FOOD AND DRUG ADMINISTRATION REGULATORY MODERNIZATION ACT OF 1997
(House of Representatives - October 07, 1997)

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   FOOD AND DRUG ADMINISTRATION REGULATORY MODERNIZATION ACT OF 1997

  Mr. BLILEY. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 1411) to amend the Federal Food, Drug, and Cosmetic Act and 
the Public Health Service Act to facilitate the development and 
approval of new drugs and biological products, and for other purposes, 
as amended.
  The Clerk read as follows:

                               H.R. 1411

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

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

       (a) Short Title.--This Act may be cited as the ``Food and 
     Drug Administration 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 radiopharmaceu-ticals.
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--

[[Page H8456]]

       ``(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.''.

[[Page H8457]]

       (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.

[[Page H8458]]

       ``(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--

[[Page H8459]]

       ``(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;

[[Page H8460]]

       ``(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

[[Page H8461]]

       ``(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.

[[Page H8462]]

     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

[[Page H8463]]

     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

[[Page H8464]]

     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

[[Page H8465]]

     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

[[Page H8466]]

     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:

[[Page H8467]]

     ``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

[[Page H8468]]

     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.

[[Page H8469]]

       ``(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:

                   ``Listing of Recognized Standards

       ``(c)(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

[[Page H8470]]

       ``(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,

[[Page H8471]]

     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.''.

[[Page H8472]]

       (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.''.

[[Page H8473]]

     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:

[[Page H8474]]

          ``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.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Virginia [Mr. Bliley] and the gentleman from Michigan [Mr. Dingell] 
each will control 20 minutes.
  The Chair recognizes the gentleman from Virginia [Mr. Bliley].


                             General Leave

  Mr. BLILEY. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days within which to revise and extend their remarks 
on this legislation and to insert extraneous material on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Virginia?
  There was no objection.
  Mr. BLILEY. Mr. Speaker, I yield myself 4 minutes.
  Mr. Speaker, if my colleagues had told me 3 years ago that FDA 
modernization would come before the House on the suspension calendar, 
well, I would have asked them to see their doctor. Yet, here we are.
  Today brings to an end almost 3 years of work by the Committee on 
Commerce. When the committee first discussed the need to modernize the 
FDA in 1995, we knew that outdated rules were slowing down the vital 
work of the FDA and that patients were the ones who were suffering.
  Vital new medicines and medical devices were not getting to the 
patients who needed them as quickly as they should. As I said back 
then, it breaks my heart to see American patients having to go overseas 
to get medicines and medical devices they need to stay alive.
  Congress had to act. But it had to act wisely, with prudence and with 
balance, because the work of the FDA is just too important to do 
otherwise. That is why our committee launched what I believe was an 
unprecedented outreach effort. Literally thousands of hours were 
devoted to reaching out to all corners of the country on this issue.
  Our FDA reform team spoke to patients, to medical specialists, to 
researchers, and to consumer groups. We held 17 hearings over the last 
3 years. We compiled more than 2,000 pages of testimony. Our goal then 
and our goal now was balanced, well-reasoned legislation, legislation 
that the President would be eager to sign, legislation that honored the 
medical oath, ``First do no harm.''
  We have fulfilled our objectives. Last year we produced a package of 
legislative proposals that have been hailed from all quarters as 
balanced and reasonable in their approach. Two of the three bills were 
unanimously reported by the committee. The third was approved by a 
voice vote.
  These are the bills that have been consolidated into the measure 
before us today: H.R. 1411, the Prescription Drug User Fee 
Reauthorization and Drug Regulatory Modernization Act of 1997, which is 
contained as title I of this bill; H.R. 1710, the Medical Device 
Regulatory Modernization Act of 1997, which is title II; and H.R. 2469, 
the Food and Nutrition Information Reform of 1997, which is title III.

                              {time}  1045

  All three of these measures prove, once again, that men and women of 
goodwill working together can bridge differences. When we put the 
interests of the American people first, there is nothing that can keep 
us apart. We have done our homework, we have reached our objectives. We 
have built a stronger, better, more efficient FDA. We have enhanced the 
safety of the medicines we take, the food we feed our children, and we 
are going to help a lot of people.
  Medicines will be approved faster and medical devices will get to 
people sooner, and those with serious and life-threatening diseases 
will get access to the best experimental new drugs that modern medicine 
can provide. That is important, Mr. Speaker, because when we are sick, 
when we are suffering, every minute counts.
  Some of my colleagues deserve special praise and thanks. Their work 
on this issue has been tireless, and the credit for this legislation 
belongs to them, the members of our FDA reform team: the gentleman from 
Florida [Mr. Bilirakis], chairman of our Subcommittee on Health and 
Environment, along with the gentleman from Pennsylvania [Mr. 
Greenwood], the gentleman from North Carolina [Mr. Burr], the gentleman 
from Texas [Mr. Barton], the gentleman from Wisconsin [Mr. Klug], and 
the gentleman from Kentucky [Mr. Whitfield].
  I want to reach across the aisle, too, to thank our friends the 
gentlewoman

[[Page H8475]]

from California [Ms. Eshoo], the gentleman from New York [Mr. Towns] 
and the gentleman from Texas [Mr. Hall], and I would like to thank our 
ranking members, the gentleman from Michigan [Mr. Dingell] and the 
gentleman from Ohio [Mr. Brown], for their invaluable contributions to 
this effort. My colleagues should all be proud of a job very well done. 
The American people thank them, and I do too.
  Mr. Speaker, I reserve the balance of my time.
  (Mr. DINGELL asked and was given permission to revise and extend his 
remarks.)
  Mr. DINGELL. Mr. Speaker, I yield myself 3 minutes.
  Mr. Speaker, this is an excellent piece of legislation. I strongly 
urge my colleagues on both sides of the aisle to support it. I believe 
it should be adopted and should be signed. It represents some 
remarkable work in terms of bipartisanship by my good friend, the 
gentleman from Virginia [Mr. Bliley], by the ranking member of the 
subcommittee, by the distinguished chairman of the subcommittee, and by 
a lot of other Members who have worked very hard on this.
  The legislation would extend the Prescription Drug User Fee Act, 
which has resulted in some enormous advances in terms of the 
functioning of FDA user fees, which have been wise and right. That is a 
program which has worked well. Today, virtually all drugs and 
biological products are reviewed in a year or less. Priority drugs for 
serious illnesses, drugs that represent true clinical breakthroughs, 
can be reviewed in 6 months or less.
  The entire pharmaceutical industry joins with FDA in supporting this 
program, and when that happens, we know that we have a winner. This 
program is indeed a winner, because we have witnessed the continued 
quality of drugs coming from FDA review, both in terms of safety and 
consumer protections, and they are a monument to the speedy and careful 
work now possible to be done by an adequately staffed FDA in this area.
  The bill contains reforms in medical device regulation. I am 
especially pleased that a number of these concerns represent actions 
suggested by the Committee on Commerce's Subcommittee on Oversight and 
Investigation's 1993 report, ``Less Than the Sum of Its Parts.''
  One of the important things accomplished during the negotiations on 
the medical device portions of the legislation was development of 
provisions that allow improvements in efficiency and reduce regulatory 
requirements while maintaining strong public health protection. The 
bill's sponsors responsibly and carefully negotiated a number of 
difficult compromises to assure patient safety would not be jeopardized 
in a careless attempt to speed up market clearance and approval of 
products. I believe that these provisions strike a difficult but 
important balance.
  Finally, Mr. Speaker, the bill includes provisions for modifications 
in food labeling requirements that will help consumers to get access to 
good information more easily and more quickly.
  In total and on balance, we have a good piece of legislation before 
us today. Members of the committee have worked closely together, and I 
want to thank the gentleman from Virginia [Mr. Bliley], the chairman of 
the committee, and the gentleman from Florida [Mr. Bilirakis], the 
chairman of the subcommittee, for their courtesies to me and other 
Democratic members of the committee.
  The staffs of the committee have worked closely together: Howard 
Cohen, Rodger Currie, Eric Berger, and Kay Holcombe, who will be, I 
regret to inform the House, leaving the committee staff at the 
conclusion of this Congress. They deserve particular thanks for 
bringing us to this point; also, the gentlewoman from California [Ms. 
Eshoo] and others who have worked so hard to make this possible deserve 
the appreciation of the committee and of the Congress.
  I strongly urge my colleagues on both sides of the aisle to support 
this legislation. It is good legislation, it serves the public 
interests, it moves forward the regulatory process, and it serves the 
interests of the consuming public.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BLILEY. Mr. Speaker, I yield 4 minutes to the gentleman from 
Florida [Mr. Bilirakis], the chairman of the subcommittee.
  (Mr. BILIRAKIS asked and was given permission to revise and extend 
his remarks.)
  Mr. BILIRAKIS. Mr. Speaker, I thank the gentleman for yielding me 
this time.
  Mr. Speaker, today the House is considering landmark legislation 
which will streamline the drug approval process, provide safer foods to 
our citizens, and address critical problems in the approval of medical 
devices.
  On September 17, the Subcommittee on Health and Environment approved 
all three FDA bills by voice vote. On September 25, the full Committee 
on Commerce approved the drug and food bills by a vote of 43 to zero, 
and the device bill by voice vote the following day.
  In the ensuing days, a small number of outstanding issues were 
diligently and successfully resolved following bipartisan discussion 
between Chairman Bliley and myself, other interested members of the 
majority, the distinguished ranking member, the gentleman from 
Michigan, Mr. Dingell, the gentleman from California, Mr. Waxman, and 
other concerned members of the minority.
  As Members may be aware, at the end of last week Chairman Bliley and 
the gentleman from Michigan, Mr. Dingell, coauthored a memo to all 
members of the Committee on Commerce informing them that these issues 
had been successfully resolved and that the legislation would be placed 
on the Suspension Calendar. Since that time, the three reported FDA 
reform bills, H.R. 1411, H.R. 1710 and H.R. 2469, were consolidated 
into the substitute version of H.R. 1411. This morning in a bipartisan 
``Dear Colleague'' letter, Chairman Bliley and the gentleman from 
Michigan, Mr. Dingell, urged all Members to support the consolidated 
bill that is now before the House.
  In short, the drafting, negotiations and markup of this legislation 
have been a shining example of what can be accomplished in the spirit 
of bipartisanship and cooperation among Members.
  The foundation of these bills was developed during the last Congress. 
For those of my colleagues who may not remember, both Republican and 
Democrat members of the Committee on Commerce sat shoulder-to-shoulder 
with the FDA on the legislative package to modernize the agency, and 
while our committee never actually marked up this legislation, these 
discussions laid the groundwork for the bill we are considering today.
  This has been an open process, one which has been open to anyone who 
is interested in FDA reform. Since the beginning of the 104th Congress, 
the Committee on Commerce conducted 17 separate formal hearings on FDA 
reform and FDA-related issues, which represented 72 hours and 44 
minutes and 2,094 pages of testimony.
  In addition, members of the committee and their staffs have met with 
patient and consumer groups, medical consumer groups, manufacturers, 
the FDA and others who are interested in FDA reform. We have had an 
open door policy throughout the process, and the fact that this bill 
was placed on the Suspension Calendar with the full support of the 
gentleman from Michigan [Mr. Dingell] is a reflection of our success.
  There are many, Mr. Speaker, who deserve credit for bringing this 
legislation before the House. First I want to thank the gentleman from 
Pennsylvania [Mr. Greenwood], who took the time to educate himself and 
other Members on complex FDA issues. He played a key role in developing 
this bill. I want to thank the gentleman from North Carolina [Mr. Burr] 
for his willingness to sponsor the drug reform legislation. His bill 
will accomplish an important goal: Improving the drug approval process.
  The gentleman from Wisconsin [Mr. Klug], along with the gentleman 
from Kentucky [Mr. Whitfield], the gentleman from Texas [Mr. Hall], and 
the gentleman from New York [Mr. Towns] have been leaders in reforming 
food laws.
  The gentleman from Texas [Mr. Barton] and the gentlewoman from 
California [Ms. Eshoo] have dedicated time and energy to writing a 
bipartisan

[[Page H8476]]

medical device bill. Both have been successful in crafting a bill which 
is considered reasonable and responsible by both Members of Congress 
and industry.
  Finally, I want to thank our full committee chairman, the gentleman 
from Virginia [Mr. Bliley], the subcommittee ranking member, the 
gentleman from Ohio [Mr. Brown], and the full committee ranking member, 
the gentleman from Michigan [Mr. Dingell]. We are considering FDA 
reform today due to their willingness to work out the details of this 
legislation with the administration and the FDA.
  And of course I also appreciate the support this process has received 
from both HHS Secretary Donna Shalala and the acting FDA Commissioner, 
Dr. Michael Friedman. Their leadership and cooperation helped us 
achieve our ultimate goal of considering practical and thoughtful FDA 
reform legislation.
  Mr. DINGELL. Mr. Speaker, I yield 3 minutes to the gentleman from 
Ohio [Mr. Brown].
  Mr. BROWN of Ohio. Mr. Speaker, I thank the gentleman for yielding me 
this time.
  Our first goal must be to ensure that patients have access to safe 
and effective new products as quickly as humanly and scientifically 
possible. While this bill continues to include some provisions that 
give me pause, I also believe it includes provisions that are workable, 
positive and contribute to the goal of ensuring an FDA operation that 
works in the best interests of its most important customers: Patients.
  Nevertheless, as we proceed with this discussion I think it is 
important to put a few facts in perspective. Many have argued that FDA 
reform is essential because new and improved drugs and medical devices 
are not reaching American patients quickly enough. The facts simply do 
not bear this out.
  For example, through FDA's own management initiatives and without any 
change in legislation, FDA's Center for Devices has overhauled its 
operations and dramatically improved its review times for new products. 
Further, I think the majority of medical device manufacturers will 
agree that the center is more user-friendly and efficient than ever 
before. I hope as we proceed to conference with this legislation we 
will look carefully at provisions relating to medical devices to ensure 
that we are not increasing requirements for FDA in a way that will set 
back the progress that has been made.
  One of the most important provisions included in this legislation is 
the reauthorization of the Prescription Drug User Fee program. PDUFA 
has provided the agency with the resources it clearly needed to allow 
it to continue to be the world leader in the review and the approval of 
new drugs. If there were one single reason for the House to pass this 
bill, drug user fees is that reason.
  I am pleased the legislation includes some process improvements 
related to FDA's regulation of generic drugs. While these products are 
not the breakthrough miracle drugs we read about in headlines, generic 
drugs are small miracles to millions of elderly patients, especially 
those living on fixed incomes, who depend on these alternatives which 
many times are vastly less expensive than brand name products. Generic 
products generally save billions of dollars in health care costs.
  I was disappointed that the bill did not go further in addressing 
what I believe are several difficult problems related to the review of 
generic drugs: Frivolous citizen petitions filed by lawyers 
representing the large drug companies which divert resources and slow 
the approval of generic alternatives. I hope we can continue to work on 
these matters, perhaps in the context of future legislation.
  I remain concerned about provisions in the bill that allow 
manufacturers to distribute information about off-label uses of their 
products. I am not convinced by the arguments that this kind of system 
is necessary for physicians to have the information they need to treat 
patients, especially given the companies' financial interest in 
promoting their products. I will closely monitor this program to 
determine whether it, in fact, is in the best interests of patients, or 
simply serves to enrich drug and device companies.
  Mr. Speaker, FDA is a remarkably effective agency. I have never been 
persuaded that massive changes in laws were needed to correct any 
dreadful problem lurking under the surface, but working with the 
gentleman from Virginia [Mr. Bliley], the gentleman from Florida [Mr. 
Bilirakis], the gentleman from Michigan [Mr. Dingell], and the 
gentlewoman from California [Ms. Eshoo], I am pleased that this 
legislation focuses more on modernizing than completely overhauling 
this very good public agency.
  Mr. BLILEY. Mr. Speaker, I yield myself such time as I may consume to 
point out that not with us this morning is the gentleman from 
Pennsylvania [Mr. Greenwood], whose father underwent bypass surgery 
yesterday, and I know all of us will want to have him in our prayers.
  With that, I yield 3 minutes to the gentleman from North Carolina 
[Mr. Burr].
  (Mr. BURR of North Carolina asked and was given permission to revise 
and extend his remarks.)
  Mr. BURR of North Carolina. Mr. Speaker, I thank the gentleman from 
Virginia [Mr. Bliley], and I thank the gentleman from Florida [Mr. 
Bilirakis], the gentleman from Michigan [Mr. Dingell], the ranking 
member, and the gentleman from Ohio [Mr. Brown]. Without their 
leadership we would not be here today talking about reform of this 
crucial agency.
  I was fortunate in the 104th Congress to be with a group of 
individuals committed and focused on FDA reform: The gentleman from 
Pennsylvania [Mr. Greenwood], the gentleman from Wisconsin [Mr. Klug], 
and the gentleman from Texas [Mr. Barton], and I truly believe that 
that was the real impetus behind our success that we are here to put 
into law today. Without their focus, and the addition of the 
gentlewoman from California [Ms. Eshoo] and the gentleman from Kentucky 
[Mr. Whitfield], we might not have completed this task, and I am 
grateful for their commitment.

                              {time}  1100

  I also realize that this has been a taxing process, one that we could 
not have completed without Howard Cohen, Eric Berger, Rodger Currie, 
and Kay Holcombe, staff members who devoted countless hours to the 
changes that Members sought in this very crucial piece of legislation.
  This is extraordinary to have H.R. 1411 on the floor, because today 
is about one thing and one thing only. It is about patients. It is 
about patients' access to safe, technologically superior, and 
affordable medical treatment.
  Mr. Speaker, throughout the past 2 years I have compiled countless 
stories of patients and their experience with the Food and Drug 
Administration. I remember Lissy Mahler from Lansing, NC, who, after 
trying everything available at the time, sought an investigational 
treatment therapy for her cancer. The investigational therapy improved 
the quality of her life and may have prolonged her life.
  And there was Frances Swaim, who wrote me as an elderly mother of a 
child with multiple sclerosis and said, ``Congressman, the only thing I 
ask is that you change the Food and Drug Administration so that drugs I 
know are available other places might be approved so my daughter, and 
others, can in fact benefit with their quality of life.''
  Countless patients across this country have visited my office. I 
remember the day that Steve Seigel came in to talk about Mary Jo's 
cancer and about the struggle that she went through and the belief that 
the FDA, to her, had no human face. What have we done over the past 
2\1/2\ years? We have placed a human face on the FDA and a human face 
on patients, and for Mary Jo, her dream has become reality.
  Mr. Speaker, I also realize that many of the people who visited my 
office this year will not be back next year because we have not done it 
quick enough. But it is important that we understand that now is the 
time for Congress and the Food and Drug Administration to work together 
to make the changes, to make sure that as the American people cross 
that ``Bridge to the 21st Century,'' that we do not look back at the 
FDA, that in fact they go across with us.
  FDA modernization is not radical, it is responsible. It is not 
senseless, it is safe. I urge my colleagues today to remember that in 
fact passage of this

