Submission of Annual Reports for Sponsors with Active Applications (paper submission form FDA 3744)

Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 2008)

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0659 can be found here:

Documents and Forms

Document Name Document Type
Form FDA 3744 Submission of Annual Reports for Sponsors with Active Applications (paper submission form FDA 3744) Form and Instruction
FDA 3744 ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION REPORT 0659 form FDA 3744 12-12-12.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Submission of Annual Reports for Sponsors with Active Applications (paper submission form FDA 3744)	Agency IC Tracking Number:

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 3744	ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION REPORT	0659 form FDA 3744 12-12-12.pdf		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 14	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	83	-111	194
Annual IC Time Burden (Hours)	4,980	-10,540	15,520
Annual IC Cost Burden (Dollars)	6,975	-100,905	107,880

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.