Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Systems Biology for Infectious Diseases (U19 Clinical Trial Not Allowed)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

Reissue of RFA-AI-16-080

Related Notices

none

Funding Opportunity Announcement (FOA) Number

RFA-AI-21-065

Companion Funding Opportunity

None

Assistance Listing Number(s)

93.855

Funding Opportunity Purpose

The purpose of the Funding Opportunity Announcement (FOA) is to support research that employs systems biology approaches to human pathogens.  The approach will generate and integrate large datasets into models that guide in vitro, in vivo and clinical studies, with the goals of predicting disease severity, predicting responses to vaccines and therapeutics, and identifying candidate targets for interventions.

Key Dates
Posted Date

September 27, 2021

Open Date (Earliest Submission Date)

December 14, 2021

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

January 14, 2022   

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date. 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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2022

Advisory Council Review

October 2022

Earliest Start Date

January 2023

Expiration Date

January 15, 2022

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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

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



  3. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. 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. Funding Opportunity Description

     

    Purpose

    This Funding Opportunity Announcement (FOA) will support Systems Biology for Infectious Diseases Centers that will use systems biology approaches to integrate diverse datasets and build predictive models for infectious diseases, including pathogens in the NIAID priority pathogens list. The Centers must clearly integrate experimental approaches and computational modeling to test and validate hypotheses of significance to the infectious diseases field. The predictive models are expected to enable in silico experimentation to address fundamental questions about host-pathogen-microbiota interactions during infection, prevention, or treatment; disease outcomes; pathogen dynamics within and between hosts; or other complex questions.  Models will leverage datasets derived from high-throughput (HTP) experimental and computational approaches. Importantly, these approaches should address questions for which the answer is the result of multiple variables and decipher the contribution of each variable to the model.

    Background

    The integration of systems-level data (genomics, transcriptomics, and other "omics" technologies) in combination with behavioral, environmental, and clinical data lay the foundation for models of host-pathogen interactions and disease progression. These systems biology applications have progressed over the last decade, yet limited strategies integrate discordant data types. Many current workflows for data integration and interpretation rely on human intelligence (i.e., “by eye”), a method that is not conducive to iterative hypothesis testing and experimentation. Therefore, additional work is required to develop models which leverage statistical methods, machine learning and artificial intelligence that have high accuracy and can move towards clinical application. In this re-issue, the Centers will continue to advance the systems biology field in infectious diseases by developing and applying models that identify drivers of disease and candidate interventions. This initiative will further establish these platforms across bacteria, viruses, fungi, parasites and their vectors, where applicable, that cause human disease.

    In 2008 NIAID/DMID launched the Systems Biology Program for Infectious Diseases Research to encourage a paradigm shift in strategies for basic infectious diseases research by adopting less traditional approaches, including a combination of HTP “omics” technology platforms, high-performance computing infrastructure, and increasingly sophisticated data processing and modeling algorithms. Most recently, Systems Biology for Infectious Diseases: The Next Generation, supported research projects on both bacterial and viral pathogens (RFA-AI-16-080). The Next Generation Program:

    • established a network of Centers focused on building predictive models of infectious diseases leveraging Systems Biology. The necessity for rapid research on SARS-CoV-2 illustrates the value of systems analyses. The Systems Biology Centers have defined global protein interaction networks to identify drug targets and leveraged high throughput assays for SARS-CoV-2 drug discovery.  In clinical samples, the Centers have described serological signatures associated with mortality and survival, and transcriptomic signatures distinct for SARS-CoV-2 pneumonia. The Centers have integrated genomic epidemiology with molecular modeling.
    •   developed high throughput CRISPR tools for bacterial pathogenesis and animal models for M. tuberculosis that more closely replicate human disease.
    • developed and improved experimental methods, technologies, bioinformatics and computational tools, machine learning software, and statistical inference methods. Major accomplishments include novel discoveries across high-impact publications; release of large datasets following the Findable, Accessible, Interoperable, Reusable (FAIR) data-sharing best practices, network models and analysis software; and robust technological advances.

    The re-issue builds upon this program history and will apply systems approaches to both fundamental research and clinical applications, transforming clinical data/metadata into models that predict severity and guide interventions and countermeasures.

