities as the Secretary determines to be appropriate.
p.(None): ‘‘(b) CESSATION OF DISSEMINATION.—
p.(None): ‘‘(1) FAILURE OF MANUFACTURER TO COMPLY WITH REQUIRE-
p.(None): MENTS.—The Secretary may order a manufacturer to cease the dissemination of information pursuant to
p.(None): section 551 if
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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): 360aaa–4.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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): 111 STAT. 2362 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): the Secretary determines that the information being dissemi- nated does not comply with the requirements
p.(None): established in this subchapter. Such an order may be issued only after the Secretary has provided notice to
p.(None): the manufacturer of the intent of the Secretary to issue the order and (unless paragraph (2)(B) applies) has
p.(None): provided an opportunity for a meeting with respect to such intent. If the failure of the manufacturer con-
p.(None): stitutes a minor violation of this subchapter, the Secretary shall delay issuing the order and provide
p.(None): to the manufacturer an opportunity to correct the violation.
p.(None): ‘‘(2) SUPPLEMENTAL APPLICATIONS.—The Secretary may
p.(None): order a manufacturer to cease the dissemination of information pursuant to section 551 if—
p.(None): ‘‘(A) in the case of a manufacturer that has submitted a supplemental application for a new use pursuant to sec- tion
p.(None): 554(a)(1), the Secretary determines that the supple- mental application does not contain adequate
p.(None): information for approval of the new use for which the application was submitted;
p.(None): ‘‘(B) in the case of a manufacturer that has submitted a certification under section 554(b), the manufacturer
p.(None): has not, within the 6-month period involved, submitted the supplemental application referred to in the
p.(None): certification; 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): 21 USC
p.(None): 360aaa–5.
p.(None): ‘‘(C) in the case of a manufacturer that has submitted a certification under section 554(c) but has not yet submit- ted
p.(None): the supplemental application referred to in the certifi- cation, the Secretary determines, after an informal hearing,
p.(None): that the manufacturer is not acting with due diligence to complete the studies involved.
p.(None): ‘‘(3) TERMINATION OF DEEMED APPROVAL OF EXEMPTION REGARDING SUPPLEMENTAL APPLICATIONS.—If under
p.(None): section
...
p.(None): The Secretary shall promulgate such regulations within 1 year after the date of the enactment of the Food
p.(None): and Drug Administration Modernization Act of 1997.’’.
p.(None): SEC. 405. INFORMAL AGENCY STATEMENTS.
p.(None): Section 701 (21 U.S.C. 371) is amended by adding at the end the following:
p.(None): ‘‘(h)(1)(A) The Secretary shall develop guidance documents with public participation and ensure that information
p.(None): identifying the existence of such documents and the documents themselves are made available to the public both
p.(None): in written form and, as feasible, through electronic means. Such documents shall not create or confer any rights for
p.(None): or on any person, although they present the views of the Secretary on matters under the jurisdiction of
p.(None): the Food and Drug Administration.
p.(None): ‘‘(B) Although guidance documents shall not be binding on the Secretary, the Secretary shall ensure that
p.(None): employees of the Food and Drug Administration do not deviate from such guidances without appropriate justification
p.(None): and supervisory concurrence. The Secretary shall provide training to employees in how to develop and use
p.(None): guidance documents and shall monitor the development and issuance of such documents.
p.(None): ‘‘(C) For guidance documents that set forth initial interpreta- tions of a statute or regulation, changes in
p.(None): interpretation or policy that are of more than a minor nature, complex scientific issues, or highly
p.(None): controversial issues, the Secretary shall ensure public participation prior to implementation of guidance
p.(None): documents, unless the Secretary determines that such prior public participation is not feasible or
p.(None): appropriate. In such cases, the Secretary shall pro- vide for public comment upon implementation and take
p.(None): such com- ment into account.
p.(None): ‘‘(D) For guidance documents that set forth existing practices or minor changes in policy, the Secretary
p.(None): shall provide for public comment upon implementation.
p.(None): ‘‘(2) In developing guidance documents, the Secretary shall ensure uniform nomenclature for such documents
p.(None): and uniform internal procedures for approval of such documents. The Secretary shall ensure that guidance documents
p.(None): and revisions of such docu- ments are properly dated and indicate the nonbinding nature of the documents.
p.(None): The Secretary shall periodically review all guidance documents and, where appropriate, revise such documents.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2369
p.(None):
p.(None):
p.(None): ‘‘(3) The Secretary, acting through the Commissioner, shall maintain electronically and update and publish
p.(None): periodically in the Federal Register a list of guidance documents. All such documents shall be made available to the
p.(None): public.
p.(None): ‘‘(4) The Secretary shall ensure that an effective appeals mecha- nism is in place to address complaints that
p.(None): the Food and Drug Administration is not developing and using guidance documents in accordance with this
p.(None): subsection.
p.(None): ‘‘(5) Not later than July 1, 2000, the Secretary after evaluating the effectiveness of the Good Guidance
p.(None): Practices document, pub- lished in the Federal Register at 62 Fed. Reg. 8961, shall promul- gate a
p.(None): regulation consistent with this subsection specifying the policies and procedures of the Food and Drug
...
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Searching for indicator education:
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p.(None): Sec. 205. Scope of review; collaborative determinations of device data requirements. Sec. 206. Premarket
p.(None): notification.
p.(None): Sec. 207. Evaluation of automatic class III designation. Sec. 208. Classification panels.
p.(None): Sec. 209. Certainty of review timeframes; collaborative review process.
p.(None): Sec. 210. Accreditation of persons for review of premarket notification reports. Sec. 211. Device tracking.
p.(None): Sec. 212. Postmarket surveillance. Sec. 213. Reports.
p.(None): Sec. 214. Practice of medicine.
p.(None): Sec. 215. Noninvasive blood glucose meter.
p.(None): Sec. 216. Use of data relating to premarket approval; product development protocol. Sec. 217. Clarification of
p.(None): the number of required clinical investigations for ap-
p.(None): proval.
p.(None): TITLE III—IMPROVING REGULATION OF FOOD
p.(None): Sec. 301. Flexibility for regulations regarding claims. Sec. 302. Petitions for claims.
p.(None): Sec. 303. Health claims for food products. Sec. 304. Nutrient content claims.
p.(None): Sec. 305. Referral statements. Sec. 306. Disclosure of irradiation. Sec. 307. Irradiation petition.
p.(None): Sec. 308. Glass and ceramic ware. Sec. 309. Food contact substances.
p.(None): TITLE IV—GENERAL PROVISIONS
p.(None): Sec. 401. Dissemination of information on new uses.
p.(None): Sec. 402. Expanded access to investigational therapies and diagnostics. Sec. 403. Approval of supplemental
p.(None): applications for approved products. Sec. 404. Dispute resolution.
p.(None): Sec. 405. Informal agency statements.
p.(None): Sec. 406. Food and Drug Administration mission and annual report. Sec. 407. Information system.
p.(None): Sec. 408. Education and training.
p.(None): Sec. 409. Centers for education and research on therapeutics.
p.(None): Sec. 410. Mutual recognition agreements and global harmonization. Sec. 411. Environmental impact review.
p.(None): Sec. 412. National uniformity for nonprescription drugs and cosmetics.
p.(None): Sec. 413. Food and Drug Administration study of mercury compounds in drugs and food.
p.(None): Sec. 414. Interagency collaboration. Sec. 415. Contracts for expert review. Sec. 416. Product classification.
p.(None): Sec. 417. Registration of foreign establishments. Sec. 418. Clarification of seizure authority.
p.(None): Sec. 419. Interstate commerce.
p.(None): Sec. 420. Safety report disclaimers.
p.(None): Sec. 421. Labeling and advertising regarding compliance with statutory require- ments.
p.(None): Sec. 422. Rule of construction.
p.(None): TITLE V—EFFECTIVE DATE
p.(None):
p.(None): Sec. 501. Effective date.
p.(None): SEC. 2. DEFINITIONS.
p.(None): In this Act, the terms ‘‘drug’’, ‘‘device’’, ‘‘food’’, and ‘‘dietary supplement’’ have the meaning given
p.(None): such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
p.(None):
p.(None): 21 USC 321 note.
p.(None):
p.(None):
p.(None): 111 STAT. 2298 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None): TITLE I—IMPROVING REGULATION OF DRUGS
p.(None): Subtitle A—Fees Relating to Drugs
p.(None):
p.(None):
p.(None): 21 USC 379g
p.(None): note.
p.(None): SEC. 101. FINDINGS.
p.(None): Congress finds that—
p.(None): (1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement
...
p.(None): ‘‘(C) a representative of consumer interests, and a rep- resentative of interests of the drug
p.(None): manufacturing industry not directly affected by the matter to be brought before the panel; and
p.(None): ‘‘(D) two or more members who are specialists or have other expertise in the particular disease or condition
p.(None): for which the drug under review is proposed to be indicated.
p.(None): Scientific, trade, and consumer organizations shall be afforded an opportunity to nominate individuals for
p.(None): appointment to the panels. No individual who is in the regular full-time employ of the United States and engaged in
p.(None): the administration of this Act may be a voting member of any panel. The Secretary shall designate one
p.(None): of the members of each panel to serve as chairman thereof.
p.(None): ‘‘(4) Each member of a panel shall publicly disclose all conflicts of interest that member may have with the work to be
p.(None): undertaken by the panel. No member of a panel may vote on any matter where the member or the immediate
p.(None): family of such member could gain financially from the advice given to the Secretary. The Sec- retary
p.(None): may grant a waiver of any conflict of interest requirement upon public disclosure of such conflict of
p.(None): interest if such waiver is necessary to afford the panel essential expertise, except that the Secretary
p.(None): may not grant a waiver for a member of a panel when the member’s own scientific work is involved.
p.(None): ‘‘(5) The Secretary shall, as appropriate, provide education and training to each new panel member before such member
p.(None): participates in a panel’s activities, including education regarding requirements under this Act and related
p.(None): regulations of the Secretary, and the administrative processes and procedures related to panel meetings. ‘‘(6)
p.(None): Panel members (other than officers or employees of the United States), while attending meetings or conferences
p.(None): of a panel or otherwise engaged in its business, shall be entitled to receive compensation for each day
p.(None): so engaged, including traveltime, at rates to be fixed by the Secretary, but not to exceed the daily
p.(None): equivalent of the rate in effect for positions classified above grade GS–15 of the General Schedule.
p.(None): While serving away from their homes or regular places of business, panel members may be allowed travel expenses
p.(None): (including per diem in lieu of subsistence) as author- ized by section 5703 of title 5, United States Code,
p.(None): for persons
p.(None): in the Government service employed intermittently.
p.(None):
p.(None):
p.(None): 111 STAT. 2320 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘(7) The Secretary shall ensure that scientific advisory panels meet regularly and at appropriate
p.(None): intervals so that any matter to be reviewed by such a panel can be presented to the panel not more
p.(None): than 60 days after the matter is ready for such review. Meetings of the panel may be held using electronic
p.(None): communication to convene the meetings.
p.(None): ‘‘(8) Within 90 days after a scientific advisory panel makes recommendations on any matter under its
p.(None): review, the Food and Drug Administration official responsible for the matter shall review the conclusions and
...
p.(None): review of all applications and submissions described in subpara- graph (A) and submitted after the date
p.(None): of enactment of the Food and Drug Administration Modernization Act of 1997; and
p.(None): ‘‘(F) eliminating backlogs in the review of applications and submissions described in subparagraph (A), by January 1,
p.(None): 2000.
p.(None):
p.(None): Federal Register, publication.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 379k.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379k
p.(None): note.
p.(None): ‘‘(g) ANNUAL REPORT.—The Secretary shall annually prepare and publish in the Federal Register and solicit
p.(None): public comment on a report that—
p.(None): ‘‘(1) provides detailed statistical information on the performance of the Secretary under the plan
p.(None): described in sub- section (f);
p.(None): ‘‘(2) compares such performance of the Secretary with the objectives of the plan and with the statutory
p.(None): obligations of the Secretary; and
p.(None): ‘‘(3) identifies any regulatory policy that has a significant negative impact on compliance with any
p.(None): objective of the plan or any statutory obligation and sets forth any proposed revision to any such regulatory
p.(None): policy.’’.
p.(None): SEC. 407. INFORMATION SYSTEM.
p.(None): (a) AMENDMENT.—Chapter VII (21 U.S.C. 371 et seq.) is amend- ed by adding at the end the following:
p.(None):
p.(None): ‘‘SUBCHAPTER D—INFORMATION AND EDUCATION
p.(None):
p.(None): ‘‘SEC. 741. INFORMATION SYSTEM.
p.(None): ‘‘The Secretary shall establish and maintain an information system to track the status and progress of
p.(None): each application or submission (including a petition, notification, or other similar form of request) submitted to
p.(None): the Food and Drug Administration request- ing agency action.’’.
p.(None): (b) REPORT.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human
p.(None): Services shall submit a report to the Committee on Labor and Human Resources of the Senate and the Committee on
p.(None): Commerce of the House of Representatives on the status of the system to be established under
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2371
p.(None):
p.(None):
p.(None): the amendment made by subsection (a), including the projected costs of the system and concerns about
p.(None): confidentiality.
p.(None): SEC. 408. EDUCATION AND TRAINING.
p.(None): (a) FOOD AND DRUG ADMINISTRATION.—Chapter VII (21 U.S.C.
p.(None): 371 et seq.), as amended by section 407, is further amended by adding at the end the following section:
p.(None): ‘‘SEC. 742. EDUCATION.
p.(None): ‘‘(a) IN GENERAL.—The Secretary shall conduct training and education programs for the employees of
p.(None): the Food and Drug Administration relating to the regulatory responsibilities and poli- cies established by
p.(None): this Act, including programs for—
p.(None): ‘‘(1) scientific training;
p.(None): ‘‘(2) training to improve the skill of officers and employees authorized to conduct inspections under section 704;
p.(None): ‘‘(3) training to achieve product specialization in such inspections; and
p.(None): ‘‘(4) training in administrative process and procedure and integrity issues.
