2011-8894. International Consortium of Orthopedic Registries; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA) is announcing a public workshop entitled “International Consortium of Orthopedic Registries (ICOR).” The 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: [e-mail];

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: [e-mail].

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.