Opportunity Information: Apply for RFA OD 20 003
The National Institutes of Health (NIH) funding opportunity titled "Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trial Required)" (Funding Opportunity Number RFA-OD-20-003) supports projects that are specifically aimed at getting clinical trials ready to launch and, if early requirements are met, carrying those trials forward. The focus is on developing clinical trials intended to treat important health conditions that commonly occur alongside Down syndrome, with the larger goal of improving health outcomes for this population under the INCLUDE initiative. A central expectation is that the project will be structured around clear, milestone-driven research aims rather than open-ended exploratory work.
This FOA uses the NIH Exploratory/Developmental Phased Innovation award mechanism (R61/R33), which is designed to move a project from early planning and feasibility work into a more advanced, implementation-ready clinical trial phase. The first stage is the R61 phase, which can provide up to two years of support for preliminary, developmental, and planning activities that are necessary to set up a high-quality clinical trial. This can include tasks like finalizing the protocol, establishing operational plans, putting recruitment and retention strategies in place, preparing data management and safety monitoring procedures, confirming feasibility at clinical sites, and completing other trial start-up activities that reduce risk before a larger commitment is made. The R61 phase is not simply a ramp-up period; it is expected to produce measurable progress against predefined milestones.
If the project achieves the required R61 milestones, it may transition to the R33 phase, which provides expanded support for up to four additional years to conduct the clinical trial activities at a larger scale. Even though the R33 phase can be as long as four years, the combined R61 plus R33 project period cannot exceed five total years. In practice, this structure pushes applicants to design a realistic work plan that can demonstrate readiness quickly, and then efficiently execute the trial within the overall time cap. The FOA explicitly requires measurable R61 milestones, meaning applicants must define concrete, objective benchmarks that NIH can use to decide whether the project is ready to move into the R33 phase.
Eligibility is broad and includes many types of U.S.-based organizations and governments. Eligible applicants listed 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; nonprofits with and without 501(c)(3) status (excluding higher education institutions when specified); for-profit organizations other than small businesses; small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized), as well as tribal organizations that are not federally recognized. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
On the international participation rules, the opportunity draws a clear line: non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible to apply, and foreign components (as defined by the NIH Grants Policy Statement) are allowed. In other words, the main applicant must be U.S.-based and eligible, but the project may still include certain foreign components when justified and compliant with NIH policy.
Administratively, this is a discretionary grant program offered by NIH, and it falls under multiple CFDA numbers (including 93.121, 93.173, 93.213, 93.233, 93.307, 93.310, 93.361, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.865, 93.866). The FOA was created on 2019-12-13, and the original closing date listed is 2021-11-03. The provided summary does not specify an award ceiling or the expected number of awards, indicating those details may have been defined elsewhere in the full announcement or depended on available appropriations.
Overall, the opportunity is best understood as a structured, milestone-based pathway for teams that are ready to do the serious groundwork needed to launch a Down syndrome-focused clinical trial targeting co-occurring conditions, with NIH support that can scale from planning and feasibility work (R61) to full trial execution (R33) within a single, tightly managed award framework.Apply for RFA OD 20 003
- The National Institutes of Health in the education, 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 Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.173, 93.213, 93.233, 93.307, 93.310, 93.361, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.865, 93.866.
- This funding opportunity was created on 2019-12-13.
- Applicants must submit their applications by 2021-11-03. (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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FAQs: NIH "Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trial Required)" (RFA-OD-20-003)
What is this funding opportunity?
This NIH funding opportunity supports projects that prepare a clinical trial to launch and, if early requirements are met, continue that work into conducting the trial. It is titled "Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trial Required)" and uses Funding Opportunity Number RFA-OD-20-003.
What is the overall goal of the program?
The goal is to improve health outcomes for individuals with Down syndrome by developing clinical trials intended to treat important health conditions that commonly occur alongside Down syndrome, under the NIH INCLUDE initiative.
What kinds of projects are a good fit for this FOA?
Projects that are specifically aimed at getting a clinical trial ready to launch, including completing trial start-up activities that reduce risk before moving into a larger-scale clinical trial phase. The program expects a clear, structured path from planning/feasibility into trial execution, rather than open-ended exploratory research.
