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Pub.L. 105-116 To amend title 38, United States Code, to prohibit interment or memorialization in certain cemeteries of persons committing Federal or State capital crimes. <> ...


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[[Page 2295]]

          FOOD AND DRUG ADMINISTRATION MODERIZATION ACT OF 1997

[[Page 111 STAT. 2296]]

Public Law 105-115
105th Congress

                                 An Act


 
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
   Service Act to improve the regulation of food, drugs, devices, and 
     biological products, and for other purposes. <<NOTE: Nov. 21, 
                           1997 -  [S. 830]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Food and Drug 
Administration Modernization Act of 1997.>> 

SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS.

     <<NOTE: 21 USC 301 note.>> (a) Short Title.--This Act may be cited 
as the ``Food and Drug Administration Modernization Act of 1997''.

    (b) References.--Except as otherwise specified, whenever in this Act 
an amendment or repeal is expressed in terms of an amendment to or a 
repeal of a section or other provision, the reference shall be 
considered to be made to that section or other provision of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
    (c) Table of Contents.--The table of contents for this Act is as 
follows:
Sec. 1. Short title; references; table of contents.
Sec. 2. Definitions.

                 TITLE I--IMPROVING REGULATION OF DRUGS

                   Subtitle A--Fees Relating to Drugs

Sec. 101. Findings.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Annual reports.
Sec. 105. Savings.
Sec. 106. Effective date.
Sec. 107. Termination of effectiveness.

                     Subtitle B--Other Improvements

Sec. 111. Pediatric studies of drugs.
Sec. 112. Expediting study and approval of fast track drugs.
Sec. 113. Information program on clinical trials for serious or life-
                    threatening diseases.
Sec. 114. Health care economic information.
Sec. 115. Clinical investigations.
Sec. 116. Manufacturing changes for drugs.
Sec. 117. Streamlining clinical research on drugs.
Sec. 118. Data requirements for drugs and biologics.
Sec. 119. Content and review of applications.
Sec. 120. Scientific advisory panels.
Sec. 121. Positron emission tomography.
Sec. 122. Requirements for radiopharmaceuticals.
Sec. 123. Modernization of regulation.
Sec. 124. Pilot and small scale manufacture.
Sec. 125. Insulin and antibiotics.
Sec. 126. Elimination of certain labeling requirements.
Sec. 127. Application of Federal law to practice of pharmacy 
                    compounding.

[[Page 111 STAT. 2297]]

Sec. 128. Reauthorization of clinical pharmacology program.
Sec. 129. Regulations for sunscreen products.
Sec. 130. Reports of postmarketing approval studies.
Sec. 131. Notification of discontinuance of a life saving product.

                TITLE II--IMPROVING REGULATION OF DEVICES

Sec. 201. Investigational device exemptions.
Sec. 202. Special review for certain devices.
Sec. 203. Expanding humanitarian use of devices.
Sec. 204. Device standards.
Sec. 205. Scope of review; collaborative determinations of device data 
                    requirements.
Sec. 206. Premarket notification.
Sec. 207. Evaluation of automatic class III designation.
Sec. 208. Classification panels.
Sec. 209. Certainty of review timeframes; collaborative review process.
Sec. 210. Accreditation of persons for review of premarket notification 
                    reports.
Sec. 211. Device tracking.
Sec. 212. Postmarket surveillance.
Sec. 213. Reports.
Sec. 214. Practice of medicine.
Sec. 215. Noninvasive blood glucose meter.
Sec. 216. Use of data relating to premarket approval; product 
                    development protocol.
Sec. 217. Clarification of the number of required clinical 
                    investigations for approval.

                 TITLE III--IMPROVING REGULATION OF FOOD

Sec. 301. Flexibility for regulations regarding claims.
Sec. 302. Petitions for claims.
Sec. 303. Health claims for food products.
Sec. 304. Nutrient content claims.
Sec. 305. Referral statements.
Sec. 306. Disclosure of irradiation.
Sec. 307. Irradiation petition.
Sec. 308. Glass and ceramic ware.
Sec. 309. Food contact substances.

                      TITLE IV--GENERAL PROVISIONS

Sec. 401. Dissemination of information on new uses.
Sec. 402. Expanded access to investigational therapies and diagnostics.
Sec. 403. Approval of supplemental applications for approved products.
Sec. 404. Dispute resolution.
Sec. 405. Informal agency statements.
Sec. 406. Food and Drug Administration mission and annual report.
Sec. 407. Information system.
Sec. 408. Education and training.
Sec. 409. Centers for education and research on therapeutics.
Sec. 410. Mutual recognition agreements and global harmonization.
Sec. 411. Environmental impact review.
Sec. 412. National uniformity for nonprescription drugs and cosmetics.
Sec. 413. Food and Drug Administration study of mercury compounds in 
                    drugs and food.
Sec. 414. Interagency collaboration.
Sec. 415. Contracts for expert review.
Sec. 416. Product classification.
Sec. 417. Registration of foreign establishments.
Sec. 418. Clarification of seizure authority.
Sec. 419. Interstate commerce.
Sec. 420. Safety report disclaimers.
Sec. 421. Labeling and advertising regarding compliance with statutory 
                    requirements.
Sec. 422. Rule of construction.

                         TITLE V--EFFECTIVE DATE

Sec. 501. Effective date.

<<NOTE: 21 USC 321 note.>> SEC. 2. DEFINITIONS.

    In this Act, the terms ``drug'', ``device'', ``food'', and ``dietary 
supplement'' have the meaning given such terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).

[[Page 111 STAT. 2298]]

                 TITLE I--IMPROVING REGULATION OF DRUGS

                   Subtitle A--Fees Relating to Drugs

<<NOTE: 21 USC 379g note.>> SEC. 101. FINDINGS.

