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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Issues Drug User Fees for FY 2007

FDA Veterinarian Newsletter 2006 Volume XXI, No III

The Center for Veterinary Medicine (CVM) has announced animal drug user fee rates and payment procedures for fiscal year (FY) 2007 under the Animal Drug User Fee Act (ADUFA).

ADUFA authorizes FDA to collect user fees for animal drug applications on animal drug products, establishments where such products are made, and sponsors of such animal drug applications and/or investigational animal drug submissions, covered under the Act.

According to a notice in the August 2, 2006, Federal Register, for FY 2007, the fees are:

  • $168,600 per application for an animal drug application
  • $84,300 for a supplemental animal drug application for which safety or effectiveness data are required
  • $4,115 for the annual product fee
  • $51,350 for the annual establishment fee, and
  • $44,850 for the annual sponsor fee

FDA will issue invoices for FY 2007 product, establishment, and sponsor fees by December 30, 2006, 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 that animal drug sponsors should use to pay the FY 2007 fees. The application fee rates are effective for applications received by FDA’s Center for Veterinary Medicine from October 1, 2006, until September 30, 2007, the dates for FY 2007.

The ADUFA legislation permits FDA to collect a total of approximately $43 million plus inflation over the five-year life of the Act. The additional resources from user fees are used to supplement appropriated resources for animal drug review.

For more information about the user fees for FY 2007, contact Robert Miller, Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-9707. Send general questions to the Center for Veterinary Medicine at cvmadufa@fda.gov.

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