[[Page H8477]]

legislation is about patients and their quality of life.
  Mr. DINGELL. Mr. Speaker, I yield 4 minutes to the distinguished 
gentlewoman from California [Ms. Eshoo].
  Ms. ESHOO. Mr. Speaker, title II of the legislation we are going to 
vote on today was known as H.R. 1710, the Medical Device Regulatory 
Modernization Act, sponsored by the gentleman from Texas [Mr. Barton] 
and myself.
  My colleague from Texas and I have worked very, very hard to craft a 
bill that can and should be broadly supported by the full House today. 
I salute the gentleman from Texas for his work on the bill and his 
commitment to making it a bipartisan effort.
  Mr. Speaker, I also want to salute the gentleman from Virginia [Mr. 
Bliley], the distinguished chairman of the Committee on Commerce; the 
gentleman from Florida [Mr. Bilirakis], the distinguished chairman of 
the Subcommittee on Health and Environment; the gentleman from Michigan 
[Mr. Dingell], our very distinguished ranking member; and the gentleman 
from Ohio [Mr. Brown]. Together I think that we have produced something 
that we can all be proud of.
  Mr. Speaker, H.R. 1710 passed the Subcommittee on Health and 
Environment and the full Committee on Commerce by a voice vote, and the 
bill enjoyed almost 150 bipartisan cosponsors.
  This bill provides the FDA with new authority to recognize 
performance standards and initially classify devices according to risk. 
Patients will get greater access. And I want to underscore that, it is 
so important to the American people. They have greater access to 
investigational devices and access to devices that will benefit small 
numbers of people, much like the successful Orphan Drug Program.
  The bill provides companies with the opportunity to meet with the FDA 
to resolve their differences and focus their research early in the 
review process. In short, Mr. Speaker, this legislation will help move 
the FDA into the next century.
  Mr. Speaker, the bill improves current law by focusing FDA's review 
process for 510(k) applications, which is the process by which lower 
risk devices get cleared by the FDA for marketing.
  To address concerns raised by the Agency that the bill was too 
restrictive on their ability to look at the intended use of the device 
not listed on the proposed label, the bill allows for very narrow 
circumstances under which the Agency could seek information beyond the 
label. Decisions to look beyond the label will be made by senior Agency 
officials, not individual reviewers, and are clearly intended to be the 
exception rather than the rule. FDA supported this.
  Mr. Speaker, the bill amends the FDA's current process for postmarket 
surveillance and replaces it with authority requiring surveillance of 
high-risk devices for 3 years, allowing for surveillance periods of 
even longer periods of time if agreed to by the FDA and the 
manufacturer. This provision, too, was fully supported by the FDA.
  I also want to point out a section of the bill dealing with outside 
reviewers, so my colleagues are clear on what the bill proposes. We 
have exempted all class III devices from outside review. We have 
exempted any class II device that is implantable, life-supporting, or 
life-sustaining from outside review. If there is a device for which FDA 
believes no qualified third party review exists, then the Agency will 
not have to accredit such an entity.
  In closing, Mr. Speaker, I want to thank some very key people from 
our respective staffs that have worked so hard to make sure that this 
legislation would move forward. In particular, I want to salute Kay 
Holcombe, Howard Cohen, Rodger Currie, and Eric Berger of the committee 
staff, Beth Hall of the staff of the gentleman from Texas [Mr. Barton], 
and Bill Bates of my own. He has aged considerably from being a very 
young man at the beginning of this process to this moment.
  Mr. Speaker, all of these individuals brought forward their 
commitment to us to bring forward a bill that we could be proud of, 
that would deserve and enjoy bipartisan support, and, most of all, 
benefit the American people by the benefit of what the industry can 
bring forward in this country.
  Mr. BLILEY. Mr. Speaker, I yield 2 minutes to the gentleman from 
Kentucky [Mr. Whitfield].
  Mr. WHITFIELD. Mr. Speaker, I thank the gentleman from Virginia [Mr. 
Bliley] very much for the leadership that he has provided in this 
effort today, and I certainly want to commend both sides of the aisle 
as they worked very hard together. I also want to emphasize the 
importance of the staff and all of the long hours that they put in on 
this legislation.
  H.R. 2469 passed the Committee on Commerce by a vote of 43 to 0. It 
is a bill that is going to help us streamline the processing of 
petitions at FDA. This is a modest first step in our efforts to 
streamline the Nutrition Labeling and Education Act of 1990. But the 
changes will provide FDA with additional flexibility as it processes 
petitions filed at the Agency, provide alternative petition methods for 
health and nutrient claims, if claims meet the significant scientific 
standard, and I want to emphasize that that standard is maintained.
  This legislation will place a statutory deadline for FDA to complete 
action on petitions and will address the first amendment problem raised 
in the Federal court case of The Nutritional Health Alliance versus 
Shalala. FDA will be required to complete its actions on petitions 
within 540 days. This is a more liberal standard for FDA than the 
nonbinding 270-day limitation it placed on itself in response to the 
Nutritional Health Alliance case I just mentioned.
  Of course, many Members wanted to do more, particularly in the area 
of national uniformity for labeling standards. But as I stated earlier, 
this is an important first step, and I want to commend all of those who 
were involved in this legislation.
  Mr. DINGELL. Mr. Speaker, I yield 2 minutes to the distinguished 
gentleman from California [Mr. Waxman].
  Mr. WAXMAN. Mr. Speaker, the bill we have before us today is the 
product of a long and intense period of negotiation between people with 
very different views of the FDA, how it works today, and how it should 
do its job in the future.
  It is a compromise and one that probably makes no one completely 
happy, but it is a good faith effort to find a common ground so that we 
could move legislation forward in a timely way to reauthorize what has 
been one of the most successful programs we have to help the FDA do its 
job and do it better and faster. That is known as the Prescription Drug 
User Fee Program, also PDUFA.
  It is a program with broad support by industry and the Agency and one 
that has been widely acknowledged as working and working extremely 
well. It has led to faster approval of drugs with no diminution of the 
thoroughness or scope of the review. Throughout the process, it has 
been the primary goal of every party of this debate to find legislation 
that could be broadly supported and achieve this reauthorization.
  If I were writing the legislation, it would be a very different 
product than we have before us today. I would not authorize off-label 
use of drugs or third party review of devices, for example. I would not 
weaken the FDA authority to fully review devices for all likely uses, 
and I firmly believe that over the long run, we will regret that we 
have changed FDA law in this way.
  But, Mr. Speaker, I recognize the broad interest in this body and in 
the Senate in trying out these changes, and I recognize that the FDA 
negotiated many protections in the way the off-label provisions would 
work and that the demonstration of third party review of devices is now 
considerably more limited than when this debate started.
  Most particularly, I recognize that we have provided for a sunset of 
each of these experimental provisions so that all of us will have an 
opportunity to understand how they have worked and reconsider them, if 
necessary. To me, that is a critical aspect of these bills.
  Mr. Speaker, I am particularly pleased to see provisions in the bill 
which expand the clinical trial data base which I think can be helpful 
to many people around the country dealing with many serious and life-
threatening diseases.
  I join in supporting this legislation, and will have a further 
statement in the Record.
  Mr. BLILEY. Mr. Speaker, I yield 3 minutes to the gentleman from 
Texas [Mr. Barton].

[[Page H8478]]

  (Mr. BARTON of Texas asked and was given permission to revise and 
extend his remarks and to include extraneous matter therein.)
  Mr. BARTON of Texas. Mr. Speaker, at the start of the last Congress, 
consumers were unhappy with the FDA, the medical community was unhappy 
with the FDA, patient groups were unhappy with the FDA. I would think 
if we took a poll within the FDA, many of the FDA employees were 
unhappy with the FDA. It was so bad that at my first hearing on the 
FDA, I said that FDA stood for ``Foot Dragging and Alibis.''
  Mr. Speaker, because of the hearings we had in this Congress and in 
the last Congress, we have before us today a bipartisan piece of 
legislation that is a giant step in the right direction toward bringing 
the FDA into the 20th and 21st century.
  I want to thank Speaker Gingrich for making this a priority. I want 
to thank the gentleman from Virginia [Mr. Bliley], chairman of the full 
committee; the gentleman from Michigan [Mr. Dingell], the ranking 
member; the gentleman from Pennsylvania [Mr. Klink], my colleague and 
ranking member; the gentleman from Florida [Mr. Bilirakis]; Donna 
Shalala; and President Clinton for making this day a possibility.
  On the medical device section of the bill, that is the section of the 
bill that the gentlewoman from California [Ms. Eshoo] and I have worked 
so long and hard on, we have a number of improvements. We have a system 
of third party review for class I and most class II medical devices. We 
have a system for expedited approval and reporting requirements for 
devices that have already been approved overseas. We have a strong 
provision to protect the practice of medicine for the medical 
community. We have a requirement that they will establish a workable 
appeals process for arbitrating scientific disputes in the statute, and 
we reclassify all existing devices so that they are not automatically 
classified as class III when they come into the Agency.
  Mr. Speaker, we allow the manufacturers to announce in the 
promotional materials that their products have actually been FDA 
approved.
  There is one section of the bill that deals with the scope of review 
that I want to go into further detail on. This is the process that 
would allow a product to come to market as long as it is substantially 
equivalent to a product already on the market.
  In the original bill, there was a provision that would require the 
FDA to make a determination solely on the intend use of the label. Some 
members of the committee and the FDA felt that this would prohibit them 
from adequately reviewing the product. So in this package, we have a 
compromise that is a very carefully constructed provision that would 
allow the FDA to go beyond the label under certain conditions. They 
have to be exceptional, they have to be carefully controlled 
circumstances, and the FDA has admitted that this authority will be 
rarely used, and only in the most exceptional cases.
  We have a good bipartisan agreement between us. The FDA no longer 
stands for ``Foot Dragging and Alibis,'' it stands for ``Fair Deals for 
All.''
  Mr. Speaker, I hope that we will unanimously support this, and I want 
to thank my staff member Beth Hall and Bill Bates from the staff of the 
gentlewoman from California [Ms. Eshoo]. They have done exceptional 
work, along with the committee staffs on both sides of the aisle.
  Mr. DINGELL. Mr. Speaker, I yield 3 minutes to the gentleman from New 
Jersey [Mr. Pallone].

                              {time}  1115

  Mr. PALLONE. Mr. Speaker, the legislation before us has been the 
product of hard work, tough negotiations and true bipartisanship, and 
the result is a well crafted bill that will reauthorize the 
Prescription Drug User Fee Act and enact common sense Food and Drug 
Administration reform.
  I want to take the opportunity to congratulate the chairmen and the 
ranking members of both the full committee and the subcommittee, as 
well as the professional staff of the Committee on Commerce on both 
sides of the aisle, particularly Kay Holcombe, whom I work with the 
most, for a job well done.
  Mr. Speaker, this legislation will take the FDA into the 21st century 
by giving the FDA the tools to continue to do its job effectively while 
keeping pace with the new technological innovations and medical 
breakthroughs.
  I just wanted to mention, concerning the drug provisions, I am 
pleased with the inclusion of a bipartisan amendment which would 
provide for the notification of discontinuance when a company 
terminates a product the absence of which would cause severe harm to a 
patient. To allay industry concerns. We have included a ``good cause'' 
waiver that allows the FDA to waive the time requirement under certain 
circumstances.
  In addition, there are two amendments concerning mercury that were 
incorporated into the bill. One of the provisions requires the FDA to 
study the impact of a form of organic mercury in nasal sprays on the 
brain. It has already been banned for use on agricultural crops since 
1969 and has been considered a neurotoxin. And the second provision 
would examine the sale of mercury as a drug or for other home use.
  Mr. Speaker, with regard to medical devices, I want to congratulate 
the gentlewoman from California [Ms. Eshoo] and the gentleman from 
Texas [Mr. Barton] for their ability to find common ground with the FDA 
and industry on these issues. I believe that the third party review 
process has been worked out well. It will free up the FDA's limited 
resources to review and approve high-risk devices.
  Finally, Mr. Speaker, I am pleased that language was included to 
ensure that this legislation does not hinder the FDA's authority to 
reduce teen smoking. We already know that 3,000 kids start smoking each 
day, and that in my State of New Jersey alone over 130,000 children 
currently under 18 will die prematurely from tobacco-related diseases.
  Mr. Speaker, it is my expectation that this bill will pass with 
overwhelming support today, but along with its passing today we must 
work quickly in conference to report out a good bill that the President 
can sign into law. The longer we delay, the more risk we take in 
slowing the drug approval process.
  I have to say certainly that the suspension process today, which I 
never thought would happen, is a very good indication that every one 
involved is seeking to move quickly and that any differences with the 
Senate can be quickly overcome. I certainly urge all of my colleagues, 
not only Members of the committee but all of our colleagues, to 
register a strong statement of support by voting overwhelmingly for 
this legislation today.
  Mr. BLILEY. Mr. Speaker, I yield 1 minute to the gentleman from 
Michigan [Mr. Upton].
  Mr. UPTON. Mr. Speaker, I rise in strong support of H.R. 1411, the 
Food and Drug Administration Regulatory Modernization Act.
  Much has been said about the able leadership of our chairman, the 
gentleman from Virginia [Mr. Bliley], the gentleman from Texas [Mr. 
Barton], the gentleman from Florida [Mr. Bilirakis], and our friends on 
the other side of the aisle, the gentleman from Michigan [Mr. Dingell], 
the gentlewoman from California [Ms. Eshoo], and the gentleman from 
Ohio [Mr. Brown].
  I would also like to comment on our terrific staff on both sides of 
the aisle. Howard Cohen, Eric Berger and Jane Williams on my staff 
spent countless hours walking Members through the myriad of different 
amendments and travails. It was terrific to see us come together in a 
great moment of bipartisan harmony and pass this legislation out of our 
full committee 43 to nothing.
  This legislation embodies several basic goals that I believe all of 
us, patients and consumers, health professionals and drug device and 
food industries, and the Congress, all share. We want to ensure that 
patients and consumers continue to enjoy the benefits of innovations in 
treatments and technologies that bring us lifesaving and enhancing 
drugs and medical devices, with a safe, abundant healthful, affordable 
food supply.
  Mr. DINGELL. Mr. Speaker, I yield 1 minute to the gentleman from 
Texas [Mr. Green].

[[Page H8479]]

  (Mr. GREEN asked and was given permission to revise and extend his 
remarks.)
  Mr. GREEN. Mr. Speaker, this morning we are considering a bill that I 
never believed would be debated under suspension rules. In fact, I 
thought my chances of winning the lottery in Texas were much better 
than the FDA reform bill being on the suspension calendar.
  This bill has had a long and contentious history on the Committee on 
Commerce. It was not always clear that a compromise bill could be 
reached. This bill is a step forward for reform. I believe both sides 
of the aisle should support it, and we have heard this morning they do.
  One of the areas that caused the most concern for me was the approval 
process for medical devices, particularly third party review. I am 
pleased that the gentlewoman from California [Ms. Eshoo] and the 
gentleman from Texas [Mr. Barton] have come together and worked out a 
compromise that would utilize the expertise of outside reviewers, 
prevent conflicts of interest, and involve the FDA in the certification 
of reviewers. Even with the use of outside reviewers, the bill still 
gives the FDA discretion to accept or deny the recommendations of 
outside reviewers.
  This reform, combined with other portions of the bill, will help 
medical device companies know what is required of them during the FDA 
review, and gives them a sense of certainty that their application will 
be handled within a certain period of time. At the same time, it 
recognizes the FDA's role at the center of the medical device and drug 
review process and reassures the American people they will be 
accountable for the safety and efficacy of drugs and devices.
  Mr. BLILEY. Mr. Speaker, I yield such time as he may consume to the 
gentleman from Florida [Mr. Foley].
  (Mr. FOLEY asked and was given permission to revise and extend his 
remarks.)
  Mr. FOLEY. Mr. Speaker, I rise in support of the bill, and will 
include concerns which were not addressed in the bill which would allow 
the FDA and EPA to ban products used by asthmatics that are medically 
necessary.
  Mr. BLILEY. Mr. Speaker, I yield 1 minute to a member of the 
committee, the gentleman from Iowa [Mr. Ganske].
  Mr. GANSKE. Mr. Speaker, I rise in strong support of H.R. 1411.
  E. coli bacteria results in between 10,000 and 20,000 illnesses a 
year. While proper cooking can kill E. coli, it deprives us of 
something that many of us really like, a nice juicy rare hamburger. 
Pasteurizing red meat with low-dose irradiation kills bacteria without 
harming the food. The process has already been approved by FDA for 
spices, poultry, pork. Why not hamburger?
  For more than 3 years the Food and Drug Administration has been 
sitting on a petition to allow the use of low-dose irradiation for red 
meat. It is time that they passed. H.R. 1411 includes an amendment I 
offered to make the FDA complete its review within 60 days. Mr. 
Speaker, we need to have safer meat. Low-dose irradiation would provide 
that. A vote for this bill will make all of us a hamburger helper.
  Mr. DINGELL. Mr. Speaker, I yield myself 1 minute for the purposes of 
a colloquy, and I yield to the distinguished gentleman from Rhode 
Island [Mr. Kennedy].
  Mr. KENNEDY of Rhode Island. Mr. Speaker, I would like to thank my 
colleague from Michigan for yielding to me.
  Thirty million Americans rely on CFC propelled metered-dose inhalers. 
These are the inhalers for asthmatics. Over 30 million Americans rely 
on them. Yet in March 1997, the FDA proposed a policy that would ban 
these metered-dose inhalers for asthmatics all across the country, 
while the FDA did not take into account what alternatives would be 
available to millions of children in this country.
  I want to thank the ranking member of the committee and the chairman 
for recognizing the need to modify this FDA policy, and look forward to 
working with them to see that appropriate amendments are made to the 
FDA law so that metered-dose inhalers are not banned for children in 
this country.
  Mr. DINGELL. Mr. Speaker, the committee considered this matter. We 
regard it as important and we will pursue it further.
  Mr. BLILEY. Mr. Speaker, I reserve the balance of my time to close.
  Mr. DINGELL. Mr. Speaker, I yield 2 minutes to the gentleman from 
Florida [Mr. Deutsch].
  Mr. DEUTSCH. Mr. Speaker, this is what this process is supposed to be 
about, making legislation to make the people's lives in the United 
States a little bit better. I believe very strongly that that is what 
this legislation will do.
  I think just for a second though we should remind ourselves that this 
was not an easy process and it was a long process. I think the work in 
particular of the gentleman from Michigan [Mr. Dingell] and other 
leadership on the Democratic side and the Democratic Members really 
have brought us toward this point in time. Just 12 months ago, 24 
months ago, the FDA legislation that was in front of us was a much more 
radical, in fact, a radical and really threatening piece of legislation 
to the American people.
  In terms of the prescription drug area, we have made some dramatic 
strides. I believe there is still one area in the conference committee, 
I know that the Members, the gentleman from North Carolina [Mr. Burr] 
in particular, as well as the gentleman from Florida [Mr. Bilirakis], 
will be working on. That is the issue of exclusivity for new antibiotic 
drugs. The bill limits exclusivity to new antibiotics and that 
exclusivity would not apply to any drug for which an NDA is already 
pending. I am also pleased that we have a commitment to continue 
working on eliminating exclusivity to antibiotics in which there is not 
a pending I, which is the final stage of clinical investigation.
  This Congress has made very significant strides in promoting the use 
of generic drugs in the United States of America as a cost containment 
and a health issue for all Americans. In an attempt to both balance the 
need for innovation in terms of resistant strain antibiotics, while at 
the same time balancing the need for generics and the purpose for 
generics that this Congress has stated very strongly on many occasions 
over the last years, I think it is important that any additional 
exclusivity that we grant in terms of antibiotics, which would be the 
first time that there would be exclusivity for antibiotic drugs, that 
it be limited in scope very narrowly to the challenge that we face in 
terms of resistant strains. I know we have made some moves in that 
direction, and hopefully as we enter the conference report we can 
continue that as much as possible within the specifics.
  Mr. DINGELL. Mr. Speaker, I yield myself 1 minute for purposes of 
closure.
  I simply want to read the language of the administration on this. It 
says:

       The administration applauds the House for its efforts to 
     produce a bipartisan FDA reform bill and appreciates the 
     responsiveness to concerns that have been raised. Because of 
     the importance of obtaining a 5-year extension of the 
     Prescription Drug User Fee Act, [PDUFA], the administration 
     has no objection to the House passage of H.R. 1411.

  I urge my colleagues to recognize that this is a compromise. This is 
a good compromise. It represents a bill which makes progress, which 
serves the public interest, which helps the manufacturers but which 
also protects the consumer with exquisite care. It is an excellent 
bill. I urge my colleagues to vote for it.
  Mr. BLILEY. Mr. Speaker, I would like to say, it has been said before 
in the debate but I want to thank the staff, particularly Howard Cohen, 
Eric Berger, Roger Carey, and Alan Hill and Kay Holcombe.
  With that, Mr. Speaker, I yield the balance of my time to the 
gentleman from Wisconsin [Mr. Klug].
  Mr. KLUG. Mr. Speaker, I thank the gentleman. I have watched a number 
of young friends in my district grow a head taller as we have worked on 
this bill for the past 3 years. And while they have outgrown last 
year's school clothes, unfortunately they cannot outgrow their 
diseases. Amber still has juvenile diabetes. Cody still has epilepsy. 
And Kristin still has asthma. Today's bill will go a long way toward 
easing their suffering by setting up special testing for new drugs 
aimed at children and expediting new uses for drugs also aimed at 
treating children's diseases.
  This bill is going to go a long way towards easing the suffering of 
millions

[[Page H8480]]