    Research Objectives and Scope 

    The Systems Biology for Infectious Diseases Centers address complex questions across bacterial, viral, fungal, and parasitic pathogens and their vectors, where applicable, with high-throughput (HTP) generation, analysis and computational modeling of large datasets (e.g. “omics”). The proposed initiative will continue to support this cross-disciplinary approach with an emphasis on integration of large datasets and metadata (e.g. primary, systems, and electronic health records (EHR)) to generate actionable hypotheses. For the purpose of this initiative, the systems biology approach consists of repeated cycles of experimental data generation, analysis and integration, modeling of systems-wide networks structures and dynamics, predictions of microbial and host ‘systems’ responses to changes/perturbations/alterations of experimental conditions and experimental validation, and  building predictive models of system-wide molecular networks structure and dynamics to identify predictive markers of infectious diseases.  Multi-component projects will be supported to transform clinical data/metadata to predict onset and severity across infectious diseases by:

    • Integrating clinical metadata, large datasets, and technologies in the context of infectious diseases.
    • Applying findings to predict disease outcome and inform treatment and/or mitigation options.
    • Validating predictions and obtaining mechanistic insight from laboratory and animal studies.
    • Refining predictive models to improve accuracy.

    The Systems Biology for Infectious Diseases initiative will emphasize a ‘reverse translational research’ or ‘bedside to benchtop (and back)’ approach, integrating clinical metadata, systems datasets, and advanced technologies in the context of infectious diseases. Projects will also perform secondary analyses on existing data and validate findings with laboratory studies. The Centers will be expected to develop or improve innovative experimental methods, technologies, bioinformatics and computational tools, machine learning software, and mathematical or statistical inference methods. These outputs can be used by the Centers and the broad infectious diseases community for systems level data analyses and applications.

    Examples of research areas include, but are not limited to:

    • Determination of host/pathogen interaction networks and predictive models which identify biosignatures that predict risk, severity and response to therapeutic intervention of an infectious disease.
    • Determination of interaction networks and predictive models focused on genetic and epigenetic pathways regulating host and pathogen responses to infection, signatures associated with preventing infection (e.g. vaccines), or therapeutic intervention.
    • Systems approaches that interrogate host/pathogen interactions across the life cycle in the vertebrate host, invertebrate vector host, and/or reservoir and use these data to identify approaches for targeted interventions.
    • Incorporation of non-traditional data sources (e.g. wearables, mobility data, etc.) with novel computational, mathematical, and statistical algorithms and methods, including artificial intelligence and machine learning approaches to predict disease risk and severity.

    Applications that propose to conduct research in the following areas will be considered non-responsive and will not be reviewed:

    • Animal models and/or cell lines in the absence of human clinical samples.
    • Studies that focus exclusively on the molecular interaction networks of the pathogen with no consideration of those in the host.
    • Studies that focus exclusively on the identification of molecular networks and signatures of the host immune response with no consideration of those in the pathogen.
    • Studies that only generate or use only genomics and transcriptomics data sets to build molecular networks and predictive models.
    • Studies proposing only pathogen sequencing.
    • Studies that propose only the use of immortalized cell cultures, and do not include human clinical samples.
    • Studies that propose samples from animal models in the absence of using material from human clinical samples (i.e. human cells or tissues, human blood, immune components, bacterial isolates).
    • Studies that solely focus on development of computational and software tools for “big-data” integration of multiple data types generated by experimental technologies, including, for example, data analysis and machine learning algorithms.
    • Projects that solely target Influenza viruses.  Projects in response to this announcement may study influenza, but should primarily focus on pathogens other than influenza.
    • Studies/applications that propose clinical trials.
    • Studies on HIV/AIDS.

    Data Sharing: It is critical to enhance data-sharing and access to ensure that NIAID-funded data be Findable, Accessible, Interoperable, and Reusable (FAIR). All NIAID-funded researchers must share research data to enhance the rigor and reproducibility of research results and secondary use per the NIAID Data Sharing Guideline at:

    https://www.niaid.nih.gov/research/data-sharing-and-release-guidelines, as appropriate and consistent with achieving the goals of the program.

    NIH and NIAID support several open domain-specific repositories and knowledgebases for broad sharing of data with the larger research community. However, we recognize that not all data have domain-specific repositories or allow self-publishing. There are several generalist repositories that can fill this gap. Researchers are encouraged to use one of their choice and/or work with their institutional library-supported repository to rapidly self-publish all useful and usable data rapidly.

    Collaborative Interdisciplinary Teams and Outreach

    The scope of this work encourages the formation of interdisciplinary teams capable of pursuing coordinated activities that bridge disparate scientific disciplines and expertise in clinical biology, microbiology, immunology, infectious diseases, microbiome, vector biology, HTP experimental and “omics” technologies, together with experts in mathematics, physics, bioinformatics, computational biology, machine learning and statistical methods and modeling. Bringing multidisciplinary groups together creates opportunities for synergy that would rarely happen otherwise. The research teams within each Center may be composed of investigators located at one institution or may be formed through a consortium of different institutions. In addition, Centers will engage in outreach activities throughout the broader scientific community that promote the use of systems biology approaches to study infectious diseases.

