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FDA Modernization Act: Section 111 (posted 11/21/97)

[DOCID: f:publ115.105]

[[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 
                rare disease or condition with regard to the indication 
                proposed in such supplement.
                    ``(F) Exception for supplements for pediatric 
                indications.--A supplement to a human drug application 
                proposing to include a new indication for use in 
                pediatric populations shall not be assessed a fee under 
                subparagraph (A).
                    ``(G) Refund of fee if application withdrawn.--If an 
                application or supplement is withdrawn after the 
                application or supplement was filed, the Secretary may 
                refund the fee or a portion of the fee if no substantial 
                work was performed on the application or supplement 
                after the application or supplement was filed. The 
                Secretary shall have the sole discretion to refund a fee 
                or a portion of the fee under this subparagraph. A 
                determination by the Secretary concerning a refund under 
                this paragraph shall not be reviewable.'';
            (3) by striking paragraph (2) and inserting the following:
            ``(2) Prescription drug establishment fee.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), each person that--
                          ``(i) is named as the applicant in a human 
                      drug application; and
                          ``(ii) after September 1, 1992, had pending 
                      before the Secretary a human drug application or 
                      supplement,
                shall be assessed an annual fee established in 
                subsection (b) for each prescription drug establishment 
                listed in its approved human drug application as an 
                establishment that manufactures the prescription drug 
                product named in the application. The annual 
                establishment fee shall be assessed in each fiscal year 
                in which the prescription drug product named in the 
                application is assessed a fee under paragraph (3) unless 
                the prescription drug establishment listed in the 
                application does not engage in the manufacture of the 
                prescription drug product during the fiscal year. The 
                establishment fee shall be payable on or before January 
                31 of each year. Each such establishment shall be 
                assessed

[[Page 111 STAT. 2301]]

                only one fee per establishment, notwithstanding the 
                number of prescription drug products manufactured at the 
                establishment. In the event an establishment is listed 
                in a human drug application by more than one applicant, 
                the establishment fee for the fiscal year shall be 
                divided equally and assessed among the applicants whose 
                prescription drug products are manufactured by the 
                establishment during the fiscal year and assessed 
                product fees under paragraph (3).
                    ``(B) Exception.--If, during the fiscal year, an 
                applicant initiates or causes to be initiated the 
                manufacture of a prescription drug product at an 
                establishment listed in its human drug application--
                          ``(i) that did not manufacture the product in 
                      the previous fiscal year; and
                          ``(ii) for which the full establishment fee 
                      has been assessed in the fiscal year at a time 
                      before manufacture of the prescription drug 
                      product was begun;
                the applicant will not be assessed a share of the 
                establishment fee for the fiscal year in which the 
                manufacture of the product began.''; and
            (4) in paragraph (3)--
                    (A) in subparagraph (A)--
                          (i) in clause (i), by striking ``is listed'' 
                      and inserting ``has been submitted for listing''; 
                      and
                          (ii) by striking ``Such fee shall be payable'' 
                      and all that follows through ``section 510.'' and 
                      inserting the following: ``Such fee shall be 
                      payable for the fiscal year in which the product 
                      is first submitted for listing under section 510, 
                      or is submitted for relisting under section 510 if 
                      the product has been withdrawn from listing and 
                      relisted. After such fee is paid for that fiscal 
                      year, such fee shall be payable on or before 
                      January 31 of each year. Such fee shall be paid 
                      only once for each product for a fiscal year in 
                      which the fee is payable.''; and
                    (B) in subparagraph (B), by striking ``505(j).'' and 
                inserting the following: ``505(j), under an abbreviated 
                application filed under section 507 (as in effect on the 
                day before the date of enactment of the Food and Drug 
                Administration Modernization Act of 1997), or under an 
                abbreviated new drug application pursuant to regulations 
                in effect prior to the implementation of the Drug Price 
                Competition and Patent Term Restoration Act of 1984.''.

    (b) Fee Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is amended to 
read as follows:
    ``(b) Fee Amounts.--Except as provided in subsections (c), (d), (f), 
and (g), the fees required under subsection (a) shall be determined and 
assessed as follows:
            ``(1) Application and supplement fees.--
                    ``(A) Full fees.--The application fee under 
                subsection (a)(1)(A)(i) shall be $250,704 in fiscal year 
                1998, $256,338 in each of fiscal years 1999 and 2000, 
                $267,606 in fiscal year 2001, and $258,451 in fiscal 
                year 2002.
                    ``(B) Other fees.--The fee under subsection 
                (a)(1)(A)(ii) shall be $125,352 in fiscal year 1998, 
                $128,169

[[Page 111 STAT. 2302]]

                in each of fiscal years 1999 and 2000, $133,803 in 
                fiscal year 2001, and $129,226 in fiscal year 2002.
            ``(2) Total fee revenues for establishment fees.--The total 
        fee revenues to be collected in establishment fees under 
        subsection (a)(2) shall be $35,600,000 in fiscal year 1998, 
        $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 2002.
            ``(3) Total fee revenues for product fees.--The total fee 
        revenues to be collected in product fees under subsection (a)(3) 
        in a fiscal year shall be equal to the total fee revenues 
        collected in establishment fees under subsection (a)(2) in that 
        fiscal year.''.

    (c) Increases and Adjustments.--Section 736(c) (21 U.S.C. 379h(c)) 
is amended--
            (1) in the subsection heading, by striking ``Increases 
        and'';
            (2) in paragraph (1)--
                    (A) by striking ``(1) Revenue'' and all that follows 
                through ``increased by the Secretary'' and inserting the 
                following: ``(1) Inflation adjustment.--The fees and 
                total fee revenues established in subsection (b) shall 
                be adjusted by the Secretary'';
                    (B) in subparagraph (A), by striking ``increase'' 
                and inserting ``change'';
                    (C) in subparagraph (B), by striking ``increase'' 
                and inserting ``change''; and
                    (D) by adding at the end the following flush 
                sentence:
        ``The adjustment made each fiscal year by this subsection will 
        be added on a compounded basis to the sum of all adjustments 
        made each fiscal year after fiscal year 1997 under this 
        subsection.'';
            (3) in paragraph (2), by striking ``October 1, 1992,'' and 
        all that follows through ``such schedule.'' and inserting the 
        following: ``September 30, 1997, adjust the establishment and 
        product fees described in subsection (b) for the fiscal year in 
        which the adjustment occurs so that the revenues collected from 
        each of the categories of fees described in paragraphs (2) and 
        (3) of subsection (b) shall be set to be equal to the revenues 
        collected from the category of application and supplement fees 
        described in paragraph (1) of subsection (b).''; and
            (4) in paragraph (3), by striking ``paragraph (2)'' and 
        inserting ``this subsection''.

    (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 379h(d)) is 
amended--
            (1) by redesignating paragraphs (1), (2), (3), and (4) as 
        subparagraphs (A), (B), (C), and (D), respectively and indenting 
        appropriately;
            (2) by striking ``The Secretary shall grant a'' and all that 
        follows through ``finds that--'' and inserting the following:
            ``(1) In general.--The Secretary shall grant a waiver from 
        or a reduction of one or more fees assessed under subsection (a) 
        where the Secretary finds that--'';
            (3) in subparagraph (C) (as so redesignated in paragraph 
        (1)), by striking ``, or'' and inserting a comma;
            (4) in subparagraph (D) (as so redesignated in paragraph 
        (1)), by striking the period and inserting ``, or'';
            (5) by inserting after subparagraph (D) (as so redesignated 
        in paragraph (1)) the following:

[[Page 111 STAT. 2303]]

                    ``(E) the applicant involved is a small business 
                submitting its first human drug application to the 
                Secretary for review.''; and
            (6) by striking ``In making the finding in paragraph (3),'' 
        and all that follows through ``standard costs.'' and inserting 
        the following:
            ``(2) Use of standard costs.--In making the finding in 
        paragraph (1)(C), the Secretary may use standard costs.
            ``(3) Rules relating to small businesses.--
                    ``(A) Definition.--In paragraph (1)(E), the term 
                `small business' means an entity that has fewer than 500 
                employees, including employees of affiliates.
                    ``(B) Waiver of application fee.--The Secretary 
                shall waive under paragraph (1)(E) the application fee 
                for the first human drug application that a small 
                business or its affiliate submits to the Secretary for 
                review. After a small business or its affiliate is 
                granted such a waiver, the small business or its 
                affiliate shall pay--
                          ``(i) application fees for all subsequent 
                      human drug applications submitted to the Secretary 
                      for review in the same manner as an entity that 
                      does not qualify as a small business; and
                          ``(ii) all supplement fees for all supplements 
                      to human drug applications submitted to the 
                      Secretary for review in the same manner as an 
                      entity that does not qualify as a small 
                      business.''.

    (e) Assessment of Fees.--Section 736(f)(1) (21 U.S.C. 379h(f)(1)) is 
amended--
            (1) by striking ``fiscal year 1993'' and inserting ``fiscal 
        year 1997''; and
            (2) by striking ``fiscal year 1992'' and inserting ``fiscal 
        year 1997 (excluding the amount of fees appropriated for such 
        fiscal year)''.

    (f) Crediting and Availability of Fees.--Section 736(g) (21 U.S.C. 
379h(g)) is amended--
            (1) in paragraph (1), by adding at the end the following: 
        ``Such sums as may be necessary may be transferred from the Food 
        and Drug Administration salaries and expenses appropriation 
        account without fiscal year limitation to such appropriation 
        account for salaries and expenses with such fiscal year 
        limitation. The sums transferred shall be available solely for 
        the process for the review of human drug applications.'';
            (2) in paragraph (2)--
                    (A) in subparagraph (A), by striking ``Acts'' and 
                inserting ``Acts, or otherwise made available for 
                obligation,''; and
                    (B) in subparagraph (B), by striking ``over such 
                costs for fiscal year 1992'' and inserting ``over such 
                costs, excluding costs paid from fees collected under 
                this section, for fiscal year 1997''; and
            (3) by striking paragraph (3) and inserting the following:
            ``(3) Authorization of appropriations.--There are authorized 
        to be appropriated for fees under this section--
                    ``(A) $106,800,000 for fiscal year 1998;
                    ``(B) $109,200,000 for fiscal year 1999;
                    ``(C) $109,200,000 for fiscal year 2000;
                    ``(D) $114,000,000 for fiscal year 2001; and
                    ``(E) $110,100,000 for fiscal year 2002,

[[Page 111 STAT. 2304]]

        as adjusted to reflect adjustments in the total fee revenues 
        made under this section and changes in the total amounts 
        collected by application, supplement, establishment, and product 
        fees.
            ``(4) Offset.--Any amount of fees collected for a fiscal 
        year under this section that exceeds the amount of fees 
        specified in appropriation Acts for such fiscal year shall be 
        credited to the appropriation account of the Food and Drug 
        Administration as provided in paragraph (1), and shall be 
        subtracted from the amount of fees that would otherwise be 
        authorized to be collected under this section pursuant to 
        appropriation Acts for a subsequent fiscal year.''.

    (g) Requirement for Written Requests for Waivers, Reductions, and 
Refunds.--Section 736 (21 U.S.C. 379h) is amended--
            (1) by redesignating subsection (i) as subsection (j); and
            (2) by inserting after subsection (h) the following:

    ``(i) Written Requests for Waivers, Reductions, and Refunds.--To 
qualify for consideration for a waiver or reduction under subsection 
(d), or for a refund of any fee collected in accordance with subsection 
(a), a person shall submit to the Secretary a written request for such 
waiver, reduction, or refund not later than 180 days after such fee is 
due.''.
     <<NOTE: 21 USC 379h note.>> (h) Special Rule for Waivers and 
Refunds.--Any requests for waivers or refunds for fees assessed under 
section 736 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 379h) 
prior to the date of enactment of this Act shall be submitted in writing 
to the Secretary of Health and Human Services within 1 year after the 
date of enactment of this Act. Any requests for waivers or refunds 
pertaining to a fee for a human drug application or supplement accepted 
for filing prior to October 1, 1997 or to a product or establishment fee 
required by such Act for a fiscal year prior to fiscal year 1998, shall 
be evaluated according to the terms of the Prescription Drug User Fee 
Act of 1992 (as in effect on September 30, 1997) and part 2 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act 
(as in effect on September 30, 1997). The term ``person'' in such Acts 
shall continue to include an affiliate thereof.

<<NOTE: 21 USC 379g note.>> SEC. 104. ANNUAL REPORTS.

    (a) Performance Report.--Beginning with fiscal year 1998, not later 
than 60 days after the end of each fiscal year during which fees are 
collected under part 2 of subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of 
Health and Human Services shall prepare and submit to the Committee on 
Commerce of the House of Representatives and the Committee on Labor and 
Human Resources of the Senate a report concerning the progress of the 
Food and Drug Administration in achieving the goals identified in the 
letters described in section 101(4) during such fiscal year and the 
future plans of the Food and Drug Administration for meeting the goals.
    (b) Fiscal Report.--Beginning with fiscal year 1998, not later than 
120 days after the end of each fiscal year during which fees are 
collected under the part described in subsection (a), the Secretary of 
Health and Human Services shall prepare and submit to the Committee on 
Commerce of the House of Representatives and the Committee on Labor and 
Human Resources of the Senate

[[Page 111 STAT. 2305]]

a report on the implementation of the authority for such fees during 
such fiscal year and the use, by the Food and Drug Administration, of 
the fees collected during such fiscal year for which the report is made.

<<NOTE: 21 USC 379g note.>> SEC. 105. SAVINGS.

    Notwithstanding section 105 of the Prescription Drug User Fee Act of 
1992, the Secretary shall retain the authority to assess and collect any 
fee required by part 2 of subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act for a human drug application or supplement 
accepted for filing prior to October 1, 1997, and to assess and collect 
any product or establishment fee required by such Act for a fiscal year 
prior to fiscal year 1998.

<<NOTE: 21 USC 379g note.>> SEC. 106. EFFECTIVE DATE.

    The amendments made by this subtitle shall take effect October 1, 
1997.

<<NOTE: 21 USC 379g note.>> SEC. 107. TERMINATION OF EFFECTIVENESS.

    The amendments made by sections 102 and 103 cease to be effective 
October 1, 2002, and section 104 ceases to be effective 120 days after 
such date.

                     Subtitle B--Other Improvements

SEC. 111. PEDIATRIC STUDIES OF DRUGS.

    Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after 
section 505 the following:

<<NOTE: 21 USC 355a.>> ``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

    ``(a) Market Exclusivity for New Drugs.--If, prior to approval of an 
application that is submitted under section 505(b)(1), the Secretary 
determines that information relating to the use of a new drug in the 
pediatric population may produce health benefits in that population, the 
Secretary makes a written request for pediatric studies (which shall 
include a timeframe for completing such studies), and such studies are 
completed within any such timeframe and the reports thereof submitted in 
accordance with subsection (d)(2) or accepted in accordance with 
subsection (d)(3)--
            ``(1)(A)(i) the period referred to in subsection 
        (c)(3)(D)(ii) of section 505, and in subsection (j)(4)(D)(ii) of 
        such section, is deemed to be five years and six months rather 
        than five years, and the references in subsections (c)(3)(D)(ii) 
        and (j)(4)(D)(ii) of such section to four years, to forty-eight 
        months, and to seven and one-half years are deemed to be four 
        and one-half years, fifty-four months, and eight years, 
        respectively; or
            ``(ii) the period referred to in clauses (iii) and (iv) of 
        subsection (c)(3)(D) of such section, and in clauses (iii) and 
        (iv) of subsection (j)(4)(D) of such section, is deemed to be 
        three years and six months rather than three years; and
            ``(B) if the drug is designated under section 526 for a rare 
        disease or condition, the period referred to in section 527(a) 
        is deemed to be seven years and six months rather than seven 
        years; and
            ``(2)(A) if the drug is the subject of--

[[Page 111 STAT. 2306]]

                    ``(i) a listed patent for which a certification has 
                been submitted under subsection (b)(2)(A)(ii) or 
                (j)(2)(A)(vii)(II) of section 505 and for which 
                pediatric studies were submitted prior to the expiration 
                of the patent (including any patent extensions); or
                    ``(ii) a listed patent for which a certification has 
                been submitted under subsections (b)(2)(A)(iii) or 
                (j)(2)(A)(vii)(III) of section 505,
        the period during which an application may not be approved under 
        section 505(c)(3) or section 505(j)(4)(B) shall be extended by a 
        period of six months after the date the patent expires 
        (including any patent extensions); or
            ``(B) if the drug is the subject of a listed patent for 
        which a certification has been submitted under subsection 
        (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the 
        patent infringement litigation resulting from the certification 
        the court determines that the patent is valid and would be 
        infringed, the period during which an application may not be 
        approved under section 505(c)(3) or section 505(j)(4)(B) shall 
        be extended by a period of six months after the date the patent 
        expires (including any patent extensions).

    ``(b) Secretary To Develop List of Drugs for Which Additional 
Pediatric Information May Be Beneficial.--Not later than 180 days after 
the date of enactment of the Food and Drug Administration Modernization 
Act of 1997, the Secretary, after consultation with experts in pediatric 
research shall develop, prioritize, and publish an initial list of 
approved drugs for which additional pediatric information may produce 
health benefits in the pediatric population. The Secretary shall 
annually update the list.
    ``(c) Market Exclusivity for Already-Marketed Drugs.--If the 
Secretary makes a written request to the holder of an approved 
application under section 505(b)(1) for pediatric studies (which shall 
include a timeframe for completing such studies) concerning a drug 
identified in the list described in subsection (b), the holder agrees to 
the request, the studies are completed within any such timeframe, and 
the reports thereof are submitted in accordance with subsection (d)(2) 
or accepted in accordance with subsection (d)(3)--
            ``(1)(A)(i) the period referred to in subsection 
        (c)(3)(D)(ii) of section 505, and in subsection (j)(4)(D)(ii) of 
        such section, is deemed to be five years and six months rather 
        than five years, and the references in subsections (c)(3)(D)(ii) 
        and (j)(4)(D)(ii) of such section to four years, to forty-eight 
        months, and to seven and one-half years are deemed to be four 
        and one-half years, fifty-four months, and eight years, 
        respectively; or
            ``(ii) the period referred to in clauses (iii) and (iv) of 
        subsection (c)(3)(D) of such section, and in clauses (iii) and 
        (iv) of subsection (j)(4)(D) of such section, is deemed to be 
        three years and six months rather than three years; and
            ``(B) if the drug is designated under section 526 for a rare 
        disease or condition, the period referred to in section 527(a) 
        is deemed to be seven years and six months rather than seven 
        years; and
            ``(2)(A) if the drug is the subject of--
                    ``(i) a listed patent for which a certification has 
                been submitted under subsection (b)(2)(A)(ii) or 
                (j)(2)(A)(vii)(II)

[[Page 111 STAT. 2307]]

                of section 505 and for which pediatric studies were 
                submitted prior to the expiration of the patent 
                (including any patent extensions); or
                    ``(ii) a listed patent for which a certification has 
                been submitted under subsection (b)(2)(A)(iii) or 
                (j)(2)(A)(vii)(III) of section 505,
        the period during which an application may not be approved under 
        section 505(c)(3) or section 505(j)(4)(B) shall be extended by a 
        period of six months after the date the patent expires 
        (including any patent extensions); or
            ``(B) if the drug is the subject of a listed patent for 
        which a certification has been submitted under subsection 
        (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the 
        patent infringement litigation resulting from the certification 
        the court determines that the patent is valid and would be 
        infringed, the period during which an application may not be 
        approved under section 505(c)(3) or section 505(j)(4)(B) shall 
        be extended by a period of six months after the date the patent 
        expires (including any patent extensions).

    ``(d) Conduct of Pediatric Studies.--
            ``(1) Agreement for studies.--The Secretary may, pursuant to 
        a written request from the Secretary under subsection (a) or 
        (c), after consultation with--
                    ``(A) the sponsor of an application for an 
                investigational new drug under section 505(i);
                    ``(B) the sponsor of an application for a new drug 
                under section 505(b)(1); or
                    ``(C) the holder of an approved application for a 
                drug under section 505(b)(1),
        agree with the sponsor or holder for the conduct of pediatric 
        studies for such drug. Such agreement shall be in writing and 
        shall include a timeframe for such studies.
            ``(2) Written protocols to meet the studies requirement.--If 
        the sponsor or holder and the Secretary agree upon written 
        protocols for the studies, the studies requirement of subsection 
        (a) or (c) is satisfied upon the completion of the studies and 
        submission of the reports thereof in accordance with the 
        original written request and the written agreement referred to 
        in paragraph (1). Not later than 60 days after the submission of 
        the report of the studies, the Secretary shall determine if such 
        studies were or were not conducted in accordance with the 
        original written request and the written agreement and reported 
        in accordance with the requirements of the Secretary for filing 
        and so notify the sponsor or holder.
            ``(3) Other methods to meet the studies requirement.--If the 
        sponsor or holder and the Secretary have not agreed in writing 
        on the protocols for the studies, the studies requirement of 
        subsection (a) or (c) is satisfied when such studies have been 
        completed and the reports accepted by the Secretary. Not later 
        than 90 days after the submission of the reports of the studies, 
        the Secretary shall accept or reject such reports and so notify 
        the sponsor or holder. The Secretary's only responsibility in 
        accepting or rejecting the reports shall be to determine, within 
        the 90 days, whether the studies fairly respond to the written 
        request, have been conducted in accordance with commonly 
        accepted scientific principles and protocols, and

[[Page 111 STAT. 2308]]

        have been reported in accordance with the requirements of the 
        Secretary for filing.

    ``(e) Delay of Effective Date for Certain Application.--If the 
Secretary determines that the acceptance or approval of an application 
under section 505(b)(2) or 505(j) for a new drug may occur after 
submission of reports of pediatric studies under this section, which 
were submitted prior to the expiration of the patent (including any 
patent extension) or the applicable period under clauses (ii) through 
(iv) of section 505(c)(3)(D) or clauses (ii) through (iv) of section 
505(j)(4)(D), but before the Secretary has determined whether the 
requirements of subsection (d) have been satisfied, the Secretary shall 
delay the acceptance or approval under section 505(b)(2) or 505(j) until 
the determination under subsection (d) is made, but any such delay shall 
not exceed 90 days. In the event that requirements of this section are 
satisfied, the applicable six-month period under subsection (a) or (c) 
shall be deemed to have been running during the period of delay.
    ``(f) Notice of Determinations on Studies Requirement.--The 
Secretary shall publish a notice of any determination that the 
requirements of subsection (d) have been met and that submissions and 
approvals under subsection (b)(2) or (j) of section 505 for a drug will 
be subject to the provisions of this section.
    ``(g) Definitions.--As used in this section, the term `pediatric 
studies' or `studies' means at least one clinical investigation (that, 
at the Secretary's discretion, may include pharmacokinetic studies) in 
pediatric age groups in which a drug is anticipated to be used.
    ``(h) Limitations.--A drug to which the six-month period under 
subsection (a) or (b) has already been applied--
            ``(1) may receive an additional six-month period under 
        subsection (c)(1)(A)(ii) for a supplemental application if all 
        other requirements under this section are satisfied, except that 
        such a drug may not receive any additional such period under 
        subsection (c)(2); and
            ``(2) may not receive any additional such period under 
        subsection (c)(1)(B).

    ``(i) Relationship to Regulations.--Notwithstanding any other 
provision of law, if any pediatric study is required pursuant to 
regulations promulgated by the Secretary and such study meets the 
completeness, timeliness, and other requirements of this section, such 
study shall be deemed to satisfy the requirement for market exclusivity 
pursuant to this section.
    ``(j) Sunset.--A drug may not receive any six-month period under 
subsection (a) or (c) unless the application for the drug under section 
505(b)(1) is submitted on or before January 1, 2002. After January 1, 
2002, a drug shall receive a six-month period under subsection (c) if--
            ``(1) the drug was in commercial distribution as of the date 
        of enactment of the Food and Drug Administration Modernization 
        Act of 1997;
            ``(2) the drug was included by the Secretary on the list 
        under subsection (b) as of January 1, 2002;
            ``(3) the Secretary determines that there is a continuing 
        need for information relating to the use of the drug in the 
        pediatric population and that the drug may provide health 
        benefits in that population; and
            ``(4) all requirements of this section are met.

[[Page 111 STAT. 2309]]

    ``(k) Report.--The Secretary shall conduct a study and report to 
Congress not later than January 1, 2001, based on the experience under 
the program established under this section. The study and report shall 
examine all relevant issues, including--
            ``(1) the effectiveness of the program in improving 
        information about important pediatric uses for approved drugs;
            ``(2) the adequacy of the incentive provided under this 
        section;
            ``(3) the economic impact of the program on taxpayers and 
        consumers, including the impact of the lack of lower cost 
        generic drugs on patients, including on lower income patients; 
        and
            ``(4) any suggestions for modification that the Secretary 
        determines to be appropriate.''.

SEC. 112. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS.

    (a) In General.--Chapter V (21 U.S.C. 351 et seq.), as amended by 
section 125, is amended by inserting before section 508 the following:

<<NOTE: 21 USC 356.>> ``SEC. 506. FAST TRACK PRODUCTS.

    ``(a) Designation of Drug as a Fast Track Product.--
            ``(1) In general.--The Secretary shall, at the request of 
        the sponsor of a new drug, facilitate the development and 
        expedite the review of such drug if it is intended for the 
        treatment of a serious or life-threatening condition and it 
        demonstrates the potential to address unmet medical needs for 
        such a condition. (In this section, such a drug is referred to 
        as a `fast track product'.)
            ``(2) Request for designation.--The sponsor of a new drug 
        may request the Secretary to designate the drug as a fast track 
        product. A request for the designation may be made concurrently 
        with, or at any time after, submission of an application for the 
        investigation of the drug under section 505(i) or section 
        351(a)(3) of the Public Health Service Act.
            ``(3) Designation.--Within 60 calendar days after the 
        receipt of a request under paragraph (2), the Secretary shall 
        determine whether the drug that is the subject of the request 
        meets the criteria described in paragraph (1). If the Secretary 
        finds that the drug meets the criteria, the Secretary shall 
        designate the drug as a fast track product and shall take such 
        actions as are appropriate to expedite the development and 
        review of the application for approval of such product.

    ``(b) Approval of Application for a Fast Track Product.--
            ``(1) In general.--The Secretary may approve an application 
        for approval of a fast track product under section 505(c) or 
        section 351 of the Public Health Service Act upon a 
        determination that the product has an effect on a clinical 
        endpoint or on a surrogate endpoint that is reasonably likely to 
        predict clinical benefit.
            ``(2) Limitation.--Approval of a fast track product under 
        this subsection may be subject to the requirements--
                    ``(A) that the sponsor conduct appropriate post-
                approval studies to validate the surrogate endpoint or 
                otherwise confirm the effect on the clinical endpoint; 
                and
                    ``(B) that the sponsor submit copies of all 
                promotional materials related to the fast track product 
                during the preapproval review period and, following 
                approval and for such period thereafter as the Secretary 
                determines to be

[[Page 111 STAT. 2310]]

                appropriate, at least 30 days prior to dissemination of 
                the materials.
            ``(3) Expedited withdrawal of approval.--The Secretary may 
        withdraw approval of a fast track product using expedited 
        procedures (as prescribed by the Secretary in regulations which 
        shall include an opportunity for an informal hearing) if--
                    ``(A) the sponsor fails to conduct any required 
                post-approval study of the fast track drug with due 
                diligence;
                    ``(B) a post-approval study of the fast track 
                product fails to verify clinical benefit of the product;
                    ``(C) other evidence demonstrates that the fast 
                track product is not safe or effective under the 
                conditions of use; or
                    ``(D) the sponsor disseminates false or misleading 
                promotional materials with respect to the product.

