Document ID: FDA-2009-N-0664-0037
Agency: fda
Document Type: Notice
Title: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2009-04-28T04:00Z

[Federal Register Volume 74, Number 80 (Tuesday, April 28, 2009)]
[Notices]
[Pages 19230-19231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9642]

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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