Document ID: FDA-2010-N-0001-0044
Agency: fda
Document Type: Notice
Title: Town Hall Discussion With the Director of the Center for Devices; Notice of Public Meeting; Request for Comments
Posted Date: 2010-04-22T04:00Z

[Federal Register: April 22, 2010 (Volume 75, Number 77)]
[Notices]               
[Page 21006]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ap10-69]                         

[[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: 
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, 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 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, 
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