80 FR 51146 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 163 (August 24, 2015)

Page Range		51146-51147
FR Document		2015-20759

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.

Federal Register, Volume 80 Issue 163 (Monday, August 24, 2015)

[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Proposed Rules]
[Pages 51146-51147]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20759]


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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.

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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: http://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 http://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 http://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, 
[email protected].

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 http://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 http://www.regulations.gov. As a matter of Agency 
practice, FDA generally does not post comments submitted by individuals 
in their individual capacity on http://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 http://www.regulations.gov; for this ANPRM, however, FDA will not be following 
this general practice. Instead, FDA will post on http://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  http://www.regulations.gov if you include that information in the body of your 
comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the body of your comment on http://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 http://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

Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Proposed Rules 51147

confidentiality, please refer to 21 CFR SIP. We are taking comments on this SUPPLEMENTARY INFORMATION:
10.20. proposal and plan to follow with a final Throughout this document, ‘‘we’’, ‘‘us’’
action. and ‘‘our’’ refer to EPA.
C. Information Identifying the Person
Submitting the Comment DATES: Written comments must be Table of Contents
received on or before September 23, I. Background
Please note that your name, contact
2015. II. The State’s Submittal
information, and other information III. EPA’s Evaluation of the State’s Submittal
identifying you will be posted on ADDRESSES: Submit your comments, A. SIP Procedural Requirements
http://www.regulations.gov if you identified by Docket ID Number EPA–R B. EPA Policy on Economic Incentives
include that information in the body of 09–OAR–2015–0489, by one of the C. Sections 110(l) and 193 of the Act
your comments. For electronic following methods: IV. Proposed Action and Public Comment
comments submitted to http:// V. Statutory and Executive Order Reviews
1. http://www.regulations.gov: Follow
www.regulations.gov, FDA will post the the on-line instructions for submitting I. Background
body of your comment on http:// comments.
www.regulations.gov along with your On July 18, 1997, EPA established
2. Email: steckel.andrew@epa.gov new national ambient air quality
State/province and country (if
provided), the name of your 3. Mail or deliver: Andrew Steckel standards (NAAQS) for particles less
representative (if any), and the category (AIR–4), U.S. Environmental Protection than or equal to 2.5 micrometers (mm) in
identifying you (e.g., individual, Agency, Region IX, 75 Hawthorne diameter (PM2.5), including an annual
consumer, academic, industry). For Street, San Francisco, CA 94105–3901. standard of 15.0 micrograms per cubic
Deliveries are only accepted during the meter (mg/m3) based on a 3-year average
written submissions submitted to the
Regional Office’s normal hours of of annual mean PM2.5 concentrations,
Division of Dockets Management, FDA
operation. and a 24-hour (daily) standard of 65 mg/
will post the body of your comments on
Instructions: All comments will be m3 based on a 3-year average of 98th
http://www.regulations.gov, but you can
included in the public docket without percentile 24-hour PM2.5
put your name and/or contact
change and may be made available concentrations.1 EPA established these
information on a separate cover sheet
online at http://www.regulations.gov, standards after considering substantial
and not in the body of your comments.
including any personal information evidence from numerous health studies
Dated: August 18, 2015. demonstrating that serious health effects
provided, unless the comment includes
Leslie Kux, Confidential Business Information (CBI) are associated with exposures to PM2.5
Associate Commissioner for Policy. or other information whose disclosure is concentrations above these levels.
[FR Doc. 2015–20759 Filed 8–21–15; 8:45 am] restricted by statute. Information that Following promulgation of a new or
BILLING CODE 4164–01–P you consider CBI or otherwise protected revised NAAQS, EPA is required under
should be clearly identified as such and Clean Air Act (CAA) section 107(d) to
should not be submitted through http:// designate areas throughout the nation as
www.regulations.gov or email. http:// attaining or not attaining the NAAQS.
ENVIRONMENTAL PROTECTION
www.regulations.gov is an anonymous On January 5, 2005, EPA published
AGENCY
initial air quality designations for the
access system, and EPA will not know
40 CFR Part 52 1997 annual and 24-hour PM2.5 NAAQS,
your identity or contact information
using air quality monitoring data for the
[EPA–R09–OAR–2015–0489; FRL–9932–74– unless you provide it in the body of
three-year periods of 2001–2003 and
Region 9] your comment. If you send email
2002–2004.2 These designations became
directly to EPA, your email address will
effective April 5, 2005.3 EPA designated
Revision to the California State be automatically captured and included
the San Joaquin Valley (SJV) area 4 as
Implementation Plan; San Joaquin as part of the public comment. If EPA
nonattainment for both the 1997 annual
Valley; Demonstration of Creditable cannot read your comment due to
PM2.5 standard (15.0 mg/m3) and the
Emission Reductions from Economic technical difficulties and cannot contact
1997 24-hour PM2.5 standard (65 mg/
Incentive Programs you for clarification, EPA may not be m3).5
able to consider your comment. Between 2007 and 2011, California
AGENCY: Environmental Protection
Agency (EPA). Docket: Generally, documents in the made six SIP submittals to address
docket for this action are available nonattainment area planning
ACTION: Proposed rule. electronically at www.regulations.gov
SUMMARY: The Environmental Protection and in hard copy at EPA Region IX, 75 1 62 FR 36852 (July 18, 1997) and 40 CFR 50.7.

