[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Notices]
[Page 58019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23868]
[[Page 58019]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Tobacco Products Scientific Advisory Committee
(TPSAC).
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 November 2, 2011, from 9
a.m. to 5 p.m., and on November 3, 2011, from 8 a.m. to 5 p.m.
Location: Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd. rm. 020B, 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 4), e-mail: [email protected], or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), and follow the prompts to the desired center or
product area. Please call the Information Line for up-to-date
information on this meeting. 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
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
Agenda: The committee will continue the discussions of issues
related to the nature and impact of the use of dissolvable tobacco
products on the public health, including such use among children, as
part of TPSAC's required report to the Secretary of Health and Human
Services. Discussion will include such topics as the composition and
characteristics of dissolvable tobacco products, product use, potential
health effects, and marketing.
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 link.
Procedure: On November 2, 2011, from 1 p.m. to 5 p.m., and on
November 3, from 8 a.m. to 5 p.m., the meeting is open to the public.
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 October 19, 2011. Oral
presentations from the public will be scheduled between approximately
11 a.m. and 12 noon on November 3, 2011. 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 October 11, 2011. 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 October 12, 2011.
Closed Committee Deliberations: On November 2, 2011, from 9 a.m. to
12 noon, the meeting will be closed to permit discussion and review of
trade secret and/or confidential commercial information (5 U.S.C.
552b(c)(4)). This portion of the meeting must be closed because the
committee will be discussing trade secret and/or confidential data
provided by the tobacco companies regarding dissolvable tobacco
products.
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: September 13, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-23868 Filed 9-16-11; 8:45 am]
BILLING CODE 4160-01-P