Animal Drug User Fee Act of 2003
PL 108-130 (S.313), enacted 11/18/2003

117 STAT. 1361
PUBLIC LAW 108–130—NOV. 18, 2003
Public Law 108–130
108th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act to establish a program of
fees relating to animal drugs.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Animal Drug User Fee Act
of 2003’’.
SEC. 2. FINDINGS.
Congress finds as follows:
(1) Prompt approval of safe and effective new animal drugs
is critical to the improvement of animal health and the public
health.
(2) Animal health and the public health will be served
by making additional funds available for the purpose of aug-
menting the resources of the Food and Drug Administration
that are devoted to the process for review of new animal drug
applications.
(3) The fees authorized by this Act will be dedicated toward
expediting the animal drug development process and the review
of new and supplemental animal drug applications and inves-
tigational animal drug submissions as set forth in the goals
identified, for purposes of part 4 of subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act, in the letters
from the Secretary of Health and Human Services to the Chair-
man of the Committee on Energy and Commerce of the House
of Representatives and the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate as set
forth in the Congressional Record.
SEC. 3. FEES RELATING TO ANIMAL DRUGS.
Subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379f et seq.) is amended by adding at
the end the following part:
‘‘PART 4—FEES RELATING TO ANIMAL DRUGS
‘‘SEC. 739. DEFINITIONS.
‘‘For purposes of this subchapter:
‘‘(1) The term ‘animal drug application’ means an applica-
tion for approval of any new animal drug submitted under
section 512(b)(1). Such term does not include either a new
21 USC 379j–11.
21 USC 379j–11
note.
21 USC 301 note.
Animal Drug
User Fee Act of
2003.
Nov. 18, 2003
[S. 313]
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117 STAT. 1362
PUBLIC LAW 108–130—NOV. 18, 2003
animal drug application submitted under section 512(b)(2) or
a supplemental animal drug application.
‘‘(2) The term ‘supplemental animal drug application’
means—
‘‘(A) a request to the Secretary to approve a change
in an animal drug application which has been approved;
or
‘‘(B) a request to the Secretary to approve a change
to an application approved under section 512(c)(2) for which
data with respect to safety or effectiveness are required.
‘‘(3) The term ‘animal drug product’ means each specific
strength or potency of a particular active ingredient or ingredi-
ents in final dosage form marketed by a particular manufac-
turer or distributor, which is uniquely identified by the labeler
code and product code portions of the national drug code, and
for which an animal drug application or a supplemental animal
drug application has been approved.
‘‘(4) The term ‘animal drug establishment’ means a foreign
or domestic place of business which is at one general physical
location consisting of one or more buildings all of which are
within 5 miles of each other, at which one or more animal
drug products are manufactured in final dosage form.
‘‘(5) The term ‘investigational animal drug submission’
means—
‘‘(A) the filing of a claim for an investigational exemp-
tion under section 512(j) for a new animal drug intended
to be the subject of an animal drug application or a supple-
mental animal drug application, or
‘‘(B) the submission of information for the purpose
of enabling the Secretary to evaluate the safety or effective-
ness of an animal drug application or supplemental animal
drug application in the event of their filing.
‘‘(6) The term ‘animal drug sponsor’ means either an
applicant named in an animal drug application, except for
an approved application for which all subject products have
been removed from listing under section 510, or a person who
has submitted an investigational animal drug submission that
has not been terminated or otherwise rendered inactive by
the Secretary.
‘‘(7) The term ‘final dosage form’ means, with respect to
an animal drug product, a finished dosage form which is
approved for administration to an animal without substantial
further manufacturing. Such term includes animal drug prod-
ucts intended for mixing in animal feeds.
‘‘(8) The term ‘process for the review of animal drug applica-
tions’ means the following activities of the Secretary with
respect to the review of animal drug applications, supplemental
animal drug applications, and investigational animal drug
submissions:
‘‘(A) The activities necessary for the review of animal
drug applications, supplemental animal drug applications,
and investigational animal drug submissions.
‘‘(B) The issuance of action letters which approve
animal drug applications or supplemental animal drug
applications or which set forth in detail the specific defi-
ciencies in animal drug applications, supplemental animal
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117 STAT. 1363
PUBLIC LAW 108–130—NOV. 18, 2003
drug applications, or investigational animal drug submis-
sions and, where appropriate, the actions necessary to place
such applications, supplements or submissions in condition
for approval.
