FD&C ACT/ Section 512(n)(1) - Phased Review Submission with Administrative ANADA

Abbreviated New Animal Drug Applications

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0669 can be found here:

Documents and Forms

Document Name Document Type
Form FDA 356v FD&C ACT/ Section 512(n)(1) - Phased Review Submission with Administrative ANADA Form and Instruction
FDA 356v Application for Approval of a New Animal Drug FDA Form 356v.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	FD&C ACT/ Section 512(n)(1) - Phased Review Submission with Administrative ANADA	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 356v	Application for Approval of a New Animal Drug	FDA Form 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: 3	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 14 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	15	-10	25
Annual IC Time Burden (Hours)	477	-318	795
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.