[Federal Register Volume 66, Number 14 (Monday, January 22, 2001)]
[Notices]
[Pages 6625-6626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1712]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Circulatory System 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: Circulatory System 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 February 5, 2001, from 8 
a.m. to 6 p.m.
    Location: Gaithersburg Marriott Washingtonian Center Salons F and 
G, 9751 Washingtonian Blvd., Gaithersburg, MD.

[[Page 6626]]

    Contact Person: Megan Moynahan, Center for Devices and Radiological 
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-443-8517, ext. 171, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12625. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will discuss and make recommendations on a 
premarket submission for a distal protection device used in the 
treatment of saphenous vein graft disease. Subsequently, the committee 
is being asked to provide input to the agency regarding the design of 
clinical trials for distal protection devices used in diseased 
saphenous vein grafts.
    Procedure: On February 5, 2001, from 8 a.m. to 3 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 
January 26, 2001. Oral presentations from the public will be scheduled 
between approximately 8 a.m. and 8:30 a.m., and a 30-minute open public 
session will be conducted for interested persons to address issues 
specific to the submission before the committee near the end of the 
panel deliberations on February 5, 2001. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before January 26, 2001, 
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 February 5, 2001, from 3 p.m. to 
6 p.m., the meeting will be closed to the public to permit discussion 
and review of trade secret and/or confidential commercial information 
(5 U.S.C. 552b(c)(4)) regarding pending and future circulatory system 
device submissions. In addition, the committee will discuss and review 
trade secret and/or confidential commercial information presented by a 
sponsor.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 12, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-1712 Filed 1-19-01; 8:45 am]
BILLING CODE 4160-01-S