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 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.

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

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.

Objectives

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.

Opportunity Funds

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.

Rapid Response

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.

Data Related Activities

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).

Improvement of FAIR

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.

Education and Mentoring

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.

Community Communication

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.

Annual Meeting

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.

Management and Oversight

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

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign 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

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.

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.

2. Cost Sharing

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

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST 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.

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:

Vanitha S. Raman, Ph.D.
Telephone: 240-457-2783
Email: vanitha.raman@nih.gov 

Page Limitations

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

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:

• Overall: required
• 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

Overall Component

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)

Complete entire form.

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:

Other Attachments:

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 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.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed CoE. Describe how the CoE will coordinate and provide strategic direction to the IID community based on NIAID priorities for multi-scale modeling development, model sharing and re-use, and pandemic response. 

Research Strategy: Provide an overview that describes the key scientific goals and overarching theme of the CoE to support and advance interdisciplinary and multi-scale IID computational modeling. Describe how the CoE will coordinate administrative, approaches and technologies for model and data sharing, and community development and education activities across the Cores. State how the Research Projects will satisfy the requirement to advance the IID modeling field to integrate systems models and mechanistic processes represented across the CoE. Highlight the biological scales that will be represented and how the connecting multi-scale models (i.e., bridge models) turn output from one scale into input for another scale. Describe the pathogens (at least one in addition to HIV/AIDS) for which models will be developed, and specifically how HIV/AIDS and immunology will be included.

Importantly, describe how the CoE will:

• Develop and conduct innovative computational multi-scale modeling research for NIAID priority biomedical questions, including, but not limited to HIV/AIDS;
• Connect the experimental and computational modeling communities to accelerate/advance multi-scale model development by leveraging complementary and cross-disciplinary IID 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/early-stage investigators;
• Enable new approaches and/or technologies  for multi-scale model sharing and reproducibility aligned with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles and the NIAID Data Ecosystem Portal; and
• Improve multi-scale modeling, technologies for model and data sharing, re-use, and, when possible, interpretability and transparency aligned with the FAIR principles and other applicable NIH sharing policies across pathogens (including HIV/AIDS), allergic and immune-mediated diseases, immunology, and/or immune-mediated diseases to benefit the entire IID research community.

Milestones and Timelines

A section entitled “Milestones and Timelines” should be provided. The section should include the overall CoE milestones and timelines and a plan describing how the CoE will ensure that milestones and activities of the Cores and Research Projects will be met and implemented effectively within the proposed timelines.

Letters of Support: Include letters of support to demonstrate strong relations with the NIAID and broader IID modeling community.

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

Other Plan(s): 

All instructions in the How to Apply- 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.
• Recipients must rapidly disseminate data, results, and analyses to the broader scientific community, using NIH/NIAID repositories (ImmPort, BV-BRC, VeuPathDB, IEDB, etc.) or existing public repositories whenever possible, and/or work with their institutional library-supported repository to rapidly self-publish all useful and usable data rapidly as a foundation for further study.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

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

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

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

Administrative Core

When preparing your application, use Component Type ‘Admin Core.’

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

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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Include costs for the following in the budget section:

Meetings:

Publications: Funds to support publications for the CoE.

Core Lead: The Core Lead must commit at least 0.6 person-months effort to the Administrative Core.

The Administrative Core budget must include the following costs for the Opportunity Funds:

• A minimum of 0.6 person months for the Opportunity Funds Management Leader.

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).

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: State the Specific Aims for the Administrative Core and provide a rationale and description of how each aim enhances the operation of the CoE and its value to the IID community. Include a description of how the Administrative Core will coordinate the distribution of Opportunity Funds projects and pivot to infectious disease outbreak, epidemic, or pandemic responses in collaboration with NIAID.

Research Strategy: In lieu of the standard Research Strategy sub-sections (Significance, Innovation, Approach), use the instructions below to explain how the Administrative Core will effectively administrate and coordinate the activities of the CoE:

Management, Leadership, and Staffing Plan

Describe plans and procedures to establish, lead, manage, and coordinate an Administrative Core that provides the organizational capacity for the CoE. Include the following:

• Describe the leadership team and how components of the CoE, including key personnel, will interact within the CoE itself and with the broader modeling community and NIAID program staff.
• Detail how the organizational and administrative structure will oversee the entire range of CoE activities and ensure collaborative efforts and interaction among the Coordinating Cores and Research Projects and other collaborating partners.
• Provide a description of how CoE resources will be prioritized, allocated and managed.

Opportunity Funds Management Plan

The Opportunity Funds management plan must include:

• An administrative structure.
• Approaches to establish the scientific scope of the Opportunity Funds and ensure that the Opportunity Funds advances opportunities for early-stage career and underrepresented groups.
• Plans for the logistics for solicitation, review, and award of pilot projects. Note: The Opportunity Funds management plan should only include information about the logistics for solicitation, review, and award of pilot projects and should not include any proposed pilot projects.
• Tracking and monitoring of timely submission and payment of invoices and plans for handling consortium agreement administration delays.
• Plans for interacting with the institutions that will receive Opportunity Funds, including the reporting on the status of the funds and consortium agreements awarded.
• Administrative structure, including a description of the qualifications of the personnel managing the Opportunity Funds.

Rapid Response Project Plan (RRP)

The Rapid Response Project Plan would be executed only in the case when NIAID requires a rapid research response (e.g., during an infectious disease outbreak, epidemic, or pandemic). The plan should include:

• A description of the process to identify and develop rapid response within the CoE including collaboration with NIAID, leadership structures and organizational planning within the CoE, and with the IID modeling community during infectious disease outbreaks, epidemics, or pandemics.
• Plans for managing progress and monitoring the success and productivity of funded rapid response projects.
• Plans for communication and sharing of all outcomes from the CoE, including models and software to the wider IID community during infectious disease outbreaks, epidemics, or pandemics.

Note: The RRP sections should only include information about the establishment and management of the projects and should not include any RRP proposed Research Projects.

Milestones and Timelines

A section of the Administrative Core entitled “Milestones and Timelines” should be provided. The section should include Administrative Core milestones and timelines and a plan describing how the Administrative Core will ensure that milestones and activities of the additional Cores and Research Projects will be met and implemented effectively within the proposed timelines.

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.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Model and Data Sharing Core

When preparing your application, use Component Type ‘Data Share Core.’

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

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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Model and Data Sharing Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Model and Data Sharing Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Model and Data Sharing Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Model and Data Sharing Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Model and Data Sharing Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Model and Data Sharing Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

• Funds to support infrastructure for central data storage, data management, and information security systems for the Center; and to support approaches and technologies for the submission of data, data analyses, and bioinformatics/computational tools to NIH approved databases, or other databases designated by NIAID.
• The Core Lead must commit at least 1.2 person-months effort to the Core.

PHS 398 Research Plan (Model and Data Sharing Core)

Specific Aims: State the Specific Aims for the Model and Data Sharing Core and provide a rationale and description of how each aim will enhance and develop new approaches for model sharing that goes beyond current practices. Describe sources of data that will be used and how they span the full scale of NIAID-funded work including basic science, clinical trials and studies, and epidemiologic research. Provide details and identify what FAIR principles will be advanced by this Core. Describe how the proposed activities will contribute to meeting the goals and objectives of the CoE.

Research Strategy: In lieu of the standard Research Strategy sub-sections (Significance, Innovation, Approach), use the instructions below to describe plans and procedures for establishing a Model and Data Sharing Core that provides the organizational capacity for the following:

Computational Models and Research Software

• Describe how the Model and Data Sharing Core will establish innovative model and data sharing approaches beyond current practices of code repositories or catalogues and explain the rationale for selection of these methods and approaches.
• Detail how the Core will work to ensure model re-use, interoperability, and transferability. Specifically, explain how the Core will develop and maintain the computational and statistical tools that support these models.
• Describe how the Core will develop standard operating procedures (SOPs), protocols and methods for new and improved technologies, project design, and analysis methods and tools for dissemination into the broader scientific community and share all outcomes (including data access, software, algorithms, and methods) publicly with the broader scientific community.

