[Federal Register Volume 78, Number 229 (Wednesday, November 27, 2013)]
[Notices]
[Page 70954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28435]
[[Page 70954]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Risk Communications 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: Risk Communications 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 December 17, 2013, from
9 a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993.
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, Office of Planning, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3274, 240-402-
5274, 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.
If you are unable to join us in person, we encourage you to watch
the free Webcast. Visit the Risk Communication Advisory Committee Web
site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/default.htm. The link will become active shortly before the open
session begins at 9 a.m.
Agenda: On December 17, 2013, the Committee will meet to identify
and discuss new methods for communicating risk information as part of
Risk Evaluation and Mitigation Strategies (REMS) to health care
providers. The discussion will also address how sponsors and FDA can
evaluate whether REMS communications are reaching the targeted
population, are increasing awareness and understanding of the key risk
messages, as well as whether the communications are having the intended
impact on knowledge, behaviors, and/or outcomes.
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
December 10, 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 December 2, 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 December 3, 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 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: November 21, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-28435 Filed 11-26-13; 8:45 am]
BILLING CODE 4160-01-P