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

ICR 202406-0910-006

OMB: 0910-0906

Federal Form Document

ICR Details
0910-0906 202406-0910-006
Received in OIRA 202205-0910-004
HHS/FDA CDER
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases - FINAL RULE
New collection (Request for a new OMB Control Number)   No
Regular 07/03/2024
  Requested Previously Approved
36 Months From Approved
1,121,083 0
478,135 0
0 0

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.

US Code: 21 USC 352 Name of Law: Misbranded drugs and devices
  
PL: Pub.L. 115 - 31 756 Name of Law: Consolidated Appropriates Act of 2017; Medical Gas Regulations

0910-AH96 Final or interim final rulemaking 89 FR 51738 06/18/2024

No

  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
No
No
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.

$20,522
No
    No
    Yes
No
No
No
No
Domini Bean 301 796-5733 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
07/03/2024


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