[Federal Register Volume 64, Number 1 (Monday, January 4, 1999)]
[Notices]
[Pages 169-170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34826]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Hematology and Pathology Devices Panel of the Medical Devices
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: Hematology and Pathology 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 January 19, 1999, 9:30
a.m. to 4 p.m., and January 20, 1999, 9 a.m. to 4:30 p.m.
Location: Holiday Inn, Walker/Whetstone Salons, Two Montgomery
Village Ave., Gaithersburg, 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 12515. Please call the Information Line for
up-to-date information on this meeting.
Agenda: On January 20, 1999, the committee will: (1) Discuss, make
recommendations, and vote on a petition for reclassification of
automated differential cell counters in Class III and (2) establish a
new classification for flow cytometers.
Procedure: On January 20, 1999, from 9 a.m. to 4:30 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
January 6, 1999. Oral presentations from the public will be scheduled
between approximately 9:15 a.m. and 9:45 a.m. Near the end of the
committee deliberations, a 30-minute open public session will be
conducted for interested persons to address issues specific to the
submission or topic before the committee. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before January 6, 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 January 19, 1999, from 9:30 a.m.
to 4 p.m., the meeting will be closed to the public. The committee will
hear and review trade secret and/or confidential commercial information
on a product
[[Page 170]]
development protocol. This portion of the meeting is 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: December 28, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-34826 Filed 12-30-98; 12:28 pm]
BILLING CODE 4160-01-F