p.(None): ‘‘(b) INTRAMURAL FELLOWSHIPS AND OTHER TRAINING PRO-
p.(None): GRAMS.—The Secretary, acting through the Commissioner, may, through fellowships and other training programs,
p.(None): conduct and sup- port intramural research training for predoctoral and postdoctoral scientists and
p.(None): physicians.’’.
p.(None): (b) CENTERS FOR DISEASE CONTROL AND PREVENTION.—
p.(None): (1) IN GENERAL.—Part B of title III of the Public Health Service Act is amended by inserting after
p.(None): section 317F (42
p.(None): U.S.C. 247b–7) the following:
p.(None): ‘‘SEC. 317G. FELLOWSHIP AND TRAINING PROGRAMS.
p.(None): ‘‘The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall
p.(None): establish fellowship and training programs to be conducted by such Centers to train individ- uals to develop
p.(None): skills in epidemiology, surveillance, laboratory analysis, and other disease detection and prevention methods.
p.(None): Such programs shall be designed to enable health professionals and health personnel trained under such programs
p.(None): to work, after receiv- ing such training, in local, State, national, and international efforts toward the prevention
p.(None): and control of diseases, injuries, and disabil- ities. Such fellowships and training may be administered
p.(None): through the use of either appointment or nonappointment procedures.’’.
p.(None): (2) EFFECTIVE DATE.—The amendment made by this sub- section is deemed to have taken effect July 1, 1995.
p.(None): SEC. 409. CENTERS FOR EDUCATION AND RESEARCH ON THERA- PEUTICS.
p.(None): Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) is amended by adding at the end of
p.(None): part A the following new section:
p.(None): ‘‘SEC. 905. DEMONSTRATION PROGRAM REGARDING CENTERS FOR EDUCATION AND RESEARCH ON THERAPEUTICS.
p.(None): ‘‘(a) IN GENERAL.—The Secretary, acting through the Adminis- trator and in consultation with the Commissioner of
p.(None): Food and Drugs, shall establish a demonstration program for the purpose of making one or more grants for the
p.(None): establishment and operation
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 379l.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 247b–8.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 247b–8
p.(None): note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 42 USC 299a–3.
p.(None):
p.(None):
p.(None): 111 STAT. 2372 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): of one or more centers to carry out the activities specified in subsection (b).
p.(None): ‘‘(b) REQUIRED ACTIVITIES.—The activities referred to in sub- section (a) are the following:
p.(None): ‘‘(1) The conduct of state-of-the-art clinical and laboratory research for the following purposes:
p.(None): ‘‘(A) To increase awareness of—
p.(None): ‘‘(i) new uses of drugs, biological products, and devices;
p.(None): ‘‘(ii) ways to improve the effective use of drugs, biological products, and devices; and
p.(None): ‘‘(iii) risks of new uses and risks of combinations of drugs and biological products.
p.(None): ‘‘(B) To provide objective clinical information to the following individuals and entities:
p.(None): ‘‘(i) Health care practitioners or other providers of health care goods or services.
...
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p.(None): volume biological product intended for single dose injection for intravenous use or infusion.’’;
p.(None): (2) in the second sentence of paragraph (3)—
p.(None): (A) by striking ‘‘Service Act, and’’ and inserting ‘‘Service Act,’’; and
p.(None): (B) by striking ‘‘September 1, 1992.’’ and inserting the following: ‘‘September 1, 1992, does not
p.(None): include a
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2299
p.(None):
p.(None): biological product that is licensed for further manufacturing use only, and does not include a drug that is not
p.(None): distributed commercially and is the subject of an application or supple- ment submitted by a State or Federal
p.(None): Government entity. Such term does include a large volume biological product intended for single dose
p.(None): injection for intravenous use or infusion.’’;
p.(None): (3) in paragraph (4), by striking ‘‘without’’ and inserting ‘‘without substantial’’;
p.(None): (4) by amending the first sentence of paragraph (5) to read as follows:
p.(None): ‘‘(5) The term ‘prescription drug establishment’ means a foreign or domestic place of business which is
p.(None): at one general physical location consisting of one or more buildings all of which are within five miles
p.(None): of each other and at which one or more prescription drug products are manufactured in final dosage
p.(None): form.’’;
p.(None): (5) in paragraph (7)(A)—
p.(None): (A) by striking ‘‘employees under contract’’ and all that follows through ‘‘Administration,’’ the second
p.(None): time it occurs and inserting ‘‘contractors of the Food and Drug Administration,’’; and
p.(None): (B) by striking ‘‘and committees,’’ and inserting ‘‘and committees and to contracts with such contractors,’’;
p.(None): (6) in paragraph (8)—
p.(None): (A) in subparagraph (A)—
p.(None): (i) by striking ‘‘August of ’’ and inserting ‘‘April of ’’; and
p.(None): (ii) by striking ‘‘August 1992’’ and inserting ‘‘April 1997’’; and
p.(None): (B) in subparagraph (B)—
p.(None): (i) by striking ‘‘section 254(d)’’ and inserting ‘‘sec- tion 254(c)’’;
p.(None): (ii) by striking ‘‘1992’’ and inserting ‘‘1997’’; and
p.(None): (iii) by striking ‘‘102d Congress, 2d Session’’ and inserting ‘‘105th Congress, 1st Session’’; and
p.(None): (7) by adding at the end the following:
p.(None): ‘‘(9) The term ‘affiliate’ means a business entity that has a relationship with a second business entity
p.(None): if, directly or indirectly—
p.(None): ‘‘(A) one business entity controls, or has the power to control, the other business entity; or
p.(None): ‘‘(B) a third party controls, or has power to control, both of the business entities.’’.
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) by striking ‘‘Beginning in fiscal year 1993’’ and inserting ‘‘Beginning in fiscal year 1998’’;
p.(None): (2) in paragraph (1)—
p.(None): (A) by striking subparagraph (B) and inserting the following:
...
p.(None): (d) FEE WAIVER OR REDUCTION.—Section 736(d) (21 U.S.C. 379h(d)) is amended—
p.(None): (1) by redesignating paragraphs (1), (2), (3), and (4) as subparagraphs (A), (B), (C), and (D), respectively
p.(None): and indenting appropriately;
p.(None): (2) by striking ‘‘The Secretary shall grant a’’ and all that follows through ‘‘finds that—’’ and inserting
p.(None): the following:
p.(None): ‘‘(1) IN GENERAL.—The Secretary shall grant a waiver from or a reduction of one or more fees assessed under
p.(None): subsection
p.(None): (a) where the Secretary finds that—’’;
p.(None): (3) in subparagraph (C) (as so redesignated in paragraph (1)), by striking ‘‘, or’’ and inserting a comma;
p.(None): (4) in subparagraph (D) (as so redesignated in paragraph (1)), by striking the period and inserting ‘‘, or’’;
p.(None): (5) by inserting after subparagraph (D) (as so redesignated in paragraph (1)) the following:
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2303
p.(None):
p.(None): ‘‘(E) the applicant involved is a small business submit- ting its first human drug application to the Secretary
p.(None): for review.’’; and
p.(None): (6) by striking ‘‘In making the finding in paragraph (3),’’ and all that follows through ‘‘standard
p.(None): costs.’’ and inserting the following:
p.(None): ‘‘(2) USE OF STANDARD COSTS.—In making the finding in paragraph (1)(C), the Secretary may use standard costs.
p.(None): ‘‘(3) RULES RELATING TO SMALL BUSINESSES.—
p.(None): ‘‘(A) DEFINITION.—In paragraph (1)(E), the term ‘small business’ means an entity that has fewer than 500 employ- ees,
p.(None): including employees of affiliates.
p.(None): ‘‘(B) WAIVER OF APPLICATION FEE.—The Secretary shall waive under paragraph (1)(E) the application fee for the
p.(None): first human drug application that a small business or its affiliate submits to the Secretary for review. After
p.(None): a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay—
p.(None): ‘‘(i) application fees for all subsequent human drug applications submitted to the Secretary for review in the
p.(None): same manner as an entity that does not qualify as a small business; and
p.(None): ‘‘(ii) all supplement fees for all supplements to human drug applications submitted to the Secretary for
p.(None): review in the same manner as an entity that does not qualify as a small business.’’.
p.(None): (e) ASSESSMENT OF FEES.—Section 736(f)(1) (21 U.S.C. 379h(f)(1)) is amended—
p.(None): (1) by striking ‘‘fiscal year 1993’’ and inserting ‘‘fiscal year 1997’’; and
p.(None): (2) by striking ‘‘fiscal year 1992’’ and inserting ‘‘fiscal year 1997 (excluding the amount of fees appropriated for
p.(None): such fiscal year)’’.
p.(None): (f) CREDITING AND AVAILABILITY OF FEES.—Section 736(g) (21
p.(None): U.S.C. 379h(g)) is amended—
p.(None): (1) in paragraph (1), by adding at the end the following: ‘‘Such sums as may be necessary may be
p.(None): transferred from the Food and Drug Administration salaries and expenses appro- priation account without fiscal
p.(None): year limitation to such appro- priation account for salaries and expenses with such fiscal year limitation.
...
p.(None): Scientific, trade, and consumer organizations shall be afforded an opportunity to nominate individuals for
p.(None): appointment to the panels. No individual who is in the regular full-time employ of the United States and engaged in
p.(None): the administration of this Act may be a voting member of any panel. The Secretary shall designate one
p.(None): of the members of each panel to serve as chairman thereof.
p.(None): ‘‘(4) Each member of a panel shall publicly disclose all conflicts of interest that member may have with the work to be
p.(None): undertaken by the panel. No member of a panel may vote on any matter where the member or the immediate
p.(None): family of such member could gain financially from the advice given to the Secretary. The Sec- retary
p.(None): may grant a waiver of any conflict of interest requirement upon public disclosure of such conflict of
p.(None): interest if such waiver is necessary to afford the panel essential expertise, except that the Secretary
p.(None): may not grant a waiver for a member of a panel when the member’s own scientific work is involved.
p.(None): ‘‘(5) The Secretary shall, as appropriate, provide education and training to each new panel member before such member
p.(None): participates in a panel’s activities, including education regarding requirements under this Act and related
p.(None): regulations of the Secretary, and the administrative processes and procedures related to panel meetings. ‘‘(6)
p.(None): Panel members (other than officers or employees of the United States), while attending meetings or conferences
p.(None): of a panel or otherwise engaged in its business, shall be entitled to receive compensation for each day
p.(None): so engaged, including traveltime, at rates to be fixed by the Secretary, but not to exceed the daily
p.(None): equivalent of the rate in effect for positions classified above grade GS–15 of the General Schedule.
p.(None): While serving away from their homes or regular places of business, panel members may be allowed travel expenses
p.(None): (including per diem in lieu of subsistence) as author- ized by section 5703 of title 5, United States Code,
p.(None): for persons
p.(None): in the Government service employed intermittently.
p.(None):
p.(None):
p.(None): 111 STAT. 2320 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘(7) The Secretary shall ensure that scientific advisory panels meet regularly and at appropriate
p.(None): intervals so that any matter to be reviewed by such a panel can be presented to the panel not more
p.(None): than 60 days after the matter is ready for such review. Meetings of the panel may be held using electronic
p.(None): communication to convene the meetings.
p.(None): ‘‘(8) Within 90 days after a scientific advisory panel makes recommendations on any matter under its
p.(None): review, the Food and Drug Administration official responsible for the matter shall review the conclusions and
p.(None): recommendations of the panel, and notify the affected persons of the final decision on the matter, or
p.(None): of the reasons that no such decision has been reached. Each such final decision shall be documented
p.(None): including the rationale for the deci- sion.’’.
...
p.(None): sup- plier, or vendor of devices and which has no organizational, material, or financial affiliation with such a
p.(None): manufacturer, supplier, or vendor.
p.(None): ‘‘(C) Such person shall be a legally constituted entity permitted to conduct the activities for
p.(None): which it seeks accreditation.
p.(None): ‘‘(D) Such person shall not engage in the design, manu- facture, promotion, or sale of devices.
p.(None): ‘‘(E) The operations of such person shall be in accord- ance with generally accepted professional and ethical
p.(None): busi- ness practices and shall agree in writing that as a minimum it will—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Federal Register, publication.
p.(None): ‘‘(i) certify that reported information accurately reflects data reviewed;
p.(None):
p.(None):
p.(None): 111 STAT. 2344 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘(ii) limit work to that for which competence and capacity are available;
p.(None): ‘‘(iii) treat information received, records, reports, and recommendations as proprietary information;
p.(None): ‘‘(iv) promptly respond and attempt to resolve com- plaints regarding its activities for which it is accred-
p.(None): ited; and
p.(None): ‘‘(v) protect against the use, in carrying out sub- section (a) with respect to a device, of any
p.(None): officer or employee of the person who has a financial conflict of interest regarding the device, and
p.(None): annually make available to the public disclosures of the extent to which the person, and the officers
p.(None): and employees of the person, have maintained compliance with require- ments under this clause relating to
p.(None): financial conflicts of interest.
p.(None): ‘‘(4) SELECTION OF ACCREDITED PERSONS.—The Secretary
p.(None): shall provide each person who chooses to use an accredited person to receive a section 510(k) report a
p.(None): panel of at least two or more accredited persons from which the regulated person may select one for a specific
p.(None): regulatory function.
p.(None): ‘‘(5) COMPENSATION OF ACCREDITED PERSONS.—Compensa-
p.(None): tion for an accredited person shall be determined by agreement between the accredited person and the person who
p.(None): engages the services of the accredited person, and shall be paid by the person who engages such services.
p.(None): ‘‘(c) DURATION.—The authority provided by this section termi- nates—
p.(None): ‘‘(1) 5 years after the date on which the Secretary notifies Congress that at least 2 persons accredited under
p.(None): subsection
p.(None): (b) are available to review at least 60 percent of the submissions under section 510(k), or
p.(None): ‘‘(2) 4 years after the date on which the Secretary notifies Congress that the Secretary has made a
p.(None): determination described in paragraph (2)(B) of subsection (a) for at least
p.(None): 35 percent of the devices that are subject to review under paragraph (1) of such subsection,
p.(None): whichever occurs first.’’.
