[Federal Register: November 30, 2006 (Volume 71, Number 230)]
[Notices]
[Page 69211]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30no06-35]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Blood Products Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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: Blood Products 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 14, 2006, from
8 a.m. to 6 p.m.
Location: Crown Plaza Silver Spring, 8777 Georgia Ave, Silver
Spring, MD. The hotel telephone number is 301-589-0800.
Contact Person: Donald W. Jehn, or Pearline K. Muckelvene, 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 3014519516. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On December 14, 2006, the committee will hear an update
summary of the October 11, 2006, Public Hearing on Emergency Research.
The committee will then discuss pre-clinical and clinical studies of
the hemoglobin-based oxygen carrier, bovine polymerized hemoglobin
(HBOC-201). In addition, the committee will discuss an emergency
research study of HBOC-201, proposed by the Naval Medical Research
Center. 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 1:15 p.m. and 2:15 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 December 6, 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 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 7, 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 Donald W. Jehn or
Pearline K. Muckelvene at least 7 days in advance of the meeting.
FDA regrets that it was unable to publish this notice 15 days prior
to the December 14, 2006, Blood Products Advisory Committee meeting.
Because the agency believes there is some urgency to bring this issue
to public discussion and qualified members of the Blood Products
Advisory Committee were available at this time, the Commissioner of
Food and Drugs concluded that it was in the public interest to hold
this meeting even if there was not sufficient time for the customary
15-day public notice.
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. E6-20265 Filed 11-29-06; 8:45 am]
BILLING CODE 4160-01-S