Leading Edge Acceleration Projects (LEAP) in Health Information Technology

FY2024 Special Emphasis Notice

The Office of the National Coordinator for Health Information Technology (ONC)
Announces Special Emphasis Notice (SEN) Interest in Projects to Develop Innovative Ways
to Evaluate and Improve the Quality of Healthcare Data Used by Artificial Intelligence
(AI) tools in Healthcare and Accelerate Adoption of Health Information Technology in
Behavioral Health
Notice Number: NAP-AX-22-001
Key Dates
Release Date: May 13, 2024
Expiration Date: July 12, 2024
Issued by
Office of the National Coordinator for Health Information Technology (ONC), U.S. Department
of Health and Human Services
Purpose
This notice announces ONC’s interest in funding projects under the Leading Edge Acceleration
Projects (LEAP) in Health Information Technology (IT) funding opportunity (see NAP-AX-22-
001 at https://grants.gov/search-results-detail/341131) in fiscal year 2024 to explore ways to
evaluate and improve the quality of healthcare data used by artificial intelligence (AI) tools in
healthcare and develop health IT tools and resources to enhance technologies in behavioral
healthcare settings.
Areas of Interest
ONC is the principal federal entity charged with coordination of nationwide efforts to implement
and use the most advanced health information technology and the electronic exchange of health
information. Created in 2004 through Executive Order 133351 and legislatively authorized in the
Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009,2
ONC is at the forefront of the federal government’s health IT efforts and is a resource to the
entire health IT and healthcare community to support the adoption of health IT and the
promotion of nationwide health information exchange to improve healthcare.
The goal of the LEAP in Health IT funding opportunity is to address well-documented and fast
emerging challenges inhibiting the development, use, or advancement of well-designed,
interoperable health IT, which are scalable across the healthcare industry. Solutions are expected
to further a new generation of health IT tools and inform the development, implementation, and
refinement of health IT standards, methods, and techniques towards enabling widespread
adoption of health IT tools to improve healthcare outcomes.
1 https://www.govinfo.gov/content/pkg/WCPD-2004-05-03/pdf/WCPD-2004-05-03-Pg702.pdf
2 https://www.healthit.gov/sites/default/files/hitech_act_excerpt_from_arra_with_index.pdf
1

---

It is critical for the health IT field to be able to innovate and leverage the latest technological
advancements and breakthroughs to optimize real-time solutions, especially in areas where
health IT has potential to improve the health and healthcare for individuals and populations.
The descriptions provided for two areas of interest, area 1 and area 2, include ways in which
applicants may approach developing a project. The areas of interest have been assigned numbers
for ease of reference, not for prioritization. While there are many challenges associated with the
use of health IT, ONC identified these two areas of interest as 2024 priority areas.
In fiscal year 2024, ONC seeks applications pursuant to the LEAP in Health IT notice of funding
opportunity for projects that address one of the following areas of interests:
• Area 1: Develop innovative ways to evaluate and improve the quality of healthcare data
used by artificial intelligence (AI) tools in healthcare
• Area 2: Accelerate adoption of health information technology in behavioral health
ONC expects to issue one cooperative agreement award per area of interest of up to $1 million
per award, totaling up to $2 million for the two awards in fiscal year 2024. Please note that all
applicants must explicitly state the area of interest for which they are applying. Applications that
do not clearly state their intended area of interest will not be considered. Eligible applicants may
apply for more than one area of interest; however, a separate application is required for each
area. Except for the specific areas of interest listed above and described below for fiscal year
2024, and the required expertise noted for each area of interest described below, all other
requirements and application review information described in the LEAP in Health IT Notice of
Funding Opportunity (NOFO) (NAP-AX-22-001 at https://grants.gov/search-results-
detail/341131) shall apply, with the exception of the applicant capabilities. Specific merit review
criteria for the applicant capabilities, as part of this SEN is provided below:
• For area of interest 1: Develop innovative ways to evaluate and improve the quality of
healthcare data used by artificial intelligence (AI) tools in healthcare:
Applicant and their proposed project team must demonstrate familiarity with an
o
understanding of the following:
 The EO 14110, the Executive Order on the Safe, Secure, and Trustworthy
Development and Use of Artificial Intelligence
 The ONC HTI-1 final rule, specifically the requirements for Predictive
DSI
 Experience evaluating and developing improvement strategies for data
quality
 Experience in developing and deploying AI tools using data derived from
EHRs
• For area of interest 2: Accelerate adoption of health information technology in behavioral
health:
Applicants and their proposed team must demonstrate familiarity with the
o
following:
2

---

 Health IT standards and health IT technology including content and
exchange standards and implementation specifications
 Behavioral healthcare systems and technology
 Behavioral healthcare settings and their interoperability gaps and needs
Area 1: Develop innovative ways to evaluate and improve the quality of healthcare data used by
artificial intelligence (AI) tools in healthcare
Goal
The goal of this area of interest is to develop scalable solutions that can evaluate and improve the
quality of healthcare data available in electronic health records (EHRs) that are used by artificial
intelligence (AI) tools. This goal aligns with the intentions of Executive Order 14110 (EO
14110) Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence3 and
ONC’s Health Data, Technology, and Interoperability: Certification Program Updates,
Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.4
Background
Responsible Artificial Intelligence
For this area of interest, AI is, as defined by EO 14110’s definition for AI (as set forth in 15
U.S.C. 9401(3)), “a machine-based system that can, for a given set of human-defined objectives,
make predictions, recommendations, or decisions influencing real or virtual environments.
Artificial intelligence systems use machine- and human-based inputs to perceive real and virtual
environments; abstract such perceptions into models through analysis in an automated manner;
and use model inference to formulate options for information or action.” The performance
behavior of such computational processes is typically not deterministic or static and can evolve
based on inputs. AI systems can substantially assist or replace discretionary decision making.
AI has the potential to usher in a new era in human progress. Advancements in AI have the
potential to drive the biggest technological shifts we will see in our lifetimes and will have
positive impacts on the way essential services are provided to people, including healthcare. At
the same time, irresponsible use of AI could exacerbate societal harms such as discrimination,
bias, and disinformation.
EO 14110 directs the U.S. Department of Health and Human Services (HHS) to “prioritize
grantmaking and other awards…to support responsible AI development and use,
including…prioritizing the allocation of 2024 Leading Edge Acceleration Project cooperative
agreement awards to initiatives that explore ways to improve healthcare-data quality to support
the responsible development of AI tools for clinical care, real-world-evidence programs,
population health, public health, and related research.”3
3 https://www.whitehouse.gov/briefing-room/presidential-actions/2023/10/30/executive-order-on-the-safe-
secure-and-trustworthy-development-and-use-of-artificial-intelligence/
4 https://www.federalregister.gov/documents/2024/01/09/2023-28857/health-data-technology-and-
interoperability-certification-program-updates-algorithm-transparency-an
3

---

EHR Data in Artificial Intelligence
Clinical decision support (CDS) provides timely information, usually at the point of care, to help
inform decisions for patient care.
EHR implementation and technology resources used to support clinical decision making have
continued to evolve and expand across the health IT ecosystem. Predictive models can be used to
inform decision makers, including clinicians, payers, researchers, and individuals, and to aid
decision making through CDS integrated in EHR systems. EHRs are the most used data in
predictive modeling for healthcare.5
The National Academy of Medicine (NAM) described in a 2019 report how predictive models
and other forms of AI have the potential to represent the “payback” of using EHRs “by
facilitating tasks that every clinician, patient, and family would want, but are impossible without
electronic assistance.”6
In many cases, EHRs are key enablers of these predictive models, often providing the data used
to build and train algorithms and serving as the vehicle to influence day-to-day decision making
for patient care.7 Both structured and unstructured data generated by, and subsequently made
available through, EHRs power the training and real-world use of predictive models. EHRs are
also often the vehicle or delivery mechanism for predictive model outputs to reach users, such as
clinicians, through clinical decision support.8, 9
The NAM report also identified a crucial “need to present each healthcare AI tool along with the
spectrum of transparency related to the potential harms and context of its use. Evaluating and
addressing appropriate transparency, in each sub-domain of data, algorithms, and performance,
and systematically reporting it, must be a priority.”6
5 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8832418/
6 Michael Matheny, et al., Artificial intelligence in health care: the hope, the hype, the promise, the peril,
WASHINGTON, DC: NATIONAL ACADEMY OF MEDICINE (2019).
7 See, e.g., Burdick, Hoyt, et al. "Effect of a sepsis prediction algorithm on patient mortality, length of stay and
readmission: a prospective multicentre clinical outcomes evaluation of real-world patient data from US
hospitals." BMJ health & care informatics 27.1 (2020).
8 Fox, A. NextGen introduces AI-enabled ambient listening that syncs with EHR. Healthcare IT News. October 11,
2023. https://www.healthcareitnews.com/news/nextgen-introduces-ai-enabled-ambient-listening-syncs-ehr.
9 Miliard, M. Oracle Cerner adds generative AI to its EHR platforms. September 19, 2023.
https://www.healthcareitnews.com/news/oracle-cerner-adds-generative-ai-its-ehr-platforms.
4

---

ONC’s Role in Improving Data Quality in Health IT for AI
On January 9, 2024, ONC published the “Health Data, Technology, and Interoperability:
Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1)”10
final rule. The HTI-1 final rule established first of its kind transparency requirements for
artificial intelligence (AI) and other predictive algorithms that are part of certified health IT
certified to the decision support interventions certification criterion in 45 CFR 170.315(b)(11).11
HTI-1 also emphasized the need for predictive decision support interventions (predictive DSIs)
to be fair, appropriate, valid, effective and safe (FAVES) when it comes to their development
and use. Evaluating Predictive DSIs while they are under development, before they are deployed,
and during their use is acknowledged as a best practice.12 However, not all healthcare
organizations will have the resources and tools to thoroughly complete these tasks, especially on
an ongoing basis. Developing standards-based tools to commoditize the evaluation,
improvement, and governance of predictive DSIs may help increase trust and safety in AI. For
example, evaluating existing AI tools can identify bias and address mistrust between AI and
clinicians, as well as other limitations.13 Solutions to improve the evaluation of predictive DSIs
and other decision-based algorithms can improve the safety and security of AI tools as aligned
with EO 14110.
The HTI-1 final rule requires developers of health IT that are certified to the decision support
interventions criterion to adhere to ongoing maintenance of certification requirements to attest
that their DSI “source attribute” information is up to date. The final rule also requires developers
that certify their health IT Module to the decision support interventions criterion to implement
risk management practices. HTI-1 identifies 31 source attributes that health IT modules certified
to the Predictive DSI criterion must support and keep information complete and up to date14.
These source attributes will provide the transparency necessary for healthcare organizations and
clinical users to better determine whether their Predictive DSIs are FAVES and create a
consistent, industry-wide baseline for responsible AI development.
The source attributes can be categorized into following:15
• Details and output of the predictive algorithms
• Purpose of the intervention
• Cautioned out-of-scope use of the intervention
• Intervention development details and input features
• Process used to ensure fairness in development of the intervention
• External validation process
• Quantitative measures of performance
• Ongoing maintenance of intervention implementation and use
• Update and continued validation or fairness assessment schedule
10 https://www.federalregister.gov/documents/2024/01/09/2023-28857/health-data-technology-and-
interoperability-certification-program-updates-algorithm-transparency-and
11 https://www.hhs.gov/about/news/2023/12/13/hhs-finalizes-rule-to-advance-health-it-interoperability-and-
algorithm-transparency.html
12 https://www.fda.gov/media/153486/download
13 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9875857/
14 https://www.healthit.gov/sites/default/files/page/2023-12/HTI-1_DSI_fact%20sheet_508.pdf
15 https://www.healthit.gov/sites/default/files/page/2023-12/HTI-1_DSI_fact%20sheet_508.pdf
5

---

The resulting information transparency is expected to increase public trust and confidence in
these technologies so that the benefits of these technologies may expand in safer, more
appropriate, and more equitable ways. Developers of health IT certified with health IT modules
certified to the 45 CFR 170.315(b)(11)- DSI criterion, will need to update their health IT to meet
these requirements and provide the updated certified health IT to customers by December 31,
2024.
Key Objectives
This area of interest is focused on the development of scalable solutions to evaluate and improve
the quality of healthcare data available in EHR technologies used by AI tools. Applicants may
propose approaches that are targeted for health IT developers, healthcare providers, or both.
Applicants must identify and explore specific requirements related to EO 14110 and the HTI-1
final rule’s “source attributes” as part of proposing solutions to address this area of interest.
Applicants will also need to describe ways to scale their proposed solution across the health IT
industry.
Applicants have wide flexibility to propose evaluation and improvement activities related to data
quality and AI tools. This could include a deep focus on a consistent and repeatable testing
approach for AI. Applicants, under this award, are also expected to actively participate in
relevant standards-based AI development activities related to healthcare, including supporting
advancement within the standards community that enables other developers to implement the
solutions developed as part of this activity in their own environment.
Applicants can seek the expertise of the health IT community and healthcare organizations to
work together to explore the activities listed in this area of interest.
For an award in this area of interest, applicants are encouraged to include a coalition of key
interested parties, who will be directly involved in the project, such as health IT developers, EHR
vendors, standards development organizations, healthcare providers, payers (e.g., Medicare,
commercial healthcare insurers), public health agencies, and health information networks
(HINs). Applicants should include letters of commitment from key stakeholders.
An applicant’s proposal must not rely on proprietary technology.
Applicants for an award in this area of interest shall demonstrate familiarity with and
understanding of the following:
• EO 14110, the Executive Order on the Safe, Secure, and Trustworthy Development and
Use of Artificial Intelligence
• ONC HTI-1 final rule and specifically the requirements for Predictive DSI
• Experience evaluating and developing improvement strategies for data quality
• Experience in developing and deploying AI tools using data derived from EHRs
6

---

Applicants for an award in this area of interest shall include the following in their application:
• Propose at least one activity related to the goal and key objectives of Area 1.
• Provide a detailed project plan and explanation of how the applicant intends to meet the
goal of this area of interest.
Area 2: Accelerate adoption of health information technology in behavioral health
Goal
The goal of this area of interest is to support the development of lightweight health information
technology (IT) solutions, using open standards, that can enhance health IT capabilities in
behavioral health settings with limited technical and financial resources and improve care
coordination between behavioral health and clinical healthcare settings. This goal supports
ONC’s mission to create systemic improvements in healthcare through access, exchange, and use
of data. It aligns with the objective of reducing the technology gap between behavioral
healthcare providers and physical healthcare providers, as outlined in the U.S. Department of
Health and Human Services (HHS) Roadmap for Behavioral Health Integration16 and the
President’s Strategy to Address our National Mental Health Crisis.17
Background
The Role of Health Information Technology in Behavioral Health
To unlock the full power of information to improve individual health and well-being, electronic
health information must be available when and where it matters most. Improving the secure
availability and use of electronic health information allows individuals to take ownership of their
health, partner with their healthcare providers and others on care preferences and decisions and
reach their health and quality of life goals.
This is especially true in the behavioral health setting, where patients with behavioral health
disorders have been found to have higher rates of physical illnesses including cardiovascular
disease, diabetes, and respiratory diseases.18 It is important that patients’ electronic health
information is interoperable between behavioral health and clinical healthcare settings to support
positive healthcare outcomes for patients. Interoperability between behavioral health and clinical
healthcare settings also promotes patient engagement, which is critical for patient and family
customer experience and direct engagement in care.
Health information technology, including EHRs, have been key tools developed by industry to
support interoperability of health information across multiple healthcare settings, facilitating care
coordination and improving patient engagement.
16 https://www.hhs.gov/about/news/2022/12/02/hhs-roadmap-for-behavioral-health-integration-fact-sheet.html
17 https://www.whitehouse.gov/briefing-room/statements-releases/2022/03/01/fact-sheet-president-biden-to-
announce-strategy-to-address-our-national-mental-health-crisis-as-part-of-unity-agenda-in-his-first-state-of-the-
union/
18 https://www.healthit.gov/sites/default/files/bhandhit_issue_brief.pdf
7

---

Health IT Gaps in Behavioral Healthcare Settings
There are large gaps in health IT adoption between behavioral healthcare providers and non-
behavioral healthcare provider. Specifically, psychiatrists (58%) and psychiatric hospitals (67%)
have lower certified EHR adoption than physical health providers (86%).19 One of the key
reasons for the lack of adoption of health IT in behavioral healthcare settings has been due to
lack of government programs specifically targeting health IT for behavioral health providers.
For example, behavioral health providers did not receive the same incentives (as hospitals and
ambulatory care providers) for EHR adoption under the HITECH Act.20 As a result, certified
EHR technologies that have been widely adopted for clinical care have not been adopted at the
same rate in behavioral health settings.20
Given this technology gap, behavioral healthcare providers also have gaps in areas of basic
health IT capabilities and functions, especially in interoperability and patient engagement
functionalities. For example, only about 30% of psychiatric hospitals report having the capability
to send health records electronically, compared to more than 70% of general hospitals.21
Similarly, only about 30% of residential treatment centers report they can electronically send
referrals, compared to about 65% of multi-setting mental health facilities. 21
There have been few programs that have specifically targeted health IT for behavioral health
providers and general funding programs haven’t provided the necessary flexibility for use of
funds for health IT. As a result, behavioral healthcare settings lack adoption of certified EHRs,
and other health IT tools to help integrate clinical information across the various healthcare
settings and provide integrated behavioral health care for patients.20
To bridge the technology gap between behavioral healthcare providers and physical healthcare
providers, and to help reduce the barrier to health IT adoption in behavioral healthcare settings,
HHS published the HHS Roadmap in September 2022 to advance the President’s Strategy to
address the National Mental Health Crisis. The HHS Roadmap highlights current programs and
activities within HHS to help strengthen system capacity in behavioral health settings.22
One of the programs includes expansion of the United States Core Data for Interoperability
(USCDI) data standard23, which sets the technical and policy foundation for the access,
exchange, and use of electronic health information to support nationwide, interoperable health
information exchange. The USCDI is a standard developed by ONC on behalf of the U.S.
Department of Health and Human Services (HHS) to serve as a baseline set of data elements for
health information exchange and to inform interoperable health IT implementations.
19 Myrick KL, McNeal M, Yin X. Table 1. Percentage of office-based physicians using any electronic health record
(EHR) system and physicians that have a certified EHR system, by selected specialty: National Electronic Health
Records Survey, 2019. National Center for Health Statistics. July 2022.and HRSA 2020 Uniform Data Set.
20 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6568002/pdf/nihms-1031682.pdf
21 National Mental Health Services Survey: 2020
22 https://aspe.hhs.gov/sites/default/files/documents/4e2fff45d3f5706d35326b320ed842b3/roadmap-behavioral-
health-integration.pdf
23 https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi
8

---

USCDI version 124 (USCDI v1) was adopted as a standard in the 21st Century Cures Act:
Interoperability, Information Blocking, and the ONC Health IT Certification Program (Cures Act
Final Rule).25 Since then, ONC has released four more versions of USCDI, three of which have
been approved under the ONC Standards Version Advancement Process (SVAP).26 The SVAP
permits health IT developers with health IT products certified under the ONC Health IT
Certification Program (Certification Program) to voluntarily update their conformance to newer
versions of adopted standards as part of the “Real World Testing” Condition and Maintenance of
Certification requirement (§ 170.405). To further advance interoperability, ONC included
USCDI v3 in the Certification Program in the recently finalized HTI-1 Final Rule.27 Participants
in the Certification Program may adopt USCDI v3 now, and starting in 2026, USCDI v3 will be
the baseline requirement in the Certification Program.
The expansion in the availability of data captured by certified EHRs will enable EHR developers
in the future to provide more targeted capabilities to support behavioral health providers,
including more seamless integration of data between behavioral health and clinical care.
Additionally, through other HHS incentive programs, described in the HHS Roadmap, including
expansion of Substance Abuse and Mental Health Services Administration’s Certified
Community Behavioral Health Clinics,28 and the Innovation in Behavioral Health (IBH) Model29
through CMS, HHS is working towards increasing adoption of certified EHRs by behavioral
healthcare providers.
Goal of Area 2: Developing Lightweight Health IT Solutions
In addition to encouraging the development of behavioral health specific capabilities in EHR
technologies and incentivizing EHR adoption by behavioral health providers, the HHS Roadmap
also identified the need for agencies to develop health IT solutions, especially targeted towards
behavioral healthcare settings that have the least technical resources and lack funding for up-
front health IT capital investments as well as on-going maintenance of health IT. These include,
but are not limited to, residential treatment centers, substance use disorders/detoxification
facilities and outpatient mental health facilities
The development of “lightweight” health IT solutions that can be adopted by behavioral
healthcare providers with limited technical and financial resources is the goal of this area of
interest.
24 https://www.healthit.gov/isa/sites/isa/files/2020-10/USCDI-Version-1-July-2020-Errata-Final_0.pdf
25 https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-
information-blocking-and-the-onc-health-it-certification
26 https://www.healthit.gov/isa/standards-version-advancement-process
27 https://www.federalregister.gov/documents/2024/01/09/2023-28857/health-data-technology-and-
interoperability-certification-program-updates-algorithm-transparency-and
28 https://www.samhsa.gov/certified-community-behavioral-health-clinics
29 https://www.cms.gov/newsroom/press-releases/cms-announces-new-model-advance-integration-behavioral-
health
9

---

Health IT developers have the potential to innovate and develop health IT solutions that deliver
value in health care.30 Key provisions of the 21st Century Cures Act have been implemented and
are dramatically improving clinical interoperability, including rollout31 of standard application
programming interfaces (APIs) across the industry using the mature HL7® Fast Healthcare
Interoperability Resources (FHIR®)32 interoperability standard based on modern internet
technology approaches. This has created a climate of innovation by allowing technology
developers to build to a common, industrywide specification. The Interoperability Standards
Advisory33 (ISA) provides a comprehensive compendium of all standards used in health care.
Standards-based APIs and applications are the key foundations of lightweight solutions that
would provide patients and behavioral health providers the enhanced access, functionality, ease
of use for care coordination, and lower barriers to adopting health IT regardless of which
technology platform they use.
One of the most mature examples of a lightweight solution is the “SMART on FHIR” approach
that has been developed by the SMART program and originally funded by ONC.34 The SMART
approach enables FHIR to work as a “apps platform”35 with the ability for the SMART
application (app) to be connected into any certified EHR using a standard FHIR API and
integrated into existing healthcare workflows, anywhere in the health system. The “apps” are
readily substitutable for another, which makes them have the potential to enhance technology
features and lower costs for healthcare settings.34
“SMART on FHIR” app support is included within ONC’s Health IT Certification Program and
is well supported by major EHR products.36 “SMART on FHIR” apps are already being used
across various healthcare settings.37 One example is the “Major Depression Outcomes App” that
provides a “snapshot” view of a patient’s depression symptoms and outcomes using scores from
the Patient Health Questionnaire-938 and clinical data to calculate and display standardized
depression outcome measures that a provider can use to monitor a patient’s response to treatment
over time.39
30 https://www.healthaffairs.org/content/forefront/delivering-promise-health-information-technology-2022
31 https://www.healthit.gov/buzz-blog/healthit-certification/on-the-road-to-cures-update-certified-api-technology
32 https://hl7.org/fhir/
33 https://www.healhit.gov/isa
34 https://www.hl7.org/fhir/smart-app-launch/
35 https://smarthealthit.org/about-smart-2/
36 https://onc-healthit.github.io/api-resource-guide/g10-criterion/#supported-search-operations-single-patient
37 https://apps.smarthealthit.org/apps/featured
38 https://www.apa.org/depression-guideline/patient-health-questionnaire.pdf
39 https://apps.smarthealthit.org/app/major-depression-outcomes-app
10

---

Key Objectives
The objective of this area of interest is to design, develop, and pilot lightweight health IT
solutions, such as SMART on FHIR apps, that can enhance health IT capabilities in behavioral
health settings and improve care coordination between behavioral health and clinical healthcare
settings. Applicants can achieve this objective by developing health IT solutions using FHIR-
based tools and develop these solutions to meet the needs of behavioral healthcare providers with
limited technical and financial resources. Applicants may consider utilizing standards identified
in the ISA and data elements identified in the USCDI as part of their technical solution.
Applicants should consider the following list of activities to achieve the goals and objectives of
Area 2:
• Design and develop one or more lightweight application(s), such as SMART on FHIR
applications, and FHIR-based APIs, to solve a specific behavioral health use case or
multiple use cases. The lightweight application must also enable a behavioral healthcare
setting to access and integrate health information from other healthcare settings that use
ONC certified health IT.
The application must be developed using open FHIR based APIs. Applicants may
o
also consider the standards adopted in HTI-1 as applicable for the lightweight
application to access data from ONC certified health IT.
• Pilot the application(s) at behavioral healthcare settings to make the application(s) ready
for adoption by behavioral health providers.
Document approaches used for testing the application(s) at behavioral healthcare
o
settings to make the tool production ready.
• Coordinate input and dialogue with health IT industry and behavioral healthcare
community/providers to inform development of the application(s) and share lessons
learned and best practices.
Applicants can seek the expertise of the health IT community and healthcare organizations to
partner in implementing solutions for behavioral health interoperability and improving care
coordination
An applicant’s proposal shall not rely on proprietary technology.
Applicants for an award in this area of interest shall demonstrate, in their application, familiarity
with and understanding of the following:
• Health IT standards and health IT technology, including content and exchange standards,
and implementation specifications
• Behavioral healthcare systems and technology, behavioral healthcare settings, and
interoperability gaps and needs
11

