[Federal Register: May 30, 2001 (Volume 66, Number 104)]
[Notices]
[Page 29336]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my01-71]
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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, 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. 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