[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]
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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.
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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: 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