of Americans across this country and obviously not just children. But 
most importantly, I think that this legislation will go a long way 
toward changing the culture at the Food and Drug Administration. It is 
a move away from scare tactics and toward sounds science on food 
policy, away from red-tape and toward sound science and speedy approval 
on new medical devices. Perhaps most importantly, it is a move away 
from bureaucracy, and finally toward compassion.
  Congratulations to my colleagues who have worked on this bill for so 
long and so hard for the past 3 years, the gentleman from Virginia [Mr. 
Bliley] and the gentleman from Michigan [Mr. Dingell], the gentleman 
from Florida [Mr. Bilirakis] and the gentleman from California [Mr. 
Waxman], the gentleman from Texas [Mr. Barton], the gentleman from 
North Carolina [Mr. Burr], and the gentleman from Pennsylvania [Mr. 
Greenwood]. Our fight has gone back a long way, back to the early days 
of 1994.
  And thanks to the professional staff on both sides who have worked so 
hard for the last 3 years as well. But most of all, congratulations to 
my three young friends. For Cody and Amber and Kristin and millions of 
Americans suffering from diseases across the country, this bill is for 
them.
  Mr. SMITH of New Jersey. Mr. Speaker, I am pleased that today the 
House has finally taken long-overdue action to reauthorize the 
Prescription Drug User Fee Act (H.R. 1411).
  In 1992, Congress enacted the Prescription Drug User Fee Act (P.L. 
102-571) to authorize the Food and Drug Administration [FDA] to collect 
user fees from pharmaceutical companies to pay for more timely reviews 
of new, breakthrough drugs. It has been estimated that over $300 
million in user fees have been collected under Public Law 102-571 to 
help finance safety and efficacy trials at the FDA. All of these user 
fees have been returned directly to the FDA, which used the money to 
expand its staff and cut review times for new drugs, thereby ensuring 
that patients ultimately benefit from the program.
  H.R. 1411 also institutes a number of important reforms to the FDA to 
reduce drug review times and provide more information to patients and 
physicians in a timely manner. The net effect of this legislation will 
be to save and improve the lives of sick and injured persons across our 
nation.
  But despite these much needed reforms to the FDA, there is much work 
that remains to be done. Specifically, I am concerned, like many 
Americans, about the FDA's plans to accelerate the elimination of 
metered dose inhalers [MDI's] that contain chlorofluorocarbons [CFC's].
  As many of you know, on March 6, 1997, the FDA proposed a plan to 
phase-out the use of CFC's and MDI's, which are used by asthma and 
cystic fibrosis patients to breathe.
  While I agree it is important to institute a transition strategy that 
will eventually eliminate CFC use, the advance notice of proposed 
rulemaking [ANPR] published by FDA on March 6 is deeply flawed and 
should be scrapped in favor of a plan that put patients--not 
international bureaucrats--first.
  And it is Congress which must ensure that the interests of patients 
are in fact upheld throughout the formation of our country's MDI 
transition strategy. To that end, my colleague and friend from Florida, 
Mr. Cliff Stearns, and I have introduced legislation, H.R. 2221, that 
will temporarily suspend the FDA's ANPR until a new proposal can be 
crafted. It is our intention to offer our legislation as an amendment 
to H.R. 1411 had we been afforded an opportunity to do so.
  Mr. Speaker, our legislation is necessary because the FDA's plan has 
numerous problems, including the fact that under the plan patients will 
have significantly fewer choices in asthma medications, which will 
leave some patients deprived of the medicines that need to breathe.
  Specifically, FDA has classified most MDI-delivered respiratory 
medications into two therapeutic classes. One therapeutic class has 
five moieties, or drug types which are delivered to the lungs by the 
MDI, and other has seven moieties. A moiety refers to the drug's active 
ingredient, and for each moiety there are usually multiple generic 
versions produced and marketed.
  According to the FDA proposal once two moieties are available in a 
non-CFC MDI form, all other drugs, including generics, in that 
therapeutic class will be banned. Thus, if you are a patient that 
relies on a moiety that is banned by the FDA policy, and the two non-
CFC MDI's that remain on the market are unsatisfactory or unusable, 
your very life could be placed at risk.
  As Congress continues to assess and debate the best way to craft a 
CFC transition strategy for metered dose inhalers, I would like to 
highlight the case of Tommy Farese, a 9-year-old boy from Spring Lake, 
NJ, who wrote to the FDA in April to oppose their plan. Tommy told the 
FDA that as someone who depends on Intal, Vanceril, and Provental every 
day to breathe, he does not want these medications taken away from him.
  Under the FDA plan, the entire therapeutic class of drugs Tommy--and 
other like him--use to survive could be banned when two different non-
CFC MDI moieties are marketed. However, if the first two non-CFC MDIs 
approved by FDA in a therapeutic class do not include the moieties for 
Intal and Vanceril, Tommy would lose access to the drugs he needs to 
physically breathe. Mr. Speaker, as the father of two daughters with 
asthma, I find any plan that could lead to such an outcome completely 
unacceptable.
  Not surprisingly, the FDA's plan has generated a firestorm of 
opposition from patients, respiratory therapists, and physicians: 
nearly 10,000 letters in opposition have been received to date by the 
FDA. Those expressing their concerns about the FDA plan include: Dr. C. 
Everett Koop, Mothers of Asthmatics, the Joint Council of Allergy, 
Asthma and Immunology [JCAAI], the Cystic Fibrosis Foundation, the 
American Medical Association, and the American Association of 
Respiratory Therapists.
  In my view, any plan to remove safe and effective medications from 
the marketplace needs to place the interests of children like Tommy 
Farese first and foremost. Sadly, the FDA plans fails in this regard. 
Indeed, the FDA plan presumes that CFC-free inhalers serve all patient 
subpopulations--such as children and the elderly--equally well, despite 
the fact that children have special needs. Therefore, I call upon all 
Members to support H.R. 2221 and stop the FDA from implementing this 
terribly flawed and environmentally marginal proposal.
  Mr. PAUL. Mr. Speaker, today, out of nowhere, comes the stealth 
Prescription Drug User Fee Re-authorization and Drug Regulatory 
Modernization Act of 1997. Regrettably, but unlike certain militarily 
procured aircraft, a little rain will not make this bill disintegrate.
  According to its proponents, this FDA-strengthening bill was more 
than 3 years in the making--a so-called compromise between industry and 
the administration, we are told. Yet, despite the 177 pages attempting 
to reform an administrative agency and its rulemaking direction, the 
leadership did not see fit to announce floor consideration of this bill 
in the Weekly Whip Notice, yesterday's Shipping Post's ``Tuesday's 
Forecast'' section or any other commonly accepted medium as near as I 
can discern. More curiously, in my attempts to draw some attention to 
the broadsweeping nature of the bill on the House floor and the process 
by which it had come up for consideration, I am told by the bill's 
proponents that ``there is no time available to speak regarding the 
bill.'' Instead, C-SPAN viewers will be treated to a love-in during 
which each of the bill's drafters and advocates commend one another for 
the fine job of corporatism and internationalism they are about to 
bestow upon the American citizenry and in such a critical aspect of 
their lives; that is, their health.
  When a 177-page bill comes to the floor under suspension with 
practically nothing more than an hours notice, one must always question 
what freedom-depriving regulation is about to be forced upon the 
citizens. Below is a sneak preview of the latest regulatory loss of 
individual liberty and State sovereignty.
  So-called harmonization language contained in the bill requires the 
Secretary, through bilateral and multilateral agreements, to 
``harmonize regulation * * * and seek appropriate reciprocal 
arrangements'' with foreign regulatory agencies. Vocal opponents of 
this harmonization language convincingly argue this internationalizing 
of what is already an unconstitutional usurpation of States rights, is 
very likely to greatly limit the availability of food supplements by 
requiring prescriptions for dispensation as is the case in certain 
parts of Europe. Perhaps with such harmonization, we will not only have 
a Federal war on drugs, but a Federal war on riboflavin, folic acid, 
and bee pollen. At last, an American alfalfa czar.
  Food supplement availability may be the least of concerns amongst 
those who still revere states' rights and acknowledge the continued 
existence of the tenth amendment. Section 28 of H.R. 1411, as available 
on the Internet, entitled ``National Uniformity,'' ``prohibits states 
and subdivisions from regulating food, drugs, or cosmetics * * *'' The 
bill permits the FDA to set national standards for cosmetics but 
permits States to issue warning labels and take defective products off 
the shelves.
  To the dismay of medical privacy advocates, the bill authorizes the 
FDA to mandate the tracking of medical patients who use certain medical 
devices for up to 36 months as well as conduct post-market surveillance 
of these patients.
  The bill limits the speech of manufacturers who would claim health 
benefits on their product labels without the approval of a scientific

[[Page H8481]]

agency of the Federal Government. The bill responsibly makes provisions 
for such Scientific Advisory Panels in section 6. According to the 
bill, these panels are to be made up of ``persons who are qualified by 
training and experience * * * and who, to the extent feasible, possess 
skill in the use of, or experience in, the development, manufacture, or 
utilization of * * * drugs or biological products.'' Here we have yet 
another chapter in the book of corporatism detailing the means by which 
one politically connected private concern gains a competitive advantage 
or Government privilege at the expense of some less-politically-
connected entity or the consumer via some Federal Government, 
regulatory framework.
  A bill effecting a major reformation of the Food and Drug 
Administration with such serious implications for individual liberties 
and for States' ability to effectuate their constitutionally-ordained 
police powers, warrants something more than the ``stealth'' procedure 
by which this regulatory ``bomb'' has been brought to the house floor. 
This bill apparently will be passed without a real opportunity for 
responsible debate or even a recorded vote. At a minimum, an 
opportunity to speak or inquire regarding the bill's provisions on the 
house floor and/or the opportunity to amend the bill to improve or 
remove offensive language, should have been provided within the 
legislative process. Unfortunately, this was not the case. For these 
reasons, I oppose H.R. 1411.
  Mr. TOWNS. Mr. Speaker, I join my colleagues in applauding the 
scheduling of this measure today. H.R. 1411, the Prescription Drug User 
Fee Reauthorization and Drug Regulatory Modernization Act of 1997 is 
the culmination of 2 years of hard work by the Commerce Committee to 
modernize procedures that the Food and Drug Administration uses to 
approve drugs, devices, and food products.
  Without the modernizing steps that have been incorporated in this 
legislation today, the FDA would continue to be seen as a barrier to 
new innovative therapies and products. The bill before us today 
represents a careful balance between a new, streamlined process and 
consumer protections against harmful products. These innovations in the 
way the FDA will do business from now on makes the approval of drugs 
and devices a more predictable process. This legislation will also 
provide patients with greater access to information about new 
investigational treatments. Additionally, we established reasonable 
national uniformity standards for OTC drugs and cosmetics. These 
standards offer a excellent beginning for future discussions about 
national uniformity for food products, discussions which I hope will 
begin next year with hearings on this issue.
  Finally, Mr. Chairman, I am most pleased about the provisions in this 
bill which relate to food products. I had the wonderful experience of 
working closely on these issues in a bipartisan fashion with the 
gentleman from Kentucky [Mr. Whitfield], the gentleman from Wisconsin 
[Mr. Klug], and the gentleman, from Texas [Mr. Hall]. While some argued 
that food reforms were too controversial to include in this bill, my 
colleagues and I never stopped believing that we could craft reasonable 
and meaningful food reforms that would be acceptable to the industry, 
FDA, and consumers alike. With the able assistance of our committee 
counsels on both sides of the aisle, Eric Berger and Kay Holcomb, the 
measures you see before today accomplished this goal. The food issues 
in this bill build on the success of the Nutrition Labeling and 
Education Act and they represent a modest downpayment on more 
significant food law reforms. The bill promises to provide important 
public health benefits to consumers by enabling FDA to act quickly on 
petitions for new health and nutrient content claims and by removing 
impediments to critical food technologies like irradiation.
  I join my colleagues from the Commerce Committee in urging the 
immediate passage of this legislation.
  Mr. FRELINGHUYSEN. Mr. Speaker, I rise today in support of H.R. 1411, 
a package of three bills reforming the Food and Drug Administration.
  Clearly, the modernization and streamlining of the FDA are important 
goals which have commanded considerable thought, time, and energy from 
Members of Congress, the Agency, and other interested parties. I am 
pleased that we are acting today on this important legislation, and I 
look forward to swift passage and enactment.
  Mr. Speaker, I come from New Jersey. And I am proud to say that my 
home State is considered the Nation's medicine chest. New Jersey is 
home to some of the world's most innovative pharmaceutical companies, 
including Johnson & Johnson, Merck, American Home Products, Schering 
Plough, Warner-Lambert, Novartis, Hoffman-La Roche, and Bristol-Myers 
Squibb, just to name some of them. More than 40,000 pharmaceutical 
company employees are working in my State, leading the way in 
discovering, researching, developing, and marketing life-saving new 
drugs. I am proud to represent these individuals and businesses.
  While the bill will benefit these individuals, by reauthorizing the 
Prescription Drug User Fee Act [PDUFA] and streamlining and modernizing 
the Agency, I am supporting H.R. 1411 today because it benefits a 
larger group: America's patients. All Americans who are in desperate 
need of new therapies for Alzheimer's, Parkinson's disease, cancer, 
AIDS, and all other maladies for which no adequate drug treatment 
exists today. Furthermore, our work benefits the world in every country 
where there is sickness and suffering.
  There is so much in this bipartisan bill that is designed to help 
patients. There is the reauthorization of PDUFA, the enactment of which 
has meant more to expediting approval of life-saving new therapies than 
anything else. Last year, the FDA approved 53 new drugs and 9 new 
biologics. Since enactment of PDUFA, FDA has approved more than 125 new 
molecular entities--totally new medicines--all of which have brought 
relief and benefit to patients.
  H.R. 1411 also provides for expedited approval of life-saving new 
medicines and access to unapproved therapies for the most critically 
ill among us. The bill allows manufacturers to disseminate information 
about unapproved uses of approved drugs, while ensuring that the 
information is balanced and encourages additional research on already-
approved products.
  The package also facilitates the development, clearance, and use of 
devices to maintain and improve public health and quality of life.
  Finally, H.R. 1411 maintains the Agency's high standards of efficacy 
and consumer safety.
  Mr. Speaker, when we enact this legislation, we will be giving the 
hope of better health and longer lives to millions of Americans and 
people around the world. That is good news for New Jersey and good news 
for America. I urge support of this legislation.
  Mr. STEARNS. Mr. Speaker, I rise in support of H.R. 1411. First, I 
would like to thank Chairman Bliley and Chairman Bilirakis and the 
staff for getting us to this point. It has been a long and at times 
very difficult process and you are to be commended for your leadership.
  I would also like to give special thanks to my colleagues, 
Representatives Richard Burr, Joe Barton, and Ed Whitfield for all 
their hard work on these three bills.
  Legislative proposals to reform the FDA to speed up the approval 
process for new drugs and medical devices and to improve the regulation 
and labeling of food is long overdue. Today's vote is historic and I am 
pleased to see that we have finally gotten to this point.
  The problems associated with FDA's regulation of products and related 
issues are already known in the biomedical industry. Several key issues 
are: how regulation affects patient access to new drugs, how it impedes 
new drugs and biotechnology products from being brought to market, and 
how regulatory delays are forcing drug and medical device companies 
overseas.
  If we are to continue to compete in this global economy, we must 
streamline the current FDA approval process. Because European review of 
new medical technologies is more efficient and timely than the FDA, 
these companies are increasingly moving out of the United States. 
Start-up biotech companies, also unable to meet the capital demands due 
to the lengthy and uncertain FDA process, have lost thousands of jobs 
through both direct exports and opportunity costs.
  While our position has slipped in recent years, the United States is 
still the world's leader in the development and production of medical 
technology. However, the sad fact is that the United States is 
beginning to lose ground in health technology to foreign competitors. 
Unless we provide relief for this industry and curb FDA's burdensome 
over regulation and countless delays in the approval process, we will 
continue to see a steady erosion in an industry in which we have always 
been recognized as a world leader.
  It is very gratifying to be a part of this process and I want to 
applaud the Commerce Committee's desire to make these necessary changes 
contained in the legislation before us today. We have an opportunity to 
reverse the trends which have our companies going outside the United 
States to conduct initial development of new products. When this 
occurs, not only do we lose jobs, but we also lose U.S.-produced 
technologies.
  One question that we might ask is: What are we doing in comparison to 
the rest of the world. For instance, it might be useful to have a list 
of these products and whether they have been approved in tier one 
countries and for how long. Perhaps there should be some type of annual 
report that provides us with that type of data. If the FDA objects to 
this, I think it might be advisable to ask what we can do to make sure 
that the FDA makes such information available in the future.

[[Page H8482]]

  While I wholeheartedly support H.R. 1411, I want to call my 
colleagues attention to an issue I believe is of tremendous importance 
and that needs to be addressed.
  On March 6, 1997, the FDA issued an advance notice of proposed 
rulemaking [ANPR] that set forth its plan to ban CFC-containing 
metered-dose inhalers once certain criteria are met. The plan was 
developed in collaboration with the Environmental Protection Agency 
[EPA] and is intended to eliminate the minuscule amount of CFC's 
currently allowed to be used for medications delivered by metered-dose 
inhalers.
  We need to protect the health and well-being of the millions of 
Americans that use chlorofluorocarbon-containing metered-dose inhalers 
to treat their respiratory conditions. My colleague, Christopher Smith, 
and I introduced H.R. 2221. This bill will require the Secretary of 
Health and Human Services to take no further action on FDA's proposed 
ban on chlorofluorocarbon [CFC]-containing metered-dose inhalers.
  During the full committee markup of PDUFA, I offered an amendment to 
rectify a serious issue that has arisen due to actions taken by the 
FDA. Because I did not want to impede the process, I withdrew my 
amendment. However, I do intend to pursue this issue until I am 
satisfied that all patients who rely on such life saving drugs will not 
be denied their rights to such medications.
  Again, I want to reiterate my support for H.R. 1411 and look forward 
to its final passage.
  Mr. RAMSTAD. Mr. Speaker, I rise in support of the package of Food 
and Drug Administration [FDA] reform bills before us today.
  I support this entire package, but I would like to specifically talk 
about title II of this bill, which addresses medical devices.
  Reforming FDA's approval process for medical devices is something I 
have worked on since I first come to Congress in 1991. I have long 
argued we can save lives, health care dollars, and jobs by creating a 
more hospitable climate for our biotechnology, pharmaceutical, food, 
and medical device industries.
  That's why, in November 1993, former Rep. Tim Valentine--D-NC--and I 
founded the bipartisan House Medical Technology Caucus to educate our 
colleagues on the issues facing the medical technology sector, 
including the FDA approval process.
  As a cosponsor of H.R. 1710, the base language for title II, I know 
the legislation to expedite review of medical devices will go a long 
way toward bringing medical devices to market faster, thereby saving 
lives and creating jobs in this country. With intelligent coordination 
of regulatory strategies consistent with good science and good 
manufacturing practices, we can move needed drugs and medical devices 
to consumers in less time without increasing risk.
  The FDA must review products and procedures promptly and effectively, 
since one of the most important ways to help individuals in need of 
lifesaving products and procedures is to make sure these products are 
made accessible as soon as possible without compromising safety.
  It now takes 15 years and $350 million to get the average new drug 
from the laboratory to the patient. The average time for the FDA to 
approve a medical device has increased from 415 days in 1990 to 773 in 
1995--even through the FDA is currently required by law to taken no 
longer than 180 days to approve new devices. In addition, the majority 
of all new drugs approved by the FDA in the last 5 years were already 
in use overseas.
  The package of FDA reform legislation will improve the approval 
process for medical devices, drugs, and biological products without 
reducing the level of protection for safety or effectiveness.
  I urge my colleagues to support this bill today. The patients in our 
country who have been denied access to lifesaving drugs and devices 
deserve nothing less.
  Mr. SHAYS. Mr. Speaker, I rise in support of H.R. 1411, the Food and 
Drug Administration Regulatory Modernization Act of 1997. I commend the 
committee for bringing this bipartisan bill to the full House for 
consideration.
  Since I became chairman of the Government Reform and Oversight 
Committee's Subcommittee on Human Resources, we have held 14 oversight 
hearings on the Food and Drug Administration [FDA]. In the course of 
oversight hearings on medical device regulatory standards, food safety, 
the food additive petition review process, and the safety of the 
Nation's blood supply, we found the agency needs to be modernized and 
streamlined. This bill makes progress toward these goals, while 
protecting the public health.
  I am particularly pleased the compromise struck by the committee 
provides greater clarity to the medical device approval process by 
ensuring that FDA's review will be based on the intended use cited on 
the proposed label submitted by the manufacturer. As an added 
safeguard, FDA will have procedures to require the manufacturer to 
place a warning on the label if the agency believes the device will be 
used for conditions other tan those listed on the label.
  Enactment of this legislation will result in lifesaving therapies 
reaching patients in a more timely fashion. I commend the Commerce 
Committee for its fair and deliberate approach to meaningful FDA 
reform.
  Mr. FRELINGHUYSEN. Mr. Speaker, I rise to day in support of H.R. 
1411, legislation which includes three important reforms and commend 
Chairman Bliley and his Commerce Committee for all their hard work on 
this bill.
  First, the bill will reauthorize the Prescription Drug User Fee Act, 
a user fee that has been tremendously effective in expediting the FDA 
drug approval process. That reauthorization is absolutely critical.
  Second, H.R. 1411 streamlines and vastly improves the FDA drug 
approval process, clearing the way for lifesaving new drugs to reach 
individuals in need of them.
  Finally, the package facilitates the development, clearance, and use 
of devices to maintain public health and improve the quality of life 
for many Americans and so many people around the world that are sick 
and suffering.
  This legislation is certainly a priority for the State of New Jersey, 
which is home to many of the most innovative pharmaceutical companies 
and more than 40,000 employees, that have led the way in research, 
development, and marketing of lifesaving new drugs throughout the 
world.
  However, New Jersey is also home to even more individuals that are in 
desperate need of new therapies for Alzheimer's, Parkinson's disease, 
cancer, AIDS and other diseases, for which no adequate drug treatment 
exists today.
  I am pleased that the legislation also maintains and strengthens 
protection for consumers under the Food and Drug Administration 
Director.
  I would like to commend the Commerce Committee for their hard work on 
this bill and urge support for H.R. 1411.
  The SPEAKER pro tempore (Mr. Quinn). The question is on the motion 
offered by the gentleman from Virginia [Mr. Bliley] that the House 
suspend the rules and pass the bill, H.R. 1411, as amended.
  The question was taken; and (two-thirds having voted in favor 
thereof) the rules were suspended and the bill, as amended, was passed.

                              {time}  1130

  The title of the bill was amended so as to read: ``A bill to amend 
the Federal Food, Drug, and Cosmetic Act to improve the regulation of 
food, drugs, cosmetics, and devices, and for other purposes.''.
  A motion to reconsider was laid on the table.
  Mr. BLILEY. Mr. Speaker, I ask unanimous consent to take from the 
Speaker's table the Senate bill (S. 830) to amend the Federal Food, 
Drug, and Cosmetic Act and the Public Health Service Act to improve the 
regulation of food, drugs, devices, and biological products, and for 
other purposes, and ask for its immediate consideration in the House.
  The Clerk read the title of the Senate bill.
  The SPEAKER pro tempore (Mr. Quinn). Is there objection to the 
request of the gentleman from Virginia?
  There was no objection.
  The Clerk read the Senate bill as follows:

                                 S. 830

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Food and Drug Administration 
     Modernization and Accountability Act of 1997''.

     SEC. 2. TABLE OF CONTENTS.

       The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References.

                   TITLE I--IMPROVING PATIENT ACCESS

Sec. 101. Mission of the Food and Drug Administration.
Sec. 102. Expanded access to investigational therapies.
Sec. 103. Expanded humanitarian use of devices.

         TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES

Sec. 201. Interagency collaboration.
Sec. 202. Sense of the committee regarding mutual recognition 
              agreements and global harmonization efforts.
Sec. 203. Contracts for expert review.
Sec. 204. Accredited-party reviews.
Sec. 205. Device performance standards.

          TITLE III--IMPROVING COLLABORATION AND COMMUNICATION

Sec. 301. Collaborative determinations of device data requirements.
Sec. 302. Collaborative review process.

[[Page H8483]]

           TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES

Sec. 401. Policy statements.
Sec. 402. Product classification.
Sec. 403. Use of data relating to premarket approval.
Sec. 404. Consideration of labeling claims for product review.
Sec. 405. Certainty of review timeframes.
Sec. 406. Limitations on initial classification determinations.
Sec. 407. Clarification with respect to a general use and specific use 
              of a device.
Sec. 408. Clarification of the number of required clinical 
              investigations for approval.
Sec. 409. Prohibited acts.

                   TITLE V--IMPROVING ACCOUNTABILITY

Sec. 501. Agency plan for statutory compliance and annual report.

     TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES

Sec. 601. Minor modifications.
Sec. 602. Environmental impact review.
Sec. 603. Exemption of certain classes of devices from premarket 
              notification requirement.
Sec. 604. Evaluation of automatic class III designation.
Sec. 605. Secretary's discretion to track devices.
Sec. 606. Secretary's discretion to conduct postmarket surveillance.
Sec. 607. Reporting.
Sec. 608. Pilot and small-scale manufacture.
Sec. 609. Requirements for radiopharmaceuticals.
Sec. 610. Modernization of regulation of biological products.
Sec. 611. Approval of supplemental applications for approved products.
Sec. 612. Health care economic information.
Sec. 613. Expediting study and approval of fast track drugs.
Sec. 614. Manufacturing changes for drugs and biologics.
Sec. 615. Data requirements for drugs and biologics.
Sec. 616. Food contact substances.
Sec. 617. Health claims for food products.
Sec. 618. Pediatric studies marketing exclusivity.
Sec. 619. Positron emission tomography.
Sec. 620. Disclosure.
Sec. 621. Referral statements relating to food nutrients.

