Center of Excellence for Systems Modeling of Infection and Immunity across Biological Scales (U54 Clinical Trial Not Allowed)

Center of Excellence for Systems Modeling of Infection and Immunity across Biological Scales (U54 Clinical Trial Not Allowed) is sponsored by National Institute of Biomedical Imaging and Bioengineering (NIBIB). Supports the establishment of a center to coordinate research in infectious and immune-mediated disease computational modeling across biological scales.

Expired RFA-AI-23-077: Center of Excellence for Systems Modeling of Infection and Immunity across Biological Scales (U54 Clinical Trial Not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Allergy and Infectious Diseases ( NIAID ) Funding Opportunity Title Center of Excellence for Systems Modeling of Infection and Immunity across Biological Scales (U54 Clinical Trial Not Allowed) U54 Specialized Center- Cooperative Agreements April 18, 2024 - Notice of Informational Webinar for RFA-AI-23-077, Center of Excellence for Systems Modeling of Infection and Immunity across Biological Scales (U54 Clinical Trial Not Allowed).

See Notice NOT-AI-24-042 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Notice of Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Notice of Funding Opportunity Purpose The purpose of this notice of funding opportunity (NOFO) is to support the establishment of one (1) Center of Excellence (CoE) to coordinate the research community of infectious and immune-mediated disease (IID) computational modelers and advance IID modeling research across biological scales.

The CoE must include three (3) Coordinating Cores and two (2) Research Projects to advance and integrate bridge models across scales in the context of IID, including HIV/AIDS. The CoE will accelerate multi-scale model development, sharing and re-use, and support collaboration to benefit the entire IID research community.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material .

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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. Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the 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. Part 1. Overview Information 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 role and impact of computational modeling of infectious and immune-mediated diseases (IID) has grown significantly over the last decade.

Modeling is used to: (1) elucidate biological mechanisms of infection and/or transmission; (2) understand immune system regulation and responses to various triggers (commensal and pathogenic organisms, vaccines, environment, autoantigens), (3) characterize longitudinal trajectories of allergic or immune-mediated diseases from initiation through progression and/or resolution, including across the lifespan and effects of microbiome, (4) optimize public health control measures in response to epidemic threats, and (5) inform epidemic trajectories and develop therapeutic interventions.

Computational modeling supports basic, clinical, and translational research that advances the National Institute of Allergy and Infectious Diseases (NIAID) mission , especially as a method to better understand the biological mechanisms of infection and immunity.

Even as the use of computational modeling in IID research is growing, computational models are rarely reused or combined to provide multi-scale, transferable, public health solutions because of technical or collaborative challenges. As a global leader in IID research, NIAID is uniquely positioned to provide guidance to the modeling community towards addressing the most pressing strategic IID research priorities.

This initiative will support the establishment of one Center of Excellence (CoE) for Systems Modeling of Infection and Immunity across Biological Scales to coordinate the community of IID modelers and advance and integrate models across scales for infectious diseases. The CoE must include at least two (2) and no more than three (3) Research Projects.

The Research Projects must model at least one pathogen, HIV and/or AIDS (HIV/AIDS), the immune response to infection, and/or allergic or immune-mediated diseases. The CoE will perform activities to coordinate the modeling community through Coordinating Cores and conduct Research Projects to advance modeling across and between scales of IID.

The CoE should be prepared to rapidly pivot research and coordinating activities to respond to community needs during infectious disease outbreaks, epidemics, or pandemics. This CoE will provide strategic direction to the research community based on NIAID priorities.

The CoE will leverage standards for multi-scale model development and sharing that have recently emerged, including the FAIR (Findable, Accessible, Interoperable, and Reusable) guiding principles and the NIAID Data Ecosystem Portal .

The CoE will accelerate modeling science for IID by coordinating the community of modelers currently funded by NIAID to improve multi-scale systems modeling methods, provide leadership on modeling priorities for IID, improve collaboration, and foster a diverse modeling community that can be rapidly mobilized to meet emerging NIAID needs.

Responsibilities of the CoE: Develop and conduct innovative computational multi-scale modeling research for NIAID priority IID biomedical questions, incorporating HIV/AIDS; Connect the experimental and computational modeling communities to accelerate/advance multi-scale model development by leveraging complementary and cross-disciplinary expertise; Coordinate and disseminate CoE Research Project outcomes leveraging the Coordinating Cores; Foster a diverse community of new and existing investigators dedicated to IID multi-scale modeling; Establish educational opportunities in IID multi-scale modeling for students, post-doctoral fellows, and new and early-stage investigators ; Enable new approaches for multi-scale model sharing and reproducibility aligned with the FAIR principles and the NIAID Data Ecosystem Portal ; and Improve approaches and technologies for multi-scale model sharing and reuse across pathogens.

