Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation; Public Workshop, 66848-66849 [2012-27147]

Download as PDF pmangrum on DSK3VPTVN1PROD with NOTICES 66848 Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Notices nonroller-type pumps which have been reviewed by the Agency: (1) Centrifugal type pumps utilize a rotor to impart energy to the blood in an extracorporeal circuit through centrifugal forces. These pumps are part of an extracorporeal circuit usually containing an oxygenator and are intended to provide cardiopulmonary support, during procedures such as cardiopulmonary bypass surgery, for periods lasting 6 hours or less. (2) Micro-axial type pumps are comprised of a pump motor, a cannula and a catheter that connects to a console. These pumps are not designed to be used with an oxygenator but are temporarily placed within the heart or vasculature to provide cardiac support only. On March 9, 1979 (44 FR 13409), FDA published a proposed rule for classification of nonroller-type cardiopulmonary bypass blood pumps as class III requiring premarket approval. The Panel recommended class III because the device is life sustaining and life supporting and is potentially hazardous to life or health even when properly used. The Panel indicated that general controls alone would not provide sufficient control over the performance characteristics of the device, and that a performance standard would not provide reasonable assurance of the safety and effectiveness of the device and, moreover, that there was not sufficient information to establish a performance standard. Consequently, the Panel believed that premarket approval was necessary to assure the safety and effectiveness of the device. Subsequent to the proposed rule, in 1980, FDA classified nonroller-type cardiopulmonary bypass blood pumps into class III after receiving no comments on the proposed rule (45 FR 7959, February 5, 1980). In 1987, FDA published a clarification by inserting language in the codified language stating that no effective date had been established for the requirement for premarket approval for nonroller-type cardiopulmonary bypass blood pumps (52 FR 17737, May 11, 1987). In 1993, FDA published a proposed rule requiring filing a PMA or Product Development Protocol (PDP) for nonroller type cardiopulmonary bypass blood pumps, and provided an opportunity to request a change in classification in the form of a reclassification petition (58 FR 36290, July 6, 1993). On July 21, 1993, FDA received a reclassification petition from manufacturers of these devices recommending reclassification to Class II (special controls). In 1995, FDA convened the Panel to review the proposed reclassification and proposed VerDate Mar<15>2010 15:43 Nov 06, 2012 Jkt 229001 special controls for nonroller-type cardiopulmonary blood pumps for use in cardiopulmonary bypass circuits for periods of up to six hours. Micro-axial type pumps as described previously were not included in the scope of the reclassification. Reclassification to Class II with special controls was supported by the Panel for nonroller-type cardiopulmonary blood pumps for use in cardiopulmonary bypass circuits for periods of up to six hours, but FDA did not issue a regulation codifying the proposed reclassification. In 2004, the July 6, 1993 proposed rule (58 FR 36290) was withdrawn because the proposed rule was no longer considered a viable candidate for final action (69 FR 68831, November 26, 2004). The discussion at the panel meeting will involve making recommendations regarding regulatory classification to either reconfirm to class III (subject to premarket approval application [PMA]) or reclassify to class I or class II (subject to premarket notification [510(k)]), as directed by section 515(i) of the Federal Food, Drug and Cosmetic Act. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 26, 2012. Oral presentations from the public will be scheduled between approximately 9:30 a.m. and 10 a.m. for session I and between 2 p.m. and 2:30 p.m. for session II. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 13, 2012. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 14, 2012. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact James Clark, Conference Management Staff, at James.Clark@fda.hhs.gov or 301–796– 5293 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 31, 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2012–27068 Filed 11–6–12; 8:45 am] BILLING CODE 4160–01–P 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. 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 SUMMARY: E:\FR\FM\07NON1.SGM 07NON1 pmangrum on DSK3VPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Notices (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 patientreported outcome (PRO) instruments used in orthopaedic extremity devicerelated 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 https://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 nonfederal 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 https://www.tribes.gatech.edu/mcidconf-2012. Registrants will receive VerDate Mar<15>2010 15:43 Nov 06, 2012 Jkt 229001 66849 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 https:// 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: https://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 https://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 https://www. fda.gov/MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm. (Select this public workshop from the posted events list). SUPPLEMENTARY INFORMATION: 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. 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 Dated: November 1, 2012. Leslie Kux, Assistant Commissioner for Policy. PO 00000 Frm 00057 Fmt 4703 Sfmt 9990 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 https://www.fda.gov/ MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) [FR Doc. 2012–27147 Filed 11–6–12; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\07NON1.SGM 07NON1

Agencies

[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.

-----------------------------------------------------------------------

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 https://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 https://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 
https://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: 
https://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 https://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 
https://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 https://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

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