[Federal Register Volume 82, Number 2 (Wednesday, January 4, 2017)]
[Notices]
[Pages 852-854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31857]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4232]


Battery Safety Concerns in Electronic Nicotine Delivery Systems; 
Public Workshop; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Public workshop; establishment of public docket; request for 
data, information, and comments.

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SUMMARY: The Food and Drug Administration (FDA) Center for Tobacco 
Products (CTP) is announcing several actions concerning issues related 
to batteries used in electronic nicotine delivery systems (ENDS), 
including electronic cigarettes (e-cigarettes). These actions are 
intended to give CTP staff an opportunity to hear from the public, 
including tobacco product manufacturers, importers, researchers, and 
academic investigators, about ENDS battery safety concerns (e.g., 
overheating, fire, explosion), risk mitigation, and design parameters. 
Additionally, FDA is interested in information related to communication 
to consumers and the general public related to ENDS battery safety 
concerns. FDA is announcing a public workshop on ENDS batteries and 
safety hazards. The 2-day public workshop will include presentations 
and panel discussions about ENDS battery safety concerns as well as how 
potential safety hazards and risks are communicated to consumers and 
the general public. In conjunction with the public workshop, FDA is 
establishing a public docket to gather data and information on hazards 
and risks associated with the use of batteries in ENDS. Regardless of 
attendance at the public workshop, interested parties are invited to 
submit comments, including data and research.

DATES: The public workshop will be held on April 19 and 20, 2017, from 
8:30 a.m. to 4:30 p.m. Individuals who wish to attend the public 
workshop must register by March 17, 2017. Electronic or written 
comments to the docket will be accepted until May 22, 2017.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public 
meeting participants (non-FDA employees) is through Building 1 where 
routine

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security check procedures will be performed. For parking, 
transportation, security, and information regarding special 
accommodations due to a disability, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments to the public docket 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-4232 for ``Battery Safety Concerns in Electronic Nicotine 
Delivery Systems (ENDS) Public Workshop; Establishment of a Public 
Docket; Request for Comments.'' Received comments 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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: Joanna Randazzo, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
75, Rm. 4411A, Silver Spring, MD 20993-0002, 1-877-287-1373, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control 
Act), amending the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
and giving FDA authority to regulate tobacco product manufacturing, 
distribution, and marketing. The FD&C Act also gives FDA the ability, 
through rulemaking, to regulate additional products that meet the legal 
definition of a tobacco product. On May 10, 2016, FDA published a final 
rule entitled ``Deeming Tobacco Products to be Subject to the Federal 
Food, Drug, and Cosmetic Act, as Amended by the Family Smoking 
Prevention and Tobacco Control Act; Restrictions on the Sale and 
Distribution of Tobacco Products and Required Warning Statements for 
Tobacco Products'' (81 FR 28974) that became effective on August 8, 
2016. Under this rule, newly deemed tobacco products, such as ENDS, are 
now subject to the provisions of the Tobacco Control Act that apply 
automatically to all products that meet the statutory definition of a 
tobacco product in section 201(rr) of the FD&C Act.
    FDA has become aware of recent reports of battery-related safety 
events such as exploding batteries in ENDS, which include e-cigarettes. 
As a result, FDA is interested in gaining knowledge about ENDS battery 
safety hazards and controls, including internal and external battery-
related factors, specifications, safety, and design parameters of the 
ENDS apparatus. In addition, FDA is interested in understanding how 
these risks currently are communicated to consumers, as well as how 
they may be communicated in the future, in an effort to determine the 
most effective method to address these problems. FDA is announcing a 
public workshop and establishing a public docket to gather data and 
information on hazards and risks associated with the use of batteries 
in ENDS. Regardless of attendance at the public workshop, interested 
parties are invited to submit comments, supported by research and data, 
regarding the topics for discussion at the public workshop (see section 
II). Information related to workshop presentations and discussion 
topics, including specific questions to be addressed at the workshop, 
can be found at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm. The information gathered through this public docket may 
be used by FDA in considering future actions.

II. Public Workshop on Battery Safety Concerns in ENDS

    FDA is announcing a 2-day public workshop to gather scientific 
information and stimulate discussion about hazards and risks associated 
with

