FDA Announces Animal Drug User Fee Rates for FY04

February 18, 2004

FDA is announcing the rates for animal drug application fees for fiscal year (FY) 2004 and payment procedures for those fees.

The Federal Food, Drug, and Cosmetic Act, as amended by the Animal Drug User Fee Act of 2003, Public Law 108-130, 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. The rates and payment procedures for product, establishment, and sponsor fees will be announced in a future Federal Register document.

The application fee rates are $61,000 for an animal drug application and $30,500 for a supplemental animal drug application for which safety or effectiveness data are required. These rates are effective for applications submitted on or after September 1, 2003, and will remain in effect through September 30, 2004. FDA may begin to collect the fees now si nc e the President signed Public Law 108-199, appropriating FY 2004 animal drug user fee revenues, on January 23, 2004. FDA will issue invoices for all fees payable for applications submitted between September 1, 2003, and March 31, 2004. Those invoices will be due and payable within 30 days of issuance. Subsequently, fees for animal drug applications and supplemental animal drug applications received on or after April 1, 2004, must be paid at the time the applications are submitted. Applications will not be accepted for review until full payment of all fees owed is received.

Payment instructions and answers to anticipated questions are included in the February 18, 2004, Federal Register. Further information is available on the FDA Home Page or from Mr. Robert Miller, Center for Veterinary Medicine, (HFV-10), Food and Drug Administration, 7529 Standish Place, Rockville, MD 20855, 301-827-5436. For general questions, you may also e-mail the Center for Veterinary Medicine at: cvmadufa@fda.gov.