IIB 
108TH CONGRESS 
1ST SESSION H. R. 1260
IN THE SENATE OF THE UNITED STATES 
OCTOBER 2, 2003
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
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 Representa-
tives of the United States of America in Congress assembled,
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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 ani-
mal health and the public health. 
(2) Animal health and 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 new animal drug applications. 
(3) The fees authorized by this title will be 
dedicated toward expediting the animal drug devel-
opment process and the review of new and supple-
mental animal drug applications and investigational 
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 Cos-
metic Act, in the letters from the Secretary of 
Health and Human Services to the Chairman of the 
Committee on Energy and Commerce of the House 
of Representatives and the Chairman of the Com-
mittee on Health, Education, Labor, and Pensions
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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 amend-
ed 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 application for approval of any new animal drug 
submitted under section 512(b)(1). Such term does 
not include either a new animal drug application 
submitted under section 512(b)(2) or a supplemental 
animal drug application. 
‘‘(2) The term ‘supplemental animal drug appli-
cation’ 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 sec-
tion 512(c)(2) for which data with respect to 
safety or effectiveness are required.
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‘‘(3) The term ‘animal drug product’ means 
each specific strength or potency of a particular ac-
tive ingredient or ingredients in final dosage form 
marketed by a particular manufacturer or dis-
tributor, 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 ap-
proved. 
‘‘(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 prod-
ucts are manufactured in final dosage form. 
‘‘(5) The term ‘investigational animal drug sub-
mission’ means—
‘‘(A) the filing of a claim for an investiga-
tional exemption under section 512(j) for a new 
animal drug intended to be the subject of an 
animal drug application or a supplemental ani-
mal drug application, or 
‘‘(B) the submission of information for the 
purpose of enabling the Secretary to evaluate 
the safety or effectiveness of an animal drug
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application or supplemental animal drug appli-
cation in the event of their filing. 
‘‘(6) The term ‘animal drug sponsor’ means ei-
ther an applicant named in an animal drug applica-
tion, 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 ani-
mal without substantial further manufacturing. Such 
term includes animal drug products intended for 
mixing in animal feeds. 
‘‘(8) The term ‘process for the review of animal 
drug applications’ means the following activities of 
the Secretary with respect to the review of animal 
drug applications, supplemental animal drug applica-
tions, and investigational animal drug submissions: 
‘‘(A) The activities necessary for the re-
view of animal drug applications, supplemental 
animal drug applications, and investigational 
animal drug submissions.