[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Notices]
[Pages 66318-66319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25371]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1978-N-0018]


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 September 24, 2021. A notice of 
availability for the Proposed Order appeared in the Federal Register of 
September 27, 2021. FDA issued the Proposed Order to amend and revise 
the deemed final administrative order concerning nonprescription 
sunscreen drug products (Deemed Final Order) established by the 
enactment of the Coronavirus Aid, 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 
nonprescription 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 September 24, 2021 (86 FR 53322). Submit electronic comments on the 
Proposed Order by 11:59 p.m. Eastern Time at the end of December 27, 
2021.

ADDRESSES: You may submit comments to Order ID OTC000008 as follows. 
Please note that late, untimely filed comments will not be considered. 
Comments must be submitted electronically on or before December 27, 
2021. The https://www.regulations.gov will accept comments at any time 
until 11:59 p.m. Eastern Time at the end of December 27, 2021.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any information that you or a third party may not wish 
to be publicly posted, such as medical information or your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment electronically in the manner detailed in 
Instructions.
    Instructions: All submissions received must include the Order ID 
Number OTC000008 and the Docket No. FDA-1978-N-0018 for ``Amending 
Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC 
Human Use.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' will be publicly viewable on 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--Under section 505G(d) of the 
FD&C Act (21 U.S.C. 355h(d)), FDA must make any information submitted 
by any person with respect to this order available to the public upon 
submission, with limited exceptions. FDA will not make public 
information pertaining to pharmaceutical quality information, unless 
such information is necessary to establish standards under which a drug 
is generally recognized as safe and effective under section 201(p)(1) 
of the FD&C Act (21 U.S.C. 321(p)(1)) (see section 505G(d)(2)(B) of the 
FD&C Act). FDA will also not make public information that is of the 
type contained in raw datasets (see section 505G(d)(2)(B) of the FD&C 
Act). To submit a comment with this specific confidential information 
that you do not wish to be made publicly available, electronically 
submit two copies of the comment as an attachment to your comment 
submission. One copy will include the information that you claim to be 
confidential with a heading or cover note that states ``THIS DOCUMENT 
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, 
including the claimed confidential information. The second copy, which 
will have the claimed information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with section 505G(d) of the FD&C Act, and other 
applicable disclosure law.
    Docket: For access to the docket to read background documents or 
the electronic comments received, go to https://www.regulations.gov and 
insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go the 
Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 240-402-7945.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 27, 
2021 (86 FR 53322), FDA announced the availability of an OTC monograph 
proposed order (order ID OTC000008), issued pursuant to section 505G(b) 
of the FD&C Act (21 U.S.C. 355g(b)) and section 3854(c)(1) of the CARES 
Act, entitled ``Amending Over-the-Counter (OTC) Monograph M020: 
Sunscreen Drug Products for OTC Human Use.'' FDA issued this Proposed 
Order to amend and revise the Deemed Final Order established by the 
enactment of the CARES Act, Public Law 116-136 (March 27, 2020).\1\ 
This Proposed Order,

[[Page 66319]]

if finalized, would replace the Deemed Final Order in its entirety with 
new conditions under which nonprescription sunscreen drug products 
would be determined to be GRASE under section 201(p)(1) of the FD&C Act 
(21 U.S.C. 321(p)(1)). It would also set forth certain characteristics 
establishing that a sunscreen drug product is not GRASE under section 
201(p)(1) of the FD&C Act.
---------------------------------------------------------------------------

    \1\ To address nonprescription sunscreen drug products that are 
also subject to provisions in other monographs, this proposed order 
also proposes to amend and revise ``OTC Monograph M016, Skin 
Protectant Drug Products for Over-the-Counter Human Use,'' and to 
consolidate existing and new provisions that identify sunscreens 
that are not GRASE in ``Non-Monograph Conditions NM020: Sunscreen 
Drug Products for Over-the-Counter Human Use.''
---------------------------------------------------------------------------

    The original close of the public comment period for this Proposed 
Order was November 12, 2021. On November 2, 2021, the Agency received a 
request to extend this comment period by a minimum of 45 days, 
conveying concern that the original comment period did not provide 
sufficient time for review of the Proposed Order or for submission of 
needed updates related to sunscreen active ingredients about which FDA 
had requested additional data. FDA considered the request and extended 
the public comment period for the Proposed Order for an additional 45 
days, until December 27, 2021.\2\ This extension will allow additional 
time for the public to submit information related to these active 
ingredients (and other proposed sunscreen conditions) that has become 
available since the closure of the comment period on the 2019 Proposed 
Rule ``Sunscreen Drug Products for Over-the-Counter Human Use'' (2019 
Proposed Rule).
---------------------------------------------------------------------------

    \2\ See https://www.regulations.gov/document/FDA-1978-N-0018-15828.
---------------------------------------------------------------------------

    The Agency reiterates that, as stated in the notice of availability 
of the Proposed Order published in the Federal Register on September 
27, 2021, and in the Proposed Order itself, the Agency will consider 
all comments that were submitted to the public docket for the 2019 
Proposed Rule within its comment period to be constructively submitted 
as comments on the Proposed Order. The Agency requests that commenters 
do not resubmit comments on this Proposed Order previously submitted on 
the 2019 Proposed Rule.

    Dated: November 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25371 Filed 11-19-21; 8:45 am]
BILLING CODE 4164-01-P