[House Report 105-399]
[From the U.S. Government Publishing Office]



105th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES

 1st Session                                                    105-399
_______________________________________________________________________


 
         FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997

                                _______
                                

                November 9, 1997.--Ordered to be printed

_______________________________________________________________________


 Mr. Bliley, from the committee of conference, submitted the following

                           CONFERENCE REPORT

                         [To accompany S. 830]

      The committee of conference on the disagreeing votes of 
the two Houses on the amendments of the House to the bill (S. 
830) 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, having met, after full and free conference, have 
agreed to recommend and do recommend to their respective Houses 
as follows:
      That the Senate recede from its disagreement to the 
amendment of the House to the text of the bill and agree to the 
same with an amendment as follows:
      In lieu of the matter proposed to be inserted by the 
House amendment, insert the following:

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 andrelisted. 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 
thetotal 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 orsupplement 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 ofenactment 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 adverseeffects 
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 submitto 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 inthe 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 thatexperts 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 conflictof 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 
``radiopharmaceutical'' 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 (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 certications,''.
                    (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 arrangementsmade 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, afterthe 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 
        healthprotection 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 Presidentfor 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 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 informationor 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 a 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 section555, 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 
toconduct 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 ofuseful 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 establishedname 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.
      And the House agree to the same.

      That the House recede from its amendment to the title of 
the bill.
                                   Tom Bliley,
                                   Michael Bilirakis,
                                   Joe Barton,
                                   James Greenwood,
                                   Richard Burr,
                                   Ed Whitfield,
                                   John D. Dingell,
                                   Sherrod Brown,
                                   Henry A. Waxman,
                                   Ron Klink,
                                 Managers on the Part of the House.

                                   Jim Jeffords,
                                   Dan Coats,
                                   Judd Gregg,
                                   Bill Frist,
                                   Mike DeWine,
                                   Edward M. Kennedy,
                                   Christopher Dodd,
                                   Tom Harkin,
                                   Barbara A. Mikulski,
                                Managers on the Part of the Senate.
       JOINT EXPLANATORY STATEMENT OF THE COMMITTEE OF CONFERENCE

      The managers on the part of the House and the Senate at 
the conference on the disagreeing votes of the two Houses on 
the amendments of the House to the bill (S. 830) 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, submit the 
following joint statement to the House and the Senate in 
explanation of the effect of the action agreed upon by the 
managers and recommended in the accompanying conference report:
      The House amendment to the text of the bill struck all of 
the Senate bill after the enacting clause and inserted a 
substitute text.
      The Senate recedes from its disagreement to the amendment 
of the House with an amendment that is substitute for the 
Senate bill and the House amendment. The differences between 
the Senate bill, the House amendment, and the substitute agreed 
to in conference are noted below, except for clerical 
corrections, conforming changes made necessary by agreements 
reached by the conferees, and minor drafting and clerical 
changes.
      The conference agreement on S. 830, the Food and Drug 
Administration Modernization Act of 1997, provides for (1) the 
reauthorization of the Prescription Drug User Fee Act of 1992; 
(2) the improvement of regulation of drugs through such reforms 
as those pertaining to pediatric studies of drugs, procedures 
relating to fast track drugs, health care economic information, 
national uniformity for over-the-counter drugs and cosmetics, 
and data requirements for drugs and biological products; (3) 
the improvement of regulation of medical devices through such 
reforms as those pertaining to device standards and data 
requirements, procedures relating to humanitarian and 
breakthrough devices, tracking and postmarket surveillance, and 
accredited party review; (4) the improvement of regulation of 
food through such reforms as those pertaining to the timetable 
and regulatory authority of the Secretary in processing health 
and nutrient content claims, food contact substance 
notifications, and information relating to irradiation 
treatment; and (5) general provisions pertaining to the 
dissemination of information, expanded access to 
investigational therapies, and consumer access to information 
about clinical trials of investigational therapies.
      Certain matters agreed to in conference are noted below:

