G/TBT/N/USA/1870  
24 May 2022  
(22-3966) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED STATES OF AMERICA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Food and Drug Administration (FDA), Health and Human Services (HHS) [1900]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the no tification shall be indicated if different from above:   
Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Quality 
(ICS code(s): 03.120); Anaesthetic, respiratory and reanimation (medical) equipment 
(ICS code(s): 11.040.10)  
5. Title, number of pages and language(s) of the notified document:  Current Good 
Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling 
Requirements for Certain Medical Gases; (55 page(s), in  English)  
6. Description of content:  Proposed rule - 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 t he 
regulatory obligations of entities that manufacture, process, pack, label, or distribute 
certain medical gases, as well as reduce regulatory burden in this area. This proposed 
rule is intended to establish requirements that are more specifically tailore d to the medical 
gas industry.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Protection of human health or safety; 
Quality requirements; Cost saving and productivity enhancement  
8. Relevant documents:   
87 Federal Register (FR) 31302, 23 May 2022; Title 21 Code of Federal Regulations (CFR) 
Parts 4, 16, 201, 210, 211, 213, 230, 314, and 514:  
https: //www.govinfo.gov/content/pkg/FR -2022-05-23/html/2022 -10458.htm  
https://www.govinfo.gov/content/pkg/FR -2022-05-23/pdf/2022 -10458.pdf  G/TBT/N/USA/1870  
 
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  This proposed rule is identified by Do cket Number FDA -2021-N-1333. The Docket Folder 
is available from Regulations.gov at https://www.regulations.gov/docket/FDA -2021-N-
1333/document  and provides access to primary and s upporting documents as well as 
comments received. Documents are also accessible from Regulations.gov  by searching 
the Docket Number. WTO Members and their stakeholders are asked to submit comments 
to the USA TBT Enquiry Point  by or before 4pm Eastern Time  on 22 August 2022. 
Comments received by the USA TBT Enquiry Point from WTO Members and their 
stakeholders will be shared with the regulator and will also be submitted to the Docket 
on Regulations.gov if received within the comment period.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  22 August 2022  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2022/TBT/USA/22_3653_00_e.pdf