FDA Announces FY 2009 Animal Drug User Fee Rates

September 15, 2008

The Food and Drug Administration announced rates and payment procedures for fiscal year (FY) 2009 animal drug user fees in a notice published in the September 15, 2008, Federal Register. The Animal Drug User Fee Amendments of 2008 (ADUFA II) reauthorizes FDA to collect user fees for certain animal drug applications, products, establishments, sponsors and investigational animal drug submissions.

For FY 2009, the fee is $246,300 per application for an animal drug application and $123,150 for a supplemental animal drug application which requires safety or effectiveness data. The annual product fee is $4,925, the annual establishment fee is $59,450, and the annual sponsor fee is $52,700. FDA will issue invoices for FY 2009 product, establishment, and sponsor fees by December 31, 2008, and these invoices will be due and payable on or before January 31, 2009. 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 2009 fees. The application fee rates are effective for applications received by FDA’s Center for Veterinary Medicine from October 1, 2008, until September 30, 2009.

In addition, Guidance for industry # 170, Animal Drug User Fees and Fee Waivers and Reductions, has been updated, to reflect minor changes, as a result of the reauthorization of ADUFA, Animal Drug User Fee Amendments of 2008.

For more information, contact Roxanne Schweitzer, Center for Veterinary Medicine (HFV-10), FDA, 7529 Standish Place, Rockville, MD 20855, 240-276-9705. Please send general questions to the Center for Veterinary Medicine at cvmadufa@fda.hhs.gov.