Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for the establishment of the Whole Person Research and Coordination Center (Whole Person RCC) under the NIH Whole Person Initiative. This center will be integral in coordinating the initial and future research programs in whole person health research. Its creation is driven by the goal to seamlessly integrate current and emerging biomedical knowledge about human health, thereby forming a comprehensive, multi-scale human knowledge network. This NOFO aims to accomplish two major objectives with the first objective of the highest priority. The first objective is to build a healthy human whole person physiome conceptual map to represent all physiological organ system functions and identify Common Data Elements (CDEs) appropriate for each major physiological function. It is envisioned that the conceptual map will not be built from data using computational methods (e.g., AI/ML), but will be mapped by a team of content experts using existing established knowledge of healthy human physiology, linking all physiological systems into a whole. The second objective is to select and test existing datasets for the conceptual map and CDEs and build at least one prototype in silico model of whole person. The Whole Person RCC’s role will additionally include fostering multidisciplinary collaboration and providing the logistical support infrastructure for the entire NIH Whole Person Initiative. 

Background 

Because humans function as whole, interconnected persons, the vision of whole person health must be guided by a well-defined and integrated understanding of complete human function and various micro, meso, and macro factors that shape it, including atomic, molecular, molecular complexes, sub-cellular, cellular, multi-cell systems, tissue, organ, multi-organ systems, organism/individual, group, organization, market, environment, and populations. This bold vision, supported by the rapidly expanding availability of “big data,” computational modeling and artificial intelligence/machine learning (AI/ML), is increasingly within reach. Approaching human health as a whole, however, is challenging in two fundamental ways.  First, there is a strong tendency for all biomedical research data to be compartmentalized into “silos”—organ/system silos (e.g., nervous, cardiovascular, digestive, musculoskeletal, immune, craniofacial, and reproductive system), biological/spatial scale silos (molecular, cellular, physiological, behavioral, social, environmental) and life-stage silos. Second, we currently lack an integrated framework that bridges across all these types of data. Such an integrated framework is essential to support the building of multi-scale mechanistic and data-driven models that span across the whole person because, without this, models will naturally fall into biological/spatial scale silos. Furthermore, such a framework needs to do more than simply linking data types—it needs to be a “knowledge network” that links established conceptual scientific and biomedical knowledge to new emerging knowledge at all scales derived from computational analyses of real-world clinical data. Because such a fundamental, multi-scale whole person scientific knowledge network does not currently exist and is needed to move the field of whole person health forward, the goal of this initiative is to fill this gap, starting with building an integrated conceptual map of healthy physiological function.  

The National Center for Complementary and Integrative Health (NCCIH), in collaboration with 14 other NIH Institutes, Centers, and Offices (ICOs), orchestrated the Methodological Approaches for Whole Person Research Workshop (September 2021). This workshop underscored the insufficiency of single-disease or single-body-part models in addressing the multifaceted health challenges facing the United States today. Current methodologies often focus narrowly on isolated symptoms or conditions, neglecting the complex interplay of factors that contribute to overall well-being. The discussions highlighted the urgent need for insights into multicomponent interventions and their impact on multisystem outcomes, paving the way for a richer understanding of pathophysiology and the design of therapeutic interventions that consider the entire individual within their environmental context. Significant gaps remain in our understanding and approach to whole person health. Therefore, NCCIH, in collaboration with multiple participating NIH ICOs, defines whole person research in NCCIH’s strategic plan as including three components: (1) exploring the fundamental science of interconnected systems; (2) investigating multicomponent interventions or therapeutic systems; and (3) examining the impact of these interventions on multisystem or multiorgan outcomes. This initiative aims to bridge the gaps in our understanding of whole person health by fostering a more integrative and holistic approach to health research. 

Objectives, Scope, and Priorities

To address these challenges and propel the field of whole person health research forward, a research and coordination center will be indispensable. The coordination center is envisioned to lay the groundwork by starting to map a multiscale human whole person knowledge network that will be augmented, updated, and embellished over many years. The ultimate vision is to create a fully integrated, human whole person multiscale knowledge network with all the interconnected multiscale component linkages. For this initial phase of the NIH Whole Person Initiative, the objectives and scope will focus solely on creating a conceptual map of the physiome layer involving all the vital organs and physiological systems in the human body. Importantly, this initial conceptual map will not be built from data using computational methods (e.g., AI/ML). Rather, it will be mapped initially by a team of content experts using existing established mechanistic knowledge of healthy human physiology, linking all physiological systems into a whole. Ongoing efforts in whole person research will add to this important initial work to leverage the knowledge and incorporate many additional scales in later years including: molecular processes (intra and extracellular), tissues, cells and microenvironment (structure and biomechanics), behavior and lifestyle factors, social determinants of health, mental health, life-span developmental factors and cultural factors, and the macroenvironment (e.g., pandemics, conflicts, climate change). Mapping out human whole person "system effects" will be crucial for building more accurate multiscale models of whole person health, and in the long-term for developing effective, sustainable, and personalized multi-component interventions in the future.  

