[Federal Register Volume 63, Number 156 (Thursday, August 13, 1998)]
[Notices]
[Page 43401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21736]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Hematology and Pathology Devices Panel and
the Immunology 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). The meeting will
be open to the public.
Name of Committee: Joint meeting of the Hematology and Pathology
Devices Panel and the Immunology 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 September 4, 1998, 9:30
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 (HFZ09440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 30109594091243, or FDA Advisory
Committee Information Line, 10980009741098138 (30109443090572 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, make recommendations, and vote
on a premarket approval application (PMA) for an immunohistochemical
device indicated for the detection of HER2 overexpression in breast
cancers.
Procedure: 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 August 21,
1998. Oral presentations from the public will be scheduled between
approximately 9:45 a.m. and 10:15 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 August 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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 6, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-21736 Filed 8-12-98; 8:45 am]
BILLING CODE 4160-01-F
