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U.S. Department of Health and Human Services

Animal & Veterinary

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Draft Guidance Available on Sponsor Fees Under ADUFA

September 28, 2004

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document for industry (GFI #173) entitled "Animal Drug Sponsor Fees under the Animal Drug User Fee Act (ADUFA)."

The Animal Drug User Fee Act of 2003 (ADUFA), enacted on November 18, 2003, amended the Federal Food, Drug, and Cosmetic Act by adding sections that require the FDA to assess and collect user fees for certain applications, products, establishments, and sponsors. This draft guidance represents the FDA's current thinking on how it intends to implement the animal drug sponsor fee provision of the Animal Drug User Fee Act.

Draft Guidance #173 is posted on the CVM Home Page. Single copies of the guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855, 301-827-3800. Please send one self-addressed adhesive label to assist in processing your request.

Additional information about this draft guidance document may be found in the September 28, 2004 , Federal Register. Questions regarding this document may be directed to Dr. David Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6967, e-mail: mailto:david.newkirk@fda.gov.

This draft guidance represents the Agency's current thinking on the topic. Written or electronic comments on the draft guidance should be submitted by October 28, 2004, to ensure their adequate consideration in preparation of the final document. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 10-61, Rockville, MD 20852. Electronic comments on the draft guidance may be submitted. Comments should be identified with the full title of the draft guidance and Docket Number 2004D-0422. The draft guidance does not create or confer any rights for or on any person and does not operate to bind FDA or the public.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855