[Federal Register Volume 66, Number 104 (Wednesday, May 30, 2001)]
[Notices]
[Page 29336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13639]


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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 will be held on June 4, 2001, 10:30 a.m. 
to 5 p.m.
    Location: Corporate Bldg., conference room 20B, 9200 Corporate 
Blvd., Rockville, 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. Background 
information and questions for the committee will be available to the 
public on June 1, 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 May 31, 2001. 
Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. to 11 a.m. 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 May 31, 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 June 4, 2001, Medical Devices Dispute Resolution Panel of the 
Medical Devices Advisory Committee meeting. Because the agency believes 
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: May 24, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-13639 Filed 5-25-01; 3:08 pm]
BILLING CODE 4160-01-S