Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products; Request for Comments; Extension of Comment Period, 51146-51147 [2015-20759]
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51146
Proposed Rules
Federal Register
Vol. 80, No. 163
Monday, August 24, 2015
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Parts 1100, 1140, and 1143
[Docket No. FDA–2015–N–1514]
RIN 0910–AH24
Nicotine Exposure Warnings and
Child-Resistant Packaging for Liquid
Nicotine, Nicotine-Containing ELiquid(s), and Other Tobacco
Products; Request for Comments;
Extension of Comment Period
Food and Drug Administration,
HHS.
Advance notice of proposed
rulemaking; extension of comment
period.
ACTION:
The Food and Drug
Administration (FDA) is extending the
comment period for the advance notice
of proposed rulemaking (ANPRM)
entitled ‘‘Nicotine Exposure Warnings
and Child-Resistant Packaging for
Liquid Nicotine, Nicotine-Containing ELiquid(s), and Other Tobacco Products’’
that appeared in the Federal Register of
July 1, 2015. In the ANPRM, FDA
requested comments, data, research
results, or other information, that may
inform regulatory actions that FDA
might take with respect to nicotine
exposure warnings and child-resistant
packaging for liquid nicotine and
nicotine-containing e-liquid(s) that are
made or derived from tobacco and
intended for human consumption, and
potentially for other tobacco products
including, but not limited to, novel
tobacco products such as dissolvables,
lotions, gels, and drinks. 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 July 1,
2015 (80 FR 37555). Submit either
electronic or written comments by
September 30, 2015.
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SUMMARY:
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Food and Drug Administration
AGENCY:
You may submit comments
by any of the following methods:
ADDRESSES:
Submit written submissions in the
following ways:
• Mail/Hand delivery/Courier (for
paper submissions): Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Instructions: All submissions received
must include the Docket No. FDA–
2015–N–1514 for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Requests for
Comments and Information’’ heading of
the SUPPLEMENTARY INFORMATION section
of this document.
Docket: For access to the docket to
read background documents or
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:
Bryant M. Godfrey or Courtney S.
Smith, Center for Tobacco Products,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993, 1–877–CTP–1373,
CTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 1, 2015
(80 FR 37555), FDA published an
ANPRM with a 60-day comment period
to request comments, data, research
results, or other information, that may
inform regulatory actions that FDA
might take with respect to nicotine
exposure warnings and child-resistant
packaging for liquid nicotine and
nicotine-containing e-liquid(s) that are
made or derived from tobacco and
intended for human consumption, and
PO 00000
Frm 00001
Fmt 4702
Sfmt 4702
potentially for other tobacco products
including, but not limited to, novel
tobacco products such as dissolvables,
lotions, gels, and drinks.
The Agency has received several
comments requesting an extension of
the comment period for the ANPRM.
These comments convey concern that
the current 60-day comment period does
not allow sufficient time to develop
meaningful or thoughtful responses to
questions raised in the ANPRM.
FDA has considered the requests and
is extending the comment period for the
ANPRM for 30 days, until September
30, 2015. The Agency believes that a 30day extension allows adequate time for
interested persons to submit comments
without significantly delaying any
potential regulatory action on these
important issues.
II. Requests for Comments and
Information
A. General Information About
Submitting Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES).
It is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document.
B. Public Availability of Comments
Received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to
the docket at https://
www.regulations.gov. As a matter of
Agency practice, FDA generally does
not post comments submitted by
individuals in their individual capacity
on https://www.regulations.gov. This is
determined by information indicating
that the submission is written by an
individual, for example, the comment is
identified with the category ‘‘Individual
Consumer’’ under the field entitled
‘‘Category (Required)’’, on the ‘‘Your
Information’’ page on https://
www.regulations.gov; for this ANPRM,
however, FDA will not be following this
general practice. Instead, FDA will post
on https://www.regulations.gov
comments to this docket that have been
submitted by individuals in their
individual capacity. If you wish to
submit any information under a claim of
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Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Proposed Rules
SIP. We are taking comments on this
proposal and plan to follow with a final
action.
confidentiality, please refer to 21 CFR
10.20.
C. Information Identifying the Person
Submitting the Comment
Dated: August 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–20759 Filed 8–21–15; 8:45 am]
BILLING CODE 4164–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2015–0489; FRL–9932–74–
Region 9]
Revision to the California State
Implementation Plan; San Joaquin
Valley; Demonstration of Creditable
Emission Reductions from Economic
Incentive Programs
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to approve a
demonstration of creditable emission
reductions submitted by California for
approval into the San Joaquin Valley
(SJV) portion of the California State
Implementation Plan (SIP). This SIP
submittal demonstrates that certain state
mobile source incentive funding
programs have achieved specified
amounts of reductions in emissions of
nitrogen oxides (NOX) and fine
particulate matter (PM2.5) in the SJV area
by 2014. The effect of this action would
be to approve these amounts of emission
reductions for credit toward an emission
reduction commitment in the California
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SUPPLEMENTARY INFORMATION:
Throughout this document, ‘‘we’’, ‘‘us’’
and ‘‘our’’ refer to EPA.
