NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

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

This Funding Opportunity Announcement (FOA) solicits applications to establish Systems Biology Centers that use systems biology approaches to build predictive models for infectious diseases. These models will be derived from hypotheses related to systems-level host/pathogen molecular interactions during infection or treatment using integrated datasets generated from a combination of high-throughput (HTP) experimental approaches, including omics technologies and computational approaches. Importantly, the Centers must clearly integrate experimental approaches and computational modeling to test and validate hypotheses of significance to the infectious diseases field.

The National Institute of Allergy and Infectious Diseases (NIAID) supports comprehensive genomics, functional genomics, structural genomics, systems biology, proteomics and bioinformatics resources for basic and applied research that may be accessed by the scientific community https://www.niaid.nih.gov/research/pathogen-genomics-related-initiatives. Advances in HTP omics technologies and informatics approaches are generating large data sets, analytical tools, reagents and other resources that can be used to provide insights into the biology of microbes, their role in pathogenesis and their interactions with the host, as well as to facilitate applied infectious diseases research.

In 2008, NIAID launched the Systems Biology for Infectious Diseases Research Program to encourage the use of less traditional approaches, such as a combination of HTP omics technology platforms, high-performance computing infrastructure, and increasingly sophisticated data processing and modeling algorithms. Unprecedented opportunities are available to examine and analyze biological systems and comprehensively integrate biological information into host-pathogen interaction networks. In doing so, systems biology can provide novel insights into the complex relationship between pathogen and host and identify, quantify, analyze, model and predict the overall behavior and dynamics of the molecular networks of infectious diseases and their hosts.

As noted, NIAID-funded projects using systems biology approaches are generating large, diverse and complex data sets using HTP approaches and other technologies, such as flow cytometry and high-content imaging. State-of-the-art HTP next-generation sequencing, genomics, transcriptomics, proteomics, metabolomics, and other "omics" technologies enable the efficient generation of experimental data sets that can be integrated with behavioral, environmental, clinical, immunological and other appropriate data sets to generate molecular interaction networks of pathogens and their host, which can be used to build/train predictive computational models of complex biological systems. These molecular networks have the potential to discover and identify predictive biosignatures that may have clinical utility for the infectious diseases field. There has been some progress in integrating and analyzing complex, diverse data sets to build predictive models and identify biosignatures for infectious disease; however, these studies are mostly limited to analyzing and integrating genomics, transcriptomics, and experimental immunological data, and lack the depth and breadth to capture human diversity and variation at a resolution to identify predictive biosignatures of infectious disease risk, severity, response to interventions, adverse drug reactions and other factors of potential clinical utility on an individual, personalized level.

The challenge of building predictive models using large, diverse and complex data sets spanning multiple scales will require the continued development of the next generation of modeling and statistical methods and machine learning algorithms and computational tools that can integrate these data sets and provide understandable models that can identify relationships with the degree of accuracy needed to identify biosignatures for clinical application. Computational methods that allow extraction of relevant phenotypes from complex data types and prediction of clinically important phenotypes before they exist, including machine learning and statistical inference methods for predictive modeling, are now being developed for cancer and neurological diseases.

The objective of this FOA is to establish a network of Systems Biology Centers focused on building predictive models of infectious diseases from hypothesis driven projects that perform large scale data generation, data analysis and integration with statistical inference modeling that will be used to discover predictive markers of disease, health and therapeutic treatment. This effort will also include support for the development of novel and/or enhanced bioinformatics, analytical, computational, and statistical tools. Centers will be expected to develop or improve innovative experimental methods, technologies, bioinformatics and computational tools, machine learning software, and statistical inference methods that can be used by the Centers and the broad infectious diseases community for systems level data analysis.

The result of this program is expected to be: 1) integrated data sets, maps of molecular networks of host-pathogen interactions, and computational predictive models of infectious diseases; 2) new and enhanced computational algorithms, methods and tools; and 3) protocols for state-of-the-art HTP technologies.

