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 purpose of this Funding Opportunity Announcement (FOA) is to support the enhancement and/or sustainment of high-value data science research software to improve the acquisition, management, analysis, and dissemination of data and knowledge across the immune-mediated and infectious-disease research continuum aligned with the research mission of NIAID. This includes infectious diseases, emerging infections, or immune-mediated diseases that include allergy, autoimmunity, or immune reactions associated with transplantation.

NIAID data-science program FOAs aim to promote research-driven data science technology across the development lifecycle to address priority needs in immune-mediated and infectious disease research with a clear rationale for the needs of the technology proposed and their benefit to immune-mediated and infectious disease research through user feedback. As one of the three FOAs in the trans-NIAID data science program, this FOA encourages applications focused on enhancement and/or sustaining operations to improve the user experience and availability of existing, widely adopted informatics tools and resources. This contrasts with exploratory (R21) and early-stage (U01) development efforts to generate these tools and resources that are supported by the companion FOAs.

Background

NIAID's basic and clinical research projects are generating large, diverse and complex data sets, including genomics/omics data, clinical data, immune phenotyping assay data, and imaging data. Similarly, the infectious and immune-mediated diseases research communities have become a data-intense enterprise. NIAID recognizes that there is a critical need to transform these data into knowledge to better understand pathogen transmission and evolution, pathogen-host interactions, host immune response, infectious and immune-mediated disease pathogenesis, as well as to develop new and improved diagnostics, therapeutics, and vaccines. Hence the need for Findable, Accessible, Interoperable, and Reusable (FAIR) software solutions that are innovative and sustainable.

In response to these complex data requirements NIAID is launching three trans-NIAID initiatives (RFA-AI-21-035, RFA- AI-21-020, and RFA- AI-21-021) to support investigator-initiated informatics and data science researchers, driven by critical research needs in infectious or immune-mediated disease research. The objective is to expand NIAID's commitment to promote informatics solutions and harness the power of data science to maximize the Institute’s potential to accelerate discoveries in NIAID’s research. The three companion FOA's will also provide new funding opportunities and demonstrate NIAID’s commitment to informatics and data science research.

The companion FOAs of the NIAID data-science program include:

• Exploratory Data Science Methods and Algorithm Development in Infectious and Immune-Mediated Diseases (R21 Clinical Trial Not Allowed): RFA-AI-21-035.
• Early-Stage Development of Data Science Technologies for Infectious and Immune-mediated Diseases (U01 Clinical Trial Not Allowed): RFA- AI-21-020.

• Enhancement or Sustainment of Data Science Tools for Infectious and Immune-Mediated diseases (U24 Clinical Trial Not Allowed): RFA-AI-21-021.

These NIAID data-science program FOAs aim to promote research-driven data science technology across the development lifecycle to address priority needs in immune-mediated and infectious disease research with a clear rationale for the needs of the technology proposed and their benefit to immune-mediated and infectious disease research through user feedback.

Specific Research Objective

This FOA encourages applications that involve the enhancement and/or sustainment of existing informatics and data science technologies that support a wide range of immune-mediated and infectious disease research including, but not limited to disease mechanism, risk prediction, epidemiology, detection and diagnosis, treatment and vaccines. The emphasis will be on uniqueness and potential impact on immune-mediated and infectious disease research.

Some examples of potential projects relevant to this FOA include but are not limited to the following:

• Technologies to mine electronic health records (EHR), clinical trial data from digital health devices and social media and other observational and experimental data to generate evidence to enhance findings from clinical trials data; technologies and platforms to support next-generation clinical trials;

• Methods to evaluate optimal linkage of data from sources, such as EHRs, health systems, clinical trial databases, diagnostic, molecular and registry data, including claims, mortality and other such sources;
• Methods to conduct patient-level disambiguation for de-identified linkage of data across networks including use of cryptographic methods to enable collaborative data use and/or analytics;
• Methods for effective data annotation in the context of data capture, mining, extraction and analyses;
• Methods and workflows for integration of heterogenous data; approaches for data/metadata acquisition, processing, provenance, wrangling, and compression including development of standards and data exchange formats for domain-specific data; validating and benchmarking analysis as well as performance analysis applications;

• Methods to improve the quality of data and distributed analyses including assessment of dimensions of data quality (e.g., completeness, accuracy, or consistency), handling of missing or inaccurate data in electronic health records (EHRs), -omics datasets (including single cell analyses) and distributed data settings;
• Community-based data models, automated metadata capture, and ontologies to facilitate data management, sharing and reuse;
• Statistical and modeling methods, graph and network theory approaches for predictive, interventional and prognostic applications to improve understanding of disease risk factors and/or disease susceptibility, predict disease outbreaks, pathogen exposure, and disease dynamics;
• Methods to address bias inherent in real-world data and computational modeling;
• Tools and technologies for collaborative research, visualization of both observational, experimental and multi-dimensional data;
• Artificial intelligence approaches to predictive and personalized medicine in immune-mediated or infectious diseases; novel machine learning/artificial intelligence methods for data analytics of high-throughput and multi-dimensional data, computer-assisted detection and diagnosis or treatment planning and medical decision support;
• Intelligent text parsing/mining technologies (including Natural Language Processing) for biomedical data.

