Bioengineering Research Grants (BRG) (R01 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH). This R01 funding opportunity supports research projects that apply engineering principles and approaches to address biological and medical problems. Projects may or may not include clinical trials.

Universities with bioengineering departments are highly encouraged to apply.

Expired PAR-22-242: Bioengineering Research Grants (BRG) (R01 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 National Cancer Institute ( NCI ) National Eye Institute ( NEI ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Neurological Disorders and Funding Opportunity Title Bioengineering Research Grants (BRG) (R01 Clinical Trial Not Allowed) R01 Research Project Grant Notices of Special Interest associated with this funding opportunity May 9, 2025 - Notice to Applicants That the Simplified Review Framework Will be Applied to All Relevant Applications for August/October 2025 Councils.

See Notice NOT-OD-25-116 . 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 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-HD-22-050 - Notice of NICHD Participation in PAR-22-242 NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III.

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

399, 93. 393, 93. 394, 93.

395, 93. 396, 93. 853, 93.

173, 93. 121, 93. 846, 93.

867, 93.

865 Funding Opportunity Purpose Purpose of this funding opportunity announcement is to encourage collaborations- between life science and physical science- that: 1) apply a multidisciplinary bioengineering approach to solve biomedical problems; and 2) develop, integrate, optimize, validate, translate or accelerate adoption of promising tools, methods and techniques: a) that fulfill an unmet need and address specific research or clinical problem in basic, translational, and/or clinical science and practice, b) capable of enhancing our understanding of health and disease, and/or c) improve practice of medicine.

Applications may propose design-directed, developmental, discovery-driven, or hypothesis-driven research, and this FOA is appropriate for small teams applying an integrative approach to increase our understanding of and solve problems in biological, clinical or translational science. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk.

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.

New Date May 24, 2025 per NOT-OD-25-113 (Originally September 08, 2025) Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) 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. 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. Funding Opportunity Description The goal of the bioengineering research grant (BRG) program is to foster development of innovative technologies, methods, tools, models or designs (for brevity, here onwards referred to as tools) that have the potential for significant impact on biomedical research by infusing principles and concepts from quantitative sciences.

The purpose of this FOA is to encourage BRG applications that: 1) apply a multidisciplinary approach to solve biomedical problems; and 2) develop, integrate, optimize, validate, translate or accelerate adoption of promising tools, methods, and techniques for a specific research or clinical problem in basic, translational, and/or clinical science and practice.

A BRG application may propose design-directed, developmental, discovery-driven, or hypothesis-driven research and the FOA is appropriate for small teams applying an integrative approach to increase our understanding of and solve problems in biological, clinical, or translational science. Many major biomedical research problems are best addressed with a multidisciplinary approach that bridges life sciences and physical sciences.

Principles and techniques in quantitative sciences such as physics, mathematics, chemistry, computer sciences, and engineering are increasingly applied to enable and advance biomedical research.

Bioengineering approaches integrate principles from diverse technical and biomedical fields, and the resulting multi-disciplinary research provides new understanding, innovative technologies, and new products that improve basic knowledge, human health, and quality of life.

This FOA seeks to encourage collaborations among investigators in the fields of quantitative science and physical science with biomedical researchers to catalyze the development of innovative bioengineering approaches to solve important problems in biomedical research, translational research, clinical investigations, and medical practice.

Significant projects may include, but are not limited to: development, validation, and translation of promising modalities for the disease continuum, including tools for risk prediction, screening, prevention, detection, diagnosis, disease progression, intervention, monitoring treatment response, prognosis, or survival; development of quantitative, predictive models of complex biological systems; integration and optimization of technologies that significantly increase sensitivity, specificity, positive predictive value, negative predictive value, efficiency, or throughput of analysis to address unsolved biological or medical questions; in vitro and in vivo models, cell/tissue culture systems and organoids that closely mimic physiological conditions and allow mechanistic studies or engineering and testing of delivery systems, molecules/cells/tissues for therapeutic purposes, therapeutics, implants, and prosthetics that may improve treatment and healthcare.

Innovation in this biomedical engineering FOA has a broad definition that includes development of new methods, ideas, or tools, integration of existing components into new combinations that deliver new and/or greater capabilities, new efficiencies, and/or greater effects.

