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Guidance on Animal Drug User Fees

03/09/2007

Federal Register Notice: FDA is making available the Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waiver/Reduction, which explains the procedures FDA will use to evaluate waiver requests under the fees exceed costs waiver provision of the Animal Drug User Fee Act of 2003. A company must send a written request to the agency for a waiver/reduction, including under the fees exceed costs waiver provision, no later than 180 days after the fee is due. To download this guidance, click here. To view this notice, click here.

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