FDA Announces FY 2012 Animal Generic Drug User Fee Rates

August 3, 2011

The Food and Drug Administration announced rates for fiscal year (FY) 2012 Animal Generic Drug User Fee Act of 2008 (AGDUFA) in a notice published in the August 1, 2011, 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 2012, the fee is $124,900 per application for an abbreviated generic new animal drug application for which safety or effectiveness data are required. The annual product fee is $6,200, the annual sponsor fee is $54,350 for each generic new animal drug sponsor paying 100 percent of the sponsor fee; $40,763 for each generic new animal drug sponsor paying 75 percent of the sponsor fee; and $27,175 for a generic new animal drug sponsor paying 50 percent of the sponsor fee. FDA will issue invoices for FY 2012 product and sponsor fees by December 31, 2011 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 2012 fees. The application fee rates are effective for applications received by FDA’s Center for Veterinary Medicine from October 1, 2011, until September 30, 2012.

For more information, contact Lisa Kable, Center for Veterinary Medicine (HFV-10), FDA, 7529 Standish Place, Rockville, MD 20855, 240-276-9718. Please send general questions to the Center for Veterinary Medicine at cvmagdufa@fda.hhs.gov.