[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Notices]
[Pages 52741-52742]
From the Federal Register Online via the Government Publishing 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]
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