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
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.
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.