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