                 Title I--Improving Regulation of Drugs

Prescription Drug User Fee Act (Subtitle A)
      The conferees believe it is important to place the PDUFA 
reauthorization provisions of the Act in the overall context of 
the budgetary agreements which have been put into place by the 
1997 Balanced Budget Agreements (BBA). This Act preserves the 
original PDUFA adjustment factor and therefore the basic 
understanding behind the 1992 enactment of this provision: that 
is, the industry willingness to pay user fees for enhanced 
performance in the drug approval process. Nevertheless the 
conferees acknowledge that the 1997 BBA places tight 
constraints on the appropriations process, particularly in the 
out years. The conferees expect the appropriators will make 
every effort to meet the trigger so that FDA is allowed to 
collect and expend user fees. However, it must be acknowledged 
that particularly in the fifth year of BBA, budgetarypressures 
on all discretionary spending will be great.
      Breakdowns of the actual spending levels at FDA have not 
traditionally been provided to the appropriators, making it 
difficult to conduct oversight. Beginning in Fiscal Year 1998, 
appropriators will require FDA to submit a directed operating 
budget as part of the annual budget request. This will serve as 
a functional breakdown of how appropriated dollars are spent, 
similar to the report FDA submits annually to show how the 
agency spent collected PDUFA user fees.
      The conferees expect the President's budgetary request 
for FDA for salaries and expenses to meet the PDUFA levels 
specified for each of these years and not be based on any 
assumption of the enactment of new substitutive user fees on 
other FDA regulated industries.
Pediatric studies of drugs (Sec. 111)
      The conference agreement provides that if the Secretary 
determines that information about a drug may produce health 
benefits in a pediatric population and makes a written request 
for pediatric studies (including a time frame for completing 
the studies), and the studies are completed and are accepted by 
the Secretary, then the sponsor or manufacturer will qualify 
for 6 months of extra market exclusivity. The agreement 
authorizes the Secretary to determine the time frame for 
completing the studies, but the conferees emphasize that such 
studies should be sought, conducted, and completed at the 
earliest possible opportunity. The conferees do not intend that 
such studies be artificially timed for market advantage.
      The agreement provides that no new market exclusivity may 
be applied to any new drug for which a new drug application is 
submitted after January 1, 2002. However, the agreement 
provides a continuation of the program for certain drugs 
already on the market on the date of enactment. The purpose of 
this limited extension is to ensure that, with respect to such 
already marketed drugs, exclusivity remains available if the 
Secretary determines there is a continuing need for additional 
information relating to the use of such drugs that may promote 
health benefits in the pediatric population. This is applicable 
only to drugs already included on the list under subsection (b) 
as of January 1, 2002. The Secretary will not list any 
additional drugs under Section 505A(b) after January 1, 2002. 
These drugs will be eligible for the applicable 6-month time 
extension if the requested studies satisfy all requirements of 
the section.
      The conferees expect the Secretary to consult with 
experts in pediatric research to develop the list of drugs 
under subsection (b), and to set priorities for studies on 
these drugs. Such experts should include representatives from 
the American Academy of Pediatrics, the Pediatric Pharmacology 
Research Unit (PPRU) Network, and the U.S. Pharmacopeia. The 
conferees note particularly the excellent efforts of NIH, 
especially through the PPRU Network, which will contribute 
significantly to this effort.
      The conference agreement also requires that a study be 
conducted on the program, by January 1, 2001, that reviews all 
aspects of the program, including its impact on the price and 
availability of drugs and the availability of generic drugs.
      With respect to any requested studies under this 
provision, the conferees intend that data collected prior to a 
request or requirement by the Secretary may be used, in 
addition to data collected after such request or requirement in 
satisfying the provisions of this section.
Clinical investigations (Sec. 115)
      The conferees note that the requirement for the Secretary 
to review existing guidance and develop additional guidance, as 
appropriate, on the inclusion of women and minorities in 
clinical trials does not require participation of women and 
minorities in any particular trial. Furthermore, FDA is 
required to consult with the National Institutes of Health, 
which has developed inclusion guidelines for subjects in 
federally funded clinical research, and with representatives of 
the drug manufacturing industry, to ensure that ethical, 
scientific, and legal issues specific to privately funded 
clinical research are considered. The conferees expect FDA to 
set forth its general policy regarding: the inclusion of women 
and minorities in drug development research; population-
specific analyses of clinical data and assessment of potential 
pharmacokinetic differences; and the conduct of specific 
additional studies in women or minorities, where appropriate.
Content and review of applications (Sec. 119)
      The Secretary is required to meet with an applicant if 
the applicant makes a reasonable written request for a meeting 
for the purpose of reaching agreement on the design and size of 
studies, if the sponsor provides the information necessary to 
discuss and reach agreement on the design and size of such 
studies. The Secretary may refuse to meet if the sponsor does 
not provide such information or if the Secretary determines 
that such meeting is premature or would not be useful.
Positron emission tomography (Sec. 121)
      The conference agreement provides for regulation of 
positron emission tomography (PET) drugs and replaces earlier 
industry guidance and regulatory standards for PET products 
promulgated by the FDA. The agreement provides that,until the 
Secretary establishes procedures under subsection (c)(1) described 
below, neither a New Drug Application (NDA) nor an Abbreviated New Drug 
Application (ANDA) is required by a licensed practitioner to produce a 
compounded PET product in accordance with United States Pharmacopiea 
(USP) standards.
      The agreement requires the Secretary, in two years, to 
establish procedures for approving PET products, including 
