[Federal Register Volume 65, Number 129 (Wednesday, July 5, 2000)]
[Notices]
[Pages 41475-41476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16810]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Ear, Nose, and Throat Devices 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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Ear, Nose, and Throat Devices Panel of the 
Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 20, 2000, 9:45 a.m. 
to 5 p.m., and July 21, 2000, 8:30 a.m. to 5 p.m.
    Location: Holiday Inn, Goshen Room, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Sara M. Thornton, Center for Devices and 
Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, <a href="/cdn-cgi/l/email-protection#a9fae4fde9eaedfbe187efede887eee6ff"><span class="__cf_email__" data-cfemail="44170910040700160c6a0200056a030b12">[email protected]</span></a>, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12522. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On July 20, 2000, the committee will discuss, make 
recommendations, and vote on a premarket approval application (PMA) for 
a direct-drive implantable middle ear hearing device intended to 
provide a useful level of sound perception via mechanical stimulation 
of the ossicles. On July 21, 2000, the committee will discuss, make 
recommendations and vote on a PMA for an implant intended to restore 
useful hearing to individuals with Neurofibromatosis Type II who have 
become deaf as a result of surgery to remove bilateral auditory nerve 
tumors.
    Procedure: On July 20, 2000, from 9:45 a.m. to 5 p.m., and on July 
21, 2000, from 9:15 a.m. to 5 p.m., the meeting is open to the public. 
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 July 13, 2000. Oral presentations 
from the public will be

[[Page 41476]]

scheduled between approximately 10 a.m. and 10:30 a.m. on July 20, 
2000, and between approximately 9:30 a.m. and 10 a.m. on July 21, 2000. 
On both days, near the end of the committee deliberations on the PMA, a 
30-minute open public session will be conducted for interested persons 
to address issues specific to the submission before the committee. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before July 
13, 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.
    Closed Committee Deliberations: On July 21, 2000, from 8:30 a.m. to 
9:15 a.m., the meeting will be closed to permit FDA to present to the 
committee trade secret and/or confidential commercial information 
regarding pending issues and applications. This portion of the meeting 
will be closed to permit discussion of this information (5 U.S.C. 
552b(c)(4)).
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 26, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-16810 Filed 7-3-00; 8:45 am]
BILLING CODE 4160-01-F


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