Revised Guidance on Waivers and Reductions of Fees for Animal Drug Applications is Issued

The Center for Veterinary Medicine has released a revised draft Guidance titled Animal Drug User Fees and Waivers and Reductions, which “describes the types of fees FDA is authorized to collect under ADUFA and how to request waivers and reductions for such fees. It clarifies the criteria for Barrier to Innovation waivers, clarifies the procedures for Small Business waivers, and makes additional clarifying changes.”  The revised Guidance can be found here.

The Guidance document discusses all of the types of fees under ADUFA, transfers of ownership or assignment of new applicants, as well as the impact on fees already paid.  Like the other “UFAs”, your application will not be filed even if requesting a waiver or reduction unless the waiver or reduction has been approved prior to submission of the application.  If the waiver or reduction are approved post-submission, the fee will be returned.

The document also outlines the types of fee waivers and reductions that may be requested and further describes the provisions pertaining to each type of request to include:

  • Significant barrier to innovation
  • Fees exceeding costs
  • Free choice feeds
  • Minor use or minor species
  • Small business

There is also a useful discussion of how and when to submit waiver and reduction requests. If you qualify for a reduction or waiver, we understand that it is really considered to be the “cat’s meow”.