[Federal Register: March 4, 2003 (Volume 68, Number 42)]
[Notices]
[Page 10253-10254]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04mr03-89]
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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.
[[Page 10254]]
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 March 13, 2003, from 8
a.m. to 6 p.m., and March 14, 2003, from 8:30 a.m. to 4 p.m.
Location: Hilton DC North--Gaithersburg, Grand Ballrooms A, B, C,
and D, 620 Perry Pkwy., Gaithersburg, MD.
Contact: 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 19516. Please call the Information Line for up-to-date
information on this meeting. 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. Persons attending FDA's advisory
committee meetings are advised that the agency is not responsible for
providing access to electrical outlets.
Agenda: On March 13, 2003, the following committee updates are
tentatively scheduled: FDA consolidation, Medical Device User Fee and
Modernization Act, Clinical Laboratory Improvement Amendments waiver
for human immunodeficiency, type 1 human immunodeficiency virus-1 (HIV-
1) rapid tests, and the Trans Net pilot program. The committee will
hear presentations, discuss, and provide recommendations on the topic
of West Nile Virus testing. On March 14, 2003, the following committee
updates are tentatively scheduled: Limitations on validation of
anticoagulant and additive solutions to permit freezing and irradiation
of red cells, and particulates in blood bags. The committee will hear
presentations, discuss, and provide recommendations on the topic of
extensions of the dating period for pooled platelets.
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 March 7, 2003.
Oral presentations from the public will be scheduled between
approximately 9:15 a.m. and 9:45 a.m.; and 3 p.m. and 4:30 p.m. on
March 13, 2003, and between approximately 9 a.m. and 9:30 a.m.; and
10:50 a.m. and noon on March 14, 2003. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before March 7, 2003,
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.
FDA regrets that was unable to publish this notice 15 days prior to
the March 13 and 14, 2003, Blood Products Advisory Committee meeting.
Because the agency believes there is some urgency to bring these issues
to public discussion and qualified members of the Blood Products
Advisory Committee were available at this time, the Commissioner of
Food and Drugs concluded that it was in the public interest to hold
this meeting even if there was not sufficient time for the customary
15-day public notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: February 26, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-4974 Filed 3-3-03; 8:45 am]
BILLING CODE 4160-01-S