Sentinel Training at the Food and Drug Administration; Public Workshop, 19063 [2017-08302]
Download as PDF
Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices
collections of information in 21 CFR
606.100, 606.121, 606.122,
606.160(b)(ix), 606.170(b), 610.40, and
630.40 have been approved under OMB
control numbers 0910–0116 and 0910–
0795; the collections of information in
21 CFR 606.171 have been approved
under OMB control number 0910–0458.
In the Federal Register of November
7, 2016 (81 FR 78170), we published a
60-day notice requesting public
comment on the proposed extension of
this collection of information. No
comments were received in response to
the notice.
Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08306 Filed 4–24–17; 8:45 am]
BILLING CODE 4164–01–P
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.
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
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:42 Apr 24, 2017
Jkt 241001
Avenue, Bldg. 51, Rm. 6314, Silver
Spring, MD 20993, 301–796–7578,
Kayla.Garvin@fda.hhs.gov.
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.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
19063
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-drugadministration-registration32503315291. 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1393]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Patent Term
Restoration, Due Diligence Petitions,
Filing, Format, and Content of
Petitions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\25APN1.SGM
Notice.
25APN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, Kayla.Garvin@fda.hhs.gov.
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