Orthopaedic and Rehabilitation Devices 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). At least one portion of the meeting will be closed to the public.

Name of Committee: Orthopaedic and Rehabilitation 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 February 18, 2000, 9 a.m. to 5 p.m.

Location: 9200 Corporate Blvd., Corporate Bldg., conference room 20B, Rockville, MD.

Contact Person: Hany W. Demian, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2036, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12521. Please call the Information Line for up-to-date information on this meeting.

Agenda: FDA staff will present an update to the committee regarding the status of submissions from past panel meetings.

Procedure: On February 18, 2000, from 9 a.m. to 10 a.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues appropriate for the committee. Written submissions may be made to the contact person by February 14, 2000. Those desiring to make formal oral presentations should notify the contact person before February 14, 2000, 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. Time allotted for the presentations may be limited.

Closed Committee Deliberations: On February 18, 2000, from 10 a.m. to 5 p.m., the meeting will be closed to the public. The committee will hear and review trade secret and/or confidential commercial information on a product development protocol. This portion of the meeting is closed to permit discussion of this information (5 U.S.C. 552b(c)(4)).

FDA regrets that it was unable to publish this notice 15 days prior to the February 18, 2000, Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meeting. Because the agency believes there is some urgency to bring these issues to public discussion and qualified members of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee were available at this time, the Commissioner of Food and Drugs concluded that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).