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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Announces Authorization to Collect AGDUFA Fees

March 16, 2009

The Food and Drug Administration (FDA) today is announcing the full implementation of the Animal Generic Drug User Fee Act (AGDUFA), which allows FDA to begin collecting fees. The President of the United States signed into law the Consolidated Appropriations Act, 2009, on March 11, 2009. The passage of this bill enables the FDA to collect user fees for those sponsors, abbreviated applications, and products which are subject to AGDUFA fees.

FDA is providing the below information on payment procedures in advance of the Federal Register publication in order to make the information available to potential sponsors as quickly as possible.

Sponsors who submit an abbreviated application on or after March 11, 2009 must create a cover sheet and submit payment via check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration, by wire transfer, or by ACH using pay.gov.

For additional information on AGDUFA, please see http://www.fda.gov/cvm/AGDUFA.htm.


Contact FDA

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

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855