Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

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

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

Conformance to all requirements (both in the Application Guide and the NOFO) 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. Notice of Funding Opportunity Description

Purpose

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for the Bioinformatics Resource Center (BRC) Program that will (1) create and manage publicly accessible integrated knowledgebases to accelerate basic and applied human infectious diseases research, (2) develop advanced innovative bioinformatics technologies for software and tools, (3) offer critical bioinformatics expertise, outreach and instruction for investigators on use of resources and (4) develop cutting-edge bioinformatics to respond to emerging needs, outbreaks, and public health emergencies. As a whole, the BRC Program will address bioinformatics needs in the research community to accelerate the development of diagnosis, prevention, and treatment of infectious diseases. In addition, during an infectious disease outbreak, the BRCs will leverage their expertise, capabilities, and resources to provide bioinformatics support to the research communities.

Background

NIAID has a long history of supporting bioinformatics research. Efforts include support for production-level sustainable knowledgebases that allow researchers to find and analyze infectious disease omics data and analytical tools including pipelines to discover, assemble, align, annotate, and build phylogenies. In addition, NIAID supports research of computational tools that allow investigators to share data with collaborators, deposit data in public repositories, and offer bioinformatics expertise and training to the research community as well as general tutorials in the use of bioinformatics relevant to infectious diseases research.

Supported research emphasizes NIAID's priority pathogen research including parasites, fungi, viruses, and antimicrobial-resistant (AMR) bacteria, but also offer resources and technologies for nearly all NIAID-supported research areas in infectious diseases within NIAID's mission. Accomplishments include advanced computational biology and bioinformatics, especially in the area of automated genome annotation and large-scale comparative genomics tools as well as application of machine learning to infer phenotypes from genotypic information (e.g., antimicrobial resistance prediction). NIAID supported research has been pivotal during emerging needs, outbreaks, and public health emergencies especially in response to emerging and pandemic viruses (e.g., influenza virus, Chikungunya virus, Zika virus, Ebola virus, SARS-CoV-2) by offering improved genomic annotations, enhanced data integration of disparate datatypes, and open-source computational tools for unique analyses.

These prior experiences highlight the importance of publicly accessible infectious disease knowledgebases that foster innovation, have the flexibility to extend systems for integrating multiple data types and analytics to respond promptly to public emergencies, and embraces community feedback for continued improvement. Therefore, the BRCs will provide critical infrastructure for infectious disease datasets from both NIAID-supported programs and across the infectious disease research community.

Specific Research Objectives and Scope

Through this NOFO, NIAID invites applications to provide knowledgebases and bioinformatics technologies that support the NIAID mission with data and tools for studies of NIAID relevant pathogens, including those in NIAID’s List of Emerging Infectious Diseases and other pathogens based on NIAID’s prototype approach for pandemic preparedness. The overarching goals of the BRCs consist of interactive knowledgebase(s) for relevant omics-based data and analysis; research and development of innovative bioinformatics tools, software, and algorithms; and access to leading-edge expertise in bioinformatics for the infectious diseases' community for complex or unique situations and during emerging needs, outbreaks, and public health emergencies. Applications MUST address at least one ENTIRE set of the following two biological domains. Applications may address both sets but must address the entirety of the sets (i.e., applicants may not mix and match or omit).

Biological Domains:

• (1) viral families; bacterial and archaea; AND metagenomics/microbiome/viromes relevant to infectious diseases
• (2) eukaryotic (e.g., unicellular including fungi, parasites, etc.) and metazoan (e.g., helminths, etc.) pathogens; vectors for human pathogens; AND hosts-pathogen interactions relevant to biomedical research

Key Elements:

The applicants MUST address all four Key Elements regardless of which Biological Domain(s) is (or are) chosen for the proposed project:

Key Element 1: Infectious disease knowledgebases that ingest, process with standardized approaches, annotate, organize, and present integrated information from the growing body of publicly available data relevant to human infectious diseases following the FAIR Data Principles. The proposed BRC knowledgebases should be modular, sustainable, and interoperable resources that leverage traditional IT and/or cloud-based infrastructure to increase data access, sharing, and computing across large omics and omics-related datasets. At minimum, the knowledgebases are expected to address:

• Integrated data types: The proposed knowledgebases are expected to include multi-omics data, host genomics, taxonomy, laboratory assay data, molecular surveillance data, structural data, data associated with samples (metadata) and/or other relevant data from various public repositories of the proposed biological domains. Emphasis should be on automated and high-throughput data ingestion and processing with minimal hands-on input to achieve maximal representation of publicly available data from structured and unstructured repositories as well as from published scientific literature.
• Analytics and visualization: The knowledgebases are expected to include collections of computational analysis and visualization tools on a computational platform for access, analysis, integration, and sharing of various data types. Software and tool development should support essential functions and maximize the efficiency of the operation and utilities of the knowledgebases. The BRC knowledgebases may include but are not limited to:
  
• data and bioinformatics technologies to support taxonomy classification and pathogen identification
• genome/gene characterization
• transcriptomics analysis
• proteomics/protein/protein structure analysis
• metabolic/pathway analysis
• phylogenetics/phylodynamics (various clustering and visualization approaches)
• lineage, variant or subspecies analysis
• molecular epidemiology and surveillance tools

Additional desired capabilities either within the knowledgebase or through access to critical research and expertise include:

• genotype to phenotype prediction tools
• metagenomics/metatranscriptomics analysis for infectious diseases
• simultaneous analysis of host-pathogen-microbiota data
  
• Resource interface and access: The knowledgebases are expected to have an interactive website (graphical user interface or GUI) and Application Programming Interface (APIs), including web services, workspaces, and/or other data transfer capabilities to access query, analysis, upload, and download data and tools that target users with varying levels of bioinformatics expertise.
• Data Quality and Efficiency of Operations: The knowledgebases are expected to establish and support methods to enhance data quality, validity, and ensure data integrity. The systems are expected to be flexible and scalable to accommodate new species, new data, and new data types to meet the evolving needs of the infectious diseases research community. The systems are expected to provide transparency in usage metrics.
• User Documentation: The knowledgebases should provide sufficient documentation, such as user guides, and made available online on how to use the BRC resources.

Key Element 2: Innovative bioinformatics technologies including development or improvement of software, algorithms, artificial intelligence, and machine learning (AI/ML), or pipelines that address existing or new opportunities to analyze, model, predict, and visualize data related to basic or translational research, especially in support of therapeutics, vaccines, and/or diagnostics against human infectious diseases.

Key Element 3: State-of-the-art bioinformatics expertise, outreach, and training provided for the research community. Resources in this element are expected to provide support for complex analyses and/or unique situations to researchers domestically and internationally. In addition, various educational formats (e.g., webinars, tutorials, workshops) should be provided to enhance the use of bioinformatics in research. The BRC is expected to establish channels for receiving and providing feedback to the research community to enhance community interactions and collaborations between researchers, and to accommodate the research community's needs.

Key Element 4: Cutting-edge informatics support to rapidly respond to emerging needs, outbreaks, and public health emergencies for the research community to detect, track, respond, assess, and accelerate the development of diagnosis, therapeutics, and vaccines. The system should include an emergency preparedness and response plan and have a platform that can be leveraged and extended without major design to accommodate possible new data and data types.

Additional aspects of the BRC Program include:

Data and Resource Sharing: One of the goals of the BRC Program is to enhance infectious diseases data sharing and stewardship in alignment with FAIR Data Principles. NIAID expects FAIR-ness of the BRC resources and all their products, including source codes, software, pipelines, educational materials, user documentation, user metrics, data and processed or precomputed data. BRC resources should be made broadly available to the community via BRC websites or public repositories throughout the award as appropriate and consistent with achieving the goals of the BRC Program.

Governance: The BRC Program should establish transparent and trustworthy governance for the BRC resources. Documentation for terms of use and resource accesses, data licenses, and policies for privacy and ethics should made broadly available to increase transparency to the research community. The repository is expected to document its trustworthiness to its user community through public evidence of data management practices, or certification based on community standards such as CoreTrustSeal, ISO 16363:2012, or other community recognized repository management best practices.

Open Community Forum: The BRC will establish an open-community forum to increase resource transparency and to enhance connectivity between the user community and with BRC resources. The open-community forum will allow the infectious diseases community to provide feedback, stimulate collaboration and interaction among the investigators and the BRC teams, and help prioritize BRC activities to accommodate the needs of the research communities. This forum could be in the form of discussion boards, community-wide Town Halls, participating in relevant conference or meetings, or other relevant activity.

Programmatic Meetings and Annual Site Visits: Recipient(s) will attend a kick-off and Annual Programmatic Meetings to present activities of the BRC Program. These meetings will report progress, updates on issues, provide opportunities for receiving feedback, stimulating discussions, and collaboration. In addition, annual site visits will be used by NIAID program staff to review, provide recommendations, and discuss project timelines, objectives, and research approaches/methodologies based on outcomes to date, accomplishments, challenges, and future plans.

