[Federal Register Volume 75, Number 119 (Tuesday, June 22, 2010)]
[Notices]
[Pages 35494-35495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15018]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-N-2010-0001]
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.
Date and Time: The meeting will be held on July 26, 2010, from 8
a.m. to approximately 5:30 p.m. and July 27, 2010, from 8 a.m. to
approximately 1 p.m.
Location: Hilton Washington DC/North, 620 Perry Pkwy.,
Gaithersburg, MD.
Contact Person: Bryan Emery or Pearline Muckelvene, Center for
Biologics 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), code 3014519516. 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 July 26, 2010, in the morning session, the committee
will hear updates on the following topics: June 10 and 11, 2010,
meeting of the Department of Health and Human Services Advisory
Committee on Blood Safety and Availability; December 14 and 15, 2009,
FDA workshop on emerging arboviruses; May 11 and 12, 2010, FDA workshop
on emerging infectious diseases; and the Q fever epidemic in the
Netherlands. The committee will also hear informational presentations
on Xenotropic Murine Leukemia Virus-Related Virus. In the
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afternoon session, the committee will discuss issues related to the
risk of Babesia infection by blood transfusions and the status of
laboratory tests. On July 27, 2010, the committee will discuss blood
donor hemoglobin/hematocrit qualifications standards, iron status, and
interdonation interval.
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
19, 2010. Oral presentations from the public will be scheduled between
approximately 11:45 a.m. and 12:30 p.m. and between 4 p.m. and 4:45
p.m. on July 26, 2010, and between approximately 10:30 a.m. and 11 a.m.
on July 27, 2010. Those desiring to make 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
9, 2010. 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 12, 2010.
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 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 15, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-15018 Filed 6-21-10; 8:45 am]
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