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

• Determination of host/pathogen disease processes or molecular networks that are relevant to multiple (at least two) species/strains/genera; for example: the analysis and comparison of organisms that are known to share molecular pathways or similar disease initiation, progression or outcome patterns, networks across pathogenic and non-pathogenic species, or mutated strains with different degrees of pathogenicity, etc.
• Determination of host/pathogen molecular networks and predictive models that may be used to discover biosignatures that may predict risk, severity and response to therapeutic intervention of an infectious disease.
• Determination of molecular networks and predictive models that focus on genetic and epigenetic (e.g., miRNA-regulated) pathways, diversity and mechanisms in regulating host response to pathogen or therapeutic intervention.

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

• 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 sequencing of pathogen and related isolates obtained from human clinical samples.
• 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.
• Studies/applications that propose clinical trials.
• Studies on HIV/AIDS.

Collaborative Interdisciplinary Teams

The scope of this work requires that interdisciplinary teams be formed that are capable of pursuing coordinated activities that bridge disparate scientific disciplines and expertise in microbiology, immunology, infectious diseases, microbiome, 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.

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 Systems Biology Center to the broader infectious disease scientific community. The outreach activities are expected to begin in the second year of the award and continue for the duration of the award and should be designed to instruct and increase the number of infectious disease researchers that can use the approaches/methodologies and resources (datasets, analysis tools, models, etc.) utilized and generated under this initiative.

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 and for 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 next generation sequencing, transcriptomics, proteomics, and metabolomics technologies and other HTP technologies to conduct not only systems-wide molecular profiling studies but also more targeted measurements, such as quantitative targeted proteomics (e.g. MRM: Multiple Reaction Monitoring) and validation of protein/protein or protein/DNA interactions on human clinical samples including microbiome analysis.

Modeling Core: The Modeling Core is responsible for identifying, quantifying, modeling and predicting the overall architecture and dynamics of the molecular interaction networks of pathogenic organisms with their host cells during infectious disease and developing predictive models of infectious diseases. The core will also be responsible for developing and maintaining computational and statistical tools, machine learning algorithms, and statistical methods necessary for building predictive models as appropriate. Additionally, the core is expected to contribute to the statistical 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.

Research Projects: Each Center must include two synergistic Research Projects organized around a common theme that utilizes a systems biology approach to identify, quantify, model and predict the overall architecture and dynamics of the molecular interaction networks of pathogenic organisms with their host cells during infectious disease and build predictive models of infectious diseases. Projects are encouraged to use one or more infectious pathogens and incorporate human microbiota analysis, where appropriate and relevant.

Annual Programmatic Meetings: Annual Programmatic Meetings will be held to facilitate communication and collaboration among funded Centers. Responsibilities associated with organizing and attending these meetings are detailed in the cooperative agreement terms and conditions of award below.

Steering Committee: A Steering Committee will be established by the NIAID in collaboration with the awardees to review the progress in meeting the goals of all projects funded under this FOA and of the Systems Biology for Infectious Diseases Research Program. The Steering Committee will also make recommendations for the continuation or re-direction of the funded projects to the PD(s)/PI(s) on an ongoing basis and in consultation with NIAID staff. The Steering Committee is expected to consist of investigators who are not current collaborators of the funded programs.

Milestones and Timelines: Milestones and timelines must be included in each Research Project, for activities related to the Administrative Core, and for the overall goals of the Center.

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

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

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)

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

Applicant Organizations

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

• 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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

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.

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

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).

A button to access the online ASSIST system 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

B. Eleazar Cohen, Ph.D.
Telephone: 240-669-5081
Fax: 301-480-2408
Email: [email protected]

Component Types Available in ASSIST	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, and Modeling Core)	6 pages each
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.

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 2

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

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.

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

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

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.

Specific Aims: Briefly describe the overall specific aims of the proposed Systems Biology Center.

Research Strategy: Provide an overview that succinctly describes the key scientific aspects and overarching theme of the Center and how the proposed research projects and cores satisfy the purpose and objectives of this FOA. 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 and synergistic to one another. This section provides the team of investigators an opportunity to give a conceptual wholeness to the entire program and then lays out 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.

