[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 830 Engrossed Amendment House (EAH)]


  1st Session

                                 S. 830

_______________________________________________________________________

                               AMENDMENTS
                In the House of Representatives, U. S.,

                                                       October 7, 1997.

    Resolved, That the bill from the Senate (S. 830) entitled ``An Act to amend 
the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to 
improve the regulation of food, drugs, devices, and biological products, and for 
other purposes.'', do pass with the following

                              AMENDMENTS:

            Strike out all after the enacting clause and insert:

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

    (a) Short Title.--This Act may be cited as the ``Food and Drug 
Administration Regulatory Modernization Act of 1997''.
    (b) References.--Except as otherwise specified, whenever in this 
Act an amendment is expressed in terms of an amendment to 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. 321 et seq.).
    (c) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; references; table of contents.

                 TITLE I--IMPROVING REGULATION OF DRUGS

Sec. 101. Fees relating to drugs.
Sec. 102. Pediatric studies of drugs.
Sec. 103. Expediting study and approval of fast track drugs.
Sec. 104. Expanded access to investigational therapies.
Sec. 105. Information program on clinical trials for serious or life-
                            threatening diseases.
Sec. 106. Dissemination of information on new uses.
Sec. 107. Studies and reports.
Sec. 108. Approval of supplemental applications for approved products.
Sec. 109. Health care economic information.
Sec. 110. Clinical investigations.
Sec. 111. Manufacturing changes for drugs.
Sec. 112. Streamlining clinical research on drugs.
Sec. 113. Data requirements for drugs.
Sec. 114. Content and review of applications.
Sec. 115. Scientific advisory panels.
Sec. 116. Dispute resolution.
Sec. 117. Informal agency statements.
Sec. 118. Positron emission tomography.
Sec. 119. Requirements for radiopharmaceuticals.
Sec. 120. Modernization of regulation.
Sec. 121. Pilot and small scale manufacture.
Sec. 122. Insulin and antibiotics.
Sec. 123. FDA mission and annual report.
Sec. 124. Information system.
Sec. 125. Education and training.
Sec. 126. Centers for education and research on drugs.
Sec. 127. Harmonization.
Sec. 128. Environmental impact review.
Sec. 129. National uniformity.
Sec. 130. FDA study of mercury compounds in drugs and food.
Sec. 131. Notification of discontinuance of a life saving product.

               TITLE II--IMPROVING REGULATION OF DEVICES

Sec. 201. Dispute resolution.
Sec. 202. Investigational device exemptions; expanded access.
Sec. 203. Special review for certain devices.
Sec. 204. Expanding humanitarian use of devices.
Sec. 205. Device standards.
Sec. 206. Scope of review.
Sec. 207. Premarket notification.
Sec. 208. Classification panels.
Sec. 209. Premarket approval.
Sec. 210. Accreditation for accredited persons.
Sec. 211. Preamendment devices.
Sec. 212. Device tracking.
Sec. 213. Postmarket surveillance.
Sec. 214. Harmonization.
Sec. 215. Reports.
Sec. 216. Practice of medicine.
Sec. 217. Clarification of definition.
Sec. 218. Labeling and advertising regarding compliance with statutory 
                            requirements.
Sec. 219. FDA mission and annual report.
Sec. 220. Information system.
Sec. 221. Noninvasive blood glucose meter.
Sec. 222. Rule of construction.

                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.
Sec. 310. Margarine.
Sec. 311. Effective date.

                 TITLE I--IMPROVING REGULATION OF DRUGS

SEC. 101. FEES RELATING TO DRUGS.

    (a) 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 title 
        will be dedicated toward expediting the drug development 
        process and the review of human drug applications as set forth 
        in the goals identified in the letters of ______________, and 
        ______________, 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 at ____ Cong. Rec. 
        ________ (daily ed. __________, 1997).
    (b) 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 5 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'';
                    (B) in subparagraph (B), by striking ``1992'' and 
                inserting ``1997''; and
                    (C) by striking the second sentence; 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.''.
    (c) Authority To Assess and Use Drug Fees.--
            (1) Types of fees.--Section 736(a) (21 U.S.C. 379h(a)) is 
        amended--
                    (A) by striking ``Beginning in fiscal year 1993'' 
                and inserting ``Beginning in fiscal year 1998'';
                    (B) in paragraph (1)--
                            (i) 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.'';
                            (ii) 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
                            (iii) 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 indications for other than rare diseases or 
                conditions. 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 
                for an 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 is filed, the Secretary may 
                waive and 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 
                waive and refund a fee or a portion of the fee under 
                this subparagraph. A determination by the Secretary 
                concerning a waiver or refund under this paragraph 
                shall not be reviewable.'';
                    (C) by striking paragraph (2) and inserting in lieu 
                the following:
            ``(2) Prescription drug establishment fee.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), each person that is named as the 
                applicant in a human drug application, and 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 1 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.''.
                    (D) in paragraph (3)--
                            (i) 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 paid'' 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 for relisting 
                                under section 510 if the product has 
                                been withdrawn from listing and 
                                relisted. After such fee is paid for 
                                that fiscal year, such fee shall be 
                                payable on or before January 31 of each 
                                year. Such fee shall be paid only once 
                                for each product for a fiscal year in 
                                which the fee is payable.''; and
                            (ii) in subparagraph (B), by striking 
                        ``505(j).'' and inserting the following: 
                        ``505(j), under an abbreviated application 
                        filed under section 507, 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.''.
            (2) 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) 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.''.
            (3) Increases and adjustments.--Section 736(c) (21 U.S.C. 
        379h(c)) is amended--
                    (A) in the subsection heading, by striking 
                ``Increases and'';
                    (B) in paragraph (1)--
                            (i) 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'';
                            (ii) in subparagraph (A), by striking 
                        ``increase'' and inserting ``change'';
                            (iii) in subparagraph (B), by striking 
                        ``increase'' and inserting ``change''; and
                            (iv) 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.'';
                    (C) 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
                    (D) in paragraph (3), by striking ``paragraph (2)'' 
                and inserting ``this subsection''.
            (4) Fee waiver or reduction.--Section 736(d) (21 U.S.C. 
        379h(d)) is amended--
                    (A) by redesignating paragraphs (1), (2), (3), and 
                (4) as subparagraphs (A), (B), (C), and (D), 
                respectively and indenting appropriately;
                    (B) 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--'';
                    (C) in subparagraph (C) (as so redesignated by 
                subparagraph (A)), by striking ``, or'' and inserting a 
                comma;
                    (D) in subparagraph (D) (as so redesignated by 
                subparagraph (A)), by striking the period and inserting 
                ``, or'';
                    (E) by inserting after subparagraph (D) (as so 
                redesignated by subparagraph (A)) the following:
                    ``(E) the applicant is a small business submitting 
                its first human drug application to the Secretary for 
                review.''; and
                    (F) 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.''.
            (5) Assessment of fees.--Section 736(f)(1) (21 U.S.C. 
        379h(f)(1)) is amended--
                    (A) by striking ``fiscal year 1993'' and inserting 
                ``fiscal year 1997''; and
                    (B) by striking ``fiscal year 1992'' and inserting 
                ``fiscal year 1997 (excluding the amount of fees 
                appropriated for such fiscal year)''.
            (6) Crediting and availability of fees.--Section 736(g) (21 
        U.S.C. 379h(g)) is amended--
                    (A) 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 within the meaning of section 735(6).'';
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by striking 
                        ``Acts'' and inserting ``Acts, or otherwise 
                        made available for obligation,''; and
                            (ii) 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
                    (C) by striking paragraph (3) and inserting the 
                following:
            ``(3) Authorization of appropriations.--There is authorized 
        to be appropriated for fees under this section--
                    ``(A) $106,800,000 for fiscal year 1998;
                    ``(B) $109,200,000 for fiscal year 1999;
                    ``(C) $109,200,000 for fiscal year 2000;
                    ``(D) $114,000,000 for fiscal year 2001; and
                    ``(E) $110,100,000 for fiscal year 2002,
        as adjusted to reflect adjustments in the total fee revenues 
        made under this section and changes in the total amounts 
        collected by application, supplement, establishment, and 
        product fees.
            ``(4) Offset.--Any amount of fees collected for a fiscal 
        year which 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 appropriation Acts for a subsequent fiscal 
        year.''.
            (7) Requirement for written requests for waivers, 
        reductions, and fees.--Section 736 (21 U.S.C. 379h) is 
        amended--
                    (A) by redesignating subsection (i) as subsection 
                (j); and
                    (B) 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.''.
            (8) Special rule for waiver, refunds, and exceptions.--Any 
        requests for waivers, refunds, or exceptions for fees assessed 
        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.
    (d) Annual Reports.--
            (1) 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 letter described in subsection (a)(4) during 
        such fiscal year and the future plans of the Food and Drug 
        Administration for meeting the goals.
            (2) 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.
    (e) Effective Date.--The amendments made by this section shall take 
effect October 1, 1997.
    (f) Termination of Effectiveness.--The amendments made by 
subsections (b) and (c) cease to be effective October 1, 2002, and 
subsection (d) ceases to be effective 120 days after such date.

