65FR37565B Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
robop...@us.govnews.org
Posting-number: Volume 65, Issue 116, Page 37565B
[Federal Register: June 15, 2000 (Volume 65, Number 116)]
[Notices]
[Page 37565-37566]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jn00-75]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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to the guidance document entitled ``Draft Guidance for Implantable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 The draft guidance, version 4.3, issued June 24, 1996,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