compounded PET products, and good manufacturing practices for 
such products, taking account of relevant differences between 
commercial manufacturers and non-profit organizations and in 
consultation with patient groups, physicians, and others. The 
Secretary may not require NDAs or ANDAs for these products for 
four years (or two years after the procedures mentioned above 
are established).
      A compounded PET drug, by definition, must be compounded 
pursuant to a valid prescription order and in accordance with 
state law, among other requirements. A PET drug that fails to 
meet these requirements is not a ``compounded PET drug'' and 
therefore is not exempt from section 501(a)(2)(B) (21 USC 
351(a)(2)(B)) or from subsections (b) and (j) of section 505 
(21 USC 355). PET drugs that fail to meet the definition of a 
``compounded PET drug'' shall be subject to the procedures and 
requirements established by the Secretary under subsection 
(c)(1).
Application of Federal law to practice of pharmacy compounding (Sec. 
        127)
      The conference report includes provisions on pharmacy 
compounding that reflect the conferees' extensive work with the 
Food and Drug Administration and other interested parties to 
reach consensus. It is the intent of the conferees to ensure 
continued availability of compounded drug products as a 
component of individualized therapy, while limiting the scope 
of compounding so as to prevent manufacturing under the guise 
of compounding. Section 503A establishes parameters under which 
compounding is appropriate and lawful. The conditions set forth 
in Section 503A should be used by the state boards of pharmacy 
and medicine for proper regulation of pharmacy compounding in 
addition to existing state-specific regulations.
      The conferees intend that, as defined in subparagraph 
(b)(2), copies of commercially available drug products do not 
include drug products in which the change from the commercially 
available drug product produces a ``significant difference'' 
for the particular patient. For example, the removal of a dye 
from a commercially available drug product for a particular 
patient who is allergic to such dye shall be presumed to be a 
``significant difference.'' The conferees expect that FDA and 
the courts will accord great deference to the licensed 
prescriber's judgement in determining whether the change 
produces a ``significant difference.'' However, where it is 
readily apparent, based on the circumstances, the ``significant 
difference'' is a mere pretext to allow compounding of products 
that are essentially copies of commercially available products, 
such compounding would be considered copying of commercially 
available products and would not qualify for the compounding 
exemptions if it is done regularly or in inordinate amounts. 
Such circumstances may include, for example, instances in which 
minor changes in strength (such as from .08% to .09%) are made 
that are not known to be significant or instances in which the 
prescribing physician is receiving financial remuneration or 
other financial incentives to write prescriptions for 
compounded products.
      The conferees also expect that the Secretary will develop 
the list of bulk drug substances described in subsection 
(b)(1)(A)(i)(III) within one year from the date of enactment. 
It is the intent of the conferees that the criteria used to 
develop the list of bulk drug substances and the list itself 
are to be developed in consultation with the United States 
Pharmacopeia. The conferees further intend that where evidence 
relating to an approval under Section 505 does not exist, the 
Secretary shall consider other criteria. Finally, the conferees 
intend that after this list is published, organizations may 
petition the FDA for inclusion of additional substances on the 
aforementioned list.
      The memorandum of understanding described in Paragraph 
(b)(3)(B)(i) shall provide guidance on the meaning of 
inordinate amounts, including any circumstances under which the 
compounding of drug products for interstate shipment in excess 
of 5 percent of total prescription orders would be included in 
a ``safe harbor'' of interstate shipments of compounded 
products that shall not be deemed inordinate.
      As stated in paragraph (e), nothing in Section 503A is 
intended to change or otherwise affect current law with respect 
to radiopharmaceuticals, including PET drugs. Further, as 
stated in paragraph (f), 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. Nothing in this 
provision is intended to change or otherwise affect the Act 
with respect to reconstitution or other similar processing that 
is done pursuant to a manufacturer's approved labeling, and 
other directions from such manufacturer that are consistent 
with that labeling. In general, such practices, as performed by 
a licensed practitioner for an identified individual patient, 
are appropriately regulated by state boards of pharmacy. The 
conferees intend that facilities required to register with the 
FDA, including those which are engaged in non-patient specific 
compounding and reconstitution activities, are appropriately 
regulated under the Federal Food, Drug and Cosmetic Act.
      Finally, with regard to the effective date described in 
paragraph (b), the conferees expect the FDA to work diligently 
to consult with necessary parties to promulgate the required 
regulations and lists. Nothing in paragraph (b) is intended to 
abrogate theSecretary's responsibility to promulgate such 
regulations through the notice and comment rulemaking process.
Reauthorization of the Clinical Pharmacology Program (Sec. 128)
      The conference agreement extends through fiscal year 2002 
the authorization of appropriations of the Clinical 
Pharmacology Training Program, a program originally authorized 
under section 2(b) of P.L. 102-222. Nothing in this section of 
the agreement prohibits the Secretary from continuing the 
awarding of grants to the original and current grantees. The 
conferees strongly recommend that the Secretary continue the 
development of the clinical pharmacology programs at the 
colleges and universities originally selected to participate in 
the program.
Regulations for sunscreen products (Sec. 129)
      The conference agreement includes a provision requiring 
FDA to continue diligently with its work to complete its 
rulemaking process on sunscreen products and to issue 
regulations within 18 months. The conferees recognize that 
various technical and scientific issues may take longer to 
resolve than other aspects of the rulemaking. The conferees do 
not intend that all regulation in this area be complete or 
comprehensive by a specified date.

