Information Collection

FD&C Act/ Section 512(n)(1) - Submission of a " Complete" ANADA by an Applicant

IC 192778 under ICR 201309-0910-007 · OMB 0910-0669.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 356v FD&C Act/ Section 512(n)(1) - Submission of a " Complete" ANADA by an Applicant	Form and Instruction
FDA 356v Application for Approval of a New Animal Drug FDA Form 356v.pdf	Form and Instruction

IC Title:

FD&C Act/ Section 512(n)(1) - Submission of a " Complete" ANADA by an Applicant

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

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	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: 18

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 14 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	18	1	17
Annual IC Time Burden (Hours)	2,862	159	2,703
Annual IC Cost Burden (Dollars)	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.