    ``(c) Review of Incomplete Applications for Approval of a Fast Track 
Product.--
            ``(1) In general.--If the Secretary determines, after 
        preliminary evaluation of clinical data submitted by the 
        sponsor, that a fast track product may be effective, the 
        Secretary shall evaluate for filing, and may commence review of 
        portions of, an application for the approval of the product 
        before the sponsor submits a complete application. The Secretary 
        shall commence such review only if the applicant--
                    ``(A) provides a schedule for submission of 
                information necessary to make the application complete; 
                and
                    ``(B) pays any fee that may be required under 
                section 736.
            ``(2) Exception.--Any time period for review of human drug 
        applications that has been agreed to by the Secretary and that 
        has been set forth in goals identified in letters of the 
        Secretary (relating to the use of fees collected under section 
        736 to expedite the drug development process and the review of 
        human drug applications) shall not apply to an application 
        submitted under paragraph (1) until the date on which the 
        application is complete.

    ``(d) Awareness Efforts.--The Secretary shall--
            ``(1) develop and disseminate to physicians, patient 
        organizations, pharmaceutical and biotechnology companies, and 
        other appropriate persons a description of the provisions of 
        this section applicable to fast track products; and
            ``(2) establish a program to encourage the development of 
        surrogate endpoints that are reasonably likely to predict 
        clinical benefit for serious or life-threatening conditions for 
        which there exist significant unmet medical needs.''.

     <<NOTE: 21 USC 356 note.>> (b) Guidance.--Within 1 year after the 
date of enactment of this Act, the Secretary of Health and Human 
Services shall issue guidance for fast track products (as defined in 
section 506(a)(1) of the Federal Food, Drug, and Cosmetic Act) that 
describes the policies and procedures that pertain to section 506 of 
such Act.
SEC. 113. INFORMATION PROGRAM ON CLINICAL TRIALS FOR SERIOUS OR 
                        LIFE-THREATENING DISEASES.

    (a) In General.--Section 402 of the Public Health Service Act (42 
U.S.C. 282) is amended--
            (1) by redesignating subsections (j) and (k) as subsections 
        (k) and (l), respectively; and

[[Page 111 STAT. 2311]]

            (2) by inserting after subsection (i) the following:

     <<NOTE: Establishment.>> ``(j)(1)(A) The Secretary, acting through 
the Director of NIH, shall establish, maintain, and operate a data bank 
of information on clinical trials for drugs for serious or life-
threatening diseases and conditions (in this subsection referred to as 
the `data bank'). The activities of the data bank shall be integrated 
and coordinated with related activities of other agencies of the 
Department of Health and Human Services, and to the extent practicable, 
coordinated with other data banks containing similar information.

    ``(B) The Secretary shall establish the data bank after consultation 
with the Commissioner of Food and Drugs, the directors of the 
appropriate agencies of the National Institutes of Health (including the 
National Library of Medicine), and the Director of the Centers for 
Disease Control and Prevention.
    ``(2) In carrying out paragraph (1), the Secretary shall collect, 
catalog, store, and disseminate the information described in such 
paragraph. The Secretary shall disseminate such information through 
information systems, which shall include toll-free telephone 
communications, available to individuals with serious or life-
threatening diseases and conditions, to other members of the public, to 
health care providers, and to researchers.
    ``(3) The data bank shall include the following:
            ``(A) A registry of clinical trials (whether federally or 
        privately funded) of experimental treatments for serious or 
        life-threatening diseases and conditions under regulations 
        promulgated pursuant to section 505(i) of the Federal Food, 
        Drug, and Cosmetic Act, which provides a description of the 
        purpose of each experimental drug, either with the consent of 
        the protocol sponsor, or when a trial to test effectiveness 
        begins. Information provided shall consist of eligibility 
        criteria for participation in the clinical trials, a description 
        of the location of trial sites, and a point of contact for those 
        wanting to enroll in the trial, and shall be in a form that can 
        be readily understood by members of the public. Such information 
        shall be forwarded to the data bank by the sponsor of the trial 
        not later than 21 days after the approval of the protocol.
            ``(B) Information pertaining to experimental treatments for 
        serious or life-threatening diseases and conditions that may be 
        available--
                    ``(i) under a treatment investigational new drug 
                application that has been submitted to the Secretary 
                under section 561(c) of the Federal Food, Drug, and 
                Cosmetic Act; or
                    ``(ii) as a Group C cancer drug (as defined by the 
                National Cancer Institute).
        The data bank may also include information pertaining to the 
        results of clinical trials of such treatments, with the consent 
        of the sponsor, including information concerning potential 
        toxicities or adverse effects associated with the use or 
        administration of such experimental treatments.

    ``(4) The data bank shall not include information relating to an 
investigation if the sponsor has provided a detailed certification to 
the Secretary that disclosure of such information would substantially 
interfere with the timely enrollment of subjects in the investigation, 
unless the Secretary, after the receipt of the certification, provides 
the sponsor with a detailed written determination that

[[Page 111 STAT. 2312]]

such disclosure would not substantially interfere with such enrollment.
     <<NOTE: Appropriation authorization.>> ``(5) For the purpose of 
carrying out this subsection, there are authorized to be appropriated 
such sums as may be necessary. Fees collected under section 736 of the 
Federal Food, Drug, and Cosmetic Act shall not be used in carrying out 
this subsection.''.

     <<NOTE: 42 USC 282 note.>> (b) Collaboration and Report.--
            (1) In general.--The Secretary of Health and Human Services, 
        the Director of the National Institutes of Health, and the 
        Commissioner of Food and Drugs shall collaborate to determine 
        the feasibility of including device investigations within the 
        scope of the data bank under section 402(j) of the Public Health 
        Service Act.
            (2) Report.--Not later than two years after the date of 
        enactment of this section, the Secretary of Health and Human 
        Services shall prepare and submit to the Committee on Labor and 
        Human Resources of the Senate and the Committee on Commerce of 
        the House of Representatives a report--
                    (A) of the public health need, if any, for inclusion 
                of device investigations within the scope of the data 
                bank under section 402(j) of the Public Health Service 
                Act;
                    (B) on the adverse impact, if any, on device 
                innovation and research in the United States if 
                information relating to such device investigations is 
                required to be publicly disclosed; and
                    (C) on such other issues relating to such section 
                402(j) as the Secretary determines to be appropriate.

SEC. 114. HEALTH CARE ECONOMIC INFORMATION.

    (a) In General.--Section 502(a) (21 U.S.C. 352(a)) is amended by 
adding at the end the following: ``Health care economic information 
provided to a formulary committee, or other similar entity, in the 
course of the committee or the entity carrying out its responsibilities 
for the selection of drugs for managed care or other similar 
organizations, shall not be considered to be false or misleading under 
this paragraph if the health care economic information directly relates 
to an indication approved under section 505 or under section 351(a) of 
the Public Health Service Act for such drug and is based on competent 
and reliable scientific evidence. The requirements set forth in section 
505(a) or in section 351(a) of the Public Health Service Act shall not 
apply to health care economic information provided to such a committee 
or entity in accordance with this paragraph. Information that is 
relevant to the substantiation of the health care economic information 
presented pursuant to this paragraph shall be made available to the 
Secretary upon request. In this paragraph, the term `health care 
economic information' means any analysis that identifies, measures, or 
compares the economic consequences, including the costs of the 
represented health outcomes, of the use of a drug to the use of another 
drug, to another health care intervention, or to no intervention.''.
     <<NOTE: 21 USC 352 note.>> (b) Study and Report.--The Comptroller 
General of the United States shall conduct a study of the implementation 
of the provisions added by the amendment made by subsection (a). Not 
later than 4 years and 6 months after the date of enactment of this Act, 
the Comptroller General of the United States shall prepare and submit to 
Congress a report containing the findings of the study.

[[Page 111 STAT. 2313]]

SEC. 115. CLINICAL INVESTIGATIONS.

    (a) Clarification of the Number of Required Clinical Investigations 
for Approval.--Section 505(d) (21 U.S.C. 355(d)) is amended by adding at 
the end the following: ``If the Secretary determines, based on relevant 
science, that data from one adequate and well-controlled clinical 
investigation and confirmatory evidence (obtained prior to or after such 
investigation) are sufficient to establish effectiveness, the Secretary 
may consider such data and evidence to constitute substantial evidence 
for purposes of the preceding sentence.''.
    (b) Women and Minorities.--Section 505(b)(1) (21 U.S.C. 355(b)(1)) 
is amended by adding at the end the following: ``The Secretary shall, in 
consultation with the Director of the National Institutes of Health and 
with representatives of the drug manufacturing industry, review and 
develop guidance, as appropriate, on the inclusion of women and 
minorities in clinical trials required by clause (A).''.

SEC. 116. MANUFACTURING CHANGES FOR DRUGS.

    (a) In General.--Chapter V, as amended by section 112, is amended by 
inserting after section 506 the following section:

<<NOTE: 21 USC 356a.>> ``SEC. 506A. MANUFACTURING CHANGES.

    ``(a) In General.--With respect to a drug for which there is in 
effect an approved application under section 505 or 512 or a license 
under section 351 of the Public Health Service Act, a change from the 
manufacturing process approved pursuant to such application or license 
may be made, and the drug as made with the change may be distributed, 
if--
            ``(1) the holder of the approved application or license 
        (referred to in this section as a `holder') has validated the 
        effects of the change in accordance with subsection (b); and
            ``(2)(A) in the case of a major manufacturing change, the 
        holder has complied with the requirements of subsection (c); or
            ``(B) in the case of a change that is not a major 
        manufacturing change, the holder complies with the applicable 
        requirements of subsection (d).

    ``(b) Validation of Effects of Changes.--For purposes of subsection 
(a)(1), a drug made with a manufacturing change (whether a major 
manufacturing change or otherwise) may be distributed only if, before 
distribution of the drug as so made, the holder involved validates the 
effects of the change on the identity, strength, quality, purity, and 
potency of the drug as the identity, strength, quality, purity, and 
potency may relate to the safety or effectiveness of the drug.
    ``(c) Major Manufacturing Changes.--
            ``(1) Requirement of supplemental application.--For purposes 
        of subsection (a)(2)(A), a drug made with a major manufacturing 
        change may be distributed only if, before the distribution of 
        the drug as so made, the holder involved submits to the 
        Secretary a supplemental application for such change and the 
        Secretary approves the application. The application shall 
        contain such information as the Secretary determines to be 
        appropriate, and shall include the information developed under 
        subsection (b) by the holder in validating the effects of the 
        change.

[[Page 111 STAT. 2314]]

            ``(2) Changes qualifying as major changes.--For purposes of 
        subsection (a)(2)(A), a major manufacturing change is a 
        manufacturing change that is determined by the Secretary to have 
        substantial potential to adversely affect the identity, 
        strength, quality, purity, or potency of the drug as they may 
        relate to the safety or effectiveness of a drug. Such a change 
        includes a change that--
                    ``(A) is made in the qualitative or quantitative 
                formulation of the drug involved or in the 
                specifications in the approved application or license 
                referred to in subsection (a) for the drug (unless 
                exempted by the Secretary by regulation or guidance from 
                the requirements of this subsection);
                    ``(B) is determined by the Secretary by regulation 
                or guidance to require completion of an appropriate 
                clinical study demonstrating equivalence of the drug to 
                the drug as manufactured without the change; or
                    ``(C) is another type of change determined by the 
                Secretary by regulation or guidance to have a 
                substantial potential to adversely affect the safety or 
                effectiveness of the drug.

    ``(d) Other Manufacturing Changes.--
            ``(1) In general.--For purposes of subsection (a)(2)(B), the 
        Secretary may regulate drugs made with manufacturing changes 
        that are not major manufacturing changes as follows:
                    ``(A) The Secretary may in accordance with paragraph 
                (2) authorize holders to distribute such drugs without 
                submitting a supplemental application for such changes.
                    ``(B) The Secretary may in accordance with paragraph 
                (3) require that, prior to the distribution of such 
                drugs, holders submit to the Secretary supplemental 
                applications for such changes.
                    ``(C) The Secretary may establish categories of such 
                changes and designate categories to which subparagraph 
                (A) applies and categories to which subparagraph (B) 
                applies.
            ``(2) Changes not requiring supplemental application.--
                    ``(A) Submission of report.--A holder making a 
                manufacturing change to which paragraph (1)(A) applies 
                shall submit to the Secretary a report on the change, 
                which shall contain such information as the Secretary 
                determines to be appropriate, and which shall include 
                the information developed under subsection (b) by the 
                holder in validating the effects of the change. The 
                report shall be submitted by such date as the Secretary 
                may specify.
                    ``(B) Authority regarding annual reports.--In the 
                case of a holder that during a single year makes more 
                than one manufacturing change to which paragraph (1)(A) 
                applies, the Secretary may in carrying out subparagraph 
                (A) authorize the holder to comply with such 
                subparagraph by submitting a single report for the year 
                that provides the information required in such 
                subparagraph for all the changes made by the holder 
                during the year.
            ``(3) Changes requiring supplemental application.--
                    ``(A) Submission of supplemental application.--The 
                supplemental application required under paragraph (1)(B)

[[Page 111 STAT. 2315]]

                for a manufacturing change shall contain such 
                information as the Secretary determines to be 
                appropriate, which shall include the information 
                developed under subsection (b) by the holder in 
                validating the effects of the change.
                    ``(B) Authority for distribution.--In the case of a 
                manufacturing change to which paragraph (1)(B) applies:
                          ``(i) The holder involved may commence 
                      distribution of the drug involved 30 days after 
                      the Secretary receives the supplemental 
                      application under such paragraph, unless the 
                      Secretary notifies the holder within such 30-day 
                      period that prior approval of the application is 
                      required before distribution may be commenced.
                          ``(ii) The Secretary may designate a category 
                      of such changes for the purpose of providing that, 
                      in the case of a change that is in such category, 
                      the holder involved may commence distribution of 
                      the drug involved upon the receipt by the 
                      Secretary of a supplemental application for the 
                      change.
                          ``(iii) If the Secretary disapproves the 
                      supplemental application, the Secretary may order 
                      the manufacturer to cease the distribution of the 
                      drugs that have been made with the manufacturing 
                      change.''.

     <<NOTE: 21 USC 356a note.>> (b) Transition Rule.--The amendment 
made by subsection (a) takes effect upon the effective date of 
regulations promulgated by the Secretary of Health and Human Services to 
implement such amendment, or upon the expiration of the 24-month period 
beginning on the date of the enactment of this Act, whichever occurs 
first.

SEC. 117. STREAMLINING CLINICAL RESEARCH ON DRUGS.

    Section 505(i) (21 U.S.C. 355(i)) is amended--
            (1) by redesignating paragraphs (1) through (3) as 
        subparagraphs (A) through (C), respectively;
            (2) by inserting ``(1)'' after ``(i)'';
            (3) by striking the last two sentences; and
            (4) by inserting after paragraph (1) (as designated by 
        paragraph (2) of this section) the following new paragraphs:

    ``(2) Subject to paragraph (3), a clinical investigation of a new 
drug may begin 30 days after the Secretary has received from the 
manufacturer or sponsor of the investigation a submission containing 
such information about the drug and the clinical investigation, 
including--
            ``(A) information on design of the investigation and 
        adequate reports of basic information, certified by the 
        applicant to be accurate reports, necessary to assess the safety 
        of the drug for use in clinical investigation; and
            ``(B) adequate information on the chemistry and 
        manufacturing of the drug, controls available for the drug, and 
        primary data tabulations from animal or human studies.

    ``(3)(A) At any time, the Secretary may prohibit the sponsor of an 
investigation from conducting the investigation (referred to in this 
paragraph as a `clinical hold') if the Secretary makes a determination 
described in subparagraph (B). The Secretary shall specify the basis for 
the clinical hold, including the specific information available to the 
Secretary which served as the basis for such clinical hold, and confirm 
such determination in writing.

[[Page 111 STAT. 2316]]

    ``(B) For purposes of subparagraph (A), a determination described in 
this subparagraph with respect to a clinical hold is that--
            ``(i) the drug involved represents an unreasonable risk to 
        the safety of the persons who are the subjects of the clinical 
        investigation, taking into account the qualifications of the 
        clinical investigators, information about the drug, the design 
        of the clinical investigation, the condition for which the drug 
        is to be investigated, and the health status of the subjects 
        involved; or
            ``(ii) the clinical hold should be issued for such other 
        reasons as the Secretary may by regulation establish (including 
        reasons established by regulation before the date of the 
        enactment of the Food and Drug Administration Modernization Act 
        of 1997).

    ``(C) Any written request to the Secretary from the sponsor of an 
investigation that a clinical hold be removed shall receive a decision, 
in writing and specifying the reasons therefor, within 30 days after 
receipt of such request. Any such request shall include sufficient 
information to support the removal of such clinical hold.
    ``(4) Regulations under paragraph (1) shall provide that such 
exemption shall be conditioned upon the manufacturer, or the sponsor of 
the investigation, requiring that experts using such drugs for 
investigational purposes certify to such manufacturer or sponsor that 
they will inform any human beings to whom such drugs, or any controls 
used in connection therewith, are being administered, or their 
representatives, that such drugs are being used for investigational 
purposes and will obtain the consent of such human beings or their 
representatives, except where it is not feasible or it is contrary to 
the best interests of such human beings. Nothing in this subsection 
shall be construed to require any clinical investigator to submit 
directly to the Secretary reports on the investigational use of 
drugs.''.

<<NOTE: 21 USC 355 note.>> SEC. 118. DATA REQUIREMENTS FOR DRUGS AND 
            BIOLOGICS.

    Within 12 months after the date of enactment of this Act, the 
Secretary of Health and Human Services, acting through the Commissioner 
of Food and Drugs, shall issue guidance that describes when abbreviated 
study reports may be submitted, in lieu of full reports, with a new drug 
application under section 505(b) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(b)) and with a biologics license application under 
section 351 of the Public Health Service Act (42 U.S.C. 262) for certain 
types of studies. Such guidance shall describe the kinds of studies for 
which abbreviated reports are appropriate and the appropriate 
abbreviated report formats.

SEC. 119. CONTENT AND REVIEW OF APPLICATIONS.

    (a) Section 505(b).--Section 505(b) (21 U.S.C. 355(b)) is amended by 
adding at the end the following:
    ``(4)(A) The Secretary shall issue guidance for the individuals who 
review applications submitted under paragraph (1) or under section 351 
of the Public Health Service Act, which shall relate to promptness in 
conducting the review, technical excellence, lack of bias and conflict 
of interest, and knowledge of regulatory and scientific standards, and 
which shall apply equally to all individuals who review such 
applications.

[[Page 111 STAT. 2317]]

    ``(B) The Secretary shall meet with a sponsor of an investigation or 
an applicant for approval for a drug under this subsection or section 
351 of the Public Health Service Act if the sponsor or applicant makes a 
reasonable written request for a meeting for the purpose of reaching 
agreement on the design and size of clinical trials intended to form the 
primary basis of an effectiveness claim. The sponsor or applicant shall 
provide information necessary for discussion and agreement on the design 
and size of the clinical trials. Minutes of any such meeting shall be 
prepared by the Secretary and made available to the sponsor or applicant 
upon request.
    ``(C) Any agreement regarding the parameters of the design and size 
of clinical trials of a new drug under this paragraph that is reached 
between the Secretary and a sponsor or applicant shall be reduced to 
writing and made part of the administrative record by the Secretary. 
Such agreement shall not be changed after the testing begins, except--
            ``(i) with the written agreement of the sponsor or 
        applicant; or
            ``(ii) pursuant to a decision, made in accordance with 
        subparagraph (D) by the director of the reviewing division, that 
        a substantial scientific issue essential to determining the 
        safety or effectiveness of the drug has been identified after 
        the testing has begun.

    ``(D) A decision under subparagraph (C)(ii) by the director shall be 
in writing and the Secretary shall provide to the sponsor or applicant 
an opportunity for a meeting at which the director and the sponsor or 
applicant will be present and at which the director will document the 
scientific issue involved.
    ``(E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, the 
field or compliance division personnel unless such field or compliance 
division personnel demonstrate to the reviewing division why such 
decision should be modified.
    ``(F) No action by the reviewing division may be delayed because of 
the unavailability of information from or action by field personnel 
unless the reviewing division determines that a delay is necessary to 
assure the marketing of a safe and effective drug.
    ``(G) For purposes of this paragraph, the reviewing division is the 
division responsible for the review of an application for approval of a 
drug under this subsection or section 351 of the Public Health Service 
Act (including all scientific and medical matters, chemistry, 
manufacturing, and controls).''.
    (b) Section 505(j).--
            (1) Amendment.--Section 505(j) (21 U.S.C 355(j)) is 
        amended--
                    (A) by redesignating paragraphs (3) through (8) as 
                paragraphs (4) through (9), respectively; and
                    (B) by adding after paragraph (2) the following:

    ``(3)(A) The Secretary shall issue guidance for the individuals who 
review applications submitted under paragraph (1), which shall relate to 
promptness in conducting the review, technical excellence, lack of bias 
and conflict of interest, and knowledge of regulatory and scientific 
standards, and which shall apply equally to all individuals who review 
such applications.
    ``(B) The Secretary shall meet with a sponsor of an investigation or 
an applicant for approval for a drug under this subsection if the 
sponsor or applicant makes a reasonable written request for

[[Page 111 STAT. 2318]]

a meeting for the purpose of reaching agreement on the design and size 
of bioavailability and bioequivalence studies needed for approval of 
such application. The sponsor or applicant shall provide information 
necessary for discussion and agreement on the design and size of such 
studies. Minutes of any such meeting shall be prepared by the Secretary 
and made available to the sponsor or applicant.
    ``(C) Any agreement regarding the parameters of design and size of 
bioavailability and bioequivalence studies of a drug under this 
paragraph that is reached between the Secretary and a sponsor or 
applicant shall be reduced to writing and made part of the 
administrative record by the Secretary. Such agreement shall not be 
changed after the testing begins, except--
            ``(i) with the written agreement of the sponsor or 
        applicant; or
            ``(ii) pursuant to a decision, made in accordance with 
        subparagraph (D) by the director of the reviewing division, that 
        a substantial scientific issue essential to determining the 
        safety or effectiveness of the drug has been identified after 
        the testing has begun.

    ``(D) A decision under subparagraph (C)(ii) by the director shall be 
in writing and the Secretary shall provide to the sponsor or applicant 
an opportunity for a meeting at which the director and the sponsor or 
applicant will be present and at which the director will document the 
scientific issue involved.
    ``(E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, the 
field or compliance office personnel unless such field or compliance 
office personnel demonstrate to the reviewing division why such decision 
should be modified.
    ``(F) No action by the reviewing division may be delayed because of 
the unavailability of information from or action by field personnel 
unless the reviewing division determines that a delay is necessary to 
assure the marketing of a safe and effective drug.
    ``(G) For purposes of this paragraph, the reviewing division is the 
division responsible for the review of an application for approval of a 
drug under this subsection (including scientific matters, chemistry, 
manufacturing, and controls).''.
            (2) Conforming amendments.--Section 505(j) (21 U.S.C. 
        355(j)), as amended by paragraph (1), is further amended--
                    (A) in paragraph (2)(A)(i), by striking ``(6)'' and 
                inserting ``(7)'';
                    (B) in paragraph (4) (as redesignated in paragraph 
                (1)), by striking ``(4)'' and inserting ``(5)'';
                    (C) in paragraph (4)(I) (as redesignated in 
                paragraph (1)), by striking ``(5)'' and inserting 
                ``(6)''; and
                    (D) in paragraph (7)(C) (as redesignated in 
                paragraph (1)), by striking ``(5)'' each place it occurs 
                and inserting ``(6)''.

SEC. 120. SCIENTIFIC ADVISORY PANELS.

    Section 505 (21 U.S.C. 355) is amended by adding at the end the 
following:
    ``(n)(1) For the purpose of providing expert scientific advice and 
recommendations to the Secretary regarding a clinical investigation of a 
drug or the approval for marketing of a drug under section 505 or 
section 351 of the Public Health Service Act, the

[[Page 111 STAT. 2319]]

Secretary shall establish panels of experts or use panels of experts 
established before the date of enactment of the Food and Drug 
Administration Modernization Act of 1997, or both.
    ``(2) The Secretary may delegate the appointment and oversight 
authority granted under section 904 to a director of a center or 
successor entity within the Food and Drug Administration.
    ``(3) The Secretary shall make appointments to each panel 
established under paragraph (1) so that each panel shall consist of--
            ``(A) members who are qualified by training and experience 
        to evaluate the safety and effectiveness of the drugs to be 
        referred to the panel and who, to the extent feasible, possess 
        skill and experience in the development, manufacture, or 
        utilization of such drugs;
            ``(B) members with diverse expertise in such fields as 
        clinical and administrative medicine, pharmacy, pharmacology, 
        pharmacoeconomics, biological and physical sciences, and other 
        related professions;
            ``(C) a representative of consumer interests, and a 
        representative of interests of the drug manufacturing industry 
        not directly affected by the matter to be brought before the 
        panel; and
            ``(D) two or more members who are specialists or have other 
        expertise in the particular disease or condition for which the 
        drug under review is proposed to be indicated.

Scientific, trade, and consumer organizations shall be afforded an 
opportunity to nominate individuals for appointment to the panels. No 
individual who is in the regular full-time employ of the United States 
and engaged in the administration of this Act may be a voting member of 
any panel. The Secretary shall designate one of the members of each 
panel to serve as chairman thereof.
    ``(4) Each member of a panel shall publicly disclose all conflicts 
of interest that member may have with the work to be undertaken by the 
panel. No member of a panel may vote on any matter where the member or 
the immediate family of such member could gain financially from the 
advice given to the Secretary. The Secretary may grant a waiver of any 
conflict of interest requirement upon public disclosure of such conflict 
of interest if such waiver is necessary to afford the panel essential 
expertise, except that the Secretary may not grant a waiver for a member 
of a panel when the member's own scientific work is involved.
    ``(5) The Secretary shall, as appropriate, provide education and 
training to each new panel member before such member participates in a 
panel's activities, including education regarding requirements under 
this Act and related regulations of the Secretary, and the 
administrative processes and procedures related to panel meetings.
    ``(6) Panel members (other than officers or employees of the United 
States), while attending meetings or conferences of a panel or otherwise 
engaged in its business, shall be entitled to receive compensation for 
each day so engaged, including traveltime, at rates to be fixed by the 
Secretary, but not to exceed the daily equivalent of the rate in effect 
for positions classified above grade GS-15 of the General Schedule. 
While serving away from their homes or regular places of business, panel 
members may be allowed travel expenses (including per diem in lieu of 
subsistence) as authorized by section 5703 of title 5, United States 
Code, for persons in the Government service employed intermittently.