SEC. 102. PEDIATRIC STUDIES OF DRUGS.

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

                      ``pediatric studies of drugs

    ``Sec. 505A. (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 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) the period during which an application may not be 
        submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of 
        section 505 shall 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 section 505 to four years, to forty-eight 
        months, and to seven and one-half years shall be deemed to be 
        four and one-half years, fifty-four months, and eight years, 
        respectively; or
            ``(B) the period of market exclusivity under subsections 
        (c)(3)(D)(iii) and (iv) and (j)(4)(D)(iii) and (iv) of section 
        505 shall be three years and six months rather than three 
        years; and
            ``(2)(A) if the drug is the subject of--
                    ``(i) a listed patent for which a certification has 
                been submitted under subsections (b)(2)(A)(ii) or 
                (j)(2)(A)(vii)(II) of section 505 and for which 
                pediatric studies were submitted prior to the 
                expiration of the patent (including any patent 
                extensions); or
                    ``(ii) a listed patent for which a certification 
                has been submitted under subsections (b)(2)(A)(iii) or 
                (j)(2)(A)(vii)(III) of section 505,
        the period during which an application may not be approved 
        under section 505(c)(3) or section 505(j)(4)(B) shall be 
        extended by a period of six months after the date the patent 
        expires (including any patent extensions); or
            ``(B) if the drug is the subject of a listed patent for   
        which   a   certification   has   been   submitted under 
        subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, 
        and in the patent infringement litigation resulting from the 
        certification the court determines that the patent is valid and 
        would be infringed, the period during which an application may 
        not be approved under section 505(c)(3) or section 505(j)(4)(B) 
        shall be extended by a period of six months after the date the 
        patent expires (including any patent extensions).
    ``(b) Secretary To Develop List of Drugs for Which Additional 
Pediatric Information May Be Beneficial.--Not later than 180 days after 
the date of enactment of this section, 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) the period during which an application may not be 
        submitted under subsection (c)(3)(D)(ii) or (j)(4)(D)(ii) of 
        section 505 shall 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 section 505 to four years, to forty-eight 
        months, and to seven and one-half years shall be deemed to be 
        four and one-half years, fifty-four months, and eight years, 
        respectively; or
            ``(B) the period of market exclusivity under subsections 
        (c)(3)(D)(iii) and (iv) and (j)(4)(D)(iii) and (iv) of section 
        505 shall be three years and six months rather than three 
        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 for studies, 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 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.
            ``(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, whether such 
        studies have been conducted in accordance with commonly 
        accepted scientific principles and protocols, and whether such 
        studies have been reported in accordance with the requirements 
        of the Secretary for filing.
    ``(e) Delay of Effective Date for Certain Applications; Period of 
Market Exclusivity.--If the Secretary determines that the acceptance or 
approval of an application under section 505(b)(2) or 505(j) for a 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 market exclusivity protection, 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), respectively, 
until the determination under subsection (d) is made, but such delay 
shall not exceed 90 days. In the event that requirements of this 
section are satisfied, the applicable period of market exclusivity 
referred to in 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 section 505(b)(2) or (j) 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) Limitation.--The holder of an approved application for a new 
drug that has already received six months of market exclusivity under 
subsection (a) or (c) may, if otherwise eligible, obtain six months of 
market exclusivity under subsection (c)(1)(B) for a supplemental 
application, except that the holder is not eligible for exclusivity 
under subsection (c)(2).
    ``(i) Relationship to Regulations.--Notwithstanding any other 
provision of law, if any pediatric study is required pursuant to 
regulations promulgated by the Secretary, such study shall be deemed to 
satisfy the requirement for market exclusivity pursuant to this 
section.
    ``(j) Sunset.--No period of market exclusivity shall be granted 
under this section based on studies commenced after January 1, 2002. 
The Secretary shall conduct a study and report to Congress not later 
than January 1, 2001, based on the experience under the program. 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 lower income patients; and
            ``(4) any suggestions for modification that the Secretary 
        deems appropriate.''.

SEC. 103. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS.

    (a) In General.--Chapter VII is amended by adding at the end the 
following:

                  ``Subchapter D--Fast Track Products

``SEC. 741. FAST TRACK PRODUCTS.

    ``(a) Designation of Drug as a Fast Track Product.--
            ``(1) In general.--The Secretary shall facilitate the 
        development and expedite the review of new drugs that are 
        intended for the treatment of serious or life-threatening 
        conditions and that demonstrate the potential to address unmet 
        medical needs for such conditions. In this section, such 
        products shall be known as `fast track products'.
            ``(2) Request for designation.--The sponsor of a 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 30 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(b) or 
        section 351 of the Public Health Service Act (21 U.S.C. 262) 
        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 deems 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 
        applicable to fast track products established under this 
        section; 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 shall issue guidance for fast track products (as 
defined in section 741(a)(1) of the Federal Food, Drug, and Cosmetic 
Act) that describes the policies and procedures that pertain to section 
741 of such Act.

SEC. 104. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES.

    Chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end 
the following:

          ``Subchapter D--Unapproved Therapies and Diagnostics

``SEC. 551. 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 (as defined in regulations prescribed by the 
Secretary) for the diagnosis 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 provide to such 
physician after compliance with the provisions of this subsection, an 
investigational drug (as defined in regulations prescribed by the 
Secretary) for the diagnosis 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 or treat the disease or condition involved, and that 
        the risk to the person from the investigational drug is not 
        greater than the 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 in the case described in paragraph (1);
            ``(3) the Secretary determines that provision of the 
        investigational drug 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 submits to the Secretary a clinical 
        protocol consistent with the provisions of section 505(i) and 
        any regulations promulgated under section 505(i) describing the 
        use of investigational drugs in a single patient or a small 
        group of patients.
    ``(c) Treatment INDs.--Upon submission by a sponsor or a physician 
of a protocol intended to provide widespread access to an 
investigational drug for eligible patients, the Secretary shall permit 
such investigational drug to be made available for expanded access 
under a treatment investigational new drug application if the Secretary 
determines that--
            ``(1) under the treatment investigational new drug 
        application, the investigational drug is intended for use in 
        the diagnosis or treatment of a serious or immediately life-
        threatening disease or condition;
            ``(2) there is no comparable or satisfactory alternative 
        therapy available to diagnose or treat that stage of disease or 
        condition in the population of patients to which the 
        investigational drug is intended to be administered;
            ``(3)(A) the investigational drug is under investigation in 
        a controlled clinical trial for the use described in paragraph 
        (1) under an effective investigational new drug application; or
            ``(B) all clinical trials necessary for approval of that 
        use of the investigational drug have been completed;
            ``(4) the sponsor of the controlled clinical trials is 
        actively pursuing marketing approval of the investigational 
        drug for the use described in paragraph (1) with due diligence;
            ``(5) the provision of the investigational drug will not 
        interfere with the enrollment of patients in ongoing clinical 
        investigations under section 505(i);
            ``(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 product 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) and regulations promulgated under section 
505(i). 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 
under expanded access protocols submitted under this subsection. The 
information provided by the Secretary, in accordance with the preceding 
sentence, shall be of 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 if the requirements under this section are no 
longer met.''.

SEC. 105. 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) The Secretary, acting through the Director of the National 
Institutes of Health, shall establish, maintain, and operate a program 
with respect to information on research relating to the treatment, 
detection, and prevention of serious or life-threatening diseases and 
conditions. The program shall, with respect to the agencies of the 
Department of Health and Human Services, be integrated and coordinated, 
and, to the extent practicable, coordinated with other data banks 
containing similar information.
    ``(2)(A) 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, the 
Secretary shall, in carrying out paragraph (1), establish a data bank 
of information on clinical trials for drugs for serious or life-
threatening diseases and conditions.
    ``(B) In carrying out subparagraph (A), the Secretary shall 
collect, catalog, store, and disseminate the information described in 
such subparagraph. 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 sections 505 of the Federal Food, Drug, 
        and Cosmetic Act that 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, 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 must be forwarded to the data bank by 
        the sponsor of the trial not later than 21 days after trials to 
        test clinical effectiveness have begun.
            ``(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 Food and 
                Drug Administration under section 551(c) of the Federal 
                Food, Drug, and Cosmetic Act; or
                    ``(ii) as a Group C cancer drug (as defined by the 
                National Cancer Institute).
        The data bank may also include information pertaining to the 
        results of clinical trials of such treatments, with the consent 
        of the sponsor, including information concerning potential 
        toxicities or adverse effects associated with the use or 
        administration of such experimental treatments.
    ``(4) The data bank shall not include information relating to an 
investigation if the sponsor has provided a detailed certification to 
the Secretary that disclosure of such information would substantially 
interfere with the timely enrollment of subjects in the investigation, 
unless the Secretary, after the receipt of the certification, provides 
the sponsor with a detailed written determination that such disclosure 
would not substantially interfere with such enrollment.
    ``(5) For the purpose of carrying out this subsection, there are 
authorized to be appropriated such sums as may be necessary. Fees 
collected under section 736 of the Federal Food, Drug, and Cosmetic Act 
shall not be used in carrying out this subsection.''.
    (b) Collaboration and Report.--
            (1) In general.--The Secretary of Health and Human 
        Services, the Director of the National Institutes of Health, 
        and the Commissioner of Food and Drugs shall collaborate to 
        determine the feasibility of including device investigations 
        within the scope of the registry requirements set forth in 
        section 402(j) of the Public Health Service Act.
            (2) Report.--Not later than 2 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 registry requirements set forth in 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 investigation is 
                required to be publicly disclosed; and
                    (C) on such other issues relating to such section 
                402(j) as the Secretary may deem appropriate.

