New animal drug sponsors w/active applications; paper submissions

Antimicrobial Animal Drug Distribution Reports and Recordkeeping

⚠️ Notice: This information collection may be referencing outdated material.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
DRAFT FDA 3744 Revision (ver 1.7) Instructions.pdf Instruction
FDA 3744 Antimicrobial Animal Drug Sales and Distribution Report DRAFT FDA 3744 Revision (ver 1.7) Form.pdf Form

Information Collection (IC) Details

IC Title:	New animal drug sponsors w/active applications; paper submissions	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 514.87(a) through (e)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction			DRAFT FDA 3744 Revision (ver 1.7) Instructions.pdf		Yes	Yes	Fillable Fileable
Form	FDA 3744	Antimicrobial Animal Drug Sales and Distribution Report	DRAFT FDA 3744 Revision (ver 1.7) Form.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: 10	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	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	75	-8	83
Annual IC Time Burden (Hours)	4,650	-330	4,980
Annual IC Cost Burden (Dollars)	216,225	209,250	6,975

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.