Tobacco Product Standard for Nicotine Level of Combusted Cigarettes; Extension of Comment Period, 26619-26620 [2018-12368]
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Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Proposed Rules
amozie on DSK3GDR082PROD with PROPOSALS1
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–
2017–N–6565 for ‘‘Regulation of Flavors
in Tobacco Products.’’ 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.
• 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
VerDate Sep<11>2014
16:24 Jun 07, 2018
Jkt 244001
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Laura Rich or Katherine Collins, Center
for Tobacco Products, Food and Drug
Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993, 1–877–287–1373, AskCTP@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 21, 2018,
FDA published an ANPRM with a 90day comment period to obtain
information related to the role that
flavors play in tobacco products.
Specifically, the ANPRM is seeking
comments, data, research results, or
other information about, among other
things, how flavors attract youth to
initiate tobacco product use and about
whether and how certain flavors may
help adult cigarette smokers reduce
cigarette use and switch to potentially
less harmful products. FDA is seeking
this information to inform regulatory
actions FDA might take with respect to
tobacco products with flavors, under the
Federal Food, Drug, and Cosmetic Act,
as amended by the Family Smoking
Prevention and Tobacco Control Act.
Potential regulatory actions include, but
are not limited to, tobacco product
standards and restrictions on sale and
distribution of tobacco products with
flavors.
The Agency has received a number of
requests for a 90-day extension of the
comment period for the ANPRM and
one request for a 105-day extension.
FDA has considered these requests and
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Sfmt 4702
26619
is extending the comment period for the
ANPRM for 30 days, until July 19, 2018.
The Agency believes that a 30-day
extension allows adequate time for
interested persons to submit comments
without significantly delaying any
potential regulatory action on these
important issues.
Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12369 Filed 6–7–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1130
[Docket No. FDA–2017–N–6189]
RIN 0910–AH86
Tobacco Product Standard for Nicotine
Level of Combusted Cigarettes;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Advance notice of proposed
rulemaking; extension of comment
period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
advance notice of proposed rulemaking
(ANPRM) that appeared in the Federal
Register of March 16, 2018. In the
ANPRM, FDA requested information for
consideration in developing a tobacco
product standard to set a maximum
nicotine level in combusted cigarettes so
that they are minimally addictive or
nonaddictive. The Agency is taking this
action in response to requests for an
extension to allow interested persons
additional time to submit comments.
DATES: FDA is extending the comment
period on the ANPRM published on
March 16, 2018 (83 FR 11818). Submit
either electronic or written comments
by July 16, 2018.
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 July 16, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 16, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
SUMMARY:
E:\FR\FM\08JNP1.SGM
08JNP1
26620
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Proposed Rules
acceptance receipt is on or before that
date.
amozie on DSK3GDR082PROD with PROPOSALS1
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–
2017–N–6189 for ‘‘Tobacco Product
Standard for Nicotine Level of
Combusted Cigarettes.’’ 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.
• 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
VerDate Sep<11>2014
16:24 Jun 07, 2018
Jkt 244001
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Gerie Voss, Center for Tobacco
Products, Food and Drug
Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993, 1–877–CTP–1373, AskCTP@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 16, 2018,
FDA published an ANPRM with a 90day comment period to obtain
information for consideration in
developing a tobacco product standard
to set a maximum nicotine level in
combusted cigarettes so that they are
minimally addictive or nonaddictive.
Comments on the scope of products to
be covered, maximum nicotine level for
a potential nicotine tobacco product
standard, implementation methods,
analytical testing methods, technical
achievability, possible countervailing
effects, and other topics will aid FDA in
its consideration regarding development
of a tobacco product standard to set a
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
maximum nicotine level in combusted
cigarettes.
The Agency has received a number of
requests for a 90-day extension of the
comment period for the ANPRM and
one request for a 120-day extension.
FDA has considered the requests and is
extending the comment period for the
ANPRM for an additional 30 days, until
July 16, 2018. The Agency believes that
a 30-day extension allows adequate time
for interested persons to submit
comments without significantly
delaying any potential regulatory action
on these important issues.
Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12368 Filed 6–7–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE INTERIOR
National Indian Gaming Commission
25 CFR Part 543
RIN 3141–AA60
Minimum Internal Control Standards
National Indian Gaming
Commission, Department of the Interior.
ACTION: Notice of proposed rulemaking.
AGENCY:
The National Indian Gaming
Commission (NIGC) proposes to amend
its minimum internal control standards
for Class II gaming under the Indian
Gaming Regulatory Act to correct an
erroneous deletion of the key control
standards and to make other minor edits
and additions for clarity.
DATES: Written comments on this
proposed rule must be received on or
before July 9, 2018.
ADDRESSES: You may submit comments
by any one of the following methods,
however, please note that comments
sent by electronic mail are strongly
encouraged.
D Email comments to: 543_
comments@nigc.gov.
D Mail comments to: National Indian
Gaming Commission, 1849 C Street NW,
MS 1621, Washington, DC 20240.
D Fax comments to: National Indian
Gaming Commission at 202–632–0045.
FOR FURTHER INFORMATION CONTACT:
Jennifer Lawson at (202) 632–7003 or by
fax (202) 632–7066 (these numbers are
not toll free).
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
The Indian Gaming Regulatory Act
(IGRA or Act), Public Law 100–497, 25
E:\FR\FM\08JNP1.SGM
08JNP1
]]>Agencies
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Proposed Rules]
[Pages 26619-26620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12368]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1130
[Docket No. FDA-2017-N-6189]
RIN 0910-AH86
Tobacco Product Standard for Nicotine Level of Combusted
Cigarettes; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking; extension of comment
period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the advance notice of proposed
rulemaking (ANPRM) that appeared in the Federal Register of March 16,
2018. In the ANPRM, FDA requested information for consideration in
developing a tobacco product standard to set a maximum nicotine level
in combusted cigarettes so that they are minimally addictive or
nonaddictive. The Agency is taking this action in response to requests
for an extension to allow interested persons additional time to submit
comments.
DATES: FDA is extending the comment period on the ANPRM published on
March 16, 2018 (83 FR 11818). Submit either electronic or written
comments by July 16, 2018.
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 July 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 16, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
[[Page 26620]]
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-2017-N-6189 for ``Tobacco Product Standard for Nicotine Level of
Combusted Cigarettes.'' 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.
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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Gerie Voss, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993, 1-877-
CTP-1373, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of March 16, 2018,
FDA published an ANPRM with a 90-day comment period to obtain
information for consideration in developing a tobacco product standard
to set a maximum nicotine level in combusted cigarettes so that they
are minimally addictive or nonaddictive. Comments on the scope of
products to be covered, maximum nicotine level for a potential nicotine
tobacco product standard, implementation methods, analytical testing
methods, technical achievability, possible countervailing effects, and
other topics will aid FDA in its consideration regarding development of
a tobacco product standard to set a maximum nicotine level in combusted
cigarettes.
The Agency has received a number of requests for a 90-day extension
of the comment period for the ANPRM and one request for a 120-day
extension. FDA has considered the requests and is extending the comment
period for the ANPRM for an additional 30 days, until July 16, 2018.
The Agency believes that a 30-day extension allows adequate time for
interested persons to submit comments without significantly delaying
any potential regulatory action on these important issues.
Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12368 Filed 6-7-18; 8:45 am]
BILLING CODE 4164-01-P
