Translational Centers for Microphysiological Systems (TraCe MPS) (U2C Clinical Trials Not Allowed) | RFA TR 23 001

Opportunity Information: Apply for RFA TR 23 001

The Translational Centers for Microphysiological Systems (TraCe MPS) funding opportunity (RFA-TR-23-001) is a National Institutes of Health (NIH) cooperative agreement designed to create multi-partner Centers that move Microphysiological Systems (MPS) closer to routine, trusted use in drug development. The main aim is not simply to invent new organ-on-chip style platforms, but to accelerate real-world translation by building MPS that industry can rely on for specific tasks and that regulators can evaluate with confidence. In this announcement, "drugs" is used broadly to include both pharmacological products and biological products unless otherwise noted, reflecting a wide set of therapeutic development pipelines the supported work could influence.

A central theme of the program is "fit-for-purpose" development tied to clearly defined contexts of use (CoUs). In practice, this means each Center is expected to focus on building and demonstrating MPS tools for well-scoped drug development decisions, rather than presenting general-purpose technology demonstrations. The work is framed around regulatory acceptance and industry adoption, so the Centers are expected to develop these MPS with applicable expectations in mind for eventual regulatory approval pathways. The intended endpoint is to position MPS as drug development tools (DDTs) that can be qualified and then made available beyond the original research teams, helping fill unmet needs in the drug development process (for example, where existing preclinical models do not adequately predict human safety or efficacy).

The award mechanism is a cooperative agreement (U2C) and explicitly states that clinical trials are not allowed, which signals that NIH expects substantial programmatic involvement while keeping the work preclinical and tool-development focused. The emphasis is on translational infrastructure and evidence generation that supports confidence, reproducibility, and decision-making utility. In other words, the Centers are meant to do the hard work required to move an MPS from a promising prototype to something that can be credibly used by pharmaceutical and biotech developers and, ultimately, supported in regulatory submissions once the tool is qualified for its intended CoU.

Eligibility is broad across the U.S. research and development ecosystem. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; certain Native American tribal organizations; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights inclusion of a range of institution types and organizations 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, and U.S. territories or possessions. At the same time, it clearly restricts non-U.S. participation: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed.

Administrative details included in the listing note the opportunity is categorized as discretionary funding and sits within education and health activity categories, with CFDA numbers 93.350, 93.395, and 93.866. The FOA was created on 2022-12-27 and had an original closing date of 2023-03-27. The listing does not provide an award ceiling or expected number of awards in the provided excerpt, but the overall structure indicates NIH intends to fund Center-level efforts with enough scope to coordinate technology development, validation, and translation activities needed for DDT qualification and broader dissemination.

Overall, TraCe MPS is aimed at bridging the gap between academic innovation in microphysiological systems and the stringent requirements of industrial and regulatory environments. The program is organized around building MPS tools that are clearly defined in purpose, supported by evidence appropriate to their intended use, and positioned for eventual qualification and availability to the wider community, rather than remaining bespoke systems confined to individual laboratories.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Translational Centers for Microphysiological Systems (TraCe MPS) (U2C Clinical Trials Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350, 93.395, 93.866.
• This funding opportunity was created on 2022-12-27.
• Applicants must submit their applications by 2023-03-27. (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 RFA TR 23 001

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