    Systems Biology Centers Programmatic Components

    Administrative Core: The Administrative Core, headed by the PD/PI, will be responsible for managing, coordinating, and supervising the entire range of Center activities; monitoring progress; and ensuring that the overall project management plan is implemented effectively and within proposed timelines. The Administrative Core will also have responsibility for outreach and instructional activities to promote the use of the systems biology approaches developed by the Center to the broader infectious disease scientific community. The outreach activities are expected to begin in the year two and continue for the duration of the award and should be designed to instruct and increase the use of approaches/methodologies and resources (datasets, analysis tools, models, etc.) utilized and generated under this initiative. The Administrative Core must include a Management and Staffing Plan and an Outreach Activities Plan; applications that do not contain these plans will be considered non-responsive and will be withdrawn without review.

    Data Management and Bioinformatics Core: The Data Management and Bioinformatics Core provides data storage, management, and information security services to the Center and all collaborating sites. The Core will also be responsible for development of new and enhanced computational tools as well as the rapid release to the broader scientific community of datasets, analysis tools, computational models, reagents, and other resources generated by the Center.

    Technology Core: The Technology Core provides HTP technologies for systems biology analysis of samples. This Core must have “omics” (e.g. genomics, transcriptomics, proteomics, metabolomics, lipidomics, methylomics, etc.) and other HTP technologies. The Core facilitates not only systems-wide molecular profiling studies, but also more targeted measurements, such as quantitative targeted proteomics and validation of protein/protein or protein/DNA interactions on human clinical samples, including microbiome analysis.

    Modeling Core: The Modeling Core is responsible for modeling and predicting outcomes that may explain disease variability and differential responses to prevention, diagnosis and treatment. The Core will use the data derived from Research Projects and other sources to model and predict the overall architecture and dynamics of the interaction between pathogen and host. The Core will also be responsible for developing and maintaining computational, mathematical, and statistical tools, machine learning algorithms, and artificial intelligence methods necessary for building predictive models, as appropriate. Additionally, the Core is expected to contribute to the experimental design of the Research Projects including, for example, power calculations, the sampling times and number of replicates in a time course infection study, etc.  Importantly, models should be publicly available, and amenable to implementation in clinically relevant scenarios.

    Research Projects: Each Center must include at least two Research Projects organized around a common theme that use a systems biology approach to identify, quantify, model and predict the overall architecture and dynamics of the interaction networks of pathogenic organisms with their host cells during infectious disease and build predictive models of infectious diseases. Investigators are encouraged to study one or more infectious pathogens, including pathogens in the NIAID priority pathogens list and vector-borne pathogens, and incorporate microbiota analysis where appropriate and relevant.

    Annual Programmatic Meetings: Both a kick-off and annual programmatic meetings will be held to establish the major roles and functions of the program and to facilitate collaborations among the Centers. Annual meetings will report progress, seek new research directions and ideas, and update NIAID on issues of need.

    Scientific Advisory Group: A Scientific Advisory Group (SAG) will be established by NIAID in collaboration with the awardees. The SAG will be composed by members of the broader scientific community not in conflict with the awardees. The SAG will assist in review of research productivity, progress toward the proposed goals, adherence to timelines, and the continued relevance of the research approach. The SAG will meet on an annual basis in conjunction with the Annual Programmatic Meetings and on ad-hoc basis by conference calls, as needed. Applicants should not name or contact potential SAG members in their application.

    Please refer to the Frequently Asked Questions (FAQ) page for additional guidance. 

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

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New
    Renewal to RFA-AI-16-080

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIAID intends to commit $10 million in FY 2023 to fund 4-5 awards.

    Award Budget

    Budgets for direct costs of up to $1,500,000 per year may be requested. Application budgets need to reflect the actual needs of the proposed project.

    Award Project Period

     The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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)

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

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    • Non-domestic (non-U.S.) Entities (Foreign Institutions)
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are  eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are  eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • 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. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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 NOT-OD-11-101).

