03-18350. Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 [phone], [e-mail], 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://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. 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.