[Federal Register: July 20, 2007 (Volume 72, Number 139)]
[Notices]
[Page 39814-39815]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jy07-63]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 16, 2007, from 8
a.m. to 5 p.m.
Location: Doubletree Hotel and Executive Meeting Center, 8120
Wisconsin Ave., Bethesda, MD 20814.
Contact Person: Donald W. Jehn or Pearline K. Muckelvene, Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike (HFM-71), 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 August 16, 2007, the Committee will hear updates on the
following topics: (1) Summary of the May 10 through 11, 2007, and the
August 6 through 7, 2007, meetings of the Department of Health and
Human Services Advisory Committee on Blood Safety and Availability; (2)
summary of the April 25 through 26, 2007, FDA Workshop on Immune
Globulins for Primary Immune Deficiency Diseases: Antibody Specificity,
Potency and Testing; and (3) summary of the August 15, 2007, FDA
Workshop on Licensure of Apheresis Blood Products. The Committee will
then hear informational presentations relating to World Health
Organization (WHO) biological standards on the following topics: (1)
Summary of the January 29 through 30, 2007, WHO meeting with WHO
collaborating centers for biological standards and standardization to
support the development of WHO biological reference preparations for
high risk blood safety-related in vitro diagnostics; (2) potency and
safety standards for plasma derivatives; and (3) joint FDA/WHO minimum
potency standards for certain blood grouping reagents. The Committee
will hear the response of the Office of Blood Research and Review to
their office level site visit of July 22, 2005. In the afternoon the
Committee will discuss measles antibody levels in U.S. 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 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
August 8, 2007. Oral presentations from the public will be
[[Page 39815]]
scheduled between approximately 11:15 a.m. and 11:45 p.m. and between
approximately 3:30 p.m. and 4 p.m. on August 16, 2007. 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 31, 2007. 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 1, 2007.
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: July 16, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-14088 Filed 7-19-07; 8:45 am]
BILLING CODE 4160-01-S