[Federal Register Volume 66, Number 165 (Friday, August 24, 2001)]
[Notices]
[Page 44638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21360]


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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, [email protected], 
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