Document ID: FDA-2011-N-0002-0037
Agency: fda
Document Type: Notice
Title: International Consortium of Orthopedic Registries; Public Workshop
Posted Date: 2011-04-13T04:00Z

[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20690-20691]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8894]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

International Consortium of Orthopedic Registries; 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 ``International Consortium of Orthopedic Registries 
(ICOR).'' The

[[Page 20691]]

purpose of the public workshop is to facilitate discussion among FDA 
and worldwide orthopedic registries that have orthopedic implant 
information and create a research network to advance the methodology 
and conduct of research related to orthopedic device performance.
    Date and Time: The public workshop will be held on May 9, 2011, 
from 8 a.m. to 5:30 p.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. Participants are encouraged to arrive early to 
ensure time for parking and security screening before the meeting.
    Contacts:
    For information regarding the public workshop and registration: 
Betty Jo Alfstad, Surgical Outcomes and Analysis, Kaiser Permanente, 
3033 Bunker Hill Street, B30, San Diego, CA 92109, 858-581-8272, e-
mail: Betty.Jo.Alfstad@kp.org;
    For information regarding this notice: Tamia Woodruff, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993, 307-796-6091, e-mail: 
Tamia.Woodruff@fda.hhs.gov.
    Registration: There is no fee to attend the public workshop, but 
attendees must register in advance. Registration will be on a first-
come, first-served basis. Non-U.S. citizens are subject to additional 
security screening, and they should register as soon as possible. 
Registration ends April 25, 2011. Onsite registration is not available. 
If registration reaches maximum capacity prior to April 25, 2011, FDA 
will post a notice closing workshop registration on FDA's Web site at 
http://www.fda.gov/cdrh/meetings.html.
    To register for the public workshop, mail or e-mail your name, 
title, organization affiliation, address, phone number, and email 
address to Betty Jo Alfstad (see Contacts). Registrants will receive e-
mail confirmation upon acceptance for their participation in the public 
workshop. If you need special accommodations due to a disability, 
please contact Tamia Woodruff (see Contacts) at least 7 days in advance 
of the public workshop.

SUPPLEMENTARY INFORMATION:

I. Why are we holding this public workshop?

    The purpose of the public workshop is to facilitate discussion 
among FDA and international orthopedic registries and develop a 
research consortium (ICOR) that will advance the methodology and 
conduct of studies for orthopedic medical devices. We are reaching out 
to registries that have relevant data and are interested in 
collaboration to establish a network that will work with FDA to 
determine the evidence gaps and questions, datasets and approaches for 
conducting robust analytic studies and improve our understanding of the 
performance of orthopedic devices.

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 data holders, researchers, and industry 
interested in advancing the infrastructure and methods for studying 
orthopedic medical devices.

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:
     Regulatory science, clinical community, payers' and 
patients' needs that led to creation of ICOR.
     New methods for distributed network based collaborative 
studies.
     The opportunities for medical device outcomes research.

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://www.fda.gov/cdrh/meetings.html.

    Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8894 Filed 4-12-11; 8:45 am]
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