‘‘(C) The inspection of animal drug establishments and
other facilities undertaken as part of the Secretary’s review
of pending animal drug applications, supplemental animal
drug applications, and investigational animal drug submis-
sions.
‘‘(D) Monitoring of research conducted in connection
with the review of animal drug applications, supplemental
animal drug applications, and investigational animal drug
submissions.
‘‘(E) The development of regulations and policy related
to the review of animal drug applications, supplemental
animal drug applications, and investigational animal drug
submissions.
‘‘(F) Development of standards for products subject to
review.
‘‘(G) Meetings between the agency and the animal drug
sponsor.
‘‘(H) Review of advertising and labeling prior to
approval of an animal drug application or supplemental
animal drug application, but not such activities after an
animal drug has been approved.
‘‘(9) The term ‘costs of resources allocated for the process
for the review of animal drug applications’ means the expenses
incurred in connection with the process for the review of animal
drug applications for—
‘‘(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug Adminis-
tration, advisory committees consulted with respect to the
review of specific animal drug applications, supplemental
animal drug applications, or investigational animal drug
submissions, and costs related to such officers, employees,
committees, and contractors, including costs for travel, edu-
cation, and recruitment and other personnel activities,
‘‘(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, furniture, scientific equipment, and other necessary
materials and supplies, and
‘‘(D) collecting fees under section 740 and accounting
for resources allocated for the review of animal drug
applications, supplemental animal drug applications, and
investigational animal drug submissions.
‘‘(10) The term ‘adjustment factor’ applicable to a fiscal
year refers to the formula set forth in section 735(8) with
the base or comparator year being 2003.
‘‘(11) The term ‘affiliate’ refers to the definition set forth
in section 735(9).
‘‘SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
‘‘(a) TYPES OF FEES.—Beginning in fiscal year 2004, the Sec-
retary shall assess and collect fees in accordance with this section
as follows:
21 USC 379j–12.
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117 STAT. 1364
PUBLIC LAW 108–130—NOV. 18, 2003
‘‘(1) ANIMAL DRUG APPLICATION AND SUPPLEMENT FEE.—
‘‘(A) IN GENERAL.—Each person that submits, on or
after September 1, 2003, an animal drug application or
a supplemental animal drug application shall be subject
to a fee as follows:
‘‘(i) A fee established in subsection (b) for an
animal drug application; and
‘‘(ii) A fee established in subsection (b) for a supple-
mental animal drug application for which safety or
effectiveness data are required, in an amount that
is equal to 50 percent of the amount of the fee under
clause (i).
‘‘(B) PAYMENT.—The fee required by subparagraph (A)
shall be due upon submission of the animal drug applica-
tion or supplemental animal drug application.
‘‘(C) EXCEPTION FOR PREVIOUSLY FILED APPLICATION OR
SUPPLEMENT.—If an animal drug application or a supple-
mental animal drug application 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 or refund), the submission of an animal
drug application or a supplemental animal drug application
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
REFUSED
FOR
FILING.—The Secretary shall refund 75 percent of the fee
paid under subparagraph (B) for any animal drug applica-
tion or supplemental animal drug application which is
refused for filing.
‘‘(E) REFUND
OF
FEE
IF
APPLICATION
WITHDRAWN.—
If an animal drug application or a supplemental animal
drug application is withdrawn after the application or
supplement was filed, the Secretary may refund the fee
or portion of the fee paid under subparagraph (B) if no
substantial work was performed on the application or
supplement after the application or supplement was filed.
The Secretary shall have the sole discretion to refund the
fee under this paragraph. A determination by the Secretary
concerning a refund under this paragraph shall not be
reviewable.
‘‘(2) ANIMAL DRUG PRODUCT FEE.—Each person—
‘‘(A) who is named as the applicant in an animal drug
application or supplemental animal drug application for
an animal drug product which has been submitted for
listing under section 510, and
‘‘(B) who, after September 1, 2003, had pending before
the Secretary an animal drug application or supplemental
animal drug application;
shall pay for each such animal drug product the annual fee
established in subsection (b). Such fee shall be payable for
the fiscal year in which the animal drug product is first sub-
mitted for listing under section 510, or is submitted for relisting
under section 510 if the animal drug product has been with-
drawn from listing and relisted. After such fee is paid for
that fiscal year, such fee shall be payable on or before January
Deadline.