Data Related Activities

• Describe sources of experimental data for the CoE and specifically the Model and Data Sharing Core that ideally spans the full scale of NIAID-funded work, including basic science, clinical trials and studies, and epidemiologic research.
• Provide a research plan to develop infrastructure to facilitate sharing of multi-model data from multiple scales across the CoE and to the greater IID community.
• Address the technical and non-technical barriers to data sharing, including sharing controlled access data, and should explain how these barriers will be overcome, for example the services, resources/support, technologies and informatic approaches that will be implemented, improved upon and developed.

Improvement of FAIR

• Identify which of the 15 FAIR Principles will be advanced by the Model and Data Sharing Core to improve FAIR for Data, Computational Models and Research Software.

Milestones and Timelines:

A section entitled “Milestones and Timelines” should be provided. The section should include the Model and Data Sharing Core milestones and timelines and a plan describing how the Model and Data Sharing Core will ensure that milestones and timelines are met.

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:

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Modeling and Data Sharing Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Community Development and Education Core

When preparing your application, use Component Type ‘Devel Ed Core.’

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

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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Community Development and Education Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Community Development and Education Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Development and Education Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Community Development and Education Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Community Development and Education Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Community Development and Education Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

• Funds to plan and host an annual modeling community meeting starting in Year 2 in the Rockville, MD area for approximately 200 participants. Assume the use of NIH meeting facilities are already covered. Include plans for travel awards for new and early-stage investigators to attend the meeting.
• Include travel funds for the PD(s)/PI(s), Research Project Leaders and Core Leaders, and Project presenters to attend annual Modeling meeting, to be held in Year 3 in the Rockville, MD area.
• Include travel funds and per diem costs for the PD(s)/PI(s), Research Project Leaders and Core Leaders to attend the Kick-off Meeting in the Rockville, MD area in Year 1 of the award.
• Include funds needed for outreach and educational activities of the CoE, including potential websites and/or social media presence.
• The Core Lead must commit at least 1.2 person-months effort to the Core.

PHS 398 Research Plan (Community Development and Education Core)

Specific Aims: State the Specific Aims for the Community Development and Education Core and provide a rationale and description of how each aim will provide educational and mentoring activities for students, postdoctoral fellows, early career investigators and investigators from underrepresented communities. Describe how the CoE will endeavor to develop interdisciplinary educational opportunities and collaborations.

Research Strategy: In lieu of the standard Research Strategy sub-sections (Significance, Innovation, Approach), explain how the Community Development and Education Core will provide the organizational capacity for the following:

Education and Mentoring

• Describe how the Community Development and Education Core will organize workshops and other educational opportunities for students and junior researchers from computational and biomedical sciences.
• Describe additional activities and opportunities that will be developed to foster community development for example, seminars, journal clubs, short courses, individualized instruction on specific technologies or methodologies, temporary placement in a collaborator’s laboratory, individualized mentoring.

Community Communication

• Detail how the Community Development and Education Core will 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.
• Describe additional activities of the Core for communicating with the research community that could include a website, social media, and/or a regular newsletter for events sharing, funding opportunities, upcoming meetings, featuring research by the community, and job and training opportunities.

Cross Disciplinary Collaboration and Development

• Describe plans to develop activities to increase the collaboration between biological scientists and computational scientists including potential educational and collaborative opportunities across experimental, computational, clinical, and behavior and behavioral researchers.

Annual Meeting

• Describe plans for the annual meeting, including educational plans for students and junior faculty.

Milestones and Timelines:

A section entitled “Milestones and Timelines” should be provided. The section should include the Community Development and Education Core milestones and timelines and a plan describing how the Community Development and Education Core will ensure that milestones and timelines are met.

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, with the following modification:

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Community Development and Education Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Optional Core

When preparing your application, use Component Type ‘Core.’

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

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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Optional Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Optional Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Optional)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Optional Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Optional Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Optional Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Optional Core)

Specific Aims: State the Specific Aims for the Optional Core and provide a rationale and description of how each aim enhances the operation of the CoE and its value to the IID community. 

