PUBLIC LAW 108–130—NOV. 18, 2003
117 STAT. 1361
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 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 Act will be dedicated toward expediting the animal drug development process and the review of new and supplemental 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 Cosmetic 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 Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record.
Nov. 18, 2003 [S. 313] Animal Drug User Fee Act of 2003. 21 USC 301 note.
21 USC 379j–11 note.
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.
21 USC 379j–11.
‘‘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
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