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, should provide a Data Sharing Plan that details the rapid sharing, release and access of datasets, analysis tools, computational models, reagents, and other resources, which are generated by the Center to the broader scientific community in adherence to the requirements and timelines described in the NIAID Data and Reagents Sharing and Release Guidelines (https://www.niaid.nih.gov/research/data-sharing-and-release-guidelines) and the NIH Genomic Data Sharing (GDS) Policy http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

When preparing your application in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

• 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 that particular Core successfully.
• The Administrative Core Lead may also lead one Research Project but may not lead the Technology Core, Data Management and Bioinformatics Core or Modeling Core.

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

The budget of the Administrative Core must include the following:

• Meetings: Funds to accommodate travel to attend 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 during the second year of award. Each Center should fund travel and attendance at yearly meetings by the PD(s)/PI(s), the Project Leads and Core Leads, and other Key Personnel who are expected to attend. 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.
• Center Administrator: Funds to support a Center Administrator to manage day-to-day operations of the Center.
• Research Resources: Funds to support deposition of research reagents such as clones, strains, etc. into existing public repositories such as NIAID’s BEI Resources Repository or designated by NIAID 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 starting in year 2 of the budget.
• Core Lead: The Core Lead must commit at least 1.2 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.

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.
• Providing a supportive structure sufficient to ensure the appropriate prioritization of resources, to accomplish all Center goals and to identify problems and effective resolutions.
• 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.
• Promoting collaboration and coordination among Core and Research Project Leaders.
• Communicating with other Centers regarding collaboration and coordination of activities and projects.
• Engaging the Steering Committee to review progress, make recommendations for the continuation or re-direction of all projects and activities of the funded Programs on an ongoing basis and in consultation with the NIAID staff. Applicants must not propose potential Steering Committee members in the application.
• Ensuring the rapid dissemination of all data and other research resources generated under the Center.

Management and Staffing Plan: A Management Plan that describes the organization of the proposed program and its management structure is required. The Management Plan must include:

• A description of how the organization of the Center and its management structure will form a cohesive, integrated and efficient Center that provides scientific and administrative oversight of all Center Cores and Research Projects.
• An overview of how the two 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 staffing plan that describes 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 infectious diseases scientific community is required. The outreach plans must 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, for example, the organization of hands-on workshops to promote the use by non-modelers of the predictive models and analysis tools developed by the program; the opportunity for post-doctoral candidates and junior faculty from the broad scientific community in the areas of microbiology and infectious diseases to spend extended periods of time at the high-throughput technology facilities and/or with the modeling laboratories, the hosting of summer school courses, etc.

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, should provide a Data Sharing Plan that details the rapid sharing, release and access of datasets, analysis tools, computational models, reagents, and other resources, which are generated by the Center to the broader scientific community in adherence to the requirements and timelines described in the NIAID Data and Reagents Sharing and Release Guidelines (https://www.niaid.nih.gov/research/data-sharing-and-release-guidelines) and the NIH Genomic Data Sharing (GDS) Policy http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, 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.

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.
• The Core Lead of the Data Management and Bioinformatics Core must not also lead the Technology Core, Administrative Core, Modeling Core or a Research Project.
• The Core Lead should have the expertise appropriate to manage all aspects of the Core successfully. 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 the NIAID Bioinformatics Resources, or other databases designated by NIAID.
• Funds to support the development of computational and bioinformatics tools.
• Funds for the development and maintenance of a public website.
• The Core Lead must commit at least 1.2 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:

• To develop, enhance, establish and maintain bioinformatics and computational tools, machine learning algorithms, and statistical inference methods that are technologically innovative and state of the art for systems level analysis of diverse data sets generated by the Research Projects to build predictive models of infectious diseases.
• To establish a process by which existing bioinformatics tools and pipelines will be used for analysis and interpretation of project data.
• 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 will provide overview of the Center and information and web links about resources that were generated and accessible to the broad scientific community including data sets, predictive models, reagents, etc.

