OMB control number
Generic Drug User Fee Program
OMB 0910-0727 · HHS/FDA.
This information collection supports FDA's User Fee program with regard to Generic Drugs. Form FDA 3794, the Generic Drug User Fee Cover Sheet, requests the minimum information necessary from applicants to enable us to determine the total amount of generic drug user fees required, and to account for and track user fees. Generic drug application holders and API and/or FDF facility’s owner will fill out the cover sheet to accompany payment. Although applicants and manufacturers may choose among several methods of payments, all applicants must create and/or submit all GDUFA Cover Sheets by using the FDA’s web-based electronic User Fee System.
The latest form for Generic Drug User Fee Program expires 2029-01-31 and can be found here.
Document Name |
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Supporting Statement A |
Justification for No Material/Nonsubstantive Change |
0727 GDUFA Program SSA 2025 EXT (1).docx
Submission of Controlled Correspondence | Revision of a currently approved collection | 2025-06-18 | ||
|
Approved without change |
No material or nonsubstantive change to a currently approved collection | 2023-10-24 | |
|
Approved without change |
Revision of a currently approved collection | 2022-02-23 | |
|
Approved without change |
Extension without change of a currently approved collection | 2019-02-27 | |
|
Approved without change |
No material or nonsubstantive change to a currently approved collection | 2017-08-08 | |
|
Approved without change |
Extension without change of a currently approved collection | 2015-10-21 | |
|
Approved without change |
New collection (Request for a new OMB Control Number) | 2012-11-09 |
Generic Drug User Fees
Federal Enterprise Architecture: Health - Consumer Health and Safety
| Form | userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp?legalsel=2&ref= | Instruction | |
| Form FDA 3794 | GDUFA Cover Sheet (e-form screenshot) | Fillable Fileable | Form |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.