                   TITLE VII--FEES RELATING TO DRUGS

Sec. 701. Short title.
Sec. 702. Findings.
Sec. 703. Definitions.
Sec. 704. Authority to assess and use drug fees.
Sec. 705. Annual reports.
Sec. 706. Effective date.
Sec. 707. Termination of effectiveness.

                       TITLE VIII--MISCELLANEOUS

Sec. 801. Registration of foreign establishments.
Sec. 802. Elimination of certain labeling requirements.
Sec. 803. Clarification of seizure authority.
Sec. 804. Intramural research training award program.
Sec. 805. Device samples.
Sec. 806. Interstate commerce.
Sec. 807. National uniformity for nonprescription drugs and cosmetics.
Sec. 808. Information program on clinical trials for serious or life-
              threatening diseases.
Sec. 809. Application of Federal law to the practice of pharmacy 
              compounding.
Sec. 810. Reports of postmarketing approval studies.
Sec. 811. Information exchange.
Sec. 812. Reauthorization of clinical pharmacology program.
Sec. 813. Monograph for sunburn products.
Sec. 814. Safety report disclaimers.

     SEC. 3. REFERENCES.

       Except as otherwise expressly provided, wherever in this 
     Act an amendment or repeal is expressed in terms of an 
     amendment to, or repeal of, a section or other provision, the 
     reference shall be considered to be made to a section or 
     other provision of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321 et seq.).
                   TITLE I--IMPROVING PATIENT ACCESS

     SEC. 101. MISSION OF THE FOOD AND DRUG ADMINISTRATION.

       Section 903 (21 U.S.C. 393) is amended--
       (1) by redesignating subsections (b) and (c) as subsections 
     (c) and (d), respectively; and
       (2) by inserting after subsection (a) the following:
       ``(b) Mission.--
       ``(1) In general.--The Secretary, acting through the 
     Commissioner, and in consultation, as determined appropriate 
     by the Secretary, with experts in science, medicine, and 
     public health, and in cooperation with consumers, users, 
     manufacturers, importers, packers, distributors, and 
     retailers of regulated products, shall protect the public 
     health by taking actions that help ensure that--
       ``(A) foods are safe, wholesome, sanitary, and properly 
     labeled;
       ``(B) human and veterinary drugs, including biologics, are 
     safe and effective;
       ``(C) there is reasonable assurance of safety and 
     effectiveness of devices intended for human use;
       ``(D) cosmetics are safe; and
       ``(E) public health and safety are protected from 
     electronic product radiation.
       ``(2) Special rules.--The Secretary, acting through the 
     Commissioner, shall promptly and efficiently review clinical 
     research and take appropriate action on the marketing of 
     regulated products in a manner that does not unduly impede 
     innovation or product availability. The Secretary, acting 
     through the Commissioner, shall participate with other 
     countries to reduce the burden of regulation, to harmonize 
     regulatory requirements, and to achieve appropriate 
     reciprocal arrangements with other countries.''.

     SEC. 102. 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 (including 
     investigational biological products), or investigational 
     devices, (as defined in regulations prescribed by the 
     Secretary) for the diagnosis, monitoring, or treatment of a 
     serious disease or condition in emergency situations.
       ``(b) Individual Patient Access to Investigational Products 
     Intended for Serious Diseases.--Any person, acting through a 
     physician licensed in accordance with State law, may request 
     from a manufacturer or distributor, and any manufacturer or 
     distributor may provide to such physician after compliance 
     with the provisions of this subsection, an investigational 
     drug (including an investigational biological product), or 
     investigational device, (as defined in regulations prescribed 
     by the Secretary) for the diagnosis, monitoring, or treatment 
     of a serious disease or condition if--
       ``(1) the licensed physician determines that the person has 
     no comparable or satisfactory alternative therapy available 
     to diagnose, monitor, or treat the disease or condition 
     involved, and that the risk to the person from the 
     investigational drug or investigational device 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 or investigational device in the 
     case described in paragraph (1);
       ``(3) the Secretary determines that provision of the 
     investigational drug or investigational device will not 
     interfere with the initiation, conduct, or completion of 
     clinical investigations to support marketing approval; and
       ``(4) the product sponsor, or clinical investigator, of the 
     investigational drug or investigational device submits to the 
     Secretary a clinical protocol consistent with the provisions 
     of section 505(i) or 520(g) and any regulations promulgated 
     under section 505(i) or 520(g) describing the use of 
     investigational drugs or investigational devices in a single 
     patient or a small group of patients.
       ``(c) Treatment INDs/IDEs.--Upon submission by a product 
     sponsor or a physician of a protocol intended to provide 
     widespread access to an investigational product for eligible 
     patients, the Secretary shall permit an investigational drug 
     (including an investigational biological product) or 
     investigational device to be made available for expanded 
     access under a treatment investigational new drug application 
     or investigational device exemption (as the terms are 
     described in regulations prescribed by the Secretary) if the 
     Secretary determines that--
       ``(1) under the treatment investigational new drug 
     application or investigational device exemption, the 
     investigational drug or investigational device is intended 
     for use in the diagnosis, monitoring, or treatment of a 
     serious or immediately life-threatening disease or condition;
       ``(2) there is no comparable or satisfactory alternative 
     therapy available to diagnose, monitor, or treat that stage 
     of disease or condition in the population of patients to 
     which the investigational drug or investigational device is 
     intended to be administered;
       ``(3)(A) the investigational drug or investigational device 
     is under investigation in a controlled clinical trial for the 
     use described in paragraph (1) under an effective 
     investigational new drug application or investigational 
     device exemption; and
       ``(B) all clinical trials necessary for approval of that 
     use of the investigational drug or investigational device 
     have been completed;
       ``(4) the sponsor of the controlled clinical trials is 
     actively pursuing marketing approval of the investigational 
     drug or investigational device for the use described in 
     paragraph (1) with due diligence;
       ``(5) the provision of the investigational drug or 
     investigational device will not interfere with the enrollment 
     of patients in ongoing clinical investigations under section 
     505(i) or 520(g);
       ``(6) in the case of serious diseases, there is sufficient 
     evidence of safety and effectiveness to support the use 
     described in paragraph (1); and
       ``(7) in the case of immediately life-threatening diseases, 
     the available scientific evidence, taken as a whole, provides 
     a reasonable basis to conclude that the product may be 
     effective for its intended use and would not expose patients 
     to an unreasonable and significant risk of illness or injury.


[[Page H8484]]


     A protocol submitted under this subsection shall be subject 
     to the provisions of section 505(i) or 520(g) and regulations 
     promulgated under section 505(i) or 520(g). The Secretary may 
     inform national, State, and local medical associations and 
     societies, voluntary health associations, and other 
     appropriate persons about the availability of an 
     investigational drug or investigational device under expanded 
     access protocols submitted under this subsection. The 
     information provided by the Secretary, in accordance with the 
     preceding sentence, shall be of the same type of information 
     that is required by section 402(j)(3).
       ``(d) Termination.--The Secretary may, at any time, with 
     respect to a person, manufacturer, or distributor described 
     in this section, terminate expanded access provided under 
     this section for an investigational drug (including an 
     investigational biological product) or investigational device 
     if the requirements under this section are no longer met.''.

     SEC. 103. EXPANDED HUMANITARIAN USE OF DEVICES.

       Section 520(m) (21 U.S.C. 360j(m)) is amended--
       (1) in paragraph (2), by adding at the end the following 
     flush sentences:

     ``The request shall be in the form of an application 
     submitted to the Secretary. Not later than 75 days after the 
     date of the receipt of the application, the Secretary shall 
     issue an order approving or denying the application.'';
       (2) in paragraph (4)--
       (A) in subparagraph (B), by inserting after ``(2)(A)'' the 
     following: ``, unless a physician determines that waiting for 
     such an approval from an institutional review committee will 
     cause harm or death to a patient, and makes a good faith 
     effort to obtain the approval, and does not receive a timely 
     response from an institutional review committee on the 
     request of the physician for approval to use the device for 
     such treatment or diagnosis''; and
       (B) by adding at the end the following flush sentences:

     ``In a case in which a physician described in subparagraph 
     (B) uses a device without an approval from an institutional 
     review committee, the physician shall, after the use of the 
     device, notify the chairperson of the institutional review 
     committee of such use. Such notification shall include the 
     identification of the patient involved, the date on which the 
     device was used, and the reason for the use.''; and
       (3) by striking paragraph (5) and inserting the following:
       ``(5) The Secretary may require a person granted an 
     exemption under paragraph (2) to demonstrate continued 
     compliance with the requirements of this subsection if the 
     Secretary believes such demonstration to be necessary to 
     protect the public health or if the Secretary has reason to 
     believe that the criteria for the exemption are no longer 
     met.''.
         TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES

     SEC. 201. INTERAGENCY COLLABORATION.

       Section 903(b) (21 U.S.C. 393(b)), as added by section 
     101(2), is amended by adding at the end the following:
       ``(3) Interagency collaboration.--The Secretary shall 
     implement programs and policies that will foster 
     collaboration between the Administration, the National 
     Institutes of Health, and other science-based Federal 
     agencies, to enhance the scientific and technical expertise 
     available to the Secretary in the conduct of the duties of 
     the Secretary with respect to the development, clinical 
     investigation, evaluation, and postmarket monitoring of 
     emerging medical therapies, including complementary 
     therapies, and advances in nutrition and food science.''.

     SEC. 202. SENSE OF THE COMMITTEE REGARDING MUTUAL RECOGNITION 
                   AGREEMENTS AND GLOBAL HARMONIZATION EFFORTS.

       It is the sense of the Committee on Labor and Human 
     Resources of the Senate that--
       (1) the Secretary of Health and Human Services should 
     support the Office of the United States Trade Representative, 
     in consultation with the Secretary of Commerce, in efforts to 
     move toward the acceptance of mutual recognition agreements 
     relating to the regulation of drugs, biological products, 
     devices, foods, food additives, and color additives, and the 
     regulation of good manufacturing practices, between the 
     European Union and the United States;
       (2) the Secretary of Health and Human Services should 
     regularly participate in meetings with representatives of 
     other foreign governments to discuss and reach agreement on 
     methods and approaches to harmonize regulatory requirements; 
     and
       (3) the Office of International Relations of the Department 
     of Health and Human Services (as established under section 
     803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     383)) should have the responsibility of ensuring that the 
     process of harmonizing international regulatory requirements 
     is continuous.

     SEC. 203. CONTRACTS FOR EXPERT REVIEW.

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

     ``SEC. 906. CONTRACTS FOR EXPERT REVIEW.

       ``(a) In General.--
       ``(1) Authority.--The Secretary may enter into a contract 
     with any organization or any individual (who is not an 
     employee of the Department) with expertise in a relevant 
     discipline, to review, evaluate, and make recommendations to 
     the Secretary on part or all of any application or submission 
     (including a petition, notification, and any other similar 
     form of request) made under this Act for the approval or 
     classification of an article or made under section 351(a) of 
     the Public Health Service Act (42 U.S.C. 262(a)) with respect 
     to a biological product. Any such contract shall be subject 
     to the requirements of section 708 relating to the 
     confidentiality of information.
       ``(2) Increased efficiency and expertise through 
     contracts.--The Secretary shall use the authority granted in 
     paragraph (1) whenever the Secretary determines that a 
     contract described in paragraph (1) will improve the 
     timeliness or quality of the review of an application or 
     submission described in paragraph (1), unless using such 
     authority would reduce the quality, or unduly increase the 
     cost, of such review. Such improvement may include providing 
     the Secretary increased scientific or technical expertise 
     that is necessary to review or evaluate new therapies and 
     technologies.
       ``(b) Review of Expert Review.--
       ``(1) In general.--Subject to paragraph (2), the official 
     of the Food and Drug Administration responsible for any 
     matter for which expert review is used pursuant to subsection 
     (a) shall review the recommendations of the organization or 
     individual who conducted the expert review and shall make a 
     final decision regarding the matter within 60 days after 
     receiving the recommendations.
       ``(2) Limitation.--A final decision under paragraph (1) 
     shall be made within the applicable prescribed time period 
     for review of the matter as set forth in this Act or in the 
     Public Health Service Act (42 U.S.C. 201 et seq.).
       ``(3) Authority of secretary.--Notwithstanding subsection 
     (a), the Secretary shall retain full authority to make 
     determinations with respect to the approval or disapproval of 
     an article under this Act, the approval or disapproval of a 
     biologics license with respect to a biological product under 
     section 351(a) of the Public Health Service Act, or the 
     classification of an article as a device under section 
     513(f)(1).''.

     SEC. 204. ACCREDITED-PARTY REVIEWS.

       (a) In General.--Subchapter A of chapter V (21 U.S.C. 351 
     et seq.) is amended by adding at the end the following:

     ``SEC. 523. ACCREDITED-PARTY PARTICIPATION.

       ``(a) Accreditation.--Not later than 1 year after the date 
     of enactment of this section, the Secretary shall accredit 
     entities or individuals who are not employees of the Federal 
     Government to review reports made to the Secretary under 
     section 510(k) for devices and make recommendations to the 
     Secretary regarding the initial classification of such 
     devices under section 513(f)(1), except that this paragraph 
     shall not apply to a report made to the Secretary under 
     section 510(k) for a device that is--
       ``(1) for a use in supporting or sustaining human life;
       ``(2) for implantation in the human body for more than 1 
     year; or
       ``(3) for a use that is of substantial importance in 
     preventing the impairment of human health.
       ``(b) Accreditation.--Within 180 days after the date of 
     enactment of this section, the Secretary shall adopt methods 
     of accreditation that ensure that entities or individuals who 
     conduct reviews and make recommendations under this section 
     are qualified, properly trained, knowledgeable about handling 
     confidential documents and information, and free of conflicts 
     of interest. The Secretary shall publish the methods of 
     accreditation in the Federal Register on the adoption of the 
     methods.
       ``(c) Withdrawal of Accreditation.--The Secretary may 
     suspend or withdraw the accreditation of any entity or 
     individual accredited under this section, after providing 
     notice and an opportunity for an informal hearing, if such 
     entity or individual acts in a manner that is substantially 
     not in compliance with the requirements established by the 
     Secretary under subsection (b), including the failure to 
     avoid conflicts of interest, the failure to protect 
     confidentiality of information, or the failure to competently 
     review premarket submissions for devices.
       ``(d) Selection and Compensation.--A person who intends to 
     make a report described in subsection (a) to the Secretary 
     shall have the option to select an accredited entity or 
     individual to review such report. Upon the request by a 
     person to have a report reviewed by an accredited entity or 
     individual, the Secretary shall identify for the person no 
     less than 2 accredited entities or individuals from whom the 
     selection may be made. Compensation for an accredited entity 
     or individual shall be determined by agreement between the 
     accredited entity or individual and the person who engages 
     the services of the accredited entity or individual and shall 
     be paid by the person who engages such services.
       ``(e) Review by Secretary.--
       ``(1) In general.--The Secretary shall require an 
     accredited entity or individual, upon making a recommendation 
     under this section with respect to an initial classification 
     of a device, to notify the Secretary in writing of the 
     reasons for such recommendation.
       ``(2) Time period for review.--Not later than 30 days after 
     the date on which the Secretary is notified under paragraph 
     (1) by an accredited entity or individual with respect to a 
     recommendation of an initial classification of a device, the 
     Secretary shall make a

[[Page H8485]]

     determination with respect to the initial classification.
       ``(3) Special rule.--The Secretary may change the initial 
     classification under section 513(f)(1) that is recommended by 
     the accredited entity or individual under this section, and 
     in such case shall notify in writing the person making the 
     report described in subsection (a) of the detailed reasons 
     for the change.
       ``(f) Duration.--The authority provided by this section 
     terminates--
       ``(1) 5 years after the date on which the Secretary 
     notifies Congress that at least 2 persons accredited under 
     subsection (b) are available to review at least 60 percent of 
     the submissions under section 510(k); or
       ``(2) 4 years after the date on which the Secretary 
     notifies Congress that at least 35 percent of the devices 
     that are subject to review under subsection (a), and that 
     were the subject of final action by the Secretary in the 
     fiscal year preceding the date of such notification, were 
     reviewed by the Secretary under subsection (e),

     whichever occurs first.
       ``(g) Report.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of this section, the Secretary shall contract with 
     an independent research organization to prepare and submit to 
     the Secretary a written report examining the use of 
     accredited entities and individuals to conduct reviews under 
     this section. The Secretary shall submit the report to 
     Congress not later than 6 months prior to the conclusion of 
     the applicable period described in subsection (f).
       ``(2) Contents.--The report by the independent research 
     organization described in paragraph (1) shall identify the 
     benefits or detriments to public and patient health of using 
     accredited entities and individuals to conduct such reviews, 
     and shall summarize all relevant data, including data on the 
     review of accredited entities and individuals (including data 
     on the review times, recommendations, and compensation of the 
     entities and individuals), and data on the review of the 
     Secretary (including data on the review times, changes, and 
     reasons for changes of the Secretary).''.
       (b) Recordkeeping.--Section 704 (21 U.S.C. 374) is amended 
     by adding at the end the following:
       ``(f)(1) A person accredited under section 523 to review 
     reports made under section 510(k) and make recommendations of 
     initial classifications of devices to the Secretary shall 
     maintain records documenting the training qualifications of 
     the person and the employees of the person, the procedures 
     used by the person for handling confidential information, the 
     compensation arrangements made by the person in accordance 
     with section 523(d), and the procedures used by the person to 
     identify and avoid conflicts of interest. Upon the request of 
     an officer or employee designated by the Secretary, the 
     person shall permit the officer or employee, at all 
     reasonable times, to have access to, to copy, and to verify, 
     the records.
       ``(2) Within 15 days after the receipt of a written request 
     from the Secretary to a person accredited under section 523 
     for copies of records described in paragraph (1), the person 
     shall produce the copies of the records at the place 
     designated by the Secretary.''.

     SEC. 205. DEVICE PERFORMANCE STANDARDS.

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

                      ``Recognition of a Standard

       ``(c)(1)(A) In addition to establishing performance 
     standards under this section, the Secretary may, by 
     publication in the Federal Register, recognize all or part of 
     a performance standard established by a nationally or 
     internationally recognized standard development organization 
     for which a person may submit a declaration of conformity in 
     order to meet premarket submission requirements or other 
     requirements under this Act to which such standards are 
     applicable.
       ``(B) If a person elects to use a performance standard 
     recognized by the Secretary under subparagraph (A) to meet 
     the requirements described in subparagraph (A), the person 
     shall provide a declaration of conformity to the Secretary 
     that certifies that the device is in conformity with such 
     standard. A person may elect to use data, or information, 
     other than data required by a standard recognized under 
     subparagraph (A) to fulfill or satisfy any requirement under 
     this Act.
       ``(2) The Secretary may withdraw such recognition of a 
     performance standard through publication of a notice in the 
     Federal Register that the Secretary will no longer recognize 
     the standard, if the Secretary determines that the standard 
     is no longer appropriate for meeting the requirements under 
     this Act.
       ``(3)(A) Subject to subparagraph (B), the Secretary shall 
     accept a declaration of conformity that a device is in 
     conformity with a standard recognized under paragraph (1) 
     unless the Secretary finds--
       ``(i) that the data or information submitted to support 
     such declaration does not demonstrate that the device is in 
     conformity with the standard identified in the declaration of 
     conformity; or
       ``(ii) that the standard identified in the declaration of 
     conformity is not applicable to the particular device under 
     review.
       ``(B) The Secretary may request, at any time, the data or 
     information relied on by the person to make a declaration of 
     conformity with respect to a standard recognized under 
     paragraph (1).
       ``(C) A person relying on a declaration of conformity with 
     respect to a standard recognized under paragraph (1) shall 
     maintain the data and information demonstrating conformity of 
     the device to the standard for a period of 2 years after the 
     date of the classification or approval of the device by the 
     Secretary or a period equal to the expected design life of 
     the device, whichever is longer.''.
       (b) Section 301.--Section 301 (21 U.S.C. 331) is amended by 
     adding at the end the following:
       ``(x) The falsification of a declaration of conformity 
     submitted under subsection (c) of section 514 or the failure 
     or refusal to provide data or information requested by the 
     Secretary under section 514(c)(3).''.
       (c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is 
     amended--
       (1) by striking ``(e)'' and inserting ``(e)(1)''; and
       (2) by inserting at the end the following:
       ``(2) If it is declared to be, purports to be, or is 
     represented as, a device that is in conformity with any 
     performance standard recognized under section 514(c) unless 
     such device is in all respects in conformity with such 
     standard.''.
          TITLE III--IMPROVING COLLABORATION AND COMMUNICATION

     SEC. 301. COLLABORATIVE DETERMINATIONS OF DEVICE DATA 
                   REQUIREMENTS.

       Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended by 
     adding at the end the following:
       ``(C)(i)(I) The Secretary, upon the written request of any 
     person intending to submit an application under section 515, 
     shall meet with such person to determine the type of valid 
     scientific evidence (within the meaning of subparagraphs (A) 
     and (B)) that will be necessary to demonstrate the 
     effectiveness of a device for the conditions of use proposed 
     by such person, to support an approval of an application. The 
     written request shall include a detailed description of the 
     device, a detailed description of the proposed conditions of 
     use of the device, a proposed plan for determining whether 
     there is a reasonable assurance of effectiveness, and, if 
     available, information regarding the expected performance 
     from the device. Within 30 days after such meeting, the 
     Secretary shall specify in writing the type of valid 
     scientific evidence that will provide a reasonable assurance 
     that a device is effective under the conditions of use 
     proposed by such person.
       ``(II) Any clinical data, including 1 or more well-
     controlled investigations, specified in writing by the 
     Secretary for demonstrating a reasonable assurance of device 
     effectiveness shall be specified as a result of a 
     determination by the Secretary--
       ``(aa) that such data are necessary to establish device 
     effectiveness; and
       ``(bb) that no other less burdensome means of evaluating 
     device effectiveness is available that would have a 
     reasonable likelihood of resulting in an approval.
       ``(ii) The determination of the Secretary with respect to 
     the specification of valid scientific evidence under clause 
     (i) shall be binding upon the Secretary, unless such 
     determination by the Secretary could be contrary to the 
     public health.''.

