UPDATED July 24, 2017
The FDA has issued the final revised version of Guidance for Industry (GFI) #170: Animal Drug User Fees and Fee Waivers and Reductions.
November 1, 2016
The U.S. Food and Drug Administration (FDA) has issued a draft revision of Guidance for Industry (GFI) #170: Animal Drug User Fees and Fee Waivers and Reductions. This guidance describes the fees the agency is authorized to collect under the Animal Drug User Fee Act of 2003 (ADUFA), as amended, the information the FDA recommends sponsors submit in support of a request for a fee waiver or reduction, how to submit such a request, and the FDA’s process for reviewing these requests. This draft revision of the guidance clarifies the criteria for Barrier to Innovation waivers, clarifies the procedures for Small Business waivers, and makes additional clarifying changes.
ADUFA was originally signed into law in 2003, and reauthorized in 2008 and 2013. It authorizes the FDA to assess and collect user fees for certain animal drug applications and supplements, products, establishments, and sponsors of animal drug applications and/or investigational animal drug submissions. It also authorizes the agency to grant a waiver from or a reduction of one or more of those fees under certain circumstances. The collected resources support FDA’s responsibilities to ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals that produce food for consumption. ADUFA III reauthorizes FDA to collect animal drug user fees through fiscal year 2018.
The FDA is accepting public comments on the draft revised guidance beginning on November 2, 2016. Although members of the public may comment on a guidance document at any time, comments should be submitted by January 3, 2017, to ensure that FDA considers the comments before it begins work on the final version of the draft revised guidance.
To submit comments electronically to the docket, visit www.regulations.gov and type FDA-2004-D-0369 in the search box.
To submit comments to the docket by mail, use the address below. Be sure to include docket number FDA-2004-D-0369 on each page of your written comments.
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
- Federal Register Notice of Availability of Final Revised Guidance: Animal Drug User Fees and Fee Waivers and Reductions
- Federal Register Notice of Availability of Draft Revised Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions
- Final Revised Guidance for Industry (#170): Animal Drug User Fees and Fee Waivers and Reductions
- Animal Drug User Fee Act (ADUFA)