Request for Information (RFI): Inviting Comments and Suggestions on Opportunities and Challenges for the Collection, Use, and Sharing of Real-World Data (RWD) Including Electronic Health Records, for National Institutes of Health (NIH) Supported Biomedical and Behavioral Research, 66860-66861 [2023-21239]
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66860
Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices
Dated: September 21, 2023.
Lawrence A. Tabak,
Acting NIH Director, National Institutes of
Health.
[FR Doc. 2023–21233 Filed 9–27–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Information (RFI): Inviting
Comments and Suggestions on
Opportunities and Challenges for the
Collection, Use, and Sharing of RealWorld Data (RWD) Including Electronic
Health Records, for National Institutes
of Health (NIH) Supported Biomedical
and Behavioral Research
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Request for information.
The purpose of this National
Institutes of Health (NIH) Request for
Information (RFI) is to solicit public
comments on the use of Real-World
Data (RWD), including Electronic Health
Records, for Biomedical and Behavioral
Research.
DATES: The NIH RFI is open for public
comment. To assure consideration, your
response must be received by December
14, 2023, 11:59 p.m. (ET).
ADDRESSES: All comments must be
submitted electronically on the
submission website at https://
datascience.nih.gov/rfi-rwd.
Responses must be received by
11:59:59 p.m. (ET) on December 14,
2023.
Responses to this RFI are voluntary
and may be submitted anonymously.
You may voluntarily include your name
and contact information with your
response. If you choose to provide NIH
with this information, NIH will not
share your name and contact
information outside of NIH unless
required by law.
Other than your name and contact
information, please do not include any
personally identifiable information or
any information that you do not wish to
make public. Proprietary, classified,
confidential, or sensitive information
should not be included in your
response. The Government will use the
information submitted in response to
this RFI at its discretion. Other than
your name and contact information, the
Government reserves the right to use
any submitted information on public
websites, in reports, in summaries of the
state of the science, in any possible
resultant solicitation(s), grant(s), or
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:09 Sep 27, 2023
Jkt 259001
cooperative agreement(s), or in the
development of future funding
opportunity announcements. This RFI is
for informational and planning purposes
only and is not a solicitation for
applications or an obligation on the part
of the Government to provide support
for any ideas identified in response to
it. Please note that the Government will
not pay for the preparation of any
information submitted or for use of that
information.
We look forward to your input and
hope that you will share this RFI
opportunity with your colleagues.
FOR FURTHER INFORMATION CONTACT:
Questions about this request for
information should be directed to Dr.
Susan Gregurick, 301–435–1923, RWDrfi@od.nih.gov, National Institutes of
Health, Office of Data Science Strategy,
9000 Rockville Pike, Bethesda,
Maryland 20892.
SUPPLEMENTARY INFORMATION: The
National Institutes of Health (NIH) is
requesting public comment on the use
of Real World Data (RWD) for NIH
supported biomedical and behavioral
research, including opportunities for
leveraging the benefits of RWD and
strategies for responsible use. NIH also
seeks to better understand community
perspectives on the potential value and
constraints—including scientific,
administrative, legal, business, and
bioethical—for the greater use of RWD
in NIH-sponsored biomedical and
behavioral research. This request for
information (RFI) is in accordance with
42 U.S.C. 281 as amended.
Background
Researchers are increasingly using
data collected in real-world settings to
augment traditional research studies, as
well as develop more effective
treatments and interventions for
patients. These ‘‘real-world data
(RWD)’’, defined by the U.S. Food and
Drug Administration, are data relating to
patient health status and/or the delivery
of health care routinely collected from
a variety of sources. Examples of RWD
include data derived from electronic
health records, medical claims data,
data from product or disease registries,
and data gathered from other sources
(such as digital health technologies) that
can inform on health status. While these
data hold tremendous promise for
biomedical and behavioral research,
they can be collected from a variety of
sources through multiple mechanisms,
creating challenges for researchers and
questions for those whose data are being
shared.
Importantly, NIH is committed to
ensuring participant privacy and
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
autonomy are protected in all NIHsupported research. As NIH establishes
health-related research data platforms
that include access to RWD, NIH
continues to prioritize maximizing data
access while upholding participant
preferences regarding the collection and
use of their data. Most recently, through
the Advisory Committee to the NIH
Director, (https://www.acd.od.nih.gov/
index.html), NIH staff met with
stakeholders to better understand their
perspectives on benefits and risks of
combining and using human datasets,
particularly from disparate sources (e.g.,
research and non-research settings) and
how their data should be used in
biomedical and behavioral research.
NIH will continue working to
incorporate these perspectives in its
research studies to build trust and honor
participant preferences. Input requested
on this RFI will be used to inform NIH’s
continuing development of guidance on
the use of RWD for research and assist
in the planning for appropriate
mechanisms and programs for research
with RWD.