---

Applicants for an award in this area of interest shall include the following in their application:
• Provide a detailed project plan and explanation of how the applicant intends to meet the
goal and objectives of this area of interest. In the project plan, the applicant should:
Describe the attributes of the application(s) that make the solution “lightweight”
o
in behavioral healthcare settings, including but not limited to the resources
required to maintain and support the application in production.
Identify all the behavioral healthcare settings that the proposed solution is
o
applicable, with preference given to under resourced providers who have
generally lower adoption of health IT, such as residential treatment centers,
substance use disorders/detoxification facilities and outpatient mental health
facilities.
• Identify at least one behavioral healthcare clinical use case based on the challenges facing
behavioral healthcare providers and provide an explanation on how the applicant plans to
build a scalable lightweight tool or resource to solve the problem associated with the use
case effectively.
• Identify at least one behavioral healthcare setting and a data exchange partner to test and
pilot the tool associated with the use case(s) identified.
• Provide a plan for engaging with the open-source community for long-term sustainability
of the tool(s)
Further Guidance
Unless otherwise indicated in this Notice, all requirements, instructions, and terms and
conditions of the Leading Edge Acceleration Projects (LEAP) in Health Information Technology
(IT) funding opportunity (NAP-AX-22-001 at https://www.grants.gov/web/grants/search-
grants.html?keywords=nap-ax-22-001) will apply to applications submitted and awards made in
response to this Notice.
Application Submission and Special Application Receipt Date. Information about the
application process can be found at https://www.healthit.gov/topic/onc-funding-
opportunities/leading-edge-acceleration-projects-leap-health-information or
https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001.
An informational session will be held on May 21, 2024. Further details about the informational
session – including the date, time, and instructions for joining – are available at:
https://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-health-
information.
12

---

Although not required, applicants are strongly encouraged to submit a non-binding e-mail letter
of intent to apply for this funding opportunity. This letter of intent will assist ONC in planning
for the application review process. When submitting your letter of intent, please identify which
area of interest your organization plans to apply for. The letter of intent is requested by 11:59
P.M. Eastern Standard Time on May 28, 2024. Interested organizations can send the letter of
intent to ONC-LEAP@hhs.gov. Please identify the name of the applicant organization, the city
and state in which the applicant organization is located, the intended area(s) of interest, and the
Notice of Funding Opportunity title and number.
Submit applications focused on the areas of interest identified in this Notice by NOON Eastern
Standard Time on July 12, 2024. This Notice will expire on July 12, 2024.
Inquiries
Please direct all program related inquiries to:
Alison Kemp and Anastasia Perchem
LEAP Program Manager
Office of the National Coordinator for Health Information Technology (ONC)
Email: ONC-LEAP@hhs.gov
Please direct all grant related inquiries to:
Carmel Halloun
Grants Branch Chief
Office of the National Coordinator for Health Information Technology (ONC)
Email: oncgrants@hhs.gov
13

---

FY 2025 LEAP Special Emphasis Notice

The Assistant Secretary for Technology Policy/Office of the National Coordinator for
Health Information Technology (ASTP) Announces Special Emphasis Notice (SEN)
Interest in Projects to Demonstrate the readiness of FHIR®-based Subscriptions Capability
as a Foundational Health IT Capability for Improved Interactivity with Third Party
Applications (apps), and Identify and Test Innovative Technical Approaches that Would
Inform Future Changes to the Trusted Exchange Framework and Common AgreementTM
(TEFCATM) Infrastructure to Increase Adoption of Individual Access Services (IAS)
Notice Number: NAP-AX-22-001
Key Dates
Release Date: January 15, 2025
Expiration Date: March 17, 2025
Issued by
Assistant Secretary for Technology Policy/Office of the National Coordinator for Health
Information Technology (ASTP), U.S. Department of Health and Human Services (HHS)
Purpose
This notice announces ASTP’s interest in funding projects under the Leading Edge Acceleration
Projects (LEAP) in Health Information Technology (IT) funding opportunity (see NAP-AX-22-
001 at https://grants.gov/search-results-detail/341131 in fiscal year 2025 to explore ways to: 1)
Demonstrate readiness of Health Level Seven® (HL7®) Fast Healthcare Interoperability
Resources (FHIR®)-based Subscriptions capability as a foundational health IT capability for
improved interactivity with third-party applications, and 2) Identify and test innovative technical
approaches that would inform future changes to Trusted Exchange Framework and Common
Agreement TM (TEFCA TM) Infrastructure to increase adoption of Individual Access Service
(IAS).
Areas of Interest
ASTP is the principal federal entity charged with coordination of nationwide efforts to
implement and advance the use of health IT and the electronic exchange of health information.
The Office of the National Coordinator for Health Information Technology was created in 2004
through Executive Order 133351 and legislatively authorized in the Health Information
Technology for Economic and Clinical Health Act (HITECH Act) of 2009,2 ASTP is at the
forefront of the federal government’s health IT efforts and is a resource to the entire health IT
1 https://www.govinfo.gov/content/pkg/WCPD-2004-05-03/pdf/WCPD-2004-05-03-Pg702.pdf
2 https://www.healthit.gov/sites/default/files/hitech_act_excerpt_from_arra_with_index.pdf
1

---

and healthcare community to support the adoption of health IT and the promotion of nationwide
health information exchange to improve healthcare.
The goal of the LEAP in Health IT funding opportunity is to address well-documented and fast
emerging challenges inhibiting the development, use, or advancement of well-designed,
interoperable health IT, which are scalable across the healthcare industry. Solutions are expected
to further a new generation of health IT tools and inform the development, implementation, and
refinement of health IT standards, methods, and techniques towards enabling widespread
adoption of health IT tools to improve healthcare outcomes.
It is critical for the health IT field to be able to innovate and leverage the latest technological
advancements and breakthroughs to optimize real-time solutions, especially in areas where
health IT has potential to improve the health and healthcare for individuals and populations.
The descriptions provided for the two areas of interest, Area 1 and Area 2, include ways
applicants may approach developing a project. The areas of interest have been assigned numbers
for ease of reference, not for prioritization. While there are many challenges associated with the
use of health IT, ASTP identified these two areas of interest as 2025 priority areas.
In fiscal year 2025, ASTP seeks applications pursuant to the LEAP in Health IT notice of
funding opportunity for projects that address one of the following areas of interests:
• Area 1: Demonstrate readiness of FHIR®-based Subscriptions capability as a
foundational health IT capability for improved interactivity with third-party applications.
• Area 2: Identify and test innovative technical approaches that would inform future
changes to the TEFCA infrastructure to increase adoption of IAS.
ASTP expects to issue one cooperative agreement award per area of interest of up to $1 million
per award, totaling up to $2 million for the two awards in fiscal year 2025. Please note that all
applicants must explicitly state the area of interest for which they are applying. Applications that
do not clearly state their intended area of interest will not be considered. Eligible applicants may
apply for more than one area of interest; however, a separate application is required for each
area. Except for the specific areas of interest listed above and described below for fiscal year
2025, and the desired expertise noted for each area of interest described below, all other
requirements and application review information described in the LEAP in Health IT Notice of
Funding Opportunity (NOFO) (NAP-AX-22-001 at https://grants.gov/search-results-
detail/341131) shall apply, with the exception of the applicant capabilities. Specific merit review
criteria for the applicant capabilities, as part of this SEN, are provided below:
• For area of interest 1: Demonstrate readiness of HL7® FHIR®-based Subscriptions
capability as a foundational health IT capability for improved interactivity with third-
party applications.
o Applicant and their proposed project team should demonstrate familiarity with
and understanding of the following:
▪ Experience with developing applications using HL7® FHIR® Release
4.0.1.
2

---

▪ Familiarity with HL7® FHIR® Subscriptions capability.
▪ Experience with engaging health IT standards community
▪ Experience with developing patient-facing apps using HL7® FHIR®
• For area of interest 2: Identify and test innovative technical approaches that would inform
future changes to the TEFCA infrastructure to increase adoption of IAS.
o Applicant and their proposed project team should demonstrate familiarity with
and understanding of the following:
▪ TEFCA, including its technical and the policy components.
▪ Understanding of IAS in TEFCA.
▪ Understanding of health IT networks
▪ Developing patient-facing apps using HL7® FHIR®
Area 1: Demonstrate readiness of HL7® FHIR®-based Subscriptions capability as a
foundational health IT capability for improved interactivity with third-party applications.
Goal
The goals of this area of interest are first, to demonstrate that HL7® FHIR®-based
Subscriptions3 is a foundational capability that supports a broad array of essential health
information interoperability needs via HL7® FHIR®-based application programming interfaces
(APIs)4. Projects should, through their implementation, demonstrate whether the implementation
specifications developed by the standards community5,6 for HL7® FHIR®-based Subscriptions
capabilities are ready to be widely implemented by health IT developers, and to be made
available to third-party client applications.
Background
HL7® FHIR® is a widely used, open standard for exchanging health information that is based
on modern internet technology approaches. Due to substantial efforts made over the last decade,
the HL7® FHIR® standard has matured since it was first created in 20127 and is now broadly
adopted by the health IT industry.8 HL7® FHIR® was incorporated into the ONC Health IT
Certification Program9 to support essential provisions of the 21st Century Cures Act10 in 2016.
3 https://hl7.org/fhir/r4/subscription.html
4 https://hl7.org/fhir/R4/
5 Argonaut FHIR Accelerator https://github.com/argonautproject/us-core-patient-data-
feed/blob/main/spec.md#patient-data-feed-subscriptions.
6 FHIR Subscriptions R5 Backport https://build.fhir.org/ig/HL7/fhir-subscription-backport-ig/.
7 http://hl7.org/fhir/directory.html
8 https://www.healthit.gov/buzz-blog/health-it/achieving-a-major-milestone-health-it-developers-certify-to-cures-
update
9 https://www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/2020-07419.pdf
10 https://www.congress.gov/bill/114th-congress/house-bill/34
3

---

As a result, HL7® FHIR®-based APIs have become more prevalent and now offer a new
baseline for accessing and exchanging electronic health information (EHI) nationwide. This
includes the establishment of HL7® FHIR® Release 4.0.1 11 as the current, mature foundational
version that health IT developers are relying on in the United States. HL7® FHIR® Release
4.0.1 was released in 2018 and has evolved into a mature standard for the health IT industry.
While a newer version of the base standard, HL7® FHIR® Release 5 (R5), has been balloted,
HHS has to date adopted implementation specifications through rulemaking (ASTP’s Health
Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency,
and Information Sharing (HTI-1)12 Final Rule and CMS’ Medicare and Medicaid Programs;
Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior
Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans,
State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP
Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated
Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible
Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program
(Interoperability and Prior Authorization Final Rule13) that are based on HL7® FHIR® Release
4.0.1.
The health IT standards community has extended the HL7® FHIR® Release 4.0.1 specifications
to address more advanced health IT use cases using an open standards approach and more
advanced capabilities within FHIR®. One such capability is HL7® FHIR® Subscriptions,14
which is a HL7® FHIR® standards framework that is used to establish proactive event
notifications from a HL7® FHIR® server to another system. One example of use of such a
capability would be to enable consumer applications to be notified when specific changes occur
in a HL7® FHIR® server’s data, which can be particularly useful in scenarios requiring timely
updates (e.g., laboratory results) to be pushed from electronic health records (EHR) technologies
to patients’ applications on their phones instead of requiring patients to keep querying for the
information from their patient portals. The HL7® FHIR® Subscriptions framework has been
designed to support many other use cases in population health and research initiatives where
there is a need for greater interactivity between HL7® FHIR servers and client applications.
While the FHIR-based Subscriptions capability has shown great promise in meeting healthcare
organizations’ technology needs, Subscriptions are presently not widely made available in EHRs
nor used broadly by client applications.15
A focused effort is needed to demonstrate that HL7® FHIR®-based Subscriptions can be a
foundational capability for the modern digital health system in the US. This would include
ensuring specifically that the application of the HL7 FHIR Subscriptions framework to US Core
Resources (e.g., patient, observation, medication request) can be widely adopted by EHR
11 https://hl7.org/fhir/R4/
12 https://www.federalregister.gov/documents/2023/04/18/2023-07229/health-data-technology-and-
interoperability-certification-program-updates-algorithm-transparency-and
13 https://www.federalregister.gov/documents/2024/02/08/2024-00895/medicare-and-medicaid-programs-
patient-protection-and-affordable-care-act-advancing-interoperability
14 https://build.fhir.org/ig/HL7/fhir-subscription-backport-ig/
15 https://ehrintelligence.com/news/api-adoption-slow-widespread-fhir-uptake-expected-by-2024; Maisel, N.
(2022, September 16). Uptake of FHIR: Where are We Today and What are the Challenges that Lie Ahead?
4

---

developers for meeting multiple customer needs and readiness of third-party client applications
to take advantage of this capability to provide superior end user experience.
Key Objectives
There are three key objectives in this area of interest, as follows:
1. Advance and mature existing HL7® FHIR®-based Subscriptions capability for readiness
to be widely adopted by health IT developers.
2. Demonstrate how use of Subscriptions capability can lead to beneficial interactive data
exchange between EHRs and third-party client applications.
3. Demonstrate how a HL7® FHIR®-based Subscriptions specification can be a
foundational health IT capability to support a modern API-based digital health care
system in the United States.
Applicants should achieve these three goals by developing a solution that is inclusive of the
following considerations:
• Standards-Based Solution: Design a technical solution or technical solutions that utilize
Subscriptions specification that is based on HL7® FHIR® Release 4.0.1 and supported
by recognized standards development organizations (SDOs). Alternatively, utilize the
HL7® FHIR® Subscriptions R5 Backport implementation guide16 that supports HL7®
FHIR® Release 4.0.1 and/or Argonaut US Core Patient Data Feed: Subscriptions for the
technical solution.17
• Interoperable with Third-Party Applications: The technical solution or technical
solutions should be readily interoperable with any third-party client applications
developed by organizations unaffiliated with the organization that provides the server that
meets HL7® FHIR® specifications used to initiate Subscriptions notifications.
Foundational Capability: The technical solution or technical solutions should be use-
case agnostic, to demonstrate the versatility of the FHIR based Subscriptions capability.
This could include providing the HL7® FHIR® Subscriptions capability on multiple data
elements from United States Core Data for Interoperability that address diverse types of
use cases, using the same technical solution and specification.
For an award in this area of interest, applicants are encouraged to include a coalition of key
interested parties who will be directly involved in the project such as EHR vendors, developers
of consumer health applications and members of the health IT standards community. Applicants
should include letters of commitment from interested parties, including, but not limited to, those
mentioned above.
16 https://build.fhir.org/ig/HL7/fhir-subscription-backport-ig/
17 https://github.com/argonautproject/us-core-patient-data-feed/blob/main/spec.md#patient-data-feed-
subscriptions
5

---

Applicants have flexibility to propose activities that achieve the goals and objectives of Area 1,
which could include (not required), for example:
• By implementing a technical solution, identifying, and resolving any shortcomings of
existing specification developed by the standards community (including but not limited to
HL7® FHIR® Release 4.0.1, HL7® FHIR® Subscriptions R5 Backport implementation
guide18, and Argonaut US Core Patient Data Feed: Subscriptions).
• Demonstrating how the developed technical solution or solutions can be used by
appropriate communities to encourage adoption of the capability by health IT developers.
• Enhancing underlying specification used in the project (including but not limited to
HL7® FHIR® Release 4.0.1, HL7® FHIR® Subscriptions R5 Backport implementation
guide19, and Argonaut US Core Patient Data Feed: Subscriptions) to improve use by
implementers including client applications and facilitate broader adoption of the
capability.
The proposal developed by the applicants are required to demonstrate readiness of HL7®
FHIR®-based Subscriptions capability but will not be required to be open source as long as the
Subscriptions capability is using open standards developed by standards development
organizations, such as HL7®, for interoperable health information exchange between clients and
servers.
Applicants for an award in this area of interest shall include, at minimum, the following elements
in their technical solution:
• The technical solution must be based on the HL7 ®FHIR® Release 4.0.1 standard.
• The technical solution must demonstrate and pilot HL7® FHIR® based Subscriptions
specification using a server and an unaffiliated third-party application acting as the
Subscriptions client.
• The technical solution must include at least one use case that demonstrates beneficial
interactive exchange with third-party client applications over query-based exchange.
Additionally, the application shall also include, at a minimum:
• Plans for encouraging acceptance of any update and modifications (e.g., identification
and fixing of errors, updating the specifications with any changes) to existing technical
specifications (including but not limited to HL7® FHIR® Release 4.0.1, HL7® FHIR®
Subscriptions R5 Backport implementation guide20, and Argonaut US Core Patient Data
Feed: Subscriptions) by the standards community.
•
• Plans for facilitating/fostering widespread adoption of the Subscriptions capability in the
health IT industry.
18 https://build.fhir.org/ig/HL7/fhir-subscription-backport-ig/
19 https://build.fhir.org/ig/HL7/fhir-subscription-backport-ig/
20 https://build.fhir.org/ig/HL7/fhir-subscription-backport-ig/
6

---

Area 2: Identify and test innovative technical approaches that would inform future changes to
the TEFCA infrastructure to increase adoption of IAS.
Goal
The goal of this area of interest is to explore and test innovative technical approaches that could
be applied to the technical infrastructure used for IAS exchange in TEFCA. These approaches
would ideally lead to increased participation of IAS Providers,21 improved responses for IAS
requests from responding nodes, and markedly increase the number of individuals using TEFCA
to access their EHI. We expect that TEFCA partners, including Qualified Health Information
Networks (QHINs),22 Participants,23 and Subparticipants24 may also be informed by the technical
approaches identified through this area of interest.
Background
TEFCA25 is a pivotal initiative aimed at improving the exchange of health information across
different networks using health IT, ensuring that health data can flow securely and efficiently
across the country.
The 21st Century Cures Act26 required the National Coordinator to “develop or support a trusted
exchange framework, including a common agreement [TEFCA] among health information
networks nationally.” One of the key goals of TEFCA is to enable individuals to gather their
electronic health care information, or EHI. TEFCA is currently operational and actively
facilitating exchange of EHI.27
21 IAS Providers include QHINs, Participants, and Subparticipants that offer Individual Access Services (IAS).
https://rce.sequoiaproject.org/wp-content/uploads/2024/01/Draft-TEFCA-Glossary-508-Compliant.pdf
22 QHINs, to the extent permitted by applicable Standard Operating Procedure(s) (SOPs), are a Health Information
Network that is a U.S. Entity that has been Designated by the Recognized Coordinating Entity ® (RCE) and is a party
to the Common Agreement countersigned by the RCE. https://rce.sequoiaproject.org/wp-
content/uploads/2024/01/Draft-TEFCA-Glossary-508-Compliant.pdf.
23 Participants, to the extent permitted by applicable SOP(s), are a U.S. Entity that has entered into the Terms of
Participation (ToP) in a legally binding contract with a QHIN to use the QHIN’s Designated Network Services to
participate in TEFCA Exchange in compliance with the ToP. https://rce.sequoiaproject.org/wp-
content/uploads/2024/01/Draft-TEFCA-Glossary-508-Compliant.pdf.
24 Subparticipants, to the extent permitted by applicable SOP(s), are a U.S. Entity that has entered into a ToP in a
legally binding contract with a Participant or Subparticipant to use the Participant's or Subparticipant's
Connectivity Services to participate in TEFCA Exchange in compliance with the ToP.
https://rce.sequoiaproject.org/wp-content/uploads/2024/01/Draft-TEFCA-Glossary-508-Compliant.pdf.
25 https://www.healthit.gov/topic/interoperability/policy/trusted-exchange-framework-and-common-agreement-
tefca
26 https://www.congress.gov/bill/114th-congress/house-bill/34
27 https://www.healthit.gov/buzz-blog/tefca/what-makes-tefca-different-new-standard-operating-procedure-
strengthens-trust
7

---

IAS28 is one of the six currently authorized TEFCA Exchange Purposes29 that is designed to
empower patients to easily access to their EHI. It enables individuals to connect to a single IAS
Provider in TEFCA and use the IAS Provider service to retrieve their EHI from all participating
organizations that are connected to TEFCA.
For patients, IAS can empower them to easily retrieve their EHI from a single application
provided by a QHIN, Participant, or Subparticipant connected to TEFCA, without having to
individually connect to all the health care provider portals that may contain their EHI. Even if
patients do not remember where all of their EHI is located, they can retrieve their EHI through
IAS as long as the organization holding the information is a TEFCA QHIN, Participant, or
Subparticipant.
Adoption of IAS in TEFCA has been slow and limited to date. While the TEFCA Recognized
Coordinating Entity (RCE) 30 has not published information on the number of IAS Providers or
number of individuals using the IAS Exchange Purpose, anecdotal evidence suggests that IAS
adoption has not scaled significantly since TEFCA went live in December 2023.31 There are a
limited number of IAS Providers and individuals that used TEFCA to access and gather their
health information.
The broader health IT community has also raised several potential technical challenges that
could hinder the broader availability and adoption of IAS. Those challenges include, but are not
limited to, patient matching issues which can limit providers from matching patient records
across different systems and organizations, and burdens on individuals using the IAS Provider
service. These challenges must be addressed to fully realize the potential of TEFCA for enabling
patient access.
Key Objectives
As described in the Background Section, TEFCA is currently operational and actively facilitating
exchange of EHI among QHINs, Participants, and Subparticipants using established technical
infrastructure and Standard Operating Procedures that define the contours of IAS exchange. Any
changes to the technical infrastructure in TEFCA would need to be well-tested in a sandbox
environment, demonstrated to meaningfully add value over existing approaches, and be likely to
be embraced by partners currently participating in TEFCA.
Based on these considerations, there are three key objectives in this area of interest, as follows:
28 https://rce.sequoiaproject.org/wp-content/uploads/2024/08/XP-Implementation-SOP-IAS.pdf
29 TEFCA Exchange Purpose refers to the reason (e.g., treatment, payment, IAS, government benefits
determination, healthcare operations, public health), that organizations connected to TEFCA are allowed to
request or respond, as authorized by a Framework Agreement.
https://www.healthit.gov/topic/interoperability/policy/trusted-exchange-framework-and-common-agreement-
tefca
30 https://rce.sequoiaproject.org/
31 https://rce.sequoiaproject.org/rce/faqs/#IsTEFCAExchangeHappeningToday
8

---

• Identify technical barriers that impede entities that could be IAS Providers from
participating in TEFCA and offering services to individuals.
• Develop and test non-proprietary innovative technical solutions to the identified technical
barriers.
• Demonstrate the technical solutions to the identified barriers that can be made to the
technical infrastructure used for IAS exchange in TEFCA.
Applicants have flexibility to propose activities that achieve the goals and objectives of Area 2,
which could include (not required), for example:
• Improvements to the technical requirements for IAS Providers and any related standard
operating procedures that would increase utilization of patient facing applications under
TEFCA.
• Implementing new ways to perform identity proofing, verification, resolution, and overall
identity management of individuals in the context of TEFCA exchange that could
simplify the process for individuals to use IAS Provider services.
• Identifying a method of replacing demographics-based patient matches with non-
proprietary deterministic approaches that could be broadly adopted within TEFCA.32
Applicants for an award in this area of interest shall include the following in their application:
• Describe in detail one or more technical barriers currently impeding entities that could be
IAS Providers from participating in TEFCA; or that impede QHINs, Participants, or
Subparticipants from becoming IAS Providers and offering IAS services to individuals;
or both.
• Describe in detail a technical solution to the technical barrier(s), including:
o Provide sufficient details on the technical solution to demonstrate it is based on
non-proprietary technologies.
o Provide a detailed plan on how the applicant intends to test the solution.
o Provide a detailed plan describing how the solution will be demonstrated in a
manner that would be informative to future changes to technical infrastructure
used for IAS exchange in TEFCA.
• Identify an approach to improve IAS exchange while adhering to data security and
privacy standards, including ensuring consistency for covered entities’ compliance with
the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule where
applicable, its implementing regulations, and other relevant regulations.
32 The awardee may ultimately propose additional changes to the existing SOPs if project work uncovers an unmet
need, inconsistency, or need for clarification.
9

