[Federal Register Volume 75, Number 86 (Wednesday, May 5, 2010)]
[Notices]
[Pages 24718-24719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10563]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0224]
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
[[Page 24719]]
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 June 22, 2010,
from 9 a.m. to 5 p.m.
Location: The public meeting will be held at the Hilton Boston/
Woburn, Two Forbes Rd., Woburn, MA 01801. The meeting will not be
videotaped or Web cast.
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/ucm206671.htm. Provide complete contact information for each attendee,
including name, title, company or organization, address, e-mail, and
telephone number. Registration requests must be received by 5 p.m. on
Wednesday, June 9, 2010.
If you wish to make an oral presentation during any of the sessions
at the meeting (see section II of this document), 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 8 a.m.
If you need special accommodations due to a disability, please
contact Susan Monahan at 301-796-5661 or e-mail:
[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 medical device industry. CDRH
is specifically interested in addressing the following question: What
mechanism(s) would you prefer or suggest for FDA to engage with
industry? The deadline for responding to this question and for
submitting other comments related to this public meeting is Wednesday,
June 9, 2010.
Regardless of attendance at the public meeting, interested persons
may submit written or electronic comments. Submit written comments to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. Submit a
single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified 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 CDRH'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 http://www.fda.gov/AboutFDA/CentersOffices/CDRH.
II. Public Meeting
The objective of this public meeting is to present CDRH's 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. It 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: April 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10563 Filed 5-4-10; 8:45 am]
BILLING CODE 4160-01-S