Reporting Associated with New Animal Drug Applications

Reporting Associated with New Animal Drug Applications and Veterinary Master Files

Documents and Forms

Document Name Document Type
Form 356V Reporting Associated with New Animal Drug Applications Form and Instruction
CVM-GFI--152-Evaluating-the-Safety-of-Antimicrobial-New-Animal-Drugs-with-Regard-to-Their-Microbiological-Effects-on-Bacteria-of Other-Agency Guidance
CVM-GFI--152-Evaluating-the-Safety-of-Antimicrobial-New-Animal-Drugs-with-Regard-to-Their-Microbiological-Effects-on-Bacteria-of Other-Agency Guidance
356V Application for Approval of a New Animal Drug (or Submis 0032 FORM FDA 356V.pdf 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 558.5 21 CFR 514

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
Other-Agency Guidance			CVM-GFI--152-Evaluating-the-Safety-of-Antimicrobial-New-Animal-Drugs-with-Regard-to-Their-Microbiological-Effects-on-Bacteria-of-Human-Health-Concern.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: 187	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 90 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	7,628	6,620	1,008
Annual IC Time Burden (Hours)	38,849	16,766	22,083
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.