[Federal Register: August 2, 2004 (Volume 69, Number 147)]
[Notices]               
[Page 46156-46157]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02au04-52]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Orthopaedic and Rehabilitation 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.

[[Page 46157]]

    Name of Committee: Orthopaedic and Rehabilitation 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 August 31, 2004, from 8 
a.m. to 4:30 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Ballroom Salons 
A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Janet L. Scudiero, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1184, ext. 176, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 3014512521. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application for an interspinous process 
distraction system intended for treatment of patients aged 50 or older 
suffering from neurogenic intermittent claudication secondary to mild 
or moderate lumbar spinal stenosis who have undergone a regimen of non-
operative treatment. Background information for the topics, including 
the 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: 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 by August 17, 
2004. Oral presentations from the public will be scheduled for 
approximately 30 minutes at the beginning of committee deliberations 
and for approximately 30 minutes near the end of the deliberations. 
Time allotted for each presentation may be limited. Those desiring to 
make formal oral presentations should notify the contact person before 
August 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.
    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 Shirley Meeks at 
301-594-1283, ext.105, 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: July 22, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-17446 Filed 7-30-04; 8:45 am]

BILLING CODE 4160-01-S