This NOFO calls for a Whole Person Research and Coordination Center (Whole Person RCC) to lead the work starting in years 1-2 by mapping the full basic “physiome” reflecting all vital human organs and physiological systems in the body for both sexes. This first mapping exercise will delineate all the vital physiological functions and their known connections across organ systems and identify relevant clinical measurements for each physiological function to eventually allow for a seamless link to patient electronic health records (EHRs; i.e., clinical markers that form Common Data Elements). This first step will lay the foundational framework for creating and testing a prototype in silico physiome model in years 3-5 using relevant existing clinical datasets for connecting the physiological organ systems (e.g., All of Us, Bridge to Artificial Intelligence [Bridge2AI], Trans-Omics for Precision Medicine [TOPMed], Stimulating Peripheral Activity to Relieve Conditions [SPARC], Molecular Transducers of Physical Activity Consortium [MoTrPAC], or Harnessing Data Science for Health Discovery and Innovation in Africa [DS-I Africa] clinical datasets). The Whole Person RCC is poised to bring order and coherence to existing physiological evidence, weaving it into an overall knowledge-based conceptual map first and then into a complex knowledge network ready to embrace and integrate relevant clinical data.  

The Whole Person RCC will accomplish the initial mapping steps using multidisciplinary domain experts who will engage in consensus discussions (e.g., workshops or meetings) drawing on the existing knowledge of physiology and clinical care using methodologies such as participatory systems mapping or systems dynamics conceptual model building or other relevant expert consensus approaches. The goal of the content experts will be to delineate a knowledge-driven conceptual map of all the vital fundamental physiological functions and their known connections to organ systems and suggest associated clinical measures that can be linked to EHRs. This conceptual map must account for both sexes, and while it may begin with healthy young adult physiology, it should allow for consideration of the physiome functioning in younger and older people. This knowledge-driven process will create an initial map of the entire healthy human physiome that can be built upon with assistance in later steps using data science and modeling tools to eventually construct a whole person physiome knowledge network reflecting the scientific evidence-base of all the interconnected physiological organ systems and functional clinical measures. Ultimately this organ-system physiome conceptual map should lay the groundwork for the creation and preliminary testing of in silico whole person physiome models using existing clinical data collections. A key future goal of the initiative will be to seed the establishment of a sustainable shareable or open-source ecosystem of data and models, and a whole person knowledge network that can integrate new evidence and scales of analysis over time.  

In addition to starting the human whole person conceptual mapping process with the physiome layer, the Whole Person RCC will serve the overarching function of coordinating all ongoing and future expansions of the NIH Whole Person Initiative research projects, programs, and networks while supporting multidisciplinary teams and fostering communication, collaboration, team science, common ontologies, interoperability, model credibility, resource sharing, harmonization, and dissemination.

The highest priority of this initiative is the initial step and the first objective to establish the healthy human whole person physiome conceptual map with the associated CDEs.  Descriptions to accomplish the second objective (to build at least one prototype in silico model of whole person) may be less detailed, focusing on the criteria and brief plans for recruiting appropriate expertise, selecting the candidate existing databases, as well as building the prototype computational model(s). Past experiences and accomplishments building collaborative research teams, utilizing existing databases to conduct research, and/or employing computational modeling methodology may also be provided as illustrative examples of potential capabilities. The plans to accomplish the second objective may be modified upon the completion of the first objective post award through the cooperative mechanism to optimize its outcomes and impact. More details are described under the required Core Elements below. 

Required Cores 

Establishing and developing this first phase of the NIH Whole Person Research Initiative will require scientific teams with a wide breadth of collective expertise spanning many disciplines especially experts in physiology, clinical measurements, basic biomedical sciences, integrative health, health services, mathematics, software development and engineering, bioethics, bioinformatics, data science, computer science, systems science, artificial intelligence, and machine learning. 

To realize these ambitious objectives, the Whole Person RCC applications to this NOFO are required to include four essential elements: a Scientific Leadership Core, an Expert Domain Mapping and Common Data Elements Core, a Data Science and Modeling Core, and a Coordination Core.  

Scientific Leadership Core - This core is charged with both guiding the scientific direction and overseeing the comprehensive coordination of the project and all cores. Endowed with biomedical and clinical research and computational expertise, its primary responsibilities encompass the establishment of a Steering Committee to lead and advise on pivotal matters, such as ethical considerations and incorporating state-of-the-art methodologies from other fields. It aims to cultivate collaboration and interaction among the 4 required elements, ensuring the overarching success of the Whole Person RCC. Integral to its operations is the collaboration with Federal partners, aligning goals, and sharing expertise. 

