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 How to Apply - 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.

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Accessible, well-maintained, and efficiently operated data repositories and knowledgebases (henceforth referred to as data resources) are critical enablers of modern biomedical research. Data resources, through good data management practices, are the key to data and knowledge discovery, integration, and data reuse, as outlined by the FAIR Data Principles (Findable, Accessible, Interoperable, and Reusable digital objects). A healthy and productive data resource ecosystem requires that each resource be scientifically impactful, be well-managed, actively engage the scientific community, and employ sustainable and trustworthy practices.

In order to better support such a modern data resource ecosystem, NIH makes a distinction between data repositories and knowledgebases. While each activity is important for advancing biomedical research, data repositories and knowledgebases can have unique functions, and metrics for success.

The funding opportunity announcements (PAR-20-089 and PAR-20-097) were first launched in 2019 to realize NIH's vision for a modernized biomedical data ecosystem as outlined in NIH’s Strategic Plan for Data Science. The funding opportunities were reissued in 2023 (PAR-23-078 and PAR-23-079) to align with the NIH Data Management and Sharing Policy. To appropriately support biomedical data resources at different stages of the development lifecycle, NIH makes a distinction between early-stage data resources and established data resources. While each activity is important for advancing biomedical research, early and established data resources can have unique functions, metrics for success, and maintenance needs. In recognition of this, the NIH is issuing two related companion funding opportunities that are modifications of PAR-23-078 and PAR-23-079 to better support the unique activities required for the establishment and maintenance of data resources, tailored to early-stage and established stages of the development lifecycle:

• PAR-23-236: (R24, Clinical Trial Not Allowed) supports the initial development of a data resource or pilot significant modification of an existing resource.
• PAR-23-237 : (this Notice of Funding Opportunity (NOFO), U24, Clinical Trial Not Allowed) supports the enhancement and maintenance of established, widely used data resources.

For the purposes of this NOFO, the following definitions apply:

• Data repositories are defined as data resources that accept submission of relevant data from the community, and that validate, store, archive/preserve and distribute the data in compliance with the FAIR data principles.
• Knowledgebases are defined as data resources that collate, extract, organize, annotate, and link the growing body of information related to and relying on core datasets from one or more repositories. They may also curate literature and generate other forms of knowledge and distribute them in compliance with FAIR data principles. Note that knowledgebases include the standalone development of data standards and ontologies.
• Early-stage repositories and knowledgebases are defined as initial development of a data resource with potential for a large increase in usage and adoption by the community. They also encompass transitioning resources that are currently supported as investigator-initiated research efforts into quality controlled, standards-based resources that address governance, and efficiency of operations. Also, early-stage can include proposals that are piloting consolidation of two or more existing repositories or knowledgebases.
• Established repositories and knowledgebases are defined as high-value data resources that are near or at optimal research community adoption and provide a critical research resource as demonstrated by their usage, utility, and impact.

Research Resource Objectives

The purpose of this Notice of Funding Opportunity (NOFO) is to support established biomedical data resources, that have demonstrated impact and have potential for continued benefit to the mission of one or more of the NIH Institutes and Centers participating in this announcement.

Each resource must: (a) deliver scientific impact to the communities served; (b) employ and promote good data management practices (as outlined by the FAIR Data Principles including adherence to the NIH desirable characteristics of repositories) and efficient operations for quality and services; (c) engage with the user community and continuously address their needs; and (d) support a process for data life-cycle analysis, long-term preservation, and trustworthy governance.

The evaluation of the data repository will be based on the primary function to ingest, archive, preserve, manage, distribute, and make accessible the biomedical data related to a particular system or systems.

The evaluation of The Biomedical Knowledgebase will be based on the function to extract, accumulate, organize, annotate and link growing bodies of information related to core datasets.

Both the data repository and the knowledgebase should provide publicly available documentation on the services offered; be responsible for providing quality services; demonstrate the utility of the data and offered services; demonstrate usage and utility; must commit to community engagement and needs, trustworthiness of stewardship, and governance.

Scope

Initiatives supporting data resources differ from typical hypothesis-driven research (e.g., U01 or R01) grants. Applications funded under this NOFO for established data resources must already exist, address the needs of the targeted biomedical research community, document scientific impact they have had thus far, and have potential for continued benefit to the community served.

Applications appropriate for this NOFO can support data resources for biomedical research, spanning biological scales including molecular, cellular, tissue, organism, and/or population data, as well as social and behavioral data. Support for software and tool development must be limited to that which provides essential functions or significantly increases the efficiency of the resource operations. An application should distinctly support either a data repository or a knowledgebase. Resources that desire to support both should submit separate applications to ensure their proper review per the distinct review criteria.

