HR 6181 CPH
102d CONGRESS
2d Session
H. R. 6181
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.
IN THE HOUSE OF REPRESENTATIVES
October 6 (legislative day, OCTOBER 5), 1992
Mr. DINGELL (for himself and Mr. WAXMAN) introduced the following bill;
which was referred to the Committee on Energy and Commerce
October 6 (legislative day, OCTOBER 5), 1992
Committee on Energy and Commerce discharged; considered and passed
A BILL
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,

df330d0e137b851f6a53863ead0576d96d6a20f143ffcca3487ea85a5ebf8e40

(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.

f7310b489c18621f34864a5a5be6484c86038d8b790f1f170b5e8360080940f0

TITLE I

-USER FEES

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 Congressional
Record H9099-H9100, September 22, 1992.

59e2830b7d60a7d7ec691e655d68542cf83fccba12ca3e581e8af5bd19d5f662

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 One Hundred
Second Congress, Second 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 thirty 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 one 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 five
hundred 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;
United States 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 sixty 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 one 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 thirty
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.'.

6f431eb8a3af651779c80c30566348355d2ff36fb2fa988f04f5291e659706d3

(a) FIRST REPORT- Within sixty 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 one hundred twenty 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.

2ebf3d51f70f21882e7c97d14d805c9a623a8e39b211378627ce753d1cfe6ce4

The amendments made by section 103 shall not be in effect after October 1,
1997 and section 104 shall not be in effect after one hundred twenty days
after such date.

041cdd67bc89a24326417b0e65bece62b87846f925de0d8e6fcfe396b697fefc

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.

acb3d6c1bc2bb5db393b7041a92a4d703aa24c060049442d1175642153756300

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'.

28a4ba70349fc1d23f5945df40a6e3cbedf5e7159b5fafa2709a89b99e842c55

(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.

24e1aa769694c94a2a564f26b520b0ab2e64ebbf86562e079feb8c3205cc0999

This title may be cited as the `Dietary Supplement Act of 1992'.

0fa67f8c46c19b0cf9b4a1c25df691d9fef7ca35cadd736eace9272e584f6e4e

TITLE II

-DIETARY SUPPLEMENTS

(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).

3937ee13cbeb6481466b86fa32766a5fc66f6f980326173c1d9d76da338d521e

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).

870022a6f024fcc9b4263ed74be1dab2f678057d4783b4a8812ac2e79e9e81ae

(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 thirty 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.

c37eaa34c4d46935ec7966f6ef6284e71e6e2942ed3a48f1094f024bcc6bbd0c

(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 five 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 twelve 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).

c1e07986d592a49c01a9ab57e2cf43cb384fcd5c103933b65d224f8f2afc25eb

(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 six 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.

0257dcf1e01c1b3b04de22f79047a5de38f6ce1accb29a61ccb7b01aab1fb493

FDA User Fee bill

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.

FDA User Fee bill

Other Sections

TITLE I

TITLE II

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