Applications including the following types of studies will be considered non-responsive and will not be reviewed:

• Projects with a significant level of data generation and/or data analysis beyond limited validation studies.
• Projects proposing to develop repositories or knowledgebases.
• Projects focused on the development of wet-lab technologies.

NOTE: This FOA differs from the companion FOAs, RFA-AI-21-035 (R21) and RFA-AI-21-020 (U01), because it uses the U24 Cooperative Agreement mechanism. Proof of concept projects that are high risk and/or paradigm shifting may be suitable for the R21 FOA. The U01 will support more advanced projects including early-stage tool development from prototyping to hardening and adaptation. The U24 FOA will support enhancements to advanced projects and/or sustaining operations to improve the user experience and availability of existing, widely adopted data science tools or software.

Awardees of the U01 and U24 FOAs will be expected to participate in additional collaborative research activities identified post-award to enhance the utility and/or interoperability of the data science technology being supported through the awards. These expansion activities are intended to further the impact of the technology that is the subject of the award and may include collaborations with other trans NIAID data science program awardees or with other investigators. Projects proposed for collaborative activities will be evaluated by processes established by the Steering Committee.

Examples of collaborative projects include, but are not limited to:

• Extension or adaptation of a tool to support the needs of an immune-mediated and infectious disease research project
• Implementation of common Application Programming Interfaces (APIs) to support data exchange among software applications and or develop workflow solutions
• Use of a common software platform/interoperability infrastructure for tool integration
• Adoption of common data standards to support semantic interoperability across application

Investigators planning to submit an application in response to this FOA are encouraged to contact and discuss their proposed research aims with the scientific contact listed in Section VII in advance of the application receipt date.

Annual Programmatic Meetings

A kick-off meeting and annual program meetings will be held to establish the major roles and functions of the program and to facilitate collaborations. Additionally, annual meetings will report progress, seek new research directions and ideas, and update NIAID on issues of need. These meetings will be attended by the PD(s)/PI(s), Key personnel, and NIAID staff. The location of the meeting will be on a rotating basis at one of the awardee's location who will then take the lead to organize that year's meeting in consultation with the meeting planning committee volunteers and NIAID program staff.

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)

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) 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

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

Sandip Bhattacharyya, PhD
Telephone: 240-292-0189
Email: [email protected]

All page limitations 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 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.

R&R Budget

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

with the following additional instructions:

Collaborative Activities: Applicants must set aside up to 10 percent of their annual direct costs in years 2 and 3 of the award to support potential collaborative projects. The collaborative budget should be included in Other Expenses and listed as "Collaborative Projects." A budget justification is required for these costs, including an estimate for the number of projects per year.

Travel: Applicants are required to include travel support for the PD/PI (or their designee from their research team) to attend an annual program meeting. In the budget justification, travel for one trip per year to these meetings for one investigator must be included. The meeting location may vary each year and will be held either at an investigator's institution site in the US or at NIAID's facilities in Bethesda, MD.

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:

Research Strategy:

The goal of this FOA is to support research-driven enhancement and/or sustainment of existing informatics and data science technology to serve the mission of NIAID. Towards this end, applicants should clearly describe:

• The significance and/or impact of the proposed informatics and data science technology research to infectious or immune-mediated diseases in general and to the collaborating research project(s) as well as how the enhancement of the informatics and data science technology will continue to benefit the research field including emerging needs.
• The level of innovation of the proposed data science technology and the advantages it offers relative to currently available competing technologies articulate the unique value proposition.
• The methodology for technology development.
• Plans of working with end-users to ensure that the technology addresses their research needs.
• The process of soliciting feedback from end-users and collaborators to ensure usability and usefulness for the research community throughout the software development process.
• The level of interaction with collaborators in the research field and the potential for adoption by the relevant research community.
• The timeline and milestones for achieving the project objectives.
• A plan for long-term sustainment of the resource if that is the primary focus of the application.
• Plans for participating in program activities, including annual meetings and potential working groups as appropriate.
• Mechanisms for assessing and maximizing the value of the resource to researchers and supporting collaboration and fostering deep engagement between the resource and the targeted research community.

The application should provide evidence of the development status of the existing software that is the subject of the application. This could include at least one of the following: a cited reference to a running hosted instance of the software; a mechanism to install and evaluate the software locally, such as binary files, a Docker container, or source code with appropriate instructions; a reference to a comprehensive description/documentation of the current software package and its functionality, including user instructions; one or more peer-reviewed publication(s) showing significant results obtained with the proposed software. Do not include URLs or hyperlinks in the application, as described in NOT-OD-20-174.