               Title II--Improving Regulation of Devices

Scope of review (Sec. 205)
      The conference agreement addresses the issue of 
regulatory burden by ensuring that the impact of the 
Secretary's necessary review, approval, and oversight functions 
is not inappropriate. This assurance is achieved by requiring 
the Secretary to consider, in consultation with an applicant 
for device approval, the method for evaluating the device's 
effectiveness that would be appropriate, least burdensome, and 
reasonably likely to result in the device's approval. The 
conferees believe that this language is necessary to and 
consistent with improving communications between the FDA and 
regulated persons, increasing regulatory efficiency, and 
decreasing the length of product review and approval.
Premature notification (Sec. 206)
      The conference agreement exempts class I devices from 
premarket notification under section 510(k), except those types 
that present a potential unreasonable risk of illness or 
injury, or that are of substantial importance in preventing 
impairment of human health. The agreement also requires the 
Secretary to publish a notice listing the types of class II 
devices that are exempt from premarket notification. The 
Secretary must publish this initial list within 60 days. 
Thereafter, class II devices may be exempted by the Secretary 
on the Secretary's own initiative or through a petition 
process. the agreement provides that the Secretary must respond 
to any such petition within 180 days or the petition will be 
deemed granted.
      The conferees do not intend by this provision that the 
Secretary should up-classify low-risk class I device in order 
to avoid exempting them. The conferees believe the appropriate 
exemption of class I and certain class II devices will allow 
the Secretary to expend limited premarket review resources on 
potentially risky and technologically advanced devices. 
Focusing resources in this manner will ensure the public 
continues to be adequately protected and will still benefit 
from the earlier availability of new products.
Accredited party review (Sec. 210)
      The conference agreement makes modifications to the House 
and Senate provisions establishing the process by which the 
Secretary will accredit persons to review and initially 
classify 510(k) devices. The agreement's provisions relating to 
the scope and the duration of the pilot program specify that an 
accredited person may not review a class III device, a class II 
device that is permanently implantable, life-sustaining or 
life-supporting, or a class II device for which clinical data 
are required. The latter category is limited in size to not 
more than six percent of all 510(k) submissions. In addition, 
the agreement provides for the termination of the pilot program 
after the Secretary has met specified targets for inclusion of 
eligible devices.
Reports (Sec. 213)
      The conference agreement amends Section 519 of the 
Federal Food, Drug and Cosmetic Act to reduce the reporting 
requirements for device distributors. Manufacturers and 
importers, however, are required to comply with the existing 
requirements for medical device reporting. The amendment to 
section 519(a)(9) requires distributors to keep records and 
make them available to the Secretary on request. Because 
distributors will no longer be submitting reports to the 
Secretary, copies of reports would also not be sent to the 
manufacturers. This is not intended to provide the FDA with any 
new statutory authority to require distributors to keep 
additional records; it merely clarifies that existing record 
keeping requirements of section 519(a) continue to apply. This 
provision also removes the registration, listing, and reporting 
requirements for distributors under section 510. Since user 
facilities and manufacturers submit medical device reports to 
the FDA, there is no need for additional reporting by 
distributors. The FDA is urged to allow all record keeping, 
includingdistributor record keeping, to be accomplished through 
either electronic means or written documentation. The FDA is also urged 
to revise its current regulations on distributor record keeping (21 
C.F.R. Sec. 804.35(b)) to provide that distributors need only keep 
records of complaints for six years from the date a complaint is 
received by the distributor, consistent with the longest statutes of 
limitations under State tort laws. Currently, FDA regulations require 
distributors to keep records for two years from the date of the record 
of complaint or the expected life of the device, whichever is greater. 
It is the intent of the conferees to simplify these requirements, since 
distributors, unlike manufacturers, are not able to determine the 
expected life of a device. Since these records will be kept by 
manufacturers as well, it is unnecessarily burdensome for distributors 
to keep these records for other than a fixed period of time.
      The conferees expect the FDA to modify its regulations 
under Sec. 519(f) to ensure that the reports under this section 
are not required from any manufacturer, importer, or 
distributor who also is regulated and required to make such 
reports under the Radiation Control for Health and Safety Act 
of 1968 (21 U.S.C. 36011).
Practice of medicine (Sec. 214)
      The conference agreement includes a provision intended by 
the conferees to emphasize that the FDA should not interfere in 
the practice of medicine. Specifically, the conferees note that 
the off-label use of a medical device by a physician using his 
or her best medical judgment in determining how and when to use 
the medical product for the care of a particular patient is not 
the province of the FDA. It is the intent of the conferees that 
this provision not be construed to affect medical professional 
liability.

