[Congressional Record Volume 143, Number 157 (Sunday, November 9, 1997)]
[House]
[Pages H10452-H10478]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


_______________________________________________________________________

CONFERENCE REPORT ON S. 830, FOOD AND DRUG ADMINISTRATION MODERNIZATION 
                              ACT OF 1997

  Mr. BLILEY submitted the following conference report and statement on 
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:

                  Conference Report (H. Rept. 105-399)

       The Committee of conference on the disagreeing votes of the 
     two Houses on the amendments of the House to the bill (S. 
     830) to amend the Federal Food, Drug, and Cosmetic Act and 
     the Public Health Service Act to improve the regulation of 
     food, drugs, devices, and biological products, and for other 
     purposes, having met, after full and free conference, have 
     agreed to recommend and do recommend to their respective 
     Houses as follows:
       That the Senate recede from its disagreement to the 
     amendment of the House to the text of the bill and agree to 
     the same with an amendment as follows:
       In lieu of the matter proposed to be inserted by the House 
     amendment, insert the following:

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

       (a) Short Title.--This Act may be cited as the ``Food and 
     Drug Administration Modernization Act of 1997''.
       (b) References.--Except as otherwise specified, whenever in 
     this Act an amendment or repeal is expressed in terms of an 
     amendment to or a repeal of a section or other provision, the 
     reference shall be considered to be made to that section or 
     other provision of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 301 et seq.).
       (c) Table of Contents.--The table of contents for this Act 
     is as follows:

Sec. 1. Short title; references; table of contents.
Sec. 2. Definitions.

                 TITLE I--IMPROVING REGULATION OF DRUGS

                   Subtitle A--Fees Relating to Drugs

Sec. 101. Findings.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Annual reports.
Sec. 105. Savings.
Sec. 106. Effective date.
Sec. 107. Termination of effectiveness.

                     Subtitle B--Other Improvements

Sec. 111. Pediatric studies of drugs.
Sec. 112. Expediting study and approval of fast track drugs.
Sec. 113. Information program on clinical trials for serious or life-
              threatening diseases.
Sec. 114. Health care economic information.
Sec. 115. Clinical investigations.
Sec. 116. Manufacturing changes for drugs.
Sec. 117. Streamlining clinical research on drugs.
Sec. 118. Data requirements for drugs and biologics.
Sec. 119. Content and review of applications.
Sec. 120. Scientific advisory panels.
Sec. 121. Positron emission tomography.
Sec. 122. Requirements for radiopharmaceuticals.
Sec. 123. Modernization of regulation.
Sec. 124. Pilot and small scale manufacture.
Sec. 125. Insulin and antibiotics.
Sec. 126. Elimination of certain labeling requirements.
Sec. 127. Application of Federal law to practice of pharmacy 
              compounding.
Sec. 128. Reauthorization of clinical pharmacology program.
Sec. 129. Regulations for sunscreen products.
Sec. 130. Reports of postmarketing approval studies.
Sec. 131. Notification of discontinuance of a life saving product.

               TITLE II--IMPROVING REGULATION OF DEVICES

Sec. 201. Investigational device exemptions.
Sec. 202. Special review for certain devices.
Sec. 203. Expanding humanitarian use of devices.
Sec. 204. Device standards.
Sec. 205. Scope of review; collaborative determinations of device data 
              requirements.
Sec. 206. Premarket notification.
Sec. 207. Evaluation of automatic class III designation.
Sec. 208. Classification panels.
Sec. 209. Certainty of review timeframes; collaborative review process.
Sec. 210. Accreditation of persons for review of premarket notification 
              reports.
Sec. 211. Device tracking.
Sec. 212. Postmarket surveillance.
Sec. 213. Reports.
Sec. 214. Practice of medicine.
Sec. 215. Noninvasive blood glucose meter.
Sec. 216. Use of data relating to premarket approval; product 
              development protocol.
Sec. 217. Clarification of the number of required clinical 
              investigations for approval.

                TITLE III--IMPROVING REGULATION OF FOOD

Sec. 301. Flexibility for regulations regarding claims.
Sec. 302. Petitions for claims.
Sec. 303. Health claims for food products.
Sec. 304. Nutrient content claims.
Sec. 305. Referral statements.
Sec. 306. Disclosure of irradiation.
Sec. 307. Irradiation petition.
Sec. 308. Glass and ceramic ware.
Sec. 309. Food contact substances.

                      TITLE IV--GENERAL PROVISIONS

Sec. 401. Dissemination of information on new uses.
Sec. 402. Expanded access to investigational therapies and diagnostics.
Sec. 403. Approval of supplemental applications for approved products.
Sec. 404. Dispute resolution.
Sec. 405. Informal agency statements.
Sec. 406. Food and Drug Administration mission and annual report.
Sec. 407. Information system.
Sec. 408. Education and training.
Sec. 409. Centers for education and research on therapeutics.
Sec. 410. Mutual recognition agreements and global harmonization.
Sec. 411. Environmental impact review.
Sec. 412. National uniformity for nonprescription drugs and cosmetics.
Sec. 413. Food and Drug Administration study of mercury compounds in 
              drugs and food.
Sec. 414. Interagency collaboration.
Sec. 415. Contracts for expert review.
Sec. 416. Product classification.
Sec. 417. Registration of foreign establishments.
Sec. 418. Clarification of seizure authority.
Sec. 419. Interstate commerce.
Sec. 420. Safety report disclaimers.
Sec. 421. Labeling and advertising regarding compliance with statutory 
              requirements.
Sec. 422. Rule of construction.

                        TITLE V--EFFECTIVE DATE

Sec. 501. Effective date.

     SEC. 2. DEFINITIONS.

       In this Act, the terms ``drug'', ``device'', ``food'', and 
     ``dietary supplement'' have the meaning given such terms in 
     section 201 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 321).
                 TITLE I--IMPROVING REGULATION OF DRUGS
                   Subtitle A--Fees Relating to Drugs

     SEC. 101. FINDINGS.

       Congress finds that--
       (1) prompt approval of safe and effective new drugs and 
     other therapies is critical to the improvement of the public 
     health so that patients may enjoy the benefits provided by 
     these therapies to treat and prevent illness and disease;
       (2) the public health will be served by making additional 
     funds available for the purpose of augmenting the resources 
     of the Food and Drug Administration that are devoted to the 
     process for review of human drug applications;
       (3) the provisions added by the Prescription Drug User Fee 
     Act of 1992 have been successful in substantially reducing 
     review times for human drug applications and should be--
       (A) reauthorized for an additional 5 years, with certain 
     technical improvements; and
       (B) carried out by the Food and Drug Administration with 
     new commitments to implement more ambitious and comprehensive 
     improvements in regulatory processes of the Food and Drug 
     Administration; and
       (4) the fees authorized by amendments made in this subtitle 
     will be dedicated toward expediting the drug development 
     process and the review of human drug applications as set 
     forth in the goals identified, for purposes of part 2 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act, in the letters from the Secretary of Health and 
     Human Services to the chairman of the Committee on Commerce 
     of the House of Representatives and the chairman of

[[Page H10453]]

     the Committee on Labor and Human Resources of the Senate, as 
     set forth in the Congressional Record.

     SEC. 102. DEFINITIONS.

       Section 735 (21 U.S.C. 379g) is amended--
       (1) in the second sentence of paragraph (1)--
       (A) by striking ``Service Act, and'' and inserting 
     ``Service Act,''; and
       (B) by striking ``September 1, 1992.'' and inserting the 
     following: ``September 1, 1992, does not include an 
     application for a licensure of a biological product for 
     further manufacturing use only, and does not include an 
     application or supplement submitted by a State or Federal 
     Government entity for a drug that is not distributed 
     commercially. Such term does include an application for 
     licensure, as described in subparagraph (D), of a large 
     volume biological product intended for single dose 
     injection for intravenous use or infusion.'';
       (2) in the second sentence of paragraph (3)--
       (A) by striking ``Service Act, and'' and inserting 
     ``Service Act,''; and
       (B) by striking ``September 1, 1992.'' and inserting the 
     following: ``September 1, 1992, does not include a biological 
     product that is licensed for further manufacturing use only, 
     and does not include a drug that is not distributed 
     commercially and is the subject of an application or 
     supplement submitted by a State or Federal Government entity. 
     Such term does include a large volume biological product 
     intended for single dose injection for intravenous use or 
     infusion.'';
       (3) in paragraph (4), by striking ``without'' and inserting 
     ``without substantial'';
       (4) by amending the first sentence of paragraph (5) to read 
     as follows:
       ``(5) The term `prescription drug establishment' means a 
     foreign or domestic place of business which is at one general 
     physical location consisting of one or more buildings all of 
     which are within five miles of each other and at which one or 
     more prescription drug products are manufactured in final 
     dosage form.'';
       (5) in paragraph (7)(A)--
       (A) by striking ``employees under contract'' and all that 
     follows through ``Administration,'' the second time it occurs 
     and inserting ``contractors of the Food and Drug 
     Administration,''; and
       (B) by striking ``and committees,'' and inserting ``and 
     committees and to contracts with such contractors,'';
       (6) in paragraph (8)--
       (A) in subparagraph (A)--
       (i) by striking ``August of '' and inserting ``April of ''; 
     and
       (ii) by striking ``August 1992'' and inserting ``April 
     1997''; and
       (B) in subparagraph (B)--
       (i) by striking ``section 254(d)'' and inserting ``section 
     254(c)'';
       (ii) by striking ``1992'' and inserting ``1997''; and
       (iii) by striking ``102d Congress, 2d Session'' and 
     inserting ``105th Congress, 1st Session''; and
       (7) by adding at the end the following:
       ``(9) The term `affiliate' means a business entity that has 
     a relationship with a second business entity if, directly or 
     indirectly--
       ``(A) one business entity controls, or has the power to 
     control, the other business entity; or
       ``(B) a third party controls, or has power to control, both 
     of the business entities.''.

     SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

       (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is 
     amended--
       (1) by striking ``Beginning in fiscal year 1993'' and 
     inserting ``Beginning in fiscal year 1998'';
       (2) in paragraph (1)--
       (A) by striking subparagraph (B) and inserting the 
     following:
       ``(B) Payment.--The fee required by subparagraph (A) shall 
     be due upon submission of the application or supplement.'';
       (B) in subparagraph (D)--
       (i) in the subparagraph heading, by striking ``not 
     accepted'' and inserting ``refused'';
       (ii) by striking ``50 percent'' and inserting ``75 
     percent'';
       (iii) by striking ``subparagraph (B)(i)'' and inserting 
     ``subparagraph (B)''; and
       (iv) by striking ``not accepted'' and inserting 
     ``refused''; and
       (C) by adding at the end the following:
       ``(E) Exception for designated orphan drug or indication.--
     A human drug application for a prescription drug product that 
     has been designated as a drug for a rare disease or condition 
     pursuant to section 526 shall not be subject to a fee under 
     subparagraph (A), unless the human drug application includes 
     an indication for other than a rare disease or condition. A 
     supplement proposing to include a new indication for a rare 
     disease or condition in a human drug application shall not be 
     subject to a fee under subparagraph (A), if the drug has been 
     designated pursuant to section 526 as a drug for a rare 
     disease or condition with regard to the indication proposed 
     in such supplement.
       ``(F) Exception for supplements for pediatric 
     indications.--A supplement to a human drug application 
     proposing to include a new indication for use in pediatric 
     populations shall not be assessed a fee under subparagraph 
     (A).
       ``(G) Refund of fee if application withdrawn.--If an 
     application or supplement is withdrawn after the application 
     or supplement was filed, the Secretary may refund the fee or 
     a portion of the fee if no substantial work was performed on 
     the application or supplement after the application or 
     supplement was filed. The Secretary shall have the sole 
     discretion to refund a fee or a portion of the fee under this 
     subparagraph. A determination by the Secretary concerning a 
     refund under this paragraph shall not be reviewable.'';
       (3) by striking paragraph (2) and inserting the following:
       ``(2) Prescription drug establishment fee.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     each person that--
       ``(i) is named as the applicant in a human drug 
     application; and
       ``(ii) after September 1, 1992, had pending before the 
     Secretary a human drug application or supplement,

     shall be assessed an annual fee established in subsection (b) 
     for each prescription drug establishment listed in its 
     approved human drug application as an establishment that 
     manufactures the prescription drug product named in the 
     application. The annual establishment fee shall be assessed 
     in each fiscal year in which the prescription drug product 
     named in the application is assessed a fee under paragraph 
     (3) unless the prescription drug establishment listed in the 
     application does not engage in the manufacture of the 
     prescription drug product during the fiscal year. The 
     establishment fee shall be payable on or before January 31 of 
     each year. Each such establishment shall be assessed only one 
     fee per establishment, notwithstanding the number of 
     prescription drug products manufactured at the establishment. 
     In the event an establishment is listed in a human drug 
     application by more than one applicant, the establishment fee 
     for the fiscal year shall be divided equally and assessed 
     among the applicants whose prescription drug products are 
     manufactured by the establishment during the fiscal year and 
     assessed product fees under paragraph (3).
       ``(B) Exception.--If, during the fiscal year, an applicant 
     initiates or causes to be initiated the manufacture of a 
     prescription drug product at an establishment listed in its 
     human drug application--
       ``(i) that did not manufacture the product in the previous 
     fiscal year; and
       ``(ii) for which the full establishment fee has been 
     assessed in the fiscal year at a time before manufacture of 
     the prescription drug product was begun;

     the applicant will not be assessed a share of the 
     establishment fee for the fiscal year in which the 
     manufacture of the product began.''; and
       (4) in paragraph (3)--
       (A) in subparagraph (A)--
       (i) in clause (i), by striking ``is listed'' and inserting 
     ``has been submitted for listing''; and
       (ii) by striking ``Such fee shall be payable'' and all that 
     follows through ``section 510.'' and inserting the following: 
     ``Such fee shall be payable for the fiscal year in which the 
     product is first submitted for listing under section 510, or 
     is submitted for relisting under section 510 if the product 
     has been withdrawn from listing and relisted. After such fee 
     is paid for that fiscal year, such fee shall be payable on 
     or before January 31 of each year. Such fee shall be paid 
     only once for each product for a fiscal year in which the 
     fee is payable.''; and
       (B) in subparagraph (B), by striking ``505(j).'' and 
     inserting the following: ``505(j), under an abbreviated 
     application filed under section 507 (as in effect on the day 
     before the date of enactment of the Food and Drug 
     Administration Modernization Act of 1997), or under an 
     abbreviated new drug application pursuant to regulations in 
     effect prior to the implementation of the Drug Price 
     Competition and Patent Term Restoration Act of 1984.''.
       (b) Fee Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is 
     amended to read as follows:
       ``(b) Fee Amounts.--Except as provided in subsections (c), 
     (d), (f), and (g), the fees required under subsection (a) 
     shall be determined and assessed as follows:
       ``(1) Application and supplement fees.--
       ``(A) Full fees.--The application fee under subsection 
     (a)(1)(A)(i) shall be $250,704 in fiscal year 1998, $256,338 
     in each of fiscal years 1999 and 2000, $267,606 in fiscal 
     year 2001, and $258,451 in fiscal year 2002.
       ``(B) Other fees.--The fee under subsection (a)(1)(A)(ii) 
     shall be $125,352 in fiscal year 1998, $128,169 in each of 
     fiscal years 1999 and 2000, $133,803 in fiscal year 2001, and 
     $129,226 in fiscal year 2002.
       ``(2) Total fee revenues for establishment fees.--The total 
     fee revenues to be collected in establishment fees under 
     subsection (a)(2) shall be $35,600,000 in fiscal year 1998, 
     $36,400,000 in each of fiscal years 1999 and 2000, 
     $38,000,000 in fiscal year 2001, and $36,700,000 in fiscal 
     year 2002.
       ``(3) Total fee revenues for product fees.--The total fee 
     revenues to be collected in product fees under subsection 
     (a)(3) in a fiscal year shall be equal to the total fee 
     revenues collected in establishment fees under subsection 
     (a)(2) in that fiscal year.''.
       (c) Increases and Adjustments.--Section 736(c) (21 U.S.C. 
     379h(c)) is amended--
       (1) in the subsection heading, by striking ``Increases 
     and'';
       (2) in paragraph (1)--
       (A) by striking ``(1) Revenue'' and all that follows 
     through ``increased by the Secretary'' and inserting the 
     following: ``(1) Inflation adjustment.--The fees and total 
     fee revenues established in subsection (b) shall be adjusted 
     by the Secretary'';
       (B) in subparagraph (A), by striking ``increase'' and 
     inserting ``change'';
       (C) in subparagraph (B), by striking ``increase'' and 
     inserting ``change''; and
       (D) by adding at the end the following flush sentence:

     ``The adjustment made each fiscal year by this subsection 
     will be added on a compounded basis to the sum of all 
     adjustments made each fiscal year after fiscal year 1997 
     under this subsection.'';
       (3) in paragraph (2), by striking ``October 1, 1992,'' and 
     all that follows through ``such

[[Page H10454]]

     schedule.'' and inserting the following: ``September 30, 
     1997, adjust the establishment and product fees described in 
     subsection (b) for the fiscal year in which the adjustment 
     occurs so that the revenues collected from each of the 
     categories of fees described in paragraphs (2) and (3) of 
     subsection (b) shall be set to be equal to the revenues 
     collected from the category of application and supplement 
     fees described in paragraph (1) of subsection (b).''; and
       (4) in paragraph (3), by striking ``paragraph (2)'' and 
     inserting ``this subsection''.
       (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 
     379h(d)) is amended--
       (1) by redesignating paragraphs (1), (2), (3), and (4) as 
     subparagraphs (A), (B), (C), and (D), respectively and 
     indenting appropriately;
       (2) by striking ``The Secretary shall grant a'' and all 
     that follows through ``finds that--'' and inserting the 
     following:
       ``(1) In general.--The Secretary shall grant a waiver from 
     or a reduction of one or more fees assessed under subsection 
     (a) where the Secretary finds that--'';
       (3) in subparagraph (C) (as so redesignated in paragraph 
     (1)), by striking ``, or'' and inserting a comma;
       (4) in subparagraph (D) (as so redesignated in paragraph 
     (1)), by striking the period and inserting ``, or'';
       (5) by inserting after subparagraph (D) (as so redesignated 
     in paragraph (1)) the following:
       ``(E) the applicant involved is a small business submitting 
     its first human drug application to the Secretary for 
     review.''; and
       (6) by striking ``In making the finding in paragraph (3),'' 
     and all that follows through ``standard costs.'' and 
     inserting the following:
       ``(2) Use of standard costs.--In making the finding in 
     paragraph (1)(C), the Secretary may use standard costs.
       ``(3) Rules relating to small businesses.--
       ``(A) Definition.--In paragraph (1)(E), the term `small 
     business' means an entity that has fewer than 500 employees, 
     including employees of affiliates.
       ``(B) Waiver of application fee.--The Secretary shall waive 
     under paragraph (1)(E) the application fee for the first 
     human drug application that a small business or its affiliate 
     submits to the Secretary for review. After a small business 
     or its affiliate is granted such a waiver, the small business 
     or its affiliate shall pay--
       ``(i) application fees for all subsequent human drug 
     applications submitted to the Secretary for review in the 
     same manner as an entity that does not qualify as a small 
     business; and
       ``(ii) all supplement fees for all supplements to human 
     drug applications submitted to the Secretary for review in 
     the same manner as an entity that does not qualify as a small 
     business.''.
       (e) Assessment of Fees.--Section 736(f)(1) (21 U.S.C. 
     379h(f)(1)) is amended--
       (1) by striking ``fiscal year 1993'' and inserting ``fiscal 
     year 1997''; and
       (2) by striking ``fiscal year 1992'' and inserting ``fiscal 
     year 1997 (excluding the amount of fees appropriated for such 
     fiscal year)''.
       (f) Crediting and Availability of Fees.--Section 736(g) (21 
     U.S.C. 379h(g)) is amended--
       (1) in paragraph (1), by adding at the end the following: 
     ``Such sums as may be necessary may be transferred from the 
     Food and Drug Administration salaries and expenses 
     appropriation account without fiscal year limitation to such 
     appropriation account for salaries and expenses with such 
     fiscal year limitation. The sums transferred shall be 
     available solely for the process for the review of human drug 
     applications.'';
       (2) in paragraph (2)--
       (A) in subparagraph (A), by striking ``Acts'' and inserting 
     ``Acts, or otherwise made available for obligation,''; and
       (B) in subparagraph (B), by striking ``over such costs for 
     fiscal year 1992'' and inserting ``over such costs, excluding 
     costs paid from fees collected under this section, for fiscal 
     year 1997''; and
       (3) by striking paragraph (3) and inserting the following:
       ``(3) Authorization of appropriations.--There are 
     authorized to be appropriated for fees under this section--
       ``(A) $106,800,000 for fiscal year 1998;
       ``(B) $109,200,000 for fiscal year 1999;
       ``(C) $109,200,000 for fiscal year 2000;
       ``(D) $114,000,000 for fiscal year 2001; and
       ``(E) $110,100,000 for fiscal year 2002,
     as adjusted to reflect adjustments in the total fee revenues 
     made under this section and changes in the total amounts 
     collected by application, supplement, establishment, and 
     product fees.
       ``(4) Offset.--Any amount of fees collected for a fiscal 
     year under this section that exceeds the amount of fees 
     specified in appropriation Acts for such fiscal year shall be 
     credited to the appropriation account of the Food and Drug 
     Administration as provided in paragraph (1), and shall be 
     subtracted from the amount of fees that would otherwise be 
     authorized to be collected under this section pursuant to 
     appropriation Acts for a subsequent fiscal year.''.
       (g) Requirement for Written Requests for Waivers, 
     Reductions, and Refunds.--Section 736 (21 U.S.C. 379h) is 
     amended--
       (1) by redesignating subsection (i) as subsection (j); and
       (2) by inserting after subsection (h) the following:
       ``(i) Written Requests for Waivers, Reductions, and 
     Refunds.--To qualify for consideration for a waiver or 
     reduction under subsection (d), or for a refund of any fee 
     collected in accordance with subsection (a), a person shall 
     submit to the Secretary a written request for such waiver, 
     reduction, or refund not later than 180 days after such fee 
     is due.''.
       (h) Special Rule for Waivers and Refunds.--Any requests for 
     waivers or refunds for fees assessed under section 736 of the 
     Federal Food, Drug, and Cosmetic Act (42 U.S.C. 379h) prior 
     to the date of enactment of this Act shall be submitted in 
     writing to the Secretary of Health and Human Services within 
     1 year after the date of enactment of this Act. Any requests 
     for waivers or refunds pertaining to a fee for a human drug 
     application or supplement accepted for filing prior to 
     October 1, 1997 or to a product or establishment fee required 
     by such Act for a fiscal year prior to fiscal year 1998, 
     shall be evaluated according to the terms of the Prescription 
     Drug User Fee Act of 1992 (as in effect on September 30, 
     1997) and part 2 of subchapter C of chapter VII of the 
     Federal Food, Drug, and Cosmetic Act (as in effect on 
     September 30, 1997). The term ``person'' in such Acts shall 
     continue to include an affiliate thereof.

     SEC. 104. ANNUAL REPORTS.

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

     SEC. 105. SAVINGS.

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

     SEC. 106. EFFECTIVE DATE.

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

     SEC. 107. TERMINATION OF EFFECTIVENESS.

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

     SEC. 111. PEDIATRIC STUDIES OF DRUGS.

