Complement-ARIE New Approach Methodologies (NAMs) Technology Development Centers (UM1 Clinical Trial Optional) | RFA RM 24 010

Opportunity Information: Apply for RFA RM 24 010

This funding opportunity, RFA-RM-24-010, is a National Institutes of Health (NIH) Common Fund Notice of Funding Opportunity designed to create Comprehensive New Approach Methodologies (NAMs) Technology Development Centers under the Complement Animal Research In Experimentation (Complement-ARIE) program. The core idea is to build and support centers that can move human-based NAMs forward faster, making them more practical and widely usable as research models. In plain terms, NIH is trying to grow a stronger toolbox of human-relevant experimental systems that can complement animal research by improving how researchers study human biology, disease mechanisms, and responses to potential therapies.

The Complement-ARIE program’s bigger mission is to accelerate the development, standardization, validation, and real-world use of NAMs. These methodologies are meant to be human-based, which generally points to approaches like advanced cell and tissue systems, microphysiological systems, organoids, computational modeling, and integrated platforms that can capture human biology more directly than many traditional models. NIH frames the expected impact as a meaningful jump in understanding human health and disease, specifically by producing a range of biomedical research models that are not only innovative but also mature enough to be broadly useful, and in some cases validated and standardized so different labs can reproduce results and compare data confidently.

A central emphasis of these Technology Development Centers is the creation of "combinatorial NAMs," meaning integrated or hybrid approaches that combine multiple NAM components into more powerful systems. The NOFO highlights the need for increased biological complexity and increased throughput at the same time, which is a challenging but important goal: complexity helps models better mimic real human physiology, while throughput makes it feasible to test more conditions, more compounds, more patient-derived samples, or more perturbations efficiently. NIH is also explicitly encouraging innovative combinatorial strategies, which suggests applicants should not simply improve a single model in isolation, but should think about how to connect platforms, assays, and data streams into end-to-end systems that solve specific biomedical research bottlenecks.

Another major requirement is a strong commitment to data sharing and data stewardship aligned with FAIR principles, meaning data should be Findable, Accessible, Interoperable, and Reusable. Practically, this means the Centers are expected to generate data and methods that others can discover, understand, integrate with other datasets, and reuse without excessive barriers. This focus on FAIR data usually implies attention to metadata standards, documentation, common ontologies or vocabularies where applicable, clear protocols, and thoughtful plans for repositories and access. The intent is to ensure the products of these Centers do not stay siloed, and that the broader community can build on them.

Because NAM development at this scale tends to be technically and scientifically complex, the NOFO stresses the need for multidisciplinary expertise. The targeted skill mix includes disease research, personalized medicine, therapeutic screening for both safety and efficacy, and regulatory science. That combination signals that NIH wants Centers that can do more than demonstrate a technology in a narrow academic setting; they want groups that can move methods toward broader confidence and usability, including contexts where regulators and translational stakeholders care about reliability, standard operating procedures, benchmarking, and clear performance characteristics.

Mechanistically, the award uses a cooperative agreement (UM1) funding instrument, which typically indicates substantial NIH involvement during the project period compared with standard research project grants. In cooperative agreements, NIH program staff often have an active partnership role in coordination, milestone setting, or network-level activities. The NOFO is labeled "Clinical Trial Optional," meaning applicants may propose a clinical trial if it is scientifically justified, but a clinical trial is not required.

Eligibility is broad and includes many U.S.-based organization types: 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 tribal governments; tribal organizations that are not federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations other than small businesses; and small businesses. The NOFO also explicitly calls out additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

At the same time, there are clear restrictions related to foreign participation. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" as defined in the NIH Grants Policy Statement are allowed, which typically means a U.S. applicant can include certain defined foreign elements (for example, specific collaborations or performance sites) if they meet NIH policy requirements and are justified, even though the applicant organization itself must be domestic.

From an administrative standpoint, the funding opportunity is categorized as discretionary, falls under the health activity category, and is associated with CFDA number 93.310. The agency is NIH, and the original closing date listed is February 28, 2025. The announcement was created on December 10, 2024. The listing does not provide an award ceiling or expected number of awards in the provided source data excerpt, so applicants would need to consult the full NOFO text for budget expectations, project period limits, the specific review criteria, and any required milestones, governance structures, or consortium expectations that commonly accompany UM1 cooperative agreements.

Overall, this opportunity is aimed at funding highly capable, collaborative centers that can produce robust, shareable, human-relevant NAM platforms, particularly integrated systems that balance physiological realism with scalability. The larger message is that NIH is investing in infrastructure-like capabilities and community-facing technology development that can raise the standard for human-based models across biomedicine, while also pushing those models toward standardization, validation readiness, and broader adoption.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Complement-ARIE New Approach Methodologies (NAMs) Technology Development Centers (UM1 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310.
• This funding opportunity was created on 2024-12-10.
• Applicants must submit their applications by 2025-02-28. (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 RM 24 010

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