[Federal Register: June 18, 2004 (Volume 69, Number 117)]
[Notices]
[Page 34175-34176]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jn04-124]
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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). The meeting will
be open 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 July 22, 2004, from 8
a.m. to 6 p.m. and on July 23, 2004, from 8 a.m. to 3 p.m.
Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave.,
Gaithersburg, MD 20877.
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 July 22, 2004, the committee will hear updates on: FDA
current thinking on transfusion related acute lung inflammation
(TRALI), and donor blood pressure determination. The committee will
also discuss and provide recommendations on the dating of irradiated
blood. In the afternoon, the committee will discuss and provide
recommendations on the new standards for platelet evaluation and
experience with monitoring of bacterial contamination of platelets. On
July 23, 2004, the committee will hear an update on West Nile Virus.
The committee will also hear presentations, discuss and provide
recommendations on hepatitis B virus nucleic acid testing (HBV NAT) for
mini-pools. In the afternoon, there will be an informational
presentation on current trends in plasma product manufacturing.
Procedure: 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 July 12, 2004.
Oral
[[Page 34176]]
presentations from the public will be scheduled between approximately
8:35 a.m. and 9 a.m., 11 a.m. and 11:30 a.m., 2 p.m. and 2:30 p.m., and
4:30 p.m. and 5 p.m. on July 22, 2004; and between approximately 10:15
a.m. and 11:15 a.m. and 2 p.m. and 2:30 p.m. on July 23, 2004. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before July
12, 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.
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,
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: June 14, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-13727 Filed 6-17-04; 8:45 am]
BILLING CODE 4160-01-S