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

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

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

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

[[Page H10455]]

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

     the period during which an application may not be approved 
     under section 505(c)(3) or section 505(j)(4)(B) shall be 
     extended by a period of six months after the date the patent 
     expires (including any patent extensions); or
       ``(B) if the drug is the subject of a listed patent for 
     which a certification has been submitted under subsection 
     (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in 
     the patent infringement litigation resulting from the 
     certification the court determines that the patent is valid 
     and would be infringed, the period during which an 
     application may not be approved under section 505(c)(3) or 
     section 505(j)(4)(B) shall be extended by a period of six 
     months after the date the patent expires (including any 
     patent extensions).
       ``(d) Conduct of Pediatric Studies.--
       ``(1) Agreement for studies.--The Secretary may, pursuant 
     to a written request from the Secretary under subsection (a) 
     or (c), after consultation with--
       ``(A) the sponsor of an application for an investigational 
     new drug under section 505(i);
       ``(B) the sponsor of an application for a new drug under 
     section 505(b)(1); or
       ``(C) the holder of an approved application for a drug 
     under section 505(b)(1),

     agree with the sponsor or holder for the conduct of pediatric 
     studies for such drug. Such agreement shall be in writing and 
     shall include a timeframe for such studies.
       ``(2) Written protocols to meet the studies requirement.--
     If the sponsor or holder and the Secretary agree upon written 
     protocols for the studies, the studies requirement of 
     subsection (a) or (c) is satisfied upon the completion of the 
     studies and submission of the reports thereof in accordance 
     with the original written request and the written agreement 
     referred to in paragraph (1). Not later than 60 days after 
     the submission of the report of the studies, the Secretary 
     shall determine if such studies were or were not conducted in 
     accordance with the original written request and the written 
     agreement and reported in accordance with the requirements of 
     the Secretary for filing and so notify the sponsor or holder.
       ``(3) Other methods to meet the studies requirement.--If 
     the sponsor or holder and the Secretary have not agreed in 
     writing on the protocols for the studies, the studies 
     requirement of subsection (a) or (c) is satisfied when such 
     studies have been completed and the reports accepted by the 
     Secretary. Not later than 90 days after the submission of the 
     reports of the studies, the Secretary shall accept or reject 
     such reports and so notify the sponsor or holder. The 
     Secretary's only responsibility in accepting or rejecting the 
     reports shall be to determine, within the 90 days, whether 
     the studies fairly respond to the written request, have been 
     conducted in accordance with commonly accepted scientific 
     principles and protocols, and have been reported in 
     accordance with the requirements of the Secretary for filing.
       ``(e) Delay of Effective Date for Certain Application.--If 
     the Secretary determines that the acceptance or approval of 
     an application under section 505(b)(2) or 505(j) for a new 
     drug may occur after submission of reports of pediatric 
     studies under this section, which were submitted prior to the 
     expiration of the patent (including any patent extension) or 
     the applicable period under clauses (ii) through (iv) of 
     section 505(c)(3)(D) or clauses (ii) through (iv) of section 
     505(j)(4)(D), but before the Secretary has determined whether 
     the requirements of subsection (d) have been satisfied, the 
     Secretary shall delay the acceptance or approval under 
     section 505(b)(2) or 505(j) until the determination under 
     subsection (d) is made, but any such delay shall not exceed 
     90 days. In the event that requirements of this section are 
     satisfied, the applicable six-month period under subsection 
     (a) or (c) shall be deemed to have been running during the 
     period of delay.
       ``(f) Notice of Determinations on Studies Requirement.--The 
     Secretary shall publish a notice of any determination that 
     the requirements of subsection (d) have been met and that 
     submissions and approvals under subsection (b)(2) or (j) of 
     section 505 for a drug will be subject to the provisions of 
     this section.
       ``(g) Definitions.--As used in this section, the term 
     `pediatric studies' or `studies' means at least one clinical 
     investigation (that, at the Secretary's discretion, may 
     include pharmacokinetic studies) in pediatric age groups in 
     which a drug is anticipated to be used.
       ``(h) Limitations.--A drug to which the six-month period 
     under subsection (a) or (b) has already been applied--
       ``(1) may receive an additional six-month period under 
     subsection (c)(1)(A)(ii) for a supplemental application if 
     all other requirements under this section are satisfied, 
     except that such a drug may not receive any additional such 
     period under subsection (c)(2); and
       ``(2) may not receive any additional such period under 
     subsection (c)(1)(B).
       ``(i) Relationship to Regulations.--Notwithstanding any 
     other provision of law, if any pediatric study is required 
     pursuant to regulations promulgated by the Secretary and such 
     study meets the completeness, timeliness, and other 
     requirements of this section, such study shall be deemed to 
     satisfy the requirement for market exclusivity pursuant to 
     this section.
       ``(j) Sunset.--A drug may not receive any six-month period 
     under subsection (a) or (c) unless the application for the 
     drug under section 505(b)(1) is submitted on or before 
     January 1, 2002. After January 1, 2002, a drug shall receive 
     a six-month period under subsection (c) if--
       ``(1) the drug was in commercial distribution as of the 
     date of enactment of the Food and Drug Administration 
     Modernization Act of 1997;
       ``(2) the drug was included by the Secretary on the list 
     under subsection (b) as of January 1, 2002;
       ``(3) the Secretary determines that there is a continuing 
     need for information relating to the use of the drug in the 
     pediatric population and that the drug may provide health 
     benefits in that population; and
       ``(4) all requirements of this section are met.
       ``(k) Report.--The Secretary shall conduct a study and 
     report to Congress not later than January 1, 2001, based on 
     the experience under the program established under this 
     section. The study and report shall examine all relevant 
     issues, including--
       ``(1) the effectiveness of the program in improving 
     information about important pediatric uses for approved 
     drugs;
       ``(2) the adequacy of the incentive provided under this 
     section;
       ``(3) the economic impact of the program on taxpayers and 
     consumers, including the impact of the lack of lower cost 
     generic drugs on patients, including on lower income 
     patients; and
       ``(4) any suggestions for modification that the Secretary 
     determines to be appropriate.''.

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

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

     ``SEC. 506. FAST TRACK PRODUCTS.

       ``(a) Designation of Drug as a Fast Track Product.--
       ``(1) In general.--The Secretary shall, at the request of 
     the sponsor of a new drug, facilitate the development and 
     expedite the review of such drug if it is intended for the 
     treatment of a serious or life-threatening condition and it 
     demonstrates the potential to address unmet medical needs for 
     such a condition. (In this section, such a drug is referred 
     to as a `fast track product'.)
       ``(2) Request for designation.--The sponsor of a new drug 
     may request the Secretary to designate the drug as a fast 
     track product. A request for the designation may be made 
     concurrently with, or at any time after, submission of an 
     application for the investigation of the drug under section 
     505(i) or section 351(a)(3) of the Public Health Service Act.
       ``(3) Designation.--Within 60 calendar days after the 
     receipt of a request under paragraph (2), the Secretary shall 
     determine whether the drug that is the subject of the request 
     meets the criteria described in paragraph (1). If the 
     Secretary finds that the drug meets the criteria, the 
     Secretary shall designate the drug as a fast track product 
     and shall take such actions as are appropriate to expedite 
     the development and review of the application for approval of 
     such product.
       ``(b) Approval of Application for a Fast Track Product.--
       ``(1) In general.--The Secretary may approve an application 
     for approval of a fast track product under section 505(c) or 
     section 351 of the Public Health Service Act upon a 
     determination that the product has an effect on a clinical 
     endpoint or on a surrogate endpoint that is reasonably likely 
     to predict clinical benefit.
       ``(2) Limitation.--Approval of a fast track product under 
     this subsection may be subject to the requirements--
       ``(A) that the sponsor conduct appropriate post-approval 
     studies to validate the surrogate endpoint or otherwise 
     confirm the effect on the clinical endpoint; and
       ``(B) that the sponsor submit copies of all promotional 
     materials related to the fast track product during the 
     preapproval review period and, following approval and for 
     such period

[[Page H10456]]

     thereafter as the Secretary determines to be appropriate, at 
     least 30 days prior to dissemination of the materials.
       ``(3) Expedited withdrawal of approval.--The Secretary may 
     withdraw approval of a fast track product using expedited 
     procedures (as prescribed by the Secretary in regulations 
     which shall include an opportunity for an informal hearing) 
     if--
       ``(A) the sponsor fails to conduct any required post-
     approval study of the fast track drug with due diligence;
       ``(B) a post-approval study of the fast track product fails 
     to verify clinical benefit of the product;
       ``(C) other evidence demonstrates that the fast track 
     product is not safe or effective under the conditions of use; 
     or
       ``(D) the sponsor disseminates false or misleading 
     promotional materials with respect to the product.
       ``(c) Review of Incomplete Applications for Approval of a 
     Fast Track Product.--
       ``(1) In general.--If the Secretary determines, after 
     preliminary evaluation of clinical data submitted by the 
     sponsor, that a fast track product may be effective, the 
     Secretary shall evaluate for filing, and may commence review 
     of portions of, an application for the approval of the 
     product before the sponsor submits a complete application. 
     The Secretary shall commence such review only if the 
     applicant--
       ``(A) provides a schedule for submission of information 
     necessary to make the application complete; and
       ``(B) pays any fee that may be required under section 736.
       ``(2) Exception.--Any time period for review of human drug 
     applications that has been agreed to by the Secretary and 
     that has been set forth in goals identified in letters of the 
     Secretary (relating to the use of fees collected under 
     section 736 to expedite the drug development process and the 
     review of human drug applications) shall not apply to an 
     application submitted under paragraph (1) until the date on 
     which the application is complete.
       ``(d) Awareness Efforts.--The Secretary shall--
       ``(1) develop and disseminate to physicians, patient 
     organizations, pharmaceutical and biotechnology companies, 
     and other appropriate persons a description of the provisions 
     of this section applicable to fast track products; and
       ``(2) establish a program to encourage the development of 
     surrogate endpoints that are reasonably likely to predict 
     clinical benefit for serious or life-threatening conditions 
     for which there exist significant unmet medical needs.''.
       (b) Guidance.--Within 1 year after the date of enactment of 
     this Act, the Secretary of Health and Human Services shall 
     issue guidance for fast track products (as defined in section 
     506(a)(1) of the Federal Food, Drug, and Cosmetic Act) that 
     describes the policies and procedures that pertain to section 
     506 of such Act.

     SEC. 113. INFORMATION PROGRAM ON CLINICAL TRIALS FOR SERIOUS 
                   OR LIFE-THREATENING DISEASES.

       (a) In General.--Section 402 of the Public Health Service 
     Act (42 U.S.C. 282) is amended--
       (1) by redesignating subsections (j) and (k) as subsections 
     (k) and (l), respectively; and
       (2) by inserting after subsection (i) the following:
       ``(j)(1)(A) The Secretary, acting through the Director of 
     NIH, shall establish, maintain, and operate a data bank of 
     information on clinical trials for drugs for serious or life-
     threatening diseases and conditions (in this subsection 
     referred to as the `data bank'). The activities of the data 
     bank shall be integrated and coordinated with related 
     activities of other agencies of the Department of Health and 
     Human Services, and to the extent practicable, coordinated 
     with other data banks containing similar information.
       ``(B) The Secretary shall establish the data bank after 
     consultation with the Commissioner of Food and Drugs, the 
     directors of the appropriate agencies of the National 
     Institutes of Health (including the National Library of 
     Medicine), and the Director of the Centers for Disease 
     Control and Prevention.
       ``(2) In carrying out paragraph (1), the Secretary shall 
     collect, catalog, store, and disseminate the information 
     described in such paragraph. The Secretary shall disseminate 
     such information through information systems, which shall 
     include toll-free telephone communications, available to 
     individuals with serious or life-threatening diseases and 
     conditions, to other members of the public, to health care 
     providers, and to researchers.
       ``(3) The data bank shall include the following:
       ``(A) A registry of clinical trials (whether federally or 
     privately funded) of experimental treatments for serious or 
     life-threatening diseases and conditions under regulations 
     promulgated pursuant to section 505(i) of the Federal Food, 
     Drug, and Cosmetic Act, which provides a description of the 
     purpose of each experimental drug, either with the consent of 
     the protocol sponsor, or when a trial to test effectiveness 
     begins. Information provided shall consist of eligibility 
     criteria for participation in the clinical trials, a 
     description of the location of trial sites, and a point of 
     contact for those wanting to enroll in the trial, and shall 
     be in a form that can be readily understood by members of the 
     public. Such information shall be forwarded to the data bank 
     by the sponsor of the trial not later than 21 days after the 
     approval of the protocol.
       ``(B) Information pertaining to experimental treatments for 
     serious or life-threatening diseases and conditions that may 
     be available--
       ``(i) under a treatment investigational new drug 
     application that has been submitted to the Secretary under 
     section 561(c) of the Federal Food, Drug, and Cosmetic Act; 
     or
       ``(ii) as a Group C cancer drug (as defined by the National 
     Cancer Institute).

     The data bank may also include information pertaining to the 
     results of clinical trials of such treatments, with the 
     consent of the sponsor, including information concerning 
     potential toxicities or adverse effects associated with the 
     use or administration of such experimental treatments.
       ``(4) The data bank shall not include information relating 
     to an investigation if the sponsor has provided a detailed 
     certification to the Secretary that disclosure of such 
     information would substantially interfere with the timely 
     enrollment of subjects in the investigation, unless the 
     Secretary, after the receipt of the certification, provides 
     the sponsor with a detailed written determination that such 
     disclosure would not substantially interfere with such 
     enrollment.
       ``(5) For the purpose of carrying out this subsection, 
     there are authorized to be appropriated such sums as may be 
     necessary. Fees collected under section 736 of the Federal 
     Food, Drug, and Cosmetic Act shall not be used in carrying 
     out this subsection.''.
       (b) Collaboration and Report.--
       (1) In general.--The Secretary of Health and Human 
     Services, the Director of the National Institutes of Health, 
     and the Commissioner of Food and Drugs shall collaborate to 
     determine the feasibility of including device investigations 
     within the scope of the data bank under section 402(j) of the 
     Public Health Service Act.
       (2) Report.--Not later than two years after the date of 
     enactment of this section, the Secretary of Health and Human 
     Services shall prepare and submit to the Committee on Labor 
     and Human Resources of the Senate and the Committee on 
     Commerce of the House of Representatives a report--
       (A) of the public health need, if any, for inclusion of 
     device investigations within the scope of the data bank under 
     section 402(j) of the Public Health Service Act;
       (B) on the adverse impact, if any, on device innovation and 
     research in the United States if information relating to such 
     device investigations is required to be publicly disclosed; 
     and
       (C) on such other issues relating to such section 402(j) as 
     the Secretary determines to be appropriate.

     SEC. 114. HEALTH CARE ECONOMIC INFORMATION.

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

     SEC. 115. CLINICAL INVESTIGATIONS.

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

     SEC. 116. MANUFACTURING CHANGES FOR DRUGS.

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

     ``SEC. 506A. MANUFACTURING CHANGES.

       ``(a) In General.--With respect to a drug for which there 
     is in effect an approved application under section 505 or 512 
     or a license under section 351 of the Public Health Service 
     Act, a change from the manufacturing process approved 
     pursuant to such application or license may be made, and the 
     drug as made with the change may be distributed, if--
       ``(1) the holder of the approved application or license 
     (referred to in this section as a `holder') has validated the 
     effects of the change in accordance with subsection (b); and

[[Page H10457]]

       ``(2)(A) in the case of a major manufacturing change, the 
     holder has complied with the requirements of subsection (c); 
     or
       ``(B) in the case of a change that is not a major 
     manufacturing change, the holder complies with the applicable 
     requirements of subsection (d).
       ``(b) Validation of Effects of Changes.--For purposes of 
     subsection (a)(1), a drug made with a manufacturing change 
     (whether a major manufacturing change or otherwise) may be 
     distributed only if, before distribution of the drug as so 
     made, the holder involved validates the effects of the change 
     on the identity, strength, quality, purity, and potency of 
     the drug as the identity, strength, quality, purity, and 
     potency may relate to the safety or effectiveness of the 
     drug.
       ``(c) Major Manufacturing Changes.--
       ``(1) Requirement of supplemental application.--For 
     purposes of subsection (a)(2)(A), a drug made with a major 
     manufacturing change may be distributed only if, before the 
     distribution of the drug as so made, the holder involved 
     submits to the Secretary a supplemental application for such 
     change and the Secretary approves the application. The 
     application shall contain such information as the Secretary 
     determines to be appropriate, and shall include the 
     information developed under subsection (b) by the holder in 
     validating the effects of the change.
       ``(2) Changes qualifying as major changes.--For purposes of 
     subsection (a)(2)(A), a major manufacturing change is a 
     manufacturing change that is determined by the Secretary to 
     have substantial potential to adversely affect the identity, 
     strength, quality, purity, or potency of the drug as they may 
     relate to the safety or effectiveness of a drug. Such a 
     change includes a change that--
       ``(A) is made in the qualitative or quantitative 
     formulation of the drug involved or in the specifications in 
     the approved application or license referred to in 
     subsection (a) for the drug (unless exempted by the 
     Secretary by regulation or guidance from the requirements 
     of this subsection);
       ``(B) is determined by the Secretary by regulation or 
     guidance to require completion of an appropriate clinical 
     study demonstrating equivalence of the drug to the drug as 
     manufactured without the change; or
       ``(C) is another type of change determined by the Secretary 
     by regulation or guidance to have a substantial potential to 
     adversely affect the safety or effectiveness of the drug.
       ``(d) Other Manufacturing Changes.--
       ``(1) In general.--For purposes of subsection (a)(2)(B), 
     the Secretary may regulate drugs made with manufacturing 
     changes that are not major manufacturing changes as follows:
       ``(A) The Secretary may in accordance with paragraph (2) 
     authorize holders to distribute such drugs without submitting 
     a supplemental application for such changes.
       ``(B) The Secretary may in accordance with paragraph (3) 
     require that, prior to the distribution of such drugs, 
     holders submit to the Secretary supplemental applications for 
     such changes.
       ``(C) The Secretary may establish categories of such 
     changes and designate categories to which subparagraph (A) 
     applies and categories to which subparagraph (B) applies.
       ``(2) Changes not requiring supplemental application.--
       ``(A) Submission of report.--A holder making a 
     manufacturing change to which paragraph (1)(A) applies shall 
     submit to the Secretary a report on the change, which shall 
     contain such information as the Secretary determines to be 
     appropriate, and which shall include the information 
     developed under subsection (b) by the holder in validating 
     the effects of the change. The report shall be submitted by 
     such date as the Secretary may specify.
       ``(B) Authority regarding annual reports.--In the case of a 
     holder that during a single year makes more than one 
     manufacturing change to which paragraph (1)(A) applies, the 
     Secretary may in carrying out subparagraph (A) authorize the 
     holder to comply with such subparagraph by submitting a 
     single report for the year that provides the information 
     required in such subparagraph for all the changes made by the 
     holder during the year.
       ``(3) Changes requiring supplemental application.--
       ``(A) Submission of supplemental application.--The 
     supplemental application required under paragraph (1)(B) for 
     a manufacturing change shall contain such information as the 
     Secretary determines to be appropriate, which shall include 
     the information developed under subsection (b) by the holder 
     in validating the effects of the change.
       ``(B) Authority for distribution.--In the case of a 
     manufacturing change to which paragraph (1)(B) applies:
       ``(i) The holder involved may commence distribution of the 
     drug involved 30 days after the Secretary receives the 
     supplemental application under such paragraph, unless the 
     Secretary notifies the holder within such 30-day period that 
     prior approval of the application is required before 
     distribution may be commenced.
       ``(ii) The Secretary may designate a category of such 
     changes for the purpose of providing that, in the case of a 
     change that is in such category, the holder involved may 
     commence distribution of the drug involved upon the receipt 
     by the Secretary of a supplemental application for the 
     change.
       ``(iii) If the Secretary disapproves the supplemental 
     application, the Secretary may order the manufacturer to 
     cease the distribution of the drugs that have been made with 
     the manufacturing change.''.
       (b) Transition Rule.--The amendment made by subsection (a) 
     takes effect upon the effective date of regulations 
     promulgated by the Secretary of Health and Human Services to 
     implement such amendment, or upon the expiration of the 24-
     month period beginning on the date of the enactment of this 
     Act, whichever occurs first.

     SEC. 117. STREAMLINING CLINICAL RESEARCH ON DRUGS.

       Section 505(i) (21 U.S.C. 355(i)) is amended--
       (1) by redesignating paragraphs (1) through (3) as 
     subparagraphs (A) through (C), respectively;
       (2) by inserting ``(1)'' after ``(i)'';
       (3) by striking the last two sentences; and
       (4) by inserting after paragraph (1) (as designated by 
     paragraph (2) of this section) the following new paragraphs:
       ``(2) Subject to paragraph (3), a clinical investigation of 
     a new drug may begin 30 days after the Secretary has received 
     from the manufacturer or sponsor of the investigation a 
     submission containing such information about the drug and the 
     clinical investigation, including--
       ``(A) information on design of the investigation and 
     adequate reports of basic information, certified by the 
     applicant to be accurate reports, necessary to assess the 
     safety of the drug for use in clinical investigation; and
       ``(B) adequate information on the chemistry and 
     manufacturing of the drug, controls available for the drug, 
     and primary data tabulations from animal or human studies.
       ``(3)(A) At any time, the Secretary may prohibit the 
     sponsor of an investigation from conducting the investigation 
     (referred to in this paragraph as a `clinical hold') if the 
     Secretary makes a determination described in subparagraph 
     (B). The Secretary shall specify the basis for the clinical 
     hold, including the specific information available to the 
     Secretary which served as the basis for such clinical hold, 
     and confirm such determination in writing.
       ``(B) For purposes of subparagraph (A), a determination 
     described in this subparagraph with respect to a clinical 
     hold is that--
       ``(i) the drug involved represents an unreasonable risk to 
     the safety of the persons who are the subjects of the 
     clinical investigation, taking into account the 
     qualifications of the clinical investigators, information 
     about the drug, the design of the clinical investigation, the 
     condition for which the drug is to be investigated, and the 
     health status of the subjects involved; or
       ``(ii) the clinical hold should be issued for such other 
     reasons as the Secretary may by regulation establish 
     (including reasons established by regulation before the date 
     of the enactment of the Food and Drug Administration 
     Modernization Act of 1997).
       ``(C) Any written request to the Secretary from the sponsor 
     of an investigation that a clinical hold be removed shall 
     receive a decision, in writing and specifying the reasons 
     therefor, within 30 days after receipt of such request. Any 
     such request shall include sufficient information to support 
     the removal of such clinical hold.
       ``(4) Regulations under paragraph (1) shall provide that 
     such exemption shall be conditioned upon the manufacturer, or 
     the sponsor of the investigation, requiring that experts 
     using such drugs for investigational purposes certify to 
     such manufacturer or sponsor that they will inform any 
     human beings to whom such drugs, or any controls used in 
     connection therewith, are being administered, or their 
     representatives, that such drugs are being used for 
     investigational purposes and will obtain the consent of 
     such human beings or their representatives, except where 
     it is not feasible or it is contrary to the best interests 
     of such human beings. Nothing in this subsection shall be 
     construed to require any clinical investigator to submit 
     directly to the Secretary reports on the investigational 
     use of drugs.''.

     SEC. 118. DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS.

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

     SEC. 119. CONTENT AND REVIEW OF APPLICATIONS.

