G/TBT/N/USA/1937/Add.2  
 
29 March 2024  
(24-3451) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  29 April 2024, is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
Title:  Color Additive Certification; Increase in Fees for Certification Services; Reopening of the 
Comment Period  
 
Reason for Addendum:  
[X] Comment period changed - date:  28 May 2024; 89 Federal Register (FR) 32384:  
https://www.govinfo.gov/content/pkg/FR -2024-04-26/html/2024 -08950.htm  
https://www.govinfo.gov/content/pkg/FR -2024-04-26/pdf/2024 -08950.pdf  
[ ] 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[ ] Notified measure withdrawn or revoked - date:  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:  
[ ] Other:  
 
Description:  The Food and Drug Administration (FDA or we) is reopening the comment period for 
the proposed rule, "Color Additive Certification; Increase in Fees for Certification Services," which 
published in the Federal Register of 2 November 2022 ( 87 FR 66116 ). We are taking this action to 
add supporting information to the administrative record and to ad just the record to reflect the same 
cost and benefits figures that were published in the preliminary regulatory impact analysis. We are 
reopening the comment period for 30 days specifically to invite public comments on the new 
information being added to th e administrative record. Either electronic or written comments must 
be submitted by 28 May 2024.  
Additionally, for transparency, we are adjusting the Preliminary Economic Analysis of Impacts, in 
Section V. B. Summary of Costs and Benefits ( 87 FR 66116  at 66118). The proposed rule did not 
include the same estimates that were published in the Preliminary Regulatory Impact Analysis (PRIA) 
listed in the referen ce section ( 87 FR 66116  at 66119). The PRIA, entitled "Color Additive 
 
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/1937/Add.2  
 
- 2 - 
 
  Certification; Increase in Fees for Certification Services" Preliminary Regulatory Impact Analysis, 
Initial Regulatory Flexibility Analysis, Unfunded Mandates Reform Act Analysis, is available at 
https://www.fda.gov/about -fda/economics -staff/regulatory -impact -analyses -ria 
(https://www.fda.gov/about -fda/economic -impact -analyses -fda-regulations/color -additive -
certification -increase -fees-certification -services ) and describes the estimates of the costs an d 
benefits of the proposed rule.  
Title 21 Code of Federal Regulations (CFR) Part 80  
This proposed rule; reopening of the comment period an d previous actions notified under the symbol 
G/TBT/N/USA/1937  are identified by Docket Number FDA -2022-N-1635. The Docket Folder is 
available on Regulations.gov at https://www.regulations.gov/docket/FDA -2022-N-1635/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. WTO Members and their 
stakeholders are asked to submit comments to t he USA TBT Enquiry Point  by or before 4pm Eastern 
Time on 28 May 2024. Comments received by the USA TBT Enquiry Point from WTO Members and 
their stakeholders will be shared wi th the regulator and will also be submitted to the Docket  on 
Regulations.gov if received within the comment period.  
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