Information Requested
NIH is requesting public comment on
the use of RWD for NIH-supported
biomedical and behavioral research,
including opportunities for leveraging
the benefits of RWD and strategies for its
responsible use. NIH also seeks to better
understand community perspectives on
the potential value and constraints—
including scientific, administrative,
legal, business, and bioethical—for the
increased use of RWD in biomedical and
behavioral research.
Response to this RFI is voluntary and
may be submitted anonymously.
Respondents are free to address any or
all topics listed below, as well as other
relevant topics, for NIH’s consideration.
1. Scientific value and quality
considerations for collection, use, and
sharing of RWD in biomedical and
behavioral research. NIH seeks broad
input on how RWD is acquired and used
in NIH-funded research, the
demonstrated and anticipated value of
RWD in research, and opportunities and
challenges related to data standards and
quality, representativeness, and
potential biases for using RWD in
research. Additionally, NIH is seeking
information on:
(a) Biomedical and behavioral
research questions that could be
investigated using RWD, including
novel unanticipated insights that have
been enabled by using RWD in research.
(b) Barriers to using RWD in research,
such as bias, underrepresentation of
populations in data, and technical
E:\FR\FM\28SEN1.SGM
28SEN1
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices
issues of data harmonization and
linkage.
2. Using RWD as part of the scientific
paradigm, including open science,
scientific rigor and reproducibility, and
team science. NIH seeks broad input on
the opportunities and challenges related
to using RWD as part of the scientific
process.
(a) Approaches or methods for using
RWD in collaborative teams and
ensuring reproducibility.
(b) How do researchers assess the
validation and verification of RWD data
that is used in research.
(c) Appropriate open science practices
and use of the FAIR principles (https://
www.nature.com/articles/sdata201618)
for research using RWD and approaches
for maximizing appropriate data sharing
when expected by the NIH Policy for
Data Management and Sharing (https://
sharing.nih.gov/data-management-andsharing-policy) or other policies.
3. Administrative and logistical
considerations for collecting, using, and
sharing RWD for biomedical and
behavioral research. NIH seeks broad
input on the opportunities and
challenges related to the process of
acquiring, using, and making RWD
available for biomedical and behavioral
research, including:
(a) Pros and cons of various
approaches for obtaining RWD through
algorithms, purchasing RWD through
trusted parties, accessing RWD through
secure enclaves, etc.
(b) Considerations regarding
licensing, costs, third party
involvement, and restrictions for data
use and sharing.
(c) Availability/utility of emerging deidentification technologies and data
storage/sharing considerations.
4. Ethical considerations for using
RWD for biomedical and behavioral
research. NIH seeks broad input on the
opportunities and challenges related to
potential bioethical issues regarding the
collection, use, and sharing of RWD,
including:
(a) Strategies for protecting
participant privacy and autonomy.
(b) Potential re-identification risks for
RWD, including the technical feasibility
of re-identifying linked data and the
possibility of anonymity for patients,
research participants, and their families.
(c) Ethical implications of data as a
‘‘commodity’’, in terms of buying and
selling personal health data.
This RFI is for planning purposes
only and should not be construed as a
solicitation for applications or
proposals, or as an obligation in any
way on the part of the United States
Government. The Government will not
pay for the preparation of any
VerDate Sep<11>2014
18:09 Sep 27, 2023
Jkt 259001
information submitted or for the
Government’s use. Additionally, the
Government cannot guarantee the
confidentiality of the information
provided.
Dated: September 21, 2023.
Tara A. Schwetz,
Acting Principal Deputy Director, National
Institutes of Health.
[FR Doc. 2023–21239 Filed 9–27–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Establishment of the Social and
Community Influences on Health
Integrated Review Group
Pursuant to the Federal Advisory
Committee Act, as amended (5 U.S.C.
1001–1014), the Director, National
Institutes of Health (NIH) announces the
establishment of the Social and
Community Influences on Health
Integrated Review Group (IRG) as
authorized by 42 U.S.C. 282(b)(16),
section 402(b)(16) of the Public Health
Service Act, as amended.
The Director, NIH, has determined
that the Social and Community
Influences on Health IRG is in the
public interest in connection with the
performance of duties imposed on NIH
by law, and that these duties can best be
performed through the advice and
counsel of the committee.
The committee provides advice and
recommendations on funding
applications and proposals, including
but not limited to, the scientific and
technical merit of applications for
grants-in-aid for research, research
training, or research-related grants and
cooperative agreements, or contract
proposals relating to scientific areas
relevant to social, interpersonal,
community, and cultural influences on
health, development, and well-being
across the life span.
Inquiries may be directed to Claire
Harris, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail code 4875), Telephone (301) 496–
2123, or Claire.Harris@nih.gov.
