The information collection supports agency guidance. The guidance provides recommendations for applicants planning to request waivers or reductions in user fees under the Prescription Drug User Fee Act, and describes the types of waivers and reductions permitted under the user fee provisions of the FD&C Act and the procedures for submitting requests for waivers or reductions.
The latest form for Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products expires 2020-10-31 and can be found here.
Approved without change |
Extension without change of a currently approved collection | 2017-08-17 | |
Approved without change |
No material or nonsubstantive change to a currently approved collection | 2015-03-26 | |
Approved with change |
Revision of a currently approved collection | 2014-07-25 | |
Approved without change |
New collection (Request for a new OMB Control Number) | 2011-08-04 |
Federal Enterprise Architecture: Health - Consumer Health and Safety
Form Form FDA 3971 | SMALL BUSINESS WAIVER AND REFUND REQUEST | Fillable Fileable | Form and instruction |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.