[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
