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U.S. Department of Health and Human Services

Animal & Veterinary

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Draft Guidance on Waivers and Reductions for Animal Drug User Fees Available

August 17, 2006

In the August 17, 2006, Federal Register, the Food and Drug Administration (FDA) announced the availability of draft guidance for industry #183 entitled “Animal Drug User Fees: Fees Exceed Costs Waivers and Reductions.” The draft guidance explains the procedures FDA expects to use to evaluate waiver requests under the fees exceed costs waiver provision of the Animal Drug User Fees Act of 2003 (ADUFA). ADUFA requires that FDA assess and collect user fees for certain applications, products, establishments, and sponsors. It also requires the Agency to grant a waiver from, or a reduction of, those fees in certain circumstances.

This draft guidance is posted on the CVM website. Single copies of the draft guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855, 240-276-9300. Please send one self-addressed adhesive label to assist in processing your request.

This Level 1 draft guidance is being issued consistent with FDA's good guidance practices regulations (GGPs). The draft guidance, when finalized, will represent the Agency's current thinking on the fees exceed costs waiver provision of ADUFA. It does not create or confer any rights for or on any person and will not operate to bind FDA or the public. Alternative methods may be used as long as they satisfy the requirements of the applicable statutes and regulations.

Written comments on the guidance document may be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted to http://www.fda.gov/dockets/ecomments. Comments should be submitted by October 31, 2006, to ensure their adequate consideration in preparation of the final document. General comments on Agency guidance documents are welcome at any time. All comments should be identified with the full title of the guidance document and Docket number 2006D-0301.

Additional information is available from 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.hhs.gov.

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Additional Information

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Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855