Blood Products Advisory Committee; Notice of Meeting, 4922 [E6-1075]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 19 (Monday, January 30, 2006)]
[Notices]
[Page 4922]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1075]


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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