
[Federal Register Volume 76, Number 183 (Wednesday, September 21, 2011)]
[Notices]
[Pages 58519-58520]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24168]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Risk Communication 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 Communication 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 November 17, 2011, from 
8 a.m. to 5 p.m. and November 18, 2011, from 8 a.m. to 2 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (Rm. 1503), 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: Lee L. Zwanziger, Office of Planning, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3278, Silver 
Spring, MD 20993-0002, 301-796-9151, FAX: 301-847-8611, e-mail: 
RCAC@fda.hhs.gov, 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: On November 17, 2011, the committee will discuss results of 
a literature review (as required in the Patient Protection and 
Affordable Care Act (Pub. L. 111-148) about communicating quantitative 
risk and benefit information in prescription drug promotional labeling 
and print advertising, and will also receive a briefing on activities 
in FDA's Office of Special Health Issues. On November 18, 2011, the 
committee will discuss implications, for strategic communication, of 
recent theoretical developments on information use in decisionmaking.
    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: 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 
November 9, 2011. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. on November 17, 2011, and 10:30 
a.m. and 11:30 a.m. on November 18, 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 November 3, 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 November 4, 2011. Interested persons can also 
log on to

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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 Lee L. Zwanziger 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 14, 2011.
 Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24168 Filed 9-20-11; 8:45 am]
BILLING CODE 4160-01-P


