[Federal Register: July 21, 2003 (Volume 68, Number 139)]
[Notices]
[Page 43133-43134]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jy03-80]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Devices Dispute Resolution 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: Medical Devices Dispute Resolution Panel of the
Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on scientific disputes between the Center
for Devices and Radiological Health and sponsors, applicants, and
manufacturers.
Date and Time: The meeting will be held on August 20, 2003, from 8
a.m. to 6 p.m.
Location: Bethesda Marriott, Congressional Ballroom, 5151 Pooks
Hill Rd., Bethesda, MD.
Contact Person: Les Weinstein, Center for Devices and Radiological
Health (HFZ-5), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-827-7991, FAX 301-827-2565, lsw@cdrh.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 10232. Please call the
Information Line for up-to-date information on this meeting.
Agenda: The committee will discuss, make recommendations, and vote
regarding a scientific dispute between the agency and CardioGenesis
Corp., related to the approvability of a premarket approval application
for the Axcis Percutaneous Myocardial Revascularization (PMR) for late
stage medically refractory angina. Background information for the day's
topic, including the attendee list, agenda, and questions for the
committee, will be posted on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panel/index.html
one business day before the meeting.
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 13,
2003. Oral presentations from the public will be scheduled between
approximately 8 a.m. and 8:30 a.m. on August 20, 2003.
[[Page 43134]]
Near the end of the committee deliberations, a 30-minute open public
session will be conducted for interested persons to address issues
specific to the dispute before the committee. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before August 13, 2003,
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: July 11, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-18350 Filed 7-18-03; 8:45 am]
BILLING CODE 4160-01-S