[Federal Register Volume 65, Number 205 (Monday, October 23, 2000)]
[Notices]
[Pages 63257-63258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-27228]


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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 Panel: 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 October 31, 2000, 1 p.m. 
to 4 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate 
Blvd., Rockville, MD.
    Contact Person: Les S. Weinstein, Center for Devices and 
Radiological Health (HFZ-5), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, e-mail: <a href="/cdn-cgi/l/email-protection#6f031c182f0c0b1d0741090b0e41080019"><span class="__cf_email__" data-cfemail="472b3430072423352f6921232669202831">[email protected]</span></a>, 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 members of the newly established Medical Devices 
Dispute Resolution Panel will be introduced to the public and will hear 
presentations by FDA staff on the purpose of the panel and its role in 
dispute resolution.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues regarding resolving scientific 
disputes concerning medical devices and on the role of this panel. 
Written submissions may be made to the contact person by October 25, 
2000. Oral presentations from the public will be scheduled between 
approximately 2 p.m. and 4 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before October 25, 2000, 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 October 31, 2000, 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).


[[Page 63258]]


    Dated: October 18, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-27228 Filed 10-19-00; 12:06 pm]
BILLING CODE 4160-01-F


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