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, should provide a Data Sharing Plan that details the rapid sharing, release and access of datasets, analysis tools, computational models, reagents, and other resources, which are generated by the Center to the broader scientific community in adherence to the requirements and timelines described in the NIAID Data and Reagents Sharing and Release Guidelines (https://www.niaid.nih.gov/research/data-sharing-and-release-guidelines) and the NIH Genomic Data Sharing (GDS) Policy http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Data Management and Bioinformatics Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, 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.

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.
• The Core Lead of the Technology Core must not also lead the Data Management and Bioinformatics Core, Administrative Core, a Research Project or Modeling Core.
• The Core Lead should have the expertise appropriate to manage successfully all aspects of the Core. 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 1.2 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 proposed 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.
• Provide studies that support the ability and experience of the Technology Core to perform the technologies in a HTP, state of the art approach for systems-wide analysis.
• Detail how the Center will support the concurrent utilization of HTP approaches, including omics approaches, in addition to genomics and transcriptomics. HTP technologies must be in place for analyzing human clinical samples. These technologies should be used to conduct not only systems-wide molecular profiling studies but also more targeted measurements, such as quantitative targeted proteomics (e.g. MRM: Multiple Reaction Monitoring) and validation of protein/protein or protein/DNA interactions.
• Describe how the Center will maintain state-of-the-art, large-scale, HTP experimental technologies, including omics technologies in a highly efficient manner to maintain continuous increases in efficiency and decreases in costs.
• Describe how the Core will contribute to and complement the proposed Research Projects.
• Describe how the Center will continue to employ innovative strategies to address new scientific opportunities and technologies in a flexible and timely manner.
• Describe how the Center will evaluate, develop and incorporate enhancements, modifications and improvements in existing genomic, metagenomics, RNA sequencing, proteomics, metabolomics, and other related technologies, platforms, pipelines and resources to maintain a high throughput state-of-the-art omics Technology Core to increase efficiency and decrease cost.
• Describe how the Center 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:

All applications, regardless of the amount of direct costs requested for any one year, should provide a Data Sharing Plan that details the rapid sharing, release and access of datasets, analysis tools, computational models, reagents, and other resources, which are generated by the Center to the broader scientific community in adherence to the requirements and timelines described in the NIAID Data and Reagents Sharing and Release Guidelines (https://www.niaid.nih.gov/research/data-sharing-and-release-guidelines) and the NIH Genomic Data Sharing (GDS) Policy http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Technology Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, 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 (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.

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.
• The Lead of the Modeling Core must not also lead the Data Management and Bioinformatics Core, Administrative Core, a Research Project or Technology Core.
• The Core Lead should have the expertise appropriate to manage successfully all aspects of the Core, including experience in building predictive models of disease and expertise in statistics.
• The Core should have considerable experience and expertise on 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 central data storage, data management, and information security systems for data generated by Research Projects to build predictive models of infectious diseases; and to support the submission of the predictive models and computational/statistical tools to the NIAID Bioinformatics Resources, or other databases designated by NIAID.
• Funds to support the development of computational and statistical tools, machine learning algorithms, and statistical methods necessary for all aspects of building predictive models using an iterative process.
• The Core Lead must commit at least 1.2 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.
• Provide the plan to contribute to the experimental design of the proposed research projects and to integrate experimental datasets and develop predictive models of infectious diseases to be inferred from the study of molecular networks of systems-wide interactions between the pathogen and the host. Describe how the models will be tested and experimentally validated.
• The plan should also describe how the systems biology approach will be utilized to undergo iterative cycles of modeling and data generation and analysis.
• 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 Center will maintain state-of-the-art, modeling capability in a highly efficient manner to maintain continuous increases in efficiency and decreases in costs and test new methods, models, algorithms and software.
• Describe how the Center will continue to employ innovative strategies to address new scientific opportunities and methods in a flexible and timely manner.
• Describe how the Center will evaluate, develop and incorporate enhancements, modifications and improvements in modeling strategies on an ongoing basis.
• Describe how the Core will contribute to and complement the proposed Research Projects.
• Describe how the Modeling core of this Center will coordinate and collaborate with other Centers to develop new methods, software and approaches for building and validating predictive models for infectious diseases.
• Describe, if appropriate, 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.
• Describe how the Center 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:

