[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]

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