[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63130-63131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-25053]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Seventh Annual Sentinel Initiative; 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 ``Seventh Annual Sentinel Initiative Public
Workshop.'' Convened by the Engelberg Center for Health Care Reform at
the Brookings Institution and supported by a cooperative agreement with
FDA, this 1-day workshop will bring the stakeholder community together
to discuss a variety of topics on active medical product surveillance.
Topics will include an overview of the transition from the Mini-
Sentinel pilot program to the full Sentinel System and what that means
for patients and other critical stakeholders. Additionally, panelists
will discuss the future of the Sentinel System and opportunities to
expand its medical product surveillance capabilities. This workshop
will also engage stakeholders to discuss current and emerging Sentinel
projects.
[[Page 63131]]
Date and Time: The public workshop will be held on February 5,
2015, from 9 a.m. to 4 p.m. EST.
Location: The public workshop will be held at the Washington Plaza
Hotel, 10 Thomas Circle NW., Washington, DC 20005. For additional
travel and hotel information, please refer to http://events.SignUp4.com/sentinel2015. (FDA has verified the Web site
addresses throughout this notice, but FDA is not responsible for
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
There will also be a live Webcast for those unable to attend the
meeting in person (see Streaming Webcast of the Public Workshop).
Contact Person: Carlos Bell, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6358, Silver Spring, MD 20993, 301-796-3714, FAX: 301-847-3529,
email: [email protected].
Registration: To attend the public workshop, you must register
before February 5, 2015, by visiting http://events.SignUp4.com/sentinel2015. You may also register for the live Webcast by visiting
this Web page. There will be no onsite registration. When registering,
please provide the following information: Your name, title, company or
organization (if applicable), postal address, telephone number, and
email address. Those without Internet access should contact Carlos Bell
to register (see Contact Person). There is no registration fee for the
public workshop. However, registration will be on a first-come, first-
served basis because seating is limited. Therefore, early registration
is recommended. A 1-hour lunch break is scheduled, but food will not be
provided. There are multiple restaurants within walking distance of the
Washington Plaza Hotel.
If you need special accommodations due to a disability, please
contact Joanna Klatzman at the Brookings Institution (202-536-3634,
email: [email protected]) at least 7 days in advance.
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast (archived video footage will be available on the
Brookings Institution Web site following the workshop). Persons
interested in viewing the live Webcast must register online by February
4, 2015, at 5 p.m. EST. Early registration is recommended because
Webcast connections are limited. Organizations are requested to
register all participants but to view using one connection per location
whenever possible. Webcast participants will be sent technical system
requirements and a test link in advance of the event. Prior to joining
the streaming Webcast of the public workshop, it is recommended that
you review these technical system requirements and test your
connection.
Meeting Materials: All event materials will be available to
registered attendees via email before the workshop and will be posted
after the event on the Brookings Institution event Web site at http://www.brookings.edu//health/events.
Transcripts: Please be advised that transcripts will not be
available.
Dated: October 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25053 Filed 10-21-14; 8:45 am]
BILLING CODE 4164-01-P