     SEC. 302. COLLABORATIVE REVIEW PROCESS.

       Section 515(d) (21 U.S.C. 360e(d)) is amended--
       (1) in paragraph (1)(A), by striking ``paragraph (2) of 
     this subsection'' each place it appears and inserting 
     ``paragraph (4)'';
       (2) by redesignating paragraphs (2) and (3) as paragraphs 
     (4) and (5), respectively; and
       (3) by inserting after paragraph (1) the following:
       ``(2)(A)(i) The Secretary shall, upon the written request 
     of an applicant, meet with the applicant, not later than 100 
     days after the receipt of an application from the applicant 
     that has been filed as complete under subsection (c), to 
     discuss the review status of the application.
       ``(ii) If the application does not appear in a form that 
     would require an approval under this subsection, the 
     Secretary shall in writing, and prior to the meeting, provide 
     to the applicant a description of any deficiencies in the 
     application identified by the Secretary based on an interim 
     review of the entire application and identify the information 
     that is required to correct those deficiencies.
       ``(iii) The Secretary and the applicant may, by mutual 
     consent, establish a different schedule for a meeting 
     required under this paragraph.
       ``(B) The Secretary shall notify the applicant immediately 
     of any deficiency identified in the application that was not 
     described as a deficiency in the written description provided 
     by the Secretary under subparagraph (A).''.
           TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES

     SEC. 401. POLICY STATEMENTS.

       Section 701(a) (21 U.S.C. 371(a)) is amended--
       (1) by striking ``(a) The'' and inserting ``(a)(1) The''; 
     and
       (2) by adding at the end the following:
       ``(2) Not later than February 27, 1999, the Secretary, 
     after evaluating the effectiveness of the Good Guidance 
     Practices document published in the Federal Register at 62 
     Fed. Reg. 8961, shall promulgate a regulation specifying the 
     policies and procedures of the Food and Drug Administration 
     for the development, issuance, and use of guidance 
     documents.''.

     SEC. 402. PRODUCT CLASSIFICATION.

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

[[Page H8486]]

  ``Subchapter D--Classification of Products and Environmental Impact 
                                Reviews

     ``SEC. 741. CLASSIFICATION OF PRODUCTS.

       ``(a) Request.--A person who submits an application or 
     submission (including a petition, notification, and any other 
     similar form of request) under this Act, may submit a request 
     to the Secretary respecting the classification of an article 
     as a drug, biological product, device, or a combination 
     product subject to section 503(g) or respecting the component 
     of the Food and Drug Administration that will regulate the 
     article. In submitting the request, the person shall 
     recommend a classification for the article, or a component to 
     regulate the article, as appropriate.
       ``(b) Statement.--Not later than 60 days after the receipt 
     of the request described in subsection (a), the Secretary 
     shall determine the classification of the article or the 
     component of the Food and Drug Administration that will 
     regulate the article and shall provide to the person a 
     written statement that identifies the classification of the 
     article or the component of the Food and Drug Administration 
     that will regulate the article and the reasons for such 
     determination. The Secretary may not modify such statement 
     except with the written consent of the person or for public 
     health reasons.
       ``(c) Inaction of Secretary.--If the Secretary does not 
     provide the statement within the 60-day period described in 
     subsection (b), the recommendation made by the person under 
     subsection (a) shall be considered to be a final 
     determination by the Secretary of the classification of the 
     article or the component of the Food and Drug Administration 
     that will regulate the article and may not be modified by the 
     Secretary except with the written consent of the person or 
     for public health reasons.''.

     SEC. 403. USE OF DATA RELATING TO PREMARKET APPROVAL.

       (a) In General.--Section 520(h)(4) (21 U.S.C. 360j(h)(4)) 
     is amended to read as follows:
       ``(4)(A) Any information contained in an application for 
     premarket approval filed with the Secretary pursuant to 
     section 515(c) (including information from clinical and 
     preclinical tests or studies that demonstrate the safety and 
     effectiveness of a device, but excluding descriptions of 
     methods of manufacture and product composition) shall be 
     available, 6 years after the application has been approved by 
     the Secretary, for use by the Secretary in--
       ``(i) approving another device;
       ``(ii) determining whether a product development protocol 
     has been completed, under section 515 for another device;
       ``(iii) establishing a performance standard or special 
     control under this Act; or
       ``(iv) classifying or reclassifying another device under 
     section 513 and subsection (l)(2).
       ``(B) The publicly available detailed summaries of 
     information respecting the safety and effectiveness of 
     devices required by paragraph (1)(A) shall be available for 
     use by the Secretary as the evidentiary basis for the agency 
     actions described in subparagraph (A).''.
       (b) Conforming Amendment.--Section 517(a) (21 U.S.C. 
     360g(a)) is amended--
       (1) in paragraph (8), by adding ``or'' at the end;
       (2) in paragraph (9), by striking ``, or'' and inserting a 
     comma; and
       (3) by striking paragraph (10).

     SEC. 404. CONSIDERATION OF LABELING CLAIMS FOR PRODUCT 
                   REVIEW.

       (a) Premarket Approval.--Section 515(d)(1)(A) (21 U.S.C. 
     360e(d)(1)(A)) is amended by adding at the end the following 
     flush sentences:

     ``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.''.
       (b) Premarket Notification.--Section 513(i)(1) (21 U.S.C. 
     360c(i)(1)) is amended by adding at the end the following:
       ``(C) Whenever the Secretary requests information to 
     demonstrate that the devices with differing technological 
     characteristics are substantially equivalent, the Secretary 
     shall only request information that is necessary to make a 
     substantial equivalence determination. In making such a 
     request, the Secretary shall consider the least burdensome 
     means of demonstrating substantial equivalence and shall 
     request information accordingly.
       ``(D) The determination of the Secretary under this 
     subsection and section 513(f)(1) with respect to the intended 
     use of a device shall be based on the intended use included 
     in the proposed labeling of the device submitted in a report 
     under section 510(k).''.
       (c) Rule of Construction.--Nothing in the amendments made 
     by subsections (a) and (b) shall be construed to alter any 
     authority of the Secretary of Health and Human Services to 
     regulate any tobacco product, or any additive or ingredient 
     of a tobacco product.

     SEC. 405. CERTAINTY OF REVIEW TIMEFRAMES.

       (a) Clarification on the 90-Day Timeframe for Premarket 
     Notification Reviews.--Section 510(k) (21 U.S.C. 360) is 
     amended by adding at the end the following flush sentence:

     ``The Secretary shall review the report required by this 
     subsection and make a determination under section 513(f)(1) 
     not later than 90 days after receiving the report.''.
       (b) One-Cycle Review.--Section 515(d) (21 U.S.C. 360e(d)), 
     as amended by section 302, is amended by inserting after 
     paragraph (2) the following:
       ``(3) Except as provided in paragraph (1), the period for 
     the review of an application by the Secretary under this 
     subsection shall be not more than 180 days. Such period may 
     not be restarted or extended even if the application is 
     amended. The Secretary is not required to review a major 
     amendment to an application, unless the amendment is made in 
     response to a request by the Secretary for information.''.

     SEC. 406. LIMITATIONS ON INITIAL CLASSIFICATION 
                   DETERMINATIONS.

       Section 510 (21 U.S.C. 360) is amended by adding at the end 
     the following:
       ``(m) The Secretary may not withhold a determination of the 
     initial classification of a device under section 513(f)(1) 
     because of a failure to comply with any provision of this Act 
     that is unrelated to a substantial equivalence decision, 
     including a failure to comply with the requirements relating 
     to good manufacturing practices under section 520(f).''.

     SEC. 407. CLARIFICATION WITH RESPECT TO A GENERAL USE AND 
                   SPECIFIC USE OF A DEVICE.

       Not later than 270 days after the date of enactment of this 
     section, the Secretary of Health and Human Services shall 
     promulgate a final regulation specifying the general 
     principles that the Secretary of Health and Human Services 
     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 section 513(f)(1) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)).

     SEC. 408. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL 
                   INVESTIGATIONS FOR APPROVAL.

       (a) Device Classes.--Section 513(a)(3)(A) (21 U.S.C. 
     360c(a)(3)(A)) is amended by striking ``clinical 
     investigations'' and inserting ``1 or more clinical 
     investigations''.
       (b) New Drugs.--Section 505(d) (21 U.S.C. 355(d)) is 
     amended by adding at the end the following: ``Substantial 
     evidence may, as appropriate, consist of data from 1 adequate 
     and well-controlled clinical investigation and confirmatory 
     evidence (obtained prior to or after such investigation), if 
     the Secretary determines, based on relevant science, that 
     such data and evidence are sufficient to establish 
     effectiveness.''.

     SEC. 409. PROHIBITED ACTS.

       Section 301(l) (21 U.S.C. 331(l)) is repealed.
                   TITLE V--IMPROVING ACCOUNTABILITY

     SEC. 501. AGENCY PLAN FOR STATUTORY COMPLIANCE AND ANNUAL 
                   REPORT.

       Section 903(b) (21 U.S.C. 393(b)), as amended by section 
     201, is further amended by adding at the end the following:
       ``(4) Agency plan for statutory compliance.--
       ``(A) In general.--Not later than 180 days after the date 
     of enactment of this paragraph, the Secretary, after 
     consultation with relevant experts, health care 
     professionals, representatives of patient and consumer 
     advocacy groups, and the regulated industry, shall develop 
     and publish in the Federal Register a plan bringing the 
     Secretary into compliance with each of the obligations of the 
     Secretary under this Act and other relevant statutes. The 
     Secretary shall biannually review the plan and shall revise 
     the plan as necessary, in consultation with such persons.
       ``(B) Objectives of agency plan.--The plan required by 
     subparagraph (A) shall establish objectives, and mechanisms 
     to be used by the Secretary, acting through the Commissioner, 
     including objectives and mechanisms that--
       ``(i) minimize deaths of, and harm to, persons who use or 
     may use an article regulated under this Act;
       ``(ii) maximize the clarity of, and the availability of 
     information about, the process for review of applications and 
     submissions (including petitions, notifications, and any 
     other similar forms of request) made under this Act, 
     including information for potential consumers and patients 
     concerning new products;
       ``(iii) implement all inspection and postmarket monitoring 
     provisions of this Act by July 1, 1999;
       ``(iv) ensure access to the scientific and technical 
     expertise necessary to ensure compliance by the Secretary 
     with the statutory obligations described in subparagraph (A);
       ``(v) establish a schedule to bring the Administration into 
     full compliance by July 1, 1999, with the time periods 
     specified in this Act for the review of all applications and 
     submissions described in clause (ii) and submitted after the 
     date of enactment of this paragraph; and
       ``(vi) reduce backlogs in the review of all applications 
     and submissions described in clause (ii) for any article with 
     the objective of eliminating all backlogs in the review of 
     the applications and submissions by January 1, 2000.
       ``(5) Annual report.--
       ``(A) Contents.--The Secretary shall prepare and publish in 
     the Federal Register and solicit public comment on an annual 
     report that--
       ``(i) provides detailed statistical information on the 
     performance of the Secretary under the plan described in 
     paragraph (4);

[[Page H8487]]

       ``(ii) compares such performance of the Secretary with the 
     objectives of the plan and with the statutory obligations of 
     the Secretary;
       ``(iii) analyzes any failure of the Secretary to achieve 
     any objective of the plan or to meet any statutory 
     obligation;
       ``(iv) identifies any regulatory policy that has a 
     significant impact on compliance with any objective of the 
     plan or any statutory obligation; and
       ``(v) sets forth any proposed revision to any such 
     regulatory policy, or objective of the plan that has not been 
     met.
       ``(B) Statistical information.--The statistical information 
     described in subparagraph (A)(i) shall include a full 
     statistical presentation relating to all applications and 
     submissions (including petitions, notifications, and any 
     other similar forms of request) made under this Act and 
     approved or subject to final action by the Secretary during 
     the year covered by the report. In preparing the statistical 
     presentation, the Secretary shall take into account the date 
     of--
       ``(i) the submission of any investigational application;
       ``(ii) the application of any clinical hold;
       ``(iii) the submission of any application or submission 
     (including a petition, notification, and any other similar 
     form of request) made under this Act for approval or 
     clearance;
       ``(iv) the acceptance for filing of any application or 
     submission described in clause (iii) for approval or 
     clearance;
       ``(v) the occurrence of any unapprovable action;
       ``(vi) the occurrence of any approvable action; and
       ``(vii) the approval or clearance of any application or 
     submission described in clause (iii).
       ``(C) Special rule.--If the Secretary provides information 
     in a report required by section 705 of the Food and Drug 
     Administration Modernization and Accountability Act of 1997 
     or a report required by the amendments made by the Government 
     Performance and Results Act of 1993 and that information is 
     required by this paragraph, the report shall be deemed to 
     satisfy the requirements of this paragraph relating to that 
     information.''.
     TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES

     SEC. 601. MINOR MODIFICATIONS.

       (a) Action on Investigational Device Exemptions.--Section 
     520(g) (21 U.S.C. 360j(g)) is amended by adding at the end 
     the following:
       ``(6)(A) The Secretary shall, not later than 120 days after 
     the date of enactment of this paragraph, by regulation modify 
     parts 812 and 813 of title 21, Code of Federal Regulations to 
     update the procedures and conditions under which a device 
     intended for human use may, upon application by the sponsor 
     of the device, be granted an exemption from the requirements 
     of this Act.
       ``(B) The regulation shall permit developmental changes in 
     a device (including manufacturing changes) in response to 
     information collected during an investigation without 
     requiring an additional approval of an application for an 
     investigational device exemption or the approval of a 
     supplement to such application, if the sponsor of the 
     investigation determines, based on credible information, 
     prior to making any such changes, that the changes--
       ``(i) do not affect the scientific soundness of an 
     investigational plan submitted under paragraph (3)(A) or the 
     rights, safety, or welfare of the human subjects involved in 
     the investigation; and
       ``(ii) do not constitute a significant change in design, or 
     a significant change in basic principles of operation, of the 
     device.''.
       (b) Action on Application.--Section 515(d)(1)(B) (21 U.S.C. 
     360e(d)(1)(B)) is amended by adding at the end the following:
       ``(iii) The Secretary shall accept and review data and any 
     other information from investigations conducted under the 
     authority of regulations required by section 520(g), to make 
     a determination of whether there is a reasonable assurance of 
     safety and effectiveness of a device subject to a pending 
     application under this section if--
       ``(I) the data or information is derived from 
     investigations of an earlier version of the device, the 
     device has been modified during or after the investigations 
     (but prior to submission of an application under subsection 
     (c)) and such a modification of the device does not 
     constitute a significant change in the design or in the basic 
     principles of operation of the device that would invalidate 
     the data or information; or
       ``(II) the data or information relates to a device approved 
     under this section, is available for use under this Act, and 
     is relevant to the design and intended use of the device for 
     which the application is pending.''.
       (c) Action on Supplements.--Section 515(d) (21 U.S.C. 
     360e(d)), as amended by section 302, is further amended by 
     adding at the end 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. 602. ENVIRONMENTAL IMPACT REVIEW.

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

     ``SEC. 742. ENVIRONMENTAL IMPACT REVIEW.

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

     SEC. 603. EXEMPTION OF CERTAIN CLASSES OF DEVICES FROM 
                   PREMARKET NOTIFICATION REQUIREMENT.

       (a) Class I and Class II Devices.--Section 510(k) (21 
     U.S.C. 360(k)) is amended by striking ``intended for human 
     use'' and inserting ``intended for human use (except a device 
     that is classified into class I under section 513 or 520 
     unless the Secretary determines such device is intended for a 
     use that is of substantial importance in preventing 
     impairment of human health or such device presents a 
     potential unreasonable risk of illness or injury, or a device 
     that is classified into class II under section 513 or 520 and 
     is exempt from the requirements of this subsection under 
     subsection (l))''.
       (b) Publication of Exemption.--Section 510 (21 U.S.C. 360) 
     is amended by inserting after subsection (k) the following:
       ``(l)(1) Not later than 30 days after the date of enactment 
     of this subsection, the Secretary shall publish in the 
     Federal Register a list of each type of class II device that 
     does not require a notification under subsection (k) to 
     provide reasonable assurance of safety and effectiveness. 
     Each type of class II device identified by the Secretary not 
     to require the notification shall be exempt from the 
     requirement to provide notification under subsection (k) as 
     of the date of the publication of the list in the Federal 
     Register.
       ``(2) Beginning on the date that is 1 day after the date of 
     the publication of a list under this subsection, the 
     Secretary may exempt a class II device from the notification 
     requirement of subsection (k), upon the Secretary's own 
     initiative or a petition of an interested person, if the 
     Secretary determines that such notification is not necessary 
     to assure the safety and effectiveness of the device. The 
     Secretary shall publish in the Federal Register notice of the 
     intent of the Secretary to exempt the device, or of the 
     petition, and provide a 30-day period for public comment. 
     Within 120 days after the issuance of the notice in the 
     Federal Register, the Secretary shall publish an order in the 
     Federal Register that sets forth the final determination of 
     the Secretary regarding the exemption of the device that was 
     the subject of the notice.''.

     SEC. 604. EVALUATION OF AUTOMATIC CLASS III DESIGNATION.

       Section 513(f) (21 U.S.C. 360c(f)) is amended--
       (1) in paragraph (1)--
       (A) in subparagraph (B), by striking ``paragraph (2)'' and 
     inserting ``paragraph (3)''; and
       (B) in the last sentence, by striking ``paragraph (2)'' and 
     inserting ``paragraph (2) or (3)'';
       (2) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively; and
       (3) by inserting after paragraph (1) the following:
       ``(2)(A) Any person who submits a report under section 
     510(k) for a type of device that has not been previously 
     classified under this Act, and that is classified into class 
     III under paragraph (1), may request, within 30 days after 
     receiving written notice of such a classification, the 
     Secretary to classify the device under the criteria set forth 
     in subparagraphs (A) through (C) subsection (a)(1). The

[[Page H8488]]

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

     SEC. 605. SECRETARY'S DISCRETION TO TRACK DEVICES.

       (a) Release of Information.--Section 519(e) (21 U.S.C. 
     360i(e)) is amended by adding at the end the following flush 
     sentence:
     ``Any patient receiving a device subject to tracking under 
     this section may refuse to release, or refuse permission to 
     release, the patient's name, address, social security number, 
     or other identifying information for the purpose of 
     tracking.''.
       (b) Publication of Certain Devices.--Not later than 180 
     days after the date of enactment of this Act, the Secretary 
     of Health and Human Services shall develop and publish in the 
     Federal Register a list that identifies each type of device 
     subject to tracking under section 519(e)(1) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)(1)). Each 
     device not identified by the Secretary of Health and Human 
     Services under this subsection or designated by the Secretary 
     under section 519(e)(2) shall be deemed to be exempt from the 
     mandatory tracking requirement under section 519 of such Act. 
     The Secretary of Health and Human Services shall have 
     authority to modify the list of devices exempted from the 
     mandatory tracking requirements.

     SEC. 606. SECRETARY'S DISCRETION TO CONDUCT POSTMARKET 
                   SURVEILLANCE.

       (a) In General.--Section 522 (21 U.S.C. 360l) is amended by 
     striking ``Sec. 522.'' and all that follows through ``(2) 
     Discretionary surveillance.--The'' and inserting the 
     following:
       ``Sec. 522. (a) Discretionary Surveillance.--The''.
       (b) Surveillance Approval.--Section 522(b) (21 U.S.C. 
     360l(b)) is amended to read as follows:
       ``(b) Surveillance Approval.--
       ``(1) In general.--Each manufacturer that receives notice 
     from the Secretary that the manufacturer is required to 
     conduct surveillance of a device under subsection (a) shall, 
     not later than 30 days after receiving the notice, submit for 
     the approval of the Secretary, a plan for the required 
     surveillance.
       ``(2) Determination.--Not later than 60 days after the 
     receipt of the plan, the Secretary shall determine if a 
     person proposed in the plan to conduct the surveillance has 
     sufficient qualifications and experience to conduct the 
     surveillance and if the plan will result in the collection of 
     useful data that can reveal unforeseen adverse events or 
     other information necessary to protect the public health and 
     to provide safety and effectiveness information for the 
     device.
       ``(3) Limitation on plan approval.--The Secretary may not 
     approve the plan until the plan has been reviewed by a 
     qualified scientific and technical review committee 
     established by the Secretary.''.

     SEC. 607. REPORTING.

       (a) Reports.--Section 519 (21 U.S.C. 360i) is amended--
       (1) in subsection (a)--
       (A) in the first sentence by striking ``make such reports, 
     and provide such information,'' and inserting ``and each such 
     manufacturer or importer shall make such reports, provide 
     such information, and submit such samples and components of 
     devices (as required by paragraph (10)),'';
       (B) in paragraph (8), by striking ``; and'' and inserting a 
     semicolon; and
       (C) 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; and'';
       (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.''.

     SEC. 608. PILOT AND SMALL-SCALE MANUFACTURE.

       (a) New Drugs.--Section 505(c) (21 U.S.C. 355(c)) is 
     amended by adding at the end the following:
       ``(4) A new drug manufactured in a pilot or other small 
     facility may be used to demonstrate the safety and 
     effectiveness of the new drug and to obtain approval of the 
     new drug prior to scaling up to a larger facility, unless the 
     Secretary determines that a full scale production facility is 
     necessary to ensure the safety or effectiveness of the new 
     drug.''.
       (b) New Animal Drugs.--Section 512(c) (21 U.S.C. 360b(c)) 
     is amended by adding at the end the following:
       ``(4) A new animal drug manufactured in a pilot or other 
     small facility may be used to demonstrate the safety and 
     effectiveness of the new drug and to obtain approval of the 
     new drug prior to scaling up to a larger facility, unless the 
     Secretary determines that a full scale production facility is 
     necessary to ensure the safety or effectiveness of the new 
     drug.''.

     SEC. 609. 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 (but 
     not be limited to) 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, 1 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. 610. MODERNIZATION OF REGULATION OF BIOLOGICAL PRODUCTS.

