Text: H.R.6181 — 102nd Congress (1991-1992)All Information (Except Text)

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--H.R.6181--
H.R.6181
One Hundred Second Congress of the United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Friday, the third day of January,
one thousand nine hundred and ninety-two
An Act
To amend the Federal Food, Drug, and Cosmetic Act to authorize human drug
application, prescription drug establishment, and prescription drug product
fees and for other purposes.
  Be it enacted by the Senate and House of Representatives of the United
  States of America in Congress assembled,
TITLE I--USER FEES
SEC. 101. SHORT TITLE AND REFERENCE.
  (a) SHORT TITLE- This title may be cited as the `Prescription Drug User
  Fee Act of 1992'.
  (b) REFERENCE- Whenever in this title an amendment or repeal is expressed
  in terms of an amendment to, or repeal of, a section or other provision,
  the reference shall be considered to be made to a section or other provision
  of the Federal Food, Drug, and Cosmetic Act.
SEC. 102. FINDINGS.
  The Congress finds that--
  (1) prompt approval of safe and effective new drugs 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; and
  (3) the fees authorized by this title will be dedicated toward expediting
  the review of human drug applications as set forth in the goals identified
  in the letters of September 14, 1992, and September 21, 1992, from
  the Commissioner of Food and Drugs to the Chairman of the Energy and
  Commerce Committee of the House of Representatives and the Chairman of
  the Labor and Human Resources Committee of the Senate, as set forth at
  138 Cong. Rec. H9099-H9100 (daily ed. September 22, 1992).
SEC. 103. FEES RELATING TO DRUGS.
  Chapter VII, as amended by section 106, is amended by adding at the end
  of subchapter C the following:
`PART 2--FEES RELATING TO DRUGS
`SEC. 735. DEFINITIONS.
  `For purposes of this subchapter:
  `(1) The term `human drug application' means an application for--
  `(A) approval of a new drug submitted under section 505(b)(1),
  `(B) approval of a new drug submitted under section 505(b)(2) after
  September 30, 1992, which requests approval of--
  `(i) a molecular entity which is an active ingredient (including any salt
  or ester of an active ingredient), or
  `(ii) an indication for a use,
that had not been approved under an application submitted under section 505(b),
  `(C) initial certification or initial approval of an antibiotic drug under
  section 507, or
  `(D) licensure of a biological product under section 351 of the Public
  Health Service Act.
Such term does not include a supplement to such an application, does not
include an application with respect to whole blood or a blood component
for transfusion, does not include an application with respect to a bovine
blood product for topical application licensed before September 1, 1992,
an allergenic extract product, or an in vitro diagnostic biologic product
licensed under section 351 of the Public Health Service Act, and does not
include an application with respect to a large volume parenteral drug product
approved before September 1, 1992.
  `(2) The term `supplement' means a request to the Secretary to approve a
  change in a human drug application which has been approved.
  `(3) The term `prescription drug product' means a specific strength or
  potency of a drug in final dosage form--
  `(A) for which a human drug application has been approved, and
  `(B) which may be dispensed only under prescription pursuant to section
  503(b).
Such term does not include whole blood or a blood component for transfusion,
does not include a bovine blood product for topical application licensed
before September 1, 1992, an allergenic extract product, or an in vitro
diagnostic biologic product licensed under section 351 of the Public Health
Service Act, and does not include a large volume parenteral drug product
approved before September 1, 1992.
  `(4) The term `final dosage form' means, with respect to a prescription
  drug product, a finished dosage form which is approved for administration
  to a patient without further manufacturing.
  `(5) The term `prescription drug establishment' means a foreign or domestic
  place of business which is--
  `(A) at one general physical location consisting of one or more buildings all
  of which are within 5 miles of each other, at which one or more prescription
  drug products are manufactured in final dosage form, and
  `(B) under the management of a person that is listed as the applicant in
  a human drug application for a prescription drug product with respect to
  at least one such product.
For purposes of this paragraph, the term `manufactured' does not include
packaging.
  `(6) The term `process for the review of human drug applications' means
  the following activities of the Secretary with respect to the review of
  human drug applications and supplements:
  `(A) The activities necessary for the review of human drug applications
  and supplements.
  `(B) The issuance of action letters which approve human drug applications
  or which set forth in detail the specific deficiencies in such applications
  and, where appropriate, the actions necessary to place such applications
  in condition for approval.
