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.
PL 102-571 (H.R.6181), enacted 10/29/1992

PUBLIC LAW 102-571—(Xrr. 29, 1992 
106 STAT. 4491 
Public Law 102-571 
102d Ck)ngress 
An Act 
To amend the Federal Food, Drug, and Cosmetic Act to authorize human drug 
Q^^ 29 1992 
application, prescription drug establishment, and prescription drug product fees 
' 
and for other purposes. 
' 
tH.R. 6181] 
Be it enacted by the Senate and House of Representatives of 
the United States of 
America in Congress assembled, 
TITLE I—USER FEES 
or^tTs^r 
Fee Act of 
SEC. 101. SHORT TITLE AND REFERENCE. 
21^USC 301 
(a) SHORT TITLE.—^This title may be cited as the "Prescription note. 
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 consiaered to 
be made to a section or other provision of the Federal Food, Drug, 
and Cosmetic Act. 
SEC. 102. FINDINGS. 
21 USC 379g 
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 
mav enjoy the benefits provided by these therapies to treat 
ana 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. 
21 USC 379g. 
"For purposes of this subchapter: 
(1) The term liimian orug application' means an applica-
tion for— 
106 STAT. 4492 
PUBLIC LAW 102-571—OCT. 29, 1992 
"(A) approval of a new drug submitted under section 
505(bXl), 
"(B) approval of a new drug submitted under section 
505(bX2) after September 30, 1992, which requests 
approval of— 
"(i) a molecular entity which is an active ingredient 
(inclu(Ung any salt or ester of an active ingredient), 
or 
"(ii) an indication for a use, 
that had not been approved imder an application submitted 
under section 505(b), 
"(C) initial certification or initial approval of an anti-
biotic drug imder section 507, or 
"(D) licensure of a biological product imder 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 aller-
genic 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 manu-
facturing. 
"(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 prescrip-
tion drug product with respect to at least one such product. 
For purposes of this paragraph, the term 'manufactured' does 
not include packaging. 
PUBLIC LAW 102-571—OCT. 29, 1992 
106 STAT. 4493 
**(6) The term 'process for the review of human drug applica-
tions' means the following activities of the Secretary with 
respect to the review of human drug applications and supple-
ments: 
*
*
(
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 appro-
priate, 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 supple-
ments. 
"(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 biologies under such section. 
"(E) Monitoring of research conducted in connection 
with the review of hirnian 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 fix-
tures, fumitiu'e, 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 o
f
— 
"(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 pro-
vided for programs in the domestic category for the imme-
diately preceding fiscal year (as reported in the Office 
of Management and Budget sequestration preview report, 
if available, required imder 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). 
106 STAT. 4494 
PUBLIC LAW 102-571—OCT. 29, 1992 
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. 
21 use 379h. 
-SEC. 736. AUTHORITY TO ASSESS AND USE DRUG FEES. 
"(a) TYPES OF FEES.—^Beginning in fiscal year 1993, the Sec-
retary shall assess and collect fees in accordance with this section 
as foUows: 
"(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 himian 
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 appUcation for which clinical data with respect 
to safety or effectiveness are not required or a supple-
ment 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 des-
ignated by the Secretary as an action letter 
described in section 735(6XB), or 
"(11) the withdrawal of the application or 
sui>plement 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 supple-
ment 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 APPUCATION NOT ACCEPTED 
FOR FILING.—^The Secretary shall refund 50 percent of the 
fee paid under subparagraph (BXi) for any application or 
supplement which is not accepted for filing. 
