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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Announces Fiscal Year 2006 Animal Drug User Fees

FDA Veterinarian Newsletter May/June 2005 Volume XX, No III

The Food and Drug Administration (FDA) announced rates for animal drug application, product, establishment, and sponsor fees for fiscal year 2006 in a notice published in the Aug.1, 2005, Federal Register.

The Animal Drug User Fee Act of 2003 (ADUFA) authorizes FDA to establish and collect user fees to enhance the performance of the animal drug review process.

ADUFA provides a formula for adjusting fees based on increases in costs due to inflation or changes in workload. The notice explains in detail how FDA calculated the rates and payment procedures.

The law permits FDA in fiscal year 2006 to collect up to $2,707,250 in fees under each of the four categories, for a total of $10,829,000. That figure represents a $2,500,000 base per category that is adjusted to reflect an 8.29 percent increase in inflation over the last two years. FDA also calculated a workload adjuster, but found that it does not alter the fee amount.

For fiscal year 2006, the fee is $151,800 per application for an animal drug application and $75,900 for a supplemental animal drug application for which safety or effectiveness data are required. The annual product fee is $3,905, the annual establishment fee is $49,200, and the annual sponsor fee is $44,400. 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 fiscal year 2006 fees. The application fee rates are effective for applications received by FDA’s Center for Veterinary Medicine (CVM) from Oct. 1, 2005, until Sept. 30, 2006. FDA will issue invoices for all other fiscal year 2006 fees by Dec. 30, 2005. Payments will be due on or before Jan. 31, 2006.

The Federal Register notice is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/05-15158.htm.

For more information, contact -Robert Miller, Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 7519 Standish Place, Rockville, MD, 20855, 240-276-9700. Send general questions to CVM at cvmadufa@fda.gov.