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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The NIH Research Evaluation and Commercialization Hub (REACH) program will accelerate the creation of small businesses and the transition of discoveries originating from academic research into products that improve patient care and enhance health. REACH Hubs foster the technology development and commercial availability of therapeutics, preventatives, diagnostics, devices, and research tools that address unmet patient and public health needs across the entire NIH mission. Applicants are encouraged to focus on building robust entrepreneurial ecosystems in the areas of highest U.S. burden of disease and disability and areas that historically attract lower levels of private biomedical capital investment. This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite applications from eligible organizations to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.

The REACH program will function as a Phase 0 Proof-of-concept Partnership pilot program in accordance with Section 5127 of the 2011 SBIR/STTR Reauthorization Act (P.L. 112-81) and reauthorized through FY2031 by Section 10 of the Small Business Innovation and Economic Security Act of 2026 (P.L. 119-83). The program aims to strengthen and de-risk technology development projects through a team-based approach that addresses downstream requirements and provides access to product development and commercialization expertise (scientific, regulatory, reimbursement, business, legal, intellectual property, project management, market research, manufacturing, and commercialization). 

Candidate technology development projects should have moved beyond scientific discovery into the early stages of product development. As a guiding principle, projects should focus on a potential commercial product that requires additional research, development, or validation to demonstrate feasibility and proof of concept, positioning it to become competitive for a Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) award. Although every technology development project is unique, broad guidelines for different types of projects are as follows:

• Small Molecule Therapeutics: The compound is at the lead optimization or preclinical stage. The target is known, and/or there is some method or assay to determine its effect.
• Biologics or Cell Based Therapies: The biologic or cell population has been identified and some reasonable method of development, sourcing, manufacture, or proliferation is proposed. Mechanism of action has been determined to a sufficient level that there is a reasonable understanding of the product to be developed or tested in the project.
• Interventional Medical Device: Physiologic experiments have been conducted or reported in the literature, providing rationale for prototype development. The proposal includes prototype development and testing, either on the bench or in animals. 
• Diagnostic Medical Device/IVD/MDx: The proposal includes prototype development and some method of testing.
• Research Tools: The tool should address a clear unmet research need or demonstrate commercially meaningful differentiation with alternative methods. The proposal should include measurable technical endpoints and validation. 
• Health IT, Software, Apps, and Algorithms: The project should be beyond the concept stage with an existing prototype or code base supported by prior evidence. The proposal should include measurable technical endpoints and validation to demonstrate efficacy, utility, usability, or readiness for commercialization.

The Hubs will establish novel partnerships, strengthen existing alliances between stakeholders (including academic, non-profit, and industry sectors), provide entrepreneurial educational opportunities for innovators, and create cultural and systemic changes to more rapidly transform breakthrough innovations into products that will have health, economic, and societal impact.

The new REACH Hubs are expected to apply what has been learned from prior NIH proof-of-concept programs (https://seed.nih.gov/portfolio/reach#publications) to train innovators and help promising academic technologies advance efficiently toward SBIR/STTR competitiveness, small business formation, follow-on investment, and commercial translation.

Objectives for this NOFO

Each Hub will assemble a group of experts in biomedical product development and will have the expertise to identify and source technology development projects that have progressed to a point where a potential commercial product can be envisioned, but additional research and development efforts are required to define the product (demonstrate feasibility and proof-of-concept). Through a combination of in-house efforts and collaboration, each Hub funded under this NOFO will perform functions to address the critical knowledge and funding gaps that hinder the early steps needed to turn novel discoveries into products with health, economic, and societal impact. The work supported by the REACH Hubs should include technical validation, facilitating business development opportunities, clarifying intellectual property and identifying barriers to entry, performing market research (including market needs and competitive advantages), and clarifying regulatory, manufacturing, clinical, or payer requirements.

Because REACH aims to strengthen local training and infrastructure that support lab-to-market translation, funding preference will be given to applications from states and territories that have historically received low levels of NIH funding - specifically, Institutional Development Award (IDeA)-eligible states and territories.

