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⚠️ Notice: This information collection may be referencing outdated material.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
GFI GDUFA II.pdf Other-Agency Guidance

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Generic Drug User Fee Program	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

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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	3,808	266	3,542
Annual IC Time Burden (Hours)	1,904	133	1,771
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.