BRAIN Initiative: Production and distribution facilities for brain cell type-specific access reagents (U24 Clinical Trial Not Allowed)

The BRAIN Initiative, led by the National Institutes of Health (NIH), has launched a new funding opportunity to support large-scale production and distribution facilities for brain cell type-specific access reagents. This effort is part of the BRAIN Initiative Armamentarium project, which aims to enable neuroscience researchers to access, manipulate, and monitor distinct brain cell types across vertebrate species, including human ex vivo tissues. The grant seeks to fund specialized Production and Distribution Facilities (PDFs) that will partner directly with Reagent Resource for Design and Development (RRDD) projects funded under a companion notice (RFA-MH-25-100). These RRDDs will develop validated reagents such as viral vectors and nucleic acid constructs, which the PDFs will produce at scale and distribute broadly. The objective of this funding opportunity is to ensure the widespread availability of sophisticated reagents for neuroscientific research. The reagents, including viral and non-viral vectors, nanoparticles, and engineered constructs, are intended to offer unprecedented precision in targeting specific brain cell types. These tools are crucial for advancing understanding of neural circuits and behavior. Facilities supported under this NOFO must execute four major functions: interface with RRDD projects to receive and refine validated reagents, scale up production of these tools, maintain a robust system for distributing reagents to users, and coordinate the dissemination of associated reagent data and metadata via data archives and consortium interfaces. NIH will commit approximately $2.4 million annually to fund 2 to 4 awards. Budgets are not capped but must be commensurate with project needs. Awards will be made as U24 cooperative agreements with a maximum period of five years. The earliest application due date is October 31, 2025, with a second deadline on July 1, 2026. Letters of intent are due 30 days prior to each submission deadline. Successful projects are expected to begin in July 2026 or April 2027, depending on the submission cycle. This opportunity does not allow for clinical trials. Eligible applicants include institutions of higher education, nonprofit and for-profit organizations, tribal and local governments, and independent school districts. Foreign organizations are not eligible to apply, though foreign components of U.S. institutions may participate. The program does not require cost sharing, and applicants must complete all registrations through SAM, Grants.gov, and eRA Commons before applying. Applications must include detailed plans for reagent production, dissemination infrastructure, data coordination strategies, and project milestones. A strong emphasis is placed on project management, catalog development, quality control, inventory systems, and feedback loops from reagent users. The grant also requires compliance with NIH data sharing policies and mandates data submission to relevant archives, notably the National Institute of Mental Health Data Archive (NDA). Contacts for scientific inquiries include Dr. Douglas S. Kim ([email protected]), and for review-related questions, Dr. Nicholas Gaiano ([email protected]). Financial queries should be directed to Heather Weiss ([email protected]). Applications must be submitted electronically via ASSIST, Grants.gov Workspace, or institutional S2S systems. Compliance with the application instructions is strictly enforced.

Ensure proposal addresses all four PDF functions and includes a detailed milestone plan; explicitly address user feedback and data sharing expectations.