[[Page 111 STAT. 2320]]

    ``(7) The Secretary shall ensure that scientific advisory panels 
meet regularly and at appropriate intervals so that any matter to be 
reviewed by such a panel can be presented to the panel not more than 60 
days after the matter is ready for such review. Meetings of the panel 
may be held using electronic communication to convene the meetings.
    ``(8) Within 90 days after a scientific advisory panel makes 
recommendations on any matter under its review, the Food and Drug 
Administration official responsible for the matter shall review the 
conclusions and recommendations of the panel, and notify the affected 
persons of the final decision on the matter, or of the reasons that no 
such decision has been reached. Each such final decision shall be 
documented including the rationale for the decision.''.

SEC. 121. POSITRON EMISSION TOMOGRAPHY.

    (a) Regulation of Compounded Positron Emission Tomography Drugs.--
Section 201 (21 U.S.C. 321) is amended by adding at the end the 
following:
    ``(ii) The term `compounded positron emission tomography drug'--
            ``(1) means a drug that--
                    ``(A) exhibits spontaneous disintegration of 
                unstable nuclei by the emission of positrons and is used 
                for the purpose of providing dual photon positron 
                emission tomographic diagnostic images; and
                    ``(B) has been compounded by or on the order of a 
                practitioner who is licensed by a State to compound or 
                order compounding for a drug described in subparagraph 
                (A), and is compounded in accordance with that State's 
                law, for a patient or for research, teaching, or quality 
                control; and
            ``(2) includes any nonradioactive reagent, reagent kit, 
        ingredient, nuclide generator, accelerator, target material, 
        electronic synthesizer, or other apparatus or computer program 
        to be used in the preparation of such a drug.''.

    (b) Adulteration.--
            (1) In general.--Section 501(a) (21 U.S.C. 351(a)) is 
        amended by striking ``; or (3)'' and inserting the following: 
        ``; or (C) if it is a compounded positron emission tomography 
        drug and the methods used in, or the facilities and controls 
        used for, its compounding, processing, packing, or holding do 
        not conform to or are not operated or administered in conformity 
        with the positron emission tomography compounding standards and 
        the official monographs of the United States Pharmacopoeia to 
        assure that such drug meets the requirements of this Act as to 
        safety and has the identity and strength, and meets the quality 
        and purity characteristics, that it purports or is represented 
        to possess; or (3)''.
             <<NOTE: 21 USC 351 note.>> (2) Sunset.--Section 
        501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 351(a)(2)(C)) shall not apply 4 years after the date of 
        enactment of this Act or 2 years after the date on which the 
        Secretary of Health and Human Services establishes the 
        requirements described in subsection (c)(1)(B), whichever is 
        later.

[[Page 111 STAT. 2321]]

     <<NOTE: 21 USC 355 note.>> (c) Requirements for Review of Approval 
Procedures and Current Good Manufacturing Practices for Positron 
Emission Tomography.--
            (1) Procedures and requirements.--
                    (A) In general.--In order to take account of the 
                special characteristics of positron emission tomography 
                drugs and the special techniques and processes required 
                to produce these drugs, not later than 2 years after the 
                date of enactment of this Act, the Secretary of Health 
                and Human Services shall establish--
                          (i) appropriate procedures for the approval of 
                      positron emission tomography drugs pursuant to 
                      section 505 of the Federal Food, Drug, and 
                      Cosmetic Act (21 U.S.C. 355); and
                          (ii) appropriate current good manufacturing 
                      practice requirements for such drugs.
                    (B) Considerations and consultation.--In 
                establishing the procedures and requirements required by 
                subparagraph (A), the Secretary of Health and Human 
                Services shall take due account of any relevant 
                differences between not-for-profit institutions that 
                compound the drugs for their patients and commercial 
                manufacturers of the drugs. Prior to establishing the 
                procedures and requirements, the Secretary of Health and 
                Human Services shall consult with patient advocacy 
                groups, professional associations, manufacturers, and 
                physicians and scientists licensed to make or use 
                positron emission tomography drugs.
            (2) Submission of new drug applications and abbreviated new 
        drug applications.--
                    (A) In general.--Except as provided in subparagraph 
                (B), the Secretary of Health and Human Services shall 
                not require the submission of new drug applications or 
                abbreviated new drug applications under subsection (b) 
                or (j) of section 505 (21 U.S.C. 355), for compounded 
                positron emission tomography drugs that are not 
                adulterated drugs described in section 501(a)(2)(C) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                351(a)(2)(C)) (as amended by subsection (b)), for a 
                period of 4 years after the date of enactment of this 
                Act, or for 2 years after the date on which the 
                Secretary establishes procedures and requirements under 
                paragraph (1), whichever is longer.
                    (B) Exception.--Nothing in this Act shall prohibit 
                the voluntary submission of such applications or the 
                review of such applications by the Secretary of Health 
                and Human Services. Nothing in this Act shall constitute 
                an exemption for a positron emission tomography drug 
                from the requirements of regulations issued under 
                section 505(i) of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 355(i)).

     <<NOTE: Federal Register, publication.>> (d) Revocation of Certain 
Inconsistent Documents.--Within 30 days after the date of enactment of 
this Act, the Secretary of Health and Human Services shall publish in 
the Federal Register a notice terminating the application of the 
following notices and rule:
            (1) A notice entitled ``Regulation of Positron Emission 
        Tomography Radiopharmaceutical Drug Products; Guidance; Public 
        Workshop'', published in the Federal Register on February 27, 
        1995, 60 Fed. Reg. 10594.

[[Page 111 STAT. 2322]]

            (2) A notice entitled ``Draft Guideline on the Manufacture 
        of Positron Emission Tomography Radiopharmaceutical Drug 
        Products; Availability'', published in the Federal Register on 
        February 27, 1995, 60 Fed. Reg. 10593.
            (3) A final rule entitled ``Current Good Manufacturing 
        Practice for Finished Pharmaceuticals; Positron Emission 
        Tomography'', published in the Federal Register on April 22, 
        1997, 62 Fed. Reg. 19493 (codified at part 211 of title 21, Code 
        of Federal Regulations).

     <<NOTE: 21 USC 355 note.>> (e) Definition.--As used in this 
section, the term ``compounded positron emission tomography drug'' has 
the meaning given the term in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321).

<<NOTE: 21 USC 355 note.>> SEC. 122. REQUIREMENTS FOR 
            RADIOPHARMACEUTICALS.

    (a) Requirements.--
            (1) Regulations.--
                    (A) Proposed regulations.--Not later than 180 days 
                after the date of enactment of this Act, the Secretary 
                of Health and Human Services, after consultation with 
                patient advocacy groups, associations, physicians 
                licensed to use radiopharmaceuticals, and the regulated 
                industry, shall issue proposed regulations governing the 
                approval of radiopharmaceuticals. The regulations shall 
                provide that the determination of the safety and 
                effectiveness of such a radiopharmaceutical under 
                section 505 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 355) or section 351 of the Public Health 
                Service Act (42 U.S.C. 262) shall include consideration 
                of the proposed use of the radiopharmaceutical in the 
                practice of medicine, the pharmacological and 
                toxicological activity of the radiopharmaceutical 
                (including any carrier or ligand component of the 
                radiopharmaceutical), and the estimated absorbed 
                radiation dose of the radiopharmaceutical.
                    (B) Final regulations.--Not later than 18 months 
                after the date of enactment of this Act, the Secretary 
                shall promulgate final regulations governing the 
                approval of the radiopharmaceuticals.
            (2) Special rule.--In the case of a radiopharmaceutical, the 
        indications for which such radiopharmaceutical is approved for 
        marketing may, in appropriate cases, refer to manifestations of 
        disease (such as biochemical, physiological, anatomic, or 
        pathological processes) common to, or present in, one or more 
        disease states.

    (b) Definition.--In this section, the term ``radiopharma-ceutical'' 
means--
            (1) an article--
                    (A) that is intended for use in the diagnosis or 
                monitoring of a disease or a manifestation of a disease 
                in humans; and
                    (B) that exhibits spontaneous disintegration of 
                unstable nuclei with the emission of nuclear particles 
                or photons; or
            (2) any nonradioactive reagent kit or nuclide generator that 
        is intended to be used in the preparation of any such article.

[[Page 111 STAT. 2323]]

SEC. 123. MODERNIZATION OF REGULATION.

    (a) Licenses.--
            (1) In general.--Section 351(a) of the Public Health Service 
        Act (42 U.S.C. 262(a)) is amended to read as follows:

    ``(a)(1) No person shall introduce or deliver for introduction into 
interstate commerce any biological product unless--
            ``(A) a biologics license is in effect for the biological 
        product; and
            ``(B) each package of the biological product is plainly 
        marked with--
                    ``(i) the proper name of the biological product 
                contained in the package;
                    ``(ii) the name, address, and applicable license 
                number of the manufacturer of the biological product; 
                and
                    ``(iii) the expiration date of the biological 
                product.

    ``(2)(A) The Secretary shall establish, by regulation, requirements 
for the approval, suspension, and revocation of biologics licenses.
    ``(B) The Secretary shall approve a biologics license application--
            ``(i) on the basis of a demonstration that--
                    ``(I) the biological product that is the subject of 
                the application is safe, pure, and potent; and
                    ``(II) the facility in which the biological product 
                is manufactured, processed, packed, or held meets 
                standards designed to assure that the biological product 
                continues to be safe, pure, and potent; and
            ``(ii) if the applicant (or other appropriate person) 
        consents to the inspection of the facility that is the subject 
        of the application, in accordance with subsection (c).

    ``(3) The Secretary shall prescribe requirements under which a 
biological product undergoing investigation shall be exempt from the 
requirements of paragraph (1).''.
            (2) Elimination of existing license requirement.--Section 
        351(d) of the Public Health Service Act (42 U.S.C. 262(d)) is 
        amended--
                    (A) by striking ``(d)(1)'' and all that follows 
                through ``of this section.'';
                    (B) in paragraph (2)--
                          (i) by striking ``(2)(A) Upon'' and inserting 
                      ``(d)(1) Upon'' and
                          (ii) by redesignating subparagraph (B) as 
                      paragraph (2); and
                    (C) in paragraph (2) (as so redesignated by 
                subparagraph (B)(ii))--
                          (i) by striking ``subparagraph (A)'' and 
                      inserting ``paragraph (1)''; and
                          (ii) by striking ``this subparagraph'' each 
                      place it appears and inserting ``this paragraph''.

    (b) Labeling.--Section 351(b) of the Public Health Service Act (42 
U.S.C. 262(b)) is amended to read as follows:
    ``(b) No person shall falsely label or mark any package or container 
of any biological product or alter any label or mark on the package or 
container of the biological product so as to falsify the label or 
mark.''.

[[Page 111 STAT. 2324]]

    (c) Inspection.--Section 351(c) of the Public Health Service Act (42 
U.S.C. 262(c)) is amended by striking ``virus, serum,'' and all that 
follows and inserting ``biological product.''.
    (d) Definition; Application.--Section 351 of the Public Health 
Service Act (42 U.S.C. 262) is amended by adding at the end the 
following:
    ``(i) In this section, the term `biological product' means a virus, 
therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or 
derivative, allergenic product, or analogous product, or arsphenamine or 
derivative of arsphenamine (or any other trivalent organic arsenic 
compound), applicable to the prevention, treatment, or cure of a disease 
or condition of human beings.''.
    (e) Conforming Amendment.--Section 503(g)(4) (21 U.S.C. 353(g)(4)) 
is amended--
            (1) in subparagraph (A)--
                    (A) by striking ``section 351(a)'' and inserting 
                ``section 351(i)''; and
                    (B) by striking ``262(a)'' and inserting ``262(i)''; 
                and
            (2) in subparagraph (B)(iii), by striking ``product or 
        establishment license under subsection (a) or (d)'' and 
        inserting ``biologics license application under subsection 
        (a)''.

     <<NOTE: 21 USC 355 note.>> (f) Special Rule.--The Secretary of 
Health and Human Services shall take measures to minimize differences in 
the review and approval of products required to have approved biologics 
license applications under section 351 of the Public Health Service Act 
(42 U.S.C. 262) and products required to have approved new drug 
applications under section 505(b)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(b)(1)).

    (g) Application of Federal Food, Drug, and Cosmetic Act.--Section 
351 of the Public Health Service Act (42 U.S.C. 262), as amended by 
subsection (d), is further amended by adding at the end the following:
    ``(j) The Federal Food, Drug, and Cosmetic Act applies to a 
biological product subject to regulation under this section, except that 
a product for which a license has been approved under subsection (a) 
shall not be required to have an approved application under section 505 
of such Act.''.
    (h) Examinations and Procedures.--Paragraph (3) of section 353(d) of 
the Public Health Service Act (42 U.S.C. 263a(d)) is amended to read as 
follows:
            ``(3) Examinations and procedures.--The examinations and 
        procedures identified in paragraph (2) are laboratory 
        examinations and procedures that have been approved by the Food 
        and Drug Administration for home use or that, as determined by 
        the Secretary, are simple laboratory examinations and procedures 
        that have an insignificant risk of an erroneous result, 
        including those that--
                    ``(A) employ methodologies that are so simple and 
                accurate as to render the likelihood of erroneous 
                results by the user negligible, or
                    ``(B) the Secretary has determined pose no 
                unreasonable risk of harm to the patient if performed 
                incorrectly.''.

SEC. 124. PILOT AND SMALL SCALE MANUFACTURE.

    (a) Human Drugs.--Section 505(c) (21 U.S.C. 355(c)) is amended by 
adding at the end the following:

[[Page 111 STAT. 2325]]

    ``(4) A drug manufactured in a pilot or other small facility may be 
used to demonstrate the safety and effectiveness of the drug and to 
obtain approval for the drug prior to manufacture of the drug in a 
larger facility, unless the Secretary makes a determination that a full 
scale production facility is necessary to ensure the safety or 
effectiveness of the drug.''.
    (b) Animal Drugs.--Section 512(c) (21 U.S.C. 360b(c)) is amended by 
adding at the end the following:
    ``(4) A drug manufactured in a pilot or other small facility may be 
used to demonstrate the safety and effectiveness of the drug and to 
obtain approval for the drug prior to manufacture of the drug in a 
larger facility, unless the Secretary makes a determination that a full 
scale production facility is necessary to ensure the safety or 
effectiveness of the drug.''.

SEC. 125. INSULIN AND ANTIBIOTICS.

    (a) Certification of Drugs Containing Insulin.--
            (1) Amendment.--Section 506 (21 U.S.C. 356), as in effect 
        before the date of the enactment of this Act, is repealed.
            (2) Conforming amendments.--
                    (A) Section 301(j) (21 U.S.C. 331(j)) is amended by 
                striking ``506, 507,''.
                    (B) Subsection (k) of section 502 (21 U.S.C. 352) is 
                repealed.
                    (C) Sections 301(i)(1), 510(j)(1)(A), and 
                510(j)(1)(D) (21 U.S.C. 331(i)(1), 360(j)(1)(A), 
                360(j)(1)(D)) are each amended by striking ``, 506, 
                507,''.
                    (D) Section 801(d)(1) (21 U.S.C. 381(d)(1)) is 
                amended by inserting after ``503(b)'' the following: 
                ``or composed wholly or partly of insulin''.
                    (E) Section 8126(h)(2) of title 38, United States 
                Code, is amended by inserting ``or'' at the end of 
                subparagraph (B), by striking ``; or'' at the end of 
                subparagraph (C) and inserting a period, and by striking 
                subparagraph (D).

    (b) Certification of Antibiotics.--
            (1) Amendment.--Section 507 (21 U.S.C. 357) is repealed.
            (2) Conforming amendments.--
                    (A) Section 201(aa) (21 U.S.C. 321(aa)) is amended 
                by striking out ``or 507'', section 201(dd) (21 U.S.C. 
                321(dd)) is amended by striking ``507,'', and section 
                201(ff)(3)(A) (21 U.S.C. 321(ff)(3)(A)) is amended by 
                striking ``, certified as an antibiotic under section 
                507,''.
                    (B) Section 301(e) (21 U.S.C. 331(e)) is amended by 
                striking ``507(d) or (g),''.
                    (C) Section 306(d)(4)(B)(ii) (21 U.S.C. 
                335a(d)(4)(B)(ii)) is amended by striking ``or 507''.
                    (D) Section 502 (21 U.S.C. 352) is amended by 
                striking subsection (l).
                    (E) Section 520(l) (21 U.S.C. 360j(l)) is amended by 
                striking paragraph (4) and by striking ``or Antibiotic 
                Drugs'' in the subsection heading.
                    (F) Section 525(a) (21 U.S.C. 360aa(a)) is amended 
                by inserting ``or'' at the end of paragraph (1), by 
                striking paragraph (2), and by redesignating paragraph 
                (3) as paragraph (2).

[[Page 111 STAT. 2326]]

                    (G) Section 525(a) (21 U.S.C. 360aa(a)) is amended 
                by striking ``, certification of such drug for such 
                disease or condition under section 507,''.
                    (H) Section 526(a)(1) (21 U.S.C. 360bb) is amended 
                by striking ``the submission of an application for 
                certification of the drug under section 507,'', by 
                inserting ``or'' at the end of subparagraph (A), by 
                striking subparagraph (B), and by redesignating 
                subparagraph (C) as subparagraph (B).
                    (I) Section 526(b) (21 U.S.C. 360bb(b)) is amended--
                          (i) in paragraph (1), by striking ``, a 
                      certificate was issued for the drug under section 
                      507,''; and
                          (ii) in paragraph (2) by striking ``, a 
                      certificate has not been issued for the drug under 
                      section 507,'' and by striking ``, approval of an 
                      application for certification under section 
                      507,''.
                    (J) Section 527(a) (21 U.S.C. 360cc(a)) is amended 
                by inserting ``or'' at the end of paragraph (1), by 
                striking paragraph (2), by redesignating paragraph (3) 
                as paragraph (2), and by striking ``, issue another 
                certification under section 507,''.
                    (K) Section 527(b) (21 U.S.C. 360cc(b)) is amended 
                by striking ``, if a certification is issued under 
                section 507 for such a drug,'', ``, of the issuance of 
                the certification under section 507,'', ``, issue 
                another certification under section 507,'', ``, of such 
                certification,'', ``, of the certification,'', and ``, 
                issuance of other certifications,''.
                    (L) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is 
                amended by striking ``, section 507 (d) or (g),''.
                    (M) Section 735(1) (21 U.S.C. 379g(1)(C)) is amended 
                by inserting ``or'' at the end of subparagraph (B), by 
                striking subparagraph (C), and by redesignating 
                subparagraph (D) as subparagraph (C).
                    (N) Subparagraphs (A)(ii) and (B) of sections 
                5(b)(1) of the Orphan Drug Act (21 U.S.C. 
                360ee(b)(1)(A), 360ee(b)(1)(B)) are each amended by 
                striking ``or 507''.
                    (O) Section 45C(b)(2)(A)(ii)(II) of the Internal 
                Revenue Code of 1986 <<NOTE: 26 USC 45C.>>  is amended 
                by striking ``or 507''.
                    (P) Section 156(f)(4)(B) of title 35, United States 
                Code, is amended by striking ``507,'' each place it 
                occurs.

    (c) Exportation.--Section 802 (21 U.S.C. 382) is amended by adding 
at the end the following:
    ``(i) Insulin and antibiotic drugs may be exported without regard to 
the requirements in this section if the insulin and antibiotic drugs 
meet the requirements of section 801(e)(1).''.
     <<NOTE: 21 USC 355 note.>> (d) Transition.--
            (1) In general.--An application that was approved by the 
        Secretary of Health and Human Services before the date of the 
        enactment of this Act for the marketing of an antibiotic drug 
        under section 507 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 357), as in effect on the day before the date of the 
        enactment of this Act, shall, on and after such date of 
        enactment, be considered to be an application that was submitted 
        and filed under section 505(b) of such Act (21 U.S.C. 355(b)) 
        and approved for safety and effectiveness under section

[[Page 111 STAT. 2327]]

        505(c) of such Act (21 U.S.C. 355(c)), except that if such 
        application for marketing was in the form of an abbreviated 
        application, the application shall be considered to have been 
        filed and approved under section 505(j) of such Act (21 U.S.C. 
        355(j)).
            (2) Exception.--The following subsections of section 505 (21 
        U.S.C. 355) shall not apply to any application for marketing in 
        which the drug that is the subject of the application contains 
        an antibiotic drug and the antibiotic drug was the subject of 
        any application for marketing received by the Secretary of 
        Health and Human Services under section 507 of such Act (21 
        U.S.C. 357) before the date of the enactment of this Act:
                    (A)(i) Subsections (c)(2), (d)(6), (e)(4), 
                (j)(2)(A)(vii), (j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), 
                and (j)(4)(D); and
                    (ii) The third and fourth sentences of subsection 
                (b)(1) (regarding the filing and publication of patent 
                information); and
                    (B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and 
                (c)(3) if the investigations relied upon by the 
                applicant for approval of the application were not 
                conducted by or for the applicant and for which the 
                applicant has not obtained a right of reference or use 
                from the person by or for whom the investigations were 
                conducted.
            (3) Publication.--For purposes of this section, the 
        Secretary is authorized to make available to the public the 
        established name of each antibiotic drug that was the subject of 
        any application for marketing received by the Secretary for 
        Health and Human Services under section 507 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 357) before the date of 
        enactment of this Act.

    (e) Definition.--Section 201 (21 U.S.C. 321), as amended by section 
121(a)(1), is further amended by adding at the end the following:
    ``(jj) The term `antibiotic drug' means any drug (except drugs for 
use in animals other than humans) composed wholly or partly of any kind 
of penicillin, streptomycin, chlortetracycline, chloramphenicol, 
bacitracin, or any other drug intended for human use containing any 
quantity of any chemical substance which is produced by a micro-organism 
and which has the capacity to inhibit or destroy micro-organisms in 
dilute solution (including a chemically synthesized equivalent of any 
such substance) or any derivative thereof.''.

SEC. 126. ELIMINATION OF CERTAIN LABELING REQUIREMENTS.

    (a) Prescription Drugs.--Section 503(b)(4) (21 U.S.C. 353(b)(4)) is 
amended to read as follows:
    ``(4)(A) A drug that is subject to paragraph (1) shall be deemed to 
be misbranded if at any time prior to dispensing the label of the drug 
fails to bear, at a minimum, the symbol `Rx only'.
    ``(B) A drug to which paragraph (1) does not apply shall be deemed 
to be misbranded if at any time prior to dispensing the label of the 
drug bears the symbol described in subparagraph (A).''.
    (b) Misbranded Drug.--Section 502(d) (21 U.S.C. 352(d)) is repealed.
    (c) Conforming Amendments.--
            (1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended--
                    (A) by striking subparagraph (A); and

[[Page 111 STAT. 2328]]

                    (B) by redesignating subparagraphs (B) and (C) as 
                subparagraphs (A) and (B), respectively.
            (2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by 
        striking ``section 502(d) and''.
            (3) Section 102(9)(A) of the Controlled Substances Act (21 
        U.S.C. 802(9)(A)) is amended--
                    (A) in clause (i), by striking ``(i)''; and
                    (B) by striking ``(ii)'' and all that follows.
SEC. 127. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHARMACY 
                        COMPOUNDING.

    (a) Amendment.--Chapter V is amended by inserting after section 503 
(21 U.S.C. 353) the following:

<<NOTE: 21 USC 353a.>> ``SEC. 503A. PHARMACY COMPOUNDING.

    ``(a) In General.--Sections 501(a)(2)(B), 502(f)(1), and 505 shall 
not apply to a drug product if the drug product is compounded for an 
identified individual patient based on the unsolicited receipt of a 
valid prescription order or a notation, approved by the prescribing 
practitioner, on the prescription order that a compounded product is 
necessary for the identified patient, if the drug product meets the 
requirements of this section, and if the compounding--
            ``(1) is by--
                    ``(A) a licensed pharmacist in a State licensed 
                pharmacy or a Federal facility, or
                    ``(B) a licensed physician,
        on the prescription order for such individual patient made by a 
        licensed physician or other licensed practitioner authorized by 
        State law to prescribe drugs; or
            ``(2)(A) is by a licensed pharmacist or licensed physician 
        in limited quantities before the receipt of a valid prescription 
        order for such individual patient; and
            ``(B) is based on a history of the licensed pharmacist or 
        licensed physician receiving valid prescription orders for the 
        compounding of the drug product, which orders have been 
        generated solely within an established relationship between--
                    ``(i) the licensed pharmacist or licensed physician; 
                and
                    ``(ii)(I) such individual patient for whom the 
                prescription order will be provided; or
                    ``(II) the physician or other licensed practitioner 
                who will write such prescription order.

    ``(b) Compounded Drug.--
            ``(1) Licensed pharmacist and licensed physician.--A drug 
        product may be compounded under subsection (a) if the licensed 
        pharmacist or licensed physician--
                    ``(A) compounds the drug product using bulk drug 
                substances, as defined in regulations of the Secretary 
                published at section 207.3(a)(4) of title 21 of the Code 
                of Federal Regulations--
                          ``(i) that--
                                    ``(I) comply with the standards of 
                                an applicable United States 
                                Pharmacopoeia or National Formulary 
                                monograph, if a monograph exists, and 
                                the United States Pharmacopoeia chapter 
                                on pharmacy compounding;
                                    ``(II) if such a monograph does not 
                                exist, are drug substances that are 
                                components of drugs approved by the 
                                Secretary; or

[[Page 111 STAT. 2329]]

                                    ``(III) if such a monograph does not 
                                exist and the drug substance is not a 
                                component of a drug approved by the 
                                Secretary, that appear on a list 
                                developed by the Secretary through 
                                regulations issued by the Secretary 
                                under subsection (d);
                          ``(ii) that are manufactured by an 
                      establishment that is registered under section 510 
                      (including a foreign establishment that is 
                      registered under section 510(i)); and
                          ``(iii) that are accompanied by valid 
                      certificates of analysis for each bulk drug 
                      substance;
                    ``(B) compounds the drug product using ingredients 
                (other than bulk drug substances) that comply with the 
                standards of an applicable United States Pharmacopoeia 
                or National Formulary monograph, if a monograph exists, 
                and the United States Pharmacopoeia chapter on pharmacy 
                compounding;
                    ``(C) does not compound a drug product that appears 
                on a list published by the Secretary in the Federal 
                Register of drug products that have been withdrawn or 
                removed from the market because such drug products or 
                components of such drug products have been found to be 
                unsafe or not effective; and
                    ``(D) does not compound regularly or in inordinate 
                amounts (as defined by the Secretary) any drug products 
                that are essentially copies of a commercially available 
                drug product.
            ``(2) Definition.--For purposes of paragraph (1)(D), the 
        term `essentially a copy of a commercially available drug 
        product' does not include a drug product in which there is a 
        change, made for an identified individual patient, which 
        produces for that patient a significant difference, as 
        determined by the prescribing practitioner, between the 
        compounded drug and the comparable commercially available drug 
        product.
            ``(3) Drug product.--A drug product may be compounded under 
        subsection (a) only if--
                    ``(A) such drug product is not a drug product 
                identified by the Secretary by regulation as a drug 
                product that presents demonstrable difficulties for 
                compounding that reasonably demonstrate an adverse 
                effect on the safety or effectiveness of that drug 
                product; and
                    ``(B) such drug product is compounded in a State--
                          ``(i) that has entered into a memorandum of 
                      understanding with the Secretary which addresses 
                      the distribution of inordinate amounts of 
                      compounded drug products interstate and provides 
                      for appropriate investigation by a State agency of 
                      complaints relating to compounded drug products 
                      distributed outside such State; or
                          ``(ii) that has not entered into the 
                      memorandum of understanding described in clause 
                      (i) and the licensed pharmacist, licensed 
                      pharmacy, or licensed physician distributes (or 
                      causes to be distributed) compounded drug products 
                      out of the State in which they are compounded in 
                      quantities that do not exceed 5 percent of the 
                      total prescription orders dispensed or distributed 
                      by such pharmacy or physician.

