Document ID: FDA-2011-N-0496-0001
Agency: fda
Document Type: Notice
Title: Town Hall Discussion with Director of Center for Devices and Radiological Health and Other Senior Center Management: Notice of Meeting
Posted Date: 2011-07-15T04:00Z

[Federal Register Volume 76, Number 136 (Friday, July 15, 2011)]
[Notices]
[Page 41804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17887]

[[Page 41804]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0496]

Town Hall Discussion With the Director of the Center for Devices 
and Radiological Health and Other Senior Center Management

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``Town Hall Discussion With the Director of the Center 
for Devices and Radiological Health and Other Senior Center 
Management.'' The purpose of this public meeting in San Francisco, CA, 
is to engage in a dialogue about issues of importance to FDA's Center 
for Devices and Radiological Health (CDRH) and to members of the 
public, including the medical device industry, health care 
professionals, patients, and consumers.
    Date and Time: The public meeting will be held on Thursday, 
September 22, 2011, from 8 a.m. to 12 noon PDT.
    Location: The public meeting will be held at the Embassy Suites 
Hotel, San Francisco Airport, 250 Gateway Blvd., South San Francisco, 
CA 94080. Attendees requiring overnight accommodations should call 650-
589-3400 and request the group rate for the ``FDA/CDRH Town Hall 
Meeting'' block of rooms.
    Contact: Heather Howell, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, rm. 4320, Silver Spring, MD 20993, 301-796-5718, e-mail: 
heather.howell@fda.hhs.gov.
    Registration and Requests for Oral Presentations: If you wish to 
attend the public meeting, you must register online at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm258228.htm. Persons without Internet access may call Heather Howell 
at 301-796-5718 to register for the meeting.
    Provide complete contact information for each attendee, including 
name, title, company or organization, address, e-mail, and telephone 
and fax number. Registration requests must be received by 5 p.m. EDT on 
Friday, September 9, 2011.
    The meeting will not be videotaped or Web cast.
    If you wish to make an oral presentation during the meeting, you 
must indicate this at the time of registration. FDA will do its best to 
accommodate requests to speak. Individuals and organizations with 
common interests are urged to consolidate or coordinate their 
presentations and to request time for a joint presentation. FDA will 
determine the amount of time allotted to each presenter and the 
approximate time that each oral presentation is scheduled to begin.
    Registration is free and will be on a first-come-first-served 
basis. Early registration is recommended because seating is limited. 
FDA may limit the number of participants from each organization based 
on space limitations. Registrants will receive confirmation once they 
have been accepted. Onsite registration the day of the public meeting 
will be provided on a space-available basis beginning at 7 a.m. PDT on 
September 22, 2011.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, 301-796-5661 or susan.monahan@fda.hhs.gov, at 
least 7 days in advance of the meeting.
    Comments: FDA is holding this public meeting to share information 
and discuss issues of importance to the public, including the medical 
device industry, health care professionals, patients, and consumers.
    Regardless of attendance at the public meeting, interested persons 
may submit either electronic or written comments. Submit electronic 
comments to http://www.regulations.gov. Submit written comments to the 
Division of Dockets Management (HFA-305), 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.

SUPPLEMENTARY INFORMATION:

I. Background

    In 2010, CDRH held three Town Hall meetings in Minneapolis, MN, 
Boston, MA, and Los Angeles, CA, to provide the public with a new venue 
to discuss issues of interest with the Center. Any member of the public 
was invited to provide comments to or ask questions of CDRH 
participants. We received positive feedback on these meetings and are 
continuing this activity in 2011 in three new locations. This year we 
have held two meetings: one in Dallas, TX, and one in Orlando, FL. The 
meeting in San Francisco will be our final meeting of 2011.

II. Public Meeting

    The objective of this public meeting is to engage in a dialogue 
about issues that are of importance to the public.
    The public meeting will open with an introduction of CDRH senior 
staff in attendance. Following introductions, Dr. Jeffrey Shuren, the 
Director of CDRH, will describe CDRH's strategic priorities for 2011. 
Members of the public will then be given the opportunity to present 
comments to CDRH senior staff followed by a question and answer session 
during which any member of the public may ask questions of the CDRH 
senior staff on any topic of interest.
    In advance of the meeting, additional information, including a 
meeting agenda with a speakers' schedule, will be made available on the 
Internet. This information will be placed on file in the public docket 
(docket number found in brackets in the heading of this document), 
which is available at http://www.regulations.gov. This information will 
also be available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate meeting from 
the list).

III. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. It may be viewed at 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857.

    Dated: July 11, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-17887 Filed 7-14-11; 8:45 am]
BILLING CODE 4160-01-P