       (a) Section 505(b).--Section 505(b) (21 U.S.C. 355(b)) is 
     amended by adding at the end the following:
       ``(4)(A) The Secretary shall issue guidance for the 
     individuals who review applications submitted under paragraph 
     (1) or under section 351 of the Public Health Service Act, 
     which shall relate to promptness in conducting the review, 
     technical excellence, lack of bias and conflict of interest, 
     and knowledge of regulatory and scientific standards, and 
     which shall apply equally to all individuals who review such 
     applications.
       ``(B) The Secretary shall meet with a sponsor of an 
     investigation or an applicant for approval for a drug under 
     this subsection or section 351 of the Public Health Service 
     Act if the sponsor or applicant makes a reasonable written 
     request for a meeting for the purpose of reaching agreement 
     on the design and size of clinical trials intended to form 
     the primary basis of an effectiveness claim. The sponsor or 
     applicant shall provide information necessary for discussion 
     and agreement on the design and size of the clinical trials. 
     Minutes of any such meeting shall be prepared by the 
     Secretary and made available to the sponsor or applicant upon 
     request.
       ``(C) Any agreement regarding the parameters of the design 
     and size of clinical trials of a new drug under this 
     paragraph that is reached between the Secretary and a sponsor 
     or applicant

[[Page H10458]]

     shall be reduced to writing and made part of the 
     administrative record by the Secretary. Such agreement shall 
     not be changed after the testing begins, except--
       ``(i) with the written agreement of the sponsor or 
     applicant; or
       ``(ii) pursuant to a decision, made in accordance with 
     subparagraph (D) by the director of the reviewing division, 
     that a substantial scientific issue essential to determining 
     the safety or effectiveness of the drug has been identified 
     after the testing has begun.
       ``(D) A decision under subparagraph (C)(ii) by the director 
     shall be in writing and the Secretary shall provide to the 
     sponsor or applicant an opportunity for a meeting at which 
     the director and the sponsor or applicant will be present and 
     at which the director will document the scientific issue 
     involved.
       ``(E) The written decisions of the reviewing division shall 
     be binding upon, and may not directly or indirectly be 
     changed by, the field or compliance division personnel unless 
     such field or compliance division personnel demonstrate to 
     the reviewing division why such decision should be modified.
       ``(F) No action by the reviewing division may be delayed 
     because of the unavailability of information from or action 
     by field personnel unless the reviewing division determines 
     that a delay is necessary to assure the marketing of a safe 
     and effective drug.
       ``(G) For purposes of this paragraph, the reviewing 
     division is the division responsible for the review of an 
     application for approval of a drug under this subsection or 
     section 351 of the Public Health Service Act (including all 
     scientific and medical matters, chemistry, manufacturing, and 
     controls).''.
       (b) Section 505(j).--
       (1) Amendment.--Section 505(j) (21 U.S.C 355(j)) is 
     amended--
       (A) by redesignating paragraphs (3) through (8) as 
     paragraphs (4) through (9), respectively; and
       (B) by adding after paragraph (2) the following:
       ``(3)(A) The Secretary shall issue guidance for the 
     individuals who review applications submitted under paragraph 
     (1), which shall relate to promptness in conducting the 
     review, technical excellence, lack of bias and conflict of 
     interest, and knowledge of regulatory and scientific 
     standards, and which shall apply equally to all 
     individuals who review such applications.
       ``(B) The Secretary shall meet with a sponsor of an 
     investigation or an applicant for approval for a drug under 
     this subsection if the sponsor or applicant makes a 
     reasonable written request for a meeting for the purpose of 
     reaching agreement on the design and size of bioavailability 
     and bioequivalence studies needed for approval of such 
     application. The sponsor or applicant shall provide 
     information necessary for discussion and agreement on the 
     design and size of such studies. Minutes of any such meeting 
     shall be prepared by the Secretary and made available to the 
     sponsor or applicant.
       ``(C) Any agreement regarding the parameters of design and 
     size of bioavailability and bioequivalence studies of a drug 
     under this paragraph that is reached between the Secretary 
     and a sponsor or applicant shall be reduced to writing and 
     made part of the administrative record by the Secretary. Such 
     agreement shall not be changed after the testing begins, 
     except--
       ``(i) with the written agreement of the sponsor or 
     applicant; or
       ``(ii) pursuant to a decision, made in accordance with 
     subparagraph (D) by the director of the reviewing division, 
     that a substantial scientific issue essential to determining 
     the safety or effectiveness of the drug has been identified 
     after the testing has begun.
       ``(D) A decision under subparagraph (C)(ii) by the director 
     shall be in writing and the Secretary shall provide to the 
     sponsor or applicant an opportunity for a meeting at which 
     the director and the sponsor or applicant will be present and 
     at which the director will document the scientific issue 
     involved.
       ``(E) The written decisions of the reviewing division shall 
     be binding upon, and may not directly or indirectly be 
     changed by, the field or compliance office personnel unless 
     such field or compliance office personnel demonstrate to the 
     reviewing division why such decision should be modified.
       ``(F) No action by the reviewing division may be delayed 
     because of the unavailability of information from or action 
     by field personnel unless the reviewing division determines 
     that a delay is necessary to assure the marketing of a safe 
     and effective drug.
       ``(G) For purposes of this paragraph, the reviewing 
     division is the division responsible for the review of an 
     application for approval of a drug under this subsection 
     (including scientific matters, chemistry, manufacturing, and 
     controls).''.
       (2) Conforming amendments.--Section 505(j) (21 U.S.C. 
     355(j)), as amended by paragraph (1), is further amended--
       (A) in paragraph (2)(A)(i), by striking ``(6)'' and 
     inserting ``(7)'';
       (B) in paragraph (4) (as redesignated in paragraph (1)), by 
     striking ``(4)'' and inserting ``(5)'';
       (C) in paragraph (4)(I) (as redesignated in paragraph (1)), 
     by striking ``(5)'' and inserting ``(6)''; and
       (D) in paragraph (7)(C) (as redesignated in paragraph (1)), 
     by striking ``(5)'' each place it occurs and inserting 
     ``(6)''.

     SEC. 120. SCIENTIFIC ADVISORY PANELS.

       Section 505 (21 U.S.C. 355) is amended by adding at the end 
     the following:
       ``(n)(1) For the purpose of providing expert scientific 
     advice and recommendations to the Secretary regarding a 
     clinical investigation of a drug or the approval for 
     marketing of a drug under section 505 or section 351 of the 
     Public Health Service Act, the Secretary shall establish 
     panels of experts or use panels of experts established before 
     the date of enactment of the Food and Drug Administration 
     Modernization Act of 1997, or both.
       ``(2) The Secretary may delegate the appointment and 
     oversight authority granted under section 904 to a director 
     of a center or successor entity within the Food and Drug 
     Administration.
       ``(3) The Secretary shall make appointments to each panel 
     established under paragraph (1) so that each panel shall 
     consist of--
       ``(A) members who are qualified by training and experience 
     to evaluate the safety and effectiveness of the drugs to be 
     referred to the panel and who, to the extent feasible, 
     possess skill and experience in the development, manufacture, 
     or utilization of such drugs;
       ``(B) members with diverse expertise in such fields as 
     clinical and administrative medicine, pharmacy, pharmacology, 
     pharmacoeconomics, biological and physical sciences, and 
     other related professions;
       ``(C) a representative of consumer interests, and a 
     representative of interests of the drug manufacturing 
     industry not directly affected by the matter to be brought 
     before the panel; and
       ``(D) two or more members who are specialists or have other 
     expertise in the particular disease or condition for which 
     the drug under review is proposed to be indicated.
     Scientific, trade, and consumer organizations shall be 
     afforded an opportunity to nominate individuals for 
     appointment to the panels. No individual who is in the 
     regular full-time employ of the United States and engaged in 
     the administration of this Act may be a voting member of any 
     panel. The Secretary shall designate one of the members of 
     each panel to serve as chairman thereof.
       ``(4) Each member of a panel shall publicly disclose all 
     conflicts of interest that member may have with the work to 
     be undertaken by the panel. No member of a panel may vote on 
     any matter where the member or the immediate family of such 
     member could gain financially from the advice given to the 
     Secretary. The Secretary may grant a waiver of any conflict 
     of interest requirement upon public disclosure of such 
     conflict of interest if such waiver is necessary to afford 
     the panel essential expertise, except that the Secretary may 
     not grant a waiver for a member of a panel when the member's 
     own scientific work is involved.
       ``(5) The Secretary shall, as appropriate, provide 
     education and training to each new panel member before such 
     member participates in a panel's activities, including 
     education regarding requirements under this Act and related 
     regulations of the Secretary, and the administrative 
     processes and procedures related to panel meetings.
       ``(6) Panel members (other than officers or employees of 
     the United States), while attending meetings or conferences 
     of a panel or otherwise engaged in its business, shall be 
     entitled to receive compensation for each day so engaged, 
     including traveltime, at rates to be fixed by the Secretary, 
     but not to exceed the daily equivalent of the rate in effect 
     for positions classified above grade GS-15 of the General 
     Schedule. While serving away from their homes or regular 
     places of business, panel members may be allowed travel 
     expenses (including per diem in lieu of subsistence) as 
     authorized by section 5703 of title 5, United States Code, 
     for persons in the Government service employed 
     intermittently.
       ``(7) The Secretary shall ensure that scientific advisory 
     panels meet regularly and at appropriate intervals so that 
     any matter to be reviewed by such a panel can be presented to 
     the panel not more than 60 days after the matter is ready for 
     such review. Meetings of the panel may be held using 
     electronic communication to convene the meetings.
       ``(8) Within 90 days after a scientific advisory panel 
     makes recommendations on any matter under its review, the 
     Food and Drug Administration official responsible for the 
     matter shall review the conclusions and recommendations of 
     the panel, and notify the affected persons of the final 
     decision on the matter, or of the reasons that no such 
     decision has been reached. Each such final decision shall be 
     documented including the rationale for the decision.''.

     SEC. 121. POSITRON EMISSION TOMOGRAPHY.

       (a) Regulation of Compounded Positron Emission Tomography 
     Drugs.--Section 201 (21 U.S.C. 321) is amended by adding at 
     the end the following:
       ``(ii) The term `compounded positron emission tomography 
     drug'--
       ``(1) means a drug that--
       ``(A) exhibits spontaneous disintegration of unstable 
     nuclei by the emission of positrons and is used for the 
     purpose of providing dual photon positron emission 
     tomographic diagnostic images; and
       ``(B) has been compounded by or on the order of a 
     practitioner who is licensed by a State to compound or order 
     compounding for a drug described in subparagraph (A), and is 
     compounded in accordance with that State's law, for a patient 
     or for research, teaching, or quality control; and
       ``(2) includes any nonradioactive reagent, reagent kit, 
     ingredient, nuclide generator, accelerator, target material, 
     electronic synthesizer, or other apparatus or computer 
     program to be used in the preparation of such a drug.''.
       (b) Adulteration.--
       (1) In general.--Section 501(a) (21 U.S.C. 351(a)) is 
     amended by striking ``; or (3)'' and inserting the following: 
     ``; or (C) if it is a compounded positron emission tomography 
     drug and the methods used in, or the facilities and controls 
     used for, its compounding, processing, packing, or holding do 
     not conform to or are not operated or administered in 
     conformity with the positron emission tomography compounding

[[Page H10459]]

     standards and the official monographs of the United States 
     Pharmacopoeia to assure that such drug meets the requirements 
     of this Act as to safety and has the identity and strength, 
     and meets the quality and purity characteristics, that it 
     purports or is represented to possess; or (3)''.
       (2) Sunset.--Section 501(a)(2)(C) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not 
     apply 4 years after the date of enactment of this Act or 2 
     years after the date on which the Secretary of Health and 
     Human Services establishes the requirements described in 
     subsection (c)(1)(B), whichever is later.
       (c) Requirements for Review of Approval Procedures and 
     Current Good Manufacturing Practices for Positron Emission 
     Tomography.--
       (1) Procedures and requirements.--
       (A) In general.--In order to take account of the special 
     characteristics of positron emission tomography drugs and the 
     special techniques and processes required to produce these 
     drugs, not later than 2 years after the date of enactment of 
     this Act, the Secretary of Health and Human Services shall 
     establish--
       (i) appropriate procedures for the approval of positron 
     emission tomography drugs pursuant to section 505 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
       (ii) appropriate current good manufacturing practice 
     requirements for such drugs.
       (B) Considerations and consultation.--In establishing the 
     procedures and requirements required by subparagraph (A), the 
     Secretary of Health and Human Services shall take due account 
     of any relevant differences between not-for-profit 
     institutions that compound the drugs for their patients and 
     commercial manufacturers of the drugs. Prior to establishing 
     the procedures and requirements, the Secretary of Health and 
     Human Services shall consult with patient advocacy groups, 
     professional associations, manufacturers, and physicians and 
     scientists licensed to make or use positron emission 
     tomography drugs.
       (2) Submission of new drug applications and abbreviated new 
     drug applications.--
       (A) In general.--Except as provided in subparagraph (B), 
     the Secretary of Health and Human Services shall not require 
     the submission of new drug applications or abbreviated new 
     drug applications under subsection (b) or (j) of section 505 
     (21 U.S.C. 355), for compounded positron emission tomography 
     drugs that are not adulterated drugs described in section 
     501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 351(a)(2)(C)) (as amended by subsection (b)), for a 
     period of 4 years after the date of enactment of this Act, or 
     for 2 years after the date on which the Secretary establishes 
     procedures and requirements under paragraph (1), whichever is 
     longer.
       (B) Exception.--Nothing in this Act shall prohibit the 
     voluntary submission of such applications or the review of 
     such applications by the Secretary of Health and Human 
     Services. Nothing in this Act shall constitute an exemption 
     for a positron emission tomography drug from the requirements 
     of regulations issued under section 505(i) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)).
       (d) Revocation of Certain Inconsistent Documents.--Within 
     30 days after the date of enactment of this Act, the 
     Secretary of Health and Human Services shall publish in the 
     Federal Register a notice terminating the application of the 
     following notices and rule:
       (1) A notice entitled ``Regulation of Positron Emission 
     Tomography Radiopharmaceutical Drug Products; Guidance; 
     Public Workshop'', published in the Federal Register on 
     February 27, 1995, 60 Fed. Reg. 10594.
       (2) A notice entitled ``Draft Guideline on the Manufacture 
     of Positron Emission Tomography Radiopharmaceutical Drug 
     Products; Availability'', published in the Federal Register 
     on February 27, 1995, 60 Fed. Reg. 10593.
       (3) A final rule entitled ``Current Good Manufacturing 
     Practice for Finished Pharmaceuticals; Positron Emission 
     Tomography'', published in the Federal Register on April 22, 
     1997, 62 Fed. Reg. 19493 (codified at part 211 of title 21, 
     Code of Federal Regulations).
       (e) Definition.--As used in this section, the term 
     ``compounded positron emission tomography drug'' has the 
     meaning given the term in section 201 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 321).

     SEC. 122. REQUIREMENTS FOR RADIOPHARMACEUTICALS.

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

     SEC. 123. MODERNIZATION OF REGULATION.

       (a) Licenses.--
       (1) In general.--Section 351(a) of the Public Health 
     Service (42 U.S.C. 262(a)) is amended to read as follows:
       ``(a)(1) No person shall introduce or deliver for 
     introduction into interstate commerce any biological product 
     unless--
       ``(A) a biologics license is in effect for the biological 
     product; and
       ``(B) each package of the biological product is plainly 
     marked with--
       ``(i) the proper name of the biological product contained 
     in the package;
       ``(ii) the name, address, and applicable license number of 
     the manufacturer of the biological product; and
       ``(iii) the expiration date of the biological product.
       ``(2)(A) The Secretary shall establish, by regulation, 
     requirements for the approval, suspension, and revocation of 
     biologics licenses.
       ``(B) The Secretary shall approve a biologics license 
     application--
       ``(i) on the basis of a demonstration that--
       ``(I) the biological product that is the subject of the 
     application is safe, pure, and potent; and
       ``(II) the facility in which the biological product is 
     manufactured, processed, packed, or held meets standards 
     designed to assure that the biological product continues to 
     be safe, pure, and potent; and
       ``(ii) if the applicant (or other appropriate person) 
     consents to the inspection of the facility that is the 
     subject of the application, in accordance with subsection 
     (c).
       ``(3) The Secretary shall prescribe requirements under 
     which a biological product undergoing investigation shall be 
     exempt from the requirements of paragraph (1).''.
       (2) Elimination of existing license requirement.--Section 
     351(d) of the Public Health Service Act (42 U.S.C. 262(d)) is 
     amended--
       (A) by striking ``(d)(1)'' and all that follows through 
     ``of this section.'';
       (B) in paragraph (2)--
       (i) by striking ``(2)(A) Upon'' and inserting ``(d)(1) 
     Upon'' and
       (ii) by redesignating subparagraph (B) as paragraph (2); 
     and
       (C) in paragraph (2) (as so redesignated by subparagraph 
     (B)(ii))--
       (i) by striking ``subparagraph (A)'' and inserting 
     ``paragraph (1)''; and
       (ii) by striking ``this subparagraph'' each place it 
     appears and inserting ``this paragraph''.
       (b) Labeling.--Section 351(b) of the Public Health Service 
     Act (42 U.S.C. 262(b)) is amended to read as follows:
       ``(b) No person shall falsely label or mark any package or 
     container of any biological product or alter any label or 
     mark on the package or container of the biological product so 
     as to falsify the label or mark.''.
       (c) Inspection.--Section 351(c) of the Public Health 
     Service Act (42 U.S.C. 262(c)) is amended by striking 
     ``virus, serum,'' and all that follows and inserting 
     ``biological product.''.
       (d) Definition; Application.--Section 351 of the Public 
     Health Service Act (42 U.S.C. 262) is amended by adding at 
     the end the following:
       ``(i) In this section, the term `biological product' means 
     a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, 
     blood component or derivative, allergenic product, or 
     analogous product, or arsphenamine or derivative of 
     arsphenamine (or any other trivalent organic arsenic 
     compound), applicable to the prevention, treatment, or cure 
     of a disease or condition of human beings.''.
       (e) Conforming Amendment.--Section 503(g)(4) (21 U.S.C. 
     353(g)(4)) is amended--
       (1) in subparagraph (A)--
       (A) by striking ``section 351(a)'' and inserting ``section 
     351(i)''; and
       (B) by striking ``262(a)'' and inserting ``262(i)''; and
       (2) in subparagraph (B)(iii), by striking ``product or 
     establishment license under subsection (a) or (d)'' and 
     inserting ``biologics license application under subsection 
     (a)''.
       (f) Special Rule.--The Secretary of Health and Human 
     Services shall take measures to minimize differences in the 
     review and approval of products required to have approved 
     biologics license applications under section 351 of the 
     Public Health Service Act (42 U.S.C. 262) and products 
     required to have approved new drug applications under section 
     505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355(b)(1)).
       (g) Application of Federal Food, Drug, and Cosmetic Act.--
     Section 351 of the Public Health Service Act (42 U.S.C. 262), 
     as amended by subsection (d), is further amended by adding at 
     the end the following:
       ``(j) The Federal Food, Drug, and Cosmetic Act applies to a 
     biological product subject to regulation under this section, 
     except that a product for which a license has been approved 
     under subsection (a) shall not be required to have an 
     approved application under section 505 of such Act.''.

[[Page H10460]]

       (h) Examinations and Procedures.--Paragraph (3) of section 
     353(d) of the Public Health Service Act (42 U.S.C. 263a(d)) 
     is amended to read as follows:
       ``(3) Examinations and procedures.--The examinations and 
     procedures identified in paragraph (2) are laboratory 
     examinations and procedures that have been approved by the 
     Food and Drug Administration for home use or that, as 
     determined by the Secretary, are simple laboratory 
     examinations and procedures that have an insignificant risk 
     of an erroneous result, including those that--
       ``(A) employ methodologies that are so simple and accurate 
     as to render the likelihood of erroneous results by the user 
     negligible, or
       ``(B) the Secretary has determined pose no unreasonable 
     risk of harm to the patient if performed incorrectly.''.

     SEC. 124. PILOT AND SMALL SCALE MANUFACTURE.

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

     SEC. 125. INSULIN AND ANTIBIOTICS.

       (a) Certification of Drugs Containing Insulin.--
       (1) Amendment.--Section 506 (21 U.S.C. 356), as in effect 
     before the date of the enactment of this Act, is repealed.
       (2) Conforming amendments.--
       (A) Section 301(j) (21 U.S.C. 331(j)) is amended by 
     striking ``506, 507,''.
       (B) Subsection (k) of section 502 (21 U.S.C. 352) is 
     repealed.
       (C) Sections 301(i)(1), 510(j)(1)(A), and 510(j)(1)(D) (21 
     U.S.C. 331(i)(1), 360(j)(1)(A), 360(j)(1)(D)) are each 
     amended by striking ``, 506, 507,''.
       (D) Section 801(d)(1) (21 U.S.C. 381(d)(1)) is amended by 
     inserting after ``503(b)'' the following: ``or composed 
     wholly or partly of insulin''.
       (E) Section 8126(h)(2) of title 38, United States Code, is 
     amended by inserting ``or'' at the end of subparagraph (B), 
     by striking ``; or'' at the end of subparagraph (C) and 
     inserting a period, and by striking subparagraph (D).
       (b) Certification of Antibiotics.--
       (1) Amendment.--Section 507 (21 U.S.C. 357) is repealed.
       (2) Conforming amendments.--
       (A) Section 201(aa) (21 U.S.C. 321(aa)) is amended by 
     striking out ``or 507'', section 201(dd) (21 U.S.C. 321(dd)) 
     is amended by striking ``507,'', and section 201(ff)(3)(A) 
     (21 U.S.C. 321(ff)(3)(A)) is amended by striking ``, 
     certified as an antibiotic under section 507,''.
       (B) Section 301(e) (21 U.S.C. 331(e)) is amended by 
     striking ``507(d) or (g),''.
       (C) Section 306(d)(4)(B)(ii) (21 U.S.C. 335a(d)(4)(B)(ii)) 
     is amended by striking ``or 507''.
       (D) Section 502 (21 U.S.C. 352) is amended by striking 
     subsection (l).
       (E) Section 520(l) (21 U.S.C. 360j(l)) is amended by 
     striking paragraph (4) and by striking ``or Antibiotic 
     Drugs'' in the subsection heading.
       (F) Section 525(a) (21 U.S.C. 360aa(a)) is amended by 
     inserting ``or'' at the end of paragraph (1), by striking 
     paragraph (2), and by redesignating paragraph (3) as 
     paragraph (2).
       (G) Section 525(a) (21 U.S.C. 360aa(a)) is amended by 
     striking ``, certification of such drug for such disease or 
     condition under section 507,''.
       (H) Section 526(a)(1) (21 U.S.C. 360bb) is amended by 
     striking ``the submission of an application for certification 
     of the drug under section 507,'', by inserting ``or'' at the 
     end of subparagraph (A), by striking subparagraph (B), and by 
     redesignating subparagraph (C) as subparagraph (B).
       (I) Section 526(b) (21 U.S.C. 360bb(b)) is amended--
       (i) in paragraph (1), by striking ``, a certificate was 
     issued for the drug under section 507,''; and
       (ii) in paragraph (2) by striking ``, a certificate has not 
     been issued for the drug under section 507,'' and by striking 
     ``, approval of an application for certification under 
     section 507,''.
       (J) Section 527(a) (21 U.S.C. 360cc(a)) is amended by 
     inserting ``or'' at the end of paragraph (1), by striking 
     paragraph (2), by redesignating paragraph (3) as paragraph 
     (2), and by striking ``, issue another certification under 
     section 507,''.
       (K) Section 527(b) (21 U.S.C. 360cc(b)) is amended by 
     striking ``, if a certification is issued under section 507 
     for such a drug,'', ``, of the issuance of the certification 
     under section 507,'', ``, issue another certification under 
     section 507,'', ``, of such certification,'', ``, of the 
     certification,'', and ``, issuance of other certications,''.
       (L) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended by 
     striking ``, section 507 (d) or (g),''.
       (M) Section 735(1) (21 U.S.C. 379g(1)(C)) is amended by 
     inserting ``or'' at the end of subparagraph (B), by striking 
     subparagraph (C), and by redesignating subparagraph (D) as 
     subparagraph (C).
       (N) Subparagraphs (A)(ii) and (B) of sections 5(b)(1) of 
     the Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A), 
     360ee(b)(1)(B)) are each amended by striking ``or 507''.
       (O) Section 45C(b)(2)(A)(ii)(II) of the Internal Revenue 
     Code of 1986 is amended by striking ``or 507''.
       (P) Section 156(f)(4)(B) of title 35, United States Code, 
     is amended by striking ``507,'' each place it occurs.
       (c) Exportation.--Section 802 (21 U.S.C. 382) is amended by 
     adding at the end the following:
       ``(i) Insulin and antibiotic drugs may be exported without 
     regard to the requirements in this section if the insulin and 
     antibiotic drugs meet the requirements of section 
     801(e)(1).''.
       (d) Transition.--
       (1) In general.--An application that was approved by the 
     Secretary of Health and Human Services before the date of the 
     enactment of this Act for the marketing of an antibiotic drug 
     under section 507 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 357), as in effect on the day before the date of 
     the enactment of this Act, shall, on and after such date of 
     enactment, be considered to be an application that was 
     submitted and filed under section 505(b) of such Act (21 
     U.S.C. 355(b)) and approved for safety and effectiveness 
     under section 505(c) of such Act (21 U.S.C. 355(c)), except 
     that if such application for marketing was in the form of an 
     abbreviated application, the application shall be considered 
     to have been filed and approved under section 505(j) of such 
     Act (21 U.S.C. 355(j)).
       (2) Exception.--The following subsections of section 505 
     (21 U.S.C 355) shall not apply to any application for 
     marketing in which the drug that is the subject of the 
     application contains an antibiotic drug and the antibiotic 
     drug was the subject of any application for marketing 
     received by the Secretary of Health and Human Services under 
     section 507 of such Act (21 U.S.C. 357) before the date of 
     the enactment of this Act:
       (A)(i) Subsections (c)(2), (d)(6), (e)(4), (j)(2)(A)(vii), 
     (j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), and (j)(4)(D); and
       (ii) The third and fourth sentences of subsection (b)(1) 
     (regarding the filing and publication of patent information); 
     and
       (B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and (c)(3) if 
     the investigations relied upon by the applicant for approval 
     of the application were not conducted by or for the applicant 
     and for which the applicant has not obtained a right of 
     reference or use from the person by or for whom the 
     investigations were conducted.
       (3) Publication.--For purposes of this section, the 
     Secretary is authorized to make available to the public the 
     established name of each antibiotic drug that was the subject 
     of any application for marketing received by the Secretary 
     for Health and Human Services under section 507 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357) before 
     the date of enactment of this Act.
       (e) Definition.--Section 201 (21 U.S.C. 321), as amended by 
     section 121(a)(1), is further amended by adding at the end 
     the following:
       ``(jj) The term `antibiotic drug' means any drug (except 
     drugs for use in animals other than humans) composed wholly 
     or partly of any kind of penicillin, streptomycin, 
     chlortetracycline, chloramphenicol, bacitracin, or any other 
     drug intended for human use containing any quantity of any 
     chemical substance which is produced by a micro-organism and 
     which has the capacity to inhibit or destroy micro-organisms 
     in dilute solution (including a chemically synthesized 
     equivalent of any such substance) or any derivative 
     thereof.''.

