Developing a Framework for Regulatory Use of Real-World Evidence; Public Workshop, 35534-35535 [2017-16021]
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Federal Register / Vol. 82, No. 145 / Monday, July 31, 2017 / Notices
November 17, 2017 by 4 p.m. If selected
for presentation, any presentation
materials must be emailed to Paula
Caposino (see FOR FURTHER INFORMATION
CONTACT) no later than November 21,
2017. No commercial or promotional
material will be permitted to be
presented or distributed at the public
workshop.
Streaming Webcast of the public
workshop: This public workshop will
also be Webcast. The Webcast link will
be available on the registration Web
page after November 21, 2017.
Organizations are requested to register
all participants, but to view using one
connection per location.
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 as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES). A link to the transcript will
also be available approximately 45 days
after the public workshop on the
Internet at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm.
(Select this public workshop from the
posted events list).
IV. References
sradovich on DSKBCFCHB2PROD with NOTICES
The following references are on
display in the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
www.regulations.gov.
1. ‘‘National Academy of Clinical
Biochemistry Laboratory Medicine
Practice Guidelines: Clinical
Characteristics and Utilization of
Biochemical Markers in Acute Coronary
Syndromes.’’ Circulation, 2007; 115,
356–375.
2. ‘‘Universal Definition of Myocardial
Infarction.’’ Circulation, 2007: 116,
2634–2653.
VerDate Sep<11>2014
17:38 Jul 28, 2017
Jkt 241001
Dated: July 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
Hampshire Ave., Bldg. 51, Rm. 6314,
Silver Spring, MD 20993, (301) 796–
7578, Kayla.Garvin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2017–16007 Filed 7–28–17; 8:45 am]
I. Background
RWD (data relating to patient health
status and/or the delivery of health care
routinely collected from a variety of
sources) and RWE (clinical evidence
regarding the usage and potential
benefits or risks of a drug derived from
analysis of RWD) are increasingly being
used by multiple stakeholders within
the health care system. Payers may rely
on RWD and RWE to refine formularies
or assist in coverage decisions.
Physicians and professional societies
can utilize RWE to further tailor clinical
practice guidelines and decisionsupport tools. Medical product
developers can use RWE to further
develop a product’s benefit-risk profile,
monitor postmarket safety and adverse
events, or generate additional
hypotheses for continued clinical
development.
The 21st Century Cures Act, section
3022 (Pub. L. 114–255), enacted on
December 13, 2016, directed FDA to
establish a program to evaluate the
potential use of RWE. The framework of
the program was to include information
describing the sources of RWE, the gaps
in data collection, standards and
methods for collection and analysis, and
the priority areas and challenges.
To date, RWD and RWE have been
used in very specific regulatory
contexts. Some treatments for rare
diseases, for example, have utilized
RWE as part of the historical controls
used for clinical study and, ultimately,
regulatory submission. Postmarket
safety surveillance has also relied
heavily on RWD-generating networks.
As part of exploring the opportunities
for enhanced use of these types of data
and evidence in additional regulatory
decision-making contexts, FDA is
seeking input on the opportunities and
challenges in using RWE to support the
approval of a new indication for an
already approved drug, and to help
support or satisfy postapproval study
requirements.
This public workshop is being held to
engage external stakeholders in
discussions around the current state of
RWE development and potential
challenge areas for using RWE in
regulatory decisions beyond postmarket
safety surveillance.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
Developing a Framework for
Regulatory Use of Real-World
Evidence; 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 ‘‘Developing a
Framework for Regulatory Use of RealWorld Evidence.’’ Convened by the
Duke-Robert J. Margolis, MD, Center for
Health Policy at Duke University and
supported by a cooperative agreement
with FDA, the purpose of the public
workshop is to bring the stakeholder
community together to discuss a variety
of topics related to the use of real-world
data (RWD) and real-world evidence
(RWE) in drug development and
regulatory decision making. Topics will
include an update on FDA’s activities to
address the use of RWE in regulatory
decisions and the development of a
framework for tackling challenges
related to RWE’s regulatory
acceptability. In addition, panelists will
discuss opportunities to improve data
development activities, study designs,
and analytical methods used to create
robust RWE.
DATES: The public workshop will be
held on September 13, 2017, from 9 a.m.
to 4:30 p.m., Eastern Time.
ADDRESSES: The public workshop will
be held at the Conference Center at 1777
F Street NW., Washington, DC 20006.
For additional travel and hotel
information, please refer to the
following Web site: https://
healthpolicy.duke.edu/events/publicworkshop-developing-frameworkregulatory-use-real-world-evidence.
There will also be a live webcast for
those unable to attend the meeting in
person (see Streaming Webcast of Public
Workshop).
