CVM GFI #199 Animal Generic Drug User Fees and Fee Waivers and Reductions December 2023

GUIDANCE DOCUMENT

• Docket Number: FDA-2009-D-0189
• Issued by: Center for Veterinary Medicine

On August 14, 2008, President Bush signed into law the Animal Generic Drug User Fee Act of 2008 (AGDUFA) (Public Law 110-316). This Act amends the Federal Food, Drug, and Cosmetic Act (FFDCA or the act) by authorizing the first ever generic animal drug user fee program. These fees will enhance the performance of the generic new animal drug review process and will enable FDA to better ensure that generic new animal drug products are safe and effective and give consumers a lower cost alternative to pioneer drugs. It also requires the Food and Drug Administration (FDA or the Agency) to grant a waiver from or a reduction of those fees in certain circumstances.

The purpose of this document is to provide guidance on the types of fees the FDA is authorized to collect under AGDUFA and how to request a waiver or a reduction of these fees. This guidance describes the types of fees; FDA’s current thinking on how it intends to implement the generic new animal drug user fee provision of AGDUFA; the type of fee waiver or reduction available; what information FDA recommends you submit in support of a request for a fee waiver or reduction; how to submit such a request; and FDA's process for reviewing requests.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0189.

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