  `(C) The inspection of prescription drug establishments and other
  facilities undertaken as part of the Secretary's review of pending human
  drug applications and supplements.
  `(D) Activities necessary for the review of applications for licensure
  of establishments subject to section 351 of the Public Health Service Act
  and for the release of lots of biologics under such section.
  `(E) Monitoring of research conducted in connection with the review of
  human drug applications.
  `(7) The term `costs of resources allocated for the process for the review
  of human drug applications' means the expenses incurred in connection with
  the process for the review of human drug applications for--
  `(A) officers and employees of the Food and Drug Administration, employees
  under contract with the Food and Drug Administration who work in facilities
  owned or leased for the Food and Drug Administration, advisory committees,
  and costs related to such officers, employees, and committees,
  `(B) management of information, and the acquisition, maintenance, and
  repair of computer resources,
  `(C) leasing, maintenance, renovation, and repair of facilities and
  acquisition, maintenance, and repair of fixtures, furniture, scientific
  equipment, and other necessary materials and supplies, and
  `(D) collecting fees under section 736 and accounting for resources
  allocated for the review of human drug applications and supplements.
  `(8) The term `adjustment factor' applicable to a fiscal year is the
  lower of--
  `(A) the Consumer Price Index for all urban consumers (all items; United
  States city average) for August of the preceding fiscal year divided by
  such Index for August 1992, or
  `(B) the total of discretionary budget authority provided for programs
  in the domestic category for the immediately preceding fiscal year (as
  reported in the Office of Management and Budget sequestration preview
  report, if available, required under section 254(d) of the Balanced Budget
  and Emergency Deficit Control Act of 1985) divided by such budget authority
  for fiscal year 1992 (as reported in the Office of Management and Budget
  final sequestration report submitted after the end of the 102d Congress,
  2d Session).
The terms `budget authority' and `category' in subparagraph (B) are as
defined in the Balanced Budget and Emergency Deficit Control Act of 1985,
as in effect as of September 1, 1992.
`SEC. 736. AUTHORITY TO ASSESS AND USE DRUG FEES.
  `(a) TYPES OF FEES- Beginning in fiscal year 1993, the Secretary shall
  assess and collect fees in accordance with this section as follows:
  `(1) HUMAN DRUG APPLICATION AND SUPPLEMENT FEE-
  `(A) IN GENERAL- Each person that submits, on or after September 1, 1992, a
  human drug application or a supplement shall be subject to a fee as follows:
  `(i) A fee established in subsection (b) for a human drug application for
  which clinical data (other than bioavailability or bioequivalence studies)
  with respect to safety or effectiveness are required for approval.
  `(ii) A fee established in subsection (b) for a human drug application for
  which clinical data with respect to safety or effectiveness are not required
  or a supplement for which clinical data (other than bioavailability or
  bioequivalence studies) with respect to safety or effectiveness are required.
  `(B) PAYMENT SCHEDULE-
  `(i) FIRST PAYMENT- 50 percent of the fee required by subparagraph (A)
  shall be due upon submission of the application or supplement.
  `(ii) FINAL PAYMENT- The remaining 50 percent of the fee required by
  subparagraph (A) shall be due upon--
  `(I) the expiration of 30 days from the date the Secretary sends to the
  applicant a letter designated by the Secretary as an action letter described
  in section 735(6)(B), or
  `(II) the withdrawal of the application or supplement after it is filed
  unless the Secretary waives the fee or a portion of the fee because no
  substantial work was performed on such application or supplement after it
  was filed.
The designation under subclause (I) or the waiver under subclause (II)
shall be solely in the discretion of the Secretary and shall not be reviewable.
  `(C) EXCEPTION FOR PREVIOUSLY FILED APPLICATION OR SUPPLEMENT- If a human
  drug application or supplement was submitted by a person that paid the fee
  for such application or supplement, was accepted for filing, and was not
  approved or was withdrawn (without a waiver), the submission of a human
  drug application or a supplement for the same product by the same person
  (or the person's licensee, assignee, or successor) shall not be subject
  to a fee under subparagraph (A).
  `(D) REFUND OF FEE IF APPLICATION NOT ACCEPTED FOR FILING- The Secretary
  shall refund 50 percent of the fee paid under subparagraph (B)(i) for any
  application or supplement which is not accepted for filing.
