RFA-OD-27-009-Full-Announcement.html

HTML file 140 KB Posted

Attached to
Limited Competition: NIH Research Evaluation and Commercialization Hubs (REACH) (SB0 Clinical Trial Optional)
Opportunity number
RFA-OD-27-009
Issued by

About this file

This is a Notice of Funding Opportunity (NOFO) for the NIH Research Evaluation and Commercialization Hubs (REACH) program under Funding Opportunity Number RFA-OD-27-009. The National Institute of General Medical Sciences (NIGMS) administers this limited competition on behalf of the NIH Office of the Director. The program aims to accelerate translation of academic biomedical discoveries into commercial products by establishing five academic entrepreneurship hubs that provide early-stage funding, technical resources, and commercialization mentorship. The application deadline is November 10, 2026, with scientific merit review in February 2027, advisory council review in May 2027, and earliest start date of June 2027. Applicants are encouraged to submit before the deadline to allow correction time.

Eligible applicants are higher education institutions (public and private), 501(c)(3) nonprofits, and non-501(c)(3) nonprofits that have been formal partners on NIH STTR awards. Previous recipients of NIH Centers for Accelerated Innovations (NCAI) and REACH awards are ineligible. Only one application per institution is permitted. The program offers up to $5 million per year for four years (maximum $1 million per year per hub), with an estimated total of $20 million funding up to five awards. Cost matching of $250,000 annually is encouraged but not required. Hubs must identify and fund at least five technology development projects annually at up to $100,000 per project in direct federal costs, supplemented by non-federal matching funds. Applications must address hub leadership, collaborations and partnerships, regional impact, technology development infrastructure, project management, educational activities, and sustainability plans. Priority will be given to applications from IDeA-eligible states and territories. Funding preference will be given to applications demonstrating distinctive public-private partnerships and institutional commitment through documented matching funds. The NOFO is issued under CFDA numbers 93.310 (Trans-NIH Research Support) and 93.859 (Biomedical Research and Research Training).

RFA-OD-27-009-Full-Announcement.html

Text of this file

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH (OD)

National Institute of General Medical Sciences (NIGMS)

This Notice of Funding Opportunity Announcement (NOFO) is developed as the NIH Phase 0 Proof of Concept Partnership pilot program (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). All NIH Small Business Program (SBIR/STTR) Institutes and Centers participate in the NIH Research Evaluation and Commercialization Hub (REACH) program. The NOFO will be administered by the National Institute of General Medical Sciences (NIGMS) on behalf of the NIH.

Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title

Limited Competition: NIH Research Evaluation and Commercialization Hubs (REACH) (SB0 Clinical Trial Optional)

Activity Code

SB0 Phase 0 Proof of Concept Partnership

Announcement Type

Reissue of

RFA-OD-23-005

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-OD-27-009

Companion Funding Opportunity

None

Number of Applications

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

Assistance Listing Number(s)

93.310, 93.859

Funding Opportunity Purpose

This Notice of Funding Opportunity (NOFO) announces the renewal of the NIH Research Evaluation and Commercialization Hub (REACH) program, established to facilitate and accelerate the translation of academic biomedical discoveries into products that improve patient care and public health. Through this program, NIH will provide the qualifying institutions with the funds to seed the creation of academic entrepreneurship Hubs. Hubs will be responsible for providing innovators with both the initial investment and resources to support the proof-of-concept work and the mentorship in product development and commercialization needed to develop high priority technologies within the NIH's mission. Funded Hubs are intended to work as a consortium to enable: (1) the infrastructure for identifying the most promising technologies, (2) funding for product definition studies (e.g. feasibility studies, prototype development, proof-of-concept studies) provided to individual researchers, (3) access to resources and expertise in areas required for early stage technology development (including scientific, regulatory, reimbursement, business, legal, and project management), and (4) skills development and hands-on experience in entrepreneurship. Establishing public-private partnerships and providing additional non-federal funds will be critical for success. 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.

Funding Opportunity Goal(s)

This listing covers multiple offices in the NIH Office of the Director that offer assistance awards or supplements to assistance awards.

Key Dates

Posted Date

September 24, 2026

Open Date (Earliest Submission Date)

October 10, 2026

Application Due Dates
Review and Award Cycles
New
Renewal / Resubmission / Revision (as allowed)
AIDS - New/Renewal/Resubmission/Revision, as allowed
Scientific Merit Review
Advisory Council Review
Earliest Start Date

November 10, 2026

Not Applicable

Not Applicable

February 2027
May 2027

June 2027

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.

Due Dates for E.O. 12372

Not Applicable

Expiration Date

November 11, 2026

Required Application Instructions

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

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

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Use the NIH ASSIST system to prepare, submit and track your application online.
Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

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

Funding Instrument

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

Application Types Allowed

New

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

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The participating Institutes and Centers intend to commit an estimated total of $20,000,000 to fund up to five awards, over 4 years at $5 million per year.

Award Budget

The maximum budget for a Hub is $1,000,000 total costs per year.

Award Project Period

The maximum project period is 4 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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.

Required Registrations

Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

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

3. Additional Information on Eligibility Number of Applications

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.

Instructions for Application Submission

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

SF424(R&R) Cover All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

SF424(R&R) Senior/Key Person Profile

R&R Budget

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

PHS 398 Cover Page Supplement

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

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.36.

