[Federal Register Volume 75, Number 77 (Thursday, April 22, 2010)]
[Notices]
[Page 21006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9242]
[[Page 21006]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
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.
Dates and Time: The public meeting will be held on May 18, 2010,
from 9 a.m. to 4 p.m.
Location: The public meeting will be held at the Hilton
Minneapolis, Saint Paul Airport, 3800 American Blvd. East, Bloomington,
MN, 55425-1658. The meeting will not be videotaped or webcast.
Contact Person: Heather Howell, Food and Drug Administration,
Center for Devices and Radiological Health, 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, May 5, 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 [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,
May 5, 2010.
Regardless of attendance at the public meeting, interested persons
may submit 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. 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 fiscal year
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 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, 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
Transcripts of the public meeting may be requested in writing from
the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public meeting at a cost of 10
cents per page. A transcript of the public meeting will be available on
the Internet at http://www.regulations.gov.
Dated: April 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9242 Filed 4-21-10; 8:45 am]
BILLING CODE 4160-01-S