[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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