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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) 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 Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The rapid expansion in the quantity and complexity of data in Behavioral and Social Science Research (BSSR) presents considerable challenges in our ability to structure, mine, standardize, and integrate information within and across health domains. Currently, there are few interoperable knowledge structures in health-related BSSR, and BSSR terminology has not been optimally integrated into standard semantic knowledge systems (e.g., Unified Medical Language System knowledge sources). Within and across sub-fields of BSSR, there are unique definitional challenges to overcome, including the proliferation of separate theories, constructs, and associated measures.

Rigorous and reproducible BSSR requires clear and consistent definitions of social and behavioral phenotypes, outcomes, and intervention components to allow effective communication between scientists and across scientific disciplines. It also requires a better understanding of the relationships between concepts. Further, identifying targets for behavioral interventions requires the ability to measure and describe a wide range of social and behavioral factors and outcomes across disciplines and diseases. Therefore, BSSR knowledge structures that include clear definitions and delineate a wide range of inter-relationships must be developed and enhanced. Finally, to be truly effective and more rapidly advance the field, ontologies must be interoperable, easily used, and widely adopted. This requires strong use cases to demonstrate an enhanced capacity to solve widespread and important problems

Definitions

Ontology: For the purposes of this FOA, an 'ontology' exists within an information sciences framework (rather than a philosophical framework). In this context, an ontology is defined as a formal, explicit, machine-readable specification of the shared knowledge within a field of BSSR, including relevant concepts, associated measures and their inter-relationships. Here, ontology development should be understood to encompass the processes of establishing and expanding agreed-upon controlled vocabularies and taxonomies, the computational infrastructure necessary for access and utilization, and the potential for interoperability with other relevant semantic knowledge resources.

Use Case: A specific situation in which an ontology or related vocabularies and taxonomies could potentially be used. For this funding opportunity, ontologies must fall within the general use case of health-related BSSR, including relevant concepts, associated measures, and their inter-relationships.

Construct: (Psychological) idea or theory including various conceptual and testable elements.

Purpose

Research projects supported though this funding opportunity should be focused on behavioral or social science ontology expansion or development, dissemination, and use. The projects must include multi-disciplinary teams of subject matter experts in behavioral and/or social science, as well as ontology related informatics. Each project should identify one or more use cases and elucidate the justification of the need and potential demand for the proposed ontological resource or tool. Examples of use cases include, but are not limited to, those listed in Ontologies in the Behavioral Sciences: Accelerating Research and the Spread of Knowledge. Projects should advance research capabilities and efficiencies and address problems not easily solved without improvement in semantic knowledge structures (e.g., controlled vocabularies, taxonomies, and ontologies). The ontological tools or resources proposed can address health-relevant social and behavioral terminology related to constructs, measures, and/or intervention components applicable to the individual level and at multiple levels beyond the individual, such as the neighborhood, community, group, social network, and policy level. The proposed tools or resources must also account for socio-behavioral cultural context in vocabulary/ontology development.

As part of a cooperative agreement, each project will focus on independent ontology development research aims and be expected to work collaboratively with the Dissemination and Coordination Center (DCC; PAR-23-181) and the other funded projects in a Behavioral and Social Science Ontology Development U01 Research Network.

For ontologies to be most useful, they should facilitate more cumulative, integrated, and efficient research within and across disciplines of study. Important aspects of successful ontology development include a well justified fit for use and potential for interoperability with existing health-related semantic knowledge structures within and outside of BSSR (e.g., Unified Medical Language System knowledge sources or ontologies found on the Open Biological and Biomedical Ontologies Foundry or the Bioportal). Developing impactful ontological approaches, tools, or resources also requires that they be widely adopted and have sustained use. Achieving these goals will require the engagement of the intended end-users throughout the development and testing process to understand fully the range of perspectives and requirements. It also requires a detailed plan for dissemination and sustainability of the ontological resource or tool. Therefore, applications will need to address all of these issues.