Expert Domain Mapping and Common Data Elements Core - This core serves as a critical component in the pursuit of the NIH Whole Person Research Initiative. It aims to coordinate the content expert mapping process to establish a comprehensive healthy human whole person physiome conceptual map. This will be accomplished via content expert consensus discussions (e.g., via workshops or meetings) drawing on the existing knowledge of physiology and clinical care using methodologies such as participatory systems mapping or systems dynamics conceptual model building or other relevant systematic collective model building approaches. As part of objective one of the research program, this core will create an organ-system conceptual map that encapsulates all known interactions of the vital bodily systems for both sexes and will identify standardized data elements crucial for clinical research and patient care. While the mapping may first focus on healthy young adult physiology, it should allow for consideration of the physiome functioning in younger and older people. This core will be instrumental in fostering consistency, comparability, and interoperability in the components of the conceptual map, including standardized ontologies ultimately setting the groundwork for in silico prototype modeling.   

• Phase 1 (Years 1-2): (1) Develop a pilot organ-system physiome map that accurately represents all of the vital physiological organ system functions and known interactions, incorporating relevant ontologies and vocabularies of precise characterization of the entire physiome, and (2) Identify clinical markers of Common Data Elements (CDEs) to effectively represent each vital physiological function in the system, ensuring consistent and standardized terminology across the research initiative. The Core will coordinate with the Data Science and Modeling Core to ensure the conceptual map can be used by a wide variety of stakeholders.   
• Phase 2 (Years 3-5): Coordinate with the Data Science and Modeling Core to develop a prototype interactive in silico physiome model utilizing AI/ML technologies if relevant for more sophisticated and dynamic mapping capabilities. 

Data Science & Modeling Core - This core is to leverage the established physiome conceptual map and CDEs developed in objective one as a foundational framework for developing a prototype holistic computational model as part of the second objective. The prototype model should aim to accurately capture the complex dimensions of the whole person physiome. This will be achieved by integrating existing clinical datasets, along with incorporating comprehensive ontologies and standard vocabularies to ensure precise and uniform representation of  interconnected physiological aspects. This core must also establish plans to share the prototype model widely to allow for new users and future NIH Whole Person Initiative projects and teams to build on the prototype model. This will require fostering computing infrastructure, team science principles, common ontologies, interoperability, model credibility, harmonization, and very clear and timely resource model sharing and dissemination plans (e.g., considering access, privacy, license and end user evaluation processes). This core will need to demonstrate credible data and model development practices and use agreements and provide for full resource-sharing and model access for any and all datasets/models developed through the U24 award support so that new users can pilot test and expand upon these initial efforts over time as part of the wider goals for developing the NIH Whole Person Initiative. This core will also ensure that all existing datasets used and resources created are disseminated according to the Findable, Accessible, Interoperable, and Reusable (FAIR) principles (https://www.nlm.nih.gov/oet/ed/cde/tutorial/02-200.html). 

• Phase 1 (Years 1-2): Bring together technical expertise across a broad  range of biomedical, clinical, and data scientists; software and data engineers; computational modelers; etc. to develop an interface for using the physiome conceptual map across multiple stakeholders. The core will coordinate with the Expert Domain Mapping and Common Data Element Core to collect feedback on the useability of the physiome conceptual map. 
• Phase 2 (Years 3-5): Choose and evaluate existing datasets for the physiome conceptual map and CDEs, perhaps utilizing artificial intelligence (AI) algorithms or other tools as relevant to refine the selection process. Then, employ computational tools and/or AI-driven techniques as relevant to construct advanced prototype in silico models that comprehensively represent the whole person physiome and associated clinical measurements. Demonstrate credible data access and data use agreements for the existing data used to develop the conceptual map and in silico models and provide for full model reuse for any and all existing clinical datasets/models within of the overall Resource Sharing Plan. 

Coordination Core - The core will be expected to provide the logistical support and infrastructure for the entire NIH Whole Person Research Initiative. It will take on the responsibilities of working in concert with the Scientific Leadership Core and all other  cores to orchestrate the scientific assemblies, from regular meetings to annual investigator convocations and various outreach programs. This core will be responsible for organizing and supporting the costs and logistics for annual face-to-face, one and one and a half-day meetings of the NIH Whole Person Research Initiative in the greater Washington, D.C. area. Acting as the backbone for logistical and communications operations, it guarantees unified efforts by the other cores to support a scientifically robust expert consensus framework. Beyond its internal functions, it stands as the central hub interlinking research endeavors and networks associated with the NIH Whole Person Research Initiative, upholding streamlined communication and efficient logistical coordination across the board, including assisting the Data Science and Modeling Core with the resource model sharing and dissemination plans and building a community of new model users and stakeholders. This core will require strong leadership to bring teams together, and the ability to provide the logistical skills needed to support a large, multi-institute NIH Whole Person Research Initiative research portfolio.