       (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) Except as provided in paragraph (4), 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 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.
       ``(3) A biologics license application shall be approved 
     only 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).
       ``(4) 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--

[[Page H8489]]

       (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 full new drug applications under 
     section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(b)(1)).

     SEC. 611. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED 
                   PRODUCTS.

       (a) Performance Standards.--Not later than 180 days after 
     the date of enactment of this section, the Secretary of 
     Health and Human Services shall publish in the Federal 
     Register performance standards for the prompt review of 
     supplemental applications submitted for approved articles 
     under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 
     et seq.).
       (b) Guidance to Industry.--Not later than 180 days after 
     the date of enactment of this section, the Secretary of 
     Health and Human Services 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 of Health 
     and Human Services shall designate an individual in each 
     center within the Food and Drug Administration (except the 
     Center for Food Safety and Applied Nutrition) to be 
     responsible for--
       (1) encouraging the prompt review of supplemental 
     applications for approved articles; and
       (2) working with sponsors to facilitate the development and 
     submission of data to support supplemental applications.
       (d) Collaboration.--The Secretary of Health and Human 
     Services 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. 612. HEALTH CARE ECONOMIC INFORMATION.

       (a) In General.--Section 502(a) (21 U.S.C. 352(a)) is 
     amended by adding at the end the following: ``Health care 
     economic information provided to a formulary committee, or 
     other similar entity, in the course of the committee or the 
     entity carrying out its responsibilities for the selection of 
     drugs for managed care or other similar organizations, shall 
     not be considered to be false or misleading 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.''.
       (b) Study and Report.--The Comptroller General of the 
     United States shall conduct a study of the implementation of 
     the provisions added by the amendment made by subsection (a). 
     Not later than 4 years and 6 months after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall prepare and submit to Congress a report 
     containing the findings of the study.

     SEC. 613. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS.

       (a) In General.--Chapter V (21 U.S.C. 351 et seq.), as 
     amended by section 102, is further amended by adding at the 
     end the following:

 ``Subchapter E--Fast Track Drugs and Reports of Post-Market Approval 
                                Studies

     ``SEC. 561. FAST TRACK DRUGS.

       ``(a) Designation of Drug as a Fast Track Drug.--
       ``(1) In general.--The Secretary shall facilitate 
     development, and expedite review and approval of new drugs 
     and biological products 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 Act, such products shall be known as 
     `fast track drugs'.
       ``(2) Request for designation.--The sponsor of a drug 
     (including a biological product) may request the Secretary to 
     designate the drug as a fast track drug. 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)(4) 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 drug and 
     shall take such actions as are appropriate to expedite the 
     development and review of the drug.
       ``(b) Approval of Application for a Fast Track Drug.--
       ``(1) In general.--The Secretary may approve an application 
     for approval of a fast track drug under section 505(b) or 
     section 351 of the Public Health Service Act (21 U.S.C. 262) 
     upon a determination that the drug has an effect on a 
     surrogate endpoint that is reasonably likely to predict 
     clinical benefit.
       ``(2) Limitation.--Approval of a fast track drug 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 clinical benefit of the drug; and
       ``(B) that the sponsor submit copies of all promotional 
     materials related to the fast track drug during the 
     preapproval review period and following approval, at least 30 
     days prior to dissemination of the materials for such period 
     of time as the Secretary deems appropriate.
       ``(3) Expedited withdrawal of approval.--The Secretary may 
     withdraw approval of a fast track drug using expedited 
     procedures (as prescribed by the Secretary in regulations) 
     including a procedure that provides 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 drug fails to 
     verify clinical benefit of the fast track drug;
       ``(C) other evidence demonstrates that the fast track drug 
     is not safe or effective under conditions of use of the drug; 
     or
       ``(D) the sponsor disseminates false or misleading 
     promotional materials with respect to the fast track drug.
       ``(c) Review of Incomplete Applications for Approval of a 
     Fast Track Drug.--
       ``(1) In general.--If preliminary evaluation by the 
     Secretary of clinical efficacy data for a fast track drug 
     under investigation shows evidence of effectiveness, the 
     Secretary shall evaluate for filing, and may commence review 
     of, portions of an application for the approval of the drug 
     if the applicant provides a schedule for submission of 
     information necessary to make the application complete and 
     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

[[Page H8490]]

     an application submitted under paragraph (1) until the date 
     on which the application is complete.
       ``(d) Awareness Efforts.--The Secretary shall--
       ``(1) develop and widely disseminate to physicians, patient 
     organizations, pharmaceutical and biotechnology companies, 
     and other appropriate persons a comprehensive description of 
     the provisions applicable to fast track drugs established 
     under this section; and
       ``(2) establish an ongoing program to encourage the 
     development of surrogate endpoints that are reasonably likely 
     to predict clinical benefit for serious or life-threatening 
     conditions for which there exist significant unmet medical 
     needs.''.
       (b) Guidance.--Within 1 year after the date of enactment of 
     this Act, the Secretary of Health and Human Services shall 
     issue guidance for fast track drugs that describes the 
     policies and procedures that pertain to section 561 of the 
     Federal Food, Drug, and Cosmetic Act.

     SEC. 614. MANUFACTURING CHANGES FOR DRUGS AND BIOLOGICS.

       (a) In General.--Chapter VII (21 U.S.C. 371 et seq.), as 
     amended by section 602, is further amended by adding at the 
     end the following:

                 ``Subchapter E--Manufacturing Changes

     ``SEC. 751. MANUFACTURING CHANGES.

       ``(a) In General.--A change in the manufacture of a new 
     drug, including a biological product, or a new animal drug 
     may be made in accordance with this section.
       ``(b) Changes.--
       ``(1) Validation.--Before distributing a drug made after a 
     change in the manufacture of the drug from the manufacturing 
     process established in the approved new drug application 
     under section 505, the approved new animal drug application 
     under section 512, or the license application under section 
     351 of the Public Health Service Act, the applicant shall 
     validate the effect of the change on the identity, strength, 
     quality, purity, and potency of the drug as the identity, 
     strength, quality, purity, and potency may relate to the 
     safety or effectiveness of the drug.
       ``(2) Reports.--The applicant shall report the change 
     described in paragraph (1) to the Secretary and may 
     distribute a drug made after the change as follows:
       ``(A) Major manufacturing changes.--
       ``(i) In general.--Major manufacturing changes, which are 
     of a type determined by the Secretary to have substantial 
     potential to adversely affect the identity, strength, 
     quality, purity, or potency of the drug as the identity, 
     strength, quality, purity, and potency may relate to the 
     safety or effectiveness of a drug, shall be submitted to the 
     Secretary in a supplemental application and drugs made after 
     such changes may not be distributed until the Secretary 
     approves the supplemental application.
       ``(ii) Definition.--In this subparagraph, the term `major 
     manufacturing changes' means--

       ``(I) changes in the qualitative or quantitative 
     formulation of a drug or the specifications in the approved 
     marketing application for the drug (unless exempted by the 
     Secretary from the requirements of this subparagraph);
       ``(II) changes that the Secretary determines by regulation 
     or issuance of guidance require completion of an appropriate 
     human study demonstrating equivalence of the drug to the drug 
     manufactured before such changes; and
       ``(III) other changes that the Secretary determines by 
     regulation or issuance of guidance have a substantial 
     potential to adversely affect the safety or effectiveness of 
     the drug.

       ``(B) Other manufacturing changes.--
       ``(i) In general.--As determined by the Secretary, 
     manufacturing changes other than major manufacturing changes 
     shall--

       ``(I) be made at any time and reported annually to the 
     Secretary, with supporting data; or
       ``(II) be reported to the Secretary in a supplemental 
     application.

       ``(ii) Distribution of the drug.--In the case of changes 
     reported in accordance with clause (i)(II)--

       ``(I) the applicant may distribute the drug 30 days after 
     the Secretary receives the supplemental application unless 
     the Secretary notifies the applicant within such 30-day 
     period that prior approval of such supplemental application 
     is required;
       ``(II) the Secretary shall approve or disapprove each such 
     supplemental application; and
       ``(III) the Secretary may determine types of manufacturing 
     changes after which distribution of a drug may commence at 
     the time of submission of such supplemental application.''.

       (b) Existing Law.--The requirements of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) and the Public 
     Health Service Act (42 U.S.C. 201 et seq.) that are in effect 
     on the date of enactment of this Act with respect to 
     manufacturing changes shall remain in effect--
       (1) for a period of 24 months after the date of enactment 
     of this Act; or
       (2) until the effective date of regulations promulgated by 
     the Secretary of Health and Human Services implementing 
     section 751 of the Federal Food, Drug, and Cosmetic Act,

     whichever is sooner.

     SEC. 615. DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS.

       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 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) for certain types of studies. Such 
     guidance shall describe the kinds of studies for which 
     abbreviated reports are appropriate and the appropriate 
     abbreviated report formats.

     SEC. 616. FOOD CONTACT SUBSTANCES.

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

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

          ``Notification Relating to a Food Contact Substance

       ``(h)(1) Subject to such regulations as may be promulgated 
     under paragraph (3), a manufacturer or supplier of a food 
     contact substance may, at least 120 days prior to the 
     introduction or delivery for introduction into interstate 
     commerce of the food contact substance, notify the Secretary 
     of the identity and intended use of the food contact 
     substance, and of the determination of the manufacturer or 
     supplier that the intended use of such food contact substance 
     is safe under the standard described in subsection (c)(3)(A). 
     The notification shall contain the information that forms the 
     basis of the determination, the fee required under paragraph 
     (5), and all information required to be submitted by 
     regulations promulgated by the Secretary.
       ``(2)(A) A notification submitted under paragraph (1) shall 
     become effective 120 days after the date of receipt by the 
     Secretary and the food contact substance may be introduced or 
     delivered for introduction into interstate commerce, unless 
     the Secretary makes a determination within the 120-day period 
     that, based on the data and information before the Secretary, 
     such use of the food contact substance has not been shown to 
     be safe under the standard described in subsection (c)(3)(A), 
     and informs the manufacturer or supplier of such 
     determination.
       ``(B) A decision by the Secretary to object to a 
     notification shall constitute final agency action subject to 
     judicial review.
       ``(C) In this paragraph, the term `food contact substance' 
     means the substance that is the subject of a notification 
     submitted under paragraph (1), and does not include a similar 
     or identical substance manufactured or prepared by a person 
     other than the manufacturer identified in the notification.
       ``(3)(A) The process in this subsection shall be utilized 
     for authorizing the marketing of a food contact substance 
     except where the Secretary determines that submission and 
     review of a petition under subsection (b) is necessary to 
     provide adequate assurance of safety, or where the Secretary 
     and any manufacturer or supplier agree that such manufacturer 
     or supplier may submit a petition under subsection (b).
       ``(B) The Secretary is authorized to promulgate regulations 
     to identify the circumstances in which a petition shall be 
     filed under subsection (b), and shall consider criteria such 
     as the probable consumption of such food contact substance 
     and potential toxicity of the food contact substance in 
     determining the circumstances in which a petition shall be 
     filed under subsection (b).
       ``(4) The Secretary shall keep confidential any information 
     provided in a notification under paragraph (1) for 120 days 
     after receipt by the Secretary of the notification. After the 
     expiration of such 120 days, the information shall be 
     available to any interested party except for any matter in 
     the notification that is a trade secret or confidential 
     commercial information.
       ``(5)(A) Each person that submits a notification regarding 
     a food contact substance under this section shall be subject 
     to the payment of a reasonable fee. The fee shall be

[[Page H8491]]

     based on the resources required to process the notification 
     including reasonable administrative costs for such 
     processing.
       ``(B) The Secretary shall conduct a study of the costs of 
     administering the notification program established under this 
     section and, on the basis of the results of such study, 
     shall, within 18 months after the date of enactment of the 
     Food and Drug Administration Modernization and Accountability 
     Act of 1997, promulgate regulations establishing the fee 
     required by subparagraph (A).
       ``(C) A notification submitted without the appropriate fee 
     is not complete and shall not become effective for the 
     purposes of subsection (a)(3) until the appropriate fee is 
     paid.
       ``(D) Fees collected pursuant to this subsection--
       ``(i) shall not be deposited as an offsetting collection to 
     the appropriations for the Department of Health and Human 
     Services;
       ``(ii) shall be credited to the appropriate account of the 
     Food and Drug Administration; and
       ``(iii) shall be available in accordance with appropriation 
     Acts until expended, without fiscal year limitation.
       ``(6) In this section, the term `food contact substance' 
     means any substance intended for use as a component of 
     materials used in manufacturing, packing, packaging, 
     transporting, or holding food if such use is not intended to 
     have any technical effect in such food.'';
       (3) in subsection (i), as so redesignated by paragraph (1), 
     by adding at the end the following: ``The Secretary shall by 
     regulation prescribe the procedure by which the Secretary may 
     deem a notification under subsection (h) to no longer be 
     effective.''; and
       (4) in subsection (j), as so redesignated by paragraph (1), 
     by striking ``subsections (b) to (h)'' and inserting 
     ``subsections (b) to (i)''.
       (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. 617. HEALTH CLAIMS FOR FOOD PRODUCTS.

       Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by 
     adding at the end the following:
       ``(C) Notwithstanding the provisions of clauses (A)(i) and 
     (B), a claim of the type described in subparagraph (1)(B) 
     that is not authorized by the Secretary in a regulation 
     promulgated in accordance with clause (B) shall be authorized 
     and may be made if--
       ``(i) an authoritative scientific body of the Federal 
     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), the National Academy of 
     Sciences, or a subdivision of the scientific body or the 
     National Academy of Sciences, has published an authoritative 
     statement, which is currently in effect, about the 
     relationship between a nutrient and a disease or health-
     related condition to which the claim refers;
       ``(ii) a person has submitted to the Secretary at least 120 
     days before the first introduction of a food into interstate 
     commerce a notice of the claim, including a concise 
     description of the basis upon which such person relied for 
     determining that the requirements of subclause (i) have been 
     satisfied;
       ``(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 paragraph, a statement shall be regarded 
     as an authoritative statement of such 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 an interim final 
     regulation--
       ``(I) under the standard in clause (B)(i), prohibiting or 
     modifying the claim; or
       ``(II) finding that the requirements of clause (C) have not 
     been met; 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.

     Where the Secretary issues a regulation under subclause (i), 
     good cause shall be deemed to exist for the purposes of 
     subsections (b)(B) and (d)(3) of section 553 of title 5, 
     United States Code. The Secretary shall solicit comments in 
     response to a regulation promulgated under subclause (i) and 
     shall publish a response to such comments.''.

     SEC. 618. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.

       (a) General Authority.--Chapter V of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
     inserting after section 505 the following:

     ``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

       ``(a) Market Exclusivity for New Drugs.--If, prior to 
     approval of an application that is submitted under section 
     505(b)(1), the Secretary determines that information relating 
     to the use of a drug in the pediatric population may produce 
     health benefits in that population, the Secretary makes a 
     written request for pediatric studies (which may 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 completed 
     within any such timeframe and the reports thereof are 
     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 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 subsection (c)(3) or (j)(4)(B) of section 505 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 subsection (c)(3) or 
     (j)(4)(B) of section 505 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 (such as the American Academy of 
     Pediatrics, the Pediatric Pharmacology Research Unit Network, 
     and the United States Pharmacopoeia) 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 for pediatric studies 
     (which may include a timeframe for completing such studies) 
     concerning a drug identified in the list described in 
     subsection (b) to the holder of an approved application under 
     section 505(b)(1) for the drug, the holder agrees to the 
     request, and the studies are completed within any such 
     timeframe and the reports thereof submitted in accordance 
     with subsection (d)(2) or completed within any such timeframe 
     and the reports thereof 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 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 subsection (c)(3) or (j)(4)(B) of section 505 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 subsection (c)(3) or 
     (j)(4)(B) of section 505 shall be extended by a period of six 
     months after the date the patent expires (including any 
     patent extensions).

[[Page H8492]]

       ``(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 
     subsection (b)(2) or (j) of section 505 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 
     subsection (b)(2) or (j), respectively, of section 505 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 subsection (b)(2) or (j) of 
     section 505 for a drug will be subject to the provisions of 
     this section.
       ``(g) 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).
       ``(h) Study and Report.--The Secretary shall conduct a 
     study and report to Congress not later than January 1, 2003 
     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; and
       ``(4) any suggestions for modification that the Secretary 
     deems appropriate.
       ``(i) Termination of Market Exclusivity Extension Authority 
     for New Drugs.--Except as provided in section 618(b) of the 
     Food and Drug Administration Modernization and Accountability 
     Act of 1997, no period of market exclusivity shall be 
     extended under subsection (a) for a drug if--
       ``(1) the extension would be based on studies commenced 
     after January 1, 2004; and
       ``(2) the application submitted for the drug under section 
     505(b)(1) was not approved by January 1, 2004.
       ``(j) Definitions.--In this section, the term `pediatric 
     studies' or `studies' means at least 1 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.''.
       (b) Market Exclusivity Under Other Authority.--
       (1) Through calendar year 2003.--
       (A) Determination.--If the Secretary requests or requires 
     pediatric studies, prior to January 1, 2004, under Federal 
     law other than section 505A of the Federal Food, Drug, and 
     Cosmetic Act (as added by subsection (a)), from the sponsor 
     of an application, or the holder of an approved application, 
     for a drug under section 505(b) of such Act (21 U.S.C. 
     355(b)), the Secretary shall determine whether the studies 
     meet the completeness, timeliness, and other submission 
     requirements of the Federal law involved.
       (B) Market exclusivity.--If the Secretary determines that 
     the studies meet the requirements involved, the Secretary 
     shall ensure that the period of market exclusivity for the 
     drug involved is extended for 6 months in accordance with the 
     requirements of subsection (a), (c), (e), and (g) (as 
     appropriate) of section 505A of such Act (as in effect on the 
     date of enactment of this Act.).
       (2) Calendar year 2004 and subsequent years.--
       (A) New drugs.--Effective January 1, 2004, if the Secretary 
     requests or requires pediatric studies, under Federal law 
     other than section 505A of the Federal Food, Drug, and 
     Cosmetic Act, from the sponsor of an application for a drug 
     under section 505(b) of such Act, nothing in such law shall 
     be construed to permit or require the Secretary to ensure 
     that the period of market exclusivity for the drug is 
     extended.
       (B) Already marketed drugs.--
       (i) Determination.--Effective January 1, 2004, if the 
     Secretary requests or requires pediatric studies, under 
     Federal law other than section 505A of the Federal Food, 
     Drug, and Cosmetic Act (as added by subsection (a)), from the 
     holder of an approved application for a drug under section 
     505(b) of such Act, the Secretary shall determine whether the 
     studies meet the completeness, timeliness, and other 
     submission requirements of the Federal law involved.
       (ii) Market exclusivity.--If the Secretary determines that 
     the studies meet the requirements involved, the Secretary 
     shall ensure that the period of market exclusivity for the 
     drug involved is extended for 6 months in accordance with the 
     requirements of subsection (a), (c), (e), and (g) (as 
     appropriate) of section 505A of such Act (as in effect on the 
     date of enactment of this Act.).
       (3) Definitions.--In this subsection:
       (A) Drug.--The term ``drug'' has the meaning given the term 
     in section 201 of such Act.
       (B) Pediatric studies.--The term ``pediatric studies'' has 
     the meaning given the term in section 505A of such Act.
       (C) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.

     SEC. 619. POSITRON EMISSION TOMOGRAPHY.

       (a) Regulation of Compounded Positron Emission Tomography 
     Drugs Under the Federal Food, Drug, and Cosmetic Act.--
       (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 or 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.

[[Page H8493]]

       (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 or 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. 620. DISCLOSURE.

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


                              ``disclosure

       ``Sec. 403C. (a) No provision of section 403(a), 201(n), or 
     409 shall be construed to require on the label or labeling of 
     a food a separate radiation disclosure statement that is more 
     prominent than the declaration of ingredients required by 
     section 403(i)(2).
       ``(b) In this section, the term `radiation disclosure 
     statement' means a written statement that discloses that a 
     food or a component of the food has been intentionally 
     subject to radiation.''.

     SEC. 621. REFERRAL STATEMENTS RELATING TO FOOD NUTRIENTS.

       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 
     panel 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.''.
                   TITLE VII--FEES RELATING TO DRUGS

     SEC. 701. SHORT TITLE.

       This title may be cited as the ``Prescription Drug User Fee 
     Reauthorization Act of 1997''.

     SEC. 702. 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 appropriate letters from the 
     Secretary of Health and Human Services to the chairman of the 
     Committee on Commerce of the House of Representatives and the 
     chairman of the Committee on Labor and Human Resources of the 
     Senate.

     SEC. 703. 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 or biological product 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 or biological product 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 striking paragraph (5) and inserting the following:
       ``(5) The term `prescription drug establishment' means a 
     foreign or domestic place of business which is at 1 general 
     physical location consisting of 1 or more buildings all of 
     which are within 5 miles of each other, at which 1 or more 
     prescription drug products are manufactured in final dosage 
     forms.'';
       (5) in paragraph (7)(A)--
       (A) by striking ``employees under contract'' and all that 
     follows through ``Administration,'' 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) by striking subparagraph (B) and inserting the 
     following:
       ``(B) 1 plus the decimal expression of the total percentage 
     increase for such fiscal year since fiscal year 1997 in basic 
     pay under the General Schedule in accordance with section 
     5332 of title 5, United States Code, as adjusted by any 
     locality-based comparability payment pursuant to section 5304 
     of such title for Federal employees stationed in the District 
     of Columbia.''; 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) 1 business entity controls, or has the power to 
     control, the other business entity; or
       ``(B) a third party controls, or has power to control both 
     of the business entities.''.

     SEC. 704. AUTHORITY TO ASSESS AND USE DRUG FEES.

