OTC Hearing Aids Final Rule - One Time Burden

Medical Device Labeling Requirements

OMB: 0910-0485

IC ID: 255348

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OTC Hearing Aids Final Rule - One Time Burden
 
No Unchanged
 
Mandatory
 
21 CFR 800; 801; 808; 874  (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

Health Consumer Health and Safety

 

105 100
   
Private Sector Businesses or other for-profits
 
   95 %

  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 945 0 0 0 0 945
Annual IC Time Burden (Hours) 87,570 0 0 0 0 87,570
Annual IC Cost Burden (Dollars) 10,100,000 0 0 0 0 10,100,000

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