Key Dates
None
Office of Strategic Coordination (Common Fund)
The purpose of this Notice is to inform the research community that the NIH Common Fund, along with its partner NIH Institutes, Centers, and Offices, is planning to issue a notice of funding opportunity (NOFO) to support the Complement Animal Research In Experimentation (Complement-ARIE) program.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
This NOFO will utilize the U24 activity code. Details of the planned NOFO are provided below.
The NIH Common Fund’s Complement Animal Research In Experimentation (Complement-ARIE) program goal is to accelerate the development, standardization, validation, and use of human-based New Approach Methodologies (NAMs).
NAMs, are laboratory (in vitro and in chemico) or computer-based (in silico) research approaches intended to more accurately model human biology, and complement, or in some cases, replace traditional research models. The Complement-ARIE program will build upon ongoing efforts in the field related to NAMs, while identifying opportunities for innovation and coordination amongst the various interest groups, including the Advisory Committee to the Director (ACD) on catalyzing the development and use of Novel Alternative Methods to Advance Biomedical Research. The ACD working group recommendations are aligned with Complement-ARIE program goals. Feedback from the scientific community was solicited through the Complement-ARIE Challenge to propel the development and refinement of human-based NAMs. These Common Fund strategic planning activities have guided the development of the Complement-ARIE program.
Complement-ARIE is expected to significantly advance understanding of human health and disease by providing a range of mature and/or validated and standardized biomedical research models. Developing these models will require multi-disciplinary expertise spanning in vitro, in silico and in chemico approaches focused on modeling and understanding human diseases and conditions, personalized medicine, environmental science, and in screening therapeutics for safety and effectiveness and environmental compounds for health hazards.
The overarching goal of the Complement-ARIE program is to catalyze the development, standardization, validation, and use of human-based NAMs that will transform the way we do basic, translational, and clinical sciences. The program goals include:
- Better model and understand human health and disease outcomes across diverse populations.
- Develop NAMs that provide insight into specific biological processes or disease states.
- Validate mature NAMs to support regulatory use and standardization.
- Complement traditional models and make biomedical research more efficient and effective.
The Complement-ARIE Program consists of three major initiatives:
- Comprehensive NAMs Technology Development Centers (TDC)
- NAMs Data Hub and Coordinating Center (NDHCC)
- Validation and Qualification Network (VQN)
This NOITP applies only to the NAMs Data Hub and Coordinating Center.
Research Scope
The overarching mission of the NDHCC is to coordinate, collect, store, curate, and disseminate all NAMs-relevant data, metadata, analyses, tools, computational models, and validation and qualification documentation generated by the Complement-ARIE Program and to do so in a manner that promotes the development of standards and ensures maximum interoperability with data from other NAMs-related repositories and consortia. The NDHCC will serve as the Coordinating Center for the overall Complement-ARIE program and as the centralized Data Hub and Data Coordinating Center for all Complement-ARIE activities. The NDHCC will create and manage an integrated data structure that supports the development, validation, and qualification of NAMs in adherence with the findable, accessible, interoperable, and reusable (FAIR) principles. The NHDCC team must effectively and productively collaborate with other major components of the Complement-ARIE program, particularly the NAMs TDCs and VQN, which collectively form the Complement-ARIE Consortium.
The major responsibilities for the NDHCC Data Hub include the following areas:
- Create a central NAMs data hub
- Build a searchable interface for NAMs data
- Establish standards for data reporting and model credibility
- Develop strategies for interoperability, sustainability, and data reuse
- Develop tools for data analytics and dissemination, including pilot projects in years 3-5 to develop tools that aid in the analysis of Complement-ARIE datasets
- Overall Consortium Coordination and Outreach
Announcements and regular updates will be posted on the program website: https://commonfund.nih.gov/complementarie. Potential applicants can also register for the listserv: go.nih.gov/ComplementARIE_listserv.
Technical Assistance Webinars
Technical assistance workshops regarding application expectations and program goals will be convened after the NOFO is published.Information about the technical assistance webinars will be posted to the Complement-ARIE FAQs page: https://commonfund.nih.gov/complementarie/faqs
Funding Information
Up to $5M in total costs per year
1
Up to $5M in total costs per year
93.310
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government
Applications are not being solicited at this time.
Inquiries
Please direct all inquiries to:
[email protected]
and Human Services (HHS)
