[Federal Register Volume 75, Number 134 (Wednesday, July 14, 2010)]
[Notices]
[Pages 40844-40845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17068]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0321]
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 meeting is to present the Center for
Devices and Radiological Health (CDRH) Fiscal Year (FY) 2010
Priorities. In addition, FDA is interested in engaging in discussions
about issues that are of importance to the medical device industry.
Date and Time: The public meeting will be held on October 7, 2010,
from 8 a.m. to 12 noon.
Location: The public meeting will be held at the Hilton Irvine/
Orange County Airport Hotel, 18800 MacArthur Blvd., Irvine, CA 92612.
The meeting will not be videotaped or webcast.
Contact: Heather Howell, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg.
66, rm. 4320, Silver Spring, MD 20993, 301-796-5718, email:
[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/ucm215113.htm. Those without Internet access may contact Heather Howell
(see Contact).
Provide complete contact information for each attendee, including
name, title, company or organization, address, email, telephone and fax
number. Registration requests must be received by 5 p.m. on Wednesday,
September 22, 2010.
If you wish to make an oral presentation during any of the
discussions at the meeting (see section II of this document, Public
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 on the day of the public
meeting will be provided on a space-available basis beginning at 7 a.m.
If you need special accommodations due to a disability, please
contact Susan Monahan at 301-796-5661 or by email:
[email protected] at least 7 days in advance.
Comments: FDA is holding this public meeting to share information
and discuss issues of importance to the medical device industry. CDRH
is specifically interested in addressing the following question: What
mechanism(s) would you prefer or suggest for FDA to
[[Page 40845]]
engage with industry? The deadline for responding to this question and
for submitting other comments related to this public meeting is
September 22, 2010.
Regardless of attendance at the public meeting, interested persons
may submit either electronic or written comments regarding this
document. 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
CDRH has announced four priority areas of activity for FY 2010,
each of which presents significant opportunities to improve the
Center's effectiveness in fulfilling our public health mission. More
information, including specific goals and actions associated with each
priority, is available under ``CDRH Strategic Planning'' at
www.fda.gov/AboutFDA/CentersOffices/CDRH.
II. Public Meeting
The objective of this public meeting is to present the CDRH FY 2010
priorities. In addition, FDA is interested in engaging in discussions
about issues that are of importance to the medical device industry.
CDRH wishes to obtain feedback/ideas for facilitating two-way
communication between CDRH and the medical device industry.
The meeting will open with an introduction of CDRH Senior Staff in
attendance. Following introductions, Dr. Jeffrey Shuren, the Director
of CDRH, will present the FY 2010 CDRH priorities. Industry
representatives and other members of the public will then be given the
opportunity to present comments to CDRH Senior Staff. Attendees from
CDRH may respond to questions presented by industry and other members
of the public.
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. The transcript may be
viewed at the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. 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 8, 2010.
Nancy Stade,
Acting Associate Director for Regulations and Policy, Center for
Devices and Radiological Health.
[FR Doc. 2010-17068 Filed 7-13-10; 8:45 am]
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