Generic Drug User Fee Cover Sheet - Form FDA 3794

Generic Drug User Fee Cover Sheet - Form FDA 3794

OMB: 0910-0727

IC ID: 204809

Information Collection (IC) Details

View Information Collection (IC)

Generic Drug User Fee Cover Sheet - Form FDA 3794 CDER
 
No Unchanged
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3794 Generic Drug User Fee Cover Sheet GDUFA FORM FDA 3794 10-16-2015.pdf Yes Yes Fillable Fileable

Health Health Care Services

 

460 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 3,542 0 0 0 0 3,542
Annual IC Time Burden (Hours) 1,771 0 0 0 0 1,771
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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