[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Page 19063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08302]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Sentinel Training at the Food and Drug Administration; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Sentinel Training 
at FDA.'' The purpose of the public workshop is to provide training to 
understand the kinds of questions that can be asked using health care 
claims data generally and within the FDA Sentinel System specifically, 
allowing an understanding of the capabilities of the Sentinel System.

DATES: The public workshop will be held on July 10, 2017, from 10 a.m. 
to 4 p.m.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (the Great Room), Silver 
Spring, MD 20993. 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: Kayla Garvin, Food and Drug 
Administration, 10903 New Hampshire Avenue, Bldg. 51, Rm. 6314, Silver 
Spring, MD 20993, 301-796-7578, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The Sentinel Initiative began in 2008 as a multiyear effort to 
create a national electronic system for monitoring the performance of 
FDA-regulated medical products. The Sentinel Initiative is FDA's 
response to the Food and Drug Administration Amendments Act of 2007 
(FDAAA) requirement that FDA work with public, academic, and private 
entities to develop a system to obtain information from existing 
electronic health care data from multiple sources to assess the safety 
of FDA approved medical products.
    The Sentinel System uses a distributed data approach in which Data 
Partners maintain physical and operational control over electronic 
health care data in their existing environments. The distributed 
approach is achieved by using a standardized data structure referred to 
as the Sentinel Common Data Model. Data Partners transform their data 
locally in accordance with the Common Data Model, which enables them to 
execute standardized computer programs that run identically at each 
Data Partner site. Data Partners are able to review the results of the 
queries before sending them back to the Sentinel Operations Center. 
Queries are distributed and results are returned through a secure 
portal to preserve privacy.

II. Topics for Discussion at the Public Workshop

    This full-day seminar, targeting clinical researchers and others 
without direct experience using health care claims data, will provide 
an overview of data that are and are not available in the Sentinel 
Distributed Database, the Sentinel Common Data Model, and a description 
of the distributed tools available to work with the data. This seminar 
will help those in attendance understand the kinds of questions that 
can be asked using health care claims data generally and within the 
Sentinel System specifically. Attendees will leave with an 
understanding of the capabilities of the Sentinel System. The Sentinel 
System can help the public, academia, and private entities better 
understand potential safety issues associated with FDA-approved medical 
products. Importantly, users can get responses to their questions in a 
matter of weeks, as compared to months, or even longer using 
traditional surveillance methods.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following Web site: https://www.eventbrite.com/e/sentinel-training-at-food-and-drug-administration-registration-32503315291. Please provide 
required contact information for each attendee, including name, title, 
affiliation, and email.
    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 
on the day of the public workshop will be provided beginning at 9 a.m.
    If you need special accommodations due to a disability, please 
contact Kayla Garvin no later than June 30, 2017.
    Streaming Webcast of the public workshop: This public workshop will 
also be Webcast at: https://collaboration.fda.gov/sentineltraining2017/.
    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 will not be 
available.

    Dated: April 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-08302 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P