[Federal Register: January 30, 2006 (Volume 71, Number 19)]
[Notices]
[Page 4922]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ja06-64]
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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 March 9, 2006, from 8
a.m. to 5 p.m. and March 10, 2006, from 8:30 a.m. to 4:30 p.m.
Location: Hilton Hotel Washington DC North/ Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
Contact Person: Donald W. Jehn, or Pearline K. Muckelvene, Center
for Biologics Evaluation 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.
Agenda: On March 9, 2006, in the morning the committee will hear
updates on the following topics: (1) Summary of the Department of
Health and Human Services Advisory Committee on Blood Safety and
Availability January 2006 meeting; (2) current considerations for blood
donor screening for West Nile Virus; (3) classification of transfusion
recipient identification (ID) systems; and (4) summary of the workshop
on behavior-based donor deferrals in the Nucleic Acid Test (NAT) era.
The committee will then discuss rapid tests for detection of bacterial
contamination of platelets. In the afternoon, the committee will
discuss public comments on the ``Guidance for Industry and FDA Review
Staff: Collection of Platelets by Automated Methods (DRAFT).'' On March
10, 2006, in the morning the committee will discuss proposed studies to
support the approval of over-the-counter (OTC) home-use human
immunodeficiency virus (HIV) test kits. 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
(CBER), as presented to a subcommittee of the Blood Products Advisory
Committee during their site visit on July 22, 2005, and discuss a
subcommittee report in closed session. Additionally, the committee will
hear an overview of the research programs in the Laboratory of
Biochemistry and Vascular Biology and the Laboratory of Cellular
Hematology, Division of Hematology, Office of Blood Research and
Review, CBER and in closed session discuss the report from the
laboratory site visit of October 6, 2005.
Procedure: On March 9, 2006, the meeting is open to the public. On
March 10, 2006, from 8:30 a.m. to 3:15 p.m. and again from 4:15 p.m. to
4:30 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 February 28, 2006. Oral presentations from the public
will be scheduled on March 9, 2006, between approximately 9:45 a.m. to
11:30 a.m. and 2:30 p.m. to 3:30 p.m. On March 10, 2006, oral
presentations from the public will be scheduled between approximately
9:30 a.m. to 10:30 a.m. and 2:45 p.m. to 2:55 p.m. Time allotted for
each presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before February 28,
2006, 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 March 10, 2006, from 3:15 p.m.
to 4:15 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. In addition,
the committee will discuss the site visit report for the Laboratory of
Biochemistry and Vascular Biology and Laboratory of Cellular
Hematology, Division of Hematology, Office of Blood Research and
Review, CBER.
Following this closed session, the committee will provide
summarized comments regarding the Office Site Visit Report in an open
public session.
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: January 20, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-1075 Filed 1-27-06; 8:45 am]
BILLING CODE 4160-01-S