Opportunity Information: Apply for RFA OD 19 014
The NIH Research Evaluation and Commercialization Hubs (REACH) Awards opportunity (RFA-OD-19-014) is a cooperative agreement program designed to help close the gap between promising biomedical discoveries and products that can realistically reach patients. NIH’s aim is to fund five REACH “hubs” that can identify, evaluate, and advance early-stage innovations into commercially viable diagnostics, devices, therapeutics, and research tools. The focus is on overcoming the common barriers that stall translation at the earliest stages, when projects often have strong scientific potential but are not yet mature enough in product definition, validation, regulatory planning, reimbursement strategy, manufacturing feasibility, or business development to attract private investment or licensing partners.
This is a U01 cooperative agreement, meaning awardees should expect substantial NIH involvement compared with a standard grant. Rather than simply funding isolated research projects, NIH intends for the five funded hubs to operate as a coordinated technology development consortium. In practice, that implies shared expectations around implementing proven “best practices” for translational acceleration, learning from prior pilot efforts, and aligning with the objectives of the Phase 0 Proof of Concept Partnership pilot program. The program is also explicitly tied to federal commercialization policy established in Section 5127 of the 2011 SBIR/STTR Reauthorization Act (P.L. 112-81) and its subsequent reauthorization through FY 2022 (referenced as H.R. 5515 Sec. 854). The underlying policy intent is to create structured, scalable pathways that move federally supported research outputs toward the marketplace in a responsible, public-benefit-driven way.
REACH hubs are meant to be more than funding conduits; they are expected to provide the kind of organized translational infrastructure that many academic and nonprofit settings lack. That typically includes disciplined project selection and milestone-based management, hands-on commercialization support, connections to industry expertise, and training opportunities that build a workforce skilled in translation and entrepreneurship. NIH frames this as aligned with broader federal research and development priorities, especially educating and training a 21st-century workforce, strengthening technology transfer from laboratories to real-world use, and increasing productive partnerships among academia, industry, and other stakeholders in the national R&D enterprise.
The opportunity is broad in who can apply. Eligible applicants include many types of government entities (state, county, city/township, special district), schools and independent school districts, public and private institutions of higher education, federally recognized tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including those other than small businesses), and small businesses. This wide eligibility reflects the program’s hub model: a hub can be led by an academic institution, nonprofit, or other organization capable of assembling the right blend of translational science, product development expertise, commercialization experience, and stakeholder engagement.
Key administrative details include an award ceiling of $1,000,000 and an expectation of five total awards. The awarding agency is the Department of Health and Human Services (HHS) through the National Institutes of Health (NIH). The FOA is categorized as discretionary funding and spans a range of NIH-related CFDA numbers, reflecting the cross-cutting nature of the program across multiple NIH institutes and centers. The posting indicates a creation date of December 17, 2018 and an original closing date of March 19, 2019, which is relevant for historical context and for locating the final FOA and associated application instructions, review criteria, and program-specific requirements.
A critical constraint is embedded in the title: “Clinical Trial Not Allowed.” Applicants should interpret that as the funded activities under this mechanism are not intended to support clinical trials. The emphasis is on preclinical, translational, and product-development-enabling work and on commercialization readiness activities, rather than human subject efficacy studies. Overall, NIH’s REACH Awards are structured to create regional or institutional hubs that can reliably de-risk early innovations, build strong development plans, and position technologies for licensing, startup formation, partnerships, or later-stage non-dilutive and private investment, ultimately aiming to accelerate improvements in patient care and public health.Apply for RFA OD 19 014
- The Department of Health and Human Services, National Institutes of Health in the education, environment, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "NIH Research Evaluation and Commercialization Hubs (REACH) Awards (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.350, 93.351, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.846, 93.847, 93.853, 93.855, 93.859, 93.865, 93.866, 93.867, 93.879.
- This funding opportunity was created on Dec 17, 2018.
- Applicants must submit their applications by Mar 19, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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NIH REACH Awards (RFA-OD-19-014) FAQ
What is the NIH REACH Awards opportunity?
The NIH Research Evaluation and Commercialization Hubs (REACH) Awards (RFA-OD-19-014) is a cooperative agreement program designed to help close the gap between promising biomedical discoveries and products that can realistically reach patients. It focuses on moving early-stage innovations toward commercially viable diagnostics, devices, therapeutics, and research tools.
What problem is this program trying to solve?
The program targets common barriers that often stall translation at the earliest stages, when a project may be scientifically strong but not yet ready to attract private investment or licensing partners. Examples of these early barriers include immature product definition, limited validation, lack of regulatory planning, weak reimbursement strategy, unclear manufacturing feasibility, and underdeveloped business development plans.
