Complement-ARIE New Approach Methodologies (NAMs) Data Hub and Coordinating Center (U24 Clinical Trial Optional) | RFA RM 24 013

Opportunity Information: Apply for RFA RM 24 013

The NIH Common Fund is soliciting applications under RFA-RM-24-013 to create and run the New Approach Methodologies (NAMs) Data Hub and Coordinating Center (NDHCC) for the Complement Animal Research In Experimentation (Complement-ARIE) program. This is a discretionary funding opportunity using a cooperative agreement mechanism (U24, clinical trial optional), meaning the awardee will not just receive funds but will also work closely with NIH program staff in a coordinated, hands-on partnership. NIH expects to make a single award, so the selected organization will effectively become the central operational backbone for the entire Complement-ARIE effort. The application due date is March 10, 2025, and the sponsoring agency is the National Institutes of Health (CFDA 93.310).

At a program level, Complement-ARIE is aimed at improving how biomedical research predicts and explains human health and disease outcomes across diverse populations by expanding the use of better, more human-relevant experimental approaches. These approaches are referred to as NAMs, which broadly include nontraditional methods that can complement or, in some contexts, reduce reliance on conventional animal models. The emphasis in this opportunity is not on running a single scientific project in isolation, but on building shared infrastructure and coordination capacity that can accelerate the development, evaluation, and adoption of NAMs across many projects and stakeholders.

The core deliverable funded through this NOFO is a centralized data hub paired with an active coordinating center function. Practically, the awardee is expected to stand up a searchable, well-organized repository capable of handling multiple NAMs data types. That typically implies supporting heterogeneous datasets (for example, assay outputs, imaging, multi-omics, microphysiological systems readouts, computational model artifacts, metadata, protocols, and associated documentation) in ways that make them findable and usable by the broader community. Beyond simply storing files, the NDHCC is intended to make the data searchable and reusable, which usually requires robust metadata capture, consistent identifiers, clear provenance, and documentation that allows others to understand how a dataset was generated and what it can and cannot be used for.

A major part of the NDHCC mission is establishing and promoting standards. The NOFO specifically calls out standards for data reporting and model credibility, which signals NIH wants more than a data warehouse: it wants common expectations for how NAMs results are described, what minimum information should accompany a dataset, and how to communicate confidence in a given model for a given context of use. Model credibility is especially important for NAMs because stakeholders often need to know when a model is fit-for-purpose, how it was qualified or validated, what its limitations are, and how reliably it predicts outcomes relevant to humans. The NDHCC will be expected to help shape and socialize those standards so that program-generated data can be compared across sites and integrated over time.

The opportunity also includes developing and implementing an Integrated Testing Strategies (ITS) framework. ITS generally refers to structured approaches that combine multiple assays, models, or evidence streams to answer biological or toxicological questions more effectively than any single method alone. In the context of Complement-ARIE, this implies the coordinating center will help define how different NAMs can be used together, how evidence should be weighted or combined, and how workflows can be designed so that results from one method inform the next step. This is closely tied to the data hub role because an ITS is only as useful as the ability to integrate data across sources, track decision logic, and make outputs interpretable to other researchers and decision-makers.

Interoperability and sustainability are also explicit expectations. Interoperability means the NDHCC should design systems so that Complement-ARIE data can work smoothly with other platforms, repositories, and tools, rather than becoming a standalone silo. That often involves using widely accepted data standards, APIs, persistent identifiers, and clear governance for access and reuse. Sustainability and data reuse strategies indicate NIH wants the hub to remain useful beyond the initial funding period, with plans for long-term maintenance, community adoption, and continued accessibility of data and tools. The NOFO also emphasizes developing tools that support data analytics, dissemination, and sharing, which points to providing not only storage and standards but also practical capabilities for users to explore, analyze, and communicate findings, potentially through dashboards, pipelines, notebooks, or other analytic and visualization resources.

Finally, the awardee will serve as the coordinating center for the overall Complement-ARIE program. This coordinating center role typically involves cross-project coordination, facilitation of communication among program participants, organizing meetings or working groups, harmonizing practices across teams, tracking milestones and deliverables, and helping ensure that data and outputs produced across the program are consistent with shared policies and standards. In other words, the NDHCC is expected to be both a technical platform and an operational hub that keeps the broader program aligned and moving efficiently.

Eligibility for this opportunity is broad across U.S.-based organizations, including state, county, city, township, and 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 tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The NOFO also highlights additional eligible applicant categories such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. However, foreign organizations are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible, so the work and applying entity must be fully domestic in scope for eligibility purposes.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Complement-ARIE New Approach Methodologies (NAMs) Data Hub and Coordinating Center (U24 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 2025-01-07.
• Applicants must submit their applications by 2025-03-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 1 candidate(s).
• 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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