                Title III--Improving Regulation of Food

Flexibility for regulations regarding claims (Sec. 301)
      The conference agreement clarifies the parameters within 
which the Secretary may use the interim final rulemaking 
authority established under this section. This authority 
enables the Secretary to make proposed regulations on claims 
effective upon publication, pending consideration of public 
comment and publication of a final regulation. The conferees' 
clarifying language emphasizes that this authority may be used 
when the Secretary determines that it is necessary to enable 
the Secretary to improve consumer access to important dietary 
information and to ban or modify a claim in a prompt fashion. 
The conferees' intent in creating this expedited rulemaking 
authority for health and nutrient content claims is that it be 
used primarily to expedite the review of petitions for health 
and nutrient content claims based on authoritative statements.
Health and nutrient content claims (Secs. 303, 304)
      The conference agreement makes streamlined procedures 
available for the Secretary to permit more scientifically sound 
nutrition information to be provided to consumers through 
health and nutrient content claims. This process is triggered 
by authoritative statements of entities such as the National 
Institutes of Health (NIH) and the Centers for Disease Control 
and Prevention (CDC), and the National Academy of Sciences 
(NAS). Although the provision specifically permits claims to be 
made on the basis of a statement produced by subsidiaries of 
NAS, the conferees intend that the lack of similar language 
with respect to entities such as NIH and CDC be interpreted as 
a reflection of the desire of the conferees that statements 
issued by entities such as NIH and CDC reflect consensus within 
those institutions. The agreement makes minor modifications to 
the House provisions on health and nutrient content claims to 
expedite the process by which such claims are processed. As 
part of the submissions to the Secretary for health claims 
based on authoritative statements, a balanced representation of 
the scientific literature may include a bibliography of such 
literature.
Disclosure of irradiation (Sec. 306)
      The conference agreement ensures that no existing 
provision of the Federal Food Drug and Cosmetic Act will be 
considered to require a separate radiation disclosure statement 
that is more prominent than the declaration of ingredients on 
the food label. To ensure the intended effect of this 
provision, the conferees direct the Secretary promptly to 
publish for public comment proposed amendments to current 
regulations relating to the labeling of foods treated with 
ionizing radiation. The conferees expect final regulations to 
be issued not more than 12 months after the date of enactment 
of this measure. The public comment process should be utilized 
by the Secretary to provide an opportunity to comment on 
whether the regulations should be amended to revise the 
prescribed nomenclature for the labeling of irradiated foods 
and on whether such labeling requirements should expire at a 
specified date in the future. The conferees intend for any 
required disclosure to be of a type and character such that it 
would not be perceived to be a warning or give rise to 
inappropriate consumer anxiety.
Food contact substances (Sec. 309)
      The conference agreement establishes a notification 
process for the regulation of components of food packaging, 
known as food contact substances, which is intended to expedite 
authorization of the marketing of a food contact substance 
except where the Secretary determines that submission and 
review of a food additive petition is necessary to provide 
adequate determination of safety. The agreement also authorizes 
appropriations to finance the costs of the new notification 
process. To protect the Agency from having to reallocate 
resources within CFSAN to meet the costs ofimplementation, the 
agreement provides that implementation is to be triggered only when the 
FDA receives an appropriation sufficient to fund the program. The 
conferees strongly encourage the House and Senate to appropriate the 
funds authorized. The conferees also urge the Committees of 
jurisdiction, when reauthorizing the notification program, to 
reevaluate fully its operational effectiveness, the appropriateness of 
its timeframes, the adequacy of funding, and its protection of the 
public health.
      On the subject of food contact substances, the conferees 
wish to commend the FDA and the Environmental Protection Agency 
(EPA) for developing an Administration policy on the question 
of returning from EPA to FDA regulatory authority over 
antimicrobials used as food contact substances. This policy 
addresses the uncertainty unintentionally created by the Food 
Quality Protection Act of 1996 (FQPA) over the authority for 
regulating antimicrobials used as food contact substances. 
Although the legislative language effecting this policy was 
considered by the conferees to be outside the scope of this 
conference, the conferees acknowledge the significant need for 
this change and urge FDA and EPA to continue to work with the 
Congress to identify and develop an appropriate and expeditious 
vehicle for action on this matter. In the interim, the 
conferees urge the agencies not to delay active review of 
pending petitions and the pursuit of the most immediate means 
to achieve resolution of this jurisdictional issue.

