[Federal Register: February 6, 2002 (Volume 67, Number 25)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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
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
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
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