Information Collection

Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728

IC 187089 under ICR 201309-0910-012 · OMB 0910-0632.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0632 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3728 Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728	Form and Instruction
FDA 3728 AGDUFA Cover Sheet agdufa coversheet.pdf	Form and Instruction

IC Title:

Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

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
Form and Instruction	FDA 3728	AGDUFA Cover Sheet	agdufa coversheet.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: 20

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	40	40
Annual IC Time Burden (Hours)	3	3
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.