[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Notices]
[Pages 66848-66849]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27147]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1075]


Minimum Clinically Important Difference: An Outcome Metric in 
Orthopaedic Device Science and Regulation; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Minimum Clinically Important 
Difference: An Outcome Metric in Orthopaedic Device Science and 
Regulation.'' FDA is co-sponsoring this public workshop together with 
the Board of Regents of the University System of Georgia by and on 
behalf of the Georgia Institute of Technology's Translational Research 
Institute for Biomedical Engineering and Science

[[Page 66849]]

(TRIBES). The purpose of this public workshop is to bring together a 
wide variety of stakeholders to discuss key topics relating to minimum 
clinically important difference (MCID) for patient-reported outcome 
(PRO) instruments used in orthopaedic extremity device-related 
procedures in order to streamline evidence-based scientific rationales 
for regulatory guidance of clinical trials and device study design.
    Date and Time: The public workshop will be held on November 27, 
2012, from 7:45 a.m. to 5:30 p.m., and on November 28, 2012, from 7:45 
a.m. to 1 p.m.
    Location: The public workshop will be held at FDA's White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (Rm. 1503), Silver Spring, MD 20993, on November 27, 2012 
(Day 1), and Building 66, Atrium, on November 28, 2012 (Day 2). 
Entrance for the public workshop participants (non-FDA employees) is 
through Building 1 on Day 1 and Building 66 on Day 2, where routine 
security check procedures will be performed. For parking and security 
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Faisal Mirza, Center for Devices and Radiological 
Health, Food and Drug Administration, Bldg. 66, Rm. 1558, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-6910 or 6311, FAX: 
301-847-8117, email: faisal.mirza@fda.hhs.gov.
    Registration: TRIBES will charge a registration fee for non-federal 
employees to cover its share of the expenses associated with the 
workshop. The registration fee is $230 for non-federal employees. 
Registration is available on a first-come, first-served basis. Persons 
interested in attending this public workshop must register online by 
November 13, 2012. Early registration is recommended because facilities 
are limited and, therefore, FDA may limit the number of participants 
from each organization. If time and space permits, onsite registration 
on Day 1 of the public workshop will be provided beginning at 6:45 a.m. 
The onsite registration fee is $275.
    If you need special accommodations due to a disability, please 
contact Joyce Raines at 301-796-5709, email: joyce.raines@fda.hhs.gov 
no later than November 13, 2012.
    To register for the public workshop, please visit the Georgia 
Institute of Technology's TRIBES Web site at http://www.tribes.gatech.edu/mcid-conf-2012. Registrants will receive 
confirmation after they have been accepted. You will be notified if you 
are on a waiting list.
    For more information on the public workshop, please see FDA's 
Medical Devices News & Events--Workshops and Conferences calendar at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
    Streaming Webcast of the Public Workshop: This public workshop will 
also be available as a Webcast for registrants only. Persons interested 
in viewing the Webcast must register online by November 13, 2012. Early 
registration is recommended because Webcast connections are limited. 
Organizations are requested to register all participants, but to view 
using one connection per location. Webcast participants will be sent 
technical system requirements after registration and will be sent 
connection access information after November 13, 2012. If you have 
never attended a Connect Pro event before, test your connection at 
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. 
To get a quick overview of the Connect Pro program, please visit: 
http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web 
site addresses in this document, but FDA is not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management, Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. A link to the transcripts will also be available 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

SUPPLEMENTARY INFORMATION:

I. Background

    Evidence-based medicine guidelines advise the use of PRO 
instruments for assessing the successes of clinical treatment in 
practice and clinical investigations. However, the selection of a valid 
instrument and accurate estimation of its respective clinically 
meaningful differences remain challenging particularly with orthopaedic 
device-related procedures. The MCID approach has been proposed to 
overcome this problem for PRO instruments. There have been various 
methodological approaches to determine MCID for particular PRO 
instruments but consistency in the literature remains elusive in 
orthopaedics and, thus, is the focus of this workshop.

II. Topics for Discussion at the Public Workshop

    Topics to be discussed at the public workshop include, but are not 
limited to:
    1. Current high-quality validated PRO instruments used in 
orthopaedic extremity device-related procedures and published MCID 
values, if any, for the various PRO instruments.
    2. The impact of variables such as gender, racial/ethnic diversity, 
age, body mass index, timeliness, patient expectations, and patient 
satisfaction on PRO response and how this affects MCID calculation 
within these diverse populations and particular target subgroups of 
interest.
    3. Methodology for determining the MCID for validated PRO 
instruments in a consistent, reliable, and reproducible manner that is 
least cumbersome.
    4. Current evidence on how the MCID, pertaining to a particular PRO 
instrument that is used in device-related orthopaedic extremity 
surgery, may affect patient outcomes and device regulation.
    5. Potential standard metric by which to gauge patient outcomes 
across the spectrum of devices, target populations, and variables of 
interest, in order to streamline evidence-based scientific rationales 
for regulatory guidance of clinical trials and device study design.
    Approximately 45 days after the workshop, presentation slides will 
be available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the 
posted events list.)

    Dated: November 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27147 Filed 11-6-12; 8:45 am]
BILLING CODE 4160-01-P