p.(None): (b) RECORDKEEPING.—Section 704 (21 U.S.C. 374) is amended by adding at the end the following:
p.(None): ‘‘(f)(1) A person accredited under section 523 to review reports made under section 510(k) and make
p.(None): recommendations of initial classifications of devices to the Secretary shall maintain records documenting
p.(None): the training qualifications of the person and the employees of the person, the procedures used by
p.(None): the person for handling confidential information, the compensation arrangements made by the person, and the
p.(None): procedures used by the person to identify and avoid conflicts of interest. Upon the request of an
p.(None): officer or employee designated by the Secretary, the person shall permit the officer or employee, at all
p.(None): reasonable times, to have access to, to copy, and to verify, the records.
p.(None): ‘‘(2) Within 15 days after the receipt of a written request from the Secretary to a person accredited
p.(None): under section 523 for copies of records described in paragraph (1), the person shall produce the
p.(None): copies of the records at the place designated by the Secretary.’’.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2345
p.(None):
p.(None):
p.(None): (c) CONFORMING AMENDMENT.—Section 301 (21 U.S.C. 331), as amended by section 204(b), is amended by
p.(None): adding at the end the following:
p.(None): ‘‘(y) In the case of a drug, device, or food—
p.(None): ‘‘(1) the submission of a report or recommendation by a person accredited under section 523 that is false or
p.(None): misleading in any material respect;
p.(None): ‘‘(2) the disclosure by a person accredited under section 523 of confidential commercial information or any
p.(None): trade secret without the express written consent of the person who submit- ted such information or secret to such
p.(None): person; or
...
p.(None): (d) or (e) of section 513, an order under subsection (f) of such section, or the approval of an
p.(None): application under section 515; ‘‘(2) the information meets the requirements of section 552;
p.(None): ‘‘(3) the information to be disseminated is not derived from clinical research conducted by another manufacturer
p.(None): or if it was derived from research conducted by another manufacturer, the manufacturer disseminating the
p.(None): information has the permission of such other manufacturer to make the dissemina- tion;
p.(None): ‘‘(4) the manufacturer has, 60 days before such dissemina- tion, submitted to the Secretary—
p.(None): ‘‘(A) a copy of the information to be disseminated;
p.(None):
p.(None): and
p.(None): ‘‘(B) any clinical trial information the manufacturer
p.(None): has relating to the safety or effectiveness of the new use, any reports of clinical experience pertinent
p.(None): to the safety of the new use, and a summary of such information;
p.(None): ‘‘(5) the manufacturer has complied with the requirements of section 554 (relating to a supplemental
p.(None): application for such use);
p.(None): ‘‘(6) the manufacturer includes along with the information to be disseminated under this subsection—
p.(None): ‘‘(A) a prominently displayed statement that discloses— ‘‘(i) that the information concerns a use of a drug
p.(None): or device that has not been approved or cleared by the Food and Drug Administration;
p.(None): ‘‘(ii) if applicable, that the information is being disseminated at the expense of the manufacturer;
p.(None): ‘‘(iii) if applicable, the name of any authors of the information who are employees of, consultants to,
p.(None): or have received compensation from, the manufacturer, or who have a significant financial interest in the
p.(None): manufacturer;
p.(None): ‘‘(iv) the official labeling for the drug or device and all updates with respect to the labeling;
p.(None): ‘‘(v) if applicable, a statement that there are prod- ucts or treatments that have been approved or cleared for the use
p.(None): that is the subject of the information being disseminated pursuant to subsection (a)(1); and
p.(None): ‘‘(vi) the identification of any person that has pro- vided funding for the conduct of a study relating to the
p.(None): new use of a drug or device for which such informa- tion is being disseminated; and
p.(None): ‘‘(B) a bibliography of other articles from a scientific reference publication or scientific or medical
p.(None): journal that
p.(None):
p.(None):
p.(None): 111 STAT. 2358 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): have been previously published about the use of the drug or device covered by the information
p.(None): disseminated (unless the information already includes such bibliography).
p.(None): ‘‘(c) ADDITIONAL INFORMATION.—If the Secretary determines, after providing notice of such determination and
p.(None): an opportunity for a meeting with respect to such determination, that the informa- tion submitted by a
p.(None): manufacturer under subsection (b)(3)(B), with respect to the use of a drug or device for which the
p.(None): manufacturer intends to disseminate information, fails to provide data, analyses, or other written matter that is
...
p.(None): applicant, or manufacturer and no specific provi- sion of the Act involved, including a regulation promulgated under
p.(None): such Act, provides a right of review of the matter in controversy, the Secretary shall, by regulation,
p.(None): establish a procedure under which such sponsor, applicant, or manufacturer may request a review of such
p.(None): controversy, including a review by an appropriate scientific advisory panel described in section 505(n) or an
p.(None): advisory committee described in section 515(g)(2)(B). Any such review shall take place in a timely manner.
p.(None): The Secretary shall promulgate such regulations within 1 year after the date of the enactment of the Food
p.(None): and Drug Administration Modernization Act of 1997.’’.
p.(None): SEC. 405. INFORMAL AGENCY STATEMENTS.
p.(None): Section 701 (21 U.S.C. 371) is amended by adding at the end the following:
p.(None): ‘‘(h)(1)(A) The Secretary shall develop guidance documents with public participation and ensure that information
p.(None): identifying the existence of such documents and the documents themselves are made available to the public both
p.(None): in written form and, as feasible, through electronic means. Such documents shall not create or confer any rights for
p.(None): or on any person, although they present the views of the Secretary on matters under the jurisdiction of
p.(None): the Food and Drug Administration.
p.(None): ‘‘(B) Although guidance documents shall not be binding on the Secretary, the Secretary shall ensure that
p.(None): employees of the Food and Drug Administration do not deviate from such guidances without appropriate justification
p.(None): and supervisory concurrence. The Secretary shall provide training to employees in how to develop and use
p.(None): guidance documents and shall monitor the development and issuance of such documents.
p.(None): ‘‘(C) For guidance documents that set forth initial interpreta- tions of a statute or regulation, changes in
p.(None): interpretation or policy that are of more than a minor nature, complex scientific issues, or highly
p.(None): controversial issues, the Secretary shall ensure public participation prior to implementation of guidance
p.(None): documents, unless the Secretary determines that such prior public participation is not feasible or
p.(None): appropriate. In such cases, the Secretary shall pro- vide for public comment upon implementation and take
p.(None): such com- ment into account.
p.(None): ‘‘(D) For guidance documents that set forth existing practices or minor changes in policy, the Secretary
p.(None): shall provide for public comment upon implementation.
p.(None): ‘‘(2) In developing guidance documents, the Secretary shall ensure uniform nomenclature for such documents
p.(None): and uniform internal procedures for approval of such documents. The Secretary shall ensure that guidance documents
p.(None): and revisions of such docu- ments are properly dated and indicate the nonbinding nature of the documents.
p.(None): The Secretary shall periodically review all guidance documents and, where appropriate, revise such documents.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2369
p.(None):
p.(None):
p.(None): ‘‘(3) The Secretary, acting through the Commissioner, shall maintain electronically and update and publish
...
p.(None):
p.(None): ‘‘SUBCHAPTER D—INFORMATION AND EDUCATION
p.(None):
p.(None): ‘‘SEC. 741. INFORMATION SYSTEM.
p.(None): ‘‘The Secretary shall establish and maintain an information system to track the status and progress of
p.(None): each application or submission (including a petition, notification, or other similar form of request) submitted to
p.(None): the Food and Drug Administration request- ing agency action.’’.
p.(None): (b) REPORT.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human
p.(None): Services shall submit a report to the Committee on Labor and Human Resources of the Senate and the Committee on
p.(None): Commerce of the House of Representatives on the status of the system to be established under
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2371
p.(None):
p.(None):
p.(None): the amendment made by subsection (a), including the projected costs of the system and concerns about
p.(None): confidentiality.
p.(None): SEC. 408. EDUCATION AND TRAINING.
p.(None): (a) FOOD AND DRUG ADMINISTRATION.—Chapter VII (21 U.S.C.
p.(None): 371 et seq.), as amended by section 407, is further amended by adding at the end the following section:
p.(None): ‘‘SEC. 742. EDUCATION.
p.(None): ‘‘(a) IN GENERAL.—The Secretary shall conduct training and education programs for the employees of
p.(None): the Food and Drug Administration relating to the regulatory responsibilities and poli- cies established by
p.(None): this Act, including programs for—
p.(None): ‘‘(1) scientific training;
p.(None): ‘‘(2) training to improve the skill of officers and employees authorized to conduct inspections under section 704;
p.(None): ‘‘(3) training to achieve product specialization in such inspections; and
p.(None): ‘‘(4) training in administrative process and procedure and integrity issues.
p.(None): ‘‘(b) INTRAMURAL FELLOWSHIPS AND OTHER TRAINING PRO-
p.(None): GRAMS.—The Secretary, acting through the Commissioner, may, through fellowships and other training programs,
p.(None): conduct and sup- port intramural research training for predoctoral and postdoctoral scientists and
p.(None): physicians.’’.
p.(None): (b) CENTERS FOR DISEASE CONTROL AND PREVENTION.—
p.(None): (1) IN GENERAL.—Part B of title III of the Public Health Service Act is amended by inserting after
p.(None): section 317F (42
p.(None): U.S.C. 247b–7) the following:
p.(None): ‘‘SEC. 317G. FELLOWSHIP AND TRAINING PROGRAMS.
p.(None): ‘‘The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall
p.(None): establish fellowship and training programs to be conducted by such Centers to train individ- uals to develop
p.(None): skills in epidemiology, surveillance, laboratory analysis, and other disease detection and prevention methods.
p.(None): Such programs shall be designed to enable health professionals and health personnel trained under such programs
p.(None): to work, after receiv- ing such training, in local, State, national, and international efforts toward the prevention
p.(None): and control of diseases, injuries, and disabil- ities. Such fellowships and training may be administered
p.(None): through the use of either appointment or nonappointment procedures.’’.
p.(None): (2) EFFECTIVE DATE.—The amendment made by this sub- section is deemed to have taken effect July 1, 1995.
...
Social / orphan
Searching for indicator orphan:
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p.(None): (iii) by striking ‘‘102d Congress, 2d Session’’ and inserting ‘‘105th Congress, 1st Session’’; and
p.(None): (7) by adding at the end the following:
p.(None): ‘‘(9) The term ‘affiliate’ means a business entity that has a relationship with a second business entity
p.(None): if, directly or indirectly—
p.(None): ‘‘(A) one business entity controls, or has the power to control, the other business entity; or
p.(None): ‘‘(B) a third party controls, or has power to control, both of the business entities.’’.
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) by striking ‘‘Beginning in fiscal year 1993’’ and inserting ‘‘Beginning in fiscal year 1998’’;
p.(None): (2) in paragraph (1)—
p.(None): (A) by striking subparagraph (B) and inserting the following:
p.(None): ‘‘(B) PAYMENT.—The fee required by subparagraph (A) shall be due upon submission of the application or supple- ment.’’;
p.(None): (B) in subparagraph (D)—
p.(None):
p.(None):
p.(None): 111 STAT. 2300 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): (i) in the subparagraph heading, by striking ‘‘NOT ACCEPTED’’ and inserting ‘‘REFUSED’’;
p.(None): (ii) by striking ‘‘50 percent’’ and inserting ‘‘75 per- cent’’;
p.(None): (iii) by striking ‘‘subparagraph (B)(i)’’ and inserting ‘‘subparagraph (B)’’; and
p.(None): (iv) by striking ‘‘not accepted’’ and inserting ‘‘refused’’; and
p.(None): (C) by adding at the end the following:
p.(None): ‘‘(E) EXCEPTION FOR DESIGNATED ORPHAN DRUG OR
p.(None): INDICATION.—A human drug application for a prescription drug product that has been designated as a drug
p.(None): for a rare disease or condition pursuant to section 526 shall not be subject to a fee under
p.(None): subparagraph (A), unless the human drug application includes an indication for other than a rare disease or
p.(None): condition. A supplement proposing to include a new indication for a rare disease or condition in a human drug
p.(None): application shall not be subject to a fee under subparagraph (A), if the drug has been des- ignated
p.(None): pursuant to section 526 as a drug for a rare disease or condition with regard to the indication proposed in such
p.(None): supplement.
p.(None): ‘‘(F) EXCEPTION FOR SUPPLEMENTS FOR PEDIATRIC
p.(None): INDICATIONS.—A supplement to a human drug application proposing to include a new indication for use in
p.(None): pediatric populations shall not be assessed a fee under subparagraph (A).
p.(None): ‘‘(G) REFUND OF FEE IF APPLICATION WITHDRAWN.—
p.(None): If an application or supplement is withdrawn after the application or supplement was filed, the Secretary
p.(None): may refund the fee or a portion of the fee if no substantial work was performed on the application or
...
p.(None): striking subparagraph (B), and by redesignating subparagraph (C) as subpara- graph (B).
p.(None): (I) Section 526(b) (21 U.S.C. 360bb(b)) is amended—
p.(None): (i) in paragraph (1), by striking ‘‘, a certificate was issued for the drug under section 507,’’; and
p.(None): (ii) in paragraph (2) by striking ‘‘, a certificate has not been issued for the drug under section
p.(None): 507,’’ and by striking ‘‘, approval of an application for certifi- cation under section 507,’’.
p.(None): (J) Section 527(a) (21 U.S.C. 360cc(a)) is amended by inserting ‘‘or’’ at the end of paragraph (1), by
p.(None): striking paragraph (2), by redesignating paragraph (3) as paragraph (2), and by striking ‘‘, issue another
p.(None): certification under section 507,’’.
p.(None): (K) Section 527(b) (21 U.S.C. 360cc(b)) is amended by striking ‘‘, if a certification is issued under
p.(None): section 507 for such a drug,’’, ‘‘, of the issuance of the certification under section 507,’’, ‘‘, issue another
p.(None): certification under section 507,’’, ‘‘, of such certification,’’, ‘‘, of the certifi- cation,’’, and ‘‘,
p.(None): issuance of other certifications,’’.