Does this opportunity require a clinical trial?
Yes. The FOA is explicitly labeled "Clinical Trial Required," and the award structure is built around developing and then conducting clinical trial activities.
What award mechanism does this FOA use?
This FOA uses the NIH Exploratory/Developmental Phased Innovation award mechanism (R61/R33), which is designed to move a project from early planning and feasibility work into a more advanced, implementation-ready clinical trial phase.
What is the R61 phase and what is it for?
The R61 phase is the first stage and can provide up to two years of support for preliminary, developmental, and planning activities needed to set up a high-quality clinical trial. It is intended to produce measurable progress toward predefined milestones that demonstrate readiness to move forward.
What activities can be supported during the R61 phase?
Examples of R61 activities described include finalizing the protocol, establishing operational plans, developing recruitment and retention strategies, preparing data management and safety monitoring procedures, confirming feasibility at clinical sites, and completing other trial start-up activities that reduce risk prior to a larger commitment.
Is the R61 phase just a "ramp-up" period?
No. The FOA emphasizes that the R61 phase is not simply a ramp-up period. It is expected to produce measurable progress against predefined, objective milestones.
What are R61 milestones and why do they matter?
R61 milestones are concrete, objective benchmarks that applicants must define. NIH uses these measurable milestones to evaluate whether the project is ready to transition from the R61 phase into the R33 phase.
What is the R33 phase and what does it support?
If the required R61 milestones are achieved, the project may transition to the R33 phase. The R33 phase provides expanded support for up to four additional years to conduct the clinical trial activities at a larger scale.
Is transition from R61 to R33 automatic?
No. Transition is contingent on achieving the required R61 milestones. NIH uses the milestone results to decide whether the project is ready to move into the R33 phase.
How long can the project last in total?
The R61 phase can be up to two years and the R33 phase can be up to four additional years, but the combined R61 plus R33 project period cannot exceed five total years.
If R33 can be up to four years, how does the five-year cap work?
Even though the R33 phase can be as long as four years, the overall R61/R33 award is capped at five years total. This means applicants need a realistic plan that demonstrates readiness quickly and executes the trial efficiently within the total time limit.
What is the FOA's expectation about the type of research aims?
The FOA has a central expectation that the project will be structured around clear, milestone-driven research aims, rather than open-ended exploratory work.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S.-based organizations and governments. Examples listed 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; nonprofits with and without 501(c)(3) status (with certain exclusions noted in the eligibility language); for-profit organizations other than small businesses; small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) and tribal organizations that are not federally recognized.
Are specific institution types highlighted as eligible?
Yes. The FOA highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISI); Historically Black Colleges and Universities (HBCUs); Hispanic-serving Institutions; Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; regional organizations; and U.S. territories or possessions.
Can a non-U.S. organization be the applicant?
No. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply as the applicant organization.
Can the project include any international or foreign components?
Yes, within limits. Non-domestic components of U.S. organizations are eligible to apply, and foreign components (as defined by the NIH Grants Policy Statement) are allowed. The main applicant must be a U.S.-based eligible organization, but certain foreign components may be included when justified and compliant with NIH policy.
What type of grant program is this administratively?
This is a discretionary grant program offered by NIH.
Which CFDA numbers are associated with this opportunity?
This opportunity falls under multiple CFDA numbers, including 93.121, 93.173, 93.213, 93.233, 93.307, 93.310, 93.361, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.865, and 93.866.
When was the FOA created and what is the listed closing date?
The FOA was created on 2019-12-13, and the original closing date listed is 2021-11-03.
Does the summary specify an award ceiling or the expected number of awards?
No. The provided summary does not specify an award ceiling or the expected number of awards, suggesting those details may be addressed elsewhere in the full announcement or may depend on available appropriations.
What is the main takeaway for applicants deciding whether to pursue this FOA?
This opportunity is best understood as a structured, milestone-based pathway for teams that are ready to do the serious groundwork needed to launch a Down syndrome-focused clinical trial targeting co-occurring conditions, with NIH support that can scale from planning and feasibility work (R61) to trial execution (R33) within a single, tightly managed award framework.
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