     SEC. 126. ELIMINATION OF CERTAIN LABELING REQUIREMENTS.

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

     SEC. 127. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHARMACY 
                   COMPOUNDING.

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

     ``SEC. 503A. PHARMACY COMPOUNDING.

       ``(a) In General.--Sections 501(a)(2)(B), 502(f)(1), and 
     505 shall not apply to a drug product if the drug product is 
     compounded for an identified individual patient based on the 
     unsolicited receipt of a valid prescription order or a 
     notation, approved by the prescribing practitioner, on the 
     prescription order that a compounded product is necessary for 
     the identified patient, if the drug product meets the 
     requirements of this section, and if the compounding--
       ``(1) is by--
       ``(A) a licensed pharmacist in a State licensed pharmacy or 
     a Federal facility, or
       ``(B) a licensed physician,

     on the prescription order for such individual patient made by 
     a licensed physician or other licensed practitioner 
     authorized by State law to prescribe drugs; or

[[Page H10461]]

       ``(2)(A) is by a licensed pharmacist or licensed physician 
     in limited quantities before the receipt of a valid 
     prescription order for such individual patient; and
       ``(B) is based on a history of the licensed pharmacist or 
     licensed physician receiving valid prescription orders for 
     the compounding of the drug product, which orders have been 
     generated solely within an established relationship between--
       ``(i) the licensed pharmacist or licensed physician; and
       ``(ii)(I) such individual patient for whom the prescription 
     order will be provided; or
       ``(II) the physician or other licensed practitioner who 
     will write such prescription order.
       ``(b) Compounded Drug.--
       ``(1) Licensed pharmacist and licensed physician.--A drug 
     product may be compounded under subsection (a) if the 
     licensed pharmacist or licensed physician--
       ``(A) compounds the drug product using bulk drug 
     substances, as defined in regulations of the Secretary 
     published at section 207.3(a)(4) of title 21 of the Code of 
     Federal Regulations--
       ``(i) that--

       ``(I) comply with the standards of an applicable United 
     States Pharmacopoeia or National Formulary monograph, if a 
     monograph exists, and the United States Pharmacopoeia chapter 
     on pharmacy compounding;
       ``(II) if such a monograph does not exist, are drug 
     substances that are components of drugs approved by the 
     Secretary; or
       ``(III) if such a monograph does not exist and the drug 
     substance is not a component of a drug approved by the 
     Secretary, that appear on a list developed by the Secretary 
     through regulations issued by the Secretary under subsection 
     (d);

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

     The Secretary shall, in consultation with the National 
     Association of Boards of Pharmacy, develop a standard 
     memorandum of understanding for use by the States in 
     complying with subparagraph (B)(i).
       ``(c) Advertising and Promotion.--A drug may be compounded 
     under subsection (a) only if the pharmacy, licensed 
     pharmacist, or licensed physician does not advertise or 
     promote the compounding of any particular drug, class of 
     drug, or type of drug. The pharmacy, licensed pharmacist, or 
     licensed physician may advertise and promote the compounding 
     service provided by the licensed pharmacist or licensed 
     physician.
       ``(d) Regulations.--
       ``(1) In general.--The Secretary shall issue regulations to 
     implement this section. Before issuing regulations to 
     implement subsections (b)(1)(A)(i)(III), (b)(1)(C), or 
     (b)(3)(A), the Secretary shall convene and consult an 
     advisory committee on compounding unless the Secretary 
     determines that the issuance of such regulations before 
     consultation is necessary to protect the public health. The 
     advisory committee shall include representatives from the 
     National Association of Boards of Pharmacy, the United States 
     Pharmacopoeia, pharmacy, physician, and consumer 
     organizations, and other experts selected by the Secretary.
       ``(2) Limiting compounding.--The Secretary, in consultation 
     with the United States Pharmacopoeia Convention, 
     Incorporated, shall promulgate regulations identifying drug 
     substances that may be used in compounding under subsection 
     (b)(1)(A)(i)(III) for which a monograph does not exist or 
     which are not components of drug products approved by the 
     Secretary. The Secretary shall include in the regulation the 
     criteria for such substances, which shall include historical 
     use, reports in peer reviewed medical literature, or other 
     criteria the Secretary may identify.
       ``(e) Application.--This section shall not apply to--
       ``(1) compounded positron emission tomography drugs as 
     defined in section 201(ii); or
       ``(2) radiopharmaceuticals.
       ``(f) Definition.--As used in this section, the term 
     `compounding' does not include mixing, reconstituting, or 
     other such acts that are performed in accordance with 
     directions contained in approved labeling provided by the 
     product's manufacturer and other manufacturer directions 
     consistent with that labeling.''.
       (b) Effective Date.--Section 503A of the Federal Food, 
     Drug, and Cosmetic Act, added by subsection (a), shall take 
     effect upon the expiration of the 1-year period beginning on 
     the date of the enactment of this Act.

     SEC. 128. REAUTHORIZATION OF CLINICAL PHARMACOLOGY PROGRAM.

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

     SEC. 129. REGULATIONS FOR SUNSCREEN PRODUCTS.

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

     SEC. 130. REPORTS OF POSTMARKETING APPROVAL STUDIES.

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

     ``SEC. 506B. REPORTS OF POSTMARKETING STUDIES.

       ``(a) Submission.--
       ``(1) In general.--A sponsor of a drug that has entered 
     into an agreement with the Secretary to conduct a 
     postmarketing study of a drug shall submit to the Secretary, 
     within 1 year after the approval of such drug and annually 
     thereafter until the study is completed or terminated, a 
     report of the progress of the study or the reasons for the 
     failure of the sponsor to conduct the study. The report shall 
     be submitted in such form as is prescribed by the Secretary 
     in regulations issued by the Secretary.
       ``(2) Agreements prior to effective date.--Any agreement 
     entered into between the Secretary and a sponsor of a drug, 
     prior to the date of enactment of the Food and Drug 
     Administration Modernization Act of 1997, to conduct a 
     postmarketing study of a drug shall be subject to the 
     requirements of paragraph (1). An initial report for such an 
     agreement shall be submitted within 6 months after the date 
     of the issuance of the regulations under paragraph (1).
       ``(b) Consideration of Information as Public Information.--
     Any information pertaining to a report described in 
     subsection (a) shall be considered to be public information 
     to the extent that the information is necessary--
       ``(1) to identify the sponsor; and
       ``(2) to establish the status of a study described in 
     subsection (a) and the reasons, if any, for any failure to 
     carry out the study.
       ``(c) Status of Studies and Reports.--The Secretary shall 
     annually develop and publish in the Federal Register a report 
     that provides information on the status of the postmarketing 
     studies--
       ``(1) that sponsors have entered into agreements to 
     conduct; and
       ``(2) for which reports have been submitted under 
     subsection (a)(1).''.
       (b) Report to Congressional Committees.--Not later than 
     October 1, 2001, the Secretary shall prepare and submit to 
     the Committee on Labor and Human Resources of the Senate and 
     the Committee on Commerce of the House of Representatives a 
     report containing--
       (1) a summary of the reports submitted under section 506B 
     of the Federal Food, Drug, and Cosmetic Act;
       (2) an evaluation of--
       (A) the performance of the sponsors referred to in such 
     section in fulfilling the agreements with respect to the 
     conduct of postmarketing studies described in such section of 
     such Act; and
       (B) the timeliness of the Secretary's review of the 
     postmarketing studies; and
       (3) any legislative recommendations respecting the 
     postmarketing studies.

     SEC. 131. NOTIFICATION OF DISCONTINUANCE OF A LIFE SAVING 
                   PRODUCT.

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

     ``SEC. 506C. DISCONTINUANCE OF A LIFE SAVING PRODUCT.

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


[[Page H10462]]


     shall notify the Secretary of a discontinuance of the 
     manufacture of the drug at least 6 months prior to the date 
     of the discontinuance.
       ``(b) Reduction in Notification Period.--The notification 
     period required under subsection (a) for a manufacturer may 
     be reduced if the manufacturer certifies to the Secretary 
     that good cause exists for the reduction, such as a situation 
     in which--
       ``(1) a public health problem may result from continuation 
     of the manufacturing for the 6-month period;
       ``(2) a biomaterials shortage prevents the continuation of 
     the manufacturing for the 6-month period;
       ``(3) a liability problem may exist for the manufacturer if 
     the manufacturing is continued for the 6-month period;
       ``(4) continuation of the manufacturing for the 6-month 
     period may cause substantial economic hardship for the 
     manufacturer;
       ``(5) the manufacturer has filed for bankruptcy under 
     chapter 7 or 11 of title 11, United States Code; or
       ``(6) the manufacturer can continue the distribution of the 
     drug involved for 6 months.
       ``(c) Distribution.--To the maximum extent practicable, the 
     Secretary shall distribute information on the discontinuation 
     of the drugs described in subsection (a) to appropriate 
     physician and patient organizations.''.
               TITLE II--IMPROVING REGULATION OF DEVICES

     SEC. 201. INVESTIGATIONAL DEVICE EXEMPTIONS.

       (a) In General.--Section 520(g) (21 U.S.C. 360j(g)) is 
     amended by adding at the end the following:
       ``(6)(A) Not later than 1 year after the date of the 
     enactment of the Food and Drug Administration Modernization 
     Act of 1997, the Secretary shall by regulation establish, 
     with respect to a device for which an exemption under this 
     subsection is in effect, procedures and conditions that, 
     without requiring an additional approval of an application 
     for an exemption or the approval of a supplement to such an 
     application, permit--
       ``(i) developmental changes in the device (including 
     manufacturing changes) that do not constitute a significant 
     change in design or in basic principles of operation and that 
     are made in response to information gathered during the 
     course of an investigation; and
       ``(ii) changes or modifications to clinical protocols that 
     do not affect--
       ``(I) the validity of data or information resulting from 
     the completion of an approved protocol, or the relationship 
     of likely patient risk to benefit relied upon to approve a 
     protocol;
       ``(II) the scientific soundness of an investigational plan 
     submitted under paragraph (3)(A); or
       ``(III) the rights, safety, or welfare of the human 
     subjects involved in the investigation.
       ``(B) Regulations under subparagraph (A) shall provide that 
     a change or modification described in such subparagraph may 
     be made if--
       ``(i) the sponsor of the investigation determines, on the 
     basis of credible information (as defined by the Secretary) 
     that the applicable conditions under subparagraph (A) are 
     met; and
       ``(ii) the sponsor submits to the Secretary, not later than 
     5 days after making the change or modification, a notice of 
     the change or modification.
       ``(7)(A) In the case of a person intending to investigate 
     the safety or effectiveness of a class III device or any 
     implantable device, the Secretary shall ensure that the 
     person has an opportunity, prior to submitting an application 
     to the Secretary or to an institutional review committee, to 
     submit to the Secretary, for review, an investigational plan 
     (including a clinical protocol). If the applicant submits a 
     written request for a meeting with the Secretary regarding 
     such review, the Secretary shall, not later than 30 days 
     after receiving the request, meet with the applicant for the 
     purpose of reaching agreement regarding the investigational 
     plan (including a clinical protocol). The written request 
     shall include a detailed description of the device, a 
     detailed description of the proposed conditions of use of the 
     device, a proposed plan (including a clinical protocol) for 
     determining whether there is a reasonable assurance of 
     effectiveness, and, if available, information regarding the 
     expected performance from the device.
       ``(B) Any agreement regarding the parameters of an 
     investigational plan (including a clinical protocol) that is 
     reached between the Secretary and a sponsor or applicant 
     shall be reduced to writing and made part of the 
     administrative record by the Secretary. Any such agreement 
     shall not be changed, except--
       ``(i) with the written agreement of the sponsor or 
     applicant; or
       ``(ii) pursuant to a decision, made in accordance with 
     subparagraph (C) by the director of the office in which the 
     device involved is reviewed, that a substantial scientific 
     issue essential to determining the safety or effectiveness of 
     the device involved has been identified.
       ``(C) A decision under subparagraph (B)(ii) by the director 
     shall be in writing, and may be made only after the Secretary 
     has provided to the sponsor or applicant an opportunity for a 
     meeting at which the director and the sponsor or applicant 
     are present and at which the director documents the 
     scientific issue involved.''.
       (b) Action on Application.--Section 515(d)(1)(B) (21 U.S.C. 
     360e(d)(1)(B)) is amended by adding at the end the following:
       ``(iii) The Secretary shall accept and review statistically 
     valid and reliable data and any other information from 
     investigations conducted under the authority of regulations 
     required by section 520(g) to make a determination of whether 
     there is a reasonable assurance of safety and effectiveness 
     of a device subject to a pending application under this 
     section if--
       ``(I) the data or information is derived from 
     investigations of an earlier version of the device, the 
     device has been modified during or after the investigations 
     (but prior to submission of an application under subsection 
     (c)) and such a modification of the device does not 
     constitute a significant change in the design or in the basic 
     principles of operation of the device that would invalidate 
     the data or information; or
       ``(II) the data or information relates to a device approved 
     under this section, is available for use under this Act, and 
     is relevant to the design and intended use of the device for 
     which the application is pending.''.

     SEC. 202. SPECIAL REVIEW FOR CERTAIN DEVICES.

       Section 515(d) (21 U.S.C. 360e(d)) is amended--
       (1) by redesignating paragraph (3) as paragraph (4); and
       (2) by adding at the end the following:
       ``(5) In order to provide for more effective treatment or 
     diagnosis of life-threatening or irreversibly debilitating 
     human diseases or conditions, the Secretary shall provide 
     review priority for devices--
       ``(A) representing breakthrough technologies,
       ``(B) for which no approved alternatives exist,
       ``(C) which offer significant advantages over existing 
     approved alternatives, or
       ``(D) the availability of which is in the best interest of 
     the patients.''.

     SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES.

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

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

     ``In a case described in subparagraph (B) in which a 
     physician uses a device without an approval from an 
     institutional review committee, the physician shall, after 
     the use of the device, notify the chairperson of the local 
     institutional review committee of such use. Such notification 
     shall include the identification of the patient involved, the 
     date on which the device was used, and the reason for the 
     use.'';
       (3) by amending paragraph (5) to read as follows:
       ``(5) The Secretary may require a person granted an 
     exemption under paragraph (2) to demonstrate continued 
     compliance with the requirements of this subsection if the 
     Secretary believes such demonstration to be necessary to 
     protect the public health or if the Secretary has reason to 
     believe that the criteria for the exemption are no longer 
     met.''; and
       (4) by amending paragraph (6) to read as follows:
       ``(6) The Secretary may suspend or withdraw an exemption 
     from the effectiveness requirements of sections 514 and 515 
     for a humanitarian device only after providing notice and an 
     opportunity for an informal hearing.''.

     SEC. 204. DEVICE STANDARDS.

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

                      ``Recognition of a Standard

       ``(c)(1)(A) In addition to establishing a performance 
     standard under this section, the Secretary shall, by 
     publication in the Federal Register, recognize all or part of 
     an appropriate standard established by a nationally or 
     internationally recognized standard development organization 
     for which a person may submit a declaration of conformity in 
     order to meet a premarket submission requirement or other 
     requirement under this Act to which such standard is 
     applicable.
       ``(B) If a person elects to use a standard recognized by 
     the Secretary under subparagraph (A) to meet the requirements 
     described in such subparagraph, the person shall provide a 
     declaration of conformity to the Secretary that certifies 
     that the device is in conformity with such standard. A person 
     may elect to use data, or information, other than data 
     required by a standard recognized under subparagraph (A) to 
     meet any requirement regarding devices under this Act.
       ``(2) The Secretary may withdraw such recognition of a 
     standard through publication of a notice in the Federal 
     Register if the Secretary determines that the standard is no 
     longer appropriate for meeting a requirement regarding 
     devices under this Act.
       ``(3)(A) Subject to subparagraph (B), the Secretary shall 
     accept a declaration of conformity that a device is in 
     conformity with a standard recognized under paragraph (1) 
     unless the Secretary finds--
       ``(i) that the data or information submitted to support 
     such declaration does not demonstrate that the device is in 
     conformity with the standard identified in the declaration of 
     conformity; or
       ``(ii) that the standard identified in the declaration of 
     conformity is not applicable to the particular device under 
     review.
       ``(B) The Secretary may request, at any time, the data or 
     information relied on by the person to make a declaration of 
     conformity with respect to a standard recognized under 
     paragraph (1).
       ``(C) A person making a declaration of conformity with 
     respect to a standard recognized under paragraph (1) shall 
     maintain the data

[[Page H10463]]

     and information demonstrating conformity of the device to the 
     standard for a period of two years after the date of the 
     classification or approval of the device by the Secretary or 
     a period equal to the expected design life of the device, 
     whichever is longer.''.
       (b) Section 301.--Section 301 (21 U.S.C. 331) is amended by 
     adding at the end the following:
       ``(x) The falsification of a declaration of conformity 
     submitted under section 514(c) or the failure or refusal to 
     provide data or information requested by the Secretary under 
     paragraph (3) of such section.''.
       (c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is 
     amended--
       (1) by striking ``(e)'' and inserting ``(e)(1)''; and
       (2) by inserting at the end the following:
       ``(2) If it is declared to be, purports to be, or is 
     represented as, a device that is in conformity with any 
     standard recognized under section 514(c) unless such device 
     is in all respects in conformity with such standard.''.
       (d) Conforming Amendments.--Section 514(a) (21 U.S.C. 
     360d(a)) is amended--
       (1) in paragraph (1), in the second sentence, by striking 
     ``under this section'' and inserting ``under subsection 
     (b)'';
       (2) in paragraph (2), in the matter preceding subparagraph 
     (A), by striking ``under this section'' and inserting ``under 
     subsection (b)'';
       (3) in paragraph (3), by striking ``under this section'' 
     and inserting ``under subsection (b)''; and
       (4) in paragraph (4), in the matter preceding subparagraph 
     (A), by striking ``this section'' and inserting ``this 
     subsection and subsection (b)''.

     SEC. 205. SCOPE OF REVIEW; COLLABORATIVE DETERMINATIONS OF 
                   DEVICE DATA REQUIREMENTS.

       (a) Section 513(a).--Section 513(a)(3) (21 U.S.C. 
     360c(a)(3)) is amended by adding at the end the following:
       ``(C) In making a determination of a reasonable assurance 
     of the effectiveness of a device for which an application 
     under section 515 has been submitted, the Secretary shall 
     consider whether the extent of data that otherwise would be 
     required for approval of the application with respect to 
     effectiveness can be reduced through reliance on postmarket 
     controls.
       ``(D)(i) The Secretary, upon the written request of any 
     person intending to submit an application under section 515, 
     shall meet with such person to determine the type of valid 
     scientific evidence (within the meaning of subparagraphs (A) 
     and (B)) that will be necessary to demonstrate for purposes 
     of approval of an application the effectiveness of a device 
     for the conditions of use proposed by such person. The 
     written request shall include a detailed description of the 
     device, a detailed description of the proposed conditions of 
     use of the device, a proposed plan for determining whether 
     there is a reasonable assurance of effectiveness, and, if 
     available, information regarding the expected performance 
     from the device. Within 30 days after such meeting, the 
     Secretary shall specify in writing the type of valid 
     scientific evidence that will provide a reasonable assurance 
     that a device is effective under the conditions of use 
     proposed by such person.
       ``(ii) Any clinical data, including one or more well-
     controlled investigations, specified in writing by the 
     Secretary for demonstrating a reasonable assurance of device 
     effectiveness shall be specified as result of a determination 
     by the Secretary that such data are necessary to establish 
     device effectiveness. The Secretary shall consider, in 
     consultation with the applicant, the least burdensome 
     appropriate means of evaluating device effectiveness that 
     would have a reasonable likelihood of resulting in approval.
       ``(iii) The determination of the Secretary with respect to 
     the specification of valid scientific evidence under clauses 
     (i) and (ii) shall be binding upon the Secretary, unless such 
     determination by the Secretary could be contrary to the 
     public health.''.
       (b) Section 513(i).--Section 513(i)(1) (21 U.S.C. 
     360c(i)(1)) is amended by adding at the end the following:
       ``(C) To facilitate reviews of reports submitted to the 
     Secretary under section 510(k), the Secretary shall consider 
     the extent to which reliance on postmarket controls may 
     expedite the classification of devices under subsection 
     (f)(1) of this section.
       ``(D) Whenever the Secretary requests information to 
     demonstrate that devices with differing technological 
     characteristics are substantially equivalent, the Secretary 
     shall only request information that is necessary to making 
     substantial equivalence determinations. In making such 
     request, the Secretary shall consider the least burdensome 
     means of demonstrating substantial equivalence and request 
     information accordingly.
       ``(E)(i) Any determination by the Secretary of the intended 
     use of a device shall be based upon the proposed labeling 
     submitted in a report for the device under section 510(k). 
     However, when determining that a device can be found 
     substantially equivalent to a legally marketed device, the 
     director of the organizational unit responsible for 
     regulating devices (in this subparagraph referred to as the 
     `Director') may require a statement in labeling that provides 
     appropriate information regarding a use of the device not 
     identified in the proposed labeling if, after providing an 
     opportunity for consultation with the person who submitted 
     such report, the Director determines and states in writing--
       ``(I) that there is a reasonable likelihood that the device 
     will be used for an intended use not identified in the 
     proposed labeling for the device; and
       ``(II) that such use could cause harm.
       ``(ii) Such determination shall--
       ``(I) be provided to the person who submitted the report 
     within 10 days from the date of the notification of the 
     Director's concerns regarding the proposed labeling;
       ``(II) specify the limitations on the use of the device not 
     included in the proposed labeling; and
       ``(III) find the device substantially equivalent if the 
     requirements of subparagraph (A) are met and if the labeling 
     for such device conforms to the limitations specified in 
     subclause (II).
       ``(iii) The responsibilities of the Director under this 
     subparagraph may not be delegated.
       ``(iv) This subparagraph has no legal effect after the 
     expiration of the five-year period beginning on the date of 
     the enactment of the Food and Drug Administration 
     Modernization Act of 1997.''.
       (c) Section 515(d).--Section 515(d) (21 U.S.C. 360e(d)) is 
     amended--
       (1) in paragraph (1)(A), by adding after and below clause 
     (ii) the following:

     ``In making the determination whether to approve or deny the 
     application, the Secretary shall rely on the conditions of 
     use included in the proposed labeling as the basis for 
     determining whether or not there is a reasonable assurance of 
     safety and effectiveness, if the proposed labeling is neither 
     false nor misleading. In determining whether or not such 
     labeling is false or misleading, the Secretary shall fairly 
     evaluate all material facts pertinent to the proposed 
     labeling.''; and
       (2) by adding after paragraph (5) (as added by section 
     202(2)) the following:
       ``(6)(A)(i) A supplemental application shall be required 
     for any change to a device subject to an approved application 
     under this subsection that affects safety or effectiveness, 
     unless such change is a modification in a manufacturing 
     procedure or method of manufacturing and the holder of the 
     approved application submits a written notice to the 
     Secretary that describes in detail the change, summarizes the 
     data or information supporting the change, and informs the 
     Secretary that the change has been made under the 
     requirements of section 520(f).
       ``(ii) The holder of an approved application who submits a 
     notice under clause (i) with respect to a manufacturing 
     change of a device may distribute the device 30 days after 
     the date on which the Secretary receives the notice, unless 
     the Secretary within such 30-day period notifies the holder 
     that the notice is not adequate and describes such further 
     information or action that is required for acceptance of such 
     change. If the Secretary notifies the holder that a 
     supplemental application is required, the Secretary shall 
     review the supplement within 135 days after the receipt of 
     the supplement. The time used by the Secretary to review the 
     notice of the manufacturing change shall be deducted from the 
     135-day review period if the notice meets appropriate content 
     requirements for premarket approval supplements.
       ``(B)(i) Subject to clause (ii), in reviewing a supplement 
     to an approved application, for an incremental change to the 
     design of a device that affects safety or effectiveness, the 
     Secretary shall approve such supplement if--
       ``(I) nonclinical data demonstrate that the design 
     modification creates the intended additional capacity, 
     function, or performance of the device; and
       ``(II) clinical data from the approved application and any 
     supplement to the approved application provide a reasonable 
     assurance of safety and effectiveness for the changed device.
       ``(ii) The Secretary may require, when necessary, 
     additional clinical data to evaluate the design modification 
     of the device to provide a reasonable assurance of safety and 
     effectiveness.''.

     SEC. 206. PREMARKET NOTIFICATION.

