Opportunity Information: Apply for PAR 21 314
Blueprint MedTech: Incubator Hubs (U54 Clinical Trial Not Allowed) is an NIH Blueprint for Neuroscience Research funding opportunity designed to stand up a national set of “incubator hubs” that help medical device innovators move neuroscience-related technologies toward human-grade prototype readiness. The program is structured as a cooperative agreement (U54), meaning awardees should expect substantial NIH involvement and active program coordination rather than a hands-off grant. The core aim is to build practical, well-managed infrastructure that can consistently identify promising device concepts and then support them with the kind of targeted resources that typically determine whether a device program advances or stalls, especially in the stage where a prototype must be suitable for eventual use in humans. As indicated by “Clinical Trial Not Allowed,” the supported activities are not intended to run clinical trials; the emphasis is on development, planning, de-risking, and prototype maturation rather than human subject efficacy testing.
The incubator hubs are expected to operate as a consortium and to function as the operational backbone of the Blueprint MedTech program. In practice, that means each hub is not just providing advice, but also coordinating services, standardizing processes, and managing a pipeline of projects across the program. The FOA highlights three main responsibilities. First, hubs will create and maintain infrastructure for identifying and selecting the most promising technologies, which implies building transparent intake, review, prioritization, and milestone tracking systems to decide which innovation projects should receive support. Second, hubs will distribute sub-award funding to innovators and pair that funding with concrete product definition resources, including needs assessments, product design work, and prototype development support. Third, hubs will ensure innovators have access to the right expertise at the right time, spanning scientific and engineering guidance as well as design, business development, and project management, reflecting an expectation that hubs can help teams think through user needs, regulatory and commercialization considerations, and disciplined execution rather than only laboratory feasibility.
Timing and administrative context are also clear from the notice and source data. The opportunity is issued by the National Institutes of Health under the NIH Blueprint for Neuroscience Research umbrella, with multiple participating NIH Institutes and Centers. The funding opportunity number is PAR-21-314, categorized as a discretionary program and tied to multiple CFDA numbers (93.121, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867), reflecting the cross-institute nature of the Blueprint effort. The notice was created on 2021-08-20, with an original closing date listed as 2021-10-20. The description also explains that NIH provided this early notice to give applicants extra time to plan strong applications and build meaningful partnerships, while reserving the right to adjust final scope, objectives, and requirements in the official FOA.
Eligibility is broad across U.S.-based organizations that can credibly run an incubator hub and manage subawards and services. Eligible applicants include state and county governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those categories as specified); for-profit organizations other than small businesses; small businesses; and other entities. The notice explicitly calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, TCCUs, eligible federal agencies, and U.S. territories or possessions. Non-domestic (non-U.S.) entities are not eligible to apply, which reinforces the expectation that hubs will be grounded in U.S. infrastructure, U.S. device development ecosystems, and the operational context relevant to eventual translation and deployment. Award ceiling and expected number of awards are not specified in the provided source, so prospective applicants would need to rely on the published FOA for budget limits, consortium structure expectations, and the precise performance metrics NIH will require.Apply for PAR 21 314
- The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Blueprint MedTech: Incubator Hubs (U54 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): 93.121, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867.
- This funding opportunity was created on 2021-08-20.
- Applicants must submit their applications by 2021-10-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), 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.
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Frequently Asked Questions (FAQs)
1) What is the Blueprint MedTech: Incubator Hubs (U54 Clinical Trial Not Allowed) opportunity?
It is an NIH Blueprint for Neuroscience Research funding opportunity to establish a national set of "incubator hubs" that help medical device innovators advance neuroscience-related technologies toward human-grade prototype readiness. The award mechanism is a cooperative agreement (U54), and the focus is on development and de-risking activities rather than running clinical trials.
2) What is the main goal of this program?
The main goal is to build practical, well-managed hub infrastructure that can consistently identify promising neuroscience device concepts and support them with targeted resources that help programs advance through prototype maturation, especially the stage where a prototype must be suitable for eventual use in humans.
3) What does "U54 cooperative agreement" mean for awardees?
A U54 cooperative agreement means awardees should expect substantial NIH involvement and active coordination. This is not a hands-off grant; NIH is expected to be meaningfully involved in program execution and oversight.
4) Are clinical trials allowed under this opportunity?
No. The opportunity is explicitly labeled "Clinical Trial Not Allowed." Supported activities are intended for development, planning, de-risking, and prototype maturation rather than human subject efficacy testing.