FOR FURTHER INFORMATION CONTACT:
Kayla Garvin, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
SUMMARY:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
II. Topics for Discussion at the Public
Workshop
During the course of the public
workshop, speakers and participants
will cover a range of issues related to
E:\FR\FM\31JYN1.SGM
31JYN1
Federal Register / Vol. 82, No. 145 / Monday, July 31, 2017 / Notices
sradovich on DSKBCFCHB2PROD with NOTICES
the development of RWE and its
applicability within specific regulatory
decision-making contexts. This will
include, but not be limited to,
challenges related to RWD collection
and quality, innovative methods for
developing RWE from RWD, and
promising areas for RWE pilot
demonstrations.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
Web site before September 12, 2017:
https://healthpolicy.duke.edu/events/
public-workshop-developingframework-regulatory-use-real-worldevidence. There will be no onsite
registration. Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone.
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. A 1-hour lunch break is
scheduled, but food will not be
provided. There are multiple restaurants
within walking distance of the
Conference Center.
If you need special accommodations
due to a disability, please contact
Joanna Higgison at the Duke-Margolis
Center for Health Policy, 908–432–4872,
joanna.higgison@duke.edu, no later
than September 6, 2017.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast and archived video
footage will be available at the DukeMargolis Web site (https://
healthpolicy.duke.edu/events/publicworkshop-developing-frameworkregulatory-use-real-world-evidence)
following the workshop. Persons
interested in viewing the live webcast
must register online by September 12,
2017, at 5 p.m. Eastern Time (see
Registration). 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 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.
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.
VerDate Sep<11>2014
17:38 Jul 28, 2017
Jkt 241001
Meeting Materials: All event materials
will be provided to registered attendees
via email prior to the workshop and
publicly available at the Duke-Margolis
Web site (https://healthpolicy.duke.edu/
events/public-workshop-developingframework-regulatory-use-real-worldevidence).
Transcripts: Please be advised that
transcripts will not be available.
Dated: July 25, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–16021 Filed 7–28–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics: Meeting
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee meeting.
Name: National Committee on Vital
and Health Statistics (NCVHS), Full
Committee and Population Health
Subcommittee Meetings.
Dates and Times:
Monday, September 11, 2017: 9:00 a.m.–
5:45 p.m.
Tuesday, September 12, 2017: 8:30
a.m.–5:00 p.m.
Wednesday, September 13, 2017: 8:45
a.m.–5:30 p.m.
Thursday, September 14, 2017: 8:30
a.m.–3:15 p.m.
Place: U.S. Department of Health and
Human Services, Hubert H. Humphrey
Building, 200 Independence Avenue
SW., Room 705A, Washington, DC
20201.
Status: Open.
Purpose: At the September 11–12,
2017 hearing, the Population Health
Subcommittee will focus on Next
Generation Vital Statistics. The purpose
of the hearing is to assess the current
state of the national vital statistics
system (NVSS) to address concerns
regarding sustainability and viability of
the system infrastructure. The focus will
be on the system’s capacity to provide
timely, high quality, secure vital
administrative and statistical data for
identity establishment and protection,
identification of trends in disease and
epidemics, e.g., the recent surge in
opioid-related deaths, and a host of
critical uses for research, finance,
planning, public records and services.
At the September 13–14, 2017 full
meeting, the Committee will hear
presentations, hold discussions on
PO 00000
Frm 00029
Fmt 4703
Sfmt 9990
35535
several health data policy topics and
begin to formulate its work plan for
2018. To inform the work plan, the
Committee will be briefed by the
Commission on Evidence-based
Policymaking (CEP) regarding the
release of its report and
recommendations as well as hear from
HHS leadership regarding data needs
and gaps. A panel will be held to
discuss the new topic ‘‘Beyond HIPAA,’’
an exploration of challenges that extend
beyond HIPAA and the range of policy
options that may be available to the
Department related to privacy, security
and access measures to protect
individually identifiable health
information in an environment of
electronic networking and multiple uses
of data. Additional discussions are
planned on the Predictability Roadmap
project in follow up to a Standards
Subcommittee workshop focused on
possible approaches to improve the
predictability and improvements in the
adoption and processes related to
updating standards and operating rules
for electronic administrative
transactions (e.g. claims, eligibility,
electronic funds transfer); and on
terminology & vocabulary development,
maintenance, and dissemination
processes. The Committee also plans to
finalize the update to its strategic plan
and selection criteria for undertaking
new Committee projects. The times and
topics are subject to change. Please refer
to the posted agenda for any updates.
Contact person for more information:
Substantive program information may
be obtained from Rebecca Hines, MHS,
Executive Secretary, NCVHS, National
Center for Health Statistics, Centers for
Disease Control and Prevention, 3311
Toledo Road, Hyattsville, Maryland
20782, telephone (301) 458–4715.
Summaries of meetings and a roster of
Committee members are available on the
home page of the NCVHS Web site:
https://www.ncvhs.hhs.gov/, where
further information including an agenda
and instructions to access the audio
broadcast of the meetings will also be
posted. Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment
Opportunity on (770) 488–3210 as soon
as possible.
Dated: July 25, 2017.
Laina Bush,
Deputy Assistant Secretary for Planning and
Evaluation, Office of the Assistant Secretary
for Planning and Evaluation.