Written comments must be
received on or before September 23,
2015.
Table of Contents
I. Background
II. The State’s Submittal
III. EPA’s Evaluation of the State’s Submittal
A. SIP Procedural Requirements
B. EPA Policy on Economic Incentives
C. Sections 110(l) and 193 of the Act
IV. Proposed Action and Public Comment
V. Statutory and Executive Order Reviews
DATES:
Please note that your name, contact
information, and other information
identifying you will be posted on
https://www.regulations.gov if you
include that information in the body of
your comments. For electronic
comments submitted to https://
www.regulations.gov, FDA will post the
body of your comment on https://
www.regulations.gov along with your
State/province and country (if
provided), the name of your
representative (if any), and the category
identifying you (e.g., individual,
consumer, academic, industry). For
written submissions submitted to the
Division of Dockets Management, FDA
will post the body of your comments on
https://www.regulations.gov, but you can
put your name and/or contact
information on a separate cover sheet
and not in the body of your comments.
SUMMARY:
51147
Submit your comments,
identified by Docket ID Number EPA–R
09–OAR–2015–0489, by one of the
following methods:
1. https://www.regulations.gov: Follow
the on-line instructions for submitting
comments.
2. Email: steckel.andrew@epa.gov
3. Mail or deliver: Andrew Steckel
(AIR–4), U.S. Environmental Protection
Agency, Region IX, 75 Hawthorne
Street, San Francisco, CA 94105–3901.
Deliveries are only accepted during the
Regional Office’s normal hours of
operation.
Instructions: All comments will be
included in the public docket without
change and may be made available
online at https://www.regulations.gov,
including any personal information
provided, unless the comment includes
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Information that
you consider CBI or otherwise protected
should be clearly identified as such and
should not be submitted through https://
www.regulations.gov or email. https://
www.regulations.gov is an anonymous
access system, and EPA will not know
your identity or contact information
unless you provide it in the body of
your comment. If you send email
directly to EPA, your email address will
be automatically captured and included
as part of the public comment. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Docket: Generally, documents in the
docket for this action are available
electronically at www.regulations.gov
and in hard copy at EPA Region IX, 75
Hawthorne Street, San Francisco,
California. While all documents in the
docket are listed at
www.regulations.gov, some information
may be publicly available only at the
hard copy location (e.g., copyrighted
material, large maps), and some may not
be publicly available in either location
(e.g., CBI). To inspect the hard copy
materials, please schedule an
appointment during normal business
hours with the contact listed in the FOR
FURTHER INFORMATION CONTACT section.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Idalia Perez, EPA Region IX, perez.
idalia@epa.gov, (415) 972–3248.
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I. Background
On July 18, 1997, EPA established
new national ambient air quality
standards (NAAQS) for particles less
than or equal to 2.5 micrometers (mm) in
diameter (PM2.5), including an annual
standard of 15.0 micrograms per cubic
meter (mg/m3) based on a 3-year average
of annual mean PM2.5 concentrations,
and a 24-hour (daily) standard of 65 mg/
m3 based on a 3-year average of 98th
percentile 24-hour PM2.5
concentrations.1 EPA established these
standards after considering substantial
evidence from numerous health studies
demonstrating that serious health effects
are associated with exposures to PM2.5
concentrations above these levels.
Following promulgation of a new or
revised NAAQS, EPA is required under
Clean Air Act (CAA) section 107(d) to
designate areas throughout the nation as
attaining or not attaining the NAAQS.
On January 5, 2005, EPA published
initial air quality designations for the
1997 annual and 24-hour PM2.5 NAAQS,
using air quality monitoring data for the
three-year periods of 2001–2003 and
2002–2004.2 These designations became
effective April 5, 2005.3 EPA designated
the San Joaquin Valley (SJV) area 4 as
nonattainment for both the 1997 annual
PM2.5 standard (15.0 mg/m3) and the
1997 24-hour PM2.5 standard (65 mg/
m3).5
Between 2007 and 2011, California
made six SIP submittals to address
nonattainment area planning
1 62 FR 36852 (July 18, 1997) and 40 CFR 50.7.
