[Federal Register Volume 80, Number 54 (Friday, March 20, 2015)]
[Notices]
[Pages 15018-15020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06388]


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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; extension of comment period.

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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 (e-cigarettes) and the public health. This will 
be the final 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 impacts on the population as a whole, 
including users and non-users of tobacco products.
    Dates and Times: The public workshop will be held on June 1 and 2, 
2015. Individuals who wish to attend the public workshop must register 
by May 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, 10903 
New Hampshire Ave., Bldg. 71, Rm. G335, 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 May 20, 2015. Please submit 
electronic requests at https://www.surveymonkey.com/s/CTP-June-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 May 25, 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) at least 7 days in advance of 
the meeting.
    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

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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 April 3, 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 III. 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 May 25, 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 population health, including prevalence and 
patterns of use, impacts of e-cigarettes on tobacco product users and 
non-users, and knowledge, attitudes, and beliefs about e-cigarette 
products. A workshop on December 10-11, 2014, focused on e-cigarette 
product science, product packaging, constituent labeling, and 
environmental impact; and a workshop on March 9-10, 2015, focused on 
the impact of e-cigarettes on individual health.
    On April 25, 2014, FDA published a document to extend its tobacco 
product authorities to additional products that meet the statutory 
definition of ``tobacco product'' 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; 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 Chapter IX of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387-387u). 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 III.

II. Extension of Comment Period

    Extension. At the start of the first workshop in this series, FDA 
announced via a Federal Register document 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). The comment period for 
submission of written comments was scheduled to end on April 15, 2015. 
The Agency is extending the comment period to end on July 2, 2015, to 
allow interested parties time to submit comments concerning the third 
workshop.
    General Information About Submitting Comments. Regardless of 
attendance at the public workshop, interested parties are invited to 
submit comments, supported by research and data, regarding e-cigarettes 
and the public health. 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.
    Interested persons may submit either electronic comments to http://www.regulations.gov or written comments to this docket to the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852. 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. 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.
    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 titled ``Category (Required),'' on the 
``Your Information'' page on www.regulations.gov. For this docket, 
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 confidentiality, please 
refer to 21 CFR 10.20.
    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://

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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.

III. 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 the population as a whole. Topics to be 
addressed include: (1) Prevalence and patterns of use; (2) impacts on 
current tobacco product users; (3) impacts on non-users of tobacco 
products; and (4) knowledge, attitudes, beliefs, and perceptions about 
e-cigarette products.
    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: March 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06388 Filed 3-19-15; 8:45 am]
 BILLING CODE 4164-01-P