[[Page 111 STAT. 2330]]

        The Secretary shall, in consultation with the National 
        Association of Boards of Pharmacy, develop a standard memorandum 
        of understanding for use by the States in complying with 
        subparagraph (B)(i).

    ``(c) Advertising and Promotion.--A drug may be compounded under 
subsection (a) only if the pharmacy, licensed pharmacist, or licensed 
physician does not advertise or promote the compounding of any 
particular drug, class of drug, or type of drug. The pharmacy, licensed 
pharmacist, or licensed physician may advertise and promote the 
compounding service provided by the licensed pharmacist or licensed 
physician.
    ``(d) Regulations.--
            ``(1) In general.--The Secretary shall issue regulations to 
        implement this section. Before issuing regulations to implement 
        subsections (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A), the 
        Secretary shall convene and consult an advisory committee on 
        compounding unless the Secretary determines that the issuance of 
        such regulations before consultation is necessary to protect the 
        public health. The advisory committee shall include 
        representatives from the National Association of Boards of 
        Pharmacy, the United States Pharmacopoeia, pharmacy, physician, 
        and consumer organizations, and other experts selected by the 
        Secretary.
            ``(2) Limiting compounding.--The Secretary, in consultation 
        with the United States Pharmacopoeia Convention, Incorporated, 
        shall promulgate regulations identifying drug substances that 
        may be used in compounding under subsection (b)(1)(A)(i)(III) 
        for which a monograph does not exist or which are not components 
        of drug products approved by the Secretary. The Secretary shall 
        include in the regulation the criteria for such substances, 
        which shall include historical use, reports in peer reviewed 
        medical literature, or other criteria the Secretary may 
        identify.

    ``(e) Application.--This section shall not apply to--
            ``(1) compounded positron emission tomography drugs as 
        defined in section 201(ii); or
            ``(2) radiopharmaceuticals.

    ``(f) Definition.--As used in this section, the term `compounding' 
does not include mixing, reconstituting, or other such acts that are 
performed in accordance with directions contained in approved labeling 
provided by the product's manufacturer and other manufacturer directions 
consistent with that labeling.''.
     <<NOTE: 21 USC 353a note.>> (b) Effective Date.--Section 503A of 
the Federal Food, Drug, and Cosmetic Act, added by subsection (a), shall 
take effect upon the expiration of the 1-year period beginning on the 
date of the enactment of this Act.

SEC. 128. REAUTHORIZATION OF CLINICAL PHARMACOLOGY PROGRAM.

    Section 2 of Public Law 102-222 (105 Stat. 1677) is amended--
            (1) in subsection (a), by striking ``a grant'' and all that 
        follows through ``Such grant'' and inserting the following: 
        ``grants for a pilot program for the training of individuals in 
        clinical pharmacology at appropriate medical schools. Such 
        grants''; and

[[Page 111 STAT. 2331]]

            (2) in subsection (b), by striking ``to carry out this 
        section'' and inserting ``, and for fiscal years 1998 through 
        2002 $3,000,000 for each fiscal year, to carry out this 
        section''.

<<NOTE: 21 USC 393 note.>> SEC. 129. REGULATIONS FOR SUNSCREEN PRODUCTS.

    Not later than 18 months after the date of enactment of this Act, 
the Secretary of Health and Human Services shall issue regulations for 
over-the-counter sunscreen products for the prevention or treatment of 
sunburn.

SEC. 130. REPORTS OF POSTMARKETING APPROVAL STUDIES.

    (a) In General.--Chapter V, as amended by section 116, is further 
amended by inserting after section 506A the following:

<<NOTE: 21 USC 356b.>> ``SEC. 506B. REPORTS OF POSTMARKETING STUDIES.

    ``(a) Submission.--
            ``(1) In general.--A sponsor of a drug that has entered into 
        an agreement with the Secretary to conduct a postmarketing study 
        of a drug shall submit to the Secretary, within 1 year after the 
        approval of such drug and annually thereafter until the study is 
        completed or terminated, a report of the progress of the study 
        or the reasons for the failure of the sponsor to conduct the 
        study. The report shall be submitted in such form as is 
        prescribed by the Secretary in regulations issued by the 
        Secretary.
            ``(2) Agreements prior to effective date.--Any agreement 
        entered into between the Secretary and a sponsor of a drug, 
        prior to the date of enactment of the Food and Drug 
        Administration Modernization Act of 1997, to conduct a 
        postmarketing study of a drug shall be subject to the 
        requirements of paragraph (1). An initial report for such an 
        agreement shall be submitted within 6 months after the date of 
        the issuance of the regulations under paragraph (1).

    ``(b) Consideration of Information as Public Information.--Any 
information pertaining to a report described in subsection (a) shall be 
considered to be public information to the extent that the information 
is necessary--
            ``(1) to identify the sponsor; and
            ``(2) to establish the status of a study described in 
        subsection (a) and the reasons, if any, for any failure to carry 
        out the study.

     <<NOTE: Federal Register, publication.>> ``(c) Status of Studies 
and Reports.--The Secretary shall annually develop and publish in the 
Federal Register a report that provides information on the status of the 
postmarketing studies--
            ``(1) that sponsors have entered into agreements to conduct; 
        and
            ``(2) for which reports have been submitted under subsection 
        (a)(1).''.

     <<NOTE: 21 USC 356b note.>> (b) Report to Congressional 
Committees.--Not later than October 1, 2001, the Secretary shall prepare 
and submit to the Committee on Labor and Human Resources of the Senate 
and the Committee on Commerce of the House of Representatives a report 
containing--
            (1) a summary of the reports submitted under section 506B of 
        the Federal Food, Drug, and Cosmetic Act;
            (2) an evaluation of--

[[Page 111 STAT. 2332]]

                    (A) the performance of the sponsors referred to in 
                such section in fulfilling the agreements with respect 
                to the conduct of postmarketing studies described in 
                such section of such Act; and
                    (B) the timeliness of the Secretary's review of the 
                postmarketing studies; and
            (3) any legislative recommendations respecting the 
        postmarketing studies.
SEC. 131. NOTIFICATION OF DISCONTINUANCE OF A LIFE SAVING PRODUCT.

    (a) In General.--Chapter V, as amended by section 130, is further 
amended by inserting after section 506B the following:

<<NOTE: 21 USC 356c.>> ``SEC. 506C. DISCONTINUANCE OF A LIFE SAVING 
            PRODUCT.

    ``(a) In General.--A manufacturer that is the sole manufacturer of a 
drug--
            ``(1) that is--
                    ``(A) life-supporting;
                    ``(B) life-sustaining; or
                    ``(C) intended for use in the prevention of a 
                debilitating disease or condition;
            ``(2) for which an application has been approved under 
        section 505(b) or 505(j); and
            ``(3) that is not a product that was originally derived from 
        human tissue and was replaced by a recombinant product,

shall notify the Secretary of a discontinuance of the manufacture of the 
drug at least 6 months prior to the date of the discontinuance.
    ``(b) Reduction in Notification Period.--The notification period 
required under subsection (a) for a manufacturer may be reduced if the 
manufacturer certifies to the Secretary that good cause exists for the 
reduction, such as a situation in which--
            ``(1) a public health problem may result from continuation 
        of the manufacturing for the 6-month period;
            ``(2) a biomaterials shortage prevents the continuation of 
        the manufacturing for the 6-month period;
            ``(3) a liability problem may exist for the manufacturer if 
        the manufacturing is continued for the 6-month period;
            ``(4) continuation of the manufacturing for the 6-month 
        period may cause substantial economic hardship for the 
        manufacturer;
            ``(5) the manufacturer has filed for bankruptcy under 
        chapter 7 or 11 of title 11, United States Code; or
            ``(6) the manufacturer can continue the distribution of the 
        drug involved for 6 months.

    ``(c) Distribution.--To the maximum extent practicable, the 
Secretary shall distribute information on the discontinuation of the 
drugs described in subsection (a) to appropriate physician and patient 
organizations.''.

                TITLE II--IMPROVING REGULATION OF DEVICES

SEC. 201. INVESTIGATIONAL DEVICE EXEMPTIONS.

    (a) In General.--Section 520(g) (21 U.S.C. 360j(g)) is amended by 
adding at the end the following:

[[Page 111 STAT. 2333]]

    ``(6)(A) Not later than 1 year after the date of the enactment of 
the Food and Drug Administration Modernization Act of 1997, the 
Secretary shall by regulation establish, with respect to a device for 
which an exemption under this subsection is in effect, procedures and 
conditions that, without requiring an additional approval of an 
application for an exemption or the approval of a supplement to such an 
application, permit--
            ``(i) developmental changes in the device (including 
        manufacturing changes) that do not constitute a significant 
        change in design or in basic principles of operation and that 
        are made in response to information gathered during the course 
        of an investigation; and
            ``(ii) changes or modifications to clinical protocols that 
        do not affect--
                    ``(I) the validity of data or information resulting 
                from the completion of an approved protocol, or the 
                relationship of likely patient risk to benefit relied 
                upon to approve a protocol;
                    ``(II) the scientific soundness of an 
                investigational plan submitted under paragraph (3)(A); 
                or
                    ``(III) the rights, safety, or welfare of the human 
                subjects involved in the investigation.

    ``(B) Regulations under subparagraph (A) shall provide that a change 
or modification described in such subparagraph may be made if--
            ``(i) the sponsor of the investigation determines, on the 
        basis of credible information (as defined by the Secretary) that 
        the applicable conditions under subparagraph (A) are met; and
            ``(ii) the sponsor submits to the Secretary, not later than 
        5 days after making the change or modification, a notice of the 
        change or modification.

    ``(7)(A) In the case of a person intending to investigate the safety 
or effectiveness of a class III device or any implantable device, the 
Secretary shall ensure that the person has an opportunity, prior to 
submitting an application to the Secretary or to an institutional review 
committee, to submit to the Secretary, for review, an investigational 
plan (including a clinical protocol). If the applicant submits a written 
request for a meeting with the Secretary regarding such review, the 
Secretary shall, not later than 30 days after receiving the request, 
meet with the applicant for the purpose of reaching agreement regarding 
the investigational plan (including a clinical protocol). The written 
request shall include a detailed description of the device, a detailed 
description of the proposed conditions of use of the device, a proposed 
plan (including a clinical protocol) for determining whether there is a 
reasonable assurance of effectiveness, and, if available, information 
regarding the expected performance from the device.
    ``(B) Any agreement regarding the parameters of an investigational 
plan (including a clinical protocol) that is reached between the 
Secretary and a sponsor or applicant shall be reduced to writing and 
made part of the administrative record by the Secretary. Any such 
agreement shall not be changed, except--
            ``(i) with the written agreement of the sponsor or 
        applicant; or
            ``(ii) pursuant to a decision, made in accordance with 
        subparagraph (C) by the director of the office in which the 
        device involved is reviewed, that a substantial scientific issue

[[Page 111 STAT. 2334]]

        essential to determining the safety or effectiveness of the 
        device involved has been identified.

    ``(C) A decision under subparagraph (B)(ii) by the director shall be 
in writing, and may be made only after the Secretary has provided to the 
sponsor or applicant an opportunity for a meeting at which the director 
and the sponsor or applicant are present and at which the director 
documents the scientific issue involved.''.
    (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 following:
    ``(iii) The Secretary shall accept and review statistically valid 
and reliable data and any other information from investigations 
conducted under the authority of regulations required by section 520(g) 
to make a determination of whether there is a reasonable assurance of 
safety and effectiveness of a device subject to a pending application 
under this section if--
            ``(I) the data or information is derived from investigations 
        of an earlier version of the device, the device has been 
        modified during or after the investigations (but prior to 
        submission of an application under subsection (c)) and such a 
        modification of the device does not constitute a significant 
        change in the design or in the basic principles of operation of 
        the device that would invalidate the data or information; or
            ``(II) the data or information relates to a device approved 
        under this section, is available for use under this Act, and is 
        relevant to the design and intended use of the device for which 
        the application is pending.''.

SEC. 202. SPECIAL REVIEW FOR CERTAIN DEVICES.

    Section 515(d) (21 U.S.C. 360e(d)) is amended--
            (1) by redesignating paragraph (3) as paragraph (4); and
            (2) by adding at the end the following:

    ``(5) In order to provide for more effective treatment or diagnosis 
of life-threatening or irreversibly debilitating human diseases or 
conditions, the Secretary shall provide review priority for devices--
            ``(A) representing breakthrough technologies,
            ``(B) for which no approved alternatives exist,
            ``(C) which offer significant advantages over existing 
        approved alternatives, or
            ``(D) the availability of which is in the best interest of 
        the patients.''.

SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES.

    Section 520(m) (21 U.S.C. 360j(m)) is amended--
            (1) in paragraph (2), by adding after and below subparagraph 
        (C) the following sentences:

``The request shall be in the form of an application submitted to the 
Secretary. Not later than 75 days after the date of the receipt of the 
application, the Secretary shall issue an order approving or denying the 
application.'';
            (2) in paragraph (4)--
                    (A) in subparagraph (B), by inserting after 
                ``(2)(A)'' the following: ``, unless a physician 
                determines in an emergency situation that approval from 
                a local institutional review committee can not be 
                obtained in time to prevent serious harm or death to a 
                patient''; and
                    (B) by adding after and below subparagraph (B) the 
                following:

[[Page 111 STAT. 2335]]

``In a case described in subparagraph (B) in which a physician uses a 
device without an approval from an institutional review committee, the 
physician shall, after the use of the device, notify the chairperson of 
the local institutional review committee of such use. Such notification 
shall include the identification of the patient involved, the date on 
which the device was used, and the reason for the use.'';
            (3) by amending paragraph (5) to read as follows:

    ``(5) The Secretary may require a person granted an exemption under 
paragraph (2) to demonstrate continued compliance with the requirements 
of this subsection if the Secretary believes such demonstration to be 
necessary to protect the public health or if the Secretary has reason to 
believe that the criteria for the exemption are no longer met.''; and
            (4) by amending paragraph (6) to read as follows:

    ``(6) The Secretary may suspend or withdraw an exemption from the 
effectiveness requirements of sections 514 and 515 for a humanitarian 
device only after providing notice and an opportunity for an informal 
hearing.''.

SEC. 204. DEVICE STANDARDS.

    (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is amended 
by adding at the end the following:

                       ``Recognition of a Standard

     <<NOTE: Federal Register, publication.>> ``(c)(1)(A) In addition to 
establishing a performance standard under this section, the Secretary 
shall, by publication in the Federal Register, recognize all or part of 
an appropriate standard established by a nationally or internationally 
recognized standard development organization for which a person may 
submit a declaration of conformity in order to meet a premarket 
submission requirement or other requirement under this Act to which such 
standard is applicable.

    ``(B) If a person elects to use a standard recognized by the 
Secretary under subparagraph (A) to meet the requirements described in 
such subparagraph, the person shall provide a declaration of conformity 
to the Secretary that certifies that the device is in conformity with 
such standard. A person may elect to use data, or information, other 
than data required by a standard recognized under subparagraph (A) to 
meet any requirement regarding devices under this Act.
     <<NOTE: Federal Register, publication.>> ``(2) The Secretary may 
withdraw such recognition of a standard through publication of a notice 
in the Federal Register if the Secretary determines that the standard is 
no longer appropriate for meeting a requirement regarding devices under 
this Act.

    ``(3)(A) Subject to subparagraph (B), the Secretary shall accept a 
declaration of conformity that a device is in conformity with a standard 
recognized under paragraph (1) unless the Secretary finds--
            ``(i) that the data or information submitted to support such 
        declaration does not demonstrate that the device is in 
        conformity with the standard identified in the declaration of 
        conformity; or
            ``(ii) that the standard identified in the declaration of 
        conformity is not applicable to the particular device under 
        review.

[[Page 111 STAT. 2336]]

    ``(B) The Secretary may request, at any time, the data or 
information relied on by the person to make a declaration of conformity 
with respect to a standard recognized under paragraph (1).
    ``(C) A person making a declaration of conformity with respect to a 
standard recognized under paragraph (1) shall maintain the data and 
information demonstrating conformity of the device to the standard for a 
period of two years after the date of the classification or approval of 
the device by the Secretary or a period equal to the expected design 
life of the device, whichever is longer.''.
    (b) Section 301.--Section 301 (21 U.S.C. 331) is amended by adding 
at the end the following:
    ``(x) The falsification of a declaration of conformity submitted 
under section 514(c) or the failure or refusal to provide data or 
information requested by the Secretary under paragraph (3) of such 
section.''.
    (c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is amended--
            (1) by striking ``(e)'' and inserting ``(e)(1)''; and
            (2) by inserting at the end the following:

    ``(2) If it is declared to be, purports to be, or is represented as, 
a device that is in conformity with any standard recognized under 
section 514(c) unless such device is in all respects in conformity with 
such standard.''.
    (d) Conforming Amendments.--Section 514(a) (21 U.S.C. 360d(a)) is 
amended--
            (1) in paragraph (1), in the second sentence, by striking 
        ``under this section'' and inserting ``under subsection (b)'';
            (2) in paragraph (2), in the matter preceding subparagraph 
        (A), by striking ``under this section'' and inserting ``under 
        subsection (b)'';
            (3) in paragraph (3), by striking ``under this section'' and 
        inserting ``under subsection (b)''; and
            (4) in paragraph (4), in the matter preceding subparagraph 
        (A), by striking ``this section'' and inserting ``this 
        subsection and subsection (b)''.
SEC. 205. SCOPE OF REVIEW; COLLABORATIVE DETERMINATIONS OF DEVICE 
                        DATA REQUIREMENTS.

    (a) Section 513(a).--Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is 
amended by adding at the end the following:
    ``(C) In making a determination of a reasonable assurance of the 
effectiveness of a device for which an application under section 515 has 
been submitted, the Secretary shall consider whether the extent of data 
that otherwise would be required for approval of the application with 
respect to effectiveness can be reduced through reliance on postmarket 
controls.
    ``(D)(i) The Secretary, upon the written request of any person 
intending to submit an application under section 515, shall meet with 
such person to determine the type of valid scientific evidence (within 
the meaning of subparagraphs (A) and (B)) that will be necessary to 
demonstrate for purposes of approval of an application the effectiveness 
of a device for the conditions of use proposed by such person. The 
written request shall include a detailed description of the device, a 
detailed description of the proposed conditions of use of the device, a 
proposed plan for determining whether there is a reasonable assurance of 
effectiveness, and, if available,

[[Page 111 STAT. 2337]]

information regarding the expected performance from the device. Within 
30 days after such meeting, the Secretary shall specify in writing the 
type of valid scientific evidence that will provide a reasonable 
assurance that a device is effective under the conditions of use 
proposed by such person.
    ``(ii) Any clinical data, including one or more well-controlled 
investigations, specified in writing by the Secretary for demonstrating 
a reasonable assurance of device effectiveness shall be specified as 
result of a determination by the Secretary that such data are necessary 
to establish device effectiveness. The Secretary shall consider, in 
consultation with the applicant, the least burdensome appropriate means 
of evaluating device effectiveness that would have a reasonable 
likelihood of resulting in approval.
    ``(iii) The determination of the Secretary with respect to the 
specification of valid scientific evidence under clauses (i) and (ii) 
shall be binding upon the Secretary, unless such determination by the 
Secretary could be contrary to the public health.''.
    (b) Section 513(i).--Section 513(i)(1) (21 U.S.C. 360c(i)(1)) is 
amended by adding at the end the following:
    ``(C) To facilitate reviews of reports submitted to the Secretary 
under section 510(k), the Secretary shall consider the extent to which 
reliance on postmarket controls may expedite the classification of 
devices under subsection (f)(1) of this section.
    ``(D) Whenever the Secretary requests information to demonstrate 
that devices with differing technological characteristics are 
substantially equivalent, the Secretary shall only request information 
that is necessary to making substantial equivalence determinations. In 
making such request, the Secretary shall consider the least burdensome 
means of demonstrating substantial equivalence and request information 
accordingly.
    ``(E)(i) Any determination by the Secretary of the intended use of a 
device shall be based upon the proposed labeling submitted in a report 
for the device under section 510(k). However, when determining that a 
device can be found substantially equivalent to a legally marketed 
device, the director of the organizational unit responsible for 
regulating devices (in this subparagraph referred to as the `Director') 
may require a statement in labeling that provides appropriate 
information regarding a use of the device not identified in the proposed 
labeling if, after providing an opportunity for consultation with the 
person who submitted such report, the Director determines and states in 
writing--
            ``(I) that there is a reasonable likelihood that the device 
        will be used for an intended use not identified in the proposed 
        labeling for the device; and
            ``(II) that such use could cause harm.

    ``(ii) Such determination shall--
            ``(I) be provided to the person who submitted the report 
        within 10 days from the date of the notification of the 
        Director's concerns regarding the proposed labeling;
            ``(II) specify the limitations on the use of the device not 
        included in the proposed labeling; and
            ``(III) find the device substantially equivalent if the 
        requirements of subparagraph (A) are met and if the labeling for 
        such device conforms to the limitations specified in subclause 
        (II).

    ``(iii) The responsibilities of the Director under this subparagraph 
may not be delegated.

[[Page 111 STAT. 2338]]

    ``(iv) This subparagraph has no legal effect after the expiration of 
the five-year period beginning on the date of the enactment of the Food 
and Drug Administration Modernization Act of 1997.''.
    (c) Section 515(d).--Section 515(d) (21 U.S.C. 360e(d)) is amended--
            (1) in paragraph (1)(A), by adding after and below clause 
        (ii) the following:

``In making the determination whether to approve or deny the 
application, the Secretary shall rely on the conditions of use included 
in the proposed labeling as the basis for determining whether or not 
there is a reasonable assurance of safety and effectiveness, if the 
proposed labeling is neither false nor misleading. In determining 
whether or not such labeling is false or misleading, the Secretary shall 
fairly evaluate all material facts pertinent to the proposed 
labeling.''; and
            (2) by adding after paragraph (5) (as added by section 
        202(2)) the following:

    ``(6)(A)(i) A supplemental application shall be required for any 
change to a device subject to an approved application under this 
subsection that affects safety or effectiveness, unless such change is a 
modification in a manufacturing procedure or method of manufacturing and 
the holder of the approved application submits a written notice to the 
Secretary that describes in detail the change, summarizes the data or 
information supporting the change, and informs the Secretary that the 
change has been made under the requirements of section 520(f).
    ``(ii) The holder of an approved application who submits a notice 
under clause (i) with respect to a manufacturing change of a device may 
distribute the device 30 days after the date on which the Secretary 
receives the notice, unless the Secretary within such 30-day period 
notifies the holder that the notice is not adequate and describes such 
further information or action that is required for acceptance of such 
change. If the Secretary notifies the holder that a supplemental 
application is required, the Secretary shall review the supplement 
within 135 days after the receipt of the supplement. The time used by 
the Secretary to review the notice of the manufacturing change shall be 
deducted from the 135-day review period if the notice meets appropriate 
content requirements for premarket approval supplements.
    ``(B)(i) Subject to clause (ii), in reviewing a supplement to an 
approved application, for an incremental change to the design of a 
device that affects safety or effectiveness, the Secretary shall approve 
such supplement if--
            ``(I) nonclinical data demonstrate that the design 
        modification creates the intended additional capacity, function, 
        or performance of the device; and
            ``(II) clinical data from the approved application and any 
        supplement to the approved application provide a reasonable 
        assurance of safety and effectiveness for the changed device.

    ``(ii) The Secretary may require, when necessary, additional 
clinical data to evaluate the design modification of the device to 
provide a reasonable assurance of safety and effectiveness.''.

SEC. 206. PREMARKET NOTIFICATION.

    (a) Section 510.--Section 510 (21 U.S.C. 360) is amended--

[[Page 111 STAT. 2339]]

            (1) in subsection (k), in the matter preceding paragraph 
        (1), by adding after ``report to the Secretary'' the following: 
        ``or person who is accredited under section 523(a)''; and
            (2) by adding at the end the following subsections:

    ``(l) A report under subsection (k) is not required for a device 
intended for human use that is exempted from the requirements of this 
subsection under subsection (m) or is within a type that has been 
classified into class I under section 513. The exception established in 
the preceding sentence does not apply to any class I device that is 
intended for a use which is of substantial importance in preventing 
impairment of human health, or to any class I device that presents a 
potential unreasonable risk of illness or injury.
     <<NOTE: Federal Register, publication.>> ``(m)(1) Not later than 60 
days after the date of enactment of the Food and Drug Administration 
Modernization Act of 1997, the Secretary shall publish in the Federal 
Register a list of each type of class II device that does not require a 
report under subsection (k) to provide reasonable assurance of safety 
and effectiveness. Each type of class II device identified by the 
Secretary as not requiring the report shall be exempt from the 
requirement to provide a report under subsection (k) as of the date of 
the publication of the list in the Federal Register.

    ``(2) Beginning on the date that is 1 day after the date of the 
publication of a list under this subsection, the Secretary may exempt a 
class II device from the requirement to submit a report under subsection 
(k), upon the Secretary's own initiative or a petition of an interested 
person, if the Secretary determines that such report is not necessary to 
assure the safety and effectiveness of the device. <<NOTE: Federal 
Register, publication.>>  The Secretary shall publish in the Federal 
Register notice of the intent of the Secretary to exempt the device, or 
of the petition, and provide a 30-day period for public comment. Within 
120 days <<NOTE: Federal Register, publication.>>  after the issuance of 
the notice in the Federal Register, the Secretary shall publish an order 
in the Federal Register that sets forth the final determination of the 
Secretary regarding the exemption of the device that was the subject of 
the notice. If the Secretary fails to respond to a petition within 180 
days of receiving it, the petition shall be deemed to be granted.''.

