
[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Notices]
[Pages 52741-52742]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21435]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0360]


MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology 
Network as a Partnership for Building Global Medical Device 
Epidemiology and Surveillance Capabilities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``MDEpiNet 2012 Annual Meeting: The 
Medical Device Epidemiology Network as a Partnership for Building 
Global Medical Device Epidemiology and Surveillance Capabilities.'' The 
topic to be discussed is setting strategic priorities and implementing 
an action plan for sustainable partnership toward improving regulatory 
science and the public health.

DATES: The public workshop will be held on September 11, 2012, from 8 
a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at the Greenbelt Marriott 
Hotel, 6400 Ivy Lane, Greenbelt, MD 20770, 301-441-3700.

FOR FURTHER INFORMATION CONTACT: 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, email: hhs.gov">Danica.Marinac-Dabic@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Registration: Registration is free and 
available on a first-come, first-served basis. Persons interested in 
attending this public workshop must register online by 5 p.m., 
September 10, 2012. Early registration is recommended because 
facilities are limited and, therefore, FDA may limit the number of 
participants from each organization. Onsite registration will not be 
available on the day of the workshop.
    If you need special accommodations due to a disability, please 
contact Joyce Raines, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4319, 
Silver Spring, MD 20993, 301-796-5709, email: joyce.raines@fda/hhs.gov; 
no later than September 5, 2012.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this public workshop from the posted events list.) Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone number. Those without 
Internet access should contact Danica Marinac-Dabic (see Contact 
Person) to register. Registrants will receive confirmation after they 
have been accepted. You will be notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. Persons interested in viewing the Webcast must 
register online by 5 p.m., September 5, 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 September 7, 2012.
    Comments: FDA is holding this public workshop to provide updates 
and obtain stakeholders' input on the Medical Device Epidemiology 
Network (MDEpiNet) as a partnership for building global medical device 
epidemiology and surveillance capabilities. 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 workshop 
topics. The deadline for submitting comments related to this public 
workshop is October 9, 2012.
    Regardless of attendance at the meeting, interested persons may 
submit either written comments regarding this document to the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852 or electronic comments to 
http://www.regulations.gov. 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. In addition, when responding to specific 
questions as outlined in section II of this document, please identify 
the question you are addressing. 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 http://www.regulations.gov.

[[Page 52742]]

    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 (see Comments). 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.)

I. Background

    MDEpiNet is a collaborative program through which the Center for 
Devices and Radiological Health and external partners share information 
and resources to enhance our understanding of how well medical devices 
work (http://www.fda.gov/mdepinet). By bridging evidentiary gaps, 
developing datasets, and innovating methodological approaches for 
conducting robust analytic studies, MDEpiNet aims to develop new ways 
to study medical devices that improve the understanding of safety and 
effectiveness performance throughout a device's life cycle.
    Accomplishing MDEpiNet's mission will require leveraging of 
resources, skills, and expertise from a variety of partners, and we 
encourage participation from all stakeholders, including other 
Government Agencies, academia, health care industry organizations, and 
patient and consumer groups. The purpose of the public workshop is to 
facilitate discussion among these key stakeholders in the scientific 
community on issues related to medical device epidemiology methodology 
and infrastructure as it relates to evidence generation and synthesis 
across the Total Product Life Cycle. This public workshop is open to 
all interested parties. The target audience is professionals from other 
Government Agencies, academia, professional societies, health care 
industry organizations, patient and consumer groups, and other 
professionals in the scientific community interested in advancing the 
infrastructure and methodology for epidemiologic understanding of 
medical devices and procedures.

II. Topics for Discussion at the Public Workshop

    We intend to discuss a large number of issues at the public 
workshop, including but not limited to the following: (1) Status and 
updates from MDEpiNet Methodology and Infrastructure Centers; (2) 
proposed partnership structure and governance; (3) MDEpiNet as a 
framework for medical device postmarket surveillance and its relation 
to the Sentinel provision in the FDA Safety and Innovation Act (calling 
for the expansion of the postmarket risk identification and analysis 
system to include devices); and (4) action plan and prioritization of 
MDEpiNet partnership efforts for the upcoming year.

    Dated: August 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-21435 Filed 8-27-12; 4:15 pm]
BILLING CODE 4160-01-P


