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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

FDA Veterinarian Newsletter July/August 2004 Volume XIX, No IV

The Food and Drug Administration (FDA) published a notice in the August 2 Federal Register announcing rates for animal drug application, product, establishment and sponsor fees for Fiscal Year (FY) 2005, as authorized under the Animal Drug User Fee Act of 2003 (ADUFA).

The Act authorizes FDA to establish and collect user fees that are used 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 provides details about the formulas FDA used to calculate the rates. It also explains 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 for each 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 CVM 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.