[Federal Register Volume 77, Number 19 (Monday, January 30, 2012)]
[Notices]
[Pages 4567-4568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-1888]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-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). 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.
DATES: Date and Time: The meeting will be held on February 29, 2012,
from 8:30 a.m. to 4 p.m.
Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy.,
Gaithersburg, MD 20877, (301) 977-8900. For those unable to attend in
person, the meeting will also be Web cast. The Blood Products Advisory
Committee Web cast will be available at http://fda.yorkcast.com/webcast/Viewer/?peid=11253ea88a9041e5a91883236f342bfc1d.
Contact Person: Bryan Emery or Pearl Muckelvene, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, (301) 827-
1281, or FDA Advisory Committee Information Line, 1-(800) 741-8138
(301) 443-0572 in the Washington, DC area), and follow the prompts to
the desired center or product area. 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 February 29, 2012, the committee will discuss the
evaluation of possible new plasma products manufactured following
storage at room temperature for up to 24 hours, namely, plasma for
transfusion prepared from whole blood held at room temperature for up
to 24 hours prior to separation and freezing, or from apheresis plasma
held at room temperature for up to 24 hours before freezing. In the
afternoon, the committee will hear the following updates: Report from
the Health and Human Services Advisory Committee on Blood Safety and
Availability and summary of the December 5-6, 2011, meeting; update on
HHS activities related to the evaluation of the donor deferral policy
for men who have had sex with other men; summary of the November 8-9,
2011, public workshop on hemoglobin standard and maintaining an
adequate blood supply; summary of the November 29, 2011, public
workshop on data and data needs to advance risk assessment for emerging
infectious diseases for blood and blood products; and an update on
thrombotic adverse events and immune globulin products.
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: 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
February 21, 2012. Oral presentations from the public will be scheduled
between approximately 11:15 a.m. and 12:45 p.m. on February 29, 2012.
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
February 13, 2012. Time allotted for each presentation may be
[[Page 4568]]
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 February
14, 2012.
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 or Pearl
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://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: January 24, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-1888 Filed 1-27-12; 8:45 am]
BILLING CODE 4160-01-P