[Federal Register Volume 62, Number 191 (Thursday, October 2, 1997)]
[Notices]
[Page 51669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26113]
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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: 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 October 24, 1997, 9:30
a.m. to 6 p.m.
Location: Gaithersburg Marriott Washingtonian Center, Salons C and
D, 9751 Washingtonian Blvd., Gaithersburg, 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.
Agenda: The committee is being asked to provide input to the agency
regarding the design of clinical trials to support premarket approval
applications for devices intended to treat atrial septal defects,
patent foramen ovale, and patent ductus arteriosus. Of particular
concern are the following issues: What are the appropriate controls to
be used in such trials? What are the appropriate safety and efficacy
measures? When should assessments of these measures be made?
Procedure: On October 24, 1997, from 12:30 p.m. to 6 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
October 14, 1997. Oral presentations from the public will be scheduled
between approximately 12:30 p.m. and 1:30 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before October 14, 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 October 24, 1997, from 9:30 a.m.
to 12:30 p.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
information regarding pending and future circulatory system device
submissions.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 25, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-26113 Filed 10-1-97; 8:45 am]
BILLING CODE 4160-01-F