p.(None): (L) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended by striking ‘‘, section 507 (d) or (g),’’.
p.(None): (M) Section 735(1) (21 U.S.C. 379g(1)(C)) is amended by inserting ‘‘or’’ at the end of subparagraph (B), by
p.(None): striking subparagraph (C), and by redesignating subparagraph (D) as subparagraph (C).
p.(None): (N) Subparagraphs (A)(ii) and (B) of sections 5(b)(1) of the Orphan Drug Act (21 U.S.C.
p.(None): 360ee(b)(1)(A), 360ee(b)(1)(B)) are each amended by striking ‘‘or 507’’.
p.(None): (O) Section 45C(b)(2)(A)(ii)(II) of the Internal Revenue
p.(None):
p.(None): 26 USC 45C.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 355 note.
p.(None): Code of 1986 is amended by striking ‘‘or 507’’.
p.(None): (P) Section 156(f)(4)(B) of title 35, United States Code, is amended by striking ‘‘507,’’ each place it occurs.
p.(None): (c) EXPORTATION.—Section 802 (21 U.S.C. 382) is amended by adding at the end the following:
p.(None): ‘‘(i) Insulin and antibiotic drugs may be exported without regard to the requirements in this section if the
p.(None): insulin and antibiotic drugs meet the requirements of section 801(e)(1).’’.
p.(None): (d) TRANSITION.—
p.(None): (1) IN GENERAL.—An application that was approved by the Secretary of Health and Human Services before
p.(None): the date of the enactment of this Act for the marketing of an antibiotic drug under section 507 of the Federal Food,
p.(None): Drug, and Cosmetic Act (21 U.S.C. 357), as in effect on the day before the date of the enactment of
p.(None): this Act, shall, on and after such date of enactment, be considered to be an application that was
p.(None): submitted and filed under section 505(b) of such Act (21 U.S.C. 355(b)) and approved for safety and effectiveness under
p.(None): section
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2327
p.(None):
p.(None): 505(c) of such Act (21 U.S.C. 355(c)), except that if such applica- tion for marketing was in the form of an
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): conduct a study of the effect on humans of the use of mercury compounds in nasal sprays. Such study
p.(None): shall include data from other studies that have been made of such use.
p.(None): (c) STUDY OF MERCURY SALES.—
p.(None): (1) STUDY.—The Secretary of Health and Human Services, acting through the Food and Drug Administration and subject to
p.(None): appropriations, shall conduct, or shall contract with the Institute of Medicine of the National Academy
p.(None): of Sciences to conduct, a study of the effect on humans of the use of elemental, organic, or inorganic mercury
p.(None): when offered for sale as a drug or dietary supplement. Such study shall, among other things, evaluate—
p.(None): (A) the scope of mercury use as a drug or dietary supplement; and
p.(None): (B) the adverse effects on health of children and other sensitive populations resulting from exposure to, or
p.(None): inges- tion or inhalation of, mercury when so used.
p.(None): In conducting such study, the Secretary shall consult with the Administrator of the Environmental Protection
p.(None): Agency, the Chair of the Consumer Product Safety Commission, and the Administrator of the Agency for Toxic
p.(None): Substances and Disease Registry, and, to the extent the Secretary believes necessary or appropriate, with any
p.(None): other Federal or private entity.
p.(None): (2) REGULATIONS.—If, in the opinion of the Secretary, the use of elemental, organic, or inorganic mercury
p.(None): offered for sale as a drug or dietary supplement poses a threat to human health, the Secretary shall promulgate
p.(None): regulations restricting the sale of mercury intended for such use. At a minimum, such regulations shall
p.(None): be designed to protect the health of children and other sensitive populations from adverse effects
p.(None): resulting from exposure to, or ingestion or inhalation of, mer- cury. Such regulations, to the
p.(None): extent feasible, should not unnecessarily interfere with the availability of mercury for use in religious
p.(None): ceremonies.
p.(None): SEC. 414. INTERAGENCY COLLABORATION.
p.(None): Section 903 (21 U.S.C. 393), as amended by section 406, is further amended by inserting after subsection
p.(None): (b) the following: ‘‘(c) INTERAGENCY COLLABORATION.—The Secretary shall imple- ment programs and
p.(None): policies that will foster collaboration between the Administration, the National Institutes of Health, and
p.(None): other science-based Federal agencies, to enhance the scientific and tech- nical expertise available to the
p.(None): Secretary in the conduct of the duties of the Secretary with respect to the development, clinical
p.(None): investigation, evaluation, and postmarket monitoring of emerging medical therapies, including
p.(None): complementary therapies, and
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2365
p.(None):
p.(None):
p.(None): (A) IN GENERAL.—The Secretary shall request the Institute of Medicine of the National Academy of
p.(None): Sciences to conduct the study required by paragraph (2), and to prepare and submit the report required
p.(None): by subparagraph (B), under an arrangement by which the actual expenses incurred by the Institute of
p.(None): Medicine in conducting the study and preparing the report will be paid by the Sec- retary. If the
p.(None): Institute of Medicine is unwilling to conduct the study under such an arrangement, the Comptroller General of
p.(None): the United States shall conduct such study.
p.(None): (B) REPORT.—Not later than September 30, 2005, the Institute of Medicine or the Comptroller General of
p.(None): the United States, as appropriate, shall prepare and submit to the Committee on Labor and Human Resources
p.(None): of the Senate, the Committee on Commerce of the House of Rep- resentatives, and the Secretary a report of the
p.(None): results of the study required by paragraph (2). The Secretary, after the receipt of the report, shall make the
p.(None): report avail- able to the public.
p.(None): SEC. 402. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES AND DIAGNOSTICS.
p.(None): Chapter V (21 U.S.C. 351 et seq.), as amended in section 401, is further amended by adding at the end the
p.(None): following:
p.(None): ‘‘SUBCHAPTER E—GENERAL PROVISIONS RELATING TO DRUGS AND
p.(None): DEVICES
p.(None): ‘‘SEC. 561. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS.
p.(None): ‘‘(a) EMERGENCY SITUATIONS.—The Secretary may, under appro- priate conditions determined by the Secretary,
p.(None): authorize the ship- ment of investigational drugs or investigational devices for the diagnosis, monitoring,
p.(None): or treatment of a serious disease or condition in emergency situations.
p.(None): ‘‘(b) INDIVIDUAL PATIENT ACCESS TO INVESTIGATIONAL PROD-
p.(None): UCTS INTENDED FOR SERIOUS DISEASES.—Any person, acting
p.(None): through a physician licensed in accordance with State law, may request from a manufacturer or distributor, and
p.(None): any manufacturer or distributor may, after complying with the provisions of this subsection, provide to
p.(None): such physician an investigational drug or investigational device for the diagnosis, monitoring, or
p.(None): treatment of a serious disease or condition if—
p.(None): ‘‘(1) the licensed physician determines that the person has no comparable or satisfactory alternative therapy
p.(None): available to diagnose, monitor, or treat the disease or condition involved, and that the probable risk to the
p.(None): person from the investigational drug or investigational device is not greater than the probable risk from the disease
p.(None): or condition;
p.(None): ‘‘(2) the Secretary determines that there is sufficient evi- dence of safety and effectiveness to support
p.(None): the use of the investigational drug or investigational device in the case described in paragraph (1);
p.(None): ‘‘(3) the Secretary determines that provision of the inves- tigational drug or investigational device will not
p.(None): interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval;
p.(None): and
p.(None):
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None):
p.(None): Public Law 105–115 105th Congress
p.(None):
p.(None):
p.(None): An Act
p.(None):
p.(None):
p.(None): Nov. 21, 1997
p.(None): To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service
p.(None): Act to improve the regulation of food, drugs, devices, and biological
p.(None): products,
p.(None):
p.(None): [S. 830]
p.(None):
p.(None):
p.(None): Food and Drug Administration Modernization Act of 1997.
p.(None): 21 USC 301 note.
p.(None): and for other purposes.
p.(None):
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; REFERENCES; TABLE OF CONTENTS.
p.(None): (a) SHORT TITLE.—This Act may be cited as the ‘‘Food and Drug Administration Modernization Act of 1997’’.
p.(None): (b) REFERENCES.—Except as otherwise specified, whenever in this Act an amendment or repeal is expressed
p.(None): in terms of an amendment to or a repeal of a section or other provision, the reference shall be
p.(None): considered to be made to that section or other provision of the Federal Food, Drug, and Cosmetic Act
p.(None): (21 U.S.C. 301 et seq.).
p.(None): (c) TABLE OF CONTENTS.—The table of contents for this Act is as follows:
p.(None): Sec. 1. Short title; references; table of contents. Sec. 2. Definitions.
p.(None): TITLE I—IMPROVING REGULATION OF DRUGS
p.(None): Subtitle A—Fees Relating to Drugs
p.(None): Sec. 101. Findings.
p.(None): Sec. 102. Definitions.
p.(None): Sec. 103. Authority to assess and use drug fees. Sec. 104. Annual reports.
p.(None): Sec. 105. Savings.
p.(None): Sec. 106. Effective date.
p.(None): Sec. 107. Termination of effectiveness.
p.(None): Subtitle B—Other Improvements Sec. 111. Pediatric studies of drugs.
p.(None): Sec. 112. Expediting study and approval of fast track drugs.
p.(None): Sec. 113. Information program on clinical trials for serious or life-threatening dis- eases.
p.(None): Sec. 114. Health care economic information. Sec. 115. Clinical investigations.
p.(None): Sec. 116. Manufacturing changes for drugs.
p.(None): Sec. 117. Streamlining clinical research on drugs. Sec. 118. Data requirements for drugs and biologics. Sec. 119.
p.(None): Content and review of applications.
p.(None): Sec. 120. Scientific advisory panels.
p.(None): Sec. 121. Positron emission tomography.
p.(None): Sec. 122. Requirements for radiopharmaceuticals. Sec. 123. Modernization of regulation.
p.(None): Sec. 124. Pilot and small scale manufacture. Sec. 125. Insulin and antibiotics.
p.(None): Sec. 126. Elimination of certain labeling requirements.
p.(None): Sec. 127. Application of Federal law to practice of pharmacy compounding.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2297
p.(None):
p.(None): Sec. 128. Reauthorization of clinical pharmacology program. Sec. 129. Regulations for sunscreen products.
p.(None): Sec. 130. Reports of postmarketing approval studies.
p.(None): Sec. 131. Notification of discontinuance of a life saving product.
p.(None): TITLE II—IMPROVING REGULATION OF DEVICES
p.(None): Sec. 201. Investigational device exemptions. Sec. 202. Special review for certain devices.
p.(None): Sec. 203. Expanding humanitarian use of devices. Sec. 204. Device standards.
...
p.(None): proval.
p.(None): TITLE III—IMPROVING REGULATION OF FOOD
p.(None): Sec. 301. Flexibility for regulations regarding claims. Sec. 302. Petitions for claims.
p.(None): Sec. 303. Health claims for food products. Sec. 304. Nutrient content claims.
p.(None): Sec. 305. Referral statements. Sec. 306. Disclosure of irradiation. Sec. 307. Irradiation petition.
p.(None): Sec. 308. Glass and ceramic ware. Sec. 309. Food contact substances.
p.(None): TITLE IV—GENERAL PROVISIONS
p.(None): Sec. 401. Dissemination of information on new uses.
p.(None): Sec. 402. Expanded access to investigational therapies and diagnostics. Sec. 403. Approval of supplemental
p.(None): applications for approved products. Sec. 404. Dispute resolution.
p.(None): Sec. 405. Informal agency statements.
p.(None): Sec. 406. Food and Drug Administration mission and annual report. Sec. 407. Information system.
p.(None): Sec. 408. Education and training.
p.(None): Sec. 409. Centers for education and research on therapeutics.
p.(None): Sec. 410. Mutual recognition agreements and global harmonization. Sec. 411. Environmental impact review.
p.(None): Sec. 412. National uniformity for nonprescription drugs and cosmetics.
p.(None): Sec. 413. Food and Drug Administration study of mercury compounds in drugs and food.
p.(None): Sec. 414. Interagency collaboration. Sec. 415. Contracts for expert review. Sec. 416. Product classification.
p.(None): Sec. 417. Registration of foreign establishments. Sec. 418. Clarification of seizure authority.
p.(None): Sec. 419. Interstate commerce.
p.(None): Sec. 420. Safety report disclaimers.
p.(None): Sec. 421. Labeling and advertising regarding compliance with statutory require- ments.
p.(None): Sec. 422. Rule of construction.
p.(None): TITLE V—EFFECTIVE DATE
p.(None):
p.(None): Sec. 501. Effective date.
p.(None): SEC. 2. DEFINITIONS.
p.(None): In this Act, the terms ‘‘drug’’, ‘‘device’’, ‘‘food’’, and ‘‘dietary supplement’’ have the meaning given
p.(None): such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
p.(None):
p.(None): 21 USC 321 note.
p.(None):
p.(None):
p.(None): 111 STAT. 2298 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None): TITLE I—IMPROVING REGULATION OF DRUGS
p.(None): Subtitle A—Fees Relating to Drugs
p.(None):
p.(None):
p.(None): 21 USC 379g
p.(None): note.
p.(None): SEC. 101. FINDINGS.
p.(None): Congress finds that—
p.(None): (1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement
p.(None): of the public health so that patients may enjoy the benefits provided by these therapies to treat and
p.(None): prevent illness and disease;
p.(None): (2) the public health will be served by making additional funds available for the purpose of augmenting
p.(None): the resources of the Food and Drug Administration that are devoted to the process for review of human drug
p.(None): applications;
...
p.(None): at one general physical location consisting of one or more buildings all of which are within five miles
p.(None): of each other and at which one or more prescription drug products are manufactured in final dosage
p.(None): form.’’;
p.(None): (5) in paragraph (7)(A)—
p.(None): (A) by striking ‘‘employees under contract’’ and all that follows through ‘‘Administration,’’ the second
p.(None): time it occurs and inserting ‘‘contractors of the Food and Drug Administration,’’; and
p.(None): (B) by striking ‘‘and committees,’’ and inserting ‘‘and committees and to contracts with such contractors,’’;
p.(None): (6) in paragraph (8)—
p.(None): (A) in subparagraph (A)—
p.(None): (i) by striking ‘‘August of ’’ and inserting ‘‘April of ’’; and
p.(None): (ii) by striking ‘‘August 1992’’ and inserting ‘‘April 1997’’; and
p.(None): (B) in subparagraph (B)—
p.(None): (i) by striking ‘‘section 254(d)’’ and inserting ‘‘sec- tion 254(c)’’;
p.(None): (ii) by striking ‘‘1992’’ and inserting ‘‘1997’’; and
p.(None): (iii) by striking ‘‘102d Congress, 2d Session’’ and inserting ‘‘105th Congress, 1st Session’’; and
p.(None): (7) by adding at the end the following:
p.(None): ‘‘(9) The term ‘affiliate’ means a business entity that has a relationship with a second business entity
p.(None): if, directly or indirectly—
p.(None): ‘‘(A) one business entity controls, or has the power to control, the other business entity; or
p.(None): ‘‘(B) a third party controls, or has power to control, both of the business entities.’’.