                      Title IV--General Provisions

Dissemination of treatment information (Sec. 401)
      The conference agreement's inclusion of this section is 
intended to provide that health care practitioners can obtain 
important scientific information about uses that are not 
included in the approved labeling of drugs, biological 
products, and devices. The conferees also wish to encourage 
that these new uses be included on the product label. 
Therefore, the agreement includes strong incentives to conduct 
the research needed and file a supplemental application for 
such uses. A manufacturer who seeks to disseminate information 
about a new use must either certify that it will file a 
supplemental application or must submit a proposed protocol and 
schedule for conducting the necessary studies and a 
certification that a supplemental application will be filed.
      Although the conferees intend to ensure that the research 
is undertaken to get new uses on product labels, the conferees 
also recognize that there may be limited circumstances when it 
is appropriate to exempt a manufacturer from the requirement to 
file a supplemental application. In making the determination of 
whether to grant an exemption pursuant to subsection (d)(2), 
the Secretary may consider, among other factors, whether: the 
new use meets the requirements of section 186(t)(2)(B) of the 
Social Security Act; a medical specialty society that is 
represented in or recognized by the Council of Medical 
Specialty Societies (or is a subspecialty of such society) or 
is recognized by the American Osteopathic Association, has 
found that the new use is consistent with sound medical 
practice; the new use is described in a recommendation or 
medical practice guideline of a Federal health agency, 
including the National Institutes of Health, the Agency for 
Health Care Policy Research, and the Centers for Disease 
Control and Prevention of the Department of Health and Human 
Services; the new use is described in one of three compendia: 
The U.S. Pharmacopeia-Drug Information, the American Medical 
Association Drug Evaluation, or the American Hospital 
Association Formulary Service Drug Information; the new use 
involves a combination of products of more than one sponsor of 
a new drug application, a biological license application, a 
device premarket notification, or a device premarket approval 
application; or the patent status of the product.
      The conferees recognize that there may be cases where the 
size of the patient population may be cause for the Secretary 
to determine that a supplemental application should not be 
filed. However, this is intended to be the exception, rather 
than the rule, in the case of populations suffering from orphan 
or rare disorders. For many years, this Congress has sought to 
encourage research into orphan diseases and the approval of 
innovative drugs for their treatment. The Secretary should 
examine very carefully whether an exemption from filing a 
supplemental application might hinder such research and 
recognize the vital importance of encouraging application for 
new drugs and new drug uses intended to treat rare disorders.
Expanded access to investigational therapies and diagnostics (Sec. 402)
      The conference report provides statutory direction to 
expand access programs and emphasizes that opportunities to 
participate in expanded access programs are available to every 
individual with a life-threatening or seriously debilitating 
illness for which there is not an effective, approved therapy. 
The conferees note that they purposely used broad language in 
this section relating to ``serious'' conditions, without 
attempting to define them, in order to permit wide flexibility 
in implementation. Illnesses that do not cause death, or 
imminent death, can nonetheless destroy the lives of both 
patients and their families. The conferees therefore intend 
that the seriousness of an illness be given broad 
consideration, to take into account all of the circumstances 
involved.
      Currently, Federal law allows drug companies to make 
experimental drugs available, under specific circumstances, to 
seriously and terminally ill patients. However, companies are 
often reluctant to do so because they fear that inclusion of 
data on such very ill patients will jeopardize the approval of 
their product because these patients' medical progress on any 
therapy may conflict with or be inconsistent with data from 
patients in the clinical studies. The conferees request that 
the FDA evaluate ways toaddress this problem, particularly for 
terminal patients who have failed existing approved therapies.
Information system (Sec. 407)
      The conferees intend that the information system shall 
provide access to the information by the applicant under 
conditions set by the Secretary, except that access shall not 