       (a) Section 510.--Section 510 (21 U.S.C. 360) is amended--
       (1) in subsection (k), in the matter preceding paragraph 
     (1), by adding after ``report to the Secretary'' the 
     following: ``or person who is accredited under section 
     523(a)''; and
       (2) by adding at the end the following subsections:
       ``(l) A report under subsection (k) is not required for a 
     device intended for human use that is exempted from the 
     requirements of this subsection under subsection (m) or is 
     within a type that has been classified into class I under 
     section 513. The exception established in the preceding 
     sentence does not apply to any class I device that is 
     intended for a use which is of substantial importance in 
     preventing impairment of human health, or to any class I 
     device that presents a potential unreasonable risk of illness 
     or injury.
       ``(m)(1) Not later than 60 days after the date of enactment 
     of the Food and Drug Administration Modernization Act of 
     1997, the Secretary shall publish in the Federal Register a 
     list of each type of class II device that does not require a 
     report under subsection (k) to provide reasonable assurance 
     of safety and effectiveness. Each type of class II device 
     identified by the Secretary as not requiring the report shall 
     be exempt from the requirement to provide a report under 
     subsection (k) as of the date of the publication of the list 
     in the Federal Register.
       ``(2) Beginning on the date that is 1 day after the date of 
     the publication of a list under this subsection, the 
     Secretary may exempt a class II device from the requirement 
     to submit a report under subsection (k), upon the Secretary's 
     own initiative or a petition of an interested person, if the 
     Secretary determines that such report is not necessary to 
     assure the safety and effectiveness of the device. The 
     Secretary shall publish in the Federal Register notice of the 
     intent of the Secretary to exempt the device, or of the 
     petition, and provide a 30-day period for public comment. 
     Within 120 days after the issuance of the notice in the 
     Federal Register, the Secretary shall publish an order in the 
     Federal Register that sets forth the final determination of 
     the Secretary

[[Page H10464]]

     regarding the exemption of the device that was the subject of 
     the notice. If the Secretary fails to respond to a petition 
     within 180 days of receiving it, the petition shall be deemed 
     to be granted.''.
       (b) Section 513(f).--Section 513(f) (21 U.S.C. 360c(f)) is 
     amended by adding at the end the following:
       ``(5) The Secretary may not withhold a determination of the 
     initial classification of a device under paragraph (1) 
     because of a failure to comply with any provision of this Act 
     unrelated to a substantial equivalence decision, including a 
     finding that the facility in which the device is manufactured 
     is not in compliance with good manufacturing requirements as 
     set forth in regulations of the Secretary under section 
     520(f) (other than a finding that there is a substantial 
     likelihood that the failure to comply with such regulations 
     will potentially present a serious risk to human health).''.
       (c) Section 513(i).--Section 513(i)(1) (21 U.S.C. 360c(i)), 
     as amended by section 205(b), is amended--
       (1) in subparagraph (A)(ii)--
       (A) in subclause (I), by striking ``clinical data'' and 
     inserting ``appropriate clinical or scientific data'' and by 
     inserting ``or a person accredited under section 523'' after 
     ``Secretary''; and
       (B) in subclause (II), by striking ``efficacy'' and 
     inserting ``effectiveness''; and
       (2) by adding at the end the following:
       ``(F) Not later than 270 days after the date of the 
     enactment of the Food and Drug Administration Modernization 
     Act of 1997, the Secretary shall issue guidance specifying 
     the general principles that the Secretary will consider in 
     determining when a specific intended use of a device is not 
     reasonably included within a general use of such device for 
     purposes of a determination of substantial equivalence under 
     subsection (f) or section 520(l).''.

     SEC. 207. EVALUATION OF AUTOMATIC CLASS III DESIGNATION.

       Section 513(f) (21 U.S.C. 360c(f)), as amended by section 
     206(b), is amended--
       (1) in paragraph (1)--
       (A) in subparagraph (B), by striking ``paragraph (2)'' and 
     inserting ``paragraph (3)''; and
       (B) in the last sentence, by striking ``paragraph (2)'' and 
     inserting ``paragraph (2) or (3)'';
       (2) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively; and
       (3) by inserting after paragraph (1) the following:
       ``(2)(A) Any person who submits a report under section 
     510(k) for a type of device that has not been previously 
     classified under this Act, and that is classified into class 
     III under paragraph (1), may request, within 30 days after 
     receiving written notice of such a classification, the 
     Secretary to classify the device under the criteria set forth 
     in subparagraphs (A) through (C) of subsection (a)(1). The 
     person may, in the request, recommend to the Secretary a 
     classification for the device. Any such request shall 
     describe the device and provide detailed information and 
     reasons for the recommended classification.
       ``(B)(i) Not later than 60 days after the date of the 
     submission of the request under subparagraph (A), the 
     Secretary shall by written order classify the device 
     involved. Such classification shall be the initial 
     classification of the device for purposes of paragraph (1) 
     and any device classified under this paragraph shall be a 
     predicate device for determining substantial equivalence 
     under paragraph (1).
       ``(ii) A device that remains in class III under this 
     subparagraph shall be deemed to be adulterated within the 
     meaning of section 501(f)(1)(B) until approved under section 
     515 or exempted from such approval under section 520(g).
       ``(C) Within 30 days after the issuance of an order 
     classifying a device under this paragraph, the Secretary 
     shall publish a notice in the Federal Register announcing 
     such classification.''.

     SEC. 208. CLASSIFICATION PANELS.

       Section 513(b) (21 U.S.C. 360c(b)) is amended by adding at 
     the end the following:
       ``(5) Classification panels covering each type of device 
     shall be scheduled to meet at such times as may be 
     appropriate for the Secretary to meet applicable statutory 
     deadlines.
       ``(6)(A) Any person whose device is specifically the 
     subject of review by a classification panel shall have--
       ``(i) the same access to data and information submitted to 
     a classification panel (except for data and information that 
     are not available for public disclosure under section 552 of 
     title 5, United States Code) as the Secretary;
       ``(ii) the opportunity to submit, for review by a 
     classification panel, information that is based on the data 
     or information provided in the application submitted under 
     section 515 by the person, which information shall be 
     submitted to the Secretary for prompt transmittal to the 
     classification panel; and
       ``(iii) the same opportunity as the Secretary to 
     participate in meetings of the panel.
       ``(B) Any meetings of a classification panel shall provide 
     adequate time for initial presentations and for response to 
     any differing views by persons whose devices are specifically 
     the subject of a classification panel review, and shall 
     encourage free and open participation by all interested 
     persons.
       ``(7) After receiving from a classification panel the 
     conclusions and recommendations of the panel on a matter that 
     the panel has reviewed, the Secretary shall review the 
     conclusions and recommendations, shall make a final decision 
     on the matter in accordance with section 515(d)(2), and shall 
     notify the affected persons of the decision in writing and, 
     if the decision differs from the conclusions and 
     recommendations of the panel, shall include the reasons for 
     the difference.
       ``(8) A classification panel under this subsection shall 
     not be subject to the annual chartering and annual report 
     requirements of the Federal Advisory Committee Act.''.

     SEC. 209. CERTAINTY OF REVIEW TIMEFRAMES; COLLABORATIVE 
                   REVIEW PROCESS.

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

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

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

     ``SEC. 523. ACCREDITED PERSONS.

       ``(a) In General.--
       ``(1) Review and classification of devices.--Not later than 
     1 year after the date of the enactment of the Food and Drug 
     Administration Modernization Act of 1997, the Secretary 
     shall, subject to paragraph (3), accredit persons for the 
     purpose of reviewing reports submitted under section 510(k) 
     and making recommendations to the Secretary regarding the 
     initial classification of devices under section 513(f)(1).
       ``(2) Requirements regarding review.--
       ``(A) In general.--In making a recommendation to the 
     Secretary under paragraph (1), an accredited person shall 
     notify the Secretary in writing of the reasons for the 
     recommendation.
       ``(B) Time period for review.--Not later than 30 days after 
     the date on which the Secretary is notified under 
     subparagraph (A) by an accredited person with respect to a 
     recommendation of an initial classification of a device, the 
     Secretary shall make a determination with respect to the 
     initial classification.
       ``(C) Special rule.--The Secretary may change the initial 
     classification under section 513(f)(1) that is recommended 
     under paragraph (1) by an accredited person, and in such case 
     shall provide to such person, and the person who submitted 
     the report under section 510(k) for the device, a statement 
     explaining in detail the reasons for the change.
       ``(3) Certain devices.--
       ``(A) In general.--An accredited person may not be used to 
     perform a review of--
       ``(i) a class III device;
       ``(ii) a class II device which is intended to be 
     permanently implantable or life sustaining or life 
     supporting; or
       ``(iii) a class II device which requires clinical data in 
     the report submitted under section 510(k) for the device, 
     except that the number of class II devices to which the 
     Secretary applies this clause for a year, less the number of 
     such reports to which clauses (i) and (ii) apply, may not 
     exceed 6 percent of the number that is equal to the total 
     number of reports submitted to the Secretary under such 
     section for such year less the number of such reports to 
     which such clauses apply for such year.
       ``(B) Adjustment.--In determining for a year the ratio 
     described in subparagraph (A)(iii), the Secretary shall not 
     include in the numerator class III devices that the Secretary 
     reclassified into class II, and the Secretary shall include 
     in the denominator class II devices for which reports under 
     section 510(k) were not required to be submitted by reason of 
     the operation of section 510(m).
       ``(b) Accreditation.--
       ``(1) Programs.--The Secretary shall provide for such 
     accreditation through programs administered by the Food and 
     Drug Administration, other government agencies, or by other 
     qualified nongovernment organizations.
       ``(2) Accreditation.--
       ``(A) In general.--Not later than 180 days after the date 
     of the enactment of the Food and Drug Administration 
     Modernization Act of 1997, the Secretary shall establish and 
     publish in the Federal Register criteria to accredit or deny 
     accreditation to persons who request to perform the duties 
     specified in subsection (a). The Secretary shall respond to a 
     request for accreditation within 60 days of the receipt of 
     the request. The accreditation of such person shall specify 
     the particular activities under subsection (a) for which such 
     person is accredited.
       ``(B) Withdrawal of accreditation.--The Secretary may 
     suspend or withdraw accreditation of any person accredited 
     under this paragraph, after providing notice and an 
     opportunity for an informal hearing, when such person is 
     substantially not in compliance with the

[[Page H10465]]

     requirements of this section or poses a threat to public 
     health or fails to act in a manner that is consistent with 
     the purposes of this section.
       ``(C) Performance auditing.--To ensure that persons 
     accredited under this section will continue to meet the 
     standards of accreditation, the Secretary shall--
       ``(i) make onsite visits on a periodic basis to each 
     accredited person to audit the performance of such person; 
     and
       ``(ii) take such additional measures as the Secretary 
     determines to be appropriate.
       ``(D) Annual report.--The Secretary shall include in the 
     annual report required under section 903(g) the names of all 
     accredited persons and the particular activities under 
     subsection (a) for which each such person is accredited and 
     the name of each accredited person whose accreditation has 
     been withdrawn during the year.
       ``(3) Qualifications.--An accredited person shall, at a 
     minimum, meet the following requirements:
       ``(A) Such person may not be an employee of the Federal 
     Government.
       ``(B) Such person shall be an independent organization 
     which is not owned or controlled by a manufacturer, supplier, 
     or vendor of devices and which has no organizational, 
     material, or financial affiliation with such a manufacturer, 
     supplier, or vendor.
       ``(C) Such person shall be a legally constituted entity 
     permitted to conduct the activities for which it seeks 
     accreditation.
       ``(D) Such person shall not engage in the design, 
     manufacture, promotion, or sale of devices.
       ``(E) The operations of such person shall be in accordance 
     with generally accepted professional and ethical business 
     practices and shall agree in writing that as a minimum it 
     will--
       ``(i) certify that reported information accurately reflects 
     data reviewed;
       ``(ii) limit work to that for which competence and capacity 
     are available;
       ``(iii) treat information received, records, reports, and 
     recommendations as proprietary information;
       ``(iv) promptly respond and attempt to resolve complaints 
     regarding its activities for which it is accredited; and
       ``(v) protect against the use, in carrying out subsection 
     (a) with respect to a device, of any officer or employee of 
     the person who has a financial conflict of interest regarding 
     the device, and annually make available to the public 
     disclosures of the extent to which the person, and the 
     officers and employees of the person, have maintained 
     compliance with requirements under this clause relating to 
     financial conflicts of interest.
       ``(4) Selection of accredited persons.--The Secretary shall 
     provide each person who chooses to use an accredited person 
     to receive a section 510(k) report a panel of at least two or 
     more accredited persons from which the regulated person may 
     select one for a specific regulatory function.
       ``(5) Compensation of accredited persons.--Compensation for 
     an accredited person shall be determined by agreement between 
     the accredited person and the person who engages the services 
     of the accredited person, and shall be paid by the person who 
     engages such services.
       ``(c) Duration.--The authority provided by this section 
     terminates--
       ``(1) 5 years after the date on which the Secretary 
     notifies Congress that at least 2 persons accredited under 
     subsection (b) are available to review at least 60 percent of 
     the submissions under section 510(k), or
       ``(2) 4 years after the date on which the Secretary 
     notifies Congress that the Secretary has made a determination 
     described in paragraph (2)(B) of subsection (a) for at least 
     35 percent of the devices that are subject to review under 
     paragraph (1) of such subsection,

     whichever occurs first.''.
       (b) Recordkeeping.--Section 704 (21 U.S.C. 374) is amended 
     by adding at the end the following:
       ``(f)(1) A person accredited under section 523 to review 
     reports made under section 510(k) and make recommendations of 
     initial classifications of devices to the Secretary shall 
     maintain records documenting the training qualifications of 
     the person and the employees of the person, the procedures 
     used by the person for handling confidential information, the 
     compensation arrangements made by the person, and the 
     procedures used by the person to identify and avoid 
     conflicts of interest. Upon the request of an officer or 
     employee designated by the Secretary, the person shall 
     permit the officer or employee, at all reasonable times, 
     to have access to, to copy, and to verify, the records.
       ``(2) Within 15 days after the receipt of a written request 
     from the Secretary to a person accredited under section 523 
     for copies of records described in paragraph (1), the person 
     shall produce the copies of the records at the place 
     designated by the Secretary.''.
       (c) Conforming Amendment.--Section 301 (21 U.S.C. 331), as 
     amended by section 204(b), is amended by adding at the end 
     the following:
       ``(y) In the case of a drug, device, or food--
       ``(1) the submission of a report or recommendation by a 
     person accredited under section 523 that is false or 
     misleading in any material respect;
       ``(2) the disclosure by a person accredited under section 
     523 of confidential commercial information or any trade 
     secret without the express written consent of the person who 
     submitted such information or secret to such person; or
       ``(3) the receipt by a person accredited under section 523 
     of a bribe in any form or the doing of any corrupt act by 
     such person associated with a responsibility delegated to 
     such person under this Act.''.
       (d) Reports on Program of Accreditation.--
       (1) Comptroller general.--
       (A) Implementation of program.--Not later than 5 years 
     after the date of the enactment of this Act, the Comptroller 
     General of the United States shall submit to the Committee on 
     Commerce of the House of Representatives and the Committee on 
     Labor and Human Resources of the Senate a report describing 
     the extent to which the program of accreditation required by 
     the amendment made by subsection (a) has been implemented.
       (B) Evaluation of program.--Not later than 6 months prior 
     to the date on which, pursuant to subsection (c) of section 
     523 of the Federal Food, Drug, and Cosmetic Act (as added by 
     subsection (a), the authority provided under subsection (a) 
     of such section will terminate, the Comptroller General shall 
     submit to the Committee on Commerce of the House of 
     Representatives and the Committee on Labor and Human 
     Resources of the Senate a report describing the use of 
     accredited persons under such section 523, including an 
     evaluation of the extent to which such use assisted the 
     Secretary in carrying out the duties of the Secretary under 
     such Act with respect to devices, and the extent to which 
     such use promoted actions which are contrary to the purposes 
     of such Act.
       (2) Inclusion of certain devices within program.--Not later 
     than 3 years after the date of the enactment of this Act, the 
     Secretary of Health and Human Services shall submit to the 
     Committee on Commerce of the House of Representatives and the 
     Committee on Labor and Human Resources of the Senate a report 
     providing a determination by the Secretary of whether, in the 
     program of accreditation established pursuant to the 
     amendment made by subsection (a), the limitation established 
     in clause (iii) of section 523(a)(3)(A) of the Federal Food, 
     Drug, and Cosmetic Act (relating to class II devices for 
     which clinical data are required in reports under section 
     510(k)) should be removed.

     SEC. 211. DEVICE TRACKING.

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

                           ``Device Tracking

       ``(e)(1) The Secretary may by order require a manufacturer 
     to adopt a method of tracking a class II or class III 
     device--
       ``(A) the failure of which would be reasonably likely to 
     have serious adverse health consequences; or
       ``(B) which is--
       ``(i) intended to be implanted in the human body for more 
     than one year, or
       ``(ii) a life sustaining or life supporting device used 
     outside a device user facility.
       ``(2) Any patient receiving a device subject to tracking 
     under paragraph (1) may refuse to release, or refuse 
     permission to release, the patient's name, address, social 
     security number, or other identifying information for the 
     purpose of tracking.''.

     SEC. 212. POSTMARKET SURVEILLANCE.

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


                       ``postmarket surveillance

       ``Sec. 522. (a) In General.--The Secretary may by order 
     require a manufacturer to conduct postmarket surveillance for 
     any device of the manufacturer which is a class II or class 
     III device the failure of which would be reasonably likely to 
     have serious adverse health consequences or which is intended 
     to be--
       ``(1) implanted in the human body for more than one year, 
     or
       ``(2) a life sustaining or life supporting device used 
     outside a device user facility.
       ``(b) Surveillance Approval.--Each manufacturer required to 
     conduct a surveillance of a device shall, within 30 days of 
     receiving an order from the Secretary prescribing that the 
     manufacturer is required under this section to conduct such 
     surveillance, submit, for the approval of the Secretary, a 
     plan for the required surveillance. The Secretary, within 60 
     days of the receipt of such plan, shall determine if the 
     person designated to conduct the surveillance has appropriate 
     qualifications and experience to undertake such surveillance 
     and if the plan will result in the collection of useful data 
     that can reveal unforeseen adverse events or other 
     information necessary to protect the public health. The 
     Secretary, in consultation with the manufacturer, may by 
     order require a prospective surveillance period of up to 36 
     months. Any determination by the Secretary that a longer 
     period is necessary shall be made by mutual agreement between 
     the Secretary and the manufacturer or, if no agreement can be 
     reached, after the completion of a dispute resolution process 
     as described in section 562.''.

     SEC. 213. REPORTS.

       (a) Reports.--Section 519 (21 U.S.C. 360i) is amended--
       (1) in subsection (a)--
       (A) in the matter preceding paragraph (1), by striking 
     ``manufacturer, importer, or distributor'' and inserting 
     ``manufacturer or importer'';
       (B) in paragraph (4), by striking ``manufacturer, importer, 
     or distributor'' and inserting ``manufacturer or importer'';
       (C) in paragraph (7), by adding ``and'' after the semicolon 
     at the end;
       (D) in paragraph (8)--
       (i) by striking ``manufacturer, importer, or distributor'' 
     each place such term appears and inserting ``manufacturer or 
     importer''; and
       (ii) by striking the semicolon at the end and inserting a 
     period;
       (E) by striking paragraph (9); and
       (F) by inserting at the end the following sentence: ``The 
     Secretary shall by regulation require distributors to keep 
     records and make such records available to the Secretary upon 
     request. Paragraphs (4) and (8) apply to distributors to

[[Page H10466]]

     the same extent and in the same manner as such paragraphs 
     apply to manufacturers and importers.'';
       (2) by striking subsection (d); and
       (3) in subsection (f), by striking ``, importer, or 
     distributor'' each place it appears and inserting ``or 
     importer''.
       (b) Registration.--Section 510(g) (21 U.S.C. 360(g)) is 
     amended--
       (1) by redesignating paragraph (4) as paragraph (5);
       (2) by inserting after paragraph (3) the following:
       ``(4) any distributor who acts as a wholesale distributor 
     of devices, and who does not manufacture, repackage, process, 
     or relabel a device; or''; and
       (3) by adding at the end the following flush sentence:

     ``In this subsection, the term `wholesale distributor' means 
     any person (other than the manufacturer or the initial 
     importer) who distributes a device from the original place of 
     manufacture to the person who makes the final delivery or 
     sale of the device to the ultimate consumer or user.''.
       (c) Device User Facilities.--
       (1) In general.--Section 519(b) (21 U.S.C. 360i(b)) is 
     amended--
       (A) in paragraph (1)(C)--
       (i) in the first sentence, by striking ``a semi-annual 
     basis'' and inserting ``an annual basis'';
       (ii) in the second sentence, by striking ``and July 1''; 
     and
       (iii) by striking the matter after and below clause (iv); 
     and
       (B) in paragraph (2)--
       (i) in subparagraph (A), by inserting ``or'' after the 
     comma at the end;
       (ii) in subparagraph (B), by striking ``, or'' at the end 
     and inserting a period; and
       (iii) by striking subparagraph (C).
       (2) Sentinel system.--Section 519(b) (21 U.S.C. 360i(b)) is 
     amended--
       (A) by redesignating paragraph (5) as paragraph (6); and
       (B) by inserting after paragraph (4) the following 
     paragraph:
       ``(5) With respect to device user facilities:
       ``(A) The Secretary shall by regulation plan and implement 
     a program under which the Secretary limits user reporting 
     under paragraphs (1) through (4) to a subset of user 
     facilities that constitutes a representative profile of user 
     reports for device deaths and serious illnesses or serious 
     injuries.
       ``(B) During the period of planning the program under 
     subparagraph (A), paragraphs (1) through (4) continue to 
     apply.
       ``(C) During the period in which the Secretary is providing 
     for a transition to the full implementation of the program, 
     paragraphs (1) through (4) apply except to the extent that 
     the Secretary determines otherwise.
       ``(D) On and after the date on which the program is fully 
     implemented, paragraphs (1) through (4) do not apply to a 
     user facility unless the facility is included in the subset 
     referred to in subparagraph (A).
       ``(E) Not later than 2 years after the date of the 
     enactment of the Food and Drug Administration Modernization 
     Act of 1997, the Secretary shall submit to the Committee on 
     Commerce of the House of Representatives, and to the 
     Committee on Labor and Human Resources of the Senate, a 
     report describing the plan developed by the Secretary under 
     subparagraph (A) and the progress that has been made toward 
     the implementation of the plan.''.

     SEC. 214. PRACTICE OF MEDICINE.

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

     ``SEC. 906. PRACTICE OF MEDICINE.

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

     SEC. 215. NONINVASIVE BLOOD GLUCOSE METER.

       (a) Findings.--The Congress finds that--
       (1) diabetes and its complications are a leading cause of 
     death by disease in America;
       (2) diabetes affects approximately 16,000,000 Americans and 
     another 650,000 will be diagnosed in 1997;
       (3) the total health care-related costs of diabetes total 
     nearly $100,000,000,000 per year;
       (4) diabetes is a disease that is managed and controlled on 
     a daily basis by the patient;
       (5) the failure to properly control and manage diabetes 
     results in costly and often fatal complications including but 
     not limited to blindness, coronary artery disease, and kidney 
     failure;
       (6) blood testing devices are a critical tool for the 
     control and management of diabetes, and existing blood 
     testing devices require repeated piercing of the skin;
       (7) the pain associated with existing blood testing devices 
     creates a disincentive for people with diabetes to test blood 
     glucose levels, particularly children;
       (8) a safe and effective noninvasive blood glucose meter 
     would likely improve control and management of diabetes by 
     increasing the number of tests conducted by people with 
     diabetes, particularly children; and
       (9) the Food and Drug Administration is responsible for 
     reviewing all applications for new medical devices in the 
     United States.
       (b) Sense of Congress.--It is the sense of the Congress 
     that the availability of a safe, effective, noninvasive blood 
     glucose meter would greatly enhance the health and well-being 
     of all people with diabetes across America and the world.

     SEC. 216. USE OF DATA RELATING TO PREMARKET APPROVAL; PRODUCT 
                   DEVELOPMENT PROTOCOL.

