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Certification & postmarket reporting for medical gases (Tables 5 and 6 FINAL RULE)

IC 253768 under ICR 202406-0910-006 · OMB 0910-0906.

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Certification & postmarket reporting for medical gases (Tables 5 and 6 FINAL RULE)
 
No Modified
 
Mandatory
 
21 CFR 230

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form FDA 3864 Request for Certification of Designated Medical Gas FDA-3864 Request for Certification of Designated Medical Gas 06-04-2024.pdf Yes Yes Fillable Fileable
Instruction FDA 3864 Instructions 06-04-2024 508 (002).pdf Yes Yes Fillable Fileable
Form FDA 5025 Annual Report for Designated Medical Gas FDA-5025 Annual Report for Designated Medical Gas Sec_05-24-2024.pdf Yes Yes Fillable Fileable
Instruction FDA-5025_instructions_05-24-2024 (002).pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

1,696 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 1,021 0 0 1,021 0 0
Annual IC Time Burden (Hours) 12,081 0 0 12,081 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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