[Federal Register: May 6, 2009 (Volume 74, Number 86)]
[Notices]
[Page 20963-20964]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06my09-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
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 June 12, 2009, from 8
a.m. to 5:45 p.m.
Location: Holiday Inn Gaithersburg, Grand Ballroom, 2 Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: William Freas or Rosanna 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 301-451-2392. 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 June 12, 2009, the Committee will review and discuss a
recent report from the UK Health Protection Agency attributing a case
of variant Creutzfeldt-Jakob (vCJD) disease infection to treatment 11
years earlier
[[Page 20964]]
with a ``vCJD-implicated'' plasma-derived coagulation factor VIII
(pdFVIII) and whether this information or any other recent scientific
information about the vCJD epidemic substantially alters FDA's risk
assessment for U.S.-licensed preparations of pdFVIII products. In the
afternoon the committee will hear informational presentations on animal
models of vCJD, diagnostic test development for transmissible
spongiform encephalopathies (TSEs) and bovine spongiform encephalopathy
(BSE) surveillance and risk management.
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 will be
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 2009 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 June
4, 2009. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. and 11:15 a.m. and between 5:00 p.m. and 5:30
p.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 May 26, 2009. 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 May 28, 2009.
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 Harvey 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.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: April 28, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-10454 Filed 5-5-09; 8:45 am]
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