This Notice of Funding Opportunity announcement (NOFO) invites applications for the Clinical and Translational Science Award (CTSA) Program hubs that will be part of a national, collaborative consortium focused on bringing more treatments for all people more quickly through advancing clinical and translational science (CTS) by (1) developing, demonstrating, and disseminating scientific and operational innovations that improve the efficiency and effectiveness of clinical translation from identification to first-in-human studies to medical practice implementation to community health dissemination; (2) promoting partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally, and nationally; (3) creating, providing, and disseminating innovative research programs and partnerships across institutions and communities to address health disparities and deliver the benefits of translational science to all; (4) creating and implementing scientific and operational innovations that increase the quality, safety, efficiency, effectiveness, and informativeness of clinical research; (5) providing a national resource for the rapid response to urgent public health needs; and (6) creating, providing, and disseminating CTS training for clinical research professionals of all disciplines on the research team.The National Institutes of Health (NIH), through its National Center for Advancing Translational Sciences (NCATS), has issued a Notice of Funding Opportunity (NOFO) for the Clinical and Translational Science Award (CTSA) Program (UM1 Clinical Trial Optional). This program seeks to fund "hubs" at medical research institutions, which will act as central points in a nationwide CTSA network, aiming to streamline and enhance the process of bringing clinical treatments to practice. The overarching purpose is to advance translational science by focusing on operational innovations in research, facilitating partnerships, addressing health disparities, providing rapid responses to public health needs, and offering comprehensive training for clinical research professionals.

The CTSA Program will utilize a UM1 cooperative agreement, allowing for substantial involvement from NIH in project activities. The award supports institutions in developing and implementing CTS resources, conducting training, and engaging with community partners to address significant translational science challenges. Each CTSA hub will be organized around five required Elements: an Overview, Strategic Management, Training and Outreach, Clinical and Translational Science Resources and Pilots, and a CTS Research Program, with specific sub-modules for workforce development, community engagement, and data science integration. Importantly, hubs must also establish robust mechanisms for stakeholder collaboration and prioritize projects that can address health disparities and improve access for underserved populations.

Funding allocations for CTSA hubs vary by institution, based on NIH funding history, and are divided into tiers with maximum direct costs ranging from $2.6 million to $6.5 million annually. Institutions can apply as single entities or collaborate with partners, although the program imposes restrictions on cross-institutional partnerships to prevent overlap in CTSA activities. Additionally, applicants must submit companion applications for the K12 career development award, and optionally for T32 and R25 programs, to ensure comprehensive career support and education within the CTS framework.

Eligible applicants include institutions of higher education, non-profits, government entities, and some for-profit organizations, with the requirement that applicants include a graduate school capable of awarding higher degrees related to CTS. Each hub’s leadership must demonstrate authority and influence to promote CTS research and integration within and across institutions, including the establishment of advisory committees with diverse expertise.

Application materials must be prepared according to NIH guidelines, with specific attachments demonstrating the institution’s organizational capacity, experience in clinical trials, CTS research track record, and a plan for coordination with companion programs. Applications must also include a Data Management and Sharing Plan (DMSP) and detailed budgets broken down by module. Proposals will undergo a rigorous review for compliance with federal regulations, and all applications must meet NIH’s strict criteria for documentation and submission.

Key deadlines include a first submission date of January 13, 2025, with rolling deadlines for subsequent application rounds. The earliest project start date is December 2025. Applicants are encouraged to submit letters of intent 30 days before due dates and to prepare for potential review cycles if applications are resubmitted or revised.