[Federal Register: July 25, 2002 (Volume 67, Number 143)]
[Page 48665-48666]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


    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 August 16, 2002, from 
10:30 a.m. to 4:30 p.m.
    Location: Holiday Inn, Walker/Whetstone Rooms, 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, 301–594–2053, ext. 
127, 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: The committee will discuss and make recommendations on a 
draft guidance entitled “Implantable Middle Ear Hearing Device; 
Draft Guidance for Industry and FDA.” The topics for discussion 
will include the appropriate study population, objective measurement 
techniques for comparison of acoustic hearing aids and middle ear 
hearing devices, and subjective questionnaire development for 
determining postoperative effectiveness and quality of life outcome 
measures. The draft guidance is available to the public on the Internet 
at http://www.fda.gov/cdrh/ode/guidance/1406.html.
    Background information, including the attendee list, agenda, and 
questions for the committee, will be available to

[[Page 48666]]

the public on August 15, 2002, on the Internet at http://www.fda.gov/
    Procedure: On August 16, 2002, from 12:30 p.m. to 4:30 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 
August 8, 2002. Oral presentations from the public will be scheduled 
between approximately 12:40 p.m. and 1:10 p.m. and 3:45 p.m. and 4:15 
p.m. Time allotted for each presentation may be limited. Those desiring 
to make formal oral presentations should notify the contact person 
before August 8, 2002, 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 August 16, 2002, from 10:30 a.m. 
to 12:30 p.m., the meeting will be closed to the public to permit 
discussion and review of trade secret and/or confidential information 
regarding pending issues and applications (5 U.S.C. 552b(c)(4)).
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Shirley Meeks, 
Conference Management Staff, at 301–594–1283, ext. 105, at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 18, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 0218774 Filed 7–24–02; 8:45 am]