NIH project scientists will be assigned to have significant involvement working directly with the Core teams on all activities to achieve the goals and adjust the milestones, as detailed below, as appropriate.

Milestones and Timeline 

Research and coordination center approaches must be driven by milestones specifying quantitative and clearly measurable performance-based goals to achieve completion of the project on time and on budget. NIH staff, in collaboration with the awardee, will closely monitor progress, milestones, and accrual of the project. Activities proposed for each of the four cores must be milestone-driven over 5 years, and these milestones may be re-negotiated prior to an award. At a minimum, the suggested timeline of milestones and deliverables should include completing a fully interconnected known physiological systems conceptual map by Year 2, and at least one whole-body in silico prototype physiome model that is representative of both sexes and reflective of healthy young adults by Year 5. Applications must include the following four cores:

Scientific Leadership Core 

Years 1-5: Bring together scientific teams with a wide breadth of collective expertise spanning many disciplines especially experts in physiology, clinical measurements, basic biomedical sciences, integrative health, health services, mathematics, software development and engineering, bioethics, bioinformatics, data science, computer science, systems science, artificial intelligence, and machine learning, and cultivate collaboration and interaction among various functions (e.g., meaningful team science partnerships), ensuring the overarching success of the proposed U24 award. 

Expert Domain Mapping and Common Data Elements Core (Objective 1)

Years 1-2: Convene the domain experts for the conceptual mapping process to establish a preliminary mapping that encapsulates the known intricate interactions of all the vital bodily organ systems and identifies standardized clinical data elements to represent whole body organ system functioning. This core will be instrumental in fostering consistency, comparability, and interoperability in the components of the conceptual map, including standardized ontologies ultimately setting the groundwork for in silico prototype modeling. Plans for timely sharing of the conceptual map and CDEs should be clearly outlined in the Resource Sharing Plan. 

Years 3-5: Begin working closely with the Data Science and Modeling Core to build a prototype in silico model (or map) of the whole person physiome and clinical measures.  

Data Science and Modeling Core  (Objective 2)

Years 1-2: Bring together technical expertise across a broad  range of biomedical, clinical, and data scientists; software and data engineers; computational modelers; etc. to develop an interface for using the physiome conceptual map across multiple stakeholders. The core will coordinate with the Expert Domain Mapping and Common Data  Elements Core to collect feedback on the useability of the physiome conceptual map. 

Years 3-5: Identify relevant existing clinical datasets that can be used to test the conceptual map and CDEs and build a prototype in silico whole person physiome model. Establish plans to share the prototype model widely and allow for new users and future NIH Whole Person Research Initiative research projects and teams to build the expert domain mapping, CDEs, and prototype model to create new and more sophisticated whole person model variations over time. This core should demonstrate resource sharing plans for credible data modeling and access as well as data use agreements and provide for full and FAIR data and model sharing. 

Coordination Core 

Years 1-5: Provide critical support infrastructure for the entire NIH Whole Person Research Initiative research program and across the Whole Person RCC U24 cores. Coordinate all relevant RCC scientific meetings and provide the logistical and communications infrastructure to facilitate the coordination for all Initiative efforts. Coordinate future NIH Whole Person Initiative inter-project scientific meetings such as hosting virtual meetings and providing minutes. This core will be responsible for organizing and supporting the costs and logistics for face-to-face annual one and one and half-day meetings of the NIH Whole Person Initiative in the greater Washington, D.C. area. As future projects are added to the program, each will be asked to budget for traveling principal investigators to the annual face-to-face meeting.   

Requirements of Structure and Governance 

The organizational framework for the Whole Person RCC must include the four major elements, described above, and is expected to promote interaction across the cores. Please see Section VI.2, Cooperative Agreement Terms and Conditions of Award, for further detail.  

The Coordination Center must also: 

•  Establish and maintain support for a Steering Committee to include principal investigators, and  scientific representatives from across the NIH Whole Person Initiative including representation from NIH. 
• In collaboration with the Steering Committee and Federal partners, develop standard operating procedures for the research program. 
• Create and manage relevant logistic infrastructure to plan and support conference calls, web-based meetings, meetings of the Steering Committee, cores, and any ad hoc working groups. 
• Create systems and maintain an ability to communicate rapidly and efficiently with investigators funded through the entire funded research program and establish ways to share the prototype model(s) and allow for new users and future NIH Whole Person Research Initiative projects and teams to build on the prototype whole person physiome model in the true spirit of data sharing supporting FAIR principles, trustworthiness, and ethics. 

Scope 

Applications will not be considered responsive to this NOFO and will be withdrawn without review if: 

• They do not include all four core requirements specified above. 
• They have no specified milestones. 
• They propose to collect new data.
• They involve animal studies.
• They do not include a Resource Sharing Plan.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Jessica McKlveen, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-8018
Email: jessica.mcklveen@nih.gov

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

, with the following exceptions or additional requirements:

For this specific NOFO, the Research Strategy is limited to 30 pages. 

