August 1, 2012
The Food and Drug Administration (FDA) announced rates for fiscal year FY 2013 Animal Generic Drug User Fee Act of 2008 (AGDUFA) in a notice published in the August 1, 2012, 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 generic new animal drugs, generic new animal drug products, and from certain sponsors of these abbreviated applications for generic new animal drugs.
For FY 2013, the fee is $148,300 per application for an abbreviated generic new animal drug application for which safety or effectiveness data are required. The annual product fee is $6,515, the annual sponsor fee is $63,000 for each generic new animal drug sponsor paying 100 percent of the sponsor fee; $47,250 for each generic new animal drug sponsor paying 75 percent of the sponsor fee; and $31,500 for a generic new animal drug sponsor paying 50 percent of the sponsor fee. FDA will issue invoices for FY 2013 product and sponsor fees by December 31, 2012 and the fees will be due 30 days from the date of the invoice. FDA will not accept an application for filing unless the sponsor has paid all the fees required.
The notice also provides procedures for animal drug sponsors to pay the FY 2013 fees. The application fee rates are effective for applications received by FDA’s Center for Veterinary Medicine (CVM) from October 1, 2012, until September 30, 2013.
For more information, please contact Lisa Kable, CVM (HFV-10), FDA, 7529 Standish Place, Rockville, MD 20855, 240-276-9718. General inquiries can be sent to firstname.lastname@example.org.