[Federal Register Volume 76, Number 82 (Thursday, April 28, 2011)]
[Notices]
[Pages 23825-23826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10273]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Study Methodologies for Diagnostics in the Postmarket Setting;
Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Study Methodologies for Diagnostics in the
Postmarket Setting.'' The purpose of the public workshop is to provide
a forum for discussion among FDA, governmental Agencies, academia,
physicians, and various stakeholders with expertise in epidemiology,
statistics, diagnostics, and biomedical research to advance the
methodologies for diagnostics in the postmarket setting.
Date and Time: The public workshop will be held on May 12, 2011,
from 8:30 a.m. to 5:15 p.m. Participants are encouraged to arrive early
to ensure time for parking and security screening before the workshop.
Sign-in will be required.
Location: The public workshop will be held at the FDA 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.
The public workshop with also be available to be viewed via online
Web-cast (see Registration).
Contact Person: Hui-Lee Wong, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 4611, Silver Spring, MD 20993-0002, 301-796-6234, e-mail: [email protected]; or Xueying Sharon Liang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4110, Silver Spring, MD 20993-0002, 301-796-9601,
e-mail: [email protected].
Registration: In-person and Web-cast registration and information
are available at the following Web site: http://www.fda.gov/
MedicalDevices/NewsEvents/WorkshopsConferences/
[[Page 23826]]
ucm251696.htm. 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. Non-U.S. citizens are subject to additional
security screening, and they should register as soon as possible.
Registration ends May 5, 2011.
If you need special accommodations because of a disability, please
contact Susan Monahan at [email protected] at least 7 days in
advance of the public workshop.
SUPPLEMENTARY INFORMATION:
I. Why are we holding this public workshop?
The purpose of the public workshop is to facilitate discussion
among FDA, governmental Agencies, academia, physicians, and the key
stakeholders in the scientific community on issues related to the
studies and methodological approaches examining diagnostics in the
postmarket settings. We aim to create a dialogue between professionals
with epidemiologic, statistical, and clinically relevant expertise in
diagnostic devices to determine the evidence gaps and questions,
datasets and approaches for conducting postmarket surveillance and
robust analytic studies to improve our understanding of the performance
of diagnostics at the postmarket settings.
II. Who is the target audience for this public workshop? Who should
attend this public workshop?
This public workshop is open to all interested parties. The target
audience is professionals in the scientific community with experience
in epidemiology, diagnostics, or biomedical research with an interest
in diagnostic devices and epidemiologic study methodology.
III. What are the topics we intend to address at the public workshop?
We intend to discuss a large number of methodological concerns at
the workshop, including, but not limited to the following:
Gaps and challenges in postmarket studies of diagnostics,
Identifying and verifying emerging data sources and
methodologies, and
Fostering interdisciplinary collaboration towards
identifying new opportunities in methodologies for diagnostic devices.
IV. Where can I find out more about this public workshop?
Background information on the public workshop, registration
information, the agenda, information about lodging, transcripts, and
other relevant information will be posted, as it becomes available, on
the Internet at http://www.fda.gov/cdrh/meetings.html.
Dated: April 22, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-10273 Filed 4-27-11; 8:45 am]
BILLING CODE 4160-01-P