Applications Not Responsive to this NOFO

The following types of applications are not responsive to this NOFO and will not be reviewed: 

• Applications with businesses as the primary applicant organization
• Applications where the primary applicant organization is a previous recipient of NIH Centers for Accelerated Innovations (NCAI) and REACH awards

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 - Includes all types

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

Nonprofits Other Than Institutions of Higher Education

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

The primary applicant organization must be a university or other research institution that participates in the NIH STTR program. Participation means that a university or other research institution has been a formal partner to a small business on an STTR award. Many NIH-supported universities or other research institutions will be eligible. Please contact the Scientific/Review staff listed below for clarification.

Preference will be given to applications from a primary applicant organization that is a university or other research institution in an IDeA-eligible state.

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not 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. Foreign organizations must obtain a NATO Commercial and Government Entity (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. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

Cost Matching: Cost matching of $250,000 per year is encouraged. However, the amount will not impact the evaluation of the application.  Institutions should document their actual contributions to the project and describe the organization(s) commitment to providing the funds for the duration of the award.

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:

Research Strategy
Provide the overall objectives of the Hub, including the short and long-term goals. Identify the challenges facing the Hub's entrepreneurial ecosystem and how the award will mitigate those obstacles. Describe how the Hub's expertise, capabilities, partnerships, and resources will enable it to have a significant influence on accelerating the pace and increasing the probability of success for discoveries and innovations being developed into products that will have health, economic, and societal impact. Each of the following components should be addressed in the Research Strategy section using the headings 1-7 titled as noted for each.

1) Hub Leadership
Applicants should provide an administrative plan appropriate for effective Hub management. Hub leadership, including PD(s)/PI(s), should demonstrate the necessary operational, business, and scientific expertise, with a documented track record of success in transitioning biomedical technologies from research performing institutions to the next stage of commercialization.

2) Collaborations and Partnerships
Hubs should provide details on how they will establish and effectively manage the range of collaborations and partnerships with stakeholders (including academic, non-profit, and industry sectors) necessary to achieve the objectives of the NOFO. Examples of partnerships include, but are not limited to, other research institutions, business schools, state economic development agencies, local incubators or accelerators, private sector investment institutions/organizations, clinical research organizations, or other existing programs accessible by the Hub.

Describe how the Hub will facilitate and promote interaction with existing institutional, local, virtual, and NIH or other federal, state, or local government programs. Describe the qualities and strengths that each partner brings to the Hub. Describe the anticipated role of the Hub in improving technology development and commercialization outcomes and rapid streamlined access to translational resources.

Applicants must indicate if they have an established and effective technology transfer or commercialization office and provide a plan for engaging that office in the program's implementation. The technology transfer or commercialization office should enable the best path forward for technologies developed with REACH funding. Applicants should provide information on the intellectual property strategy and how intellectual property will be managed. Use or development of standardized, simplified institutional agreements to streamline interactions and decrease barriers to technology transfer and commercialization is strongly encouraged. Any agreements designed to reduce the burden of licensing and hurdles to downstream commercialization of technologies should be described. If applications contain multiple partnering research institutions for sourcing technology development projects, applicants must present a plan to ensure appropriate coordination and to facilitate licensing and technology transfer.

3) Regional and Local Impact
Applicants should describe their plans to address features of the institution and its local and regional environment that would allow the Hub to make a unique impact on small business development, entrepreneurial culture, and health disparities. Applicants should describe their plans to address local or regional needs in areas such as economic development, entrepreneurial education, research funding, disease burden, and health disparities. Hubs are strongly encouraged to partner with multiple educational institutions, particularly those that focus on education and training and have not been major recipients of past NIH research and development support.

4) Technology Development
Applicants must describe the infrastructure and processes the Hub will use to solicit, evaluate, select, fund, and support promising early-stage technology development projects with potential health, economic, or societal impact that might not otherwise receive proof-of-concept support.

Applicants must describe how they will establish a rigorous External Review Board (ERB) composed of local experts in translational and proof-of-concept research. The ERB should include expertise from industry, start-ups, investment, technology development, finance, business, and university technology transfer. Applicants must describe the process for establishing the ERB and the criteria and procedures it will use to evaluate candidate projects. Applicants must not contact or identify potential ERB members in the application.

Before REACH funds may be used, each Technology Development Project must be reviewed by NIH staff and confirmed to:

• Be at a stage of development consistent with the goals of this NOFO, as described in Section I; and
• Align with the NIH mission and priorities.

