[Federal Register Volume 79, Number 35 (Friday, February 21, 2014)]
[Notices]
[Pages 9910-9911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03705]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
The Tobacco Products Scientific Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: The Tobacco Products Scientific Advisory
Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on April 16, 2014, from
8:30 a.m. to 5 p.m.; on April 17, 2014, from 8:30 a.m. to 5 p.m.; and
on April 18, 2014, from 8:30 a.m. to 3 p.m.
Location: Center for Tobacco Products, 9200 Corporate Blvd.,
Rockville, MD 20850, 1-877-287-1373.
Contact Person: Caryn Cohen, Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-
287-1373 (choose option 5), email: [email protected], 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 http://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: On April 16, 2014, the committee will consider scientific
issues pertaining to dependence and addiction, including the
development of addiction, measurement of dependence and addiction, and
concepts concerning the assessment of addiction in the review of
product submissions.
On April 17, 2014, the committee will receive information on
population modeling in the assessment of tobacco product applications
and discuss the ways modeling can inform decisions critical to
population health.
On April 18, 2014, the committee will discuss possible approaches
for evaluating information on the risks and potential benefits of a
proposed modified risk tobacco product to the health of individual
tobacco users and to the population as a whole.
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 http://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
[[Page 9911]]
submissions may be made to the contact person on or before April 2,
2014. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 1:30 p.m. on April 16; between approximately 1
p.m. and 1:30 p.m. on April 17; and between approximately 11:30 a.m.
and 12 p.m. on April 18. 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 March 25, 2014. 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 March 24,
2014.
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 accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Caryn Cohen 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 http://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: February 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03705 Filed 2-20-14; 8:45 am]
BILLING CODE 4160-01-P