E6-4760. Joint Meeting of the Dental Products Panel of the Medical Devices Advisory Committee of the Center for Devices and Radiological Health and the Peripheral and Central Nervous System Drugs Advisory Committee of the Center for Drug Evaluation ...

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.

Names of Committees: The Dental Products Panel of the Medical Devices Advisory Committee of the Center for Devices and Radiological Health (CDRH) and the Peripheral and Central Nervous System Drugs Advisory Committee of the Center for Drug Evaluation and Research (CDER). This will be a joint meeting of the two committees.

General Function of the Joint Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on September 6 and 7, 2006, from 8 a.m. to 5 p.m.

Location: Holiday Inn, Walker/Whetstone Rm., Two Montgomery Village Ave., Gaithersburg, MD.

Contact Person: Michael E. Adjodha, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283, ext. 123, e-mail: [e-mail] or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572) in the Washington, DC area), code 3014512518. Please call the Information Line for up-to-date information on this meeting.

Agenda: This joint committee will review and discuss peer-reviewed scientific literature on dental amalgam devices. Dental amalgam, also called “encapsulated amalgam,” consists of dental mercury and amalgam alloys. This joint committee will review and discuss peer-reviewed scientific literature on dental amalgam and its potential mercury toxicity, specifically as it relates to neurotoxic effects. Certain consumer groups have raised concerns about the effects of using mercury as a component of dental restorative materials; therefore, we are combining the expertise of the Dental Products Panel of the Medical Device Advisory Committee with the neurology expertise of the Peripheral and Central Nervous System Drugs Advisory Committee.

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 23, 2006. On September 6 and 7, 2006, oral presentations from the public will be scheduled at the beginning of committee deliberations and near the end of the deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should submit written notification to the contact person by August 23, 2006, and include 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 we are 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 Ann Marie Williams, Conference Management Staff, 240-276-0450 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: March 22, 2006.

Scott Gottlieb,

Deputy Commissioner for Policy.