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

The applicant must include funds for the RCC PD/PI and key personnel to support and attend annual one-and-one half-day meetings in the greater Washington D.C. area. Funds need to be included for the RCC to host the meeting, including the meeting room and all other expenses. As future projects are added to the program, each project will be asked to budget for traveling principal investigators to the annual face-to-face meeting.   

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: Applicants should present a clear vision, detailed objectives, and specific goals for the establishment of the Whole Person RCC. The Specific Aims page should concisely summarize the following aspects: 

Objectives for Establishing the Center: Outline the primary aims of the proposed center, focusing on the development of a healthy human whole person physiological systems conceptual map (Objective 1) and a prototype in-silico whole person physiome model (Objective 2). 

Organizational Framework and Management: Describe the proposed structural and governance framework of the four required cores for the RCC. 

Professional Expertise Recruitment Strategy: Specify the types of expertise and professional backgrounds targeted for recruitment to contribute to the Center's development. 

Essential Components for Center Infrastructure: Identify and explain the fundamental components and resources necessary for the establishment and operation of the RCC including possible data types/resources that the team anticipates for the program and plans for resource /model sharing to accommodate new users and teams as the initiative grows. 

Anticipated Outcomes and Long- Term Objectives: Highlight the expected outcomes from the center's activities and discuss how these align with and contribute to a vision of the NIH Whole Person Initiative. 

Research Strategy: The Research Strategy should consist of the following sections: 

Scientific Objectives and Significance: The application should provide a thorough exploration of the essential goals and the two required objectives of the RCC. It should emphasize the significance and relevance of these goals in advancing the field. This section must extend beyond the information provided in the biographical sketches to detail the collective expertise and unique strengths of the team toward meeting the scientific objectives proposed.  

Emphasis should be placed on the innovative methods and strategies that the team will employ, highlighting how these approaches set this Center apart. A critical part of this segment is to provide concrete metrics and examples of past successful scientific coordination projects to indicate the likelihood of success. This section should also describe the conducive and supportive work environment that will foster these innovations. 

Structure and Governance: The Structure and Governance section should provide full details on the organizational structure and governance model of the RCC and each of the four required cores. The processes involved in developing comprehensive terms of use, including the establishment of protocols for data licensing and the implementation of robust privacy and ethical guidelines need  to be provided in detail. The emphasis should be on documenting these processes in a manner that aligns with industry best practices and regulatory standards. 

In addition, the application should include a detailed management plan that outlines strategies for effective coordination across various institutions. This is particularly crucial for projects that span multiple organizations. The plan should describe the mechanisms for seamless collaboration, ensuring that activities at one institution complement and enhance but do not duplicate efforts at others. This section should also address how the Center's proposed activities will integrate with and support relevant ongoing projects at participating institutions and how to resolve disagreements/conflicts. 

"Expertise, Research Initiative Needs and Engagement": This section must articulate the Center’s approach to cultivating a multidisciplinary research culture for the program. It should detail strategies for attracting and nurturing a broad  array of experts from various fields. The focus should be on creating a collaborative ecosystem that not only encourages but actively supports interdisciplinary and diverse teams aligned with NIH’s interest in  diversity (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html). This includes establishing platforms and opportunities for these teams to engage, share insights, and work cohesively to achieve the objectives and all the proposed activities of the RCC.  

The application should also outline how the Center will enhance communication and collaboration among researchers. It needs to describe the implementation of systems and technologies that promote interoperability between different research groups, facilitating the open exchange of data, models, and ideas and accommodating new users over time. The credibility of the models developed within the Center is paramount, so the application should describe the processes in place to ensure their reliability and accuracy. 

Moreover, the Center should demonstrate its commitment to harmonizing various research efforts. This involves synchronizing activities, methodologies, and goals across different projects and programs to achieve a cohesive research strategy. The dissemination of findings and knowledge is another critical aspect, and the application should include a Resource Sharing Plan that addresses  timely and effective resource sharing, including for the conceptual map, the CDEs, and any models and results with the broader scientific community, new modelers/users, and stakeholders. 

In addition, this section should emphasize the Center's role in overseeing and coordinating an expanding program of potential future initiatives related to the NIH Whole Person Research Initiative. This includes outlining a framework for integrating new projects and networks under the Center's umbrella, ensuring that they align with the overarching objectives and contribute to the Whole Person Research Initiative advancement. 

Whole Person Physiological System Conceptual Map Development and Management Plan: The application should clearly state how the cores of the RCC  will interact and the role of each  core in meeting the objectives and responsibilities of the RCC. The applicant should describe each  core separately and the integration between cores, with a focus on how the overall RCC will achieve the goals driven by milestones specifying quantitative and clearly measurable performance-based goals to achieve completion of the project on time and on budget. It should also describe the governance and organizational structure of the leadership team, including communication plans, the process for making decisions on scientific direction, and procedures for resolving conflicts. 

