Electronic Cigarettes and the Public Health; Public Workshop, 78450-78452 [2014-30450]
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Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices
General Function of the Committee:
The Science Board provides advice
primarily to the Commissioner of Food
and Drugs and other appropriate
officials on specific complex scientific
and technical issues important to the
FDA and its mission, including
emerging issues within the scientific
community. Additionally, the Science
Board provides advice to the Agency on
keeping pace with technical and
scientific developments including in
regulatory science, input into the
Agency’s research agenda, on upgrading
its scientific and research facilities, and
training opportunities. It will also
provide, where requested, expert review
of Agency-sponsored intramural and
extramural scientific research programs.
Date and Time: The meeting will be
held on March 4, 2015, from 8:30 a.m.
to 4 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503 B and C) Silver Spring, MD
20993–0002. For those unable to attend
in person, the meeting will also be
Webcast. The link for the Webcast is
available at https://
collaboration.fda.gov/sb315/.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Martha Monser,
Office of the Commissioner, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, Rm. 3309,
Silver Spring, MD 20993–0002, 301–
796–4627, martha.monser@fda.hhs.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
site at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: The Science Board will be
provided with a progress report or a
final draft report the Commissioner’s
Fellowship Program Evaluation
subcommittee and will hear a progress
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report from Science Moving Forward
subcommittee. The Science Board will
be asked to provide feedback on FDA’s
public access policy. FDA will seek the
Science Board’s input regarding
approaches to regulatory science
training coordination. The Science
Board will be provided with a follow up
on FDA’s activities regarding the reintroduction of bovine heparin and will
hear an overview of science-related
activities from one of the centers. A
recipient of one of the Fiscal Year 2014
Scientific Achievement Awards
(selected by the Science Board) will
provide an overview of the activities for
which the award was given.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before February 25, 2015.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 1:30 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before February
17, 2015. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by February 18, 2015.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
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accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Ms. Martha
Monser at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–30516 Filed 12–29–14; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
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mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices
G335, 10903 New Hampshire Ave.,
Silver Spring, MD 20993–0002, 1–877–
287–1373, email: workshop.CTPOS@
fda.hhs.gov.
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/CTPMarch-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 https://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
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21:42 Dec 29, 2014
Jkt 235001
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 workshop.CTPOS@fda.hhs.gov 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 https://www.fda.gov/
TobaccoProducts/NewsEvents/
ucm238308.htm as soon as the official
transcript is finalized. It will also be
posted to the docket at https://
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 ecigarettes 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
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Fmt 4703
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78451
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, https://www.gpo.gov/
fdsys/pkg/FR-2014-12-02/pdf/201428261.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
E:\FR\FM\30DEN1.SGM
30DEN1
78452
Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices
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 https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Responsibility of Applicants
for Promoting Objectivity in Research
for Which Public Health Service (PHS)
Funding Is Sought 42 CFR Part 50
Subpart F and Responsible
Prospective Contractors 45 CFR Part
94 (OD)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
Office of the Director (OD), National
Institutes of Health (NIH), will publish
SUMMARY:
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
DATES: Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Title:
Responsibility of Applicants for
Promoting Objectivity in Research for
which Public Health Service (PHS)
Funding is Sought 42 CFR part 50
Subpart F and Responsible Prospective
Contractors 45 CFR part 94 OMB# 0925–
0417, Expiration Date: 02/2015,
EXTENSION, National Institutes of
Health (NIH), Office of the Director
(OD).
Need and Use of Information
Collection: This is a request for OMB
Approval for an extension of the
information collection and
recordkeeping requirements contained
in the final rule 42 CFR part 50, subpart
F and 45 CFR part 94. The purpose of
these regulations is to promote
objectivity in research by requiring
institutions to establish standards that
provide a reasonable expectation that
the design, conduct, and reporting of
research funded under PHS grants,
cooperative agreements and contracts
will be free from bias resulting from
Investigator financial conflicts of
interest.
OMB approval is requested for an
extension of 3 years. There are operating
costs and/or maintenance costs per
response. The total estimated
annualized burden hours are 676,130.
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To submit comments and for further
information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Ms. Kathy Hancock,
Assistant Grants Compliance Officer,
Division of Grants Compliance and
Oversight, Office of Policy for
Extramural Research Administration
(OPERA), 6705 Rockledge Drive, Room
3523, Bethesda, MD 20892, or call nontoll-free number (301) 435–1962, or
Email your request, including your
address to: FCOICompliance@
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Type of respondent based on applicable section of regulation
Average
burden per
response
(in hours)
Total annual
burden hour
Reporting
mstockstill on DSK4VPTVN1PROD with NOTICES
Initial Reports under 42 CFR 50.605(b)(1) and (b)(3) or 45 CFR 94.5(b)(1)
and (b)(3) from Awardee Institutions ...........................................................
Subsequent Reports under 42 CFR 50.605(a)(3)(iii) and (b)(2) or 45 CFR
94.5(a)(iii) and (b)(2) from Awardee Institutions ..........................................
Mitigation Reports under 45 CFR 94.5(a)(3)(iii) and (b)(2) from Awardee Institutions .......................................................................................................
Annual Report under 42 CFR 50.605(b)(4) or 45 CFR 94.5(b)(4) from
Awardee Institution .......................................................................................
Subsequent Reports under 42 CFR 60.606(a) or 45 CFR 94.6(a) from
Awardee Institution .......................................................................................
950
1
2
1,900
50
1
2
100
5
1
2
10
950
1
1
950
20
1
10
200
2,000
1
4
8,000
3,000
38,000
2,000
1
1
1
81
30/60
6
243,000
19,000
12,000
Record Keeping
Under 42 CFR 50.604(i) or 45 CFR 94.4(i) from Awardee Institutions ..........
Disclosure
Under 42 CFR 50.604(a) or 45 CFR 94.4(a) for Investigators .......................
Under 42 CFR 50.604(b) or 45 CFR 94.4(b) for Investigators .......................
Under 42 CFR 50.604(b) or 45 CFR 94.4(b) for Institutions ..........................
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21:42 Dec 29, 2014
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]]>Agencies
[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78450-78452]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30450]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: workshop.CTPOS@fda.hhs.gov.
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 https://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 workshop.CTPOS@fda.hhs.gov 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 https://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm as soon as the official transcript is finalized. It will
also be posted to the docket at https://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, https://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 https://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
