HEAL Initiative: HEALthy Brain and Child Development Study (U01 - Clinical Trial Not Allowed) | RFA DA 21 021

Opportunity Information: Apply for RFA DA 21 021

The funding opportunity titled "HEAL Initiative: HEALthy Brain and Child Development Study (U01 - Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-DA-21-021) is a National Institutes of Health (NIH) cooperative agreement designed to build out the HEALthy Brain and Child Development (HBCD) Study, a large, multi-site research effort under the broader NIH Helping to End Addiction Long-term (HEAL) Initiative. The main purpose is to support research project sites that will contribute to a coordinated consortium focused on understanding brain and child development in the context of early life experiences and exposures that are closely tied to substance use and related health outcomes. Because this is a U01 cooperative agreement, awardees are not operating in isolation; they are expected to work actively with NIH scientific staff, who will assist in guiding, coordinating, and participating in key project activities. The FOA is explicitly "Clinical Trial Not Allowed," meaning applicants need to propose observational and/or other non-trial research activities rather than interventional clinical trials.

This specific FOA solicits applications for "unlinked Research Project Sites." In practice, that means an applicant can propose a research site that will participate in the HBCD Study without being formally linked to a paired or partnered site application under the companion "linked Research Project Sites" announcement (RFA-DA-21-020). The NIH set up parallel, companion announcements to fund the different pieces required to run a national consortium: research sites (both linked and unlinked), a single Consortium Administrative Core (RFA-DA-21-022) to handle overall program administration and coordination, and a single Data Coordinating Center (RFA-DA-21-023) to manage data systems, harmonization, and related coordinating functions. The structure signals that NIH is aiming for standardization across sites, shared protocols and measures, and a common approach to data collection and management so findings can be pooled and compared across diverse populations and locations.

Multiple NIH Institutes and Offices are participating, which is a strong clue about the study's intended scope and the kinds of expertise NIH expects across the consortium. The effort is led within the HEAL Initiative and includes the National Institute on Drug Abuse (NIDA) along with the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the Office of Behavioral and Social Sciences Research (OBSSR), the Office of Research on Womens Health (ORWH), the National Institute of Environmental Health Sciences (NIEHS), and the National Institute on Minority Health and Health Disparities (NIMHD). That mix points to a broad, interdisciplinary agenda spanning neurodevelopment, mental health, substance and alcohol-related exposures, environmental influences, maternal and child health, and health disparities, with an emphasis on rigorous behavioral and social science measurement and attention to sex/gender and womens health considerations.

Eligibility is intentionally broad and includes many types of U.S. organizations and several non-U.S. entities. Eligible applicants listed in the opportunity include state, county, and city/township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits both with and without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other types of organizations. The FOA also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). This breadth is consistent with a national consortium that wants participation from institutions serving diverse communities and the capability to recruit and follow cohorts that reflect the full range of socioeconomic, geographic, and cultural contexts.

In terms of administrative details, the opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument (U01). It is associated with multiple CFDA numbers (93.113, 93.242, 93.273, 93.279, 93.286, 93.307, 93.313, 93.853), reflecting the multi-Institute nature of the program. The sponsoring agency is NIH. The original closing date listed is 2021-03-31, and the opportunity record shows a creation date of 2021-01-11. The publicly shown fields for award ceiling and expected awards are not populated in the provided source, so the summary cannot state a maximum award amount or the anticipated number of awards based solely on the text provided.

Overall, this FOA is best understood as a call for institutions to serve as contributing research sites in a tightly coordinated, NIH-led consortium studying early brain and child development in ways that are highly relevant to the HEAL Initiative's mission. Successful applicants would need to be prepared for a collaborative, protocol-driven environment with strong expectations around coordination, standardized methods, and active engagement with NIH program staff and the broader HBCD consortium infrastructure (including the Administrative Core and Data Coordinating Center funded under the companion announcements).

• The National Institutes of Health in the education, environment, health sector is offering a public funding opportunity titled "HEAL Initiative: HEALthy Brain and Child Development Study (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, 93.242, 93.273, 93.279, 93.286, 93.307, 93.313, 93.853.
• This funding opportunity was created on 2021-01-11.
• Applicants must submit their applications by 2021-03-31. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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