[Federal Register Volume 73, Number 59 (Wednesday, March 26, 2008)]
[Notices]
[Pages 16023-16024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-6208]
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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). At least one
portion of the meeting will be closed 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 1, 2008, from 8:30
a.m. to 5:30 p.m. and on May 2, 2008, from 8:30 a.m. to 4 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), 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 the morning of May 1, 2008, the committee will hear
updates on the following: (1) Summaries of August 22-23, 2007, and
January 9-10, 2008, meetings of the Department of Health and Human
Services Advisory Committee on Blood Safety and Availability; (2) 2007
West Nile Virus Epidemiology and the use of nucleic acid tests to
reduce the risk of transmission of West Nile Virus in Whole Blood and
blood components for transfusion and Human Cells, Tissues, and Cellular
and Tissue-based products (HCT/Ps); (3) implementation of blood donor
screening for infection with Trypanosoma cruzi and the use of
serological tests to reduce the risk of transmission of T. cruzi
infection in Whole Blood and blood components for transfusion and HCT/
Ps; (4) FDA's proposal to lower the minimum recommended lot release
titer for measles antibodies in Immune Globulin Intravenous (Human) and
Immune Globulin Subcutaneous (Human); (5) Gambro/Fenwal Post Approval
Surveillance Study of Platelet Outcomes, Release Tested (PASSPORT) Post
Marketing Study--7 Day Platelets; (6) Experience with 7 Day Platelets
Versus 5 Day Platelets; and (7) FDA Perspective on the PASSPORT Study.
These updates will be followed by informational presentations on FDA's
Center for Biologics Evaluation and Research Safety Teams related to
blood and tissue. In the afternoon, the committee will discuss the
Biomedical Excellence for Safer Transfusion Committee Report on red
blood cell recovery standards. On the morning of May 2, 2008, the
committee will discuss Lev Pharmaceutical's plasma-derived C1 esterase
inhibitor (CINRYZE). Then, in the afternoon the committee will review
the research programs in the Laboratory of Hepatitis and Related
Emerging Agents, Division of Emerging and Transfusion Transmitted
Diseases, Office of Blood Research and Review, CBER Site Visit of
November 8, 2007.
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: The entire day of May 1, 2008, and on May 2, 2008, from
8:30 a.m. to 3:15 p.m., the meeting is open to the public. 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 April 23, 2008. Oral presentations
from the public will be scheduled between approximately 11:50 a.m. and
12:20 p.m. and between approximately 4:20 p.m. and 4:50 p.m. on May 1,
2008, and between approximately 10:40 a.m. and 11:10 a.m. and 2:40 p.m.
and 3 p.m. on May 2, 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 April 15, 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 April 16,
2008.
Closed Committee Deliberations: On May 2, 2008, between 3:15 p.m.
and 4 p.m., the meeting will be closed to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of
intramural research programs and make recommendations regarding
personnel staffing decisions.
Persons attending FDA's advisory committee meetings are advised
that the
[[Page 16024]]
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: March 20, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-6208 Filed 3-25-08; 8:45 am]
BILLING CODE 4160-01-S