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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Announces FY 2008 Animal Drug User Fee Rates

FDA Veterinarian Newsletter 2007 Volume XXII, No III

The Food and Drug Administration has announced the animal drug user fee rates for Fiscal Year 2008.

The fees are authorized under the Federal Food, Drug, and Cosmetic Act, as amended by the Animal Drug User Fee Act of 2003. The funds collected support the new animal drug review activity of FDA’s Center for Veterinary Medicine.

The FY 2008 fees are:

  • Animal drug application – $172,500
  • Supplemental animal drug application, for which safety or effectiveness data are required – $86,250
  • Annual product fee – $4,125
  • Annual establishment fee – $52,700
  • Annual sponsor fee – $43,900

The application fees apply to applications submitted to FDA on or after October 1, 2007, to September 30, 2008.

FDA will issue FY 2008 invoices for product, establishment, and sponsor fees by December 30, 2007. The invoices will be due and payable by January 31, 2008. FDA will not accept any animal drug applications for review until the sponsor has paid all the fees it owes.