[Federal Register Volume 77, Number 217 (Thursday, November 8, 2012)]
[Notices]
[Pages 67013-67014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27323]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee

[[Page 67014]]

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 December 4, 2012, from 
12 noon to 5:30 p.m. and on December 5, 2012, from 8 a.m. to 4:30 p.m.
    Location: 5630 Fishers Lane, FDA Conference Room 1066, Rockville, 
MD 20857. For those unable to attend in person, the meeting will also 
be Webcast. The Webcast will be available at the following links:
    December 4, 2012: Blood Products Advisory Committee Day 1: http://fda.yorkcast.com/webcast/Viewer/?peid=fea7b950961349e88d443de17679b20c1d.
    December 5, 2012: Blood Products Advisory Committee Day 2: http://fda.yorkcast.com/webcast/Viewer/?peid=9528ed4e66ca4fbb862be35598b621321d.
    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, 301-827-1277 
or 301-827-1281, or FDA Advisory Committee Information Line, 1-800-741-
8138 (301-443-0572 in the Washington, DC area). 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 December 4, 2012, the Committee will meet in open 
session to discuss labeling of Red Blood Cells with historical antigen 
typing results. On December 5, 2012, the Committee will meet in open 
session to discuss performance data considerations for infectious 
disease assays used to screen organ donors.
    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 
November 27, 2012. On December 4, oral presentations from the public 
will be scheduled between approximately 3 p.m. and 4 p.m. On December 
5, oral presentations will be scheduled between approximately 11:20 
a.m. and 12:20 p.m. 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 19, 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 November 
20, 2012.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets. Seating for this meeting may be limited, so the public is 
encouraged to watch the free Webcast if you are unable to attend. The 
link for the Webcast will be available at 8 a.m. on December 4 and 5, 
2012 (see Location).
    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 5, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-27323 Filed 11-7-12; 8:45 am]
BILLING CODE 4160-01-P