The BSSR semantic knowledge practices developed in this research network could be modeled on (and where possible, expand upon) successful efforts in biomedicine. They should align with data standards and principles (e.g., FHIR and FAIR). As noted, development of BSSR knowledge structures should build on and/or allow for interface with existing knowledge structures and data repositories.

Deliverables across the Network will include multiple sustainable research resources such as: enhanced ontological infrastructure and technology platforms to facilitate data integration and exchange; advanced computational methodologies to develop and curate ontologies more rapidly in the future; tools to support ontology dissemination and use; and support of professional networks to engage, inform, and build capacity for ontology use in BSSR. Achieving these goals will ensure that BSSR data can efficiently be accessed, transmitted, interpreted, and aggregated across research and clinical systems to accelerate discovery, increase the return on investment in research, and ultimately improve public health.

Research Project Requirements

Applications must include the following features:

• Identify one or more use cases and articulate a strong justification for the proposed ontological approach, resource, or tool with an emphasis on tool and resources that are fit for use. The justification must include information about how the proposed semantic knowledge resources will more efficiently and effectively solve a problem/s or accelerate cumulative and integrative BSSR. Examples of use cases include, but are not limited to, those listed in Ontologies in the Behavioral Sciences: Accelerating Research and the Spread of Knowledge.
• Clearly define the parameters and scope of the ontology and describe how it will meet the needs of important end users (e.g., researchers, practitioners, or decision makers).
• Account for socio-behavioral cultural context in vocabulary/ontology development. This includes testing for bias and ensure the relevance of the ontology and related resources to diverse communities through the inclusion of subject matter experts with diverse perspectives related to terminology, definitions, measurement and meaning that may differ across cultural and demographic populations including sexual and gender minorities, and racial and ethnic groups.
• The behavioral and social science ontological resources and tools developed must be able to learn (i.e., evolve, adapt, be refined) as new perspectives are incorporated and new discoveries are made.
• The resources or tools developed must have the potential to be interoperable with or, where applicable, build upon existing health-related semantic knowledge structures within and outside of BSSR (e.g., Unified Medical Language System knowledge sources or ontologies found on the Open Biological and Biomedical Ontologies Foundry or the Bioportal).
• The proposed process of development and testing of the ontological tools and resources must be clearly outlined and include a timeline with well-defined milestones.
• To maximize the usefulness of the resources and tools developed, the application must include a plan for iterative improvement and active ongoing engagement with the intended end-users throughout the development and deployment of the resources or tools.
• Include multi-disciplinary subject matter expertise (SME) in the BSSR domains of engagement, ontology related informatics, and advanced computational approaches.
• Include a plan to apply effective team science principles for managing the research team and facilitating engagement with a variety of relevant researcher audiences and end users. This includes a plan to work collaboratively with the Dissemination and Coordination Center (U24) and the other funded projects in a Behavioral and Social Science Ontology Development U01 Research Network.
• Promote rigor and reproducibility and ensure that the products developed meet the FHIR and FAIR principles.
• To support widespread adoption, use, and sustainability, the application must include a detailed plan for dissemination and maintenance of the ontological resources and tools.

Institute and Center Priorities

Potential applicants are strongly encouraged to consult with the Institute, Center, or Office (ICO) Scientific/Research contact listed in Section VII for the appropriateness of submission to this NOFO. ICO priorities relevant to this funding opportunity are outlined below:

NIA

NIDCR

The National Institute of Dental and Craniofacial Research (NIDCR) encourages applications aligned with its Strategic Plan, and with its broad mission to advance fundamental knowledge about dental, oral, and craniofacial health and disease and translate these findings into prevention, early detection, and treatment strategies that improve overall health for all individuals and communities across the lifespan. Specific to this announcement, NIDCR encourages behavioral ontology research focusing on use cases relevant to dental, oral, or craniofacial (DOC) health. Projects consistent with NIDCR’s Behavioral and Social Sciences Research Program, and Oral Health Disparities and Inequities Research Program, are of high priority, including research that informs future prevention or intervention studies, and/or that advances understanding of behavioral and social determinants of DOC health.

