Information Collection

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

IC 192778 under ICR 201004-0910-009 · 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⚠️ Notice: This information collection may be referencing outdated material.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

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

Information Collection (IC) Details

View Information Collection (IC)

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: New

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	356v	Application for Approval of A New Animal Drug ( or Submission to Support New Animal Drug Approval.)	Form FDA 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: 17	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 10 %

	Approved	Program Change Due to New Statute
Annual Number of Responses for this IC	17	17
Annual IC Time Burden (Hours)	2,703	2,703
Annual IC Cost Burden (Dollars)	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.