Generic Drug User Fees

Generic Drug User Fee Program

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0727 can be found here:

Documents and Forms

Document Name Document Type
GDUFA Cover Sheet.pdf Other-E-form Screenshot
GDUFA Cover Sheet.pdf Other-E-form Screenshot
GFI GDUFA II.pdf Other-Agency Guidance
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
Form FDA 3794 GDUFA Cover Sheet Instructions.pdf userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp?legalsel=2&ref= Instruction
FDA 3794 GDUFA Cover Sheet (e-form screenshot) Form FDA 3794 GDUFA Cover Sheet Screenshot.pdf Form
FDA 3794 GDUFA Cover Sheet (e-form screenshot) Form FDA 3794 GDUFA Cover Sheet Screenshot.pdf Form

Information Collection (IC) Details

IC Title:	Generic Drug User Fees	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection 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

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 %

	Approved	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

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.