Research Strategy: In lieu of the standard Research Strategy sub-sections (Significance, Innovation, Approach), use the instructions below to explain how the Optional Core will effectively administrate and coordinate the activities of the CoE.

Describe the functions, services, technologies, and/or any efficiencies that will be provided by the proposed Core. Include a justification for the Core’s activities that includes a description of why the proposed Core activities are not redundant with the required structures of the CoE.

Describe the overall management of the Core including the decision-making process for use of Core services.

Milestones and Timelines:

A section entitled “Milestones and Timelines” should be provided. The section should include the Optional Core milestones and timelines and a plan describing how the Optional Core will ensure that milestones and timelines are met.

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.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Optional Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Research Projects

When preparing your application, use Component Type ‘Project.’

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

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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Project)

Specific Aims:  Describe the broad objectives and goals of the proposed Research Project. State the Specific Aims for the Research Project and provide a rationale and description of how each aim will contribute to the scientifically distinct Research Project that will also develop “bridge models” to connect systems models at the molecular to organism-scale and the organism to population-scale.

Research Strategy: The Approach section should address the following:

• Provide an overview and justification of the pathogens and infectious diseases (including HIV/AIDS), allergic and immune-mediated diseases, and immune processes that will be included in the Research Project.
• Describe the modeling processes that must produce computational models that are mechanistic, transferable, re-usable, and wherever possible, transparent, and interpretable.
• Describe how the Research Project will advance computational methods for systems modeling across biological scales of infection, allergic and immune-mediated diseases and/or immunity. Include details of the approaches in computer sciences, mathematics, statistics, and other related fields that will be leveraged and integrated to create these bridge models and advance computation modeling.
• Describe the computational representation of the biological process, model parameterization methods, and proposed framework for model testing.
• Describe innovative approaches such as statistical, model parameterization, and technological.
• Provide a description of how the Research Project will endeavor to produce models that are mechanistic, transferable, re-usable, and wherever possible, transparent and interpretable.
• Describe how the Research Project will address both determinants and risk factors, such as vaccination, antimicrobials, pathogen evolution and co-circulation, host genetics, climate factors, or vulnerable populations, etc.

Milestones and Timelines.

A section entitled “Milestones and Timelines” should be provided. The section should include the Research Project milestones and timelines and a plan describing how the Research Project will ensure that milestones and timelines are met.

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.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 How to Apply - Application Guide. 

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the National Institute of Allergy and Infectious Diseases, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications must include annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

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

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

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:

• How well does the proposed CoE address the key scientific goals and overarching theme to support and advance interdisciplinary and multi-scale IID computational modeling?
• To what extent are the approaches and technologies to coordinate administrative, model and data sharing, and community development and education activities across the Cores adequately described?
• How appropriate are the plans of the proposed Cores and Research Projects to integrate the required components of IID, including HIV/AIDS, in multi-scale bridge models?
• To what extent will the applicant’s proposed approaches and technologies for model and data sharing lead to outcomes that will advance current approaches in the field(s)?
• 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:

• 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:

• How likely is it that the proposed modeling research will produce transformational outcomes for NIAID priority biomedical questions, including HIV/AIDS?
• 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

• How well does the proposed CoE describe the approaches and technologies for model and data sharing, re-use, interoperability and, when possible, interpretability and transparency aligned with the FAIR principles, the NIAID Data Ecosystem and applicable NIH sharing policies? 
• How well will the CoE establish education opportunities in IID for students and junior investigators?
• 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:

• How well does the interdisciplinary CoE leverage unique research resources to model the infectious, allergic, and immune-mediated diseases they propose to study?
• To what extent will the CoE foster a community of new and existing investigators dedicated to immune and infectious diseases modeling?
• To what extent will the CoE establish educational opportunities in modeling of IID for students and junior investigators?
• 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?

Overall Impact – Individual Cores

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Core activities to meet the needs of the Cores, and to contribute to CoE goals and objectives, in consideration of the following points (as applicable for the Core proposed).