---

• Provide details of any changes that the applicant believes might be needed to TEFCA
SOPs related to IAS exchange to implement the technical solution.
Further Guidance
Unless otherwise indicated in this Notice, all requirements, instructions, and terms and
conditions of the LEAP in Health Information Technology (IT) funding opportunity (NAP-AX-
22-001 at https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001) will
apply to applications submitted and awards made in response to this Notice.
Application Submission and Special Application Receipt Date. Information about the
application process can be found at https://www.healthit.gov/topic/onc-funding-
opportunities/leading-edge-acceleration-projects-leap-health-information or
https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001.
An informational session will be held on January 28, 2025. Further details about the
informational session – including the date, time, and instructions for joining – are available at:
https://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-
leap-health-information.
Although not required, applicants are strongly encouraged to submit a non-binding e-mail letter
of intent to apply for this funding opportunity. This letter of intent will assist ASTP in planning
for the application review process. When submitting your letter of intent, please identify which
area of interest your organization plans to apply for. The letter of intent is requested by 11:59
P.M. Eastern Standard Time on February 4, 2025. Interested organizations can send the letter of
intent to ASTP-LEAP@hhs.gov. Please identify the name of the applicant organization, the city
and state in which the applicant organization is located, the intended area(s) of interest, and the
Notice of Funding Opportunity title and number.
Submit applications focused on the areas of interest identified in this Notice by NOON Eastern
Standard Time on March 17, 2025. This Notice will expire on March 17, 2025.
Inquiries
Please direct all program related inquiries to:
Sara Valek
LEAP Program Manager
Assistant Secretary for Technology Policy (ASTP)
Email: ASTP-LEAP@hhs.gov
Please direct all grant related inquiries to:
Carmel Halloun
10

---

Grants Branch Chief
Assistant Secretary for Technology Policy (ASTP)
Email: ASTPGrants@hhs.gov
11

---

Revised SEN 02252025

The Assistant Secretary for Technology Policy/Office of the National Coordinator for
Health Information Technology (ASTP) Announces Special Emphasis Notice (SEN)
Interest in Projects to Demonstrate the Readiness of FHIR®-based Subscriptions
Capability as a Foundational Health IT Capability for Improved Interactivity with Third
Party Applications (apps), and Identify and Test Innovative Technical Approaches that
Would Inform Future Changes to the Trusted Exchange Framework and Common
AgreementTM (TEFCATM) Infrastructure to Increase Adoption of Individual Access
Services (IAS)
Notice Number: NAP-AX-22-001
Key Dates
Release Date: January 15, 2025
Expiration Date: April 25, 2025
Issued by
Assistant Secretary for Technology Policy/Office of the National Coordinator for Health
Information Technology (ASTP), U.S. Department of Health and Human Services (HHS)
Purpose
This notice announces ASTP’s interest in funding projects under the Leading Edge Acceleration
Projects (LEAP) in Health Information Technology (IT) funding opportunity (see NAP-
AX-22-001 at https://grants.gov/search-results-detail/341131 in fiscal year 2025 to explore ways
to: 1) Demonstrate readiness of Health Level Seven® (HL7®) Fast Healthcare Interoperability
Resources (FHIR®)-based Subscriptions capability as a foundational health IT capability for
improved interactivity with third-party applications, and 2) Identify and test innovative technical
approaches that would inform future changes to Trusted Exchange Framework and Common
Agreement TM (TEFCA TM) Infrastructure to increase adoption of Individual Access Service
(IAS).
Areas of Interest
ASTP is the principal federal entity charged with coordination of nationwide efforts to
implement and advance the use of health IT and the electronic exchange of health information.
The Office of the National Coordinator for Health Information Technology was created in 2004
through Executive Order 133351 and legislatively authorized in the Health Information
Technology for Economic and Clinical Health Act (HITECH Act) of 2009,2 ASTP is at the
forefront of the federal government’s health IT efforts and is a resource to the entire health IT
1 https://www.govinfo.gov/content/pkg/WCPD-2004-05-03/pdf/WCPD-2004-05-03-Pg702.pdf
2 https://www.healthit.gov/sites/default/files/hitech_act_excerpt_from_arra_with_index.pdf
1

---

and healthcare community to support the adoption of health IT and the promotion of nationwide
health information exchange to improve healthcare.
The goal of the LEAP in Health IT funding opportunity is to address well-documented and fast
emerging challenges inhibiting the development, use, or advancement of well-designed,
interoperable health IT, which are scalable across the healthcare industry. Solutions are expected
to further a new generation of health IT tools and inform the development, implementation, and
refinement of health IT standards, methods, and techniques towards enabling widespread
adoption of health IT tools to improve healthcare outcomes.
It is critical for the health IT field to be able to innovate and leverage the latest technological
advancements and breakthroughs to optimize real-time solutions, especially in areas where
health IT has potential to improve the health and healthcare for individuals and populations.
The descriptions provided for the two areas of interest, Area 1 and Area 2, include ways
applicants may approach developing a project. The areas of interest have been assigned numbers
for ease of reference, not for prioritization. While there are many challenges associated with the
use of health IT, ASTP identified these two areas of interest as 2025 priority areas.
In fiscal year 2025, ASTP seeks applications pursuant to the LEAP in Health IT notice of
funding opportunity for projects that address one of the following areas of interests:
• Area 1: Demonstrate readiness of FHIR®-based Subscriptions capability as a
foundational health IT capability for improved interactivity with third-party applications.
• Area 2: Identify and test innovative technical approaches that would inform future
changes to the TEFCA infrastructure to increase adoption of IAS.
ASTP expects to issue one cooperative agreement award per area of interest of up to $1 million
per award, totaling up to $2 million for the two awards in fiscal year 2025. Please note that all
applicants must explicitly state the area of interest for which they are applying. Applications that
do not clearly state their intended area of interest will not be considered. Eligible applicants may
apply for more than one area of interest; however, a separate application is required for each
area. Except for the specific areas of interest listed above and described below for fiscal year
2025, and the desired expertise noted for each area of interest described below, all other
requirements and application review information described in the LEAP in Health IT Notice of
Funding Opportunity (NOFO) (NAP-AX-22-001 at https://grants.gov/search-results-
detail/341131) shall apply, with the exception of the applicant capabilities. Specific merit review
criteria for the applicant capabilities, as part of this SEN, are provided below:
• For area of interest 1: Demonstrate readiness of HL7® FHIR®-based Subscriptions
capability as a foundational health IT capability for improved interactivity with third-
party applications.
Applicant and their proposed project team should demonstrate familiarity with
o
and understanding of the following:
 Experience with developing applications using HL7® FHIR® Release
4.0.1.
2

---

 Familiarity with HL7® FHIR® Subscriptions capability.
 Experience with engaging health IT standards community
 Experience with developing patient-facing apps using HL7® FHIR®
• For area of interest 2: Identify and test innovative technical approaches that would inform
future changes to the TEFCA infrastructure to increase adoption of IAS.
Applicant and their proposed project team should demonstrate familiarity with
o
and understanding of the following:
 TEFCA, including its technical and the policy components.
 Understanding of IAS in TEFCA.
 Understanding of health IT networks
 Developing patient-facing apps using HL7® FHIR®
Area 1: Demonstrate readiness of HL7® FHIR®-based Subscriptions capability as a
foundational health IT capability for improved interactivity with third-party applications.
Goal
The goals of this area of interest are first, to demonstrate that HL7® FHIR®-based
Subscriptions3 is a foundational capability that supports a broad array of essential health
information interoperability needs via HL7® FHIR®-based application programming interfaces
(APIs)4. Projects should, through their implementation, demonstrate whether the implementation
specifications developed by the standards community5,6 for HL7® FHIR®-based Subscriptions
capabilities are ready to be widely implemented by health IT developers, and to be made
available to third-party client applications.
Background
HL7® FHIR® is a widely used, open standard for exchanging health information that is based
on modern internet technology approaches. Due to substantial efforts made over the last decade,
the HL7® FHIR® standard has matured since it was first created in 20127 and is now broadly
adopted by the health IT industry.8 HL7® FHIR® was incorporated into the ONC Health IT
Certification Program9 to support essential provisions of the 21st Century Cures Act10 in 2016.
3 https://hl7.org/fhir/r4/subscription.html
4 https://hl7.org/fhir/R4/
5 Argonaut FHIR Accelerator https://github.com/argonautproject/us-core-patient-data-
feed/blob/main/spec.md#patient-data-feed-subscriptions.
6 FHIR Subscriptions R5 Backport https://build.fhir.org/ig/HL7/fhir-subscription-backport-ig/.
7 http://hl7.org/fhir/directory.html
8 https://www.healthit.gov/buzz-blog/health-it/achieving-a-major-milestone-health-it-developers-certify-to-cures-
update
9 https://www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/2020-07419.pdf
10 https://www.congress.gov/bill/114th-congress/house-bill/34
3

---

As a result, HL7® FHIR®-based APIs have become more prevalent and now offer a new
baseline for accessing and exchanging electronic health information (EHI) nationwide. This
includes the establishment of HL7® FHIR® Release 4.0.1 11 as the current, mature foundational
version that health IT developers are relying on in the United States. HL7® FHIR® Release
4.0.1 was released in 2018 and has evolved into a mature standard for the health IT industry.
While a newer version of the base standard, HL7® FHIR® Release 5 (R5), has been balloted,
HHS has to date adopted implementation specifications through rulemaking (ASTP’s Health
Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency,
and Information Sharing (HTI-1)12 Final Rule and CMS’ Medicare and Medicaid Programs;
Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior
Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans,
State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP
Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated
Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible
Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program
(Interoperability and Prior Authorization Final Rule13) that are based on HL7® FHIR® Release
4.0.1.
The health IT standards community has extended the HL7® FHIR® Release 4.0.1 specifications
to address more advanced health IT use cases using an open standards approach and more
advanced capabilities within FHIR®. One such capability is HL7® FHIR® Subscriptions,14
which is a HL7® FHIR® standards framework that is used to establish proactive event
notifications from a HL7® FHIR® server to another system. One example of use of such a
capability would be to enable consumer applications to be notified when specific changes occur
in a HL7® FHIR® server’s data, which can be particularly useful in scenarios requiring timely
updates (e.g., laboratory results) to be pushed from electronic health records (EHR) technologies
to patients’ applications on their phones instead of requiring patients to keep querying for the
information from their patient portals. The HL7® FHIR® Subscriptions framework has been
designed to support many other use cases in population health and research initiatives where
there is a need for greater interactivity between HL7® FHIR servers and client applications.
While the FHIR-based Subscriptions capability has shown great promise in meeting healthcare
organizations’ technology needs, Subscriptions are presently not widely made available in EHRs
nor used broadly by client applications.15
A focused effort is needed to demonstrate that HL7® FHIR®-based Subscriptions can be a
foundational capability for the modern digital health system in the US. This would include
ensuring specifically that the application of the HL7 FHIR Subscriptions framework to US Core
Resources (e.g., patient, observation, medication request) can be widely adopted by EHR
11 https://hl7.org/fhir/R4/
12 https://www.federalregister.gov/documents/2023/04/18/2023-07229/health-data-technology-and-
interoperability-certification-program-updates-algorithm-transparency-and
13 https://www.federalregister.gov/documents/2024/02/08/2024-00895/medicare-and-medicaid-programs-
patient-protection-and-affordable-care-act-advancing-interoperability
14 https://build.fhir.org/ig/HL7/fhir-subscription-backport-ig/
15 https://ehrintelligence.com/news/api-adoption-slow-widespread-fhir-uptake-expected-by-2024; Maisel, N.
(2022, September 16). Uptake of FHIR: Where are We Today and What are the Challenges that Lie Ahead?
4

---

developers for meeting multiple customer needs and readiness of third-party client applications
to take advantage of this capability to provide superior end user experience.
Key Objectives
There are three key objectives in this area of interest, as follows:
1. Advance and mature existing HL7® FHIR®-based Subscriptions capability for readiness
to be widely adopted by health IT developers.
2. Demonstrate how use of Subscriptions capability can lead to beneficial interactive data
exchange between EHRs and third-party client applications.
3. Demonstrate how a HL7® FHIR®-based Subscriptions specification can be a
foundational health IT capability to support a modern API-based digital health care
system in the United States.
Applicants should achieve these three goals by developing a solution that is inclusive of the
following considerations:
• Standards-Based Solution: Design a technical solution or technical solutions that utilize
Subscriptions specification that is based on HL7® FHIR® Release 4.0.1 and supported
by recognized standards development organizations (SDOs). Alternatively, utilize the
HL7® FHIR® Subscriptions R5 Backport implementation guide16 that supports HL7®
FHIR® Release 4.0.1 and/or Argonaut US Core Patient Data Feed: Subscriptions for the
technical solution.17
• Interoperable with Third-Party Applications: The technical solution or technical
solutions should be readily interoperable with any third-party client applications
developed by organizations unaffiliated with the organization that provides the server that
meets HL7® FHIR® specifications used to initiate Subscriptions notifications.
Foundational Capability: The technical solution or technical solutions should be use-
case agnostic, to demonstrate the versatility of the FHIR based Subscriptions capability.
This could include providing the HL7® FHIR® Subscriptions capability on multiple data
elements from United States Core Data for Interoperability that address diverse types of
use cases, using the same technical solution and specification.
For an award in this area of interest, applicants are encouraged to include a coalition of key
interested parties who will be directly involved in the project such as EHR vendors, developers
of consumer health applications and members of the health IT standards community. Applicants
should include letters of commitment from interested parties, including, but not limited to, those
mentioned above.
16 https://build.fhir.org/ig/HL7/fhir-subscription-backport-ig/
17 https://github.com/argonautproject/us-core-patient-data-feed/blob/main/spec.md#patient-data-feed-
subscriptions
5

---

Applicants have flexibility to propose activities that achieve the goals and objectives of Area 1,
which could include (not required), for example:
• By implementing a technical solution, identifying, and resolving any shortcomings of
existing specification developed by the standards community (including but not limited to
HL7® FHIR® Release 4.0.1, HL7® FHIR® Subscriptions R5 Backport implementation
guide18, and Argonaut US Core Patient Data Feed: Subscriptions).
• Demonstrating how the developed technical solution or solutions can be used by
appropriate communities to encourage adoption of the capability by health IT developers.
• Enhancing underlying specification used in the project (including but not limited to
HL7® FHIR® Release 4.0.1, HL7® FHIR® Subscriptions R5 Backport implementation
guide19, and Argonaut US Core Patient Data Feed: Subscriptions) to improve use by
implementers including client applications and facilitate broader adoption of the
capability.
The proposal developed by the applicants are required to demonstrate readiness of HL7®
FHIR®-based Subscriptions capability but will not be required to be open source as long as the
Subscriptions capability is using open standards developed by standards development
organizations, such as HL7®, for interoperable health information exchange between clients and
servers.
Applicants for an award in this area of interest shall include, at minimum, the following elements
in their technical solution:
• The technical solution must be based on the HL7 ®FHIR® Release 4.0.1 standard.
• The technical solution must demonstrate and pilot HL7® FHIR® based Subscriptions
specification using a server and an unaffiliated third-party application acting as the
Subscriptions client.
• The technical solution must include at least one use case that demonstrates beneficial
interactive exchange with third-party client applications over query-based exchange.
Additionally, the application shall also include, at a minimum:
• Plans for encouraging acceptance of any update and modifications (e.g., identification
and fixing of errors, updating the specifications with any changes) to existing technical
specifications (including but not limited to HL7® FHIR® Release 4.0.1, HL7® FHIR®
Subscriptions R5 Backport implementation guide20, and Argonaut US Core Patient Data
Feed: Subscriptions) by the standards community.
• Plans for facilitating/fostering widespread adoption of the Subscriptions capability in the
health IT industry.
18 https://build.fhir.org/ig/HL7/fhir-subscription-backport-ig/
19 https://build.fhir.org/ig/HL7/fhir-subscription-backport-ig/
20 https://build.fhir.org/ig/HL7/fhir-subscription-backport-ig/
6

---

Area 2: Identify and test innovative technical approaches that would inform future changes to
the TEFCA infrastructure to increase adoption of IAS.
Goal
The goal of this area of interest is to explore and test innovative technical approaches that could
be applied to the technical infrastructure used for IAS exchange in TEFCA. These approaches
would ideally lead to increased participation of IAS Providers,21 improved responses for IAS
requests from responding nodes, and markedly increase the number of individuals using TEFCA
to access their EHI. We expect that TEFCA partners, including Qualified Health Information
Networks (QHINs),22 Participants,23 and Subparticipants24 may also be informed by the technical
approaches identified through this area of interest.
Background
TEFCA25 is a pivotal initiative aimed at improving the exchange of health information across
different networks using health IT, ensuring that health data can flow securely and efficiently
across the country.
The 21st Century Cures Act26 required the National Coordinator to “develop or support a trusted
exchange framework, including a common agreement [TEFCA] among health information
networks nationally.” One of the key goals of TEFCA is to enable individuals to gather their
electronic health care information, or EHI. TEFCA is currently operational and actively
facilitating exchange of EHI.27
21 IAS Providers include QHINs, Participants, and Subparticipants that offer Individual Access Services (IAS).
https://rce.sequoiaproject.org/wp-content/uploads/2024/01/Draft-TEFCA-Glossary-508-Compliant.pdf
22 QHINs, to the extent permitted by applicable Standard Operating Procedure(s) (SOPs), are a Health Information
Network that is a U.S. Entity that has been Designated by the Recognized Coordinating Entity ® (RCE) and is a party
to the Common Agreement countersigned by the RCE. https://rce.sequoiaproject.org/wp-
content/uploads/2024/01/Draft-TEFCA-Glossary-508-Compliant.pdf.
23 Participants, to the extent permitted by applicable SOP(s), are a U.S. Entity that has entered into the Terms of
Participation (ToP) in a legally binding contract with a QHIN to use the QHIN’s Designated Network Services to
participate in TEFCA Exchange in compliance with the ToP. https://rce.sequoiaproject.org/wp-
content/uploads/2024/01/Draft-TEFCA-Glossary-508-Compliant.pdf.
24 Subparticipants, to the extent permitted by applicable SOP(s), are a U.S. Entity that has entered into a ToP in a
legally binding contract with a Participant or Subparticipant to use the Participant's or Subparticipant's
Connectivity Services to participate in TEFCA Exchange in compliance with the ToP.
https://rce.sequoiaproject.org/wp-content/uploads/2024/01/Draft-TEFCA-Glossary-508-Compliant.pdf.
25 https://www.healthit.gov/topic/interoperability/policy/trusted-exchange-framework-and-common-agreement-
tefca
26 https://www.congress.gov/bill/114th-congress/house-bill/34
27 https://www.healthit.gov/buzz-blog/tefca/what-makes-tefca-different-new-standard-operating-procedure-
strengthens-trust
7

---

IAS28 is one of the six currently authorized TEFCA Exchange Purposes29 that is designed to
empower patients to easily access to their EHI. It enables individuals to connect to a single IAS
Provider in TEFCA and use the IAS Provider service to retrieve their EHI from all participating
organizations that are connected to TEFCA.
For patients, IAS can empower them to easily retrieve their EHI from a single application
provided by a QHIN, Participant, or Subparticipant connected to TEFCA, without having to
individually connect to all the health care provider portals that may contain their EHI. Even if
patients do not remember where all of their EHI is located, they can retrieve their EHI through
IAS as long as the organization holding the information is a TEFCA QHIN, Participant, or
Subparticipant.
Adoption of IAS in TEFCA has been slow and limited to date. While the TEFCA Recognized
Coordinating Entity (RCE) 30 has not published information on the number of IAS Providers or
number of individuals using the IAS Exchange Purpose, anecdotal evidence suggests that IAS
adoption has not scaled significantly since TEFCA went live in December 2023.31 There are a
limited number of IAS Providers and individuals that used TEFCA to access and gather their
health information.
The broader health IT community has also raised several potential technical challenges that
could hinder the broader availability and adoption of IAS. Those challenges include, but are not
limited to, patient matching issues which can limit providers from matching patient records
across different systems and organizations, and burdens on individuals using the IAS Provider
service. These challenges must be addressed to fully realize the potential of TEFCA for enabling
patient access.
Key Objectives
As described in the Background Section, TEFCA is currently operational and actively facilitating
exchange of EHI among QHINs, Participants, and Subparticipants using established technical
infrastructure and Standard Operating Procedures that define the contours of IAS exchange. Any
changes to the technical infrastructure in TEFCA would need to be well-tested in a sandbox
environment, demonstrated to meaningfully add value over existing approaches, and be likely to
be embraced by partners currently participating in TEFCA.
Based on these considerations, there are three key objectives in this area of interest, as follows:
28 https://rce.sequoiaproject.org/wp-content/uploads/2024/08/XP-Implementation-SOP-IAS.pdf
29 TEFCA Exchange Purpose refers to the reason (e.g., treatment, payment, IAS, government benefits
determination, healthcare operations, public health), that organizations connected to TEFCA are allowed to
request or respond, as authorized by a Framework Agreement.
https://www.healthit.gov/topic/interoperability/policy/trusted-exchange-framework-and-common-agreement-
tefca
30 https://rce.sequoiaproject.org/
31 https://rce.sequoiaproject.org/rce/faqs/#IsTEFCAExchangeHappeningToday
8

---

• Identify technical barriers that impede entities that could be IAS Providers from
participating in TEFCA and offering services to individuals.
• Develop and test non-proprietary innovative technical solutions to the identified technical
barriers.
• Demonstrate the technical solutions to the identified barriers that can be made to the
technical infrastructure used for IAS exchange in TEFCA.
Applicants have flexibility to propose activities that achieve the goals and objectives of Area 2,
which could include (not required), for example:
• Improvements to the technical requirements for IAS Providers and any related standard
operating procedures that would increase utilization of patient facing applications under
TEFCA.
• Implementing new ways to perform identity proofing, verification, resolution, and overall
identity management of individuals in the context of TEFCA exchange that could
simplify the process for individuals to use IAS Provider services.
• Identifying a method of replacing demographics-based patient matches with non-
proprietary deterministic approaches that could be broadly adopted within TEFCA.32
Applicants for an award in this area of interest shall include the following in their application:
• Describe in detail one or more technical barriers currently impeding entities that could be
IAS Providers from participating in TEFCA; or that impede QHINs, Participants, or
Subparticipants from becoming IAS Providers and offering IAS services to individuals;
or both.
• Describe in detail a technical solution to the technical barrier(s), including:
Provide sufficient details on the technical solution to demonstrate it is based on
o
non-proprietary technologies.
Provide a detailed plan on how the applicant intends to test the solution.
o
Provide a detailed plan describing how the solution will be demonstrated in a
o
manner that would be informative to future changes to technical infrastructure
used for IAS exchange in TEFCA.
• Identify an approach to improve IAS exchange while adhering to data security and
privacy standards, including ensuring consistency for covered entities’ compliance with
the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule where
applicable, its implementing regulations, and other relevant regulations.
32 The awardee may ultimately propose additional changes to the existing SOPs if project work uncovers an unmet
need, inconsistency, or need for clarification.
9

---

• Provide details of any changes that the applicant believes might be needed to TEFCA
SOPs related to IAS exchange to implement the technical solution.
Further Guidance
Unless otherwise indicated in this Notice, all requirements, instructions, and terms and
conditions of the LEAP in Health Information Technology (IT) funding opportunity (NAP-AX-
22-001 at https://grants.gov/search-results-detail/341131) will apply to applications submitted
and awards made in response to this Notice.
Application Submission and Special Application Receipt Date. Information about the
application process can be found at https://www.healthit.gov/topic/onc-funding-
opportunities/leading-edge-acceleration-projects-leap-health-information or
https://grants.gov/search-results-detail/341131.
An informational session will be held on March 6, 2025. Further details about the informational
session – including the date, time, and instructions for joining – are available at:
https://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-
leap-health-information.
Although not required, applicants are strongly encouraged to submit a non-binding e-mail letter
of intent to apply for this funding opportunity. This letter of intent will assist ASTP in planning
for the application review process. When submitting your letter of intent, please identify which
area of interest your organization plans to apply for. The letter of intent is requested by 11:59
P.M. Eastern Standard Time on March 27, 2025. Interested organizations can send the letter of
intent to ASTP-LEAP@hhs.gov. Please identify the name of the applicant organization, the city
and state in which the applicant organization is located, the intended area(s) of interest, and the
Notice of Funding Opportunity title and number.
Submit applications focused on the areas of interest identified in this Notice by NOON Eastern
Standard Time on April 25, 2025. This Notice will expire on April 25, 2025.
Inquiries
Please direct all program related inquiries to:
Alison Kemp
LEAP Program Manager
Assistant Secretary for Technology Policy (ASTP)
Email: ASTP-LEAP@hhs.gov
Please direct all grant related inquiries to:
Carmel Halloun
10