  `(2) PRESCRIPTION DRUG ESTABLISHMENT FEE- Each person that--
  `(A) owns a prescription drug establishment, at which is manufactured at
  least 1 prescription drug product which is not the, or not the same as
  a, product approved under an application filed under section 505(b)(2)
  or 505(j), and
  `(B) after September 1, 1992, had pending before the Secretary a human
  drug application or supplement,
shall be subject to the annual fee established in subsection (b) for each
such establishment, payable on or before January 31 of each year.
  `(3) PRESCRIPTION DRUG PRODUCT FEE-
  `(A) IN GENERAL- Except as provided in subparagraph (B), each person--
  `(i) who is named as the applicant in a human drug application for a
  prescription drug product which is listed under section 510, and
  `(ii) who, after September 1, 1992, had pending before the Secretary a
  human drug application or supplement,
shall pay for each such prescription drug product the annual fee established
in subsection (b). Such fee shall be payable at the time of the first such
listing of such product in each calendar year. Such fee shall be paid only
once each year for each listed prescription drug product irrespective of
the number of times such product is listed under section 510.
  `(B) EXCEPTION- The listing of a prescription drug product under section
  510 shall not require the person who listed such product to pay the fee
  prescribed by subparagraph (A) if such product is the same product as
  a product approved under an application filed under section 505(b)(2)
  or 505(j).
  `(b) FEE AMOUNTS-
  `(1) SCHEDULE- Except as provided in paragraph (2) and subsections (c),
  (d), (f), and (g), the fees required under subsection (a) shall be paid
  in accordance with the following schedule:
-------------------------------------------------------------------------------------------------------------------
                              Fiscal Year 1993 Fiscal Year 1994 Fiscal Year
                              1995 Fiscal Year 1996 Fiscal Year 1997
-------------------------------------------------------------------------------------------------------------------
  Subsection (a)(1)(A)(i) fee $100,000                 $150,000
  $208,000         $217,000         $233,000
Subsection (a)(1)(A)(ii)  fee $50,000                   $75,000
$104,000         $108,000         $116,000
                  Fee revenue $12,000,000           $18,000,000
                  $25,000,000      $26,000,000      $28,000,000
      Fee per estab- lishment $60,000                   $88,000
      $126,000         $131,000         $138,000
                  Fee revenue $12,000,000           $18,000,000
                  $25,000,000      $26,000,000      $28,000,000
              Fee per product $6,000                     $9,000
              $12,500          $13,000          $14,000
                  Fee revenue $12,000,000           $18,000,000
                  $25,000,000      $26,000,000      $28,000,000
           Total fee revenues $36,000,000           $54,000,000
           $75,000,000      $78,000,000      $84,000,000
-------------------------------------------------------------------------------------------------------------------
  `(2) SMALL BUSINESS EXCEPTION- Any business which has fewer than 500
  employees, including employees of affiliates, and which does not have a
  prescription drug product introduced or delivered for introduction into
  interstate commerce shall pay one-half the amount of the fee for human
  drug applications it submits and shall pay the entire amount of the fee
  for supplements it submits. Such a business shall not be required to pay
  any portion of any fee required under subsection (a)(1)(A) until 1 year
  after the date of the submission of the application involved. For purposes
  of this paragraph, one business is an affiliate of another business when,
  directly or indirectly, one business controls, or has the power to control,
  the other business or a third party controls, or has the power to control,
  both businesses.
  `(c) INCREASES AND ADJUSTMENTS-
  `(1) REVENUE INCREASE- The total fee revenues established by the schedule in
  subsection (b)(1) shall be increased by the Secretary by notice, published
  in the Federal Register, for a fiscal year to reflect the greater of--
  `(A) the total percentage increase that occurred during the preceding
  fiscal year in the Consumer Price Index for all urban consumers (all items;
  U.S. city average), or
  `(B) the total percentage increase for such fiscal year in basic pay
  under the General Schedule in accordance with section 5332 of title 5,
  United States Code, as adjusted by any locality-based comparability payment
  pursuant to section 5304 of such title for Federal employees stationed in
  the District of Columbia.
  `(2) ANNUAL FEE ADJUSTMENT- Subject to the amount appropriated for a fiscal
  year under subsection (g), the Secretary shall, within 60 days after the
  end of each fiscal year beginning after October 1, 1992, adjust the fees
  established by the schedule in subsection (b)(1) for the following fiscal
  year to achieve the total fee revenues, as may be increased under paragraph
  (1). Such fees shall be adjusted under this paragraph to maintain the
  proportions established in such schedule.