       (a) Use of Data Relating to Premarket Approval.--
       (1) In general.--Section 520(h)(4) (21 U.S.C. 360j(h)(4)) 
     is amended to read as follows:
       ``(4)(A) Any information contained in an application for 
     premarket approval filed with the Secretary pursuant to 
     section 515(c) (including information from clinical and 
     preclinical tests or studies that demonstrate the safety and 
     effectiveness of a device, but excluding descriptions of 
     methods of manufacture and product composition and other 
     trade secrets) shall be available, 6 years after the 
     application has been approved by the Secretary, for use by 
     the Secretary in--
       ``(i) approving another device;
       ``(ii) determining whether a product development protocol 
     has been completed, under section 515 for another device;
       ``(iii) establishing a performance standard or special 
     control under this Act; or
       ``(iv) classifying or reclassifying another device under 
     section 513 and subsection (l)(2).
       ``(B) The publicly available detailed summaries of 
     information respecting the safety and effectiveness of 
     devices required by paragraph (1)(A) shall be available for 
     use by the Secretary as the evidentiary basis for the agency 
     actions described in subparagraph (A).''.
       (2) Conforming amendments.--Section 517(a) (21 U.S.C. 
     360g(a)) is amended--
       (A) in paragraph (8), by adding ``or'' at the end;
       (B) in paragraph (9), by striking ``, or'' and inserting a 
     comma; and
       (C) by striking paragraph (10).
       (b) Product Development Protocol.--Section 515(f)(2) (21 
     U.S.C. 360e(f)(2)) is amended by striking ``he shall'' and 
     all that follows and inserting the following: ``the 
     Secretary--
       ``(A) may, at the initiative of the Secretary, refer the 
     proposed protocol to the appropriate panel under section 513 
     for its recommendation respecting approval of the protocol; 
     or
       ``(B) shall so refer such protocol upon the request of the 
     submitter, unless the Secretary finds that the proposed 
     protocol and accompanying data which would be reviewed by 
     such panel substantially duplicate a product development 
     protocol and accompanying data which have previously been 
     reviewed by such a panel.''.

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

       Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended 
     by striking ``clinical investigations'' and inserting ``1 or 
     more clinical investigations''.
                TITLE III--IMPROVING REGULATION OF FOOD

     SEC. 301. FLEXIBILITY FOR REGULATIONS REGARDING CLAIMS.

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

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

     SEC. 302. PETITIONS FOR CLAIMS.

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

     SEC. 303. HEALTH CLAIMS FOR FOOD PRODUCTS.

       Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by 
     adding at the end thereof the following:
       ``(C) Notwithstanding the provisions of clauses (A)(i) and 
     (B), a claim of the type described in subparagraph (1)(B) 
     which is not authorized by the Secretary in a regulation 
     promulgated in accordance with clause (B) shall be

[[Page H10467]]

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

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

     SEC. 304. NUTRIENT CONTENT CLAIMS.

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

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

     SEC. 305. REFERRAL STATEMENTS.

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

     SEC. 306. DISCLOSURE OF IRRADIATION.

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


                              ``disclosure

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

     SEC. 307. IRRADIATION PETITION.

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

     SEC. 308. GLASS AND CERAMIC WARE.

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

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

     SEC. 309. FOOD CONTACT SUBSTANCES.

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

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

          ``Notification Relating to a Food Contact Substance

       ``(h)(1) Subject to such regulations as may be promulgated 
     under paragraph (3), a manufacturer or supplier of a food 
     contact substance may, at least 120 days prior to the 
     introduction or delivery for introduction into interstate 
     commerce of the food contact substance, notify the

[[Page H10468]]

     Secretary of the identity and intended use of the food 
     contact substance, and of the determination of the 
     manufacturer or supplier that the intended use of such food 
     contact substance is safe under the standard described in 
     subsection (c)(3)(A). The notification shall contain the 
     information that forms the basis of the determination and all 
     information required to be submitted by regulations 
     promulgated by the Secretary.
       ``(2)(A) A notification submitted under paragraph (1) shall 
     become effective 120 days after the date of receipt by the 
     Secretary and the food contact substance may be introduced or 
     delivered for introduction into interstate commerce, unless 
     the Secretary makes a determination within the 120-day period 
     that, based on the data and information before the Secretary, 
     such use of the food contact substance has not been shown to 
     be safe under the standard described in subsection (c)(3)(A), 
     and informs the manufacturer or supplier of such 
     determination.
       ``(B) A decision by the Secretary to object to a 
     notification shall constitute final agency action subject to 
     judicial review.
       ``(C) In this paragraph, the term `food contact substance' 
     means the substance that is the subject of a notification 
     submitted under paragraph (1), and does not include a similar 
     or identical substance manufactured or prepared by a person 
     other than the manufacturer identified in the notification.
       ``(3)(A) The process in this subsection shall be utilized 
     for authorizing the marketing of a food contact substance 
     except where the Secretary determines that submission and 
     review of a petition under subsection (b) is necessary to 
     provide adequate assurance of safety, or where the Secretary 
     and any manufacturer or supplier agree that such manufacturer 
     or supplier may submit a petition under subsection (b).
       ``(B) The Secretary is authorized to promulgate regulations 
     to identify the circumstances in which a petition shall be 
     filed under subsection (b), and shall consider criteria such 
     as the probable consumption of such food contact substance 
     and potential toxicity of the food contact substance in 
     determining the circumstances in which a petition shall be 
     filed under subsection (b).
       ``(4) The Secretary shall keep confidential any information 
     provided in a notification under paragraph (1) for 120 days 
     after receipt by the Secretary of the notification. After the 
     expiration of such 120 days, the information shall be 
     available to any interested party except for any matter in 
     the notification that is a trade secret or confidential 
     commercial information.
       ``(5)(A)(i) Except as provided in clause (ii), the 
     notification program established under this subsection shall 
     not operate in any fiscal year unless--
       ``(I) an appropriation equal to or exceeding the applicable 
     amount under clause (iv) is made for such fiscal year for 
     carrying out such program in such fiscal year; and
       ``(II) the Secretary certifies that the amount appropriated 
     for such fiscal year for the Center for Food Safety and 
     Applied Nutrition of the Food and Drug Administration 
     (exclusive of the appropriation referred to in subclause (I)) 
     equals or exceeds the amount appropriated for the Center for 
     fiscal year 1997, excluding any amount appropriated for new 
     programs.
       ``(ii) The Secretary shall, not later than April 1, 1999, 
     begin accepting and reviewing notifications submitted under 
     the notification program established under this subsection 
     if--
       ``(I) an appropriation equal to or exceeding the applicable 
     amount under clause (iii) is made for the last six months of 
     fiscal year 1999 for carrying out such program during such 
     period; and
       ``(II) the Secretary certifies that the amount appropriated 
     for such period for the Center for Food Safety and Applied 
     Nutrition of the Food and Drug Administration (exclusive of 
     the appropriation referred to in subclause (I)) equals or 
     exceeds an amount equivalent to one-half the amount 
     appropriated for the Center for fiscal year 1997, excluding 
     any amount appropriated for new programs.
       ``(iii) For the last six months of fiscal year 1999, the 
     applicable amount under this clause is $1,500,000, or the 
     amount specified in the budget request of the President for 
     the six-month period involved for carrying out the 
     notification program in fiscal year 1999, whichever is 
     less.
       ``(iv) For fiscal year 2000 and subsequent fiscal years, 
     the applicable amount under this clause is $3,000,000, or the 
     amount specified in the budget request of the President for 
     the fiscal year involved for carrying out the notification 
     program under this subsection, whichever is less.
       ``(B) For purposes of carrying out the notification program 
     under this subsection, there are authorized to be 
     appropriated such sums as may be necessary for each of the 
     fiscal years 1999 through fiscal year 2003, except that such 
     authorization of appropriations is not effective for a fiscal 
     year for any amount that is less than the applicable amount 
     under clause (iii) or (iv) of subparagraph (A), whichever is 
     applicable.
       ``(C) Not later than April 1 of fiscal year 1998 and 
     February 1 of each subsequent fiscal year, the Secretary 
     shall submit a report to the Committees on Appropriations of 
     the House of Representatives and the Senate, the Committee on 
     Commerce of the House of Representatives, and the Committee 
     on Labor and Human Resources of the Senate that provides an 
     estimate of the Secretary of the costs of carrying out the 
     notification program established under this subsection for 
     the next fiscal year.
       ``(6) In this section, the term `food contact substance' 
     means any substance intended for use as a component of 
     materials used in manufacturing, packing, packaging, 
     transporting, or holding food if such use is not intended to 
     have any technical effect in such food.'';
       (3) in subsection (i), as so redesignated by paragraph (1), 
     by adding at the end the following: ``The Secretary shall by 
     regulation prescribe the procedure by which the Secretary may 
     deem a notification under subsection (h) to no longer be 
     effective.''; and
       (4) in subsection (j), as so redesignated by paragraph (1), 
     by striking ``subsections (b) to (h)'' and inserting 
     ``subsections (b) to (i)''.
                      TITLE IV--GENERAL PROVISIONS

     SEC. 401. DISSEMINATION OF INFORMATION ON NEW USES.

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

         ``Subchapter D--Dissemination of Treatment Information

     ``SEC. 551. REQUIREMENTS FOR DISSEMINATION OF TREATMENT 
                   INFORMATION ON DRUGS OR DEVICES.

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

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

[[Page H10469]]

     ``SEC. 552. INFORMATION AUTHORIZED TO BE DISSEMINATED.

       ``(a) Authorized Information.--A manufacturer may 
     disseminate information under section 551 on a new use only 
     if the information--
       ``(1) is in the form of an unabridged--
       ``(A) reprint or copy of an article, peer-reviewed by 
     experts qualified by scientific training or experience to 
     evaluate the safety or effectiveness of the drug or device 
     involved, which was published in a scientific or medical 
     journal (as defined in section 556(5)), which is about a 
     clinical investigation with respect to the drug or device, 
     and which would be considered to be scientifically sound by 
     such experts; or
       ``(B) reference publication, described in subsection (b), 
     that includes information about a clinical investigation with 
     respect to the drug or device that would be considered to be 
     scientifically sound by experts qualified by scientific 
     training or experience to evaluate the safety or 
     effectiveness of the drug or device that is the subject of 
     such a clinical investigation; and
       ``(2) is not false or misleading and would not pose a 
     significant risk to the public health.
       ``(b) Reference Publication.--A reference publication 
     referred to in subsection (a)(1)(B) is a publication that--
       ``(1) has not been written, edited, excerpted, or published 
     specifically for, or at the request of, a manufacturer of a 
     drug or device;
       ``(2) has not been edited or significantly influenced by a 
     such a manufacturer;
       ``(3) is not solely distributed through such a manufacturer 
     but is generally available in bookstores or other 
     distribution channels where medical textbooks are sold;
       ``(4) does not focus on any particular drug or device of a 
     manufacturer that disseminates information under section 551 
     and does not have a primary focus on new uses of drugs or 
     devices that are marketed or under investigation by a 
     manufacturer supporting the dissemination of information; and
       ``(5) presents materials that are not false or misleading.

     ``SEC. 553. ESTABLISHMENT OF LIST OF ARTICLES AND 
                   PUBLICATIONS DISSEMINATED AND LIST OF PROVIDERS 
                   THAT RECEIVED ARTICLES AND REFERENCE 
                   PUBLICATIONS.

       ``(a) In General.--A manufacturer may disseminate 
     information under section 551 on a new use only if the 
     manufacturer prepares and submits to the Secretary 
     biannually--
       ``(1) a list containing the titles of the articles and 
     reference publications relating to the new use of drugs or 
     devices that were disseminated by the manufacturer to a 
     person described in section 551(a) for the 6-month period 
     preceding the date on which the manufacturer submits the list 
     to the Secretary; and
       ``(2) a list that identifies the categories of providers 
     (as described in section 551(a)) that received the articles 
     and reference publications for the 6-month period described 
     in paragraph (1).
       ``(b) Records.--A manufacturer that disseminates 
     information under section 551 shall keep records that may be 
     used by the manufacturer when, pursuant to section 555, such 
     manufacturer is required to take corrective action and 
     shall be made available to the Secretary, upon request, 
     for purposes of ensuring or taking corrective action 
     pursuant to such section. Such records, at the Secretary's 
     discretion, may identify the recipient of information 
     provided pursuant to section 551 or the categories of such 
     recipients.

     ``SEC. 554. REQUIREMENT REGARDING SUBMISSION OF SUPPLEMENTAL 
                   APPLICATION FOR NEW USE; EXEMPTION FROM 
                   REQUIREMENT.

       ``(a) In General.--A manufacturer may disseminate 
     information under section 551 on a new use only if--
       ``(1)(A) the manufacturer has submitted to the Secretary a 
     supplemental application for such use; or
       ``(B) the manufacturer meets the condition described in 
     subsection (b) or (c) (relating to a certification that the 
     manufacturer will submit such an application); or
       ``(2) there is in effect for the manufacturer an exemption 
     under subsection (d) from the requirement of paragraph (1).
       ``(b) Certification on Supplemental Application; Condition 
     in Case of Completed Studies.--For purposes of subsection 
     (a)(1)(B), a manufacturer may disseminate information on a 
     new use if the manufacturer has submitted to the Secretary an 
     application containing a certification that--
       ``(1) the studies needed for the submission of a 
     supplemental application for the new use have been completed; 
     and
       ``(2) the supplemental application will be submitted to the 
     Secretary not later than 6 months after the date of the 
     initial dissemination of information under section 551.
       ``(c) Certification on Supplemental Application; Condition 
     in Case of Planned Studies.--
       ``(1) In general.--For purposes of subsection (a)(1)(B), a 
     manufacturer may disseminate information on a new use if--
       ``(A) the manufacturer has submitted to the Secretary an 
     application containing--
       ``(i) a proposed protocol and schedule for conducting the 
     studies needed for the submission of a supplemental 
     application for the new use; and
       ``(ii) a certification that the supplemental application 
     will be submitted to the Secretary not later than 36 months 
     after the date of the initial dissemination of information 
     under section 551 (or, as applicable, not later than such 
     date as the Secretary may specify pursuant to an extension 
     under paragraph (3)); and
       ``(B) the Secretary has determined that the proposed 
     protocol is adequate and that the schedule for completing 
     such studies is reasonable.
       ``(2) Progress reports on studies.--A manufacturer that 
     submits to the Secretary an application under paragraph (1) 
     shall submit to the Secretary periodic reports describing the 
     status of the studies involved.
       ``(3) Extension of time regarding planned studies.--The 
     period of 36 months authorized in paragraph (1)(A)(ii) for 
     the completion of studies may be extended by the Secretary 
     if--
       ``(A) the Secretary determines that the studies needed to 
     submit such an application cannot be completed and submitted 
     within 36 months; or
       ``(B) the manufacturer involved submits to the Secretary a 
     written request for the extension and the Secretary 
     determines that the manufacturer has acted with due diligence 
     to conduct the studies in a timely manner, except that an 
     extension under this subparagraph may not be provided for 
     more than 24 additional months.
       ``(d) Exemption From Requirement of Supplemental 
     Application.--
       ``(1) In general.--For purposes of subsection (a)(2), a 
     manufacturer may disseminate information on a new use if--
       ``(A) the manufacturer has submitted to the Secretary an 
     application for an exemption from meeting the requirement of 
     subsection (a)(1); and
       ``(B)(i) the Secretary has approved the application in 
     accordance with paragraph (2); or
       ``(ii) the application is deemed under paragraph (3)(A) to 
     have been approved (unless such approval is terminated 
     pursuant to paragraph (3)(B)).
       ``(2) Conditions for approval.--The Secretary may approve 
     an application under paragraph (1) for an exemption if the 
     Secretary makes a determination described in subparagraph (A) 
     or (B), as follows:
       ``(A) The Secretary makes a determination that, for reasons 
     defined by the Secretary, it would be economically 
     prohibitive with respect to such drug or device for the 
     manufacturer to incur the costs necessary for the submission 
     of a supplemental application. In making such determination, 
     the Secretary shall consider (in addition to any other 
     considerations the Secretary finds appropriate)--
       ``(i) the lack of the availability under law of any period 
     during which the manufacturer would have exclusive marketing 
     rights with respect to the new use involved; and
       ``(ii) the size of the population expected to benefit from 
     approval of the supplemental application.
       ``(B) The Secretary makes a determination that, for reasons 
     defined by the Secretary, it would be unethical to conduct 
     the studies necessary for the supplemental application. In 
     making such determination, the Secretary shall consider (in 
     addition to any other considerations the Secretary finds 
     appropriate) whether the new use involved is the standard of 
     medical care for a health condition.
       ``(3) Time for consideration of application; deemed 
     approval.--
       ``(A) In general.--The Secretary shall approve or deny an 
     application under paragraph (1) for an exemption not later 
     than 60 days after the receipt of the application. If the 
     Secretary does not comply with the preceding sentence, the 
     application is deemed to be approved.
       ``(B) Termination of deemed approval.--If pursuant to a 
     deemed approval under subparagraph (A) a manufacturer 
     disseminates written information under section 551 on a new 
     use, the Secretary may at any time terminate such approval 
     and under section 555(b)(3) order the manufacturer to cease 
     disseminating the information.
       ``(e) Requirements Regarding Applications.--Applications 
     under this section shall be submitted in the form and manner 
     prescribed by the Secretary.

     ``SEC. 555. CORRECTIVE ACTIONS; CESSATION OF DISSEMINATION.

       ``(a) Postdissemination Data Regarding Safety and 
     Effectiveness.--
       ``(1) Corrective actions.--With respect to data received by 
     the Secretary after the dissemination of information under 
     section 551 by a manufacturer has begun (whether received 
     pursuant to paragraph (2) or otherwise), if the Secretary 
     determines that the data indicate that the new use involved 
     may not be effective or may present a significant risk to 
     public health, the Secretary shall, after consultation with 
     the manufacturer, take such action regarding the 
     dissemination of the information as the Secretary determines 
     to be appropriate for the protection of the public health, 
     which may include ordering that the manufacturer cease the 
     dissemination of the information.
       ``(2) Responsibilities of manufacturers to submit data.--
     After a manufacturer disseminates information under section 
     551, the manufacturer shall submit to the Secretary a 
     notification of any additional knowledge of the manufacturer 
     on clinical research or other data that relate to the safety 
     or effectiveness of the new use involved. If the manufacturer 
     is in possession of the data, the notification shall include 
     the data. The Secretary shall by regulation establish the 
     scope of the responsibilities of manufacturers under this 
     paragraph, including such limits on the responsibilities as 
     the Secretary determines to be appropriate.
       ``(b) Cessation of Dissemination.--
       ``(1) Failure of manufacturer to comply with 
     requirements.--The Secretary may order a manufacturer to 
     cease the dissemination of information pursuant to section 
     551 if the Secretary determines that the information being 
     disseminated does not comply with the requirements 
     established in this subchapter. Such an order may be issued 
     only after the Secretary has provided notice to the 
     manufacturer of the intent of the Secretary to issue the 
     order and (unless paragraph (2)(B) applies) has provided an 
     opportunity for a meeting with respect to such intent. If the 
     failure of the manufacturer constitutes a minor violation of 
     this subchapter, the

[[Page H10470]]

     Secretary shall delay issuing the order and provide to the 
     manufacturer an opportunity to correct the violation.
       ``(2) Supplemental applications.--The Secretary may order a 
     manufacturer to cease the dissemination of information 
     pursuant to section 551 if--
       ``(A) in the case of a manufacturer that has submitted a 
     supplemental application for a new use pursuant to section 
     554(a)(1), the Secretary determines that the supplemental 
     application does not contain adequate information for 
     approval of the new use for which the application was 
     submitted;
       ``(B) in the case of a manufacturer that has submitted a 
     certification under section 554(b), the manufacturer has not, 
     within the 6-month period involved, submitted the 
     supplemental application referred to in the certification; or
       ``(C) in the case of a manufacturer that has submitted a 
     certification under section 554(c) but has not yet submitted 
     the supplemental application referred to in the 
     certification, the Secretary determines, after an informal 
     hearing, that the manufacturer is not acting with due 
     diligence to complete the studies involved.
       ``(3) Termination of deemed approval of exemption regarding 
     supplemental applications.--If under section 554(d)(3) the 
     Secretary terminates a deemed approval of an exemption, the 
     Secretary may order the manufacturer involved to cease 
     disseminating the information. A manufacturer shall comply 
     with an order under the preceding sentence not later than 60 
     days after the receipt of the order.
       ``(c) Corrective Actions by Manufacturers.--
       ``(1) In general.--In any case in which under this section 
     the Secretary orders a manufacturer to cease disseminating 
     information, the Secretary may order the manufacturer to take 
     action to correct the information that has been disseminated, 
     except as provided in paragraph (2).
       ``(2) Termination of deemed approval of exemption regarding 
     supplemental applications.--In the case of an order under 
     subsection (b)(3) to cease disseminating information, the 
     Secretary may not order the manufacturer involved to take 
     action to correct the information that has been disseminated 
     unless the Secretary determines that the new use described in 
     the information would pose a significant risk to the public 
     health.

     ``SEC. 556. DEFINITIONS.

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

     ``SEC. 557. RULES OF CONSTRUCTION.

       ``(a) Unsolicited Request.--Nothing in section 551 shall be 
     construed as prohibiting a manufacturer from disseminating 
     information in response to an unsolicited request from a 
     health care practitioner.
       ``(b) Dissemination of Information on Drugs or Devices Not 
     Evidence of Intended Use.--Notwithstanding subsection (a), 
     (f), or (o) of section 502, or any other provision of law, 
     the dissemination of information relating to a new use of a 
     drug or device, in accordance with section 551, shall not be 
     construed by the Secretary as evidence of a new intended use 
     of the drug or device that is different from the intended use 
     of the drug or device set forth in the official labeling of 
     the drug or device. Such dissemination shall not be 
     considered by the Secretary as labeling, adulteration, or 
     misbranding of the drug or device.
       ``(c) Patent Protection.--Nothing in section 551 shall 
     affect patent rights in any manner.
       ``(d) Authorization for Dissemination of Articles and Fees 
     for Reprints of Articles.--Nothing in section 551 shall be 
     construed as prohibiting an entity that publishes a 
     scientific journal (as defined in section 556(5)) from 
     requiring authorization from the entity to disseminate an 
     article published by such entity or charging fees for the 
     purchase of reprints of published articles from such 
     entity.''.
       (b) Prohibited Act.--Section 301 (21 U.S.C. 331), as 
     amended by section 210, is amended by adding at the end the 
     following:
       ``(z) The dissemination of information in violation of 
     section 551.''.
       (c) Regulations.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall promulgate regulations to implement the 
     amendments made by this section.
       (d) Effective Date.--The amendments made by this section 
     shall take effect 1 year after the date of enactment of this 
     Act, or upon the Secretary's issuance of final regulations 
     pursuant to subsection (c), whichever is sooner.
       (e) Sunset.--The amendments made by this section cease to 
     be effective September 30, 2006, or 7 years after the date on 
     which the Secretary promulgates the regulations described in 
     subsection (c), whichever is later.
       (f) Studies and Reports.--
       (1) General accounting office.--
       (A) In general.--The Comptroller General of the United 
     States shall conduct a study to determine the impact of 
     subchapter D of chapter V of the Federal Food, Drug, and 
     Cosmetic Act, as added by this section, on the resources of 
     the Department of Health and Human Services.
       (B) Report.--Not later than January 1, 2002, the 
     Comptroller General of the United States shall prepare and 
     submit to the Committee on Labor and Human Resources of the 
     Senate and the Committee on Commerce of the House of 
     Representatives a report of the results of the study.
       (2) Department of health and human services.--
       (A) In general.--In order to assist Congress in determining 
     whether the provisions of such subchapter should be extended 
     beyond the termination date specified in subsection (e), the 
     Secretary of Health and Human Services shall, in accordance 
     with subparagraph (B), arrange for the conduct of a study of 
     the scientific issues raised as a result of the enactment of 
     such subchapter including issues relating to--
       (i) the effectiveness of such subchapter with respect to 
     the provision of useful scientific information to health care 
     practitioners;
       (ii) the quality of the information being disseminated 
     pursuant to the provisions of such subchapter;
       (iii) the quality and usefulness of the information 
     provided, in accordance with such subchapter, by the 
     Secretary or by the manufacturer at the request of the 
     Secretary; and
       (iv) the impact of such subchapter on research in the area 
     of new uses, indications, or dosages, particularly the impact 
     on pediatric indications and rare diseases.
       (3) Procedure for study.--
       (A) In general.--The Secretary shall request the Institute 
     of Medicine of the National Academy of Sciences to conduct 
     the study required by paragraph (2), and to prepare and 
     submit the report required by subparagraph (B), under an 
     arrangement by which the actual expenses incurred by the 
     Institute of Medicine in conducting the study and preparing 
     the report will be paid by the Secretary. If the Institute of 
     Medicine is unwilling to conduct the study under such an 
     arrangement, the Comptroller General of the United States 
     shall conduct such study.
       (B) Report.--Not later than September 30, 2005, the 
     Institute of Medicine or the Comptroller General of the 
     United States, as appropriate, shall prepare and submit to 
     the Committee on Labor and Human Resources of the Senate, the 
     Committee on Commerce of the House of Representatives, and 
     the Secretary a report of the results of the study required 
     by paragraph (2). The Secretary, after the receipt of the 
     report, shall make the report available to the public.