    Congress finds that--
            (1) prompt approval of safe and effective new drugs and 
        other therapies is critical to the improvement of the public 
        health so that patients may enjoy the benefits provided by these 
        therapies to treat and prevent illness and disease;
            (2) the public health will be served by making additional 
        funds available for the purpose of augmenting the resources of 
        the Food and Drug Administration that are devoted to the process 
        for review of human drug applications;
            (3) the provisions added by the Prescription Drug User Fee 
        Act of 1992 have been successful in substantially reducing 
        review times for human drug applications and should be--
                    (A) reauthorized for an additional 5 years, with 
                certain technical improvements; and
                    (B) carried out by the Food and Drug Administration 
                with new commitments to implement more ambitious and 
                comprehensive improvements in regulatory processes of 
                the Food and Drug Administration; and
            (4) the fees authorized by amendments made in this subtitle 
        will be dedicated toward expediting the drug development process 
        and the review of human drug applications as set forth in the 
        goals identified, for purposes of part 2 of subchapter C of 
        chapter VII of the Federal Food, Drug, and Cosmetic Act, in the 
        letters from the Secretary of Health and Human Services to the 
        chairman of the Committee on Commerce of the House of 
        Representatives and the chairman of the Committee on Labor and 
        Human Resources of the Senate, as set forth in the Congressional 
        Record.

SEC. 102. DEFINITIONS.

    Section 735 (21 U.S.C. 379g) is amended--
            (1) in the second sentence of paragraph (1)--
                    (A) by striking ``Service Act, and'' and inserting 
                ``Service Act,''; and
                    (B) by striking ``September 1, 1992.'' and inserting 
                the following: ``September 1, 1992, does not include an 
                application for a licensure of a biological product for 
                further manufacturing use only, and does not include an 
                application or supplement submitted by a State or 
                Federal Government entity for a drug that is not 
                distributed commercially. Such term does include an 
                application for licensure, as described in subparagraph 
                (D), of a large volume biological product intended for 
                single dose injection for intravenous use or 
                infusion.'';
            (2) in the second sentence of paragraph (3)--
                    (A) by striking ``Service Act, and'' and inserting 
                ``Service Act,''; and
                    (B) by striking ``September 1, 1992.'' and inserting 
                the following: ``September 1, 1992, does not include a

[[Page 111 STAT. 2299]]

                biological product that is licensed for further 
                manufacturing use only, and does not include a drug that 
                is not distributed commercially and is the subject of an 
                application or supplement submitted by a State or 
                Federal Government entity. Such term does include a 
                large volume biological product intended for single dose 
                injection for intravenous use or infusion.'';
            (3) in paragraph (4), by striking ``without'' and inserting 
        ``without substantial'';
            (4) by amending the first sentence of paragraph (5) to read 
        as follows:
            ``(5) The term `prescription drug establishment' means a 
        foreign or domestic place of business which is at one general 
        physical location consisting of one or more buildings all of 
        which are within five miles of each other and at which one or 
        more prescription drug products are manufactured in final dosage 
        form.'';
            (5) in paragraph (7)(A)--
                    (A) by striking ``employees under contract'' and all 
                that follows through ``Administration,'' the second time 
                it occurs and inserting ``contractors of the Food and 
                Drug Administration,''; and
                    (B) by striking ``and committees,'' and inserting 
                ``and committees and to contracts with such 
                contractors,'';
            (6) in paragraph (8)--
                    (A) in subparagraph (A)--
                          (i) by striking ``August of '' and inserting 
                      ``April of ''; and
                          (ii) by striking ``August 1992'' and inserting 
                      ``April 1997''; and
                    (B) in subparagraph (B)--
                          (i) by striking ``section 254(d)'' and 
                      inserting ``section 254(c)'';
                          (ii) by striking ``1992'' and inserting 
                      ``1997''; and
                          (iii) by striking ``102d Congress, 2d 
                      Session'' and inserting ``105th Congress, 1st 
                      Session''; and
            (7) by adding at the end the following:
            ``(9) The term `affiliate' means a business entity that has 
        a relationship with a second business entity if, directly or 
        indirectly--
                    ``(A) one business entity controls, or has the power 
                to control, the other business entity; or
                    ``(B) a third party controls, or has power to 
                control, both of the business entities.''.

SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

    (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is amended--
            (1) by striking ``Beginning in fiscal year 1993'' and 
        inserting ``Beginning in fiscal year 1998'';
            (2) in paragraph (1)--
                    (A) by striking subparagraph (B) and inserting the 
                following:
                    ``(B) Payment.--The fee required by subparagraph (A) 
                shall be due upon submission of the application or 
                supplement.'';
                    (B) in subparagraph (D)--

[[Page 111 STAT. 2300]]

                          (i) in the subparagraph heading, by striking 
                      ``not accepted'' and inserting ``refused'';
                          (ii) by striking ``50 percent'' and inserting 
                      ``75 percent'';
                          (iii) by striking ``subparagraph (B)(i)'' and 
                      inserting ``subparagraph (B)''; and
                          (iv) by striking ``not accepted'' and 
                      inserting ``refused''; and
                    (C) by adding at the end the following:
                    ``(E) Exception for designated orphan drug or 
                indication.--A human drug application for a prescription 
                drug product that has been designated as a drug for a 
                rare disease or condition pursuant to section 526 shall 
                not be subject to a fee under subparagraph (A), unless 
                the human drug application includes an indication for 
                other than a rare disease or condition. A supplement 
                proposing to include a new indication for a rare disease 
                or condition in a human drug application shall not be 
                subject to a fee under subparagraph (A), if the drug has 
                been designated pursuant to section 526 as a drug for a 

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