Document ID: FDA-2010-N-0224-0001
Agency: fda
Document Type: Notice
Title: Meetings: Town Hall Discussion With Director of Center for Devices and Radiological Health and Other Senior Center Management
Posted Date: 2010-05-05T04:00Z

[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Notices]               
[Page 24718-24719]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my10-104]                         

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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: 
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/
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: 
susan.monahan@fda.hhs.gov 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