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U.S. GOVERNMENT
INFORMATION
GP
Calendar No. 104
108TH CONGRESS REPORT
1st Session SENATE 108-51
ANIMAL DRUG USER FEE ACT OF 2003
MAY 21, 2003.-Ordered to be printed
Mr. GREGG, from the Committee on Health, Education, Labor, and
Pensions, submitted the following
REPORT
[To accompany S. 313]
The Committee on Health, Education, Labor, and Pensions, to
which was referred the bill (S. 313) to amend the Federal Food,
Drug, and Cosmetic Act to establish a program of fees relating to
animal drugs, having considered the same, reports favorably there-
on with amendments and recommends that the bill (as amended)
do pass.
CONTENTS
Page
I. Purpose and summary of legislation ........................................................... 1
II. Com m ittee action .......................................................................................... 2
III. Background and need for legislation ........................................................... 2
IV . Cost estim ate .................................................................................................. 4
V. Application of law to the legislative branch ................................................ 6
VI. Regulatory im pact statem ent ........................................................................ 7
VII. Section-by-section analysis ............................................................................ 7
VIII. Changes in existing law ................................................................................ 10
I. PURPOSE AND SUMMARY OF LEGISLATION
The Animal Drug User Fee Act (ADUFA) of 2003 (S. 313) would
authorize a program of fees by the Food and Drug Administration
(FDA) relating to the review of new animal drugs. Under this pro-
posal, the additional revenues generated from fees paid by the ani-
mal health industry would be dedicated for use in expediting the
new animal drug review process, in accordance with performance
goals that would be developed by FDA in consultation with the in-
dustry. This legislation will provide resources to improve the ani-
mal drug review process through the hiring of new personnel and
purchase and maintenance of technological management and infor-
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