  `(3) LIMIT- The total amount of fees charged, as adjusted under paragraph
  (2), for a fiscal year may not exceed the total costs for such fiscal
  year for the resources allocated for the process for the review of human
  drug applications.
  `(d) FEE WAIVER OR REDUCTION- The Secretary shall grant a waiver from or
  a reduction of 1 or more fees under subsection (a) where the Secretary
  finds that--
  `(1) such waiver or reduction is necessary to protect the public health,
  `(2) the assessment of the fee would present a significant barrier to
  innovation because of limited resources available to such person or other
  circumstances,
  `(3) the fees to be paid by such person will exceed the anticipated present
  and future costs incurred by the Secretary in conducting the process for
  the review of human drug applications for such person, or
  `(4) assessment of the fee for an application or a supplement filed under
  section 505(b)(1) pertaining to a drug containing an active ingredient
  would be inequitable because an application for a product containing the
  same active ingredient filed by another person under section 505(b)(2)
  could not be assessed fees under subsection (a)(1).
In making the finding in paragraph (3), the Secretary may use standard costs.
  `(e) EFFECT OF FAILURE TO PAY FEES- A human drug application or supplement
  submitted by a person subject to fees under subsection (a) shall be
  considered incomplete and shall not be accepted for filing by the Secretary
  until all fees owed by such person have been paid.
  `(f) ASSESSMENT OF FEES-
  `(1) LIMITATION- Fees may not be assessed under subsection (a) for a fiscal
  year beginning after fiscal year 1993 unless appropriations for salaries
  and expenses of the Food and Drug Administration for such fiscal year
  (excluding the amount of fees appropriated for such fiscal year) are
  equal to or greater than the amount of appropriations for the salaries
  and expenses of the Food and Drug Administration for the fiscal year 1992
  multiplied by the adjustment factor applicable to the fiscal year involved.
  `(2) AUTHORITY- If the Secretary does not assess fees under subsection
  (a) during any portion of a fiscal year because of paragraph (1) and if
  at a later date in such fiscal year the Secretary may assess such fees,
  the Secretary may assess and collect such fees, without any modification
  in the rate, for human drug applications and supplements, prescription
  drug establishments, and prescription drug products at any time in such
  fiscal year notwithstanding the provisions of subsection (a) relating to
  the date fees are to be paid.
  `(g) CREDITING AND AVAILABILITY OF FEES-
  `(1) IN GENERAL- Fees collected for a fiscal year pursuant to subsection (a)
  shall be credited to the appropriation account for salaries and expenses
  of the Food and Drug Administration and shall be available in accordance
  with appropriation Acts until expended without fiscal year limitation.
  `(2) COLLECTIONS AND APPROPRIATION ACTS- The fees authorized by this
  section--
  `(A) shall be collected in each fiscal year in an amount equal to the
  amount specified in appropriation Acts for such fiscal year, and
  `(B) shall only be collected and available to defray increases in the costs
  of the resources allocated for the process for the review of human drug
  applications (including increases in such costs for an additional number
  of full-time equivalent positions in the Department of Health and Human
  Services to be engaged in such process) over such costs for fiscal year
  1992 multiplied by the adjustment factor.
  `(3) AUTHORIZATION OF APPROPRIATIONS- There are authorized to be appropriated
  for fees under this section--
  `(A) $36,000,000 for fiscal year 1993,
  `(B) $54,000,000 for fiscal year 1994,
  `(C) $75,000,000 for fiscal year 1995,
  `(D) $78,000,000 for fiscal year 1996, and
  `(E) $84,000,000 for fiscal year 1997,
as adjusted to reflect increases in the total fee revenues made under
subsection (c)(1).
  `(h) COLLECTION OF UNPAID FEES- In any case where the Secretary does not
  receive payment of a fee assessed under subsection (a) within 30 days
  after it is due, such fee shall be treated as a claim of the United
  States Government subject to subchapter II of chapter 37 of title 31,
  United States Code.
  `(i) CONSTRUCTION- This section may not be construed to require that the
  number of full-time equivalent positions in the Department of Health and
  Human Services, for officers, employers, and advisory committees not engaged
  in the process of the review of human drug applications, be reduced to offset
  the number of officers, employees, and advisory committees so engaged.'.
SEC. 104. ANNUAL REPORTS.
  (a) FIRST REPORT- Within 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, the Secretary of Health and Human
  Services shall submit a report stating the Food and Drug Administration's
  progress in achieving the goals identified in section 102(3) of this
  Act during such fiscal year and that agency's future plans for meeting
  such goals.
