New Animal Drug Application, 21 CFR Part 514

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0032 can be found here:

Documents and Forms

Document Name Document Type
Form 356 V New Animal Drug Application, 21 CFR Part 514 Form and Instruction
356 V Application for Approval of A New Animal Drug 0910-0032 FDA Form 356V.pdf Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	New Animal Drug Application, 21 CFR Part 514	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 514.1(b) (8) 21 CFR 514.8 ( c ) (1) 21 CFR 514,4 21 CFR 514.5 (b)(d)&(f) 21 CFR 514.8(b) 21 CFR 514.8 ( c ) (2) & (3) 21 CFR 514.11 21 CFR 514.5(i) (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	356 V	Application for Approval of A New Animal Drug	0910-0032 FDA Form 356V.pdf		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 134	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 New Statute	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	1,412	0	6	1,406
Annual IC Time Burden (Hours)	30,421	-310,437	0	340,858
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.