    (b) Section 513(f).--Section 513(f) (21 U.S.C. 360c(f)) is amended 
by adding at the end the following:
    ``(5) The Secretary may not withhold a determination of the initial 
classification of a device under paragraph (1) because of a failure to 
comply with any provision of this Act unrelated to a substantial 
equivalence decision, including a finding that the facility in which the 
device is manufactured is not in compliance with good manufacturing 
requirements as set forth in regulations of the Secretary under section 
520(f) (other than a finding that there is a substantial likelihood that 
the failure to comply with such regulations will potentially present a 
serious risk to human health).''.
    (c) Section 513(i).--Section 513(i)(1) (21 U.S.C. 360c(i)), as 
amended by section 205(b), is amended--
            (1) in subparagraph (A)(ii)--
                    (A) in subclause (I), by striking ``clinical data'' 
                and inserting ``appropriate clinical or scientific 
                data'' and by inserting ``or a person accredited under 
                section 523'' after ``Secretary''; and
                    (B) in subclause (II), by striking ``efficacy'' and 
                inserting ``effectiveness''; and

[[Page 111 STAT. 2340]]

            (2) by adding at the end the following:

    ``(F) Not later than 270 days after the date of the enactment of the 
Food and Drug Administration Modernization Act of 1997, the Secretary 
shall issue guidance specifying the general principles that the 
Secretary will consider in determining when a specific intended use of a 
device is not reasonably included within a general use of such device 
for purposes of a determination of substantial equivalence under 
subsection (f) or section 520(l).''.

SEC. 207. EVALUATION OF AUTOMATIC CLASS III DESIGNATION.

    Section 513(f) (21 U.S.C. 360c(f)), as amended by section 206(b), is 
amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (B), by striking ``paragraph 
                (2)'' and inserting ``paragraph (3)''; and
                    (B) in the last sentence, by striking ``paragraph 
                (2)'' and inserting ``paragraph (2) or (3)'';
            (2) by redesignating paragraphs (2) and (3) as paragraphs 
        (3) and (4), respectively; and
            (3) by inserting after paragraph (1) the following:

    ``(2)(A) Any person who submits a report under section 510(k) for a 
type of device that has not been previously classified under this Act, 
and that is classified into class III under paragraph (1), may request, 
within 30 days after receiving written notice of such a classification, 
the Secretary to classify the device under the criteria set forth in 
subparagraphs (A) through (C) of subsection (a)(1). The person may, in 
the request, recommend to the Secretary a classification for the device. 
Any such request shall describe the device and provide detailed 
information and reasons for the recommended classification.
    ``(B)(i) Not later than 60 days after the date of the submission of 
the request under subparagraph (A), the Secretary shall by written order 
classify the device involved. Such classification shall be the initial 
classification of the device for purposes of paragraph (1) and any 
device classified under this paragraph shall be a predicate device for 
determining substantial equivalence under paragraph (1).
    ``(ii) A device that remains in class III under this subparagraph 
shall be deemed to be adulterated within the meaning of section 
501(f)(1)(B) until approved under section 515 or exempted from such 
approval under section 520(g).
     <<NOTE: Federal Register, publication.>> ``(C) Within 30 days after 
the issuance of an order classifying a device under this paragraph, the 
Secretary shall publish a notice in the Federal Register announcing such 
classification.''.

SEC. 208. CLASSIFICATION PANELS.

    Section 513(b) (21 U.S.C. 360c(b)) is amended by adding at the end 
the following:
    ``(5) Classification panels covering each type of device shall be 
scheduled to meet at such times as may be appropriate for the Secretary 
to meet applicable statutory deadlines.
    ``(6)(A) Any person whose device is specifically the subject of 
review by a classification panel shall have--
            ``(i) the same access to data and information submitted to a 
        classification panel (except for data and information that are 
        not available for public disclosure under section 552 of title 
        5, United States Code) as the Secretary;

[[Page 111 STAT. 2341]]

            ``(ii) the opportunity to submit, for review by a 
        classification panel, information that is based on the data or 
        information provided in the application submitted under section 
        515 by the person, which information shall be submitted to the 
        Secretary for prompt transmittal to the classification panel; 
        and
            ``(iii) the same opportunity as the Secretary to participate 
        in meetings of the panel.

    ``(B) Any meetings of a classification panel shall provide adequate 
time for initial presentations and for response to any differing views 
by persons whose devices are specifically the subject of a 
classification panel review, and shall encourage free and open 
participation by all interested persons.
    ``(7) After receiving from a classification panel the conclusions 
and recommendations of the panel on a matter that the panel has 
reviewed, the Secretary shall review the conclusions and 
recommendations, shall make a final decision on the matter in accordance 
with section 515(d)(2), and shall notify the affected persons of the 
decision in writing and, if the decision differs from the conclusions 
and recommendations of the panel, shall include the reasons for the 
difference.
    ``(8) A classification panel under this subsection shall not be 
subject to the annual chartering and annual report requirements of the 
Federal Advisory Committee Act.''.
SEC. 209. CERTAINTY OF REVIEW TIMEFRAMES; COLLABORATIVE REVIEW 
                        PROCESS.

    (a) Certainty of Review Timeframes.--Section 510 (21 U.S.C. 360), as 
amended by section 206(a)(2), is amended by adding at the end the 
following subsection:
    ``(n) The Secretary shall review the report required in subsection 
(k) and make a determination under section 513(f)(1) not later than 90 
days after receiving the report.''.
    (b) Collaborative Review Process.--Section 515(d) (21 U.S.C. 
360e(d)), as amended by section 202(1), is amended by inserting after 
paragraph (2) the following:
    ``(3)(A)(i) The Secretary shall, upon the written request of an 
applicant, meet with the applicant, not later than 100 days after the 
receipt of an application that has been filed as complete under 
subsection (c), to discuss the review status of the application.
    ``(ii) The Secretary shall, in writing and prior to the meeting, 
provide to the applicant a description of any deficiencies in the 
application that, at that point, have been identified by the Secretary 
based on an interim review of the entire application and identify the 
information that is required to correct those deficiencies.
    ``(iii) The Secretary shall notify the applicant promptly of--
            ``(I) any additional deficiency identified in the 
        application, or
            ``(II) any additional information required to achieve 
        completion of the review and final action on the application,

that was not described as a deficiency in the written description 
provided by the Secretary under clause (ii).
    ``(B) The Secretary and the applicant may, by mutual consent, 
establish a different schedule for a meeting required under this 
paragraph.

[[Page 111 STAT. 2342]]

SEC. 210. ACCREDITATION OF PERSONS FOR REVIEW OF PREMARKET 
                        NOTIFICATION REPORTS.

    (a) In General.--Subchapter A of chapter V is amended by adding at 
the end the following:

<<NOTE: 21 USC 360m.>> ``SEC. 523. ACCREDITED PERSONS.

    ``(a) In General.--
            ``(1) Review and classification of devices.--Not later than 
        1 year after the date of the enactment of the Food and Drug 
        Administration Modernization Act of 1997, the Secretary shall, 
        subject to paragraph (3), accredit persons for the purpose of 
        reviewing reports submitted under section 510(k) and making 
        recommendations to the Secretary regarding the initial 
        classification of devices under section 513(f)(1).
            ``(2) Requirements regarding review.--
                    ``(A) In general.--In making a recommendation to the 
                Secretary under paragraph (1), an accredited person 
                shall notify the Secretary in writing of the reasons for 
                the recommendation.
                    ``(B) Time period for review.--Not later than 30 
                days after the date on which the Secretary is notified 
                under subparagraph (A) by an accredited person with 
                respect to a recommendation of an initial classification 
                of a device, the Secretary shall make a determination 
                with respect to the initial classification.
                    ``(C) Special rule.--The Secretary may change the 
                initial classification under section 513(f)(1) that is 
                recommended under paragraph (1) by an accredited person, 
                and in such case shall provide to such person, and the 
                person who submitted the report under section 510(k) for 
                the device, a statement explaining in detail the reasons 
                for the change.
            ``(3) Certain devices.--
                    ``(A) In general.--An accredited person may not be 
                used to perform a review of--
                          ``(i) a class III device;
                          ``(ii) a class II device which is intended to 
                      be permanently implantable or life sustaining or 
                      life supporting; or
                          ``(iii) a class II device which requires 
                      clinical data in the report submitted under 
                      section 510(k) for the device, except that the 
                      number of class II devices to which the Secretary 
                      applies this clause for a year, less the number of 
                      such reports to which clauses (i) and (ii) apply, 
                      may not exceed 6 percent of the number that is 
                      equal to the total number of reports submitted to 
                      the Secretary under such section for such year 
                      less the number of such reports to which such 
                      clauses apply for such year.
                    ``(B) Adjustment.--In determining for a year the 
                ratio described in subparagraph (A)(iii), the Secretary 
                shall not include in the numerator class III devices 
                that the Secretary reclassified into class II, and the 
                Secretary shall include in the denominator class II 
                devices for which reports under section 510(k) were not 
                required to be submitted by reason of the operation of 
                section 510(m).

    ``(b) Accreditation.--

[[Page 111 STAT. 2343]]

            ``(1) Programs.--The Secretary shall provide for such 
        accreditation through programs administered by the Food and Drug 
        Administration, other government agencies, or by other qualified 
        nongovernment organizations.
            ``(2) Accreditation.--
                     <<NOTE: Federal Register, publication.>> ``(A) In 
                general.--Not later than 180 days after the date of the 
                enactment of the Food and Drug Administration 
                Modernization Act of 1997, the Secretary shall establish 
                and publish in the Federal Register criteria to accredit 
                or deny accreditation to persons who request to perform 
                the duties specified in subsection (a). The Secretary 
                shall respond to a request for accreditation within 60 
                days of the receipt of the request. The accreditation of 
                such person shall specify the particular activities 
                under subsection (a) for which such person is 
                accredited.
                    ``(B) Withdrawal of accreditation.--The Secretary 
                may suspend or withdraw accreditation of any person 
                accredited under this paragraph, after providing notice 
                and an opportunity for an informal hearing, when such 
                person is substantially not in compliance with the 
                requirements of this section or poses a threat to public 
                health or fails to act in a manner that is consistent 
                with the purposes of this section.
                    ``(C) Performance auditing.--To ensure that persons 
                accredited under this section will continue to meet the 
                standards of accreditation, the Secretary shall--
                          ``(i) make onsite visits on a periodic basis 
                      to each accredited person to audit the performance 
                      of such person; and
                          ``(ii) take such additional measures as the 
                      Secretary determines to be appropriate.
                    ``(D) Annual report.--The Secretary shall include in 
                the annual report required under section 903(g) the 
                names of all accredited persons and the particular 
                activities under subsection (a) for which each such 
                person is accredited and the name of each accredited 
                person whose accreditation has been withdrawn during the 
                year.
            ``(3) Qualifications.--An accredited person shall, at a 
        minimum, meet the following requirements:
                    ``(A) Such person may not be an employee of the 
                Federal Government.
                    ``(B) Such person shall be an independent 
                organization which is not owned or controlled by a 
                manufacturer, supplier, or vendor of devices and which 
                has no organizational, material, or financial 
                affiliation with such a manufacturer, supplier, or 
                vendor.
                    ``(C) Such person shall be a legally constituted 
                entity permitted to conduct the activities for which it 
                seeks accreditation.
                    ``(D) Such person shall not engage in the design, 
                manufacture, promotion, or sale of devices.
                    ``(E) The operations of such person shall be in 
                accordance with generally accepted professional and 
                ethical business practices and shall agree in writing 
                that as a minimum it will--
                          ``(i) certify that reported information 
                      accurately reflects data reviewed;

[[Page 111 STAT. 2344]]

                          ``(ii) limit work to that for which competence 
                      and capacity are available;
                          ``(iii) treat information received, records, 
                      reports, and recommendations as proprietary 
                      information;
                          ``(iv) promptly respond and attempt to resolve 
                      complaints regarding its activities for which it 
                      is accredited; and
                          ``(v) protect against the use, in carrying out 
                      subsection (a) with respect to a device, of any 
                      officer or employee of the person who has a 
                      financial conflict of interest regarding the 
                      device, and annually make available to the public 
                      disclosures of the extent to which the person, and 
                      the officers and employees of the person, have 
                      maintained compliance with requirements under this 
                      clause relating to financial conflicts of 
                      interest.
            ``(4) Selection of accredited persons.--The Secretary shall 
        provide each person who chooses to use an accredited person to 
        receive a section 510(k) report a panel of at least two or more 
        accredited persons from which the regulated person may select 
        one for a specific regulatory function.
            ``(5) Compensation of accredited persons.--Compensation for 
        an accredited person shall be determined by agreement between 
        the accredited person and the person who engages the services of 
        the accredited person, and shall be paid by the person who 
        engages such services.

    ``(c) Duration.--The authority provided by this section terminates--
            ``(1) 5 years after the date on which the Secretary notifies 
        Congress that at least 2 persons accredited under subsection (b) 
        are available to review at least 60 percent of the submissions 
        under section 510(k), or
            ``(2) 4 years after the date on which the Secretary notifies 
        Congress that the Secretary has made a determination described 
        in paragraph (2)(B) of subsection (a) for at least 35 percent of 
        the devices that are subject to review under paragraph (1) of 
        such subsection,

whichever occurs first.''.
    (b) Recordkeeping.--Section 704 (21 U.S.C. 374) is amended by adding 
at the end the following:
    ``(f)(1) A person accredited under section 523 to review reports 
made under section 510(k) and make recommendations of initial 
classifications of devices to the Secretary shall maintain records 
documenting the training qualifications of the person and the employees 
of the person, the procedures used by the person for handling 
confidential information, the compensation arrangements made by the 
person, and the procedures used by the person to identify and avoid 
conflicts of interest. Upon the request of an officer or employee 
designated by the Secretary, the person shall permit the officer or 
employee, at all reasonable times, to have access to, to copy, and to 
verify, the records.
    ``(2) Within 15 days after the receipt of a written request from the 
Secretary to a person accredited under section 523 for copies of records 
described in paragraph (1), the person shall produce the copies of the 
records at the place designated by the Secretary.''.

[[Page 111 STAT. 2345]]

    (c) Conforming Amendment.--Section 301 (21 U.S.C. 331), as amended 
by section 204(b), is amended by adding at the end the following:
    ``(y) In the case of a drug, device, or food--
            ``(1) the submission of a report or recommendation by a 
        person accredited under section 523 that is false or misleading 
        in any material respect;
            ``(2) the disclosure by a person accredited under section 
        523 of confidential commercial information or any trade secret 
        without the express written consent of the person who submitted 
        such information or secret to such person; or
            ``(3) the receipt by a person accredited under section 523 
        of a bribe in any form or the doing of any corrupt act by such 
        person associated with a responsibility delegated to such person 
        under this Act.''.

     <<NOTE: 21 USC 360m note.>> (d) Reports on Program of 
Accreditation.--
            (1) Comptroller general.--
                    (A) Implementation of program.--Not later than 5 
                years after the date of the enactment of this Act, the 
                Comptroller General of the United States shall submit to 
                the Committee on Commerce of the House of 
                Representatives and the Committee on Labor and Human 
                Resources of the Senate a report describing the extent 
                to which the program of accreditation required by the 
                amendment made by subsection (a) has been implemented.
                    (B) Evaluation of program.--Not later than 6 months 
                prior to the date on which, pursuant to subsection (c) 
                of section 523 of the Federal Food, Drug, and Cosmetic 
                Act (as added by subsection (a)), the authority provided 
                under subsection (a) of such section will terminate, the 
                Comptroller General shall submit to the Committee on 
                Commerce of the House of Representatives and the 
                Committee on Labor and Human Resources of the Senate a 
                report describing the use of accredited persons under 
                such section 523, including an evaluation of the extent 
                to which such use assisted the Secretary in carrying out 
                the duties of the Secretary under such Act with respect 
                to devices, and the extent to which such use promoted 
                actions which are contrary to the purposes of such Act.
            (2) Inclusion of certain devices within program.--Not later 
        than 3 years after the date of the enactment of this Act, the 
        Secretary of Health and Human Services shall submit to the 
        Committee on Commerce of the House of Representatives and the 
        Committee on Labor and Human Resources of the Senate a report 
        providing a determination by the Secretary of whether, in the 
        program of accreditation established pursuant to the amendment 
        made by subsection (a), the limitation established in clause 
        (iii) of section 523(a)(3)(A) of the Federal Food, Drug, and 
        Cosmetic Act (relating to class II devices for which clinical 
        data are required in reports under section 510(k)) should be 
        removed.

SEC. 211. DEVICE TRACKING.

    Effective 90 days after the date of the enactment of this Act, 
section 519(e) (21 U.S.C. 360i(e)) is amended to read as follows:

[[Page 111 STAT. 2346]]

                            ``Device Tracking

    ``(e)(1) The Secretary may by order require a manufacturer to adopt 
a method of tracking a class II or class III device--
            ``(A) the failure of which would be reasonably likely to 
        have serious adverse health consequences; or
            ``(B) which is--
                    ``(i) intended to be implanted in the human body for 
                more than one year, or
                    ``(ii) a life sustaining or life supporting device 
                used outside a device user facility.

    ``(2) Any patient receiving a device subject to tracking under 
paragraph (1) may refuse to release, or refuse permission to release, 
the patient's name, address, social security number, or other 
identifying information for the purpose of tracking.''.

SEC. 212. POSTMARKET SURVEILLANCE.

    Effective 90 days after the date of the enactment of this Act, 
       section 522 (21 U.S.C. 360l) is amended to read as follows:

    ``Sec. 522. (a) In General.--The Secretary may by order require a 
manufacturer to conduct postmarket surveillance for any device of the 
manufacturer which is a class II or class III device the failure of 
which would be reasonably likely to have serious adverse health 
consequences or which is intended to be--
            ``(1) implanted in the human body for more than one year, or
            ``(2) a life sustaining or life supporting device used 
        outside a device user facility.

    ``(b) Surveillance Approval.--Each manufacturer required to conduct 
a surveillance of a device shall, within 30 days of receiving an order 
from the Secretary prescribing that the manufacturer is required under 
this section to conduct such surveillance, submit, for the approval of 
the Secretary, a plan for the required surveillance. The Secretary, 
within 60 days of the receipt of such plan, shall determine if the 
person designated to conduct the surveillance has appropriate 
qualifications and experience to undertake such surveillance and if the 
plan will result in the collection of useful data that can reveal 
unforeseen adverse events or other information necessary to protect the 
public health. The Secretary, in consultation with the manufacturer, may 
by order require a prospective surveillance period of up to 36 months. 
Any determination by the Secretary that a longer period is necessary 
shall be made by mutual agreement between the Secretary and the 
manufacturer or, if no agreement can be reached, after the completion of 
a dispute resolution process as described in section 562.''.

SEC. 213. REPORTS.

    (a) Reports.--Section 519 (21 U.S.C. 360i) is amended--
            (1) in subsection (a)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``manufacturer, importer, or distributor'' and 
                inserting ``manufacturer or importer'';
                    (B) in paragraph (4), by striking ``manufacturer, 
                importer, or distributor'' and inserting ``manufacturer 
                or importer'';

[[Page 111 STAT. 2347]]

                    (C) in paragraph (7), by adding ``and'' after the 
                semicolon at the end;
                    (D) in paragraph (8)--
                          (i) by striking ``manufacturer, importer, or 
                      distributor'' each place such term appears and 
                      inserting ``manufacturer or importer''; and
                          (ii) by striking the semicolon at the end and 
                      inserting a period;
                    (E) by striking paragraph (9); and
                    (F) by inserting at the end the following sentence: 
                ``The Secretary shall by regulation require distributors 
                to keep records and make such records available to the 
                Secretary upon request. Paragraphs (4) and (8) apply to 
                distributors to the same extent and in the same manner 
                as such paragraphs apply to manufacturers and 
                importers.'';
            (2) by striking subsection (d); and
            (3) in subsection (f), by striking ``, importer, or 
        distributor'' each place it appears and inserting ``or 
        importer''.

    (b) Registration.--Section 510(g) (21 U.S.C. 360(g)) is amended--
            (1) by redesignating paragraph (4) as paragraph (5);
            (2) by inserting after paragraph (3) the following:
            ``(4) any distributor who acts as a wholesale distributor of 
        devices, and who does not manufacture, repackage, process, or 
        relabel a device; or''; and
            (3) by adding at the end the following flush sentence:

``In this subsection, the term `wholesale distributor' means any person 
(other than the manufacturer or the initial importer) who distributes a 
device from the original place of manufacture to the person who makes 
the final delivery or sale of the device to the ultimate consumer or 
user.''.
    (c) Device User Facilities.--
            (1) In general.--Section 519(b) (21 U.S.C. 360i(b)) is 
        amended--
                    (A) in paragraph (1)(C)--
                          (i) in the first sentence, by striking ``a 
                      semi-annual basis'' and inserting ``an annual 
                      basis'';
                          (ii) in the second sentence, by striking ``and 
                      July 1''; and
                          (iii) by striking the matter after and below 
                      clause (iv); and
                    (B) in paragraph (2)--
                          (i) in subparagraph (A), by inserting ``or'' 
                      after the comma at the end;
                          (ii) in subparagraph (B), by striking ``, or'' 
                      at the end and inserting a period; and
                          (iii) by striking subparagraph (C).
            (2) Sentinel system.--Section 519(b) (21 U.S.C. 360i(b)) is 
        amended--
                    (A) by redesignating paragraph (5) as paragraph (6); 
                and
                    (B) by inserting after paragraph (4) the following 
                paragraph:

    ``(5) With respect to device user facilities:
            ``(A) The Secretary shall by regulation plan and implement a 
        program under which the Secretary limits user reporting

[[Page 111 STAT. 2348]]

        under paragraphs (1) through (4) to a subset of user facilities 
        that constitutes a representative profile of user reports for 
        device deaths and serious illnesses or serious injuries.
            ``(B) During the period of planning the program under 
        subparagraph (A), paragraphs (1) through (4) continue to apply.
            ``(C) During the period in which the Secretary is providing 
        for a transition to the full implementation of the program, 
        paragraphs (1) through (4) apply except to the extent that the 
        Secretary determines otherwise.
            ``(D) On and after the date on which the program is fully 
        implemented, paragraphs (1) through (4) do not apply to a user 
        facility unless the facility is included in the subset referred 
        to in subparagraph (A).
            ``(E) Not later than 2 years after the date of the enactment 
        of the Food and Drug Administration Modernization Act of 1997, 
        the Secretary shall submit to the Committee on Commerce of the 
        House of Representatives, and to the Committee on Labor and 
        Human Resources of the Senate, a report describing the plan 
        developed by the Secretary under subparagraph (A) and the 
        progress that has been made toward the implementation of the 
        plan.''.

SEC. 214. PRACTICE OF MEDICINE.

    Chapter IX is amended by adding at the end the following:

<<NOTE: 21 USC 396.>> ``SEC. 906. PRACTICE OF MEDICINE.

    ``Nothing in this Act shall be construed to limit or interfere with 
the authority of a health care practitioner to prescribe or administer 
any legally marketed device to a patient for any condition or disease 
within a legitimate health care practitioner-patient relationship. This 
section shall not limit any existing authority of the Secretary to 
establish and enforce restrictions on the sale or distribution, or in 
the labeling, of a device that are part of a determination of 
substantial equivalence, established as a condition of approval, or 
promulgated through regulations. Further, this section shall not change 
any existing prohibition on the promotion of unapproved uses of legally 
marketed devices.''.

SEC. 215. NONINVASIVE BLOOD GLUCOSE METER.

    (a) Findings.--The Congress finds that--
            (1) diabetes and its complications are a leading cause of 
        death by disease in America;
            (2) diabetes affects approximately 16,000,000 Americans and 
        another 650,000 will be diagnosed in 1997;
            (3) the total health care-related costs of diabetes total 
        nearly $100,000,000,000 per year;
            (4) diabetes is a disease that is managed and controlled on 
        a daily basis by the patient;
            (5) the failure to properly control and manage diabetes 
        results in costly and often fatal complications including but 
        not limited to blindness, coronary artery disease, and kidney 
        failure;
            (6) blood testing devices are a critical tool for the 
        control and management of diabetes, and existing blood testing 
        devices require repeated piercing of the skin;
            (7) the pain associated with existing blood testing devices 
        creates a disincentive for people with diabetes to test blood 
        glucose levels, particularly children;

[[Page 111 STAT. 2349]]

            (8) a safe and effective noninvasive blood glucose meter 
        would likely improve control and management of diabetes by 
        increasing the number of tests conducted by people with 
        diabetes, particularly children; and
            (9) the Food and Drug Administration is responsible for 
        reviewing all applications for new medical devices in the United 
        States.

    (b) Sense of Congress.--It is the sense of the Congress that the 
availability of a safe, effective, noninvasive blood glucose meter would 
greatly enhance the health and well-being of all people with diabetes 
across America and the world.
SEC. 216. USE OF DATA RELATING TO PREMARKET APPROVAL; PRODUCT 
                        DEVELOPMENT PROTOCOL.

    (a) Use of Data Relating to Premarket Approval.--
            (1) In general.--Section 520(h)(4) (21 U.S.C. 360j(h)(4)) is 
        amended to read as follows:

    ``(4)(A) Any information contained in an application for premarket 
approval filed with the Secretary pursuant to section 515(c) (including 
information from clinical and preclinical tests or studies that 
demonstrate the safety and effectiveness of a device, but excluding 
descriptions of methods of manufacture and product composition and other 
trade secrets) shall be available, 6 years after the application has 
been approved by the Secretary, for use by the Secretary in--
            ``(i) approving another device;
            ``(ii) determining whether a product development protocol 
        has been completed, under section 515 for another device;
            ``(iii) establishing a performance standard or special 
        control under this Act; or
            ``(iv) classifying or reclassifying another device under 
        section 513 and subsection (l)(2).

    ``(B) The publicly available detailed summaries of information 
respecting the safety and effectiveness of devices required by paragraph 
(1)(A) shall be available for use by the Secretary as the evidentiary 
basis for the agency actions described in subparagraph (A).''.
            (2) Conforming amendments.--Section 517(a) (21 U.S.C. 
        360g(a)) is amended--
                    (A) in paragraph (8), by adding ``or'' at the end;
                    (B) in paragraph (9), by striking ``, or'' and 
                inserting a comma; and
                    (C) by striking paragraph (10).

    (b) Product Development Protocol.--Section 515(f)(2) (21 U.S.C. 
360e(f)(2)) is amended by striking ``he shall'' and all that follows and 
inserting the following: ``the Secretary--
            ``(A) may, at the initiative of the Secretary, refer the 
        proposed protocol to the appropriate panel under section 513 for 
        its recommendation respecting approval of the protocol; or
            ``(B) shall so refer such protocol upon the request of the 
        submitter, unless the Secretary finds that the proposed protocol 
        and accompanying data which would be reviewed by such panel 
        substantially duplicate a product development protocol and 
        accompanying data which have previously been reviewed by such a 
        panel.''.

[[Page 111 STAT. 2350]]

SEC. 217. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL 
                        INVESTIGATIONS FOR APPROVAL.

    Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended by 
striking ``clinical investigations'' and inserting ``1 or more clinical 
investigations''.

                 TITLE III--IMPROVING REGULATION OF FOOD

SEC. 301. FLEXIBILITY FOR REGULATIONS REGARDING CLAIMS.

    Section 403(r) (21 U.S.C. 343(r)) is amended by adding at the end 
the following:
    ``(7) The Secretary may make proposed regulations issued under this 
paragraph effective upon publication pending consideration of public 
comment and publication of a final regulation if the Secretary 
determines that such action is necessary--
            ``(A) to enable the Secretary to review and act promptly on 
        petitions the Secretary determines provide for information 
        necessary to--
                    ``(i) enable consumers to develop and maintain 
                healthy dietary practices;
                    ``(ii) enable consumers to be informed promptly and 
                effectively of important new knowledge regarding 
                nutritional and health benefits of food; or
                    ``(iii) ensure that scientifically sound nutritional 
                and health information is provided to consumers as soon 
                as possible; or
            ``(B) to enable the Secretary to act promptly to ban or 
        modify a claim under this paragraph.