What does NIH plan to fund under REACH?
NIH’s stated aim is to fund five REACH “hubs” that can identify, evaluate, and advance early-stage innovations into commercially viable diagnostics, devices, therapeutics, and research tools. The emphasis is on organized translational infrastructure and commercialization readiness rather than isolated research projects.
How many awards are expected?
The opportunity indicates an expectation of five total awards.
What is the maximum award amount?
The listed award ceiling is $1,000,000.
What type of NIH funding mechanism is this?
This is a U01 cooperative agreement. In a cooperative agreement, awardees should expect substantial NIH involvement compared with a standard grant mechanism.
What does “substantial NIH involvement” mean in practice for this program?
Based on the description, NIH intends the funded hubs to operate as a coordinated technology development consortium rather than as standalone efforts. That implies shared expectations around implementing proven “best practices” for translational acceleration, learning from prior pilot efforts, and aligning with the objectives of the Phase 0 Proof of Concept Partnership pilot program.
Is this program intended to fund individual research projects?
The program is framed as funding hubs, not simply funding isolated research projects. The hubs are expected to run organized processes for selecting projects and advancing them through milestone-based development and commercialization-readiness activities.
What kinds of technologies are in scope?
The opportunity explicitly mentions diagnostics, devices, therapeutics, and research tools as the types of products and technologies the hubs should help move toward commercial viability.
What stage of development is this funding aimed at?
The focus is early-stage innovation, especially where projects are not yet mature enough in areas like product definition, validation, regulatory planning, reimbursement strategy, manufacturing feasibility, or business development to attract investment or licensing partners.
Are clinical trials allowed under this opportunity?
No. The title includes “Clinical Trial Not Allowed,” which indicates the funded activities are not intended to support clinical trials. The emphasis is on preclinical, translational, and product-development-enabling work and commercialization readiness activities rather than human subject efficacy studies.
If clinical trials are not allowed, what kinds of work are emphasized?
The opportunity emphasizes preclinical and translational development activities and commercialization readiness work. It highlights the need to strengthen product definition, validation planning, regulatory planning, reimbursement strategy, manufacturing feasibility, and business development so technologies can be positioned for licensing, startup formation, partnerships, or later-stage funding.
What is a REACH “hub” expected to do beyond distributing funds?
REACH hubs are described as more than funding conduits. They are expected to provide organized translational infrastructure, which typically includes disciplined project selection, milestone-based management, hands-on commercialization support, connections to industry expertise, and training opportunities that build a workforce skilled in translation and entrepreneurship.
How does NIH describe the broader goals of the hub model?
NIH frames the program as aligned with broader federal research and development priorities, including educating and training a 21st-century workforce, strengthening technology transfer from laboratories to real-world use, and increasing productive partnerships among academia, industry, and other stakeholders in the national R&D enterprise.
Who is eligible to apply?
Eligibility is broad and includes many types of government entities (state, county, city/township, special district), schools and independent school districts, public and private institutions of higher education, federally recognized tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including those other than small businesses), and small businesses.
Does the program require the hub to be led by a specific type of organization?
The description indicates a hub can be led by an academic institution, nonprofit, or other organization capable of assembling the right blend of translational science, product development expertise, commercialization experience, and stakeholder engagement.
Which federal agency is offering this opportunity?
The awarding agency is the Department of Health and Human Services (HHS) through the National Institutes of Health (NIH).
Is this discretionary funding?
Yes. The FOA is categorized as discretionary funding.
What CFDA number is associated with this opportunity?
The posting indicates the FOA spans a range of NIH-related CFDA numbers, reflecting that the program is cross-cutting across multiple NIH institutes and centers (rather than being tied to a single CFDA entry in the summary).
When was this opportunity posted, and what was the original due date?
The posting indicates a creation date of December 17, 2018 and an original closing date of March 19, 2019. This is useful for historical context and for locating the final FOA and associated application instructions and requirements.
How is REACH connected to other NIH or federal commercialization efforts?
The program is described as explicitly tied to federal commercialization policy established in Section 5127 of the 2011 SBIR/STTR Reauthorization Act (P.L. 112-81) and its subsequent reauthorization through FY 2022 (referenced as H.R. 5515 Sec. 854). It is also described as aligning with the objectives of the Phase 0 Proof of Concept Partnership pilot program.
What is the intended end result for technologies supported through REACH hubs?
The opportunity states that hubs should de-risk early innovations, build strong development plans, and position technologies for licensing, startup formation, partnerships, or later-stage non-dilutive and private investment, with the ultimate aim of accelerating improvements in patient care and public health.
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