Document ID: FDA-2014-N-0001-0090
Agency: fda
Document Type: Notice
Title: Seventh Annual Sentinel Initiative; Public Workshop
Posted Date: 2014-10-22T04:00Z

[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63130-63131]
From the Federal Register Online via the Government Printing 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: SentinelInitiative@fda.hhs.gov.
    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: SentinelEvent@Brookings.edu) 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