2010-14084. Dental Products 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: Dental Products 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 December 14 and 15, 2010, from 8 a.m. to 6 p.m.

Location: Holiday Inn-Gaithersburg, Main Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD 20879.

Contact Person: Olga I. Claudio, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, rm. 1553, Silver Spring, MD 20993-0002, 301-796-7608 or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 301-451-2518. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

Comments: FDA is opening a docket for public comment on this document. The docket number is FDA-2010-N-0268. The docket will be open for public comment on June 11, 2010. The docket will close on December 3, 2010. Interested persons are encouraged to use the docket to submit either electronic or written comments regarding this meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Agenda: On December 14 and 15, 2010, the committee will discuss and make recommendations on scientific issues raised in petitions received by FDA concerning the final rule on the classification of dental amalgam, which published in the Federal Register on August 4, 2009 (74 FR 38686). These petitions (docket numbers FDA-2008-N-0163 and FDA-2009-P-0357) can be viewed at http://www.regulations.gov/​search/​Regs/​home.html#documentDetail?​R=​09000064809fbe3f; http://www.regulations.gov/​search/​Regs/​home.html#documentDetail?​R=​0900006480a1d1bc; http://www.regulations.gov/​search/​Regs/​home.html#documentDetail?​R=​0900006480a24048; and http://www.regulations.gov/​search/​Regs/​home.html#documentDetail?​R=​0900006480a80ae5. Issues raised in the petitions include the adequacy of the risk assessment performed by FDA in classifying dental amalgam in light of a new report on risk assessments issued by the National Academy of Sciences, entitled “Science and Decisions: Advancing Risk Assessment,” NAP, 2009.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/​AdvisoryCommittees/​Calendar/​default.htm. Scroll down to the appropriate advisory committee link.

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 on or before December 6, 2010. Oral presentations from the public will be scheduled at 1 p.m. on December 14, 2010 and at 8 a.m. on December 15, 2010. Those desiring to make formal oral presentations should notify the contact person 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 on or before November 29, 2010. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by December 1, 2010.

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, 301-796-5966, at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/​AdvisoryCommittees/​AboutAdvisoryCommittees/​ucm111462.htm for procedures on public conduct during advisory committee meetings.

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

Dated: June 8, 2010.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.