Document ID: FDA-2012-N-0001-0005
Agency: fda
Document Type: Notice
Title: Blood Products Advisory Committee Meeting
Posted Date: 2012-01-30T05:00Z

[Federal Register Volume 77, Number 19 (Monday, January 30, 2012)]
[Notices]
[Pages 4567-4568]
From the Federal Register Online via the Government Printing 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