Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:

1. NIH ASSIST
2. An institutional system-to-system (S2S) solution
3. Grants.gov Workspace

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) solicits applications from research partnerships formed by academic and industrial investigators to drive the development and speed the adoption of promising bioengineering tools and technologies that can address important biomedical problems for which insufficient or no solutions exist. The partners on each application will establish an inter-disciplinary, multi-institutional research team to develop these tools and technologies as robust, well-characterized solutions that fulfill an unmet need. Collaboration with an industrial partner is required. The use of engineering principles is encouraged to establish integrative, quantitative, and innovative bioengineering approaches to developing technologies that are capable of enhancing our understanding of life science processes or the practice of medicine. The intended outcome is technological innovations that deliver new capabilities which can realize meaningful solutions within 5 – 10 years. Developing a technology is expected to require innovation, but novelty in and of itself is not a primary requirement.

Background

For many years, the NIH has recognized that the application of principles and techniques from physics, mathematics, chemistry, computer sciences, and engineering can be used to solve significant biomedical problems, leading in turn to new understanding of biological processes, novel products, and innovative tools to improve health. Such solutions typically require inter-disciplinary, multi-institutional partnerships to combine strengths unique to each group to accelerate the development and adoption of promising bioengineering technologies. Moreover, it is essential to engage industry for the eventual broader application and adoption of the technologies and tools by end-users in the medical community to realize the full potential and bring the benefits of these technological innovations to patients.

Partnerships expand access to a range of resources and facilitate problem-solving from initiation through validation, a Federally required approval process, to market delivery and clinical use. For example, technology testing and validation often require specialized animal research facilities and/or clinical settings with patients and clinical expertise. These resources are common in many academic settings, but unusual for most industrial environments. Academic investigators may also experience barriers. They often focus on the discovery phase of an invention with the typical priorities set on the demonstration of feasibility (a proof of principle studies) and publication of their findings. The tasks of robust system engineering and validation studies that would eventually lead to a broader application and acceptance of the technologies by end-users in the medical community are usually considered to be part of product development process. Moreover, by establishing the academic-industrial team, combined diverse expertise and points of view of the participants become a unique resource that may considerably facilitate and accelerate solving diverse problems associated with the inception and development of new ideas. The partnership model is expected to more readily overcome various barriers to accelerating the development and adoption of promising tools and technologies faced by either academia or industry working alone.

Objectives

The primary objective of this NOFO is to support Bioengineering Partnerships with Industry (BPI) to: 1) establish a robust engineering solution to a problem in biomedical research or the practice of medicine; 2) develop a strategic alliance of multi-disciplinary partners, one of which must be an industrial partner, based on a well-defined leadership plan; and 3) realize a specific endpoint and deliverables within 5-10 years based on a detailed plan with a timeline and quantitative milestones.

A distinguishing feature of this NOFO will be the requirement of an appropriate academic-industrial partnership: a strategic alliance of academic and industrial investigators who work together as partners to identify and translate a technological solution to advance human health. These partnerships are expected to solidify pre-existing collaborations or spur the creation of new collaborations to drive the fields of bioengineering and biomedical imaging further than if they had not been formed.

Achieving the goal of the BPI program will likely require leveraging the expertise of engineering and the life, physical, or computational sciences. Engaging clinical researchers or clinician scientists in the relevant biomedical fields, when appropriate, is strongly encouraged, although not required.

Scope of the Program

Projects proposed in response to this NOFO must propose to accelerate the development and adoption of promising, integrative, and quantitative bioengineering tools and technologies as robust, well-characterized solutions that can address an important and unmet biomedical need. Projects may span the development in the research settings, validation, translation into clinical settings as needed, and incorporation of these solutions as endpoints into research protocols to enhance our understanding of life science processes or the practice of medicine to benefit patients.

Funding may be requested to develop, adapt, enhance, optimize, validate, or otherwise accelerate the adoption of promising biomedical engineering solutions, but not for support of commercial production or later stage (Phase II or Phase III) clinical trials.

A project may bring together new or existing technologies to form creative and practical solutions that have the potential to be widely adopted and improve human health. To deliver practical solutions within the time-frame of 5-10 years, applicants are encouraged to use a design-directed research strategy with well-defined end goals and intermediate, quantitative milestones. Goals may include, but are not limited to, establishing proof of concept, pre-commercial prototype production, licensure, release of software packages, designs, or models, demonstrating the biological effectiveness of engineered constructs, elucidating the structural and functional relevance of biomolecules or tissues, first-in-human testing, or starting the investigational device exemption or investigational new drug process.

