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.Apply for RFA TR 23 001
- 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.
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Frequently Asked Questions (FAQs): Translational Centers for Microphysiological Systems (TraCe MPS) - RFA-TR-23-001
What is the TraCe MPS funding opportunity (RFA-TR-23-001)?
TraCe MPS (Translational Centers for Microphysiological Systems) is a National Institutes of Health (NIH) funding opportunity that supports multi-partner Centers focused on moving Microphysiological Systems (MPS) closer to routine, trusted use in drug development.
What is the overall purpose of TraCe MPS?
The purpose is to accelerate real-world translation of MPS by developing systems that industry can rely on for specific drug development tasks and that regulators can evaluate with confidence, rather than focusing primarily on inventing new organ-on-chip style platforms.
Is this opportunity focused on inventing new organ-on-chip technologies?
No. While MPS technology development is part of the space, the emphasis in this opportunity is on translation and adoption: building MPS that are credible, reproducible, and decision-useful for well-defined applications in drug development.
What does NIH mean by "drugs" in this announcement?
In this announcement, "drugs" is used broadly to include both pharmacological products and biological products unless otherwise noted. This reflects a wide range of therapeutic development pipelines the supported work could influence.
What are Microphysiological Systems (MPS) in the context of this FOA?
MPS refers to microphysiological systems used as preclinical tools (often described as organ-on-chip style systems) intended to improve how drug developers assess human safety and efficacy, especially where existing preclinical models may not be predictive enough.
What is meant by "fit-for-purpose" development?
"Fit-for-purpose" means the Centers should build and demonstrate MPS tools that are designed for clearly defined tasks and decisions in drug development, rather than broad, general-purpose demonstrations.
What is a "context of use (CoU)" and why does it matter here?
A context of use (CoU) is the clearly defined way an MPS tool is intended to be used to support a specific drug development decision. This FOA centers on tying MPS development and evidence generation to a well-scoped CoU so the tool can be evaluated, trusted, and potentially qualified for that use.
What kinds of endpoints or outcomes are Centers expected to work toward?
The intended endpoint is to position MPS as drug development tools (DDTs) that can be qualified for their intended CoU and made available beyond the original research teams, helping address unmet needs in drug development (for example, when existing preclinical models do not adequately predict human safety or efficacy).
How does this program relate to regulatory acceptance?
The work is framed around regulatory acceptance and industry adoption. Centers are expected to develop MPS with applicable expectations in mind for eventual regulatory pathways, producing evidence that supports confidence in the tools for their intended use.
How does this program relate to industry adoption?
The program is designed to move MPS from promising prototypes to tools that pharmaceutical and biotech developers can credibly use in real drug development workflows for specific tasks, rather than bespoke systems limited to individual labs.
What is the award mechanism for TraCe MPS?
The award mechanism is a cooperative agreement (U2C), which indicates NIH expects substantial programmatic involvement during the project.
Are clinical trials allowed under this funding opportunity?
No. The opportunity explicitly states that clinical trials are not allowed, signaling that the work is expected to remain preclinical and focused on tool development and translation.
What does it mean that this is a cooperative agreement (U2C)?
Based on the listing, U2C indicates a cooperative agreement structure where NIH has substantial programmatic involvement. The FOA emphasizes translational infrastructure and evidence generation needed to support reproducibility and decision-making utility.
What kinds of organizations are eligible to apply?
Eligibility is broad and includes: 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); small businesses; and other highlighted institution types listed in the announcement.
Are universities and colleges eligible?
Yes. Both public and state-controlled institutions of higher education and private institutions of higher education are eligible applicants.
Are nonprofit organizations eligible?
Yes. Nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status (other than institutions of higher education) are included among eligible applicants.
Are for-profit companies eligible?
Yes. For-profit organizations (other than small businesses) are eligible, and small businesses are also explicitly listed as eligible applicants.
Are small businesses eligible?
Yes. Small businesses are included in the eligibility list.
Are government entities eligible to apply?
Yes. Eligible applicants include multiple forms of government entities, such as state, county, city or township, and special district governments, as well as independent school districts.
Are federally recognized Tribal governments eligible?
Yes. Federally recognized Native American tribal governments are included among eligible applicants.
Are U.S. territories or possessions included in the eligible ecosystem?
Yes. The announcement highlights inclusion of U.S. territories or possessions among the range of institution types and organizations it seeks to include.
Are foreign (non-U.S.) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply under this opportunity.
Can a U.S. organization apply if part of the work will be done outside the United States?
No. The opportunity states that non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed.
Does the announcement specifically encourage participation by certain institution types?
Yes. The listing highlights inclusion of a range of institution types and organizations, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, and regional organizations.
What funding category does this opportunity fall under?
The listing categorizes the opportunity as discretionary funding.
What activity categories are associated with this opportunity?
The listing places the opportunity within education and health activity categories.
What CFDA numbers are associated with this FOA?
The listing cites CFDA numbers 93.350, 93.395, and 93.866.
When was this FOA created?
The FOA was created on 2022-12-27.
What was the original closing date listed for this opportunity?
The listing notes an original closing date of 2023-03-27.
Does the provided information state an award ceiling or the expected number of awards?
No. The excerpt provided does not include an award ceiling or the expected number of awards. It does indicate NIH intends to fund Center-level efforts with enough scope to coordinate development, validation, and translation activities.
What makes this a "Center" program rather than a typical research project?
It is designed to create multi-partner Centers that coordinate technology development, validation, and translation activities to move MPS toward routine use in drug development, with a focus on reproducibility and evidence generation tied to specific contexts of use.
How is success framed in TraCe MPS?
Success is framed around bridging the gap between academic innovation and industrial/regulatory requirements, producing MPS tools that are clearly defined in purpose, supported by evidence appropriate to their intended use, and positioned to be available to the broader community rather than remaining bespoke tools in individual labs.
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