OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

Generic Drug User Fees

IC 204809 under ICR 202411-0910-010 · OMB 0910-0727.

Documents and Forms
Document Name
Document Type
Other-E-form Screenshot
Other-Agency Guidance
Instruction
Other-GDUFA Performance Goals
Form
Information Collection (IC) Details

View Information Collection (IC)

Generic Drug User Fees CDER
 
No Unchanged
 
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
Other-GDUFA Performance Goals GDUFA Performance Goals and Program Enhancements 2023-2027.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

500 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Requested 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

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.