 SEC. 106. DISSEMINATION OF INFORMATION ON NEW USES.

    (a) In General.--Chapter VII (2 U.S.C. 371 et seq.), as amended by 
section 103, is amended by adding at the end the following:

        ``Subchapter E--Dissemination of Treatment Information 

``SEC. 745. REQUIREMENTS FOR DISSEMINATION OF TREATMENT INFORMATION ON 
              DRUGS.

    ``(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 if the 
manufacturer meets the requirements of subsection (b).
    ``(b) Specific Requirements.--A manufacturer may disseminate 
information about a new use of a drug under subsection (a) only if--
            ``(1) there is in effect for such drug an application filed 
        under section 505(b) or a biologics license issued under 
        section 351 of the Public Health Service Act;
            ``(2) the information meets the requirements of section 
        746;
            ``(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 748 (relating to certification that the manufacturer 
        will submit a supplemental application with respect to 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 that has not been approved 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 
                        and all updates with respect to the labeling;
                            ``(v) if applicable, a statement that there 
                        are products or treatments that have been 
                        approved 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 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 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 for which the manufacturer intends to disseminate information, 
fails to provide data, analyses, or other written matter that is 
objective and balanced, the Secretary may require the manufacturer to 
disseminate--
            ``(1) additional objective and scientifically sound 
        information that pertains to the safety or effectiveness of the 
        use and is necessary to provide objectivity and balance, 
        including any information that the manufacturer has submitted 
        to the Secretary or, where appropriate, a summary of such 
        information or any other information that the Secretary has 
        authority to make available to the public; and
            ``(2) an objective statement of the Secretary, based on 
        data or other scientifically sound information available to the 
        Secretary, that bears on the safety or effectiveness of the new 
        use of the drug.

``SEC. 746. INFORMATION AUTHORIZED TO BE DISSEMINATED.

    ``(a) Authorized Information.--A manufacturer may disseminate the 
information on the new use of a drug under section 745 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, which was published in a scientific or 
                medical journal (as defined in section 750(6)), which 
                is about a clinical investigation with respect to the 
                drug, 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 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 
                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;
            ``(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 of a 
        manufacturer that disseminates information under section 745 
        and does not have a primary focus on new uses of drugs 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. 747. 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 745 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 that 
        were disseminated by the manufacturer to a person described in 
        section 745(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 745(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 745 shall keep records that may be used by the manufacturer 
when, pursuant to section 749, 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 745 
or the categories of such recipients.

``SEC. 748. REQUIREMENT REGARDING SUBMISSION OF SUPPLEMENTAL 
              APPLICATION FOR NEW USE; EXEMPTION FROM REQUIREMENT.

    ``(a) In General.--A manufacturer may disseminate information under 
section 745 on a new use only if--
            ``(1) the manufacturer meets the condition described in 
        subsection (b) or in subsection (c); or
            ``(2) there is in effect for the manufacturer an exemption 
        under subsection (d) from the requirement of paragraph (1).
    ``(b) Supplemental Application; Condition in Case of Completed 
Studies.--For purposes of subsection (a)(1), 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 745.
    ``(c) Supplemental Application; Condition in Case of Planned 
Studies.--
            ``(1) In general.--For purposes of subsection (a)(1), 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 745 (or, as 
                        applicable, not later than such date as the 
                        Secretary may specify pursuant to an extension 
                        under this paragraph or paragraph (3)); and
                    ``(B) the Secretary has determined that the 
                proposed protocol is adequate and that the schedule for 
                completing such studies is reasonable.
        The Secretary may grant a longer period of time for a 
        manufacturer to submit a supplemental application if the 
        Secretary determines that the studies needed to submit such an 
        application cannot be completed and submitted within 36 months.
            ``(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 the 
        manufacturer involved submits to the Secretary a written 
        request for the extension and the Secretary determines that the 
        manufacturer has acted with due diligence to conduct the 
        studies in a timely manner. Such extension may not provide 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 only if the 
        Secretary determines that--
                    ``(A) it would be economically prohibitive with 
                respect to such drug for the manufacturer to incur the 
                costs necessary for the submission of a supplemental 
                application for reasons, as defined by the Secretary, 
                such as the lack of availability under law of any 
                period during which the manufacturer would have 
                exclusive marketing rights with respect to the new use 
                involved or that the population expected to benefit 
                from approval of the supplemental application is small; 
                or
                    ``(B) it would be unethical to conduct the studies 
                necessary for the supplemental application for a reason 
                such as 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 745 on a new use, the Secretary may at any time 
                terminate such approval and under section 749(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.
    ``(f) Transition Rule.--For purposes of this section, in any case 
in which a manufacturer has submitted to the Secretary a supplemental 
application for which action by the Secretary is pending as of the date 
of the enactment of the Food and Drug Administration Regulatory 
Modernization Act of 1997, the application is deemed to be a 
supplemental application submitted under subsection (b).

``SEC. 749. 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 745 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 pursuant to 
        section 745, 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 745 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 has provided an 
        opportunity for a meeting with respect to such intent unless 
        paragraph (2)(B) applies. 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 745 if the Secretary determines that--
                    ``(A) in the case of a manufacturer to which 
                section 748(b) applies, the Secretary determines that 
                the supplemental application received under such 
                section does not contain adequate information for 
                approval of the new use with respect to which the 
                application was submitted; or
                    ``(B) in the case of a manufacturer to which 
                section 748(c) applies, 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 748(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. 750. 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.
            ``(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 who is licensed by such person to 
        distribute or market the drug.
            ``(4) The term `new use', with respect to a drug, means a 
        use that is not included in the approved labeling of the drug.
            ``(5) The term `pharmacy benefit manager' means an 
        organization that--
                    ``(A) manages pharmaceutical costs through--
                            ``(i) pharmacy benefit administration, 
                        including claims processing adjudication, 
                        pharmacy networks, mail service, and data 
                        reporting;
                            ``(ii) formulary management and 
                        contracting, including evaluating drugs for 
                        formulary status, negotiations of contracts 
                        with manufacturers, and disbursement of 
                        rebates; and
                            ``(iii) utilization management, including 
                        communicating and enforcing therapy guidelines 
                        and drug use principles to physicians, 
                        pharmacists, and patients; and
                    ``(B) serves 2 principal types of customers which 
                are--
                            ``(i) employers, both private- and public-
                        sector, who use either self-funded health 
                        benefits through a third party administrator's 
                        insurance carrier or use traditional indemnity 
                        coverage, using providers from a preferred 
                        provider network or in a fee-for-service 
                        capacity; and
                            ``(ii) health maintenance organizations.
            ``(6) 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 
                1 or more manufacturers.

``SEC. 751. RULES OF CONSTRUCTION.

    ``(a) Unsolicited Request.--Nothing in section 745 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 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, in accordance with section 745, shall 
not be construed by the Secretary as evidence of a new intended use of 
the drug that is different from the intended use of the drug set forth 
in the official labeling of the drug. Such dissemination shall not be 
considered by the Secretary as labeling, adulteration, or misbranding 
of the drug.
    ``(c) Patent Protection.--Nothing in section 745 shall affect 
patent rights in any manner.
    ``(d) Authorization for Dissemination of Articles and Fees for 
Reprints of Articles.--Nothing in section 745 shall be construed as 
prohibiting an entity that publishes a scientific journal (as defined 
in section 750(6)) 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) is amended by 
adding at the end the following:
    ``(x) The dissemination of information in violation of section 
745.''.
    (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.

SEC. 107. STUDIES AND REPORTS.