Key to this NOFO is the required partnership with industry, which typically consists of partners from multiple institutions or multiple departments from the same institution and industrial partners, with each partner bringing critical strengths to the project.  Both the academic and industrial partners are expected to provide substantive contributions to the intellectual or technical aspects of the project. The roles of the industrial partner(s) should be clearly differentiated from team members who supply necessary but not unique components for the project.  The team may require experience in technology development, appropriate model systems for validation, human factors research, regulatory approval, project management or commercialization to realize and disseminate a robust solution. Potential beneficiaries should be active participants in the partnership from the beginning, to provide assurance that proposed solutions will meet community needs. Partnerships with companies and industrial partners that have relevant expertise or may eventually engage in future commercialization or with organizations that can test and disseminate technologies are encouraged.

To be responsive to this FOA, application must include an academic-industrial partnership. Applications that do not include an academic-industrial partnership will not go forward to peer review. Additionally, projects must be consistent with the mission of one or more of the NIH Institutes or Centers (ICs) participating in this NOFO. Investigators are strongly encouraged to contact the Scientific/Research contacts identified in this NOFO to discuss the scope and relevance of their proposed project and guidance on the development of appropriate goals and milestones.

Institute statements of interest:

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological function or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to contact the appropriate Program Director in their scientific program area of interest (https://www.nibib.nih.gov/research-funding)to determine if their research fits within the NIBIB mission.

NIBIB Guidance for Support of Clinical Trial Applications

NOTE: For this Notice of Funding Opportunity, if an application proposes a clinical trial NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications". Briefly, NIBIB will only support mission-focused (see NIBIB's program areas) early stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development. 

Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this NOFO for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies (https://grants.nih.gov/policy/clinical-trials.htm) and consistent with the types of clinical trial applications that NIBIB supports.

Prior to funding an application, NIBIB program staff will contact the applicant to discuss the proposed timeline and go-no go milestones and any changes suggested by the review panel or program staff. A final timeline and approved milestones will be specified in the Notice of Award. Progress toward achieving the milestones will be evaluated by NIBIB program staff. Program staff may involve independent consultants or subject matter experts with relevant expertise. If justified, future milestones may be revised based on data and information obtained during the previous project period. If a funded project does not meet the milestones, funding for the project may be discontinued.

National Institute on Aging (NIA)

NIA is interested in applying bioengineering approaches to studies of brain aging and Alzheimer's Disease and AD-Related Dementias (AD/ADRD). As described in the AD/ADRD Research Implementation Milestones based on recommendations from the NIH AD/ADRD Research Summits, NIA is interested in supporting research aimed at enabling technologies and AD/ADRD monitoring. This includes studies of wearable technologies, high frequency data capture platforms to enable continuous monitoring of research participants, technologies to capture environmental exposures, and methods for monitoring individuals at all stages of AD/ADRD progression to better understand the collective influence of biological, environmental, and behavioral and social factors on aging and AD/ADRD. NIA is also interested in supporting research on standardized diagnostic screening of MCI and dementia, technologies to prevent/slow cognitive decline, practical applications of innovative technologies to support people living with AD/ADRD and their caregivers (telemedicine GPS, robotics, and social networking), biosensors and prosthetic devices to improve physical function, new technologies for sleep disorders in older persons, improved imaging technology to visualize neural activity during cognitive behavior in older adults, and development of high-throughput measuring and monitoring of neural function in 3D or organoid cultures of human brain cells.

NIA is also interested in potential applications of novel imaging and bioengineering technologies and associated computational and display tools to the biology of aging, aging systems design, and age-related changes and diseases. Additionally, NIA seeks to promote imaging of any of the pillars or hallmarks of aging which include protein homeostasis, nuclear and DNA integrity, metabolism and mitochondrial quality control, cellular senescence, autophagy and cell death, and other proposed hallmarks as described in the literature. More specifically, NIA is interested in applications that compare unperturbed to altered aging, where the comparison is between whether there is an intervention that may include any of the numerous pharmacological, genetic, dietary and/or exercise interventions or other experimental paradigms that alter the apparent rate of aging. This may also be considered in the context of human populations, where possible, with a special interest in health disparities, comparisons among groups within the human population covering a range of multi-morbidities, the known progeroid syndromes or existing well-controlled study cohorts where there are rigorous data on health and behaviors. NIA is also interested in the application of imaging of aging to test whether short-term manipulations can be effective surrogates for longer-term studies of aging (e.g., acute versus chronic low-level stressors).

NIA also encourages small businesses developing technologies for the development and testing of innovative technologies that address aging and/or AD/ADRD. Clinical trial applications involving behavioral interventions are expected to be guided by the NIH Stage Model for Behavioral Intervention Development.

