[Federal Register Volume 64, Number 195 (Friday, October 8, 1999)]
[Notices]
[Pages 54900-54901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26219]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Clinical Chemistry and Clinical Toxicology Devices Panel of the
Medical Devices 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: Clinical Chemistry and Clinical Toxicology
Devices Panel of the Medical Devices 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 October 28, 1999, 8:30
a.m. to 5 p.m.
Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, MD.
Contact Person: Veronica J. Calvin, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-1243, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 12514. Please call the Information Line for
up-to-date information on this meeting.
Agenda: The committee will discuss and make recommendations on a
premarket notification for an over-the-
[[Page 54901]]
counter device that measures triglycerides from whole blood
fingersticks.
Procedure: On October 28, 1999, from 9 a.m. to 5 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 15, 1999. Oral presentations from the public will be scheduled
between approximately 9:45 a.m. and 10:15 a.m. and between
approximately 1:45 p.m. and 2:15 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before October 15, 1999,
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 October 28, 1999, from 8:30 a.m.
to 9 a.m., the meeting will be closed to permit discussion and review
of trade secret and/or confidential commercial information regarding
pending and future FDA issues. This portion of the meeting will be
closed to permit discussion of this information (5 U.S.C. 552b(c)(4)).
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 30, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-26219 Filed 10-7-99; 8:45 am]
BILLING CODE 4160-01-F
