Information Collection

New Animal Drug Application, 21 CFR Part 514

IC 5688 under ICR 200803-0910-001 · OMB 0910-0032.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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:

table that charts list of 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

Federal Enterprise Architecture Business Reference Module

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 %

table that charts list of burden
	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

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.