Effective December 18, 2006, EPA strengthened the
24-hour PM2.5 NAAQS by lowering the level to 35
mg/m3. 71 FR 61144 (October 17, 2006) and 40 CFR
50.13. Effective March 18, 2013, EPA strengthened
the annual PM2.5 NAAQS by lowering the level to
12 mg/m3. 78 FR 3086 (January 15, 2013) and 40
CFR 50.18. In this preamble, all references to the
PM2.5 NAAQS, unless otherwise specified, are to
the 1997 24-hour standard (65 mg/m3) and annual
standard (15.0 mg/m3) as codified in 40 CFR 50.7.
2 70 FR 944 (January 5, 2005).
3 Id.
4 The SJV area encompasses over 23,000 square
miles and includes all or part of eight counties in
California’s central valley: San Joaquin, Stanislaus,
Merced, Madera, Fresno, Tulare, Kings, and Kern.
For a precise description of the geographic
boundaries of the San Joaquin Valley nonattainment
area, see 40 CFR 81.305.
5 40 CFR 81.305.
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Agencies
[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Proposed Rules]
[Pages 51146-51147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20759]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 /
Proposed Rules
[[Page 51146]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1100, 1140, and 1143
[Docket No. FDA-2015-N-1514]
RIN 0910-AH24
Nicotine Exposure Warnings and Child-Resistant Packaging for
Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco
Products; Request for Comments; 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) is extending the
comment period for the advance notice of proposed rulemaking (ANPRM)
entitled ``Nicotine Exposure Warnings and Child-Resistant Packaging for
Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco
Products'' that appeared in the Federal Register of July 1, 2015. In
the ANPRM, FDA requested comments, data, research results, or other
information, that may inform regulatory actions that FDA might take
with respect to nicotine exposure warnings and child-resistant
packaging for liquid nicotine and nicotine-containing e-liquid(s) that
are made or derived from tobacco and intended for human consumption,
and potentially for other tobacco products including, but not limited
to, novel tobacco products such as dissolvables, lotions, gels, and
drinks. 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 July
1, 2015 (80 FR 37555). Submit either electronic or written comments by
September 30, 2015.
ADDRESSES: You may submit comments by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Docket No.
FDA-2015-N-1514 for this rulemaking. All comments received may be
posted without change to https://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Requests for Comments and Information'' heading of
the SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
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: Bryant M. Godfrey or Courtney S.
Smith, Center for Tobacco Products, Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993, 1-877-CTP-1373,
CTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 1, 2015 (80 FR 37555), FDA
published an ANPRM with a 60-day comment period to request comments,
data, research results, or other information, that may inform
regulatory actions that FDA might take with respect to nicotine
exposure warnings and child-resistant packaging for liquid nicotine and
nicotine-containing e-liquid(s) that are made or derived from tobacco
and intended for human consumption, and potentially for other tobacco
products including, but not limited to, novel tobacco products such as
dissolvables, lotions, gels, and drinks.
The Agency has received several comments requesting an extension of
the comment period for the ANPRM. These comments convey concern that
the current 60-day comment period does not allow sufficient time to
develop meaningful or thoughtful responses to questions raised in the
ANPRM.
FDA has considered the requests and is extending the comment period
for the ANPRM for 30 days, until September 30, 2015. 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.
II. Requests for Comments and Information
A. General Information About Submitting Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document.
B. Public Availability of Comments
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at https://www.regulations.gov. As a matter of Agency
practice, FDA generally does not post comments submitted by individuals
in their individual capacity on https://www.regulations.gov. This is
determined by information indicating that the submission is written by
an individual, for example, the comment is identified with the category
``Individual Consumer'' under the field entitled ``Category
(Required)'', on the ``Your Information'' page on https://www.regulations.gov; for this ANPRM, however, FDA will not be following
this general practice. Instead, FDA will post on https://www.regulations.gov comments to this docket that have been submitted by
individuals in their individual capacity. If you wish to submit any
information under a claim of
[[Page 51147]]
confidentiality, please refer to 21 CFR 10.20.
C. Information Identifying the Person Submitting the Comment
Please note that your name, contact information, and other
information identifying you will be posted on https://www.regulations.gov if you include that information in the body of your
comments. For electronic comments submitted to https://www.regulations.gov, FDA will post the body of your comment on https://www.regulations.gov along with your State/province and country (if
provided), the name of your representative (if any), and the category
identifying you (e.g., individual, consumer, academic, industry). For
written submissions submitted to the Division of Dockets Management,
FDA will post the body of your comments on https://www.regulations.gov,
but you can put your name and/or contact information on a separate
cover sheet and not in the body of your comments.
Dated: August 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20759 Filed 8-21-15; 8:45 am]
BILLING CODE 4164-01-P