Battery Safety Concerns in Electronic Nicotine Delivery Systems; Public Workshop; Establishment of a Public Docket; Request for Comments, 852-854 [2016-31857]
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Federal Register / Vol. 82, No. 2 / Wednesday, January 4, 2017 / Notices
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.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.
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Kevin Rice, Center for Veterinary
Medicine (HFV–140), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0680,
kevin.rice@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK3G9T082PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft GIF #242 entitled ‘‘In-Use
Stability Studies and Associated
Labeling Statements for Multiple-Dose
Injectable Animal Drug Products.’’ The
purpose of in-use stability testing is to
establish a period of time during which
a multiple-dose drug product may be
used while retaining acceptable quality
specifications once the container is
opened (e.g., after a container has been
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needle-punctured). This draft guidance
reflects the Agency’s current thinking
on how to formulate in-use statements,
as well as how to design and carry out
in-use stability studies to support these
in-use statements, for multiple-dose
injectable drug products intended for
use in animals. This current thinking
pertains to both generic drug products
and pioneer drug products regardless of
whether or not the pioneer RLNAD
currently has an in-use statement on the
labeling.
II. Significance of Guidance
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on ‘‘In-Use Stability
Studies and Associated Labeling
Statements for Multiple-Dose Injectable
Animal Drug Products.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 514 have
been approved under OMB control
number 0910–0032. The collections of
information in 21 CFR part 511 have
been approved under OMB control
number 0910–0117. The collections of
information in sections 512(b) and (n) of
the Federal Food, Drug, and Cosmetic
Act have been approved under OMB
control number 0910–0669.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: December 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31855 Filed 1–3–17; 8:45 am]
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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.
Public workshop; establishment
of public docket; request for data,
information, and comments.
ACTION:
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.
SUMMARY:
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
ADDRESSES:
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Federal Register / Vol. 82, No. 2 / Wednesday, January 4, 2017 / Notices
security check procedures will be
performed. For parking, transportation,
security, and information regarding
special accommodations due to a
disability, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments to the
public docket as follows:
mstockstill on DSK3G9T082PROD with NOTICES
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
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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: https://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: CTPRegulations@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Pub. L. 111–
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853
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 https://
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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854
Federal Register / Vol. 82, No. 2 / Wednesday, January 4, 2017 / Notices
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 eliquids), 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
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related to workshop presentations and
discussions topics, including specific
questions, can be found at https://
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 https://
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
PO 00000
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the above information, along with the
topic(s) on which you would like to
speak, to workshop.CTPOS@fda.hhs.gov
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 https://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 AskCTP@
fda.hhs.gov 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
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 853]]
security check procedures will be performed. For parking,
transportation, security, and information regarding special
accommodations due to a disability, please refer to https://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: https://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:
CTPRegulations@fda.hhs.gov.
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 https://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
[[Page 854]]
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 https://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 https://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 workshop.CTPOS@fda.hhs.gov 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 https://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 AskCTP@fda.hhs.gov 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