     

    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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    Letter of Intent

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

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

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

    The letter of intent should be sent to:

    Yong Gao, Ph.D.
    Telephone: 240-669-5048
    Fax: 301-480-2408
    Email: yong.gao@nih.gov

     

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    12

    Admin Core (use for Administrative Core)

    6

    Core (use for Data Management and Bioinformatics Core, Technology Core)

    6 pages each

    Modeling Core (Use for Modeling Core)

    12 pages

    Project (use for Research Projects)

    12 pages each

    Additional page limits described in the SF424 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 the SF424 (R&R) 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
    • Data Management and Bioinformatics Core: required, maximum of 1
    • Technology Core: required, maximum of 1
    • Modeling Core: required, maximum of 1
    • Research Projects: 2 required, maximum of 3
    Overall Component

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

    All instructions in the SF424 (R&R) 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.

    Project/Performance Site Location(s) (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 & Related Senior/Key Person Profile (Overall)

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

    In the bio sketches, provide evidence that the PD/PI, or multi-PD/PIs have the capability to lead multi-disciplinary scientific teams.

    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 Systems Biology Center. Describe the hypothesis or hypotheses to be tested. 

    Research Strategy:  Provide an overview that describes the key scientific aspects and overarching theme of the Center, and how the proposed Research Projects and Cores satisfy the requirement to employ systems biology approaches to human pathogens.  Research Projects will generate and integrate large datasets into models that guide in vitro, in vivo and clinical studies, with the goals of predicting disease severity, predicting responses to vaccines and therapeutics, and identifying candidate targets for interventions. The multi-component, multi-disciplinary application should be viewed as a confederation of interrelated Cores and Research Projects, each capable of standing on its own merit, but complementary to one another. This section provides the team of investigators an opportunity to give a conceptual wholeness to the entire program and outlines a broad strategy for accomplishing the stated goals. When developing the Center’s design, each Core and Research Project should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique. A visual representation of the interactions amongst the components and complementary scientific endeavors is encouraged. Importantly: 

    • Describe how the individual Projects and Cores relate to the overall goals of the Center and provide a cohesive whole.
    • Describe how the individual Projects and Cores leverage systems approaches that will improve the ability to model disease severity; responses to vaccines and/or therapeutics; and/or identify candidate targets for interventions.
    • Describe how the individual Projects and Cores will enable predictive model implementation and subsequent use of modeling approaches more broadly, including implementation in the clinic.
    • Describe how the multi-disciplinary Centers leverage unique research resources and patient populations to advance understanding of the pathogens that they propose to study.
    • Clearly define the approach for dissemination, validation, and implementation of Center outputs, such as models that forecast infectious disease severity or patient outcome.

    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:

    • All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.
    • Awardees 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.
    • The Data Sharing Plan must ensure that the data are Findable, Accessible, Interoperable, and Reusable (FAIR) per the NIAID Data Sharing Guideline at https://www.niaid.nih.gov/research/data-sharing-and-release-guidelines, as appropriate and consistent with achieving the goals of the program.

    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 (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 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, 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 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

    PHS Assignment Request Form (Overall)

    All instructions in the SF424 (R&R) 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.

    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.

    Facilities & Other Resources: Include an attachment entitled "Facilities & Other Resources" to provide information on resources available for the Administrative Core. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities available to be used for the Systems Biology Program. 

    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. 
    • The Administrative Core must be headed by the contact PD/PI of the application. Include details of the experience, expertise and ability of the Administrative Core Lead and key personnel to manage all aspects of the Core successfully.    
    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: Funds to travel to the initial Kick-Off Meeting within the first 6 months of the award, and to the Annual Programmatic Meeting for all Centers funded under this FOA starting the second year of award. Each Center should fund travel and attendance at yearly meetings by the PD(s)/PI(s), the Project Leads, Core Leads, and other Key Personnel. These meetings are anticipated to be held at a location at/near Bethesda, Maryland or at another agreed-upon site following consultation with NIAID staff.  Travel and per diem costs to attend the initial Kick-Off Meeting and Annual Programmatic Meeting must be included in the budget; costs associated with organizing the Annual Programmatic Meeting are not allowable expenses.
    • Research Resources: Funds to support deposition of research reagents such as clones, strains, etc. into existing public repositories to ensure access of these resources to the broad research community.
    • Publications: Funds to support publications for the Center.
    • Outreach Activities: Funds for the overall administrative efforts for the outreach activities should be requested beginning in year 2.
    • Core Lead: The Core Lead must commit at least 0.6 person-months effort to the Administrative Core.
    • Cross-Center Programmatic Activities: Funds for personnel to participate in Program-wide working groups (e.g., Data Dissemination Working Groups, Modeling Working Groups, cross-center workshops) should be requested for each year.   

