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