   
  
G/TBT/N/USA/324/Add.2  
 
13 September 2021  
(21-6756) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  13 September 2021 , is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
Title: Requirements for Human Blood and Blood Components Intended for Transfusion or for Further 
Manufacturing Use  
 
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[  ] Notified measure withdrawn or revoked - date:  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  and text available from1:  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[X] Other: https://www.govinfo.gov/content/pkg/FR -2021-09-07/html/2021 -19220.htm  
https://www.govinfo.gov/content/pkg/FR -2021-09-07/pdf/2021 -19220.pdf  
https://members.wto .org/crnattachments/2021/TBT/USA/21_5710_00_e.pdf  
 
Description:  TITLE: Revision to Restrictions on Shipment or Use for Human Blood and Blood 
Components Exceptions; Technical Amendment  
AGENCY: Food and Drug Administration, Department of Health and Human Services (HHS)  
ACTION: Final rule; technical amendment  
SUMMARY: Th e Food and Drug Administration (FDA or we) is amending the biologics regulation to 
improve clarity and revise an incorrect citation. This action is being taken to ensure the accuracy 
and clarity of the biologics regulation.  
DATES: This rule is [effective]  7 September 2021.  
This final rule; technical amendment is identified by Docket Number FDA -2021-N-0011. The Docket 
Folder is available at https://www.regulations.gov/docket/FDA -2021-N-0011/document  and 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  G/TBT/N/USA/324/Add.2  
 
- 2 - 
 
  provides access to primary documents as well as comments received. Documents are also accessible 
from Regulations.gov  by searching the Docket Number.  
Requirements for Blood and Blood Components Intended for Transfusion or for Further 
Manufacturing Use; Final Rule published 22 May 2015:  
https://www.govinfo.gov/content/pkg/FR -2015-05-22/html /2015 -12228.htm  
https://www.govinfo.gov/content/pkg/FR -2015-05-22/pdf/2015 -12228.pdf  
The May 2015 final rule as well as previous actions notified under the sym bol G/TBT/N/USA/324  are 
identified by Docket Number FDA -2006-N-0040 (formerly Docket No. 2006N -0221). The Docket 
Folder is available at https://www.regulations.gov/docket/FDA -2006-N-0040/document  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.  
__________  
 
 