Scored Review Criteria – Individual Cores

Reviewers will consider each of the review criteria below, as appropriate for the individual Core, in the determination of merit and will give an overall impact score for each Core but will not give separate scores for each criterion.

Administrative Core

Management and Staffing Plan:

• To what extent is the administrative and organizational structure clearly described and is it appropriate and adequate to accomplish the objectives of the Administrative Core?
• How well does the Management and Staffing Plan for the Administration Core describe plans to interact within the CoE itself and with the broader modeling community and NIAID program staff?
• To what extent does the Administrative Core plan clearly describe how CoE resources will be prioritized, allocated, and managed?

Opportunity Funds:

• How well are the proposed Opportunity Funds management services to the CoE program described?
• How clearly do the plans for the Opportunity Funds detail the processes for solicitation, review, and award of pilot projects and invoice tracking and monitoring and how sufficient is the justification provided for the management methods proposed for the Opportunity Funds?
• How appropriate are the qualifications of the personnel charged with managing the Opportunity Funds?

Rapid Response Project Plan:

• To what extent does the rapid response project plan describe how the CoE will effectively pivot research activities?
• How well do the plans for Rapid Response provide details for developing approaches and technologies to facilitate dissemination of outcomes (e.g., models, software, data access) from the CoE, to the wider IID community during infectious disease outbreaks, epidemics, or pandemics?

Model and Data Sharing Core

• To what extent will the proposed plans for innovative model and data sharing approaches and technologies lead to advancement beyond current practices of code repositories or catalogues and improved model and data re-use and sharing across the broader scientific community?
• To what extent do the plans address the development of standard operating procedures (SOPs), protocols and methods for new and improved technologies, project design, and analysis methods and tools for dissemination into the broader scientific community?
• To what extent will the Core maintain and support the computational and statistical tools that support the models and data?
• How clearly do the plans describe sources of experimental data and to what extent does this address NIAID basic science, clinical trials and studies, and epidemiologic research?
• To what extent will the Model and Data Sharing Core advance FAIR and which principles will be the focus of this Core?

Community Development and Education Core

• To what extent will the proposed core provide educational and mentoring activities for students, postdoctoral fellows, and early career investigators?
• How appropriate are the plans to maintain an open and inclusive environment?
• To what extent does the plan provide details around community development and sharing educational materials to the wider IID modeling community?
• How well are plans for an annual meeting described, including opportunities for students and junior faculty?

Optional Core

• To what extent are the proposed activities of the Optional Core justified and provide activities that are not redundant with the required structures of the CoE?

Overall Impact - Individual Research Projects

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Research 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 – Individual Research Projects

Reviewers will consider each of the review criteria below, as appropriate for the individual project, in the determination of merit and will give an overall impact score for each Project but will not give separate scores for each criterion.

• To what extent will the Research Projects generate bridge models between systems and across ‘scales’ of infection and immunity, from molecular to organism-scale processes and organism to population-level processes?
• To what extent do the Research Projects describe and justify the pathogens, infectious diseases and immune processes/immune-mediated diseases, in addition to HIV and/or AIDS, that will be included in the research projects?
• To what extent will the Research Projects advance computational methods for systems modeling across biological scales of infection and immunity.
• How well do the Research Projects detail how computer sciences, mathematics, statistics, or other related fields will be leveraged?
• To what extent will the Research Project produce computational models that are mechanistic, transferable, re-usable, and wherever possible, transparent and interpretable?

Additional Review Criteria - Overall, Cores, and Research Projects

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.

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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. 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

Additional Review Considerations - Overall, Cores, and Research Projects

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

Not Applicable

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) (e.g., 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 by the National Institute of Allergy and Infectious Diseases, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

Applications will be assigned 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 National Advisory Allergy and Infectious Diseases Council. 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 their Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information

1. Award Notices

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

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.6. 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: Grantee 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.

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 Standard Terms and Conditions for Research Grants
• 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.

