G/TBT/N/USA/1889  
29 June 2022  
(22-5018) 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) [1916]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the no tification 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 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Nonprescription drug product with an additional condition for nonprescription use (ACNU); 
Pharmaceutics (ICS code(s): 11.120); Domestic safety (ICS code(s): 13.120)  
5. Title, number of pages and language(s) of the notified document:  Nonprescription 
Drug Product With an Additional Condition for Nonprescription Use; ( 19 page(s), in 
English)  
6. Description of content:  Proposed rule - The Food and Drug Administration (FDA, the 
Agency, or we) is proposing to establish requirements for a nonprescription drug product 
with an additional condition for nonprescription use (AC NU). The proposed rule, if 
finalized, would establish requirements for a nonprescription drug product that has an 
ACNU that an applicant must implement to ensure appropriate self -selection or 
appropriate actual use, or both, by consumers without the superv ision of a healthcare 
practitioner. The proposed rule is intended to increase options for applicants to develop 
and market safe and effective nonprescription drug products, which could improve public 
health by broadening the types of nonprescription drug p roducts available to consumers.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Cost saving and productivity enhancement  
8. Relevant documents:   
87 Federal Register (FR) 38313, 28 June 2022; Title 21 Code of Federal Regulations (CFR) 
Parts 201 and 314:  
https://www.govinfo.gov/content/pkg/FR -2022-06-28/html/2022 -13309.htm  
https://www.govinfo.gov/content/pkg/FR -2022-06-28/pdf/2022 -13309.pdf  
This proposed rule is identified by Docket Number FDA -2021-N-0862. The Docket Folder 
is available from Regulations.gov at https://www.regulations.gov/docket/FDA -2021-N-G/TBT/N/USA/1889  
 
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  0862/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 the USA TBT Enquiry Point  by or before 4pm Eastern Time  on 26 October 2022. 
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:  26 October 2022  
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/2022/TBT/USA/22_4403_00_e.pdf