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.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Scored Review Criteria

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

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

Specific to this NOFO:

Significance

How likely is the proposed Hub to accelerate the transition of academic discoveries into products, licenses, startups, SBIR/STTR applications, partnerships, or other appropriate next-stage commercialization outcomes?
To what extent does the application demonstrate that the proposed Hub will address a significant unmet need in the applicant's region or innovation ecosystem, including needs related to disease burden, health impact, economic development, entrepreneurial culture, research capacity, or linking academic innovations to private biomedical capital investment? How compelling is the sustainability rationale, including the likelihood that the capacity, partnerships, processes, educational activities, and resources developed through the award will endure beyond the project period?
Does the application propose distinctive or high-value public-private partnerships, regional collaborations, or institutional arrangements that are likely to improve technology development outcomes?

Innovation

How innovative and effective is the proposed Hub model in bridging academic discovery and commercial readiness, including its approach to identifying, evaluating, selecting, and advancing technologies with strong potential for health, economic, and societal impact and leveraging the full range of product-development and commercialization expertise?
How innovative are the proposed entrepreneurial education, mentoring, and hands-on training activities, particularly in preparing innovators to assess commercial potential, develop product development plans, engage stakeholders, and pursue next-stage funding or commercialization opportunities?
How strong is the rationale for the proposed Hub model, including the evidence that the applicant's technology portfolio, partner institutions, catchment area, and stakeholder network contain a sufficient number of promising technologies at an appropriate stage for REACH support?
Does the application propose novel or streamlined mechanisms, agreements, tools, templates, repositories, or dissemination strategies that could reduce barriers to technology transfer and be useful to the broader biomedical innovation community?

Factor 2. Rigor and Feasibility (Approach)

Specific to this NOFO:

Hub Operating Model and Governance

How well does the application describe an integrated Hub operating model with clear governance, leadership responsibilities, decision-making authority, communication processes, and coordination across Hub functions and partner organizations?
Are the proposed administrative and management processes appropriate for a complex technology-development program involving academic innovators, technology transfer offices, external experts, investors, industry partners, and other stakeholders?
How feasible is the plan for coordinating activities across participating institutions and supporting innovators both within and beyond the Hub's primary institution or subawardees?

Technology Pipeline, Solicitation, Review, and Selection

How strong is the plan to maintain a robust and diverse pipeline of candidate technology-development projects across the NIH mission that are at an appropriate stage for REACH support?
How rigorous, transparent, consistent, and well documented are the proposed processes for evaluating technical merit, unmet need, commercial potential, intellectual property position, regulatory pathway, reimbursement or payer considerations, market opportunity, competitive landscape, feasibility, and innovator readiness?
How appropriate is the proposed External Review Board or comparable review structure, including the range of expertise represented and its role in recommending projects for support?

Technology Development Support

How strong is the Hub's plan to provide comprehensive resources and expertise to conduct product definition studies, feasibility studies, prototype development, validation studies, proof-of-concept studies, market analyses, regulatory planning, reimbursement planning, intellectual property assessment, and business case development?
How well does the application describe the process for assembling individualized project-support teams with appropriate scientific, technical, business, regulatory, reimbursement, intellectual property, clinical, manufacturing, investment, and project-management expertise?
Are the proposed services appropriately tailored to the needs of different technology types, including therapeutics, biologics, devices, diagnostics, research tools, software, apps, algorithms, and health IT?

Milestone-Driven Project Management

How rigorous and practical is the proposed project-management approach for establishing milestones, monitoring progress, identifying risks, and making timely go/no-go, pivot, continuation, or resource-reallocation decisions?
Does the application describe clear criteria and processes for terminating or redirecting projects that do not meet milestones or no longer present a compelling commercialization opportunity?
Are the proposed project managers, advisory structures, meeting cadence, reporting processes, and accountability mechanisms adequate to support timely progress toward next-stage commercialization outcomes?

Evidence Generation and Lessons Learned

How likely are the proposed technology-development processes to generate reliable, reproducible, and decision-enabling data that can support product development, licensing, startup formation, SBIR/STTR applications, investment, or partnerships?
Are plans adequate to ensure appropriate study design, controls, data quality, analysis, interpretation, documentation, and reporting for supported technology-development projects?
How well will the Hub capture, analyze, and apply lessons learned from both successful and unsuccessful technology-development projects?

Entrepreneurial Education and Mentoring

How clear, concrete, and actionable is the plan for product development and entrepreneurial education, mentoring, and hands-on learning for innovators at multiple career stages?
How well do the outreach strategies promote broad access to educational activities across the Hub's institutional, local, regional, and partner ecosystem?
How rigorous is the plan to collect feedback from participants and continuously improve and enhance education and mentoring?

Partnerships, Evaluation, and Dissemination

How well does the application demonstrate access to appropriate stakeholder and user groups, including academic institutions, technology transfer offices, industry partners, investors, accelerators, incubators, economic development organizations, federal and state programs, clinical or research networks, and other translational resources?
Are the plans for collecting, analyzing, and reporting education and technology development metrics likely to support continuous improvement of the Hub?
How well does the application describe mechanisms for sharing resources, tools, templates, best practices, training materials, and lessons learned with the broader research and innovation community?

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

Investigator(s)
How strong is the PD(s)/PI(s), Hub leadership, and key personnel's documented track record (as appropriate for career stage) in biomedical product development and commercialization across the NIH mission?
For multi-PD/PI or multi-institutional applications, how strong is the leadership structure for coordination, accountability, communication, conflict resolution, and shared decision-making?
How appropriate is the expertise of proposed project managers, mentors, advisors, technology transfer personnel, and other contributors for supporting milestone-driven technology development projects and entrepreneurial education?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items while…

This is the start of the file's text. The full file is on GovTribe.

Other files

File Type Posted
PKG00294234.pdf PDF

On GovTribe

Work with this file

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

File details come from the government source that posted it. Updated .