Issue Date: March 9, 2007
Issued by: Center for Veterinary Medicine
Topic(s): User Fees,
Status: Final
CVM GFI #183 Animal Drug User Fees: Fees Exceed Costs Waiver/Reduction
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.
Download the Guidance Document