    (a) In general.--The Comptroller General of the United States shall 
conduct a study--
            (1) to determine the impact of the amendments made by 
        section 7 on the resources of the Department of Health and 
        Human Services; and
            (2) of the scientific issues raised as a result of the 
        amendments made by section 7, including issues relating to--
                    (A) the effectiveness of such amendments with 
                respect to the provision of useful scientific 
                information to health care practitioners;
                    (B) the quality of the information being 
                disseminated pursuant to such amendments;
                    (C) the quality and usefulness of the information 
                provided, in accordance with such amendments, by the 
                Secretary or by a manufacturer at the request of the 
                Secretary; and
                    (D) the impact of such amendments on research in 
                the area of new uses of drugs, indications for new 
                uses, or dosages of drugs for new uses, particularly 
                the impact on pediatric indications and rare diseases.
    (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 under subsection (a).

SEC. 108. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED PRODUCTS.

    (a) Performance Standards.--Not later than 180 days after the date 
of enactment of this Act, the Secretary shall publish in the Federal 
Register performance standards for the prompt review of supplemental 
applications submitted for approved drugs under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321 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 which 
is responsible for the review of applications for approval of drugs 
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. 109. HEALTH CARE ECONOMIC INFORMATION.

    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 if the health care 
economic information directly relates to an indication approved under 
section 505 or 507 or section 351(a) of the Public Health Service Act 
(42 U.S.C. 262(a)) for such drug and is based on competent and reliable 
scientific evidence. The requirements set forth in section 505(a), 507, 
or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) 
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.''.

SEC. 110. 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, 
review and develop guidance, as appropriate, on the inclusion of women 
and minorities in clinical trials required by clause (A).''.

SEC. 111. MANUFACTURING CHANGES FOR DRUGS.

    (a) In General.--Chapter VII (21 U.S.C. 371 et seq.), as amended by 
section 106, is amended by adding at the end the following subchapter:

                 ``Subchapter F--Manufacturing Changes

``SEC. 755. 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, bioequivalence, bioavailability, 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--
                    ``(A) 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, bioequivalence, 
                bioavailability, or effectiveness of a drug; and
                    ``(B)(i) is made in the qualitative or quantitative 
                formulation of the drug involved or in the 
                specifications in the approved application or license 
                referred to in subsection (a) for the drug (unless 
                exempted by the Secretary from the requirements of this 
                subsection);
                    ``(ii) 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
                    ``(iii) is 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 authorize holders to 
                distribute such drugs without prior approval by the 
                Secretary.
                    ``(B) The Secretary may 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. 112. STREAMLINING CLINICAL RESEARCH ON DRUGS.

    Section 505(i) (21 U.S.C. 355(i)) is amended by adding ``(1)'' 
before ``The Secretary'', by redesignating paragraphs (1), (2), and (3) 
as subparagraphs (A), (B), and (C), respectively, by striking the last 
two sentences, and by adding 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 subject 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 Regulatory 
        Modernization Act of 1997).
Such regulations shall provide that such exemption shall be conditioned 
upon the manufacturer, or the sponsor of the investigation, requiring 
that experts using such drugs for investigational purposes certify to 
such manufacturer or sponsor that they will inform any human beings to 
whom such drugs, or any controls used in connection therewith, are 
being administered, or their representatives, that such drugs are being 
used for investigational purposes and will obtain the consent of such 
human beings or their representatives, except where they deem it not 
feasible or, in their professional judgment, 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.
    ``(C) Any 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.''.

SEC. 113. DATA REQUIREMENTS FOR DRUGS.

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

SEC. 114. 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 review of 
applications submitted under paragraph (1) relating to promptness, 
technical excellence, lack of bias and conflict of interest, and 
knowledge of regulatory and scientific standards 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 under this section or section 351 of the 
Public Health Service Act if the sponsor or applicant makes a 
reasonable request for a meeting, for the purpose of reaching agreement 
on the design and size of clinical trials. Minutes of any such meeting 
shall be prepared by the Secretary and made available to the sponsor or 
applicant upon request.
    ``(C) Agreement regarding the parameters of the design and size of 
clinical trials of a new drug that are 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 division in which the 
        drug is reviewed, 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 
documents 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. For purposes of this paragraph, the 
reviewing division is the division responsible for the review of an 
application for approval of a drug (including all scientific and 
medical matters, chemistry, manufacturing, and controls).
    ``(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.''.
    (b) Section 505(j).--
            (1) Amendment.--Section 505(j) (21 U.S.C 355(j)) is amended 
        by redesignating paragraphs (3) through (8) as paragraphs (4) 
        through (9), respectively, and by adding after paragraph (2) 
        the following:
    ``(3)(A) The Secretary shall issue guidance for the review of 
applications submitted under paragraph (1) relating to promptness, 
technical excellence, lack of bias and conflict of interest, and 
knowledge of regulatory and scientific standards which shall apply 
equally to all individuals who review such applications.
    ``(B) The Secretary shall meet with an applicant for approval of a 
drug under this subsection if the applicant makes a reasonable request 
for a meeting for the purpose of reaching agreement on the design and 
size of studies needed for approval of such application. Minutes of any 
such meeting shall be prepared by the Secretary and made available to 
the sponsor or applicant.
    ``(C) Agreements regarding the parameters of design and size of 
bioavailability and bioequivalence trials of a drug under this 
subsection that are 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 division in which the 
        drug is reviewed, 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 
documents 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. For purposes of this paragraph, the 
reviewing division is the division responsible for the review of an 
application under this subsection (including scientific matters, 
chemistry, manufacturing, and controls).
    ``(F) No action by the reviewing division may at any time 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.''.
            (2) Conforming amendments.--Section 505(j) (21 U.S.C. 
        355(j)), as amended by paragraph (1), is amended--
                    (A) in paragraph (2)(A)(i), by striking ``(6)'' and 
                inserting ``(7)'';
                    (B) in paragraph (4), by striking ``(4)'' and 
                inserting ``(5)'';
                    (C) in paragraph (4)(I), by striking ``(5)'' and 
                inserting ``(6)''; and
                    (D) in paragraph (7)(C), by striking ``(5)'' each 
                place it occurs and inserting ``(6)''.

SEC. 115. 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 the enactment of this subsection, 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) 2 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 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 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 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 meeting.
    ``(8) Within 60 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.
    ``(9) A scientific advisory panel under this subsection shall not 
be subject to the annual chartering and annual report requirements of 
the Federal Advisory Committee Act.''.

SEC. 116. DISPUTE RESOLUTION.

    Chapter V (21 U.S.C. 351 et seq.), as amended by section 102, is 
amended by inserting after section 505A the following:

                          ``dispute resolution

    ``Sec. 506. If, regarding an obligation under this Act, there is a 
scientific controversy between the Secretary and a person who is a 
sponsor, applicant, or manufacturer and no specific provision of this 
Act or regulation promulgated under this 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 by an appropriate 
scientific advisory panel under section 505(n). Such review shall take 
place in a timely manner. The Secretary shall promulgate such 
regulations within 180 days of the date of the enactment of the Food 
and Drug Administration Regulatory Modernization Act of 1997.''.

SEC. 117. 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 the existence of such documents 
and the documents themselves are made available to the public both in 
written form and 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.
    ``(C) For guidance documents that set forth initial interpretations 
of 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 any guidance documents, unless the Secretary 
determines that for reasons of the public health need, such prior 
public participation is not feasible. 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 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.
    ``(3) The Secretary, through the Food and Drug Administration, 
shall maintain electronically and publish periodically in the Federal 
Register a list of guidance documents. Such list shall be updated 
quarterly. All such documents shall be made available to the public.
    ``(4) The Secretary shall report to the Committee on Commerce of 
the House of Representatives and the Committee on Labor and Human 
Resources of the Senate no later than July 1, 2000, on the 
implementation of these practices.''.

SEC. 118. POSITRON EMISSION TOMOGRAPHY.

    (a) Regulation of Compounded Positron Emission Tomography Drugs.--
            (1) Definition.--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)(2) (21 U.S.C. 351(a)(2)) 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 
        Pharmacopeia 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 compounded 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 compounded 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 
                compounded 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 later.
                    (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 compounded 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)) for 
                such drugs.
    (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, to the 
extent the notices and rule relate to compounded positron emission 
tomography drugs:
            (1) A notice entitled ``Regulation of Positron Emission 
        Tomographic Drug Products: Guidance; Public Workshop'', 
        published in the Federal Register on February 27, 1995.
            (2) A notice entitled ``Guidance for Industry: Current Good 
        Manufacturing Practices for Positron Emission Tomographic (PET) 
        Drug Products; Availability'', published in the Federal 
        Register on April 22, 1997.
            (3) A final rule entitled ``Current Good Manufacturing 
        Practice for Finished Pharmaceuticals; Positron Emission 
        Tomography'', published in the Federal Register on April 22, 
        1997.
    (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. 119. 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 designed for 
                diagnosis and monitoring of diseases and conditions. 
                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 
        intended to be used for diagnostic or monitoring purposes, 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. 120. 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) 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 which have been approved by the 
        Food and Drug Administration for home use or which, as 
        determined by the Secretary, are simple laboratory examinations 
        and procedures which have an insignificant risk of an erroneous 
        result, including those which--
                    ``(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. 121. PILOT AND SMALL SCALE MANUFACTURE.

