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GUIDANCE DOCUMENT

CVM GFI #173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA) February 2005

Download the Final Guidance Document
Final
Docket Number:
FDA-2004-D-0181
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The Animal Drug User Fee Act of 2003 (ADUFA), enacted on November 18, 2003, amends the Federal Food, Drug, and Cosmetic Act (the act) by adding Sections 739 and 740 (21 U.S.C. 379j-11, and j-12) which require the Food and Drug Administration (FDA) to assess and collect user fees for certain applications, products, establishments, and sponsors. This guidance represents the FDA’s current thinking on how it intends to implement the animal drug sponsor fee provision of ADUFA.

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All written comments should be identified with this document's docket number: FDA-2004-D-0181.

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