[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