---

Grants Branch Chief
Assistant Secretary for Technology Policy (ASTP)
Email: ASTPGrants@hhs.gov
11

---

LEAP FY2023 Special Emphasis Notice

The Office of the National Coordinator for Health Information Technology (ONC)
Announces Special Emphasis Notice (SEN) Interest in Applications to Advance Fast
Healthcare Interoperability Resources (FHIR®) Capabilities and Identify Data Quality
Improvements for USCDI Data Elements
Notice Number: NAP-AX-22-001
Key Dates
Release Date: April 10, 2023
Expiration Date: June 12, 2023
Issued by
Office of the National Coordinator for Health Information Technology (ONC)
Purpose
This notice announces ONC’s interest in funding projects under the Leading Edge Acceleration
Projects (LEAP) in Health Information Technology (IT) funding opportunity (see NAP-AX-22-
001 at https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001) in
fiscal year 2023 to advance Health Level Seven (HL7®) Fast Healthcare Interoperability
Resources (FHIR®) Capabilities and Identify Data Quality Improvements for USCDI Data
Elements.
Areas of Interest
ONC is the principal federal entity charged with coordination of nationwide efforts to implement
and use the most advanced health information technology and the electronic exchange of health
information. Created in 2004 through Executive Order 133351 and legislatively authorized in the
Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009,2
ONC is at the forefront of the federal government’s health IT efforts and is a resource to the
entire health IT and health care community to support the adoption of health IT and the
promotion of nationwide health information exchange (HIE) to improve health care.
The goal of the LEAP in Health IT funding opportunity is to address well-documented and fast
emerging challenges inhibiting the development, use, or advancement of well-designed,
interoperable health IT, which are scalable across the health care industry. Solutions are expected
to further a new generation of health IT research and inform the development, implementation,
and refinement of standards, methods, and techniques for overcoming major barriers and
challenges in an innovative fashion as they are identified.
It is critical that the field of health care innovate and leverage the latest technological
advancements and breakthroughs far quicker than it currently does to optimize real-time
solutions, especially in areas which are ripe for acceleration. The descriptions provided for Area
1 and Area 2 include ways in which applicants may approach developing a project. The Areas of
1 https://www.govinfo.gov/content/pkg/WCPD-2004-05-03/pdf/WCPD-2004-05-03-Pg702.pdf
2 https://www.healthit.gov/sites/default/files/hitech_act_excerpt_from_arra_with_index.pdf
1

---

Interest have been assigned numbers for ease of reference, not for prioritization. While there are
many challenges associated with the use of health IT, these two Areas of Interest have been
identified as critical priority areas for ONC.
In fiscal year 2023, ONC is soliciting applications pursuant to the LEAP in Health IT funding
opportunity for projects that address one of the following areas of interest:
• Area 1: Exploring the Use of Advanced Fast Healthcare Interoperability Resources
(FHIR®) Capabilities
• Area 2: Identifying Data Quality Improvements for USCDI Data Elements
ONC expects to issue one cooperative agreement award per area of interest up to $1 million per
award, totaling up to $2 million for the two awards in fiscal year 2023. Please note that all
applicants must explicitly state the area of interest for which they are applying. Applications that
do not clearly state their intended area of interest will not be considered. Eligible applicants may
apply for more than one area of interest; however, a separate application is required for each
area. Except for the specific areas of interest listed above and described below for fiscal year
2023, and the required expertise noted for each area of interest described below, all other
requirements and evaluation criteria described in the LEAP in Health IT Notice of Funding
Opportunity (NOFO) (NAP-AX-22-001 at https://www.grants.gov/web/grants/search-
grants.html?keywords=nap-ax-22-001) shall apply.
Area 1: Exploring the Use of Advanced FHIR Capabilities
The goal of this area of interest is to accelerate the adoption readiness of existing, advanced
FHIR capabilities developed by the health IT community and demonstrate the value of health IT
to solving complex problems in health care. Applicants can achieve this goal by performing a
rigorous technical exploration of advanced FHIR capabilities, including identifying use case(s)
that will benefit from the use of the advanced feature(s), software development, implementation,
testing, and piloting under real-world conditions.
During 2023, ONC anticipates the continued deployment of secure, standardized application
programming interfaces (APIs).3 Due to substantial efforts made over the last decade, the FHIR
standard has matured since it was first created in 20124 and is now broadly adopted by the health
IT industry.5 The business and technical advances ushered in by the 21st Century Cures Act:
Interoperability, Information Blocking, and the ONC Health IT Certification Program6 (ONC
Cures Act Final Rule)7 have established APIs and apps as core drivers of enhanced access,
functionality, and user and patient experience in health care interoperability.
3 https://www.healthaffairs.org/do/10.1377/forefront.20220217.71427
4 http://hl7.org/fhir/directory.html
5 https://www.healthit.gov/buzz-blog/health-it/the-heat-is-on-us-caught-fhir-in-2019
6 https://www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/2020-07419.pdf
7 https://www.healthit.gov/topic/oncs-cures-act-final-
rule#:~:text=ONC's%20Cures%20Act%20Final%20Rule%20supports%20seamless%20and%20secure%20access,se
cure%20access%20to%20health%20information.
2

---

The Recognized Coordinating Entity, which administers the Common Agreement component of
the Trusted Exchange Framework and Common Agreement (TEFCA)8 on behalf of ONC, has
released a FHIR Roadmap9 that outlines how FHIR APIs can also become an established part of
network exchange, such as through business-to-business (B2B) clinical interoperability
supporting high-volume, high-reliability, high-trust exchange patterns. Adding FHIR-based
exchange to network exchange creates the ability to conduct exchange at-scale.10
The health IT community has leveraged this common, industry-wide specification to innovate
and extend FHIR to address more advanced use cases to meet the complex needs of health care,
including performing more complex interactions with FHIR servers that go beyond the secure
API-enabled “read” services for single and multiple patients established as part of the ONC
Health IT Certification Program.11 These types of FHIR-based capabilities, if further proven,
could improve interoperability as well as user experiences for patients and providers. The
following are examples of advanced FHIR capabilities of which ONC is aware:
• FHIR Subscription12
• Clinical Decision Support (CDS) Hooks13
• FHIR Standard for Scheduling14
• SMART Health Cards15
• SMART Health Links16
• FHIR Write17
• Electronic Health Information (EHI) Export API18
• FHIRCast19
• Network-facilitated FHIR Exchange20
Each of these advanced FHIR capabilities has support across the health IT community, and some
are actively being addressed by the developer community through the Argonaut Project.21
Additionally, most of these capabilities have a draft implementation specification that has gone
through peer review; multiple rounds of testing, piloting, and standardization; or both, by the
HL7 standards development organization.
8 https://rce.sequoiaproject.org/tefca-and-rce-resources/
9 https://rce.sequoiaproject.org/wp-content/uploads/2022/01/FHIR-Roadmap-v1.0_updated.pdf
10 https://confluence.hl7.org/display/FAST/FHIR+at+Scale+Taskforce+%28FAST%29+Home
11 https://www.healthit.gov/test-method/standardized-api-patient-and-population-services#ccg
12 https://build.fhir.org/subscription
13 https://cds-hooks.org/specification/current
14 https://github.com/smart-on-fhir/smart-scheduling-links
15 https://smarthealth.cards/en/
16 https://hackmd.io/kvyVFD5cQK2Bg1_vnXSh_Q
17 https://confluence.hl7.org/display/AP/Argo+Write+Homepage
18 https://confluence.hl7.org/display/AP/EHI+Export+API
19 https://fhircast.org/
20 https://rce.sequoiaproject.org/wp-content/uploads/2022/12/TEFCA-Facilitated-FHIR-Implementation-Guide-
Draft-2-Pilot-Version.pdf
21 https://confluence.hl7.org/display/AP/Argonaut+Project+Home
3

---

While many of these advanced FHIR capabilities show great promise in meeting health care
organizations’ technology needs, they have not yet been widely adopted by health IT developers
or requested by health care organizations for these capabilities.22 Several reasons may exist for
this, including a lack of sustained resources among the health IT community to fully test these
capabilities in real-world settings (e.g., test and validate that these capabilities can handle the
scale, response times, workflow integration, implementation, and other requirements from health
IT systems running in production environment) and a lack of sustained resources to mature the
specifications to provide evidence to the health IT community of their readiness for industry-
wide adoption.
As an example, the HL7 SMART Application Launch Framework Implementation Guide,23
which is widely adopted by industry and the Secretary has adopted for use in certified health
IT,24 was initially developed as an advanced FHIR capability by the SMART Health IT
program.25 It took sustained time and resources from the standards community to mature the
specification and health IT industry-led testing by the Argonaut Project,26 which eventually
resulted in the publication of Version 1.0.0 in 2018 by the HL7 Standards Development
Organization. The Secretary finalized the adoption of SMART Application Launch Framework
Implementation Guide Version 1.0.0, at 45 C.F.R. § 170.215(a)(3), in the ONC Cures Act Final
Rule (85 FR 25741).27
There are several other examples that have undergone a similar process, including the maturation
and adoption of the FHIR Bulk Data Access (Flat FHIR) implementation specification.28
Applicants can seek the expertise of the health IT community and health care organizations to
work together to implement and pilot advanced FHIR capabilities. Implementation pilots of the
advanced FHIR capabilities can provide insights into technical limitations of the health IT
infrastructure and the capability of the electronic health record (EHR) system to scale FHIR
across multiple health care settings. The observations derived from these pilots help industry
make necessary changes to ensure advanced FHIR capabilities are ready for industry-wide
adoption. Industry-wide adoption of advanced FHIR capabilities can improve the exchange of
health information, patient access to health data, and health data management.
22 https://ehrintelligence.com/news/api-adoption-slow-widespread-fhir-uptake-expected-by-2024; Maisel, N. (2022,
September 16). Uptake of FHIR: Where are We Today and What are the Challenges that Lie Ahead? [PowerPoint
presentation]. 2022 ONC Virtual Tech Forum, https://www.healthit.gov/news/events/2022-onc-virtual-tech-forum
23 https://www.hl7.org/fhir/smart-app-launch/
24 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B/section-170.215
25 https://smarthealthit.org/
26 https://confluence.hl7.org/display/AP/Implementation+Guides
27 https://www.federalregister.gov/d/2020-07419/p-1184
28 http://hl7.org/fhir/uv/bulkdata/STU1/
4

---

Applicants are encouraged to consider the following as activities that could achieve the overall
goal of Area 1:
• Performing technical exploration, as described hereafter, of one or more existing
advanced FHIR capabilities in at least two use cases.
• The technical exploration of the FHIR capability could include:
Testing the advanced FHIR capability across multiple dimensions, such as
o
scalability, response times, infrastructure needs, and other relevant technical
functions to determine if the advanced FHIR capabilities can meet the needs of
industry.
Piloting the FHIR capability or capabilities in a setting that provides maximum
o
insights into an organization’s ability to adopt advanced FHIR capabilities within
the organization.
Additional testing or other activities necessary for production implementation of
o
the FHIR capability or capabilities, if planned by the applicant as part of their
proposal.
Actively participating in all relevant FHIR standards activities, including
o
supporting the advancement of specifications within the HL7 standards
development organization29 and associated FHIR Accelerator Projects,30 keeping
the FHIR community aware of the findings, and implementing the solutions, for
the use cases proposed, in an open-source environment that enables other
developers to implement the software in their own environment.
• Documenting the software requirements and associated artifacts of the advanced FHIR
capability or capabilities so that the software source code can be readily used by software
developers as an open-source tool and a learning example for independently
implementing software in their own development environments.
• Demonstrating the applicability of the advanced FHIR capability or capabilities to meet
the goals of the use cases and enhance access, functionality, and user experience in health
care interoperability.
• Developing, publishing, and disseminating a report on each advanced FHIR capability
and its readiness for industry-wide adoption. This type of report would help health IT
implementers to advance FHIR capabilities to improve the exchange of health
information and health data management to improve patient care. For example, the report
could include the following types of information:
Standard technical security configurations and considerations with the adoption of
o
FHIR that can be used as a secure implementation guide.
Findings on limitations or challenges in the FHIR capability, recommendations,
o
and next steps to mitigate these limitations and challenges.
29 https://www.hl7.org/index.cfm
30 https://confluence.hl7.org/
5

---

Applicants for an award in this area of interest are encouraged to include, as part of their
applications, a coalition of key stakeholders who will be directly involved in the project, such as
health IT developers, Certified Health IT vendors, health care providers, payers (i.e., Medicare,
commercial healthcare insurers), public health agencies, and health information networks.
Applicants should include letters of commitment from key stakeholders.
An applicant’s proposal must not rely on proprietary technology.
Applicants for an award in this area of interest shall demonstrate expertise in the following:
• API Standards31 adopted for the ONC Health IT Certification Program.
• The advanced FHIR capability or capabilities they propose in their use cases.
Applicants for an award in this area of interest shall include the following in their application:
• Propose at least one advanced FHIR capability, including but not limited to those
explicitly listed in this SEN, so long as they provide evidence that the selected advanced
capability or capabilities were previously developed by the FHIR community and are
openly available for implementation. This is to ensure that the applicant focuses on
existing advanced FHIR capabilities in need of maturity rather than developing a brand-
new capability as part of this LEAP award.
Applicants can propose a single advanced FHIR capability to meet two separate
o
use cases if each use case is independently tested as specified further below.
• Identify at least two use cases and provide detailed explanation on how the applicant
plans to test the advanced FHIR capability or capabilities to solve the problem associated
with the use case effectively, as compared to existing solutions.
• Provide a detailed project plan for meeting the goal of this area of interest, including
performing technical exploration, as described in this SEN.
Area 2: Identifying Data Quality Improvements for USCDI Data Elements
The goal of this area of interest is to identify, understand, and assess the quality of USCDI data
elements that are collected, exchanged, and used by various health IT systems (e.g., EHRs,
health information networks, laboratory information systems, etc.) and implement non-
proprietary solutions to improve data quality. Applicants can achieve this goal by performing a
360-degree evaluation, in real world clinical settings, of data quality of the selected data
elements collected (e.g., identify and assess any missing), the degree of conformance to data
standards (e.g., use of mature standards and vocabulary codes) and the ability (or lack thereof) to
successfully match patient records, perform aggregation of the data, and compare data obtained
from disparate sources.
31 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B/section-170.215
6

---

Ready, reliable, and consistent access, exchange, and use of EHI32 can improve health care
quality, safety, and patient outcomes. High quality, interoperable data will help power future
generations of tools for clinical decision making, population health management, disease
surveillance, and research. Data quality is defined as data that is fit for use within a specific
context and is typically addressed in the following dimensions: (1) measurable components of
data quality to include accuracy, completeness, concordance, consistency, currency, and
redundancy, and (2) conformance to mature health IT content, terminology, and exchange
standards.
For this area of interest, “data quality” focuses on when, where in workflows/practices, and how
data needs to be standardized so that it can be effectively and efficiently used for, as well as
beyond, the initial purpose for which it was collected or exchanged (e.g., medication
reconciliation, quality measurement, health equity analyses). What makes data “high” quality to
its users and recipients involves several sociotechnical factors. Such factors include the clinical
and business processes motivating collection of data workflows involved in recording the data,
what standards may be attributed to the data, mechanisms influencing enforcement of standards,
and data comprehensiveness, completeness, and accuracy.
Data quality assessment is key for enabling appropriate use and analysis as well as understanding
and quantifying research limitations.33 Assessing data quality is subjective, where the quality of
the data being evaluated must be judged in relation to the activities for which they are used. In
this way, data quality assessment outputs may only be comparable within a specific use case,
such as immunization or laboratory reporting. Further, data quality improvement and
standardization can improve patient matching, thus ensuring that patients and clinicians have
better data on which to make decisions to enhance patient safety and care quality.34 Thus, data
quality evaluation involves identifying root causes as to why certain use cases have “low” quality
data, whether standards are available, whether such standards are used and applied consistently,
and ultimately proposing solutions to make improvements.
Often, when it comes to interoperability and data quality, format (structure) and meaning (code
systems and value sets) are two relevant standards facets. For instance, when coding for race,
using the same code system is necessary for race data to be aggregated and consistently
compared across different data sources. Race and ethnicity data in patient demographics are
important to support everything from precision medicine initiatives to identifying health care
disparities on a population health level. However, the quality and completeness of this
32 https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-
information-blocking-and-the-onc-health-it-certification#p-216
33 Rajan, N. S., Gouripeddi, R., Mo, P., Madsen, R. K., & Facelli, J. C. (2019). Towards a content agnostic
computable knowledge repository for data quality assessment. Computer methods and programs in biomedicine,
177, 193–201. https://doi.org/10.1016/j.cmpb.2019.05.017
34 Shaun J Grannis, Huiping Xu, Joshua R Vest, Suranga Kasthurirathne, Na Bo, Ben Moscovitch, Rita Torkzadeh,
Josh Rising, Evaluating the effect of data standardization and validation on patient matching accuracy, Journal of the
American Medical Informatics Association, Volume 26, Issue 5, May 2019, Pages 447–456,
https://doi.org/10.1093/jamia/ocy191
7

---

information is a challenge,35 and this data may be collected in non-standardized ways or different
stakeholders may adhere to different standards.36
Another example of the importance of data quality is understanding the uptake and use of
Logical Observation Identifiers Names and Codes (LOINC) among laboratories in the United
States. Gaining a better understanding of the update and use of LOINC would broaden awareness
of the types of tests for which they are being used.37 Much attention has been given to lab
interoperability due to the COVID-19 pandemic, thus highlighting the need to prioritize and
ensure consistent and accurate intake and exchange of laboratory data. For example, the
Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD)
collaborative, a current federal and industry initiative, aims to improve the quality of laboratory
data within and between institutions.37 Based on preliminary findings from the 2022 Lab
Interoperability Survey developed by SHIELD, only 1 in 5 hospital laboratories are using
LOINC for issuing orders; and only 2 in 5 are using LOINC for reporting results.38 Thus a more
granular and systematic approach is needed to assess not only the extent of coding, but also how
the standards are being used.
While there is a need to assess and improve the quality of EHI data broadly, given the variability
of EHI across health care,39 it is more practical and feasible for this LEAP award to focus on the
data elements specified in United States Core Data for Interoperability versions 1 through 3
(USCDI v1 through USCDI v3).40 As part of the ONC Cures Act Final Rule,41 ONC established
USCDI v1 as a standardized set of health data classes and constituent data elements that could be
used for nationwide health information exchange. Such data elements include patient
demographics related to race, ethnicity, and preferred language, as well as laboratory test results,
medication data, and problems. USCDI v1 includes key data elements which are critical to be
accessed, exchanged, and used accurately amongst all health care participants to support
patients’ health care.
Applicants can seek the expertise of the health IT community and health care organizations to
work together to determine patterns and root causes (where possible) of data quality issues, with
an aim towards improving the interoperability (exchange) of USCDI data elements. Identifying
data quality issues and creating solutions to address these issues can improve interoperability of
USCDI data elements and lead to improved clinical decision making, population health
management, disease surveillance, and research.
35 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6696496/
36 Andrews, R. M. (2011). Race and Ethnicity Reporting in Statewide Hospital Data. Journal of Public Health
Management and Practice, 17 (2), 167-173. doi: 10.1097/PHH.0b013e3181f5426c.
37 https://aspe.hhs.gov/shield-standardization-lab-data-enhance-patient-centered-outcomes-research-value-based-
care
38 Patel, V. & Richwine, C. (2022, October 26). Lab Interoperability and Use of LOINC among U.S. Based
Laboratories [PowerPoint presentation]. LOINC Annual Meeting, https://loinc.org/conference/france-2022/
39 https://www.healthit.gov/buzz-blog/information-blocking/say-hi-to-ehi
40 https://www.healthit.gov/isa/sites/isa/files/2020-10/USCDI-Version-1-July-2020-Errata-Final_0.pdf;
https://www.healthit.gov/isa/sites/isa/files/2021-07/USCDI-Version-2-July-2021-Final.pdf;
https://www.healthit.gov/isa/sites/isa/files/2022-10/USCDI-Version-3-October-2022-Errata-Final.pdf
41 https://www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/2020-07419.pdf
8

---

Applicants are encouraged to consider the following activities as activities that could achieve the
overall goal of Area 2:
• Identifying at least two data elements in USCDI (v1 through v3) and assess the data
quality of these data elements collected in real world clinical settings. Such data elements
include race, ethnicity, and preferred language,42 as well as tests, medications, and
problems.43,44,45 While ONC has identified these data elements related to health equity
and laboratory interoperability as being of interest to meet critical program needs, as
described above, applicant could propose any data elements present in USCDI, subject to
the requirement immediately below.
Any identified data elements proposed must have applicable vocabulary
o
standard(s) specified in USCDI as well as content exchange standard and
implementation specifications as adopted in the ONC Cures Act Final Rule (85
FR 25676).
• Developing one or more measures to assess data quality of the identified data elements
across selected health IT system actors or within a health care system. The assessments of
data quality and detailed “root cause” analysis of data quality issues should be based on
large production data sets aggregated from disparate practice settings and health IT
systems to clearly surface variations that exist in real world settings.
• Based on the assessment of the current state of data quality, piloting at least one non-
proprietary solution to assess and improve the quality of data that can be scaled across
other health care settings and health IT systems. The solution could include a focus on
policies and workflows.
• Developing and publicly sharing a comprehensive dissemination plan so that project
findings may be used by other interested parties. The dissemination plan could include a
plan for sharing scalable actions, strategies, and the solution piloted by the applicant,
along with recommendations and lessons learned resulting from the assessment related to
data quality, standards conformance, and patient matching.
• Developing, publishing, and disseminating a report on each identified data element, with
information on root causes of data quality issues (where possible) and readiness for
industry-wide adoption of the solution. The report could include the following: any
limitations and challenges in the capability and considerations by potential adopting
organization, recommendations and next steps around these limitations and challenges.
This report would help inform industry and health IT implementers by providing
potential solutions to address data quality issues to improve data exchange of USCDI
data elements.
Applicants for an award in this area of interest are encouraged to include a coalition of key
stakeholders, who will be directly involved in the project, such as health IT developers, EHR
vendors, health care providers, payers (i.e., Medicare, commercial healthcare insurers), public
42 https://www.healthit.gov/isa/uscdi-data-class/patient-demographicsinformation#uscdi-v3
43 https://www.healthit.gov/isa/uscdi-data-class/laboratory#uscdi-v3
44 https://www.healthit.gov/isa/uscdi-data-class/medications#uscdi-v3
45 https://www.healthit.gov/isa/uscdi-data-class/problems#uscdi-v3
9

---

health agencies, and health information networks (HINs). Applicants should include letters of
commitment from key stakeholders.
An applicant’s proposal shall not rely on proprietary technology.
Applicants for an award in this area of interest shall demonstrate, in their application, familiarity
with and understanding of the following:
• USCDI, applicable vocabulary standards and the appropriate content and exchange
standards and implementation specifications used in the access, exchange, and use of
these data elements.
• Ability to perform data quality assessment and standards conformance on real-world
demographic and clinical data in real word settings (e.g., hospitals, integrated delivery
networks, academic medical centers, HINs, etc.)
• Ability to develop scalable measures that can provide clear and transparent assessment of
the quality of identified data elements.
Applicants for an award in this area of interest shall include the following in their application:
• Provide detailed explanation on their ability to conduct a pilot(s) of any identified
solution(s).
• Provide a detailed project plan for meeting the goal of this area of interest.
Further Guidance
Unless otherwise indicated in this Notice, all requirements, instructions, and terms and
conditions of the Leading Edge Acceleration Projects (LEAP) in Health Information Technology
(IT) funding opportunity (NAP-AX-22-001 at https://www.grants.gov/web/grants/search-
grants.html?keywords=nap-ax-22-001) will apply to applications submitted and awards made in
response to this Notice.
Application Submission and Special Application Receipt Date. Information about the
application process can be found at https://www.healthit.gov/topic/onc-funding-
opportunities/leading-edge-acceleration-projects-leap-health-information or
https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001.
An informational session will be held on April 25, 2023. Further details about the informational
session – including the date, time, and instructions for joining – are available at:
https://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-
leap-health-information.
Although not required, applicants are strongly encouraged to submit a non-binding e-mail letter
of intent to apply for this funding opportunity. This letter of intent will assist ONC in planning
for the application review process. When submitting your letter of intent, please identify which
area of interest your organization plans to apply for. The letter of intent is requested by 11:59
P.M. Eastern Standard Time on April 28, 2023. Interested organizations can send the letter of
intent to ONC-LEAP@hhs.gov. Please identify the name of the applicant organization, the city
and state in which the applicant organization is located, the intended area(s) of interest, and the
Notice of Funding Opportunity title and number.
10

