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 UM1 activity code, Clinical Trial Optional. 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 in 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 Comprehensive NAMs Technology Development Centers.
Research Scope
The goal of the Comprehensive NAMs Technology Development Centers is to stimulate the development of combinatorial NAMs to support the areas of greatest need, with emphasis on increased biological complexity and throughput, innovative combinatorial approaches, and data sharing according to FAIR principles. Training and outreach components will be required to facilitate dissemination, capacity building, and adoption. This initiative will solicit UM1 applications for the Comprehensive NAMs Technology Development Centers.
Comprehensive NAMs Technology Development Centers
Application structure
- Element A: Center Overview
- Element B: Strategic Management
- Module B1: Center Management
- Module B2: Consortium Liaison
- Element C: Integrated NAMs Technology Development
- Module C1: NAMs Technology Development
- Module C2: Technology Pilot projects
- Element D: Center Core Facilities
- Module D1: Administration
- Module D2: Data Collection and Bioinformatics
- Module D3: Resources
- Element E: Technical Characterization
- Element F: Training & Outreach
- Module F1: Workforce Development and Training
- Module F2: Community and Stakeholder Engagement Research
- Module F3: Ethical, legal and social implications (ELSI)
This Notice encourages investigators with expertise and insights into this area of New Approach Methodologies to begin to consider applying for this new NOFO.
In addition, collaborative investigations combining expertise in in vitro, in silico, and in chemico NAMs are encouraged.
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
$18M total in total costs per year
4-5
$2M per year in direct costs
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:
Complement-ARIE@od.nih.gov
and Human Services (HHS)
