Leveraging Randomized Clinical Trials To Generate Real-World Evidence for Regulatory Purposes; Public Workshop, 26882-26883 [2019-12113]
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26882
Federal Register / Vol. 84, No. 111 / Monday, June 10, 2019 / Notices
I. Background
are required and fewer rebuttals are
expected.
Dated: June 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12109 Filed 6–7–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0001]
Leveraging Randomized Clinical Trials
To Generate Real-World Evidence for
Regulatory Purposes; 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 ‘‘Leveraging
Randomized Clinical Trials to Generate
Real-World Evidence for Regulatory
Purposes.’’ Convened by Duke
University’s Robert J. Margolis, MD,
Center for Health Policy (Duke Margolis)
and supported by a cooperative
agreement with FDA, the purpose of the
public workshop is to bring the
stakeholder community together to
explore key considerations for using
randomized designs, such as large
simple trials or those that incorporate
pragmatic elements to generate realworld evidence (RWE).
DATES: The public workshop will be
held on July 11, 2019, from 8:30 a.m. to
5 p.m., Eastern Time and July 12, 2019,
from 9 a.m. to 1 p.m., Eastern Time. See
the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public workshop will
be held at The Westin City Center, 1400
M St. NW, Washington, DC 20005. For
additional travel and hotel information,
please refer to the following website:
https://healthpolicy.duke.edu/events/
leveraging-randomized-clinical-trialsand-real-world-data-generate-realworld-evidence. There will also be a live
webcast for those unable to attend the
meeting in person (see Streaming
Webcast of the Public Workshop).
FOR FURTHER INFORMATION CONTACT:
Dianne Paraoan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3326,
Silver Spring, MD 20993, 301–796–
2500, Dianne.Paraoan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:45 Jun 07, 2019
Jkt 247001
Section 3022 of the 21st Century
Cures Act (Cures Act) amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) to add section 505F,
Utilizing real world evidence (21 U.S.C.
355g). This section requires the
establishment of a program to evaluate
the potential use of RWE to help
support the approval of a new
indication for a drug approved under
section 505(c) of the FD&C Act (21
U.S.C. 355(c)) and to help to support or
satisfy postapproval study requirements.
In December 2018, FDA published the
Framework for the RWE program
(https://www.fda.gov/media/120060/
download). To inform FDA’s RWE
Framework, on September 13, 2017,
through its cooperative agreement with
Duke Margolis, FDA convened a public
meeting that explored the use of RWE
for regulatory decisions.
The RWE Framework includes
information describing sources of RWE,
gaps in data collection activities,
standards and methodologies for
collecting and analyzing RWE, and
priority areas, remaining challenges,
and potential pilot opportunities to
address the overarching Cures Act
requirements. The RWE Framework also
discusses the integration of clinical
trials into clinical care settings and
FDA’s intent to issue guidance on this
subject. The public workshop
announced in this notice is a part of
FDA’s ongoing efforts to implement the
RWE Framework by exploring the utility
of RWE for regulatory decision making.
This workshop will focus on how
randomized clinical trial designs can
use real-world data (RWD) to generate
RWE, particularly in clinical care
settings.
II. Topics for Discussion at the Public
Workshop
This workshop will explore key
considerations for using randomized
clinical trial designs and RWD to
generate RWE, particularly in clinical
care settings. Considerations for
discussion include: (1) Selection of
interventions appropriate in clinical
care settings, (2) study design elements
and study populations, (3) capturing
outcomes in clinical care settings, and
(4) addressing potential challenges
around blinding, randomization, and
bias. The workshop will also explore
regulatory considerations for
randomized clinical trials using RWD,
such as safety and product monitoring
and maintaining data integrity.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
website: https://healthpolicy.duke.edu/
events/leveraging-randomized-clinicaltrials-and-real-world-data-generate-realworld-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. Persons interested in
attending this public workshop must
register by July 10, 2019, 11:59 p.m.
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
registered. We will let registrants know
if registration closes before the day of
the public workshop.
