PAR-25-131: Computational Approaches to Curation at Scale for Biomedical Research Assets (R01 Clinical Trial Not Allowed)

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.

Department of Health and Human Services

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Part 1. Overview Information

Participating Organization(s)

• National Institutes of Health (NIH)

Components of Participating Organizations

• National Library of Medicine (NLM)

Funding Opportunity Title

• Computational Approaches to Curation at Scale for Biomedical Research Assets (R01 Clinical Trial Not Allowed)

Activity Code

• R01 (Research Project Grant)

Announcement Type

• Reissue of PAR-20-304

Related Notices

• May 14, 2025
  • Notice of Change to Advisory Council Review for PAR-25-131. See Notice NOT-LM-25-001.
• 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.
• April 4, 2024
  • Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084.
• 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.

Funding Opportunity Number (FON)

• PAR-25-131

Companion Funding Opportunity

• None

Number of Applications

• See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

• 93.879

Funding Opportunity Purpose

NLM wishes to accelerate access to, and availability of, secure, complete datasets and computational models that can serve as the basis for transformative biomedical discoveries. Innovative at-scale computational approaches that increase the speed and scope of curation processes are needed for data mining and knowledge discovery from growing quantities of biomedical data being produced from ongoing data science advances.

Key Dates

• Posted Date: October 29, 2024
• Open Date (Earliest Submission Date): December 27, 2024
  Dates in bold and italics reflect changes per NOT-LM-25-001.

Application Due 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.

Review and Award Cycles

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

Scientific Merit Review

• February 24, 2025
• June 13, 2025
• October 15, 2025
• February 17, 2027
• June 15, 2026
• October 15, 2025
• February 13, 2026
• June 15, 2026
• October 15, 2026
• February 17, 2027
• June 15, 2027
• October 15, 2027

Advisory Council Review

• April 25, 2025
• August 15, 2025
• December 15, 2025
• April 26, 2026
• August 14, 2026
• December 15, 2026
• April 15, 2027
• July 2027

(Earliest Start Date and additional dates appear below exactly as provided.)

Earliest Start Date

• January 28, 2025
• May 15, 2025
• September 15, 2025
• January 15, 2026
• September 15, 2026
• January 15, 2027

Other dates in the provided list:

• July 2025
• October 2025
• December 2025
• March 2026
• May 2026
• July 2026
• April 2026
• September 15, 2025
• November 2025
• January 2026
• March 2026
• May 2026
• July 2026
• January 15, 2026
• February 13, 2026
• April 15, 2026
• July 2026
• October 2026
• December 2026
• May 15, 2026
• June 15, 2026
• August 14, 2026
• November 2026
• January 2027
• April 2027
• September 15, 2026
• October 15, 2026
• December 15, 2026
• March 2027
• May 2027
• July 2027
• January 15, 2027
• February 17, 2027
• April 15, 2027
• July 2027
• October 2027
• December 2027

Expiration Date

• April 16, 2027

Due Dates for E.O. 12372

• Not Applicable

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.

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.

• Use the NIH ASSIST system to prepare, submit and track your application online.
• 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.
• 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

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Part 2. Full Text of Announcement

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Section I. Notice of Funding Opportunity Description

Purpose

NLM wishes to accelerate access to, and availability of, secure, complete datasets and computational models that can serve as the basis for transformative biomedical discoveries. Growing quantities of biomedical data produced from ongoing data science advances have resulted in continuous needs for data mining and knowledge discovery for a diverse range of biomedical data types. Innovative research strategies are needed to develop at-scale computational approaches that increase the speed and scope of curation processes, which catalog biomedical data and maximize data reach. This Notice of Funding Opportunity seeks applications for novel computational approaches focused on automating curation of biomedical digital assets in support of Goal 1 of the NLM Strategic Plan 2017-2027: “An important research direction will develop strategies for curation at scale,” and to foster open science policies and practices “that preserve and make publications, data, and other research outputs discoverable and accessible to the broadest possible audience.”

