Submission of Annual Reports for Sponsors with Active Applications (paper submission form FDA 3744)

Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 2008)

OMB: 0910-0659

IC ID: 192140

Information Collection (IC) Details

View Information Collection (IC)

Submission of Annual Reports for Sponsors with Active Applications (paper submission form FDA 3744)
 
No Modified
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3744 ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION REPORT 0659 form FDA 3744 12-12-12.pdf Yes No Printable Only

Health Consumer Health and Safety

 

14 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 83 0 0 -111 0 194
Annual IC Time Burden (Hours) 4,980 0 0 -10,540 0 15,520
Annual IC Cost Burden (Dollars) 6,975 0 0 -100,905 0 107,880

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