[Federal Register Volume 63, Number 187 (Monday, September 28, 1998)]
[Notices]
[Pages 51584-51585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25905]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Orthopaedic and Rehabilitation 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: Orthopaedic and Rehabilitation 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 October 8, 1998, 9:30
a.m. to 6 p.m., and October 9, 1998, 8 a.m. to 5 p.m.
Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, MD.
Contact Person: Hany W. Demian, Center for Devices and Radiological
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-2036, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 12521. Please call the Information Line for up-to-date
information on this meeting.
Agenda: On October 8, 1998, the committee will consider issues
relating to the study and evaluation of spinal device assemblies. In
the context of a preliminary background document entitled ``Guidance
Document for the Preparation of IDE's for Spinal Assemblies,'' the
committee will be asked to address scientific issues pertaining to the
development of investigational device exemptions (IDE's) applications
for spinal device assemblies. This will include inclusion/exclusion
criteria, type of control(s), study endpoints, and length of followup.
Single copies of the preliminary background document are available to
the public by contacting the Division of Small Manufacturers
[[Page 51585]]
Assistance (DSMA), Center for Devices and Radiological Health, Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 1-800-638-
2041 or 301-443-6597, or by FAX 301-443-8818 and requesting by shelf
number 2250.
On October 9, 1998, the committee will discuss, make
recommendations, and vote on a premarket approval application for a
cancellous bone cement.
Procedure: On October 8, 1998, from 11:30 a.m. to 6 p.m., and on
October 9, 1998, from 8 a.m. to 5 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 1, 1998. Oral
presentations from the public will be scheduled between approximately
1:30 p.m. and 2 p.m. on October 8, 1998, and between approximately 8:15
a.m. and 8:45 a.m. on October 9, 1998. Near the end of committee
deliberations on both days, a 30-minute open public hearing will be
conducted for interested persons to address issues specific to the
submission before the committee. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should
notify the contact person by October 1, 1998, 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 Presentation of Data: On October 8, 1998, from 9:30 a.m. to
10:30 a.m., the meeting will be closed to the public to permit the
committee to hear and review trade secret and/or confidential
commercial information (5 U.S.C. 552b(c)(4)) on IDE's.
Closed Committee Deliberations: On October 8, 1998, from 10:30 a.m.
to 11:30 a.m., the meeting will be closed to the public to permit FDA
to present to the committee trade secret and/or confidential
information (5 U.S.C. 552b(c)(4)) regarding present and future FDA
issues.
FDA regrets that it was unable to publish this notice 15 days prior
to the October 8 and 9, 1998, Orthopaedic and Rehabilitation 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 Orthopaedic and Rehabilitation
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 22, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-25905 Filed 9-23-98; 4:88 pm]
BILLING CODE 4160-01-F
