G/TBT/N/USA/1777  
17 September 2021  
(21-6936) 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:  Consumer Product Safety Commission (CPSC) [1806]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicat ed if different from above:   
Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Child-
resistant packaging; baloxavir marboxil tablets; Pharmaceutics (ICS 11.120), Domestic 
safety (ICS 13.120), Packaging materials and accessories (ICS 55.040)  
5. Title, number of pages and language(s) of the notified document:  Poison 
Prevention Packaging Requirements; Proposed Exemption of Baloxavir Marboxil Tablets 
in Packages Containing Not More Than 80 mg of the Drug (4  page(s), in English)  
6. Description of content:  Notice of proposed rulemaking - The Consumer Product Safety 
Commission (Commission or CPSC) is proposing to amend the child -resistant packaging 
requirements to exempt baloxavir marboxil tablets in packages containing not more than 
80 mg of the drug, currently marketed as XOFLUZA,TM from the special packaging 
requirements. XOFLUZA is used to treat the flu, and is taken in one dose within 48 hours 
of experiencing flu symptoms. The proposed rule would exempt th is prescription drug 
product on the basis that child -resistant packaging is not needed to protect young children 
from serious injury or illness because the product is not acutely toxic and lacks adverse 
human experience associated with ingestion.  
7. Objec tive and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Prevention of deceptive practices and 
consumer protection; Protection of human health or safety  
8. Relevant documents:  86 Federal Register (FR) 51640, 16 September 2021; Title 16 
Code of Federal Regulations (CFR) Part 1700:  
https://www.govinfo.gov/content/pkg/FR -2021-09-16/html/2021 -19953.htm  
https://www.govinfo.gov/content/pkg/FR -2021-09-16/pdf/2021 -19953.pdf  
 
This notice of proposed rulemaking is identified by Docket Number CPSC -2021-0027. T he 
Docket Folder is available on Regulations.gov at 
https://www.regulations.gov/document/CPSC_FRDOC_0001 -1148 and provides access 
to primary documents as well as comments  received. Documents are also accessible from G/TBT/N/USA/1777  
 
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  Regulations.gov  by searching the Docket Number. WTO Members and their stakeholders 
are asked to submit comments to the USA TB T Enquiry Point . Comments received by the 
USA TBT Enquiry Point from WTO Members and their stakeholders will be shared with the 
regulator and will also be submitted to the Docket  on Regulations.gov if received within 
the comment period.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  30 November 2021  
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_5869_00_e.pdf