If a recipient receives and award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, 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 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 (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

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

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

• Coordinating the Projects and Cores within the overall Program.
• Serving as the lead for scientific and administrative oversight for the proposed research, including overseeing, managing, and coordinating the overall Program including working with the NIAID program officials and Project Scientist.
• Defining the research objectives, approaches, and details of the projects within the guidelines of the NOFO, and retaining primary responsibility for the planning, directing, and executing the proposed scientific activities.
• Organizing, participating, and chairing the Annual Programmatic Meeting.
• Organizing and chairing annual site visit activities.
• Managing the Opportunity Funds and Rapid Response Projects as applicable.
• Ensuring that results obtained from the Program are analyzed and published in a timely manner.
• Seeking opportunities for collaborative activities with the aim of producing software tools that are FAIR in order to maximize their utility and actively solicit feedback from the user community to integrate them in the software development plan.
• Ensuring that software is compatible with requirements of the NIAID Data Ecosystem Portal for metadata formats, discoverability, and for possible integration with analytical workflows that may exist in the NIAID community.
• Provide updates at least annually on implementation of the PEDP.

Program Generated Data, Software and Other Resources

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 HHS, PHS, and NIH policies.

Program-generated data and software include, for example:

• all research data (both experimentally and computationally generated) and associated metadata.
• database schema and specifications.
• experimental protocols and Standard Operating Procedures (SOPs).
• data analysis tools, models and algorithms generated under this cooperative agreement, including source code, complete use documentation, and tutorials.

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

An NIAID Project Scientist will serve as an overall program coordinator. The main responsibilities of the Project Scientist include:

• Monitoring the progress of the Program, help coordinate research approaches and contribute to the shaping of Research Projects or approaches as warranted. The NIAID Project Scientist will support and coordinate this process but will not direct it.
• Keeping the CoE Program informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing/collaboration in infectious and immune-mediated disease research. The NIAID Project Scientist will coordinate access for the Program to other NIAID resources, as well as assist the research efforts of the Program by facilitating access to fiscal and intellectual resources provided by the EAC, industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.
• Providing technical input and suggest modifications to the project as required to ensure research objectives are satisfactorily met.
• Facilitating interactions amongst the projects and other parts of the overall data science program such as those between collaborating projects and establish working groups, annual meeting input.
• Coordinating workshops and meetings among recipients and the EAC to share ideas and approaches on good practices for software development in the IID domain.
• Coordinate activities with recipients to ensure software is discoverable through FAIR compliant metadata and is compatible with requirements of the NIAID Data Ecosystem Portal.

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 NIAID Project Scientist will coordinate with the PD(s)/PI(s) and hold regular CoE -wide discussions to facilitate the achievement of CoE Program goals. In the event that some members of the CoE Program and investigators outside of the CoE program develop common research interests working groups may be formed to pursue collaborative activities.
• PD(s)/PI(s), Research Project and Core Leaders and the NIAID Project Scientist will discuss potential projects to be funded through the Opportunity Funds and Rapid Response Project Program.
• Bimonthly teleconferences will be held to discuss progress, problems, proposed solutions and any matter that is relevant to the scientific and financial administration of the CoE and future activities. The schedule for those meetings will be established by the PD(s)/PI(s) and the NIAID Project Scientist.

Dispute Resolution:

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

3. Data Management and Sharing

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

• Recipients must rapidly disseminate data, results, and analyses to the broader scientific community, using NIH/NIAID repositories or existing public repositories whenever possible, and/or work with their institutional library-supported repository to rapidly self-publish all useful and usable data rapidly as a foundation for further study.

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.

Awardees 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 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to  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 (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 – Award Term and Condition 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

Office of Data Science and Emerging Technologies (ODSET)
National Institute of Allergy and Infectious Disease (NIAID)
Telephone: 301-761-6549
Email: datascience-foa@niaid.nih.gov 

Vanitha S. Raman, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-457-2783
Email: vanitha.raman@nih.gov 

Jason Lundgren 
National Institutes of Allergy and Infectious Diseases
Telephone: 240-669-2973
Email: lundgrenj@mail.nih.gov 

Section VIII. Other Information

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

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