    (a) Human Drugs.--Section 505(c) (21 U.S.C. 355(c)) is amended by 
adding at the end thereof 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 prior to scaling up to 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 prior to scaling up to 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. 122. 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 
                certificate 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, or'', ``of the issuance of 
                the certification under section 507,'', and ``issue 
                another certification under section 507, or''.
                    (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 thereof 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) Effect.--The amendments made by subsection (b) shall not apply 
with respect to any application for a drug that contains an active 
ingredient (including any ester or salt of the active ingredient) that 
was an antibiotic drug within the meaning of section 507 of such Act 
and was the subject of an approved or pending application under such 
section 507 for certification or exemption from certification before 
the date of the enactment of this Act.

SEC. 123. FDA MISSION AND ANNUAL REPORT.

    (a) Mission.--Section 903 (21 U.S.C. 393) is amended by 
redesignating subsections (b) and (c) as subsections (c) and (d), 
respectively, and by adding after subsection (a) the following:
    ``(b) Mission.--The Food and Drug Administration shall 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, and with respect to such products shall protect the 
public health by ensuring that--
            ``(1) foods are safe, wholesome, sanitary, and properly 
        labeled;
            ``(2) human and veterinary drugs are safe and effective;
            ``(3) there is reasonable assurance of safety and 
        effectiveness of devices intended for human use;
            ``(4) cosmetics are safe and properly labeled; and
            ``(5) public health and safety are protected from 
        electronic product radiation.
The Food and Drug Administration shall participate with other countries 
to reduce the burden of regulation, harmonize regulatory requirements, 
and achieve appropriate reciprocal arrangements.''.
    (b) Annual Report.--Section 903 (21 U.S.C. 393), as amended by 
subsection (a), is amended by adding at the end the following:
    ``(e) Annual Report.--The Secretary shall, simultaneously with the 
submission each year of the budget for the Food and Drug 
Administration, submit to the Committee on Commerce of the House of 
Representatives and the Committee on Labor and Human Resources of the 
Senate an annual report which shall--
            ``(1) review the performance of the Food and Drug 
        Administration in meeting its mission and the development of 
        Food and Drug Administration policies to implement such 
        mission;
            ``(2) review the performance of the Food and Drug 
        Administration in meeting its own performance standards, 
        including its own outcome measurements, and statutory deadlines 
        for the approval of products or for other purposes contained in 
        this Act;
            ``(3) describe the staffing and resources of the Food and 
        Drug Administration;
            ``(4)(A) list each bilateral and multinational meeting held 
        by the Food and Drug Administration to address methods and 
        approaches to reduce the burden of regulation, to harmonize 
        regulation, and to seek appropriate reciprocal arrangements, 
        (B) describe the goals, activities, and accomplishments of the 
        Food and Drug Administration in such meetings, and (C) list 
        issues that the Food and Drug Administration is considering or 
        has presented for each such meeting.''.

SEC. 124. INFORMATION SYSTEM.

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

``SEC. 906. 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.''.

SEC. 125. EDUCATION AND TRAINING.

    Chapter IX, as amended by section 124, is amended by adding at the 
end the following sections:

``SEC. 907. EDUCATION.

    ``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 scientific training and training in 
administrative process and procedure and integrity issues.''.

SEC. 126. CENTERS FOR EDUCATION AND RESEARCH ON DRUGS.

    Chapter IX, as amended by section 125, is amended by adding at the 
end the following section:

``SEC. 908. DEMONSTRATION PROGRAM REGARDING CENTERS FOR EDUCATION AND 
              RESEARCH ON DRUGS.

    ``(a) In General.--The Secretary, acting through 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 new uses of drugs 
                and the unforeseen risks of new uses of drugs.
                    ``(B) To provide objective clinical information to 
                the following 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.
                    ``(C) To improve the quality of health care while 
                reducing the cost of health care through the prevention 
                of adverse effects of drugs and the consequences of 
                such effects, such as unnecessary hospitalizations.
            ``(2) The conduct of research on the comparative 
        effectiveness and safety of drugs.
            ``(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 fiscal year 1999.''.

SEC. 127. HARMONIZATION.

    Section 803 (21 U.S.C. 383) is amended by adding at the end the 
following:
    ``(c) The Secretary shall participate 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. The Secretary 
shall report to the Committee on Commerce of the House of 
Representatives and the Committee on Labor and Human Resources of the 
Senate at least 60 days before executing any bilateral or multilateral 
agreement under subsection (b).''.

SEC. 128. ENVIRONMENTAL IMPACT REVIEW.

    Chapter VII, as amended by section 111, is amended by adding at the 
end the following:

              ``Subchapter G--Environmental Impact Review

``SEC. 761. ENVIRONMENTAL IMPACT REVIEW.

    ``Notwithstanding any other provision of law, an environmental 
impact statement prepared in accordance with the regulations published 
at part 25 of 21 C.F.R. (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.''.

SEC. 129. NATIONAL UNIFORMITY.

    (a) Nonprescription Drugs.--Chapter VII (21 U.S.C. 371 et seq.), as 
amended by section 128, is amended by adding at the end the following:

``Subchapter H--National Uniformity for Nonprescription Drugs for Human 
       Use and Preemption for Labeling or Packaging of Cosmetics

``SEC. 771. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS FOR HUMAN 
              USE.

    ``(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 intended for 
        human use that is not subject to the requirements of section 
        503(b)(1); 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.--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--
            ``(1) protects an important public interest that would 
        otherwise be unprotected;
            ``(2) would not cause any drug to be in violation of any 
        applicable requirement or prohibition under Federal law; and
            ``(3) would not unduly burden interstate commerce.
    ``(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 507 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 this section.
            ``(2) State initiatives.--This section shall not apply to a 
        State public initiative enacted prior to the date of enactment 
        of this section.
    ``(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.--Paragraph (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 deemed 
        appropriate by the Secretary, the proportion of each active 
        ingredient, including the quantity, kind, and proportion of any 
        alcohol, and also including whether active or not the 
        established name and quantity or if deemed 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 deemed appropriate by the Secretary, on 
        the immediate container, as prescribed in regulation 
        promulgated by the Secretary, but nothing in this clause shall 
        be deemed to require that any trade secret be divulged, except 
        that the requirements of this subclause with respect to 
        alphabetical order shall apply only to nonprescription drugs 
        that are not also cosmetics and 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 clause 
(A)(ii) or (iii) or this subparagraph is impracticable, exemptions 
shall be established by regulations promulgated by the Secretary.''.
    (d) Cosmetics.--Subchapter H of chapter VII, as amended by 
subsection (a), is further amended by adding at the end the following:

``SEC. 772. PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS.

    ``(a) In General.--Except as provided in subsection (b), (d), or 
(e), a State or political subdivision of a State shall not impose 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 that is 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 
and 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 requirements 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. 130. FDA STUDY OF MERCURY COMPOUNDS IN DRUGS AND FOOD.

    (a) List and Analysis.--The Secretary of Health and Human Services 
shall, 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 the enactment of this section and shall provide 
the analysis required by paragraph (2) within 2 years of 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. 131. NOTIFICATION OF DISCONTINUANCE OF A LIFE SAVING PRODUCT.

    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 129, is 
further amended by adding at the end the following:

  ``Subchapter I--Notification of the Discontinuance of a Life Saving 
                                Product

``SEC. 781. DISCONTINUANCE OF A LIFE SAVING PRODUCT.

    ``(a) In General.--A manufacturer that is the sole manufacturer of 
a drug (including a biological product) or device--
            ``(1) that is--
                    ``(A) life supporting;
                    ``(B) life sustaining; or
                    ``(C) intended for use in the prevention of a 
                debilitating disease or condition; and
            ``(2) for which an application has been approved under 
        section 505(b), 505(j), or 515(d),
shall notify the Secretary of a discontinuance of the manufacture of 
the drug or device at least 6 months prior to the date of the 
discontinuance.
    ``(b) Reduction in Notification Period.--On application of a 
manufacturer, the Secretary may reduce the notification period required 
under subsection (a) for the manufacturer if 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; or
            ``(5) the manufacturer has filed for bankruptcy under 
        chapter 7 or 11 of title 11, United States Code.
    ``(c) Distribution.--To the maximum extent practicable, the 
Secretary shall distribute information on the discontinuation of the 
drugs and devices described in subsection (a) to appropriate physician 
and patient organizations.''.