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) by striking ‘‘Beginning in fiscal year 1993’’ and inserting ‘‘Beginning in fiscal year 1998’’;
p.(None): (2) in paragraph (1)—
p.(None): (A) by striking subparagraph (B) and inserting the following:
p.(None): ‘‘(B) PAYMENT.—The fee required by subparagraph (A) shall be due upon submission of the application or supple- ment.’’;
p.(None): (B) in subparagraph (D)—
p.(None):
p.(None):
p.(None): 111 STAT. 2300 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): (i) in the subparagraph heading, by striking ‘‘NOT ACCEPTED’’ and inserting ‘‘REFUSED’’;
p.(None): (ii) by striking ‘‘50 percent’’ and inserting ‘‘75 per- cent’’;
p.(None): (iii) by striking ‘‘subparagraph (B)(i)’’ and inserting ‘‘subparagraph (B)’’; and
p.(None): (iv) by striking ‘‘not accepted’’ and inserting ‘‘refused’’; and
p.(None): (C) by adding at the end the following:
p.(None): ‘‘(E) EXCEPTION FOR DESIGNATED ORPHAN DRUG OR
p.(None): INDICATION.—A human drug application for a prescription drug product that has been designated as a drug
p.(None): for a rare disease or condition pursuant to section 526 shall not be subject to a fee under
p.(None): subparagraph (A), unless the human drug application includes an indication for other than a rare disease or
...
p.(None): September 30, 1997). The term ‘‘person’’ in such Acts shall continue to include an affiliate thereof.
p.(None): SEC. 104. ANNUAL REPORTS.
p.(None): (a) PERFORMANCE REPORT.—Beginning with fiscal year 1998, not later than 60 days after the end of each
p.(None): fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal
p.(None): Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of Health and Human Services shall prepare
p.(None): and submit to the Committee on Commerce of the House of Rep- resentatives and the Committee on Labor
p.(None): and Human Resources of the Senate a report concerning the progress of the Food and Drug Administration in
p.(None): achieving the goals identified in the letters described in section 101(4) during such fiscal year and the
p.(None): future plans of the Food and Drug Administration for meeting the goals.
p.(None): (b) FISCAL REPORT.—Beginning with fiscal year 1998, not later than 120 days after the end of each fiscal year
p.(None): during which fees are collected under the part described in subsection (a), the Secretary of Health and
p.(None): Human Services shall prepare and submit to the Committee on Commerce of the House of Representatives and the
p.(None): Committee on Labor and Human Resources of the Senate
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2305
p.(None):
p.(None):
p.(None): a report on the implementation of the authority for such fees during such fiscal year and the use, by the
p.(None): Food and Drug Adminis- tration, of the fees collected during such fiscal year for which the report is made.
p.(None): SEC. 105. SAVINGS.
p.(None): Notwithstanding section 105 of the Prescription Drug User Fee Act of 1992, the Secretary shall retain the
p.(None): authority to assess and collect any fee required by part 2 of subchapter C of chapter VII of the Federal
p.(None): Food, Drug, and Cosmetic Act for a human drug application or supplement accepted for filing prior to October 1,
p.(None): 1997, and to assess and collect any product or establishment fee required by such Act for a fiscal
p.(None): year prior to fiscal year 1998.
p.(None): SEC. 106. EFFECTIVE DATE.
p.(None): The amendments made by this subtitle shall take effect October 1, 1997.
p.(None): SEC. 107. TERMINATION OF EFFECTIVENESS.
p.(None): The amendments made by sections 102 and 103 cease to be effective October 1, 2002, and section 104
p.(None): ceases to be effective 120 days after such date.
p.(None): Subtitle B—Other Improvements
p.(None): SEC. 111. PEDIATRIC STUDIES OF DRUGS.
p.(None): Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 505 the following:
p.(None): ‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
p.(None): ‘‘(a) MARKET EXCLUSIVITY FOR NEW DRUGS.—If, prior to
p.(None): approval of an application that is submitted under section 505(b)(1), the Secretary determines that information
p.(None): relating to the use of a new drug in the pediatric population may produce health benefits in that population, the
p.(None): Secretary makes a written request for pedi- atric studies (which shall include a timeframe for completing such
p.(None): studies), and such studies are completed within any such timeframe and the reports thereof submitted in
p.(None): accordance with subsection (d)(2) or accepted in accordance with subsection (d)(3)—
...
p.(None): ‘‘(C) is another type of change determined by the Sec- retary by regulation or guidance to have a substantial
p.(None): potential to adversely affect the safety or effectiveness of the drug.
p.(None): ‘‘(d) OTHER MANUFACTURING CHANGES.—
p.(None): ‘‘(1) IN GENERAL.—For purposes of subsection (a)(2)(B), the Secretary may regulate drugs made with
p.(None): manufacturing changes that are not major manufacturing changes as follows: ‘‘(A) The Secretary may in accordance with
p.(None): paragraph
p.(None): (2) authorize holders to distribute such drugs without submitting a supplemental application for
p.(None): such changes. ‘‘(B) The Secretary may in accordance with paragraph
p.(None): (3) require that, prior to the distribution of such drugs, holders submit to the Secretary supplemental
p.(None): applications for such changes.
p.(None): ‘‘(C) The Secretary may establish categories of such changes and designate categories to which
p.(None): subparagraph
p.(None): (A) applies and categories to which subparagraph (B) applies.
p.(None): ‘‘(2) CHANGES NOT REQUIRING SUPPLEMENTAL APPLICA- TION.—
p.(None): ‘‘(A) SUBMISSION OF REPORT.—A holder making a manufacturing change to which paragraph (1)(A) applies
p.(None): shall submit to the Secretary a report on the change, which shall contain such information as the
p.(None): Secretary determines to be appropriate, and which shall include the information developed under subsection (b) by
p.(None): the holder in validating the effects of the change. The report shall be submitted by such date as the
p.(None): Secretary may specify. ‘‘(B) AUTHORITY REGARDING ANNUAL REPORTS.—In the
p.(None): case of a holder that during a single year makes more than one manufacturing change to which paragraph (1)(A)
p.(None): applies, the Secretary may in carrying out subparagraph
p.(None): (A) authorize the holder to comply with such subparagraph by submitting a single report for the year that
p.(None): provides the information required in such subparagraph for all the changes made by the holder during the year.
p.(None): ‘‘(3) CHANGES REQUIRING SUPPLEMENTAL APPLICATION.— ‘‘(A) SUBMISSION OF SUPPLEMENTAL APPLICATION.—The
p.(None): supplemental application required under paragraph (1)(B)
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2315
p.(None):
p.(None):
p.(None): for a manufacturing change shall contain such information as the Secretary determines to be appropriate, which shall
p.(None): include the information developed under subsection (b) by the holder in validating the effects of the change.
p.(None): ‘‘(B) AUTHORITY FOR DISTRIBUTION.—In the case of a
p.(None): manufacturing change to which paragraph (1)(B) applies: ‘‘(i) The holder involved may commence distribu-
p.(None): tion of the drug involved 30 days after the Secretary receives the supplemental application under such para-
p.(None): graph, unless the Secretary notifies the holder within such 30-day period that prior approval of the
p.(None): applica- tion is required before distribution may be commenced. ‘‘(ii) The Secretary may designate a category of
p.(None): such changes for the purpose of providing that, in the case of a change that is in such category, the
p.(None): holder involved may commence distribution of the drug involved upon the receipt by the Secretary of a supple-
p.(None): mental application for the change.
p.(None): ‘‘(iii) If the Secretary disapproves the supplemental application, the Secretary may order the manufacturer to cease
p.(None): the distribution of the drugs that have been made with the manufacturing change.’’.
p.(None): (b) TRANSITION RULE.—The amendment made by subsection
p.(None): (a) takes effect upon the effective date of regulations promulgated by the Secretary of Health and Human
p.(None): Services to implement such amendment, or upon the expiration of the 24-month period beginning on the
p.(None): date of the enactment of this Act, whichever occurs first.
p.(None): SEC. 117. STREAMLINING CLINICAL RESEARCH ON DRUGS.
p.(None): Section 505(i) (21 U.S.C. 355(i)) is amended—
p.(None): (1) by redesignating paragraphs (1) through (3) as subpara- graphs (A) through (C), respectively;
p.(None): (2) by inserting ‘‘(1)’’ after ‘‘(i)’’;
p.(None): (3) by striking the last two sentences; and
...
p.(None): of an application for approval of a drug under this subsection (including scientific mat- ters, chemistry,
p.(None): manufacturing, and controls).’’.
p.(None): (2) CONFORMING AMENDMENTS.—Section 505(j) (21 U.S.C. 355(j)), as amended by paragraph (1), is further
p.(None): amended—
p.(None): (A) in paragraph (2)(A)(i), by striking ‘‘(6)’’ and insert- ing ‘‘(7)’’;
p.(None): (B) in paragraph (4) (as redesignated in paragraph (1)), by striking ‘‘(4)’’ and inserting ‘‘(5)’’;
p.(None): (C) in paragraph (4)(I) (as redesignated in paragraph (1)), by striking ‘‘(5)’’ and inserting ‘‘(6)’’; and
p.(None): (D) in paragraph (7)(C) (as redesignated in paragraph (1)), by striking ‘‘(5)’’ each place it occurs and
p.(None): inserting ‘‘(6)’’.
p.(None): SEC. 120. SCIENTIFIC ADVISORY PANELS.
p.(None): Section 505 (21 U.S.C. 355) is amended by adding at the end the following:
p.(None): ‘‘(n)(1) For the purpose of providing expert scientific advice and recommendations to the Secretary
p.(None): regarding a clinical inves- tigation of a drug or the approval for marketing of a drug under section
p.(None): 505 or section 351 of the Public Health Service Act, the
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2319
p.(None):
p.(None): Secretary shall establish panels of experts or use panels of experts established before the date of enactment of
p.(None): the Food and Drug Administration Modernization Act of 1997, or both.
p.(None): ‘‘(2) The Secretary may delegate the appointment and oversight authority granted under section 904 to a director
p.(None): of a center or successor entity within the Food and Drug Administration.
p.(None): ‘‘(3) The Secretary shall make appointments to each panel established under paragraph (1) so that each
p.(None): panel shall consist of—
p.(None): ‘‘(A) members who are qualified by training and experience to evaluate the safety and effectiveness of the
p.(None): drugs to be referred to the panel and who, to the extent feasible, possess skill and experience in the
p.(None): development, manufacture, or utili- zation of such drugs;
p.(None): ‘‘(B) members with diverse expertise in such fields as clini- cal and administrative medicine, pharmacy,
p.(None): pharmacology, pharmacoeconomics, biological and physical sciences, and other related professions;
p.(None): ‘‘(C) a representative of consumer interests, and a rep- resentative of interests of the drug
p.(None): manufacturing industry not directly affected by the matter to be brought before the panel; and
p.(None): ‘‘(D) two or more members who are specialists or have other expertise in the particular disease or condition
p.(None): for which the drug under review is proposed to be indicated.
p.(None): Scientific, trade, and consumer organizations shall be afforded an opportunity to nominate individuals for
p.(None): appointment to the panels. No individual who is in the regular full-time employ of the United States and engaged in
p.(None): the administration of this Act may be a voting member of any panel. The Secretary shall designate one
p.(None): of the members of each panel to serve as chairman thereof.