National Eye Institute (NEI)

The National Eye Institute (NEI) supports a broad range of basic, translational and clinical research related to the health and disease of the eye and visual system. Research proposed should focus on the development of tools, novel therapies, or diagnostics for the treatment of visual system diseases and disorders. NEI will only support clinical trial applications for this FOA that fulfill the NIH requirements for either a mechanistic or minimal risk trials. A mechanistic trial is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. A minimal risk trial is one in which the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

National Cancer Institute (NCI)

NCI is interested in the translation of scientific discoveries and engineering developments into methods or tools that address problems in basic cancer research for the purpose of advance the understanding of cancer biology; or in applied cancer research for assessment of cancer risk, cancer prevention, diagnosis, treatment and/or disease management.

Examples of focused research areas include, but are not limited to:

• In vitro and in vivo imaging technologies
• Liquid biopsy technologies that are focused on known and emerging molecular and cellular entities in liquid biopsy for improving cancer detection, diagnosis and treatment, monitoring treatment response, assessing cancer risk, risk of recurrence, prognosis, and minimal residual disease
• Technologies for the detection and evaluation of cancers of unknown primary
• Technologies for neoantigen identification, including circulating dendritic cell-displayed antigens and neoantigens.
• Advanced technologies for circulating neoantigen-specific immune repertoire profiling
• Technologies to evaluate metastatic potential of circulating hybrid cells

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized).

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

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.

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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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).

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.

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.

Other Attachments: Applicants are required to include a Leadership Plan. For applications that do not utilize Multiple PDs/PIs, this item must be uploaded as a separate attachment in pdf format with a filename that corresponds to the item (Leadership Plan). For Multiple PD/PI applications, the Leadership Plan should be uploaded using the Multiple PD/PI Leadership Plan attachment on the PHS 398 Research Plan form. Applications lacking this required item will be deemed incomplete and will not be reviewed.

The Leadership Plan is limited to 6 pages.

Leadership Plan: All applications are required to develop a strategic alliance of multi-disciplinary partners, one of which must be an industrial partner, based on a well-defined Leadership Plan. As part of the Leadership Plan, applicants are encouraged to build collaborations and partnerships among allied quantitative and biomedical disciplines. An organizational structure that clearly defines the partnership and relationships among the various components must be described in the Leadership Plan and illustrated in an organizational chart. This plan should also describe the governance and organizational structure of the leadership team and the research project, including communication plans, processes for making decisions on scientific direction, intellectual property, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators, including clear descriptions regarding the roles of the industrial partner(s). For publications, policies to address the ordering and recognition of authors, and decisions about what material to publish, consistent with the interests of commercial partners (where applicable) should be presented. Under terms and procedures to be defined in the Leadership Plan, the partnership has the responsibility and authority to use BPI funds in the most productive way to achieve the goals defined at the time that the award is made. To accomplish these tasks, the PDs/PIs can adjust funding among BPI participants to support new partners or to reduce support to existing partners as needed. Plans for enhancing the abilities and opportunities for investigators to work across disciplinary boundaries should also be included.

SF424(R&R) Senior/Key Person Profile

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

Biographical Sketch. Indicate experience in project management as well as assessing and meeting stakeholder needs.

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:

Specific Aims: The problems to be addressed and the timeliness and appropriateness of the solution must be stated concisely. Key milestones, uniqueness of the team, and the expected outcomes of the project, if successful, should be described succinctly.

Research Strategy: As part of the Research Strategy, applicants are asked to address the following points:

Note for Applications Proposing the involvement of Human Subjects and/or Clinical Trials: Use the Research Strategy section to discuss the overall strategy, methodology, and analyses of your proposed research, but do not duplicate information collected in the PHS Human Subjects and Clinical Trial Information form. The PHS Human Subjects and Clinical Trial Information form will capture detailed study information, including eligibility criteria; inclusion of women, minorities, and children; protection and monitoring plans; and statistical design and power. You are encouraged to refer to information in the PHS Human Subjects and Clinical Trial Information form as appropriate in your discussion of the Research Strategy (e.g., see Section 2.4 Inclusion of Women, Minorities, and Children).

Significance: Briefly describe the area of bioengineering research that is the focus of the BPI. Explain why a multidisciplinary multi-institutional approach with both academic and industrial participations is needed to realize a solution. Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice by providing new capabilities to users. Critically evaluate existing knowledge and approaches that have been or are being applied in the area and specifically describe how the proposed BPI approach will advance the field.

Innovation: Describe the innovative features of the proposed project, based on a coherent plan that applies integrative, quantitative bioengineering approaches to accelerating the development and delivery of new capabilities to fulfill an unmet biomedical need, including through the integration of proven approaches. Describe how the project develops new or brings together existing technologies to form creative and practical solutions that have the potential to be widely adopted and improve human health. For this announcement, innovation is defined as the likelihood to deliver robust, well-characterized tools that can be used in the research or clinical settings to enhance our understanding of life science processes or the practice of medicine.

