[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Notices]
[Pages 50538-50539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19402]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0352]


Intent To Prepare an Environmental Impact Statement for Certain 
Sunscreen Drug Products for Over-the-Counter Use; Reopening of the 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of intent; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is reopening 
the comment period for public scoping on the environmental impact 
statement (EIS) described in the notice entitled ``Intent To Prepare an 
Environmental Impact Statement for Certain Sunscreen Drug Products for 
Over-the-Counter Use'' that appeared in the Federal Register of May 13, 
2021. The Agency is taking this action to allow interested persons 
additional time to submit comments.

DATES: FDA is reopening the comment period for public scoping on the 
EIS identified in the notice published May 13, 2021 (86 FR 26224). To 
ensure the Agency considers your comments on the draft EIS, submit 
either electronic or written comments on the scoping process discussed 
in the notice by September 23, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 23, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 23, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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 confidential information that you or a third party 
may not wish to be posted, such as medical information, 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.
    <bullet> 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 as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2021-N-0352 for ``Intent To Prepare an Environmental Impact 
Statement for Certain Sunscreen Drug Products for Over-the-Counter 
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,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
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, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper 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 to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Trang Q. Tran, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New

[[Page 50539]]

Hampshire Ave., Bldg. 22, Rm. 4139, Silver Spring, MD 20993; 240-402-
7945.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 13, 2021 (86 FR 26224), FDA 
published a notice entitled ``Intent To Prepare an Environmental Impact 
Statement for Certain Sunscreen Drug Products for Over-the-Counter 
Use,'' which announced the initiation of a public scoping period that 
would end on June 14, 2021, and stated that comments on scoping would 
need to be submitted prior to the close of this period. In the Federal 
Register of June 25, 2021 (86 FR 33712), FDA reopened the docket to 
allow comments on scoping to be filed until July 14, 2021. To allow 
additional comments to be submitted to the docket, FDA is reopening the 
comment period for public scoping on the EIS for an additional 14 days, 
until September 23, 2021. The Agency believes that a 14-day extension 
will allow adequate time for interested persons to submit comments 
without significantly delaying publication of the draft EIS.

II. Electronic Access

    Persons with access to the internet may obtain the notice of intent 
through the Agency's web link ``Environmental Impact Statement (EIS) 
for Certain Sunscreen Drug Products,'' available at https://www.fda.gov/drugs/guidance-compliance-regulatory-information or by 
searching for the above docket number at https://www.regulations.gov.

    Dated: September 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19402 Filed 9-8-21; 8:45 am]
BILLING CODE 4164-01-P