[Federal Register Volume 62, Number 227 (Tuesday, November 25, 1997)]
[Notices]
[Pages 62777-62778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31064]
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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 regulatory issues.
Date and Time: The meeting will be held on December 4, 1997, 8 a.m.
to 5 p.m.
Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, MD.
Contact Person: John E. Stuhlmuller, Center for Devices and
Radiological Health (HFZ-450), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8243, ext. 157, 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.
Procedure: On December 4, 1997, from 8 a.m. to 9 a.m., the meeting
is open to the public. Interested persons may present data,
information, or views, orally or in writing, on issues appropriate for
the committee. Written submissions may be made to the contact person by
December 3, 1997. Oral presentations from the public will be scheduled
between 8 a.m. and 9 a.m. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before December 3, 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.
[[Page 62778]]
FDA regrets that it was unable to publish this notice 15 days prior
to the December 4, 1997, Circulatory System Devices Panel of the
Medical Devices Advisory Committee meeting. Because the agency believes
there is some urgency to bring this issue 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 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.
Closed Committee Deliberations: On December 4, 1997, from 9 a.m. to
5 p.m., the meeting will be closed to permit discussion and review of
trade secret and/or confidential commercial information on a product
development protocol. This portion of the meeting will be closed to
permit discussion of this information (5 U.S.C. 552b (c)(4)).
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 20, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-31064 Filed 11-21-97; 11:12 am]
BILLING CODE 4160-01-F
