Current Good Manufacturing
Practice, Certification, Postmarketing Safety Reporting, and
Labeling Requirements for Certain Medical Gases
New
collection (Request for a new OMB Control Number)
No
Regular
05/23/2022
Requested
Previously Approved
36 Months From Approved
1,114,282
0
431,149
0
0
0
The Food and Drug Administration (FDA,
the Agency, or we) is proposing new regulations that would amend
the requirements concerning current good manufacturing practice
(CGMP) and postmarketing safety reporting that apply to certain
medical gases. FDA further proposes to establish regulations
regarding certification of designated medical gases and amend the
labeling regulations that apply to certain medical gases. This
action, if finalized, will clarify the regulatory obligations of
entities that manufacture, process, pack, label, or distribute
certain medical gases, as well as reduce regulatory burden in this
area.
US Code:
21
USC 352 Name of Law: Misbranded drugs and devices
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.