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)

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Description

The National Institute on Drug Abuse (NIDA), in partnership with other NIH Institutes and the NIH HEAL Initiative, is forecasting a limited competition opportunity to support the Coordinating Administrative Core (HCAC) and the Data Coordinating Center (HDCC) for the HEALthy Brain and Child Development (HBCD) study. The HBCD study is a large, multi-site, longitudinal cohort of approximately 7,200 pregnant women and their children, recruited during the 2nd or 3rd trimester and followed into childhood. The study focuses on neurodevelopmental trajectories and outcomes in children exposed pre- or perinatally to prescription and illicit opioids, marijuana, stimulants, alcohol, and/or nicotine.

The HDCC will coordinate, standardize, and integrate all core data collection, processing, storage, and analytic activities, and facilitate data sharing with the broader scientific community. The HCAC will provide leadership and management for the consortium, including oversight of budget, performance metrics, protocol standardization, policies, and outreach/dissemination.

This is a renewal for the second 5-year funding period. Applications are not being solicited at this time; this notice is provided to allow potential applicants time to develop collaborations and responsive projects.

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Due Dates

• Estimated Application Due Date: October 17, 2025
• Estimated Post Date: July 18, 2025
• Estimated Award Date: July 1, 2026
• Estimated Project Start Date: July 1, 2026

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Funding Amount

• Duration: 5 years (renewal period)
• Award Ceiling/Floor: Not specified in the forecast
• Funding Mechanism: Cooperative Agreement (U24)
• Cost Sharing/Matching: Not required

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Eligibility

• Eligible Organizations:

  • Public and State controlled institutions of higher education
  • Private institutions of higher education
  • State governments
  • County governments
  • Native American tribal governments (Federally recognized)
  • Native American tribal organizations (other than Federally recognized)
  • Nonprofits with 501(c)(3) status (other than institutions of higher education)
  • Eligible federal agencies (including NIH intramural program)

• Key Restrictions:

  • Only investigators who are current PDs/PIs, Co-Investigators, or subcontractors of the HBCD study (funded under RFA-DA-21-023 or RFA-DA-21-022) may apply.
  • Applicants may apply as PD/PI for only one component (HDCC, HCAC, or research site) but may serve as co-investigator on more than one.
  • A multiple PD/PI structure (2–4 PD/PIs) is required.

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Application Process

• This is a forecasted opportunity; applications are not yet being accepted.
• The official Notice of Funding Opportunity (NOFO) is expected to be published in July 2025.
• Potential applicants are encouraged to begin developing collaborations and project plans in anticipation of the NOFO release.
• The application will use the NIH U24 cooperative agreement mechanism.
• Clinical trials are not allowed under this opportunity.

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Additional Information

• The HBCD study includes comprehensive assessments of child and caregiver outcomes, including growth, medical and family history, activity and sleep, biospecimens, social, emotional, and cognitive function, socioenvironmental and cultural factors, and neuroimaging (MRI, EEG).
• The HDCC and HCAC are central to the success of the HBCD consortium, ensuring data quality, standardization, and effective management.
• This is a limited competition renewal; only current HBCD study affiliates are eligible to apply as PD/PI.

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External Links

• NIH Funder Homepage
• Official Grants.gov Opportunity Listing
• Assistance Listing 93.279 – Drug Use and Addiction Research Programs

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Contact Information