The National Institute on Aging (NIA) supports research in aging and the health and well-being of older people. The Institute seeks to understand the aging process and conditions associated with growing older, in order to extend the healthy, active years of life. NIA places a strong emphasis on life course research, including early- and mid-life experiences and processes that play a causal role in shaping trajectories of aging. NIA is also the primary federal agency supporting and conducting Alzheimer’s disease and related dementias (AD/ADRD) research and seeks to identify strategies and treatments to effectively prevent, delay, or slow cognitive decline and dementia.

The NIA Division of Behavioral and Social Research (DBSR) supports basic social, behavioral, psychological, and economic research on the processes of aging as well as behavioral intervention development across biological, behavioral, interpersonal, institutional, sociocultural, and environmental levels of analysis. Programmatic priorities include, but are not limited to: cognitive aging including AD/ADRD; affective functioning and regulation; stress and resilience; family and interpersonal relationships, including caregiving for people living with dementia; social isolation and loneliness; neuropsychological measures development; human factors and functional assessments in real-world settings; mechanisms of behavior change; the impacts of sociocultural, institutional, geographic, and environmental factors influencing aging; health disparities. NIA and DBSR emphasize a life-course perspective, with an interest in measuring, accounting for, and understanding behaviors and behavior change across multiple timescales. Ontology development relevant to any and all of these areas would be of interest to NIA. Prospective applicants are strongly encouraged to reach out to the NIA Scientific Contact listed in Section VII.

NCI

NCI welcomes applications aligned with the NCI mission and scientific priorities and centered on the development or expansion of behavioral ontology tools and resources to improve semantic knowledge across the cancer continuum (i.e., cancer epidemiology and surveillance; cancer etiology and risk factors, detection and prevention, diagnosis and treatment, and survivorship). NCI is interested in resources focused on:

• Cancer-related risk factors, measures, and behavioral endpoints: physical (in)activity, diet/nutrition, UV radiation/sun exposure, cannabis use, tobacco or alcohol use, sleep and circadian disruption, stress/allostatic load, aging, screening, symptoms, and quality of life.
• Psychological constructs and processes affecting outcomes of cancer-related interventions and cancer care (e.g., affect, cognition, knowledge, motivation, attention, sensation, risk perception, attitudes, adherence, decision-making).
• Social determinants of health including social context and connectedness, health access and quality, the neighborhood and built environment (e.g., physical activity space, food environment, housing, transportation, broadband internet access, occupational exposure), economic stability (e.g., food and/or housing security), and education access and quality.
• Health communication and digital health technology related outcomes including media source and technology use, trust, health literacy and numeracy, digital literacy, communication quality, and related behaviors (e.g., engagement with and use of digital health technology, accessing personal health records through patient portals).

NIMHD

The mission of the NIMHD is to lead scientific research to improve minority health and reduce health disparities. NIMHD focuses on all aspects of health and health care for racial and ethnic minority populations in the U.S. and the full continuum of health disparity causes as well as the interrelation of these causes. NIMHD projects must include a focus on one or more of the following populations that NIH-designates as experiencing health disparities in the United States and its territories: African Americans, Latinos/Hispanics, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, less privileged socioeconomic groups, underserved rural populations, and sexual and gender minorities. Comparison groups/populations may also be included as appropriate for the research questions posed. Studies based outside the U.S. or its territories will not be supported by NIMHD under this FOA.

For the current initiative, NIMHD is interested in supporting ontological development projects that will advance the science of minority health and health disparities, including, but not limited to:

• Ontologies encompassing multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for more information)
• Ontological content integrating NIMHD Core Common Data Elements (CCDEs), including behaviors and constructs such as English proficiency, usual place one chooses to receive health care, behaviors related to financial security, and others
• Ontologies incorporating psychosocial, cultural, and behavioral constructs relevant to health disparities, including minority stress, stereotyping and prejudice, racism, discrimination, acts of violence (e.g., hate crimes against people because of race, ethnicity, poverty, and/or sexual and gender minority status) and related behavioral factors

NIDCD

NIDCD invites responsive applications that align with the Institute's scientific programs of: normal and disordered hearing and balance; normal and disordered taste and smell; communication disorders of voice, speech, and language. For more information, please see: https://www.nidcd.nih.gov/about/strategic-plans.

