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‘‘(i) shall be retained in each fiscal 
year in an amount not to exceed the 
amount specified in appropriation Acts, or 
otherwise made available for obligation for 
such fiscal year, and 
‘‘(ii) shall only be collected and avail-
able to defray increases in the costs of the 
resources allocated for the process for the 
review of animal drug applications (includ-
ing increases in such costs for an addi-
tional number of full-time equivalent posi-
tions in the Department 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 ad-
justment 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—
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‘‘(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 fol-
lowing the subsequent fiscal year are de-
creased by the amount in excess of 3 per-
cent 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 sub-
paragraph (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
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fees, supplemental animal drug application fees, ani-
mal 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 appropria-
tion account of the Food and Drug Administration 
as provided in paragraph (1), and shall be sub-
tracted from the amount of fees that would other-
wise be authorized to be collected under this section 
pursuant to appropriation Acts for a subsequent fis-
cal year. 
‘‘(h) COLLECTION OF UNPAID FEES.—In any case 
where the Secretary does not receive payment of a fee as-
sessed under subsection (a) within 30 days after it is due, 
such fee shall be treated as a claim of the United States 
Government subject to subchapter II of chapter 37 of title 
31, United States Code. 
‘‘(i) WRITTEN REQUESTS
FOR WAIVERS, REDUC-
TIONS, AND REFUNDS.—To qualify for consideration for 
a waiver or reduction under subsection (d), or for a refund 
of any fee collected in accordance with subsection (a), a 
person shall submit to the Secretary a written request for
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such waiver, reduction, or refund not later than 180 days 
after such fee is due. 
‘‘(j) CONSTRUCTION.—This section may not be con-
strued to require that the number of full-time equivalent 
positions in the Department of Health and Human Serv-
ices, for officers, employees, and advisory committees not 
engaged in the process of the review of animal drug appli-
cations, be reduced to offset the number of officers, em-
ployees, and advisory committees so engaged. 
‘‘(k) ABBREVIATED NEW ANIMAL DRUG APPLICA-
TIONS.—The Secretary shall—
‘‘(1) to the extent practicable, segregate the re-
view of abbreviated new animal drug applications 
from the process for the review of animal drug appli-
cations, 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 
rec-
ommendations 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
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fiscal year 2008, and for the reauthorization of sec-
tions 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 ‘‘Secretary’’) shall consult with the 
Committee on Energy and Commerce of the House 
of Representatives, the Committee on Health, Edu-
cation, 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 rec-
ommendations under paragraph (1), after nego-
tiations 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 rec-
ommendations. 
(b) PERFORMANCE REPORTS.—Beginning with fiscal 
year 2004, not later than 60 days after the end of each
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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 Commerce of the House 
of Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report con-
cerning 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 process and the review of the new and 
supplemental animal drug applications and investigational 
animal drug submissions during such fiscal year, the fu-
ture plans of the Food and Drug Administration for meet-
ing 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 applica-
tions are not increased from their current level due to ac-
tivities 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 de-
scribed in subsection (a), the Secretary shall prepare and 
submit to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on Health,
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Education, Labor, and Pensions of the Senate a report 
on the implementation of the authority for such fees dur-
ing 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.
Passed the House of Representatives October 1, 
2003. 
Attest: 
JEFF TRANDAHL, 
Clerk.