Reporting Associated with New Animal Drug Applications

Reporting Associated with New Animal Drug Applications and Veterinary Master Files

OMB: 0910-0032

IC ID: 5688

Information Collection (IC) Details

View Information Collection (IC)

Reporting Associated with New Animal Drug Applications CVM
No Modified
21 CFR 558.5 21 CFR 514

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

Health Consumer Health and Safety


187 0
Private Sector Businesses or other for-profits
   90 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 7,628 0 0 6,620 0 1,008
Annual IC Time Burden (Hours) 38,849 0 0 16,766 0 22,083
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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.

© 2024 | Privacy Policy