September 15, 2008
FDA Announces FY 2009 Animal Generic Drug User Fee Rates
The Food and Drug Administration announced rates for fiscal year (FY) 2009 Animal Generic Drug User Fee Act of 2008 (AGDUFA) in a notice published in the September 15, 2008, Federal Register, http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-21453.htm. This Act amends the Food, Drug and Cosmetic Act by authorizing the first ever generic animal drug user fee program. AGDUFA authorizes FDA to collect user fees for certain abbreviated applications for a generic new animal drug, generic new animal drug products, and certain sponsors of such abbreviated applications for generic new animal drugs and investigational submissions for generic new animal drugs.
For FY 2009, the fee is $41,400 per application for an abbreviated generic new animal drug application for which safety or effectiveness data are required. The annual product fee is $3,005, the annual sponsor fee is $56,350 for each generic new animal drug sponsor paying 100 percent of the sponsor fee; $42,265 for each generic new animal drug sponsor paying 75 percent of the sponsor fee; and $28,175 for a generic new animal drug sponsor paying 50 percent of the sponsor fee.
The Food and Drug Administration is unable to collect user fees because Congress has not yet made appropriations for the Animal Generic User Fee program. FDA states in the Federal Register notice of September 15, 2008 that there will be a subsequent notice once appropriations have been granted and that this notice will provide payment instructions and payment procedures.
For more information, contact Bryan Walsh, Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 7529 Standish Place, Rockville, MD 20855, 240-276-9730. Please send general questions to the Center for Veterinary Medicine at cvmagdufa@fda.hhs.gov.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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