NIMH

The NIMH mission is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. Applications considered for funding by the NIMH must fall within the areas of research priority detailed in the NIMH Strategic Plan (https://www.nimh.nih.gov/about/strategic-planning-reports). Applicants are strongly encouraged to contact Scientific/Research Contact(s) prior to submission.

NEI

The mission of the National Eye Institute is to eliminate vision loss and improve quality of life through vision research. NEI welcomes responsive applications that fall within the research priority areas described in the NEI Strategic Plan (https://www.nei.nih.gov/about/strategic-planning). Applicants are strongly encouraged to contact Scientific/Research Contact(s) prior to submission.

NLM

The National Library of Medicine (NLM) supports innovative research and development in biomedical informatics and data science. The scope of NLM's interest includes bioinformatics, clinical informatics, public health and population informatics, translational informatics, personal health informatics, social and behavioral science and informatics research, biomedical informatics and health disparities/health equity research, and data science. NLM supports research with an emphasis on new and innovative methods and approaches to foster data driven discovery in the biomedical and clinical health sciences as well as domain-independent, scalable, and reusable/reproducible approaches to discovery, curation, analysis, organization, and management of health-related digital products.

NCCIH

NCCIH supports the investigation of complementary and integrative health approaches, which include a broad range of practices and interventions that are not typically part of conventional medical care and can be classified by their primary therapeutic input, including nutritional (e.g., special diets, dietary supplements, herbs, probiotics, and microbial-based therapies), psychological (e.g., meditation, hypnosis, music-based interventions, relaxation therapies), physical (e.g., acupuncture, massage, chiropractic manipulation, other force-based manipulations, or devices related to these approaches), or a combination of psychological and physical (e.g., yoga, tai chi, dance therapies, or some forms of art therapies, such as music-based interventions) input.

Through this solicitation, NCCIH is interested in supporting ontological development projects and resources related to:

• Multicomponent behavioral interventions and their promotion of healthy behaviors, health restoration, resilience, whole person health, and well-being.
• Non-pharmacological interventions involving psychological and/or physical input
• Behavioral mechanisms of complementary and integrative health approaches
• The relation of healthy behaviors and behavioral interventions to other domains (i.e., biological, social, and environmental)
• Healthy behaviors and behavioral interventions as related to health disparity populations (including racial and ethnic minorities, sexual and gender minorities, socioeconomically disadvantaged populations, and underserved rural populations), across the health spectrum and lifespan.
• Ontological development projects and resources related to the following areas of high interest to NCCIH:
  • Emotional Well-Being
  • Music and Health
  • Force-Based Manipulations interventions (i.e., involving light touch, pressure, mobilization, thrust, adjustment and/or needling)

Research Network Structure:

The Behavioral and Social Science Ontology Research Network will consist of several U01 Research Network Projects and a Dissemination and Coordinating Center (DCC). The DCC and each of the Research Network Projects will work collaboratively with each other and one or more Science Officers and Program Officers from NIH institutes, centers, and offices (ICOs).

The Research Network priorities and activities will be governed by a Steering Committee (SC) which at a minimum will include at least two representatives from each of the Research Projects (representing BSSR and informatics expertise), two from the DCC, and at least one NIH representative. The Research Network EC will be chaired by the PI/s from the U24 and meet at least monthly. Based on the priorities set by the EC, workgroups will be established to carry out cross-project activities. For example, NIH anticipates there will be at least three workgroups, one on methodology, one on community engagement, and one on network dissemination and sustainability activities. Each U01 supported by this funding opportunity will also be expected to have up to 5 members of the research team participate in one in-person study group meeting a year and budget accordingly.

