[Federal Register Volume 63, Number 9 (Wednesday, January 14, 1998)]
[Notices]
[Pages 2248-2249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-882]


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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 regulatory issues.
    Date and Time: The meeting will be held on January 28, 1998, 9:30 
a.m. to 5 p.m.
    Location: Parklawn Conference Center, conference rooms G and H, 
5600 Fishers Lane, 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 12515. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: The committee will discuss a premarket approval (PMA) 
supplement for a computerized automated Papanicolaou (PAP) smear reader 
that is indicated for use as a primary screener to select a 
subpopulation of smears that will be designated for no further review.
    Procedure: On January 28, 1998, from 10:30 a.m. to 11:30 a.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 21, 1998. Oral presentations from the public will be

[[Page 2249]]

scheduled between approximately 10:30 a.m. and 11:30 a.m. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before January 21, 
1998, 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 28, 1998, from 9:30 a.m. 
to 10 a.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 
FDA staff will present to the committee confidential information 
regarding present or future issues.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the January 28, 1998, Hematology and Pathology Devices Panel of the 
Medical Devices Advisory Committee meeting. Because the agency believes 
there is some urgency to bring this issue to public discussion and 
qualified members of the Hematology and Pathology Devices Panel of the 
Medical Devices Advisory Committee were available at this time, the 
Commissioner 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: January 8, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-882 Filed 1-9-98; 2:15 pm]
BILLING CODE 4160-01-F