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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Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
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The National Institute on Drug Abuse (NIDA), in collaboration with other NIH Institutes and Centers and the NIH HEAL Initiative, plans to issue a Notice of Funding Opportunity (NOFO) for a limited competition to support the Coordinating Administrative Core (HCAC) and Data Coordinating Center (HDCC) of the HEALthy Brain and Child Development (HBCD) study. This initiative aims to renew funding for the second five-year period of the HBCD project, which tracks a cohort of approximately 7,200 pregnant women and their children from the second or third trimester of pregnancy into childhood. The cohort includes children exposed prenatally or perinatally to various substances such as opioids, marijuana, stimulants, alcohol, and nicotine, with comprehensive multi-domain assessments encompassing growth, medical and family history, behavioral and cognitive outcomes, biospecimens, socioenvironmental factors, and brain imaging. The HDCC plays a critical role in managing and harmonizing all data-related activities, including collection, processing, storage, and analysis, while facilitating data sharing with the broader scientific community. Meanwhile, the HCAC oversees overall leadership and management of the consortium, including budget oversight, performance monitoring, protocol standardization, policy development, and outreach efforts. Applications for this limited competition, classified under the U24 activity code and excluding clinical trials, will undergo standard NIH peer review with funding awarded based on merit. This announcement serves to inform potential applicants to prepare collaborative and responsive proposals ahead of the forthcoming solicitation.
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The National Institute on Drug Abuse (NIDA), with other NIH Institutes and Centers (ICs) including the NIH HEAL Initiative intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for the Coordinating Administrative Core (HCAC) and the Data Coordinating Center (HDCC) for the HEALthy Brain and Child Development (HBCD) study. This is a Forecast for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Eligibility Section for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.
HBCD is a large cohort of pregnant women and their children (~N = 7,200 dyads) recruited during their 2nd or 3rd trimester of pregnancy and followed longitudinally into childhood. This is a renewal that will continue the funding for the second 5-year period. The HBCD cohort includes babies exposed pre- or perinatally to prescription and illicit opioids, marijuana, stimulants, alcohol and/or nicotine, and the study protocol includes assessments that span multiple domains of child and caregiver outcomes, including measures of growth, medical and family history, activity and sleep levels, biospecimens, social, emotional, and cognitive function, socioenvironmental and cultural factors, and brain indices using MRI and EEG. The HDCC coordinates, standardizes, and integrates all core data collection, processing, storage, and analytic activities of the consortium, and facilitates data sharing to the broader scientific community to enable broad use of HBCD data. The HCAC is responsible for leadership and management of the HBCD consortium; including, budget, performance metrics, protocol standardization, policies, outreach and dissemination plans across the consortium Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This limited competition NOFO will utilize the U24 activity code.
