HEAL Initiative: Limited Competition: Data Coordinating Center for Completion of the Outcomes of Babies with Opioid Exposure (OBOE) Study (U24 Clinical Trial Not Allowed) | RFA HD 24 015

Opportunity Information: Apply for RFA HD 24 015

This funding opportunity is a limited-competition NIH cooperative agreement (U24; clinical trial not allowed) under the Helping to End Addiction Long-term (HEAL) Initiative, administered through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Its purpose is narrowly defined: it invites an application specifically from the institution that is already serving as the Data Coordinating Center (DCC) for the Outcomes of Babies with Opioid Exposure (OBOE) consortium. The intent is not to launch a new study or bring in a new coordinating site, but to provide support so the current DCC can finish the ongoing OBOE study work and complete follow-up of enrolled participants.

The core activities implied by this NOFO revolve around data coordination responsibilities needed to bring a multi-site consortium study to completion. In practice, a DCC in this context typically manages and harmonizes study data across sites, oversees data quality and consistency, maintains or supports study databases and reporting systems, coordinates data submissions and timelines, and helps ensure that follow-up data are captured and curated in a way that supports final analyses and closeout. Because the announcement emphasizes completion and follow-up, the work is oriented toward wrapping up remaining study operations, ensuring complete and accurate longitudinal data collection, and supporting the consortium in producing the final, usable dataset and associated outputs.

The mechanism is a cooperative agreement, which means NIH expects substantial involvement during the project rather than a fully hands-off grant. While the text provided does not list specific cooperative agreement terms, the U24 structure generally signals an ongoing partnership where NIH program staff may participate in coordination, oversight, and milestone-driven progress to ensure the study finishes on time and according to agreed standards. The “clinical trial not allowed” designation indicates that the application should not propose a new clinical trial; the emphasis is on completing existing study activities and coordinating the data infrastructure and processes needed for that completion.

Eligibility is described in two layers. First, the competition is functionally limited to the institution that is currently participating as the OBOE Data Coordinating Center, since the NOFO is explicitly seeking an application from that current DCC to complete the work. At the same time, the NOFO lists a broad range of applicant organization types that NIH commonly allows for many opportunities, including state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized governments; nonprofit organizations with or without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other eligible entities. It also highlights categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, tribal governments other than federally recognized, and U.S. territories or possessions.

There are clear restrictions related to foreign involvement. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. In addition, foreign components as defined by the NIH Grants Policy Statement are not allowed. In other words, the applicant organization and the work proposed under this award must remain within allowable domestic boundaries as defined by NIH policy for this announcement.

Administrative details included in the source information identify the opportunity as RFA HD 24 015, categorized as discretionary funding, with a cooperative agreement funding instrument. The activity category is listed as Health, Income Security and Social Services, and the CFDA numbers associated with it are 93.213 and 93.865. The opportunity was created on 2023-10-19, and the original closing date was 2023-12-19. The award ceiling and expected number of awards are not specified in the provided excerpt, which usually means applicants need to consult the full NOFO text for budget limits, project period expectations, and any specific milestone or deliverable requirements tied to the completion of OBOE.

Overall, the defining feature of this grant is its limited-competition nature and its completion-focused scope: it is designed to ensure the existing OBOE consortium Data Coordinating Center has the resources and authority, under close NIH collaboration, to finish participant follow-up and finalize the data coordination work needed to complete the study rather than expand it or initiate new clinical trial activity.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "HEAL Initiative: Limited Competition: Data Coordinating Center for Completion of the Outcomes of Babies with Opioid Exposure (OBOE) Study (U24 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): 93.213, 93.865.
• This funding opportunity was created on 2023-10-19.
• Applicants must submit their applications by 2023-12-19. (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.

Apply for RFA HD 24 015

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