[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Notices]
[Pages 55803-55804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22805]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-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
[[Page 55804]]
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 October 28, 2010, from
8:30 a.m. to approximately 5 p.m. and on October 29, 2010, from 8:30
a.m. to approximately 12:30 p.m.
Location: Holiday Inn, Gaithersburg, 2 Montgomery Village Ave.,
Gaithersburg, MD, 20879.
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, 301-827-0314, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 3014512392. 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 October 28, 2010, the Committee will discuss: (1) FDA's
risk assessment for potential exposure to the variant Creutzfeldt-Jakob
disease (vCJD) agent in U.S.-licensed plasma-derived Factor VIII and
(2) labeling of blood and blood components and plasma-derived products,
including plasma-derived albumin and products containing plasma-derived
albumin, to address the possible risk of transmission of vCJD. On
October 29, 2010, the Committee will hear informational presentations
related to FDA's geographic donor deferral policy to reduce the
possible risk of transmission of CJD and vCJD by blood and blood
products and human cells, and tissue and cellular and tissue based
products. The Committee will also hear updates on the following topics:
The development of devices to remove transmissible spongiform
encephalopathy agents from blood components and chronic wasting
disease.
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
October 21, 2010. Oral presentations from the public will be scheduled
on October 28, 2010, between approximately 11 a.m. and 11:45 a.m. and
between approximately 3:30 p.m. and 4 p.m. and on October 29, 2010,
between approximately 10:30 a.m. and 11 a.m. Those desiring to make
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 13, 2010. 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 14, 2010.
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 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: September 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22805 Filed 9-13-10; 8:45 am]
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