If you need special accommodations
due to a disability, please contact Sarah
Supsiri at the Duke-Margolis Center for
Health Policy (phone: 202–791–9561,
email: sarah.supsiri@duke.edu) no later
than July 5, 2019.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast, and archived video
footage will be available at the DukeMargolis website (https://
healthpolicy.duke.edu/events/
leveraging-randomized-clinical-trialsand-real-world-data-generate-realworld-evidence) following the
workshop. Persons interested in viewing
the live webcast are encouraged to
register in advance (see Registration).
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
website addresses in this document, as
of the date this document publishes in
the Federal Register, but websites 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
website (https://healthpolicy.duke.edu/
events/leveraging-randomized-clinicaltrials-and-real-world-data-generate-realworld-evidence).
Transcripts: Transcripts of the public
workshop will not be available.
E:\FR\FM\10JNN1.SGM
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26883
Federal Register / Vol. 84, No. 111 / Monday, June 10, 2019 / Notices
Dated: June 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12113 Filed 6–7–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]
Agency Information Collection
Request: 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before July 10, 2019.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
SUMMARY:
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: State-Level
Paid Family Leave Policy Project.
Type of Collection: New.
0990–NEW—Office of the Secretary/
Office on Women’s Health (OWH)
Abstract: The Department of Health
and Human Services (DHHS) Office on
Women’s Health (OWH) ‘‘provides
national leadership and coordination to
improve the health of women and girls
through policy, education, and
innovative programs.’’ Through the
State-Level Paid Family Leave Policy
Project, OWH will explore the
relationship between women’s health
and state-level paid family leave (PFL)
programs, which provide partial wage
replacement to eligible employees to
bond with a new child. The project aims
to increase awareness of women’s health
effects in relation to state-level PFL
programs among key stakeholders,
including advocates, state and federal
policymakers, and state program
administrators. This information will be
used to inform the national conversation
about these programs.
The State-Level Paid Family Leave
Policy Project involves the collection of
information on new mothers’ health,
health behaviors, and ability to fulfill
their roles in the workplace, family and
community. Data will be collected
through 16 one-time focus groups in the
four states with fully functioning statelevel PFL programs (California, New
Jersey, Rhode Island, and New York)
with both women who used and women
who did not use the program. A
questionnaire will be administered prior
to the focus groups to collect
information on participants’
demographic characteristics and other
external factors that may affect health.
Data collection and analysis will take
approximately one year.
Interested individuals will be
screened for eligibility. Participants
must be mothers with a child under the
age of one and be eligible for their
state’s respective PFL program. To
participate as a state-level PFL user,
mothers must have used the entire statelevel PFL benefit. To participate as a
state-level PFL non-user, mothers must
have a baby older than the ‘‘state-level
PFL threshold’’ and have not taken any
state-level PFL. We define the threshold
as the time after which mothers are
typically out of the temporary disability
insurance (TDI) and state-level PFL
window (approximately 12 weeks).
ANNUALIZED BURDEN HOUR TABLE
Average
burden per
response
(within hours)
Type of
respondents
Focus group screener .......................
Demographic questionnaire ..............
Focus group protocol ........................
Interested Individuals .......................
Focus group participants ..................
Focus group participants ..................
384
96
96
1
1
1
15/60
15/60
1.25
96
24
120
Total ...........................................
...........................................................
........................
........................
........................
240
Terry Clark,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2019–12098 Filed 6–7–19; 8:45 am]
National Institutes of Health
BILLING CODE 4150–33–P
khammond on DSKBBV9HB2PROD with NOTICES
Number of
respondents
Number of
responses per
respondent
Forms
National Center For Complementary &
Integrative Health; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
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Total burden
hours
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Complementary and Integrative Health
Special Emphasis Panel; NCCIH Training,
Fellowship, and Career Development Review
Panel (CT).
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)]
[Notices]
[Pages 26882-26883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12113]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0001]
Leveraging Randomized Clinical Trials To Generate Real-World
Evidence for Regulatory Purposes; 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 ``Leveraging
Randomized Clinical Trials to Generate Real-World Evidence for
Regulatory Purposes.'' Convened by Duke University's Robert J.
