Part 1. Overview Information

Key Dates

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

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The goal of this FOA is to support a Coordinating Center for the Human Immunology Project Consortium (HIPC) program. The HIPC program, supported through a separate companion FOA (RFA-AI-20-079), will consist of U19 multi-project cooperative agreements to measure the diversity and commonalities of human immune responses under a variety of conditions and over time using high-throughput systems immunology approaches coupled with detailed clinical phenotyping in well-characterized human cohorts. The HIPC Coordinating Center, supported by this FOA, will be responsible for: coordinating cross-HIPC data integration, analysis, and visualization; developing and maintaining a public HIPC website/knowledgebase to support cross-HIPC data analysis and visualization; and fostering collaborations amongst HIPC-funded investigators by managing the HIPC subcommittees and an opportunity fund to support collaborative studies.

Background

Vaccines against infectious agents have improved the lives of countless people worldwide. While much is known about vaccine elicited immunity, immune correlates of vaccine efficacy remain elusive for most licensed and candidate vaccines. Similarly, the mechanisms involved in the induction and progression of immune-mediated diseases are yet to be determined. The human population is diverse with respect to age, ethnicity, gender, sub-clinical disease, genetic pre-disposition to disease, medication use, environmental exposures, and nutritional status. Each of these factors is known to influence the activation and regulation of the immune system, and outcomes regarding infectious and immune-mediated disease progression and vaccine efficacy. The 2019 SARS-CoV-2 pandemic is the most recent example of how host factors and immune regulation, or its dysregulation, contribute to disease severity and patient outcome.

The NIAID is strongly committed to building a comprehensive understanding of the human immune system as it responds to infection, vaccination, and other antigenic challenges. NIAID’s investment in systems biology and immunology spans nearly 20 years and includes programs to discover new immune response genes and mechanisms important for protection from infectious and immune-mediated diseases using animal models, development of computational models of immunity, and systems biology of infectious diseases.

NIAID established the Human Immunology Project Consortium (HIPC) in 2010 and renewed it in 2015 and 2017 to employ established and recent advances in immune profiling technologies to study the human immune system (1) before and after vaccination against an infectious disease; (2) before and after administration of an adjuvant that selectively targets immune components; and (3) during or following naturally-occurring infections, including HIV.

The current HIPC consists of nine U19 awardees, each supported by the U19 cooperative agreement mechanism, three subcommittees (Assay, Bioinformatics and Clinical), a public website, and a HIPC-specific knowledgebase, ImmuneSpace, for visualization and analysis of HIPC-related datasets. Over 1000 publications reference HIPC funding, 91 HIPC studies are publicly available through the ImmPort repository, and 108 HIPC and related human immune phenotyping studies are available for advanced data analysis and visualization in ImmuneSpace. In addition, cross-HIPC collaborative projects have been supported through an Infrastructure and Opportunities Fund (IOF), and a number of collaborative projects, initiated through subcommittee activities, have been supported through this fund. Some accomplishments associated with these cross-collaborative projects include: development of the ImmuneSpace knowledgebase (www.immunespace.org); updates to the Cell Ontology (http://www.obofoundry.org/ontology/cl.html) regarding immune cell subsets; development of new or revised data standards adopted by ImmPort; and the development of a framework to capture and disseminate immune transcriptional signatures associated with vaccine responses (http://hipc-dashboard.org) to the broader research community.

Research Objectives and Scope

The goal of this initiative is to establish a Coordinating Center for the HIPC program that will be responsible for conducting and integrating the following:

• Develop and maintain a public HIPC website and knowledgebase (e.g., encourage approaches that combine/incorporate elements of the current HIPC website and ImmuneSpace).

The HIPC website will include:

• A publicly accessible site for community access to promote awareness of the HIPC program, including information about the overall goals of the HIPC program, project summaries, publications and resources/technologies generated by HIPC investigators.
• A private portal accessible only to HIPC investigators and relevant staff, NIAID program staff, and the external advisory board for submission and review of Infrastructure and Opportunities Fund project proposals. These activities also will include a complete record of funding decisions and related actions; and
• Processes and information to facilitate cross-HIPC collaborations and subcommittee activities.

