[Federal Register: November 29, 2006 (Volume 71, Number 229)]
[Notices]
[Page 69134-69135]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no06-62]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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.
[[Page 69135]]
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 December 15, 2006, from
8 a.m. to 3:30 p.m.
Location: Crown Plaza Silver Spring, 8777 Georgia Ave., Silver
Spring, MD. The hotel telephone number is 301-589-0800.
Contact Person: William Freas, or Rosanna L. Harvey, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 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.
Agenda: On December 15, 2006, the committee will discuss FDA's risk
assessment for potential exposure to variant Creutzfeldt-Jakob disease
in human plasma-derived antihemophilic factor (FVIII) products
manufactured from U. S. plasma donors and related communication
materials. In the afternoon, the committee will discuss levels of
transmissible spongiform encephalopathy clearance in the manufacture of
plasma-derived Factor VIII products. FDA intends to make background
material available to the public no later than one business day 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm
, click on the year 2006 and 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
December 11, 2006. Oral presentations from the public will be scheduled
between approximately 10:25 and 10:55 a.m. and 1:35 and 2:05 p.m. on
December 15, 2006. 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
December 7, 2006. 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 8,
2006.
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 William Freas or
Rosanna L. Harvey at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 22, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-20251 Filed 11-28-06; 8:45 am]
BILLING CODE 4160-01-S