The “Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional)” grant is offered through the National Institutes of Health (NIH) and represents a collaborative effort by several NIH components. These include the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), and the Office of Research on Women’s Health (ORWH). The overarching goal of this Notice of Funding Opportunity (NOFO) is to support translational and clinical research that enhances precision medicine for pregnant and lactating women, children, and related populations through the development of innovative tools, models, and therapeutic approaches.

The purpose of this NOFO is to advance translational and clinical research focused on improving precision therapeutics in maternal and pediatric populations, including those with disabilities. It targets three primary objectives: the development of novel tools and technologies with clinical utility; an enhanced understanding of pharmacodynamics and pharmacokinetics influenced by physiological and ontogenetic changes; and the discovery, development, or repurposing of therapeutics for safer, more effective treatment. It encourages the exploration of in vitro, in silico, or real-world models, and the application of machine learning and artificial intelligence in predictive and precision medicine.

Funding is available to support diverse research areas, such as new devices predicting fetal drug exposure, AI-based dosing algorithms, studies on biological therapeutics in neonates, and drug safety prediction methods. Projects must align with the interests of the participating institutes and centers. NIAID and NIDA, for instance, emphasize immune development and substance use disorders, respectively, while NIMH focuses on developing pharmacodynamic markers for psychiatric drugs in children. The inclusion of underrepresented populations and interdisciplinary collaborations is encouraged.

Eligible applicants include a wide range of organizations such as higher education institutions, nonprofits, small and for-profit businesses, local and tribal governments, housing authorities, and international organizations. Foreign entities and components are eligible, provided they comply with NIH requirements. Applicants must complete several registrations including SAM, eRA Commons, and Grants.gov. Submission can be made through the NIH ASSIST system, institutional S2S solutions, or Grants.gov Workspace. A letter of intent is requested 30 days before the chosen application deadline.

Applications must adhere strictly to NIH guidelines. Required elements include a comprehensive research strategy, milestones and timelines, and—if proposing clinical trials involving therapeutics—an initial dose selection rationale. A Data Management and Sharing Plan is also mandatory. NIH expects data, biospecimens, and results to be broadly shared, preferably through repositories such as DASH. Proposals may request any budget size appropriate to the project’s needs, with a maximum project period of five years.

Applications will be reviewed on scientific merit, rigor, innovation, feasibility, investigator expertise, and alignment with NIH priorities. The submission and peer review process follows NIH’s standard multi-phase approach. Applications must be submitted by NIH’s standard dates (February 5, June 5, and October 5), with advisory council reviews and earliest start dates scheduled accordingly. The NOFO remains open until May 8, 2026. All inquiries should be directed to the scientific and grants management contacts listed in the NOFO.