[Federal Register: February 25, 2004 (Volume 69, Number 37)]
[Notices]
[Page 8666]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe04-75]
[[Page 8666]]
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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 18, 2004, from 8
a.m. to 5 p.m. and on March 19, 2004, from 8 a.m. to 3 p.m.
Location: Holiday Inn, Gaithersburg, Two Montgomery Ave.,
Gaithersburg, MD.
Contact Person: Linda A. Smallwood, Center for Biologics Evaluation
and Research (HFM-302), Food and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301-827-3514, 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 18, 2004, the committee will hear presentations,
discuss, and provide recommendations on clinical trials for licensing
hepatitis B immune globulin as treatment to prevent hepatitis B virus
(HBV) liver disease following liver transplantation in HBV+ recipients.
The committee will also hear updates on the following topics: (1)
Summary of meeting of the Public Health Service Advisory Committee on
Blood Safety and Availability; (2) summary of the meeting of the
Transmissible Spongiform Encephalopathies Advisory Committee Meeting;
(3) current thinking on draft guidance for nucleic acid testing (NAT)
for human immunodeficiency virus (HIV) and hepatitis C virus (HCV):
Testing, product disposition, and donor deferral and re-entry; (4)
current thinking on guidance for use of NAT on pooled and individual
samples from donors of whole blood and blood components to adequately
and appropriately reduce the risk of transmission of HIV-1 and HCV; and
(5) current thinking on variances to address the specificity issues of
Ortho HBsAg 3.0 assays. In the afternoon, the committee will hear
presentations, discuss, and provide recommendations on supplemental
testing for HIV and HCV. On March 19, 2004, the committee will hear
presentations, discuss, and provide recommendations on platelet
apheresis quality control: A statistical quality control model, and
hear presentations relevant to the site visit report on the review of
the research programs of the Laboratory of Hepatitis and Emerging
Bacterial Agents and the Laboratory of Bacterial, Parasitic, and
Unconventional Agents.
Procedure: On March 18, 2004, from 8 a.m. to 5 p.m. and on March
19, 2004, 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 February 27, 2004. Oral
presentations from the public will be scheduled between approximately
9:30 a.m. and 10 a.m., 3:45 p.m. and 4:15 p.m. on March 18, 2004; and
between approximately 9:30 a.m. and 10 a.m. on March 19, 2004. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before
February 27, 2004, 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 19, 2004, 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)). The committee will discuss the reports
of the review of individual research programs in the Division of
Emerging and Transfusion Transmitted Diseases, Office of Blood Research
and Review, Center for Biologics Evaluation and Research.
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 Linda A. Smallwood
at 301-827-3514 or Pearline K. Muckelvene at 301-827-1281 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: February 19, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-4033 Filed 2-24-04; 8:45 am]
BILLING CODE 4160-01-S