[Federal Register: October 14, 2005 (Volume 70, Number 198)]
[Page 60093-60094]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Blood Products Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


    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 
    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hear updates on the following topics: (1) West Nile Virus; (2) draft 
guidance on nucleic acid testing (NAT) for human immunodeficiency virus 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 
    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]