Such proposed regulations shall be deemed final agency action for 
purposes of judicial review.''.

SEC. 302. PETITIONS FOR CLAIMS.

    Section 403(r)(4)(A)(i) (21 U.S.C. 343(r)(4)(A)(i)) is amended--
            (1) by adding after the second sentence the following: ``If 
        the Secretary does not act within such 100 days, the petition 
        shall be deemed to be denied unless an extension is mutually 
        agreed upon by the Secretary and the petitioner.'';
            (2) in the fourth sentence (as amended by paragraph (1)) by 
        inserting immediately before the comma the following: ``or the 
        petition is deemed to be denied''; and
            (3) by adding at the end the following: ``If the Secretary 
        does not act within such 90 days, the petition shall be deemed 
        to be denied unless an extension is mutually agreed upon by the 
        Secretary and the petitioner. If the Secretary issues a proposed 
        regulation, the rulemaking shall be completed within 540 days of 
        the date the petition is received by the Secretary. If the 
        Secretary does not issue a regulation within such 540 days, the 
        Secretary shall provide the Committee on Commerce of the House 
        of Representatives and the Committee on Labor and Human 
        Resources of the Senate the reasons action on the regulation did 
        not occur within such 540 days.''.

SEC. 303. HEALTH CLAIMS FOR FOOD PRODUCTS.

    Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by adding at the 
end thereof the following:

[[Page 111 STAT. 2351]]

    ``(C) Notwithstanding the provisions of clauses (A)(i) and (B), a 
claim of the type described in subparagraph (1)(B) which is not 
authorized by the Secretary in a regulation promulgated in accordance 
with clause (B) shall be authorized and may be made with respect to a 
food if--
            ``(i) a scientific body of the United States Government with 
        official responsibility for public health protection or research 
        directly relating to human nutrition (such as the National 
        Institutes of Health or the Centers for Disease Control and 
        Prevention) or the National Academy of Sciences or any of its 
        subdivisions has published an authoritative statement, which is 
        currently in effect, about the relationship between a nutrient 
        and a disease or health-related condition to which the claim 
        refers;
            ``(ii) a person has submitted to the Secretary, at least 120 
        days (during which the Secretary may notify any person who is 
        making a claim as authorized by clause (C) that such person has 
        not submitted all the information required by such clause) 
        before the first introduction into interstate commerce of the 
        food with a label containing the claim, (I) a notice of the 
        claim, which shall include the exact words used in the claim and 
        shall include a concise description of the basis upon which such 
        person relied for determining that the requirements of subclause 
        (i) have been satisfied, (II) a copy of the statement referred 
        to in subclause (i) upon which such person relied in making the 
        claim, and (III) a balanced representation of the scientific 
        literature relating to the relationship between a nutrient and a 
        disease or health-related condition to which the claim refers;
            ``(iii) the claim and the food for which the claim is made 
        are in compliance with clause (A)(ii) and are otherwise in 
        compliance with paragraph (a) and section 201(n); and
            ``(iv) the claim is stated in a manner so that the claim is 
        an accurate representation of the authoritative statement 
        referred to in subclause (i) and so that the claim enables the 
        public to comprehend the information provided in the claim and 
        to understand the relative significance of such information in 
        the context of a total daily diet.

For purposes of this clause, a statement shall be regarded as an 
authoritative statement of a scientific body described in subclause (i) 
only if the statement is published by the scientific body and shall not 
include a statement of an employee of the scientific body made in the 
individual capacity of the employee.
    ``(D) A claim submitted under the requirements of clause (C) may be 
made until--
            ``(i) such time as the Secretary issues a regulation under 
        the standard in clause (B)(i)--
                    ``(I) prohibiting or modifying the claim and the 
                regulation has become effective, or
                    ``(II) finding that the requirements of clause (C) 
                have not been met, including finding that the petitioner 
                has not submitted all the information required by such 
                clause; or
            ``(ii) a district court of the United States in an 
        enforcement proceeding under chapter III has determined that the 
        requirements of clause (C) have not been met.''.

[[Page 111 STAT. 2352]]

SEC. 304. NUTRIENT CONTENT CLAIMS.

    Section 403(r)(2) (21 U.S.C. 343(r)(2)) is amended by adding at the 
end the following:
    ``(G) A claim of the type described in subparagraph (1)(A) for a 
nutrient, for which the Secretary has not promulgated a regulation under 
clause (A)(i), shall be authorized and may be made with respect to a 
food if--
            ``(i) a scientific body of the United States Government with 
        official responsibility for public health protection or research 
        directly relating to human nutrition (such as the National 
        Institutes of Health or the Centers for Disease Control and 
        Prevention) or the National Academy of Sciences or any of its 
        subdivisions has published an authoritative statement, which is 
        currently in effect, which identifies the nutrient level to 
        which the claim refers;
            ``(ii) a person has submitted to the Secretary, at least 120 
        days (during which the Secretary may notify any person who is 
        making a claim as authorized by clause (C) that such person has 
        not submitted all the information required by such clause) 
        before the first introduction into interstate commerce of the 
        food with a label containing the claim, (I) a notice of the 
        claim, which shall include the exact words used in the claim and 
        shall include a concise description of the basis upon which such 
        person relied for determining that the requirements of subclause 
        (i) have been satisfied, (II) a copy of the statement referred 
        to in subclause (i) upon which such person relied in making the 
        claim, and (III) a balanced representation of the scientific 
        literature relating to the nutrient level to which the claim 
        refers;
            ``(iii) the claim and the food for which the claim is made 
        are in compliance with clauses (A) and (B), and are otherwise in 
        compliance with paragraph (a) and section 201(n); and
            ``(iv) the claim is stated in a manner so that the claim is 
        an accurate representation of the authoritative statement 
        referred to in subclause (i) and so that the claim enables the 
        public to comprehend the information provided in the claim and 
        to understand the relative significance of such information in 
        the context of a total daily diet.

For purposes of this clause, a statement shall be regarded as an 
authoritative statement of a scientific body described in subclause (i) 
only if the statement is published by the scientific body and shall not 
include a statement of an employee of the scientific body made in the 
individual capacity of the employee.
    ``(H) A claim submitted under the requirements of clause (G) may be 
made until--
            ``(i) such time as the Secretary issues a regulation--
                    ``(I) prohibiting or modifying the claim and the 
                regulation has become effective, or
                    ``(II) finding that the requirements of clause (G) 
                have not been met, including finding that the petitioner 
                had not submitted all the information required by such 
                clause; or
            ``(ii) a district court of the United States in an 
        enforcement proceeding under chapter III has determined that the 
        requirements of clause (G) have not been met.''.

[[Page 111 STAT. 2353]]

SEC. 305. REFERRAL STATEMENTS.

    Section 403(r)(2)(B) (21 U.S.C. 343(r)(2)(B)) is amended to read as 
follows:
    ``(B) If a claim described in subparagraph (1)(A) is made with 
respect to a nutrient in a food and the Secretary makes a determination 
that the food contains a nutrient at a level that increases to persons 
in the general population the risk of a disease or health-related 
condition that is diet related, the label or labeling of such food shall 
contain, prominently and in immediate proximity to such claim, the 
following statement: `See nutrition information for ____ content.' The 
blank shall identify the nutrient associated with the increased disease 
or health-related condition risk. In making the determination described 
in this clause, the Secretary shall take into account the significance 
of the food in the total daily diet.''.

SEC. 306. DISCLOSURE OF IRRADIATION.

    Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting after 
                       section 403B the following:

     <<NOTE: 21 USC 343-3.>> ``Sec. 403C. (a) No provision of section 
201(n), 403(a), or 409 shall be construed to require on the label or 
labeling of a food a separate radiation disclosure statement that is 
more prominent than the declaration of ingredients required by section 
403(i)(2).

    ``(b) In this section, the term `radiation disclosure statement' 
means a written statement that discloses that a food has been 
intentionally subject to radiation.''.

SEC. 307. IRRADIATION PETITION.

    Not later than 60 days following the date of the enactment of this 
Act, the Secretary of Health and Human Services shall make a final 
determination on any petition pending with the Food and Drug 
Administration that would permit the irradiation of red meat under 
section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act. If the 
Secretary does not make such determination, the Secretary shall, not 
later than 60 days following the date of the enactment of this Act, 
provide the Committee on Commerce of the House of Representatives and 
the Committee on Labor and Human Resources of the Senate an explanation 
of the process followed by the Food and Drug Administration in reviewing 
the petition referred to in paragraph (1) and the reasons action on the 
petition was delayed.

<<NOTE: 21 USC 348 note.>> SEC. 308. GLASS AND CERAMIC WARE.

    (a) In General.--The Secretary may not implement any requirement 
which would ban, as an unapproved food additive, lead and cadmium based 
enamel in the lip and rim area of glass and ceramic ware before the 
expiration of one year after the date such requirement is published.
    (b) Lead and Cadmium Based Enamel.--Unless the Secretary determines, 
based on available data, that lead and cadmium based enamel on glass and 
ceramic ware--
            (1) which has less than 60 millimeters of decorating area 
        below the external rim, and
            (2) which is not, by design, representation, or custom of 
        usage intended for use by children,

[[Page 111 STAT. 2354]]

is unsafe, the Secretary shall not take any action before January 1, 
2003, to ban lead and cadmium based enamel on such glass and ceramic 
ware. Any action taken after January 1, 2003, to ban such enamel on such 
glass and ceramic ware as an unapproved food additive shall be taken by 
regulation and such regulation shall provide that such products shall 
not be removed from the market before 1 year after publication of the 
final regulation.

SEC. 309. FOOD CONTACT SUBSTANCES.

    (a) Food Contact Substances.--Section 409(a) (21 U.S.C. 348(a)) is 
amended--
            (1) in paragraph (1)--
                    (A) by striking ``subsection (i)'' and inserting 
                ``subsection (j)''; and
                    (B) by striking at the end ``or'';
            (2) by striking the period at the end of paragraph (2) and 
        inserting ``; or'';
            (3) by inserting after paragraph (2) the following:
            ``(3) in the case of a food additive as defined in this Act 
        that is a food contact substance, there is--
                    ``(A) in effect, and such substance and the use of 
                such substance are in conformity with, a regulation 
                issued under this section prescribing the conditions 
                under which such additive may be safely used; or
                    ``(B) a notification submitted under subsection (h) 
                that is effective.''; and
            (4) by striking the matter following paragraph (3) (as added 
        by paragraph (3)) and inserting the following flush sentence:

``While such a regulation relating to a food additive, or such a 
notification under subsection (h)(1) relating to a food additive that is 
a food contact substance, is in effect, and has not been revoked 
pursuant to subsection (i), a food shall not, by reason of bearing or 
containing such a food additive in accordance with the regulation or 
notification, be considered adulterated under section 402(a)(1).''.
    (b) Notification for Food Contact Substances.--Section 409 (21 
U.S.C. 348), as amended by subsection (a), is further amended--
            (1) by redesignating subsections (h) and (i), as subsections 
        (i) and (j), respectively;
            (2) by inserting after subsection (g) the following:

           ``Notification Relating to a Food Contact Substance

    ``(h)(1) Subject to such regulations as may be promulgated under 
paragraph (3), a manufacturer or supplier of a food contact substance 
may, at least 120 days prior to the introduction or delivery for 
introduction into interstate commerce of the food contact substance, 
notify the Secretary of the identity and intended use of the food 
contact substance, and of the determination of the manufacturer or 
supplier that the intended use of such food contact substance is safe 
under the standard described in subsection (c)(3)(A). The notification 
shall contain the information that forms the basis of the determination 
and all information required to be submitted by regulations promulgated 
by the Secretary.
    ``(2)(A) A notification submitted under paragraph (1) shall become 
effective 120 days after the date of receipt by the Secretary and the 
food contact substance may be introduced or delivered for introduction 
into interstate commerce, unless the Secretary

[[Page 111 STAT. 2355]]

makes a determination within the 120-day period that, based on the data 
and information before the Secretary, such use of the food contact 
substance has not been shown to be safe under the standard described in 
subsection (c)(3)(A), and informs the manufacturer or supplier of such 
determination.
    ``(B) A decision by the Secretary to object to a notification shall 
constitute final agency action subject to judicial review.
    ``(C) In this paragraph, the term `food contact substance' means the 
substance that is the subject of a notification submitted under 
paragraph (1), and does not include a similar or identical substance 
manufactured or prepared by a person other than the manufacturer 
identified in the notification.
    ``(3)(A) The process in this subsection shall be utilized for 
authorizing the marketing of a food contact substance except where the 
Secretary determines that submission and review of a petition under 
subsection (b) is necessary to provide adequate assurance of safety, or 
where the Secretary and any manufacturer or supplier agree that such 
manufacturer or supplier may submit a petition under subsection (b).
    ``(B) The Secretary is authorized to promulgate regulations to 
identify the circumstances in which a petition shall be filed under 
subsection (b), and shall consider criteria such as the probable 
consumption of such food contact substance and potential toxicity of the 
food contact substance in determining the circumstances in which a 
petition shall be filed under subsection (b).
    ``(4) The Secretary shall keep confidential any information provided 
in a notification under paragraph (1) for 120 days after receipt by the 
Secretary of the notification. After the expiration of such 120 days, 
the information shall be available to any interested party except for 
any matter in the notification that is a trade secret or confidential 
commercial information.
    ``(5)(A)(i) Except as provided in clause (ii), the notification 
program established under this subsection shall not operate in any 
fiscal year unless--
            ``(I) an appropriation equal to or exceeding the applicable 
        amount under clause (iv) is made for such fiscal year for 
        carrying out such program in such fiscal year; and
            ``(II) the Secretary certifies that the amount appropriated 
        for such fiscal year for the Center for Food Safety and Applied 
        Nutrition of the Food and Drug Administration (exclusive of the 
        appropriation referred to in subclause (I)) equals or exceeds 
        the amount appropriated for the Center for fiscal year 1997, 
        excluding any amount appropriated for new programs.

    ``(ii) The Secretary shall, not later than April 1, 1999, begin 
accepting and reviewing notifications submitted under the notification 
program established under this subsection if--
            ``(I) an appropriation equal to or exceeding the applicable 
        amount under clause (iii) is made for the last six months of 
        fiscal year 1999 for carrying out such program during such 
        period; and
            ``(II) the Secretary certifies that the amount appropriated 
        for such period for the Center for Food Safety and Applied 
        Nutrition of the Food and Drug Administration (exclusive of the 
        appropriation referred to in subclause (I)) equals or exceeds an 
        amount equivalent to one-half the amount appropriated for the 
        Center for fiscal year 1997, excluding any amount appropriated 
        for new programs.

[[Page 111 STAT. 2356]]

    ``(iii) For the last six months of fiscal year 1999, the applicable 
amount under this clause is $1,500,000, or the amount specified in the 
budget request of the President for the six-month period involved for 
carrying out the notification program in fiscal year 1999, whichever is 
less.
    ``(iv) For fiscal year 2000 and subsequent fiscal years, the 
applicable amount under this clause is $3,000,000, or the amount 
specified in the budget request of the President for the fiscal year 
involved for carrying out the notification program under this 
subsection, whichever is less.
    ``(B) For purposes of carrying out the notification program under 
this subsection, there are authorized to be appropriated such sums as 
may be necessary for each of the fiscal years 1999 through fiscal year 
2003, except that such authorization of appropriations is not effective 
for a fiscal year for any amount that is less than the applicable amount 
under clause (iii) or (iv) of subparagraph (A), whichever is applicable.
    ``(C) Not later than April 1 of fiscal year 1998 and February 1 of 
each subsequent fiscal year, the Secretary shall submit a report to the 
Committees on Appropriations of the House of Representatives and the 
Senate, the Committee on Commerce of the House of Representatives, and 
the Committee on Labor and Human Resources of the Senate that provides 
an estimate of the Secretary of the costs of carrying out the 
notification program established under this subsection for the next 
fiscal year.
    ``(6) In this section, the term `food contact substance' means any 
substance intended for use as a component of materials used in 
manufacturing, packing, packaging, transporting, or holding food if such 
use is not intended to have any technical effect in such food.'';
            (3) in subsection (i), as so redesignated by paragraph (1), 
        by adding at the end the following: ``The Secretary shall by 
        regulation prescribe the procedure by which the Secretary may 
        deem a notification under subsection (h) to no longer be 
        effective.''; and
            (4) in subsection (j), as so redesignated by paragraph (1), 
        by striking ``subsections (b) to (h)'' and inserting 
        ``subsections (b) to (i)''.

                      TITLE IV--GENERAL PROVISIONS

SEC. 401. DISSEMINATION OF INFORMATION ON NEW USES.

    (a) In General.--Chapter V (21 U.S.C. 351 et seq.) is amended by 
inserting after subchapter C the following:

         ``Subchapter D--Dissemination of Treatment Information

<<NOTE: 21 USC 360aaa.>> ``SEC. 551. REQUIREMENTS FOR 
                          DISSEMINATION OF TREATMENT INFORMATION 
                          ON DRUGS OR DEVICES.

    ``(a) In General.--Notwithstanding sections 301(d), 502(f), and 505, 
and section 351 of the Public Health Service Act (42 U.S.C. 262), a 
manufacturer may disseminate to--
            ``(1) a health care practitioner;
            ``(2) a pharmacy benefit manager;
            ``(3) a health insurance issuer;
            ``(4) a group health plan; or

[[Page 111 STAT. 2357]]

            ``(5) a Federal or State governmental agency;

written information concerning the safety, effectiveness, or benefit of 
a use not described in the approved labeling of a drug or device if the 
manufacturer meets the requirements of subsection (b).
    ``(b) Specific Requirements.--A manufacturer may disseminate 
information under subsection (a) on a new use only if--
            ``(1)(A) in the case of a drug, there is in effect for the 
        drug an application filed under subsection (b) or (j) of section 
        505 or a biologics license issued under section 351 of the 
        Public Health Service Act; or
            ``(B) in the case of a device, the device is being 
        commercially distributed in accordance with a regulation under 
        subsection (d) or (e) of section 513, an order under subsection 
        (f) of such section, or the approval of an application under 
        section 515;
            ``(2) the information meets the requirements of section 552;
            ``(3) the information to be disseminated is not derived from 
        clinical research conducted by another manufacturer or if it was 
        derived from research conducted by another manufacturer, the 
        manufacturer disseminating the information has the permission of 
        such other manufacturer to make the dissemination;
            ``(4) the manufacturer has, 60 days before such 
        dissemination, submitted to the Secretary--
                    ``(A) a copy of the information to be disseminated; 
                and
                    ``(B) any clinical trial information the 
                manufacturer has relating to the safety or effectiveness 
                of the new use, any reports of clinical experience 
                pertinent to the safety of the new use, and a summary of 
                such information;
            ``(5) the manufacturer has complied with the requirements of 
        section 554 (relating to a supplemental application for such 
        use);
            ``(6) the manufacturer includes along with the information 
        to be disseminated under this subsection--
                    ``(A) a prominently displayed statement that 
                discloses--
                          ``(i) that the information concerns a use of a 
                      drug or device that has not been approved or 
                      cleared by the Food and Drug Administration;
                          ``(ii) if applicable, that the information is 
                      being disseminated at the expense of the 
                      manufacturer;
                          ``(iii) if applicable, the name of any authors 
                      of the information who are employees of, 
                      consultants to, or have received compensation 
                      from, the manufacturer, or who have a significant 
                      financial interest in the manufacturer;
                          ``(iv) the official labeling for the drug or 
                      device and all updates with respect to the 
                      labeling;
                          ``(v) if applicable, a statement that there 
                      are products or treatments that have been approved 
                      or cleared for the use that is the subject of the 
                      information being disseminated pursuant to 
                      subsection (a)(1); and
                          ``(vi) the identification of any person that 
                      has provided funding for the conduct of a study 
                      relating to the new use of a drug or device for 
                      which such information is being disseminated; and
                    ``(B) a bibliography of other articles from a 
                scientific reference publication or scientific or 
                medical journal that

[[Page 111 STAT. 2358]]

                have been previously published about the use of the drug 
                or device covered by the information disseminated 
                (unless the information already includes such 
                bibliography).

    ``(c) Additional Information.--If the Secretary determines, after 
providing notice of such determination and an opportunity for a meeting 
with respect to such determination, that the information submitted by a 
manufacturer under subsection (b)(3)(B), with respect to the use of a 
drug or device for which the manufacturer intends to disseminate 
information, fails to provide data, analyses, or other written matter 
that is objective and balanced, the Secretary may require the 
manufacturer to disseminate--
            ``(1) additional objective and scientifically sound 
        information that pertains to the safety or effectiveness of the 
        use and is necessary to provide objectivity and balance, 
        including any information that the manufacturer has submitted to 
        the Secretary or, where appropriate, a summary of such 
        information or any other information that the Secretary has 
        authority to make available to the public; and
            ``(2) an objective statement of the Secretary, based on data 
        or other scientifically sound information available to the 
        Secretary, that bears on the safety or effectiveness of the new 
        use of the drug or device.

<<NOTE: 21 USC 360aaa-1.>> ``SEC. 552. INFORMATION AUTHORIZED TO BE 
            DISSEMINATED.

    ``(a) Authorized Information.--A manufacturer may disseminate 
information under section 551 on a new use only if the information--
            ``(1) is in the form of an unabridged--
                    ``(A) reprint or copy of an article, peer-reviewed 
                by experts qualified by scientific training or 
                experience to evaluate the safety or effectiveness of 
                the drug or device involved, which was published in a 
                scientific or medical journal (as defined in section 
                556(5)), which is about a clinical investigation with 
                respect to the drug or device, and which would be 
                considered to be scientifically sound by such experts; 
                or
                    ``(B) reference publication, described in subsection 
                (b), that includes information about a clinical 
                investigation with respect to the drug or device that 
                would be considered to be scientifically sound by 
                experts qualified by scientific training or experience 
                to evaluate the safety or effectiveness of the drug or 
                device that is the subject of such a clinical 
                investigation; and
            ``(2) is not false or misleading and would not pose a 
        significant risk to the public health.

    ``(b) Reference Publication.--A reference publication referred to in 
subsection (a)(1)(B) is a publication that--
            ``(1) has not been written, edited, excerpted, or published 
        specifically for, or at the request of, a manufacturer of a drug 
        or device;
            ``(2) has not been edited or significantly influenced by 
        such a manufacturer;
            ``(3) is not solely distributed through such a manufacturer 
        but is generally available in bookstores or other distribution 
        channels where medical textbooks are sold;
            ``(4) does not focus on any particular drug or device of a 
        manufacturer that disseminates information under section

[[Page 111 STAT. 2359]]

        551 and does not have a primary focus on new uses of drugs or 
        devices that are marketed or under investigation by a 
        manufacturer supporting the dissemination of information; and
            ``(5) presents materials that are not false or misleading.
<<NOTE: 21 USC 360aaa-2.>> ``SEC. 553. ESTABLISHMENT OF LIST OF 
                          ARTICLES AND PUBLICATIONS DISSEMINATED 
                          AND LIST OF PROVIDERS THAT RECEIVED 
                          ARTICLES AND REFERENCE PUBLICATIONS.

    ``(a) In General.--A manufacturer may disseminate information under 
section 551 on a new use only if the manufacturer prepares and submits 
to the Secretary biannually--
            ``(1) a list containing the titles of the articles and 
        reference publications relating to the new use of drugs or 
        devices that were disseminated by the manufacturer to a person 
        described in section 551(a) for the 6-month period preceding the 
        date on which the manufacturer submits the list to the 
        Secretary; and
            ``(2) a list that identifies the categories of providers (as 
        described in section 551(a)) that received the articles and 
        reference publications for the 6-month period described in 
        paragraph (1).

    ``(b) Records.--A manufacturer that disseminates information under 
section 551 shall keep records that may be used by the manufacturer 
when, pursuant to section 555, such manufacturer is required to take 
corrective action and shall be made available to the Secretary, upon 
request, for purposes of ensuring or taking corrective action pursuant 
to such section. Such records, at the Secretary's discretion, may 
identify the recipient of information provided pursuant to section 551 
or the categories of such recipients.
<<NOTE: 21 USC 360aaa-3.>> ``SEC. 554. REQUIREMENT REGARDING 
                          SUBMISSION OF SUPPLEMENTAL APPLICATION 
                          FOR NEW USE; EXEMPTION FROM REQUIREMENT.

    ``(a) In General.--A manufacturer may disseminate information under 
section 551 on a new use only if--
            ``(1)(A) the manufacturer has submitted to the Secretary a 
        supplemental application for such use; or
            ``(B) the manufacturer meets the condition described in 
        subsection (b) or (c) (relating to a certification that the 
        manufacturer will submit such an application); or
            ``(2) there is in effect for the manufacturer an exemption 
        under subsection (d) from the requirement of paragraph (1).

    ``(b) Certification on Supplemental Application; Condition in Case 
of Completed Studies.--For purposes of subsection (a)(1)(B), a 
manufacturer may disseminate information on a new use if the 
manufacturer has submitted to the Secretary an application containing a 
certification that--
            ``(1) the studies needed for the submission of a 
        supplemental application for the new use have been completed; 
        and
            ``(2) the supplemental application will be submitted to the 
        Secretary not later than 6 months after the date of the initial 
        dissemination of information under section 551.

    ``(c) Certification on Supplemental Application; Condition in Case 
of Planned Studies.--
            ``(1) In general.--For purposes of subsection (a)(1)(B), a 
        manufacturer may disseminate information on a new use if--
                    ``(A) the manufacturer has submitted to the 
                Secretary an application containing--

[[Page 111 STAT. 2360]]

                          ``(i) a proposed protocol and schedule for 
                      conducting the studies needed for the submission 
                      of a supplemental application for the new use; and
                          ``(ii) a certification that the supplemental 
                      application will be submitted to the Secretary not 
                      later than 36 months after the date of the initial 
                      dissemination of information under section 551 
                      (or, as applicable, not later than such date as 
                      the Secretary may specify pursuant to an extension 
                      under paragraph (3)); and
                    ``(B) the Secretary has determined that the proposed 
                protocol is adequate and that the schedule for 
                completing such studies is reasonable.
            ``(2) Progress reports on studies.--A manufacturer that 
        submits to the Secretary an application under paragraph (1) 
        shall submit to the Secretary periodic reports describing the 
        status of the studies involved.
            ``(3) Extension of time regarding planned studies.--The 
        period of 36 months authorized in paragraph (1)(A)(ii) for the 
        completion of studies may be extended by the Secretary if--
                    ``(A) the Secretary determines that the studies 
                needed to submit such an application cannot be completed 
                and submitted within 36 months; or
                    ``(B) the manufacturer involved submits to the 
                Secretary a written request for the extension and the 
                Secretary determines that the manufacturer has acted 
                with due diligence to conduct the studies in a timely 
                manner, except that an extension under this subparagraph 
                may not be provided for more than 24 additional months.

