[Federal Register: August 24, 2001 (Volume 66, Number 165)]
[Notices]
[Page 44638]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au01-94]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Devices Dispute Resolution 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). The meeting will
be open to the public.
Name of Committee: Medical Devices Dispute Resolution Panel of the
Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on scientific disputes between the Center
for Devices and Radiological Health and sponsors, applicants, and
manufacturers.
Date and Time: The meeting, which is rescheduled from June 4, 2001,
will be held on September 6, 2001, from 8 a.m. to 6 p.m.
Location: Marriott, Salons E, F, and G, 9751 Washingtonian Blvd.,
Gaithersburg, MD.
Contact: Les Weinstein, Center for Devices and Radiological Health
(HFZ-5), Food and Drug Administration, 9200 Corporate Blvd., Rockville,
MD 20850, 301-443-6220, ext. 119, FAX 301-827-2565, lsw@cdrh.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 10232. Please call the
Information Line for up-to-date information on this meeting.
Agenda: The committee will discuss, make recommendations, and vote
regarding a scientific dispute between the agency and Lifecore
Biomedical, Inc., related to the approvability of a premarket approval
application for Intergel, an adhesion prevention solution for use in
gynecologic pelvic surgery. Background information and questions for
the committee will be available to the public on September 5, 2001, on
the Internet at http://www.fda.gov/cdrh/panelmtg.html.
Procedure: 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 September 4,
2001. Oral presentations from the public will be scheduled between
approximately 8 a.m. and 8:30 a.m. on September 6, 2001. Near the end
of the committee deliberations, a 30-minute open public session will be
conducted for interested persons to address issues specific to the
dispute before the committee. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before September 4, 2001, 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.
FDA regrets that it was unable to publish this notice 15 days prior
to the Medical Devices Dispute Resolution Panel of the Medical Devices
Advisory Committee meeting. Because the agency believes that there is
some urgency to bring this issue to public discussion and qualified
members of the Medical Devices Dispute Resolution 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: August 16, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-21360 Filed 8-23-01; 8:45 am]
BILLING CODE 4160-01-S