[Federal Register Volume 63, Number 70 (Monday, April 13, 1998)]
[Notices]
[Pages 18028-18029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9704]
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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 regulatory issues.
Date and Time: The meeting will be held on April 27, 1998, 10:30
a.m. to 5 p.m., and April 28, 1998, 8 a.m. to 6 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 April 28, 1998, the committee will: (1) Discuss and make
recommendations on a reclassification petition for
Polymethylmethacrylate (PMMA) bone cement; (2) consider issues relating
to the study and evaluation of bone growth stimulator devices as
discussed in the draft guidance document entitled ``Guidance Document
for Industry and CDRH Staff for the Preparation of Investigational
Device Exemptions and Premarket Approval Applications for Bone Growth
Stimulator Devices;'' and (3) address scientific issues pertaining to
investigations and marketing considerations of bone growth stimulators
(e.g., inclusion/exclusion criteria, type of control(s), study
endpoints, and length of followup). Single copies of the draft guidance
document are available to the public by contacting the Division of
Small Manufacturers Assistance, Center for Devices and Radiological
Health (HFZ-220), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 1-800-638-2041, by faxing your request to 301-443-
8818. The agency will publish in the near future a notice of
availability which will include the web site.
Procedure: On April 27, 1998, from 10:30 a.m. to 11:30 a.m., and on
April 28, 1998, from 8 a.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 April 20, 1998. Oral
presentations from the public will be scheduled between approximately
9:45 a.m. and 10:45 a.m., on April 27, 1998, and between approximately
2:45 p.m. and 3:45 p.m., on April 28, 1998. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the
[[Page 18029]]
contact person before April 20, 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 Committee Deliberations: On April 27, 1998, from 11:30 a.m.
to 5 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)).
This portion of the meeting will be closed to permit discussion of this
material.
FDA regrets that it was unable to publish this notice 15 days prior
to the April 27, 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: April 8, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-9704 Filed 4-9-98; 12:38 pm]
BILLING CODE 4160-01-F