[Federal Register: July 29, 2008 (Volume 73, Number 146)]
[Notices]
[Page 43941-43942]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jy08-64]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
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 September 10, 2008, from
8 a.m. to 5:45 p.m. and on September 11, 2008, from 8 a.m. to 3 p.m.
Location: Hilton Hotel, Washington, DC/Rockville Executive Meeting
Center, 1750 Rockville Pike, Rockville, MD 20852.
Contact Person: Donald W. Jehn or Pearline K. Muckelvene, Center
for Biologics Evaluation and Research (CBER) (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 the morning of September 10, 2008, the Committee will
hear an update on the May 29 to 30, 2008, meeting of the Department of
Health and Human Services Advisory Committee on Blood Safety and
Availability. Following this update, the Committee will discuss
strategies to enhance bacterial safety of 7 day platelets for
transfusion. In the afternoon, the Committee will discuss iron status
in blood donors. On September 11, 2008, the Committee will hear updates
on the following topics: (1)
[[Page 43942]]
April 29 to 30, 2008, workshop on hemoglobin based oxygen carriers; (2)
July 10 to 11, 2008, blood establishment computer software conference;
(3) the development of an automated Biologics License Application
submission system; and (4) Draft Guidance for Industry: Re-
qualification Method for Re-entry of Blood Donors Deferred Because of
Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-
HBc). Following these updates, the Committee will discuss options for
blood donor screening and re-entry for malaria. 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/ohrms/dockets/ac/acmenu.htm, click on the year 2008 and
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
September 2, 2008. Oral presentations from the public will be scheduled
between approximately 10:45 a.m. and 11:30 a.m. and between
approximately 4 p.m. and 4:30 p.m. on September 10, 2008, and between
approximately 9:15 a.m. and 9:45 a.m. and between approximately 1:30
p.m. and 2 p.m. on September 11, 2008. 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 August 22, 2008. 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 August
25, 2008.
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 Donald W. Jehn or
Pearline K. 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/oc/advisory/
default.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 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-17359 Filed 7-28-08; 8:45 am]
BILLING CODE 4160-01-S