Applicants must demonstrate their ability to maintain a robust pipeline of candidate projects at an appropriate stage of development. The application must:

• Describe existing activities that foster the development of early-stage technologies across the NIH mission;
• Describe the breadth of the early-stage technology portfolio available to the Hub; and
• Present a plan for soliciting, selecting, funding, and supporting projects from innovators within the Hub's partner institutions, subawardee institutions, and other institutions in the Hub's research and development ecosystem.

Applicants must describe how the Hub will provide individual investigators with funding and access to translational resources, services, and product development and commercialization expertise. The proposed approach should be informed by and build upon the best practices, processes, and resources developed by the NCAI and REACH awardees (https://seed.nih.gov/portfolio/reach#publications), including through appropriate adaptation, enhancement, or expansion to meet the needs of the Hub and its research and development ecosystem. 

Federal support for each Technology Development Project may include up to $100,000 in direct costs from the award, supplemented by any amount from the Hub's non-federal matching funds. Each Hub is expected to select and fund at least five Technology Development Projects annually. Supported activities may include feasibility studies, validation, prototype development, and proof-of-concept studies. The application must also describe the full range of product development and commercialization expertise identified in Section I that the Hub will use to accomplish the goals of this NOFO.

5) Project Management
Applicants must describe how the Hub will develop and implement a milestone-driven, market-focused project management and oversight process for early-stage technology development. The process must support continuous assessment of each Technology Development Project against established milestones and enable timely, strategic decisions to continue, modify, pivot, provide additional resources to, or terminate a project and reallocate resources, as appropriate.

Recognizing that development needs will vary by technology type and stage, the innovator's experience, and the available product development resources, applicants must describe how the Hub will:

• Provide agile, individualized project management and assemble a package of resources, services, and expertise tailored to each project;
• Provide access to project managers with relevant life sciences or biomedical industry experience or formal project management training; 
• Assemble project teams with the industry, start-up, investment, technical, financial, business, regulatory, reimbursement, and other expertise needed to advance projects toward commercial potential; and 
• Track project milestones and use the REACH consortium's standardized technology development metrics to assess progress, inform go/no-go and resource-allocation decisions, and monitor participation in educational activities.

Salary support for project managers is considered part of the direct costs of the individual Technology Development Projects they support.

6) Educational Activities
Applicants must describe how the Hub will leverage and supplement local product development and entrepreneurial education, expertise, and resources to provide academic investigators at all career levels with the knowledge and hands-on experience needed to design and implement technology development projects and advance promising technologies toward commercialization. Educational activities should address pathways such as follow-on financing, formation of a start-up company, and technology licensing.

The application must describe plans to:

• Train innovators to assess the commercial potential of research discoveries and develop comprehensive product development and commercialization plans; 
• Provide focused, hands-on learning opportunities that enable scientists to engage directly in entrepreneurial and technology commercialization activities; 
• Recruit experienced entrepreneurs, scientists, and other qualified experts to provide mentoring, guidance, and practical training; 
• Provide access to forums, seminars, workshops, networking events, and related educational activities; and 
• Provide cross-disciplinary professional development in areas such as science, business, regulatory strategy, reimbursement, intellectual property, and financing to expose innovators to the range of activities required to translate discoveries into marketable products.
• Applicants must also describe outreach strategies for attracting and engaging innovators across all career levels, including individuals who may not otherwise have access to entrepreneurial training and commercialization resources. The plan must explain how the Hub will collect and use participant feedback to identify opportunities for improvement and enhance the effectiveness, relevance, and accessibility of its educational, mentoring, and networking activities.

7) Sustainability Plan
Sustainability specifically refers to the post-award durability of the principles, approaches, mechanisms, and resources developed or assembled over the course of the award. Applicants should describe how the capacity developed under their REACH award will endure at their institutions, including assimilation into existing or new innovation management strategies, academic entrepreneurship support functions, technology transfer or commercialization offices, and other supportive programs and policies at their institutions. The applicant's ability to secure at least $250,000 annually in matching funds will serve as evidence of institutional commitment and the Hub's potential to sustain its activities beyond the award period.

