[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)]
[Notices]
[Pages 55619-55620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6230]


Tenth Annual Sentinel Initiative; 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 ``Tenth Annual Sentinel Initiative Public Workshop.'' 
The purpose of this 2-day public workshop is to bring the stakeholder 
community together to discuss a variety of topics on active medical 
product surveillance. Attendees will leave with a deeper understanding 
of how to use the Sentinel System tools to address safety questions.

DATES: The public workshop will be held on February 7 and 8, 2018. Day 
1 of the public workshop will be held on February 7, 2018, from 9 a.m. 
to 4:30 p.m. Day 2 of the public workshop will be held on February 8, 
2018, from 9 a.m. to 2 p.m. See the SUPPLEMENTARY INFORMATION section 
for registration date and information.

ADDRESSES: The public workshop will be held at two separate locations. 
On Day 1 the public workshop will be held at the Hyatt Regency 
Bethesda, 1 Bethesda Metro Center, Bethesda, MD 20814. On Day 2 the 
public workshop will be held at the FDA White Oak Campus, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 1503 (the Great Room), Silver Spring, MD 
20993-0002. Entrance for the public workshop participants (non-FDA 
employees) is through Building 1 where routine security check 
procedures will be performed. For parking and security information, 
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Lieutenant Commander Jamila Mwidau, 
Food and Drug Administration, Center for Drug Evaluation and Research, 
10903 New Hampshire Ave., Bldg. 22, Rm. 4481, Silver Spring, MD 20993; 
301-796-4989, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The purpose of this 2-day public workshop is to bring the 
stakeholder community together to discuss a variety of topics on active 
medical product surveillance. Day 1 will be convened by the Duke-
Margolis Center for Health Policy at Duke University with support by a 
cooperative agreement with FDA. Key discussion topics will include an 
update on the state of FDA's Sentinel Initiative, key safety 
surveillance activities, and emerging uses of the Sentinel System. In 
addition, panelists, representing diverse stakeholder perspectives, 
will provide comments on Sentinel and opportunities to expand its 
analytic capabilities. This workshop will also provide an opportunity 
for stakeholder engagement and input on Sentinel's continued 
modernization.
    Day 2 will be a public workshop sponsored by FDA targeting 
researchers who are experienced in using claims data and will build 
upon prior public training conducted by FDA on July 10, 2017 (82 FR 
19063, April 25, 2017). This second day of the workshop will address 
more advanced training topics, including Sentinel's inferential 
analytic capabilities and methods of identifying unexpected safety 
concerns. Attendees will leave with a deeper understanding of how to 
use the Sentinel System tools to address safety questions. Attendees 
are encouraged to review the material FDA presented on July 10, 2017, 
by visiting the Web site: https://www.sentinelinitiative.org/communications/sentinel-initiative-events/public-sentinel-training-fda.

II. Participating in the Public Workshop

    Registration: To attend the public workshop, you may register for 
one or both days, but you must register for each day of the workshop 
separately. The Duke-Margolis Center for Health Policy at Duke 
University will manage registration for Day 1 and FDA will manage 
registration for Day 2.
    Day 1: To attend the public workshop on Day 1, you must register 
before February 6, 2018, by visiting https://healthpolicy.duke.edu/events/10th-annual-sentinel-public-workshop. 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. There is no registration fee. 
However, registration will be on a first-come, first-served basis 
because seating is limited. A 1-hour lunch break is scheduled, but food 
will not be provided. There are multiple restaurants within walking 
distance of Hyatt Regency Bethesda. If you need special accommodations 
due to a disability, please contact Elizabeth Murphy at the Duke-
Margolis Center for Health Policy (202-621-2801, email: 
[email protected]) no later than February 6, 2018.
    Streaming Webcast for Day 1: The workshop will be webcast (archived 
video footage will be available following the workshop at https://healthpolicy.duke.edu/events/10th-annual-sentinel-public-workshop). 
Persons interested in viewing the live webcast must register online 
before February 6, 2018. Early registration is recommended because 
webcast connections are limited. Webcast participants will be sent 
technical system requirements 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.
    All Day 1 event materials will be available to registered attendees 
via email before the workshop at the Duke-Margolis Web site at https://healthpolicy.duke.edu/events/10th-annual-sentinel-public-workshop.
    Day 2: To register to attend Day 2 of the workshop in person or 
virtually via webcast, you must register before February 6, 2018, by 
visiting: https://www.eventbrite.com/e/february-8-2018-training-at-fda-tickets-37914164286.
    Please provide complete contact information for each attendee, 
including name, title, affiliation, telephone number, and email 
address. Registration is free and based on space availability, with 
priority given to early registrants. Early registration is recommended 
because seating is limited; therefore, FDA may limit the number of 
participants from each organization. If time and space permit, onsite 
registration will be provided beginning at 8 a.m.
    If you need special accommodations due to a disability, please 
contact Lieutenant Commander Jamila Mwidau no later than January 24, 
2018.
    Streaming Webcast of the Public Workshop Day 2: The FDA training

[[Page 55620]]

public workshop will also be webcast at https://collaboration.fda.gov/sentinelworkshop.
    If you have never attended a Connect Pro event 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 https://www.adobe.com/go/connectpro_overview. FDA has verified 
the Web site addresses in this document, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.
    Transcripts: Please be advised that transcripts of the 2-day public 
workshop will not be available.

    Dated: November 16, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25251 Filed 11-21-17; 8:45 am]
 BILLING CODE 4164-01-P