     SEC. 402. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES AND 
                   DIAGNOSTICS.

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

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

     ``SEC. 561. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND 
                   DIAGNOSTICS.

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

[[Page H10471]]

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

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

     SEC. 403. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED 
                   PRODUCTS.

       (a) Standards.--Not later than 180 days after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall publish in the Federal Register standards for 
     the prompt review of supplemental applications submitted for 
     approved articles under the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 301 et seq.) or section 351 of the Public 
     Health Service Act (42 U.S.C. 262).
       (b) Guidance to Industry.--Not later than 180 days after 
     the date of enactment of this Act, the Secretary shall issue 
     final guidances to clarify the requirements for, and 
     facilitate the submission of data to support, the approval of 
     supplemental applications for the approved articles described 
     in subsection (a). The guidances shall--
       (1) clarify circumstances in which published matter may be 
     the basis for approval of a supplemental application;
       (2) specify data requirements that will avoid duplication 
     of previously submitted data by recognizing the availability 
     of data previously submitted in support of an original 
     application; and
       (3) define supplemental applications that are eligible for 
     priority review.
       (c) Responsibilities of Centers.--The Secretary shall 
     designate an individual in each center within the Food and 
     Drug Administration (except the Center for Food Safety and 
     Applied Nutrition) to be responsible for--
       (1) encouraging the prompt review of supplemental 
     applications for approved articles; and
       (2) working with sponsors to facilitate the development and 
     submission of data to support supplemental applications.
       (d) Collaboration.--The Secretary shall implement programs 
     and policies that will foster collaboration between the Food 
     and Drug Administration, the National Institutes of Health, 
     professional medical and scientific societies, and other 
     persons, to identify published and unpublished studies that 
     may support a supplemental application, and to encourage 
     sponsors to make supplemental applications or conduct further 
     research in support of a supplemental application based, in 
     whole or in part, on such studies.

     SEC. 404. DISPUTE RESOLUTION.

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

     ``SEC. 562. DISPUTE RESOLUTION.

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

     SEC. 405. INFORMAL AGENCY STATEMENTS.

       Section 701 (21 U.S.C. 371) is amended by adding at the end 
     the following:
       ``(h)(1)(A) The Secretary shall develop guidance documents 
     with public participation and ensure that information 
     identifying the existence of such documents and the documents 
     themselves are made available to the public both in written 
     form and, as feasible, through electronic means. Such 
     documents shall not create or confer any rights for or on any 
     person, although they present the views of the Secretary on 
     matters under the jurisdiction of the Food and Drug 
     Administration.
       ``(B) Although guidance documents shall not be binding on 
     the Secretary, the Secretary shall ensure that employees of 
     the Food and Drug Administration do not deviate from such 
     guidances without appropriate justification and supervisory 
     concurrence. The Secretary shall provide training to 
     employees in how to develop and use guidance documents and 
     shall monitor the development and issuance of such documents.
       ``(C) For guidance documents that set forth initial 
     interpretations of a statute or regulation, changes in 
     interpretation or policy that are of more than a minor 
     nature, complex scientific issues, or highly controversial 
     issues, the Secretary shall ensure public participation prior 
     to implementation of guidance documents, unless the Secretary 
     determines that such prior public participation is not 
     feasible or appropriate. In such cases, the Secretary shall 
     provide for public comment upon implementation and take such 
     comment into account.
       ``(D) For guidance documents that set forth existing 
     practices or minor changes in policy, the Secretary shall 
     provide for public comment upon implementation.
       ``(2) In developing guidance documents, the Secretary shall 
     ensure uniform nomenclature for such documents and uniform 
     internal procedures for approval of such documents. The 
     Secretary shall ensure that guidance documents and revisions 
     of such documents are properly dated and indicate the 
     nonbinding nature of the documents. The Secretary shall 
     periodically review all guidance documents and, where 
     appropriate, revise such documents.
       ``(3) The Secretary, acting through the Commissioner, shall 
     maintain electronically and update and publish periodically 
     in the Federal Register a list of guidance documents. All 
     such documents shall be made available to the public.
       ``(4) The Secretary shall ensure that an effective appeals 
     mechanism is in place to address complaints that the Food and 
     Drug Administration is not developing and using guidance 
     documents in accordance with this subsection.
       ``(5) Not later than July 1, 2000, the Secretary after 
     evaluating the effectiveness of the Good Guidance Practices 
     document, published in the Federal Register at 62 Fed. Reg. 
     8961, shall promulgate a regulation consistent with this 
     subsection specifying the policies and procedures of the Food 
     and Drug Administration for the development, issuance, and 
     use of guidance documents.''.

     SEC. 406. FOOD AND DRUG ADMINISTRATION MISSION AND ANNUAL 
                   REPORT.

       (a) Mission.--Section 903 (21 U.S.C. 393) is amended--
       (1) by redesignating subsections (b) and (c) as subsections 
     (d) and (e), respectively; and
       (2) by inserting after subsection (a) the following:
       ``(b) Mission.--The Administration shall--
       ``(1) promote the public health by promptly and efficiently 
     reviewing clinical research and taking appropriate action on 
     the marketing of regulated products in a timely manner;
       ``(2) with respect to such products, protect the public 
     health by ensuring that--
       ``(A) foods are safe, wholesome, sanitary, and properly 
     labeled;
       ``(B) human and veterinary drugs are safe and effective;
       ``(C) there is reasonable assurance of the safety and 
     effectiveness of devices intended for human use;

[[Page H10472]]

       ``(D) cosmetics are safe and properly labeled; and
       ``(E) public health and safety are protected from 
     electronic product radiation;
       ``(3) participate through appropriate processes with 
     representatives of other countries to reduce the burden of 
     regulation, harmonize regulatory requirements, and achieve 
     appropriate reciprocal arrangements; and
       ``(4) as determined to be appropriate by the Secretary, 
     carry out paragraphs (1) through (3) in consultation with 
     experts in science, medicine, and public health, and in 
     cooperation with consumers, users, manufacturers, importers, 
     packers, distributors, and retailers of regulated 
     products.''.
       (b) Annual Report.--Section 903 (21 U.S.C. 393), as amended 
     by subsection (a), is further amended by adding at the end 
     the following:
       ``(f) Agency Plan for Statutory Compliance.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of the Food and Drug Administration Modernization 
     Act of 1997, the Secretary, after consultation with 
     appropriate scientific and academic experts, health care 
     professionals, representatives of patient and consumer 
     advocacy groups, and the regulated industry, shall develop 
     and publish in the Federal Register a plan bringing the 
     Secretary into compliance with each of the obligations of the 
     Secretary under this Act. The Secretary shall review the plan 
     biannually and shall revise the plan as necessary, in 
     consultation with such persons.
       ``(2) Objectives of agency plan.--The plan required by 
     paragraph (1) shall establish objectives and mechanisms to 
     achieve such objectives, including objectives related to--
       ``(A) maximizing the availability and clarity of 
     information about the process for review of applications and 
     submissions (including petitions, notifications, and any 
     other similar forms of request) made under this Act;
       ``(B) maximizing the availability and clarity of 
     information for consumers and patients concerning new 
     products;
       ``(C) implementing inspection and postmarket monitoring 
     provisions of this Act;
       ``(D) ensuring access to the scientific and technical 
     expertise needed by the Secretary to meet obligations 
     described in paragraph (1);
       ``(E) establishing mechanisms, by July 1, 1999, for meeting 
     the time periods specified in this Act for the review of all 
     applications and submissions described in subparagraph (A) 
     and submitted after the date of enactment of the Food and 
     Drug Administration Modernization Act of 1997; and
       ``(F) eliminating backlogs in the review of applications 
     and submissions described in subparagraph (A), by January 1, 
     2000.
       ``(g) Annual Report.--The Secretary shall annually prepare 
     and publish in the Federal Register and solicit public 
     comment on a report that--
       ``(1) provides detailed statistical information on the 
     performance of the Secretary under the plan described in 
     subsection (f);
       ``(2) compares such performance of the Secretary with the 
     objectives of the plan and with the statutory obligations of 
     the Secretary; and
       ``(3) identifies any regulatory policy that has a 
     significant negative impact on compliance with any objective 
     of the plan or any statutory obligation and sets forth any 
     proposed revision to any such regulatory policy.''.

     SEC. 407. INFORMATION SYSTEM.

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

               ``Subchapter D--Information and Education

     ``SEC. 741. INFORMATION SYSTEM.

       ``The Secretary shall establish and maintain an information 
     system to track the status and progress of each application 
     or submission (including a petition, notification, or other 
     similar form of request) submitted to the Food and Drug 
     Administration requesting agency action.''.
       (b) Report.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall submit a report to the Committee on Labor and 
     Human Resources of the Senate and the Committee on Commerce 
     of the House of Representatives on the status of the system 
     to be established under the amendment made by subsection (a), 
     including the projected costs of the system and concerns 
     about confidentiality.

     SEC. 408. EDUCATION AND TRAINING.

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

     ``SEC. 742. EDUCATION.

       ``(a) In General.--The Secretary shall conduct training and 
     education programs for the employees of the Food and Drug 
     Administration relating to the regulatory responsibilities 
     and policies established by this Act, including programs 
     for--
       ``(1) scientific training;
       ``(2) training to improve the skill of officers and 
     employees authorized to conduct inspections under section 
     704;
       ``(3) training to achieve product specialization in such 
     inspections; and
       ``(4) training in administrative process and procedure and 
     integrity issues.
       ``(b) Intramural Fellowships and Other Training Programs.--
     The Secretary, acting through the Commissioner, may, through 
     fellowships and other training programs, conduct and support 
     intramural research training for predoctoral and postdoctoral 
     scientists and physicians.''.
       (b) Centers for Disease Control and Prevention.--
       (1) In general.--Part B of title III of the Public Health 
     Service Act is amended by inserting after section 317F (42 
     U.S.C. 247b-7) the following:

     ``SEC. 317G. FELLOWSHIP AND TRAINING PROGRAMS.

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

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

       Title IX of the Public Health Service Act (42 U.S.C. 299 et 
     seq.) is amended by adding at the end of part A the following 
     new section:

     ``SEC. 905. DEMONSTRATION PROGRAM REGARDING CENTERS FOR 
                   EDUCATION AND RESEARCH ON THERAPEUTICS.

       ``(a) In General.--The Secretary, acting through the 
     Administrator and in consultation with the Commissioner of 
     Food and Drugs, shall establish a demonstration program for 
     the purpose of making one or more grants for the 
     establishment and operation of one or more centers to carry 
     out the activities specified in subsection (b).
       ``(b) Required Activities.--The activities referred to in 
     subsection (a) are the following:
       ``(1) The conduct of state-of-the-art clinical and 
     laboratory research for the following purposes:
       ``(A) To increase awareness of--
       ``(i) new uses of drugs, biological products, and devices;
       ``(ii) ways to improve the effective use of drugs, 
     biological products, and devices; and
       ``(iii) risks of new uses and risks of combinations of 
     drugs and biological products.
       ``(B) To provide objective clinical information to the 
     following individuals and entities:
       ``(i) Health care practitioners or other providers of 
     health care goods or services.
       ``(ii) Pharmacy benefit managers.
       ``(iii) Health maintenance organizations or other managed 
     health care organizations.
       ``(iv) Health care insurers or governmental agencies.
       ``(v) Consumers.
       ``(C) To improve the quality of health care while reducing 
     the cost of health care through--
       ``(i) the appropriate use of drugs, biological products, or 
     devices; and
       ``(ii) the prevention of adverse effects of drugs, 
     biological products, and devices and the consequences of such 
     effects, such as unnecessary hospitalizations.
       ``(2) The conduct of research on the comparative 
     effectiveness and safety of drugs, biological products, and 
     devices.
       ``(3) Such other activities as the Secretary determines to 
     be appropriate, except that the grant may not be expended to 
     assist the Secretary in the review of new drugs.
       ``(c) Application for Grant.--A grant under subsection (a) 
     may be made only if an application for the grant is submitted 
     to the Secretary and the application is in such form, is made 
     in such manner, and contains such agreements, assurances, and 
     information as the Secretary determines to be necessary to 
     carry out this section.
       ``(d) Peer Review.--A grant under subsection (a) may be 
     made only if the application for the grant has undergone 
     appropriate technical and scientific peer review.
       ``(e) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated $2,000,000 for fiscal year 1998, and $3,000,000 
     for each of fiscal years 1999 through 2002.''.

     SEC. 410. MUTUAL RECOGNITION AGREEMENTS AND GLOBAL 
                   HARMONIZATION.

       (a) Good Manufacturing Practice Requirements.--Section 
     520(f)(1)(B) (21 U.S.C. 360j(f)(1)(B)) is amended--
       (1) in clause (i), by striking ``, and'' at the end and 
     inserting a semicolon;
       (2) in clause (ii), by striking the period and inserting 
     ``; and''; and
       (3) by inserting after clause (ii) the following:
       ``(iii) ensure that such regulation conforms, to the extent 
     practicable, with internationally recognized standards 
     defining quality systems, or parts of the standards, for 
     medical devices.''.
       (b) Harmonization Efforts.--Section 803 (21 U.S.C. 383) is 
     amended by adding at the end the following:
       ``(c)(1) The Secretary shall support the Office of the 
     United States Trade Representative, in consultation with the 
     Secretary of Commerce, in meetings with representatives of 
     other countries to discuss methods and approaches to reduce 
     the burden of regulation and harmonize regulatory 
     requirements if the Secretary determines that such 
     harmonization continues consumer protections consistent with 
     the purposes of this Act.
       ``(2) The Secretary shall support the Office of the United 
     States Trade Representative, in consultation with the 
     Secretary of Commerce, in efforts to move toward the 
     acceptance of mutual recognition agreements relating to the 
     regulation of drugs, biological products, devices, foods, 
     food additives, and color additives, and the regulation of 
     good manufacturing practices, between the European Union and 
     the United States.
       ``(3) The Secretary shall regularly participate in meetings 
     with representatives of other foreign governments to discuss 
     and reach agreement on

[[Page H10473]]

     methods and approaches to harmonize regulatory requirements.
       ``(4) The Secretary shall, not later than 180 days after 
     the date of enactment of the Food and Drug Administration 
     Modernization Act of 1997, make public a plan that 
     establishes a framework for achieving mutual recognition of 
     good manufacturing practices inspections.
       ``(5) Paragraphs (1) through (4) shall not apply with 
     respect to products defined in section 201(ff).''.

     SEC. 411. ENVIRONMENTAL IMPACT REVIEW.

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

              ``Subchapter E--Environmental Impact Review

     ``SEC. 746. ENVIRONMENTAL IMPACT.

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

     SEC. 412. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND 
                   COSMETICS.

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

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

     ``SEC. 751. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS.

       ``(a) In General.--Except as provided in subsection (b), 
     (c)(1), (d), (e), or (f), no State or political subdivision 
     of a State may establish or continue in effect any 
     requirement--
       ``(1) that relates to the regulation of a drug that is not 
     subject to the requirements of section 503(b)(1) or 
     503(f)(1)(A); and
       ``(2) that is different from or in addition to, or that is 
     otherwise not identical with, a requirement under this Act, 
     the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 
     et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 
     1451 et seq.).
       ``(b) Exemption.--
       ``(1) In general.--Upon application of a State or political 
     subdivision thereof, the Secretary may by regulation, after 
     notice and opportunity for written and oral presentation of 
     views, exempt from subsection (a), under such conditions as 
     may be prescribed in such regulation, a State or political 
     subdivision requirement that--
       ``(A) protects an important public interest that would 
     otherwise be unprotected, including the health and safety of 
     children;
       ``(B) would not cause any drug to be in violation of any 
     applicable requirement or prohibition under Federal law; and
       ``(C) would not unduly burden interstate commerce.
       ``(2) Timely action.--The Secretary shall make a decision 
     on the exemption of a State or political subdivision 
     requirement under paragraph (1) not later than 120 days after 
     receiving the application of the State or political 
     subdivision under paragraph (1).
       ``(c) Scope.--
       ``(1) In general.--This section shall not apply to--
       ``(A) any State or political subdivision requirement that 
     relates to the practice of pharmacy; or
       ``(B) any State or political subdivision requirement that a 
     drug be dispensed only upon the prescription of a 
     practitioner licensed by law to administer such drug.
       ``(2) Safety or effectiveness.--For purposes of subsection 
     (a), a requirement that relates to the regulation of a drug 
     shall be deemed to include any requirement relating to public 
     information or any other form of public communication 
     relating to a warning of any kind for a drug.
       ``(d) Exceptions.--
       ``(1) In general.--In the case of a drug described in 
     subsection (a)(1) that is not the subject of an application 
     approved under section 505 or section 507 (as in effect on 
     the day before the date of enactment of the Food and Drug 
     Administration Modernization Act of 1997) or a final 
     regulation promulgated by the Secretary establishing 
     conditions under which the drug is generally recognized as 
     safe and effective and not misbranded, subsection (a) shall 
     apply only with respect to a requirement of a State or 
     political subdivision of a State that relates to the same 
     subject as, but is different from or in addition to, or that 
     is otherwise not identical with--
       ``(A) a regulation in effect with respect to the drug 
     pursuant to a statute described in subsection (a)(2); or
       ``(B) any other requirement in effect with respect to the 
     drug pursuant to an amendment to such a statute made on or 
     after the date of enactment of the Food and Drug 
     Administration Modernization Act of 1997.
       ``(2) State initiatives.--This section shall not apply to a 
     State requirement adopted by a State public initiative or 
     referendum enacted prior to September 1, 1997.
       ``(e) No Effect on Product Liability Law.--Nothing in this 
     section shall be construed to modify or otherwise affect any 
     action or the liability of any person under the product 
     liability law of any State.
       ``(f) State Enforcement Authority.--Nothing in this section 
     shall prevent a State or political subdivision thereof from 
     enforcing, under any relevant civil or other enforcement 
     authority, a requirement that is identical to a requirement 
     of this Act.''.
       (b) Inspections.--Section 704(a)(1) (21 U.S.C. 374(a)(1)) 
     is amended by striking ``prescription drugs'' each place it 
     appears and inserting ``prescription drugs, nonprescription 
     drugs intended for human use,''.
       (c) Misbranding.--Subparagraph (1) of section 502(e) (21 
     U.S.C. 352(e)(1)) is amended to read as follows:
       ``(1)(A) If it is a drug, unless its label bears, to the 
     exclusion of any other nonproprietary name (except the 
     applicable systematic chemical name or the chemical 
     formula)--
       ``(i) the established name (as defined in subparagraph (3)) 
     of the drug, if there is such a name;
       ``(ii) the established name and quantity or, if determined 
     to be appropriate by the Secretary, the proportion of each 
     active ingredient, including the quantity, kind, and 
     proportion of any alcohol, and also including whether active 
     or not the established name and quantity or if determined to 
     be appropriate by the Secretary, the proportion of any 
     bromides, ether, chloroform, acetanilide, acetophenetidin, 
     amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, 
     arsenic, digitalis, digitalis glucosides, mercury, 
     ouabain, strophanthin, strychnine, thyroid, or any 
     derivative or preparation of any such substances, 
     contained therein, except that the requirement for stating 
     the quantity of the active ingredients, other than the 
     quantity of those specifically named in this subclause, 
     shall not apply to nonprescription drugs not intended for 
     human use; and
       ``(iii) the established name of each inactive ingredient 
     listed in alphabetical order on the outside container of the 
     retail package and, if determined to be appropriate by the 
     Secretary, on the immediate container, as prescribed in 
     regulation promulgated by the Secretary, except that nothing 
     in this subclause shall be deemed to require that any trade 
     secret be divulged, and except that the requirements of this 
     subclause with respect to alphabetical order shall apply only 
     to nonprescription drugs that are not also cosmetics and that 
     this subclause shall not apply to nonprescription drugs not 
     intended for human use.
       ``(B) For any prescription drug the established name of 
     such drug or ingredient, as the case may be, on such label 
     (and on any labeling on which a name for such drug or 
     ingredient is used) shall be printed prominently and in type 
     at least half as large as that used thereon for any 
     proprietary name or designation for such drug or ingredient, 
     except that to the extent that compliance with the 
     requirements of subclause (ii) or (iii) of clause (A) or this 
     clause is impracticable, exemptions shall be established by 
     regulations promulgated by the Secretary.''.
       (d) Cosmetics.--Subchapter F of chapter VII, as amended by 
     subsection (a), is further amended by adding at the end the 
     following:

     ``SEC. 752. PREEMPTION FOR LABELING OR PACKAGING OF 
                   COSMETICS.

       ``(a) In General.--Except as provided in subsection (b), 
     (d), or (e), no State or political subdivision of a State may 
     establish or continue in effect any requirement for labeling 
     or packaging of a cosmetic that is different from or in 
     addition to, or that is otherwise not identical with, a 
     requirement specifically applicable to a particular cosmetic 
     or class of cosmetics under this Act, the Poison Prevention 
     Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair 
     Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
       ``(b) Exemption.--Upon application of a State or political 
     subdivision thereof, the Secretary may by regulation, after 
     notice and opportunity for written and oral presentation of 
     views, exempt from subsection (a), under such conditions as 
     may be prescribed in such regulation, a State or political 
     subdivision requirement for labeling or packaging that--
       ``(1) protects an important public interest that would 
     otherwise be unprotected;
       ``(2) would not cause a cosmetic to be in violation of any 
     applicable requirement or prohibition under Federal law; and
       ``(3) would not unduly burden interstate commerce.
       ``(c) Scope.--For purposes of subsection (a), a reference 
     to a State requirement that relates to the packaging or 
     labeling of a cosmetic means any specific requirement 
     relating to the same aspect of such cosmetic as a requirement 
     specifically applicable to that particular cosmetic or class 
     of cosmetics under this Act for packaging or labeling, 
     including any State requirement relating to public 
     information or any other form of public communication.
       ``(d) No Effect on Product Liability Law.--Nothing in this 
     section shall be construed to modify or otherwise affect any 
     action or the liability of any person under the product 
     liability law of any State.
       ``(e) State Initiative.--This section shall not apply to a 
     State requirement adopted by a State public initiative or 
     referendum enacted prior to September 1, 1997.''.

     SEC. 413. FOOD AND DRUG ADMINISTRATION STUDY OF MERCURY 
                   COMPOUNDS IN DRUGS AND FOOD.

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

     The Secretary shall compile the list required by paragraph 
     (1) within 2 years after the date of enactment of the Food 
     and Drug Administration Modernization Act of 1997 and shall 
     provide the analysis required by paragraph (2) within 2 years 
     after such date of enactment.
       (b) Study.--The Secretary of Health and Human Services, 
     acting through the Food and

[[Page H10474]]

     Drug Administration, shall conduct a study of the effect on 
     humans of the use of mercury compounds in nasal sprays. Such 
     study shall include data from other studies that have been 
     made of such use.
       (c) Study of Mercury Sales.--
       (1) Study.--The Secretary of Health and Human Services, 
     acting through the Food and Drug Administration and subject 
     to appropriations, shall conduct, or shall contract with the 
     Institute of Medicine of the National Academy of Sciences to 
     conduct, a study of the effect on humans of the use of 
     elemental, organic, or inorganic mercury when offered for 
     sale as a drug or dietary supplement. Such study shall, among 
     other things, evaluate--
       (A) the scope of mercury use as a drug or dietary 
     supplement; and
       (B) the adverse effects on health of children and other 
     sensitive populations resulting from exposure to, or 
     ingestion or inhalation of, mercury when so used.

     In conducting such study, the Secretary shall consult with 
     the Administrator of the Environmental Protection Agency, the 
     Chair of the Consumer Product Safety Commission, and the 
     Administrator of the Agency for Toxic Substances and Disease 
     Registry, and, to the extent the Secretary believes necessary 
     or appropriate, with any other Federal or private entity.
       (2) Regulations.--If, in the opinion of the Secretary, the 
     use of elemental, organic, or inorganic mercury offered for 
     sale as a drug or dietary supplement poses a threat to human 
     health, the Secretary shall promulgate regulations 
     restricting the sale of mercury intended for such use. At a 
     minimum, such regulations shall be designed to protect the 
     health of children and other sensitive populations from 
     adverse effects resulting from exposure to, or ingestion or 
     inhalation of, mercury. Such regulations, to the extent 
     feasible, should not unnecessarily interfere with the 
     availability of mercury for use in religious ceremonies.

     SEC. 414. INTERAGENCY COLLABORATION.

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

     SEC. 415. CONTRACTS FOR EXPERT REVIEW.

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

     ``SEC. 907. CONTRACTS FOR EXPERT REVIEW.

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

     SEC. 416. PRODUCT CLASSIFICATION.

