Information Collection

Generic Drug User Fees

IC 204809 under ICR 202411-0910-010 · OMB 0910-0727.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
GDUFA Cover Sheet.pdf	Other-E-form Screenshot
GFI GDUFA II.pdf	Other-Agency Guidance
Form FDA 3794 GDUFA Cover Sheet Instructions.pdf userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp?legalsel=2&ref=	Instruction
GDUFA Performance Goals and Program Enhancements 2023-2027.pdf	Other-GDUFA Performance Goals
FDA 3794 GDUFA Cover Sheet (e-form screenshot) Form FDA 3794 GDUFA Cover Sheet Screenshot.pdf	Form

IC Title:

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-E-form Screenshot			GDUFA Cover Sheet.pdf		Yes	Yes	Fillable Fileable
Other-Agency Guidance			GFI GDUFA II.pdf		Yes	Yes	Fillable Fileable
Form	FDA 3794	GDUFA Cover Sheet (e-form screenshot)	Form FDA 3794 GDUFA Cover Sheet Screenshot.pdf		Yes	Yes	Fillable Fileable
Instruction			Form FDA 3794 GDUFA Cover Sheet Instructions.pdf	https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp?legalsel=2&ref=	Yes	Yes	Fillable Fileable
Other-GDUFA Performance Goals			GDUFA Performance Goals and Program Enhancements 2023-2027.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 500

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Previously Approved
Annual Number of Responses for this IC	3,808	3,808
Annual IC Time Burden (Hours)	1,904	1,904
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.