[Federal Register: March 17, 2009 (Volume 74, Number 50)]
[Notices]
[Page 11376-11377]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr09-54]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
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). At least one
portion of the meeting will be closed 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 1, 2009, from 8
a.m. to 6 p.m. and on April 2, 2009, from 8 a.m. to 4:45 p.m.
Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD 20877, 301-977-8900.
Contact Person: William Freas 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. 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.
[[Page 11377]]
Agenda: On April 1, 2009, the committee will hear updates on the
following topics: National Biovigilance Data Collection and Analysis
Program; a summary of the December 16 and 17, 2008, meeting of the
Department of Health and Human Services Advisory Committee on Blood
Safety and Availability; and a summary of the September 12, 2008, FDA
Workshop on Approaches to Minimize the Risk of Transfusion-Transmitted
Babesiosis in the United States. The committee will then discuss blood
donor screening and testing donors of human cells, tissues and cellular
and tissue-based products (HCT/Ps) for hepatitis B virus infection by
nucleic acid testing. In the afternoon, the committee will discuss
potential testing strategies for Trypanosoma cruzi infection in blood
donors. On April 2, 2009, the committee will discuss FDA's current
considerations on plasma obtained from a Whole Blood donor for further
manufacturing use and in the afternoon will review the research
programs in the Laboratory of Molecular Virology, Division of Emerging
and Transfusion Transmitted Diseases, CBER Site Visit held on October
22, 2008.
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://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: On April 1, 2009, from 8 a.m. to 6 p.m. and on April 2,
2009, from 8 a.m. to 3:45 p.m, the meeting is open to the public.
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 March 25, 2009. Oral
presentations from the public will be scheduled between approximately
11:30 a.m. and 12 noon and between approximately 4:15 p.m. and 4:45
p.m. on April 1, 2009, and between approximately 10:45 a.m. and 11:45
a.m. and between approximately 3:15 p.m. and 3:45 p.m. on April 2,
2009. 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
March 23, 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 March 24, 2009.
Closed Committee Deliberations: On April 2, 2009, between 4 p.m.
and 4:45 p.m., the meeting will be closed to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of
intramural research programs and make recommendations regarding
personnel staffing decisions.
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
Pearline K. Muckelvene 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: March 10, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-5734 Filed 3-16-09; 8:45 am]
BILLING CODE 4160-01-S