       (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is 
     amended--
       (1) by striking ``Beginning in fiscal year 1993'' and 
     inserting ``Beginning in fiscal year 1998'';
       (2) in paragraph (1)--
       (A) by striking subparagraph (B) and inserting the 
     following:
       ``(B) Payment.--The fee required by subparagraph (A) shall 
     be due upon submission of the application or supplement.'';
       (B) in subparagraph (D)--
       (i) in the subparagraph heading, by striking ``not 
     accepted'' and inserting ``refused'';
       (ii) by striking ``50 percent'' and inserting ``75 
     percent'';
       (iii) by striking ``subparagraph (B)(i)'' and inserting 
     ``subparagraph (B)''; and
       (iv) by striking ``not accepted'' and inserting 
     ``refused''; and
       (C) by adding at the end the following:
       ``(E) Exception for designated orphan drug or indication.--
     A human drug application for a prescription drug product that 
     has been designated as a drug for a rare disease or condition 
     pursuant to section 526 shall not be subject to a fee under 
     subparagraph (A),

[[Page H8494]]

     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), provided that 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.'';
       (3) by striking paragraph (2) and inserting the following:
       ``(2) Prescription drug establishment fee.--
       ``(A) In general.--Each person that--
       ``(i) is named as the applicant in a human drug 
     application; and
       ``(ii) after September 1, 1992, had pending before the 
     Secretary a human drug application or supplement;

     shall be assessed an annual fee established in subsection (b) 
     for each prescription drug establishment listed in its 
     approved human drug application as an establishment that 
     manufactures the prescription drug product named in the 
     application. The annual establishment fee shall be assessed 
     in each fiscal year in which the prescription drug product 
     named in the application is assessed a fee under paragraph 
     (3) unless the prescription drug establishment listed in the 
     application does not engage in the manufacture of the 
     prescription drug product during the fiscal year. The 
     establishment fee shall be payable on or before January 31 of 
     each year. Each such establishment shall be assessed only 1 
     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 manufacture of 
     the product began.''; and
       (4) in paragraph (3)--
       (A) in subparagraph (A)--
       (i) in clause (i), by striking ``is listed'' and inserting 
     ``has been submitted for listing''; and
       (ii) by striking ``Such fee shall be payable'' and all that 
     follows through ``section 510.'' and inserting the following: 
     ``Such fee shall be payable for the fiscal year in which the 
     product is first submitted for listing under section 510, or 
     for relisting under section 510 if the product has been 
     withdrawn from listing and relisted. After such fee is paid 
     for that fiscal year, such fee shall be payable on or before 
     January 31 of each year. Such fee shall be paid only once for 
     each product for a fiscal year in which the fee is 
     payable.''; and
       (B) in subparagraph (B), by striking ``505(j).'' and 
     inserting the following: ``505(j), 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, or is a product approved 
     under an application filed under section 507 that is 
     abbreviated.''.
       (b) Fee Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is 
     amended to read as follows:
       ``(b) Fee Amounts.--Except as provided in subsections (c), 
     (d), (f), and (g), the fees required under subsection (a) 
     shall be determined and assessed as follows:
       ``(1) Application and supplement fees.--
       ``(A) Full fees.--The application fee under subsection 
     (a)(1)(A)(i) shall be $250,704 in fiscal year 1998, $256,338 
     in each of fiscal years 1999 and 2000, $267,606 in fiscal 
     year 2001, and $258,451 in fiscal year 2002.
       ``(B) Other fees.--The fee under subsection (a)(1)(A)(ii) 
     shall be $125,352 in fiscal year 1998, $128,169 in each of 
     fiscal years 1999 and 2000, $133,803 in fiscal year 2001, and 
     $129,226 in fiscal year 2002.
       ``(2) Fee revenues for establishment fees.--The total fee 
     revenues to be collected in establishment fees under 
     subsection (a)(2) shall be $35,600,000 in fiscal year 1998, 
     $36,400,000 in each of fiscal years 1999 and 2000, 
     $38,000,000 in fiscal year 2001, and $36,700,000 in fiscal 
     year 2002.
       ``(3) Total fee revenues for product fees.--The total fee 
     revenues to be collected in product fees under subsection 
     (a)(3) in a fiscal year shall be equal to the total fee 
     revenues collected in establishment fees under subsection 
     (a)(2) in that fiscal year.''.
       (c) Increases and Adjustments.--Section 736(c) (21 U.S.C. 
     379h(c)) is amended--
       (1) in the subsection heading, by striking ``Increases 
     and'';
       (2) in paragraph (1)--
       (A) by striking ``(1) Revenue'' and all that follows 
     through ``increased by the Secretary'' and inserting the 
     following: ``(1) Inflation adjustment.--The fees and total 
     fee revenues established in subsection (b) shall be adjusted 
     by the Secretary'';
       (B) in subparagraph (A), by striking ``increase'' and 
     inserting ``change'';
       (C) in subparagraph (B), by striking ``increase'' and 
     inserting ``change''; and
       (D) by adding at the end the following flush sentence:

     ``The adjustment made each fiscal year by this subsection 
     will be added on a compounded basis to the sum of all 
     adjustments made each fiscal year after fiscal year 1997 
     under this subsection.'';
       (3) in paragraph (2), by striking ``October 1, 1992,'' and 
     all that follows through ``such schedule.'' and inserting the 
     following: ``September 30, 1997, adjust the establishment and 
     product fees described in subsection (b) for the fiscal year 
     in which the adjustment occurs so that the revenues collected 
     from each of the categories of fees described in paragraphs 
     (2) and (3) of subsection (b) shall be set to be equal to the 
     revenues collected from the category of application and 
     supplement fees described in paragraph (1) of subsection 
     (b).''; and
       (4) in paragraph (3), by striking ``paragraph (2)'' and 
     inserting ``this subsection''.
       (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 
     379h(d)) is amended--
       (1) by redesignating paragraphs (1), (2), (3), and (4) as 
     subparagraphs (A), (B), (C), and (D), respectively, and 
     indenting appropriately;
       (2) by striking ``The Secretary shall grant a'' and all 
     that follows through ``finds that--'' and inserting the 
     following:
       ``(1) In general.--The Secretary shall grant a waiver from 
     or a reduction of 1 or more fees assessed under subsection 
     (a) where the Secretary finds that--'';
       (3) in subparagraph (C) (as so redesignated by paragraph 
     (1)), by striking ``, or'' and inserting a comma;
       (4) in subparagraph (D) (as so redesignated by paragraph 
     (1)), by striking the period and inserting ``, or'';
       (5) by inserting after subparagraph (D) (as so redesignated 
     by paragraph (1)) the following:
       ``(E) the applicant is a small business submitting its 
     first human drug application to the Secretary for review.''; 
     and
       (6) by striking ``In making the finding in paragraph (3),'' 
     and all that follows through ``standard costs.'' and 
     inserting the following:
       ``(2) Use of standard costs.--In making the finding in 
     paragraph (1)(C), the Secretary may use standard costs.
       ``(3) Rules relating to small businesses.--
       ``(A) Definition.--In paragraph (1)(E), the term `small 
     business' means an entity that has fewer than 500 employees, 
     including employees of affiliates.
       ``(B) Waiver of application fee.--The Secretary shall waive 
     under paragraph (1)(E) the application fee for the first 
     human drug application that a small business or its affiliate 
     submits to the Secretary for review. After a small business 
     or its affiliate is granted such a waiver, the small business 
     or its affiliate shall pay--
       ``(i) application fees for all subsequent human drug 
     applications submitted to the Secretary for review in the 
     same manner as an entity that does not qualify as a small 
     business; and
       ``(ii) all supplement fees for all supplements to human 
     drug applications submitted to the Secretary for review in 
     the same manner as an entity that does not qualify as a small 
     business.''.
       (e) Assessment of Fees.--Section 736(f)(1) (21 U.S.C. 
     379h(f)(1)) is amended--
       (1) by striking ``fiscal year 1993'' and inserting ``fiscal 
     year 1997''; and
       (2) by striking ``fiscal year 1992'' and inserting ``fiscal 
     year 1997 (excluding the amount of fees appropriated for such 
     fiscal year)''.
       (f) Crediting and Availability of Fees.--Section 736(g) (21 
     U.S.C. 379h(g)) is amended--
       (1) in paragraph (1), by adding at the end the following: 
     ``Such sums as may be necessary may be transferred from the 
     Food and Drug Administration salaries and expenses 
     appropriation account without fiscal year limitation to such 
     appropriation account for salaries and expenses with such 
     fiscal year limitation. The sums transferred shall be 
     available solely for the process for the review of human drug 
     applications within the meaning of section 735(6).'';
       (2) in paragraph (2)--
       (A) in subparagraph (A), by striking ``Acts'' and inserting 
     ``Acts, or otherwise made available for obligation,''; and
       (B) in subparagraph (B), by striking ``over such costs for 
     fiscal year 1992'' and inserting ``over such costs, excluding 
     costs paid from fees collected under this section, for fiscal 
     year 1997''; and

[[Page H8495]]

       (3) 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.''.
       (g) Requirement for Written Requests for Waivers, 
     Reductions, and Fees.--Section 736 (21 U.S.C. 379h) is 
     amended--
       (1) by redesignating subsection (i) as subsection (j); and
       (2) by inserting after subsection (h) the following:
       ``(i) Written Requests for Waivers, Reductions, and 
     Refunds.--To qualify for consideration for a waiver or 
     reduction under subsection (d), or for a refund, of any fee 
     collected in accordance with subsection (a), a person shall 
     submit to the Secretary a written request for such waiver, 
     reduction, or refund not later than 180 days after such fee 
     is due.''.
       (h) Special Rule for Waiver, Refunds, and Exceptions.--Any 
     requests for waivers, refunds, or exceptions for fees paid 
     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.

     SEC. 705. ANNUAL REPORTS.

       (a) First 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 section 
     702(4) during such fiscal year and the future plans of the 
     Food and Drug Administration for meeting the goals.
       (b) Second Report.--Beginning with fiscal year 1998, not 
     later than 120 days after the end of each fiscal year during 
     which fees are collected under the part described in 
     subsection (a), the Secretary of Health and Human Services 
     shall prepare and submit to the Committee on Commerce of the 
     House of Representatives and the Committee on Labor and Human 
     Resources of the Senate a report on the implementation of the 
     authority for such fees during such fiscal year and the use, 
     by the Food and Drug Administration, of the fees collected 
     during such fiscal year for which the report is made.

     SEC. 706. EFFECTIVE DATE.

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

     SEC. 707. TERMINATION OF EFFECTIVENESS.

       The amendments made by sections 703 and 704 cease to be 
     effective October 1, 2002 and section 705 ceases to be 
     effective 120 days after such date.
                       TITLE VIII--MISCELLANEOUS

     SEC. 801. REGISTRATION OF FOREIGN ESTABLISHMENTS.

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

     SEC. 802. ELIMINATION OF CERTAIN LABELING REQUIREMENTS.

       (a) Prescription Drugs.--Section 503(b)(4) (21 U.S.C. 
     353(b)(4)) is amended to read as follows:
       ``(4)(A) A drug that is subject to paragraph (1) shall be 
     deemed to be misbranded if at any time prior to dispensing 
     the label of the drug fails to bear, at a minimum, the symbol 
     `Rx only'.
       ``(B) A drug to which paragraph (1) does not apply shall be 
     deemed to be misbranded if at any time prior to dispensing 
     the label of the drug bears the symbol described in 
     subparagraph (A).''.
       (b) Misbranded Drug.--Section 502(d) (21 U.S.C. 352(d)) is 
     repealed.
       (c) Conforming Amendments.--
       (1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended--
       (A) by striking subparagraph (A); and
       (B) by redesignating subparagraphs (B) and (C) as 
     subparagraphs (A) and (B), respectively.
       (2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by 
     striking ``section 502(d) and''.
       (3) Section 102(9)(A) of the Controlled Substances Act (21 
     U.S.C. 802(9)(A)) is amended--
       (A) in clause (i), by striking ``(i)''; and
       (B) by striking ``(ii)'' and all that follows.

     SEC. 803. CLARIFICATION OF SEIZURE AUTHORITY.

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

     SEC. 804. INTRAMURAL RESEARCH TRAINING AWARD PROGRAM.

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

     ``SEC. 907. INTRAMURAL RESEARCH TRAINING AWARD PROGRAM.

       ``(a) In General.--The Secretary, acting through the 
     Commissioner of Food and Drugs, may, directly or through 
     grants, contracts, or cooperative agreements, conduct and 
     support intramural research training in regulatory scientific 
     programs by predoctoral and postdoctoral scientists and 
     physicians, including support through the use of fellowships.
       ``(b) Limitation on Participation.--A recipient of a 
     fellowship under subsection (a) may not be an employee of the 
     Federal Government.
       ``(c) Special Rule.--The Secretary, acting through the 
     Commissioner of Food and Drugs, may support the provision of 
     assistance for fellowships described in subsection (a) 
     through a Cooperative Research and Development Agreement.''.

     SEC. 805. DEVICE SAMPLES.

       (a) Recall Authority.--
       (1) In general.--Section 518(e)(2) (21 U.S.C. 360h(e)(2)) 
     is amended by adding at the end the following:
       ``(C) If the Secretary issues an amended order under 
     subparagraph (A), the Secretary may require the person 
     subject to the order to submit such samples of the device and 
     of components of the device as the Secretary may reasonably 
     require. If the submission of such samples is impracticable 
     or unduly burdensome, the requirement of this subparagraph 
     may be met by the submission of complete information 
     concerning the location of 1 or more such devices readily 
     available for examination and testing.''.
       (2) Technical amendment.--Section 518(e)(2)(A) (21 U.S.C. 
     360h(e)(2)(A)) is amended by striking ``subparagraphs (B) and 
     (C)'' and inserting ``subparagraph (B)''.
       (b) Records and Reports on Devices.--Section 519(a) (21 
     U.S.C. 360i(a)) is amended by inserting after paragraph (9) 
     the following:
       ``(10) may reasonably require a manufacturer or importer to 
     submit samples of a device and of components of the device 
     that may have caused or contributed to a death or serious 
     injury, except that if the submission of such samples is 
     impracticable or unduly burdensome, the requirement of this 
     paragraph may be met by the submission of complete 
     information concerning the location of 1 or more such devices 
     readily available for examination and testing.''.

     SEC. 806. INTERSTATE COMMERCE.

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

     SEC. 807. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND 
                   COSMETICS.

       (a) Nonprescription Drugs.--Chapter VII (21 U.S.C. 371 et 
     seq.), as amended by section 614(a), is further amended by 
     adding at the end the following:

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

     ``SEC. 761. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS.

       ``(a) In General.--Except as provided in subsection (b), 
     (c)(1), (d), (e), or (f), no State or political subdivision 
     of a State may establish or continue in effect any 
     requirement--
       ``(1) that relates to the regulation of a drug that is not 
     subject to the requirements of section 503(b)(1) or 
     503(f)(1)(A); and
       ``(2) that is different from or in addition to, or that is 
     otherwise not identical with, a requirement under this Act, 
     the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 
     et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 
     1451 et seq.).
       ``(b) Exemption.--
       ``(1) In general.--Upon application of a State or political 
     subdivision thereof, the Secretary may by regulation, after 
     notice and opportunity for written and oral presentation of 
     views, exempt from subsection (a), under such conditions as 
     may be prescribed in such regulation, a State or political 
     subdivision requirement that--
       ``(A) protects an important public interest that would 
     otherwise be unprotected, including the health and safety of 
     children;

[[Page H8496]]

       ``(B) would not cause any drug to be in violation of any 
     applicable requirement or prohibition under Federal law; and
       ``(C) would not unduly burden interstate commerce.
       ``(2) Timely action.--The Secretary shall make a decision 
     on the exemption of a State or political subdivision 
     requirement under paragraph (1) not later than 120 days after 
     receiving the application of the State or political 
     subdivision under paragraph (1).
       ``(c) Scope.--
       ``(1) In general.--This section shall not apply to--
       ``(A) any State or political subdivision requirement that 
     relates to the practice of pharmacy; or
       ``(B) any State or political subdivision requirement that a 
     drug be dispensed only upon the prescription of a 
     practitioner licensed by law to administer such drug.
       ``(2) Safety or effectiveness.--For purposes of subsection 
     (a), a requirement that relates to the regulation of a drug 
     shall be deemed to include any requirement relating to public 
     information or any other form of public communication 
     relating to a warning of any kind for a drug.
       ``(d) Exceptions.--
       ``(1) In general.--In the case of a drug described in 
     subsection (a)(1) that is not the subject of an application 
     approved under section 505 or 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: Provided, That the 
     requirement for stating the quantity of the active 
     ingredients, other than the quantity of those specifically 
     named in this paragraph, 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: 
     Provided, That the requirements of this clause with respect 
     to alphabetical order shall apply only to nonprescription 
     drugs that are not also cosmetics: and Provided further, That 
     this clause 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: 
     Provided, That to the extent that compliance with the 
     requirements of clause (A)(ii) or (iii) or this clause of 
     this subparagraph is impracticable, exemptions shall be 
     established by regulations promulgated by the Secretary.''.
       (d) Cosmetics.--Subchapter F of chapter VII, as amended by 
     subsection (a), is further amended by adding at the end the 
     following:

     ``SEC. 762. 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 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. 808. 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 and subject to the availability 
     of appropriations, 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, and biologicals, 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 and 520 of the Federal 
     Food, Drug, and Cosmetic Act that provides a description of 
     the purpose of each experimental drug or biological protocol, 
     either with the consent of the protocol sponsor, or when a 
     trial to test efficacy 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 the approval by the 
     Food and Drug Administration.
       ``(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 pursuant to part 312 of title 21, Code of 
     Federal Regulations; or
       ``(ii) as a Group C cancer drug.

     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.

[[Page H8497]]

       ``(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 finds 
     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 (21 U.S.C. 379h) shall not be 
     authorized or appropriated for use 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 
     subsection (j) of section 402 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 that shall 
     consider, among other things--
       (A) the public health need, if any, for inclusion of device 
     investigations within the scope of the registry requirements 
     set forth in subsection (j) of section 402 of the Public 
     Health Service Act; and
       (B) 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.

     SEC. 809. APPLICATION OF FEDERAL LAW TO THE PRACTICE OF 
                   PHARMACY COMPOUNDING.

       Section 503 (21 U.S.C. 353) is amended by adding at the end 
     the following:
       ``(h)(1) Sections 501(a)(2)(B), 502(f)(1), 502(l), 505, and 
     507 shall not apply to a drug product if--
       ``(A) the drug product is compounded for an identified 
     individual patient, based on a medical need for a compounded 
     product--
       ``(i) by a licensed pharmacist in a State licensed pharmacy 
     or a Federal facility, or a licensed physician, on the 
     prescription order of a licensed physician or other licensed 
     practitioner authorized by State law to prescribe drugs; or
       ``(ii) by a licensed pharmacist or licensed physician in 
     limited quantities, prior to the receipt of a valid 
     prescription order for the identified individual patient, and 
     is compounded based on a history of the licensed pharmacist 
     or licensed physician receiving valid prescription orders for 
     the compounding of the drug product that have been generated 
     solely within an established relationship between the 
     licensed pharmacist, or licensed physician, and--
       ``(I) the individual patient for whom the prescription 
     order will be provided; or
       ``(II) the physician or other licensed practitioner who 
     will write such prescription order; and
       ``(B) the licensed pharmacist or licensed physician--
       ``(i) compounds the drug product using bulk drug 
     substances--
       ``(I) that--

       ``(aa) comply with the standards of an applicable United 
     States Pharmacopeia or National Formulary monograph; or
       ``(bb) in a case in which such a monograph does not exist, 
     are drug substances that are covered by regulations issued by 
     the Secretary under paragraph (3);

       ``(II) that are manufactured by an establishment that is 
     registered under section 510 (including a foreign 
     establishment that is registered under section 510(i)); and
       ``(III) that are accompanied by valid certificates of 
     analysis for each bulk drug substance;
       ``(ii) compounds the drug product using ingredients (other 
     than bulk drug substances) that comply with the standards of 
     an applicable United States Pharmacopeia or National 
     Formulary monograph and the United States Pharmacopeia 
     chapter on pharmacy compounding;
       ``(iii) only advertises or promotes the compounding service 
     provided by the licensed pharmacist or licensed physician and 
     does not advertise or promote the compounding of any 
     particular drug, class of drug, or type of drug;
       ``(iv) does not compound a drug product that appears on a 
     list published by the Secretary in the Federal Register of 
     drug products that have been withdrawn or removed from the 
     market because such drug products or components of such drug 
     products have been found to be unsafe or not effective;
       ``(v) does not compound a drug product that is identified 
     by the Secretary in regulation as presenting demonstrable 
     difficulties for compounding that reasonably demonstrate an 
     adverse effect on the safety or effectiveness of that drug 
     product; and
       ``(vi) does not distribute compounded drugs outside of the 
     State in which the drugs are compounded, unless the principal 
     State agency of jurisdiction that regulates the practice of 
     pharmacy in such State has entered into a memorandum of 
     understanding with the Secretary regarding the regulation of 
     drugs that are compounded in the State and are distributed 
     outside of the State, that provides for appropriate 
     investigation by the State agency of complaints relating to 
     compounded products distributed outside of the State.
       ``(2)(A) The Secretary shall, after consultation with the 
     National Association of Boards of Pharmacy, develop a 
     standard memorandum of understanding for use by States in 
     complying with paragraph (1)(B)(vi).
       ``(B) Paragraph (1)(B)(vi) shall not apply to a licensed 
     pharmacist or licensed physician, who does not distribute 
     inordinate amounts of compounded products outside of the 
     State, until--
       ``(i) the date that is 180 days after the development of 
     the standard memorandum of understanding; or
       ``(ii) the date on which the State agency enters into a 
     memorandum of understanding under paragraph (1)(B)(vi),

     whichever occurs first.
       ``(3) The Secretary, after consultation with the United 
     States Pharmacopeia Convention Incorporated, shall promulgate 
     regulations limiting compounding under paragraph 
     (1)(B)(i)(I)(bb) to drug substances that are components of 
     drug products approved by the Secretary and to other drug 
     substances as the Secretary may identify.
       ``(4) The provisions of paragraph (1) shall not apply--
       ``(A) to compounded positron emission tomography drugs as 
     defined in section 201(ii); or
       ``(B) to radiopharmaceuticals.
       ``(5) In this subsection, the term `compound' does not 
     include to mix, reconstitute, or perform another similar act, 
     in accordance with directions contained in approved drug 
     labeling provided by a drug manufacturer and other drug 
     manufacturer directions consistent with that labeling.''.

