FDA Announces FY 2010 Animal Drug User Fee Rates

August 3, 2009

The Food and Drug Administration announced rates and payment procedures for fiscal year (FY) 2010 animal drug user fees in a notice published in the August 3, 2009, Federal Register. The Animal Drug User Fee Amendments of 2008 (ADUFA II) reauthorizes FDA to collect user fees for certain animal drug applications, supplemental applications, products, establishments, and sponsors.

For FY 2010, the fee is $290,400 per application for an animal drug application and $145,200 for a supplemental animal drug application which requires safety or effectiveness data. In the Federal Register notice publication under the Supplementary Information Section I the application fee rate was inadvertently transposed as $209,400 and should read $290,400. A corrected version of the Federal Register notice will publish in the next few days. The annual product fee is $6,185, the annual establishment fee is $73,850, and the annual sponsor fee is $57,100. FDA will issue invoices for FY 2010 product, establishment, and sponsor fees by December 31, 2009 and will be due 30 days from 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 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 cvmadufa@fda.hhs.gov.