G/TBT/N/USA/1785  
6 October 2021  
(21-7520) 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 AMERICA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Food and Drug Administration (FDA), Health and Human Services 
(HHS) [1814]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the not ification shall be indicated if different 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]: [ X ] 
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Tobacco 
products; TOBACCO AND MANUFACTURED TOBACCO SUBSTITUTES (HS 24); Information 
sciences. Publishing (ICS 01.140), Domestic safety (ICS 13.120), Tobacco, tobacco 
products and related equipment (ICS 65.160)  
5. Title, number of pages and language(s) of  the notified document:  Content and 
Format of Substantial Equivalence Reports; Food and Drug Administration Actions on 
Substantial Equivalence Reports (77 page(s), in English)  
6. Description of content:  Final rule - The Food and Drug Administration (FDA, the Agency, 
or we) is  issuing this final rule to provide additional information on the content and format 
of reports intended to demonstrate the substantial equivalence of a tobacco product (SE 
Reports). The final rule also establishes the general procedur es FDA intends to follow 
when evaluating SE Reports, including procedures that address communications with the 
applicant and the confidentiality of data in an SE Report. The final rule will provide 
applicants with more certainty and clarity related to prep aring and submitting SE Reports.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Prevention of deceptive practices and consumer protection; Protection of 
human health or safety  
8. Relevant documents:   
86 Federal Register (FR) 55224,  5 October 2021; Title  21 Code of Federal Regulations 
(CFR) Parts 16, 1100, 1107 et al.:  
https://www.govinfo.gov/content/pkg/FR -2021-10-05/html/2021 -21009.htm  
https://www.govinfo.gov/content/pkg/FR -2021-10-05/pdf/2021 -21009.pdf  
This final rule is identified by Docket Number FDA -2016-N-3818. The Docket Folder is 
available on Regulations.gov at  https://www.regulations.gov/docket/FDA -2016-N-
3818/document  and provides access to primary and supporting documents as well as G/TBT/N/USA/1785  
 
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  comments received. Documents are also accessible from  Regula tions.gov  by searching 
the Docket Number.  
9. Proposed date of adoption:  5 October 2021  
Proposed date of entry into force:  4 November 2021  
10. Final date for comments:  None 
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2021/TBT/USA/21_6434_00_e.pdf