---

Submit applications focused on the areas of interest identified in this Notice by NOON Eastern
Standard Time on June 12, 2023. This Notice will expire on June 12, 2023.
Inquiries
Please direct all program related inquiries to:
Lolita Kachay
LEAP Program Manager
Office of the National Coordinator for Health Information Technology (ONC)
Email: ONC-LEAP@hhs.gov
Please direct all grant related inquiries to:
Carmel Halloun
Grants Branch Chief
Office of the National Coordinator for Health Information Technology (ONC)
Email: oncgrants@hhs.gov
11

---

Notice of Funding Opportunity

U.S. Department of Health and Human Services
Office of the National Coordinator for Health Information
Technology
Notice of Funding Opportunity
Leading Edge Acceleration Projects (LEAP) in Health
Information Technology
Assistance Listings (CFDA) Number
93.345
Application Due Date: August 15, 2022
Anticipated Award Date: September 26, 2022
Program Contact Grants Contact
Wei Chang Carmel Halloun
Anastasia Perchem Office of the National Coordinator
Office of the National Coordinator 330 C Street SW
330 C Street SW Washington, D.C., 20201
Washington, D.C., 20201 ONCGrants@hhs.gov
ONC-LEAP@hhs.gov
Page 1 of 59

---

Table of Contents
Executive Summary
A. Program Description/Purpose
Background Description
Purpose
Structure and Approach
Areas of Interest
Project Activities
Performance Goals and Objectives
B. Funding Opportunity Award Information
Key Award Parameters
Cooperative Agreement and Substantial ONC Involvement
Intergovernmental Review
Key Dates
Informational Session
Letter of Intent
C. Eligibility Information
D. Application and Submission Information
Application Package
Application Submission Instructions
Restrictions on Oral Conversations
Funding Restrictions
E. Application Review Information
Screening Review
Merit Review
Pre-Award Risk Assessment
Award Decisions
F. Federal Award Administration Information
Federal Award Notices
Terms and Conditions
G. Appendix
Appendix A – Tips for Writing a Strong Application
Appendix B – Instructions – SF-424 Application for Federal Assistance
Appendix C – Instructions – SF-424A, Budget Information for Non-Construction
Programs
Page 2 of 59

---

Appendix D – Budget Narrative/Justification Template
Appendix E – Letter of Commitment Template
Page 3 of 59

---

Executive Summary
This Notice of Funding Opportunity (NOFO) seeks Leading Edge Acceleration Projects (LEAP) in
Health Information Technology (Health IT) to address well-documented and fast emerging challenges
that inhibit the development, use, and/or advancement of well-designed, interoperable health IT. Project
solutions are expected to further a new generation of innovative health IT research and inform the
development, implementation, and refinement of standards, methods, and techniques for overcoming
major barriers in health information access, exchange, and use.
This NOFO outlines two Areas of Interest that are a priority for the Office of the National Coordinator
for Health Information Technology (ONC):
• Area 1: Address health equity and social determinants of health through innovative, open-source
technology tools, and electronic health records; and
• Area 2: Demonstrate the use of equity-enhancing patient-generated health data for clinical care
and research.
ONC expects to issue one cooperative agreement award per area of interest (the “Area of Interest”), up
to $1 million per award, totaling up to $2 million for the two awards in fiscal year 2022. These awards
will have a two-year project and budget period at initial award. However, applicants are encouraged to
submit their applications based on a five-year budget period. Additional funding for years three to five
may be provided, contingent upon availability of funds, meaningful progress, and ONC priorities.
This funding opportunity will have a five-year open application period. ONC may issue future awards
under this NOFO to other eligible applicants for future areas of interest.
Page 4 of 59

---

A. Program Description/Purpose
Background Description
Created in 2004 through Executive Order 133351 and statutorily authorized by the Health Information
Technology for Economic and Clinical Health Act (HITECH Act) of 2009, ONC is the principal federal
entity charged with coordination of nationwide efforts to implement the most advanced health IT and the
electronic exchange of health information. At the forefront of the administration’s health IT efforts,
ONC is a resource to the entire health system to support the adoption of health IT and the promotion of
nationwide, standards-based health information exchange to improve healthcare.
In 2010, through the HITECH Act, ONC created the Strategic Health Information Technology
Advanced Research Projects (SHARP) cooperative agreement program.2 The SHARP program was
created to support advanced research activities to address short- and long-term challenges to the
implementation of HITECH and its programs, with a focus on solving currently known, as well as
anticipated challenges to the adoption and the meaningful use of health IT.
Since the HITECH Act was enacted and the SHARP program was created, the healthcare ecosystem and
the technology supporting it have rapidly evolved. Many providers have implemented electronic health
record (EHR) systems,3 and sophisticated health IT tools and applications are quickly coming to market.
As the electronic exchange of health information has matured, the amount and types of health data
available has expanded. Data standards such as Health Level Seven International (HL7®)’s Fast
Healthcare Interoperability Resources (FHIR®)4 and application programming interfaces (APIs) are
making it easier for consumers to seamlessly access and share their health data with providers and allow
health systems to integrate disparate data sources.
Passage of the 21st Century Cures Act5 (Cures Act) in 2016 strengthened ONC’s mandate to improve
the interoperability of health information, facilitate information exchange, address barriers to
interoperability, and reduce provider burden when using EHRs.
Purpose
While working to implement Cures Act provisions, ONC identified gaps with respect to leveraging EHR
data to support population-level analyses and delivery of services, as well as integrating clinical
knowledge into routine clinical practice.6 The reasons for these gaps range from a lack of data standards
and interoperability to the digitization, integration, and presentation of new evidence into clinical
workflows in safe, useful, and useable ways.
1 https://www.gpo.gov/fdsys/pkg/FR-2004-04-30/pdf/04-10024.pdf
2 https://www.healthit.gov/buzz-blog/sharp/health-it-challenges-and-the-future-of-healthcare/
3 https://www.healthit.gov/sites/default/files/2016_report_to_congress_on_healthit_progress.pdf
4 http://www.hl7.org/fhir/
5 21st Century Cures Act, Pub. L. No. 114-255, 130 Stat. 1033 (December 13, 2016).
6 https://www.healthit.gov/sites/default/files/jsr-17-task-002_aiforhealthandhealthcare12122017.pdf
Page 5 of 59

---

Therefore, this funding opportunity will support innovative and breakthrough solutions critical to
maximize the potential of health IT and achieve the goal of a transformed healthcare delivery system
through various methods, such as:
• Determining the fundamental questions, the answers to which will identify barriers to nationwide
interoperability and electronic exchange of health data.
• Engaging the health IT industry, along with academic researchers, to identify and develop
innovative solutions that address barriers to interoperability.
• Disseminating findings from research while fostering collaboration, advancement, and
implementation of solutions and lessons learned with the health IT industry.
Structure and Approach
ONC expects to award two cooperative agreements for a project period of two years for each recipient to
focus on areas where breakthrough improvements are needed to address problems that have impeded the
innovative use of health IT and thereby accelerate progress in the areas identified.
Areas of Interest
The two Areas of Interest identified below describe priorities ONC is interested in continuing to
explore and advance. The descriptions include ways in which applicants may approach developing a
project. The Areas of Interest have been assigned numbers for ease of reference, not for
prioritization. While there are many challenges associated with the use of health IT, these two Areas
of Interest have been identified as critical priority areas for ONC.
Area 1: Address health equity and social determinants of health through innovative, open-source
technology tools, and electronic health records
Background
Social determinants of health (SDOH) refer to the conditions in which people live, learn, work, and play,
and affects a wide range of health risks and outcomes while health equity is everyone attaining their full
potential for health and well-being.7 An integral part of healthcare delivery involves understanding the
social and environmental factors of patients’ lives outside of the healthcare system. Addressing
inequities in these conditions may be supported by the collection, exchange, and use of SDOH data.8
This data can be used to identify and help eliminate health disparities by improving health outcomes at
an individual and population level. Advancing the use and interoperability of SDOH data is a priority for
ONC in keeping with our mission to improve the health and well-being of individuals and communities
through the use of technology and health information that is accessible when and where it matters most.
In January of 2021, the President issued an Executive Order on Advancing Racial Equity and Support
for Underserved Communities to address barriers to equity via program delivery and stakeholder
engagement. Taking a comprehensive approach to address barriers to health equity across the federal
government as well as among private and public stakeholders will be fundamental to improving health
and reducing health inequities. As part of that approach, ONC is committed to advancing the
development and use of health IT, establishing expectations for standardizing and sharing data, and
ensuring that these benefits are available to communities that have historically faced structural barriers
7 https://www.who.int/health-topics/health-equity#tab=tab_1
8 https://www.healthit.gov/sites/default/files/page/2020-10/Federal%20Health%20IT%20Strategic%20Plan_2020_2025.pdf
Page 6 of 59

---

to accessing healthcare and health IT. More specifically, ONC is focused on improving data collection
through the development and adoption of standards to mitigate some of the challenges encountered in
the collection and the equity-focused analysis of race, ethnicity, and SDOH data.9,10,11
Project Goals
Through this Area of Interest, ONC aims to advance the adoption and use of SDOH-related standards
and data in underserved communities to address disparities, and to identify the challenges and
opportunities inherent in scaling health IT solutions across communities.
In alignment with the Executive Order on Advancing Racial Equity and Support for Underserved
Communities, this Area of Interest seeks to help address barriers to health equity by implementing
innovative, scalable, and easily replicable data-system based, non-proprietary health IT solutions to
support SDOH data collection, exchange, and use among individuals who belong to underserved
communities (including Black, Latino, and Indigenous and Native American persons, Asian Americans
and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual,
transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas;
and persons otherwise adversely affected by persistent poverty or inequality).12
Using open, non-proprietary standards, the awardee shall create and implement a comprehensive
technology solution that supports 1) the collection and analysis of SDOH data in an EHR to identify
population-level use cases for addressing health disparities, 2) closed loop referrals between an EHR and
appropriate Community Based Organizations (CBOs) 13supporting human and social services, and 3)
patient-facing technology, such as, but not limited to web-based platforms and applications (apps) that
allows patients to manage their data, provide consent for various purposes, and share sensitive
information with other organizations. The comprehensive technology solution may include, without
limitation, a combination of apps, web-based platforms, and directories via APIs to allow data to be
shared between an EHR, a CBO, and a patient.
Key Objectives
1) Create specific use cases for the technology platform based on high-risk population factors like
chronic diseases (which may include, but are not limited to, heart disease, hypertension, and
cancer) and/or social risk factors (which may include, but are not limited to housing instability,
food insecurity, and transportation insecurity) in underserved communities. While creating the
use cases, the applicant must use standardized SDOH data collected within the EHR.
2) Create and implement non-proprietary technical solutions for referring patients to CBOs that
interface seamlessly with a health system or community health center’s EHR.
9 https://www.healthit.gov/sites/default/files/page/2021-07/Standards_Bulletin_2021-3.pdf
10 https://www.healthit.gov/isa/sites/isa/files/2021-07/USCDI-Version-2-July-2021-Final.pdf
11 https://www.healthit.gov/buzz-blog/interoperability/onc-health-it-framework-for-advancing-sdoh-data-use-and-
interoperability
12 https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-
support-for-underserved-communities-through-the-federal-government/
13A CBO refers to public or private not-for-profit resource hubs that provide specific services to the community or a targeted
population within the community.
https://www.phe.gov/Preparedness/planning/abc/Pages/engaging-CBO.aspx
Page 7 of 59

---

3) Create and implement technology that supports patient engagement that at minimum allows
patients to manage their data by suggesting edits to their SDOH data and provide consent and
authorization to use sensitive data.
4) Coordinate forums to share implementation strategies, lessons learned, and recommendations
with other healthcare providers and CBOs.14 Forums may include, but are not limited to,
workshops, webinars, and documents.
Applicants shall include the following activities in the project plan that they will develop15:
• Assess current SDOH data collection and use activities to ensure efforts are aligned with prior
work, including, but not limited to, previous ONC LEAP projects, the Gravity Project, and 360X.
• Collect SDOH data using nationally recognized16 open standards (e.g., United States Core Data
for Interoperability (USCDI), US Core Implementation Guide , 360X, and the Social
Determinants of Health Clinical Care Implementation Guide (SDOHCC IG)).
• Utilize innovative analysis techniques and real data to identify patients with negative health
outcomes among underserved populations with a need for human and social services, such as,
but not limited to, elderly and aging services, access to medicine, and shelter assistance.
Innovative analysis techniques could include linking different types of data, stratifying
data, natural language processing.
• Use findings from the above analysis to develop at least one use case for referring patients to
CBOs using non-proprietary EHR-embedded or third party closed loop referral technology.
CBOs that are expected to use this technology shall be included in the development of the use
case. This may require a CBO to understand the feasibility of developing the use case and the
technology, which may require education from the project team.
• Create and implement closed loop referral technology in a real-world environment involving at
least one health system or community health center, their EHR developer, and at least one
CBO.17 The awardee will be expected to provide feedback on the challenges and successes that
the health system or community health center and CBO experience while using the technology in
underserved communities.18
• Create and implement patient-facing technology that allows a patient to indicate changes in
social risk factors and allows those changes to be incorporated into an EHR.19
• Develop, publish, and disseminate training and education tools (such as, but not limited to, white
papers, blog posts, and reports) that document implementation strategies, lessons learned, and
best practices for implementation. The strategies, lessons learned, and best practices should
reflect input from implementers, CBO sites, developers, and health IT experts. The training tools
should include guidance for using the technology solution.20
14 https://www.phe.gov/Preparedness/planning/abc/Pages/engaging-CBO.aspx
15 The Project Activities and Performance Goals and Objectives sections of this NOFO describe the project plan requirement.
16 https://www.healthit.gov/isa/
17 https://www.ahrq.gov/chsp/chsp-reports/resources-for-understanding-health-systems/defining-health-systems.html
18 https://www.healthit.gov/topic/leading-edge-acceleration-projects-leap-health-information-technology-health-it
19 https://www.healthit.gov/topic/leading-edge-acceleration-projects-leap-health-information-technology-health-it
20 May also include an overview of SDOH data collection, use, and exchange and its impact on health equity. The awardee
may work in collaboration with awardees from the Public Health Informatics & Technology (PHIT) Workforce Development
Program.
Page 8 of 59

---

• Conduct forums to educate participants on implementation strategies, lessons learned, and best
practices from the project to allow the work to expand across communities.
• Develop and implement evaluation tools that measure and document the outcomes of the
implementation of the technology platform and the return on investment of the technology in
supporting underserved communities.
An applicant’s proposal shall not rely on proprietary technology for apps or web portals. The proposed
technical solution for this Area of Interest should leverage previous work funded by ONC (such as, but
not limited to ONC LEAP projects, the Gravity Project, 360X) and not duplicate efforts.
Area 2: Demonstrate the use of equity-enhancing patient-generated health data for clinical care
and research
Background
Patient-generated health data (PGHD) is increasingly becoming critical for both clinical care and
research. PGHD are health-related data that are created, recorded, or gathered by or from patients (or
family members or other caregivers) to help address a health concern.21 PGHD related technologies such
as mobile phones, apps, remote monitoring devices, and wearable technology (such as, but not limited to
fitness trackers, smart watches, and body-mounted sensors) are more accessible now than before and can
be cost effective methods to monitor and track health outside of the clinical care setting. PGHD can also
support patients’ healthcare goals byproviding patients, providers, and researchers with more
information about a patient’s conditions or health situation.
The 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT
Certification Program Final Rule adopted the United States Core Data for Interoperability (USCDI)
version 1 as a standard.22 USCDI version 1 sets a foundation for broader sharing of electronic health
information to support patient care23and USCDI version 2 reinforced the importance of incorporating
SDOH in healthcare settings. SDOH may prevent or make it difficult for some patients to appropriately
follow up with providers, have their conditions monitored24, or obtain and adhere to medical care. It is
also well documented that these types of factors disproportionately affect underserved communities
when they try to access care and that these communities are underrepresented in research.25,26
PGHD technologies may ease some of these barriers. For example, PGHD technologies can facilitate
patient engagement by providing patients the opportunity to monitor and track their condition outside of
the clinical care setting via multiple avenues such as a patient portal or via a third-party app on their
smartphone. Patients can also decide when and with whom to share their clinical data. Improving the
interoperability of PGHD can also increase patient knowledge, access to care, and control of their
conditions.27 Providers can use PGHD to monitor aspects of their patients’ healthcare from a distance
and between visits. Providers can also use these data to facilitate joint decision-making, resulting in the
provision of better care over time. Currently, the integration of PGHD into EHR and clinical workflows
21 https://www.healthit.gov/topic/otherhot-topics/what-are-patient-generated-health-data
22 https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-
blocking-and-the-onc-health-it-certification
23 https://www.healthit.gov/cures/sites/default/files/cures/2020-03/USCDI.pdf
24 https://pubmed.ncbi.nlm.nih.gov/22092449/
25 https://muse.jhu.edu/article/430672
26 https://www.nature.com/articles/d41586-018-05049-5
27 https://www.healthit.gov/sites/default/files/onc_pghd_final_white_paper.pdf
Page 9 of 59

---

is not robust. Subsequently, it is often difficult for researchers to access PGHD that are connected to
EHR data they may already be requesting. Researchers will often have to set up separate systems to
collect PGHD.
The ONC National Health IT Priorities for Research: A Policy and Development Agenda (the Agenda)
highlighted key several of which are related to the enhancement of PGHD.28 Specifically, Priority 5
spotlights the need to integrate emerging health and health-related data sources.29 Improvements in the
collection, use, and sharing of PGHD will contribute to the types of data that can be leveraged for
research and the advancement of a health IT infrastructure that supports research. Not only has the
usefulness of PGHD technologies been identified in literature and in practice, but ONC has also
highlighted its value in previous work as well. Projects such as Advancing Standards for Precision
Medicine and the Patient-Centered Outcomes Research (PCOR) project on PGHD have examined the
collection, use, and standardization of PGHD and demonstrated the opportunities that PGHD can
provide.30,31 PGHD technologies offer a unique opportunity to leverage health IT to directly support the
Biden Administration’s priority of ending “disparities in healthcare access and education”, particularly
by addressing barriers to health equity among underserved communities (i.e. Black, Latino, and
Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of
color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+)
persons; persons with disabilities; persons who live in rural areas).32
Despite the innovative possibilities that the use of PGHD brings to care and research, there are also
several challenges associated with the advancement of PGHD. Difficulties experienced by patients
include a lack of access to PGHD technologies, varying health and technology literacy levels, and data
privacy and security concerns.33 Clinician and researcher challenges include apprehension regarding the
accuracy of PGHD and specifically for providers, the impact on clinical workflow.34 In addition, the
sharing of PGHD for research is still nascent. Though many wearable technology and apps use APIs, the
capture, use, and sharing of PGHD are not standardized.35 For example, many PGHD related
technologies have not adopted standards, such as FHIR, and the interoperability of PGHD, though
emerging, is still relatively new.36 Even with the promising use of PGHD for greater health equity, there
is also the concern that collection of PGHD may have unintended consequences on underserved
communities, based on a potential “digital divide” resulting from the use of costly PGHD related
technologies.
Project Goals
The goal of this project is to develop the infrastructure and standards-based PGHD technologiesneeded
to demonstrate the scalable use of equity enhancing patient-generated health data for clinical care and
research from the point of care to the researcher. The proposed PGHD technology solution can be
comprised of apps, remote monitoring devices, or wearable technology that collect data to monitor and
28 https://www.healthit.gov/topic/scientific-initiatives/national-health-it-priorities-research-policy-and-development-agenda
29 https://www.healthit.gov/topic/scientific-initiatives/national-health-it-priorities-research-policy-and-development-agenda
30 https://www.healthit.gov/topic/advancing-standards-precision-medicine
31 https://www.healthit.gov/topic/scientific-initiatives/pcor/patient-generated-health-data-pghd
32 https://www.whitehouse.gov/priorities/
33 https://www.healthit.gov/sites/default/files/onc_pghd_final_white_paper.pdf
34 https://www.healthit.gov/sites/default/files/onc_pghd_practical_guide.pdf
35 https://www.healthit.gov/sites/default/files/page/2021-01/Advancing-Standards-in-Precision-Medicine.pdf
36 Hussein, R., Crutzen, R., Gutenberg, J., Kulnik, S. T., Sareban, M., & Niebauer, J. (2021). Patient-Generated Health Data
(PGHD) Interoperability: An Integrative Perspective. In Public Health and Informatics (pp. 228-232). IOS Press.
Page 10 of 59

---

track health outside of the clinical care setting. Additionally, the awardee of the project shall do the
following:
• Examine the capabilities of current health IT infrastructure that is available to support PGHD
technologies and identify standards-based technology that needs to be developed to effectively
integrate PGHD into one or multiple EHRs and for PGHD to subsequently be used by both
clinicians and researchers.
• Identify and propose a PGHD technology solution that is most useful for healthcare research
with an emphasis on underserved communities and their unique needs, while considering the
accuracy of the type of PGHD that is collected.
• Demonstrate the use of a PGHD solution that leverages nationally recognized open standards
(e.g. USCDI37 and the Interoperability Standards Advisory (ISA)38) and standards-based
approaches or resources (e.g. FHIR “Write” APIs, HL7 FHIR, Substitutable Medical
Applications and Reusable Technologies (SMART) on FHIR, and Mobile Health
Implementation Guides) for integrating PGHD with clinical EHR data, with the appropriate
privacy, security, and other data provenance considerations.
• Demonstrate a path to scalability by implementing the proposed PGHD technology solution in at
least two separate healthcare locations or by demonstrating how the same proposed PGHD
technology solution can be used for two different use cases.
• Capture and document lessons learned, challenges encountered, and recommendations for a
blueprint that can be used by others to advance the use of PGHD for research and in clinical care.
Key Objectives
1) Perform a landscape analysis/environmental scan to understand the current standards and
interoperability of PGHD technologies related to the proposed PGHD technology solution (such
as across device manufacturers and different EHRs).
2) Per the above landscape analysis/environmental scan, identify at least two separate healthcare
locations and at least two use cases around clinical care and research that require PGHD and
incorporate the needs of underserved communities.
3) Create and develop plans for at least two demonstration projects with consideration on reuse and
scalability of the proposed PGHD technology solution. To result in two demonstration projects,
the proposed PGHD technology solution should be implemented at two separate healthcare
locations affiliated with the awardee, and the proposed PGHD technology solution should be
implemented for two different use cases (e.g. high blood pressure and respiratory diseases) that
use the same underlying technology. This will show how the solution can be reused.
4) Convene a coalition of key stakeholders (e.g. clinicians, researchers, technical experts, and/or
patients) that will be directly involved in the development and implementation of the
demonstration projects.
5) Engage standards development organizations (SDOs) to identify opportunities and practical
solutions for the advancement of standards that are necessary to capture, exchange, integrate, and
use PGHD in clinical and research settings. This includes leveraging and testing existing
standards for the proposed PGHD technology solution and can also include balloting and
updating implementation guides with information resulting from the demonstration projects.
6) Develop the proposed PGHD technology solution (incorporating standards-based solutions) that
collects and shares PGHD among patients, providers, and researchers.
37 https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi
38 https://www.healthit.gov/isa/
Page 11 of 59

