Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products; Extension of Comment Period, 14647-14648 [2017-05490]
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Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Proposed Rules
airworthiness directive (AD) for certain
CFE Company (CFE) turbofan engines
that published in the Federal Register
on January 5, 2017. The proposed action
that published in the Federal Register
on January 5, 2017 was a duplicate of
an NPRM, Directorate Identifier 2016–
NE–21–AD, that published in the
Federal Register on January 3, 2017.
Accordingly, we withdraw the proposed
rule that published in the Federal
Register on January 5, 2017.
As of March 22, 2017, the
proposed rule published January 5, 2017
(82 FR 52) is withdrawn.
DATES:
FOR FURTHER INFORMATION CONTACT:
Issued in Burlington, Massachusetts, on
March 8, 2017.
Carlos A. Pestana,
Acting Assistant Manager, Engine & Propeller
Directorate, Aircraft Certification Service.
[FR Doc. 2017–05242 Filed 3–21–17; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1132
[Docket No. FDA–2016–N–2527]
Tobacco Product Standard for NNitrosonornicotine Level in Finished
Smokeless Tobacco Products;
Extension of Comment Period
The FAA
proposed to amend 14 CFR part 39 with
a proposed AD (82 FR 1258, January 5,
2017). Since we published the NPRM,
Directorate Identifier 2016–NE–21–AD,
in the Federal Register on January 5,
2017 (82 FR 1258), we discovered that
it was a duplicate of an NPRM,
Directorate Identifier 2016–NE–21–AD,
that published in the Federal Register
on January 3, 2017 (82 FR 52). This
duplication created overlapping
comment periods with different
comment period closing dates, which is
confusing to commenters.
Withdrawal of the NPRM (82 FR 1258,
January 5, 2017) constitutes only such
action, and does not preclude the
agency from issuing another notice in
the future, nor does it commit the
agency to any course of action in the
future.
Since this action only withdraws a
notice of proposed rulemaking, it is
neither a proposed nor a final rule.
Therefore, Executive Order 12866, the
Regulatory Flexibility Act, or DOT
Regulatory Policies and Procedures (44
FR 11034, February 26, 1979) do not
cover this withdrawal.
HHS.
jstallworth on DSK7TPTVN1PROD with PROPOSALS
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
The Withdrawal
Accordingly, the notice of proposed
rulemaking, Docket No. FAA–2016–
9380; Directorate Identifier 2016–NE–
21–AD, published in the Federal
Register on January 5, 2017 (82 FR
1258), is withdrawn.
VerDate Sep<11>2014
14:55 Mar 21, 2017
Jkt 241001
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.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Martin Adler, Aerospace Engineer,
Engine Certification Office, FAA, 1200
District Avenue, Burlington, MA 01803;
phone: 781–238–7157; fax: 781–238–
7199; email: martin.adler@faa.gov.
SUPPLEMENTARY INFORMATION:
14647
AGENCY:
Food and Drug Administration,
Proposed rule; extension of
comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
proposed rule that appeared in the
Federal Register of January 23, 2017. In
the proposed rule, FDA requested
comments on its proposal to establish a
limit of N-nitrosonornicotine (NNN) in
finished smokeless tobacco products.
The Agency is taking this action in
response to requests for an extension to
allow interested persons additional time
to submit comments. The Agency is also
providing notice of a typographical error
in a formula in the Laboratory
Information Bulletin (LIB) titled,
‘‘Determination of N-nitrosonornicotine
(NNN) in Smokeless Tobacco and
Tobacco Filler by HPLC–MS/MS’’ (LIB
No. 4620, January 2017). In accordance
with the memorandum of January 20,
2017, from the Assistant to the President
and Chief of Staff, entitled ‘‘Regulatory
Freeze Pending Review’’, the Agency is
also taking this opportunity to provide
notice that, as with all regulatory
actions subject to such memorandum,
this proposed rule is being reviewed
consistent with the memorandum.
DATES: FDA is extending the comment
period on the proposed rule published
January 23, 2017 (82 FR 8004). Submit
either electronic or written comments
by July 10, 2017[. Late, untimely filed
comments will not be considered.
