[Federal Register Volume 76, Number 129 (Wednesday, July 6, 2011)]
[Notices]
[Page 39405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16859]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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.
Date and Time: The meeting will be held on August 2, 2011, from
1:30 p.m. to 5 p.m. and on August 3, 2011, from 8 a.m. to 2:30 p.m.
Location: Hilton Hotel, 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 Day 1: http://fda.yorkcast.com/webcast/Viewer/?peid=b6ce0d080a594ddf9d362a0b1815b4491d.
Blood Products Advisory Committee Day 2: http://fda.yorkcast.com/webcast/Viewer/?peid=68d4630cf50847c5aaec06b1720f205f1d.
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, 301-827-0314, 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 August 2, 2011, the committee will discuss a study on
the incidence of Trypanosoma cruzi infection in blood donors and its
implications for selective testing of blood donors. On August 3, 2011,
the committee will discuss measures to preserve the blood supply during
a severe emergency. In the afternoon, the committee will hear the
following updates: Summary of the June 7-8, 2011, Health and Human
Services Advisory Committee on Blood Safety and Availability meeting;
summary of the May 17-18, 2011, public workshop on risk mitigation
strategies to address procoagulant activity in immune globulin
products; and summary of the August 1-2, 2011, Transmissible Spongiform
Encephalopathies Advisory Committee meeting.
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 July
26, 2011. Oral presentations from the public will be scheduled on
August 2, 2011, between approximately 3:30 and 4 p.m. and on August 3,
2011, between approximately 11 and 11:30 a.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 July 18, 2011. 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 July 19, 2011.
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
Rosanna Harvey 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: June 30, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-16859 Filed 7-5-11; 8:45 am]
BILLING CODE 4160-01-P