Document ID: FDA-2010-N-0321-0001
Agency: fda
Document Type: Notice
Title: Town Hall Discussion With the Director of the Center for Devices and Radiological Health and Other Senior Center Management
Posted Date: 2010-07-14T04:00Z

[Federal Register: July 14, 2010 (Volume 75, Number 134)]
[Notices]               
[Page 40844-40845]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy10-94]                         

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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: 
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/
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: 
susan.monahan@fda.hhs.gov 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]
BILLING CODE 4160-01-S