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

• Projects that do not address the ENTIRE set of organisms in one or both of the Biological Domain(s).
• Projects that do not address ALL four Key Elements for the BRCs.
• Projects that exclusively focus on a single data type, pathogen, or organism.
• Projects that only support HIV or AIDS data.
• Projects that do not demonstrate ability for automated, high-throughput data ingestion that is representative of the majority of publicly available genomic and multi-omics datasets relevant to the proposed Biological Domain.

Plan for Enhancing Diverse Perspectives (PEDP)

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

For additional information about the Bioinformatics Resource Centers (BRCs), see the "Frequently Asked Questions (FAQ)" link here: https://www.niaid.nih.gov/grants-contracts/questions-and-answers-rfa-ai-23-032.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

• 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.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

This NOFO 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, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, 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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Richard Kostriken, Ph.D.
Telephone: 240-731-2021
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 NOFO, 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 NOFO.

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.

Other Attachments

Plan for Enhancing Diverse Perspectives (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers, and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

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 exceptions:

Budget requests in applications for one Biological Domain are expected not to exceed $2,500,000 in direct costs and applications that address both Biological Domains requests are not expected to exceed $4,800,000 direct costs.

Include funds to support travel for the PD(s)/PI(s) and other key personnel to attend in-person Programmatic Meetings in the Bethesda, MD area for the 1st year Kick-off meeting and an annual programmatic meeting in the 3rd year of the award. Programmatic meetings will be held virtually on the other years (2nd, 4th, and 5th).

The application may not request funding for a sustainability plan outside the project award period.

PEDP implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

R&R Subaward Budget

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 in priority order the broad, long-range objectives and goals of the proposed Bioinformatics Resource Center. Briefly describe the vision and characteristics of the resource.

Research Strategy:

Use clearly marked sections to address the following:

Overview

Describe the overarching structure and theme for the proposed BRC, including any innovation and bioinformatics technology development. Explain ongoing, planned, and potential future collaborations, nationally and internationally, and especially how this BRC will be interoperable with other existing resources. Describe how lessons learned from any prior experience, usage metrics, and significant accomplishments in establishing knowledgebases, supporting bioinformatics tool development and training will be applied to the BRC. Importantly, applications MUST address at least one ENTIRE set of Biological Domains as follows. Applications may address both sets, but must address the entirety of the sets (i.e. applicants may not mix and match), and are especially encouraged to address NIAID’s List of Emerging Infectious Diseases and other pathogens based on NIAID’s Prototype approach for pandemic preparedness.

Biological Domains

• (1) viral families; bacterial and archaea; AND metagenomics/microbiome/viromes relevant to infectious diseases
• (2) eukaryotic (e.g., unicellular including fungi, parasites, etc.) and metazoan (e.g., helminths, etc.) pathogens; vectors for human pathogens; AND hosts-pathogen interactions relevant to biomedical research

Key Elements

For each Key Element below, applications must address:

• A detailed plan and description of preliminary data for how the applicant proposes to meet the element’s objectives.
• Evaluation benchmarks and metrics for success and a description of the evaluation plan.
• Proposed timelines for completion and milestones for the whole project period.
• A description of anticipated key issues and challenges.

Key Element 1. Establish infectious diseases knowledge bases:Describe how the proposed infectious disease knowledgebases will facilitate users to readily find, access and analyze high-quality, large-scale integrated data imported from various public repositories relevant to the basic understanding of and the development of diagnostics, prevention, and treatment of human infectious diseases, including the following:

• Describe the proposed computational infrastructure either utilizing cloud-based or traditional IT resources, including methods to ensure system security, system operability, enhance FAIR Data Principles and the project's governance structure.
• Describe the initial data types and volume that will be incorporated in the knowledgebase and address mechanisms for data ingestion, system level data processing and integration, and scalability of data, including emerging data types and increasing volume of omics and phenotypes data.
• Describe how the proposed BRC will ensure high quality, integrity and versioning of data and metadata.
• Include details on the proposed analytical and visualization capabilities and how the system will support third party tools.
• Describe how the proposed BRC will support graphical user interfaces (GUI), application programming interfaces (API), web services, workspaces, and/or other interactions and data transfer capabilities to/from the database.
• Describe how the BRC will enable users to bring their own data and tools for analysis, visualization, and computation in the context of existing BRC data.
• Describe plans for sustainability of the data and tools from the knowledgebase.
• Describe a plan to adhere and support use of community standards for data and metadata, data identifiers e.g., digital object identifier (DOI), provenance of data, adequate infrastructure, and storage, or other.