Margolis, MD, Center for Health Policy (Duke Margolis) and supported by
a cooperative agreement with FDA, the purpose of the public workshop is
to bring the stakeholder community together to explore key
considerations for using randomized designs, such as large simple
trials or those that incorporate pragmatic elements to generate real-
world evidence (RWE).
DATES: The public workshop will be held on July 11, 2019, from 8:30
a.m. to 5 p.m., Eastern Time and July 12, 2019, from 9 a.m. to 1 p.m.,
Eastern Time. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will be held at The Westin City Center,
1400 M St. NW, Washington, DC 20005. For additional travel and hotel
information, please refer to the following website: https://healthpolicy.duke.edu/events/leveraging-randomized-clinical-trials-and-real-world-data-generate-real-world-evidence. There will also be a live
webcast for those unable to attend the meeting in person (see Streaming
Webcast of the Public Workshop).
FOR FURTHER INFORMATION CONTACT: Dianne Paraoan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993, 301-796-
2500, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 3022 of the 21st Century Cures Act (Cures Act) amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act) to add section 505F,
Utilizing real world evidence (21 U.S.C. 355g). This section requires
the establishment of a program to evaluate the potential use of RWE to
help support the approval of a new indication for a drug approved under
section 505(c) of the FD&C Act (21 U.S.C. 355(c)) and to help to
support or satisfy postapproval study requirements. In December 2018,
FDA published the Framework for the RWE program (https://www.fda.gov/media/120060/download). To inform FDA's RWE Framework, on September 13,
2017, through its cooperative agreement with Duke Margolis, FDA
convened a public meeting that explored the use of RWE for regulatory
decisions.
The RWE Framework includes information describing sources of RWE,
gaps in data collection activities, standards and methodologies for
collecting and analyzing RWE, and priority areas, remaining challenges,
and potential pilot opportunities to address the overarching Cures Act
requirements. The RWE Framework also discusses the integration of
clinical trials into clinical care settings and FDA's intent to issue
guidance on this subject. The public workshop announced in this notice
is a part of FDA's ongoing efforts to implement the RWE Framework by
exploring the utility of RWE for regulatory decision making. This
workshop will focus on how randomized clinical trial designs can use
real-world data (RWD) to generate RWE, particularly in clinical care
settings.
II. Topics for Discussion at the Public Workshop
This workshop will explore key considerations for using randomized
clinical trial designs and RWD to generate RWE, particularly in
clinical care settings. Considerations for discussion include: (1)
Selection of interventions appropriate in clinical care settings, (2)
study design elements and study populations, (3) capturing outcomes in
clinical care settings, and (4) addressing potential challenges around
blinding, randomization, and bias. The workshop will also explore
regulatory considerations for randomized clinical trials using RWD,
such as safety and product monitoring and maintaining data integrity.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: https://healthpolicy.duke.edu/events/leveraging-randomized-clinical-trials-and-real-world-data-generate-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. Persons interested in attending this public
workshop must register by July 10, 2019, 11:59 p.m. Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when they have been registered.
We will let registrants know if registration closes before the day of
the public workshop.
If you need special accommodations due to a disability, please
contact Sarah Supsiri at the Duke-Margolis Center for Health Policy
(phone: 202-791-9561, email: [email protected]) no later than July
5, 2019.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast, and archived video footage will be available at the
Duke-Margolis website (https://healthpolicy.duke.edu/events/leveraging-randomized-clinical-trials-and-real-world-data-generate-real-world-evidence) following the workshop. Persons interested in viewing the
live webcast are encouraged to register in advance (see Registration).
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 website addresses in this document,
as of the date this document publishes in the Federal Register, but
websites 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 website (https://healthpolicy.duke.edu/events/leveraging-randomized-clinical-trials-and-real-world-data-generate-real-world-evidence).
Transcripts: Transcripts of the public workshop will not be
available.
[[Page 26883]]
Dated: June 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12113 Filed 6-7-19; 8:45 am]
BILLING CODE 4164-01-P
