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GUIDANCE DOCUMENT

CVM GFI #183 Animal Drug User Fees: Fees Exceed Costs Waiver/Reduction March 2007

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2006-D-0361
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

Enacted on November 18, 2003, the Animal Drug User Fee Act (ADUFA) (Public Law 108-130) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and requires the FDA to assess and collect user fees for certain applications, products, establishments, and sponsors. It also requires the Agency to grant a waiver from or a reduction of those fees in certain circumstances.

FDA issued Guidance for Industry #170 to provide guidance on the types of fees the Food and Drug Administration (FDA) is authorized to collect under ADUFA and how to request waivers and reductions from these fees. This guidance further explains the procedures FDA uses to evaluate waiver requests under the fees exceed costs waiver provision of ADUFA.

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

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2006-D-0361.

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