[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