Enacted on November 18, 2003, the Animal Drug User Fee Act of 2003 (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 authorizes 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 Food and Drug Administration (FDA or the Agency) is authorized to collect under ADUFA and how to request waivers and reductions from these fees. This revised guidance describes the types of fees and fee waivers and reductions; 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.

Questions?