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117 STAT. 1365
PUBLIC LAW 108–130—NOV. 18, 2003
31 of each year. Such fee shall be paid only once for each
animal drug product for a fiscal year in which the fee is payable.
‘‘(3) ANIMAL DRUG ESTABLISHMENT FEE.—Each person—
‘‘(A) who owns or operates, directly or through an affil-
iate, an animal drug establishment, and
‘‘(B) who is named as the applicant in an animal drug
application or supplemental animal drug application for
an animal drug product which has been submitted for
listing under section 510, and
‘‘(C) who, after September 1, 2003, had pending before
the Secretary an animal drug application or supplemental
animal drug application,
shall be assessed an annual fee established in subsection (b)
for each animal drug establishment listed in its approved
animal drug application as an establishment that manufactures
the animal drug product named in the application. The annual
establishment fee shall be assessed in each fiscal year in which
the animal drug product named in the application is assessed
a fee under paragraph (2) unless the animal drug establishment
listed in the application does not engage in the manufacture
of the animal drug product during the fiscal year. The fee
shall be paid on or before January 31 of each year. The
establishment shall be assessed only one fee per fiscal year
under this section: Provided, however, That where a single
establishment manufactures both animal drug products and
prescription drug products, as defined in section 735(3), such
establishment shall be assessed both the animal drug establish-
ment fee and the prescription drug establishment fee, as set
forth in section 736(a)(2), within a single fiscal year.
‘‘(4) ANIMAL DRUG SPONSOR FEE.—Each person—
‘‘(A) who meets the definition of an animal drug
sponsor within a fiscal year; and
‘‘(B) who, after September 1, 2003, had pending before
the Secretary an animal drug application, a supplemental
animal drug application, or an investigational animal drug
submission,
shall be assessed an annual fee established under subsection
(b). The fee shall be paid on or before January 31 of each
year. Each animal drug sponsor shall pay only one such fee
each fiscal year.
‘‘(b) FEE AMOUNTS.—Except as provided in subsection (a)(1)
and subsections (c), (d), (f), and (g), the fees required under sub-
section (a) shall be established to generate fee revenue amounts
as follows:
‘‘(1) TOTAL FEE REVENUES FOR APPLICATION AND SUPPLE-
MENT FEES.—The total fee revenues to be collected in animal
drug application fees under subsection (a)(1)(A)(i) and supple-
mental 
animal 
drug 
application 
fees 
under 
subsection
(a)(1)(A)(ii) shall be $1,250,000 in fiscal year 2004, $2,000,000
in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007,
and 2008.
‘‘(2) TOTAL FEE REVENUES FOR PRODUCT FEES.—The total
fee revenues to be collected in product fees under subsection
(a)(2) shall be $1,250,000 in fiscal year 2004, $2,000,000 in
fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007,
and 2008.
Deadline.
Deadline.
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117 STAT. 1366
PUBLIC LAW 108–130—NOV. 18, 2003
‘‘(3) TOTAL FEE REVENUES FOR ESTABLISHMENT FEES.—The
total fee revenues to be collected in establishment fees under
subsection (a)(3) shall be $1,250,000 in fiscal year 2004,
$2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years
2006, 2007, and 2008.
‘‘(4) TOTAL FEE REVENUES FOR SPONSOR FEES.—The total
fee revenues to be collected in sponsor fees under subsection
(a)(4) shall be $1,250,000 in fiscal year 2004, $2,000,000 in
fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007,
and 2008.
‘‘(c) ADJUSTMENTS.—
‘‘(1) INFLATION ADJUSTMENT.—The revenues established in
subsection (b) shall be adjusted by the Secretary by notice,
published in the Federal Register, for a fiscal year to reflect
the greater of—
‘‘(A) the total percentage change that occurred in the
Consumer Price Index for all urban consumers (all items;
United States city average) for the 12-month period ending
June 30 preceding the fiscal year for which fees are being
established; or
‘‘(B) the total percentage change for the previous 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.
