FDA Announces FY 2011 Animal Generic Drug User Fees

The Food and Drug Administration is publishing a notice in the Federal Register on August 3, 2010, announcing the rates and payment procedures for generic animal drug user fees for fiscal year (FY) 2011. The Animal Generic Drug User Fee Act of 2008 (AGDUFA) authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for a generic new animal drug and/or investigational submissions for a generic new animal drug.

For FY 2011, the fee is $92,600 per application for an abbreviated generic new animal drug application, which requires safety or effectiveness data. The annual product fee is $5,440. The annual sponsor fee is $55,950 for each generic new animal drug sponsor paying 100 percent of the sponsor fee, $41,963 for each generic new animal drug sponsor paying 75 percent of the sponsor fee, and $27,975 for a generic new animal drug sponsor paying 50 percent of the sponsor fee. FDA will issue invoices for FY 2011 product and sponsor fees by December 31, 2010, and the fees 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 instructions for paying the FY 2011 fees. The application fee rates are effective for applications received by FDA’s Center for Veterinary Medicine from October 1, 2010 to September 30, 2011.

For more information, contact Bryan Walsh at 1.240-276-9730. For general AGDUFA questions contact cvmagdufa@fda.gov.