Bioengineering Research Partnerships (U01 Clinical Trial Required) | PAR 19 157

Opportunity Information: Apply for PAR 19 157

The National Institutes of Health (NIH) funding opportunity titled "Bioengineering Research Partnerships (U01 Clinical Trial Required)" (PAR-19-157) is a discretionary, health-focused cooperative agreement designed to speed up the creation and real-world adoption of promising bioengineering tools and technologies that tackle important biomedical problems. The core idea is not just to invent something new, but to move a technology far enough along that it becomes a dependable, well-understood solution that clearly fills an unmet need. NIH is looking for projects where the resulting tool or technology can materially improve how scientists study life processes or how medicine is practiced, meaning the expected outcomes should go beyond proof-of-concept and toward something robust, characterized, and broadly usable.

A defining feature of this FOA is the emphasis on partnerships and multidisciplinary, team-based work. Projects are expected to bring together bioengineers with biomedical researchers and/or clinicians in a tightly integrated way throughout the project, rather than treating clinical or biological expertise as a late-stage add-on. The program is geared toward teams that use an integrative, quantitative bioengineering approach, which generally implies rigorous measurement, modeling, validation, and iterative design. Because the mechanism is a U01 cooperative agreement, NIH anticipates substantial programmatic involvement during the award period, with NIH staff collaborating with awardees on scientific and technical direction, milestones, and coordination typical of cooperative agreements.

The opportunity specifically signals that clinical trials are required under this announcement, so applicants should be prepared for a development path that includes human studies and the infrastructure that goes with them, such as regulatory planning, safety considerations, data management, and clinically meaningful endpoints where relevant. At a program level, NIH frames the desired trajectory as one where projects can deliver meaningful, practical solutions within a 5 to 10 year horizon, indicating an interest in translational readiness, reproducibility, and a clear path to adoption by the intended users (research labs, clinical settings, or both).

Eligibility is broad and includes a wide range of public and private organizations. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations (other than small businesses) as well as small businesses; and other entities. The announcement also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This wide eligibility aligns with the partnership theme, encouraging cross-sector collaboration and inclusion of institutions serving diverse communities.

From the source data, the funding instrument type is a cooperative agreement and the activity category is health, with CFDA numbers 93.273, 93.286, and 93.866 associated with the opportunity. The original closing date listed is 2022-01-07, and the FOA creation date is 2019-01-08. The award ceiling and expected number of awards are not specified in the provided extract, which means applicants would typically need to consult the full FOA for budget guidance, project period limits, and other administrative requirements.

In practical terms, a competitive application under this FOA would usually be expected to: clearly define the biomedical problem and unmet need; justify why the proposed technology is promising and how it improves on existing options; lay out a quantitative development and validation strategy that results in a robust, well-characterized tool; demonstrate deep engagement from biomedical researchers or clinicians who will shape requirements and evaluate performance; and present a credible plan for clinical trial execution and eventual adoption. The overarching message of the program is acceleration with accountability: NIH is inviting ambitious bioengineering development, but with strong emphasis on rigor, characterization, usability, and a realistic pathway to impact within the next decade.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Bioengineering Research Partnerships (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273, 93.286, 93.866.
• This funding opportunity was created on 2019-01-08.
• Applicants must submit their applications by 2022-01-07. (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 19 157

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