    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: Briefly describe the broad objectives and goals and the proposed activities and services of the proposed Administrative Core.   

    Research Strategy:   Describe plans and procedures for establishing and effectively managing an Administrative Core that provides the organizational and administrative capacity to ensure the following:

    • Managing, coordinating, and supervising the entire range of Center activities; monitoring progress; and ensuring that the overall project management plan is implemented effectively and within proposed timelines, which includes sponsoring activities to advance the Center’s activities and goals.
    • Communicating and interacting with the NIAID Project Scientist, Program Officer or other NIAID staff.
    • Assisting other Cores and Research Project Leaders with administrative aspects of their projects, such as gathering of annual progress reports, monitoring progress and facilitating other communications with awardees.
    • Communicating with other Centers regarding collaboration and coordination of activities and projects.
    • Ensuring the rapid dissemination of all data and other research resources generated under the Center.
    • Ensuring that there are representatives for all Program-wide activities (e.g. working groups). 

    Management and Staffing Plan: A Management and Staffing Plan that describes the organization of the proposed program and its management structure is required. Applications that do not contain a Management and Staffing Plan will be considered non-responsive and will be withdrawn without review.

    The Management and Staffing Plan must include:

    • A description of how the organization of the Center and its management structure will form a cohesive Center that provides scientific and administrative oversight of all Center Cores and Research Projects.
    • An overview of how the Research Projects will be coordinated, integrated, and scientifically and technically managed to answer the scientific questions and hypotheses proposed within the application and within the scope of the FOA.
    • A description of the structure and roles of the administrative and scientific staff.

    Outreach Activities Plan: A description of outreach activities that promote the use of systems biology approaches that are based on the combined use of “omics” technologies and mathematical modeling to study infectious diseases throughout the broader scientific community is required.

    Applications that do not contain an Outreach Activities Plan will be considered non-responsive and will be withdrawn without review.

    The outreach plans should include:

    • An overall description of outreach activities that will inform researchers about the approaches and resources (datasets, analysis tools, predictive models) utilized and generated under this initiative and promote collaborations with the pertinent scientific communities.
    • Examples of appropriate outreach forums may include, but are not limited to, the organization of hands-on workshops; the opportunity for post-doctoral candidates and junior faculty from the broad scientific community visit technology facilities, modeling laboratories, the hosting of summer school courses, etc.

    Outreach to underrepresented communities is encouraged.    

    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:

    Not Applicable for each component. A Resource and Data Sharing Plan should be submitted only in the Overall section. See instructions in the Overall section.

    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

    Data Management and Bioinformatics 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.

    SF424 (R&R) Cover (Data Management and Bioinformatics 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 (Data Management and Bioinformatics Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Data Management and Bioinformatics 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.

    Facilities & Other Resources: Include an attachment entitled "Facilities & Other Resources" to provide information on resources available for the Data Management and Bioinformatics Core. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities available to be used for the Systems Biology Program.

    Project /Performance Site Location(s) (Data Management and Bioinformatics 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 (Data Management and Bioinformatics 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.
    • Include details of the experience, expertise and ability of the Core Lead and key personnel to manage the Data Management and Bioinformatics Core.

    Budget (Data Management and Bioinformatics Core)

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

    Include the following:

    • Funds to support central data storage, data management, and information security systems for the Center; and to support 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 0.6 person-months effort to the Core.

    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 (Data Management and Bioinformatics Core)

    Specific Aims: Briefly describe the broad objectives and goals and the proposed activities and services of the proposed Data Management and Bioinformatics Core.

    Research Strategy: Describe plans and procedures for establishing and effectively managing a Data Management and Bioinformatics Core that provides the organizational capacity to ensure the ability of the Center:

    • To develop, enhance, establish and maintain innovative bioinformatics and computational tools, machine learning algorithms, and statistical inference methods for systems level analysis of diverse data sets generated by the Research Projects to build predictive models of infectious diseases.
    • To establish a process for the management of project data, tracking samples, and monitoring activities of the Center and its collaborators.
    • To develop and maintain a public website that provides an overview of the Center and Center resources available to the broad scientific community such data sets, predictive models, and reagents.

    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:

    Not Applicable for each component. A Resource and Data Sharing Plan should be submitted only in the Overall section. See instructions in the Overall section.

    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 (Data Management and Bioinformatics 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.

    Technology 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.

    SF424 (R&R) Cover (Technology 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 (Technology Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Technology 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.

