[Federal Register: August 18, 2004 (Volume 69, Number 159)]
[Notices]               
[Page 51316-51317]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18au04-67]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Joint Meeting of the Ear, Nose, and Throat Devices Panel and the 
Dental Products 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: Joint meeting of the Ear, Nose, and Throat 
Devices Panel and the Dental Products 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 October 6, 2004, from 8 
a.m. to 5:30 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and 
C, 620 Perry Pkwy., 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 3014512522. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: The committee will discuss general issues surrounding the 
prescription use versus over the counter (OTC) use of devices intended 
to treat snoring or mild to severe obstructive sleep apnea (OSA). The 
discussion will include the role of the medical/dental provider in the 
diagnosis, treatment, and followup of snoring and OSA; the ability of 
the patient to self diagnose and treat OSA; the types of clinical data 
that would be needed to support an OTC intended use; and the components 
of adequate device labeling. The discussion will not include continuous 
positive airway pressure (CPAP) devices and surgical treatments for 
OSA. Background information, including the attendee list, agenda, and 
questions for the committee, will be available to the public 1 business 
day before the meeting, on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html
.

    Procedure: On October 6, 2004, from 8:30 a.m. to 5:30 p.m., the 
meeting will be open to the public. Interested persons may present 
data, information, or views, orally or in writing, on issues pending 
before the committee. Written

[[Page 51317]]

submissions may be made to the contact person by September 17, 2004. 
Oral presentations from the public will be scheduled between 
approximately 9:15 a.m. and 9:45 a.m. Near the end of the committee 
discussion, a second 30-minute open public session will be conducted 
for interested persons to comment further on the discussion topic. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
September 17, 2004, 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 October 6, 2004, from 8 a.m. to 
8:30 a.m., the meeting will be closed to permit FDA staff to present to 
the committee trade secret and/or confidential commercial information 
relevant to pending and future device submissions for ear, nose, and 
throat devices. This portion of the meeting will be closed to permit 
discussion of this information (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 
outlets.
    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 AnnMarie Williams, 
Conference Management Staff, at 301-594-1283, ext. 113, 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: August 11, 2004.
William K. Hubbard,
Associate Commissioner Policy and Planning.
[FR Doc. 04-18849 Filed 8-17-04; 8:45 am]

BILLING CODE 4160-01-S