OMB control number
Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
OMB 0910-0693 · HHS/FDA.
OMB 0910-0693
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 is listed under ICR 201706-0910-016.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 Appeal Requests |
Information collection |
| Reconsideration Requests |
Information collection |
| Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 201706-0910-016 | Extension without change of a currently approved collection | 2017-08-17 | Approved without change | |
| 201503-0910-011 | No material or nonsubstantive change to a currently approved collection | 2015-03-26 | Approved without change | |
| 201407-0910-012 | Revision of a currently approved collection | 2014-07-25 | Approved with change | |
| 201108-0910-004 | New collection (Request for a new OMB Control Number) | 2011-08-04 | Approved without change |
OMB Details
Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
Federal Enterprise Architecture: Health - Consumer Health and Safety
| Form | Name | Electronic access | Type |
|---|---|---|---|
| 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.