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.Apply for RFA OD 19 018
- 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.
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Frequently Asked Questions (FAQs)
What is the purpose of this NIH funding opportunity?
This NIH opportunity supports milestone-driven development and execution of clinical trials focused on important health conditions that commonly co-occur in individuals with Down syndrome. The intent is to move promising interventions into well-designed, actionable clinical testing by requiring careful early planning, feasibility work, and clear go/no-go decision points before larger and more expensive trial activities begin.
What is the full title and funding opportunity number (FOA)?
The FOA is titled "Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trials Required)" and the Funding Opportunity Number is RFA-OD-19-018.
How does this opportunity connect to the NIH INCLUDE initiative?
This FOA sits within NIH priorities connected to INCLUDE, an NIH initiative aimed at improving health and quality of life for people with Down syndrome by stimulating targeted research and strengthening the evidence base for prevention and treatment strategies.
What grant mechanism is used, and what does "phased" mean here?
This FOA uses the Exploratory/Developmental Phased Innovation Award mechanism (R61/R33). "Phased" means the project starts with an early, milestone-based development period (R61). Only if predefined milestones are met can the project transition into a larger clinical trial phase (R33).
Are clinical trials required under this FOA?
Yes. The announcement explicitly states "Clinical Trials Required," so the application is expected to include a clinical trial component structured within the R61/R33 phased approach.
What is the R61 phase meant to support?
The R61 phase supports early, developmental, and planning work needed to responsibly initiate a clinical trial in individuals with Down syndrome. This includes trial-readiness activities and feasibility steps that reduce risk before expanding into larger trial operations.
How long can the R61 phase last?
The R61 phase can provide support for up to two years.
What kinds of activities can be included in the R61 phase?
Based on the FOA description, R61 activities may include 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 clinical trial readiness steps.
What are milestones, and why are they central to this FOA?
Milestones are measurable, concrete criteria proposed by the applicant for the R61 phase. NIH uses these milestones as decision-quality go/no-go points to determine whether the project is ready to transition from the R61 development phase to the R33 clinical trial phase. Applications are expected to be organized around these milestones rather than open-ended exploratory aims.
What triggers transition from R61 to R33?
Transition is contingent on successfully meeting the R61 phase milestones. NIH will assess whether the milestones were achieved to determine readiness to move into the expanded clinical trial activities supported under the R33 phase.
What is the R33 phase meant to support?
If the R61 milestones are met, the R33 phase can support expanded clinical trial activities. This phase represents the larger-scale trial effort that follows successful completion of the development and feasibility work.
How long can the R33 phase last?
The R33 phase can provide up to four additional years of support after the R61 phase.
What is the maximum total project period for an R61/R33 award under this FOA?
Although the R61 (up to 2 years) plus the R33 (up to 4 years) could total six years in theory, this FOA explicitly caps the total project period at five years. Applicants need to plan a development-to-trial timeline that fits within a five-year maximum.
Why does the five-year cap matter for application planning?
Because the FOA limits the combined project period to five years, the application needs a realistic schedule that clearly shows what will be accomplished in each phase, when milestones will be reached, and how the overall clinical trial effort will fit within that maximum timeline.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organizations and government entities. Examples listed 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.
Are minority-serving institutions and other specific organization types included as eligible applicants?
Yes. The FOA text explicitly 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), as well as 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.
Can non-U.S. (foreign) organizations apply as the primary applicant?
No. Non-domestic (non-U.S.) entities are not eligible to apply as applicant organizations under this FOA.
Can a U.S. applicant include a non-U.S. component in the project?
Yes, foreign components are allowed as defined in the NIH Grants Policy Statement. This means a U.S. applicant may include certain international collaboration or performance sites if they meet NIH definitions and requirements, even though a foreign institution cannot be the primary applicant.
Are non-domestic components of U.S. organizations eligible to apply?
No. Non-domestic (non-U.S.) components of U.S. organizations are not eligible to apply as the applicant organization under this FOA.
What type of grant program is this considered administratively?
The opportunity is described as a discretionary grant program run by NIH and is categorized under broad public policy areas including health and related social services domains.
Which CFDA numbers are associated with this FOA?
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, and 93.867. This reflects NIH's multi-institute structure and the cross-cutting nature of research on Down syndrome and co-occurring conditions.
When was this opportunity originally posted, and what was the original closing date?
The source information lists an original posting date of 2019-02-05 and an original closing date of 2019-03-14.
Does the provided information include an award ceiling or the expected number of awards?
No. The excerpt does not specify an award ceiling or the expected number of awards. In practice, applicants would typically consult the full FOA text and NIH budget guidance to understand likely award sizes, cost categories, and any institute-specific expectations.
What kinds of research projects are a good fit for this FOA (based on the description provided)?
This FOA is aimed at teams ready to move beyond basic conceptual planning and into structured, milestone-based clinical trial development for interventions that could meaningfully improve outcomes for individuals with Down syndrome who experience significant co-occurring health conditions.
What is the overall philosophy behind the R61/R33 structure for this program?
The phased structure is designed to reduce risk and encourage disciplined project management. It emphasizes careful planning and feasibility in the R61 phase, with progression to expanded trial activities in the R33 phase justified by clear, measurable evidence of readiness.
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