[Federal Register Volume 67, Number 25 (Wednesday, February 6, 2002)]
[Notices]
[Pages 5602-5603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2883]


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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). At least one 
portion of the meeting will be closed 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 4, 2002, from 10 
a.m. to 5 p.m., and on March 5, 2002, from 8 a.m. to 3 p.m.
    Location: Gaithersburg Marriott Washingtonian Center, Salons A, B, 
C, and D, 9751 Washingtonian Blvd., Gaithersburg, MD.
    Contact: Lesley L. Ewing, Center for Devices and Radiological 
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-443-8320, ext. 161, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12625. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On March 4, 2002, the committee will discuss, make 
recommendations, and vote on a supplement to a premarket approval 
application (PMA) for a left ventricular assist device to be used as 
destination therapy in patients with end stage congestive heart 
failure. On March 5, 2002, the committee will discuss, make 
recommendations, and vote on a PMA for an implantable pacemaker/
defibrillator used for treatment of both congestive heart failure and 
life threatening dysrhythmias. Background information for each day's 
topic, 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://www.fda.gov/cdrh/panelmtg.html. Material for the 
March 4 session will be posted on March 1, 2002; material for the March 
5 session will be posted on March 4, 2002.
    Procedure: On March 4, 2002, from 10 a.m. to 4 p.m., and on March 
5, 2002, from 8 a.m. to 3 p.m., the meeting is open to the public. 
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 February 21, 2002. On both days, 
oral presentations from the public will be scheduled for approximately 
30 minutes at the beginning of each topic and for approximately 30 
minutes near the end of the committee deliberations. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before February 21, 
2002, 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, 
Conference Management Staff, at 301-594-1283, ext. 113, at least 7 days 
in advance of the meeting.
    Closed Committee Deliberations: On March 4, 2002, from 4 p.m. to 5 
p.m., the meeting will be closed to permit FDA staff to present to the 
committee trade secret and/or confidential commercial information 
regarding pending and future device submissions. This portion of the 
meeting will be closed to permit discussion of this information (5 
U.S.C. 552b(c)(4)).
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).


[[Page 5603]]


    Dated: January 30, 2002.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 02-2883 Filed 2-5-02; 8:45 am]
BILLING CODE 4160-01-S