Digital curation supports data-driven biomedical discovery by providing access to large quantities of biomedical, health-related and basic biological research data, to computational models and tools, and to open-source software and code. Curation processes support data integration and harmonization involving the characterization, annotation, management and preservation of digital assets, including research datasets, computational and other types of models, reusable visualization tools, and other digital assets. Proficient curation supports FAIR (Findable, Accessible, Interoperable, Reusable) data management by maximizing data findability, accessibility, interoperability and reuse potential. It helps to preserve data, assure reproducibility of research, minimize duplication, and simplify the process of finding, managing, visualizing and mining a wide variety of digital assets. The wide array of biomedical data assets of interest to this funding opportunity include, but are not limited to:

• Public health or epidemiological data
• Molecular biology data types such as genomic, epigenomic, proteomic or genetic variant data
• Biomedical literature and associated metadata
• Biomedical imaging data
• Metabolomic data
• Environmental measurements
• Observational health data such as electronic health records, family histories or sensor readings from personal trackers
• Various other data assets of biomedical interest

Continued advances and breakthroughs in machine learning (ML) and artificial intelligence (AI) technologies are expected across a wide range of research fields over the coming years, but are reliant on large volumes of well-curated, FAIR data. As the volume and complexity of digital assets continue to grow, manual curation cannot scale and is not sufficiently wide-reaching to meet ongoing research needs. Thus, ever-increasing amounts of biomedical data will need to be curated, integrated and harmonized using innovative computational approaches. This funding opportunity invites applications for the development of novel computational methodologies to accomplish at-scale curation for ongoing data-driven research needs for a diverse range of data types. It is expected that these approaches will:

• Increase the speed and assure quality and security of storage techniques, retrieval strategies, annotation methods, data standards, visualization tools and other advanced data management approaches.
• Improve FAIR-ness for data access, sharing and management.
• Foster the production of reliable, accurate, credible, trusted, high-value curated datasets or tools that will serve to advance mission-related research.

Research Objectives

To achieve FAIR access to huge collections of biomedical digital data assets, new or improved approaches for automated curation and management of digital assets must be designed, tested, validated, and widely adopted. Applications may propose development of new computational methods or extend existing open-source tools and pipelines in order to enhance automation, improve efficiency, quality and security, and control costs. The following expectations must be addressed in all applications:

• A durable product is expected to inform and advance further research.
• Proposed approaches must identify the type of digital asset(s) being employed, including clear descriptions of data provenance and credibility.
• Intended use cases must be clearly stated and evaluated, with approaches expected to be wide-reaching.
• Detailed descriptions of approaches are expected, with metrics provided for the scope and scale of the study.
• Improvements over comparable existing management or curation approaches must be documented, and any limitations, trade-offs or risks resulting from the proposed innovative approach must be described and addressed.
• Applicants must describe a plan to account for accuracy of the product, to maintain the product, and to capture and communicate ethical considerations for downstream data use.
• All awardees are expected to widely disseminate the results of their research including software.

Funding will be provided for the development, processing and dissemination of FAIR, curated datasets and/or tools.

Initial input data employed by the product are expected to be preexisting, i.e., funding will not be provided for initial raw data derivation, such as for performance of medical tests or wet laboratory research.

Potential topics to be addressed include, but are not limited to:

• Fully automated curation that meets community-defined standards for metadata.
• Automated approaches to curate and harmonize public health data.
• Automated approaches for mining, formatting and harmonizing genomic, proteomic or genetic variant data found in disparate supplemental files in the biomedical literature.
• Automated curation and categorization of epidemiological data, such as data across the socioeconomic spectrum.
• Automated approaches to curate metabolomic data.
• Automated approaches for curation of multi-faceted data, such as bioclinical, multi-omic, text metadata and bioimaging data suitable for combined ingestion and cataloging.
• Approaches for streamlining the effective capture and communication of ethical considerations for downstream data use.
• Approaches to achieve accurate, reliable and scalable community-driven curation of biomedical data.
• Automated annotation via extraction from text or other digital sources, linking the extracted information to a dataset or other digital asset.
• Automated quality control approaches that increase the completeness, accuracy or quality of a dataset or model.

