[Federal Register Volume 77, Number 32 (Thursday, February 16, 2012)]
[Notices]
[Pages 9256-9257]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3606]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0123]
Design and Methodology for Postmarket Surveillance Studies Under
Section 522 of the Federal Food, Drug, and Cosmetic Act; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Design and Methodology for Postmarket Surveillance
Studies under Section 522 of the Federal Food, Drug and Cosmetic Act''.
The purpose of the public workshop is to provide a forum for discussion
among FDA, industry, governmental agencies, academia, clinicians and
various stakeholders with experience in epidemiology, statistics, and
biomedical research to advance the design and methodologies for medical
device surveillance studies in the ``postmarket'' setting, i.e., after
FDA premarket approval or clearance of the device and marketing of the
device has begun.
DATES: The meeting will be held on March 7, 2012, from 8 a.m. to 5:30
p.m.
ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31, Rm 1503 (the Great Room), Silver Spring,
MD 20993. For parking and security information, please visit the
following Web site: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The
public workshop will also be available to be viewed online via webcast.
FOR FURTHER INFORMATION CONTACT: Samantha Jacobs, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4201C, Silver Spring, MD 20993, 301-796-
6897, email: samantha.jacobs@fda.hhs.gov; or Mary Beth Ritchey, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 4118, Silver Spring, MD 20993,
301-796-6638, email: maryelizabeth.ritchey@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Registration: To register for the public
workshop, please visit the following Web site: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm289465.htm (or go to
http://www.fda.gov and select the FDA Medical Devices News & Events--
Workshops & Conferences calendar and 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. For persons interested in attending this workshop
and without Internet access, please call one of the people listed in
the FOR FURTHER INFORMATION CONTACT section in this document in order
to register. Registrants will receive confirmation once they have been
accepted. You will be notified if you are on a waitlist. There is no
fee to attend the public workshop, but attendees must register in
advance. Registration will be on a first-come, first-served basis.
Persons interesting in attending this workshop must register online by
February 29, 2012. Registration is mandatory as space is limited and
onsite registration will not be available. FDA may limit the number of
participants from each organization.
If you need special accommodations due to a disability, please
contact Susan Monahan at susan.monahan@fda.hhs.gov no later than March
1, 2012.
Security: Non-U.S. citizens are subject to additional security
screening, and they should register as soon as possible. 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 visit the Web site address in
the ADDRESSES section of this document.
Streaming Webcast of the Public Workshop: This workshop will also
be webcast. Persons interested in viewing the webcast must register
online by 5 p.m. on February 29, 2012. Early registration is
recommended because webcast connections are limited. Organizations are
requested to register all participants, but view using one connection
per location. Webcast participants will be sent technical system
requirements after registration, and will be sent connection access
information after March 1, 2012. If you have never attended a Connect
Pro meeting 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.)
Background: Under section 522(a) of the Federal Food, Drug and
Cosmetic Act (FD&C Act), enacted by the Food and Drug Administration
Modernization Act of 1997 (FDAMA) (Pub. L. 105-115, Sec. 212, 111
Stat. 2346), codified at 21 U.S.C. 360l(a), FDA may order a
manufacturer to conduct postmarket surveillance for any Class II or
Class III device (i) Intended to be implanted in the human body for
more than 1 year or to be used to sustain or support life outside a
device user facility, or (ii) whose failure would be reasonably likely
to have serious adverse health consequences. The Food and Drug
Administration Amendments of 2007 (FDAAA) (Pub. L. 110-85, Sec. 307,
121 Stat. 865) expanded the scope of section 522 to include devices
intended for pediatric use.
Agenda for the Public Workshop
1. Why are we holding this public workshop?
The purpose of the proposed workshop is to facilitate discussion
among the FDA, industry, governmental agencies, academia, clinicians,
and key stakeholders with experience in epidemiology, statistics, and
biomedical research in the scientific community to advance the design
and methodologies for medical device surveillance studies in the
postmarket setting.
2. Who is the target audience for this public workshop? Who should
attend this public workshop?
This workshop is open to all interested parties. The target
audience is professionals in the scientific community interested in
advancing the infrastructure and methodology for postmarket
surveillance studies.
3. What are the topics we intend to address at the public workshop?
We intend to discuss a large number of issues at the workshop,
including, but not limited to the following:
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Regulations for postmarket surveillance studies,
Challenges and opportunities for collaborative efforts,
Innovative methodologies and scientific infrastructure to
promote innovation,
Role of networks, registries and observational studies,
4. Where can I find out more about this public workshop?
Background information on the public workshop, registration
information, the agenda, information about lodging, and other relevant
information will be posted, as it becomes available, on the Internet at
http://www.fda.gov/cdrh/meetings.html.
Comments: Regardless of attendance at the public workshop,
interested persons may submit electronic comments, or written comments
by April 6, 2012. Submit electronic comments to http://www.regulations.gov. Submit written comment to the Division of Dockets
Management (HFA-305), Food and Drug Administration 5630 Fishers Lane,
rm, 1061, Rockville, MD 20852. Comments are to be identified with the
docket number found in brackets in the heading of this document. In
addition, when responding to specific topics listed in paragraph 3 of
the ``Agenda for the Public Workshop'' section of this document, please
identify the topic 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.
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 (HFA-305), 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. Any written
request for a transcript is to be sent to the Division of Freedom of
Information. Written requests are to be sent to 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 on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select this public
workshop from the posted events list), approximately 45 days after the
public workshop.
Dated February 10, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-3606 Filed 2-15-12; 8:45 am]
BILLING CODE 4160-01-P