The adjustment made each fiscal year by this subsection will
be added on a compounded basis to the sum of all adjustments
made each fiscal year after fiscal year 2004 under this sub-
section.
‘‘(2) WORKLOAD ADJUSTMENT.—After the fee revenues are
adjusted for inflation in accordance with paragraph (1), the
fee revenues shall be further adjusted each fiscal year after
fiscal year 2004 to reflect changes in review workload. With
respect to such adjustment:
‘‘(A) This adjustment shall be determined by the Sec-
retary based on a weighted average of the change in the
total number of animal drug applications, supplemental
animal drug applications for which data with respect to
safety or effectiveness are required, manufacturing supple-
mental animal drug applications, investigational animal
drug study submissions, and investigational animal drug
protocol submissions submitted to the Secretary. The Sec-
retary shall publish in the Federal Register the fees
resulting from this adjustment and the supporting meth-
odologies.
‘‘(B) Under no circumstances shall this workload
adjustment result in fee revenues for a fiscal year that
are less than the fee revenues for that fiscal year estab-
lished in subsection (b), as adjusted for inflation under
paragraph (1).
‘‘(3) FINAL YEAR ADJUSTMENT.—For fiscal year 2008, the
Secretary may further increase the fees to provide for up to
3 months of operating reserves of carryover user fees for the
process for the review of animal drug applications for the
first 3 months of fiscal year 2009. If the Food and Drug
Administration has carryover balances for the process for the
Federal Register,
publication.
Federal Register,
publication.
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117 STAT. 1367
PUBLIC LAW 108–130—NOV. 18, 2003
review of animal drug applications in excess of 3 months of
such operating reserves, then this adjustment will not be made.
If this adjustment is necessary, then the rationale for the
amount of the increase shall be contained in the annual notice
setting fees for fiscal year 2008.
‘‘(4) ANNUAL FEE SETTING.—The Secretary shall establish,
60 days before the start of each fiscal year beginning after
September 30, 2003, for that fiscal year, animal drug applica-
tion fees, supplemental animal drug application fees, animal
drug sponsor fees, animal drug establishment fees, and animal
drug product fees based on the revenue amounts established
under subsection (b) and the adjustments provided under this
subsection.
‘‘(5) LIMIT.—The total amount of fees charged, as adjusted
under this subsection, 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 animal drug applications.
‘‘(d) FEE WAIVER OR REDUCTION.—
‘‘(1) IN GENERAL.—The Secretary shall grant a waiver from
or a reduction of 1 or more fees assessed under subsection
(a) where the Secretary finds that—
‘‘(A) the assessment of the fee would present a signifi-
cant barrier to innovation because of limited resources
available to such person or other circumstances,
‘‘(B) 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 animal
drug applications for such person,
‘‘(C) the animal drug application or supplemental
animal drug application is intended solely to provide for
use of the animal drug in—
‘‘(i) a Type B medicated feed (as defined in section
558.3(b)(3) of title 21, Code of Federal Regulations
(or any successor regulation)) intended for use in the
manufacture of Type C free-choice medicated feeds,
or
‘‘(ii) a Type C free-choice medicated feed (as defined
in section 558.3(b)(4) of title 21, Code of Federal Regu-
lations (or any successor regulation)),
‘‘(D) the animal drug application or supplemental
animal drug application is intended solely to provide for
a minor use or minor species indication, or
‘‘(E) the sponsor involved is a small business submit-
ting its first animal drug application to the Secretary for
review.
‘‘(2) USE OF STANDARD COSTS.—In making the finding in
paragraph (1)(B), the Secretary may use standard costs.
‘‘(3) RULES FOR SMALL BUSINESSES.—
‘‘(A) DEFINITION.—In paragraph (1)(E), the term ‘small
business’ means an entity that has fewer than 500
employees, including employees of affiliates.
‘‘(B) WAIVER OF APPLICATION FEE.—The Secretary shall
waive under paragraph (1)(E) the application fee for the
first animal drug application that a small business or its
affiliate submits to the Secretary for review. After a small
business or its affiliate is granted such a waiver, the small
business or its affiliate shall pay application fees for all
Deadline.
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117 STAT. 1368
PUBLIC LAW 108–130—NOV. 18, 2003
subsequent animal drug applications and supplemental
animal drug applications for which safety or effectiveness
data are required in the same manner as an entity that
does not qualify as a small business.