Overall impact of these advances may include improving our understanding of molecular mechanisms, reducing disparities in access to care, promoting wellness and independent living, increasing access to and utility of technologies to improve quality of life, reducing the cost and complexity of procedures, and/or increasing throughput, sensitivity, and specificity of diagnostic tests.

A project must clearly serve the mission of one or more of the NIH Institutes or Centers participating in this FOA. Investigators are encouraged to contact the designated Scientific/Research contacts for individual institute focus areas that will be supported. Applicants who seek to establish proof-of-concept are encouraged to respond to the Exploratory Bioengineering Research Grant (EBRG) FOA [ https://grants.

nih. gov/grants/guide/pa-files/par-22-091. html ].

National Institute of Dental and Craniofacial Research (NIDCR) The NIDCR conducts and fosters research on the etiology, pathogenesis, prevention, diagnosis, and treatment of oral, craniofacial, and dental (DOC) diseases and conditions.

Within the goals of this FOA, NIDCR is interested in supporting applied and translational research that leverages multidisciplinary principles and concepts from quantitative, biological and clinical sciences to advance the development of innovative technologies, model systems, techniques, designs, and methods with potential to significantly improve DOC health.

Specific topics could include but are not limited to: Development and translation of technologies targeted at regeneration and restoration of diseased and injured tissues of the oral and craniofacial complex.

Of interest are multi-tissue composites and organs, such as vascularized and innervated bone and muscle, salivary gland, tooth, periodontium, bone-periodontal ligament-cementum interface and osteochondral complexes such as the TMJ condyle. Imagining diagnostics to accelerate clinical implementation of reliable, reproducible, highly specific, and sensitive diagnostic instruments for various DOC applications.

Safe and effective biosensors for noninvasive, dynamic, real-time monitoring of physiological status in the human body using the oral cavity as the sensing site.

Methods, materials, and devices for orthodontic, prosthetic, periodontic, endodontic and craniofacial applications including those that can be used for bone distraction, reconstruction, hard and soft tissue healing, and regeneration, and scarless tissue repair of the craniofacial complex.

Microphysiological systems and organoids that can be adapted to high-throughput formats for a broad range of applications, such as analysis of biomaterial and tissue function, drug efficacy and toxicology assays, biocompatibility assays, genetic screening, and elucidating mechanisms of DOC development and disease.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) In addition to mission-relevant R01 projects, the NIAMS would specifically like to stimulate and promote research in building complex 3-dimensional in vitro human musculoskeletal and skin tissue models to study developmental biology, physiology, and disease pathogenesis of musculoskeletal tissues and skin as well as for drug discovery and toxicity studies.

NIAMS is not interested in applications that are developing 3D tissues for transplantation, or engineering non-human tissue models, or developing simple 3-D models that do not go significantly beyond those currently in use, such as human skin equivalents composed of only normal keratinocytes and fibroblasts.

National Eye Institute (NEI) The NEI supports a broad range of basic and clinical research, clinical trials, epidemiologic studies related to health and disease in the eye and visual system. Research proposed should address a significant aspect of the leading causes of blindness and impaired vision, mechanisms of visual function, preservation of sight, or the special health problems and requirements of the blind.

National Cancer Institute (NCI) The NCI leads, conducts, and supports cancer research across the nation to advance scientific knowledge and help all people live longer, healthier lives.

As the leader of the cancer research enterprise, collectively known as the National Cancer Program, and the largest funder of cancer research in the world, NCI manages a broad range of research, training, and information dissemination activities that reach across the entire country, meeting the needs of all demographics rich and poor, urban and rural, and all racial/ethnic populations.