"(2) PRESCRIPTION DRUG ESTABLISHMENT FEE.—^Each person 
that— 
PUBLIC LAW 102-571—OCT. 29, 1992 
106 STAT. 4495 
**(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(bX2)or505(j). 
"(b) FEE AMOUNTS.— 
"(1) SCHEDULE.—^Except as provided in paragraph (2) and 
subsections (c), (d), (f), and (g), the fees required under sub-
section (a) shall be paid in accordance with the following 
schedule: 
Drug application fee: 
Subsection 
(aXlXAXi) fee 
Subsection 
(aXlXAXii) fee 
Annual establishment 
fee: 
Fee per estab-
Annual product fee: 
Fee revenue 
Fiscal Year 
1993 
$100,000 
$50,000 
$12,000,000 
$60,000 
$12,000,000 
$6,000 
$12,000,000 
$36,000,000 
Fiscal Year 
1994 
$150,000 
$75,000 
$18,000,000 
$88,000 
$18,000,000 
$9,000 
$18,000,000 
$54,000,000 
Fiscal Year 
1995 
$208,000 
$104,000 
$25,000,000 
$126,000 
$25,000,000 
$12,600 
$25,000,000 
$75,000,000 
Fiscal Year 
1996 
$217,000 
$108,000 
$26,000,000 
$131,000 
$26,000,000 
$13,000 
$26,000,000 
$78,000,000 
Fiscal Year 
1997 
$233,000 
$116,000 
$28,000,000 
$138,000 
$28,000,000 
$14,000 
$28,000,000 
$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 
106 STAT. 4496 
PUBLIC LAW 102-571—OCT. 29, 1992 
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 (aXlXA) 
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 busi-
ness or a third party controls, or has the power to control, 
both businesses. 
"(c) INCREASES AND ADJUSTMENTS.— 
Federal 
"(1) REVENUE INCREASE.—The total fee revenues estab-
Register, 
lished by the schedule in subsection (b)(1) shall be increased 
publication. 
jjy tjjg 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 sched-
ule in subsection (bXD 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 main-
tain the proportions established in such schedule. 
"(3) LIMIT.—^The total amoimt 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 himian 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 circimistances, 
"(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 applica-
tions for such person, or 
"(4) assessment of the fee for an application or a supple-
ment filed under section 505(b)(1) pertaining to a drug contain-
ing an active ingredient would be inequitable because an 
application for a product containing the same active ingredient 
filed by another person under section 505(bX2) could not be 
assessed fees under subsection (aXD-
In making the finding in paragraph (3), the Secretary may use 
standard costs. 
-
PUBLIC LAW 102-571—OCT. 29, 1992 
106 STAT. 4497 
"(e) EFFECT OF FAILURE TO PAY FEES.—A human drug applica-
tion 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 OP FEES.— 
"(1) LIMITATION.—^Fees may not be assessed under sub-
section (a) for a fiscal year beginning after fiscal year 1993 
unless appropriations for salaries and expenses of the Food 
and Drug Acuninistration 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 ac^ustment factor applicable 
to the fiscal yecur 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 estabUshments, and prescription drug products at any 
time in such fiscal year notwithstanding the provisions of sub-
section (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) CoLLEcmoNS A
N
D A
P
P
R
O
P
R
I
A
T
I
O
N 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 defiray 
increases in the costs of the resources allocated for the 
process for the review of human drug applications (includ-
ing increases in such costs for an additional number of 
fiili-time equivalent positions in the Department of Healtii 
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 (cXD. 
"(h) COLLECTION OF UNPAID FEES.—In any case where the 
Secretary does not receive payment of a fee assessed under sub-
section (a) within 30 days after it is due, such fee shall be treated 
as a claim of the United Stetes Government subject to subchapter 
II of chapter 37 of title 31, United Stetes Code. 
106 STAT. 4498 
PUBLIC LAW 102-571—OCT. 29, 1992 
"(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 advisoiy 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.". 
21USC379g 
SEC. 104. ANNUAL REPORTS. 
(a) FIRST REPORT.—Within 60 days after the end of each fiscal 
year during which fees are collected imder part 2 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic Act, 
the Secretary of Health and Himian 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 agenc/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 Secretery 
of Health and Human Services shall submit a report on the 
implementetion of the authority for such fees during such fiscal 
year £md 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 Representetives and the Committee on Labor and 
Human Resources of the Senate. 
