[Federal Register Volume 75, Number 227 (Friday, November 26, 2010)]
[Notices]
[Pages 72834-72835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29818]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


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 December 14, 2010, from 
8 a.m. to approximately 5:30 p.m. and on December 15, 2010, from 8 a.m. 
to approximately 12:45 p.m.
    Location: Hilton Washington DC/North, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact Person: Bryan Emery or Pearline Muckelvene, Center for 
Biologics Evaluation and Research, Food and Drug Administration (HFM-
71), 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. 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 December 14, 2010, in the morning, the committee will 
discuss the risk of dengue virus infection in blood donors. In the 
afternoon, the committee will discuss murine leukemia virus-related 
human retroviruses and blood safety. On December 15, 2010, in the 
morning, the committee will hear updates on the following topics: (1) 
November 4 and 5, 2010, meeting of the Health and Human Services 
Advisory Committee on Blood Safety and Availability and (2) December 9 
and 10, 2010, FDA workshop entitled ``Product Development Program for 
Interventions in Patients With Severe Bleeding Due to Trauma and Other 
Causes,'' and (3) Research programs in the Laboratories of Hemostasis 
and Plasma Derivatives, Division of Hematology, Office of Blood 
Research and Review, Center for Biologics Evaluation and Research.
    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://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: On December 14, from 8 a.m. to 5:30 p.m. the meeting is 
open to the public. On December 15, from 8 a.m. to 12 noon 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 December 7, 2010. Oral presentations from the public will be 
scheduled between approximately 10:15 a.m. and 11 a.m. and between 3:45 
p.m. and 4:15 p.m. on December 14, 2010, and between approximately 
11:30 a.m. and 12 noon on December 15, 2010. Those individuals 
interested in making 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 November 29, 2010. 
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 November 30, 2010.
    Closed Committee Deliberations: On December 15, from 12 noon to 
12:45 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

[[Page 72835]]

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 Bryan Emery 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://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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: November 19, 2010.
Thinh Nguyen,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-29818 Filed 11-24-10; 8:45 am]
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