---

7) Prepare a final report that includes lessons learned and recommendations that provide
experiential insights for others who wish to implement similar types of PGHD technology
solutions at their organizations.
8) Develop at least one manuscript that details the demonstration project results and submit to
appropriate journal.
Project Activities
Awardees shall carry out at a minimum, the following set of activities:
• Define a project plan that will include all key objectives
o The project plan will identify key issues and potential challenges.
o The project plan will map all project activities to a two-year timeframe.
o Engage with ONC and other federal HHS partners as identified by ONC, to establish
and refine key issues and potential challenges in the project’s Area of Interest.
• Document and report progress throughout the project timeframe.
• Utilize research methods to inform the demonstration projects.
• Publish (e.g., manuscript, report, blog post, and white paper) and disseminate project findings
in a way that translates project outcomes into useable knowledge and insights for federal
partners, health IT industry, SDOs, CBOs, developers, healthcare systems, and providers to
maximize the accessibility of this knowledge to the entire health IT community.
• Select measurable outcomes that are specific to the project’s Area of Interest and key
objectives.
• Conduct virtual mid-point demonstrations and provide an update regarding any proposed
approaches, prototype(s), and/or revisions to the project plan to illustrate their progress on the
Area of Interest.
In addition, applicants will provide a draft project plan as an appendix to the application, with a
corresponding table of key dates and objectives to demonstrate that key objectives can be met within the
two-year period (see Section D, Application and Submission Information).
Performance Goals and Objectives
A performance goal is a target level of performance expressed as a tangible, measurable objective,
against which actual achievement can be compared.
ONC will utilize the following objectives to assess project performance and progress:
• The quality of the two-year project plan and the description of how performance goals and
objectives will be met.
• The identification and securement of subject matter experts (SMEs), as appropriate, to provide
guidance and review strategies, research methods, and results.
• Scheduling, conducting, and participating in status, strategy and/or SME meetings with ONC and
the coalition of key stakeholders.
• Communicating findings and providing quarterly programmatic progress reports, including a risk
register to ensure timely deliverables.
Page 12 of 59

---

B. Funding Opportunity Award Information
Key Award Parameters
Title: Leading Edge Acceleration Projects (LEAP) in Health Information Technology
Federal Funding Agency: Department of Health and Human Services
Office of the National Coordinator for Health Information Technology
Announcement Type: Cooperative Agreement
Application Type: New
Funding Opportunity Number: NAP-AX-22-001
Catalog of Federal Domestic Assistance (CFDA) Number: 93.345
Eligible Applicants:
This is a competitive funding opportunity open to public or non-profit private institutions, such as a
university, college, or a faith-based or community-based organization; units of local or state
government, eligible agencies of the federal government, Indian/Native American Tribal Governments
(federally recognized, other than federally recognized, and tribally designated organizations).
For-profit organizations may participate in projects as members of a consortia or as a sub-recipient
only. Because the purpose of this NOFO is to improve healthcare in the United States, foreign
institutions may participate in projects as members of a consortia or as a sub-recipient only.
Applications submitted by for-profit organizations or foreign institutions will not be reviewed.
Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying
activities are not eligible.
HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the
planned project activity and not merely serve as a conduit of funds to another party or parties. If
consortium/contractual activities represent a significant portion of the overall project, the applicant shall
justify why the applicant organization, rather than the party(s) performing this portion of the overall
project, should be the recipient and what substantive role the applicant organization will play.
Applicant organizations may submit more than one application, provided that each application is
scientifically distinct.
Legislative Authority: Consolidated Appropriations Act, 2022, Pub. L. 117-103, Division H, Title II
Approximate Amount of Available Funding (inclusive of direct and indirect costs) :
Anticipated Number of Awards: 2 (1 award per Area of Interest)
Approximately Amount of Each Award: $1,000,000
Page 13 of 59

---

Project Period: September 26, 2022-September 25, 2027
Budget Period(s): September 26, 2022-September 25, 2024
Under this announcement, as new emerging issues and vexing problems/challenges are documented,
program will call attention to these specific areas of interest for further investigation via a special
emphasis notice (SEN). This funding opportunity will have a 5-year open application period. ONC may
issue future awards to other eligible applicants for future priority areas of interest to address
emerging challenges in the field, via SEN; again, contingent on the availability of funds and ONC
priorities. Any SENs will be issued at least 60 days prior to the due date of applications.
Funding of future non-competing continuation awards will be determined by ONC and is conditioned on
the availability of funds, satisfactory progress by the recipient, and an awarding office determination that
continued funding of the award is in the best interests of the Government.
Cooperative Agreement and Substantial ONC Involvement
The funding instrument used for this program will be the cooperative agreement, an assistance
mechanism, in which substantial ONC programmatic involvement is anticipated during the project
period. Under the cooperative agreement, the ONC purpose is to support and stimulate the recipient’s
activities by involvement in, and otherwise working jointly with, each recipient in a partnership role. It
is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this
premise, the dominant role and prime responsibility resides with the recipient for the project as a whole.
To facilitate appropriate involvement, during the period of this cooperative agreement, ONC and the
recipient will be in contact monthly and more frequently when appropriate.
ONC involvement may include, but is not limited to:
• Participating in monthly (minimum) check-in meetings
• Ensuring compliance of timely programmatic reporting, project progress, and other terms
and conditions of the award
• Review and approve quarterly programmatic progress reports on Confluence
o Quarterly programmatic progress reports are due one month after each quarter
(January, April, July, and October)
• Participating in the selection of key personnel
• Releasing funds based on achievement of performance goals and objectives
• Agency review and approval of substantive provisions of proposed subawards or
contracts
• Reviewing and approving deliverables
• Selecting meeting/panel members and subject matter experts
• Participating in communities of practice
• Providing tactical guidance and feedback during project execution
• Engaging with leadership of the recipient’s organization to ensure successful execution of
the cooperative agreement
• Ending an activity if performance specifications are not met
Page 14 of 59

---

Program Income
There are four potential ways in which ONC may require that a recipient apply program income as
specified in the Notice of Grant Award (NGA): 1) deduct it from total allowable program costs to
determine the net allowable costs on which the Federal share of costs is based; 2) add it to funds
otherwise available for the program, generally resulting in an increase to the total approved budget; 3)
use it to meet a matching or cost sharing requirement; or 4) a combination of these alternatives.
Costs paid by program income generally are subject to the applicable cost principles and other Federal
requirements and shall be disbursed for program purposes before requesting additional payments of
Federal funds. In the event program income remains at the end of the award, the additional income is
considered part of the award funding and shall be returned to ONC. If program income is generated,
the recipient shall use the additive method.
Intergovernmental Review
Applications for this Cooperative Agreement are not subject to review by states under Executive Order
12372, “Intergovernmental Review of Federal Programs” (45 CFR 100). Please check box “C” on item
19 of the SF 424 (Application for Federal Assistance) as Review by State Executive Order 12372, does
not apply to this Cooperative Agreement.
Key Dates
Milestone Date
NOFO Released June 14, 2022
Informational Session June 28, 2022
Letters of Intent Due June 30, 2022
Applications Due August 15, 2022
Anticipated Award Date September 26, 2022
Anticipated Project Start Date September 26, 2022
Informational Session
ONC will conduct an informational session, via a webinar, to:
• Discuss the background, purpose, scope, terms and conditions and other provisions in the NOFO;
• Explain the eligibility and application requirements;
• Describe the application review process; and
• Provide an opportunity for interested parties to ask questions.
Page 15 of 59

---

Further details about the informational session – including the date, time, and instructions for joining –
are available at https://us06web.zoom.us/meeting/register/tZMtf-yurDgvH9wNRzED7Sm0MZR76l8vs0Nq
To ensure that ONC addresses all comments and questions regarding this announcement during the
information session, please submit any comments and questions, via email, to ONC-LEAP@hhs.gov no
later than three days prior to the call.
Letter of Intent
Although not required, applicants are strongly encouraged to submit a non-binding e-mail letter of intent
to apply for this funding opportunity. This letter of intent will assist ONC in planning for the application
review process.
The Letter of Intent is requested by 11:59 P.M. Eastern Standard Time on June 30, 2022 and should be
sent to ONC-LEAP@hhs.gov. The notice should identify the name of the applicant organization, the city
and state in which the applicant organization is located, and the Notice of Funding Opportunity title and
number.
Page 16 of 59

---

C. Eligibility Information
See Section B, Funding Opportunity Award Information, for eligibility, cost-sharing, and other key
award information.
Priority will be given to applicants who demonstrate provision of services to primarily underserved
communities (i.e. Black, Latino, and Indigenous and Native American persons, Asian Americans and
Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual,
transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas)
and provide evidence of this in the application.
Page 17 of 59

---

D. Application and Submission Information
Application Package
The following documents comprise, as applicable, the application package. Additional information
regarding each of these documents is further provided.
• Project Abstract
• Project Narrative
• Appendices
o Form SF-424, Application for Federal Assistance
o Form SF-424A, Budget Information for Non-Construction Programs
o Form SF-424B, Assurances for Non-Construction Programs
o Form SF-LLL, Disclosure of Lobbying Activities
o Budget Narrative
o Letters of Commitment
o Proof of Non-Profit Status (if, applicable)
o Indirect Cost Agreement(s) – including recipient, sub-recipient, and contractors’
agreements (if applicable)
Appendix A, Tips for Writing a Strong Application, can be used as a resource.
The project narrative and budget narrative sections of the application shall be double-spaced, on 8-1/2”
X 11” plain white paper with 1” margins on all sides and use either Cambria or Times New Roman font
size of not less than 11 point. Smaller font sizes may be used to fill in the Standard Forms, exhibits, and
figures, though all text in forms, exhibits, and figures shall not be smaller than 8-point font.
Project Abstract
Applicants shall include a one-page abstract that is no more than 500 words. This abstract is often
distributed to the public and Congress and represents a high-level summary of the project. As a result,
applicant should prepare a clear, accurate, concise abstract that can be understood without reference to
other parts of the application and that provides a description of the proposed project, including: the
project’s goal(s), objectives, overall approach, anticipated outcomes, products, and duration.
The applicant shall place the following information at the top of the Project Abstract (this information is
not included in the 500-word maximum):
• Project Title
• Applicant Name
• Physical Address
• Contact Name
• Contact Phone Numbers (Voice, Fax)
• E-Mail Address
• Web Site Address, if applicable
Page 18 of 59

---

Project Narrative
The project narrative should describe the proposed project in a clear and concise manner. The project
narrative should address the elements articulated in the Areas of Interest section of this NOFO. The
project narrative should also align with the Performance Goals and Objectives and Merit Review criteria
presented in this NOFO.
The project narrative shall be double-spaced, formatted to 8 ½” x 11” (letter-size) pages, 1” or larger
margins on all sides, and using no less than 11-point font size. The maximum length allowed for the
project narrative is 35 pages. A project narrative that exceeds the 35-page limit will not be accepted.
Resumes of key personnel (personnel required for the project), are not counted as part of the project
narrative and are not included in the 35-page limit.
Your project narrative should include the following components. These components will be counted as
part of the page limit. The suggested lengths of the components, given below, are guidelines to help
applicants create a balanced document. They are not mandatory restrictions:
1. Understanding of Project Purpose (2-3 pages)
2. Proposed Approach and Activities (10-14 pages)
3. Applicant Capabilities (9-15 pages)
4. Budget Narrative (2-3 Pages)
1. Understanding of Project Purpose
This section should offer the applicant’s conceptualization of the selected Area of Interest. This
should include, from the applicant’s perspective, a specific delineation of the objectives and research
challenges the proposed project will address, specifically distinguishing between challenges that can
be addressed in the self-contained project period (two years) and challenges requiring a longer
period (three to five years). Applicants shall clearly state which Area of Interest the proposed project
will address. (2-3 pages).
2. Proposed Approach and Activities
This section should provide a clear and concise description of the approach the applicant is
proposing to use to conduct the research and development work, including identifying the major
challenges and proposed activities used in the approach. This section should be organized so that
each element of the project plan is clear and aligns to the project’s key objectives and project goals.
The applicant should include the usage of novel concepts, approaches, methodologies, tools, and/or
technologies and provide insight as to how their usage will inform the field of health IT.
Additionally, the approach should include proposed strategies on how the results of the project may
be disseminated and transitioned to field at large.
Each key objective being addressed should be described as a discrete activity, and each activity
should have a separately itemized budget as described below. The applicant shall clearly identify
each activity and denote whether it is a short-term objective (two years) or a long-term objective
(three to five years).
The approach should include as much details as possible given the page limitation. Notwithstanding,
the plan for each activity, at a minimum, shall state, (a) specific aims, (b) previous work of the
investigative team on which the proposed research is directly based, (c) the methods that will be
applied, the anticipated outcomes of the work, and their potential significance in addressing the
Page 19 of 59

---

challenges of the selected Area of Interest, and (d) the key personnel who will be involved.
Statements of previous work should not be redundant with general statements of experience in the
“Organizational Capability Statement” section described below.
Applications should justify the project’s proposed approaches through relevant scholarly articles and
other literature. Up to 100 citations may be included. Citations will be judged by quality, not
quantity. Applicants should avoid multiple, partially redundant citations. Where an assertion in the
narrative is supported by a large number of citations, we recommend applicants consider stating in
the narrative the number of citations that support the assertion and then including in the citation list
only the most important exemplars. (10-14 pages)
3. Applicant Capabilities
Project Team. This section should describe the applicant’s project team, personnel qualifications,
and past performance demonstrating experience consistent with successfully meeting the goals of the
cooperative agreement. This section should discuss the overall project management approach and the
types and level of staffing, resources, and infrastructure in place to support the project. This would
include identifying the roles of key staff, identifying the roles of subcontractors and/or any other
external consultants or subject matter experts, as well as communication strategy with ONC to
provide updates and progress reports. The applicant must provide the names of staff that will be
overseeing the analysis of the data and preparation of the ongoing reports. This section should also
include any quality assurance or quality control processes your organization plans to conduct
throughout the project. It is recommended that the project team be comprised of, but is not limited
to, the following roles:
• Project Director/Principal Investigator (PD/PI):
o Only one PD/PI may be designated on the application.
o An eligible PD/PI may come from a variety of areas including, but not limited to, nurses,
pharmacists, medical doctors, health service researchers, economists, health system
administrators, health IT experts, industrial and systems engineers, computer and
cognitive scientists, human factors professionals, and health informatics professionals.
Any individual with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with their institution to develop an application for
support.
o The PD/PI is expected to contribute a minimum of 20% effort annually throughout the
course of the cooperative agreement. If less time is allocated, an explicit justification of
the lower level of effort shall be included.
• At least one person on the proposed team shall possess health IT expertise.
• For Area of Interest 1: Address health equity and social determinants of health (SDOH) through
innovative, open-source technology tools, and electronic health records:
o Discuss the proposed project team’s expertise in the following areas:
▪ Data standards development and balloting
▪ API development and EHR integration
o Discuss the proposed project team’s knowledge in the following areas:
▪ Implementation of EHRs and collection of SDOH data and electronic patient
consent and authorization.
▪ Stakeholder coordination and project management with clinical care providers
and CBOs.
▪ Patient engagement, information dissemination, and education.
Page 20 of 59

---

▪ Workflow and technical architecture development supporting referral
management, patient engagement, and privacy and security.
▪ Data analysis such as, but not limited to, outcomes measurement, population
health, and health disparities.
▪ Work directly on health disparities in collaboration with specific historically
marginalized communities and/or community organizations that represent the
perspectives and interests of historically marginalized communities.
o To be considered for an award in Area of Interest 1, an applicant’s proposal shall include
a collaborative team of key stakeholders who will be directly involved in the project,
which we refer to as the coalition. Coalition members shall include stakeholders such as
healthcare providers, CBOs, human and social service organizations, health information
exchanges (HIEs), health IT developers and vendors, and state/local agencies. An
applicant’s proposal shall include letters of commitment from stakeholders who will be
part of the coalition.
• For Area of Interest 2: Demonstrate the use of equity-enhancing patient-generated
health data for clinical care and research
o Discuss the proposed project team’s expertise in the following areas:
▪ User-centered design
▪ Workflow design
▪ Data visualization
▪ Cognitive support
o Discuss the proposed project team’s knowledge in the following areas:
▪ Use of nationally recognized health IT standards and standards development to
support the exchange of PGHD.
▪ Stakeholder coordination with patients/patient advocates, clinicians, and
researchers.
▪ Excellent project management of large projects with multi-stakeholder facets and
workflows.
▪ Workflow and technical architecture development that supports the sharing of
PGHD from collection to researchers.
▪ Data analysis such as, but not limited to, population health, health disparities, and
other relevant types of research and analysis.
o To be considered for an award in Area of Interest 2, an applicant’s proposal shall include
a collaborative team of key stakeholders who will be directly involved in the project,
which we refer to as the coalition. Coalition members shall include healthcare providers
or professionals across healthcare settings (e.g. Physicians, Nurses, and Physical
Therapists, health information exchanges (HIEs), health IT developers or vendors, and
researchers). An applicant’s proposal shall include letters of commitment from
stakeholders who will be part of the coalition.
Plan for Disseminating and Transitioning Appropriate Research Results into Practice. This section
should include a plan for engaging industry stakeholders to adopt, disseminate, and transition
findings from the project into data standards, data infrastructures, health IT products, tools, and best
practices. Collaborative arrangements with industry and other groups outside of the applicant
institution should be accompanied by appropriate letters of support.
Page 21 of 59

---

In the event an applicant’s solution include the development of a prototype, the applicant should also
submit a plan for approval by ONC, illustrating how the prototype will be made and maintained in a
publicly available and acceptable domain at no cost to the general public. (2-3 pages)
Stakeholder Coordination. This section should describe plans to establish and operate a technical
expert panel of relevant and appropriate stakeholders, including names of members who have
committed to join or proposed to join to help inform the work to be conducted on the relevant Area
of Interest. (2-3 pages)
Project Management. This section should include a clear delineation of the roles and responsibilities
of the principal investigator, participating researchers, project staff, consultants, and collaborating
organizations, and how they will contribute to achieving the research objectives and outcomes. If the
application includes subcontractors, plans for coordinating activities across multiple organizations
should be described. This section should specify who would have day-to-day responsibilities for key
tasks such as: leadership of project, monitoring the project’s on-going progress, preparation of
reports, and communications with other collaborating organizations and ONC. Recipients will be
required to maintain information relevant to executing the proposed project plan and performance-
based outcomes. The application should describe the approach that will be used to assess project
performance and monitor and track progress toward meeting key objectives. The application should
include a detailed project timeline as an appendix that incorporates those objectives. The project
timeline will not count towards the narrative page limit. The applicant should also include an
organizational chart as an appendix that reflects roles and responsibilities. The organizational chart
will not count towards the narrative page limit. (3-5 pages)
Organizational Capability Statement. The statement should describe the organization’s capabilities,
qualifications, and approach to address the work to be completed. Applicants are strongly
encouraged to propose the development of technology using open-source approaches (freely
available without a license) and share the outcomes of their research in open-source communities.
The statement should highlight potential strategies the organization may employ to sustain research
efforts and activities beyond the scope of the project timeframe.
The statement should include the relevant organizational resources available to perform the proposed
project (e.g., facilities, equipment, and other resources). Also, the applicant should include
information about any organization(s) that will have a significant role(s) in the research project and
achieving research goals, including those proposed to receive sub-awards. Applicants who are
working with project counterparts as part of a consortia shall also provide letters of commitment
from them. The letters of commitment shall be included with the appendices and will not count
towards the page limit. (2-4 pages)
4. Budget Narrative
This section should include a detailed breakdown of how the applicant plans to spend the allotted
resources to complete the activities detailed in the NOFO. More details about the requirements of
this section can be found in the Budget Narrative section on page 24. (2-3 Pages)
Appendices
Applicants may submit no more than 30 pages of appendix material. Appendix material should be used
to provide additional materials (for example, key papers or reports or excerpts) that will be of assistance
in evaluating the merit of the application. Do not use the Appendix to circumvent the page limitations of
Page 22 of 59

---

the project narrative component. Applications that use appendix material as a mechanism to exceed the
page length limitations of the project narrative will not be considered for award.
Form SF-424, Application for Federal Assistance
Appendix B provides line-by-line instructions to complete the form. Please note that the SF-424 is used
for a wide variety of Federal grant programs, and Federal agencies have the discretion to require some or
all of the information on these forms. Accordingly, when completing the form, please use the
instructions in Appendix B in lieu of the standard instructions attached to SF-424.
Form SF-424A, Budget Information for Non-Construction Programs
Appendix C provides line-by-line instructions to complete the form. Please note that the SF-424A is
used for a wide variety of Federal grant programs, and Federal agencies have the discretion to require
some of or all the information on these forms. Accordingly, when completing the form, please use the
instructions in Appendix C in lieu of the standard instructions attached to SF-424A. All direct and
indirect costs shall be allowable, allocable, reasonable, and necessary.
Form SF-424B, Assurances for Non-Construction Programs
This form contains laws and other assurances applicants shall comply with under the discretionary funds
programs administered by the Office of the National Coordinator for Health Information Technology.
Please note that a duly authorized representative of the applicant organization shall certify that the
organization is in compliance with these assurances.
Form SF-LLL, Disclosure of Lobbying Activities
This form contains the name and address of lobbying registrants. Please note that a duly authorized
representative of the applicant organization shall sign the disclosure form. Failure to complete and sign
the form may result in civil penalties ranging from $10,000 to $100,000.
Budget Narrative
The budget narrative describes how the proposed budget, as articulated in the SF-424A, aligns with the
applicant’s project narrative. That is to ensure that costs are realistic (not artificially too low) and
reasonable (not inflated) in view of programmatic requirements. Appendix D provides a template to
complete the budget narrative populated with sample information.
When more than 33% of a project’s total budget falls under a contractual expense, a detailed budget
narrative/justification shall be provided for each sub-contractor or sub-recipient. Applicants requesting
funding for multi-year grant programs are required to provide a combined multi-year budget
narrative/justification, as well as a detailed budget narrative/justification for each year of potential grant
funding. A separate budget narrative/justification is also required for each potential year of grant
funding requested.
The full budget narrative/justification should be included in the application immediately following the
SF 424 forms. The budget narrative shall be double-spaced, formatted to 8 ½” x 11” (letter-size) pages,
1” or larger margins on all sides, and a font size of not less than 11 point.
Letters of Commitment
Include letters of commitment confirming the support to the project (should it be funded) made by key
collaborating organizations and agencies. Any organization that is specifically named to have a
significant coordination role in carrying out the project should be considered an essential collaborator
Page 23 of 59

---

such as interstate, intrastate, and regional partners. At a minimum, the letter shall explain the
demonstrated commitment to the project and how they will advance coordination and collaboration
among critical stakeholders. See Appendix E for an example letter of commitment.
Applicants will also provide a letter of commitment from entities that will be responsible for generating
reports based on transactional data (e.g. health information service providers, technology developers or
vendors, or others). These entities should have the capacity and resources to produce required reports on
adoption and use in a timely manner. See Appendix E for an example letter of commitment.
These letters should not be considered as part of the page limit. Signed letters of commitment should be
scanned and included as attachments.
Proof of Non-Profit Status
Non-profit applicants shall submit proof of non-profit status. Any of the following constitutes acceptable
proof of such status:
• A copy of a currently valid IRS tax exemption certificate.
• A statement from a state taxing body, state attorney general, or other appropriate state official
certifying that the applicant organization has a non-profit status and that none of the net earnings
accrue to any private shareholders or individuals.
• A certified copy of the organization’s certificate of incorporation or similar document that
clearly establishes non-profit status.
Indirect Cost Agreement(s)
Applicants that have included indirect costs in their budgets shall include a copy of the current indirect
cost rate agreement approved by the Department of Health and Human Services or another federal
agency. This is optional for applicants that have not included indirect costs in their budgets. Further, if
any sub-contractors or sub-recipients are requesting indirect costs, copies of their indirect cost
agreements shall also be included with the application. Cost allocation plans are not accepted.
Application Submission Instructions
1) You shall access the electronic application for this program via http://www.grants.gov. You can
search the downloadable application page by the Notice of Funding Opportunity Number NAP-
AX-22-001 or CFDA number 93.345.
2) Applicants will be able to download a copy of the application packet and complete it off-line. In
order to complete the application, an organization shall have a Unique Entity Identifier (UEI). A
UEI can be obtained via registering at http://SAM.gov and typically takes 7 to 10 business days.
Please plan accordingly.
3) Completed applications are uploaded into Grants.gov. APPLICATIONS WILL NOT BE
ACCEPTED THROUGH ANY OTHER WEBSITE, AND WILL NOT BE ACCEPTED
THROUGH PAPER MAIL, COURIER, OR DELIVERY SERVICE.
In order to upload applications into Grants.gov:
a) An applicant shall be registered in the System for Award Management (SAM), at sam.gov
and use their UEI. The SAM registration process takes 7 to 10 business days so please plan
Page 24 of 59

