[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Pages 11207-11208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03577]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Transmissible Spongiform Encephalopathies 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: Transmissible Spongiform Encephalopathies
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 March 14, 2013, from 8
a.m. to 4 p.m.
[[Page 11208]]
Location: 5630 Fishers Lane, FDA Conference Room 1066, Rockville,
MD 20857. For those unable to attend in person, the meeting will also
be Webcast. The Web cast will be available at the following link http://fda.yorkcast.com/webcast/Viewer/?peid=63bc1bd2838040b48eb7db7cbedfc4191d.
Contact Person: Bryan Emery or Rosanna Harvey, Center for Biologics
Evaluation and Research (HFM-71), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852, 301-827-1277 or 301-827-1297, 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 March 14, 2013, the Committee will meet in open session
to discuss FDA's draft risk assessment model for potential exposure to
the variant Creutzfeldt-Jakob disease (vCJD) agent in Red Blood Cells
for transfusion in the United States.
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
March 7, 2013. On March 14, 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
February 27, 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 February 28,
2013.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets. Seating for this meeting may be limited, so the public is
encouraged to watch the free Webcast if you are unable to attend. The
link for the Webcast will be available beginning at 8 a.m. on March 14,
2013 (see Location).
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 Bryan Emery 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: February 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03577 Filed 2-14-13; 8:45 am]
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