Plan for Enhancing Diverse Perspectives (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

Non-Responsiveness Criteria

Potential applicants are strongly encouraged to consult with the Scientific/Research contact listed in Section VII for the appropriateness of submission to this NOFO.

Applications that will be considered non-responsive and withdrawn prior to review are those that:

• Lack a focus on and expertise in BSSR.
• Lack a focus on and expertise in ontology development.
• Lack expertise in Team Science and/or the Science of Science.
• Do not include a comprehensive Resource Sharing Plan for disseminating network resources, products, and opportunities with the field at large.
• Do not adhere to FAIR principles and the NIH Strategic Plan for Data Science.

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 Government

• 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 Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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 SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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 registration; 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 SF424 (R&R) Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

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 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 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 SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the 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:

Michael Spittel, Ph.D.
Telephone: 301-825-3990
Email: spittelm@od.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PEDP implementation costs:

• Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• Identify one or more use cases and articulate a strong justification for the proposed ontological approach, resource, or tool with an emphasis on tool and resources that are fit for use. The justification must include information about how the proposed semantic knowledge resources will more efficiently and effectively solve a problem/s or accelerate cumulative and integrative BSSR. Examples of use cases include, but are not limited to, those listed in Ontologies in the Behavioral Sciences: Accelerating Research and the Spread of Knowledge.
• Clearly define the parameters and scope of the ontology and describe how it will meet the needs of important end users (e.g., researchers, practitioners, or decision makers).
• Account for socio-behavioral cultural context in vocabulary/ontology development. This includes testing for bias and ensure the relevance of the ontology and related resources to diverse communities through the inclusion of subject matter experts with diverse perspectives related to terminology, definitions, measurement and meaning that may differ across cultural and demographic populations including sexual and gender minorities, and racial and ethnic groups.
• The behavioral and social science ontological resources and tools developed must be able to learn (i.e., evolve, adapt, be refined) as new perspectives are incorporated and new discoveries are made.
• The resources or tools developed must have the potential to be interoperable with or, where applicable, build upon existing health-related semantic knowledge structures within and outside of BSSR (e.g., Unified Medical Language System knowledge sources or ontologies found on the Open Biological and Biomedical Ontologies Foundry or the Bioportal).
• The proposed process of development and testing of the ontological tools and resources must be clearly outlined and include a timeline with well-defined milestones.
• To maximize the usefulness of the resources and tools developed, the application must include a plan for iterative improvement and active ongoing engagement with the intended end-users throughout the development and deployment of the resources or tools.
• Include multi-disciplinary subject matter expertise (SME) in the BSSR domains of engagement, ontology related informatics, and advanced computational approaches.
• Include a plan to apply effective team science principles for managing the research team and facilitating engagement with a variety of relevant researcher audiences and end users. This includes a plan to work collaboratively with the Dissemination and Coordination Center (U24) and the other funded projects in a Behavioral and Social Science Ontology Development U01 Research Network.
• Promote rigor and reproducibility and ensure that the products developed meet the FHIR and FAIR principles.
• To support widespread adoption, use, and sustainability, the application must include a detailed plan for dissemination and maintenance of the ontological resources and tools.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R& R ) Application Guide.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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 SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

See Part 1. 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

Part I. Overview Information 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 Policy on Late Application Submission.

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 SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 SF424 (R&R) 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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

Any instructions provided here are in addition to the instructions 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.

Overall 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).

Scored Review Criteria

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this NOFO:

Have the investigators included a use case with a strong justification for the proposed ontological approach, resource, or tool that includes information about how they will more efficiently and effectively solve a problem or accelerate cumulative and integrative BSSR? Are the parameters and scope of the ontology, including how it will meet the needs of the end users (e.g., researchers, practitioners, or decision makers), well defined and justifiable? To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Specific to this NOFO:

Does the research team include multi-disciplinary subject matter expertise (SME) in the BSSR domains of interest, ontology related informatics, and advanced computational approaches? Does the PD(s)/PI(s), have the expertise and/or resources to apply effective team science principles for managing the research team well as facilitating engagement with a variety of relevant researcher audiences and end users? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this NOFO:

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO:

Does the approach to ontology development and deployment include diverse perspectives related to terminology, definitions, measurement and meaning that occur across cultural and demographic populations including sexual and gender minorities, and racial and ethnic groups? Will the approach to developing and deploying the behavioral and social science ontological resources allow for the ontology to learn (i.e., evolve, adapt, be refined) as new perspectives are tested and new discoveries are made? Is the plan for iterative improvement and active and ongoing engagement with the intended end-users throughout the development and deployment of the resources or tools well justified and feasible? Is the plan for dissemination and maintenance of the ontological resources and tools well justified and feasible? Do the proposed BSSR knowledge structures build on and/or interface with existing knowledge structures and data repositories? Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this NOFO:

To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

Additional Review Criteria

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.

Will the proposed resources or tools meet the following parameters?

• Will they be interoperable with or, where applicable, build upon existing health-related semantic knowledge structures within and outside of BSSR?
• Promote rigor and Reproducibility and ensure that any products' development meet the FHIR and/or FAIR principles.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

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.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, 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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. 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 appropriate national Advisory Council or Board. 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.

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 VI. Award Administration Information

1. Award Notices

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. 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, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, 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 .

HHS recognizes that 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.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs 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.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement 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 Part 75.205 and 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.

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 (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR 200, and other DHHS, 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

All aspects of their study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators.

The recipient agrees to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the study including those outlined under "NIH Staff Responsibilities" and to work cooperatively with other recipients and the Coordinating Center where it is scientifically advantageous to pursue common methods and protocols.

Recipients will participate in annual meetings of the recipients and will support any committees, task forces, and advisory panels related to the project, as needed and will participate in regularly scheduled conference calls with the awarding agency. Project budgets should include travel for participation in these activities.

Support or other involvement of industry or any other third party in the study--e.g., participation by the third party; involvement of project resources or citing the name of the project or the NIH support; or special access to project results, data, findings, or resources--may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur with the concurrence by the NIH Program Officer to ensure objectivity of research.

Obtaining prior written approval of the NIH Grants Management Specialist in consultation with the NIH Program Officer for a change in any of the key personnel identified in the Notice of Award.

Award recipients should aim to make resulting publications, code, and to the extent possible, the underlying primary data immediately and broadly available to the public. See Section 8.2.3.1of the NIH GPS.

Award recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

The NIH Project Scientists will have access to the data and work with the PD(s)/PI(s) to ensure the objectives of the program are being met. The primary responsibility for the program resides with the recipient, although specific tasks and activities will be shared among the recipient and the NIH Project Scientists.

NIH staff will act as resources and facilitators for activities of the recipient and will coordinate activities with federal and non-federal agencies outside of the project recipients.

The NIH, as primary funder and administrator reserves the right to phase out or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting. NIH support of this study is contingent upon adequate participant recruitment based on the Grantee’s Milestone Accrual Plan submitted at the time of funding.

NIH staff will ensure the recipient demonstrates best effort compliance. Failure to achieve minimally acceptable milestone recruitment levels may result in the withholding future support and/or negotiating an orderly close-out of this study.

NIH staff will serve as resources to provide: scientific/programmatic support in the development and modification of study protocols and the design of project activities; advice in the selection of sources or resources; advice in management and technical performance; and assistance in the preparation of publications, as warranted.

NIH staff will participate in the monitoring of issues relating to recruitment, retention and follow-up of study participants (if applicable), and monitoring of data integrity and quality control through consideration of the annual reports, site visits, patient logs, etc. This review may include, but is not limited to, compliance with the study protocol, meeting enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting as needed to the coordinating center.

NIH Scientific Officers will interact with the PD(s)/PI(s) on a regular basis to monitor progress. Monitoring may include: regular communication with the PD(s)/PI(s) and his/her staff, periodic site visits for discussion with the recipients research team, observation of field data collection and management techniques, fiscal reviews, and other relevant stewardship matters.

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:

The PD(s)/PI(s) provide, in concert with the NIH staff, support necessary to ensure that sites and investigators, and NIH and other research partners fully comply with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.'