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

     ``SEC. 563. CLASSIFICATION OF PRODUCTS.

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

     SEC. 417. REGISTRATION OF FOREIGN ESTABLISHMENTS.

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

     SEC. 418. CLARIFICATION OF SEIZURE AUTHORITY.

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

     SEC. 419. INTERSTATE COMMERCE.

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

     SEC. 420. SAFETY REPORT DISCLAIMERS.

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

                     ``Subchapter G--Safety Reports

     ``SEC. 756. SAFETY REPORT DISCLAIMERS.

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

     SEC. 421. LABELING AND ADVERTISING REGARDING COMPLIANCE WITH 
                   STATUTORY REQUIREMENTS.

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

     SEC. 422. RULE OF CONSTRUCTION.

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

     SEC. 501. EFFECTIVE DATE.

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

       That the House recede from its amendment to the title of 
     the bill.
     Tom Bliley,
     Michael Bilirakis,
     Joe Barton,

[[Page H10475]]

     James Greenwood,
     Richard Burr,
     Ed Whitfield,
     John D. Dingell,
     Sherrod Brown,
     Henry A. Waxman,
     Ron Klink,
                                Managers of the Part of the House.

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

       JOINT EXPLANATORY STATEMENT OF THE COMMITTEE OF CONFERENCE

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

                 Title I--Improving Regulation of Drugs

     Prescription Drug User Fee Act (Subtitle A)
       The conferees believe it is important to place the PDUFA 
     reauthorization provisions of the Act in the overall context 
     of the budgetary agreements which have been put into place by 
     the 1997 Balanced Budget Agreements (BBA). This Act preserves 
     the original PDUFA adjustment factor and therefore the basic 
     understanding behind the 1992 enactment of this provision: 
     that is, the industry willingness to pay user fees for 
     enhanced performance in the drug approval process. 
     Nevertheless the conferees acknowledge that the 1997 BBA 
     places tight constraints on the appropriations process, 
     particularly in the out years. The conferees expect the 
     appropriators will make every effort to meet the trigger so 
     that FDA is allowed to collect and expend user fees. However, 
     it must be acknowledged that particularly in the fifth year 
     of BBA, budgetary pressures on all discretionary spending 
     will be great.
       Breakdowns of the actual spending levels at FDA have not 
     traditionally been provided to the appropriators, making it 
     difficult to conduct oversight. Beginning in Fiscal Year 
     1998, appropriators will require FDA to submit a directed 
     operating budget as part of the annual budget request. This 
     will serve as a functional breakdown of how appropriated 
     dollars are spent, similar to the report FDA submits annually 
     to show how the agency spent collected PDUFA user fees.
       The conferees expect the President's budgetary request for 
     FDA for salaries and expenses to meet the PDUFA levels 
     specified for each of these years and not be based on any 
     assumption of the enactment of new substitutive user fees on 
     other FDA regulated industries.
     Pediatric studies of drugs (Sec. 111)
       The conference agreement provides that if the Secretary 
     determines that information about a drug may produce health 
     benefits in a pediatric population and makes a written 
     request for pediatric studies (including a time frame for 
     completing the studies), and the studies are completed and 
     are accepted by the Secretary, then the sponsor or 
     manufacturer will qualify for 6 months of extra market 
     exclusivity. The agreement authorizes the Secretary to 
     determine the time frame for completing the studies, but the 
     conferees emphasize that such studies should be sought, 
     conducted, and completed at the earliest possible 
     opportunity. The conferees do not intend that such studies be 
     artificially timed for market advantage.
       The agreement provides that no new market exclusivity may 
     be applied to any new drug for which a new drug application 
     is submitted after January 1, 2002. However, the agreement 
     provides a continuation of the program for certain drugs 
     already on the market on the date of enactment. The purpose 
     of this limited extension is to ensure that, with respect to 
     such already marketed drugs, exclusivity remains available if 
     the Secretary determines there is a continuing need for 
     additional information relating to the use of such drugs that 
     may promote health benefits in the pediatric population. This 
     is applicable only to drugs already included on the list 
     under subsection (b) as of January 1, 2002. The Secretary 
     will not list any additional drugs under Section 505A(b) 
     after January 1, 2002. These drugs will be eligible for the 
     applicable 6-month time extension if the requested studies 
     satisfy all requirements of the section.
       The conferees expect the Secretary to consult with experts 
     in pediatric research to develop the list of drugs under 
     subsection (b), and to set priorities for studies on these 
     drugs. Such experts should include representatives from the 
     American Academy of Pediatrics, the Pediatric Pharmacology 
     Research Unit (PPRU) Network, and the U.S. Pharmacopeia. The 
     conferees note particularly the excellent efforts of NIH, 
     especially through the PPRU Network, which will contribute 
     significantly to this effort.
       The conference agreement also requires that a study be 
     conducted on the program, by January 1, 2001, that reviews 
     all aspects of the program, including its impact on the price 
     and availability of drugs and the availability of generic 
     drugs.
       With respect to any requested studies under this provision, 
     the conferees intend that data collected prior to a request 
     or requirement by the Secretary may be used, in addition to 
     data collected after such request or requirement in 
     satisfying the provisions of this section.
     Clinical investigations (Sec. 115)
       The conferees note that the requirement for the Secretary 
     to review existing guidance and develop additional guidance, 
     as appropriate, on the inclusion of women and minorities in 
     clinical trials does not require participation of women and 
     minorities in any particular trial. Furthermore, FDA is 
     required to consult with the National Institutes of Health, 
     which has developed inclusion guidelines for subjects in 
     federally funded clinical research, and with representatives 
     of the drug manufacturing industry, to ensure that ethical, 
     scientific, and legal issues specific to privately funded 
     clinical research are considered. The conferees expect FDA to 
     set forth its general policy regarding: the inclusion of 
     women and minorities in drug development research; 
     population-specific analyses of clinical data and assessment 
     of potential pharmacokinetic differences; and the conduct of 
     specific additional studies in women or minorities, where 
     appropriate.
     Content and review of applications (Sec. 119)
       The Secretary is required to meet with an applicant if the 
     applicant makes a reasonable written request for a meeting 
     for the purpose of reaching agreement on the design and size 
     of studies, if the sponsor provides the information necessary 
     to discuss and reach agreement on the design and size of such 
     studies. The Secretary may refuse to meet if the sponsor does 
     not provide such information or if the Secretary determines 
     that such meeting is premature or would not be useful.
     Positron emission tomography (Sec. 121)
       The conference agreement provides for regulation of 
     positron emission tomography (PET) drugs and replaces earlier 
     industry guidance and regulatory standards for PET products 
     promulgated by the FDA. The agreement provides that, until 
     the Secretary establishes procedures under subsection 
     (c)(1) described below, neither a New Drug Application 
     (NDA) nor an Abbreviated New Drug Application (ANDA) is 
     required by a licensed practitioner to produce a 
     compounded PET product in accordance with United States 
     Pharmacopiea (USP) standards.
       The agreement requires the Secretary, in two years to 
     establish procedures for approving PET products, including 
     compounded PET products, and good manufacturing practices for 
     such products, taking account of relevant differences between 
     commercial manufacturers and non-profit organizations and in 
     consultation with patient groups, physicians, and others. The 
     Secretary may not require NDAs or ANDAs for these products 
     for four years (or two years after the procedures mentioned 
     above are established).
       A compounded PET drug, by definition, must be compounded 
     pursuant to a valid prescription order and in accordance with 
     state law, among other requirements. A PET drug that fails to 
     meet these requirements is not a ``compounded PET drug'' and 
     therefore is not exempt from section 501(a)(2)(B) (21 USC 
     351(a)(2)(B)) or from subsections (b) and (j) of section 505 
     (21 USC 355). PET drugs that fail to meet the definition of a 
     ``compounded PET drug'' shall be subject to the procedures 
     and requirements established by the Secretary under 
     subsection (c)(1).

[[Page H10476]]

     Application of Federal law to practice of pharmacy 
         compounding (Sec. 127)
       The conference report includes provisions on pharmacy 
     compounding that reflect the conferees' extensive work with 
     the Food and Drug Administration and other interested parties 
     to reach consensus. It is the intent of the conferees to 
     ensure continued availability of compounded drug products as 
     a component of individualized therapy, while limiting the 
     scope of compounding so as to prevent manufacturing under the 
     guise of compounding. Section 503A establishes parameters 
     under which compounding is appropriate and lawful. The 
     conditions set forth in Section 503A should be used by the 
     state boards of pharmacy and medicine for proper regulation 
     of pharmacy compounding in addition to existing state-
     specific regulations.
       The conferees intend that, as defined in subparagraph 
     (b)(2), copies of commercially available drug products do not 
     include drug products in which the change from the 
     commercially available drug product produces a ``significant 
     difference'' for the particular patient. For example, the 
     removal of a dye from a commercially available drug product 
     for a particular patient who is allergic to such dye shall be 
     presumed to be a ``significant difference.'' The conferees 
     expect that FDA and the courts will accord great deference to 
     the licensed prescriber's judgement in determining whether 
     the change produces a ``significant difference.'' However, 
     where it is readily apparent, based on the circumstances, the 
     ``significant difference'' is a mere pretext to allow 
     compounding of products that are essentially copies of 
     commercially available products, such compounding would be 
     considered copying of commercially available products and 
     would not qualify for the compounding exemptions if it is 
     done regularly or in inordinate amounts. Such circumstances 
     may include, for example, instances in which minor changes in 
     strength (such as from .08% to .09% are made that are not 
     known to be significant or instances in which the prescribing 
     physician is receiving financial remuneration or other 
     financial incentives to write prescription for compounded 
     products.
       The conferees also expect that the Secretary will develop 
     the list of bulk drug substances described in subsection 
     (b)(1)(A)(i)(III) within one year from the date of enactment. 
     It is the intent of the conferees that the criteria used to 
     develop the list of bulk drug substances and the list itself 
     are to be developed in consultation with the United States 
     Pharmacopoeia. The conferees further intend that where 
     evidence relating to an approval under Section 505 does not 
     exist, the Secretary shall consider other criteria. Finally, 
     the conferees intend that after this list is published, 
     organizations may petition the FDA for inclusion of 
     additional substances on the aforementioned list.
       The memorandum of understanding described in Paragraph 
     (b)(3)(B)(i) shall provide guidance on the meaning of 
     inordinate amounts, including any circumstances under which 
     the compounding of drug products for interstate shipment in 
     excess of 5 percent of total prescription order would be 
     included in a ``safe harbor'' of interstate shipments of 
     compounded products that shall not be deemed inordinate.
       As stated in paragraph (e), nothing in Section 503A is 
     intended to change or otherwise affect current law with 
     respect to radiopharmaceuticals, including PET drugs. 
     Further, as stated in paragraph (f), the term compounding 
     does not include mixing reconstituting or other such acts 
     that are performed in accordance with directions contained in 
     approved labeling provided by the product's manufacturer and 
     other manufacturer directions consistent with that labeling. 
     Nothing in this provision is intended to change or otherwise 
     affect the Act with respect to reconstitution or other 
     similar processing that is done pursuant to a manufacturer's 
     approved labeling, and other directions from such 
     manufacturer that are consistent with that labeling. In 
     general, such practices, as performed by a licensed 
     practitioner for an identified individual patient, are 
     appropriately regulated by state boards of pharmacy. The 
     conferees intend that facilities required to register with 
     the FDA, including those which are engaged in non-patient 
     specific compounding and reconstitution activities, are 
     appropriately regulated under the Federal Food, Drug and 
     Cosmetic Act.
       Finally, with regard to the effective date described in 
     paragraph (b), the conferees expect the FDA to work 
     diligently to consult with necessary parties to promulgate 
     the required regulations and lists. Nothing in paragraph (b) 
     is intended to abrogate the Secretary's responsibility to 
     promulgate such regulations through the notice and comment 
     rulemaking process.
     Reauthorization of the Clinical Pharmacology Program (Sec. 
         128)
       The conference agreement extends through fiscal year 2002 
     the authorization of appropriations of the Clinical 
     Pharmacology Training Program, a program originally 
     authorized under section 2(b) of P.L. 102-222. Nothing in 
     this section of the agreement prohibits the Secretary from 
     continuing the awarding of grants to the original and current 
     grantees. The conferees strongly recommend that the Secretary 
     continue the development of the clinical pharmacology 
     programs at the colleges and universities originally selected 
     to participate in the program.
     Regulations for sunscreen products (Sec. 129)
       The conference agreement includes a provision requiring FDA 
     to continue diligently with its work to complete its 
     rulemaking process on sunscreen products and to issue 
     regulations within 18 months. The conferees recognize that 
     various technical and scientific issues may take longer to 
     resolve than other aspects of the rulemaking. The conferees 
     do not intend that all regulation in this area be complete or 
     comprehensive by a specified date.

               Title II--Improving Regulation of Devices

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

[[Page H10477]]

     that the reports under this section are not required from any 
     manufacturer, importer, or distributor who also is regulated 
     and required to make such reports under the Radiation Control 
     for Health and Safety Act of 1968 (21 U.S.C. 36011).
     Practice of medicine (Sec. 214)
       The conference agreement includes a provision intended by 
     the conferees to emphasize that the FDA should not interfere 
     in the practice of medicine. Specifically, the conferees note 
     that the off-label use of a medical device by a physician 
     using his or her best medical judgment in determining how and 
     when to use the medical product for the care of a particular 
     patient is not the province of the FDA. It is the intent of 
     the conferees that this provision not be construed to affect 
     medical professional liability.

                Title III--Improving Regulation of Food

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

                      Title IV--General Provisions

     Dissemination of treatment information (Sec. 401)
       The conference agreement's inclusion of this section is 
     intended to provide that health care practitioners can obtain 
     important scientific information about uses that are not 
     included in the approved labeling of drugs, biological 
     products, and devices. The conferees also wish to encourage 
     that these new uses be included on the product label. 
     Therefore, the agreement includes strong incentives to 
     conduct the research needed and file a supplemental 
     application for such uses. A manufacturer who seeks to 
     disseminate information about a new use must either certify 
     that it will file a supplemental application or must submit a 
     proposed protocol and schedule for conducting the necessary 
     studies and a certification that a supplemental application 
     will be filed.
       Although the conferees intend to ensure that the research 
     is undertaken to get new uses on product labels, the 
     conferees also recognize that there may be limited 
     circumstances when it is appropriate to exempt a manufacturer 
     from the requirement to file a supplemental application. In 
     making the determination of whether to grant an exemption 
     pursuant to subsection (d)(2), the Secretary may consider, 
     among other factors, whether: the new use meets the 
     requirements of section 186(t)(2)(B) of the Social Security 
     Act; a medical specialty society that is represented in or 
     recognized by the Council of Medical Specialty Societies (or 
     is a subspecialty of such society) or is recognized by the 
     American Osteopathic Association, has found that the new use 
     is consistent with sound medical practice; the new use is 
     described in a recommendation or medical practice guideline 
     of a Federal health agency, including the National Institutes 
     of Health, the Agency for Health Care Policy Research and the 
     Centers for Disease Control and Prevention of the Department 
     of Health and Human Services; the new use is described in one 
     of three compedia: The U.S. Pharmacopeia-Drug Information, 
     the American Medical Association Drug Evaluation, or the 
     American Hospital Association Formulary Service Drug 
     Information; the new use involves a combination of products 
     of more than one sponsor of a new drug application, a 
     biological license application, a device premarket 
     notification, or a device premarket approval application; or 
     the patent status of the product.
       The conferees recognize that there may be cases where the 
     size of the patient population may be cause for the Secretary 
     to determine that a supplemental application should not be 
     filed. However, this is intended to be the exception, rather 
     than the rule, in the case of populations suffering from 
     orphan or rare disorders. For many years, this Congress has 
     sought to encourage research into orphan diseases and the 
     approval of innovative drugs for their treatment. The 
     Secretary should examine very carefully whether an exemption 
     from filing a supplemental application might hinder such 
     research and recognize the vital importance of encouraging 
     application for new drugs and new drug uses intended to treat 
     rare disorders.
     Expanded access to investigational therapies and diagnostics 
         (Sec. 402)
       The conference report provides statutory direction to 
     expand access programs and emphasizes that opportunities to 
     participate in expanded access programs are available to 
     every individual with a life-threatening or seriously 
     debilitating illness for which there is not an effective, 
     approved therapy. The conferees note that they purposely used 
     broad language in this section relating to ``serious'' 
     conditions, without attempting to define them, in order to 
     permit wide flexibility in implementation. Illnesses that do 
     not cause death, or imminent death, can nonetheless destroy 
     the lives of both patients and their families. The conferees 
     therefore intend that the seriousness of an illness be given 
     broad consideration, to take into account all of the 
     circumstances involved.
       Currently, Federal law allows drug companies to make 
     experimental drugs available, under specific circumstances, 
     to seriously and terminally ill patients. However, companies 
     are often reluctant to do so because they fear that inclusion 
     of data on such very ill patients will jeopardize the 
     approval of their product because these patients' medical 
     progress on any therapy may conflict with or be inconsistent 
     with data from patients in the clinical studies. The 
     conferees request that the FDA evaluate ways to address this 
     problem, particularly for terminal

[[Page H10478]]

     patients who have failed existing approved therapies.
     Information system (Sec. 407)
       The conferees intend that the information system shall 
     provide access to the information by the applicant under 
     conditions set by the Secretary, except that access shall not 
     be provided under any particular form of information system 
     to any applicant until appropriate safeguards are in place to 
     ensure that integrity and confidentiality of the information 
     for which access is provided.
     Education and training (Sec. 408)
       The conference agreement authorizes the Centers of the FDA 
     that conduct intramural research to provide fellowships and 
     training to appropriate undergraduate, pre-doctoral, and/or 
     post-doctoral candidates. In the past, FDA's Centers provided 
     for a limited number of scientific training positions through 
     Full Time Equivalent programs or interagency agreements with 
     other federal agencies which have the statutory authority to 
     hire trainees through third parties. However, many of the 
     benefits of the training program have been reduced because 
     FDA has not had specific direct authority to conduct and 
     support them. In light of the additional overhead costs, 
     reduced training flexibility, increased paperwork, and hiring 
     delays that have resulted, it is increasingly difficult and 
     impractical for FDA to hire trainees as FTE Service Fellows. 
     As a result, the Intramural Research and Training Authority 
     authorized here is intended to provide the FDA the authority 
     to conduct and support directly the selection and training of 
     fellows, allow more efficient use of appropriated funds by 
     reducing overhead and other costs, and permit the training of 
     such candidates as non-FTE positions. The conference 
     agreement also provides similar authority for the Centers for 
     Disease Control and Prevention.
     Centers for education and research on therapeutics (Sec. 409)
       The conference agreement establishes a demonstration 
     program to conduct research and increase awareness of new 
     products and ways to improve their effective use, and to 
     increase awareness of risks of both new uses and combinations 
     of therapies. In carrying out this demonstration program, the 
     Secretary is directed to act through the Agency for Health 
     Care Policy and Research (AHCPR) in consultation with the FDA 
     Commissioner. The conferees designated AHCPR as the lead 
     agency because of its expertise in the evaluation of the 
     effectiveness of clinical care, its non-regulatory role, and 
     its close working relationship with the health care community 
     in the improvement of the quality of care. Accordingly, this 
     section establishes a new Section 928 in Title IX of the 
     Public Health Service Act, the authorizing statute for AHCPR.
       To ensure appropriate coordination and to avoid unnecessary 
     duplication, AHCPR is required to consult closely with the 
     FDA in the development and operation of this demonstration 
     program. The conferees expanded the focus of this 
     demonstration to include ways to improve the effective use of 
     drugs, biological products, and devices as well as risks of 
     new combinations of such products and directed that the 
     clinical information gained in the project would be provided 
     to consumers as well as health care practitioners and 
     insurers. Finally, the conferees direct AHCPR also to 
     consider the appropriate use of products in meeting the 
     purposes of this section.
     Environmental impact review (Sec. 411)
       The conferees believe that FDA's new procedures 
     implementing the National Environmental Policy Act (NEPA) 
     appropriately eliminate unnecessary paperwork and delays 
     associated with prior agency practices. Section 411 makes 
     clear that an environmental impact statement (EIS) prepared 
     in accordance with those regulations will meet the 
     requirements of NEPA. The conferees do not intend this 
     section to preclude judicial review of EISs. The conferees 
     understand that the FDA may modify its regulations 
     periodically, in consultation with the Council on 
     Environmental Quality and the FDA's authorizing committees, 
     as new circumstances or information warrants.
       Because the Clean Air Act authorizes production of limited 
     quantities of Class I and Class II substances for use in 
     medical devices, there will be a continuing, but limited, 
     supply of these substances. The EPA shall not dictate, 
     promote or otherwise encourage a policy preference for 
     disposal by incineration of the contents of metered-dose 
     inhalers, but instead allow such contents to be recaptured, 
     recycled or reused consistent with section 608(a)(3) of the 
     Clean Air Act until such time that Congress conducts 
     oversight hearings into the issue.
     National uniformity for nonprescription drugs and cosmetics 
         (Sec. 412)
       Confidentiality of OTC company self-audits
       Public policy should encourage drug manufacturers to 
     conduct audits of their activities to candidly alert 
     management to potential problems so that they can be 
     addressed quickly and effectively. If FDA were to assert 
     routine access to these audits, it would create serious 
     disincentives to conducting appropriate audits and preparing 
     thorough reports of the results. FDA already has a policy of 
     not ordinarily requesting audit reports, which is set forth 
     in compliance policy guide (#7151.02, Sec. 130.300) that 
     applies to prescription drug firms. It is expected that OTC 
     drug firms would be subject to the same compliance policy 
     guide. Thus, during routine inspections of OTC drug 
     establishments, FDA would not be expected to request or to 
     review or copy reports and records that result from the 
     firm's own audits and inspections of its operations to assure 
     compliance with applicable FDA requirements such as good 
     manufacturing practice (GMP) regulations. FDA would 
     reserve the right to review such audits in certain limited 
     circumstances as outlined in the compliance guide.
       OTC and cosmetics inspection
       The conferees intend that FDA exercise its new records 
     inspection authority fairly and carefully, especially with 
     regard to inspections at facilities that manufacture products 
     that are both cosmetics and over-the-counter drugs. Cosmetic 
     products that are also OTC drugs will, under the provisions 
     of this bill, benefit from full national uniformity relating 
     to all regulatory requirements, including those associated 
     with ingredients, labeling, and packaging. Therefore, under 
     these provisions, manufacturers of such OTC products will be 
     subject to records inspection by FDA. The conferees want to 
     make clear that any records inspection applies only to those 
     products for which there is full national uniformity. This 
     new records inspection authority applies only to products 
     determined to be over-the-counter drugs. It does not apply to 
     products that are solely cosmetics.
       In the case of an inspection at a facility which deals both 
     with cosmetic products that are OTC drugs and those that are 
     not, FDA inspectors do not have access to any records 
     relating to the cosmetic products. Further, the conferees 
     want to make clear that there is no records inspection 
     authority under these provisions for facilities dealing 
     exclusively with cosmetics.
       Finally, the conferees expect that FDA will provide 
     sufficient time and guidance to the over-the-counter drug 
     industry prior to initiating any program of records 
     inspection and in the early stages of implementing this new 
     requirement.
       Effect of national uniformity on state enforcement ``little 
           FTC'' laws
       All states have laws prohibiting false and misleading 
     advertising, modeled on the Federal Trade Commission Act. 
     These laws have been applied to prohibit unsubstantiated 
     claims for nonprescription drugs and cosmetics, and to 
     require corrective advertising. This provision is not 
     intended to preempt the application of these laws under such 
     circumstances.
       The Conference Committee intends to make clear that 
     ``Little FTC'' laws, as they have historically been written 
     and applied, are not preempted. The scope of national 
     uniformity is modified to only apply to state requirements 
     that relate to labeling and packaging or, if they go beyond 
     labeling and packaging, to requirements relating to warnings. 
     Thus, advertising issues relating to claims substantiation, 
     fair balance, and misleading or deceptive claims are outside 
     the scope of preemption.
       Effect of national uniformity on state food labeling laws
       This provision is not intended to pre-empt or prohibit 
     States from regulating the labeling of food which derives 
     from animals treated with non-prescription drugs. Nor are 
     these provisions intended to void State regulations on the 
     use of these drugs.
     Product classification (Sec. 416)
       Subsections (b) and (c) have been amended to make clear 
     that FDA may only modify product classifications for public 
     health reasons based on scientific information.
     Tom Bliley,
     Michael Bilirakis,
     Joe Barton,
     James Greenwood,
     Richard Burr,
     Ed Whitfield,
     John D. Dingell,
     Sherrod Brown,
     Henry A. Waxman,
     Ron Klink,
                                Managers on the Part of the House.

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

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