[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45638-45639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18724]
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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.
[[Page 45639]]
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 September 20, 2012, from
8 a.m. to 5 p.m. and September 21, 2012, from 8 a.m. to 4 p.m.
Location: 5630 Fishers Lane, rm. 1066, Rockville, MD 20857. For
those unable to attend in person, the meeting will also be Web cast.
The Web cast will be available at the following links: On September 20,
2012, Blood Products Advisory Committee Day 1, http://fda.yorkcast.com/webcast/Viewer/?peid=27146555dd9347f09571f29589297e0c1d and on
September 21, 2012, Blood Products Advisory Committee Day 2, http://fda.yorkcast.com/webcast/Viewer/?peid=8effe88a1e834779b4932f882b67e3391d.
Contact Person: Bryan Emery or Pearline 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), to find out further information
regarding FDA advisory committee information. 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 at http://www.fda.gov/AdvisoryCommittees/default.htm
and scroll down to the appropriate advisory committee meeting link, or
call the advisory committee information line to learn about possible
modifications before coming to the meeting.
Agenda: On September 20, 2012, the committee will discuss hepatitis
E virus and blood transfusion safety. In the afternoon, the committee
will discuss Octapharma's biologics license application for Pooled
Plasma (Human, Solvent/Detergent Treated). On September 21, 2012, the
committee will discuss considerations for strategies to further reduce
the risk of bacterial contamination in Platelets. In the late afternoon
the committee will hear the following update: Summary of September 6-7,
2012, public workshop on the risks and benefits of hydroxyethyl starch
solutions.
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 meeting
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
September 13, 2012. Oral presentations from the public will be
scheduled between approximately 10:30 a.m. to 11:15 a.m. and 3:30 p.m.
to 4 p.m. on September 20, 2012, and also between approximately 1 p.m.
and 2 p.m. on September 21, 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 September 5, 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 September 6, 2012.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets. The public is encouraged to watch the free Web cast if you are
unable to attend this meeting. The link for the Web cast will be
available at 8 a.m. each day September 20-21, 2012, located under the
Location section of this notice.
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 Pearline Muckelvine, 301-827-1281, 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: July 26, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-18724 Filed 7-31-12; 8:45 am]
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