Note: HIV/AIDS must be included in the CoE in addition to one other pathogen, the immunological response, and/or allergic and immune-mediated diseases. Center of Excellence (CoE) Scope and Structure The overall structure of the CoE will support interdisciplinary and multi-scale computational modeling efforts.

The CoE will include three (3) Coordinating Cores (Administrative Core, Model and Data Sharing Core, and Community Development and Education Core) with the option to propose one (1) additional Core, and two (2) Research Projects with the option to propose one (1) additional Research Project. The activities of the Cores will be informed by the concurrent activities of the Research Projects.

The CoE will include activities that share approaches and technologies for IID multi-scale models, data access, and software. The Cores will enable community building activities, such as an annual meeting, workshops, educational opportunities, and Opportunity Funds. The CoE will prioritize coordination of modelers already funded by grants, contracts, and cooperative agreements.

Administrative Core: The CoE must include an Administrative Core that will be responsible for managing, coordinating, and overseeing the entire range of Center activities, monitoring progress, and ensuring that project milestones are being met and implemented effectively within the proposed timelines.

Management, Leadership, and Staffing Plan The Administrative Core will be responsible for organizing and coordinating with other organizations and NIAID. This Core will also oversee subawards that contribute to the activities of the CoE. This notice of funding opportunity (NOFO) will support Opportunity Funds that will complement and augment the research program of the CoE and capitalize on emerging opportunities.

The Opportunity Funds will be managed in the Administrative Core by establishing the scientific scope of the Opportunity Funds, an administrative structure, eligibility, review criteria, disbursement and tracking of funds, and reporting status.

Examples of activities supported by the Opportunity Funds could include collaborative and pilot/feasibility projects; resource development and sharing opportunities; and/or translational projects. Opportunity Funds projects must be within the scope of this NOFO and may be submitted by outside investigators independently, or in collaboration with the CoE.

The Administrative Core, in collaboration with NIAID, will ensure that the CoE pivots when a rapid response is required (e.g., during an infectious disease outbreak, epidemic, or pandemic).

Model and Data Sharing Core: The CoE must include a Model and Data Sharing Core that will develop novel technologies and informatic approaches to improve computational model and research software reproducibility and sharing, facilitate and ensure access to models, software, and data for the community, and advance and improve FAIR. These innovative approaches will improve sharing between the CoE and its collaborators.

All outcomes will be made publicly available to the broader scientific community. Computational Models and Research Software The model sharing approaches developed by the Model and Data Sharing Core will go beyond current practices of code repositories or catalogues, for example leveraging executable workflow technology, the FAIR guiding principles, and the NIAID Data Ecosystem Portal to ensure re-use and transferability.

The Model and Data Sharing Core will develop innovative methods that can address, at minimum, some of these challenges and will be discoverable, publicly accessibility, and interoperable. The Core will ensure research software sharing and development best practices, including the use of open-source resources and code-sharing repositories such as GitHub.

Research software resources will be made available to the CoE and community members to create a facile, rapidly stood-up environment for collaboration, for example a shared high-performance computing (HPC) workspace or cloud platform.

Additional activities of the Model and Data Sharing Core could include a library or catalogue for computational models and research software that could also be re-used or repurposed for research by the CoE or pivoting during an infectious disease outbreak, epidemic, or pandemic.

The CoE will facilitate data access to the community and existing data streams that are already available (e.g., wet lab, human subjects, environmental, and epidemiological data).

These data could include sources of experimental data that may be internal to CoE investigators or in collaboration with those external to the CoE, and that ideally spans the full scale of NIAID-funded work, including basic science, clinical trials and studies, and epidemiologic research. Innovative approaches to improve model and data sharing technologies will be organized and managed by the Model and Data Sharing Core.

The approaches should address the technical and non-technical barriers to data sharing, including sharing controlled access data. Examples of services, resources, technologies, and informatic approaches that could be improved include websites, portals, dashboards, catalogues, metadata models and schemas, APIs, or a graphical user interface (GUI).

The Model and Data Sharing Core is expected to improve and advance FAIR by addressing a subset of the 15 FAIR principles and FAIR enabling resources (e.g., ontologies, structured vocabularies, standards, and/or data models) to improve FAIR for Data, Computational Models, and Research Software. The Core will also facilitate and help community members to comply with applicable NIH sharing policies.