In years 1-2, Whole Person RCC should prioritize its work on mapping the full basic “physiome” reflecting all vital human organs and physiological systems in the body for both sexes. In years 3-5, the Whole Person RCC sh ould focus on populating the established physiome conceptual map and CDEs from years 1-2 with data from existing cohort studies and develop at least one whole person physiological prototype computational model to ascertain inter-system connections and interactions utilizing AI/ML technologies. The highest priority is to build the healthy human whole person physiome conceptual map to represent all vital physiological organ system functions, and identify CDEs  appropriate for each major physiological function. Important details Past experiences and accomplishments building collaborative research teams, utilizing existing databases to conduct research, and/or employing computational modeling methodology may also be provided as illustrative examples of potential capabilities.  

Applications are required to include four essential elements: a Scientific Leadership Core, an Expert Domain Mapping and Common Data Elements Core, a Data Science and Modeling Core, and a Coordination Core.   

Scientific Leadership Core:  

The emphasis of the Scientific Leadership Core should be on integrating broad  areas of expertise to guide the research and development process effectively. It should serve as the central hub for intellectual leadership and strategic direction, ensuring that the project remains innovative, ethically sound, and aligned with the broader objectives of NIH and the scientific community. 

Role and Task Specification: This core should explicitly outline the distinct roles and responsibilities it will undertake. This includes leadership roles, research oversight, project management, and coordination tasks. The aim is to define a clear structure for decision making, problem solving, and strategy development within the project. 

Scientific Expertise: The core should encompass a wide array of scientific disciplines to foster a comprehensive approach and should include expertise in organizational science and/or team science.  Expertise will be needed such as from the basic biological sciences for foundational research; physiology, clinical measurements, and integrative health for a holistic view of health and wellness; health services to incorporate healthcare delivery aspects; mathematics and engineering for technical problem-solving and innovation; bioethics to ensure ethical considerations; data science and computer science for managing and analyzing large data sets; systems science to understand complex interrelations; and AI/ML for advanced computational solutions. This blend of expertise will ensure a multifaceted approach to research and development. 

Collaboration With NIH Partners: The core must establish a framework for effective collaboration with NIH program officials. This includes setting up communication channels for regular updates and consultations, collaborative workshops, or meetings to discuss progress and challenges, and joint task forces for specific research or development areas, fostering a synergistic relationship that enhances the overall outcomes. Applicants should describe their willingness to be flexible in determination of areas of responsibilities in this collaborative program. Applicants must indicate their willingness to cooperate with future projects that will be added to this program and with the NIH in the development of the physiome conceptual map and the associated CDEs and the conceptual model.  Applicants should describe their prior experience working collaboratively in research consortia and other collaborative projects to accomplish shared goals.

Expert Domain Mapping and Common Data Element Core: 

• Should describe the roles and activities to be held in this core 
• Should describe the collective technical expertise to be involved in this Core (e.g., physiology, biomedical, clinical measurement, data scientists) 
• Should define the comprehensive scope of physiological organ systems/functions to be represented in the human whole person physiological conceptual map 
• Should describe how to define CDEs appropriate for each vital physiological function and clinical measures to be modeled by the knowledge framework 
• Should define how to standardize CDEs  
• Should describe the coordination with the Data Science and Modeling Core to build a prototype of interactive in silico whole person model (or map) of the whole person physiome 
• Should describe resource sharing plans to share the conceptual whole person map and affiliated CDEs in a timely manner.

Data Science and Modeling Core: 

• Should describe the collective technical expertise to be involved in this core (e.g., biomedical, clinical measurements, data scientists, computational modeling experts, software engineers) and how this expertise will contribute to a truly comprehensive model of whole person health 
• Should describe the coordination with Expert Domain Mapping and Common Data Elements Core to ensure framework, data, and model interoperability by identifying or developing suitable technologies 
• Should provide an illustrative description of existing data sets and CDEs anticipated to be integral to the development of the in silico whole person physiome model 
• Should describe how to build a prototype in silico models of the whole person physiome 
• Should describe resource sharing plans for the prototype model widely and allow for new users and future NIH Whole Person Initiative research projects and teams to build on the prototype model including plans for computing infrastructure or repositories, team science principles, common ontologies, data and model interoperability, credibility, harmonization, and dissemination 

Coordination Core: 

• Should describe all activities (scientific meetings, annual investigator meetings, outreach efforts, etc.) to be organized and managed by this core 
• Should provide the logistical infrastructure to facilitate the coordination of all NIH Whole Person Initiative efforts to build a scientifically driven consensus framework 
• Should describe how to connect all the research and network activities related to the NIH Whole Person Initiative through coordinated communications and logistics 
• Should describe their willingness to be flexible in determination of areas of responsibilities in this collaborative program
• Must indicate their willingness to cooperate with Demonstration Project teams supported in any potential future NOFOs and with the NIH in the development and design of research approaches, methods, processes, policies, and tools used in this program
• Should describe their prior experience working collaboratively in research consortia and other collaborative projects to accomplish shared goals
   