Agency (EPA) is proposing to approve a Hawthorne Street, San Francisco, Effective December 18, 2006, EPA strengthened the
California. While all documents in the 24-hour PM2.5 NAAQS by lowering the level to 35
demonstration of creditable emission mg/m3. 71 FR 61144 (October 17, 2006) and 40 CFR
reductions submitted by California for docket are listed at 50.13. Effective March 18, 2013, EPA strengthened
approval into the San Joaquin Valley www.regulations.gov, some information the annual PM2.5 NAAQS by lowering the level to
may be publicly available only at the 12 mg/m3. 78 FR 3086 (January 15, 2013) and 40
(SJV) portion of the California State CFR 50.18. In this preamble, all references to the
Implementation Plan (SIP). This SIP hard copy location (e.g., copyrighted PM2.5 NAAQS, unless otherwise specified, are to
submittal demonstrates that certain state material, large maps), and some may not the 1997 24-hour standard (65 mg/m3) and annual
mobile source incentive funding be publicly available in either location standard (15.0 mg/m3) as codified in 40 CFR 50.7.
rmajette on DSK2VPTVN1PROD with PROPOSALS

programs have achieved specified (e.g., CBI). To inspect the hard copy 2 70 FR 944 (January 5, 2005).
3 Id.
amounts of reductions in emissions of materials, please schedule an
4 The SJV area encompasses over 23,000 square
nitrogen oxides (NOX) and fine appointment during normal business
miles and includes all or part of eight counties in
particulate matter (PM2.5) in the SJV area hours with the contact listed in the FOR California’s central valley: San Joaquin, Stanislaus,
by 2014. The effect of this action would FURTHER INFORMATION CONTACT section. Merced, Madera, Fresno, Tulare, Kings, and Kern.
For a precise description of the geographic
be to approve these amounts of emission FOR FURTHER INFORMATION CONTACT: boundaries of the San Joaquin Valley nonattainment
reductions for credit toward an emission Idalia Perez, EPA Region IX, perez. area, see 40 CFR 81.305.
reduction commitment in the California idalia@epa.gov, (415) 972–3248. 5 40 CFR 81.305.

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Document Created: 2015-12-15 10:55:06
Document Modified: 2015-12-15 10:55:06

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Advance notice of proposed rulemaking; extension of comment period.
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.
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, [email protected]
FR Citation		80 FR 51146
RIN Number		0910-AH24
CFR Citation		21 CFR 1100 21 CFR 1140 21 CFR 1143

80 FR 51146 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 163 (August 24, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration