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GUIDANCE DOCUMENT

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

Final

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

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

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

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Food and Drug Administration
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