Key Element 2. Develop innovative bioinformatics technologies. Describe how the proposed BRC will advance bioinformatics technologies, software, algorithms, and tools that will accelerate basic and translational research in infectious diseases, including:

• Describe how the proposed knowledgebase technologies, methodologies, data types and volume will support the evolving needs of the research community.
• Provide no more than five (5) specific examples of bioinformatics, software or tools including data analysis, AI/ML modeling, predicting that will be improved and/or developed by the proposed BRC.
• Provide plans on how to collaborate or incorporate the innovative technologies that are developed from other resources into the BRC Program.

Key Element 3. Offer critical bioinformatics expertise, outreach, and training to the community.

• Describe how the proposed BRC will offer support for complex analyses and/or unique situations that are either not made available through the knowledgebase in Key Element 1 or are not feasible under most research environments (e.g., larger than expected data computation, standalone capability).
• Describe how the BRC will promote, advertise, solicit, evaluate, and allocate access to these critical resources.
• Describe plans for providing educational materials (tutorials, workshops, courses, webinars, etc.) to enable users to maximize the resource's utilities (knowledgebase, tools, and expertise).
• Describe plans for providing educational materials (tutorials, workshops, courses, webinars, etc.) to enable users to maximize the resource's utilities (knowledgebase, tools, and expertise).

Key Element 4. Provide cutting-edge informatics support to rapidly respond to emerging needs, outbreaks, and pandemic preparedness. Describe how the BRC will track, integrate, and provide data analysis, visualization, and situational reports related to emerging needs, outbreaks, and public health emergencies, including:

• Provide an Emergency Preparedness and Response Plan that describes the baseline capabilities that can be leveraged, extended, prioritized, allocated, and monitored for emergency preparedness and response plan that would be activated in case of emerging needs, outbreaks, and public health emergencies. Describe how emergency responses will be coordinated with NIAID.
• Provide plans and procedures for the platform to expand, without major redesign, to accommodate possible new data, data types, and possible new species to respond to emerging needs, outbreaks, and public health emergencies.
• Provide plans and procedures for receiving users feedback and to provide on-line help support.

Project Management and Sustainability Plan

• Provide a Project Management and Sustainability Plan for how the PD(s)/PI(s), and qualified team members will manage and maintain the entire BRC resource. Include descriptions of responsibilities, frequency of updating the resources, and issues that will be addressed while establishing or maintaining the resource.
• Describe timelines and milestones for the development and implementation of all proposed activities, plans for conflicts resolutions, as well as the provisioning of data for research use.
• For emerging needs, outbreaks, and public health emergencies, provide plans on managing including re-prioritize and re-allocate resources/funds and procedures proposed in the application and in consultation with NIAID, as long as these changes are within the scope of the award's scientific priorities.
• Describe the long-term sustainability of the data and resource that extends beyond the lifetime of the award. This section should also include plans and criteria for data archival in cold storage, data security and data sunsetting within the knowledgebase.

Governance and Open Community Forum Plan:

Describe the BRC Governance and Open Community Forum Plan including the following items:

• Describe details for developing terms of use, data licenses, and policies for privacy and ethics.
• Describe how the BRC will establish, foster, and demonstrate its transparency and trustworthiness to the user community.
• Describe the establishment and monitoring of the Open Community Forum that informs the BRC Program about current innovations, needs, challenges, and opportunities in the respective research communities. The Forum can be in the form of discussion web boards, community-wide Town Halls, and participating in relevant conference or meetings.
• Describe how the community feedback though the various channels, including the open forum, will be incorporated into the BRC Program and advertised back to the community in a timely manner.

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.

• Applicants should provide a resource sharing plan for the BRCs and all products including source codes, software, algorithms, user documentations, and educational materials, etc. generated by the BRC Program. The plan should describe when and where the source code will be shared publicly and available to the broad community.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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.

Delayed Onset Study

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

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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in 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 NIAID, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

The BRC award will support well defined resources that shall extract, accumulate, organize, annotate and link growing bodies of information related to core datasets. The resource should provide publicly available documentation on the services offered; be responsible for providing high technical quality services; demonstrate a focus on the uses of the data and offered services; demonstrate capability to support long-term sustainability, data preservation and use/reuse; and demonstrate a robust infrastructure to support repository operations. Repository management could consider adopting best practice management principles, such as, but not limited to, OAIS (ISO 14721), ISO 16363, or CoreTrustSeal.

Overall Impact

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).