be provided under any particular form of information system to 
any applicant until appropriate safeguards are in place to 
ensure that integrity and confidentiality of the information 
for which access is provided.
Education and training (Sec. 408)
      The conference agreement authorizes the Centers of the 
FDA that conduct intramural research to provide fellowships and 
training to appropriate undergraduate, pre-doctoral, and/or 
post-doctoral candidates. In the past, FDA's Centers provided 
for a limited number of scientific training positions through 
Full Time Equivalent programs or interagency agreements with 
other federal agencies which have the statutory authority to 
hire trainees through third parties. However, many of the 
benefits of the training program have been reduced because FDA 
has not had specific direct authority to conduct and support 
them. In light of the additional overhead costs, reduced 
training flexibility, increased paperwork, and hiring delays 
that have resulted, it is increasingly difficult and 
impractical for FDA to hire trainees as FTE Service Fellows. As 
a result, the Intramural Research and Training Authority 
authorized here is intended to provide the FDA the authority to 
conduct and support directly the selection and training of 
fellows, allow more efficient use of appropriated funds by 
reducing overhead and other costs, and permit the training of 
such candidates as non-FTE positions. The conference agreement 
also provides similar authority for the Centers for Disease 
Control and Prevention.
Centers for education and research on therapeutics (Sec. 409)
      The conference agreement establishes a demonstration 
program to conduct research and increase awareness of new 
products and ways to improve their effective use, and to 
increase awareness of risks of both new uses and combinations 
of therapies. In carrying out this demonstration program, the 
Secretary is directed to act through the Agency for Health Care 
Policy and Research (AHCPR) in consultation with the FDA 
Commissioner. The conferees designated AHCPR as the lead agency 
because of its expertise in the evaluation of the effectiveness 
of clinical care, its non-regulatory role, and its close 
working relationship with the health care community in the 
improvement of the quality of care. Accordingly, this section 
establishes a new Section 928 in Title IX of the Public Health 
Service Act, the authorizing statute for AHCPR.
      To ensure appropriate coordination and to avoid 
unnecessary duplication, AHCPR is required to consult closely 
with the FDA in the development and operation of this 
demonstration program. The conferees expanded the focus of this 
demonstration to include ways to improve the effective use of 
drugs, biological products, and devices as well as risks of new 
combinations of such products and directed that the clinical 
information gained in the project would be provided to 
consumers as well as health care practitioners and insurers. 
Finally, the conferees direct AHCPR also to consider the 
appropriate use of products in meeting the purposes of this 
section.
Environmental impact review (Sec. 411)
      The conferees believe that FDA's new procedures 
implementing the National Environmental Policy Act (NEPA) 
appropriately eliminate unnecessary paperwork and delays 
associated with prior agency practices. Section 411 makes clear 
that an environmental impact statement (EIS) prepared in 
accordance with those regulations will meet the requirements of 
NEPA. The conferees do not intend this section to preclude 
judicial review of EISs. The conferees understand that the FDA 
may modify its regulations periodically, in consultation with 
the Council on Environmental Quality and the FDA's authorizing 
committees, as new circumstances or information warrants.
      Because the Clean Air Act authorizes production of 
limited quantities of Class I and Class II substances for use 
in medical devices, there will be a continuing, but limited, 
supply of these substances. The EPA shall not dictate, promote 
or otherwise encourage a policy preference for disposal by 
incineration of the contents of metered-dose inhalers, but 
instead allow such contents to be recaptured, recycled or 
reused consistent with section 608(a)(3) of the Clean Air Act 
until such time that Congress conducts oversight hearings into 
the issue.
National uniformity for nonprescription drugs and cosmetics (Sec. 412)
            Confidentiality of OTC company self-audits
      Public policy should encourage drug manufacturers to 
conduct audits of their activities to candidly alert management 
to potential problems so that they can be addressed quickly and 
effectively. If FDA were to assert routine access to these 
audits, it would create serious disincentives to conducting 
appropriate audits and preparing thorough reports of the 
results. FDA already has a policy of not ordinarily requesting 
