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

Abbreviated New Animal Drug Applications

OMB: 0910-0669

IC ID: 192779

Information Collection (IC) Details

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FD&C ACT/ Section 512(n)(1) - Phased Review Submission with Administrative ANADA
 
No Modified
 
Mandatory
 

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

Health Consumer Health and Safety

 

3 0
   
Private Sector Businesses or other for-profits
 
   14 %

  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 15 0 0 -10 0 25
Annual IC Time Burden (Hours) 477 0 0 -318 0 795
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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