Scored Review Criteria

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 proposed Resource address the needs of the research programs that it will serve? Is the scope of activities proposed for the Resource appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research field?

Specific to this NOFO:

• To what extent will the proposed BRC enable research relevant to a basic understanding of and to the development of diagnostics, prevention, and treatment of human infectious diseases?
• To what extent are the proposed knowledgebase technologies, methodologies, data types and volume appropriate to support the evolving needs of the research community and to respond to emerging needs, outbreaks, and public health emergencies?
• To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Resource? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing knowledgebases and bioinformatics research? Do the investigators demonstrate significant experience with coordinating collaborative bioinformatics research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach and governance plans appropriate for the Resource? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this NOFO:

• To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research programs the Resource will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this NOFO:

• To what extent are the proposed bioinformatics technologies for software and tools innovative?
• To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research programs the Resource will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the Resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the Resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Are an appropriate plan for workflow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

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

Specific to this NOFO:

• To what extent is the described Project Management and Sustainability Plan appropriate for the breadth of activities proposed for the BRC Program?
• How well is the Emergency Preparedness and Response Plan described and how well does the plan effectively facilitate the responses to emerging needs, outbreaks, and public health emergencies?
• To what extent is the proposed Governance and Open Community Forum Plan appropriate to have a meaningful impact on the success of the proposed BRC Program?
• To what extent does the proposed computational infrastructure include methods to ensure system security, system operability, and alignment with FAIR Data Principles?
• Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

Environment

Will the institutional environment in which the Resource will operate contribute to the probability of success in facilitating the research programs it serves? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the Resource proposed? Will the Resource benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Specific to this NOFO:

• To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

Additional Review Criteria

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 Animals Section.

Biohazards

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

Resubmissions

Not applicable

Renewals

Not applicable

Revisions

Not applicable

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 Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For resources 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 (NIAID), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

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

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients 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 NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: 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 recipient 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, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. 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.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws 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 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipient(s) is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipient(s') activities by involvement in and otherwise working jointly with the recipient(s) 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 recipient(s) for the project as a whole, although specific tasks and activities may be shared among the recipient(s) and the NIH as defined below.

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

• Managing, coordinating, and defining the details of project activities scientifically and administratively within the overall Program.
• Agreeing to accept close coordination, cooperation, and participation of NIH staff in aspects of scientific and technical management of the project as stated in these terms and conditions.
• Adhering to timelines and milestones.
• Providing summaries of progress toward timeline and milestone goals, including the Project Management and Sustainability Plan.
• Providing updates at least annually on implementation of the PEDP.
• Notifying NIAID staff within 48 hours of being made aware of a data management incident, security breach, data loss, or system wide loss of data access.
• Advertising the resources available to the community through outreach activities.
• Informing NIAID of any workshops or conference participation where the BRC resources will be showcased.

Recipient(s) 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. If there is more than one BRC recipient, each recipient PD/PI will organize, participate, and chair at least one of the Annual Programmatic Meetings of BRC recipient(s) funded under this NOFO.

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

• The role of the NIAID Project Scientist in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PDs/PIs.
• The NIAID Project Scientist will:
  • Coordinate research approaches among BRC(s) and contribute to the shaping of Research Projects or approaches as warranted.
  • Support and facilitate the BRC Program but will not direct it.
  • Serve as an information resource and coordinate activities for the recipient(s) about NIAID and NIH priorities.
  • Keep the BRC Program informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing and/or collaboration in infectious diseases research.
  • Coordinate access for the BRC Program to other NIAID resources, as well as assist the research efforts of the Program by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.
• Additionally, an agency Program Official or IC Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The NIAID Project Scientist will work collaboratively with the BRC PD(s)/PI(s) to:

• Promote interoperability of host-pathogen data analysis among similar or related NIAID and NIH projects.
• Facilitate collaborations and leverage the resources available to the Program.
• Hold regular BRC Program-wide meetings and discussions to facilitate the achievement of BRC Program goals.
• Coordinate outreach and training related to international and global activities.
• Define the program technical objectives, operational approaches, and details of the projects (e.g., milestones, timelines, etc.) to address all four Key Elements and other requirements within the guidelines of the NOFO in the event of emerging needs, outbreaks, or public health emergencies.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between 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'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. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

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

4. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $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 and 2 CFR Part 200 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: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

Wiriya Rutvisuttinunt, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-771-1065
Email: [email protected]

Richard Kostriken Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-731-2021
Email: [email protected]

Vandhana Khurana
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2966
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 and 2 CFR Part 200.