Electronic comments must be submitted
on or before July 10, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
[July 10, 2017. Comments received by
SUMMARY:
PO 00000
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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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–N–2527 for ‘‘Tobacco Product
Standard for N-nitrosonornicotine Level
in Finished Smokeless Tobacco
Products.’’ Received comments, those
filed in a timely manner (see DATES),
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
E:\FR\FM\22MRP1.SGM
22MRP1
14648
Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Proposed Rules
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 Division of Dockets
Management. 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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
jstallworth on DSK7TPTVN1PROD with PROPOSALS
FOR FURTHER INFORMATION CONTACT:
Beth
Buckler or Colleen Lee, Office of
Regulations, Center for Tobacco
Products (CTP), Food and Drug
Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993–0002, 877–287–1373,
CTPRegulations@fda.hhs.gov.
In the
Federal Register of January 23, 2017,
FDA published a proposed rule with a
75-day comment period to request
comments on our proposal to establish
a limit for NNN in finished smokeless
tobacco products. Comments on the
proposed rule will inform FDA’s
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
14:55 Mar 21, 2017
Jkt 241001
rulemaking to establish a tobacco
product standard for NNN.
The Agency has received requests for
a 75-day extension of the comment
period for the proposed rule. Each
request expressed concern that the
current 75-day comment period does
not allow the public sufficient time to
develop thoughtful responses to the
proposed rule.
The Agency also has received a
request to clarify a formula in the
Laboratory Information Bulletin (LIB)
titled, ‘‘Determination of Nnitrosonornicotine (NNN) in Smokeless
Tobacco and Tobacco Filler by HPLC–
MS/MS’’ (LIB No. 4620, January 2017).
Upon further review, FDA has
determined that the formula for
converting NNN on a wet weight basis
to a dry weight basis contains a
typographical error—some of the terms
and variables in the numerator and
denominator were inadvertently
switched. FDA has revised the LIB to
correct this error (LIB No. 4623, March
2017, available at https://www.fda.gov/
downloads/ScienceResearch/
FieldScience/UCM546874.pdf). We note
that the typographical error in the LIB
did not affect our calculations in the
preamble of the proposed rule or the
supporting analyses.
FDA has considered the requests and
is extending the comment period for the
proposed rule for 90 days, until [July 10,
2017. The 90-day extension will provide
additional time for interested persons to
submit comments on all aspects of the
proposed rule, including whether the
approach proposed in the rule is
appropriate.
Dated: March 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05490 Filed 3–21–17; 8:45 am]
BILLING CODE 4164–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R10–OAR–2016–0785: FRL–9959–02Region 10]
Air Plan Approval; Washington:
General Regulations for Air Pollution
Sources, Energy Facility Site
Evaluation Council
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to revise the
Washington State Implementation Plan
SUMMARY:
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
(SIP) to approve updates to the Energy
Facility Site Evaluation Council
(EFSEC) air quality regulations. The
EFSEC regulations primarily adopt by
reference the Washington Department of
Ecology (Ecology) general air quality
regulations, which the EPA approved in
the fall of 2014 and spring of 2015.
Consistent with our approval of the
Ecology general air quality regulations,
we are also proposing to approve
revisions to implement the
preconstruction permitting regulations
for large industrial (major source)
facilities in attainment and
unclassifiable areas, called the
Prevention of Significant Deterioration
(PSD) program. The PSD program for
major energy facilities under EFSEC’s
jurisdiction has historically been
operated under a Federal
Implementation Plan (FIP), in
cooperation with the EPA and Ecology.
If finalized, the EPA’s proposed
approval of the EFSEC PSD program
would narrow the FIP to include only
those few potential facilities, emission
sources, geographic areas, and permits
for which EFSEC does not have
jurisdiction or authority. The EPA is
also proposing to approve EFSEC’s
visibility protection permitting program
which overlaps significantly with the
PSD program in most cases.
Written comments must be
received on or before April 21, 2017.
DATES:
Submit your comments,
identified by Docket ID No. EPA–R10–
OAR–2016–0785 at https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Once submitted, comments cannot be
edited or removed from Regulations.gov.
