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)

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, 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.

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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