[Federal Register: February 28, 2005 (Volume 70, Number 38)]
[Notices]               
[Page 9658]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28fe05-82]                         

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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 March 17, 2005, from 8 
a.m. to 4 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Crystals 
Ballroom, 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 discuss and make recommendations 
regarding a premarket notification submission for use in the induction, 
maintenance, and reversal of mild hypothermia in the treatment of 
unconscious adult patients with spontaneous circulation after out-of-
hospital cardiac arrest when the initial rhythm was ventricular 
fibrillation.
    Background information for the topic, including the agenda and 
questions for the committee, will be available to the public one 
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 March 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 March 
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 Shirley Meeks at 
240-276-0450, 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: February 17, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-3742 Filed 2-25-05; 8:45 am]

BILLING CODE 4160-01-S