[Federal Register: April 9, 2007 (Volume 72, Number 67)]
[Notices]
[Page 17558]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap07-84]
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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.
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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: 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 April 26, 2007, from 2
p.m. to 6 p.m. and on April 27, 2007, from 8 a.m. to 3:30 p.m.
Location: Hilton Hotel, Washington, DC North/Gaithersburg, 620
Perry Pkwy., Gaithersburg, MD 20877.
Contact Person: Donald W. Jehn or Pearline K. Muckelvene, Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike (HFM-71), 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 April 26, 2007, the committee will hear an update on a
summary of August 30 and 31, 2006, meeting of the Department of Health
and Human Services Advisory Committee on Blood Safety and Availability.
The committee will then discuss issues related to implementation of
blood donor screening for infection with Trypanosoma cruzi and issues
related to transmissibility of Trypanosoma cruzi in donors of human
cells, tissue, and cellular and tissue-based products. On April 27,
2007, the committee will hear updates on summary of December 15, 2006,
meeting of the Transmissible Spongiform Encephelopathies Advisory
Committee, FDA's risk communication on plasma-derived Factor VIII and
Factor XI, and summary of September 25 and 26, 2006, FDA Workshop on
Molecular Methods in Immunohematology. The committee will then discuss
transfusion related acute lung injury, and discuss issues related to
implementation of blood donor screening for infection with West Nile
Virus.
FDA intends to make background material available to the public no
later than 1 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 2007 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
April 18, 2007. Oral presentations from the public will be scheduled
between approximately 4:30 p.m. and 5 p.m. on April 26, 2007, and
between approximately 10:45 a.m. and 11:15 a.m. on April 27, 2007.
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 April 10, 2007. 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 April 11, 2007.
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 3, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-6594 Filed 4-6-07; 8:45 am]
BILLING CODE 4160-01-S