[Federal Register: October 14, 2005 (Volume 70, Number 198)]
[Notices]
[Page 60093-60094]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc05-51]
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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 November 3, 2005, from 8
a.m. to 5:30 p.m., and on November 4, 2005, from 8 a.m. to 3:30 p.m.
Location: Holiday Inn Gaithersburg, 2 Montgomery Village Ave.,
Gaithersburg, MD 20879.
Contact Person: Donald W. Jehn or Pearline K. Muckelvene, Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory
Committee Information Line, 1-800-
[[Page 60094]]
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.
Agenda: On November 3, 2005, in the morning, the committee will
hear updates on the following topics: (1) West Nile Virus; (2) draft
guidance on nucleic acid testing (NAT) for human immunodeficiency virus
(HIV)-1 and hepatitis C virus (HCV): Testing, product disposition, and
donor deferral and re-entry; (3) summary of the Department of Health
and Human Services Advisory Committee on Blood Safety and Availability
held on September 19 and 20, 2005; and (4) re-entry of donors deferred
based on hepatitis B core antigen (anti-HBc) test results. The
committee will discuss approaches to over-the-counter (OTC) home-use
HIV test kits the rest of the day. On November 4, 2005, in the morning,
the committee will hear information on serious adverse events resulting
from interference with measurement of blood glucose following infusion
of maltose-containing immune globulin intravenous (human) and will
discuss Alpha-1-Proteinase Inhibitor products. In the afternoon, the
committee will hear an overview of the research programs of the Office
of Blood Research and Review, Center for Biologics Evaluation and
Research, as presented to a subcommittee of the Blood Products Advisory
Committee during their site visit on July 22, 2005, and discuss a
subcommittee report.
Procedure: On November 3, 2005, the entire meeting is open to the
public. On November 4, 2005, from 8 a.m. to 2:15 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 by October 25,
2005. Oral presentations from the public will be scheduled on November
3, 2005, between approximately 2 p.m. and 3:45 p.m. and on November 4,
2005, between 10:30 a.m. and 11 a.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before October 25, 2005,
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.
Closed Committee Deliberations: On November 4, 2005, from 2:15 p.m.
to 3 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)), and to permit discussion and review of
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). The
committee will discuss a subcommittee's report of the internal research
programs in the Office of Blood Research and Review, CBER.
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: October 6, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-20560 Filed 10-13-05; 8:45 am]
BILLING CODE 4160-01-S