[Federal Register: January 4, 1999 (Volume 64, Number 1)]
[Notices]               
[Page 169-170]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja99-79]

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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.

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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: 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