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###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of public workshop.

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: MaryElizabeth.Ritchey@fda.hhs.gov;*                         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: Ellen.Pinnow@fda.hhs.gov.*

*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.                          ( print 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:
    - Establishment of the MDEpiNet infrastructure,
    - Gaps and challenges in medical device outcomes and epidemiologic studies,
    - 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]

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