Approach: Describe the preliminary results upon which the technical feasibility for the approach is established so that any risks present can be mitigated using engineering and project management principles. The robustness and reproducibility of preliminary results should be described along with independent validation or replication of results if available. Alternative interpretations of preliminary data, including relevant literature in support or disagreement with the results, should be described. Compare proposed performance specifications with current practice, such as sensitivity, specificity, reproducibility, reliability, portability, throughput, operability by biological researchers or healthcare workers, potential research or clinical utility and cost of acquisition and operation as applicable. Details for making the performance of technologies sufficiently selective, sensitive, or otherwise appropriate for the identified problem should be supported with quantitative benchmarks. Describe the multidisciplinary nature (consisting of both academic and industrial entities) of the approach. An integrative systems approach or a design-driven approach and their appropriateness for the proposed project should be described, including plans for collecting, analyzing, interpreting, and archiving data. Potential technical challenges and possible alternative approaches to achieve the aims of the project should be discussed. If the proposed BPI research is closely related to ongoing research, explain how the research activities of the BPI will complement but not overlap with the existing research. For projects that pursue feasibility in humans, the approach should describe contact with appropriate regulatory bodies and milestones for achieving regulatory approval.

Project Milestones, Timeline and Deliverables: To deliver practical solutions within the timeframe of 5-10 years, applicants must include as part of the Approach Section well-defined end goals and intermediate, quantitative Milestones, a project Timeline and Deliverables. Include quantitative milestones that briefly proposes indicators of progress at critical junctures, a schedule of tasks and events including responsible personnel, and/or other evaluative criteria. For each milestone, provide details on methods, assumptions, experimental designs, and data analysis plans (if applicable) to permit a thoughtful evaluation of precisely what will be achieved throughout the duration of the project. Quantitative criteria for success in the milestones may also be used for making go/no-go decisions and this should be specified. Applicants are encouraged to discuss impediments that could require a revision to the research plan, milestones, or timeline, with a discussion of alternative approaches.

Specific deliverables should be clearly described, which may include, but are not limited to, establishing proof of concept, pre-commercial prototype production, licensure, release of software packages, designs, or models, demonstrating the biological effectiveness of engineered constructs, elucidating the structural and functional relevance of biomolecules or tissues, first-in-human testing, or starting the investigational device exemption or investigational new drug process.

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:

All applications, regardless of the amount of direct costs requested for any one year, should address a:

Data Sharing Plan.

The plan should include details for sharing raw (unreduced) data with other researchers who may wish to analyze them independently, and include plans for disseminating resources. Investigators are expected to be aware of and abide by all applicable NIH guidance for sharing of research resources and data, consistent with existing laws, regulations, and policies. Please see https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm

There is no prescribed sharing approach for software produced by a project. However, reviewers will be asked to comment on the adequacy and effectiveness of plans based on their likely impact. Program staff may negotiate modifications of software sharing plans with the PD/PI before making recommendations on funding of an application.

All applications should describe plans for disseminating the techniques and technologies to end-users. The plan should complement the research and development strategy, and may involve additional partnership with industry, professional organizations, or community engagement.

Letters of Support: To highlight the clinical applicability and anticipated dissemination of new technologies and methods, it is encouraged to include letter(s) of support from university-based tech transfer office(s); industrial supporters or collaborators in support of the commercialization of the academic Intellectual Property associated with the aims of the research.

Organizational structure and leadership plan:

The arrangements for collaborations must allow administration of the joint effort as a single project. Describe the overall organization, major tasks each partnering organization will complete, and what contributions each partner will bring to the effort. Describe the extent an award under this NOFO could advance the product or service far enough to attract sufficient, independent third-party financing and/or strategic partnerships in carrying out full commercialization. Include details on shared leadership, administration, cost sharing (if any), conflict resolution, as well as technical, pre-clinical and clinical responsibilities, as appropriate.

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

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the 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.

Foreign Institutions

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

Foreign Organizations

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.

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.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed. Applications lacking an academic-industrial partnership will not go forward to peer review.

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.

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

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.

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. 

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.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific review , in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. 

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

• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• None; all responsibilities are divided between recipients and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

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.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (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: support@grants.gov

Guoying Liu, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone:301-594-5220
Email: liug@mail.nih.gov

Leonid Tsap, Ph.D.
National Institute on Aging (NIA)
Phone: 301-402-7747
Email: tsapl@mail.nih.gov

Miguel R. Ossandon, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5714
Email:  ossandom@mail.nih.gov

Tony Douglas Gover
NEI - NATIONAL EYE INSTITUTE
Phone: 301-529-7370
E-mail: tony.gover@nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Katie Ellis
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4791
Email: kellis@mail.nih.gov

Jessi Perez
National Institute on Aging (NIA)
Phone: (301) 402-7739
Email: jessi.perez@nih.gov

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: Shane.Woodward@nih.gov

Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: kyr@nei.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.