...
p.(None): plan (including a clinical protocol) for determining whether there is a reasonable assurance of
p.(None): effectiveness, and, if available, information regarding the expected performance from the device.
p.(None): ‘‘(B) Any agreement regarding the parameters of an investiga- tional plan (including a clinical protocol) that
p.(None): is reached between the Secretary and a sponsor or applicant shall be reduced to writing and made part of the
p.(None): administrative record by the Secretary. Any such agreement shall not be changed, except—
p.(None): ‘‘(i) with the written agreement of the sponsor or applicant;
p.(None): or
p.(None): ‘‘(ii) pursuant to a decision, made in accordance with
p.(None): subparagraph (C) by the director of the office in which the device involved is reviewed, that a
p.(None): substantial scientific issue
p.(None):
p.(None):
p.(None): 111 STAT. 2334 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): essential to determining the safety or effectiveness of the device involved has been identified.
p.(None): ‘‘(C) A decision under subparagraph (B)(ii) by the director shall be in writing, and may be made only after
p.(None): the Secretary has provided to the sponsor or applicant an opportunity for a meeting at which the
p.(None): director and the sponsor or applicant are present and at which the director documents the scientific issue
p.(None): involved.’’.
p.(None): (b) ACTION ON APPLICATION.—Section 515(d)(1)(B) (21 U.S.C. 360e(d)(1)(B)) is amended by adding at the end the
p.(None): following:
p.(None): ‘‘(iii) The Secretary shall accept and review statistically valid and reliable data and any other
p.(None): information from investigations conducted under the authority of regulations required by section 520(g) to
p.(None): make a determination of whether there is a reasonable assurance of safety and effectiveness of a device subject
p.(None): to a pending application under this section if—
p.(None): ‘‘(I) the data or information is derived from investigations of an earlier version of the device, the device
p.(None): has been modified during or after the investigations (but prior to submission of an application under
p.(None): subsection (c)) and such a modification of the device does not constitute a significant change in the
p.(None): design or in the basic principles of operation of the device that would invalidate the data or information;
p.(None): or
p.(None): ‘‘(II) the data or information relates to a device approved under this section, is available for use
p.(None): under this Act, and is relevant to the design and intended use of the device for which the application is
p.(None): pending.’’.
p.(None): SEC. 202. SPECIAL REVIEW FOR CERTAIN DEVICES.
p.(None): Section 515(d) (21 U.S.C. 360e(d)) is amended—
p.(None): (1) by redesignating paragraph (3) as paragraph (4); and
p.(None): (2) by adding at the end the following:
p.(None): ‘‘(5) In order to provide for more effective treatment or diagnosis of life-threatening or irreversibly
p.(None): debilitating human diseases or conditions, the Secretary shall provide review priority for devices—
p.(None): ‘‘(A) representing breakthrough technologies, ‘‘(B) for which no approved alternatives exist,
p.(None): ‘‘(C) which offer significant advantages over existing approved alternatives, or
p.(None): ‘‘(D) the availability of which is in the best interest of the patients.’’.
p.(None): SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES.
p.(None): Section 520(m) (21 U.S.C. 360j(m)) is amended—
...
p.(None):
p.(None): ‘‘(ii) limit work to that for which competence and capacity are available;
p.(None): ‘‘(iii) treat information received, records, reports, and recommendations as proprietary information;
p.(None): ‘‘(iv) promptly respond and attempt to resolve com- plaints regarding its activities for which it is accred-
p.(None): ited; and
p.(None): ‘‘(v) protect against the use, in carrying out sub- section (a) with respect to a device, of any
p.(None): officer or employee of the person who has a financial conflict of interest regarding the device, and
p.(None): annually make available to the public disclosures of the extent to which the person, and the officers
p.(None): and employees of the person, have maintained compliance with require- ments under this clause relating to
p.(None): financial conflicts of interest.
p.(None): ‘‘(4) SELECTION OF ACCREDITED PERSONS.—The Secretary
p.(None): shall provide each person who chooses to use an accredited person to receive a section 510(k) report a
p.(None): panel of at least two or more accredited persons from which the regulated person may select one for a specific
p.(None): regulatory function.
p.(None): ‘‘(5) COMPENSATION OF ACCREDITED PERSONS.—Compensa-
p.(None): tion for an accredited person shall be determined by agreement between the accredited person and the person who
p.(None): engages the services of the accredited person, and shall be paid by the person who engages such services.
p.(None): ‘‘(c) DURATION.—The authority provided by this section termi- nates—
p.(None): ‘‘(1) 5 years after the date on which the Secretary notifies Congress that at least 2 persons accredited under
p.(None): subsection
p.(None): (b) are available to review at least 60 percent of the submissions under section 510(k), or
p.(None): ‘‘(2) 4 years after the date on which the Secretary notifies Congress that the Secretary has made a
p.(None): determination described in paragraph (2)(B) of subsection (a) for at least
p.(None): 35 percent of the devices that are subject to review under paragraph (1) of such subsection,
p.(None): whichever occurs first.’’.
p.(None): (b) RECORDKEEPING.—Section 704 (21 U.S.C. 374) is amended by adding at the end the following:
p.(None): ‘‘(f)(1) A person accredited under section 523 to review reports made under section 510(k) and make
p.(None): recommendations of initial classifications of devices to the Secretary shall maintain records documenting
p.(None): the training qualifications of the person and the employees of the person, the procedures used by
p.(None): the person for handling confidential information, the compensation arrangements made by the person, and the
p.(None): procedures used by the person to identify and avoid conflicts of interest. Upon the request of an
p.(None): officer or employee designated by the Secretary, the person shall permit the officer or employee, at all
p.(None): reasonable times, to have access to, to copy, and to verify, the records.
...
p.(None): adding at the end the following:
p.(None): ‘‘(y) In the case of a drug, device, or food—
p.(None): ‘‘(1) the submission of a report or recommendation by a person accredited under section 523 that is false or
p.(None): misleading in any material respect;
p.(None): ‘‘(2) the disclosure by a person accredited under section 523 of confidential commercial information or any
p.(None): trade secret without the express written consent of the person who submit- ted such information or secret to such
p.(None): person; or
p.(None): ‘‘(3) the receipt by a person accredited under section 523 of a bribe in any form or the doing of
p.(None): any corrupt act by such person associated with a responsibility delegated to such person under this Act.’’.
p.(None): (d) REPORTS ON PROGRAM OF ACCREDITATION.—
p.(None): (1) COMPTROLLER GENERAL.—
p.(None): (A) IMPLEMENTATION OF PROGRAM.—Not later than 5 years after the date of the enactment of this Act, the
p.(None): Comptroller General of the United States shall submit to the Committee on Commerce of the House of Representa-
p.(None): tives and the Committee on Labor and Human Resources of the Senate a report describing the extent to
p.(None): which the program of accreditation required by the amendment made by subsection (a) has been implemented.
p.(None): (B) EVALUATION OF PROGRAM.—Not later than 6 months prior to the date on which, pursuant to subsection
p.(None): (c) of section 523 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the authority
p.(None): provided under subsection (a) of such section will terminate, the Comptroller General shall submit to the
p.(None): Committee on Commerce of the House of Representatives and the Committee on Labor and Human
p.(None): Resources of the Senate a report describing the use of accredited persons under such section 523,
p.(None): including an evaluation of the extent to which such use assisted the Secretary in carrying out the
p.(None): duties of the Secretary under such Act with respect to devices, and the extent to which such use
p.(None): promoted actions which are contrary to the purposes of such Act.
p.(None): (2) INCLUSION OF CERTAIN DEVICES WITHIN PROGRAM.—Not later than 3 years after the date of the enactment
p.(None): of this Act, the Secretary of Health and Human Services shall submit to the Committee on Commerce of the House of
p.(None): Representatives and the Committee on Labor and Human Resources of the Senate a report providing a
p.(None): determination by the Secretary of whether, in the program of accreditation established pursu- ant to the
p.(None): amendment made by subsection (a), the limitation established in clause (iii) of section 523(a)(3)(A) of the
p.(None): Federal Food, Drug, and Cosmetic Act (relating to class II devices for which clinical data are required
p.(None): in reports under section 510(k)) should be removed.
p.(None): SEC. 211. DEVICE TRACKING.
p.(None): Effective 90 days after the date of the enactment of this Act, section 519(e) (21 U.S.C. 360i(e)) is
p.(None): 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): reporting
p.(None):
p.(None):
p.(None): 111 STAT. 2348 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): under paragraphs (1) through (4) to a subset of user facilities that constitutes a representative profile
p.(None): of user reports for device deaths and serious illnesses or serious injuries.
p.(None): ‘‘(B) During the period of planning the program under subparagraph (A), paragraphs (1) through (4) continue to
p.(None): apply. ‘‘(C) During the period in which the Secretary is providing
p.(None): for a transition to the full implementation of the program, paragraphs (1) through (4) apply except to
p.(None): the extent that the Secretary determines otherwise.
p.(None): ‘‘(D) On and after the date on which the program is fully implemented, paragraphs (1) through (4) do
p.(None): not apply to a user facility unless the facility is included in the subset referred to in subparagraph (A).
p.(None): ‘‘(E) Not later than 2 years after the date of the enactment of the Food and Drug Administration Modernization
p.(None): Act of 1997, the Secretary shall submit to the Committee on Com- merce of the House of Representatives,
p.(None): and to the Committee on Labor and Human Resources of the Senate, a report describ- ing the plan developed by
p.(None): the Secretary under subparagraph
p.(None): (A) and the progress that has been made toward the implementation of the plan.’’.
p.(None): SEC. 214. PRACTICE OF MEDICINE.
p.(None): Chapter IX is amended by adding at the end the following:
p.(None):
p.(None): 21 USC 396.
p.(None): ‘‘SEC. 906. PRACTICE OF MEDICINE.
p.(None): ‘‘Nothing in this Act shall be construed to limit or interfere with the authority of a health care
p.(None): practitioner to prescribe or administer any legally marketed device to a patient for any condi- tion or disease
p.(None): within a legitimate health care practitioner-patient relationship. This section shall not limit any existing
p.(None): authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the
p.(None): labeling, of a device that are part of a determination of substantial equivalence, established as a condi- tion
p.(None): of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the
p.(None): promotion of unapproved uses of legally marketed devices.’’.
p.(None): SEC. 215. NONINVASIVE BLOOD GLUCOSE METER.
p.(None): (a) FINDINGS.—The Congress finds that—
p.(None): (1) diabetes and its complications are a leading cause of death by disease in America;
p.(None): (2) diabetes affects approximately 16,000,000 Americans and another 650,000 will be diagnosed in 1997;
p.(None): (3) the total health care-related costs of diabetes total nearly $100,000,000,000 per year;
p.(None): (4) diabetes is a disease that is managed and controlled on a daily basis by the patient;
p.(None): (5) the failure to properly control and manage diabetes results in costly and often fatal complications
p.(None): including but not limited to blindness, coronary artery disease, and kidney failure;
p.(None): (6) blood testing devices are a critical tool for the control and management of diabetes, and existing blood
p.(None): testing devices require repeated piercing of the skin;
p.(None): (7) the pain associated with existing blood testing devices creates a disincentive for people with
p.(None): diabetes to test blood glucose levels, particularly children;
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2349
p.(None):
p.(None): (8) a safe and effective noninvasive blood glucose meter would likely improve control and management of
...
p.(None): ‘‘(vi) the identification of any person that has pro- vided funding for the conduct of a study relating to the
p.(None): new use of a drug or device for which such informa- tion is being disseminated; and
p.(None): ‘‘(B) a bibliography of other articles from a scientific reference publication or scientific or medical
p.(None): journal that
p.(None):
p.(None):
p.(None): 111 STAT. 2358 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): have been previously published about the use of the drug or device covered by the information
p.(None): disseminated (unless the information already includes such bibliography).
p.(None): ‘‘(c) ADDITIONAL INFORMATION.—If the Secretary determines, after providing notice of such determination and
p.(None): an opportunity for a meeting with respect to such determination, that the informa- tion submitted by a
p.(None): manufacturer under subsection (b)(3)(B), with respect to the use of a drug or device for which the
p.(None): manufacturer intends to disseminate information, fails to provide data, analyses, or other written matter that is
p.(None): objective and balanced, the Secretary may require the manufacturer to disseminate—
p.(None): ‘‘(1) additional objective and scientifically sound informa- tion that pertains to the safety or
p.(None): effectiveness of the use and is necessary to provide objectivity and balance, including any information
p.(None): that the manufacturer has submitted to the Secretary or, where appropriate, a summary of such information or any
p.(None): other information that the Secretary has authority to make available to the public; and
p.(None): ‘‘(2) an objective statement of the Secretary, based on data or other scientifically sound information available
p.(None): to the Sec- retary, that bears on the safety or effectiveness of the new use of the drug or device.
p.(None):
p.(None): 21 USC
p.(None): 360aaa–1.
p.(None): ‘‘SEC. 552. INFORMATION AUTHORIZED TO BE DISSEMINATED.
p.(None): ‘‘(a) AUTHORIZED INFORMATION.—A manufacturer may dissemi- nate information under section 551 on a new use only if the
p.(None): informa- tion—
p.(None): ‘‘(1) is in the form of an unabridged—
p.(None): ‘‘(A) reprint or copy of an article, peer-reviewed by experts qualified by scientific training or
p.(None): experience to evaluate the safety or effectiveness of the drug or device involved, which was published in
p.(None): a scientific or medical journal (as defined in section 556(5)), which is about a clinical investigation
p.(None): with respect to the drug or device, and which would be considered to be scientifically sound by such
p.(None): experts; or
p.(None): ‘‘(B) reference publication, described in subsection (b), that includes information about a clinical
p.(None): investigation with respect to the drug or device that would be considered to be scientifically sound by
p.(None): experts qualified by scientific training or experience to evaluate the safety or effectiveness of the drug or
p.(None): device that is the subject of such a clinical investigation; and
...
p.(None): establishing conditions under which the drug is generally recognized as safe and effective and not mis-
p.(None): branded, subsection (a) shall apply only with respect to a requirement of a State or political
p.(None): subdivision of a State that
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2375
p.(None):
p.(None): relates to the same subject as, but is different from or in addition to, or that is otherwise not identical
p.(None): with—
p.(None): ‘‘(A) a regulation in effect with respect to the drug pursuant to a statute described in subsection
p.(None): (a)(2); or ‘‘(B) any other requirement in effect with respect to
p.(None): the drug pursuant to an amendment to such a statute made on or after the date of enactment of the
p.(None): Food and Drug Administration Modernization Act of 1997.
p.(None): ‘‘(2) STATE INITIATIVES.—This section shall not apply to a State requirement adopted by a State
p.(None): public initiative or referendum enacted prior to September 1, 1997.
p.(None): ‘‘(e) NO EFFECT ON PRODUCT LIABILITY LAW.—Nothing in this
p.(None): section shall be construed to modify or otherwise affect any action or the liability of any person under the
p.(None): product liability law of any State.
p.(None): ‘‘(f) STATE ENFORCEMENT AUTHORITY.—Nothing in this section shall prevent a State or political subdivision
p.(None): thereof from enforcing, under any relevant civil or other enforcement authority, a require- ment that is identical to a
p.(None): requirement of this Act.’’.
p.(None): (b) INSPECTIONS.—Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended by striking ‘‘prescription drugs’’
p.(None): each place it appears and inserting ‘‘prescription drugs, nonprescription drugs intended for human use,’’.