  (b) SECOND REPORT- Within 120 days after the end of each fiscal year during
  which such fees are collected, the Secretary of Health and Human Services
  shall submit a report on the implementation of the authority for such fees
  during such fiscal year and on the use the Food and Drug Administration made
  of the fees collected during such fiscal year for which the report is made.
  (c) COMMITTEES- The reports described in subsections (a) and (b) shall
  be submitted to the Committee on Energy and Commerce of the House of
  Representatives and the Committee on Labor and Human Resources of the Senate.
SEC. 105. SUNSET.
  The amendments made by section 103 shall not be in effect after October 1,
  1997 and section 104 shall not be in effect after 120 days after such date.
SEC. 106. CONFORMING AMENDMENTS TO CHAPTER VII
  Chapter VII is amended--
  (1) by striking out in the chapter heading `ADMINISTRATIVE PROVISIONS'
  and inserting in lieu thereof `AUTHORITY',
  (2) by inserting before the section heading for section 701 the following:
`Subchapter A--General Administrative Provisions',
  (3) by redesignating section 702A (21 U.S.C. 372a) as section 706 and
  by inserting it after section 705 (21 U.S.C. 375) and by redesignating
  section 712 (21 U.S.C. 379d) as section 711,
  (4) by moving section 706 (21 U.S.C 376), as in effect on the date of the
  enactment of this Act, to the end of chapter VII, by redesignating the
  section as section 721, and by inserting before the section heading for
  the section the following:
`Subchapter B--Colors',
  (5) by inserting after section 721 (as so redesignated) the following:
`Subchapter C--Fees
`PART 1--FREEDOM OF INFORMATION FEES', and
  (6) by inserting section 711 (21 U.S.C. 379c), as in effect on the date
  of the enactment of this Act, after the heading for part 1 of subchapter
  C and redesignating it as section 731.
SEC. 107. GENERAL CONFORMING AMENDMENTS.
  To conform the Federal Food, Drug, and Cosmetic Act, to the amendments made
  to that Act by section 106(4), the following conforming amendments are made:
  (1) Section 201(u) (21 U.S.C. 321(u)) is amended by striking out `706'
  and inserting in lieu thereof `721'.
  (2) Section 301(i)(1) (21 U.S.C. 331(i)(1)) is amended by striking out
  `706' and inserting in lieu thereof `721'.
  (3) Section 301(j) (21 U.S.C. 331(j)) is amended by striking out `706'
  and inserting in lieu thereof `721'.
  (4) Section 402(c) (21 U.S.C. 342(c)) is amended by striking out `706'
  and inserting in lieu thereof `721'.
  (5) Section 403(i) (21 U.S.C. 343(i)) is amended by striking out `706'
  and inserting in lieu thereof `721'.
  (6) Section 403(m) (21 U.S.C. 343(m)) is amended by striking out `706'
  and inserting in lieu thereof `721'.
  (7) Section 408(g) (21 U.S.C. 346a(g)) is amended by striking out `706'
  and inserting in lieu thereof `721'.
  (8) Section 501(a)(4) (21 U.S.C 351(a)(4)) is amended by striking out
  `706' each place it occurs and inserting in lieu thereof `721'.
  (9) Section 502(m) (21 U.S.C. 352(m)) is amended by striking out `706'
  and inserting in lieu thereof `721'.
  (10) Section 520(g)(2)(A) (21 U.S.C. 360j(g)(2)(A)) is amended by striking
  out `706' and by inserting in lieu thereof `721'.
  (11) Section 601(e) (21 U.S.C. 361(e)) is amended by striking out `706'
  and inserting in lieu thereof `721'.
  (12) Section 602(e) (21 U.S.C. 362(e)) is amended by striking out `706'
  and inserting in lieu thereof `721'.
  (13) Section 4(g)(2)(D) of the Poultry Products Inspection Act (21
  U.S.C. 453(g)(2)(D)) is amended by striking out `706' and inserting in
  lieu thereof `721'.
  (14) Section 1(m)(2)(D) of the Federal Meat Inspection Act (21
  U.S.C. 601(m)(2)(D)) is amended by striking out `706' and inserting in
  lieu thereof `721'.
  (15) Section 4(a)(2)(D) of the Egg Products Inspection Act (21
  U.S.C. 1033(a)(2)(D)) is amended by striking out `706' and inserting in
  lieu thereof `721'.
