October 28, 2009: Anesthesiology and Respiratory Therapy Advisory Committee Meeting Announcement

Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.

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 October 28, 2009, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, & C,
620 Perry Pkwy., Gaithersburg, MD.

Contact Person: Neel J. Patel, Center for Devices and Radiological Health
(Bldg. 66, rm. 2532), Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,

301–796–5580, 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: On October 28, 2009, the committee will discuss, make
recommendations, and vote on a premarket approval application for the
Alair Bronchial Thermoplasty System sponsored by Asthmatx, Inc. The device
is indicated for the treatment of severe persistent asthma in adults.
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 on the FDA Internet under the appropriate date at http://www.fda.gov/
AdvisoryCommittees/Calendar/default.htm. 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 October 22, 2009.
Oral presentations from the public will be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make formal oral presentations should notify
the contact person 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 on or before October 15, 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
October 16, 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 301–796–5966, 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/Advisory
Committees/AboutAdvisoryCommittees/ucm111462.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: September 17, 2009. David Horowitz,
Assistant Commissioner for Policy.