‘‘(C) CERTIFICATION.—The Secretary shall require any
person who applies for a waiver under paragraph (1)(E)
to certify their qualification for the waiver. The Secretary
shall periodically publish in the Federal Register a list
of persons making such certifications.
‘‘(e) EFFECT OF FAILURE TO PAY FEES.—An animal drug applica-
tion or supplemental animal drug application 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. An investigational animal
drug submission under section 739(5)(B) that is submitted by a
person subject to fees under subsection (a) shall be considered
incomplete and shall not be accepted for review by the Secretary
until all fees owed by such person have been paid. The Secretary
may discontinue review of any animal drug application, supple-
mental animal drug application or investigational animal drug
submission from a person if such person has not submitted for
payment all fees owed under this section by 30 days after the
date upon which they are due.
‘‘(f) ASSESSMENT OF FEES.—
‘‘(1) LIMITATION.—Fees may not be assessed under sub-
section (a) for a fiscal year beginning after fiscal year 2003
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 2003 (excluding the amount of fees appropriated
for such fiscal year) 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 animal drug applications, supplemental animal drug
applications, investigational animal drug submissions, animal
drug sponsors, animal drug establishments and animal 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 authorized under subsection (a)
shall be collected and available for obligation only to the extent
and in the amount provided in advance in appropriations Acts.
Such fees are authorized to be appropriated to remain available
until expended. Such sums as may be necessary may be trans-
ferred from the Food and Drug Administration salaries and
expenses appropriation account without fiscal year limitation
to such appropriation account for salary and expenses with
such fiscal year limitation. The sums transferred shall be avail-
able solely for the process for the review of animal drug applica-
tions.
Federal Register,
publication.
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117 STAT. 1369
PUBLIC LAW 108–130—NOV. 18, 2003
‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.—
‘‘(A) IN
GENERAL.—The fees authorized by this
section—
‘‘(i) shall be retained in each fiscal year in an
amount not to exceed the amount specified in appro-
priation Acts, or otherwise made available for obliga-
tion for such fiscal year, and
‘‘(ii) shall only be collected and available to defray
increases in the costs of the resources allocated for
the process for the review of animal drug applications
(including increases in such costs for an additional
number of full-time equivalent positions in the Depart-
ment of Health and Human Services to be engaged
in such process) over such costs, excluding costs paid
from fees collected under this section, for fiscal year
2003 multiplied by the adjustment factor.
‘‘(B) COMPLIANCE.—The Secretary shall be considered
to have met the requirements of subparagraph (A)(ii) in
any fiscal year if the costs funded by appropriations and
allocated for the process for the review of animal drug
applications—
‘‘(i) are not more than 3 percent below the level
specified in subparagraph (A)(ii); or
‘‘(ii)(I) are more than 3 percent below the level
specified in subparagraph (A)(ii), and fees assessed
for the fiscal year following the subsequent fiscal year
are decreased by the amount in excess of 3 percent
by which such costs fell below the level specified in
subparagraph (A)(ii); and
‘‘(II) such costs are not more than 5 percent below
the level specified in subparagraph (A)(ii).
‘‘(3) 
AUTHORIZATION
OF
APPROPRIATIONS.—There 
are
authorized to be appropriated for fees under this section—
‘‘(A) $5,000,000 for fiscal year 2004;
‘‘(B) $8,000,000 for fiscal year 2005;
‘‘(C) $10,000,000 for fiscal year 2006;
‘‘(D) $10,000,000 for fiscal year 2007; and
‘‘(E) $10,000,000 for fiscal year 2008;
as adjusted to reflect adjustments in the total fee revenues
made under this section and changes in the total amounts
collected by animal drug application fees, supplemental animal
drug application fees, animal drug sponsor fees, animal drug
establishment fees, and animal drug product fees.
‘‘(4) OFFSET.—Any amount of fees collected for a fiscal
year under this section that exceeds the amount of fees specified
in appropriations Acts for such fiscal year shall be credited
to the appropriation account of the Food and Drug Administra-
tion as provided in paragraph (1), and shall be subtracted
from the amount of fees that would otherwise be authorized
to be collected under this section pursuant to appropriation
Acts for a subsequent fiscal year.
