Complement-ARIE New Approach Methodologies (NAMs) Data Hub and Coordinating Center (U24 Clinical Trial Optional)

The National Institutes of Health (NIH), through its Office of Strategic Coordination (Common Fund), has announced a funding opportunity titled Complement-ARIE New Approach Methodologies (NAMs) Data Hub and Coordinating Center (NDHCC). This initiative aims to establish a centralized data hub and coordinating center as part of the Complement Animal Research In Experimentation (Complement-ARIE) program. The NDHCC will serve as the backbone of the program, supporting the collection, integration, and dissemination of NAMs data while also coordinating activities across the program's research centers. NAMs are innovative methodologies, including in vitro, in chemico, and in silico approaches, that aim to complement traditional animal models in biomedical research. The NDHCC will focus on developing a secure, flexible infrastructure for NAMs data, implementing standards for data reporting and model credibility, advancing interoperability, and fostering sustainability and data reuse. Additionally, the NDHCC will oversee tools for analytics and dissemination while also serving as the central administrative and logistical hub for the Complement-ARIE program. The core goals of the NDHCC include creating and maintaining a NAMs Data Hub, which will provide secure storage, searchable data repositories, and a federated search interface for consortium members and the broader scientific community. The center will also be responsible for data standardization, harmonization, and integration, ensuring that NAMs datasets are FAIR-compliant (Findable, Accessible, Interoperable, and Reusable) and can integrate seamlessly with existing NIH and NAMs-related resources. The NDHCC will develop analytics tools, facilitate collaboration among the Technology Development Centers (TDCs) and the Validation and Qualification Network (VQN), and establish a roadmap for long-term data sustainability. Outreach, coordination, and capacity-building will also be central responsibilities, including organizing meetings, developing training resources, and facilitating communication across the consortium. This funding opportunity will support a single award with an anticipated budget of approximately $5 million per year for up to five years, spanning fiscal years 2026 to 2030. While the budget is not capped, it must reflect the actual needs of the proposed project. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local governments, tribal organizations, and other eligible entities. Foreign organizations are not eligible, though foreign components of U.S.-based institutions are allowed. Key personnel must meet specific effort requirements, with the Principal Investigator (PI) required to dedicate a minimum of 2.4 person-months per year to the project, while multi-PI applications have adjusted effort requirements. Applications must include a detailed Plan for Enhancing Diverse Perspectives (PEDP), outlining actionable strategies for increasing inclusivity and promoting diverse perspectives within the project. This plan will be assessed during peer review. Additionally, the application must address four core components: Data Hub infrastructure development and maintenance, data coordination and standardization, tool and software development for data analytics, and overall consortium coordination and outreach. A letter of intent is encouraged but not required and must be submitted by February 10, 2025. Full applications are due by March 10, 2025, and late submissions will not be accepted. Evaluation criteria will include the scientific and technical merit of the proposal, the qualifications and experience of the investigative team, the adequacy of the management and coordination plan, and the feasibility of achieving the program's goals. Applicants must demonstrate their ability to manage complex data infrastructure, implement data standards, and facilitate collaboration across diverse stakeholders. They must also show a strong commitment to sustainability and long-term reuse of program-generated data. The earliest anticipated start date for the funded project is December 2025. The NDHCC will play a critical role in supporting the NIH’s broader goals of advancing NAMs to improve human health research outcomes. Through strategic coordination, robust data management, and innovative analytics tools, the NDHCC aims to establish a foundation for reproducible, transparent, and impactful NAMs research. Applicants are encouraged to thoroughly review the NIH guidelines and consult with program staff before submitting their applications to ensure alignment with the NOFO requirements.