Dated: September 21, 2023.
Lawrence A. Tabak,
Acting NIH Director, National Institutes of
Health.
[FR Doc. 2023–21234 Filed 9–27–23; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00066
Fmt 4703
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66861
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, National Cancer Institute.
This meeting will be a hybrid meeting
held in-person and virtually and will be
open to the public as indicated below
with attendance limited to space
available. Individuals who plan to
attend in-person or view the virtual
meeting and need special assistance or
other reasonable accommodations,
should notify the Contact Person listed
below in advance of the meeting. The
open session can be accessed from the
NIH Videocast at the following link:
https://videocast.nih.gov/.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in sections
552b(c)(6), title 5 U.S.C., as amended for
the review, discussion, and evaluation
of individual intramural programs and
projects conducted by the National
Cancer Institute, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, National Cancer Institute.
Date: November 13, 2023.
Open: 10:00 a.m. to 10:30 a.m.
Agenda: Remarks from the NCI Director.
Closed: 10:30 a.m. to 4:00 p.m.
Agenda: Personnel qualifications and
performance, and competence of individual
investigators.
Name of Committee: Board of Scientific
Counselors, National Cancer Institute.
Date: November 14, 2023.
Closed: 11:00 a.m. to 1:45 p.m.
Agenda: Personnel qualifications and
performance, and competence of individual
investigators.
Place: National Institute of Health,
Building 31, C Wing, 6th Floor, Conference
Room C, 9000 Rockville Pike, Bethesda, MD
20892 (Hybrid Meeting).
Contact Person: Brian E. Wojcik, Ph.D.,
Senior Review Administrator, Institute
Review Office, Office of the Director,
National Cancer Institute, National Institutes
of Health, 9609 Medical Center Drive, Room
3W414, Rockville, MD 20850, 240–276–5660,
wojcikb@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
E:\FR\FM\28SEN1.SGM
28SEN1
]]>Agencies
[Federal Register Volume 88, Number 187 (Thursday, September 28, 2023)]
[Notices]
[Pages 66860-66861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21239]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Information (RFI): Inviting Comments and Suggestions
on Opportunities and Challenges for the Collection, Use, and Sharing of
Real-World Data (RWD) Including Electronic Health Records, for National
Institutes of Health (NIH) Supported Biomedical and Behavioral Research
AGENCY: National Institutes of Health, HHS.
ACTION: Request for information.
-----------------------------------------------------------------------
SUMMARY: The purpose of this National Institutes of Health (NIH)
Request for Information (RFI) is to solicit public comments on the use
of Real-World Data (RWD), including Electronic Health Records, for
Biomedical and Behavioral Research.
DATES: The NIH RFI is open for public comment. To assure consideration,
your response must be received by December 14, 2023, 11:59 p.m. (ET).
ADDRESSES: All comments must be submitted electronically on the
submission website at https://datascience.nih.gov/rfi-rwd.
Responses must be received by 11:59:59 p.m. (ET) on December 14,
2023.
Responses to this RFI are voluntary and may be submitted
anonymously. You may voluntarily include your name and contact
information with your response. If you choose to provide NIH with this
information, NIH will not share your name and contact information
outside of NIH unless required by law.
Other than your name and contact information, please do not include
any personally identifiable information or any information that you do
not wish to make public. Proprietary, classified, confidential, or
sensitive information should not be included in your response. The
Government will use the information submitted in response to this RFI
at its discretion. Other than your name and contact information, the
Government reserves the right to use any submitted information on
public websites, in reports, in summaries of the state of the science,
in any possible resultant solicitation(s), grant(s), or cooperative
agreement(s), or in the development of future funding opportunity
announcements. This RFI is for informational and planning purposes only
and is not a solicitation for applications or an obligation on the part
of the Government to provide support for any ideas identified in
response to it. Please note that the Government will not pay for the
preparation of any information submitted or for use of that
information.
We look forward to your input and hope that you will share this RFI
opportunity with your colleagues.
FOR FURTHER INFORMATION CONTACT: Questions about this request for
information should be directed to Dr. Susan Gregurick, 301-435-1923,
[email protected], National Institutes of Health, Office of Data
Science Strategy, 9000 Rockville Pike, Bethesda, Maryland 20892.
SUPPLEMENTARY INFORMATION: The National Institutes of Health (NIH) is
requesting public comment on the use of Real World Data (RWD) for NIH
supported biomedical and behavioral research, including opportunities
for leveraging the benefits of RWD and strategies for responsible use.
NIH also seeks to better understand community perspectives on the
potential value and constraints--including scientific, administrative,
legal, business, and bioethical--for the greater use of RWD in NIH-
sponsored biomedical and behavioral research. This request for
information (RFI) is in accordance with 42 U.S.C. 281 as amended.
