Early-stage Biomedical Data Repositories and Knowledgebases (R24 Clinical Trial Not Allowed) (PAR-23-236)

Early-stage Biomedical Data Repositories and Knowledgebases (R24 Clinical Trial Not Allowed) (PAR-23-236) is sponsored by National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). This Notice of Funding Announcement (NOFO) supports the development of early-stage or new data repositories and knowledgebases that could be valuable for the biomedical research community.

Expired PAR-23-236: Early-stage Biomedical Data Repositories and Knowledgebases (R24 Clinical Trial Not Allowed) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Office of Data Science Strategy ( ODSS ) National Eye Institute ( NEI ) National Heart, Lung, and Blood Institute ( NHLBI ) National Human Genome Research Institute ( NHGRI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute on Drug Abuse ( NIDA ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of Neurological Disorders and National Institute on Minority Health and Health Disparities ( NIMHD ) National Center for Complementary and Integrative Health ( NCCIH ) Funding Opportunity Title Early-stage Biomedical Data Repositories and Knowledgebases (R24 Clinical Trial Not Allowed) R24 Resource-Related Research Projects March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. December 18, 2024 - Notice of NIA Withdrawal from Participation in PAR-23-236, "Early-stage Biomedical Data Repositories and Knowledgebases (R24 Clinical Trial Not Allowed)". See Notice NOT-AG-24-093 April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 October 11, 2024 - Notice of NIAMS Withdrawal from PAR-23-236 "Early-stage Biomedical Data Repositories and Knowledgebases (R24 Clinical Trial Not Allowed)". See Notice NOT-AR-24-020 April 11, 2024 - Notice of Pre-Application Webinar for the NIH Biomedical Data Repositories and Knowledgebases Program (DRKB).

See Notice NOT-OD-24-097 October 27, 2023 - Adjustments to NIH Grant Application Due Dates on or Between October 28, 2023 and October 31, 2023. See Notice NOT-OD-24-020 . December 22, 2022 - Biomedical Knowledgebase (U24 - Clinical Trials Not Allowed).

See NOFO PAR-23-078 December 22, 2022 - Biomedical Data Repository (U24 - Clinical Trials Not Allowed). See NOFO PAR-23-079 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 . Notice of Funding Opportunity (NOFO) Number Companion Funding Opportunity Resource-Related Research Project (Cooperative Agreements) See Section III.

3. Additional Information on Eligibility. Assistance Listing Number(s) 93.

310, 93. 307, 93. 867, 93.

173, 93. 837, 93. 838, 93.

839, 93. 840, 93. 233, 93.

172, 93. 273, 93. 846, 93.

113, 93. 213, 93. 279, 93.

866, 93. 853 Funding Opportunity Purpose This Notice of Funding Announcement (NOFO) supports the development of early-stage or new data repositories and knowledgebases that could be valuable for the biomedical research community.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 60 days prior to the application due date August 31, 2023 ; November 26, 2023; July 27, 2024; November 26, 2024; July 27, 2025; November 26, 2025 The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

Required Application Instructions 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.

Part 1. Overview Information 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 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 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.

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

For this NOFO (PAR-23-236) and the companion NOFO ( PAR-23-237 ) 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. Knowledgebases 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 This Notice of Funding Opportunity (NOFO) supports the development of early-stage or new data repositories or knowledgebases that could be valuable for the biomedical research community. The overall goal is to support pilot activities that demonstrate the need and potential impact of the data resource.

The NOFO will also support transitioning resources that are currently supported as investigator-initiated research efforts into quality controlled, standards-based resources that address governance, and efficiency of operations. Efforts to consolidate existing data repositories or independent knowledgebases are also in scope for this NOFO.

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.

Initiatives supporting data resources differ from typical hypothesis-driven research (e.g., U01 or R01) grants. Data resources funded under this NOFO can support 1) creation of a new data resource or 2) propose activities required to combine/transition existing data resources. Projects have the potential to mature into an established data resource eligible for support via the established resources NOFO ( PAR-23-237 ).

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 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 for 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: Duplicative 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 Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

ODSS anticipates co-funding applications funded by Institutes/Centers/Offices based on program priorities and relevance to more than one NIH Institute/Center/Office The following NIH components intend to commit the following amounts : NINDS intends to support up to 2 awards in each fiscal year NHGRI intends to support up to 2 awards in each fiscal year Application budgets need to reflect the actual needs of the proposed project and may not exceed $350K direct costs per year.

The scope of the proposed project should determine the project period. The maximum project period is four (4) years. 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 Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 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 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.

Eligible Individuals (Program Director/Principal Investigator) 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement. 3.

Additional Information on Eligibility 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. A Letter of Intent is strongly encouraged , however, it 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 for the application 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 All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

For this NOFO, the Research Strategy section is limited to 12 pages. Instructions for Application Submission 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.

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.

All instructions in the SF424 (R&R) Application Guide must be followed. The additional instructions apply: 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 also be Institute specific minimum levels of effort for the PI/PD. 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.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: The Research Strategy must include the following two subsections uploaded as a single PDF attachment: Critical Requirements for the Proposed Biomedical Data Resource (data repository or knowledgebase) 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 Biomedical 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 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.

The application should clearly identify the community, clearly articulate the unmet need, describe its uniqueness and relationship to other data resources that serve the same community, and include use cases that support the significance of the resource 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: The application should document the methods used to engage targeted research community(ies) to understand their needs and to regularly evaluate whether their needs are being met.

The application should also describe planned processes for quantitative and qualitative evaluation of the value to the community including plans for public sharing of usage metrics.

The application must also include a rationale for the community need for an independent and standalone resource and should propose to evaluate whether the targeted community is best served in the long-term by incorporating the proposed data resource into another existing resource.

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 data repositories ( NOT-OD-21-016 ), as relevant to the proposed resource. Describe quality control/quality assurance procedures and community standards adopted for data and metadata and data resources.

Knowledgebase applications are additionally expected to consider capabilities beyond manual curation and to scale curation of data. The resources should also consider plans to address improvements in the overall efficiency of operations. 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. Letters of Support: Applicants are encouraged to provide individual letters of support (no more than 10) from collaborators and/or potential users in the relevant research community.

These letters should provide details on the nature of the proposed interaction/collaboration and describe how the proposed new data resource will benefit their research. B. Project Management Plan 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 suitable 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. A Resource Sharing Plan is not applicable for this NOFO. 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: 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.

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 (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. 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.

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, non-compliant and/or nonresponsive 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. Application budgets need to reflect the actual needs of the proposed project and may not exceed $350K direct costs per year.

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 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