  (16) Section 10(b) of the Nutrition Labeling and Education Act of 1990
  (21 U.S.C. 343 note) is amended--
  (A) in paragraph (2)--
  (i) by striking `(1) 24' and inserting `(A) 24'; and
  (ii) by striking `(2) action' and inserting `(B) action';
  (B) by indenting, and aligning the margins of, paragraph (2) so as to
  align with paragraph (1); and
  (C) by indenting, and aligning the margins of, subparagraphs (A) and (B)
  of paragraph (2) (as so designated by subparagraph (A)) so as to align
  with the subparagraphs of paragraph (1).
  (17) Section 10(c)(2)(A) of the Nutrition Labeling and Education Act of 1990
  (21 U.S.C. 343 note) (as amended by section 1 of the Act entitled `An Act
  to make Technical Amendments to the Nutrition Information and Labeling Act,
  and for other purposes', approved August 17, 1991 (Public Law 102-108;
  105 Stat. 549) is amended by striking `706' and inserting `721'.
SEC. 108. ANIMAL DRUG USER FEE STUDY.
  (a) STUDY- The Secretary, in consultation with manufacturers of animal drug
  products and other interested persons, shall undertake a study to evaluate
  whether, and under what conditions, to impose user fees to supplement
  appropriated funds in order to improve the process of reviewing applications
  (including abbreviated and supplemental applications) for new animal drugs
  under section 512 of the Federal Food, Drug, and Cosmetic Act. The study
  shall include--
  (1) an assessment of the overall review process for animal drugs at the
  Center for Veterinary Medicine, including the number of applications
  received, and the average times for interim and final decisions on each
  type of application,
  (2) the current allocation of funds to the animal drug review process,
  (3) recommendations for goals for decision making times on applications
  submitted to the Center for Veterinary Medicine and for additional resources
  required to meet the goals, and
  (4) recommendations for supplementing the resources for the animal drug
  review process through user fees.
  (b) COMPLETION- The results of the study required by subsection (a) shall
  be presented no later than January 4, 1994, to the Committee on Energy
  and Commerce of the House of Representatives and the Committee on Labor
  and Human Resources of the Senate.
TITLE II--DIETARY SUPPLEMENTS
SEC. 201. SHORT TITLE.
  This title may be cited as the `Dietary Supplement Act of 1992'.
SEC. 202. PROHIBITION.
  (a) IN GENERAL-
  (1) PROHIBITION ON IMPLEMENTATION- Notwithstanding any other provision
  of law and except as provided in subsection (b) and in the amendment
  made by paragraph (2)(A), the Secretary of Health and Human Services may
  not implement the Nutrition Labeling and Education Act of 1990 (Public
  Law 101-535; 104 Stat. 2353), or any amendment made by such Act, earlier
  than December 15, 1993, with respect to dietary supplements of vitamins,
  minerals, herbs, or other similar nutritional substances.
  (2) FEDERAL REGULATORY ACTION-
  (A) PROPOSED REGULATIONS- The first sentence of section 2(b)(1), and
  the first sentence of section 3(b)(1)(A), of the Nutrition Labeling and
  Education Act of 1990 (21 U.S.C. 343 note) are each amended by inserting
  before the period the following: `, except that the Secretary shall issue,
  not later than June 15, 1993, proposed regulations that are applicable
  to dietary supplements of vitamins, minerals, herbs, or other similar
  nutritional substances to implement such section'.
  (B) FINAL REGULATIONS-
  (i) ISSUANCE OF FINAL REGULATIONS- The second sentence of section 2(b)(1),
  and section 3(b)(1)(B), of the Nutrition Labeling and Education Act of
  1990 (21 U.S.C. 343 note) are each amended by inserting before the period
  the following: `, except that the Secretary shall issue, not later than
  December 31, 1993, such a final regulation applicable to dietary supplements
  of vitamins, minerals, herbs, or other similar nutritional substances.'.
  (ii) REGULATIONS CONSIDERED TO BE FINAL- The first sentence of section
  2(b)(2), and the first sentence of section 3(b)(2), of the Nutrition
  Labeling and Education Act of 1990 (21 U.S.C. 343 note) are each amended
  by inserting before the period the following: `, except that the proposed
  regulations applicable to dietary supplements of vitamins, minerals,
  herbs, or other similar nutritional substances shall not be considered to
  be final regulations until December 31, 1993'.
