Notice2021-19402
Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use; Reopening of the Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 9, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 172 (Thursday, September 9, 2021)</title>
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[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Notices]
[Pages 50538-50539]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information">https://www.fda.gov/drugs/guidance-compliance-regulatory-information</a> or by
searching for the above docket number at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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