Request Waivers or Reductions in User Fees - Sections 735 and 736 of the FD&C Act

Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products

OMB: 0910-0693

IC ID: 198750

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Document Type
Other-Guidance
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Request Waivers or Reductions in User Fees - Sections 735 and 736 of the FD&C Act
 
No Modified
 
Voluntary
 
21 CFR 379g and 379h FD&C Act  (To search for a specific CFR, visit the Code of Federal Regulations.)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance GUIDANCE 0693 7-17-14.pdf Yes Yes Printable Only

Health Consumer Health and Safety

 

100 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 120 0 0 30 0 90
Annual IC Time Burden (Hours) 1,920 0 0 480 0 1,440
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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