[Federal Register Volume 76, Number 61 (Wednesday, March 30, 2011)]
[Notices]
[Pages 17657-17658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7434]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Medical Device Epidemiology Network 2011: Second Annual Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Medical Device Epidemiology Network (MDEpiNet) 
2011: Second Annual Public Workshop.'' The purpose of the public 
workshop is to provide a public update on the development of MDEpiNet 
and to facilitate discussion among FDA and all stakeholders with 
expertise in epidemiology and health services research on issues 
related to the methodology for studying medical device performance.

Date and Time:  The public workshop will be held on April 25, 2011 from 
8 a.m. to 5 p.m. Participants are encouraged to arrive early to ensure 
time for parking and security screening before the meeting. 
Registration will begin at 7 a.m.

Location:  The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (the Great Room), 
Silver Spring, MD 20993.

Contacts:  Mary Beth Ritchey, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Avenue, 
Silver Spring, MD 20993, 301-796-6638, e-mail: 
<a href="/cdn-cgi/l/email-protection#521f33202b173e3b28333037263a7c003b26313a372b123436337c3a3a217c353d24"><span class="__cf_email__" data-cfemail="e3ae82919aa68f8a99828186978bcdb18a97808b869aa3858782cd8b8b90cd848c95">[email protected]</span></a>; or Ellen Pinnow, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-6066, e-mail: 
<a href="/cdn-cgi/l/email-protection#1b5e77777e75354b727575746c5b7d7f7a35737368357c746d"><span class="__cf_email__" data-cfemail="81c4edede4efafd1e8efefeef6c1e7e5e0afe9e9f2afe6eef7">[email protected]</span></a>.
    Registration: Registration is available through April 15, 2011, at 
the following Web site: http://fda-ws.s-3.net/EpiNetWSApr11/. There is 
no fee to attend the workshop, but attendees must register in advance. 
Registration will be on a first-come, first-served basis and we ask 
that one person per institution be selected to represent the entity at 
the workshop. Non-U.S. citizens are subject to additional security 
screening, and they should register as soon as possible. If you need 
special accommodations because of a disability, please contact Mary 
Beth Ritchey (see CONTACTS) at least 7 days before the public workshop.

SUPPLEMENTARY INFORMATION:

I. Why are we holding this public workshop?

    The purpose of the public workshop is to facilitate continuing 
discussion among FDA, the academic epidemiology and health services 
research community, and all stakeholders on issues related to the 
methodology of studies for medical device performance. We aim to 
describe and solicit feedback on the establishment of a network that 
works with FDA experts to determine the evidence gaps and questions, 
datasets and approaches for conducting robust analytic studies and 
improve our understanding of the performance of medical devices 
(including comparative effectiveness studies). We also aim to reach out 
to stakeholders to initiate development of scientific, methodology, and 
device-area priorities for MDEpiNet.

II. Who is the target audience for this public workshop? Who should 
attend this public workshop?

    This workshop is open to all interested parties. The target 
audience is comprised of academic researchers with experience in 
epidemiology or health services research with an interest in medical 
device outcome and epidemiologic study methodology.

[[Page 17658]]

III. What are the topics we intend to address at the public workshop?

    We intend to discuss a large number of issues at the workshop, 
including, but not limited to the following:
    <bullet> Establishment of the MDEpiNet infrastructure,
    <bullet> Gaps and challenges in medical device outcomes and 
epidemiologic studies,
    <bullet> Opportunities for medical device epidemiologic research 
and partnerships between the Center for Devices and Radiological Health 
and academia.

IV. Where can I find out more about this public workshop?

    Background information on the public workshop, registration 
information, the agenda, information about lodging, and other relevant 
information will be posted, as it becomes available, on the Internet at 
http://fda-ws.s-3.net/EpiNetWSApr11/.

    Dated: March 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7434 Filed 3-29-11; 8:45 am]
BILLING CODE 4160-01-P


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