               TITLE II--IMPROVING REGULATION OF DEVICES

SEC. 201. DISPUTE RESOLUTION.

    Section 506, as added by section 116, is amended in the first 
sentence by inserting before the period the following: ``, or under 
section 515(g)(2)(B), as applicable''.

SEC. 202. INVESTIGATIONAL DEVICE EXEMPTIONS; EXPANDED ACCESS.

    Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end 
the following:
    ``(6)(A) Not later than 120 days after the date of the enactment of 
the Food and Drug Administration Regulatory 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, the 
following:
            ``(i) Procedures and conditions under which the Secretary 
        will, 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 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 the validity of data or 
                information resulting from the completion of an 
                approved protocol and do not alter the relationship of 
                likely patient risk to benefit relied upon to approve a 
                protocol.
            ``(ii) Procedures and conditions under which the Secretary 
        will, outside of an approved investigational protocol (subject 
        to compliance with regulations for the protection of patients), 
        permit uses of the device in the diagnosis, monitoring, or 
        treatment of diseases or conditions that are life-threatening 
        or could be irreversibly debilitating, when--
                    ``(I) the treating physician determines that the 
                investigational use of the device likely will provide a 
                benefit; that the risk of not using the device exceeds 
                the probable risk of using the device; and that there 
                is no legally marketed device alternative for the 
                satisfactory treatment or diagnosis of such disease or 
                condition;
                    ``(II) the Secretary determines that there is 
                sufficient evidence of safety and effectiveness to 
                support the investigational use of the device in the 
                case described in subclause (I);
                    ``(III) the Secretary determines that the 
                investigational use of the device will not interfere 
                with the initiation, conduct, or completion of clinical 
                investigations to support marketing approval; and
                    ``(IV) the sponsor, or clinical investigator, of 
                the investigational use of the device submits to the 
                Secretary a clinical protocol consistent with the 
                provisions of paragraph (3) and any regulations 
                promulgated under such paragraph describing the 
                investigational use of devices in a single patient or a 
                small group of patients.
    ``(B) Regulations under subparagraph (A)(i) shall provide that a 
change or modification described in such subparagraph is not permitted 
unless, not later than 5 days after making the change or modification, 
a notice of the change or modification is submitted to the Secretary.
    ``(C) Regulations under subparagraph (A)(ii) shall provide that, 
under appropriate conditions described by the Secretary in the 
regulations, the Secretary will authorize the shipment of 
investigational devices (as defined in the regulations) for the 
diagnosis, monitoring, or treatment of a serious disease or condition 
in emergency situations.
    ``(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 board, to submit to the Secretary, for review, an 
investigational plan (including a clinical protocol). If the applicant 
requests a meeting with the Secretary regarding such review, the 
Secretary shall meet with the applicant not later than 30 days after 
receiving the request for the meeting.
    ``(B) Agreements regarding the parameters of an investigational 
plan (including clinical protocol) that are 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 
agreements 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.''.

SEC. 203. SPECIAL REVIEW FOR CERTAIN DEVICES.

    Section 515(d) (21 U.S.C. 360e(d)) is amended--
            (1) by redesignating paragraphs (2) and (3) as paragraphs 
        (3) and (4), respectively; 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. 204. EXPANDING HUMANITARIAN USE OF DEVICES.

    (a) Section 520(m).--Section 520(m) (21 U.S.C. 360j(m)) is 
amended--
            (1) in paragraph (2), by inserting after and below 
        subparagraph (C) the following:
``The request shall be in the form of an application to the Secretary. 
Within 60 days of the date of the receipt of an application, the 
Secretary shall issue an order approving or denying the application, 
except that if the Secretary convenes a scientific advisory panel, the 
Secretary shall within 120 days of the receipt of an application issue 
such order.'';
            (2) by amending paragraph (5) to read as follows:
    ``(5) The Secretary may suspend or withdraw an exemption from the 
effectiveness requirements of sections 514 and 515 for a humanitarian 
device, after providing notice and an opportunity for an informal 
hearing, if any condition for granting such exemption for such device 
set forth in paragraphs (2) through (4) no longer is met.''; and
            (3) by amending paragraph (6) to read as follows:
    ``(6) 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.''.
    (b) Regulations.--Any provision in a regulation included in title 
21 of the Code of Federal Regulations pertaining to humanitarian 
devices which is inconsistent with the amendments made by subsection 
(a) shall be deemed rescinded on the date of the enactment of this Act. 
The Secretary shall amend regulations pertaining to humanitarian 
devices to conform with the amendments made by subsection (a).

SEC. 205. DEVICE STANDARDS.

    (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is amended 
by adding at the end thereof the following:
    ``(c) Listing of Recognized Standards.--(1) The Secretary shall 
issue notices identifying and adopting applicable nationally or 
internationally recognized standards (or portions of such standards) to 
which a person may self-certify compliance for the purpose of 
demonstrating a reasonable assurance that a device is safe or effective 
or to determine compliance with any requirement of this Act. Such 
notices shall be published in the Federal Register, and the Secretary 
shall provide an opportunity for public comment on the standards 
involved.
    ``(2) The Secretary shall accept a certification that a device 
conforms with each type of standard referenced in subsection (a) and 
identified in such certification to the extent such standard applies, 
except that the Secretary may, at any time, require the person who 
submitted the certification to submit the data and information which 
such person relied upon in making such certification, and may reject 
the certification if the Secretary determines that the data and 
information do not demonstrate compliance with the standards identified 
in the certification. Such person shall maintain the data and 
information for a period of 2 years after the submission of the 
certification, or for the expected design life of the device, whichever 
is later.
    ``(3) The Secretary may remove from the list of standards adopted 
under subsection (a) a standard (or portion of a standard) which the 
Secretary determines is not reliable for the purpose set out in such 
subsection.
    ``(4) In the case of a person who does not self-certify compliance 
pursuant to paragraph (1) regarding a device, the person may elect to 
utilize data other than those required by standards under paragraph (1) 
to demonstrate a reasonable assurance of the safety or effectiveness of 
the device.''.
    (b) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by 
section 106(b), is amended by adding at the end the following:
    ``(y) The falsification of a certification under section 514(c) or 
the failure or refusal to provide data or information required by the 
Secretary under such section.''.
    (c) Adulterated Devices.--Section 501(e) (21 U.S.C. 351(e)) is 
amended by striking ``subject to a performance standard'' and all that 
follows and inserting the following: ``subject to a performance 
standard established under subsection (b) of section 514, unless such 
device is in all respects in conformity with such standard; or subject 
to a standard listed under subsection (c) of such section (in the case 
of a person who has self-certified to such standard), unless such 
device is in all respects in conformity with such standard.''.
    (d) Conforming Amendments.--
            (1) Definition of class ii device.--Section 513(a)(1)(B) 
        (21 U.S.C. 360c(a)(1)(B) is amended by inserting after 
        ``performance standards,'' the following: ``the listing of 
        standards under section 514(c),''.
            (2) Relationship to performance standards.--Section 514(a) 
        (21 U.S.C. 360d(a)) is amended--
                    (A) in paragraph (1), in the second sentence, by 
                striking ``under this section'' and inserting ``under 
                subsection (b)'';
                    (B) in paragraph (2), in the matter preceding 
                subparagraph (A), by striking ``under this section'' 
                and inserting ``under subsection (b)'';
                    (C) in paragraph (3), by striking ``under this 
                section'' and inserting ``under subsection (b)''; and
                    (D) in paragraph (4), in the matter preceding 
                subparagraph (A), by striking ``this section'' and 
                inserting ``this subsection and subsection (b)''.

SEC. 206. SCOPE OF REVIEW.

    (a) Section 513(a).--Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is 
amended--
            (1) in subparagraph (A) by inserting ``one or more'' before 
        ``clinical investigation''; and
            (2) 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) Upon the request of any person intending to submit an 
application under section 515, the Secretary shall, not later than 30 
days after receiving such request, meet with the person to determine 
the type of valid scientific evidence within the meaning of 
subparagraphs (A) and (B) that will be necessary to demonstrate the 
effectiveness of a device for the proposed conditions of use. Within 30 
days of such meeting, the Secretary shall identify, and confirm in 
writing, the type of valid scientific evidence that will provide a 
reasonable assurance that a device is effective under the proposed 
conditions of use.
    ``(ii) Agreements under section 515 regarding the parameters of 
valid scientific evidence for a device that are 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 
agreements 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 
        clause (iii) 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 has been identified.
    ``(iii) A decision under clause (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) 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), unless the director of the 
organizational unit responsible for regulating devices (in this 
subparagraph referred to as the `Director'), after providing an 
opportunity for consultation with the person who submitted such report, 
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) on the 
basis of data or the absence of data, 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 limitations on the device's labeling which 
        proscribe the use not included in proposed labeling; and
            ``(III) find the device substantially equivalent when the 
        labeled intended use and the technological characteristics of 
        the device relative to a legally marketed device conform with 
        the requirements of subparagraph (A).
    ``(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 Regulatory 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 
        5(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 premarket approval 
supplement 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. 207. PREMARKET NOTIFICATION.