21 use 379g 
SEC. 106. 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 "ADMINISTRA-
TIVE PROVISIONS" and inserting in lieu thereof "AUTHOR-
ITY", 
(2) by inserting before the section heading for section 701 
the following: 
"SUBCHAPTER A—GENERAL ADMINISTRATIVE PROVISIONS", 
21 use 379a, 
(3) by redesignating section 702A (21 U.S.C. 372a) as sec-
^'^^- 
tion 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. 
21 use 376, 
(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 insert-
ing before the section heading for the section the following: 
"SUBCHAPTER B—COLORS", 
(5) by inserting after section 721 (as so redesignated) the 
following: 
379e. 
PUBLIC LAW 102-571—OCT. 29, 1992 
106 STAT. 4499 
"SUBCHAPTER C—FEES 
"PART 1—FREEDOM OF INFORMATION FEES", 
and 
(6) by inserting section 711 (21 U.S.C. 379c), as in effect 2i use 379c, 
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)(l) (21 U.S.C. 331(iXl)) 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 strik-
ing out "706" and inserting in lieu thereof "721". 
(7) Section 408(g) (21 U.S.C. 346a(g)) is amended by strik-
ing out "706" and inserting in Ueu thereof "721". 
(8) Section 501(aX4) (21 U.S.C 351(aX4)) 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 strik-
ing out "706" and inserting in lieu thereof "721". 
(10) Section 520(gX2XA) (21 U.S.C. 360j(gX2XA)) is amend-
ed by striking out "706" and by inserting in lieu thereof "721". 
(11) Section 601(e) (21 U.S.C. 361(e)) is amended by strik-
ing out "706" and inserting in lieu thereof "721". 
(12) Section 602(e) (21 U.S.C. 362(e)) is amended by strik-
ing out "706" and inserting in lieu thereof "721". 
(13) Section 4(gX2XD) of the Poultry Products Inspection 
Act (21 U.S.C. 453(gX2XD)) is amended by striking out "706" 
and inserting in lieu thereof "721". 
(14) Section l(mX2XD) of the Federal Meat Inspection Act 
(21 U.S.C. 601(mX2XD)) is amended by striking out "706" and 
inserting in lieu thereof "721". 
(15) Section 4(aX2XD) of the Egg Products Inspection Act 
(21 U.S.C. 1033(aX2XD)) 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— 
21 use 343-1 
(A) in paragraph (2)— 
note. 
(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, para-
graph (2) so as to align with paragraph (1); and 
106 STAT. 4500 
PUBLIC LAW 102-571—OCT. 29, 1992 
(C) by indenting, and aligning the margins of, subpara-
graphs (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(cX2XA) of the Nutrition Labeling and Edu-
cation 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**. 
21 u s e 379g 
SEC. 108. ANIMAL DRUG USER FEE STUDY. 
(a) STUDY.—^The Secretary, in consultation with manufacturers 
of animal drug products and other interested persons, shall under-
take 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 abbre-
viated 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 sub-
section (a) shall be presented no later than January 4, 1994, to 
the Committee on Energy and Commerce of the House of Represent-
atives and the Committee on Labor and Human Resources of the 
Senate. 
sSppi7ment 
TITLE II—DIETARY SUPPLEMENTS 
Act of 1992. 
21 use 301 
SEC. 201. SHORT TITLE. 
This title may be cited as the "Dietary Supplement Act of 
1992**. 
SEC. 202. PROHIBITION. 
21 use 343 
(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 (2XA), the Sec-
retary 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.— 
PUBLIC LAW 102-571—OCT. 29, 1992 
106 STAT. 4501 
(A) PROPOSED REGULATIONS.—^The first sentence of sec-
tion 2(bXl), and the first sentence of section 3(bXl)(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(bXl), and section 3(bXlXB), 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 nutri-
tional 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 Edu-
cation Act of 1990 (21 U.S.C. 343 note) are each amend-
ed 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 21 use 343 
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(aXl)(C) of the Nutrition 
LabeUng 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 
21 use 343-1 
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.—Not-
withstanding 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-l(a) (4) and (5)) that pertain to dietary supplements of 
vitamins, minerals, herbs, or other similar nutritional sub-
stances 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 supple-
ments.". 