The knowledgebase will:

• Interact with the ImmPort database (www.ImmPort.org) to access and download HIPC-generated data and associated meta-data, as needed to support cross-HIPC data analysis and visualization;
• Interact with other relevant knowledgebases or domain-specific programs and repositories, as recommended by NIAID or the HIPC Steering Committee; and
• Develop/adopt, incorporate and implement appropriate ontologies and bioinformatics and/or computational modeling methods and tools to: facilitate the identification and public dissemination of molecular signatures that define immune response categories or profiles; and identify biomarkers that correlate with or predict outcomes of vaccinations, vaccine adjuvants or infections in humans.

• Collaborate with staff from ImmPort and other related organizations (e.g., Cell Ontology, OBI, etc.) to further develop data standards, controlled vocabularies and ontologies necessary to promote public dissemination, integration and visualization of clinical and experimental immune profiling data sets developed through HIPC.

• Coordinate cross-HIPC activities to include:

• Manage the formation and operation of HIPC subcommittees to facilitate cross-collaborative activities regarding clinical studies; data analysis, visualization and integration; and assay harmonization.
• Support development/deployment of sophisticated bioinformatics and/or computational tools to manage, analyze, and visualize the large data sets resulting from human immune profiling studies conducted in HIPC or other relevant studies. The tool development will be coordinated with knowledgebase activities, described above, to ensure that the tools being generated meet the needs of the HIPC community and are compatible with knowledgebase systems.

• Manage the HIPC Infrastructure and Opportunity Fund (IOF). This Fund will be made available each year to support cross-HIPC projects undertaken by HIPC investigators that harness and integrate data, findings, and tools generated by the individual projects. $600,000 total costs per year will be available to support cross-collaborative projects. Duties for managing this fund include:

• Establishing an administrative structure to manage the IOF.
• Disbursing and tracking IOF funds under the advice of the HIPC Steering Committee.
• Implementing plans for interacting with the institutions that will receive IOF funds.
• Establishing procedures, formats, and timelines for reporting on the status of IOF projects and expenditures to the NIAID and the HIPC Steering Committee.

• Work closely with NIAID staff to develop strategies to promote the HIPC program domestically and internationally.

Steering Committee

To promote scientific collaboration, exchange of scientific findings among HIPC U19 centers, and coordination of data dissemination to the broader scientific community, a HIPC Steering Committee will be established and serve an advisory role for the HIPC collaborative research program. Each HIPC center will be represented by one PD/PI as a voting member of the HIPC Steering Committee. In addition, the Director of the HIPC Coordinating Center (U01) will be a voting member, while NIAID Project Scientists will be non-voting members.

External Advisory Board (EAB)

An EAB will be convened by NIAID to review, evaluate, and prioritize the scientific progress of the individual HIPC awardees and the Consortium as a whole. EAB members will be selected by NIAID after award and potential EAB members should not be proposed or contacted by applicants.

Applicants are encouraged to visit the Frequently Asked Questions site at: https://www.niaid.nih.gov/grants-contracts/questions-answers-RFA-AI-20-080

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

Letter of Intent

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

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

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

The letter of intent should be sent to:

Konrad Krzewski, PhD
Telephone: 240-747-7526
Email: [email protected]

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

, with the following exceptions or additional requirements: For this specific FOA, the Research Strategy section is limited to 30 pages.

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

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

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

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

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

, with the following additional instructions.

Where applicable, the biosketches should include descriptions of previous experience and achievement in:

• Administration of complex scientific programs, including managing subcontracts/Opportunity Funds and fostering collaborations amongst colleagues;
• Development and maintenance of public websites/portals; and
• Data management and analyses, including development and use of data standards and data analysis and visualization methods.

R&R or Modular Budget

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

, with the following additional instructions:

• Request funds to support the travel of the PD(s)/PI(s), and at the discretion of the PD/PI up to three (3) additional scientific staff per project, to attend semi-annual face-to-face HIPC meetings to be held in the Rockville, MD area and organized by the NIAID staff (2 meetings per year, 2 full days per meeting).
• Direct Costs for the entire U01 should not exceed $1.8M per year. Personnel costs to support management of the IOF shall be included in the overall U01 budget. Of the $1.8M overall budget, up to $600,000 Direct Costs per year shall be set-aside to support 4-6 IOF Projects.
• For budgeting purposes, enter the IOF Direct Costs into the Other Expenses category and include the full negotiated F&A rate for the parent institution. Applications must include a budget justification for the $600,000 Direct Costs per year for the costs anticipated for each IOF project.