Resource Sharing and Dissemination Plan:

• A Resource Sharing Plan is required for all applicants. 
• Resource Sharing products can include (but are not limited to) code, web resources, tools or guides to support research.
• Moreover, the Resource Sharing Plan should address the plans for timely and effective resource sharing, including for the conceptual map, the CDEs, and any models and results with the broader scientific community, new modelers/users, and stakeholders.
• The resources should be made rapidly available to the research community. The rapid dissemination of the resources will accelerate scientific exploration, enhance research rigor and reproducibility, and avoid duplicative resource development efforts. The application should provide specific plans for sharing and distributing the resources via open repositories. NIH staff will be responsible for any additional administrative review of the plan for sharing resources and may negotiate modifications of the plan with the prospective awardee prior to award. The final negotiated version of the resource sharing plan will become a term and condition of the award of the cooperative agreement.
• The application should provide specific plans for sharing and distributing the resources via open repositories. NIH staff will be responsible for any additional administrative review of the plan for sharing resources and may negotiate modifications of the plan with the prospective awardee prior to award. 
• The final negotiated version of the resource sharing plan will become a term and condition of the award of the cooperative agreement.

Milestones and Timeline:

The research strategy must provide milestones specifying quantitative and clearly measurable performance-based goals to achieve completion of the project on time and on budget. Milestones should be proposed for each of the four cores over the project period, and these milestones may be re-negotiated prior to an award. At a minimum, the suggested timeline of milestones and deliverables should include completing a fully interconnected known physiological systems conceptual map by Year 2, and at least one whole-body in silico prototype physiome model by year 5. NIH staff, in collaboration with the awardee, will closely monitor progress and milestones achievement.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

• A Resource Sharing Plan is required for all applicants. 

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

•  A Data Management and Sharing Plan is not applicable for this NOFO. This NOFO does not support the generation of scientific data. 

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NCCIH. Applications that are incomplete, non compliant, and/or nonresponsive will not be reviewed.

To expedite review, applicants are requested to notify the NCCIH Referral Office by email at jessica.mcklveen@nih.gov when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular Notice of Funding Opportunity (NOFO), the highest priority of this initiative is the initial step and the first objective to establish the healthy human whole person physiome conceptual map with the associated common data elements (CDEs). Descriptions to accomplish the second objective (to build at least one prototype in silico model of whole person) may be less detailed, focusing on the criteria and brief plans for recruiting appropriate expertise, selecting the candidate existing databases, as well as building the prototype computational model(s). Past experiences and accomplishments building collaborative research teams, utilizing existing databases to conduct research, and/or employing computational modeling methodology may also be provided as illustrative examples of potential capabilities for completing the second objective. The plans to accomplish the second objective may be modified upon the completion of the first objective post award through the cooperative mechanism to optimize its outcomes and impact.  

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCCIH, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned on the basis of established PHS referral guidelines to NCCIH . Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Complementary and Integrative Health. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review 
• Availability of funds 
• Relevance of the proposed project to program priorities 

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies. 

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the award recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below. 

The PD(s)/PI(s) will have the primary responsibility for: 

• Developing objectives, approaches, and research strategies to build the Whole Person RCC. 
• Defining general structure and governance of the RCC with well-delineated roles and responsibilities. 
• Designating investigators to serve as members on a Steering Committee and other subcommittees, as appropriate. 
• Attending quarterly (or as needed) virtual Steering Committee meetings. 
• Agreeing to accept close coordination, cooperation, and management of the project with NIH, including those outlined below in the "NIH Staff" section. The PD/PI(s) will be expected to maintain close communications with the NIH Project Scientist(s) and, where appropriate, the Program Officer(s). The Project Scientist(s) will have substantial scientific involvement that is above and beyond the normal stewardship role in awards. 
• Managing and coordinating project activities scientifically and administratively at the recipient institution and with any collaborating institutions. 
• Although no new data will be collected by this U24, the prototype modeling phase will utilize pre-existing clinical datasets. The PD/PIs will be responsible for disseminating code related to the development of the models as part of the Resource Sharing Plan and according to FAIR principles
• Developing and proposing milestones that will be achieved during the project period. 
• Updating goals and milestones at the time of award and providing summaries of progress toward those goals, including the Project Management Plan, at least yearly, as requested by NIH. 
• Collaborating and communicating effectively with NIH and across the NIH Program Official to achieve project goals. 
• Participating in regular discussions with NIH staff. 
• Sharing the physiological conceptual map, prototype models, resources, and software as appropriate and consistent with achieving the goals of the program and in a manner consistent with the requirements of the Model Organism and Research Tools sharing policies for NIH. 
• Although no new data will be collected by this U24, the prototype modeling phase will utilize pre-existing clinical datasets. The PD/PIs will be responsible for disseminating prototype models, and codes as part of the Resource Sharing Plan and according to FAIR principles

