Generic Drug User Fee Cover Sheet - Form FDA 3794

⚠️ Notice: This information collection may be referencing outdated material.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
Form FDA 3794 Generic Drug User Fee Cover Sheet - Form FDA 3794 Form and Instruction
FDA 3794 Generic Drug User Fee Cover Sheet GDUFA FORM FDA 3794 10-16-2015.pdf Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Generic Drug User Fee Cover Sheet - Form FDA 3794	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3794	Generic Drug User Fee Cover Sheet	GDUFA FORM FDA 3794 10-16-2015.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 460	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	3,542	-308	3,850
Annual IC Time Burden (Hours)	1,771	-154	1,925
Annual IC Cost Burden (Dollars)	0	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.