  (C) CONSTRUCTION- The amendments made by subparagraph (B) shall not be
  construed to modify the effective date of final regulations under sections
  2(b) and 3(b) of the Nutrition Labeling and Education Act of 1990 (21
  U.S.C. 343 note) with respect to foods that are not such dietary supplements.
  (3) STATE ACTION- Section 10(a)(1)(C) of the Nutrition Labeling and
  Education Act of 1990 (21 U.S.C. 343 note) is amended by inserting before
  the comma the following: `, except that such amendments shall take effect
  with respect to such dietary supplements on December 31, 1993'.
  (4) PREEMPTION- Section 10(b) of the Nutrition Labeling and Education Act
  of 1990 (21 U.S.C. 343 note) is amended by adding at the end the following:
  `(3) REQUIREMENTS PERTAINING TO CERTAIN CLAIMS- Notwithstanding subparagraphs
  (D) and (E) of paragraph (1) and except with respect to claims approved
  in accordance with section 202(b) of the Dietary Supplement Act of 1992,
  the requirements described in paragraphs (4) and (5) of section 403A(a) of
  the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-1(a) (4) and (5))
  that pertain to dietary supplements of vitamins, minerals, herbs, or other
  similar nutritional substances shall not take effect until the date final
  regulations take effect to implement subsection (q) or (r), as appropriate,
  of section 403 of such Act with respect to such dietary supplements.'.
  (b) HEALTH CLAIMS- Notwithstanding section 403(r)(5)(D) of the Federal
  Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(5)(D)) and subsection (a),
  the Secretary of Health and Human Services may, earlier than December 15,
  1993, approve claims made with respect to dietary supplements of vitamins,
  minerals, herbs, or other similar nutritional substances that are claims
  described in clauses (vi) and (x) of section 3(b)(1)(A) of the Nutrition
  Labeling and Education Act of 1990 (21 U.S.C. 343 note).
SEC. 203. UNITED STATES RECOMMENDED DAILY ALLOWANCES.
  Notwithstanding any other provision of Federal law, no regulations that
  require the use of, or are based upon, recommended daily allowances
  of vitamins or minerals may be promulgated before November 8, 1993
  (other than regulations establishing the United States recommended
  daily allowances specified at section 101.9(c)(7)(iv) of title 21, Code
  of Federal Regulations, as in effect on October 6, 1992, or regulations
  under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21
  U.S.C. 343(r)(1)(A)) that are based on such recommended daily allowances).
SEC. 204. ENFORCEMENT REPORT.
  (a) CONTENTS- The Secretary of Health and Human Services shall prepare a
  report containing a statement of the enforcement priorities and practices
  of the Food and Drug Administration under section 409 of the Federal Food,
  Drug, and Cosmetic Act (21 U.S.C. 348) with respect to dietary supplements
  of vitamins, minerals, herbs, or other similar nutritional substances.
  (b) REPORT- Not later than 30 days after the date of enactment of this Act,
  the Secretary of Health and Human Services shall submit the report described
  in subsection (a) to the Committee on Energy and Commerce of the House of
  Representatives and the Committee on Labor and Human Resources of the Senate.
SEC. 205. MANAGEMENT ACTIVITIES STUDY.
  (a) STUDY- The Comptroller General shall conduct a study of the management of
  activities of the Food and Drug Administration that are related to dietary
  supplements of vitamins, minerals, herbs, or other similar nutritional
  substances.
  (b) CONTENTS- In conducting the study, the Comptroller General shall examine,
  with respect to such activities--
  (1) the means by which the Food and Drug Administration makes a determination
  that a substance poses a risk to public health and safety that justifies
  the expenditure of resources by the agency;
  (2) the means by which the Food and Drug Administration makes a determination
  that a substance is adulterated, misbranded, or improperly manufactured;
  (3) the means by which the Food and Drug Administration makes a determination
  relating to the quantitative management of the agency response to specific
  issues, in order to adjust the efforts of the agency to be commensurate
  with the severity of the problem addressed by the agency;
  (4) the approach by which the Food and Drug Administration determines
  the adequacy of proof related to the risk posed by, or the safety of,
  a substance, and the adequacy of such approach; and
  (5) the relationship between--
  (A)(i) the number of hours devoted by Food and Drug Administration personnel,
  and the expertise of such personnel, in conducting such activities;
  (ii) the cost of conducting such activities; and
  (iii) the cost to manufacturers of such supplements to achieve compliance
  with such activities; and
  (B)(i) the level of risk suspected to be posed by such supplements; and
  (ii) the level of risk determined to be posed by such supplements.
