G/TBT/N/USA/1443/Add.3  
 
23 November  2021 
(21-8828) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  23 November 2021 , is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
Title: Sunscreen Drug Products for Over-the-Counter Human Use  
 
Reason for Addendum:  
[X] Comment period changed - date:  27 December 2021; FDA is extending the comment 
period on the Proposed Order issued on 24 September 2021 (86 FR 53322).  
[  ] 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[  ] Notified measure withdrawn or revoked - date:  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:  
[X] Other: https://www.govinfo.gov/content/pkg/FR -2021-11-22/html/2021 -25371.htm  
https://www.govinfo.gov/content/pkg/FR -2021-11-22/pdf/2021 -25371.pdf  
https://members.wto .org/crnattachments/2021/TBT/USA/21_7289_00_e.pdf  
 
Description:  TITLE: Amending Over -the-Counter Monograph M020: Sunscreen Drug Products for 
Over-The-Counter Human Use; Over -The-Counter Monograph Proposed Order (OTC 000008) 
Extension of Comment Period  
 
AGENCY: Food and Drug Administration, HHS  
 
ACTION: Proposed order;  extension of comment period.  
 
SUMMARY: The Food and Drug Administration (FDA or Agency) has extended the comment period 
for the over -the-counter (OTC) monograph proposed order (order ID OTC000008) entitled 
"Amending Over -the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human 
Use" (Proposed  Order), which was issued on 24 September 2021. A notice of availability for the 
Proposed Order appeared i n the Federal Register of 27 September 2021 . FDA issued the Proposed 
 
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/1443/Add.3  
 
- 2 - 
 
  Order to amend and revise the deemed final administrative order concerning non -
prescription  sunscreen drug products (Deemed Final Order) established by the enactment of the 
Coronavirus Ai d, Relief, and Economic Security Act (CARES Act). The Proposed Order, if finalized, 
would replace the Deemed Final Order in its entirety with new conditions under which  non-
prescription sunscreen drug products would be determined to be generally recognized  as safe and 
effective (GRASE) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It would also set 
forth certain characteristics that would establish that a sunscreen drug  product is not GRASE. FDA 
has extended the comment period for the Proposed Order in response to a request for an extension 
to allow interested persons additional time to submit comments.  
 
DATES: FDA is extending the comment period on the Proposed Order issued on 24 September 2021 
(86 FR 53322) to 27 December 2021.    
 
This extensi on of comment period and previous actions notified under the symbol 
G/TBT/N/USA/1443  are identified by Docket Number FDA -1978-N-0018. The Docket Folder is 
available on Regulations.gov  at https://www.regulations.gov/docket/FDA -1978-N-0018/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 stakeh olders are asked to submit comments to the USA WTO TBT Enquiry 
Point by 4:00 p.m. Eastern Standard Time (EST)  at the end of 27 December 2021. Co mments 
received by the USA WTO 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.  
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