G/TBT/N/USA/1228  
 
28 November 2016  
(16-6510) 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 AME RICA  
If applicable, name of local government involved  (Article 3.2 and 7.2) : 
2. Agency responsible : Food and Drug Admini stration (FDA), Health and Human Services 
(HHS) [1248]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification  shall be indicated if d ifferent from above : 
Please submit comments to : USA WTO TBT Enquiry Point  
Email : usatbtep@nist.gov   
3. Notified under Article 2.9.2 [  ], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other : X 
4. Products covered (HS or CCCN w here applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable) : Medical gas containers 
and closures . Medical equipment (ICS : 11.040), Fluid storage devices (ICS : 23.020)  
5. Title, number of pages  and languag e(s) of the notified document : Medical Gas 
Containers and Closures; Current Good Manufacturing Practice Requirements (13 pages, in 
English)  
6. Description of content : The Food and Drug Administration (FDA or the Agency) is 
amending its current good manufa cturing practice (CGMP) and labeling regulations 
regarding medical gases. FDA is requiring that portable cryog enic medical gas containers 
not manufactured with permanent gas use outlet connections have gas -specific use outlet 
connections that cannot be rea dily removed or replaced except by the manufacturer. FDA 
is also requiring that portable cryog enic medical gas containers and high-pressure medical 
gas cylinders meet certain labeling, naming, and color requirements. These requirements 
are intended to incr ease the likelihood that the contents of medical gas containers are 
accurately identified and reduce the likelihood of the wrong gas being connected to a gas 
supply system or container. FDA is also revising an existing regulation that conditionally 
exempts  certain medical gases from certain otherwise -applicable labelling requirements in 
order to add oxygen and nitrogen to the list of gases subject to the exemption, and to 
remove cyclopropane and ethylene from the list.  
7. Objective and rationale , including  the nature of urgent problems where 
applicable : Prevention of deceptive practices and consumer protection  
8. Relevant documents : 
 81 Federal Register (FR) 81685, 18 November 2016; Title 21 Code of Federal 
Regulations (CFR) Parts 201 and 211  
 Medical Gas Co ntainers and Closures; Current Good Manufacturing Practice 
Requirements , Proposed Rule 10 April 2006: https://www.gpo.gov/fdsys/pkg/FR -
2006-04-10/html/06 -3370.htm ; https://www.gpo.gov/fdsys/pkg/FR -2006-04-
10/pdf/06 -3370.pdf  G/TBT/N/USA/1228  
 
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  9. Proposed date of adoption : 17 January 2017  
Proposed date of entry into force : 17 May 2017  
10. Final date for comments : None 
11. Texts available from : National enquiry point  [ ] or address, telephone and fax 
number s and e mail and website address es, if available , of other body : 
https://members.wto.org/ crnattachments/2016/TBT/USA/16_4857_00_e.pdf