Information Collection

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

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

Documents and Forms

Documents and forms in this information collection
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

IC Title:

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.