  (c) APPROACH- In conducting the study, the Comptroller General shall analyze
  the current practices of the Food and Drug Administration and the practices
  of the agency within the 5 years prior to the date of enactment of this Act.
  (d) ANALYSIS- In conducting the study, the Comptroller General shall--
  (1) determine the relative proportion of resources devoted to Food and Drug
  Administration regulatory and enforcement activities that are related to--
  (A) dietary supplements of vitamins, minerals, herbs, or other similar
  nutritional substances;
  (B) food additives that are not such dietary supplements;
  (C) foods that are not such dietary supplements;
  (D) drugs that are not such dietary supplements, and devices; or
  (E) cosmetics; and
  (2) determine, with respect to such supplements, with respect to food
  additives, and with respect to foods, the proportion of the resources
  devoted to such regulatory and enforcement activities that are used to--
  (A) determine whether a substance is misbranded;
  (B) determine whether an improper manufacturing practice occurred during
  the manufacturing of a substance;
  (C) determine whether a substance is unsafe; and
  (D) determine whether a substance is adulterated or otherwise in violation
  of the Federal Food, Drug, and Cosmetic Act (other than by making a
  determination described in subparagraph (A), (B), or (C)).
  (e) REPORTS-
  (1) INTERIM REPORT-
  (A) IN GENERAL- Not later than 6 months after the date of enactment of this
  Act, the Comptroller General shall prepare and submit to the Committee on
  Energy and Commerce of the House of Representatives and the Committee on
  Labor and Human Resources of the Senate an interim report containing the
  findings resulting from the study and the recommendations described in
  subparagraph (B).
  (B) RECOMMENDATIONS- Such report shall include the recommendations of the
  Comptroller General for administrative reform, including recommendations
  regarding opportunities for encouraging economy and efficiency through
  the appropriate targeting of problems, managing resources appropriately,
  and making adequate determinations of risk or safety, in carrying out
  activities related to such supplements.
  (2) FINAL REPORT-
  (A) IN GENERAL- Not later than 12 months after the date of enactment of
  this Act, the Comptroller General shall prepare and submit to the Committee
  on Energy and Commerce of the House of Representatives and the Committee
  on Labor and Human Resources of the Senate a final report containing the
  findings resulting from the study and the recommendations described in
  subparagraph (B).
  (B) RECOMMENDATIONS- Such report shall contain the recommendations described
  in paragraph (1)(B).
SEC. 206. SAFETY AND REGULATORY OUTCOMES STUDY.
  (a) SAFETY STUDY- The Director of the Office of Technology Assessment,
  in cooperation with the Congressional Research Service and subject to the
  approval of the Technology Assessment Board, shall conduct a study of the
  relationship between--
  (1) regulatory systems affecting the development and sale of dietary
  supplements of vitamins, minerals, herbs, or other similar nutritional
  substances; and
  (2) health outcomes.
  (b) CONTENTS-
  (1) IN GENERAL- In carrying out the study, the Director of the Office of
  Technology Assessment shall examine the efforts of industrialized nations
  (including the United States) to regulate the manufacture and sale of such
  dietary supplements and the effect of the regulatory efforts on human health.
  (2) INFORMATION- The study shall include information regarding--
  (A) whether and how other countries regulate products that are regulated
  as such dietary supplements in the United States;
  (B) the classification systems used in regulating such products, such as
  systems that classify such supplements by safety, function, source, usage,
  dose, or other characteristics;
  (C) the effect of the classification on the regulation of the supplements;
  (D) how safety concerns, including safety concerns at the time of manufacture
  and sale of the product are addressed by the regulatory process;
  (E) how deception concerns (including misbranding) are addressed by the
  regulatory process; and
  (F) the labeling requirements, if any, for the sale of the products.
  (3) ANALYSIS- The study shall also examine--
  (A) whether there are disparate rates of morbidity and mortality associated
  with the consumption of such dietary supplements among nations;
  (B) whether particular regulatory systems may be associated with lower
  morbidity and mortality rates; and
  (C) whether a causal relationship may be demonstrated between the regulatory
  system used and the health outcomes of the populations affected.
  (c) REPORT- The Director of the Office of Technology Assessment shall,
  not later than 6 months after the date on which the study is approved by
  the Technology Assessment Board, submit a report containing the findings
  of the study to the Committee on Energy and Commerce of the House of
  Representatives and the Committee on Labor and Human Resources of the Senate.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.