5) What kinds of activities are expected to be supported if clinical trials are not allowed?
Based on the description, supported activities emphasize product and program advancement steps such as needs assessment, product definition, product design work, prototype development support, milestone planning, and other work that prepares a technology for eventual human-use readiness without conducting clinical trials.
6) What are "incubator hubs" expected to do in this program?
The hubs are expected to function as the operational backbone of the Blueprint MedTech program and operate as a consortium. They are expected to coordinate services, standardize processes, and manage a pipeline of projects across the program rather than only providing advice.
7) What are the three main responsibilities described for the hubs?
The description highlights three main responsibilities: (1) create and maintain infrastructure for identifying and selecting promising technologies (including intake, review, prioritization, and milestone tracking); (2) distribute sub-award funding to innovators and pair that funding with product definition resources such as needs assessments, design work, and prototype development support; and (3) ensure innovators can access the right expertise at the right time across scientific, engineering, design, business development, and project management domains.
8) What does it mean that hubs must create infrastructure for "identifying and selecting" technologies?
It implies the hubs should build transparent systems for intake and evaluation of project ideas, structured review and prioritization processes, and milestone tracking to decide which innovation projects receive support and how their progress is managed over time.
9) Will hubs provide funding directly to innovators?
Yes. The hubs are expected to distribute sub-award funding to innovators and combine that funding with practical support services that help define and develop the product and prototype.
10) What types of non-funding support should hubs provide to innovators?
The description indicates support should include product definition resources (for example, needs assessments, product design work, and prototype development support) and access to expertise spanning scientific and engineering guidance, design, business development, and project management.
11) Does the program expect hubs to help with commercialization and regulatory planning?
Yes, in the sense that hubs are expected to help teams think through user needs and regulatory and commercialization considerations, alongside disciplined project execution. The emphasis is on preparing technologies for translation rather than limiting support to laboratory feasibility.
12) Who is the issuing agency and what broader initiative is this under?
The opportunity is issued by the National Institutes of Health (NIH) under the NIH Blueprint for Neuroscience Research umbrella, with multiple participating NIH Institutes and Centers.
13) What is the funding opportunity number (FOA number)?
The funding opportunity number is PAR-21-314.
14) What administrative or catalog identifiers are associated with this opportunity?
The opportunity is described as a discretionary program and is tied to multiple CFDA numbers: 93.121, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867. These identifiers reflect the cross-institute nature of the NIH Blueprint effort.
15) When was the notice created and what closing date is listed?
The notice was created on 2021-08-20, and the original closing date listed is 2021-10-20.
16) Why did NIH provide an early notice for this opportunity?
The description states NIH provided the early notice to give applicants extra time to plan strong applications and build meaningful partnerships.
17) Can NIH change the final program scope or requirements?
Yes. The notice indicates NIH reserved the right to adjust final scope, objectives, and requirements in the official FOA.
18) Who is eligible to apply?
Eligibility is broad across U.S.-based organizations that can credibly run an incubator hub and manage subawards and services. Eligible applicants include state and county governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those categories as specified); for-profit organizations other than small businesses; small businesses; and other entities.
19) Are any specific institution types explicitly called out as eligible?
Yes. The notice explicitly calls out eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, TCCUs, eligible federal agencies, and U.S. territories or possessions.
20) Are non-U.S. (non-domestic) entities eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply.
21) Is this opportunity only for universities, or can companies apply?
It is not limited to universities. The eligibility list includes for-profit organizations other than small businesses, small businesses, nonprofits, and government entities, in addition to institutions of higher education.
22) Does the provided information specify the award ceiling or the expected number of awards?
No. The award ceiling and expected number of awards are not specified in the provided source information. Applicants would need to consult the published FOA for budget limits, expected awards, and detailed consortium structure and performance expectations.
23) What does it mean that hubs will operate as a consortium?
It means hubs are expected to work together as a coordinated network, aligning processes and services and collectively supporting a pipeline of projects across the Blueprint MedTech program, rather than operating as isolated sites.
24) What stage of technology development is emphasized by this opportunity?
The emphasis is on moving neuroscience-related medical device technologies toward human-grade prototype readiness, focusing on the development and maturation steps that often determine whether a device program advances or stalls.
25) If a project involves human testing, can it be supported under this award?
The opportunity states "Clinical Trial Not Allowed," and the described emphasis is on development, planning, de-risking, and prototype maturation rather than human subject efficacy testing. Based on the provided information alone, projects should be structured to avoid clinical trial activities under this award.
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