International Consortium of Cardiovascular Registries, 19716-19717 [2013-07579]

Download as PDF 19716 Federal Register / Vol. 78, No. 63 / Tuesday, April 2, 2013 / Notices notice with a 30-day comment period to request comments on the findings and recommendations contained in the IFT report and the submission of information relevant to improving product tracing. Comments on the findings and recommendations contained in the IFT report and the submission of information relevant to improving product tracing will help FDA as it forms its own recommendations, to be contained in the Agency report to Congress that is required by the FDA Food Safety Modernization Act (FSMA), and as it implements the FSMA provisions relating to the tracking and tracing of food. The Agency has received requests for a 120-day extension of the comment period for the notice. Each request conveyed concern that the current 30day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the notice. FDA has considered the requests and is extending the comment period for all interested persons for 90 days, until July 3, 2013. The Agency believes that a 90day extension allows adequate time for interested persons to submit comments. II. Request for Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. 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 will be posted to the docket at https:// www.regulations.gov. Dated: March 26, 2013. Peter Lurie, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2013–07580 Filed 4–1–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration srobinson on DSK4SPTVN1PROD with NOTICES [Docket No. FDA–2013–N–0331] International Consortium of Cardiovascular Registries AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: VerDate Mar<15>2010 19:35 Apr 01, 2013 Jkt 229001 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 https:// 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 https:// 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, SUMMARY: PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 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 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.) 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 https:// 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 E:\FR\FM\02APN1.SGM 02APN1 Federal Register / Vol. 78, No. 63 / Tuesday, April 2, 2013 / Notices srobinson on DSK4SPTVN1PROD with NOTICES will be posted to the docket at https:// www.regulations.gov. Transcripts: Transcripts will not be provided. SUPPLEMENTARY INFORMATION: 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 realworld 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, VerDate Mar<15>2010 19:35 Apr 01, 2013 Jkt 229001 • Goals of the International Consortium of Cardiovascular Registries, • 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] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Wednesday, February 27, 2013 (78 FR 13347). The meeting was shortened to one day, as it was later determined that in order to be more financially prudent all three topics could fit into one day. FOR FURTHER INFORMATION CONTACT: Sara J. Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993–0002, Sara.Anderson@fda.hhs.gov, 301–796– 7047, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting. SUMMARY: In FR doc. 2013–04543, appearing on page 13347 in the Federal Register of Wednesday, February 27, 2013, the following correction is made: 1. On page 13347, in the first column, under the section entitled ‘‘Date and Time’’, the date is corrected to be April 25, 2013. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 19717 2. On page 13347, in the second column, the section entitled ‘‘Agenda’’ is corrected to read as follows: Agenda: On April 25, 2013, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as methotrexate enzyme immunoassays. Methotrexate enzyme immunoassays are considered preAmendment devices since they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. Methotrexate enzyme immunoassays are currently regulated under the heading of ‘‘Enzyme Immunoassay, Methotrexate,’’ Product Code LAO, as unclassified under the 510(k) premarket notification authority. Methotrexate enzyme immunoassays are for the quantitative determination of methotrexate. The measurements obtained are used in monitoring levels of methotrexate to ensure appropriate drug therapy. FDA is seeking panel input on the safety and effectiveness of methotrexate enzyme immunoassays. The committee will also discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as phencyclidine (PCP) enzyme immunoassays and PCP radioimmunoassays. PCP enzyme immunoassays and PCP radioimmunoassays are considered preAmendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. PCP enzyme immunoassays are currently regulated under the heading of ‘‘Enzyme Immunoassay, Phencyclidine,’’ Product Code LCM, and ‘‘Radioimmunoassay, Phencyclidine,’’ Product Code LCL, as unclassified under the 510(k) premarket notification authority. FDA is seeking panel input on the safety and effectiveness of PCP enzyme immunoassays and PCP radioimmunoassays. The committee will also discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as isoniazid test strips. Isoniazid test strips are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. Isoniazid test strips are currently regulated under the heading of ‘‘Strip, Test Isoniazid,’’ Product Code MIG, as unclassified under the 510(k) premarket notification authority. Isoniazid test strips are a qualitative assay used for detecting isonicotinic acid and its metabolites in E:\FR\FM\02APN1.SGM 02APN1

Agencies

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


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 https://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 https://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 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.)
    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 https://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 https://www.regulations.gov.
    Transcripts: Transcripts will not be provided.

SUPPLEMENTARY INFORMATION:

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 
Registries,
     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]
BILLING CODE 4160-01-P

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