[Federal Register Volume 65, Number 116 (Thursday, June 15, 2000)]
[Notices]
[Pages 37565-37566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15204]


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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.

[[Page 37566]]

    Date and Time: The meeting will be held on June 19, 2000, 10 a.m. 
to 6 p.m. and on June 20, 2000, 10 a.m. to 4 p.m.
    Location: Hilton, Salons A, B, and C, 620 Perry Pkwy., 
Gaithersburg, MD.
    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: On June 19, 2000, the committee will discuss, make 
recommendations, and vote on a premarket approval application for an 
intravascular radiation device used in the treatment of instent 
restenosis. On June 20, 2000, the committee will discuss a modification 
to the guidance document entitled ``Draft Guidance for Implantable 
Cardioverter-Defibrillators.'' Specifically, the modification would 
allow general indications for use for implantable cardioverter 
defibrillators. The draft guidance, version 4.3, issued June 24, 1996, 
is available to the public on the Internet at http://www.fda.gov/cdrh/ode/965.html. Background information, questions for the panel, and a 
bibliography for this topic will be available to the public on the 
Internet at http://www.fda.gov/cdrh/panelmtg.html.
    Procedure: On June 19, 2000, from 10 a.m. to 6 p.m. and on June 20, 
2000, from 10 a.m. to 4 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 June 15, 2000. Oral presentations 
from the public will be scheduled between approximately 10 a.m. and 
10:30 a.m., and near the end of the panel deliberations on June 19, 
2000, and between approximately 10 a.m. and 10:30 a.m., and near the 
end of the panel deliberations on June 20, 2000. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before June 12, 2000, 
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 June 20, 2000, from 8 a.m. to 10 
a.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential commercial information (5 U.S.C. 
552b(c)(4)).
    FDA regrets that it was unable to publish this notice 15 days prior 
to the Circulatory System Devices Panel of the Medical Devices Advisory 
Committee meeting. Because the agency believes there is some urgency to 
bring these issues to public discussion and qualified members of the 
Circulatory System Devices Panel of the Medical Devices Advisory 
Committee were available at this time, the Commissioner of Food and 
Drugs concluded that it was in the public interest to hold this meeting 
even if there was not sufficient time for the customary 15-day public 
notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 9, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-15204 Filed 6-13-00; 8:45 am]
BILLING CODE 4160-01-F