[FR Doc. 2017–16036 Filed 7–28–17; 8:45 am]
BILLING CODE 4151–05–P
E:\FR\FM\31JYN1.SGM
31JYN1
Agencies
[Federal Register Volume 82, Number 145 (Monday, July 31, 2017)]
[Notices]
[Pages 35534-35535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16021]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0001]
Developing a Framework for Regulatory Use of Real-World Evidence;
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 ``Developing a
Framework for Regulatory Use of Real-World Evidence.'' Convened by the
Duke-Robert J. Margolis, MD, Center for Health Policy at Duke
University and supported by a cooperative agreement with FDA, the
purpose of the public workshop is to bring the stakeholder community
together to discuss a variety of topics related to the use of real-
world data (RWD) and real-world evidence (RWE) in drug development and
regulatory decision making. Topics will include an update on FDA's
activities to address the use of RWE in regulatory decisions and the
development of a framework for tackling challenges related to RWE's
regulatory acceptability. In addition, panelists will discuss
opportunities to improve data development activities, study designs,
and analytical methods used to create robust RWE.
DATES: The public workshop will be held on September 13, 2017, from 9
a.m. to 4:30 p.m., Eastern Time.
ADDRESSES: The public workshop will be held at the Conference Center at
1777 F Street NW., Washington, DC 20006. For additional travel and
hotel information, please refer to the following Web site: https://healthpolicy.duke.edu/events/public-workshop-developing-framework-regulatory-use-real-world-evidence. There will also be a live webcast
for those unable to attend the meeting in person (see Streaming Webcast
of Public Workshop).
FOR FURTHER INFORMATION CONTACT: Kayla Garvin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6314, Silver Spring, MD 20993, (301) 796-
7578, Kayla.Garvin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
RWD (data relating to patient health status and/or the delivery of
health care routinely collected from a variety of sources) and RWE
(clinical evidence regarding the usage and potential benefits or risks
of a drug derived from analysis of RWD) are increasingly being used by
multiple stakeholders within the health care system. Payers may rely on
RWD and RWE to refine formularies or assist in coverage decisions.
Physicians and professional societies can utilize RWE to further tailor
clinical practice guidelines and decision-support tools. Medical
product developers can use RWE to further develop a product's benefit-
risk profile, monitor postmarket safety and adverse events, or generate
additional hypotheses for continued clinical development.
The 21st Century Cures Act, section 3022 (Pub. L. 114-255), enacted
on December 13, 2016, directed FDA to establish a program to evaluate
the potential use of RWE. The framework of the program was to include
information describing the sources of RWE, the gaps in data collection,
standards and methods for collection and analysis, and the priority
areas and challenges.
To date, RWD and RWE have been used in very specific regulatory
contexts. Some treatments for rare diseases, for example, have utilized
RWE as part of the historical controls used for clinical study and,
ultimately, regulatory submission. Postmarket safety surveillance has
also relied heavily on RWD-generating networks. As part of exploring
the opportunities for enhanced use of these types of data and evidence
in additional regulatory decision-making contexts, FDA is seeking input
on the opportunities and challenges in using RWE to support the
approval of a new indication for an already approved drug, and to help
support or satisfy postapproval study requirements.
This public workshop is being held to engage external stakeholders
in discussions around the current state of RWE development and
potential challenge areas for using RWE in regulatory decisions beyond
postmarket safety surveillance.
II. Topics for Discussion at the Public Workshop
During the course of the public workshop, speakers and participants
will cover a range of issues related to
[[Page 35535]]
the development of RWE and its applicability within specific regulatory
decision-making contexts. This will include, but not be limited to,
challenges related to RWD collection and quality, innovative methods
for developing RWE from RWD, and promising areas for RWE pilot
demonstrations.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following Web site before September 12, 2017: https://healthpolicy.duke.edu/events/public-workshop-developing-framework-regulatory-use-real-world-evidence. There will be no onsite
registration. Please provide complete contact information for each
attendee, including name, title, affiliation, address, email, and
telephone.
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. A 1-hour lunch break is scheduled, but food
will not be provided. There are multiple restaurants within walking
distance of the Conference Center.
If you need special accommodations due to a disability, please
contact Joanna Higgison at the Duke-Margolis Center for Health Policy,
908-432-4872, joanna.higgison@duke.edu, no later than September 6,
2017.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast and archived video footage will be available at the
Duke-Margolis Web site (https://healthpolicy.duke.edu/events/public-workshop-developing-framework-regulatory-use-real-world-evidence)
following the workshop. Persons interested in viewing the live webcast
must register online by September 12, 2017, at 5 p.m. Eastern Time (see
Registration). 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 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.
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.
Meeting Materials: All event materials will be provided to
registered attendees via email prior to the workshop and publicly
available at the Duke-Margolis Web site (https://healthpolicy.duke.edu/events/public-workshop-developing-framework-regulatory-use-real-world-evidence).
Transcripts: Please be advised that transcripts will not be
available.
Dated: July 25, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-16021 Filed 7-28-17; 8:45 am]
BILLING CODE 4164-01-P