[Federal Register Volume 78, Number 121 (Monday, June 24, 2013)]
[Notices]
[Page 37821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-14947]
[[Page 37821]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Joint Meeting of the Risk Communication Advisory Committee and
Tobacco Products Scientific Advisory Committee; Notice of Joint 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: Risk Communication Advisory Committee and
Tobacco Products Scientific Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
DATES: Date and Time: The meeting will be held on August 15, 2013 from
9 a.m. to 5 p.m.
ADDRESSES: Food and Drug Administration, White Oak Campus.
Location: FDA White Oak Conference Center, Bldg. 31, Rm. 1503,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://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: Luis G. Bravo, Designated Federal Official, 10903
New Hampshire Ave., Bldg. 32, Rm. 3274, Silver Spring, MD 20993, 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), to find out further information regarding FDA
advisory committee information. 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: The Federal Food, Drug & Cosmetic Act (the FD&C Act)
requires tobacco product manufacturers and importers to report
quantities of harmful and potentially harmful constituents (HPHCs) in
tobacco products or tobacco smoke by brand and subbrand. The FD&C Act
also requires the Agency to publish a list of HPHCs by brand and by
quantity in each brand and subbrand by April of 2013, in a format that
is understandable and not misleading to the layperson.
On August 15, 2013, the Committees will meet in joint session to
discuss the results of the FDA consumer research ``Experimental Study
on the Public Display of Lists of Harmful and Potential Harmful Tobacco
Constituents'' [OMB Control No. 0910-0736] to assess the impact of HPHC
information on consumer perceptions and comprehension, and how to
effectively communicate information about the HPHCs of tobacco products
to the general public.
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 1 p.m. and 2 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 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. Interested persons can also
log on to https://collaboration.fda.gov/rcac/ to hear and see the
proceedings.
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 Luis G. Bravo 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: June 18, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-14947 Filed 6-21-13; 8:45 am]
BILLING CODE 4160-01-P