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

Forms and Documents

Document Name	Status
Form FDA 3864 Certification & postmarket reporting for medical gases (Tables 5 and 6 FINAL RULE) Form	Modified
RIN AH96 Designated Medical Gases SSA June 2024.docx Supporting Statement A	2024-07-03
FRIAMedGases-CLEAN (002).docx Supplementary Document	2024-07-02

IC Document Collections

IC ID	Document Title	Status
253768	Certification & postmarket reporting for medical gases (Tables 5 and 6 FINAL RULE) Form	Modified
253767	Current Good Manufacturing Practice for Medical Gases (Tables 3 and 4 from FINAL RULE)	Modified
253766	Labeling of medical gas containers (Table 2 from FINAL RULE)	Modified

ICR Details

OMB Control No: 0910-0906	ICR Reference No: 202406-0910-006
Status: Received in OIRA	Previous ICR Reference No: 202205-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases - FINAL RULE
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/03/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	1,121,083	0
Time Burden (Hours)	478,135	0
Cost Burden (Dollars)	0	0

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Abstract: The Food and Drug Administration (FDA, the Agency, or we) is establishing new regulations that amend current good manufacturing practice (CGMP) requirements, postmarketing safety reporting, and product labeling, that apply to certain medical gases. Conforming changes are also being made in associated regulations that apply to medical gases. The regulations are intended to promote greater efficiency in the regulation of medical gases while helping to ensure that they adhere to all applicable safety and quality standards.

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Authorizing Statute(s): US Code: 21 USC 352 Name of Law: Misbranded drugs and devices
  

Citations for New Statutory Requirements: PL: Pub.L. 115 - 31 756 Name of Law: Consolidated Appropriates Act of 2017; Medical Gas Regulations

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH96	Final or interim final rulemaking	89 FR 51738	06/18/2024

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Certification & postmarket reporting for medical gases (Tables 5 and 6 FINAL RULE)	FDA 3864, FDA 5025	Request for Certification of Designated Medical Gas ,   Annual Report for Designated Medical Gas
Current Good Manufacturing Practice for Medical Gases (Tables 3 and 4 from FINAL RULE)
Labeling of medical gas containers (Table 2 from FINAL RULE)

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	1,121,083	0	0	0	1,121,083	0
Annual Time Burden (Hours)	478,135	0	0	0	478,135	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection request. The rulemaking introduces new information collections totaling 1,121,083 responses and 478,135 hours annually, a slightly upward adjustment from estimates in our proposed rule. We expect most of the burden to remain in OMB control no. 0910-0906, established to support this rulemaking and regulatory requirements in 21 CFR new parts 213 and 230; while we expect recurring burden attributable to the labeling of medical gases to be included in OMB control no. 0910-0572. The rule provides for an 18-month compliance period.

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Annual Cost to Federal Government: $20,522

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/03/2024

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