    Facilities & Other Resources: Include an attachment entitled "Facilities & Other Resources" to provide information on resources available for the Technology Core. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities available to be used for the Systems Biology Program.

    Project /Performance Site Location(s) (Technology 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 (Technology 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.
    • Include details of the experience, expertise and ability of the Core Lead and key personnel to manage the Technology Core.

    Budget (Technology Core)

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

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

    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 (Technology Core)

    Specific Aims:   Briefly describe the broad objectives and goals and the proposed activities and services of the proposed Technology Core.

    Research Strategy:  Describe plans and procedures for establishing and effectively managing a Technology Core. Specifically:

    • Describe how the Core activities will contribute to meeting the Center’s goals and objectives and explain the rationale for selection of the general methods, technologies, and approaches proposed to accomplish the specific aims of the Center’s Research Projects.
    • Detail how the Core will support the concurrent utilization of HTP approaches, including “omics” approaches, in addition to genomics and transcriptomics.
    • Describe how the Core will evaluate, develop and incorporate enhancements, modifications and improvements in existing “omics” technologies, platforms, pipelines and resources to increase efficiency and decrease cost.
    • Describe how HTP technologies are currently in place for analyzing human clinical samples.
    • Describe how the Core will continue to employ innovative strategies to address new scientific opportunities and technologies in a flexible and timely manner.
    • 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.

    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:

    Not Applicable for each component. A Resource and Data Sharing Plan should be submitted only in the Overall section. See instructions in the Overall section.

    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 (Technology 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

    Modeling Core

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

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

    SF424 (R&R) Cover (Modeling 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 (Modeling Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Modeling 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.

    Facilities & Other Resources: Include an attachment entitled "Facilities & Other Resources" to provide information on resources available for the Modeling Core. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities available to be used for the Systems Biology Program.

    Project /Performance Site Location(s) (Modeling 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 (Modeling 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.
    • Describe the experience of the Core Lead in building predictive models of disease and expertise in statistics.
    • Describe the experience and expertise of the Core personnel in data analysis and computational modeling to identify, quantify, model and predict systems-wide host/pathogen molecular interaction networks.

    Budget (Modeling Core)

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

    Include the following:

    • Funds to support the submission of the predictive models and computational/statistical tools to NIH approved databases, or other databases designated by NIAID.
    • Funds to support the development, validation, and implementation of computational and statistical tools, machine learning algorithms, and statistical methods necessary for all aspects of building predictive models.
    • The Core Lead must commit at least 0.6 person-months effort to the Core.

    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 (Modeling Core)

    Specific Aims: Briefly describe the broad objectives and goals and the proposed activities and services of the proposed Modeling Core.

    Research Strategy: Describe plans and procedures for establishing and effectively managing a Modeling Core.  Include the following:

    • Describe how the proposed Core activities will contribute to meeting the Center’s goals and objectives, and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims.
    • Describe how the Core’s modeling approach will be utilized to undergo iterative cycles of application, validation, and refinement. 
    • Describe the incorporation of non- “omics” data that are relevant to the proposed hypothesis to use behavioral (i.e., mobile sensor device) clinical, electronic health records (EHR), drug susceptibility, surveillance, environmental, immunological data to build predictive models.
    • Provide a plan to contribute to the experimental design of the proposed Research Projects and to integrate experimental datasets and develop predictive models of infectious diseases.
    • Describe how the Core will develop and maintain any computational and statistical tools, machine learning algorithms, and statistical methods necessary for building predictive models.
    • Describe how the Core will coordinate and collaborate with other Centers to develop new methods, software and approaches for building and validating predictive models for infectious diseases.
    • 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.

    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:

    Not Applicable for each component. A Resource and Data Sharing Plan should be submitted only in the Overall section. See instructions in the Overall section.

    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 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.

    SF424 (R&R) Cover (Research Projects)

    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 Projects)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Research Projects)

    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.

    Facilities & Other Resources: Include an attachment entitled "Facilities & Other Resources" to provide information on resources available for that project. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities available to be used for the Systems Biology Program.

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

    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 Projects)
    • 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 Projects)

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

    The Project Lead must commit at least 0.6 person-months effort to the project.

    Note: If samples for the proposed studies are to be collected from an independently-funded clinical research project or trial you may include the following costs: the costs of re-consenting study participants, and additional sample collection, preparation, and shipping. Prospective samples may be paid for only for the first two years.

    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 Projects)

    Specific Aims: Briefly describe the broad objectives and goals of the proposed Research Project.  Concisely and realistically describe the hypothesis or hypotheses to be tested.  State the Research Project’s relationship to the Center’s goals and how they relate to the other Research Projects and Cores.

