[Federal Register: April 28, 2009 (Volume 74, Number 80)]
[Notices]
[Page 19230-19231]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap09-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Anesthesiology and Respiratory Therapy 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). The meeting will
be open to the public.
Name of Committee: Anesthesiology and Respiratory Therapy
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 May 28, 2009, from 8
a.m. to 5 p.m.
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Neel J. Patel, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., 240-276-3700, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512624. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced
advisory committee meeting cannot always be published quickly enough
to provide timely notice. Therefore, you should always check the
agency's Web site and call the appropriate advisory committee hot
line/phone line to learn about possible modifications before coming
to the meeting.
Agenda: The committee will discuss, make recommendations, and
vote on a premarket approval application for the SEDASYS\TM\
Computer-Assisted Personalized Sedation System sponsored by Ethicon
Endo-Surgery, Inc. The device is indicated for the intravenous
administration of 1% (10 milligrams/milliliters) propofol injectable
emulsion for the initiation and maintenance of minimal to moderate
sedation, as identified by the American Society of Anesthesiologists
Continuum of Depth of Sedation, in adult patients (American Society
of Anesthesiology physical status I, II, or III) undergoing
colonoscopy and esophagogastroduodenoscopy procedures.
FDA intends to make background material available to the public
no later than 2 business days before the meeting. If FDA is unable
to post the background material on its Web site prior to the
meeting, the background material will be made publicly available at
the location of the advisory committee meeting, and the background
material will be posted on FDA's Web site after the meeting.
Background material is available at http://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the year 2009 and scroll down to the
appropriate advisory committee link.
Procedure: 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 on or before
May 15, 2009. Oral presentations from the public will be scheduled
for approximately 30 minutes at the beginning of the committee
deliberations and for approximately 30 minutes near the end of
committee deliberations. Those desiring to make formal oral
presentations should notify the contact person and submit a brief
statement of the
[[Page 19231]]
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 on or
before May 6, 2009. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person
will notify interested persons regarding their request to speak by
May 7, 2009.
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 240-276-8932, at least 7
days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory
committee meetings. Please visit our Web site at http://www.fda.gov/
oc/advisory/default.htm for procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 22, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-9642 Filed 4-27-09; 8:45 am]
BILLING CODE 4160-01-S