FDA Announces FY 2008 Animal Drug User Fee Rates

August 3, 2007

The Food and Drug Administration announced rates and payment procedures for fiscal year (FY) 2008 animal drug user fees in a notice published in the August 2, 2007, Federal Register. The Animal Drug User Fee Act of 2003 (ADUFA) authorizes FDA to collect user fees for certain animal drug applications, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions.

For FY 2008, the fee is $172,500 per application for an animal drug application and $86,250 for a supplemental animal drug application for which safety or effectiveness data are required. The annual product fee is $4,125, the annual establishment fee is $52,700, and the annual sponsor fee is $43,900. FDA will issue invoices for FY 2008 product, establishment, and sponsor fees by December 30, 2007, and these invoices will be due and payable 30 days after they are issued. 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 2008 fees. The application fee rates are effective for applications received by FDA’s Center for Veterinary Medicine from October 1, 2007, until September 30, 2008.

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