All applications, regardless of the amount of direct costs requested for any one year, should provide a Data Sharing Plan that details the rapid sharing, release and access of datasets, analysis tools, computational models, reagents, and other resources, which are generated by the Center to the broader scientific community in adherence to the requirements and timelines described in the NIAID Data and Reagents Sharing and Release Guidelines (https://www.niaid.nih.gov/research/data-sharing-and-release-guidelines) and the NIH Genomic Data Sharing (GDS) Policy http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Modeling Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, 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.

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.
• The Research Project Lead must not also be the leader of the Data Management and Bioinformatics Core, Technology Core or Modeling Core.
• The Research Project should be headed by a Lead whose expertise is appropriate to manage all aspects of the Research Project successfully.

Budget (Research Projects)

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

The Project Lead must commit at least 1.2 person-months effort to the project.

Note: If proposing to use samples from human subjects, costs associated with prospective human sample collection cannot be requested in the application budget.

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.

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 molecular 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.

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.
• Given that a goal of the FOA is to propose a systems biology approach that must integrate experimental data and computational modeling to test and validate a hypothesis in an iterative process and build predictive models, describe how the proposed Research Project will perform experimental data generation, analysis and integration, modeling of system-wide networks structures and dynamics and building predictive models of infectious diseases.
• Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies. 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. Animal models alone in the absence of use of primary cells or human clinical samples are not responsive to the FOA.
• For samples from human subjects indicate the source of the samples and provide evidence that the samples are appropriate for use by the project, for example the number of samples available, relevant sample metadata, expected quality and quantity of materials for omics profiling, sample de-identification protocol, etc.
• Provide evidence that the human primary cells and human samples are adequate to create predictive models, identify predictive biosignatures, and accomplish project objectives.
• 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.
• Describe and detail how the proposed Research Project will employ the concurrent utilization of HTP approaches, including omics approaches, in addition to genomics and transcriptomics. Examples of HTP technologies of interest include, but are not limited to, proteomics, metabolomics, lipidomics, single cell analysis and others. These technologies may be used to conduct not only systems-level molecular profiling studies, but also more targeted measurements, such as quantitative targeted proteomics (e.g. MRM: Multiple Reaction Monitoring) or validation of protein/protein or protein/DNA interactions.
• Describe and detail the experimental validation of the new hypotheses generated through the systems biology. An example of experimental validation is by testing in an animal model the predicted role of a host factor in antibiotic resistance, through the assessment of the effects on the outcome of the infection of the host gene knockout or by RNA interference.

Milestones and Timelines-Required. 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.

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, should provide a Data Sharing Plan that details the rapid sharing, release and access of datasets, analysis tools, computational models, reagents, and other resources, which are generated by the Center to the broader scientific community in adherence to the requirements and timelines described in the NIAID Data and Reagents Sharing and Release Guidelines (https://www.niaid.nih.gov/research/data-sharing-and-release-guidelines) and the NIH Genomic Data Sharing (GDS) Policy http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Research Projects)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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.

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

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

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

This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

Reviewers will consider each of the review criteria below in the determination of scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Is the Center as a whole scientifically compelling?

