Reporting Associated with New Animal Drug Applications

Reporting Associated with New Animal Drug Applications and Veterinary Master Files

⚠️ Notice: This information collection may be referencing outdated material.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 356V Reporting Associated with New Animal Drug Applications Form and Instruction
356V Application for Approval of a New Animal Drug (or Submis 0032 FORM FDA 356V.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Reporting Associated with New Animal Drug Applications	Agency IC Tracking Number:	CVM

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 514.5 21 CFR 514.8 21 CFR 514.11 21 CFR 514.1 21 CFR 514.6 21 CFR 558.5

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	356V	Application for Approval of a New Animal Drug (or Submission to Support New Animal Drug Approval)	0032 FORM FDA 356V.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: 182	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 75 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,008	0	1,008
Annual IC Time Burden (Hours)	22,083	124	21,959
Annual IC Cost Burden (Dollars)	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.