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

ICR 202205-0910-004

OMB: 0910-0906

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2022-05-23
Supporting Statement A
2022-05-23
ICR Details
202205-0910-004
Received in OIRA
HHS/FDA CDER
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
  
None

0910-AH96 Proposed rulemaking 87 FR 31302 05/23/2022

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 1,114,282 0 0 0 1,114,282 0
Annual Time Burden (Hours) 431,149 0 0 0 431,149 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new information collection.

$18,910
No
    No
    Yes
No
No
No
No
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
05/23/2022


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