[Federal Register Volume 78, Number 63 (Tuesday, April 2, 2013)]
[Pages 19716-19717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07579]



Food and Drug Administration

[Docket No. FDA-2013-N-0331]

International Consortium of Cardiovascular Registries

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``International Consortium of Cardiovascular 
Registries.'' The purpose of this meeting is to discuss the development 
of an international consortium of cardiovascular registries with a 
broad array of interested stakeholders. The initial pilot phase of this 
effort will be developing relationships and analysis strategies for 
transcatheter cardiac valve registries, with the understanding that 
these efforts would be expanded to additional cardiovascular devices in 
the future.
    Date and Time: The meeting will be held on April 22, 2013, from 8 
a.m. to 5 p.m.
    Location: The public meeting will be held at FDA's White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public 
meeting participants (non-FDA employees) is through Building 1 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 Persons: Benjamin Eloff, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4210, Silver Spring, MD 20993, 301-796-8528, 
Benjamin.eloff@fda.hhs.gov; or Danica Marinac-Dabic, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4110, Silver Spring, MD 20993, 301-796-
6689, Danica.marinac-dabic@fda.hhs.gov.
    Registration: Registration is free and will be on a first-come, 
first-served basis. Persons interested in attending this public meeting 
must register online by 5 p.m. on April 11, 2013. Early registration is 
recommended because facilities are limited and, therefore, FDA may 
limit the number of participants from each organization. If time and 
space permit, onsite registration on the day of the public meeting will 
be provided beginning at 7 a.m.
    To register for the public meeting, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
Select this public meeting from the posted events list. Please provide 
complete contact information for each attendee, including name, title, 
affiliation, mailing address, email address, and telephone number. 
Those without Internet access should contact Susan Monahan to register 
(Susan.Monahan@fda.hhs.gov or 301-796-5661). Registrants will receive 
confirmation after they have been accepted. You will be notified if you 
are on a waiting list.
    If you need special accommodations due to a disability, please 
contact Susan Monahan (Susan.Monahan@fda.hhs.gov or 301-796-5661) no 
later than April 11, 2013.
    Streaming Webcast of the Public Meeting: This meeting will also be 
available via Webcast. Persons interested in viewing the Webcast must 
register online by 5 p.m. on April 11, 2013. 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 connection access 
information after April 16, 2013. 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, 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.)
    Comments: FDA is holding this public meeting to obtain information 
on the topics identified in section II. In order to permit the widest 
possible opportunity to obtain public comment, FDA is soliciting either 
electronic or written comments on all aspects of the public meeting 
topics. The deadline for submitting comments related to this public 
meeting is May 22, 2013. No commercial or promotional material will be 
permitted to be presented or distributed at the meeting.
    Regardless of attendance at the public meeting, interested persons 
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of 
comments. Please identify comments with the docket number found in 
brackets in the heading of this document. Received comments may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and

[[Page 19717]]

will be posted to the docket at http://www.regulations.gov.
    Transcripts: Transcripts will not be provided.


I. Background

    Cardiovascular procedures are performed in hundreds of thousands of 
patients every year to treat all manner of cardiovascular disease from 
coronary artery disease to peripheral vascular disease, intracardiac 
ablation to surgical interventions, implant of stents to implants of 
pacemakers, defibrillators, and their associated leads. Information 
obtained from clinical trials is often limited due to small size, short 
followup, and lack of generalizability. Observational studies and 
registries have become increasingly important data sources for 
assessing the performance of cardiovascular therapeutic medical devices 
in the real-world setting. However, these registries are often limited 
in scope and size to a specific country, region, or health care 
provider system.
    Developing a comprehensive understanding of the performance of 
these devices requires not only an indepth analysis across data sources 
to link device use to clinical outcomes, but also to incorporate data 
from international experience with these devices and procedures. FDA is 
holding this workshop to discuss the development of an international 
consortium of cardiovascular registries that would allow for broad-
based analysis and surveillance of medical device exposure and related 
clinical outcomes. This effort follows on the successful model of the 
International Consortium of Orthopedic Registries (ICOR), which has 
developed a framework for distributed analysis across their member 
registries around the world. The development of a similar consortium of 
cardiovascular registries will begin with a narrowed scope 
incorporating transcatheter valve therapy devices and procedures.
    At the end of this workshop, FDA intends that the participants and 
stakeholders will develop a comprehensive plan for the development of 
an operational international consortium of cardiovascular registries. 
This plan will identify specific issues that must be addressed and 
provide a ``roadmap'' for full implementation.

II. Topics

    Topics to be discussed at this meeting include:
     The role of registry consortia in postmarket surveillance,
     Goals of the International Consortium of Cardiovascular 
     Lessons learned from the development of the ICOR,
     Development of an international consortium of 
transcatheter valve registries as a pilot phase,
     Analysis of near- and long-term outcomes reported through 
registries, and
     Discussion of capabilities, challenges, and limitations of 
existing transcatheter valve registries.

    Dated: March 27, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07579 Filed 4-1-13; 8:45 am]