Document ID: FDA-2008-N-0038-0086
Agency: fda
Document Type: Notice
Title: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2008-11-13T05:00Z

[Federal Register: November 13, 2008 (Volume 73, Number 220)]
[Notices]               
[Page 67187-67188]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no08-49]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

 
Anesthesiology and Respiratory Therapy Devices 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). 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 December 5, 2008, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and 
C, 620 Perry Pkwy., 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, sponsored by Emphasys Medical, 
Inc., for the Emphasys Zephyr Endobronchial Valve System, which is 
intended to improve forced expiratory volume in the first second (FEV1) 
and 6-minute walk test distance in patients with severe heterogeneous 
emphysema who have received optimal medical management. FDA intends to 
make background material available to the public no later than 2 
business days before the meeting.

[[Page 67188]]

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 2008 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 
November 26, 2008. 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 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 November 20, 2008. 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 November 
24, 2008.
    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: November 5, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-26965 Filed 11-12-08; 8:45 am]

BILLING CODE 4160-01-S