Applications Not Responsive to this NOFO

The following types of projects will be considered non-responsive to the scope of NLM’s Computational Approaches to Curation at Scale for Biomedical Research Assets program:

• Projects that are not focused on the development, processing and/or dissemination of FAIR, curated datasets and/or tools.
• Manual curation projects that do not employ computational approaches, or any project that does not involve at-scale curation.
• Projects about non-biomedically relevant data assets, e.g., financial data assets.
• Projects involving NIH’s definition of a clinical trial.
• Projects that duplicate NLM products and databases such as biomedical literature indexing projects.
• Projects that do not produce open access datasets or tools.

Non-responsive applications will not be reviewed. Potential applicants are strongly encouraged to discuss their proposed project with the Scientific/Research Contacts listed in Section VII for guidance about the application process and suitability of the project for support by NLM.

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

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Section II. Award Information

Funding Instrument

• Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

• New
• Renewal
• Resubmission

The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

• 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.

Award Budget

• Application budgets are limited to $250,000 direct costs per year (excluding consortium F&A costs) and need to reflect the actual needs of the proposed project.

Award Project Period

• The scope of the proposed project should determine the project period. The maximum project period is 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.

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Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

• 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
  • 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
  • Foreign Organizations
    • Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
    • Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    • Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Foreign Organizations (Non-domestic (non-U.S.) Entities) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• 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 How to Apply-Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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).

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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.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

• SF424(R&R) Cover
  All instructions in the How to Apply - Application Guide must be followed.
• SF424(R&R) Project/Performance Site Locations
  All instructions in the How to Apply - Application Guide must be followed.
• SF424(R&R) Other Project Information
  All instructions in the How to Apply - Application Guide must be followed.
• SF424(R&R) Senior/Key Person Profile
  All instructions in the How to Apply - Application Guide must be followed.
• R&R or Modular Budget
  All instructions in the How to Apply - Application Guide must be followed.
• R&R Subaward Budget
  All instructions in the How to Apply-Application Guide must be followed.
• PHS 398 Cover Page Supplement
  All instructions in the How to Apply- Application Guide must be followed.
• PHS 398 Research Plan
  All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

The following modifications apply:
In addition to the dissemination and testing plan outlined for Other Plan(s) below, applicants are expected to include a general plan for sharing the resource widely, with appropriate timelines, as appropriate and consistent with achieving the goals of the program. A software dissemination plan, with appropriate timelines, is expected to be included to meet the goals of this initiative.

There is no prescribed single license for software produced through grants responding to this announcement. However, reviewers will be instructed to evaluate the dissemination plans relative to these goals:

• Any developed software should be freely available to biomedical researchers, curators, and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
• The terms of software availability should include the ability of outside researchers to modify the source code and to share modifications with other colleagues as well as with the investigators. The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Applicants are expected to propose a plan to manage and disseminate the improvements or customization of their tools and resources that are contributed by others. This application may include a plan to incorporate the enhancements into the "official" core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

Other Plan(s):

All instructions in the How to Apply-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.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Research Strategy: As part of the Research Strategy Section, applications should clearly address the following aspects:

• Identify the curation process(es) and domain of interest being addressed and how the proposed approach will make digital data assets more findable, accessible, interoperable or reusable.
• Describe who would use this approach, e.g., curator, data manager, bioclinical personnel and/or scientist, and describe when use of the proposed approach is most helpful, e.g., data generation, data deposition in the research/data lifecycle.
• Define the challenging problem for computational curation of biomedical data or models within the chosen area of use, giving particular emphasis to the specific aspects of the problem that create the challenge and the shortcomings of existing approaches.
• Describe current tools and approaches available to address this problem area and how the proposed approach differs.
• Describe the proposed approach (e.g., what tools or methods will be developed, what the basis of comparison will be, and how the proposed approach will be tested). Applicants should clearly state whether the proposed work is a new tool or an improvement of an existing tool, and they should include a timeline that lays out steps for design, testing and dissemination.
• Describe the approach for dissemination and testing by the user community.
• For a new tool or curated dataset product, the applicant should justify the need for the product, and must provide baseline data and compare the product to existing approaches. For improvements to an existing product, the applicant is expected to describe the innovation, and to undertake comparative testing to show the benefits of changes made to the original product.
• The metrics that will be used to evaluate the proposed approach must be described (e.g., efficiency, effectiveness, accuracy or quality). It is expected that the final product or approach will include appropriate metrics for tracking curation work, such as completeness, accuracy, reliability, production time, quality of metadata, utility for re-use, integration or interdisciplinary application, downstream ethical use considerations, cost-effectiveness, product durability and maintenance, and similar factors.
• For applications that incorporate the aggregation of public or non-controlled-access data, applicants are expected to address methods for mitigating privacy concerns that may arise from such aggregated data. Privacy protections for human subjects are expected to be long-term and must extend beyond the funding period.

