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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Announces FY 2005 Animal Drug User Fee Rates

August 2, 2004

The Food and Drug Administration announced rates for animal drug application, product, establishment, and sponsor fees for Fiscal Year (FY) 2005 in a notice published in the August 2 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 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 FY 2005 to collect up to $2,088,400 in fees under each of the four categories, for a total of $8,353,600. That figure represents a $2,000,000 base per category that is adjusted to reflect a 4.42 percent increase in inflation. FDA also calculated a workload adjuster, but found that it does not alter the fee amount.

For FY 2005, the fee is $119,300 per application for an animal drug application and $59,650 for a supplemental animal drug application for which safety or effectiveness data are required. The annual product fee is $3,085, the annual establishment fee is $42,600, and the annual sponsor fee is $32,150. 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 FY 2005 fees. The application fee rates are effective for applications received by FDA’s Center for Veterinary Medicine from October 1, 2004, until September 30, 2005. FDA will issue invoices for all other FY 2005 fees by December 30, 2004. Payments will be due January 31, 2005.

For more information, contact Robert Miller, Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 301-827-5436. Send general questions to the Center for Veterinary Medicine at cvmadufa@fda.gov.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855