---

accordingly. If you have already registered with the SAM, but have not renewed your
registration in the last 12 months, you will need to renew your registration.
b) Please note that entities registering in SAM shall submit a notarized letter appointing their
authorized Entity Administrator. This will not impact the registration approval process, but is
required as part of your registration. For additional information, read SAM’s updated FAQs
to learn more about changes to the notarized letter review process and other system
improvements.
The following website depicts the SAM registration process:
http://www.grants.gov/web/grants/applicants/organization-registration.html
c) An applicant shall be registered in Grants.gov which can take several days. To that end,
applicants are strongly encouraged to register and test Grants.gov logins and passwords well
in advance of the application deadline date. For assistance with www.grants.gov, please
contact them at support@Grants.gov or 1-800-518-4726. Resources are available 24 hours a
day/7 days a week.
A depiction of the Grants.gov application process can be found at
http://www.grants.gov/web/grants/applicants/apply-for-grants.html
4) After electronically submitting your application, Grants.gov will generate an email a tracking
number and date of receipt verification confirming that the application was received, the date and
time the application was received, and a tracking number. This notification does not ensure that
your application could be opened and read -- only that the application was received.
The deadline for the submission of applications under this Funding Opportunity is
12:00PM Eastern Standard Time on August 15, 2022. Applications that fail to meet the
application deadline will not be reviewed and will receive no further consideration.
Page 25 of 59

---

Restrictions on Oral Conversations
This funding opportunity is subject to restrictions on oral conversations during the period of time
commencing with the submission of a formal application by an individual or entity and ending with the
award of the competitive funds. Federal officials may not participate in oral communications initiated by
any person or entity concerning a pending application for a competitive grant or other competitive form
of federal financial assistance, whether the initiating party is a federally registered lobbyist or not.
This restriction applies unless:
• The communication is purely logistical
• The communication is made at a widely attended gathering
• The communication is to or from a federal agency official and another federal Government
employee
• The communication is to or from a federal agency official and an elected chief executive of a
state, local, or tribal government, or to or from a federal agency official and the Presiding Officer
or Majority Leader in each chamber of a state legislature
• The communication is initiated by the federal agency official
Funding Restrictions
Funds cannot be used for the following purposes:
• To supplant or replace current public or private funding
• To supplant ongoing or usual activities of any organization involved in the project
• To purchase or improve land, or to purchase, construct, or make permanent improvements to any
building
• To reimburse pre-award costs
Page 26 of 59

---

E. Application Review Information
Screening Review
Applicants that do not meet the following screening criteria will be eliminated and will not be sent forward
for merit review:
• The application is received by the required deadline through http://www.grants.gov
• The application contains all required components (e.g. Project Abstract, project narrative, SF-
424 etc.)
• The application meets the formatting and length requirements. The project narrative shall not
exceed 35 pages. The Project Abstract and resumes do not count as part of the project narrative
length limitation.
• Appendices and attachments are not used as a mechanism to exceed page limits of the project
narrative
Merit Review
An independent review panel will evaluate applications that meet the screening review criteria identified
above. These reviewers will be experts in their fields from academic institutions, private and non-profit
organizations, and state, tribal, local, territorial, and federal government agencies. Panelists will review,
evaluate, and score applications, in accordance with the criteria identified below.
• Understanding of Project Purpose (10 points)
• Proposed Approach and Activities (40 points)
• Applicant Capabilities (30 points)
• Budget Narrative (20 points)
Understanding of Project Purpose (10 points)
• The extent to which the application addresses the objectives and project goals of this NOFO.
• The extent to which the application identifies a project plan and activities that align with one of
the two identified Areas of Interest within the NOFO.
• The extent to which the application identifies barriers and ways to mitigate those barriers with
one of the two identified Areas of Interest within the NOFO.
• The extent to which the applicant describes how the project, expected outcomes, and results will
inform future health IT development, research, and implementation.
Proposed Approach and Activities (40 points)
• The extent to which the approach, design, methods, and analyses are specifically stated,
adequately developed, well-integrated, well-reasoned, and appropriate to the project
goals/key objectives of the Area of Interest (20 points), to include:
o The extent to which proposed activities for achieving the research objectives are
clear, feasible, and appropriate.
o The extent to which development or utilization of novel concepts, approaches,
methodologies, tools, or technologies, or a combination of common elements, are
described and generate insight to inform the field of health IT.
• The extent to which the applicant proposes a clear and detailed plan for disseminating and
Page 27 of 59

---

transitioning appropriate research results into practice. This section of the application should
include a plan for engaging industry stakeholders to adopt, disseminate, and transition
findings from the project to stakeholders who will continue to advance the work. (15 points)
• The extent to which the plan describes a project management approach for ensuring project
success. (5 points)
Applicant Capabilities (30 points)
• The extent to which the applicant identifies all the resources necessary to perform the
proposed work and outline strategies to complete this work within a two-year time frame.
(5 points)
• The extent to which the scientific environment(s) in which the work will be done contributes
to the probability of success, employs useful collaborative arrangements, and has evidence of
institutional support. (5 points)
• The extent to which the project proposal integrates and provides an appropriate level of
research and technical knowledge and subject matter expertise. (20 points).
▪ Does the application include a project team drawing from diverse fields? Are
needed expertise or relevant disciplines adequately represented across the
project team?
▪ Does the application demonstrate that the project team will have adequate
administrative structure and processes in place to oversee the successful
conduct of the proposed project, which includes addressing weaknesses
encountered during the project?
▪ For Area of Interest 1: Address health equity and social determinants of health
(SDOH) through innovative, open-source technology tools, and electronic
health records:
• Does the proposed project team have expertise in the following areas?
o Data standards development and balloting
o API development and EHR integration
• Is the proposed project team able to demonstrate knowledge in the
following areas?
o Implementation of EHRs and collection of SDOH data and
electronic patient consent and authorization.
o Stakeholder coordination and project management with clinical
care providers and CBOs.
o Patient engagement, information dissemination, and education.
o Workflow and technical architecture development supporting
referral management, patient engagement, and privacy and
security.
o Data analysis such as, but not limited to, outcomes
measurement, population health, and health disparities.
o Work directly on health disparities in collaboration with
specific historically marginalized communities and/or
community organizations that represent the perspectives and
interests of historically marginalized communities.
• To be considered for an award in Area of Interest 1, an applicant’s
proposal shall include a collaborative team of key stakeholders who
will be directly involved in the project, which we refer to as the
Page 28 of 59

---

coalition. Coalition members shall include stakeholders such as
healthcare providers, CBOs, human and social service organizations,
health information exchanges (HIEs), health IT developers and
vendors, and state/local agencies. An applicant’s proposal shall include
letters of commitment from stakeholders who will be part of the
coalition.
▪ For Area of Interest 2: Demonstrate the use of equity-enhancing patient-
generated health data for clinical care and research
• Does the proposed project team demonstrate expertise in the following
areas?
o User-centered design
o Workflow design
o Data visualization
o Cognitive support
• Is the proposed project team able to demonstrate knowledge in the
following areas?
o Use of nationally recognized health IT standards and standards
development to support the exchange of PGHD.
o Stakeholder coordination with patients/patient advocates,
clinicians, and researchers.
o Excellent project management of large projects with multi-
stakeholder facets and workflows.
o Workflow and technical architecture development that supports
the sharing of PGHD from collection to researchers.
o Data analysis such as, but not limited to, population health,
health disparities, and other relevant types of research and
analysis.
• To be considered for an award in Area of Interest 2, an applicant’s
proposal shall include a collaborative team of key stakeholders who
will be directly involved in the project, which we refer to as the
coalition. Coalition members shall include healthcare providers or
professionals across healthcare settings (e.g. Physicians, Nurses, and
Physical Therapists, health information exchanges (HIEs), health IT
developers or vendors, and researchers). An applicant’s proposal shall
include letters of commitment from stakeholders who will be part of
the coalition.
Budget Narrative (20 points)
• Does the application provide the proposed levels of effort of the project team and consultants
(if needed) and describe how they are adequate and appropriate to advance the project in
accordance with the project plan?
• Does the application include an explanation of how the proposed budget supports the project
and is cost-efficient and reasonable for meeting the project activities?
Pre-Award Risk Assessment
ONC is required to conduct a risk assessment to assess the risk posed by a potential recipient, prior to
issuing an award. In doing so, ONC will consider the applicant’s financial stability, quality of
Page 29 of 59

---

management systems, history of performance, reports and findings from audits, and the applicant’s
ability to effectively implement statutory, regulatory, or other requirements imposed on non-Federal
entities. To facilitate this assessment, ONC may review information available in systems, review
documentation, such as previous audits, and/or desk reviews or site visits conducted from previous
awards. ONC may elect not to fund applicants with management or financial instability that directly
relates to the organization’s ability to implement statutory, regulatory, or other requirements (45 CFR
75.205).
For any Federal award issued under a Notice of Funding Opportunity (NOFO), if the HHS awarding
agency anticipates that the total Federal share will be greater than the simplified acquisition
threshold on any Federal award under a notice of funding opportunity may include, over the period
of performance (see §75.2 Simplified Acquisition Threshold), this section shall also inform
applicants:
• That the HHS awarding agency, prior to making a Federal award with a total amount of
Federal share greater than the simplified acquisition threshold, is required to review and
consider any information about the applicant that is in the designated integrity and
performance system accessible through SAM (currently FAPIIS) (see 41 U.S.C. 2313).
• ONC is required to review and consider any information about the applicant that is in the
Federal Awardee Performance and Integrity Information System (FAPIIS), www.fapiis.gov/,
before making any award greater than the simplified acquisition threshold over the period of
performance. An applicant may review and comment on any information about itself that a
federal awarding agency has previously entered into FAPIIS. ONC will consider any
comments by the applicant, in addition to other information in FAPIIS, in making a judgment
about the applicant's integrity, business ethics, and record of performance under federal
awards when completing the review of risk posed by applicants as described in 45 CFR §
75.205(a)(2) Federal Awarding Agency Review of Risk Posed by Applicants.
Award Decisions
The final award decision will be made by ONC or an authorized designee, taking into consideration
several factors such as the results of the merit review process; results of the pre-award risk assessment;
compliance with programmatic and grants management requirements; the reasonableness of the
estimated costs, available funding, geographical dispersion, program priorities, any mandatory statutes
or regulations associated to this program; and the likelihood that the proposed project will result in the
benefits expected. All applicants will receive a summary of the independent review panel’s assessment
of the application’s strengths, weaknesses, and score.
Page 30 of 59

---

F. Federal Award Administration Information
Federal Award Notices
Successful applicants will receive a letter of notification acknowledging that an award was funded but
does not provide authorization for the applicant to begin performance and expend funds associated with
the award.
Following this notice, successful applicants will receive a Notice of Award (NOA). The NOA will
include, at a minimum, the following:
• Legal name and address of the organization or institutions to whom ONC has issued an award
• Award number assigned by ONC
• Project period, specifying the amount of time ONC intends to support the project without
requiring re-competition for funds
• Total amount of financial assistance approved by ONC during the project period
• Budget period, specifying the increments in which the project will be funded, subject to the
availability of funds
• Applicable award terms and conditions
• Performance goals, indicators, objectives, or expected outcomes (such as outputs, or services
performed or public impacts of any of these) with an expected timeline for accomplishment
The successful applicants’ Authorized Representatives will receive the NOA electronically from ONC.
The recipient accepts the award by drawing down funds. By accepting an ONC award, the recipient
assumes legal, financial, administrative, and programmatic responsibility for administering the award in
accordance with the terms and conditions of the award, as well as applicable laws, rules, regulations, and
Executive Orders governing HHS assistance awards, all of which are to be incorporated into the award
by reference. Failure to comply with these requirements may result in suspension or termination of the
awards and/or ONC’s recovery of award funds.
Terms and Conditions
Administrative and National Policy Requirements
Awards issued under this announcement are subject to 45 CFR Part 75 - Uniform Administrative
Requirements, Cost Principles, and Audit Requirements for HHS Awards currently in effect or
implemented during the period of award, other Department regulations and policies in effect at the
time of award, and applicable statutory provisions. The Code of Federal Regulations (CFR) is
available at www.ecfr.gov.
An application funded with the release of federal funds through a grant award does not constitute, or
imply compliance with federal regulations. Funded organizations are responsible for ensuring that their
activities comply with all applicable federal regulations.
Page 31 of 59

---

HHS Grants Policy Statement
The HHS Grants Policy Statement (HHS GPS) is the Department of Health and Human
Services' single policy guide for discretionary grants and cooperative agreements. ONC grant awards are
subject to the requirements of the HHS GPS, which covers basic grants processes, standard terms and
conditions, and points of contact, as well as important agency-specific requirements. The general terms
and conditions in the HHS GPS will apply as indicated unless there are statutory, regulatory, or award-
specific requirements to the contrary that are specified in the Notice of Award (NOA). The HHS GPS is
available at https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf
Specific terms and conditions are further delineated below due to their importance in terms of integrity,
achieving programmatic objectives, and/or sound financial stewardship of federal funds.
Non-Discrimination Legal Requirements for Recipients of Federal Financial Assistance
Per Executive Order (E.O.) 13985 entitled Advancing Racial Equity and Support for Underserved
Communities Through the Federal Government (Jan. 20, 2021), should you successfully compete for an
award, recipients of federal financial assistance (FFA) from HHS shall administer their programs in
compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national
origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender
identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons
with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides
guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-
rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-
individuals/nondiscrimination/index.html.
.
• Recipients of FFA shall ensure that their programs are accessible to persons with
limited English proficiency. For guidance on meeting your legal obligation to take
reasonable steps to ensure meaningful access to your programs or activities by limited
English proficient individuals. See https://www.hhs.gov/civil-rights/forindividuals/special -
topics/limited-english-proficiency/fact-sheet-guidance/index.htmland https://www.lep.gov.
• For information on your specific legal obligations for serving qualified individuals with
disabilities, including reasonable modifications and making services accessible to
them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs shall be administered in an environment
free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-
discrimination/index.html.
• For guidance on administering your program in compliance with applicable federal
religious nondiscrimination laws and applicable federal conscience protection and
associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscience-
protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Performance Reporting
ONC Program Progress Reports (PPR) are due quarterly. The PPR will address, to the extent applicable:
Page 32 of 59

---

• Degree to which performance goals were attained (actual performance versus targeted
performance)
• Data source and validation method for performance measures
• Opportunities to address performance deficiencies
• Accomplishments
• Next steps
• Challenges/barriers
• Recommendations to address challenges and barriers
ONC will provide specific guidance regarding the content, format, and deadlines for submitting the PPRs
before each report is due.
Each report will be due throughout the fiscal year as follows:
Reporting Period Reporting Due Date
October 1 through December 31 No later than January 31
January 1 through March 31 No later than April 30
April 1 through June 30 No later than July 31
July 1 through September 30 No later than October 31
Additional programmatic requirements, include, but not limited to:
• A Kick-Off Meeting no later than two (2) weeks after award date with members of each recipient
team and ONC is required. The purpose of this meeting is to establish points of contacts,
expectations, and set-up regular check-in calls.
• A monthly (minimum) check-in meeting to be scheduled with project team and your ONC
Project Officer to discuss implementation trajectory, accomplishments, next steps, challenges,
barriers, and recommendations to address challenges and barriers.
• Draft of the Final Report shall be submitted to ONC at least three (3) months prior to the end of
the grant period of performance project period in Microsoft Word and include the following
elements:
o Title Page that includes the following:
1. Title of Project
2. Principal Investigator and Team Members
3. Organization
4. Project Dates
5. Federal Project Officer
6. Acknowledgment of Agency Support
7. Grant Award Number
Final Report Components
Include the following six components using these headings:
Page 33 of 59

---

1. Structured Abstract not to exceed 500 words and with the following sections
a. Purpose
b. Scope
c. Methods
d. Results
e. Key Words
2. Purpose (Project Objectives)
3. Scope (e.g., Background, Context, Settings, Participants, Incidence, Prevalence)
4. Approach (e.g., Study Design, Data Sources/Collection, Interventions, Measures,
Limitations)
5. Results (Principal Findings, Outcomes, Discussion, Conclusions, Significance,
Implications)
6. List of Publications and Products (Bibliography of Published Works and Electronic
Resources from Study)
o A final version of report that incorporates project official feedback shall be submitted to
ONC for review and approval by your project by no later than 90 days after the end of the
grant.
Additional closeout information and requirements may be disseminated prior to the expiration of the
period of performance.
Final Prototype Development
In the event an applicant’s solution include the development of a prototype, the applicant will obtain
ONC’s approval and make the prototype publicly available at no cost to the general public.
Financial Reporting
Expenditures shall be reported, on a semi-annual basis, using the SF-425, Federal Financial Report
(FFR). Reports are due to HHS no later than April 30 of each year the award is active for funds
expended between October and March, and no later than October 31 for funds expended between April
and September. The semi-annual FFR will be submitted using the Payment Management System (PMS).
ONC will not accept reports sent directly to the ONC Grants mailbox.
Federal Funding and Accountability and Transparency Act of 2006
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act) includes a
requirement for recipients of Federal grants to report information about first-tier sub-awards and
executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of
ONC grants and cooperative agreements are required to report to the Federal Subaward Reporting
System (FSRS) available at www.fsrs.gov on all sub-awards over $25,000.
Federal Recipient Performance and Integrity Information System (FAPIIS)
As of January 1, 2016, recipients of Federal grants and cooperative agreements are subject to mandatory
disclosure requirements. Recipients that have Federal contracts, grants, and cooperative agreement
awards from all Federal awarding agencies with a cumulative total value greater than $10,000,000
shall maintain the currency of information reported to the System for Award Management (SAM) that is
made available in the designated integrity and performance system (currently FAPIIS), any information
about criminal, civil, and administrative proceedings that reached its final disposition during the most
Page 34 of 59

---

recent five-year period in connection with the award or performance of a grant, cooperative, agreement,
or procurement contract from the Federal Government. Reporting shall specifically include the
following:
Proceedings About Which You Shall Report
Submit the information required about each proceeding that:
a. Is in connection with the award or performance of a grant, cooperative agreement, or procurement
contract from the Federal Government;
b. Reached its final disposition during the most recent five year period; and
c. If one of the following:
(1) A criminal proceeding that resulted in a conviction, as defined in paragraph 5 of this award
term and condition;
(2) A civil proceeding that resulted in a finding of fault and liability and payment of a monetary
fine, penalty, reimbursement, restitution, or damages of $5,000 or more;
(3) An administrative proceeding, as defined in paragraph 5 of this award term and condition,
that resulted in a finding of fault and liability and your payment of either a monetary fine or
penalty of $5,000 or more or reimbursement, restitution, or damages in excess of $100,000; or
(4) Any other criminal, civil, or administrative proceeding if:
(i) It could have led to an outcome described in paragraph 2.c.(1), (2), or (3) of this award
term and condition;
(ii) It had a different disposition arrived at by consent or compromise with an
acknowledgement of fault on your part; and
(iii) The requirement in this award term and condition to disclose information about the
proceeding does not conflict with applicable laws and regulations.
Reporting Procedures
Enter in the SAM Entity Management area the information that SAM requires about each proceeding
described in paragraph 2 of this award term and condition. You do not need to submit the information a
second time under assistance awards that you received if you already provided the information through
SAM because you were required to do so under Federal procurement contracts that you were awarded.
Reporting Frequency
During any period of time when you are subject to this requirement in paragraph 1 of this award term
and condition, you shall report proceedings information through SAM for the most recent five-year
period, either to report new information about any proceeding(s) that you have not reported previously
or affirm that there is no new information to report. Recipients that have Federal contract, grant, and
cooperative agreement awards with a cumulative total value greater than $10,000,000 shall disclose
semiannually any information about the criminal, civil, and administrative proceedings.
For purposes of this award term and condition:
a. Administrative proceeding means a non-judicial process that is adjudicatory in nature in order to make
a determination of fault or liability (e.g., Securities and Exchange Commission Administrative
proceedings, Civilian Board of Contract Appeals proceedings, and Armed Services Board of Contract
Appeals proceedings). This includes proceedings at the Federal and State level but only in connection
with performance of a Federal contract or grant. It does not include audits, site visits, corrective plans, or
inspection of deliverables.
Page 35 of 59

---

b. Conviction, for purposes of this award term and condition, means a judgment or conviction of a
criminal offense by any court of competent jurisdiction, whether entered upon a verdict or a plea, and
includes a conviction entered upon a plea of nolo contendere.
c. Total value of currently active grants, cooperative agreements, and procurement contracts includes -
(1) Only the Federal share of the funding under any Federal award with a recipient cost share or
match; and
(2) The value of all expected funding increments under a Federal award and options, even if not
yet exercised
This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).
All information posted in the designated integrity and performance system on or after April 15, 2011,
except past performance reviews required for Federal procurement contracts, will be publicly available.
Conflict of Interest
The term “organizational conflict of interest” means that the applicant, including its chief executives,
directors, consultants, sub recipients, or any other personnel that are substantially involved in the
performance of this assistance agreement, has interests which:
• May diminish its capacity to give impartial, technically sound, objective assistance and advise in
performing this task.
• May otherwise result in a biased work product under this assistance agreement; or,
• May result in an unfair competitive advantage to itself or others.
In accordance with 45 CFR 75.112 of the Uniform Administrative Requirements, Cost Principles, and
Audit Requirements for All Federal Awards, all applicants and non-federal entities shall disclose, in
writing, any potential conflict of interest (COI) that they have with the awarding agency and/or any
other pass-through entities. The applicant shall notify the ONC grants management officer (GMO) when
they believe an actual or potential COI may exist.
If, after award, a recipient discovers a COI, with respect to the assistance agreement, it shall make an
immediate and full disclosure in writing to the ONC GMO. The disclosure shall include identification of
the actual or potential conflict, the manner in which it arose, and a description of the action the recipient
has taken, or proposed to take, to avoid, eliminate, or neutralize the conflict.
In the event the recipient was aware of an organizational COI, prior to award of the assistance
agreement, and did not disclose the conflict to the GMO, or becomes aware of an organizational COI
after award of this assistance agreement and does not disclose the COI within ten (10) days of becoming
aware of such conflict, the Government may terminate the assistance agreement and the recipient shall
not be entitled to reimbursement of any costs incurred in performing the assistance agreement.
The rights and remedies of the Government, under this term and condition, shall not be exclusive and
are in addition to any other rights and remedies provided to the Government under law, regulation, or
any other available enforcement mechanism.
Non-Disclosure Requirements
The federal award may require the recipient to have access to information relating to any and all aspects
of grants management operations that may be of a technical, legal, sensitive and/or confidential nature
and which may be the sole property of the U.S. Government. To mitigate risks associated with such
access, the recipient shall ensure that all its personnel, including chief executives, directors, consultants,
Page 36 of 59

---

sub recipients, or any other personnel substantially involved in the performance of this award sign a
non-disclosure agreement prior to the commencement of any work on the award.
In addition, recipients shall put in place appropriate procedures for the protection of such information
and shall be liable to the Government for any misuse or unauthorized disclosure of such information by
its personnel.
The rights and remedies of the Government, under this term and condition, shall not be exclusive and
are in addition to any other rights and remedies provided to the Government under law, regulation, or
any other available enforcement mechanism.
Mandatory Disclosures
In accordance with 45 CFR 75.113, Mandatory Disclosures, of the Uniform Administrative
Requirements, Cost Principles, and Audit Requirements for HHS Awards. The non-Federal entity or
applicant for a Federal award shall disclose, in a timely manner, in writing to the Federal awarding
agency or pass-through entity all violations of Federal criminal law involving fraud, bribery, or gratuity
violations potentially affecting the Federal award. Failure to make required disclosures can result in any
of the remedies described in Section 75.371 of the Uniform Requirements including suspension or
debarment.
Health IT Coordination Requirements
Title XIII of the HITECH Act provides for the advancement of health information technology and health
information exchange through the use of standards and implementation specifications, and through
health information technology certification criteria established by the Secretary.
For grants or cooperative agreements where funding will be used to implement, acquire, upgrade, or
utilize health information technology for activities involving health care providers in ambulatory or
hospital settings (as such health care providers are defined as eligible under Sections 4101, 4102 and
4201 of the HITECH Act), the recipient must implement, acquire, upgrade, or utilize health information
technology certified under the ONC Health IT Certification Program if certified technology can support
the activity and such technology has been certified to the standards and implementation specifications
adopted under section 3004 of the Public Health Service Act.
For all grants or cooperative agreement activities involving the adoption or use of health information
technology standards and systems, or the interoperability (as defined 45 C.F.R. 170.102) of health
information technology, the recipient must implement, acquire, upgrade, or utilize health information
technology that meets standards and implementation specifications adopted under section 3004 of the
Public Health Service Act (PHSA) (identified in 45 CFR Part 170, Subpart B “Standards and
Implementation Specifications for Health Information Technology” (170.200-170.299)) if standards and
implementation specifications in 45 CFR Part 170, Subpart B can support the activity. If standards and
implementation specifications adopted under Section 3004 of the Public Health Service Act cannot
support the activity, the recipient should implement, acquire, update, or utilize technology that meets
non-proprietary standards and implementation specifications that are developed by consensus-based
standards development organizations. This may include standards identified in the ONC Interoperability
Standards Advisory (Link: https://www.healthit.gov/isa/).
Page 37 of 59

