Annual Reports for Sponsors with Active Applications (e-form FDA 3744a)

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⚠️ Notice: This information collection may be referencing outdated material.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 Annual Reports for Sponsors with Active Applications (e-form FDA 3744a) Form and Instruction
FDA 3744 Electronic Form FDA 3744 Antimicrobial Animal Drug Distr 0910-0659 FDA 3744a ADUFA eForm Screenshots Dec 2012.doc Form and Instruction

Information Collection (IC) Details

IC Title:	Annual Reports for Sponsors with Active Applications (e-form FDA 3744a)	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	Electronic Form FDA 3744 Antimicrobial Animal Drug Distribution Report for ADUFA Section 105	0910-0659 FDA 3744a ADUFA eForm Screenshots Dec 2012.doc		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 12	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	80	-1	-11	92
Annual IC Time Burden (Hours)	4,000	1	3,907	92
Annual IC Cost Burden (Dollars)	0	0	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.