Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use; Reopening of the Comment Period, 50538-50539 [2021-19402]
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50538
Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001 and in 21 CFR part
601 under OMB control number 0910–
0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.regulations.gov, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances.
Dated: September 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–19410 Filed 9–8–21; 8:45 am]
BILLING CODE 4164–01–P
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-theCounter Use; Reopening of the
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of intent; reopening of
the comment period.
ACTION:
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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:38 Sep 08, 2021
Jkt 253001
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:
• 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.
• 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:
• 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.
• 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
PO 00000
Frm 00015
Fmt 4703
Sfmt 4703
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.
• 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-201509-18/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
E:\FR\FM\09SEN1.SGM
09SEN1
Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices
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/guidancecompliance-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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0166]
lotter on DSK11XQN23PROD with NOTICES1
International Council for
Harmonisation Q12: Implementation
Considerations for Food and Drug
Administration-Regulated Products;
Draft Guidance for Industry;
Reopening of the Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
VerDate Sep<11>2014
19:38 Sep 08, 2021
Jkt 253001
reopening the comment period for the
draft guidance for industry entitled
‘‘ICH Q12: Implementation
Considerations for FDA-Regulated
Products’’ published in the Federal
Register of May 20, 2021. FDA is
reopening the comment period to allow
interested persons additional time to
submit comments.
DATES: FDA is reopening the comment
period on the notice published May 20,
2021 (86 FR 27437). Submit either
electronic or written comments by
October 12, 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 October 12,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 12, 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:
• 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.
• 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:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
PO 00000
Frm 00016
Fmt 4703
Sfmt 4703
50539
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• 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–D–0166 for ‘‘ICH Q12:
Implementation Considerations for
FDA-Regulated Products; Draft
Guidance for Industry; Reopening of the
Comment Period.’’ 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.
• 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-201509-18/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
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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.
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:
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.
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.
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