The U.S. Food and Drug Administration (FDA) has issued the final revised version 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.
The section of the Guidance pertaining to aquaculture is Section D: Minor Use and Minor Use Species. This section states that the FDA shall grant a waiver from or a reduction of one or more of the fees where FDA finds that the animal drug application or supplemental animal drug application is intended solely to provide for a minor use or minor species indication.
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.
Read the Guidance