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below: 

• NIH will assign (a) Program Officer(s) who will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. 
• NIH Scientists will serve as active member(s) of the Steering Committee.
• NIH will designate additional staff to provide advice to the recipient on specific scientific and/or analytic issues. Such staff may include (a) Project Scientist(s) or Analyst, who will provide direct technical assistance to the recipients to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites. 
• NIH staff may participate in cores, sub-groups, and committees, including the Steering Committee, as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.
• It is anticipated that decisions in all activities will be reached by consensus of the program and NIH staff will be given the opportunity to offer input to this process.
• NIH staff will interact with the PD(s)/Pl(s) on a regular basis to monitor progress. Monitoring may include regular communication with the PD(s)/Pl(s) and their staff. 
• NIH staff will provide input, expert advice, and suggestions in the design, development, and coordination and implementation of the study objectives. 
• NIH reserves the right to terminate or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting. 
• NIH staff will make recommendations to NIH for continued funding based on performance and compliance with the Terms and Conditions of the award. 
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.  

Areas of Joint Responsibility include: 

Collaborative Responsibilities: 

• Clarifying and negotiating the milestones and timelines. 
• Coordination of site visits, if needed, at critical milestones or transition points of the award. 
• Participating in quarterly (or as needed) virtual Steering Committee meetings. 
• The members of this collaborative effort should be made aware of the requirement for confidentiality due to any intent of the recipient to pursue commercialization of any qualified outcomes. Contractors and consultants of NIH will be made aware of the confidential nature of work done under this collaborative effort. 

Dispute Resolution: 

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16. 

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Elizabeth Ginexi, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-827-0160
Email: elizabeth.ginexi@nih.gov

Emrin Horgusluoglu, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 240-383-5302
Email: emrin.horgusluoglu-moloch@nih.gov 

Grace Peng
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: 301-451-4778
E-mail: penggr@mail.nih.gov

Bramaramba Kowtha MS, RDN, LDN
Office of Disease Prevention (ODP)
Telephone: 301-435-8052
Email: bramaramba.kowtha@nih.gov

Lori A.J. Scott-Sheldon, Ph.D.
Division of AIDS Research
National Institute of Mental Health
Telephone: 301-792-2309
Email: lori.scott-sheldon@nih.gov

LaVerne L. Brown, Ph.D.
Office of Dietary Supplements (ODS)
Phone:  301-443-5459
Email:  LaVerne.Brown@nih.gov

Veerasamy Ravichandran, Ph.D
NIDDK - NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Phone: (301) 594-2388
E-mail: veerasamy.ravichandra@nih.gov

Christopher Siwy
ODSS - Office of Data Science Strategy
Phone: none
E-mail: christopher.siwy@nih.gov 

Uday K. Shankar, M.Sc., Ph.D.  
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone:  301-761-7643
Email:  uday.shankar@nih.gov

Margaret M. Grisius, DDS 
National Institute of Dental and Craniofacial Research (NIDCR)
Phone: 301-451-5096
Email: margaret.grisius@nih.gov

Rita Jean Valentino
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
E-mail: rita.valentino@nih.gov

Thaddeus Schug
NIEHS - National Institute of Environmental Health
Phone:  984-287-3319
E-Mail:  schugt2@niehs.nih.gov

I-Jen Castle, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-827-4406
Email: i-jen.castle@nih.gov

Gregory Bloss, M.A., M.P.P.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-3865
Email: gregory.bloss@nih.gov

Fei Wang, Ph.D.
NATIONAL INSTITUTE ON AGING (NIA)
Phone: (301) 496-6402
E-mail: fei.wang@nih.gov

Sung Sug (Sarah) Yoon, RN, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: sungsug.yoon@nih.gov
 

Jessica McKlveen, PhD
National Center for Complementary & Integrative Health (NCCIH)
Telephone: 301-594-8018
Email: jessica.mcklveen@nih.gov

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email:siscor@mail.nih.gov

Ashley Ranellone 
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone:  301-594-8541
Email:  ranelloneac@niaid.nih.gov

Gabriel Hidalgo, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Phone: 301-827-4630
Email: gabriel.hidalgo@nih.gov

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Jenny Greer
NIEHS - National Institute of Environmental Health
Phone:  984-287-3332
E-Mail:  jenny.greer@nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: judy.fox@nih.gov

Jeni Smits
NATIONAL INSTITUTE ON AGING (NIA)
E-mail: jeni.smits@nih.gov

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: wertzr@mail.nih.gov
 

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.