     SEC. 810. REPORTS OF POSTMARKETING APPROVAL STUDIES.

       (a) In General.--Chapter V (21 U.S.C. 351 et seq.), as 
     amended by section 613(a), is further amended by adding at 
     the end the following:

     ``SEC. 562. REPORTS OF POSTMARKETING STUDIES.

       ``(a) Submission.--
       ``(1) In general.--A sponsor of a drug that has entered 
     into an agreement with the Secretary to conduct a 
     postmarketing study of a drug shall submit to the Secretary, 
     within 1 year after the approval of such drug and annually 
     thereafter until the study is completed or terminated, a 
     report of the progress of the study or the reasons for the 
     failure of the sponsor to conduct the study. The report shall 
     be submitted in such form as prescribed by the Secretary in 
     regulations issued by the Secretary.
       ``(2) Agreements prior to effective date.--An agreement 
     entered into between the Secretary and a sponsor of a drug, 
     prior to the date of enactment of this section, to conduct a 
     postmarketing study of a drug shall be subject to the 
     requirements of paragraph (1). An initial report for such an 
     agreement shall be submitted within 6 months after the date 
     of the issuance of the regulations under paragraph (1).
       ``(b) Consideration of Information as Public Information.--
     Any information pertaining to a report described in paragraph 
     (1) shall be considered to be public information to the 
     extent that the information is necessary--
       ``(1) to identify the sponsor; and
       ``(2) to establish the status of a study described in 
     subsection (a) and the reasons, if any, for any failure to 
     carry out the study.
       ``(c) Status of Studies and Reports.--The Secretary shall 
     annually develop and publish in the Federal Register a report 
     that provides a status of the postmarketing studies--
       ``(1) that sponsors have entered into agreements to 
     conduct; and
       ``(2) for which reports have been submitted under 
     subsection (a)(1).''.
       (b) Report to Congressional Committees.--Not later than 
     October 1, 2001, the Secretary shall prepare and submit to 
     the Committee on Labor and Human Resources of the Senate and 
     the Committee on Commerce of the House of Representatives a 
     report containing--
       (1) a summary of the reports submitted under section 562 of 
     the Federal Food, Drug, and Cosmetic Act; and
       (2) an evaluation of--
       (A) the performance of the sponsors in fulfilling the 
     agreements with respect to the conduct of postmarketing 
     studies described in such section of such Act;
       (B) the timeliness of the Secretary's review of the 
     postmarketing studies; and
       (C) any legislative recommendations respecting 
     postmarketing studies.

      SEC. 811. INFORMATION EXCHANGE.

       (a) In General.--Chapter VII (2 U.S.C. 371 et seq.), as 
     amended by section 807, is further amended by adding at the 
     end the following:

        ``Subchapter G--Dissemination of Treatment Information 

     ``SEC. 771. DISSEMINATION OF TREATMENT INFORMATION ON DRUGS, 
                   BIOLOGICAL PRODUCTS, AND DEVICES.

       ``(a) Dissemination of Treatment Information.--
       ``(1) In general.--Notwithstanding sections 301(d), 502(f), 
     505, and 507 and section 351 of the Public Health Service Act 
     (42 U.S.C. 262), and subject to the requirements of 
     paragraphs (2) through (6) and subsection (b), a manufacturer 
     may disseminate to a health care practitioner, a pharmacy 
     benefit manager, a health maintenance organization or

[[Page H8498]]

     other managed health care organization, or a health care 
     insurer or governmental agency, written information 
     concerning the safety, effectiveness, or benefit (whether or 
     not such information is contained in the official labeling) 
     of a drug, biological product, or device for which--
       ``(A) an approval of an application filed under section 
     505(b), 505(j), or 515, a clearance in accordance with 
     section 510(k), an approval in accordance with section 507, 
     or a biologics license issued under section 351 of the Public 
     Health Service Act, is in effect; and
       ``(B) if the use is not described in the approved labeling 
     of the product, the manufacturer has submitted to the 
     Secretary a certification that a supplemental application for 
     that use will be submitted to the Secretary pursuant to 
     paragraph (3) or the manufacturer has received an exemption 
     under paragraph (3)(C).
       ``(2) Authorized information.--A manufacturer may 
     disseminate the written information under paragraph (1) only 
     if the information--
       ``(A) is in the form of an unabridged--
       ``(i) reprint or copy of a peer-reviewed article from a 
     scientific or medical journal (as defined in subsection 
     (c)(5)) of a clinical investigation, with respect to a drug, 
     biological product or device, that would be considered to be 
     scientifically sound by experts qualified by scientific 
     training or experience to evaluate the safety or 
     effectiveness of the drug, biological product, or device that 
     is the subject of such clinical investigation; or
       ``(ii) reference textbook (as defined in subsection (c)(4)) 
     that includes information about a clinical investigation with 
     respect to a drug, biological product, or device, that would 
     be considered to be scientifically sound by experts qualified 
     by scientific training or experience to evaluate the safety 
     or effectiveness of the drug, biological product, or device 
     that is the subject of such clinical investigation; and
       ``(B) is not false, not misleading, and would not pose a 
     significant risk to the public health.
       ``(3) Commitment to file a supplemental application; 
     incentives for research.--
       ``(A) In general.--A manufacturer may disseminate 
     information about a use not described in the approved 
     labeling of a drug, biological product, or device pursuant to 
     paragraph (1) only if--
       ``(i) the manufacturer has submitted to the Secretary a 
     certification that the studies needed to file a supplemental 
     application for such use have been completed and such 
     supplement will be filed within 6 months after the date of 
     the initial dissemination of information under paragraph (1); 
     or
       ``(ii)(I) the manufacturer has submitted to the Secretary a 
     proposed protocol and schedule for conducting the studies 
     needed to submit a supplemental application for such use and 
     has certified that the supplement will be submitted within 36 
     months after the date of the initial dissemination of 
     information under paragraph (1); and
       ``(II) the Secretary has determined that the protocol for 
     conducting such studies is adequate and that the schedule for 
     completing such studies is reasonable.
       ``(B) Extension.--
       ``(i) Longer period of time.--The Secretary may grant a 
     longer period of time for a manufacturer to submit a 
     supplemental application pursuant to subparagraph (A) if the 
     Secretary determines that the studies needed to submit a 
     supplemental application cannot be completed and submitted 
     within 36 months.
       ``(ii) Extension of 3-year period.--The Secretary may 
     extend the time within which a manufacturer must submit a 
     supplemental application pursuant to subparagraph (A) if the 
     manufacturer demonstrates that the manufacturer has acted 
     with due diligence to conduct the studies in a timely manner. 
     Such extension shall not exceed a period of 24 months.
       ``(C) Exemptions.--A manufacturer may file a request for an 
     exemption from the requirements set forth in subparagraph 
     (A). Such request shall be submitted in the form and manner 
     prescribed by the Secretary and shall demonstrate that--
       ``(i) due to the size of the patient population or the lack 
     of potential benefit to the sponsor, the cost of obtaining 
     clinical information and submitting a supplemental 
     application is economically prohibitive; or
       ``(ii) it would be unethical to conduct the studies 
     necessary to obtain adequate evidence for approval of a 
     supplemental application.

     The Secretary shall act on a request for an exemption under 
     this subparagraph within 60 days after the receipt of the 
     request. If the Secretary fails to act within 60 days, the 
     manufacturer may begin to disseminate information pursuant to 
     paragraph (1) without complying with subparagraph (A). If the 
     Secretary subsequently denies the request for an exemption, 
     the manufacturer either shall cease dissemination or shall 
     comply with the requirements of subparagraph (A) within 60 
     days after such denial. If the manufacturer ceases 
     dissemination pursuant to this subparagraph solely on the 
     basis that the manufacturer does not comply with subparagraph 
     (A), the Secretary may take appropriate corrective action, 
     but may not order the manufacturer to take corrective action.
       ``(D) Report.--A manufacturer who submits a certification 
     to the Secretary under subparagraph (A) shall provide the 
     Secretary periodic reports that describe the status of the 
     studies being conducted to obtain adequate evidence for 
     approval of a supplemental application.
       ``(4) Information on new uses.--
       ``(A) In general.--If the information being disseminated 
     under paragraph (1) meets the requirements of this section, a 
     manufacturer may disseminate information under paragraph (1) 
     concerning the new use of a drug, biological product, or 
     device (described in paragraph (1)) 60 calendar days after 
     the manufacturer has submitted to the Secretary--
       ``(i) a copy of the information; and
       ``(ii) any clinical trial information the manufacturer has 
     relating to the safety or efficacy of the new use, any 
     reports of clinical experience pertinent to the safety of the 
     new use, and a summary of such information.

     If any of the information required to be provided under 
     clause (ii) has already been provided to the Secretary, the 
     manufacturer may meet the requirements of clause (ii) by 
     providing any such information obtained by the manufacturer 
     since the manufacturer's last submission to the Secretary and 
     a summary that identifies the information previously 
     provided.
       ``(B) Additional information.--If the Secretary determines 
     that the information submitted by a manufacturer under 
     subparagraph (A)(i) with respect to a new use of a drug, 
     biological product, or device fails to provide data, 
     analyses, or other written matter, that is objective and 
     balanced, the Secretary may require the manufacturer to 
     disseminate along with the information described in 
     subparagraph (A)--
       ``(i) additional information with respect to the new use of 
     the drug, biological product, or device that--

       ``(I) is in the form of an article described in paragraph 
     (2)(A); and
       ``(II) provides data, analyses, or other written matter, 
     that is scientifically sound;

       ``(ii) additional objective and scientifically sound 
     information that pertains to the safety or efficacy 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;
       ``(iii) an objective statement prescribed by the Secretary 
     based on information described in clause (i) or (ii), 
     provided the manufacturer has access to the data that forms 
     the basis of such statement unless the Secretary is 
     prohibited from making such data available to the 
     manufacturer; and
       ``(iv) a statement that describes any previous public 
     announcements by the Secretary relevant to the new use.
       ``(5) New information.--If a manufacturer that is 
     disseminating information pursuant to paragraph (1) becomes 
     aware of new information relating to the safety or efficacy 
     of a new use of a drug, biological product, or device for 
     which information was disseminated under paragraph (1), the 
     manufacturer shall notify the Secretary with respect to the 
     new information. If the Secretary determines that the new 
     information demonstrates that a drug, biological product, or 
     device may not be effective or may present a significant risk 
     to public health, the Secretary shall, in consultation with 
     the manufacturer, take such appropriate action as the 
     Secretary determines necessary to ensure public health and 
     safety. The Secretary may limit the types of new information 
     that must be submitted under this paragraph.
       ``(6) Cessation of dissemination; corrective action.--The 
     Secretary may order a manufacturer to cease the dissemination 
     of all information being disseminated pursuant to paragraph 
     (1) if--
       ``(A) the Secretary finds that a supplemental application 
     does not contain adequate information for approval for the 
     use that is the subject of the information;
       ``(B) the Secretary determines, after an informal hearing, 
     that the manufacturer is not acting with due diligence to 
     complete the studies necessary to file a supplemental 
     application for the use that is the subject of the 
     information being disseminated; or
       ``(C) the Secretary determines that the information being 
     disseminated does not comply with the requirements set forth 
     in this section, after providing notice, an opportunity for a 
     meeting, and for minor violations of this section (if there 
     has been substantial compliance with this section), an 
     opportunity to correct such information.

     If the Secretary orders cessation of dissemination pursuant 
     to this paragraph, the Secretary may order the manufacturer 
     to take appropriate corrective action.
       ``(7) Sponsored research.--If a manufacturer has sponsored 
     research that results in information as described in 
     paragraph (2)(A), another manufacturer may not distribute the 
     information under this section, unless such manufacturer is 
     required by the Secretary to distribute the information.
       ``(b) Disclosure Statement.--In order to afford a full and 
     fair evaluation of the information described in subsection 
     (a), a manufacturer disseminating the information shall 
     include along with the information--
       ``(1) a prominently displayed statement that discloses--
       ``(A) that the information concerns a use of a drug, 
     biological product, or device or other attribute of a drug, 
     biological product, or device that has not been approved by 
     the Food and Drug Administration;

[[Page H8499]]

       ``(B) if applicable, that the information is being 
     disseminated at the expense of the manufacturer;
       ``(C) if applicable, the name of any authors of the 
     information who are employees of, or consultants to, or have 
     received compensation from, the manufacturer, or who have a 
     significant financial interest in the manufacturer;
       ``(D) the official labeling for the drug, biological 
     product, or device and all updates with respect to the 
     labeling;
       ``(E) 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
       ``(F) the identification of any person that has provided 
     funding for the conduct of a study relating to a new use of a 
     drug, biological product, or device for which such 
     information is being disseminated; and
       ``(2) a bibliography of other articles from a scientific 
     reference textbook or scientific or medical journal that have 
     been previously published about the new use of a drug, 
     biological product, or device covered by the information 
     disseminated (unless the information already includes such 
     bibliography).
       ``(c) Definitions.--As used in this section:
       ``(1) Health care practitioner.--The term `health care 
     practitioner' means a medical provider that is licensed to 
     prescribe a drug or biological product, or to prescribe or 
     use a device, for the treatment of a disease or other medical 
     condition.
       ``(2) Manufacturer.--The term `manufacturer' includes a 
     person who manufactures, distributes, or markets a drug, 
     biological product, or device.
       ``(3) New use.--The term `new use' used with respect to a 
     drug, biological product, or device means a use of a drug, 
     biological product, or device not included in the approved 
     labeling of such drug, biological product, or device.
       ``(4) Reference textbook.--The term `reference textbook' 
     means a reference publication that--
       ``(A) has not been written, edited, excerpted, or published 
     specifically for, or at the request of a manufacturer of a 
     drug, biological product, or device;
       ``(B) has not been edited or significantly influenced by a 
     manufacturer of a drug, biological product, or device;
       ``(C) is not solely distributed through a manufacturer of a 
     drug, biological product, or device but is generally 
     available in bookstores or other distribution channels where 
     medical textbooks are sold;
       ``(D) does not focus on any particular drug, biological 
     product, or device of a manufacturer that disseminates 
     information under subsection (a), and does not have a primary 
     focus on new uses of drugs, biological products, or devices 
     that are marketed or under investigation by a manufacturer 
     supporting the dissemination of information; and
       ``(E) presents materials that are not false or misleading.
       ``(5) Scientific or medical journal.--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;
       ``(E) that presents materials that are not false or 
     misleading; and
       ``(F) that is not in the form of a special supplement that 
     has been funded in whole or in part by 1 or more 
     manufacturers.
       ``(d) Construction.--Nothing in this section shall be 
     construed as prohibiting a manufacturer from disseminating 
     information in response to an unsolicited request from a 
     health care practitioner.
       ``(e) Studies and Reports.--
       ``(1) General accounting office.--
       ``(A) In general.--The Comptroller General of the United 
     States shall conduct a study to determine the impact of this 
     section on the resources of the Department of Health and 
     Human Services.
       ``(B) Report.--Not later than January 1, 2002, the 
     Comptroller General of the United States shall prepare and 
     submit to the Committee on Labor and Human Resources of the 
     Senate and the Committee on Commerce of the House of 
     Representatives a report of the results of the study.
       ``(2) Department of health and human services.--
       ``(A) In general.--In order to assist Congress in 
     determining whether the provisions of this section should be 
     extended beyond the termination date specified in section 
     811(e) of the Food and Drug Administration Modernization and 
     Accountability Act of 1997, the Secretary of Health and Human 
     Services shall, in accordance with subparagraph (B), arrange 
     for the conduct of a study of the scientific issues raised as 
     a result of the enactment of this section, including issues 
     relating to--
       ``(i) the effectiveness of this section with respect to the 
     provision of useful scientific information to health care 
     practitioners;
       ``(ii) the quality of the information being disseminated 
     pursuant to the provisions of this section;
       ``(iii) the quality and usefulness of the information 
     provided, in accordance with this section, by the Secretary 
     or by the manufacturer at the request of the Secretary; and
       ``(iv) the impact of this section on research in the area 
     of new uses, indications, or dosages, particularly the impact 
     on pediatric indications and rare diseases.
       ``(3) Procedure for study.--
       ``(A) In general.--The Secretary shall request the 
     Institute of Medicine of the National Academy of Sciences to 
     conduct the study required by paragraph (2), and to prepare 
     and submit the report required by subparagraph (B), under an 
     arrangement by which the actual expenses incurred by the 
     Institute of Medicine in conducting the study and preparing 
     the report will be paid by the Secretary. If the Institute of 
     Medicine is unwilling to conduct the study under such an 
     arrangement, the Secretary shall enter into a similar 
     arrangement with another appropriate nonprofit private group 
     or association under which the group or association will 
     conduct the study and prepare and submit the report.
       ``(B) Report.--Not later than September 30, 2005, the 
     Institute of Medicine, the group, or association, as 
     appropriate, shall prepare and submit to the Committee on 
     Labor and Human Resources of the Senate, the Committee on 
     Commerce of the House of Representatives, and the Secretary a 
     report of the results of the study required by paragraph (2). 
     The Secretary, after the receipt of the report, shall make 
     the report available to the public.
       ``(4) Authorization of appropriation.--There are authorized 
     to be appropriated such sums as are necessary to carry out 
     this subsection.

     ``SEC. 772. ESTABLISHMENT OF LIST OF ARTICLES AND TEXTBOOKS 
                   DISSEMINATED AND LIST OF PROVIDERS THAT 
                   RECEIVED ARTICLES AND REFERENCE TEXTBOOKS.

       ``(a) In General.--A manufacturer that disseminates 
     information in the form of articles or reference textbooks 
     under section 771 shall prepare and submit to the Secretary 
     biannually--
       ``(1) a list containing the titles of the articles and 
     reference textbooks relating to the new use of drugs, 
     biological products, and devices that were disseminated by 
     the manufacturer to a person described in section 771(a)(1) 
     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 771(a)(1)) that received the 
     articles and reference textbooks for the 6-month period 
     described in paragraph (1).
       ``(b) Records.--A manufacturer that disseminates 
     information under section 771 shall keep records that 
     identify the recipients of articles and textbooks provided 
     pursuant to section 771. Such records are to be used by the 
     manufacturer when, pursuant to section 771(a)(6), 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 
     paragraph (3), (5), or (6) of section 771(a).

     ``SEC. 773. CONSTRUCTION.

       ``(a) Dissemination of Information on Drugs or Devices Not 
     Evidence of Intended Use.--Notwithstanding subsection (a), 
     (f), or (o) of section 502, or any other provision of law, 
     the dissemination of information relating to a new use of a 
     drug or device, in accordance with section 771, shall not be 
     construed by the Secretary as evidence of a new intended use 
     of the drug or device that is different from the intended use 
     of the drug or device set forth in the official labeling of 
     the drug or device. Such dissemination shall not be 
     considered by the Secretary as labeling, adulteration, or 
     misbranding of the drug or device.
       ``(b) Patent Protection.--Nothing in section 771 shall 
     affect patent rights in any manner.
       ``(c) Authorization for Dissemination of Articles and Fees 
     for Reprints of Articles.--Nothing in section 771 shall be 
     construed as prohibiting an entity that publishes a 
     scientific journal (as defined in section 771(c)(5)) from 
     requiring authorization from the entity to disseminate an 
     article published by such entity and from charging fees for 
     the purchase of reprints of published articles from such 
     entity.''.
       (b) Prohibited Act.--Section 301 (21 U.S.C. 331), as 
     amended by section 205(b), is further amended by adding at 
     the end the following:
       ``(y) The dissemination of information pursuant to section 
     771 by a manufacturer who fails to comply with the 
     requirements of such section.''.
       (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.

[[Page H8500]]

       (e) Termination of Effectiveness.--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. 812. REAUTHORIZATION OF CLINICAL PHARMACOLOGY PROGRAM.

       Section 2 of Public Law 102-222 (105 Stat. 1677) is 
     amended--
       (1) in subsection (a), by striking ``a grant'' and all that 
     follows through ``Such grant'' and inserting the following: 
     ``grants for a pilot program for the training of individuals 
     in clinical pharmacology at appropriate medical schools. Such 
     grants''; and
       (2) in subsection (b), by striking ``to carry out this 
     section'' and inserting ``, and for fiscal years 1998 through 
     2002 $3,000,000 for each fiscal year, to carry out this 
     section''.

     SEC. 813. MONOGRAPH FOR SUNBURN PRODUCTS.

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

     SEC. 814. SAFETY REPORT DISCLAIMERS.

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

     ``SEC. 908. SAFETY REPORT DISCLAIMERS.

       ``With respect to any entity that submits or is required to 
     submit a safety report or other information in connection 
     with the safety of a product (including a product which is a 
     food, drug, new drug, device, dietary supplement, or 
     cosmetic) under this Act (and any release by the Secretary of 
     that report or information), such report or information shall 
     not be construed to necessarily reflect a conclusion by the 
     entity or the Secretary that the report or information 
     constitutes an admission that the product involved caused or 
     contributed to an adverse experience, or otherwise caused or 
     contributed to a death, serious injury, serious illness, or 
     malfunction. Such an entity need not admit, and may deny, 
     that the report or information submitted by the entity 
     constitutes an admission that the product involved caused or 
     contributed to an adverse experience or caused or contributed 
     to a death, serious injury, serious illness, or 
     malfunction.''.


                      Motion Offered by Mr. Bliley

  Mr. BLILEY. Mr. Speaker, I offer a motion.
  The SPEAKER pro tempore. The Clerk will report the motion.
  The Clerk read as follows:

       Mr. Bliley moves to strike out all after the enacting 
     clause, and insert in lieu thereof the text of H.R. 1411, as 
     passed by the House.

  The motion was agreed to.
  The Senate bill was ordered to be read a third time, was read the 
third time, and passed.
  The title of the Senate bill was amended so as to read: ``A bill to 
amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
Service Act to facilitate the development and approval of new drugs and 
biological products, and for other purposes.''
  A motion to reconsider was laid on the table.
  A similar House bill (H.R. 1411) was laid on the table.

                          ____________________