The EPA may publish any comment
received to its public docket. Do not
submit electronically any information
you consider to be Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute. Multimedia
submissions (audio, video, etc.) must be
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. The EPA will generally not
consider comments or comment
contents located outside of the primary
submission (i.e. on the web, cloud, or
other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www2.epa.gov/dockets/
commenting-epa-dockets.
ADDRESSES:
E:\FR\FM\22MRP1.SGM
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Agencies
[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Proposed Rules]
[Pages 14647-14648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05490]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1132
[Docket No. FDA-2016-N-2527]
Tobacco Product Standard for N-Nitrosonornicotine Level in
Finished Smokeless Tobacco Products; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the proposed rule that appeared in the
Federal Register of January 23, 2017. In the proposed rule, FDA
requested comments on its proposal to establish a limit of N-
nitrosonornicotine (NNN) in finished smokeless tobacco products. The
Agency is taking this action in response to requests for an extension
to allow interested persons additional time to submit comments. The
Agency is also providing notice of a typographical error in a formula
in the Laboratory Information Bulletin (LIB) titled, ``Determination of
N-nitrosonornicotine (NNN) in Smokeless Tobacco and Tobacco Filler by
HPLC-MS/MS'' (LIB No. 4620, January 2017). In accordance with the
memorandum of January 20, 2017, from the Assistant to the President and
Chief of Staff, entitled ``Regulatory Freeze Pending Review'', the
Agency is also taking this opportunity to provide notice that, as with
all regulatory actions subject to such memorandum, this proposed rule
is being reviewed consistent with the memorandum.
DATES: FDA is extending the comment period on the proposed rule
published January 23, 2017 (82 FR 8004). Submit either electronic or
written comments by July 10, 2017[. Late, untimely filed comments will
not be considered. Electronic comments must be submitted on or before
July 10, 2017. The https://www.regulations.gov electronic filing system
will accept comments until midnight Eastern Time at the end of [July
10, 2017. 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.
ADDRESSES: You may submit comments as follows:
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-2527 for ``Tobacco Product Standard for N-nitrosonornicotine
Level in Finished Smokeless Tobacco Products.'' Received comments,
those filed in a timely manner (see DATES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management
[[Page 14648]]
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 Division of Dockets Management. 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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Beth Buckler or Colleen Lee, Office of
Regulations, Center for Tobacco Products (CTP), Food and Drug
Administration, Document Control Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 877-287-1373,
CTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 23, 2017,
FDA published a proposed rule with a 75-day comment period to request
comments on our proposal to establish a limit for NNN in finished
smokeless tobacco products. Comments on the proposed rule will inform
FDA's rulemaking to establish a tobacco product standard for NNN.
The Agency has received requests for a 75-day extension of the
comment period for the proposed rule. Each request expressed concern
that the current 75-day comment period does not allow the public
sufficient time to develop thoughtful responses to the proposed rule.
The Agency also has received a request to clarify a formula in the
Laboratory Information Bulletin (LIB) titled, ``Determination of N-
nitrosonornicotine (NNN) in Smokeless Tobacco and Tobacco Filler by
HPLC-MS/MS'' (LIB No. 4620, January 2017). Upon further review, FDA has
determined that the formula for converting NNN on a wet weight basis to
a dry weight basis contains a typographical error--some of the terms
and variables in the numerator and denominator were inadvertently
switched. FDA has revised the LIB to correct this error (LIB No. 4623,
March 2017, available at https://www.fda.gov/downloads/ScienceResearch/FieldScience/UCM546874.pdf). We note that the typographical error in
the LIB did not affect our calculations in the preamble of the proposed
rule or the supporting analyses.
FDA has considered the requests and is extending the comment period
for the proposed rule for 90 days, until [July 10, 2017. The 90-day
extension will provide additional time for interested persons to submit
comments on all aspects of the proposed rule, including whether the
approach proposed in the rule is appropriate.
Dated: March 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05490 Filed 3-21-17; 8:45 am]
BILLING CODE 4164-01-P