These activities could include educational or informational webinars, and associated technologies. Additionally, the Core will collaborate with NIAID to improve the discovery of data and software and re-use through the NIAID Data Ecosystem Portal.

Community Development and Education Core: In accordance with a NIAID priority to support the next generation of biomedical researchers , the CoE must include a Community Development and Education Core. The Core will provide and develop innovative approaches, such as on-line virtual platforms, for educational and mentoring activities, and communication with the community.

These activities should emphasize opportunities for students, postdoctoral fellows, and early stage investigators , especially those from underrepresented groups, and provide opportunities for cross-disciplinary collaboration and development. The Community Development and Education Core will also be responsible for organizing the annual meeting of the CoE and modeling community.

The Community Development and Education Core will organize workshops and other educational opportunities for students and junior researchers from computational and biomedical sciences that are interested in advancing quantitative and computational expertise (e.g., multi-scale model development, parameter estimation, model testing and validation, FAIR, Big Data methods, HPC/Cloud, software development).

Additional potential activities that may be led by this Core include seminars, journal clubs, short courses, individualized instruction on specific technologies or methodologies, temporary placement in a collaborator’s laboratory, individualized mentoring on specific areas of scientific research or grant writing, or mock study sections.

The CoE is expected to establish channels for receiving and providing feedback to the research community to enhance community interactions and collaborations between researchers, and to accommodate the research community's needs. The Core will also coordinate communications between NIAID, modelers, and other community members, especially during times of emerging needs, e.g., mailing lists, conference calls, ad-hoc working groups.

Cross Disciplinary Collaboration and Development The Community Development and Education Core will develop activities to increase the collaboration between biological scientists and computational scientists by developing educational and collaborative opportunities across experimental, computational, clinical, and behavior and behavioral researchers.

The purpose of the annual meeting is to bring together the modeling community to share experiences, technologies, approaches, methods, data, to foster collaborations, and engage with NIAID program and staff.

The annual meeting will also connect and synchronize with other modeling communities and NIAID supported networks such as the Interagency Modeling and Analysis Group ( IMAG ), Ecology and Evolution of Infectious Diseases ( EEID ), Models of Infectious Disease Agent Study ( MIDAS ), HIV modeling networks, Human Immunology Project Consortium ( HIPC ) and ImmuneSpace , Systems Biology for Infectious Diseases ( SBID ), and Automating Scientific Knowledge Extraction and Modeling ( ASKEM ).

The Community Development and Education Core will organize an annual meeting and should highlight participation opportunities for early-career researchers at the meeting. Optional Core : The application may include one (1) additional core that is relevant to the overall objectives and activities of the CoE.

An Optional Core could include technologies cores such as HPC or cloud compute services, software development services, or interaction with public health support, or model development. The application should justify the need for the additional Core if one is proposed. A dedicated data generation core is not in scope as an Optional Core and will be considered non-responsive for this NOFO.

Research Projects: The CoE will advance and integrate computational modeling for IID through at least two (2) Research Projects that develop “bridge models” for infectious diseases, immunity, and/or immune-mediated diseases, and must incorporate HIV/AIDS.

For the purposes of this NOFO, a bridge model is considered a model that connects across biological scales, such as molecular to organism-scale processes and organism to population-level processes. Applicants may propose one (1) optional additional Research Project.

The Research Projects are expected to include mechanistic modeling of processes related to infection, to the immune response against infection or vaccination, and/or to immune-mediated diseases, and address both determinants and risk factors, such as vaccination, antimicrobials, pathogen evolution and co-circulation, host genetics, climate factors, or vulnerable populations, among others.

Because the primary focus of the CoE is computational modeling, the acquisition of new experimental, clinical, or epidemiologic data may be appropriate for the purpose of designing, testing, and validating computational models. However, the focus of the research should be on computational modeling development.

The ideal computational model would directly inform and advance further experimental, clinical, or epidemiologic research, and would be firmly situated in a cyclical research process of data acquisition and computational modeling. The computational models produced by the Research Projects should be transparent and interpretable, wherever possible. Within the Research Projects, at least one pathogen is required, in addition to HIV/AIDS.

The specific pathogen(s) beyond HIV/AIDS, as well as the allergic, and/or immune-mediated diseases that the CoE will select will depend on the CoE expertise.

Examples of NIAID pathogens that cause human disease beyond HIV/AIDS include, but are not limited to, antimicrobial resistant pathogens, respiratory pathogens, sexually transmitted pathogens, water-borne and vector-borne pathogens, and pathogens associated with hospital acquired infections.