    Research Strategy: Preliminary Studies for projects should be included as part of the Approach section, and include the following:

    • Describe how the proposed Research Project will contribute to achieving the Center’s goals and objectives and explain the rationale for selecting the methods, technologies and strategies to accomplish the specific aims. State the biological significance of the research, indicate the project's relevance to the primary theme of the application.
    • Describe how the proposed Research Project will perform experimental data generation, analysis and integration into predictive system-wide models that forecast infectious disease onset, severity, and/or outcome.
    • Describe any new methodology and its advantage over existing methodologies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims.
    • Describe the samples to be used in the proposed research project.  For samples from human subjects, indicate the source of the samples and provide evidence that the samples are appropriate for use by the project. Pertinent information may include the number of samples available, relevant sample metadata, expected quality and quantity of materials for “omics” profiling, sample de-identification protocol, etc. 
    • Describe how both patient samples and in vitro/in vivo laboratory approaches are adequate to identify predictive biosignatures and both develop, apply, validate, and refine predictive models.
    • If using animal models in the proposed projects, provide a description of how the research findings are applicable and relevant to the study of the infectious diseases in humans. 

    Milestones and Timelines.  A milestones and timelines section must be provided for the Research Project that addresses all research activities and includes data generation, analysis, and integration and building predictive models in an iterative process. Adequate time should be allocated to experimental data generation, data analysis, and integration to develop high quality predictive models. The project timelines should allow for iterative model refinement. Applications that do not contain a Milestones and Timeline section for each Research Project will be considered non-responsive and will not be reviewed.

    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:

    Not Applicable for each component. A Resource and Data Sharing Plan should be submitted only in the Overall section. See instructions in the Overall section.

    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 Projects)

    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.    

    Foreign Institutions

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

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

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

    4. Submission Dates and Times

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

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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 Policy on Late Application Submission.

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

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    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.

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    For information on how your application will be automatically assembled for review and funding consideration after submission go 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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

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

    Post Submission Materials

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

    Section V. Application Review Information
    1. Criteria

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

    Overall Impact - Overall

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center  proposed).

    Scored Review Criteria - Overall

    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 Center  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 Center  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 FOA: 

    • Does the Center leverage systems approaches to improve the ability to model disease severity; responses to vaccines and/or therapeutics; and/or identify candidate targets for interventions?
    • Will the project enable predictive model implementation and subsequent use of modeling approaches more broadly, including implementation in the clinic?
    • Will the Center significantly advance the Systems Biology field?
    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center ? 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 FOA:

    • Do the PD(s)/PI(s) have the leadership, scientific, and managerial experience required to develop, manage, and direct a program that consists of multiple Projects and Cores?
    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?

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center ? Have 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 Center  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 FOA:

    • Do all the individual Projects and Cores relate to the overall goals of the Center and provide a cohesive and synergistic whole?
    • Are the plans for implementation of a systems biology approach in the Projects and Cores well justified for the hypothesis being tested, and will the Center generate valuable pathogen-host network interactions and predictive models of infectious diseases?
    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 FOA:

    • Do the multi-disciplinary centers leverage unique research resources and patient populations to advance understanding of the pathogens they propose to study?
    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.

    • Does Project data generation include multiple datatypes and does data integration provide a comprehensive model of disease that goes beyond incremental advances?
    • Are the targeted pathogens, clinical samples, and host systems adequate to address Research Projects hypotheses? 
    • To what extend are the proposed host systems documented and characterized? If using animal models, is the model relevant and appropriate to investigate human infectious diseases?
    • Are the proposed samples and experimental models adequate to develop predictive models, identify predictive biosignatures, and accomplish Project objectives? Are the samples proposed technically adequate for analyses by HTP “omics” and other technologies with respect to quality and quantity of the materials?
    • To what extent are the proposed technologies (e.g. “omics” and other HTP technologies) well justified, critical, and relevant to the research project specific aims?
    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 individual Research Projects or other Cores, and to contribute to Center 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
    • Is the administrative and organizational structure clearly described and is it appropriate and adequate to accomplish the objectives of the Center?
    • Are the Management and Staffing Plans appropriate to facilitate attainment of the objectives of the proposed Center?
    • To what extent is the experience, level of commitment, and availability of the Administrative Core Director adequate to manage the overall Center?
    • Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the program appropriate?
    • Are the outreach plans to promote awareness of systems biology to the broad scientific community, including the underrepresented scientific communities, through the democratization of information in the systems biology field adequate?
    • Are the plans to support the professional development of systems biology researchers adequate?
    Data Management and Bioinformatics Core
    • Will the Core bridge innovative data, promote development of practices and stewardship beyond the Center?
    • Are the proposed plans to develop, enhance, establish and maintain bioinformatics and computational tools, machine learning algorithms, and statistical inference methods by the Research Projects sufficient to build predictive models of infectious diseases?
    Technology Core
    • To what extent are the proposed plans to evaluate, develop and incorporate enhancements, modifications and improvements in existing ”omics”, and other related technologies described?
    Modeling Core
    • Does the Core demonstrate an iterative process of model development, testing, validation, and refinement that supports the Overall and Research Projects?
    • Are the proposed computational modeling approaches, computational and statistical tools, machine learning algorithms and statistical methods, sufficient to build predictive models of infectious diseases in an iterative process?
    • To what extent does the Core maintain state-of-the-art, modeling capabilities that increase efficiency and decreases costs, while test new methods, models, algorithms and software?   
    Additional Review Criteria - Overall, Cores and Research Projects

