[Federal Register Volume 62, Number 156 (Wednesday, August 13, 1997)]
[Notices]
[Page 43333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21552]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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 September 5, 1997, 10 
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 (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 quality control issues for home-
use prothrombin time devices.

    Procedure: On September 5, 1997, from 10:30 a.m. to 5 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 
August 22, 1997. Oral presentations from the public will be scheduled 
between approximately 11 a.m. and 12:15 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before August 22, 1997, 
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 September 5, 1997, from 10 a.m. 
to 10:30 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 trade secret and/or confidential 
commercial information regarding present or future issues.

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 11, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-21552 Filed 8-12-97; 8:45 am]
BILLING CODE 4160-01-F