[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Notices]
[Pages 20643-20644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8167]
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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.
Date and Time: The meeting will be held on May 15, 2012, from 8:30
a.m. to 5 p.m. and May 16, 2012 from 8 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 Web cast will be
available at the following links.
Blood Products Advisory Committee Web Cast Link
May 15
http://fda.yorkcast.com/webcast/Viewer/?peid=ba104b31fe4c4c099568bacda9a4e5401d.
May 16
http://fda.yorkcast.com/webcast/Viewer/?peid=19caf3c8c1624acdaab205ddde9c48581d.
Contact Person: Bryan Emery or Rosanna Harvey, Center for Biologics
Evaluation and Research (HFM-71), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852, 301-827-1297, 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 May 15, 2012, the committee will discuss as a device
panel the evaluation of the safety and effectiveness of the OraQuick
In-Home HIV Test. On May 16, 2012, the committee will discuss the
evaluation of possible new plasma products frozen following in-process
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 update presentations on the
following topics: HHS activities related to the evaluation of the donor
deferral policy for men who have had sex with other men; a summary of
the November 8-9, 2011, public workshop on hemoglobin standards and
maintaining an adequate blood supply; and a 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.
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 May
8, 2012. Oral presentations from the public will be scheduled between
approximately 1:30 p.m. and 3:15 p.m. on May 15, 2012, and between
approximately 11:30 a.m. and 12:45 p.m. on May 16, 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
April 30, 2012. 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 May 1, 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, 301-
827-1277, or Rosanna Harvey, 301-827-1297, 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/Advisory
[[Page 20644]]
Committees/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: March 30, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-8167 Filed 4-4-12; 8:45 am]
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