Request for Drug Facts Exemption or Deferral

SPF Labeling and Testing Requirements for OTC Sunscreen Products

OMB: 0910-0717

IC ID: 202346

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Request for Drug Facts Exemption or Deferral CDER
 
No Modified
 
Mandatory
 
21 CFR 201.66(e)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety

 

1 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 24 0 0 -36 0 60
Annual IC Time Burden (Hours) 3 0 0 -27 0 30
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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