[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Pages 20643-20644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8167]



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 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

May 16

    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 
    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]