    ``(d) Exemption From Requirement of Supplemental Application.--
            ``(1) In general.--For purposes of subsection (a)(2), a 
        manufacturer may disseminate information on a new use if--
                    ``(A) the manufacturer has submitted to the 
                Secretary an application for an exemption from meeting 
                the requirement of subsection (a)(1); and
                    ``(B)(i) the Secretary has approved the application 
                in accordance with paragraph (2); or
                    ``(ii) the application is deemed under paragraph 
                (3)(A) to have been approved (unless such approval is 
                terminated pursuant to paragraph (3)(B)).
            ``(2) Conditions for approval.--The Secretary may approve an 
        application under paragraph (1) for an exemption if the 
        Secretary makes a determination described in subparagraph (A) or 
        (B), as follows:
                    ``(A) The Secretary makes a determination that, for 
                reasons defined by the Secretary, it would be 
                economically prohibitive with respect to such drug or 
                device for the manufacturer to incur the costs necessary 
                for the submission of a supplemental application. In 
                making such determination, the Secretary shall consider 
                (in addition to any other considerations the Secretary 
                finds appropriate)--
                          ``(i) the lack of the availability under law 
                      of any period during which the manufacturer would 
                      have exclusive marketing rights with respect to 
                      the new use involved; and

[[Page 111 STAT. 2361]]

                          ``(ii) the size of the population expected to 
                      benefit from approval of the supplemental 
                      application.
                    ``(B) The Secretary makes a determination that, for 
                reasons defined by the Secretary, it would be unethical 
                to conduct the studies necessary for the supplemental 
                application. In making such determination, the Secretary 
                shall consider (in addition to any other considerations 
                the Secretary finds appropriate) whether the new use 
                involved is the standard of medical care for a health 
                condition.
            ``(3) Time for consideration of application; deemed 
        approval.--
                    ``(A) In general.--The Secretary shall approve or 
                deny an application under paragraph (1) for an exemption 
                not later than 60 days after the receipt of the 
                application. If the Secretary does not comply with the 
                preceding sentence, the application is deemed to be 
                approved.
                    ``(B) Termination of deemed approval.--If pursuant 
                to a deemed approval under subparagraph (A) a 
                manufacturer disseminates written information under 
                section 551 on a new use, the Secretary may at any time 
                terminate such approval and under section 555(b)(3) 
                order the manufacturer to cease disseminating the 
                information.

    ``(e) Requirements Regarding Applications.--Applications under this 
section shall be submitted in the form and manner prescribed by the 
Secretary.

<<NOTE: 21 USC 360aaa-4.>> ``SEC. 555. CORRECTIVE ACTIONS; CESSATION OF 
            DISSEMINATION.

    ``(a) Postdissemination Data Regarding Safety and Effectiveness.--
            ``(1) Corrective actions.--With respect to data received by 
        the Secretary after the dissemination of information under 
        section 551 by a manufacturer has begun (whether received 
        pursuant to paragraph (2) or otherwise), if the Secretary 
        determines that the data indicate that the new use involved may 
        not be effective or may present a significant risk to public 
        health, the Secretary shall, after consultation with the 
        manufacturer, take such action regarding the dissemination of 
        the information as the Secretary determines to be appropriate 
        for the protection of the public health, which may include 
        ordering that the manufacturer cease the dissemination of the 
        information.
            ``(2) Responsibilities of manufacturers to submit data.--
        After a manufacturer disseminates information under section 551, 
        the manufacturer shall submit to the Secretary a notification of 
        any additional knowledge of the manufacturer on clinical 
        research or other data that relate to the safety or 
        effectiveness of the new use involved. If the manufacturer is in 
        possession of the data, the notification shall include the 
        data. <<NOTE: Regulations.>>  The Secretary shall by regulation 
        establish the scope of the responsibilities of manufacturers 
        under this paragraph, including such limits on the 
        responsibilities as the Secretary determines to be appropriate.

    ``(b) Cessation of Dissemination.--
            ``(1) Failure of manufacturer to comply with requirements.--
        The Secretary may order a manufacturer to cease the 
        dissemination of information pursuant to section 551 if

[[Page 111 STAT. 2362]]

        the Secretary determines that the information being disseminated 
        does not comply with the requirements established in this 
        subchapter. Such an order may be issued only after the Secretary 
        has provided notice to the manufacturer of the intent of the 
        Secretary to issue the order and (unless paragraph (2)(B) 
        applies) has provided an opportunity for a meeting with respect 
        to such intent. If the failure of the manufacturer constitutes a 
        minor violation of this subchapter, the Secretary shall delay 
        issuing the order and provide to the manufacturer an opportunity 
        to correct the violation.
            ``(2) Supplemental applications.--The Secretary may order a 
        manufacturer to cease the dissemination of information pursuant 
        to section 551 if--
                    ``(A) in the case of a manufacturer that has 
                submitted a supplemental application for a new use 
                pursuant to section 554(a)(1), the Secretary determines 
                that the supplemental application does not contain 
                adequate information for approval of the new use for 
                which the application was submitted;
                    ``(B) in the case of a manufacturer that has 
                submitted a certification under section 554(b), the 
                manufacturer has not, within the 6-month period 
                involved, submitted the supplemental application 
                referred to in the certification; or
                    ``(C) in the case of a manufacturer that has 
                submitted a certification under section 554(c) but has 
                not yet submitted the supplemental application referred 
                to in the certification, the Secretary determines, after 
                an informal hearing, that the manufacturer is not acting 
                with due diligence to complete the studies involved.
            ``(3) Termination of deemed approval of exemption regarding 
        supplemental applications.--If under section 554(d)(3) the 
        Secretary terminates a deemed approval of an exemption, the 
        Secretary may order the manufacturer involved to cease 
        disseminating the information. A manufacturer shall comply with 
        an order under the preceding sentence not later than 60 days 
        after the receipt of the order.

    ``(c) Corrective Actions by Manufacturers.--
            ``(1) In general.--In any case in which under this section 
        the Secretary orders a manufacturer to cease disseminating 
        information, the Secretary may order the manufacturer to take 
        action to correct the information that has been disseminated, 
        except as provided in paragraph (2).
            ``(2) Termination of deemed approval of exemption regarding 
        supplemental applications.--In the case of an order under 
        subsection (b)(3) to cease disseminating information, the 
        Secretary may not order the manufacturer involved to take action 
        to correct the information that has been disseminated unless the 
        Secretary determines that the new use described in the 
        information would pose a significant risk to the public health.

<<NOTE: 21 USC 360aaa-5.>> ``SEC. 556. DEFINITIONS.

    ``For purposes of this subchapter:
            ``(1) The term `health care practitioner' means a physician, 
        or other individual who is a provider of health care, who is 
        licensed under the law of a State to prescribe drugs or devices.

[[Page 111 STAT. 2363]]

            ``(2) The terms `health insurance issuer' and `group health 
        plan' have the meaning given such terms under section 2791 of 
        the Public Health Service Act.
            ``(3) The term `manufacturer' means a person who 
        manufactures a drug or device, or who is licensed by such person 
        to distribute or market the drug or device.
            ``(4) The term `new use'--
                    ``(A) with respect to a drug, means a use that is 
                not included in the labeling of the approved drug; and
                    ``(B) with respect to a device, means a use that is 
                not included in the labeling for the approved or cleared 
                device.
            ``(5) The term `scientific or medical journal' means a 
        scientific or medical publication--
                    ``(A) that is published by an organization--
                          ``(i) that has an editorial board;
                          ``(ii) that utilizes experts, who have 
                      demonstrated expertise in the subject of an 
                      article under review by the organization and who 
                      are independent of the organization, to review and 
                      objectively select, reject, or provide comments 
                      about proposed articles; and
                          ``(iii) that has a publicly stated policy, to 
                      which the organization adheres, of full disclosure 
                      of any conflict of interest or biases for all 
                      authors or contributors involved with the journal 
                      or organization;
                    ``(B) whose articles are peer-reviewed and published 
                in accordance with the regular peer-review procedures of 
                the organization;
                    ``(C) that is generally recognized to be of national 
                scope and reputation;
                    ``(D) that is indexed in the Index Medicus of the 
                National Library of Medicine of the National Institutes 
                of Health; and
                    ``(E) that is not in the form of a special 
                supplement that has been funded in whole or in part by 
                one or more manufacturers.

<<NOTE: 21 USC 360aaa-6.>> ``SEC. 557. RULES OF CONSTRUCTION.

    ``(a) Unsolicited Request.--Nothing in section 551 shall be 
construed as prohibiting a manufacturer from disseminating information 
in response to an unsolicited request from a health care practitioner.
    ``(b) Dissemination of Information on Drugs or Devices Not Evidence 
of Intended Use.--Notwithstanding subsection (a), (f), or (o) of section 
502, or any other provision of law, the dissemination of information 
relating to a new use of a drug or device, in accordance with section 
551, shall not be construed by the Secretary as evidence of a new 
intended use of the drug or device that is different from the intended 
use of the drug or device set forth in the official labeling of the drug 
or device. Such dissemination shall not be considered by the Secretary 
as labeling, adulteration, or misbranding of the drug or device.
    ``(c) Patent Protection.--Nothing in section 551 shall affect patent 
rights in any manner.
    ``(d) Authorization for Dissemination of Articles and Fees for 
Reprints of Articles.--Nothing in section 551 shall be construed as 
prohibiting an entity that publishes a scientific journal

[[Page 111 STAT. 2364]]

(as defined in section 556(5)) from requiring authorization from the 
entity to disseminate an article published by such entity or charging 
fees for the purchase of reprints of published articles from such 
entity.''.
    (b) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended by 
section 210, is amended by adding at the end the following:
    ``(z) The dissemination of information in violation of section 
551.''.
     <<NOTE: 21 USC 360aaa note.>> (c) Regulations.--Not later than 1 
year after the date of enactment of this Act, the Secretary of Health 
and Human Services shall promulgate regulations to implement the 
amendments made by this section.

     <<NOTE: 21 USC 360aaa note.>> (d) Effective Date.--The amendments 
made by this section shall take effect 1 year after the date of 
enactment of this Act, or upon the Secretary's issuance of final 
regulations pursuant to subsection (c), whichever is sooner.

     <<NOTE: 21 USC 360aaa note.>> (e) Sunset.--The amendments made by 
this section cease to be effective September 30, 2006, or 7 years after 
the date on which the Secretary promulgates the regulations described in 
subsection (c), whichever is later.

     <<NOTE: 21 USC 360aaa note.>> (f) Studies and Reports.--
            (1) General accounting office.--
                    (A) In general.--The Comptroller General of the 
                United States shall conduct a study to determine the 
                impact of subchapter D of chapter V of the Federal Food, 
                Drug, and Cosmetic Act, as added by this section, on the 
                resources of the Department of Health and Human 
                Services.
                    (B) Report.--Not later than January 1, 2002, the 
                Comptroller General of the United States shall prepare 
                and submit to the Committee on Labor and Human Resources 
                of the Senate and the Committee on Commerce of the House 
                of Representatives a report of the results of the study.
            (2) Department of health and human services.--
                    (A) In general.--In order to assist Congress in 
                determining whether the provisions of such subchapter 
                should be extended beyond the termination date specified 
                in subsection (e), the Secretary of Health and Human 
                Services shall, in accordance with subparagraph (B), 
                arrange for the conduct of a study of the scientific 
                issues raised as a result of the enactment of such 
                subchapter including issues relating to--
                          (i) the effectiveness of such subchapter with 
                      respect to the provision of useful scientific 
                      information to health care practitioners;
                          (ii) the quality of the information being 
                      disseminated pursuant to the provisions of such 
                      subchapter;
                          (iii) the quality and usefulness of the 
                      information provided, in accordance with such 
                      subchapter, by the Secretary or by the 
                      manufacturer at the request of the Secretary; and
                          (iv) the impact of such subchapter on research 
                      in the area of new uses, indications, or dosages, 
                      particularly the impact on pediatric indications 
                      and rare diseases.
            (3) Procedure for study.--

[[Page 111 STAT. 2365]]

                    (A) In general.--The Secretary shall request the 
                Institute of Medicine of the National Academy of 
                Sciences to conduct the study required by paragraph (2), 
                and to prepare and submit the report required by 
                subparagraph (B), under an arrangement by which the 
                actual expenses incurred by the Institute of Medicine in 
                conducting the study and preparing the report will be 
                paid by the Secretary. If the Institute of Medicine is 
                unwilling to conduct the study under such an 
                arrangement, the Comptroller General of the United 
                States shall conduct such study.
                    (B) Report.--Not later than September 30, 2005, the 
                Institute of Medicine or the Comptroller General of the 
                United States, as appropriate, shall prepare and submit 
                to the Committee on Labor and Human Resources of the 
                Senate, the Committee on Commerce of the House of 
                Representatives, and the Secretary a report of the 
                results of the study required by paragraph (2). The 
                Secretary, after the receipt of the report, shall make 
                the report available to the public.
SEC. 402. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES AND 
                        DIAGNOSTICS.

    Chapter V (21 U.S.C. 351 et seq.), as amended in section 401, is 
further amended by adding at the end the following:

    ``Subchapter E--General Provisions Relating to Drugs and Devices

<<NOTE: 21 USC 360bbb.>> ``SEC. 561. EXPANDED ACCESS TO UNAPPROVED 
                          THERAPIES AND DIAGNOSTICS.

    ``(a) Emergency Situations.--The Secretary may, under appropriate 
conditions determined by the Secretary, authorize the shipment of 
investigational drugs or investigational devices for the diagnosis, 
monitoring, or treatment of a serious disease or condition in emergency 
situations.
    ``(b) Individual Patient Access to Investigational Products Intended 
for Serious Diseases.--Any person, acting through a physician licensed 
in accordance with State law, may request from a manufacturer or 
distributor, and any manufacturer or distributor may, after complying 
with the provisions of this subsection, provide to such physician an 
investigational drug or investigational device for the diagnosis, 
monitoring, or treatment of a serious disease or condition if--
            ``(1) the licensed physician determines that the person has 
        no comparable or satisfactory alternative therapy available to 
        diagnose, monitor, or treat the disease or condition involved, 
        and that the probable risk to the person from the 
        investigational drug or investigational device is not greater 
        than the probable risk from the disease or condition;
            ``(2) the Secretary determines that there is sufficient 
        evidence of safety and effectiveness to support the use of the 
        investigational drug or investigational device in the case 
        described in paragraph (1);
            ``(3) the Secretary determines that provision of the 
        investigational drug or investigational device will not 
        interfere with the initiation, conduct, or completion of 
        clinical investigations to support marketing approval; and

[[Page 111 STAT. 2366]]

            ``(4) the sponsor, or clinical investigator, of the 
        investigational drug or investigational device submits to the 
        Secretary a clinical protocol consistent with the provisions of 
        section 505(i) or 520(g), including any regulations promulgated 
        under section 505(i) or 520(g), describing the use of the 
        investigational drug or investigational device in a single 
        patient or a small group of patients.

    ``(c) Treatment Investigational New Drug Applications and Treatment 
Investigational Device Exemptions.--Upon submission by a sponsor or a 
physician of a protocol intended to provide widespread access to an 
investigational drug or investigational device for eligible patients 
(referred to in this subsection as an `expanded access protocol'), the 
Secretary shall permit such investigational drug or investigational 
device to be made available for expanded access under a treatment 
investigational new drug application or treatment investigational device 
exemption if the Secretary determines that--
            ``(1) under the treatment investigational new drug 
        application or treatment investigational device exemption, the 
        investigational drug or investigational device is intended for 
        use in the diagnosis, monitoring, or treatment of a serious or 
        immediately life-threatening disease or condition;
            ``(2) there is no comparable or satisfactory alternative 
        therapy available to diagnose, monitor, or treat that stage of 
        disease or condition in the population of patients to which the 
        investigational drug or investigational device is intended to be 
        administered;
            ``(3)(A) the investigational drug or investigational device 
        is under investigation in a controlled clinical trial for the 
        use described in paragraph (1) under an investigational drug 
        application in effect under section 505(i) or investigational 
        device exemption in effect under section 520(g); or
            ``(B) all clinical trials necessary for approval of that use 
        of the investigational drug or investigational device have been 
        completed;
            ``(4) the sponsor of the controlled clinical trials is 
        actively pursuing marketing approval of the investigational drug 
        or investigational device for the use described in paragraph (1) 
        with due diligence;
            ``(5) in the case of an investigational drug or 
        investigational device described in paragraph (3)(A), the 
        provision of the investigational drug or investigational device 
        will not interfere with the enrollment of patients in ongoing 
        clinical investigations under section 505(i) or 520(g);
            ``(6) in the case of serious diseases, there is sufficient 
        evidence of safety and effectiveness to support the use 
        described in paragraph (1); and
            ``(7) in the case of immediately life-threatening diseases, 
        the available scientific evidence, taken as a whole, provides a 
        reasonable basis to conclude that the investigational drug or 
        investigational device may be effective for its intended use and 
        would not expose patients to an unreasonable and significant 
        risk of illness or injury.

A protocol submitted under this subsection shall be subject to the 
provisions of section 505(i) or 520(g), including regulations 
promulgated under section 505(i) or 520(g). The Secretary may inform 
national, State, and local medical associations and societies,

[[Page 111 STAT. 2367]]

voluntary health associations, and other appropriate persons about the 
availability of an investigational drug or investigational device under 
expanded access protocols submitted under this subsection. The 
information provided by the Secretary, in accordance with the preceding 
sentence, shall be the same type of information that is required by 
section 402(j)(3) of the Public Health Service Act.
    ``(d) Termination.--The Secretary may, at any time, with respect to 
a sponsor, physician, manufacturer, or distributor described in this 
section, terminate expanded access provided under this section for an 
investigational drug or investigational device if the requirements under 
this section are no longer met.
    ``(e) Definitions.--In this section, the terms `investigational 
drug', `investigational device', `treatment investigational new drug 
application', and `treatment investigational device exemption' shall 
have the meanings given the terms in regulations prescribed by the 
Secretary.''.
<<NOTE: 21 USC 371 note.>> SEC. 403. APPROVAL OF SUPPLEMENTAL 
                        APPLICATIONS FOR APPROVED PRODUCTS.

    (a) Standards.--Not later than 180 days after the date of enactment 
of this Act, the Secretary of Health and Human Services shall publish in 
the Federal Register standards for the prompt review of supplemental 
applications submitted for approved articles under the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or section 351 of the 
Public Health Service Act (42 U.S.C. 262).
    (b) Guidance to Industry.--Not later than 180 days after the date of 
enactment of this Act, the Secretary shall issue final guidances to 
clarify the requirements for, and facilitate the submission of data to 
support, the approval of supplemental applications for the approved 
articles described in subsection (a). The guidances shall--
            (1) clarify circumstances in which published matter may be 
        the basis for approval of a supplemental application;
            (2) specify data requirements that will avoid duplication of 
        previously submitted data by recognizing the availability of 
        data previously submitted in support of an original application; 
        and
            (3) define supplemental applications that are eligible for 
        priority review.

    (c) Responsibilities of Centers.--The Secretary shall designate an 
individual in each center within the Food and Drug Administration 
(except the Center for Food Safety and Applied Nutrition) to be 
responsible for--
            (1) encouraging the prompt review of supplemental 
        applications for approved articles; and
            (2) working with sponsors to facilitate the development and 
        submission of data to support supplemental applications.

    (d) Collaboration.--The Secretary shall implement programs and 
policies that will foster collaboration between the Food and Drug 
Administration, the National Institutes of Health, professional medical 
and scientific societies, and other persons, to identify published and 
unpublished studies that may support a supplemental application, and to 
encourage sponsors to make supplemental applications or conduct further 
research in support of a supplemental application based, in whole or in 
part, on such studies.

[[Page 111 STAT. 2368]]

SEC. 404. DISPUTE RESOLUTION.

    Subchapter E of chapter V, as added by section 402, is amended by 
adding at the end the following:

<<NOTE: 21 USC 360bbb-1. Regulations.>> ``SEC. 562. DISPUTE RESOLUTION.

    ``If, regarding an obligation concerning drugs or devices under this 
Act or section 351 of the Public Health Service Act, there is a 
scientific controversy between the Secretary and a person who is a 
sponsor, applicant, or manufacturer and no specific provision of the Act 
involved, including a regulation promulgated under such Act, provides a 
right of review of the matter in controversy, the Secretary shall, by 
regulation, establish a procedure under which such sponsor, applicant, 
or manufacturer may request a review of such controversy, including a 
review by an appropriate scientific advisory panel described in section 
505(n) or an advisory committee described in section 515(g)(2)(B). Any 
such review shall take place in a timely manner. The Secretary shall 
promulgate such regulations within 1 year after the date of the 
enactment of the Food and Drug Administration Modernization Act of 
1997.''.

SEC. 405. INFORMAL AGENCY STATEMENTS.

    Section 701 (21 U.S.C. 371) is amended by adding at the end the 
following:
    ``(h)(1)(A) The Secretary shall develop guidance documents with 
public participation and ensure that information identifying the 
existence of such documents and the documents themselves are made 
available to the public both in written form and, as feasible, through 
electronic means. Such documents shall not create or confer any rights 
for or on any person, although they present the views of the Secretary 
on matters under the jurisdiction of the Food and Drug Administration.
    ``(B) Although guidance documents shall not be binding on the 
Secretary, the Secretary shall ensure that employees of the Food and 
Drug Administration do not deviate from such guidances without 
appropriate justification and supervisory concurrence. The Secretary 
shall provide training to employees in how to develop and use guidance 
documents and shall monitor the development and issuance of such 
documents.
    ``(C) For guidance documents that set forth initial interpretations 
of a statute or regulation, changes in interpretation or policy that are 
of more than a minor nature, complex scientific issues, or highly 
controversial issues, the Secretary shall ensure public participation 
prior to implementation of guidance documents, unless the Secretary 
determines that such prior public participation is not feasible or 
appropriate. In such cases, the Secretary shall provide for public 
comment upon implementation and take such comment into account.
    ``(D) For guidance documents that set forth existing practices or 
minor changes in policy, the Secretary shall provide for public comment 
upon implementation.
    ``(2) In developing guidance documents, the Secretary shall ensure 
uniform nomenclature for such documents and uniform internal procedures 
for approval of such documents. The Secretary shall ensure that guidance 
documents and revisions of such documents are properly dated and 
indicate the nonbinding nature of the documents. The Secretary shall 
periodically review all guidance documents and, where appropriate, 
revise such documents.

[[Page 111 STAT. 2369]]

    ``(3) The Secretary, acting through the Commissioner, shall maintain 
electronically and update and publish periodically in the Federal 
Register a list of guidance documents. All such documents shall be made 
available to the public.
    ``(4) The Secretary shall ensure that an effective appeals mechanism 
is in place to address complaints that the Food and Drug Administration 
is not developing and using guidance documents in accordance with this 
subsection.
     <<NOTE: Regulations.>> ``(5) Not later than July 1, 2000, the 
Secretary after evaluating the effectiveness of the Good Guidance 
Practices document, published in the Federal Register at 62 Fed. Reg. 
8961, shall promulgate a regulation consistent with this subsection 
specifying the policies and procedures of the Food and Drug 
Administration for the development, issuance, and use of guidance 
documents.''.
SEC. 406. FOOD AND DRUG ADMINISTRATION MISSION AND ANNUAL REPORT.

    (a) Mission.--Section 903 (21 U.S.C. 393) is amended--
            (1) by redesignating subsections (b) and (c) as subsections 
        (d) and (e), respectively; and
            (2) by inserting after subsection (a) the following:

    ``(b) Mission.--The Administration shall--
            ``(1) promote the public health by promptly and efficiently 
        reviewing clinical research and taking appropriate action on the 
        marketing of regulated products in a timely manner;
            ``(2) with respect to such products, protect the public 
        health by ensuring that--
                    ``(A) foods are safe, wholesome, sanitary, and 
                properly labeled;
                    ``(B) human and veterinary drugs are safe and 
                effective;
                    ``(C) there is reasonable assurance of the safety 
                and effectiveness of devices intended for human use;
                    ``(D) cosmetics are safe and properly labeled; and
                    ``(E) public health and safety are protected from 
                electronic product radiation;
            ``(3) participate through appropriate processes with 
        representatives of other countries to reduce the burden of 
        regulation, harmonize regulatory requirements, and achieve 
        appropriate reciprocal arrangements; and
            ``(4) as determined to be appropriate by the Secretary, 
        carry out paragraphs (1) through (3) in consultation with 
        experts in science, medicine, and public health, and in 
        cooperation with consumers, users, manufacturers, importers, 
        packers, distributors, and retailers of regulated products.''.

    (b) Annual Report.--Section 903 (21 U.S.C. 393), as amended by 
subsection (a), is further amended by adding at the end the following:
    ``(f) Agency Plan for Statutory Compliance.--
             <<NOTE: Federal Register, publication.>> ``(1) In 
        general.--Not later than 1 year after the date of enactment of 
        the Food and Drug Administration Modernization Act of 1997, the 
        Secretary, after consultation with appropriate scientific and 
        academic experts, health care professionals, representatives of 
        patient and consumer advocacy groups, and the regulated 
        industry, shall develop and publish in the Federal Register a 
        plan bringing the Secretary into compliance with each of the 
        obligations of the Secretary under this Act. The

[[Page 111 STAT. 2370]]

        Secretary shall review the plan biannually and shall revise the 
        plan as necessary, in consultation with such persons.
            ``(2) Objectives of agency plan.--The plan required by 
        paragraph (1) shall establish objectives and mechanisms to 
        achieve such objectives, including objectives related to--
                    ``(A) maximizing the availability and clarity of 
                information about the process for review of applications 
                and submissions (including petitions, notifications, and 
                any other similar forms of request) made under this Act;
                    ``(B) maximizing the availability and clarity of 
                information for consumers and patients concerning new 
                products;
                    ``(C) implementing inspection and postmarket 
                monitoring provisions of this Act;
                    ``(D) ensuring access to the scientific and 
                technical expertise needed by the Secretary to meet 
                obligations described in paragraph (1);
                    ``(E) establishing mechanisms, by July 1, 1999, for 
                meeting the time periods specified in this Act for the 
                review of all applications and submissions described in 
                subparagraph (A) and submitted after the date of 
                enactment of the Food and Drug Administration 
                Modernization Act of 1997; and
                    ``(F) eliminating backlogs in the review of 
                applications and submissions described in subparagraph 
                (A), by January 1, 2000.

     <<NOTE: Federal Register, publication.>> ``(g) Annual Report.--The 
Secretary shall annually prepare and publish in the Federal Register and 
solicit public comment on a report that--
            ``(1) provides detailed statistical information on the 
        performance of the Secretary under the plan described in 
        subsection (f);
            ``(2) compares such performance of the Secretary with the 
        objectives of the plan and with the statutory obligations of the 
        Secretary; and
            ``(3) identifies any regulatory policy that has a 
        significant negative impact on compliance with any objective of 
        the plan or any statutory obligation and sets forth any proposed 
        revision to any such regulatory policy.''.

SEC. 407. INFORMATION SYSTEM.

    (a) Amendment.--Chapter VII (21 U.S.C. 371 et seq.) is amended by 
adding at the end the following:

                ``Subchapter D--Information and Education

<<NOTE: 21 USC 379k.>> ``SEC. 741. INFORMATION SYSTEM.

    ``The Secretary shall establish and maintain an information system 
to track the status and progress of each application or submission 
(including a petition, notification, or other similar form of request) 
submitted to the Food and Drug Administration requesting agency 
action.''.
     <<NOTE: 21 USC 379k note.>> (b) Report.--Not later than 1 year 
after the date of enactment of this Act, the Secretary of Health and 
Human Services shall submit a report to the Committee on Labor and Human 
Resources of the Senate and the Committee on Commerce of the House of 
Representatives on the status of the system to be established under

[[Page 111 STAT. 2371]]

the amendment made by subsection (a), including the projected costs of 
the system and concerns about confidentiality.

SEC. 408. EDUCATION AND TRAINING.

    (a) Food and Drug Administration.--Chapter VII (21 U.S.C. 371 et 
seq.), as amended by section 407, is further amended by adding at the 
end the following section:

<<NOTE: 21 USC 379l.>> ``SEC. 742. EDUCATION.

    ``(a) In General.--The Secretary shall conduct training and 
education programs for the employees of the Food and Drug Administration 
relating to the regulatory responsibilities and policies established by 
this Act, including programs for--
            ``(1) scientific training;
            ``(2) training to improve the skill of officers and 
        employees authorized to conduct inspections under section 704;
            ``(3) training to achieve product specialization in such 
        inspections; and
            ``(4) training in administrative process and procedure and 
        integrity issues.

    ``(b) Intramural Fellowships and Other Training Programs.--The 
Secretary, acting through the Commissioner, may, through fellowships and 
other training programs, conduct and support intramural research 
training for predoctoral and postdoctoral scientists and physicians.''.
    (b) Centers for Disease Control and Prevention.--
            (1) In general.--Part B of title III of the Public Health 
        Service Act is amended by inserting after section 317F (42 
        U.S.C. 247b-7) the following:

<<NOTE: 42 USC 247b-8.>> ``SEC. 317G. FELLOWSHIP AND TRAINING PROGRAMS.

    ``The Secretary, acting through the Director of the Centers for 
Disease Control and Prevention, shall establish fellowship and training 
programs to be conducted by such Centers to train individuals to develop 
skills in epidemiology, surveillance, laboratory analysis, and other 
disease detection and prevention methods. Such programs shall be 
designed to enable health professionals and health personnel trained 
under such programs to work, after receiving such training, in local, 
State, national, and international efforts toward the prevention and 
control of diseases, injuries, and disabilities. Such fellowships and 
training may be administered through the use of either appointment or 
nonappointment procedures.''.
             <<NOTE: 42 USC 247b-8 note.>> (2) Effective date.--The 
        amendment made by this subsection is deemed to have taken effect 
        July 1, 1995.

SEC. 409. CENTERS FOR EDUCATION AND RESEARCH ON THERAPEUTICS.

    Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) is 
amended by adding at the end of part A the following new section:
<<NOTE: 42 USC 299a-3.>> ``SEC. 905. DEMONSTRATION PROGRAM 
                          REGARDING CENTERS FOR EDUCATION AND 
                          RESEARCH ON THERAPEUTICS.

    ``(a) In General.--The Secretary, acting through the Administrator 
and in consultation with the Commissioner of Food and Drugs, shall 
establish a demonstration program for the purpose of making one or more 
grants for the establishment and operation

[[Page 111 STAT. 2372]]

of one or more centers to carry out the activities specified in 
subsection (b).
    ``(b) Required Activities.--The activities referred to in subsection 
(a) are the following:
            ``(1) The conduct of state-of-the-art clinical and 
        laboratory research for the following purposes:
                    ``(A) To increase awareness of--
                          ``(i) new uses of drugs, biological products, 
                      and devices;
                          ``(ii) ways to improve the effective use of 
                      drugs, biological products, and devices; and
                          ``(iii) risks of new uses and risks of 
                      combinations of drugs and biological products.
                    ``(B) To provide objective clinical information to 
                the following individuals and entities:
                          ``(i) Health care practitioners or other 
                      providers of health care goods or services.
                          ``(ii) Pharmacy benefit managers.
                          ``(iii) Health maintenance organizations or 
                      other managed health care organizations.
                          ``(iv) Health care insurers or governmental 
                      agencies.
                          ``(v) Consumers.
                    ``(C) To improve the quality of health care while 
                reducing the cost of health care through--
                          ``(i) the appropriate use of drugs, biological 
                      products, or devices; and
                          ``(ii) the prevention of adverse effects of 
                      drugs, biological products, and devices and the 
                      consequences of such effects, such as unnecessary 
                      hospitalizations.
            ``(2) The conduct of research on the comparative 
        effectiveness and safety of drugs, biological products, and 
        devices.
            ``(3) Such other activities as the Secretary determines to 
        be appropriate, except that the grant may not be expended to 
        assist the Secretary in the review of new drugs.

    ``(c) Application for Grant.--A grant under subsection (a) may be 
made only if an application for the grant is submitted to the Secretary 
and the application is in such form, is made in such manner, and 
contains such agreements, assurances, and information as the Secretary 
determines to be necessary to carry out this section.
    ``(d) Peer Review.--A grant under subsection (a) may be made only if 
the application for the grant has undergone appropriate technical and 
scientific peer review.
    ``(e) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $2,000,000 for 
fiscal year 1998, and $3,000,000 for each of fiscal years 1999 through 
2002.''.
SEC. 410. MUTUAL RECOGNITION AGREEMENTS AND GLOBAL HARMONIZATION.

    (a) Good Manufacturing Practice Requirements.--Section 520(f)(1)(B) 
(21 U.S.C. 360j(f)(1)(B)) is amended--
            (1) in clause (i), by striking ``, and'' at the end and 
        inserting a semicolon;
            (2) in clause (ii), by striking the period and inserting ``; 
        and''; and

[[Page 111 STAT. 2373]]

            (3) by inserting after clause (ii) the following:
            ``(iii) ensure that such regulation conforms, to the extent 
        practicable, with internationally recognized standards defining 
        quality systems, or parts of the standards, for medical 
        devices.''.

    (b) Harmonization Efforts.--Section 803 (21 U.S.C. 383) is amended 
by adding at the end the following:
    ``(c)(1) The Secretary shall support the Office of the United States 
Trade Representative, in consultation with the Secretary of Commerce, in 
meetings with representatives of other countries to discuss methods and 
approaches to reduce the burden of regulation and harmonize regulatory 
requirements if the Secretary determines that such harmonization 
continues consumer protections consistent with the purposes of this Act.
    ``(2) The Secretary shall support the Office of the United States 
Trade Representative, in consultation with the Secretary of Commerce, in 
efforts to move toward the acceptance of mutual recognition agreements 
relating to the regulation of drugs, biological products, devices, 
foods, food additives, and color additives, and the regulation of good 
manufacturing practices, between the European Union and the United 
States.
    ``(3) The Secretary shall regularly participate in meetings with 
representatives of other foreign governments to discuss and reach 
agreement on methods and approaches to harmonize regulatory 
requirements.
    ``(4) The Secretary shall, not later than 180 days after the date of 
enactment of the Food and Drug Administration Modernization Act of 1997, 
make public a plan that establishes a framework for achieving mutual 
recognition of good manufacturing practices inspections.
    ``(5) Paragraphs (1) through (4) shall not apply with respect to 
products defined in section 201(ff).''.

SEC. 411. ENVIRONMENTAL IMPACT REVIEW.

    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 407, is 
further amended by adding at the end the following:

               ``Subchapter E--Environmental Impact Review

<<NOTE: 21 USC 379o.>> ``SEC. 746. ENVIRONMENTAL IMPACT.

    ``Notwithstanding any other provision of law, an environmental 
impact statement prepared in accordance with the regulations published 
in part 25 of title 21, Code of Federal Regulations (as in effect on 
August 31, 1997) in connection with an action carried out under (or a 
recommendation or report relating to) this Act, shall be considered to 
meet the requirements for a detailed statement under section 102(2)(C) 
of the National Environmental Policy Act of 1969 (42 U.S.C. 
4332(2)(C)).''.
SEC. 412. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND 
                        COSMETICS.

    (a) Nonprescription Drugs.--Chapter VII (21 U.S.C. 371 et seq.), as 
amended by section 411, is further amended by adding at the end the 
following:

[[Page 111 STAT. 2374]]

   ``Subchapter F--National Uniformity for Nonprescription Drugs and 
            Preemption for Labeling or Packaging of Cosmetics

<<NOTE: 21 USC 379r.>> ``SEC. 751. NATIONAL UNIFORMITY FOR 
            NONPRESCRIPTION DRUGS.

    ``(a) In General.--Except as provided in subsection (b), (c)(1), 
(d), (e), or (f), no State or political subdivision of a State may 
establish or continue in effect any requirement--
            ``(1) that relates to the regulation of a drug that is not 
        subject to the requirements of section 503(b)(1) or 
        503(f)(1)(A); and
            ``(2) that is different from or in addition to, or that is 
        otherwise not identical with, a requirement under this Act, the 
        Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et 
        seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et 
        seq.).

    ``(b) Exemption.--
            ``(1) In general.--Upon application of a State or political 
        subdivision thereof, the Secretary may by regulation, after 
        notice and opportunity for written and oral presentation of 
        views, exempt from subsection (a), under such conditions as may 
        be prescribed in such regulation, a State or political 
        subdivision requirement that--
                    ``(A) protects an important public interest that 
                would otherwise be unprotected, including the health and 
                safety of children;
                    ``(B) would not cause any drug to be in violation of 
                any applicable requirement or prohibition under Federal 
                law; and
                    ``(C) would not unduly burden interstate commerce.
            ``(2) Timely action.--The Secretary shall make a decision on 
        the exemption of a State or political subdivision requirement 
        under paragraph (1) not later than 120 days after receiving the 
        application of the State or political subdivision under 
        paragraph (1).

    ``(c) Scope.--
            ``(1) In general.--This section shall not apply to--
                    ``(A) any State or political subdivision requirement 
                that relates to the practice of pharmacy; or
                    ``(B) any State or political subdivision requirement 
                that a drug be dispensed only upon the prescription of a 
                practitioner licensed by law to administer such drug.
            ``(2) Safety or effectiveness.--For purposes of subsection 
        (a), a requirement that relates to the regulation of a drug 
        shall be deemed to include any requirement relating to public 
        information or any other form of public communication relating 
        to a warning of any kind for a drug.

    ``(d) Exceptions.--
            ``(1) In general.--In the case of a drug described in 
        subsection (a)(1) that is not the subject of an application 
        approved under section 505 or section 507 (as in effect on the 
        day before the date of enactment of the Food and Drug 
        Administration Modernization Act of 1997) or a final regulation 
        promulgated by the Secretary establishing conditions under which 
        the drug is generally recognized as safe and effective and not 
        misbranded, subsection (a) shall apply only with respect to a 
        requirement of a State or political subdivision of a State that

[[Page 111 STAT. 2375]]

        relates to the same subject as, but is different from or in 
        addition to, or that is otherwise not identical with--
                    ``(A) a regulation in effect with respect to the 
                drug pursuant to a statute described in subsection 
                (a)(2); or
                    ``(B) any other requirement in effect with respect 
                to the drug pursuant to an amendment to such a statute 
                made on or after the date of enactment of the Food and 
                Drug Administration Modernization Act of 1997.
            ``(2) State initiatives.--This section shall not apply to a 
        State requirement adopted by a State public initiative or 
        referendum enacted prior to September 1, 1997.

    ``(e) No Effect on Product Liability Law.--Nothing in this section 
shall be construed to modify or otherwise affect any action or the 
liability of any person under the product liability law of any State.
    ``(f) State Enforcement Authority.--Nothing in this section shall 
prevent a State or political subdivision thereof from enforcing, under 
any relevant civil or other enforcement authority, a requirement that is 
identical to a requirement of this Act.''.
    (b) Inspections.--Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended 
by striking ``prescription drugs'' each place it appears and inserting 
``prescription drugs, nonprescription drugs intended for human use,''.
    (c) Misbranding.--Subparagraph (1) of section 502(e) (21 U.S.C. 
352(e)(1)) is amended to read as follows:
    ``(1)(A) If it is a drug, unless its label bears, to the exclusion 
of any other nonproprietary name (except the applicable systematic 
chemical name or the chemical formula)--
            ``(i) the established name (as defined in subparagraph (3)) 
        of the drug, if there is such a name;
            ``(ii) the established name and quantity or, if determined 
        to be appropriate by the Secretary, the proportion of each 
        active ingredient, including the quantity, kind, and proportion 
        of any alcohol, and also including whether active or not the 
        established name and quantity or if determined to be appropriate 
        by the Secretary, the proportion of any bromides, ether, 
        chloroform, acetanilide, acetophenetidin, amidopyrine, 
        antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, 
        digitalis glucosides, mercury, ouabain, strophanthin, 
        strychnine, thyroid, or any derivative or preparation of any 
        such substances, contained therein, except that the requirement 
        for stating the quantity of the active ingredients, other than 
        the quantity of those specifically named in this subclause, 
        shall not apply to nonprescription drugs not intended for human 
        use; and
            ``(iii) the established name of each inactive ingredient 
        listed in alphabetical order on the outside container of the 
        retail package and, if determined to be appropriate by the 
        Secretary, on the immediate container, as prescribed in 
        regulation promulgated by the Secretary, except that nothing in 
        this subclause shall be deemed to require that any trade secret 
        be divulged, and except that the requirements of this subclause 
        with respect to alphabetical order shall apply only to 
        nonprescription drugs that are not also cosmetics and that this 
        subclause shall not apply to nonprescription drugs not intended 
        for human use.

    ``(B) For any prescription drug the established name of such drug or 
ingredient, as the case may be, on such label (and on

[[Page 111 STAT. 2376]]

any labeling on which a name for such drug or ingredient is used) shall 
be printed prominently and in type at least half as large as that used 
thereon for any proprietary name or designation for such drug or 
ingredient, except that to the extent that compliance with the 
requirements of subclause (ii) or (iii) of clause (A) or this clause is 
impracticable, exemptions shall be established by regulations 
promulgated by the Secretary.''.
    (d) Cosmetics.--Subchapter F of chapter VII, as amended by 
subsection (a), is further amended by adding at the end the following:
<<NOTE: 21 USC 379s.>> ``SEC. 752. PREEMPTION FOR LABELING OR 
                          PACKAGING OF COSMETICS.

    ``(a) In General.--Except as provided in subsection (b), (d), or 
(e), no State or political subdivision of a State may establish or 
continue in effect any requirement for labeling or packaging of a 
cosmetic that is different from or in addition to, or that is otherwise 
not identical with, a requirement specifically applicable to a 
particular cosmetic or class of cosmetics under this Act, the Poison 
Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair 
Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
    ``(b) Exemption.--Upon application of a State or political 
subdivision thereof, the Secretary may by regulation, after notice and 
opportunity for written and oral presentation of views, exempt from 
subsection (a), under such conditions as may be prescribed in such 
regulation, a State or political subdivision requirement for labeling or 
packaging that--
            ``(1) protects an important public interest that would 
        otherwise be unprotected;
            ``(2) would not cause a cosmetic to be in violation of any 
        applicable requirement or prohibition under Federal law; and
            ``(3) would not unduly burden interstate commerce.

    ``(c) Scope.--For purposes of subsection (a), a reference to a State 
requirement that relates to the packaging or labeling of a cosmetic 
means any specific requirement relating to the same aspect of such 
cosmetic as a requirement specifically applicable to that particular 
cosmetic or class of cosmetics under this Act for packaging or labeling, 
including any State requirement relating to public information or any 
other form of public communication.
    ``(d) No Effect on Product Liability Law.--Nothing in this section 
shall be construed to modify or otherwise affect any action or the 
liability of any person under the product liability law of any State.
    ``(e) State Initiative.--This section shall not apply to a State 
requirement adopted by a State public initiative or referendum enacted 
prior to September 1, 1997.''.
<<NOTE: 21 USC 393 note.>> SEC. 413. FOOD AND DRUG ADMINISTRATION 
                        STUDY OF MERCURY COMPOUNDS IN DRUGS AND 
                        FOOD.

    (a) List and Analysis.--The Secretary of Health and Human Services 
shall, acting through the Food and Drug Administration--
            (1) compile a list of drugs and foods that contain 
        intentionally introduced mercury compounds, and
            (2) provide a quantitative and qualitative analysis of the 
        mercury compounds in the list under paragraph (1).

The Secretary shall compile the list required by paragraph (1) within 2 
years after the date of enactment of the Food and Drug Administration 
Modernization Act of 1997 and shall provide the

[[Page 111 STAT. 2377]]

analysis required by paragraph (2) within 2 years after such date of 
enactment.
    (b) Study.--The Secretary of Health and Human Services, acting 
through the Food and Drug Administration, shall conduct a study of the 
effect on humans of the use of mercury compounds in nasal sprays. Such 
study shall include data from other studies that have been made of such 
use.
    (c) Study of Mercury Sales.--
            (1) Study.--The Secretary of Health and Human Services, 
        acting through the Food and Drug Administration and subject to 
        appropriations, shall conduct, or shall contract with the 
        Institute of Medicine of the National Academy of Sciences to 
        conduct, a study of the effect on humans of the use of 
        elemental, organic, or inorganic mercury when offered for sale 
        as a drug or dietary supplement. Such study shall, among other 
        things, evaluate--
                    (A) the scope of mercury use as a drug or dietary 
                supplement; and
                    (B) the adverse effects on health of children and 
                other sensitive populations resulting from exposure to, 
                or ingestion or inhalation of, mercury when so used.
        In conducting such study, the Secretary shall consult with the 
        Administrator of the Environmental Protection Agency, the Chair 
        of the Consumer Product Safety Commission, and the Administrator 
        of the Agency for Toxic Substances and Disease Registry, and, to 
        the extent the Secretary believes necessary or appropriate, with 
        any other Federal or private entity.
            (2) Regulations.--If, in the opinion of the Secretary, the 
        use of elemental, organic, or inorganic mercury offered for sale 
        as a drug or dietary supplement poses a threat to human health, 
        the Secretary shall promulgate regulations restricting the sale 
        of mercury intended for such use. At a minimum, such regulations 
        shall be designed to protect the health of children and other 
        sensitive populations from adverse effects resulting from 
        exposure to, or ingestion or inhalation of, mercury. Such 
        regulations, to the extent feasible, should not unnecessarily 
        interfere with the availability of mercury for use in religious 
        ceremonies.

SEC. 414. INTERAGENCY COLLABORATION.

    Section 903 (21 U.S.C. 393), as amended by section 406, is further 
amended by inserting after subsection (b) the following:
    ``(c) Interagency Collaboration.--The Secretary shall implement 
programs and policies that will foster collaboration between the 
Administration, the National Institutes of Health, and other science-
based Federal agencies, to enhance the scientific and technical 
expertise available to the Secretary in the conduct of the duties of the 
Secretary with respect to the development, clinical investigation, 
evaluation, and postmarket monitoring of emerging medical therapies, 
including complementary therapies, and advances in nutrition and food 
science.''.

SEC. 415. CONTRACTS FOR EXPERT REVIEW.

    Chapter IX (21 U.S.C. 391 et seq.), as amended by section 214, is 
further amended by adding at the end the following:

<<NOTE: 21 USC 397.>> ``SEC. 907. CONTRACTS FOR EXPERT REVIEW.

    ``(a) In General.--

[[Page 111 STAT. 2378]]

            ``(1) Authority.--The Secretary may enter into a contract 
        with any organization or any individual (who is not an employee 
        of the Department) with relevant expertise, to review and 
        evaluate, for the purpose of making recommendations to the 
        Secretary on, part or all of any application or submission 
        (including a petition, notification, and any other similar form 
        of request) made under this Act for the approval or 
        classification of an article or made under section 351(a) of the 
        Public Health Service Act (42 U.S.C. 262(a)) with respect to a 
        biological product. Any such contract shall be subject to the 
        requirements of section 708 relating to the confidentiality of 
        information.
            ``(2) Increased efficiency and expertise through 
        contracts.--The Secretary may use the authority granted in 
        paragraph (1) whenever the Secretary determines that use of a 
        contract described in paragraph (1) will improve the timeliness 
        of the review of an application or submission described in 
        paragraph (1), unless using such authority would reduce the 
        quality, or unduly increase the cost, of such review. The 
        Secretary may use such authority whenever the Secretary 
        determines that use of such a contract will improve the quality 
        of the review of an application or submission described in 
        paragraph (1), unless using such authority would unduly increase 
        the cost of such review. Such improvement in timeliness or 
        quality may include providing the Secretary increased scientific 
        or technical expertise that is necessary to review or evaluate 
        new therapies and technologies.

    ``(b) Review of Expert Review.--
            ``(1) In general.--Subject to paragraph (2), the official of 
        the Food and Drug Administration responsible for any matter for 
        which expert review is used pursuant to subsection (a) shall 
        review the recommendations of the organization or individual who 
        conducted the expert review and shall make a final decision 
        regarding the matter in a timely manner.
            ``(2) Limitation.--A final decision by the Secretary on any 
        such application or submission shall be made within the 
        applicable prescribed time period for review of the matter as 
        set forth in this Act or in the Public Health Service Act (42 
        U.S.C. 201 et seq.).''.

SEC. 416. PRODUCT CLASSIFICATION.

    Subchapter E of chapter V, as amended by section 404, is further 
amended by adding at the end the following:

<<NOTE: 21 USC 360bbb-2.>> ``SEC. 563. CLASSIFICATION OF PRODUCTS.

    ``(a) Request.--A person who submits an application or submission 
(including a petition, notification, and any other similar form of 
request) under this Act for a product, may submit a request to the 
Secretary respecting the classification of the product as a drug, 
biological product, device, or a combination product subject to section 
503(g) or respecting the component of the Food and Drug Administration 
that will regulate the product. In submitting the request, the person 
shall recommend a classification for the product, or a component to 
regulate the product, as appropriate.
    ``(b) Statement.--Not later than 60 days after the receipt of the 
request described in subsection (a), the Secretary shall determine the 
classification of the product under subsection (a), or the component of 
the Food and Drug Administration that will regulate the product, and 
shall provide to the person a written statement

[[Page 111 STAT. 2379]]

that identifies such classification or such component, and the reasons 
for such determination. The Secretary may not modify such statement 
except with the written consent of the person, or for public health 
reasons based on scientific evidence.
    ``(c) Inaction of Secretary.--If the Secretary does not provide the 
statement within the 60-day period described in subsection (b), the 
recommendation made by the person under subsection (a) shall be 
considered to be a final determination by the Secretary of such 
classification of the product, or the component of the Food and Drug 
Administration that will regulate the product, as applicable, and may 
not be modified by the Secretary except with the written consent of the 
person, or for public health reasons based on scientific evidence.''.

SEC. 417. REGISTRATION OF FOREIGN ESTABLISHMENTS.

    Section 510(i) (21 U.S.C. 360(i)) is amended to read as follows:
    ``(i)(1) Any establishment within any foreign country engaged in the 
manufacture, preparation, propagation, compounding, or processing of a 
drug or a device that is imported or offered for import into the United 
States shall register with the Secretary the name and place of business 
of the establishment and the name of the United States agent for the 
establishment.
    ``(2) The establishment shall also provide the information required 
by subsection (j).
    ``(3) The Secretary is authorized to enter into cooperative 
arrangements with officials of foreign countries to ensure that adequate 
and effective means are available for purposes of determining, from time 
to time, whether drugs or devices manufactured, prepared, propagated, 
compounded, or processed by an establishment described in paragraph (1), 
if imported or offered for import into the United States, shall be 
refused admission on any of the grounds set forth in section 801(a).''.

SEC. 418. CLARIFICATION OF SEIZURE AUTHORITY.

    Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended--
            (1) in the fifth sentence, by striking ``paragraphs (1) and 
        (2) of section 801(e)'' and inserting ``subparagraphs (A) and 
        (B) of section 801(e)(1)''; and
            (2) by inserting after the fifth sentence the following: 
        ``Any person seeking to export an imported article pursuant to 
        any of the provisions of this subsection shall establish that 
        the article was intended for export at the time the article 
        entered commerce.''.

SEC. 419. INTERSTATE COMMERCE.

    Section 709 (21 U.S.C. 379a) is amended by striking ``a device'' and 
inserting ``a device, food, drug, or cosmetic''.

SEC. 420. SAFETY REPORT DISCLAIMERS.

    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 412, is 
further amended by adding at the end the following:

                     ``Subchapter G--Safety Reports

<<NOTE: 21 USC 379v.>> ``SEC. 756. SAFETY REPORT DISCLAIMERS.

    ``With respect to any entity that submits or is required to submit a 
safety report or other information in connection with the safety of a 
product (including a product that is a food, drug,

[[Page 111 STAT. 2380]]

device, dietary supplement, or cosmetic) under this Act (and any release 
by the Secretary of that report or information), such report or 
information shall not be construed to reflect necessarily a conclusion 
by the entity or the Secretary that the report or information 
constitutes an admission that the product involved malfunctioned, caused 
or contributed to an adverse experience, or otherwise caused or 
contributed to a death, serious injury, or serious illness. Such an 
entity need not admit, and may deny, that the report or information 
submitted by the entity constitutes an admission that the product 
involved malfunctioned, caused or contributed to an adverse experience, 
or caused or contributed to a death, serious injury, or serious 
illness.''.
SEC. 421. LABELING AND ADVERTISING REGARDING COMPLIANCE WITH 
                        STATUTORY REQUIREMENTS.

    Section 301 (21 U.S.C. 331) is amended by striking paragraph (l).

<<NOTE: 21 USC 321 note.>> SEC. 422. RULE OF CONSTRUCTION.

    Nothing in this Act or the amendments made by this Act shall be 
construed to affect the question of whether the Secretary of Health and 
Human Services has any authority to regulate any tobacco product, 
tobacco ingredient, or tobacco additive. Such authority, if any, shall 
be exercised under the Federal Food, Drug, and Cosmetic Act as in effect 
on the day before the date of the enactment of this Act.

                         TITLE V--EFFECTIVE DATE

<<NOTE: 21 USC 321 note.>> SEC. 501. EFFECTIVE DATE.

    Except as otherwise provided in this Act, this Act and the 
amendments made by this Act, other than the provisions of and the 
amendments made by sections 111, 121, 125, and 307, shall take effect 90 
days after the date of enactment of this Act.

    Approved November 21, 1997.

LEGISLATIVE HISTORY--S. 830 (H.R. 1411):
---------------------------------------------------------------------------

HOUSE REPORTS: Nos. 105-310, accompanying H.R. 1411 (Comm. on Commerce) 
and 105-399 (Comm. of Conference).
SENATE REPORTS: No. 105-43 (Comm. on Labor and Human Resources).
CONGRESSIONAL RECORD, Vol. 143 (1997):
            Sept. 11, 16, 18, 19, 23, 24, considered and passed Senate.
            Oct. 7, considered and passed House, amended, in lieu of 
                H.R. 1411.
            Nov. 9, Senate and House agreed to conference report.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 33 (1997):
            Nov. 21, Presidential remarks.

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