Letters of SupportApplicants must include documentation, if applicable, indicating:

• Institutional commitment to the program (Required).
• Support for the activities described in the sustainability plan (Required).
• Non-Federal Matching Funding (Optional, but highly encouraged): Hubs are encouraged to obtain $250,000 of non-federal funding each year of the award to support technology development projects. Sources of non-federal funding could include, but are not limited to, foundations, participating institutions, a state or local governmental body, investment firms, individual benefactors, or any combination of the above. Applicants should include details on non-federal funding and resources that have already been secured or are anticipated during the project period. Applicants should provide verifiable details on the sources of non-federal funding, including clearly itemizing the funding that will be secured, and indicate the total. If the fundraising efforts of the Hub are in progress at the time of submission, and/or if the third-party funding is contingent upon NIH selecting the application for funding, then such plans should be clearly described. Examples of adequate documentation of planned non-federal funding may include a letter of commitment or term sheet from the source of funds stipulating the terms of the proposed commitment/investment, although other forms of documentation may be considered. Additional documentation may be requested as part of the Just-in-Time (JIT) process.
• In-kind support from non-federal sources (Optional, but highly encouraged): In addition to securing non-federal funds for Technology Development Projects, applicants are encouraged to obtain in-kind contributions, such as personnel time, facilities, equipment, services, or other non-cash resources, to support Hub operations.

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 how relevant resources (e.g., training presentation slides or videos, template documents, best practice handouts, how and why go/no-go decisions are made, etc.) resulting from the award will be freely shared with the public.

 Other Plan(s): 

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

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

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

• Template or Sample Institutional Agreements: Template or sample institutional agreements to streamline interactions and decrease barriers to technology transfer and commercialization may be included in the Appendix. The role of such agreements should also be described in the Research Strategy.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form

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

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the  How to Apply – Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the  How to Apply – Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. 

The primary applicant organization must be a university or other research institution that participates in the NIH STTR program. Participation means that a university or other research institution has been a formal partner to a small business on an STTR award. The primary applicant organization cannot be a previous recipient of NIH Centers for Accelerated Innovations (NCAI) and REACH awards. 

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 4.1.36.

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 CSR, 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.

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO. 

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 National Advisory General Medical Sciences Council. 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.

Awarding institutes, centers, and offices may give priority to applications in the following areas: 

• Lead institutions in IDEA-eligible states

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.

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.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

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:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• 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.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

Under the NIH Grants Policy Statement, SBIR/STTR indirect costs are provided a maximum of 40% if the applicant does not have a formal Negotiated Indirect Cost Rate (NICRA). Companies that have an active approved indirect cost rate may apply their approved rate instead of the 40% ceiling. As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

In administering programs under this and all funding announcements, NIH prioritizes: 

• Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
• Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
• NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 

Not applicable

Recipients of SBIR and STTR funding may retain the rights to data generated during the performance of an SBIR or STTR award for up to 20 years after the award date, per the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive. Further information about SBIR and STTR data rights are enumerated in the Grants Policy Statement Section 18.5.5.2 Intellectual property. Data Management and Sharing Plan is not applicable for this NOFO.

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.

Evaluation of the program will be based on the REACH consortiums standardized metrics and any other relevant information collected by the awardees. Standardized metrics will include:

• Characteristics of the participants in educational activities and applicants for technology development project support:
  • Total number of participants
  • Innovator/trainee demographics
• Indicators of progression of technology development projects:
  • Product types, therapeutic areas, and stages of development
  • Maturation of technologies
  • Follow-on funding secured for further technology development
  • Start-up company formation
  • Licensing and option-to-license agreements
  • SBIR and STTR applications and awards
  • Regulatory milestones and approvals, including technologies in clinical testing and technologies in the market

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

NIGMS Small Business
Email: NIGMS_SmallBusiness@nigms.nih.gov

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

National Institute of General Medical Sciences (NIGMS)
Email: nigms_gab_sbir@nigms.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.

The SBIR and STTR Programs are mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) P.L. 102-564, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011), as reauthorized and extended under P.L. 114-328, Section 1834, P.L. 115-232, P.L. 117-183, and P.L. 119-83. The basic design of the NIH STTRProgram is in accordance with the Small Business Administration (SBA) SBIR and STTR Policy Directive.