Limited Competition for the HEAL Initiative: HEALthy Brain and Child Development (HBCD) Study Coordinating Administrative Core and Data Coordinating Center (U24 Clinical Trial Not Allowed)

The National Institute on Drug Abuse (NIDA), operating under the U.S. Department of Health and Human Services and in collaboration with other NIH Institutes and Centers, will release a Notice of Funding Opportunity (NOFO) under the NIH HEAL (Helping to End Addiction Long-term) Initiative. This forthcoming opportunity will focus on supporting two critical components of the HEALthy Brain and Child Development (HBCD) study: the Coordinating Administrative Core (HCAC) and the Data Coordinating Center (HDCC). The NOFO will use the U24 cooperative agreement mechanism and is classified as a limited competition. The HBCD study is a large, ongoing longitudinal research effort that follows approximately 7,200 pregnant women and their children through childhood. It captures a wide range of developmental data to understand the impact of pre- and perinatal exposure to substances such as opioids, marijuana, stimulants, alcohol, and nicotine. The study also collects biospecimens and uses neuroimaging (MRI and EEG) to monitor early brain development in relation to environmental, cognitive, and social-emotional influences. This funding opportunity will provide support for the HCAC and HDCC roles, which are essential to the operation and governance of the HBCD consortium. The HDCC is tasked with coordinating and standardizing all data-related activities, including collection, storage, processing, and analysis. It also manages external data sharing to facilitate broad scientific use of the data. Meanwhile, the HCAC is responsible for the leadership and strategic direction of the entire HBCD consortium. This includes oversight of budgets, performance metrics, protocol implementation, and outreach and dissemination strategies. Eligibility is limited to institutions or investigators who have participated in the prior HBCD study through RFA-DA-21-023 or RFA-DA-21-022, as a PD/PI, co-investigator, or subcontractor. Moreover, applications must include a Multiple PD/PI structure consisting of two to four investigators. Eligible applicant institutions include federally recognized tribal governments, state and county governments, higher education institutions (public and private), and 501(c)(3) nonprofit organizations not classified as higher education institutions. NIH intramural program investigators are also eligible. The opportunity is currently in a forecasted stage, with the application window estimated to open on 2025-11-18 and close on 2026-02-17. Awards are expected to be made by 2026-09-01, with project start dates aligning the same day. No cost sharing or matching funds are required. The NOFO will provide a renewed five-year funding period, continuing from the initial cohort study. While no funding amounts are currently listed, applicants can anticipate substantial funding consistent with similar NIH cooperative agreements. Further inquiries should be directed to Janani Prabhakar, PhD, at the National Institute on Drug Abuse. She can be contacted via email at janani.prabhakar@nih.gov or by phone at 301-827-4729. This forecasted NOFO is intended to provide potential applicants adequate time to build collaborations and prepare responsive proposals.