Limited Competition for the HEAL Initiative: HEALthy Brain and Child Development (HBCD) Study (Collaborative U01- Clinical Trial Not Allowed)

The National Institute on Drug Abuse (NIDA), a component of the U.S. Department of Health and Human Services’ National Institutes of Health, has announced a forecasted funding opportunity under the HEAL Initiative. The funding opportunity, identified as FOR-DA-26-002, is titled “Limited Competition for the HEAL Initiative: HEALthy Brain and Child Development (HBCD) Study (Collaborative U01 - Clinical Trial Not Allowed).” This is a limited competition opportunity that will use the U01 cooperative agreement mechanism, with applications solicited from a restricted pool of eligible organizations. The initiative is designed to build upon existing research in child development and continue work initiated during the first five-year phase of the HBCD study. The purpose of this funding opportunity is to advance the HEALthy Brain and Child Development (HBCD) Study, which is one of the largest long-term research efforts of its kind. The study involves a cohort of approximately 7,200 pregnant women and their children, enrolled beginning in the second trimester of pregnancy and followed through childhood. The HBCD study seeks to understand how prenatal and perinatal exposures, including to prescription and illicit opioids, marijuana, stimulants, alcohol, and nicotine, impact brain and behavioral development. By examining these early exposures and developmental trajectories, the program aims to build an evidence base that informs interventions to support resilience and well-being in children. Applicants funded under this competition will be responsible for participant recruitment and retention, conducting behavioral assessments, collecting biospecimens, and administering neuroimaging protocols. These tasks are central to the continuation of the HBCD study’s comprehensive dataset, which integrates biological, behavioral, and neurodevelopmental measures. The cooperative agreement structure indicates that NIH program staff will be actively involved in the project’s scientific and operational management, providing oversight and guidance throughout the award period. The eligibility for this program includes a wide range of organizations such as state governments, county governments, Native American tribal governments (federally recognized), public and state-controlled institutions of higher education, private institutions of higher education, and nonprofits with 501(c)(3) status other than institutions of higher education. For-profit organizations, individuals, and foreign entities are not listed among the eligible applicant types in this forecast. The scope of eligibility suggests NIH’s intent to encourage applications from institutions with significant research capacity and experience in large-scale human cohort studies. As this is a forecasted opportunity, applications are not yet being accepted. The estimated post date for the Notice of Funding Opportunity (NOFO) is November 18, 2025. The estimated application due date is February 17, 2026, with awards expected to be issued by September 1, 2026. Funded projects will begin on September 1, 2026, and are anticipated to cover a five-year project period. There are no cost sharing or matching requirements for applicants. While the estimated number of awards is 27, no total program funding amount, award ceiling, or award floor has been specified in this forecast. Applications submitted will undergo NIH’s standard peer review process, ensuring that only meritorious proposals receive funding. This forecast is being provided in advance to allow applicants sufficient time to build collaborative networks, design responsive projects, and align institutional resources with the goals of the initiative. Interested applicants are encouraged to review eligibility and begin preparing potential proposals well before the official posting date. For more information, potential applicants may contact the program officer, Dr. Janani Prabhakar, at 301-827-4729 or via email at janani.prabhakar@nih.gov.