Bioengineering Partnerships with Industry (U01 Clinical Trial Optional) | PAR 22 123

Opportunity Information: Apply for PAR 22 123

Bioengineering Partnerships with Industry (U01 Clinical Trial Optional) is a National Institutes of Health (NIH) funding opportunity that supports academic-industry research partnerships aimed at speeding up the development and real-world adoption of new bioengineering tools and technologies. The central idea is to bring together multidisciplinary teams that can combine engineering, quantitative analysis, and biomedical insight to create technologies that solve important biomedical problems, especially where there is a clear unmet need. Rather than funding early, speculative concepts alone, the program is geared toward moving promising technologies into robust, well-characterized solutions that other researchers, clinicians, or developers can actually use with confidence.

The FOA emphasizes integrative and quantitative bioengineering approaches, meaning projects are expected to do more than show a proof of principle. Teams should be working toward technologies that are engineered for performance and reliability, with careful characterization, validation, and clear benchmarks that demonstrate the tool is ready to be adopted beyond the original lab. The outcomes NIH is looking for include tools or platforms that can significantly improve how life science processes are studied or how medicine is practiced, such as enabling new types of measurement, manipulation, analysis, or intervention that were not previously feasible or practical.

This opportunity uses the U01 cooperative agreement mechanism, which generally means NIH anticipates being actively involved in the project in partnership with the awardee, for example through substantial programmatic involvement, coordination, and milestone-driven oversight. The Clinical Trial Optional designation indicates that applicants may propose a clinical trial if it is appropriate for the technology being developed, but a clinical trial is not required to be eligible. In practice, that flexibility allows projects to range from advanced preclinical development and validation through to carefully justified clinical evaluation when that is the logical next step for adoption.

The program’s time horizon is explicitly translational: it is intended to support technological innovations that deliver new capabilities and can plausibly lead to meaningful solutions within about 5 to 10 years. That framing encourages applicants to think in terms of realistic development pathways, adoption barriers, and the steps required to make a technology broadly usable, such as reproducibility, usability, manufacturability or scalability, quality controls, and fit within existing research or clinical workflows. Because the program is designed around partnerships with industry, applicants should expect that collaboration structures, roles, and contributions between academic and industrial partners will be important, including how the partnership accelerates development, de-risks adoption, and positions the technology for dissemination or commercialization when relevant.

Eligibility is broad. In addition to standard applicant types such as public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), small businesses, and various levels of government (state, county, city/township, special districts), the FOA also highlights eligibility for a wide range of mission-aligned institutions and organizations. These include Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, tribal governments (federally recognized) and tribal organizations (other than federally recognized). The announcement also notes that non-U.S. (foreign) entities may be eligible, which can be important for collaborations where specialized expertise, datasets, or development capabilities are located internationally.

Key administrative details from the source include the Funding Opportunity Number PAR-22-123, the NIH as the funding agency, and a discretionary funding category under education and health. The funding instrument is a cooperative agreement, and the associated CFDA/assistance listing numbers include 93.286, 93.394, 93.395, 93.866, and 93.867. The original closing date listed is 2025-01-07, and the posting (creation) date is 2022-03-08. Award ceiling and expected number of awards are not specified in the provided data, so applicants typically need to consult the full FOA text for budget limits, project period constraints, and any institute- or center-specific priorities.

Overall, this FOA is best understood as a development-focused NIH program for teams that can show a strong, practical path to building a bioengineering technology into a dependable, widely adoptable solution, with academic and industry partners working together to accelerate progress and shorten the gap between a promising prototype and a tool that can make a measurable difference in biomedical research or clinical care.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Bioengineering Partnerships with Industry (U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.286, 93.394, 93.395, 93.866, 93.867.
• This funding opportunity was created on 2022-03-08.
• Applicants must submit their applications by 2025-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

Apply for PAR 22 123

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: