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

Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases - FINAL RULE

Documents and Forms

Document Name Document Type
Form FDA 3864 Certification & postmarket reporting for medical gases (Tables 5 and 6 FINAL RULE) Form
FDA 3864 Instructions 06-04-2024 508 (002).pdf Instruction
FDA-5025_instructions_05-24-2024 (002).pdf Instruction
FDA 3864 Request for Certification of Designated Medical Gas FDA-3864 Request for Certification of Designated Medical Gas 06-04-2024.pdf Form
FDA 5025 Annual Report for Designated Medical Gas FDA-5025 Annual Report for Designated Medical Gas Sec_05-24-2024.pdf Form

Information Collection (IC) Details

IC Title:	Certification & postmarket reporting for medical gases (Tables 5 and 6 FINAL RULE)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 230

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,696	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	1,021	1,021
Annual IC Time Burden (Hours)	12,081	12,081
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.