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

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

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

Specific Aims: List the broad, long-range objectives and goals of the proposed project. Describe the work to be completed.

Research Strategy: Summarize the overall research strategy for the HIPC coordinating center and explain how the proposed program satisfies the purpose and objectives of this FOA. Then describe the plans and procedures that will be used to address the four components as described below.

In a section clearly labeled " Administration"

Describe plans and procedures that will be employed to coordinate or develop:

• Cross-HIPC activities to include formation and management of HIPC subcommittees;
• Processes to foster development and execution of cross-collaborative projects across the HIPC network; and
• Communication with NIAID to provide program updates, address project issues and promote the HIPC program domestically and internationally.

In addition, provide a clear, concise

• Staffing plan that describes staff roles that will help accomplish project goals and ensure continuity for the life of the project.

In a section clearly labeled " HIPC Website, Knowledgebase and Data Analyses"

Describe the plans and procedures for:

• Development and maintenance of a public HIPC website that contains a public portal and a private portal for the HIPC investigators:

• The public portal should comply with FAIR (Findable, Accessible, Interoperable, and Reusable) principles and provide human subject protections, including maintenance of anonymity.
• The private portal should provide security for all unpublished, proprietary information included in the portal, including IOF proposals and review documents, HIPC annual meeting slides, or other documents/information shared amongst the HIPC research sites.

• Development, testing, and maintenance of a HIPC knowledgebase to support cross-HIPC data analysis and visualization and development and dissemination of biomarker and immune signatures that correlate with the outcomes of vaccinations, adjuvants or pathogenic infections in humans.
• Methods that will be used to collaborate with the ImmPort database (https://www.immport.org/shared/home ) to access and download HIPC-generated data and meta-data, as needed to support cross-HIPC site and integrative data analysis and visualization within the HIPC knowledgebase.
• Development, testing, validation and deployment of relevant biomedical ontologies and sophisticated bioinformatics and/or computational tools to manage, analyze, and visualize large data sets resulting from HIPC and other relevant human immune profiling studies; including those tools developed by HIPC investigators or their collaborators through the IOF program.
• Application of FAIR principles and human subject protections and maintenance of anonymity.
• Methods that will be used to collaborate with ImmPort for data and meta-data transfer, and methods for interactions with ImmPort and other related organizations to further develop data standards, controlled vocabularies and ontologies necessary to promote public dissemination, integration and visualization of clinical and experimental immune profiling data sets developed through HIPC or other relevant projects (domestic and international). ImmPort staff contact information is available at: https://www.immport.org/shared/teamCurrent.

In a clearly labeled section entitled Project Milestones and Timelines

• Describe specific quantifiable, planned baseline milestones and include annual timelines for the HIPC Coordinating Center. Milestones must specify the outcome(s) for each activity. Milestone criteria should not simply be a restatement of the specific aims. Using a Gantt chart or equivalent tool, describe the associated timelines and identified outcomes of the Coordinating Center activities.

In a clearly labeled section entitled, Infrastructure and Opportunity Fund

• Provide a clear plan for implementing the HIPC Infrastructure and Opportunity Fund (IOF) program.
• Describe processes and procedures for:

• Establishing administrative structure and processes for managing solicitation, submission, and review of IOF projects, including management of any possible conflicts of interest (COIs).
• Disbursing and tracking IOF funds under the direction of the HIPC Steering Committee and NIAID staff.
• Implementing plans for interacting with the institutions that will receive IOF funds.
• Establishing procedures, formats, and timelines for reporting on the status of IOF projects and expenditures to the NIAID and the HIPC Steering Committee.

NOTE: Do not include specific projects.

NOTE: Investigators applying to both this FOA and its companion HIPC U19 FOA, RFA-AI-20-079, must include in this section a plan for avoiding potential Conflicts of Interest (COI) with respect to the IOF program, including procedures to mitigate COI with respect to the selection, award, and management of the IOF program.

