Advancing Bioinformatics, Translational Bioinformatics and Computational Biology Research (R01 Clinical Trial Optional)

The National Library of Medicine (NLM) seeks applications for research projects that drive groundbreaking innovation and advanced development in the fields of bioinformatics, translational bioinformatics, and computational biology. The primary goal of this initiative is to support the creation and implementation of cutting-edge methods, tools, and approaches that can transform the landscape of biomedical data science. This NOFO aims to address the growing need to leverage transformative technologies — such as artificial intelligence (AI), machine learning, and large-scale computational platforms — to extract actionable knowledge from vast, diverse, and complex biological datasets. By enabling more effective interpretation and integration of multi-dimensional biological and biomedical data, this research will ultimately contribute to improving individual and population health outcomes.

Funding Opportunity Number: PAR-26-040. Assistance Listing: 93.879. Funding Instrument: G. Category: HL. Award Amount: Up to $250K per award.

PAR-26-040: Advancing Bioinformatics, Translational Bioinformatics and Computational Biology Research (R01 Clinical Trial Optional) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Library of Medicine ( NLM ) Funding Opportunity Title Advancing Bioinformatics, Translational Bioinformatics and Computational Biology Research (R01 Clinical Trial Optional) R01 Research Project Grant Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON) Companion Funding Opportunity See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose The National Library of Medicine (NLM) seeks applications for research projects that drive groundbreaking innovation and advanced development in the fields of bioinformatics, translational bioinformatics, and computational biology.

The primary goal of this initiative is to support the creation and implementation of cutting-edge methods, tools, and approaches that can transform the landscape of biomedical data science.

This NOFO aims to address the growing need to leverage transformative technologies — such as artificial intelligence (AI), machine learning, and large-scale computational platforms — to extract actionable knowledge from vast, diverse, and complex biological datasets.

By enabling more effective interpretation and integration of multi-dimensional biological and biomedical data, this research will ultimately contribute to improving individual and population health outcomes. Funding Opportunity Goal(s) To advance bioinformatics and biomedical computing by supporting research in biomedical informatics, bioinformatics, and related fields of computer, information, and data sciences.

Open Date (Earliest Submission Date) 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.

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.

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 The National Library of Medicine (NLM) wishes to advance groundbreaking and innovative research in bioinformatics, translational bioinformatics and computational biology, which are related areas of biomedical informatics that aim to understand biological data using storage, analytic and interpretive methods.

This initiative will support NLM's mission to accelerate discovery by enhancing human health through data-driven research. This Notice of Funding Opportunity (NOFO) aims to address the growing need to leverage transformative technologies—such as artificial intelligence (AI), machine learning, and large-scale computational platforms—to extract actionable knowledge from vast, diverse, and complex biological datasets.

By enabling more effective interpretation and integration of multi-dimensional biological and biomedical data, this research will ultimately contribute to improving individual and population health outcomes. Applications that promote interdisciplinary collaboration and focus on scalable, autonomous innovations will be encouraged.

Additionally, emphasis will be placed on the development of cutting-edge methodologies that advance the field beyond predictive modeling to yielding functional insights that can explain biological phenomena and mechanisms underlying human diseases, including chronic diseases.

Projects may span a wide range of topics, including but not limited to omics-based bioinformatics at the molecular level, as well as computational biology studies at the cellular, tissue, organismal, and population levels. Advancements may draw from innovations in multiple disciplines, including biology, chemistry, physics, biodata imaging, computer science, information engineering, mathematics and statistics.

For this NOFO, areas of bioinformatics and computational biology for which methodological advances are of interest include, but are not limited to: Various types of omics and multi-omics studies, including genomics, transcriptomics, proteomics, epigenomics, structural or spatial omics, comparative omics, and multimodal integrations of those. Microbiome studies, including studies on host-microbiome interactions.

Metagenomic and/or metaproteomic studies. Studies that use artificial intelligence (AI) and machine learning (ML) applications for predictive and analytical bioinformatics research. Computational biology method development for analysis of genomic or non-genomic biological data and related phenomena.

Genetic variation and disease association studies, including methodological advances for determining combinatorial variant associations, and for accelerating discovery beyond rare diseases, such as for chronic diseases. Phenotypic studies, including methodological advances for complex trait analyses.

Translational bioinformatic studies that aim to provide a pathway for effective treatment strategies or have a tangible effect on health outcomes. Translational bioinformatic studies applicable to personalized or genomic medicine. Pathway and/or regulatory network studies.

Systems biology studies, including analysis and visualization of large datasets. Cell-cell interaction informatics, and other types of cellular/tissue/organism networking studies. Informatics related to biomarker discovery.

Analysis of drug targets. Various emerging or other informatics studies on biological data, including but not limited to multimodal studies that encompass multiple data types and/or research domains, or studies relevant to bioinformatic data harmonization, integration and reuse. Example topics of interest include, but are not limited to: Interdisciplinary approaches that are informed by functional biological and/or biomedical data.

Approaches that result in whole usable pipelines, workflows or resources, rather than software products that perform segmented functions in a larger workflow. Tools and methods that can be developed, applied, evaluated and disseminated within the scope of the proposed project, and which are durable and autonomously updatable.

