[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 830 Enrolled Bill (ENR)]

        S.830

                       One Hundred Fifth Congress

                                 of the

                        United States of America


                          AT THE FIRST SESSION

          Begun and held at the City of Washington on Tuesday,
 the seventh day of January, one thousand nine hundred and ninety-seven


                                 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

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

    (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.
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.

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).

                 TITLE I--IMPROVING REGULATION OF DRUGS
                   Subtitle A--Fees Relating to Drugs

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 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)--
                (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 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 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:
            ``(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,
    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.''.
    (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.

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 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.

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.

SEC. 106. EFFECTIVE DATE.

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

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:

``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--
            ``(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) 
        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 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.
    ``(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:

``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 
        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.''.
    (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
        (2) by inserting after subsection (i) the following:
    ``(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 such disclosure 
would not substantially interfere with such enrollment.
    ``(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.''.
    (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.''.
    (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.

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:

``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.
        ``(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) 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.''.
    (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.
    ``(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.''.

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.
    ``(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 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 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.
    ``(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)''.
        (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.
    (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)).
    (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.
        (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).
    (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).

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.

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.''.
    (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)''.
    (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:
    ``(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).
            (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 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).''.
    (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 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
            (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:

``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
                    ``(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.
    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.''.
    (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
        (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''.

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:

``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.
    ``(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).''.
    (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--
            (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:

``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:
    ``(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 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:
``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

    ``(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.
    ``(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.
    ``(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, 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.
    ``(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--
        (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.
    ``(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. 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 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
        (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).
    ``(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;
        ``(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.
    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:

``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.--
        ``(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.--
            ``(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;
                ``(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.''.
    (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.''.
    (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:

                           ``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:


                        ``postmarket surveillance

    ``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'';
            (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 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:

``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;
        (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.''.
    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:
    ``(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.''.

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.''.

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:


                               ``disclosure

    ``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.

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,
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 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.
    ``(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

``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
        ``(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 
        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.

``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 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.
``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.
``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--
                ``(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
                ``(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.

``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. 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 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.

``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.
        ``(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.

``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 (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.''.
    (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.
    (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.
    (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.
    (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.--
            (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

``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
        ``(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, 
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.''.
    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.

SEC. 404. DISPUTE RESOLUTION.

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

``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.
    ``(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.
    ``(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.--
        ``(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 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.
    ``(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

``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.''.
    (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 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:

``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:

``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.''.
        (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:
``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 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
        (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

``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:

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

``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 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 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:
``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.''.
    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 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:

``SEC. 907. CONTRACTS FOR EXPERT REVIEW.

    ``(a) In General.--
        ``(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:

``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 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

``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, 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).

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

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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.