HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required) | RFA HD 21 031

Opportunity Information: Apply for RFA HD 21 031

The funding opportunity titled "HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required)" (Funding Opportunity Number RFA-HD-21-031) is a National Institutes of Health (NIH) cooperative agreement aimed at improving clinical care for infants with Neonatal Opioid Withdrawal Syndrome (NOWS). The core purpose of the announcement is to support Clinical Centers that will take part in designing and carrying out a multi-center, comparative effectiveness randomized controlled trial (RCT) focused on identifying the best pharmacological treatment approach for NOWS. In practical terms, this means the funded sites are expected to do more than simply enroll participants; they are intended to help implement a coordinated, rigorously designed trial that directly compares medication-based treatment strategies in real clinical settings to determine which options lead to better outcomes for affected newborns.

This initiative sits within the broader HEAL (Helping to End Addiction Long-term) Initiative, which emphasizes research that can produce actionable, evidence-based solutions to the opioid crisis. Within that context, the trial described in the FOA is meant to fill an important evidence gap: despite widespread clinical need, practice can vary across hospitals and regions when it comes to which medications are used for NOWS and how those medications are administered and tapered. A comparative effectiveness RCT is designed to address that variability by generating head-to-head evidence under controlled conditions, with the goal of informing clinical standards and improving consistency and quality of care across health systems.

The award mechanism is a UG1 cooperative agreement, which signals substantial NIH involvement during the project period. Unlike a standard research grant where the grantee typically has broad autonomy, a cooperative agreement usually includes significant programmatic collaboration with NIH staff, shared expectations about milestones, and coordination across participating sites. The "Clinical Trial Required" designation also makes clear that the central activity must be a clinical trial, and applicants should be prepared to operate within NIH clinical trial rules, reporting expectations, and oversight requirements typical of a multi-site RCT environment.

Eligibility is broad and includes many types of U.S.-based organizations and governmental units. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private 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; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Indian/Native American Tribal Governments other than federally recognized entities, regional organizations, eligible agencies of the federal government, and U.S. territories or possessions. At the same time, the opportunity clearly excludes non-domestic (non-U.S.) entities and foreign institutions, and it also disallows non-domestic components of U.S. organizations as well as any foreign components as defined in the NIH Grants Policy Statement.

From an administrative standpoint, the opportunity is categorized as discretionary funding and falls under the Health, Income Security and Social Services activity category, with CFDA number 93.865. The posting indicates an award ceiling of $150,000, a creation date of January 11, 2021, and an original closing date of March 30, 2021. While the number of expected awards is not specified in the provided source data, the structure of a multi-center RCT implies that NIH anticipated supporting multiple clinical sites that could work together under a shared protocol and coordinated study governance.

Overall, this FOA is best understood as NIH seeking capable, research-ready clinical sites to participate in a coordinated, multi-center randomized trial that directly compares medication treatments for NOWS. The intended result is stronger, more definitive evidence to guide neonatal withdrawal pharmacotherapy and improve outcomes for newborns experiencing withdrawal after prenatal opioid exposure.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
• This funding opportunity was created on 2021-01-11.
• Applicants must submit their applications by 2021-03-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $150,000.00 in funding.
• 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.

Apply for RFA HD 21 031

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