
[Federal Register Volume 78, Number 122 (Tuesday, June 25, 2013)]
[Notices]
[Pages 38059-38060]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15102]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


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: 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 August 16, 2013, from 
8:30 a.m. to 3 p.m.
    Location: Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver 
Spring, MD 20910.
    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: TPSAC@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 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 August 16, 2013, the Committee will discuss possible 
approaches for evaluating information on the risks and potential 
benefits of a proposed modified risk tobacco product (MRTP) to the 
population as a whole. MRTPs are tobacco products that are sold or 
distributed for use to reduce harm or the risk of tobacco-related 
disease associated with commercially marketed tobacco products. Before 
an MRTP can be introduced or delivered for introduction into interstate 
commerce, an order from FDA under section 911(g) (21 U.S.C. 387k(g)) of 
the Federal Food, Drug, and Cosmetic Act must be in effect with respect 
to the tobacco product. 21 U.S.C. 387k(a).
    In reviewing MRTP applications, among other things, FDA must 
evaluate the effects of a proposed product on the health of individual 
tobacco users and the population as a whole, taking into account: (1) 
The relative health risks to individuals of the MRTP; (2) the increased 
or decreased likelihood that existing users of tobacco products who 
would otherwise stop using such products will switch to the MRTP; (3) 
the increased or decreased likelihood that persons who do not use 
tobacco products will start using the MRTP; (4) the risks and benefits 
to persons from the use of the MRTP compared to the use of smoking 
cessation drug or device products approved by FDA to treat nicotine 
dependence; and (5) comments, data, and information submitted to FDA by 
interested persons. 21 U.S.C. 387k(g)(4).
    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 submissions may be made to the contact person on or before 
August 1, 2013. Oral presentations from the public will be scheduled 
between approximately 11 a.m. and 12 noon. 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 July 25, 2013. 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 July 26, 2013.
    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).


[[Page 38060]]


    Dated: June 19, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-15102 Filed 6-24-13; 8:45 am]
BILLING CODE 4160-01-P


