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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Announces FY 2010 Animal Generic Drug User Fee Rates

August 3, 2009

The Food and Drug Administration announced rates for fiscal year (FY) 2010 Animal Generic Drug User Fee Act of 2008 (AGDUFA) in a notice published in the August 3, 2009, Federal Register. This Act amends the Food, Drug and Cosmetic Act by authorizing the first ever generic animal drug user fee program. AGDUFA authorizes FDA to collect user fees for certain abbreviated applications for a generic new animal drug, generic new animal drug products, and certain sponsors of such abbreviated applications for generic new animal drugs.

For FY 2010, the fee is $75,000 per application for an abbreviated generic new animal drug application for which safety or effectiveness data are required. The annual product fee is $3,255, the annual sponsor fee is $54,050 for each generic new animal drug sponsor paying 100 percent of the sponsor fee; $40,537 for each generic new animal drug sponsor paying 75 percent of the sponsor fee; and $27,025 for a generic new animal drug sponsor paying 50 percent of the sponsor fee. FDA will issue invoices for FY 2010 product and sponsor fees by December 31, 2009 and will be due 30 days from the issuance of the invoice. FDA will not accept an application for filing unless the sponsor has paid all the fees it owes.

The notice also provides procedures animal drug sponsors should use to pay the FY 2010 fees. The application fee rates are effective for applications received by FDA’s Center for Veterinary Medicine from October 1, 2009, until September 30, 2010.

For more information, contact Bryan Walsh, Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 7529 Standish Place, Rockville, MD 20855, 240-276-9730. Please send general questions to the Center for Veterinary Medicine at cvmagdufa@fda.hhs.gov.



Contact FDA

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

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855