(b) HEALTH CLAIMS.—Notwithstanding section 403(rX5XD) of 21 use 343 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(rX5XD)) 
" ° ^ 
and subsection (a), the Secretary of Health and Human Services 
106 STAT. 4502 
PUBLIC LAW 102-571—OCT. 29, 1992 
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(bXlXA) of the Nutrition Labeling 
and Education Act of 1990 (21 U.S.C. 343 note). 
21 use 343 
SEC. 203. UNITED STATES RECOMMENDED DAILY ALLOWANCES. 
Notwithstanding any other provision of Federal law, no regula-
tions 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(cX7)(iv) of title 21, Code of Federal Regulations, as in effect 
on October 6, 1992, or regulations under section 403(rXlXA) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(rXlXA)) 
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 imder 
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. 
21 use 393 
SEC. 205. MANAGEMENT AdTVITIES STUDY. 
(a) STUDY.—^The Comptroller General shall conduct a study 
of the management of activities of the Food and Drug Administra-
tion that are related to dietary supplements of vitamins, minerals, 
herbs, or other similar nutritional substances. 
(b) CONTENTS.—^In conducting the study, the Comptroller Gen-
eral shall examine, with respect to such activities— 
(1) the means by wnich 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, mis-
branded, or improperly manufactured; 
(3) the means by which the Food and Drug Administration 
makes a determination relating to the quantitative manage-
ment 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 Administra-
tion 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— 
(AXi) the number of hours devoted by Food and Drug 
Administration personnel, and the expertise of such person-
nel, in conducting such activities; 
(ii) the cost of conducting such activities; and 
PUBLIC LAW 102-571—OCT. 29,1992 
106 STAT. 4503 
(iii) the cost to manufacturers of such supplements 
to achieve compliance with such activities; and 
(BXi) 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 Gen-
eral 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 Gen-
eral 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 supple-
ments; 
(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 propor-
tion of the resources devoted to such regulatory and enforce-
ment 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 Cos-
metic 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 suopara-
graph (B). 
(B) RECOMMENDATIONS.—Such report shall include the 
recommendations of the Comptroller General for adminis-
trative 
reform, 
including 
recommendations 
regarding 
opportunities for encouraging economy and 
efficiency 
through the appropriate targeting of problems, managing 
resources appropriately, and making adequate determina-
tions 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 
59-194 O—93 
28 : QL 3 (Pt. 5) 
106 STAT. 4504 
PUBLIC LAW 102-571—OCT. 29, 1992 
M: 
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 (IXB). 
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 regu-
late the manufacture and sale of such dietary supplements 
and the effect of the regulatory efforts on hiunan health. 
(2) INFORMATION.—^The study shall include information 
regarding— 
(A) whether and how other coimtries 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 character-
istics; 
(C) the effect of the classification on the regulation 
of the supplements; 
(D) now 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 morbiditv 
and mortality associated with the consimiption of such 
dietary supplements among nations; 
(B) whether particular regulatory systems may be asso-
ciated with lower morbidity and mortality rates; and 
(C) whether a causal relationship may be demonstrated 
between the regulatory system used and the health out-
comes of the populations affected. 
PUBLIC LAW 102-571—OCT. 29,1992 
106 STAT. 4505 
(c) REPORT.—The Director of the Office of Technology Assess-
ment 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 ofthe study to the Committee 
on Energy and Commerce of the House of Representatives and 
the Committee on Labor and Human Resources of the Senate. 
Approved October 29,1992. 
LEGISLATIVE HISTORY—H.R. 6181: 
CONGRESSIONAL RECORD, Vol. 138 (1992): 
Oct. 5, considered and passed House. 
Oct. 7, considered and passed Senate.