p.(None): (c) MISBRANDING.—Subparagraph (1) of section 502(e) (21
p.(None): U.S.C. 352(e)(1)) is amended to read as follows:
p.(None): ‘‘(1)(A) If it is a drug, unless its label bears, to the exclusion of any other nonproprietary name (except
p.(None): the applicable systematic chemical name or the chemical formula)—
p.(None): ‘‘(i) the established name (as defined in subparagraph (3)) of the drug, if there is such a name;
p.(None): ‘‘(ii) the established name and quantity or, if determined to be appropriate by the Secretary, the
p.(None): proportion of each active ingredient, including the quantity, kind, and proportion of any alcohol, and
p.(None): also including whether active or not the established name and quantity or if determined to be appro-
p.(None): priate by the Secretary, the proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin,
p.(None): amidopyrine, anti- pyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digi- talis glucosides, mercury,
p.(None): ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such sub- stances,
p.(None): contained therein, except that the requirement for stating the quantity of the active ingredients, other
p.(None): than the quantity of those specifically named in this subclause, shall not apply to nonprescription drugs
...
p.(None): Section 903 (21 U.S.C. 393), as amended by section 406, is further amended by inserting after subsection
p.(None): (b) the following: ‘‘(c) INTERAGENCY COLLABORATION.—The Secretary shall imple- ment programs and
p.(None): policies that will foster collaboration between the Administration, the National Institutes of Health, and
p.(None): other science-based Federal agencies, to enhance the scientific and tech- nical expertise available to the
p.(None): Secretary in the conduct of the duties of the Secretary with respect to the development, clinical
p.(None): investigation, evaluation, and postmarket monitoring of emerging medical therapies, including
p.(None): complementary therapies, and
p.(None): advances in nutrition and food science.’’.
p.(None): SEC. 415. CONTRACTS FOR EXPERT REVIEW.
p.(None): Chapter IX (21 U.S.C. 391 et seq.), as amended by section 214, is further amended by adding at the end the
p.(None): following:
p.(None): ‘‘SEC. 907. CONTRACTS FOR EXPERT REVIEW.
p.(None): ‘‘(a) IN GENERAL.—
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 397.
p.(None):
p.(None):
p.(None): 111 STAT. 2378 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): ‘‘(1) AUTHORITY.—The Secretary may enter into a contract with any organization or any individual (who is not an
p.(None): employee of the Department) with relevant expertise, to review and evalu- ate, for the purpose of making
p.(None): recommendations to the Sec- retary on, part or all of any application or submission (including a petition,
p.(None): notification, and any other similar form of request) made under this Act for the approval or
p.(None): classification of an article or made under section 351(a) of the Public Health Serv- ice Act (42 U.S.C. 262(a))
p.(None): with respect to a biological product. Any such contract shall be subject to the requirements of section 708
p.(None): relating to the confidentiality of information.
p.(None): ‘‘(2) INCREASED EFFICIENCY AND EXPERTISE THROUGH CON-
p.(None): TRACTS.—The Secretary may use the authority granted in para- graph (1) whenever the Secretary determines that
p.(None): use of a contract described in paragraph (1) will improve the timeliness of the review of an application or
p.(None): submission described in paragraph (1), unless using such authority would reduce the quality, or unduly
p.(None): increase the cost, of such review. The Sec- retary may use such authority whenever the Secretary deter-
p.(None): mines that use of such a contract will improve the quality of the review of an application or
p.(None): submission described in paragraph (1), unless using such authority would unduly increase the cost of
p.(None): such review. Such improvement in timeli- ness or quality may include providing the Secretary increased
p.(None): scientific or technical expertise that is necessary to review or evaluate new therapies and technologies.
p.(None): ‘‘(b) REVIEW OF EXPERT REVIEW.—
p.(None): ‘‘(1) IN GENERAL.—Subject to paragraph (2), the official of the Food and Drug Administration responsible for
p.(None): any matter for which expert review is used pursuant to subsection (a) shall review the recommendations
p.(None): of the organization or individual who conducted the expert review and shall make a final decision
p.(None): regarding the matter in a timely manner. ‘‘(2) LIMITATION.—A final decision by the Secretary on any such
p.(None): application or submission shall be made within the applicable prescribed time period for review of
p.(None): the matter as set forth in this Act or in the Public Health Service Act (42
p.(None): U.S.C. 201 et seq.).’’.
p.(None): SEC. 416. PRODUCT CLASSIFICATION.
p.(None): Subchapter E of chapter V, as amended by section 404, is further amended by adding at the end the following:
p.(None):
p.(None): 21 USC
p.(None): 360bbb–2.
p.(None): ‘‘SEC. 563. CLASSIFICATION OF PRODUCTS.
p.(None): ‘‘(a) REQUEST.—A person who submits an application or submis- sion (including a petition, notification, and any
p.(None): other similar form of request) under this Act for a product, may submit a request to the Secretary
p.(None): respecting the classification of the product as a drug, biological product, device, or a combination product
...
p.(None): component of the Food and Drug Administration that will regulate the product, as applicable, and
p.(None): may not be modified by the Secretary except with the written consent of the person, or for public
p.(None): health reasons based on scientific evidence.’’.
p.(None): SEC. 417. REGISTRATION OF FOREIGN ESTABLISHMENTS.
p.(None): Section 510(i) (21 U.S.C. 360(i)) is amended to read as follows: ‘‘(i)(1) Any establishment within any foreign
p.(None): country engaged
p.(None): in the manufacture, preparation, propagation, compounding, or processing of a drug or a device that
p.(None): is imported or offered for import into the United States shall register with the Secretary the name and
p.(None): place of business of the establishment and the name of the United States agent for the establishment.
p.(None): ‘‘(2) The establishment shall also provide the information required by subsection (j).
p.(None): ‘‘(3) The Secretary is authorized to enter into cooperative arrangements with officials of foreign
p.(None): countries to ensure that ade- quate and effective means are available for purposes of determining, from time to
p.(None): time, whether drugs or devices manufactured, pre- pared, propagated, compounded, or processed by an
p.(None): establishment described in paragraph (1), if imported or offered for import into the United States, shall be
p.(None): refused admission on any of the grounds set forth in section 801(a).’’.
p.(None): SEC. 418. CLARIFICATION OF SEIZURE AUTHORITY.
p.(None): Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended—
p.(None): (1) in the fifth sentence, by striking ‘‘paragraphs (1) and
p.(None): (2) of section 801(e)’’ and inserting ‘‘subparagraphs (A) and
p.(None): (B) of section 801(e)(1)’’; and
p.(None): (2) by inserting after the fifth sentence the following: ‘‘Any person seeking to export an imported article
p.(None): pursuant to any of the provisions of this subsection shall establish that the article was intended for
p.(None): export at the time the article entered commerce.’’.
p.(None): SEC. 419. INTERSTATE COMMERCE.
p.(None): Section 709 (21 U.S.C. 379a) is amended by striking ‘‘a device’’ and inserting ‘‘a device, food, drug, or cosmetic’’.
p.(None): SEC. 420. SAFETY REPORT DISCLAIMERS.
p.(None): Chapter VII (21 U.S.C. 371 et seq.), as amended by section 412, is further amended by adding at the end the
p.(None): following:
p.(None): ‘‘SUBCHAPTER G—SAFETY REPORTS
p.(None): ‘‘SEC. 756. SAFETY REPORT DISCLAIMERS.
p.(None): ‘‘With respect to any entity that submits or is required to submit a safety report or other information
p.(None): in connection with the safety of a product (including a product that is a food, drug,
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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 379v.
p.(None):
p.(None):
p.(None): 111 STAT. 2380 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
p.(None): device, dietary supplement, or cosmetic) under this Act (and any release by the Secretary of that report or
p.(None): information), such report or information shall not be construed to reflect necessarily a conclu- sion by the entity
p.(None): or the Secretary that the report or information constitutes an admission that the product involved
p.(None): malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death,
p.(None): serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or informa- tion
p.(None): submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed
p.(None): to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.’’.
p.(None): SEC. 421. LABELING AND ADVERTISING REGARDING COMPLIANCE WITH STATUTORY REQUIREMENTS.
p.(None):
p.(None):
p.(None): (l).
p.(None): Section 301 (21 U.S.C. 331) is amended by striking paragraph
p.(None):
p.(None): 21 USC 321 note.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 21 USC 321 note.
p.(None): SEC. 422. RULE OF CONSTRUCTION.
p.(None): Nothing in this Act or the amendments made by this Act shall be construed to affect the question of
p.(None): whether the Secretary of Health and Human Services has any authority to regulate any tobacco product,
p.(None): tobacco ingredient, or tobacco additive. Such authority, if any, shall be exercised under the Federal Food,
p.(None): Drug, and Cosmetic Act as in effect on the day before the date of the enactment of this Act.
p.(None): TITLE V—EFFECTIVE DATE
p.(None): SEC. 501. EFFECTIVE DATE.
p.(None): Except as otherwise provided in this Act, this Act and the amendments made by this Act, other than the
p.(None): provisions of and the amendments made by sections 111, 121, 125, and 307, shall take effect 90 days after
p.(None): the date of enactment of this Act.
p.(None): Approved November 21, 1997.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): LEGISLATIVE HISTORY—S. 830 (H.R. 1411):
p.(None): HOUSE REPORTS: Nos. 105–310, accompanying H.R. 1411 (Comm. on Commerce) and 105–399 (Comm. of Conference).
p.(None): SENATE REPORTS: No. 105–43 (Comm. on Labor and Human Resources). CONGRESSIONAL RECORD, Vol. 143 (1997):
p.(None): Sept. 11, 16, 18, 19, 23, 24, considered and passed Senate.
p.(None): Oct. 7, considered and passed House, amended, in lieu of H.R. 1411. Nov. 9, Senate and House agreed to conference
p.(None): report.
p.(None): WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 33 (1997):
p.(None): Nov. 21, Presidential remarks.
...
Orphaned Trigger Words
p.(None): or
p.(None): ‘‘(II) the data or information relates to a device approved under this section, is available for use
p.(None): under this Act, and is relevant to the design and intended use of the device for which the application is
p.(None): pending.’’.
p.(None): SEC. 202. SPECIAL REVIEW FOR CERTAIN DEVICES.
p.(None): Section 515(d) (21 U.S.C. 360e(d)) is amended—
p.(None): (1) by redesignating paragraph (3) as paragraph (4); and
p.(None): (2) by adding at the end the following:
p.(None): ‘‘(5) In order to provide for more effective treatment or diagnosis of life-threatening or irreversibly
p.(None): debilitating human diseases or conditions, the Secretary shall provide review priority for devices—
p.(None): ‘‘(A) representing breakthrough technologies, ‘‘(B) for which no approved alternatives exist,
p.(None): ‘‘(C) which offer significant advantages over existing approved alternatives, or
p.(None): ‘‘(D) the availability of which is in the best interest of the patients.’’.
p.(None): SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES.
p.(None): Section 520(m) (21 U.S.C. 360j(m)) is amended—
p.(None): (1) in paragraph (2), by adding after and below subpara- graph (C) the following sentences:
p.(None): ‘‘The request shall be in the form of an application submitted to the Secretary. Not later than 75
p.(None): days after the date of the receipt of the application, the Secretary shall issue an order approv- ing or denying
p.(None): the application.’’;
p.(None): (2) in paragraph (4)—
p.(None): (A) in subparagraph (B), by inserting after ‘‘(2)(A)’’ the following: ‘‘, unless a physician determines in an
p.(None): emer- gency situation that approval from a local institutional review committee can not be obtained in
p.(None): time to prevent serious harm or death to a patient’’; and
p.(None): (B) by adding after and below subparagraph (B) the following:
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2335
p.(None):
p.(None):
p.(None): ‘‘In a case described in subparagraph (B) in which a physician uses a device without an approval from
p.(None): an institutional review committee, the physician shall, after the use of the device, notify the chairperson
p.(None): of the local institutional review committee of such use. Such notification shall include the identification of the
p.(None): patient involved, the date on which the device was used, and the reason for the use.’’;
p.(None): (3) by amending paragraph (5) to read as follows:
p.(None): ‘‘(5) The Secretary may require a person granted an exemption under paragraph (2) to demonstrate continued
p.(None): compliance with the requirements of this subsection if the Secretary believes such demonstration to be
p.(None): necessary to protect the public health or if the Secretary has reason to believe that the criteria for the
p.(None): exemp- tion are no longer met.’’; and
p.(None): (4) by amending paragraph (6) to read as follows:
p.(None): ‘‘(6) The Secretary may suspend or withdraw an exemption from the effectiveness requirements of sections
p.(None): 514 and 515 for a humanitarian device only after providing notice and an oppor- tunity for an informal
p.(None): hearing.’’.
p.(None): SEC. 204. DEVICE STANDARDS.
p.(None): (a) ALTERNATIVE PROCEDURE.—Section 514 (21 U.S.C. 360d) is amended by adding at the end the following:
p.(None): ‘‘Recognition of a Standard
p.(None): ‘‘(c)(1)(A) In addition to establishing a performance standard under this section, the Secretary shall, by
p.(None): publication in the Federal Register, recognize all or part of an appropriate standard estab- lished by a
p.(None): nationally or internationally recognized standard devel- opment organization for which a person may submit a
p.(None): declaration of conformity in order to meet a premarket submission requirement or other requirement under this Act
p.(None): to which such standard is applicable.
p.(None): ‘‘(B) If a person elects to use a standard recognized by the Secretary under subparagraph (A) to
p.(None): meet the requirements described in such subparagraph, the person shall provide a declara- tion of conformity to
p.(None): the Secretary that certifies that the device is in conformity with such standard. A person may elect to
p.(None): use data, or information, other than data required by a standard recog- nized under subparagraph (A) to meet any
p.(None): requirement regarding devices under this Act.
p.(None): ‘‘(2) The Secretary may withdraw such recognition of a standard through publication of a notice in the Federal
...
p.(None): ‘‘(2) Any patient receiving a device subject to tracking under paragraph (1) may refuse to release, or refuse
p.(None): permission to release, the patient’s name, address, social security number, or other identi- fying information for the
p.(None): purpose of tracking.’’.
p.(None): SEC. 212. POSTMARKET SURVEILLANCE.