Background
Researchers are increasingly using data collected in real-world
settings to augment traditional research studies, as well as develop
more effective treatments and interventions for patients. These ``real-
world data (RWD)'', defined by the U.S. Food and Drug Administration,
are data relating to patient health status and/or the delivery of
health care routinely collected from a variety of sources. Examples of
RWD include data derived from electronic health records, medical claims
data, data from product or disease registries, and data gathered from
other sources (such as digital health technologies) that can inform on
health status. While these data hold tremendous promise for biomedical
and behavioral research, they can be collected from a variety of
sources through multiple mechanisms, creating challenges for
researchers and questions for those whose data are being shared.
Importantly, NIH is committed to ensuring participant privacy and
autonomy are protected in all NIH-supported research. As NIH
establishes health-related research data platforms that include access
to RWD, NIH continues to prioritize maximizing data access while
upholding participant preferences regarding the collection and use of
their data. Most recently, through the Advisory Committee to the NIH
Director, (https://www.acd.od.nih.gov/), NIH staff met with
stakeholders to better understand their perspectives on benefits and
risks of combining and using human datasets, particularly from
disparate sources (e.g., research and non-research settings) and how
their data should be used in biomedical and behavioral research. NIH
will continue working to incorporate these perspectives in its research
studies to build trust and honor participant preferences. Input
requested on this RFI will be used to inform NIH's continuing
development of guidance on the use of RWD for research and assist in
the planning for appropriate mechanisms and programs for research with
RWD.
Information Requested
NIH is requesting public comment on the use of RWD for NIH-
supported biomedical and behavioral research, including opportunities
for leveraging the benefits of RWD and strategies for its responsible
use. NIH also seeks to better understand community perspectives on the
potential value and constraints--including scientific, administrative,
legal, business, and bioethical--for the increased use of RWD in
biomedical and behavioral research.
Response to this RFI is voluntary and may be submitted anonymously.
Respondents are free to address any or all topics listed below, as well
as other relevant topics, for NIH's consideration.
1. Scientific value and quality considerations for collection, use,
and sharing of RWD in biomedical and behavioral research. NIH seeks
broad input on how RWD is acquired and used in NIH-funded research, the
demonstrated and anticipated value of RWD in research, and
opportunities and challenges related to data standards and quality,
representativeness, and potential biases for using RWD in research.
Additionally, NIH is seeking information on:
(a) Biomedical and behavioral research questions that could be
investigated using RWD, including novel unanticipated insights that
have been enabled by using RWD in research.
(b) Barriers to using RWD in research, such as bias,
underrepresentation of populations in data, and technical
[[Page 66861]]
issues of data harmonization and linkage.
2. Using RWD as part of the scientific paradigm, including open
science, scientific rigor and reproducibility, and team science. NIH
seeks broad input on the opportunities and challenges related to using
RWD as part of the scientific process.
(a) Approaches or methods for using RWD in collaborative teams and
ensuring reproducibility.
(b) How do researchers assess the validation and verification of
RWD data that is used in research.
(c) Appropriate open science practices and use of the FAIR
principles (https://www.nature.com/articles/sdata201618) for research
using RWD and approaches for maximizing appropriate data sharing when
expected by the NIH Policy for Data Management and Sharing (https://sharing.nih.gov/data-management-and-sharing-policy) or other policies.
3. Administrative and logistical considerations for collecting,
using, and sharing RWD for biomedical and behavioral research. NIH
seeks broad input on the opportunities and challenges related to the
process of acquiring, using, and making RWD available for biomedical
and behavioral research, including:
(a) Pros and cons of various approaches for obtaining RWD through
algorithms, purchasing RWD through trusted parties, accessing RWD
through secure enclaves, etc.
(b) Considerations regarding licensing, costs, third party
involvement, and restrictions for data use and sharing.
(c) Availability/utility of emerging de-identification technologies
and data storage/sharing considerations.
4. Ethical considerations for using RWD for biomedical and
behavioral research. NIH seeks broad input on the opportunities and
challenges related to potential bioethical issues regarding the
collection, use, and sharing of RWD, including:
(a) Strategies for protecting participant privacy and autonomy.
(b) Potential re-identification risks for RWD, including the
technical feasibility of re-identifying linked data and the possibility
of anonymity for patients, research participants, and their families.
(c) Ethical implications of data as a ``commodity'', in terms of
buying and selling personal health data.
This RFI is for planning purposes only and should not be construed
as a solicitation for applications or proposals, or as an obligation in
any way on the part of the United States Government. The Government
will not pay for the preparation of any information submitted or for
the Government's use. Additionally, the Government cannot guarantee the
confidentiality of the information provided.
Dated: September 21, 2023.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2023-21239 Filed 9-27-23; 8:45 am]
BILLING CODE 4140-01-P
