Bioengineering Partnerships with Industry (U01 Clinical Trial Optional) | PAR 24 325

Frequently Asked Questions (FAQs)

What is the funding opportunity?

This is a National Institutes of Health (NIH) funding opportunity titled "Bioengineering Partnerships with Industry (U01 Clinical Trial Optional)" under Funding Opportunity Number (FON) PAR-24-325. It supports collaborative projects that pair academic researchers with industry partners to speed the development, validation, and real-world adoption of promising bioengineering tools and technologies.

What is the main purpose of PAR-24-325?

The main purpose is to move bioengineering technologies beyond early prototypes and isolated demonstrations and into robust, well-characterized, genuinely usable solutions that address clear biomedical needs. NIH is looking for tools and technologies positioned to meaningfully improve how scientists study biology or how clinicians diagnose, monitor, or treat disease.

What kinds of projects are NIH looking for under this program?

NIH emphasizes projects that deliver new capabilities through an integrative, quantitative bioengineering approach. Proposals should combine relevant expertise (engineering, computation, biology, and medicine) and include rigorous performance measurement and characterization so the resulting technology is reliable, reproducible, and ready for broader use.

Does this opportunity focus on early-stage prototypes or later-stage development?

The emphasis is on pushing technologies beyond early prototypes. The program is intended to help mature promising bioengineering tools into robust, well-characterized solutions that work reliably outside narrow laboratory conditions and are credible candidates for broader adoption.

What does "Bioengineering Partnerships with Industry" mean in practice?

It means the project should be structured around a real partnership where academic and industry participants both play essential roles. NIH expects collaboration that helps move the technology forward through development, validation, and steps toward scaling or dissemination.

What is the award mechanism for this opportunity?

The mechanism is a U01 cooperative agreement. A U01 typically involves substantial NIH programmatic involvement compared with a standard research project grant, and it often fits projects that benefit from coordination, defined milestones, and active collaboration to keep technology development on track.

What does "Clinical Trial Optional" mean?

"Clinical Trial Optional" means a clinical trial may be included if it is appropriate for the technology and the project goals, but it is not required. Projects can range from advanced preclinical development and testing to clinical evaluation when justified.

How quickly is NIH expecting supported technologies to translate into real-world solutions?

NIH frames the program around delivering new capabilities with an expectation that supported innovations could lead to meaningful solutions within about 5 to 10 years. Applicants should be prepared to describe a credible path from development through validation and toward adoption.

What approach does NIH want teams to use?

NIH highlights multidisciplinary teams using an integrative, quantitative bioengineering approach. In practical terms, proposals should blend expertise across engineering, computation, biology, and medicine, and should include rigorous characterization and performance measurement.

What does NIH mean by "robust" and "well-characterized" technologies?

Within the context provided, NIH is emphasizing technologies that are reliable and reproducible, supported by rigorous performance measurement and characterization, and not limited to working only under narrow lab conditions. The goal is a tool or technology that others can adopt and use with confidence.

Who is eligible to apply?

Eligibility is broad. Eligible applicants include various government entities (state, county, city or township governments; special district governments; independent school districts), public and state-controlled institutions of higher education, private institutions of higher education, Native American tribal governments (federally recognized), tribal organizations (including those other than federally recognized tribal governments), public housing authorities/Indian housing authorities, nonprofits with and without 501(c)(3) status (other than higher education institutions), for-profit organizations other than small businesses, and small businesses.

Are small businesses eligible?

Yes. Small businesses are listed as eligible applicants.

Are for-profit organizations eligible?

Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also separately listed as eligible.

Are nonprofits eligible, including those without 501(c)(3) status?

Yes. Nonprofits with and without 501(c)(3) status (other than higher education institutions) are included as eligible applicants.

Are universities and colleges eligible?

Yes. Public and state-controlled institutions of higher education and private institutions of higher education are both listed as eligible applicants.

Are tribal entities eligible?

Yes. Native American tribal governments (federally recognized) and tribal organizations (including those other than federally recognized tribal governments) are included as eligible.

Are non-U.S. organizations eligible?

Yes. The opportunity highlights non-U.S. entities (foreign organizations) as eligible.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are listed among the eligible groups.

Are specific institution types called out as eligible (for example, HBCUs or HSIs)?

Yes. The announcement highlights additional eligible groups such as 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 (AANAPISI).

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly highlighted as eligible.

Are eligible federal agencies included?

Yes. Eligible federal agencies are included in the highlighted eligible groups.

What is the funding type and activity area for this opportunity?

The opportunity is categorized as discretionary funding and falls under the broad activity areas of education and health.

What CFDA numbers are associated with this opportunity?

The opportunity is associated with multiple CFDA numbers: 93.286, 93.394, 93.395, 93.866, and 93.867.

When was the FOA created?

The FOA was created on 2024-11-06.

What is the closing date for this opportunity?

The listed original closing date is 2027-09-07. The information provided also indicates a multi-year window in which applications may be accepted according to NIH receipt dates and cycles.

Does the information provided specify an award ceiling or number of awards?

No. The source data provided does not specify an award ceiling or the expected number of awards. Applicants would typically look to the full FOA text and NIH institute-specific guidance for budget expectations, project period norms, and anticipated award scale.

What are the key elements of a strong application, based on the description provided?

Based on the description provided, NIH is looking for teams that can convincingly show: (1) a high-impact biomedical problem and unmet need, (2) a bioengineering technology that can realistically be matured into a reliable, well-understood tool, and (3) a partnership structure where industry and academic investigators each play essential roles in development, validation, scaling, or dissemination.

What is NIH trying to avoid funding under this program?

The emphasis suggests NIH is trying to avoid tools that are only interesting on paper or that only work under narrow lab conditions. The program description prioritizes technologies that are positioned for validation and broader adoption as dependable solutions to clear biomedical needs.

What range of work can a project cover?

Projects can range from advanced preclinical development and testing to clinical evaluation when justified, since clinical trials are optional rather than required.