‘‘(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 States Government subject to subchapter
II of chapter 37 of title 31, United States Code.
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117 STAT. 1370
PUBLIC LAW 108–130—NOV. 18, 2003
‘‘(i) WRITTEN
REQUESTS
FOR
WAIVERS, REDUCTIONS, 
AND
REFUNDS.—To qualify for consideration for a waiver or reduction
under subsection (d), or for a refund of any fee collected in accord-
ance with subsection (a), a person shall submit to the Secretary
a written request for such waiver, reduction, or refund not later
than 180 days after such fee is due.
‘‘(j) 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, employees,
and advisory committees not engaged in the process of the review
of animal drug applications, be reduced to offset the number of
officers, employees, and advisory committees so engaged.
‘‘(k) ABBREVIATED NEW ANIMAL DRUG APPLICATIONS.—The Sec-
retary shall—
‘‘(1) to the extent practicable, segregate the review of abbre-
viated new animal drug applications from the process for the
review of animal drug applications, and
‘‘(2) adopt other administrative procedures to ensure that
review times of abbreviated new animal drug applications do
not increase from their current level due to activities under
the user fee program.’’.
SEC. 4. ACCOUNTABILITY AND REPORTS.
(a) PUBLIC ACCOUNTABILITY.—
(1) CONSULTATION.—In developing recommendations to
Congress for the goals and plans for meeting the goals for
the process for the review of animal drug applications for
the fiscal years after fiscal year 2008, and for the reauthoriza-
tion of sections 739 and 740 of the Federal Food, Drug, and
Cosmetic Act (as added by section 3), the Secretary of Health
and Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall consult with the Committee on Energy and Com-
merce of the House of Representatives, the Committee on
Health, Education, Labor, and Pensions of the Senate, appro-
priate scientific and academic experts, veterinary professionals,
representatives of consumer advocacy groups, and the regulated
industry.
(2) RECOMMENDATIONS.—The Secretary shall—
(A) publish in the Federal Register recommendations
under paragraph (1), after negotiations with the regulated
industry;
(B) present the recommendations to the Committees
referred to in that paragraph;
(C) hold a meeting at which the public may comment
on the recommendations; and
(D) provide for a period of 30 days for the public
to provide written comments on the recommendations.
(b) PERFORMANCE REPORTS.—Beginning with fiscal year 2004,
not later than 60 days after the end of each fiscal year during
which fees are collected under part 4 of subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act, the Secretary
shall prepare and submit to the Committee on Energy and Com-
merce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a report
concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in section
2(3) of this Act toward expediting the animal drug development
Deadline.
Federal Register,
publication.
21 USC 379j–11
note.
Deadline.
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117 STAT. 1371
PUBLIC LAW 108–130—NOV. 18, 2003
LEGISLATIVE HISTORY—S. 313:
SENATE REPORTS: No. 108–51 (Comm. on Health, Education, Labor, and Pen-
sions).
CONGRESSIONAL RECORD, Vol. 149 (2003):
May 23, considered and passed Senate.
June 3, passage vitiated; reconsidered and passed Senate.
Nov. 4, considered and passed House, amended.
Nov. 7, Senate concurred in House amendment.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 39 (2003):
Nov. 18, Presidential statement.
process and the review of the new and supplemental animal drug
applications and investigational animal drug submissions during
such fiscal year, the future plans of the Food and Drug Administra-
tion for meeting the goals, the review times for abbreviated new
animal drug applications, and the administrative procedures
adopted by the Food and Drug Administration to ensure that review
times for abbreviated new animal drug applications are not
increased from their current level due to activities under the user
fee program.
(c) FISCAL REPORT.—Beginning with fiscal year 2004, not later
than 120 days after the end of each fiscal year during which
fees are collected under the part described in subsection (b), the
Secretary shall prepare and submit to the Committee on Energy
and Commerce of the House of Representatives and the Committee
on Health, Education, Labor, and Pensions of the Senate a report
on the implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected during such fiscal year for which the report
is made.
SEC. 5. SUNSET.
The amendments made by section 3 shall not be in effect
after October 1, 2008, and section 4 shall not be in effect after
120 days after such date.
Approved November 18, 2003.
21 USC 379j–11
note.
Deadline.
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