[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78450-78452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30450]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1936]


Electronic Cigarettes and the Public Health; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA), Center for Tobacco 
Products, is announcing a public workshop to obtain information on 
electronic cigarettes and the public health. This will be the second in 
a series of three workshops. The workshop will include presentations 
and panel discussions about the current state of the science and will 
focus on individual health impacts. FDA intends to follow this workshop 
with an electronic cigarette workshop on population health effects.

DATES AND TIMES: The public workshop will be held on March 9, 2015, 
from 8 a.m. to 5 p.m. and on March 10, 2015, from 8 a.m. to 5 p.m. 
Individuals who wish to attend the public workshop must register by 
February 20, 2015.

LOCATION: The public workshop will be held at the Marriott Inn and 
Conference Center, University of Maryland University College, Potomac 
Ballroom, 3501 University Blvd. East, Hyattsville, MD 20783. The 
conference center's telephone number is 301-985-7300.

CONTACT PERSON: Caryn Cohen, Office of Science, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, Bldg. 
71, Rm.

[[Page 78451]]

G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-
287-1373, email: [email protected].
    Registration to Attend the Workshop: If you wish to attend the 
workshop in person or by Webcast, you must register by submitting an 
electronic or written request no later than February 20, 2015. Please 
submit electronic requests at https://www.surveymonkey.com/s/CTP-March-Workshop. Persons without Internet access may send written requests for 
registration to Caryn Cohen (see Contact Person). 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 attend in person or view 
the live Webcast. Seating and viewership are limited, so early 
registration is recommended. FDA may limit the number of registrants 
from a single organization and the total number of participants if 
registration reaches full capacity. For registrants with Internet 
access, confirmation of registration will be emailed to you no later 
than February 23, 2015. Onsite registration may be allowed if space is 
available. If registration reaches maximum capacity, FDA will post a 
notice closing registration at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm. If you need special accommodations due to a 
disability, please contact Caryn Cohen (see Contact Person) no later 
than March 2, 2015.
    Presenters and Panelists: FDA is interested in gathering scientific 
information from individuals with a broad range of backgrounds on the 
scientific topics to be discussed at the workshop. To be considered 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 the 
speaker's scientific expertise on the specific topic(s) being 
presented, nature of the individual's 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 the following:
     A one page biosketch that describes and supports the 
speaker's scientific expertise on the specific topic(s) being 
presented, nature of the individual's experience and research in the 
scientific field, positions held, and any program development 
activities.
    If you are interested in serving as a presenter or panelist, please 
submit the requested information, along with the topic on which you 
would like to speak, to [email protected] by January 22, 2015.
    Oral Presentations by Members of the Public: This workshop includes 
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 that are identified in section II. 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. For those 
requesters with Internet access, Caryn Cohen (see Contact Person) will 
email you regarding your request to speak during the public comment 
period by February 23, 2015.
    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 will 
also be posted to the docket at http://www.regulations.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop to gather scientific 
information and stimulate discussion among scientists about electronic 
cigarettes (e-cigarettes). The focus of this workshop will be the 
impact of e-cigarettes on individual health, including user exposure, 
topography, abuse liability, dependence, and short and long-term health 
effects. A workshop focusing on product science, product packaging, 
constituent labeling, and environmental impact was held in December 
2014. FDA intends to follow this workshop with an additional workshop 
that will address the impact of e-cigarettes on the population, 
including discussions of product appeal (e.g., impact of advertising, 
marketing, flavorings, consumer perceptions) and product safety 
labeling.
    On April 25, 2014, FDA published a proposed rule to extend its 
tobacco product authorities to additional products that meet the 
statutory definition of ``tobacco product'' ``Deeming Tobacco Products 
to Be Subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act), 
as Amended by the Family Smoking Prevention and Tobacco Control Act; 
Regulations on the Sale and Distribution of Tobacco Products and 
Required Warning Statements for Tobacco Products'' (79 FR 23141, April 
25, 2014, Docket No. FDA-2014-N-0189) (proposed deeming rule). If the 
proposed deeming rule is finalized as proposed, e-cigarettes that are 
tobacco products would be subject to FDA regulation under the FD&C Act. 
As stated in the proposed deeming rule, FDA ``is aware of the recent 
significant increase in the prevalence in e-cigarette use'' (79 FR 
23141 at 23152), and there is much to be learned about these relatively 
new entrants to the market.
    These workshops are intended to better inform FDA about these 
products. Should the Agency move forward as proposed to regulate e-
cigarettes, additional information about the products would assist the 
Agency in carrying out its responsibilities under the law. This would 
be true regardless of the details of any such final rule. Accordingly, 
FDA is working to obtain such information now rather than waiting for 
the conclusion of the deeming rulemaking.
    Participants should note that this workshop is not intended to 
inform the Agency's deeming rulemaking. All comments regarding the 
proposed deeming rule were to be submitted to the Agency by August 8, 
2014 (Docket No. FDA-2014-N-0189). As such, the scope of this workshop 
is limited to the topics presented in Section II.
    At the start of the first workshop in this series, FDA announced 
via a Federal Register notice the opening of a docket for submission of 
written comments regarding all three workshops (see Establishment of a 
Public Docket; Electronic Cigarettes and the Public Health Workshop, 
Docket No. FDA-2014-N-1936, http://www.gpo.gov/fdsys/pkg/FR-2014-12-02/pdf/2014-28261.pdf). Regardless of attendance at the public workshops, 
interested persons are invited to submit comments to the docket. 
Comments submitted to the docket will not be added to other dockets, 
such as the docket for the proposed rule deeming additional tobacco 
products subject to the FD&C Act.

II. Topics for Discussion

    The public workshop will include presentations and panel discussion 
regarding e-cigarettes and the public health, specifically relating to 
the impact of e-cigarettes on individual health. Topics to be addressed 
include, for example: (1) Topography; (2) exposures and toxicological 
considerations; (3) pharmacokinetics

[[Page 78452]]

and pharmacodynamics of nicotine exposure in users; (4) abuse liability 
and dependence; (5) short and long-term health effects in users; (6) 
considerations for high risk or vulnerable populations; and (7) human 
factors. Additional 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.

    Dated: December 22, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30450 Filed 12-29-14; 8:45 am]
BILLING CODE 4164-01-P