NIH ICs participating in this NOFO are interested in resources that apply to biomedical questions and diseases relevant to their own Institutes and Centers as outlined at https://www.nih.gov/institutes-nih/list-institutes-centers. Applicants are strongly encouraged to request consultation with ODSS and staff at the appropriate participating Institute/Centers when planning an application through submission of a Letter of Intent (LOI). Early contact provides an opportunity for NIH scientific/research staff to determine relevance and priorities of the ICs, provide guidance on program scope and appropriateness of the proposed resource, and suitability to this NOFO. Applicants that do not consult with NIH prior to submission may be less likely to receive funding, as such applications may not align with the IC program priorities.

Non-Responsive Applications

Applications primarily addressing the following topics will be deemed non-responsive and will not be reviewed:

• Applications for new data resources.
• Applications that combine data repository and knowledgebase functions.
• Experimental data production activities.
• Collections of samples or other biological materials.
• Collections or significant development of analysis tools or software platforms.
• Organization of challenges, competitions, or scientific conferences.
• Applications supporting hypothesis-driven research.
• Applications not aligned to any participating NIH Institute/Center/Office mission.

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 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted 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 registrations; 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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 How to Apply - 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

A letter of intent is strongly encouraged; however, does not enter into the review of a subsequent application.

This letter will allow NIH to better plan the review. It will also help the program office coordinating the NOFO to ensure program priorities and identify the most relevant NIH IC(s) for assignment.

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 the application, url of the resource
• Specific aims proposed
• 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:

Office of Data Science Strategy
Email: [email protected]

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. The additional instructions apply:

For this 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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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:

Applicants are required to include travel support for an investigator from their research team to attend the annual program meeting. The budget must include one trip per year to these meetings. The meeting location may be at the NIH Offices or another location in the United States.

There may be Institute specific minimum levels of effort for the PI/PD.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

The Research Strategy must consist of the following two sub-sections, uploaded as a single PDF attachment:

• Critical Requirements for the Proposed Data Resource (data repository or knowledgebase)
• Project Management Plan for the Enhancement and Management of the Resource

In addition, the required review criteria specific to this NOFO listed in Section V must be addressed to be responsive to this NOFO.

A. Critical Requirements for the Proposed Data Resource:

The application must clearly indicate whether it is for a data repository resource or a knowledgebase resource and should present a compelling justification for continued development of the biomedical data resource being proposed. The application should address the following considerations:

• Scientific Significance: Describe how the data resource will reach global significance, with a mission that aligns with the relevant NIH scientific domain. Describe the community for the data resource, its uniqueness and relationship to other data resources that serve the same community, and clearly articulate the continued unmet need for the data resource. Provide examples of use cases that support the significance of the resources to biomedical research. Both data repository and knowledgebase applications should address a critical need to a significant segment of the biomedical research community, describe plans to implement, adopt, or contribute to community-based best practices for openly shared metrics and other evidence that will be used to measure and evaluate usage, utility, and scientific impact through the lifecycle of the resource. Knowledgebase resources should additionally demonstrate advancement of knowledge and understanding within its primary and related scientific fields of science.
• Community Needs and Engagement: Describe methods used to engage the relevant research community(ies) to understand their needs and to regularly evaluate whether their needs are being met. Detail processes for quantitative and qualitative evaluation of the value to the community. Include a rationale for the community need and the current research trends to require the continued independent management of this established data resource; propose plans to evaluate whether the relevant community is best served in the long-term by the resource in its current state or would benefit from merging with other data resources. Applicants are encouraged to include individual letters of support (no more than 10) from members of the relevant research community.
• Quality of Services and Efficiency of Operations: The application should address the quality of data services, including adherence to and support of the desirable characteristics for all federally funded repositories (NOT-OD-21-016) as relevant to the proposed resource; applicants for established repositories and knowledgebases must conduct and include results of a self-assessment to identify and address deficiencies or gaps. Describe quality control/quality assurance procedures and community standards adopted for data and metadata. Knowledgebase resources are expected to consider capabilities beyond manual curation and to scale curation of data including quality and coverage of curated information. The resources should also include plans to regularly implement improvements in the overall efficiency of operations that will result in cost-savings and alternate models for resource stewardship. The architecture of the data resource including that of data and infrastructure management can use emerging technologies or cloud services including leveraging the NIH STRIDES initiative, as appropriate. To the extent that an applicant intends to use or include commercial solutions or related products in its design, the products must be available both to the U.S. Government and the public through standard commercial terms.

• Governance: The application must document processes for developing terms of use, appropriate processes for data licenses and policies for data access, privacy, and ethics. Plans for use of an external advisory committee must be included. The application should describe the role of the external advisory committee; however, names of existing or proposed committee members should not be included in the application and members should not be contacted or appointed prior to review of this application. Describe plans to assess resource trustworthiness to its user community through public evidence of data management practices, certification based on community standards, or other community recognized repository management best practices throughout the lifecycle of the resource.

B. Project Management Plan for the Enhancement and Management of the Resource:

Describe plans to develop and manage the proposed resource including a timeline with tasks, milestones, and deliverables. Criteria for acceptable outcomes for each task should be defined.