    (a) Section 510.--Section 510 (21 U.S.C. 360) is amended--
            (1) in subsection (k)--
                    (A) in the matter preceding paragraph (1), by 
                adding after ``report to the Secretary'' the following: 
                ``or person who is accredited under section 712(a)''; 
                and
                    (B) by adding after and below paragraph (2) the 
                following:
``Such a report is not required for a device intended for human use 
that is exempted from the requirements of this subsection under 
subsection (l) or is 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 to be life supporting or life 
sustaining or 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. With 
respect to a person who is accredited under section 712(a), such 
accredited person shall review a report under this subsection that is 
received by such person and shall submit, not later than 60 days after 
receiving the report, to the Secretary such person's recommendation for 
action to be taken by the Secretary on the report.''; and
            (2) by adding after subsection (k) the following 
        subsection:
    ``(l) Not later than 30 days after the date of the enactment of the 
Food and Drug Administration Regulatory 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 listed by the Secretary shall be exempt from the 
requirement to file a report under subsection (k) as of the date of the 
publication of the list in the Federal Register. Beginning on the date 
that is 1 day after the date of the publication of the list, any person 
may petition the Secretary to exempt a type of class II device from the 
reporting requirement of subsection (k). 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. If the Secretary fails to respond to a petition within 120 
days of receiving it, the petition shall be deemed to be granted.''.
    (b) Initial Classification.--Section 513(f) (21 U.S.C. 360c(f)) is 
amended--
            (1) in the second sentence of paragraph (1) by striking the 
        period at the end and inserting the following: ``unless within 
        30 days of receiving an order classifying the device into class 
        III the person who submits a report under section 510(k) for 
        such device requests review with respect to the classification 
        of the device and a final order of classification from the 
        Secretary. Such person shall submit to the Secretary data and 
        information supporting the classification of the device into 
        class I or II. After the request, a device classified into 
        class III under this paragraph remains in class III, but shall 
        not be deemed to be finally classified until the Secretary has 
        determined the classification of the device based on the 
        classification criteria set forth in subparagraphs (A) through 
        (C) of subsection (a)(1), within 60 days of receiving the 
        request to review and classify a device. Any device found under 
        this paragraph not to be substantially equivalent to a device 
        described in subparagraph (A)(i) and which is classified by the 
        Secretary into class III may not be commercially distributed in 
        commerce before it is approved under section 515.''; and
            (2) by adding at the end the following:
    ``(4) 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 the failure to comply with such 
regulations is directly related to the safety or effectiveness of the 
device).''.
    (c) Section  513.--Section 513(i)(1) (21 U.S.C. 360c(i)), as 
amended by section 206(b), is amended--
            (1) in subparagraph (A)(ii)(I), by striking ``clinical 
        data'' and inserting ``appropriate clinical or scientific 
        data'' and by inserting ``or a person accredited under section 
        712'' after ``Secretary'';
            (2) in subparagraph (A)(ii)(II), by striking ``efficacy'' 
        and inserting ``effectiveness''; and
            (3) by adding at the end of paragraph (1) the following:
    ``(F) For purposes of subparagraph (A), the term `legally marketed 
device' includes any device introduced into interstate commerce for 
commercial distribution before May 28, 1976, and any device determined 
to be substantially equivalent to such device which has not been 
removed from the market by an order of the Secretary or a judicial 
order because it is not safe or not effective.
    ``(G) Not later than 270 days after the date of the enactment of 
the Food and Drug Administration Regulatory 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).''.
    (d) Sunset.--The amendments made by subsections (a)(1)(A) and 
(c)(1), to the extent that they relate to an accredited person under 
section 712 of the Federal Food, Drug, and Cosmetic Act, shall be of no 
force or effect upon the expiration of 7 years from the date of the 
enactment of this Act.

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 the same rights as the 
Secretary regarding--
            ``(i) 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);
            ``(ii) the submission, for review by a classification 
        panel, of 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 participation of the persons at 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 scientific advisory panel under this subsection shall not 
be subject to the annual chartering and annual report requirements of 
the Federal Advisory Committee Act.''.

SEC. 209. PREMARKET APPROVAL.

    Section 515(d) (21 U.S.C. 360e(d)), as amended by section 203(1), 
is amended by inserting after paragraph (1) the following:
    ``(2) Each application received under subsection (c) shall be 
reviewed in a manner to achieve final action on such application within 
180 days of its receipt. At the request of the applicant, the Secretary 
shall meet with an applicant under such an application within 90 days 
of the date of the application's submission.''.

SEC. 210. ACCREDITATION FOR ACCREDITED PERSONS.

    (a) Amendment.--Subchapter A of chapter VII is amended by adding at 
the end the following:

                          ``accredited persons

    ``Sec. 712. (a) In General.--The Secretary shall, not later than 1 
year after the date of the enactment of the Food and Drug 
Administration Regulatory Modernization Act of 1997, accredit persons 
for the purpose of reviewing and initially classifying devices under 
section 513(f)(1) that are subject to a report under section 510(k). An 
accredited person may not be used to perform a review of a class III 
device, or a class II device which is intended to be permanently 
implantable or life sustaining or life supporting.
    ``(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) General rule.--Not later than 180 days after 
                the date of the enactment of the Food and Drug 
                Administration Regulatory Modernization Act of 1997, 
                the Secretary shall establish and publish in the 
                Federal Register requirements 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 withdraw accreditation of any person accredited 
                under this paragraph, after providing notice and an 
                opportunity for an informal hearing, when such person 
                acts in a manner that is inconsistent with the purposes 
                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(e)(2) 
                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 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.
                    ``(B) Such person shall be a legally constituted 
                entity permitted to conduct the activities for which it 
                seeks accreditation.
                    ``(C) Such person shall not engage in the design, 
                manufacture, promotion, or sale of devices.
                    ``(D) Such person shall be operated 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 2 or more 
        accredited persons from which the regulated person may select 1 
        for a specific regulatory function.''.
    (b) Conforming Amendment.--Section 301 (21 U.S.C. 331), as amended 
by section 205(b), is amended by adding at the end the following:
    ``(z) In the case of a drug, device, or food--
            ``(1) the submission of a report or recommendation by a 
        person accredited under section 712 that is false or misleading 
        in any material respect;
            ``(2) the disclosure by a person accredited under section 
        712 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 712 
        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.''.
    (c) Sunset.--The amendments made by subsections (a) and (b) to the 
extent they relate to an accredited person under section 712 of the 
Federal Food, Drug, and Cosmetic Act shall be of no force or effect 
upon the expiration of 7 years from the date of the enactment of this 
Act.
    (d) Report.--Not later than 5 years after the date of the enactment 
of this Act, the Comptroller General of the United States shall report 
to the Committee on Commerce of the House of Representatives and the 
Committee on Labor and Human Resources of the Senate on the use of 
accredited persons under section 712 of the Federal Food, Drug, and 
Cosmetic Act, the extent to which such use was helpful in the 
implementation of such Act, and the extent to which such use promoted 
actions which were contrary to the purposes of such Act.

SEC. 211. PREAMENDMENT DEVICES.

    Section 515(i) (21 U.S.C. 360e(i)) is amended to read as follows:

                               ``Revision

    ``(i) Not later than 180 days after the date of the enactment of 
the Food and Drug Administration Regulatory Modernization Act of 1997, 
the Secretary shall publish in the Federal Register a list of the types 
of devices classified into class III under section 513(d), which are 
not subject to a regulation under subsection (b), and for which the 
Secretary has determined after classification of such devices that 
premarket approval is unnecessary to protect the public health. Each 
such type of device listed in the Federal Register publication shall be 
reclassified into class II or class I, as appropriate.''.

SEC. 212. DEVICE TRACKING.

    Subsection (e) of section 519 (21 U.S.C. 360i) is amended to read 
as follows:

                           ``Device Tracking

    ``(e) The Secretary may by order require a manufacturer to adopt a 
method of tracking a class II or class III device--
            ``(1) the failure of which would be reasonably likely to 
        have serious adverse health consequences; or
            ``(2) which is--
                    ``(A) intended to be an implantable device, or
                    ``(B) a life sustaining or life supporting device 
                used outside a device user facility.''.

SEC. 213. POSTMARKET SURVEILLANCE.

