[Federal Register: December 9, 2004 (Volume 69, Number 236)]
[Notices]               
[Page 71419]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de04-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Circulatory System 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: Circulatory System 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 January 13, 2005, from 9 
a.m. to 5 p.m.
    Location: Hilton Washington DC North, The Ballrooms, 620 Perry 
Pkwy., Gaithersburg, MD.
    Contact Person: Geretta Wood, Center for Devices and Radiological 
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-443-8320, ext. 143, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512625. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will hear a presentation on the FDA Critical 
Path Initiative. The committee will also discuss, make recommendations, 
and vote on a premarket approval application for a thoracic 
endoprosthesis intended for endovascular repair of the descending 
thoracic aorta.
    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 January 5, 
2005. 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 
January 5, 2005, 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 AnnMarie Williams, 
at 301-594-1283, ext. 113, 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: December 1, 2004.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 04-26994 Filed 12-8-04; 8:45 am]

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