Small business waiver requests

Prescription Drug User Fee Program

OMB: 0910-0297

IC ID: 242948

Information Collection (IC) Details

View Information Collection (IC)

Small business waiver requests
 
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-Agency Guidance GFI User-Fee-Waivers--Reductions--and-Refunds-for-Drug-and-Biological-Products.pdf Yes Yes Fillable Fileable
Form and Instruction FDA 3971 Small Business Waiver and Refund Request Form FDA 3971 Small Business Waiver and Refund Request.pdf Yes Yes Fillable Fileable
Other-Statutory Authority 21 USC 379h.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

37 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 37 0 0 -146 0 183
Annual IC Time Burden (Hours) 74 0 0 -2,556 0 2,630
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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