  
  
G/TBT/N/USA/214/Add.3/Corr.2  
6 April 2021  
(21-2815) Page: 1/1 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
Corrigendum  
The following communication, dated 6 April 2021, is being circulated at the request of the delegation 
of the United States of America . 
 
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Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, 
Includin g Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs  
TITLE: Requirements for Foreign and Domestic Establishment Registration and Listing for Human 
Drugs, Including Drugs That Are Regulated Under a Biologics License Application , and Animal Drugs; 
Corrections  
AGENCY: Food and Drug Administration, Department of Health and Human Services (HHS)  
ACTION: Final rule; correcting amendments  
SUMMARY: On 31 August 2016, the Food and Drug Administration (FDA or Agency) published an 
amended final rule that listed inaccurate cross - references to FDA's drug establishment registration 
and drug listing regulations. This document corrects the inaccurate cross -references used in the final 
regulations.  
This rule is effective 1 April 2021.  
This final  rule; correcting amendments and previous actions notified under the symbol 
G/TBT/N/USA/214  are identified by Docket Number FDA -2005-N-0464. The Docket Folder is 
available on Regulations.gov at https://www.regulations.gov/docket/FDA -2005-N-0464/document  
and provides access to primary and supporting documents as well as comments received. Documents 
are also accessible from Regulations.gov  by search ing the Docket Number.  
https://www.govinfo.gov/content/pkg/FR -2021-04-01/html/2021 -06677.htm  
https://www.govinfo.gov/content/pkg/FR -2021-04-01/pdf/2021 -06677.pdf  
https://members.wto.org/crnattachments/2021/TBT/USA/21_2445_00_e.pdf  
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