[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.

-----------------------------------------------------------------------

     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