It is at the discretion of the investigator to determine how to incorporate HIV/AIDS, additional pathogen(s), and immune or allergic diseases across the Research Projects. For example, there could be three distinct Research Projects focused on HIV/AIDS, another pathogen(s), and immunologic and/or allergic diseases, respectively.

Alternatively, two Research Projects could incorporate HIV/AIDS, another pathogen(s), and immunological responses to the pathogens within each Research Project. Examples of research areas include, but are not limited to: Multi-scale models of pathogens that differentiate between within-host dynamics and between-host pathogen transmission to inform outcomes such as superspreader events.

Multi-scale models that incorporate emerging technologies such as artificial intelligence to improve diagnosis, treatment, and prevention of infectious diseases. Multi-scale modeling of disease induction, progression, or remission of immune-mediated diseases within NIAID’s mission (e.g., allergy, asthma, autoimmunity, transplant rejection (cell, tissue, and/or organ).

Multi-scale modeling of environmental and/or climatological data as it relates to IID (pathogen distribution, asthma, immunological complications, immune-mediated diseases, etc.). Multi-scale models to inform outcomes of local, systemic, and drug resistant bacterial infections. Multi-scale computational models of respiratory virus infection and treatment.

Multi-scale models to define immune-mediated sequalae, including autoimmune responses, following pathogenic infection, leveraging systems immunology or other comprehensive analyses. Multi-scale models of immune system dysfunction in response to infection, as well as the development and progression of immune system development, function, or autoimmunity.

Multi-scale models that define and predict response to vaccines, therapeutics, and/or immunomodulatory therapies for immune-mediated diseases. Multi-scale models to inform effectiveness of vaccine responses, including immune boosting from variant vaccines and/or repeat infection by pathogen variants.

Multi-scale models that incorporate pathogen genomic heterogeneity (e.g., HIV or Staphylococcus aureus) and the immune response applied to within-host or between-host scales. Multi-scale models that predict time to viral rebound in persons living with HIV who each stop conventional antiretroviral therapy (ART) or models that advance understanding of the persistent HIV reservoir.

External Advisory Committee (EAC): The EAC is an external advisory body that will review progress of the overall CoE program and share recommendations for maximizing productivity and collaboration across the program with CoE PD(s)/PI(s) as part of an NIAID-sponsored annual scientific meeting. Potential members of the EAC should not be named in the application or solicited prior to award.

However, the application could describe the expertise and responsibilities of the potential EAC members. Applications with the following will be deemed non-responsive and will not be reviewed: Applications that do not address at least one pathogen in addition to HIV/AIDS. Applications that do not address allergic and immune-mediated diseases.

Applications that do not include a plan to pivot during infectious disease outbreaks, epidemics, or pandemics. Applications that propose a dedicated data generation core as an Optional Core. For additional information about the Center of Excellence for Systems Modeling of Infection and Immunity across Biological Scales, see the "Frequently Asked Questions (FAQ)" link here: https://www.

niaid. nih. gov/grants-contracts/questions-and-answers-systems-modeling-infection-immunity .

Plan for Enhancing Diverse Perspectives (PEDP) This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310, submitted as Other Project Information as an attachment (see Section IV). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material .

The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

See Section VI. 2 for additional information about the substantial involvement for this NOFO. Application Types Allowed The OER Glossary and the How to Apply - Application Guide provides details on these application types.

Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards NIAID intends to commit $3. 125 M in FY 2025 to fund 1 award and includes total cost of $0. 3M to support an Infrastructure and Opportunities fund.

Application budgets are not expected to exceed $3. 125 million in direct costs per year, which includes an expectation that the budget for the Opportunity Fund will not exceed $0. 3 million in direct costs per year.

Application budgets need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Organization) 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 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 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.

Eligible Individuals (Program Director/Principal Investigator) 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 his/her 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 . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2- Definitions of Terms.

3. Additional Information on Eligibility 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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed in this notice of funding opportunity to do otherwise and where instructions in the How to Apply - Application Guide are directly related to the Grants. gov downloadable forms currently used with most NIH opportunities.

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.

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

Component Type for Submission Model and Data Sharing Core Community Development and Education Core Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

The application should consist of the following components: Administrative Core: required, maximum of 1 Model and Data Sharing Core: required, maximum of 1 Community Development and Education Core: required, maximum of 1 Core: Optional, maximum 1, Research Projects: required minimum 2, maximum 3 When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted. SF424(R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall) Follow standard instructions,with the following additional instructions: 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 historically under-represented in the biomedical, behavioral, and clinical research workforce. Proposed monitoring activities