• Are the overall goals of the Centers significant and focused on studies that meet the purpose and objectives of the FOA?
• Are there coordination and synergy of the individual research projects and cores towards the achievement of the central objectives of the Center?
• Do the individual research projects relate to the overall goals of the Center and provide a cohesive and synergistic whole?
• Is the Program sufficiently focused on the study of molecular interactions of the pathogen/s with the host during the course of infection and building molecular networks of pathogen host interactions and predictive models of infectious diseases?
• Do(es) the PD(s)/PI(s) have the leadership and scientific ability, scientific and technical skills, and managerial competence to develop, manage, and direct an integrated and focused Research Center, including the time commitment and demonstrated ability and experience to establish and manage collaborations?
• Do the applicant and proposed collaborators have prior and productive experience of using a systems biology approach and if so, have their accomplishments made a significant impact on the field of infectious diseases or successfully achieved their original goals?
• Are the experience, level of commitment, and availability of the PI(s)/PD(s), Research Projects and Core Leads adequate to manage the overall Program?
• Is there adequate evidence of sufficient institutional support for the PD(s)/PI(s) in terms of laboratory space, equipment and other resources?
• For applications designated multiple PD(s)/PI(s), is the Multiple PD/PI Leadership Plan both adequate and appropriate to ensure that there will be sufficient coordination and communication among the PD(s)/PI(s)?
• Is the management plan for fiscal accountability and communication within the Center appropriate?
• Are the proposed timelines and performance objectives for the overall Center adequate?

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).

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.

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

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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? Does the Project Lead have documented training, leadership skills, scientific and technical skills, and managerial competence to successfully plan, manage, conduct and direct the Research Project?

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?

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

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

Are the targeted pathogens (species, strains, genera) and host systems adequate for the Research Projects proposed?

Are the proposed host systems adequate, well-documented and characterized? If using animal models, is the model relevant and appropriate to investigate human infectious diseases?

Are the proposed human primary cells adequate and human samples, well-documented and characterized and available for the research project proposed? Are the proposed human primary cells and human samples adequate to create 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?

Are the timelines and milestones provided well-justified and appropriate for the scope of the research project? Is adequate time allocated to experimental data generation, data analysis, and data integration? Will the timelines and milestones presented be adequate to develop high quality predictive models? Does the project timeline allow for iterative refining of the predictive models?

Are the proposed omics and other HTP technologies well justified, critical and relevant to the research project specific aims?

Is the project’s implementation of a systems biology approach well justified for the hypothesis being tested and will it generate high quality pathogen-host network interactions and predictive models of infectious diseases?

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?

Reviewers will provide an overall impact score for each individual core to reflect an assessment of the likelihood that the core will contribute in an important way to the success of the program

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.

• Is the administrative and organizational structure clearly defined 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?
• Are 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?
• Is the plan to establish the Outreach Program adequate and appropriate?

• Are the described data management activities sufficient?
• Are the proposed plans to develop, enhance, establish and maintain bioinformatics and computational tools, machine learning algorithms, and statistical inference methods that are technologically innovative and state of the art for systems level analysis of diverse data sets generated by the Research Projects to build predictive models of infectious diseases adequate?
• Is the Plan for sharing, access and release and public dissemination of generated data and research resources adequate and reasonable?
• Are the experience, level of commitment, and expertise of the Core Leader and key personnel adequate to manage the Core?

• Are the proposed plans that describe how the Center will evaluate, develop and incorporate enhancements, modifications and improvements in existing genomic, metagenomics, RNA sequencing, proteomics, metabolomics, and other related technologies, platforms, pipelines and resources to maintain a high throughput state-of-the-art omics Technology Core to increase efficiency and decrease cost adequate?
• Are the experience, level of commitment, and expertise of the Core Leader and key personnel adequate to manage the Core?

• Are the appropriate statistical plans, power calculations and controls included?
• Are the proposed computational modeling approaches, computational and statistical tools, machine learning algorithms and statistical methods, appropriate to build predictive models of infectious diseases in an iterative process?
• Is the plan to contribute to the experimental design of the proposed research projects and to integrate experimental datasets and develop predictive models of infectious diseases to be inferred from the study of molecular networks of systems-wide interactions between the pathogen and the host adequate?
• Is the plan to describe how the Center will maintain state-of-the-art, modeling capability in a highly efficient manner to maintain continuous increases in efficiency and decreases in costs and test new methods, models, algorithms and software adequate?
• Are the experience, level of commitment, and expertise of the Core Leader and key personnel adequate to manage the Core?

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.

For research that involves human subjects but does not involve one of the six 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 six 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.

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 children 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.

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.

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.

Not Applicable

Not Applicable

Not Applicable

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.

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.