Letters of Support: Provide any letters of support from collaborators that are specific to the project.

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.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.
• Resource Sharing Plans must also be included in the application in regard to the sharing of any bioinformatics, computational tools, software and/or models developed under this award. The Resource Sharing Plan must ensure that shared resources and data are Findable, Accessible, Interoperable, and Reusable (FAIR) per the NIAID Data Sharing Guideline (https://www.niaid.nih.gov/research/data-sharing-guidelines) as appropriate and consistent with achieving the goals of the program.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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

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

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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. See Section III of this FOA for information on registration requirements.

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. 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. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

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

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

Significance

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

Investigator(s)

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

Specific for this FOA:

Is the staffing plan appropriate?

Do the investigators or their collaborators, staff have expertise in:

• administration of complex scientific programs?
• development and maintenance of public websites/portals?
• data management and analyses?

Innovation

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

Specific for this FOA:

• Are the proposed knowledgebase, bioinformatics and computational tool development plans innovative and reasonable?

Approach

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

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

Specific to this FOA:

• Do the plans for development and maintenance of a public HIPC website containing a public portal/knowledgebase adequately reflect an understanding of compliance with FAIR principles (https://www.go-fair.org/fair-principles/) and Human subject protections/maintenance of anonymity?
• Are the plans for development and maintenance of a private portal for the HIPC investigators adequate?
• Are the methods that will be used to collaborate with ImmPort for data and meta-data transfer, and methods for interactions with ImmPort and other related organizations reasonable and achievable?
• Are the plans for data sharing appropriate and adequate to ensure that NIAID-funded data will be Findable, Accessible, Interoperable, and Reusable (FAIR) and consistent with achieving the goals for the program?
• Are the plans for development, testing/validating and deployment of sophisticated bioinformatics and/or computational tools reasonable?
• Do the investigators provide a clear and concise plan for how to coordinate and facilitate overall collaboration amongst the HIPC awardees?
• If applicable, are plans to mitigate COI that may arise for selection, award, and management of IOF projects appropriate?
• Do the investigators provide a clear plan for achieving defined Project Milestones and Timelines?
• Is the plan for implementing the HIPC Infrastructure and Opportunity Fund (IOF) program reasonable and achievable?

Environment

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

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

• 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.

• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and 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 recipientsis 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 recipientsfor the project as a whole, although specific tasks and activities may be shared among the recipientsand the NIH as defined below.

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

• Retaining primary responsibility for the planning, directing, and executing the proposed research study through oversight, management, and coordination of the participating sites, personnel and outcomes.
• Developing operating guidelines and consistent policies for dealing with situations that require coordinated action across HIPC sites or within the Coordinating Center.
• Recipientswill retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

• The NIH Project Scientist will support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PD(s)/PI(s).
• Select and recruit the EAB members for the entire HIPC.
• Coordinate NIAID staff assistance, including participation in periodic on-site monitoring with respect to compliance with Federal regulations, quality control, accuracy of data recording, sample accrual, enrollment, etc.
• Facilitate collaborations with and provide access to other NIAID-supported research resources and services.
• The NIH Project Scientist will review and assist in developing the operating guidelines and consistent policies for dealing with situations that require coordinated action.
• The NIH Project Scientist will periodically review the data generated under this award. The NIH Project Scientist will review progress towards achieving the final set of agreed upon milestones annually.Determinations for future year funding will be based on satisfactory annual progress reported in the RPPR and meeting annual milestones.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• The PD(s)/PI(s) and NIH Project Scientist will update the program milestones annually, taking into consideration recommendations from the EAB.
• The NIH Project Scientist and the PD(s)/PI(s) will coordinate the scientific objectives and progress to facilitate the achievement of program goals.

Dispute Resolution:

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

3. Reporting

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Alison Deckhut Augustine, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3475
Email: [email protected]

Alkis Togias, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3587
Email: [email protected]

Konrad Krzewski, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-747-7526
Email: [email protected]

Trevor Alford
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-747-7398
Email: [email protected]

Section VIII. Other Information

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

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