Examples of technologies that are of interest to NCI include, but are not limited to: That assess the fit-for-purpose of biospecimens: determine the effects of collection, handling, processing, and storage on molecular and cellular components of interest; For quantitative and qualitative measurement of molecular and cellular markers of cancer risk, causation, and risk modification- specifically the technologies that address preanalytic factors and optimized to work with non-invasive, minimally invasive or archived samples collected from multiple populations to enable high throughput analysis at scale; For automated sample preparation for -omic analysis, and advanced multiplex and biosensor technologies for multiomic analysis Portable non-sequencing based multiplex genotyping assays; That measure cancer-relevant exposures, and molecular and cellular markers of exposures including human and microbial metabolites associated with cancer; Computational and AI strategies intended for predicting cancer-relevant exposures or history of human exposures- based on host response including immune response, pathologies, molecular markers, and metabolites to inform basic and translational studies; For advanced multiplex high-throughput technologies and biosensors for measuring natural anti-tumor immunity, immuno- genotyping and phenotyping Blood immune cell and molecular profiling; To monitor cancer treatment-related adverse events; Wearable devices and biosensors to monitor lifestyle factors and cancer-relevant exposures; At-home, high sensitivity and specific point-of-care or point-of-need cancer risk or prognostic tools; Innovative tools intended for disseminating information such as risk, and cancer-related health outcomes to different population group; Synthetic biology devices to advance understanding of cancer biology with a goal of improving cancer diagnosis and treatment; Nanotechnologies capable of biological discovery; Tools to enable deep tissue ex vivo and in vivo imaging and integration; Next-generation non-invasive cancer molecular diagnostics platforms beyond tissue biopsies; In vitro imaging diagnostic technologies; Liquid biopsy technologies with the goal of improving cancer diagnosis and treatment; Technologies for the detection and evaluation of cancer of unknown primary (CUP); Technologies for neoantigen identification, including dendritic cell-displayed antigens and neoantigens; and Engineered biomaterials that display, detect, or respond to physiologically-relevant properties of tumors or the tumor microenvironment.

National Institute of Neurological Disorders and Stroke (NINDS) Within the goals of this FOA, NINDS is particularly interested in bioengineering research that advances technologies directly related to the nervous system and its disorders.

Examples of areas of interest include the development and validation of invasive and non-invasive devices, diagnostic/monitoring tools, advanced imaging techniques, computational models, tissue engineering, and other innovative methods directly related to reducing the negative impact of neurological disorders and stroke. Applicants are strongly encouraged to contact NINDS Scientific Program staff prior to submission.

Applicants interested in translational activities of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems may be more appropriate for other NINDS translational research opportunities ( Translational Devices | National Institute of Neurological Disorders and Stroke (nih. gov) ). Applications Not Responsive to this FOA The following types of studies are not responsive to this FOA.

Applications proposing such studies will be considered non-responsive and will not be reviewed: Applications that do not seek to demonstrate feasibility and/or potential utility of new capabilities or improvements for solution of problems in basic biomedical, pre-clinical, or clinical research, clinical care delivery, or accessibility will be considered nonresponsive to this funding opportunity announcement, for example: Pursuit of a biological or clinical hypothesis where no technology development is proposed; Using existing technologies that do not need modifications or adaptations to answer a biomedical question; and Traditional biological hypothesis-driven research using unmodified existing technologies.

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 FOA.

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.

Application budgets are not limited but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum award period is 5 years depending on the policy of each NIH Institute.

Applicants are encouraged to review the current funding policy of each NIH Institute. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA. 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 Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and 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 his/her 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 FOA 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 2. 3.

7. 4 Submission of Resubmission Application . This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ) Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement 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. All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. 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. 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.

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 and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

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 SF424 (R&R) Application Guide must be followed, with the following additional instructions: The Research Strategy should clearly address the purpose of this FOA and indicate: How the technology developments being proposed address unmet needs or unaddressed problems in human health, decrease in disparities, or increase access to care; How the proposed approach will use the concepts from engineering, physical science, computational, or other multidisciplinary methods to address the biomedical problem identified in the application; A coherent plan to advance the solution, which may include a long-term intent to translate, disseminate or otherwise promote adoption and use by potential end-users; Quantitative benchmarks for success; and Anticipated risks and limitations.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. The following modifications also apply: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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 Policy on Late Application Submission. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E. O.

12372) This initiative is not subject to intergovernmental review. All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement .

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 fieldof 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 FOA 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 NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy . Any instructions provided here are in addition to the instructions in the policy. Section V.

Application Review Information Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review. 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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?

How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training?

If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the