New animal drug sponsors w/inactive applications; electronic 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⚠️ Notice: This information collection may be referencing outdated material.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
Form FDA 3744 New animal drug sponsors w/inactive applications; electronic submissions Form and Instruction
FDA 3744 Antimicrobial Animal Drug Distribution Report FDA-3744_02-23-16_not-secure.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	New animal drug sponsors w/inactive applications; electronic submissions	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 514

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	FDA-3744_02-23-16_not-secure.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: 3	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	105	0	105
Annual IC Time Burden (Hours)	210	0	210
Annual IC Cost Burden (Dollars)	12,587	2,822	9,765

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.