Appendix:

• Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- 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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

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

See Part 2. 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. 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 How to Apply-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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

• Applications must be submitted electronically following the instructions described in the How to Apply 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 How to Apply 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.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

• Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

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.

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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:

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Scored Review Criteria

Reviewers will evaluate Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate criterion score.

Factor 1. Importance of the Research (Significance and Innovation)

Significance

• Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly.
• Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.
• Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.

Innovation

• Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field.
• Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.

Factor 2. Rigor and Feasibility (Approach)

Approach

Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).

Rigor:

• Evaluate the potential to produce unbiased, reproducible, robust data.
• Evaluate the rigor of experimental design and whether appropriate controls are in place.
• Evaluate whether the sample size is sufficient and well-justified.
• Assess the quality of the plans for analysis, interpretation, and reporting of results.
• Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.

For applications involving human subjects or vertebrate animals, also evaluate:

• the rigor of the intervention or study manipulation (if applicable to the study design).
• whether outcome variables are justified.
• whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
• whether the sample is appropriate and sufficiently diverse to address the proposed question(s).

For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility:

• Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances.
• For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain an appropriately diverse population of participants. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, race, ethnicity, and sex.
• For clinical trial applications, evaluate whether the study timeline and milestones are feasible.

Factor 3. Expertise and Resources (Investigator(s) and Environment)

Investigator(s)

• Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work.
• For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

Environment

• Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

Additional Review Criteria

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

• 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, 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, 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.

• Vertebrate Animals
  When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals 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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

• Biohazards
  When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.

• Resubmissions
  As applicable, evaluate the full application as now presented.

• Renewals
  As applicable, evaluate the progress made in the last funding period.

• Revisions
  As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

• 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, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults), as required by statute, 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.

Additional Review Considerations

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.

• Authentication of Key Biological and/or Chemical Resources
  For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.
• Budget and Period of Support
  Evaluate 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 Library of Medicine, in accordance with NIH peer review policies and practices, 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 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. 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.
• Portfolio balance.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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.

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Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant’s own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
• HHS recognizes that NIH 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.
• All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.

Cooperative Agreement Terms and Conditions of Award

• Not Applicable

3. Data Management and Sharing

Consistent with the 2023 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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. 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 2 CFR Part 200.301.

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Section VII. Agency Contacts

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

Application Submission Contacts

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]

Scientific/Research Contact(s)

• Catherine Farrell, PhD
  • National Library of Medicine (NLM)
  • Telephone: 301-402-7081
  • Email: [email protected]
• Clayton Bingham, PhD
  • National Library of Medicine (NLM)
  • Telephone: 301-594-5929
  • Email: [email protected]
• Yanli Wang, PhD
  • National Library of Medicine (NLM)
  • Telephone: 301-435-4372
  • Email: [email protected]

Peer Review Contact(s)

• Zoe Huang, MD
  • National Library of Medicine (NLM)
  • Telephone: 301-594-4937
  • Email: [email protected]

Financial/Grants Management Contact(s)

• Andrea Culhane
  • National Library of Medicine (NLM)
  • Telephone: 301-402-0069
  • Email: [email protected]

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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.

Authority and Regulations

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 2 CFR Part 200.

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