Blueprint MedTech: Incubator Hubs (U54 Clinical Trial Not Allowed) | PAR 21 314

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.

• 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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