Plans to share any software developed in support of the data resource (for example, supporting the back-end, front-end, and/or data processing pipelines/workflows) as open source and licensed under a non-viral license must also be included. URLs of publicly available websites may be cited for the purpose of referencing the existing data resource, associated open-source software or code that is the subject of the proposed work, or for the purpose of demonstrating dissemination and outreach activities.

In addition, the project management plan must include a transition plan to another responsible steward and long-term archival of the data. This is required if the current team no longer manages the data resource, or the entire resource is sunset.

Resource Sharing Plan: A Resource Sharing Plan is not applicable for this NOFO.

Other Plan(s): Note:

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

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix: 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.

PHS Human Subjects and Clinical Trials Information

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.

PHS Assignment Request Form

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

Foreign Institutions

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

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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 components of participating organizations , NIH. Applications that are incomplete or non-compliant will not be reviewed.

In order to expedite review, applicants are requested to notify the NIH Office of Data Science Strategy by email at [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact the ODSS Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

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

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

As stated in the research strategy section, NIH makes a distinction between data repositories and knowledgebases and reviewers must incorporate these distinctions in their evaluations. Applications should limit software and tool development to that which provides essential functions or significantly increases the efficiency of operation of the repository.

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.

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.

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.

2. Review and Selection Process

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

Applications will be assigned and coordinated by ODSS on the basis of established PHS referral guidelines, 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 appropriate national Advisory Council or Board. 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 2.4.4 Disposition of Applications.

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.6. 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 Standard Terms and Conditions for Research Grants
• 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 term and condition of receiving the grant, to administer their 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. Please 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.html and https://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 recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Recipients 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 HHS, PHS, and NIH policies.
• Defining the details for the project. PD(s)/PI(s) will agree to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the project as described under "Program Staff Responsibilities";
• Participate in organizing and hosting necessary annual scientific or programmatic meetings;
• Advertising the resources available to the community through outreach activities;
• Assemble the External Advisory Committee (EAC) and participate in EAC activities;
• Manage and coordinate project activities scientifically and administratively at the awardee institution and with any collaborating institutions;
• Seeking opportunities for collaboration with other projects funded under this program initiative with the aim of addressing common capabilities including the desirable characteristics of repositories, adoption of best practices, and FAIR practices in general;
• Ensure that all data and information are disseminated according to the FAIR principles;
• Ensure that all data and information involving human subjects has the appropriate security and clearances;
• Wherever possible, adhere to open science best practices, to enable the right of others to read, redistribute, modify, and freely use any applicable software;
• Update goals and milestones at the time of award and provide summaries of progress toward those goals, including the Project Management Plan, at least yearly, as requested by NIH. The milestones will be reviewed annually (and at other times, if necessary), and new milestones will be negotiated, as needed by working with the Project Coordinator as appropriate;

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

Program Official:

• Responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice;
• Review the progress of the project and monitor for compliance with NIH Grants Policy;
• Make recommendations to the NIH for continued funding based on performance and compliance with the Terms and Conditions of the award;
• Conduct more frequent progress reviews, with the possibility that the awardee submit quarterly progress reports should problems arise in the conduct of the study;
• Serve as an ex officio member of any External Advisory Committee;

Project Coordinator:

One or more NIH Program Staff may serve as Project Coordinator (PC), to monitor progress in scientific aims, identify possible collaborations with other NIH funded initiatives, review milestones and other scientific issues, and oversee collaborative projects amongst awardees. The PC will serve as a scientific representative of the NIH to the investigators in accordance with policies and procedures of the cooperative agreement mechanism. The PC will provide NIH scientific programmatic involvement with the recipient that is anticipated during the performance of the activities supported by this Cooperative Agreement, including review of milestones. The PC will work closely with the PD/PI to maximize progress towards the goals of the project and the program and will serve as a non-voting member of the External Advisory Committee. Specifically, the PC will:

• Participate in the process of coordinating collaborative project efforts and setting priorities;
• In consultation with the program officer, provide advice in the development of operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action
• Serve as a non-voting member of any External Advisory Committee or Steering Committee as a representative of the NIH extramural staff;
• Serve as a liaison to the NIH, and as an information resource for the awardees about related research activities

Areas of Joint Responsibility include:

• PD(s)/PI(s) will establish the External Advisory Committee (EAC) and this committee is expected to consist of individuals who are not key personnel or collaborators of the key personnel of the award. The EAC meetings will include NIH staff and may include the PD(s)/PI(s) and other members of the funded project. The EAC will select one member to act as the Chair of the committee and the Chair may not be an NIH employee. The EAC will meet at least once a year.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: 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 HHS 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.

The Data Management and Sharing Plan is not applicable to this NOFO.

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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 Condition 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]

Office of Data Science Strategy (ODSS)
Email: [email protected]

Center for Scientific Review (CSR)
Email: [email protected]

Joseph Miree
Office of Data Science Strategy (ODSS)
Telephone: 301-402-2470
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.