---

Intangible Property and Copyrights
Intangible property, as defined in 45 CFR 75.2 means property having no physical existence, such as
trademarks, copyrights, patents and patent applications and property, such as loans, notes and other debt
instruments, lease agreements, stock, and other instruments of property, ownership (whether the
property is tangible or intangible).
(a) Title to intangible property (see 45 CFR §75.2 Intangible property) acquired under a Federal award
vests upon acquisition in the non-Federal entity. The non-Federal entity shall use that property for the
originally authorized purpose, and shall not encumber the property without approval of the HHS
awarding agency. When no longer needed for the originally authorized purpose, disposition of the
intangible property shall occur in accordance with the provisions in 45 CFR §75.320(e).
(b) The Non-Federal entity may copyright any work that is subject to copyright and was developed, or
for which ownership was acquired, under a Federal award. The HHS awarding agency reserves a
royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work
for Federal purposes, and to authorize others to do so. (Please note, for the purpose of this funding
opportunity “work” can be considered as: writings, films, sound recordings, pictorial
reproductions, drawings, designs, or other graphic representations, procedural manuals, forms,
diagrams, work flow charts, equipment descriptions, data files, data processing or computer
programs (software), statistical records, and other technical research data.)
(c) The Non-Federal entity is subject to applicable regulations governing patents and inventions,
including government-wide regulations issued by the Department of Commerce at 37 CFR part 401.
(d) The Federal Government has the right to:
(1) Obtain, reproduce, publish, or otherwise use the data produced under a Federal award; and
(2) Authorize others to receive, reproduce, publish, or otherwise use such data for Federal
purposes
(e) Freedom of Information Act (FOIA). (1) In response to a Freedom of Information Act (FOIA)
request for research data relating to published research findings produced under a Federal award that
were used by the Federal Government in developing an agency action that has the force and effect of
law, the HHS awarding agency shall request, and the non-Federal entity shall provide, within a
reasonable time, the research data so that they can be made available to the public through the
procedures established under the FOIA. If the HHS awarding agency obtains the research data solely in
response to a FOIA request, the HHS awarding agency may charge the requester a reasonable fee
equaling the full incremental cost of obtaining the research data. This fee should reflect costs incurred
by the Federal agency and the non-Federal entity. This fee is in addition to any fees the HHS awarding
agency may assess under the FOIA (5 U.S.C. 552(a)(4)(A)).
(2) Published research findings means when:
(i) Research findings are published in a peer-reviewed scientific or technical journal; or
(ii) A Federal agency publicly and officially cites the research findings in support of an
agency action that has the force and effect of law. “Used by the Federal Government in
developing an agency action that has the force and effect of law” is defined as when an
agency publicly and officially cites the research findings in support of an agency action
that has the force and effect of law.
Page 38 of 59

---

(3) Research data means the recorded factual material commonly accepted in the scientific
community as necessary to validate research findings, but not any of the following: Preliminary
analyses, drafts of scientific papers, plans for future research, peer reviews, or communications
with colleagues. This “recorded” material excludes physical objects (e.g., laboratory samples).
Research data also do not include:
(i) Trade secrets, commercial information, materials necessary to be held confidential by
a researcher until they are published, or similar information which is protected under law;
and
(ii) Personnel and medical information and similar information the disclosure of which
would constitute a clearly unwarranted invasion of personal privacy, such as information
that could be used to identify a particular person in a research study.
(f) The requirements set forth in paragraph (e)(1) of this section do not apply to commercial
organizations.
For any work owned by a third party that was licensed by the recipient under this award, recipient will
assure that said license also reserves for the Government a royalty free, nonexclusive, and irrevocable
right to reproduce, publish, or otherwise use the work for Federal purposes and to authorize others to do
so.
Records Retention
Recipients generally shall retain financial and programmatic records, supporting documents, statistical
records, and all other records that are required by the terms of an award, or may reasonably be
considered pertinent to a grant/cooperative agreement, for a period of three years from the date the final
FFR is submitted. For awards where the FFR is submitted at the end of the competitive segment, the
three-year retention period will be calculated from the date the final FFR, for the entire competitive
segment, is submitted.
45 CFR Part 75.361 provides exceptions and qualifications to the three-year retention requirement. For
example, if any litigation, claim, financial management review, or audit is started before the expiration
of the three-year period, the records shall be retained until all litigation, claims, or audit findings
involving the records have been resolved and final action taken. This section also specifies the retention
period for other types of grant-related records, including indirect cost proposals and property records.
See 45 CFR Part 75.335 for record retention and access requirements for contracts under
grants/cooperative agreements.
Modifications
Modifications and/or amendments to the cooperative agreement shall be effective upon the mutual
agreement of both parties, except where ONC is authorized under the Terms and Conditions of award,
45 CFR Part 75, or other applicable regulation or statute to make unilateral amendments.
Audit Requirements
OMB’s Uniform Administrative Requirements, Cost Principles, and Audit Requirements, Subpart F,
Audit Requirements sets forth standards for obtaining consistency and uniformity among Federal
agencies for the audit of non-Federal entities expending Federal awards. In general, a non-Federal entity
that expends $750,000 or more during the non-Federal entity’s fiscal year in Federal awards shall have a
single or program-specific audit. Subpart F provides further guidance including the manner in which
Page 39 of 59

---

expenditures are determined, the distinction between a single audit and a program-specific audit,
frequency of audits, and roles and responsibilities in the conduct of audits.
Enforcement Actions/Termination
Per 45 CFR Part 75.371, ONC will generally allow the recipient an opportunity to take appropriate
corrective action before terminating a program. ONC may terminate the Cooperative Agreement if the
recipient does not take appropriate corrective action. ONC may also terminate the award, without the
option for corrective action, if the deficiency is so serious as to warrant immediate termination or if
public health or welfare concerns require immediate action.
ONC or the recipient may mutually terminate a Cooperative Agreement, partially or totally, if the two
parties agree upon the termination conditions, including the effective date and the portion to be
terminated. If the recipient decides to terminate a portion of a Cooperative Agreement, ONC may
determine that the remaining portion of the Cooperative Agreement will not accomplish the purposes for
which the Cooperative Agreement was originally awarded. The recipient shall contact the ONC
representative should it decide to terminate all, or part of its Cooperative Agreement as outlined in 45
CFR Part 75.372.
When an award is terminated or partially terminated, the recipient is still responsible for closing out the
award per 45 CFR Part 75.381. The recipient is required to contact their assigned Grants Management
Specialist to obtain closeout instructions. In the event of termination, the recipient will be required to
continue supporting functions of the Cooperative Agreement throughout a 90-day closeout period. This
support includes the transfer of all Work Products created under the Cooperative Agreement to ONC
immediately upon completion/termination of the award.
For the purpose of this program, if the recipient is terminated, the recipient agrees to the transfer of and
future use by ONC and any successor recipient of any Work Products developed under this Cooperative
Agreement.
Please review all HHS regulatory provisions for Termination at 45 CFR Part 75.372.
Page 40 of 59

---

Steven’s Amendment
When issuing statements, press releases, requests for proposals, bid solicitations, and other documents
describing projects or programs funded in whole or in part with Federal money, all receiving Federal
funds included in this Act, including but not limited to State and local governments and recipients of
Federal research grants, shall clearly state—
(1) the percentage of the total costs of the program or project which will be financed with Federal
money;
(2) the dollar amount of Federal funds for the project or program; and
(3) percentage and dollar amount of the total costs of the project or program that will be financed by
non-governmental sources.
Recipients are required to use the following acknowledgement and disclaimer on all products produced
by ONC grant funds:
“This project is/was supported by the Office of the National Coordinator for Health Information
Technology (ONC) of the U.S. Department of Health and Human Services (HHS) under grant number
and title for grant amount (specify grant number, title, total award amount and percentage financed with
nongovernmental sources). This information or content and conclusions are those of the author and
should not be construed as the official position or policy of, nor should any endorsements be inferred by
ONC, HHS or the U.S. Government.”
Recipients are required to use this language when issuing statements, press releases, requests for
proposals, bid solicitations, and other ONC supported publications and forums describing projects or
programs funded in whole or in part with ONC funding. Examples of ONC supported publications
include, but are not limited to, manuals, toolkits, resource guides, case studies, and issues briefs.
508 Compliance
ONC requires its recipients to ensure that any material meant for public release developed by way of
ONC funding is in compliance with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d)
accessible to people with disabilities.
Whistleblower Protections
Recipients of this award must comply with the National Defense Authorization Act (NDAA) for Fiscal
Year (FY) 2013 (Pub. L. 112-239, 41 U.S.C. § 4712) “Enhancement of contractor protection from
reprisal for disclosure of certain information,” and 48 CFR part 3 subpart 3.9, “Whistleblower
Protections for Contractor Employees.” For more information see:
https://oig.hhs.gov/fraud/whistleblower/
Page 41 of 59

---

G. Appendix
Appendix A
Tips for Writing a Strong Application
Include your organization’s Unique Entity Identifier (UEI). You shall include a UEI to have your
application reviewed. For additional information regarding UEI, please access
https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-
management/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-
update.
Keep your audience in mind. Reviewers will use only the information contained in the application to
assess the application. Be sure the application and responses to the program requirements and
expectations are complete and clearly written. Do not assume that reviewers are familiar with the lead
recipient organization. Keep the review criteria in mind when writing the application.
Prepare early. Start preparing the application early. Allow plenty of time to gather required information
from various sources.
Follow the instructions in this guidance carefully. Place all information in the order requested in the
guidance. If the information is not placed in the requested order, you may receive a lower score.
Be brief, concise, and clear. Make your points understandable. Provide accurate and honest
information, including candid accounts of problems and realistic plans to address them. If any required
information or data is omitted, explain why. Make sure the information provided in each table, chart,
attachment, etc., is consistent with the proposal narrative and information in other tables.
Be organized and logical. Many applications fail to receive a high score because the reviewers cannot
follow the thought process of the lead recipient or because parts of the application do not fit together.
Be careful in the use of attachments. Do not use the attachments for information that is required in the
body of the application. Be sure to cross-reference all tables and attachments to the appropriate text in
the application.
Carefully proofread the application. Misspellings and grammatical errors will impede reviewers in
understanding the application. Be sure that page limits are followed. Limit the use of abbreviations and
acronyms, and define each one at its first use and periodically throughout application. Make sure you
submit your application in final form, without markups.
Print out and carefully review an electronic application to ensure accuracy and completion. When
submitting electronically, print out the application before submitting it to ensure appropriate formatting
and adherence to page limit requirements. Check to ensure that all attachments are included before
sending the application forward.
Ensure that all information is submitted at the same time. We will not consider additional
information and/or materials submitted after your initial submission, nor will we accept e-mailed
applications or supplemental materials once your application has been received.
Page 42 of 59

---

Page 43 of 59

---

Appendix B
Instructions – SF-424, Application for Federal Assistance
This is a standard form required for use as a cover sheet for submission of pre-applications and
applications and related information under discretionary programs. Some of the items are required and
some are optional at the discretion of the applicant or the federal agency (agency). Required fields on the
form are identified with an asterisk (*) and are also specified as "Required" in the instructions below.
Item Field Name Information
1. Type of Submission: (Required) Select one type of submission in accordance with agency
instructions.
• Pre-application
• Application
• Changed/Corrected Application - Check if this submission is to
change or correct a previously submitted application. Unless
requested by the agency, applicants may not use this form to
submit changes after the closing date.
2. Type of Application: (Required) Select one type of application in accordance with agency
instructions.
• New - An application that is being submitted to an agency for
the first time.
• Continuation - An extension for an additional funding/budget
period for a project with a projected completion date. This can
include renewals.
• Revision - Any change in the federal government's financial
obligation or contingent liability from an existing obligation. If
a revision, enter the appropriate letter(s). More than one may
be selected. If "Other" is selected, please specify in text box
provided.
A. Increase Award
B. Decrease Award
C. Increase Duration
D. Decrease Duration
E. Other (specify)
3. Date Received: Leave this field blank. This date will be assigned by the Federal
agency.
4. Applicant Identifier: Enter the entity identifier assigned by the Federal agency, if any, or the
applicant's control number if applicable.
5a. Federal Entity Identifier: Enter the number assigned to your organization by the federal agency,
if any.
5b. Federal Award Identifier: For new applications leave blank. For a continuation or revision to an
existing award, enter the previously assigned federal award identifier
number. If a changed/corrected application, enter the federal identifier
in accordance with agency instructions.
Page 44 of 59

---

Item Field Name Information
6. Date Received by State: Leave this field blank. This date will be assigned by the state, if
applicable.
7. State Application Identifier: Leave this field blank. This identifier will be assigned by the state, if
applicable.
8. Applicant Information: Enter the following in accordance with agency instructions:
a. Legal Name: (Required) Enter the legal name of applicant that will undertake the
assistance activity. This is the organization that has registered with the
Central Contractor Registry (CCR). Information on registering with
CCR may be obtained by visiting www.Grants.gov.
b. Employer/Taxpayer Number (Required) Enter the employer or taxpayer identification number (EIN
(EIN/TIN): or TIN) as assigned by the Internal Revenue Service. If your
organization is not in the US, enter 44-4444444.
c. Unique Entity Identifier: (Required) Enter the organization's UEI received from SAM.gov, upon
registering. Information on obtaining a UEI may be obtained by
visiting https://www.gsa.gov/about-us/organization/federal-
acquisition-service/office-of-systems-management/integrated-award-
environment-iae/iae-systems-information-kit/unique-entity-identifier-
update
d. Address: Enter address: Street 1 (Required); city (Required); County/Parish,
State (Required if country is US), Province, Country (Required), 9-
digit zip/postal code (Required if country US).
e. Organizational Unit: Enter the name of the primary organizational unit, department or
division that will undertake the assistance activity.
f. Name and contact information Enter the first and last name (Required); prefix, middle name, suffix,
of person to be contacted on title. Enter organizational affiliation if affiliated with an organization
matters involving this other than that in 7.a. Telephone number and email (Required); fax
application: number.
9. Type of Applicant: (Required) A. State Government
Select up to three applicant B. County Government
type(s) in accordance with C. City or Township Government
agency instructions. D. Special District Government
E. Regional Organization
F. U.S. Territory or Possession
G. Independent School District
H. Public/State Controlled Institution of Higher Education
I. Indian/Native American Tribal Government (Federally Recognized)
J. Indian/Native American Tribal Government (Other than Federally
Recognized)
K. Indian/Native American Tribally Designated Organization
L. Public/Indian Housing
M. Nonprofit
N. Private Institution of Higher Education
O. Individual
P. For-Profit Organization (Other than Small Business)
Page 45 of 59

---

Item Field Name Information
Q. Small Business
R. Hispanic-serving Institution
S. Historically Black Colleges and Universities (HBCUs)
T. Tribally Controlled Colleges and Universities (TCCUs)
U. Alaska Native and Native Hawaiian Serving Institutions
V. Non-US Entity
W. Other (specify)
10. Name of Federal Agency: (Required) Enter the name of the federal agency from which assistance
is being requested with this application.
11. Catalog of Federal Domestic Enter the Catalog of Federal Domestic Assistance number and title of
Assistance Number/Title: the program under which assistance is requested, as found in the
program announcement, if applicable.
12. Funding Opportunity (Required) Enter the Funding Opportunity Number and title of the
Number/Title: opportunity under which assistance is requested, as found in the
program announcement.
13. Competition Identification Enter the competition identification number and title of the
Number/Title: competition under which assistance is requested, if applicable.
14. Areas Affected by Project: This data element is intended for use only by programs for which the
area(s) affected are likely to be different than the place(s) of
performance reported on the SF-424 Project/Performance Site
Location(s) Form. Add attachment to enter additional areas, if needed.
15. Descriptive Title of Applicant's (Required) Enter a brief descriptive title of the project. If appropriate,
Project: attach a map showing project location (e.g., construction or real
property projects). For pre-applications, attach a summary description
of the project.
16. Congressional Districts Of: 15a. (Required) Enter the applicant's congressional district. 15b. Enter
all district(s) affected by the program or project. Enter in the format: 2
characters state abbreviation - 3 characters district number, e.g., CA-
005 for California 5th district, CA-012 for California 12 district, NC-
103 for North Carolina's 103 district. If all congressional districts in a
state are affected, enter "all" for the district number, e.g., MD-all for
all congressional districts in Maryland. If nationwide, i.e. all districts
within all states are affected, enter US-all. If the program/project is
outside the US, enter 00-000. This optional data element is intended
for use only by programs for which the area(s) affected are likely to be
different than place(s) of performance reported on the SF-424
Project/Performance Site Location(s) Form. Attach an additional list of
program/project congressional districts, if needed.
17. Proposed Project Start and End (Required) Enter the proposed start date and end date of the project.
Dates:
18. Estimated Funding:
(Required) Enter the amount requested, or to be contributed during the first funding/budget period by each
contributor. Value of in-kind contributions should be included on appropriate lines, as applicable. If the
Page 46 of 59

---

Item Field Name Information
action will result in a dollar change to an existing award, indicate only the amount of the change. For
decreases, enclose the amounts in parentheses.
Applicants should review matching principles contained in 45 CFR _art 75 before completing Item 18. All
budget information entered under item 18 should cover the upcoming budget period. For sub-item 18a, enter
the federal funds being requested. Sub-items 18b-18e is considered matching funds. The dollar amounts
entered in sub-items 18b-18f shall total at least [cite percentage or fraction] of the amount of federal funds
being requested (the amount in 18a). For sub-item 18f, enter only the amount, if any, which is will be used as
part of the required match.
There are two types of match: 1) non-federal cash and 2) non-federal in-kind. In general, costs borne by the
applicant and cash contributions of any and all third parties involved in the project, including sub-recipients,
contractors and consultants, are considered matching funds. Generally, most contributions from sub-
contractors or sub-recipients (third parties) will be non-federal in-kind matching funds. Volunteered time and
use of facilities to hold meetings or conduct project activities may be considered in-kind (third party)
donations. Examples of non-federal cash match include budgetary funds provided from the applicant
agency’s budget for costs associated with the project.
ONC’s Match Requirement – (Sample Language)
Under this program, the applicant’s match requirement is $1 for every $3 Federal dollars In other words, for
every three (3) dollars received in Federal funding, the applicant shall contribute at least one (1) dollar in
non-Federal resources toward the project’s total cost. This “three-to-one” ratio is reflected in the following
formula which you can use to calculate your minimum required match:
Federal Funds Request/3 = Minimum Match Requirement
For example, if you request $100,000 in Federal funds, then your minimum match requirement is $100,000/3
or $33,333. In this example the project’s total cost would be $133,333.
If the required non-Federal share is not met by a funded project, ONC will disallow any unmatched Federal
dollars.
Indirect charges may only be requested if: (1) the applicant has a current indirect cost rate agreement
approved by the Department of Health and Human Services or another federal agency; or (2) the applicant is
a state or local government agency. State governments should enter the amount of indirect costs determined
in accordance with HHS requirements. If indirect costs are to be included in the application, a copy of the
approved indirect cost agreement shall be included with the application. Further, if any sub-contractors or
sub-recipients are requesting indirect costs, copies of their indirect cost agreements shall also be included
with the application.
19. Is Application Subject to (Required) Applicants should contact the State Single Point of Contact
Review by State Under (SPOC) for Federal Executive Order 12372 to determine whether the
Executive Order 12372 application is subject to the State intergovernmental review process.
Process? Select the appropriate box. If "a." is selected, enter the date the
application was submitted to the State.
20. Is the Applicant Delinquent on (Required) Select the appropriate box. This question applies to the
any Federal Debt? applicant organization, not the person who signs as the authorized
Page 47 of 59

---

Item Field Name Information
representative. Categories of federal debt include but, may not be
limited to: delinquent audit disallowances, loans and taxes. If yes,
include an explanation in an attachment.
21. Authorized Representative: To be signed and dated by the authorized representative of the
applicant organization. Enter the first and last name (Required); prefix,
middle name, suffix. Enter title, telephone number, email (Required);
and fax number. A copy of the governing body's authorization for you
to sign this application as the official representative shall be on file in
the applicant's office. (Certain federal agencies may require that this
authorization be submitted as part of the application.)
Page 48 of 59

---

Appendix C
Instructions – SF-424A, Budget Information for Non-Construction Programs
Standard Form 424A is designed to accommodate applications for multiple grant programs; thus, for
purposes of this program, many of the budget item columns and rows are not applicable. You should
only consider and respond to the budget items for which guidance is provided below. Unless otherwise
indicated, the SF 424A should reflect a two-year budget.
Section A Budget Summary
Line 5: Leave columns (c) and (d) blank. Enter TOTAL federal costs in column (e) and total nonfederal
costs (including third party in-kind contributions and any program income to be used as part of the
recipient match) in column (f). Enter the sum of columns (e) and (f) in column (g).
Section B Budget Categories
Column 3: Enter the breakdown of how you plan to use the federal funds being requested by object class
category (see instructions for each object class category below).
Column 4: Enter the breakdown of how you plan to use the non-federal share by object class category.
Column 5: Enter the total funds required for the project (sum of Columns 3 and 4) by object class
category.
Separate Budget Narrative/Justification Requirement
You shall submit a separate budget narrative/justification as part of your application. When more than
33% of a project’s total budget falls under a contractual expense, a detailed budget
narrative/justification shall be provided for each sub-contractor or sub-recipient. Applicants
requesting funding for multi-year grant programs are required to provide a combined multi-year
budget narrative/justification, as well as a detailed budget narrative/justification for each year of
potential grant funding. A separate budget narrative/justification is also required for each potential
year of grant funding requested.
In your budget narrative/justification, you should include a breakdown of the budgetary costs for all of
the object class categories noted in Section B, across three columns: federal; non-federal cash; and
non-federal in-kind. Cost breakdowns, or justifications, are required for any cost of $1,000 or more.
The budget narratives/justification should fully explain and justify the costs in each of the major
budget items for each of the object class categories, as described below. Non-federal cash as well as,
sub-contractor or sub-recipient (third party) in-kind contributions designated as match shall be clearly
identified and explained in the budget narrative/justification. The full budget narrative/justification
should be included in the application immediately following the SF 424 forms. This should include a
budget narrative for the entire period of performance.
Page 49 of 59

---

Line 6a: Personnel: Enter total costs of salaries and wages of applicant/recipient staff. Do not include the
cost of consultants. Consultant costs should be included under 6h, Other. In the budget
narrative/justification: Identify the project director, if known. Specify the key staff, their titles, brief
summary of project related duties, and the percent of their time commitments to the project in the budget
narrative/justification.
Some Points to Consider:
Is the basis for determining each employee’s compensation described (annual salary and % time
devoted)?
Is each position identified by title/responsibility?
Are time commitments and the amount of compensation stated and reasonable?
Are salary increases anticipated during the grant period and are they justified (COLA, etc.)?
Are any personnel costs unallowable?
o Dual Compensation
o Federal Employee
Line 6b: Fringe Benefits: Enter the total costs of fringe benefits unless treated as part of an approved
indirect cost rate. In the justification: Provide a breakdown of amounts and percentages that comprise
fringe benefit costs, such as health insurance, FICA, retirement insurance, etc.
Some Points to Consider:
Is the amount specified as a separate line item?
Is each type of benefit indicated separately or does the organization have an approved fringe
benefit rate?
Are fringe increases contemplated during the grant period?
Are any fringe costs unallowable?
Line 6c: Travel: Enter total costs of out-of-town travel (travel requiring per diem) for staff of the project.
Do not enter costs for consultant’s travel - this should be included in line 6h. In the justification: Include
the total number of trips, destinations, purpose, and length of stay, subsistence allowances and
transportation costs (including mileage rates).
Line 6d: Equipment: Enter the total costs of all equipment to be acquired by the project. For all
recipients, “equipment” is nonexpendable tangible personal property having a useful life of more than
one year and an acquisition cost of $5,000 or more per unit. If the item does not meet the $5,000
threshold, include it in your budget under Supplies, line 6e. In the justification: Equipment to be
purchased with federal funds shall be justified as necessary for the conduct of the project. The
equipment shall be used for project-related functions; the equipment, or a reasonable facsimile, shall not
be otherwise available to the applicant or its sub recipients. The justification also shall contain plans for
the use or disposal of the equipment after the project ends.
Some Points to Consider:
Are equipment items specified by unit and cost?
Is the request reasonable and allowable under the project?
Does the organization have a procurement policy in place?
Is a lease vs. purchase study necessary (vehicles, large items of equipment)?
Are purchases distinguishable from rentals?
Page 50 of 59

---

[Document continues — 9 more pages]