[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]
BILLING CODE 4160-01-P