Tools and workflows that are FAIR (Findable, Accessible, Interoperable, Reusable) and easily findable by the wide research community in well-documented, user-friendly, publicly available resources, and which encompass ethical considerations for data representation and downstream use. Translational bioinformatics approaches that are broadly adaptable and generalizable.

Non-translational bioinformatics advances that contribute tangible functional knowledge for downstream use. Computational models that are adaptable, credible, explainable and testable by real-world data. Research approaches should foster data-driven discovery to accomplish NLM mission-related goals.

Additionally, the following expectations should be addressed in all applications: Research should exemplify scientific rigor, feasibility, technological innovation, and the potential for significant impact across biomedical and clinical domains.

Outputs should be transformative and generalizable across diseases and biological systems; use of specific biological systems may be permissible for proof-of-concept and initial methodology development, but applicants must demonstrate broad applicability beyond that. Products should be durable with the potential to inform and advance further research.

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 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(s), to maintain the product(s), and to capture and communicate considerations for downstream use. All awardees are expected to widely disseminate the results of their research, including software products, datasets, resources and platforms.

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.

Applications Not Responsive to this NOFO The following types of projects will be considered non-responsive to the scope of NLM’s Advancing Bioinformatics, Translational Bioinformatics and Computational Biology Research program: Projects that do not align with current NIH or Department of Health and Human Services priorities, including projects that partially incorporate non-aligning activities.

Projects not centrally focused on, or not clearly pertaining to, bioinformatics, translational bioinformatics or computational biology. Projects focused on social determinants of health (SDOH), or ethical, legal and social issues (ELSI). Projects that duplicate NLM products and databases.

Projects that do not produce open-access datasets, methods, resources or tools. Projects focused on mere incremental improvements of, or on the maintenance of, existing bioinformatic tools, resources or platforms; significant innovation and advancement is expected from this initiative.

Projects with most of the effort devoted to experimental research; only a small portion of the budget may be permitted for experimental validation of computational approaches. Projects narrowly focused on specific diseases and with limited potential to yield broadly applicable 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. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information 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 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. Optional: Accepting applications that either propose or do not propose clinical trial(s).

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. Application budgets are limited to $250,000 per year in direct costs and need to reflect the actual needs of the proposed project.

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.

Section III.

Eligibility Information Higher Education Institutions - Includes all types 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 Organizations) Foreign Organizations/ International Collaborations NIH will no longer issue awards (new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025. Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors. Foreign Organizations/International Collaborations Non-domestic (non-U.S.) Entities (Foreign Organizations) 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. NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025. Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

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. 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 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 (in this NOFO, in a policy notice , or other notice from NIH Guide for Grants and Contracts ). 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. 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.

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

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Applicants are also expected to demonstrate the potential for scalability and generalizability of the proposed tool or approach beyond the specific use case, including how proposed innovations could enhance applicability and adoption across diverse biomedical domains and settings (see Factor 1—Importance of the Research [Significance and Innovation]).

Applicants are also expected to demonstrate robust metrics for describing the scope, scale, and evaluation of use cases; well-defined strategies for benchmarking, validation, and comparison to existing methodologies; clear identification and mitigation of limitations, trade-offs, or risks; and sound plans to ensure product accuracy, ongoing maintenance, and effective communication of considerations for downstream use (see Factor 2—Rigor and Feasibility [Approach]).

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 also apply: Applicants are expected to include a general plan for timely dissemination and sharing of data and resources, e.g., code, widely, as appropriate, and consistent with achieving the goals of the program in concert with NIH and NLM policies. A software dissemination plan, with appropriate timelines, is expected to be included to meet the goals of this initiative.

A major goal of this NOFO is the development of bioinformatic and computational biology methods and tools that can transform the landscape of biomedical data science. Applicants should therefore include detailed plans for open dissemination of methods, software, and tools to the community such that they are readily usable and extensible, where applicable. These should be made freely available to biomedical researchers and educators.

There is no prescribed license for software produced by applications responding to this announcement, but any software license selected by applicants should allow for unrestricted redistribution and modification of software. Methods, tools, and software should be well documented and where applicable made available via version-controlled public repositories.

Where applicable, applicants should describe solutions for portable implementations to cloud computing environments. Solutions that enhance reproducibility when used by the community and ability of the community to integrate into automated pipelines should be emphasized.

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 if the original investigators are unwilling or unable to do so.

Resource sharing should focus on the following to ensure scalability and reusability: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Management and Sharing Plan for the purpose of reusability. Software or other resources resulting from the research must include a plan for resource sharing the resources including coding methods and code editing upon post publication use.

Data Management and Sharing Plans must be consistent with the funding agency’s current Data Management & Sharing Policy. Considerations should be given to how and where data will be housed and shared with other researchers.

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. 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.

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.

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply- Application Guide. 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. 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. 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.

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 grantdisclosures@oig.

hhs. gov . Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described 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, please note the NOFO-specific review criteria listed for Factors 1 and 2 below.

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.

Reviewers will consider 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 factor score. Factor 1.

Importance of the Research (Significance and Innovation) 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. 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.

Evaluate whether the proposed tool or approach has the potential to be generalized beyond the specific use case. Consider the extent to which the approach could be adapted or applied to other biomedical domains and settings. Evaluate the extent to which innovation contributes to the scalability and generalizability of