Generic Drug User Fees

Generic Drug User Fee Program

OMB: 0910-0727

IC ID: 204809

Information Collection (IC) Details

View Information Collection (IC)

Generic Drug User Fees CDER
 
No Modified
 
Required to Obtain or Retain Benefits
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-E-form Screenshot GDUFA Cover Sheet.pdf Yes Yes Fillable Fileable
Other-Agency Guidance GFI GDUFA II.pdf Yes Yes Fillable Fileable
Form FDA 3794 GDUFA Cover Sheet (e-form screenshot) Form FDA 3794 GDUFA Cover Sheet Screenshot.pdf Yes Yes Fillable Fileable
Instruction Form FDA 3794 GDUFA Cover Sheet Instructions.pdf https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp?legalsel=2&ref= Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

500 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 3,808 0 0 0 0 3,808
Annual IC Time Burden (Hours) 1,904 0 0 0 0 1,904
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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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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