Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trials Required) | RFA OD 19 018

Opportunity Information: Apply for RFA OD 19 018

The National Institutes of Health (NIH) grant opportunity titled "Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trials Required)" (Funding Opportunity Number RFA-OD-19-018) is designed to accelerate the development of clinical trials that address important health conditions that commonly co-occur in people with Down syndrome. The overall goal is to move promising interventions toward well-designed, actionable clinical testing, with a strong emphasis on careful planning, feasibility, and clear go/no-go decision points before launching larger and more expensive trial activities. The opportunity sits within NIH priorities tied to INCLUDE, an initiative focused on improving health and quality of life for individuals with Down syndrome by stimulating targeted research and strengthening the evidence base for prevention and treatment strategies.

The award uses a phased mechanism, specifically the Exploratory/Developmental Phased Innovation model (R61/R33), and clinical trials are required under this announcement. In practice, this means applicants are expected to propose a project that starts with an early, milestone-driven development period and, only if that stage is successful, can transition into an expanded clinical trial phase. The first phase, the R61, can support up to two years of preliminary, developmental, and planning work that is necessary to responsibly initiate a clinical trial in this population. This can include activities like protocol finalization, defining endpoints that are meaningful for individuals with Down syndrome, establishing recruitment and retention approaches that work for participants and families, confirming feasibility of study procedures, setting up data and safety monitoring plans, training clinical sites, and completing other trial-readiness steps. A key feature is that the R61 must include measurable milestones, and these milestones function as concrete criteria NIH will use to judge whether the project is ready to move forward.

If the R61 phase milestones are met, the project may transition to the R33 phase, which provides up to four additional years of support for expanded clinical trial activities. Even though the R61 and R33 phases together could add up to six years on paper (two plus four), the FOA explicitly caps the total project period at five years. That cap is important for planning: applicants need to design a realistic development-to-trial timeline that fits within a maximum five-year window and clearly explains what will be accomplished in each phase and when. The phased structure is meant to reduce risk and encourage disciplined project management, so applications are expected to be organized around decision-quality milestones rather than open-ended exploratory aims.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants listed for this opportunity include state, county, city or township, and 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); Native American tribal organizations (other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education when applicable); for-profit organizations other than small businesses; small businesses; and other categories. The FOA also calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions.

At the same time, there are clear restrictions related to foreign participation. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) components of U.S. organizations are not eligible to apply as applicant organizations under this FOA. However, foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a U.S. applicant can include certain types of international collaboration or performance sites if they meet NIH definitions and requirements, even though a foreign institution cannot be the primary applicant.

Administratively, the opportunity is a discretionary grant program run by NIH, and it is categorized under broad public policy areas including health and related social services domains. The FOA is associated with multiple CFDA numbers (93.113, 93.121, 93.172, 93.173, 93.213, 93.233, 93.307, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 93.853, 93.865, 93.866, 93.867), reflecting NIH’s multi-institute structure and the cross-cutting nature of Down syndrome research and co-occurring conditions. The original posting date in the source data is 2019-02-05, with an original closing date of 2019-03-14. The source excerpt does not specify an award ceiling or the expected number of awards, so applicants would typically look to the full FOA text and NIH budget guidance to understand likely award sizes, cost categories, and institute-specific expectations.

In short, this FOA is aimed at investigators and organizations ready to move beyond basic conceptual planning and into structured, milestone-based trial development for interventions that could meaningfully improve outcomes for people with Down syndrome who experience significant co-occurring health conditions. The R61/R33 structure is intended to ensure that early feasibility and readiness work is completed to a high standard, and that progression to the larger clinical trial effort is justified by clear, measurable evidence of preparedness and likelihood of success within a five-year total project period.

• The National Institutes of Health in the education, environment, health, income security and social services sector is offering a public funding opportunity titled "Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trials Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.172, 93.173, 93.213, 93.233, 93.307, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2019-02-05.
• Applicants must submit their applications by 2019-03-14. (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 OD 19 018

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: