Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Women, and Persons with Disabilities (UG3/UH3 - Clinical Trial Optional)

The National Institutes of Health (NIH), through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), has released a Notice of Funding Opportunity (NOFO) PAR-25-311. This funding initiative aims to leverage NICHD’s clinical research network infrastructure to support innovative, investigator-initiated, multisite clinical trials and observational studies. The populations of interest include infants, children, women—including those who are pregnant or lactating—and individuals with disabilities. The grant operates under a UG3/UH3 phased award cooperative agreement mechanism, where an initial start-up phase (UG3) may last up to two years and, upon meeting milestones, transition to a full implementation phase (UH3) of up to five years, allowing for a total maximum project period of seven years. This NOFO represents a reissue of PAR-23-037 and reflects updated priorities of NICHD, incorporating lessons from previous funding cycles. It supports projects aligned with one or more NICHD-supported Clinical Research Networks. These networks include the Collaborative Pediatric Critical Care Research Network (CPCCRN), Global Network for Women’s and Children’s Health Research (GN), Maternal-Fetal Medicine Units (MFMU) Network, Neonatal Research Network (NRN), and Pelvic Floor Disorders Network (PFDN). Projects must align with the mission of these networks and be submitted in collaboration with their respective Data Coordinating Center (DCC). The grant is intended to generate impactful evidence that can inform clinical care guidelines, influence FDA indications or labeling, and improve health outcomes. Emphasis is placed on studies that utilize pragmatic and innovative designs, real-world data, and approaches that can be incorporated into clinical care settings. The program strongly encourages involvement of junior investigators and supports projects with cost-effective, data-rich, and representative study designs. Investigators interested in studying pharmacologic interventions are encouraged to engage with NICHD’s MPRINT Hub or Pediatric Trials Network. Prior to application submission, a rigorous pre-application process is required, where project feasibility and alignment with NICHD’s priorities are reviewed. Only projects approved during this stage are eligible to submit full applications. Funding is contingent on meeting well-defined milestones in each phase. A maximum of $6,250,000 in direct costs is allowed for both phases combined, although budgets exceeding this cap may be approved through pre-application negotiation. Eligible applicants include a wide range of U.S.-based entities such as academic institutions, government agencies, nonprofit organizations, and small or for-profit businesses. Foreign organizations are not eligible to apply, although foreign components within U.S. institutions may participate. Applications are accepted on a recurring basis with three annual due dates: March 14, July 15, and November 14. The earliest submission date for this cycle is February 15, 2025, with the current opportunity scheduled to expire on November 16, 2027. Applicants must submit through Grants.gov using ASSIST, Workspace, or institutional systems and are required to follow detailed application guidelines. A letter of support from the relevant network Steering Committee is required, and applications must include detailed budgets, milestones, and a data management and sharing plan in compliance with NIH policies. Program contacts include Dr. Robert Tamburro (NICHD) and Dr. Elena Gorodetsky (Office of Research on Women’s Health), who can provide scientific and technical assistance. The peer review contact is Dr. Joanna Kubler-Kielb, and financial/grants management questions can be directed to Margaret Young at NICHD. Applications that do not align with an NICHD Network or lack pre-application approval will be deemed non-responsive and will not be reviewed.

Start early due to required pre-application process. Ensure alignment with NICHD networks. Justify study design and budget with rigorous detail.