Advisory Committees

December 14-15, 2010: Dental Products Panel Meeting Announcement

 

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;

Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

The Food and Drug Administration (FDA) is announcing an amendment

to the notice of meeting of the Dental Products Panel of the Medical Devices

Advisory Committee. This meeting was announced in the Federal Register of

June 11, 2010 (75 FR 33315). The amendment is being made to reflect a change

in the Agenda portion of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Olga I. Claudio, Food and Drug

Administration, Center for Devices and Radiological Health, 10903 New

Hampshire Ave., Bldg. 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 3014512518. Please call the

Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 11, 2010, FDA

announced that a meeting of the Dental Products Panel of the Medical Devices

Advisory Committee would be held on December 14 and 15, 2010. On page

33316, in the first column, in the Agenda portion of the document, in the

second full paragraph, in the second sentence, the phrase ‘‘(docket numbers

FDA–2008–N–0163 and FDA–2009–P–0357)’’ is changed to read as follows:

 ‘‘(docket numbers FDA–2008–N–0163, FDA–2009–P–0357, and FDA–

2010–P–0056–0001)’’

This notice is issued under the Federal Advisory Committee Act (5 U.S.C.

app. 2) and 21 CFR part 14, relating to the advisory committees.

Dated: September 21, 2010.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.

(Original Notice is as follows)

 

 

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.

 


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, WO66, 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/Regshome.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

 

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]

 

BILLING CODE 4160–01–S

 

 

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