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Dental Products Panel of the Medical Devices Advisory Committee

Agenda:
The committee will discuss, make recommendations, and vote on a petition to reclassify tricalcium phosphate granules for dental bone repair (21 CFR 872.3930) from Class III to Class II (Special Controls). Background information, including the agenda and questions for the committee, will be available to the public one business day before the meeting on the Internet at /cdrh/panel/index.html. Material will be posted on May 21, 2003.

Closed Committee Deliberations:
On May 22, 2003, from 4:00 p.m. to 4:30 p.m., the meeting will be closed to the public to permit FDA to present to the committee trade secret and/or confidential commercial information regarding pending and future agency issues (5 U.S.C.552b(c)(4)).

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 May 7, 2003. Oral presentations from the public will be scheduled for approximately 60 minutes at the beginning of committee deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 7, 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, 301–594–1283, ext. 113, at least 7 days in advance of the meeting.

Contact Person:
Michael E. Adjodha, Center for Devices and Radiological Health (HFZ–480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, via email at mea@cdrh.fda.gov, or by phone: 301–827–5283, ext. 123, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12518. Please call the Information Line for up-to-date information on this meeting.

[Full FR Notice]