[Federal Register Volume 75, Number 112 (Friday, June 11, 2010)]
[Notices]
[Pages 33315-33316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14084]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0268]


Dental Products Panel of the Medical Devices Advisory Committee; 
Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    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.

[[Page 33316]]

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.
[FR Doc. 2010-14084 Filed 6-10-10; 8:45 am]
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