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the use of batteries in ENDS, including e-cigarettes. In particular, 
the workshop seeks to gather information, including research and data, 
on: (1) ENDS battery safety concerns (e.g., overheating, fire, 
explosion, other modes of failure); (2) factors that contribute to ENDS 
battery failures; and (3) information on ENDS design features and other 
parameters that may impact the occurrence of these failures. The 
workshop is intended to better inform FDA about the hazards and risks 
associated with the use of batteries in ENDS. FDA is seeking input from 
a broad group of stakeholders, including, but not limited to: 
Scientific and medical experts; ENDS manufacturers, importers, 
distributors, wholesalers, and retailers; manufacturers of batteries 
for ENDS and other consumer products; state, and local government 
agencies; and other interested stakeholders, such as academic 
researchers and public health organizations.
    Topics for Discussion: The public workshop will include 
presentations and panel discussions regarding substantive scientific 
information, specifically relating to hazards and risks associated with 
the use of batteries in ENDS, including e-cigarettes. Topics to be 
addressed include, for example: (1) Factors that contribute to failure 
of rechargeable and non-rechargeable ENDS batteries resulting in 
overheating, fire, explosion, or other modes of failure (this may 
include factors relating to batteries, charging equipment, components 
and parts such as voltage and temperature controllers or other 
circuitry, other ENDS design features, user modification of ENDS, and 
e-liquids), and what influence these factors have on the mode of 
failure (e.g., battery overheating versus explosion); (2) safety 
features (e.g., circuit protection, charging safety features) and 
battery standards that may be applied to ENDS batteries to limit their 
potential for overheating, fire, explosion, or other mode of failure; 
(3) changes, improvements, and innovations to battery and ENDS design 
that would limit the potential for overheating, fire, explosion, or 
other mode of failure; (4) other public health risks associated with 
ENDS batteries (e.g., leakage); (5) ENDS design changes that could 
mitigate public health risks upon battery failure; (6) battery safety 
information that is communicated to ENDS consumers and the general 
public; and (7) best practices to effectively communicate potential 
risks associated with ENDS batteries to consumers and the general 
public (e.g., via labeling, instructions for use, warnings). Additional 
information related to workshop presentations and discussions topics, 
including specific questions, can be found at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm.
    Attendance and Registration: To attend the workshop in person or by 
Webcast, individuals must register by submitting either an electronic 
or written request no later than March 17, 2017. Please submit 
electronic requests to register at https://www.surveymonkey.com/r/FDACTP_ENDS_Battery_Workshop. Persons without Internet access may send 
written requests for registration to Dhanya John, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., 
Document Control Center, Building 71, Rm. G335, Silver Spring, MD 
20993-0002. Requests for registration must include the prospective 
attendee's name, title, affiliation, address, email address if 
available, and telephone number. Registration is free and you may 
register to either attend in-person or view the live Webcast. For 
registrants with Internet access, confirmation of registration will be 
emailed to you no later than March 21, 2017. For additional information 
regarding public workshop location and attendance capacities please 
refer to http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm.
    Presenters and Panelists: FDA is interested in gathering scientific 
information from individuals with a broad range of perspectives on 
technical topics to be discussed at the workshop. To be considered to 
serve as a presenter, please provide the following:
     A brief abstract for each presentation: The abstract 
should identify the specific topic(s) to be addressed and the amount of 
time requested.
     A one-page biosketch that describes and supports your 
scientific expertise on the specific topic(s) being presented, nature 
of your experience and research in the scientific field, positions 
held, and any program development activities.
    Panelists will discuss their scientific knowledge on the questions 
and presentations in each session. To be considered to serve as a 
panelist, please provide a one-page biosketch that describes and 
supports your scientific expertise on the specific topic(s) being 
presented, nature of your experience and research in the scientific 
field, positions held, and any program development activities.
    If you are interested in serving as a presenter or a panelist, 
please submit the above information, along with the topic(s) on which 
you would like to speak, to [email protected] by February 17, 
2017.
    Oral Presentations by Members of the Public: This workshop will 
include a public comment session. Persons wishing to present during the 
public comment session must make this request at the time of 
registration and should identify the topic they wish to address from 
among those topics under consideration, which are identified in section 
II of this document. FDA will do its best to accommodate requests to 
present. FDA urges individuals and organizations with common interests 
to consolidate or coordinate their comments, and request a single time 
for a joint presentation. Requesters with Internet access and who have 
submitted a working email address will receive an email regarding their 
request to speak during the public comment session by March 21, 2017.
    Transcripts: A transcript of the proceedings will be available 
after the workshop at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm as soon as the official transcript is finalized. It also 
will be posted to the docket at https://www.regulations.gov.

III. Additional Opportunities To Speak With FDA

    As is always the case, we welcome entities interested in meeting 
with FDA to discuss any of these ENDS battery safety topics to contact 
FDA directly. To facilitate such meetings, you may submit requests for 
an informal meeting to the attention of the Director, Office of 
Science, CTP, via email to [email protected] or U.S. mail to the 
following address: Food and Drug Administration, Center for Tobacco 
Products, Document Control Center, 10903 New Hampshire Ave., Building 
71, Rm. G335, Silver Spring, MD 20993-0002. Please prominently identify 
your request as ``ENDS battery informal meeting.'' Please refer to 
section II for more information regarding submitting comments to the 
public docket.

    Dated: December 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31857 Filed 1-3-17; 8:45 am]
BILLING CODE 4164-01-P