[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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