Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 ( 21 U.S.C. 379j-21); Emergency Request

Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 ( 21 U.S.C. 379j - 21) Emergency Request

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Document Name Document Type
Form 3728 Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 ( 21 U.S.C. 379j-21); Emergency Request Form and Instruction
3728 Animal Generic Drug User Fee Cover Sheet Form FDA 3728 AGDUFA Cover Sheet.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 ( 21 U.S.C. 379j-21); Emergency Request	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

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
Form and Instruction	3728	Animal Generic Drug User Fee Cover Sheet	Form FDA 3728 AGDUFA Cover Sheet.pdf		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 69	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	Program Change Due to New Statute
Annual Number of Responses for this IC	69	69
Annual IC Time Burden (Hours)	3	3
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.