A critical goal of this program is to encourage activities that maximize the value of the resource, and encourage community engagement, both as a user as well as a contributing developer. In a separate section entitled "Collaborative Activity" within the "Research Strategy" section, describe a framework or a vision for potential collaborations with or without identifying the potential collaborator(s), who may or may not be an awardee of this program. Include a discussion of plans for facilitating the collaborative activities that will increase the impact, enhance the utility and/or interoperability of the data technology that is developed in response to this FOA.

Letters of Support: Applicants must provide letters of support (not to exceed 25) from collaborators and/or potential users in the immune-mediated and infectious diseases research community. These letters should provide details on the nature of the proposed interaction/collaboration and describe how the proposed new development will benefit their research and/or why the resource needs to be sustained.

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.
• The Data Sharing Plan must include a distinct section, titled, "Software Sharing Plan," that includes appropriate timelines and addresses all the following points:
  • The software developed in the project must be openly available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
  • The terms of software availability must permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
  • To preserve utility to the community, the software must be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
  • The terms of software availability must include the ability of researchers to modify the source code and to share modifications with other colleagues.
  • To further enhance the potential impact of their software, applicants must include a plan to manage and disseminate the improvements or customizations of their tools and resources by others. In support of this goal, awardees must manage and disseminate their source code through an open revision control and source code management system; for example, through a repository such as GitHub.

Prior to making an award, program staff may negotiate modifications of software sharing plans with the applicant. The software dissemination plan represents a commitment by the institution (and its subcontractors, as applicable), to support and abide by the plan. The final version of the accepted software sharing plan will become a condition of the award.

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.

Foreign Institutions

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

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

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

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?

Specific for this FOA: Is the informatics technology appropriately useful and usable to the collaborating projects and to the broader immune-mediated and infectious diseases research field in general? How significant will the proposed enhancement and/or sustainment plan be to the immune-mediated or infectious diseases community? Will the proposed sustainment plan lead to continued advancement of immune-mediated or infectious disease research?

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: Do the scientific expertise and track record of the PD(s)/PI(s) and any associated investigators in informatics technology innovation and dissemination adequately support the goals of the project?

Innovation

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

Specific for this FOA:Is the proposed technology adequately distinct and innovative? What is the advantage of enhancing or sustaining this resource in comparison to competing technologies?

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 for this FOA: Is the development status of the existing software clearly described? Are there plans to evolve the research resource to address emerging needs of the targeted research communities and ensure that the research resource is sustainable and maintains relevance to the research it supports? Are the proposed timeline and milestones for technology enhancement sound and realistic? Are the plans and processes for engaging end-users appropriate? Are there clear plans for supporting the user community?

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.

Data Sharing Plan

Is the data sharing plan appropriate and adequate for the proposed project?

Specific for this FOA: Is the plan for Software Sharing in the Data Sharing Plan appropriate and adequate to ensure the following:

• The software developed in the project is openly available for academic use.
• The software is available through an open, revision control and source code management system to foster a community of code contributors and allows transfer to another individual/team to sustain development.
• The terms of the software availability permit reuse, modification, and commercialization.

Collaborations

Are there adequate plans for the effective interaction and coordination with the collaborating research project(s), the program investigator(s), and NIAID?

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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

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

Select Agent Research

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

Resource Sharing Plans

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

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 awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's 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:

• Serving as the lead for scientific and administrative oversight for the proposed research, including overseeing, managing, and coordinating the overall Program including working with the NIAID program officials and Project Scientist.
• Seeking opportunities for collaborative activities with the aim of producing software tools that are FAIR in order to maximize their utility and actively solicit feedback from the user community to integrate them in the software development plan.
• Ensuring successful completion of the data-sharing and other resource-sharing plans negotiated with NIAID.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

• 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. Additionally, an NIAID Project Scientist will have significant programmatic involvement and will serve as an overall program coordinator. The main responsibilities of the Project Scientist include:

• Providing technical input and suggest modifications to the project as required to ensure research objectives are satisfactorily met.
• Evaluating the adequacy of data/software-sharing and other resource-sharing plans. NIAID program staff may require modifications of sharing plans with the applicant.
• Facilitating interactions amongst the projects and other parts of the overall data science program such as those between collaborating projects and establish working groups, annual meeting input.
• Make final decisions for the release of collaborative projects funds, based on the recommendations of the Steering Committee.

Areas of Joint Responsibility include:

• The NIAID Project Scientists and the PDs/PIs will coordinate the scientific objectives and progress to facilitate the achievement of program goals.
• The NIAID Project Scientists and the PDs/PIs will collaborate to revise project milestones annually.
• Establishing the Steering Committee. The primary responsibilities of the Steering Committee are to establish procedures for the solicitation, evaluation and recommendation to awardees of collaborative projects.

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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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]

Steve Tsang, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3330
Email: [email protected]

Sandip Bhattacharyya, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-0189
Email: [email protected]

Shaun Gratton
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3594
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.