HEAL Initiative: Limited Competition for the HEALthy Brain and Child Development Study - Research Project Sites (Collaborative U01- Clinical Trial Not Allowed) | RFA DA 27 013

Opportunity Information: Apply for RFA DA 27 013

The NIH is offering a limited-competition funding opportunity under the HEAL Initiative to renew the HEALthy Brain and Child Development (HBCD) Study Research Project Sites. This program uses the cooperative agreement mechanism (Collaborative U01) and is explicitly designated as clinical trial not allowed. The goal is to continue and strengthen a nationwide, multi-site, longitudinal research effort that follows children from birth through childhood to understand how early life experiences shape brain and behavioral development, with particular emphasis on the impacts of prenatal substance exposure on later health and developmental outcomes. As a renewal-focused competition, the intent is to maintain continuity of established sites and preserve the scientific value of ongoing cohort follow-up, harmonized measures, and shared infrastructure across the consortium.

The HBCD Study is structured as a tightly coordinated consortium with three interdependent parts. First are the linked Research Project Sites, which are the primary locations where participants are recruited and followed over time and where core study procedures and assessments are carried out. Second is a single Consortium Administrative Core (HCAC), which provides overall operational leadership, consortium-wide coordination, and administrative management. Third is a single central Data Coordinating Center (HDCC), which supports data management, harmonization, quality control, and cross-site integration so that the study functions as one coherent national platform rather than a collection of separate projects. Because these components are designed to work as a unified system, this NOFO for Research Project Sites runs alongside a companion NOFO that solicits applications for the HCAC and HDCC (RFA-DA-27-014). Applicants to this sites NOFO should expect close interconnection with those central components in day-to-day study execution.

A key feature of this opportunity is the cooperative agreement structure, which signals that NIH will have substantial scientific and programmatic involvement beyond typical grant stewardship. Funded investigators are expected to work jointly with NIH scientific staff to assist, guide, coordinate, and participate in consortium activities. In practice, that generally means aligning with shared protocols and common data elements, participating in consortium governance and working groups, adhering to coordinated timelines and quality standards, and contributing to cross-site problem solving so that recruitment, retention, assessment, and data flows remain consistent and comparable over time. The cooperative model is meant to support rigorous standardization and collaboration across sites, which is essential for a large-scale longitudinal study intended to generate broadly usable, high-impact datasets and findings.

Eligibility is intentionally narrow because this is a limited competition tied to renewing existing HBCD infrastructure. Only organizations (or their subrecipients) that were previously funded under RFA-DA-21-020 or RFA-DA-21-021 are eligible to apply. This restriction reflects the renewal purpose of the NOFO and the need to sustain continuity in established cohorts, site capacity, staffing expertise, and standardized procedures that have already been developed under the earlier awards. The NOFO notes that applications will undergo standard NIH peer review, and only proposals judged meritorious will be considered for funding, even within the limited pool of eligible applicants.

The opportunity also allows international involvement in several forms. Non-U.S. entities (foreign organizations) are eligible to apply, non-U.S. components of U.S. organizations are eligible, and foreign components as defined in the NIH Grants Policy Statement are allowed. This flexibility can support specific expertise, populations, or technical capabilities that may reside outside the United States, while still operating within the consortium framework and the study’s harmonized approach.

Administrative details provided in the notice include the NOFO number RFA-DA-27-013 and an original closing date of July 10, 2026. The funding instrument is a cooperative agreement, and the activity category is health. The notice anticipates making 26 awards, reflecting the scale of the multi-site network. Multiple CFDA numbers are listed, indicating that several NIH funding authorities and institutes or centers may be involved in supporting components of the work under the broader HEAL Initiative umbrella. Overall, the opportunity is best understood as a renewal and continuation mechanism for the existing HBCD Research Project Sites, designed to keep a large, coordinated national study on track as it follows children longitudinally and examines how prenatal substance exposure and related early-life factors shape neurodevelopment and health.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "HEAL Initiative: Limited Competition for the HEALthy Brain and Child Development Study - Research Project Sites (Collaborative U01- Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.242, 93.273, 93.279, 93.286, 93.307, 93.313, 93.853, 93.865, 93.867.
• This funding opportunity was created on 2026-06-10.
• Applicants must submit their applications by 2026-07-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 26 candidate(s).
• Eligible applicants include: Others.

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