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).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

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.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by 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.

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.

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 grantee’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.

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, Grantees, 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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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:

• Coordinating the Projects and Cores within the overall Program.
• 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.
• Organizing, attending and chairing one of the Annual Programmatic Meetings of all Programs funded under this RFA; these meetings and their organization will rotate among the Programs sites on an annual basis. The programmatic kick-off meeting will be held within 3 months of award and will be organized by the NIAID Project Scientist in coordination with all funded Programs.
• Organizing and chairing annual site visit activities.
• Making sure that the NIAID Data Release Guidelines (see below) are properly implemented by the personnel of the Research Projects and Cores.
• Advertising the availability of the Program generated resources through outreach activities.
• Ensuring that results obtained from the Program are analyzed and published in a timely manner.
• Providing suggestions for members of the Steering Committee within the first 6 months from award.
• Participating in the activities of the Steering Committee as needed and following the policies and procedures developed by the Steering Committee.
• Provide semi-annual progress reports in a format to be defined by the NIAID after award.

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.
• The NIAID Project Scientist will serve as a non-voting member of the Steering Committee and will assist in developing the operating guidelines and consistent policies for dealing with situations that require coordinated action.
• The NIAID Project Scientist will review, make recommendations and provide suggestions for Supplemental Research Project proposals.

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

The NIAID Project Scientist will provide overall coordination across all funded Programs, will coordinate with the PD(s)/PI(s) and hold regular program-wide discussions to facilitate the achievement of program goals. 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 Steering Committee activities as needed.

• Annual Site Visits

These visits will be used by NIAID program staff to 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.

• Bimonthly Teleconferences

These teleconferences will be held to discuss progress, problems, proposed solutions and any matter that is relevant to the scientific and financial administration of the Center and future activities. The schedule for those meetings will be established by the PD(s)/PI(s) and the NIAID Project Scientist.

• Project Milestone Negotiations

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.

Steering Committee

A Steering Committee will be established by the NIAID to review the progress in meeting the goals of all Programs funded under this RFA, including also the activities of all Training and Supplemental Research Projects as well as the data/other resources dissemination activities. The PD(s)/PI(s) of the awarded programs will provide NIAID with suggestions for members of the Steering Committee within the first 6 months from award. The Steering Committee is expected to consist of approximately 10 individuals who are not key personnel or collaborators of the key personnel of any of the awardees. The Steering Committee will make recommendations to the PD(s)/PI(s) for the continuation or re-direction of all projects and activities of the funded Programs on an ongoing basis and in consultation with the NIAID staff. The NIAID may re-budget individual U19 funds based on recommendations of the Steering Committee.

The Steering Committee will prepare concise (3-4 pages) summaries of the Steering Committee meetings which will be delivered to members of the group and NIAID within 30 days. The Committee will meet on an annual basis in conjunction with the Annual Programmatic Meetings and on ad-hoc basis by conference calls, as needed. Committee’s meetings will include NIAID staff, and may include PD(s)/PI(s) and other members of the funded Programs as necessary.

The Steering Committee will select one member to be the Chair of the Committee and the Chair will not be a NIAID staff member.

Federally Mandated Regulatory Requirements for Clinical Research

Each institution participating in clinical research is required to meet DHHS regulations for the protection of human subjects. At a minimum, this includes:

• Methods for assuring that each institution at which Program investigators are conducting clinical studies has registered with the Office of Human Research Protections (OHRP; http://www.hhs.gov/ohrp/) and has a Federal wide Assurance; that study protocols are reviewed and approved by the responsible Institutional Review Board (IRB) prior to participant entry; that active protocols are reviewed at least annually by the IRB, and that amendments are approved by the IRB.
• Methods for assuring or documenting that each participant, or participant’s parent/legal guardian, gives fully informed consent to participation in a research protocol prior to the initiation of the intervention.

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 progress report, 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.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Marciela DeGrace, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3460
Email: [email protected]

B. Eleazar Cohen, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669=5081
Email: [email protected]

Adam Graham
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6260
Email: [email protected]

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

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