Issue Date: February 7, 2005
Issued by: Center for Veterinary Medicine
Topic(s): User Fees,
Status: Final
CVM GFI #173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
The Animal Drug User Fee Act of 2003 (ADUFA), enacted on November 18, 2003, amends the Federal Food, Drug, and Cosmetic Act (the act) by adding Sections 739 and 740 (21 U.S.C. 379j-11, and j-12) which require the Food and Drug Administration (FDA) to assess and collect user fees for certain applications, products, establishments, and sponsors. This guidance represents the FDA’s current thinking on how it intends to implement the animal drug sponsor fee provision of ADUFA.
Download the Guidance Document
