   
  
G/TBT/N/USA/1113/Add.3  
 
24 August 2020  
(20-5753) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  24 August 2020 , is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
Title: Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self -Injurious 
or Aggressive Behavior  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[  ] Notified measure adopted - date:  
[  ] Notified measure published - date:  
[  ] Notified measure enters into force - date:  
[  ] Text of final measure available from1:  
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[  ] Content or scope of notified measure changed  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[X] Other: https://www.govinfo.gov/content/pkg/FR -2020-08-19/html/2020 -16595.htm  
https://www.govinfo.gov/content/pkg/FR -2020-08-19/pdf/2020 -16595.pdf  
https://members.wto .org/crnattachments/2020/TBT/USA/20_5054_00_e.pdf  
 
Description:  AGENCY: Food and Drug Administration, HHS  
ACTION: Final rule; notification of administrative stay  
SUMMARY: The Food and Drug Administration (FDA or Agency) is providing notice of a stay of the 
effectiveness of provisions for devices in use on specific individuals who have or would need to obtain 
a physician - directed transition plan as of the date of publication on 6 March 2020, of the final 
regulation banning electrical stimulation devices (ESDs) for self -injurious or aggressive behavior. 
FDA is publishing this notification in response to petitions for an administrative stay of action in 
accordance with regulatory requirements.  
DATES: FDA is administratively staying temporarily the final reg ulation published on 6 March 2020 
(85 FR 13312), for those devices in use on specific individuals as described in SUPPLEMENTARY 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final measure and/or interpretive guidance can be obtained.  G/TBT/N/USA/1113/Add.3  
 
- 2 - 
 
  INFORMATION. FDA will publish a document in the Federal Register lifting the stay or taking further 
action as needed.  
Actions no tified under the symbol G/TBT/N/USA/1113  are identified by Docket Number FDA -2016-
N-1111.   The Docket Folder is available on Regulations.gov at 
https://www.regulations.gov/docket?D=FDA -2016-N-1111, and provides access to primary and 
supporting documents as well as comments received. Documents are also accessible from 
Regulations.gov  by searching the Docket Number.  
__________  
 
 