p.(None): Effective 90 days after the date of the enactment of this Act, section 522 (21 U.S.C. 360l) is amended to
p.(None): read as follows:
p.(None): ‘‘POSTMARKET SURVEILLANCE
p.(None): ‘‘SEC. 522. (a) IN GENERAL.—The Secretary may by order require a manufacturer to conduct postmarket
p.(None): surveillance for any device of the manufacturer which is a class II or class III device the failure of
p.(None): which would be reasonably likely to have serious adverse health consequences or which is intended to be—
p.(None): ‘‘(1) implanted in the human body for more than one year,
p.(None): or
p.(None): ‘‘(2) a life sustaining or life supporting device used outside
p.(None): a device user facility.
p.(None): ‘‘(b) SURVEILLANCE APPROVAL.—Each manufacturer required to conduct a surveillance of a device shall, within 30 days of
p.(None): receiving an order from the Secretary prescribing that the manufacturer is required under this section to
p.(None): conduct such surveillance, submit, for the approval of the Secretary, a plan for the required surveil-
p.(None): lance. The Secretary, within 60 days of the receipt of such plan, shall determine if the person designated
p.(None): to conduct the surveillance has appropriate qualifications and experience to undertake such surveillance and
p.(None): if the plan will result in the collection of useful data that can reveal unforeseen adverse events or other
p.(None): information necessary to protect the public health. The Secretary, in consulta- tion with the manufacturer,
p.(None): may by order require a prospective surveillance period of up to 36 months. Any determination by the
p.(None): Secretary that a longer period is necessary shall be made by mutual agreement between the Secretary and the
p.(None): manufacturer or, if no agreement can be reached, after the completion of a dispute resolu- tion process as described
p.(None): in section 562.’’.
p.(None): SEC. 213. REPORTS.
p.(None): (a) REPORTS.—Section 519 (21 U.S.C. 360i) is amended—
p.(None): (1) in subsection (a)—
p.(None): (A) in the matter preceding paragraph (1), by striking ‘‘manufacturer, importer, or distributor’’ and
p.(None): inserting ‘‘manufacturer or importer’’;
p.(None): (B) in paragraph (4), by striking ‘‘manufacturer, importer, or distributor’’ and inserting
p.(None): ‘‘manufacturer or importer’’;
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2347
p.(None):
p.(None): (C) in paragraph (7), by adding ‘‘and’’ after the semi- colon at the end;
p.(None): (D) in paragraph (8)—
p.(None): (i) by striking ‘‘manufacturer, importer, or distribu- tor’’ each place such term appears and inserting ‘‘manu-
p.(None): facturer or importer’’; and
p.(None): (ii) by striking the semicolon at the end and insert- ing a period;
p.(None): (E) by striking paragraph (9); and
p.(None): (F) by inserting at the end the following sentence: ‘‘The Secretary shall by regulation require
p.(None): distributors to keep records and make such records available to the Sec- retary upon request.
p.(None): Paragraphs (4) and (8) apply to distributors to the same extent and in the same manner as such
p.(None): paragraphs apply to manufacturers and import- ers.’’;
p.(None): (2) by striking subsection (d); and
...
p.(None): days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the
p.(None): Secretary and the petitioner.’’;
p.(None): (2) in the fourth sentence (as amended by paragraph (1)) by inserting immediately before the comma the
p.(None): following: ‘‘or the petition is deemed to be denied’’; and
p.(None): (3) by adding at the end the following: ‘‘If the Secretary does not act within such 90 days, the petition
p.(None): shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the
p.(None): petitioner. If the Secretary issues a proposed regulation, the rulemaking shall be completed within
p.(None): 540 days of the date the petition is received by the Secretary. If the Secretary does not issue a
p.(None): regulation within such 540 days, the Secretary shall provide the Committee on Commerce of the House of
p.(None): Representatives and the Committee on Labor and Human Resources of the Senate the reasons action on the
p.(None): regulation did not occur within such 540 days.’’.
p.(None): SEC. 303. HEALTH CLAIMS FOR FOOD PRODUCTS.
p.(None): Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by adding at the end thereof the following:
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2351
p.(None):
p.(None): ‘‘(C) Notwithstanding the provisions of clauses (A)(i) and (B), a claim of the type described in
p.(None): subparagraph (1)(B) which is not authorized by the Secretary in a regulation promulgated in accordance
p.(None): with clause (B) shall be authorized and may be made with respect to a food if—
p.(None): ‘‘(i) a scientific body of the United States Government with official responsibility for public health protection
p.(None): or research directly relating to human nutrition (such as the National Institutes of Health or the
p.(None): Centers for Disease Control and Prevention) or the National Academy of Sciences or any of its
p.(None): subdivisions has published an authoritative statement, which is currently in effect, about the
p.(None): relationship between a nutrient and a disease or health-related condition to which the claim refers;
p.(None): ‘‘(ii) a person has submitted to the Secretary, at least 120 days (during which the Secretary may
p.(None): notify any person who is making a claim as authorized by clause (C) that such person has not submitted all
p.(None): the information required by such clause) before the first introduction into interstate commerce of the food
p.(None): with a label containing the claim, (I) a notice of the claim, which shall include the exact words used
p.(None): in the claim and shall include a concise description of the basis upon which such person relied for
p.(None): determining that the require- ments of subclause (i) have been satisfied, (II) a copy of the statement
p.(None): referred to in subclause (i) upon which such person relied in making the claim, and (III) a balanced
p.(None): representation of the scientific literature relating to the relationship between a nutrient and a disease
p.(None): or health-related condition to which the claim refers;
p.(None): ‘‘(iii) the claim and the food for which the claim is made are in compliance with clause (A)(ii) and
p.(None): are otherwise in compliance with paragraph (a) and section 201(n); and
p.(None): ‘‘(iv) the claim is stated in a manner so that the claim is an accurate representation of the
p.(None): authoritative statement referred to in subclause (i) and so that the claim enables the public to comprehend
p.(None): the information provided in the claim and to understand the relative significance of such information in the context of
p.(None): a total daily diet.
p.(None): For purposes of this clause, a statement shall be regarded as an authoritative statement of a scientific
p.(None): body described in sub- clause (i) only if the statement is published by the scientific body and shall
p.(None): not include a statement of an employee of the scientific body made in the individual capacity of the employee.
p.(None): ‘‘(D) A claim submitted under the requirements of clause (C) may be made until—
p.(None): ‘‘(i) such time as the Secretary issues a regulation under the standard in clause (B)(i)—
p.(None): ‘‘(I) prohibiting or modifying the claim and the regula- tion has become effective, or
p.(None): ‘‘(II) finding that the requirements of clause (C) have not been met, including finding that the
p.(None): petitioner has not submitted all the information required by such clause; or
p.(None): ‘‘(ii) a district court of the United States in an enforcement proceeding under chapter III has determined that the
p.(None): require- ments of clause (C) have not been met.’’.
p.(None):
p.(None):
p.(None): 111 STAT. 2352 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None): SEC. 304. NUTRIENT CONTENT CLAIMS.
p.(None): Section 403(r)(2) (21 U.S.C. 343(r)(2)) is amended by adding at the end the following:
p.(None): ‘‘(G) A claim of the type described in subparagraph (1)(A) for a nutrient, for which the Secretary has not
p.(None): promulgated a regulation under clause (A)(i), shall be authorized and may be made with respect to a food if—
p.(None): ‘‘(i) a scientific body of the United States Government with official responsibility for public health protection
p.(None): or research directly relating to human nutrition (such as the National Institutes of Health or the
p.(None): Centers for Disease Control and Prevention) or the National Academy of Sciences or any of its
p.(None): subdivisions has published an authoritative statement, which is currently in effect, which identifies the
p.(None): nutrient level to which the claim refers;
p.(None): ‘‘(ii) a person has submitted to the Secretary, at least 120 days (during which the Secretary may
p.(None): notify any person who is making a claim as authorized by clause (C) that such person has not submitted all
p.(None): the information required by such clause) before the first introduction into interstate commerce of the food
p.(None): with a label containing the claim, (I) a notice of the claim, which shall include the exact words used
p.(None): in the claim and shall include a concise description of the basis upon which such person relied for
p.(None): determining that the require- ments of subclause (i) have been satisfied, (II) a copy of the statement
p.(None): referred to in subclause (i) upon which such person relied in making the claim, and (III) a balanced
p.(None): representation of the scientific literature relating to the nutrient level to which the claim refers;
p.(None): ‘‘(iii) the claim and the food for which the claim is made are in compliance with clauses (A) and
p.(None): (B), and are otherwise in compliance with paragraph (a) and section 201(n); and
p.(None): ‘‘(iv) the claim is stated in a manner so that the claim is an accurate representation of the
p.(None): authoritative statement referred to in subclause (i) and so that the claim enables the public to comprehend
p.(None): the information provided in the claim and to understand the relative significance of such information in the context of
p.(None): a total daily diet.
p.(None): For purposes of this clause, a statement shall be regarded as an authoritative statement of a scientific
p.(None): body described in sub- clause (i) only if the statement is published by the scientific body and shall
p.(None): not include a statement of an employee of the scientific body made in the individual capacity of the employee.
p.(None): ‘‘(H) A claim submitted under the requirements of clause (G) may be made until—
p.(None): ‘‘(i) such time as the Secretary issues a regulation—
p.(None): ‘‘(I) prohibiting or modifying the claim and the regula- tion has become effective, or
p.(None): ‘‘(II) finding that the requirements of clause (G) have not been met, including finding that the
p.(None): petitioner had not submitted all the information required by such clause; or
p.(None): ‘‘(ii) a district court of the United States in an enforcement proceeding under chapter III has determined that the
p.(None): require- ments of clause (G) have not been met.’’.
p.(None):
p.(None):
p.(None): PUBLIC LAW 105–115—NOV. 21, 1997 111 STAT. 2353
p.(None):
p.(None):
p.(None): SEC. 305. REFERRAL STATEMENTS.
p.(None): Section 403(r)(2)(B) (21 U.S.C. 343(r)(2)(B)) is amended to read as follows:
p.(None): ‘‘(B) If a claim described in subparagraph (1)(A) is made with respect to a nutrient in a food and the
p.(None): Secretary makes a determina- tion that the food contains a nutrient at a level that increases to persons in
p.(None): the general population the risk of a disease or health- related condition that is diet related, the label or
p.(None): labeling of such food shall contain, prominently and in immediate proximity to such claim, the following
p.(None): statement: ‘See nutrition information for ll content.’ The blank shall identify the nutrient associated with the
p.(None): increased disease or health-related condition risk. In making the determination described in this clause,
p.(None): the Secretary shall take into account the significance of the food in the total daily diet.’’.
...
p.(None): determination, the Secretary shall consider (in addition to any other considerations the Secretary finds
p.(None): appropriate) whether the new use involved is the standard of medical care for a health condition. ‘‘(3) TIME
p.(None): FOR CONSIDERATION OF APPLICATION; DEEMED
p.(None): APPROVAL.—
p.(None): ‘‘(A) IN GENERAL.—The Secretary shall approve or deny an application under paragraph (1) for an exemption not
p.(None): later than 60 days after the receipt of the application. If the Secretary does not comply with the
p.(None): preceding sen- tence, the application is deemed to be approved.
p.(None): ‘‘(B) TERMINATION OF DEEMED APPROVAL.—If pursuant
p.(None): to a deemed approval under subparagraph (A) a manufac- turer disseminates written information under section 551
p.(None): on a new use, the Secretary may at any time terminate such approval and under section 555(b)(3) order the
p.(None): manu- facturer to cease disseminating the information.
p.(None): ‘‘(e) REQUIREMENTS REGARDING APPLICATIONS.—Applications
p.(None): under this section shall be submitted in the form and manner prescribed by the Secretary.
p.(None): ‘‘SEC. 555. CORRECTIVE ACTIONS; CESSATION OF DISSEMINATION.
p.(None): ‘‘(a) POSTDISSEMINATION DATA REGARDING SAFETY AND
p.(None): EFFECTIVENESS.—
p.(None): ‘‘(1) CORRECTIVE ACTIONS.—With respect to data received by the Secretary after the dissemination of
p.(None): information under section 551 by a manufacturer has begun (whether received pursuant to paragraph (2) or
p.(None): otherwise), if the Secretary deter- mines that the data indicate that the new use involved may not be
p.(None): effective or may present a significant risk to public health, the Secretary shall, after consultation with the
p.(None): manufac- turer, take such action regarding the dissemination of the information as the Secretary determines
p.(None): to be appropriate for the protection of the public health, which may include ordering that the manufacturer cease
p.(None): the dissemination of the informa- tion.
p.(None): ‘‘(2) RESPONSIBILITIES OF MANUFACTURERS TO SUBMIT
p.(None): DATA.—After a manufacturer disseminates information under section 551, the manufacturer shall submit to the
p.(None): Secretary a notification of any additional knowledge of the manufacturer on clinical research or other data that
p.(None): relate to the safety or effectiveness of the new use involved. If the manufacturer is in possession of
p.(None): the data, the notification shall include the data. The Secretary shall by regulation establish the scope
p.(None): of the responsibilities of manufacturers under this paragraph, including such limits on the
p.(None): responsibilities as the Secretary determines to be appropriate.
p.(None): ‘‘(b) CESSATION OF DISSEMINATION.—
p.(None): ‘‘(1) FAILURE OF MANUFACTURER TO COMPLY WITH REQUIRE-
p.(None): MENTS.—The Secretary may order a manufacturer to cease the dissemination of information pursuant to
p.(None): section 551 if
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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): 360aaa–4.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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): 111 STAT. 2362 PUBLIC LAW 105–115—NOV. 21, 1997
p.(None):
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| children | Child |
| drug | Drug Usage |
| education | education |
| emergency | Public Emergency |
| employees | employees |
| family | Motherhood/Family |
| home | Property Ownership |
| illness | Physically Disabled |
| impairment | Cognitive Impairment |
| minor | Youth/Minors |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| orphan | orphan |
| party | political affiliation |
| political | political affiliation |
| religious | Religion |
| single | Marital Status |
| substance | Drug Usage |
| threat | Threat of Stigma |
| union | Trade Union Membership |
| usage | Drug Usage |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['substance', 'usage'] |
| party | ['political'] |
| political | ['party'] |
| substance | ['drug', 'usage'] |
| usage | ['drug', 'substance'] |
Trigger Words
capacity
consent
developing
harm
protect
protection
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input