The National Heart, Lung, and Blood Institute invites applications for early-phase clinical trials focused on diagnostic and therapeutic interventions for heart, lung, blood, and sleep disorders in adults and children. The funding opportunity employs a bi-phasic, milestone-driven R61/R33 mechanism to support both preparatory preclinical activities and the execution of Phase I clinical trials. Eligible projects may include single or multi-site trials and bridging studies to extend data from one population, such as adults, to another, such as pediatric patients. The initiative emphasizes efficiency, scientific excellence, and diversity in trial participation.

The R61 phase is intended to support late-stage product development, including formulation studies, protocol finalization, regulatory approvals, and site readiness. Applicants can request up to two years and $250,000 annually for these activities. Transition to the R33 phase, which supports the execution of Phase I clinical trials, will depend on the successful completion of pre-specified milestones. Up to three years and $1,515,000 annually may be requested for the R33 phase, covering trial implementation and data collection.

Eligible applicants include domestic and foreign higher education institutions, government entities, nonprofits, and for-profit organizations. Multiple applications may be submitted if they are scientifically distinct. All applicants must complete necessary registrations with NIH systems, SAM.gov, and Grants.gov, and follow detailed application instructions. The process requires a letter of intent, a comprehensive project management plan, and evidence of clinical trial experience.

Applications will be evaluated based on significance, innovation, rigor, feasibility, investigator expertise, and institutional resources. A focus on inclusion of women, minorities, and participants of all ages is mandatory, along with adherence to NHLBI’s data sharing and safety monitoring policies. Applications addressing unmet medical needs and knowledge gaps that align with NHLBI’s strategic priorities are encouraged.

The program offers funding for milestone-driven projects with clear timelines, emphasizing contingency planning to prevent delays. Key deliverables in the R61 phase include finalized protocols, IRB approvals, and Good Clinical Practice training, while R33 milestones include recruitment benchmarks and data dissemination. Regular reporting of progress through NHLBI platforms is required, with transition decisions based on milestone achievement.

Key dates include application deadlines of February 3, June 4, and October 2 annually through January 8, 2027. Prospective applicants are advised to engage with NHLBI staff early in the process to align their proposals with program goals and expectations. Further details and contact information are available through the NIH and NHLBI websites.