New animal drug sponsors w/active applications; paper submissions

Antimicrobial Animal Drug Distribution Reports and Recordkeeping

OMB: 0910-0659

IC ID: 192140

Information Collection (IC) Details

View Information Collection (IC)

New animal drug sponsors w/active applications; paper submissions
 
No Modified
 
Mandatory
 
21 CFR 514.87(a) through (e)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Instruction DRAFT FDA 3744 Revision (ver 1.7) Instructions.pdf Yes Yes Fillable Fileable
Form FDA 3744 Antimicrobial Animal Drug Sales and Distribution Report DRAFT FDA 3744 Revision (ver 1.7) Form.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

10 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 75 0 -8 0 0 83
Annual IC Time Burden (Hours) 4,650 0 -330 0 0 4,980
Annual IC Cost Burden (Dollars) 216,225 0 209,250 0 0 6,975

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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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