audit reports, which is set forth in compliance policy guide 
(#7151.02, Sec. 130.300) that applies to prescription drug 
firms. It is expected that OTC drug firms would be subject to 
the same compliance policy guide. Thus, during routine 
inspections of OTC drug establishments, FDA would not be 
expected to request or to review or copy reports and records 
that result from the firm's own audits and inspections of its 
operations toassure compliance with applicable FDA requirements 
such as good manufacturing practice (GMP) regulations. FDA would 
reserve the right to review such audits in certain limited 
circumstances as outlined in the compliance guide.
            OTC and cosmetics inspection
      The conferees intend that FDA exercise its new records 
inspection authority fairly and carefully, especially with 
regard to inspections at facilities that manufacture products 
that are both cosmetics and over-the-counter drugs. Cosmetic 
products that are also OTC drugs will, under the provisions of 
this bill, benefit from full national uniformity relating to 
all regulatory requirements, including those associated with 
ingredients, labeling, and packaging. Therefore, under these 
provisions, manufacturers of such OTC products will be subject 
to records inspection by FDA. The conferees want to make clear 
that any such records inspection applies only to those products 
for which there is full national uniformity. This new records 
inspection authority applies only to products determined to be 
over-the-counter drugs. It does not apply to products that are 
solely cosmetics.
      In the case of an inspection at a facility which deals 
both with cosmetic products that are OTC drugs and those that 
are not, FDA inspectors do not have access to any records 
relating to the cosmetic products. Further, the conferees want 
to make clear that there is no records inspection authority 
under these provisions for facilities dealing exclusively with 
cosmetics.
      Finally, the conferees expect that FDA will provide 
sufficient time and guidance to the over-the-counter drug 
industry prior to initiating any program of records inspection 
and in the early stages of implementing this new requirement.
            Effect of national uniformity on state enforcement ``little 
                    FTC'' laws
      All states have laws prohibiting false and misleading 
advertising, modeled on the Federal Trade Commission Act. These 
laws have been applied to prohibit unsubstantiated claims for 
nonprescription drugs and cosmetics, and to require corrective 
advertising. This provision is not intended to preempt the 
application of these laws under such circumstances.
      The Conference Committee intends to make clear that 
``Little FTC'' laws, as they have historically been written and 
applied, are not preempted. The scope of national uniformity is 
modified to only apply to state requirements that relate to 
labeling and packaging or, if they go beyond labeling and 
packaging, to requirements relating to warnings. Thus, 
advertising issues relating to claims substantiation, fair 
balance, and misleading or deceptive claims are outside the 
scope of preemption.
            Effect of national uniformity on state food labeling laws
      This provision is not intended to pre-empt or prohibit 
States from regulating the labeling of food which derives from 
animals treated with non-prescription drugs. Nor are these 
provisions intended to void State regulations on the use of 
these drugs.
Product classification (Sec. 416)
      Subsections (b) and (c) have been amended to make clear 
that FDA may only modify product classifications for public 
health reasons based on scientific information.
                                   Tom Bliley,
                                   Michael Bilirakis,
                                   Joe Barton,
                                   James Greenwood,
                                   Richard Burr,
                                   Ed Whitfield,
                                   John D. Dingell,
                                   Sherrod Brown,
                                   Henry A. Waxman,
                                   Ron Klink,
                                 Managers on the Part of the House.

                                   Jim Jeffords,
                                   Dan Coats,
                                   Judd Gregg,
                                   Bill Frist,
                                   Mike DeWine,
                                   Edward M. Kennedy,
                                   Christopher Dodd,
                                   Tom Harkin,
                                   Barbara A. Mikulski,
                                Managers on the Part of the Senate.

                                
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