Information Collection

New animal drug sponsors w/active applications; electronic submissions

IC 192141 under ICR 201605-0910-004 · OMB 0910-0659.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

IC Title:

New animal drug sponsors w/active applications; electronic submissions

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

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

Information Collection Instruments:

table that charts list of 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: 100 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	75	-5	80
Annual IC Time Burden (Hours)	3,900	-100	4,000
Annual IC Cost Burden (Dollars)	181,350	181,350	0

Documents for IC

table that charts IC Documents
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.