    As applicable for the Center  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.

    Data Sharing Plan:

    Is the Data sharing plan for each Center appropriate and adequate to ensure that NIAID-funded data will be Findable, Accessible, Interoperable, and Reusable (FAIR)?

    Are specific data repositories clearly identified? Is there a reasonable timeline for data deposition following data generation? Is there a reasonable plan to collecting and standardizing dataset metadata?

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Individuals Across the Lifespan  

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

    Vertebrate Animals

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

    For Renewals, the committee will consider the progress made in the last funding period.

    Revisions

    Not Applicable

    Additional Review Considerations - Overall

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

    Applications from Foreign Organizations

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

    Select Agent Research

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

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Sharing Model Organisms; and 2) Genomic Data Sharing Plan .


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

    As part of the scientific peer review, all applications:

    • 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.
    • Will receive a written critique.

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

    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 FOA. 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 his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information
    1. Award Notices

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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

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

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

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

     
    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency.  The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.  Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

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

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 awardees 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 award 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

    • Defining the research objectives, approaches, and details of the projects within the guidelines of the RFA, and retaining primary responsibility for the planning, directing, and executing the proposed scientific activities.
    • Ensuring that the NIAID Data Release Guidelines are properly implemented by the personnel of the Research Projects and Cores.
    • Advertising the availability of the Program generated resources through outreach activities.

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

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

    • The role of the NIAID/NIH Project Scientist in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PDs/PIs.  The NIAID Project Scientist will work closely with the PD(s)/PI(s) and other Program member scientists to facilitate collaborations and to leverage the resources available to the Program.
    • The NIAID Project Scientist will monitor the progress of the Program, help coordinate research approaches among all Programs funded through the RFA, and contribute to the shaping of Research Projects or approaches as warranted. The NIAID Project Scientist will support and facilitate this process but will not direct it. 
    • The NIAID Project Scientist will keep the Program informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing/collaboration in infectious diseases 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 industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.

    Additionally, a NIAID program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program official may also serve as the NIAID Project Scientist.

    Areas of Joint Responsibilities

    In the event that some members of the Programs develop common research interests working groups may be formed to pursue collaborative activities. In addition, PD(s)/PI(s), Research Project and Core Leaders and the NIAID Project Scientist will participate in the establishment of the SAG.

    • The PD/PI and NIAID program staff will review and discuss progress; problems and obstacles and approaches to overcoming identified problems and obstacles; recommendations for modifications in project timelines, objectives, and research approaches/ methodologies based on outcomes to date; and future plans. 
    • The PD/PI and NIAID program staff will discuss progress, problems, proposed solutions and any matter that is relevant to the scientific and financial administration of the Center and future activities. 
    • The PD(s)/PI(s) and NIH Project Scientist will collaborate to revise project milestones prior to the initial or annual awards, based on peer review of the originally proposed milestones and/or the PD(s)/PI(s)’s and/or NIH Project Scientist’s assessment of the proposed yearly milestones.

    Dispute Resolution:

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the SAG 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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    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.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    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: http://grants.nih.gov/support/ (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: 301-945-7573

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

    Scientific/Research Contact(s)

    Reed Shabman, Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-761-6433
    Email: reed.shabman@nih.gov

    Peer Review Contact(s)

    Yong Gao, Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-5048
    Email: yong.gao@nih.gov

    Financial/Grants Management Contact(s)


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

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.    

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