Recipients and NIH will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data.

All recipients and NIH will cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers and health care and other systems as appropriate.

The Steering Committee (managed by the Coordinating Center) is the primary governing body of the network. Recipients must participate in the Steering Committee. The Steering Committee reviews and approves the agenda for collaborative research activities, develops and monitors policies and procedures guiding the research activities, and oversees communications. Recipients agree to abide by the procedures and policies established by the Steering Committee.

The Steering Committee, with the support of the Coordinating Center, will facilitate these and other joint activities including, but not limited to: coordination of research protocols when appropriate, human subjects and other regulatory protocols when appropriate, data harmonization and archiving, manuscript and other information dissemination planning, and initial clearance of manuscripts or other dissemination products resulting from collaborative projects across the network.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: 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 DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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.

Ensure that copyrights and open-source licenses allow for broad sharing of the tools, as well as the resulting data.

Promote rigor and reproducibility and ensure that the research products meet the FAIR principles: findable, accessible, interoperable, and reusable.

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.

Recipients will provide updates at least annually on implementation of the PEDP.

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. 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

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 subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, 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. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

OBSSR does not accept assignment of applications or manage awards that are funded. Please contact an IC-based scientific contact for inquiries regarding the suitability of the proposed project for the RFA and the IC’s research portfolio.

Lillian Shum, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Division of Extramural Research
Telephone: 301-594-0618
Email: shuml@nidcr.nih.gov

Holly Lynn Storkel
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301.451.6842
E-mail: holly.storkel@nih.gov

Steve Tsang, PhD
Office of Data Science Strategy (ODSS)
Phone: 240-234-0702
Email: steve.tsang@nih.gov

Cheri Wiggs
NEI - NATIONAL EYE INSTITUTE
Phone: (301) 402-0276
E-mail: cheri.wiggs@nih.gov

Audie Atienza, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Phone: 301-435-0198
Email: audie.atienza@nih.gov

Jenni Pacheco, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3645
Email: jenni.pacheco@nih.gov

Arielle Gillman, Ph.D., M.P.H.
Social and Behavioral Sciences Administrator (Program Officer)
Division of Integrative Biological and Behavioral Sciences
arielle.gillman@nih.gov

Meryl Sufian, PhD
National Library of Medicine
Phone: 301-496-4671
Email: sufianm@mail.nih.gov

Janine Simmons, M.D., Ph.D.
NATIONAL INSTITUTE ON AGING (NIA)
Division of Behavioral and Social Research (DBSR)
Phone: 301-443-6652
E-mail: simmonsj@mail.nih.gov

Dana Wolff-Hughes, PhD
National Cancer Institute (NCI)
Telephone: 240-620-0673
Email: dana.wolff@nih.gov

Erin Burke Quinlan, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: (301) 451-0636
Email: erin.quinlan@nih.gov

Center for Scientific Review (CSR)
Email: FOAReviewContact@csr.nih.gov

OBSSR does not accept assignment of applications or manage awards that are funded. Please contact an IC-based grants management professional for financial-related inquiries.

Christopher Myers
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: (301) 435-0713
E-mail: myersc@nidcd.nih.gov

Karen Robinsonsmith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: kyr@nei.nih.gov

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: tjarosik@mail.nih.gov

Priscilla Grant, JD
Chief Grants Management Officer

National Institute on Minority Health and Health Disparities
National Institutes of Health
Bethesda, MD 20892

Email: pg38h@nih.gov
Phone: 301-594-8412

Samantha Tempchin
National Library of Medicine
Phone: 301-496-4222
Email: samantha.tempchin@nih.gov

Ryan Blakeney
NATIONAL INSTITUTE ON AGING (NIA)
Phone: 301-451-9802
E-mail: blakeneyr@mail.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: crystal.wolfrey@mail.nih.gov

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

Zulema Eldridge
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-443-3066
Email: zulema.eldridge@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 45 CFR Part 75 and 2 CFR Part 200.