21 U.S.C. § 379j–11
Definitions
United States · Title 21 — FOOD AND DRUGS · Status: effective
Cite this
- Citation
- 21 U.S.C. § 379j–11, Definitions, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454414
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Full text
For purposes of this subpart:
The term “animal drug application” means—
The term “supplemental animal drug application” means—
The term “investigational animal drug submission” means—
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 applications, and investigational animal drug submissions:
The term “costs of resources allocated for the process for the review of animal drug applications” means the expenses in connection with the process for the review of animal drug applications for—
Legislative history
The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone.
- Animal Drug User Fee Act of 2003House: no recorded tallySenate: no recorded tally
- Food and Drug Administration Amendments Act of 2007House: 405–7Senate: no recorded tally
- To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, to establish a program of fees relating to generic new animal drugs, to make certain technical corrections to the Food and Drug Administration Amendments Act of 2007, and for other purposes.House: no recorded tallySenate: no recorded tally
- Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013House: 390–12Senate: no recorded tally
- Animal Drug and Animal Generic Drug User Fee Amendments of 2018House: no recorded tallySenate: no recorded tally
- Continuing Appropriations Act, 2024 and Other Extensions Act