    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) an implantable device, 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 
such plan will result in information necessary to determine the 
occurrence of unforeseen events. The Secretary, in consultation with 
the manufacturer, may by order require a prospective surveillance 
period of up to 36 months. Any determination by the Secretary that a 
longer period is necessary shall be made by mutual agreement between 
the Secretary and the manufacturer or, if no agreement can be reached, 
after the completion of a dispute resolution process as described in 
section 506A.''.

SEC. 214. HARMONIZATION.

    (a) Section 520(f).--Section 520(f)(1)(B) (21 U.S.C. 360j(f)(1)(B)) 
is amended by striking ``and'' at the end of clause (i), by striking 
the period at the end of clause (ii) and inserting ``; and'' and by 
adding after clause (ii) the following:
            ``(iii) ensure that such regulation conforms, to the extent 
        practicable, with internationally recognized standards defining 
        quality systems, or parts thereof, for medical devices.''.
    (b) Section 803.--Section 803 (21 U.S.C. 383), as amended by 
section 127, is amended in subsection (c)--
            (1) by adding at the end the following sentence: ``The 
        Secretary shall, not later than 180 days after the date of 
        enactment of the Food and Drug Administration Regulatory 
        Modernization Act of 1997, make public a plan that establishes 
        a framework for achieving mutual recognition of good 
        manufacturing practices inspections.'';
            (2) by inserting ``(1)'' after ``(c)''; and
            (3) by adding at the end the following:
    ``(2) The Secretary shall report to the Committee on Commerce of 
the House of Representatives and the Committee on Labor and Human 
Resources of the Senate at least 60 days before executing any bilateral 
or multilateral agreement under paragraph (1).''.

SEC. 215. 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''; and
                    (B) by striking paragraph (9) and inserting the 
                following:
            ``(9) shall require distributors to keep records and make 
        such records available to the Secretary upon request.'';
            (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 
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 that are hospitals or 
nursing homes:
            ``(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 hospitals and nursing 
        homes 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 
        to such device user facilities.
            ``(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 to such facilities 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 such a 
        facility unless the facility is included in the subset referred 
        to in subparagraph (A).
            ``(E) Not later than one year after the date of the 
        enactment of the Food and Drug Administration Regulatory 
        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. 216. PRACTICE OF MEDICINE.

    Chapter IX, as amended by section 126, is amended by adding at the 
end the following:

``SEC. 909. 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. 217. CLARIFICATION OF DEFINITION.

    Section 201(h) (21 U.S.C. 321) is amended by adding at the end the 
following: ``A computer software product shall not be considered a 
device under this paragraph solely on the basis that the primary use of 
such product is related to the provision of health care.''.

SEC. 218. LABELING AND ADVERTISING REGARDING COMPLIANCE WITH STATUTORY 
              REQUIREMENTS.

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

SEC. 219. FDA ANNUAL REPORT.

    Section 903 (21 U.S.C. 393), as amended by section 123(b), is 
amended in subsection (e)--
            (1) by striking the period at the end of paragraph (4) and 
        inserting ``; and''; and
            (2) by adding at the end the following:
            ``(5) summarize and explain each instance in the previous 
        fiscal year in which an application received under section 
        515(c) was not reviewed in a manner to achieve final action on 
        such application within 180 days of its receipt.''.

SEC. 220. INFORMATION SYSTEM.

    Section 906, as added by section 124, is amended by adding at the 
end the following: ``With respect to devices, the system shall permit 
access by the applicant under conditions specified by the Secretary.''.

SEC. 221. 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. 222. RULE OF CONSTRUCTION.

    Nothing in this title or the amendments made by this title 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 III--IMPROVING REGULATION OF FOOD

SEC. 301. FLEXIBILITY FOR REGULATIONS REGARDING CLAIMS.

    Section 403(r)(4) (21 U.S.C. 343(r)(4)) is amended by adding at the 
end the following:
    ``(D) Subject to the time period in the last sentence of clause 
(A)(i), proposed regulations under this paragraph may be made effective 
upon publication at the discretion of the Secretary, notwithstanding 
the provisions of section 553 of title 5, United States Code, pending 
consideration of public comment and publication of a final regulation. 
Such 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 such a proposed 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 proposed 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 
        150 days (during which the Secretary may issue a regulation 
        described in subparagraph (4)(D) and 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, including a bibliography of such 
        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 
        (including a regulation described in subparagraph (4)(D)) under 
        the standard in clause (B)(i)--
                    ``(I) prohibiting or modifying the claim and the 
                regulation has become effective, or
                    ``(II) finding that the requirements of clause (C) 
                have not been met, including finding that the 
                petitioner has not submitted all the information 
                required by such clause; or
            ``(ii) a district court of the United States in an 
        enforcement proceeding under chapter III has determined that 
        the requirements of clause (C) have not been met.''.

SEC. 304. NUTRIENT CONTENT CLAIMS.

    Section 403(r)(2) (21 U.S.C. 343(r)(2)) is amended by adding at the 
end the following:
    ``(G) A claim of the type described in subparagraph (1)(A) for a 
nutrient, for which the Secretary has not promulgated a regulation 
under clause (A)(i), shall be authorized and may be made with respect 
to a food if--
            ``(i) a scientific body of the United States Government 
        with official responsibility for public health protection or 
        research directly relating to human nutrition (such as the 
        National Institutes of Health or the Centers for Disease 
        Control and Prevention) or the National Academy of Sciences or 
        any of its subdivisions has published an authoritative 
        statement, which is currently in effect, which identifies the 
        nutrient level to which the claim refers;
            ``(ii) a person has submitted to the Secretary, at least 
        150 days (during which the Secretary may issue a regulation 
        described in subparagraph (4)(D) and 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, including a bibliography of such 
        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 
        (including a regulation described in subparagraph (4)(D))--
                    ``(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, then 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 or symbol 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--
            (1) 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; or
            (2) 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 
paints 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 Paint.--Lead and cadmium based paint may 
not be banned as an unapproved food additive if it is 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.

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 that is a food contact 
        substance, there is--
                    ``(A) in effect for such substance a regulation 
                issued under this section prescribing the conditions 
                under which such substance may be safely used and such 
                substance and the use of such substance are in 
                conformity with such regulation; or
                    ``(B) a notification submitted under subsection (h) 
                that is in effect.''; and
            (4) in the flush matter following paragraph (3) (as added 
        by paragraph (3)), by inserting ``or notification'' after 
        ``regulation'' each place it appears.
    (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 person manufacturing or supplying 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--
            ``(A) name of the person;
            ``(B) identity and intended use of the food contact 
        substance; and
            ``(C) determination of the person 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, within the 120-day period, the 
Secretary--
            ``(i) makes a determination 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), or
            ``(ii) makes a determination under paragraph (3) with 
        respect to the need for a petition under subsection (b) for 
        such food contact substance,
and informs the person of such determination.
    ``(B) A determination by the Secretary under subparagraph (A)(i) 
shall constitute final agency action subject to judicial review.
    ``(C) A notification under this subsection shall be effective only 
with respect to the person identified in the notification.
    ``(3)(A) The notification 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 the person 
manufacturing or supplying the food contact substance agree that such 
person should submit a petition under subsection (b).
    ``(B) The Secretary may 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 a 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) with respect to the food contact substance.
    ``(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) 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 be no longer in 
        effect.''; and
            (4) in subsection (j), as so redesignated by paragraph (1), 
        by striking ``subsections (b) to (h)'' and inserting 
        ``subsections (b) to (i)''.
    (c) Effective Date.--Notifications under section 409(h) of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (b), may 
be submitted beginning 18 months after the date of enactment of this 
Act.

SEC. 310. MARGARINE.

    (a) Section 301(m).--Paragraph (m) of section 301 (21 U.S.C. 331) 
is amended by striking ``section 407(b) or 407(c)'' and inserting 
``section 407''.
    (b) Section 407.--Section 407 (21 U.S.C. 347) is amended to read as 
follows:

                     ``oleomargarine and margarine

    ``Sec. 407. No person shall sell, or offer for sale, oleomargarine 
or colored margarine unless the principal display panel of such 
oleomargarine or margarine bears as one of its principal features the 
word `oleomargarine' or `margarine' which is in--
            ``(1) bold type on such panel;
            ``(2) a size reasonably related to the most prominent 
        printed matter; and
            ``(3) lines generally parallel to the base on which the 
        package rests as it is designed to be displayed.''.
    (c) Act of March 16, 1950.--Sections 3(a) and 6 of the Act of March 
16, 1950 (21 U.S.C. 347a, 347b) are repealed.

SEC. 311. EFFECTIVE DATE.

    The amendments made by this title shall take effect on the date of 
the enactment of this Act.

            Amend the title so as to read ``An Act to amend the Federal 
        Food, Drug, and Cosmetic Act to improve the regulation of food, 
        drugs, cosmetics, and devices, and for other purposes.''.

            Attest:

                                                                 Clerk.