Opportunity Information: Apply for RFA OD 21 007
The NIH funding opportunity titled "INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Exploratory/Developmental Research Grant Award (R21 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-OD-21-007) supports early-stage, high-impact research ideas aimed at advancing the goals of the INCLUDE Project. The core purpose is to seed new exploratory or developmental studies that respond to critical needs in Down syndrome research, especially research that helps explain, prevent, or better manage health conditions that commonly co-occur with Down syndrome across the lifespan. The R21 mechanism is designed for projects that are still at a formative stage, where preliminary data may be limited, but the scientific premise is strong and the potential payoff is significant.
This FOA is oriented toward innovative, sometimes higher-risk concepts that could open new directions rather than simply extending established work. Examples of the kinds of projects envisioned include feasibility studies that test whether a novel research question or emerging experimental system can work in practice, or projects that apply an existing method in a unique way to answer a new scientific question relevant to Down syndrome and its associated conditions. The emphasis is on ideas that could lead to breakthroughs, or that could produce new tools and resources for the field, such as novel models, agents, methods, technologies, or analytical approaches with broad usefulness for biomedical, behavioral, or clinical research related to Down syndrome.
A key boundary condition is that this is an "R21 Clinical Trial Not Allowed" announcement, meaning applicants cannot propose a clinical trial as defined by NIH policy under this FOA. In practical terms, the projects can still be clinically relevant and may involve human data or clinical populations when appropriate, but the work must not be structured as an interventional clinical trial intended to prospectively assign participants to an intervention to study health-related outcomes. Applicants typically use this type of FOA to build foundational knowledge, develop or validate methods, generate preliminary evidence, or establish feasibility that could later support larger-scale studies through other mechanisms.
Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; and federally recognized Native American tribal governments. Higher education institutions are eligible, including public/state controlled and private institutions of higher education. The FOA also allows applications from nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education), for-profit organizations other than small businesses, and small businesses. In addition, the announcement highlights several categories of "other eligible applicants" 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), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and Indian/Native American Tribal Governments that are not federally recognized.
There are important limits on foreign participation. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" are allowed as defined in the NIH Grants Policy Statement, which generally means a U.S. applicant can include certain elements of the project that involve international collaboration or performance sites when scientifically justified and appropriately documented, even though a foreign institution cannot be the direct applicant.
Administrative details provided in the source data indicate this is a discretionary grant opportunity offered by the National Institutes of Health. The opportunity was created on 2021-09-24, and the original closing date listed is 2022-11-03. Multiple CFDA (now often referenced as Assistance Listing) numbers are associated with the opportunity, reflecting the multi-institute, cross-cutting nature of the INCLUDE initiative and the wide set of NIH programs that may be involved in supporting Down syndrome research aligned with INCLUDE objectives. Overall, the FOA is best read as an entry point for creative, development-focused projects that can quickly test promising ideas and generate momentum toward larger future studies that meaningfully improve understanding of Down syndrome and co-occurring conditions across life stages.Apply for RFA OD 21 007
- The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Exploratory/Developmental Research Grant Award (R21 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): 93.121, 93.173, 93.213, 93.233, 93.310, 93.351, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.855, 93.865, 93.866, 93.867.
- This funding opportunity was created on 2021-09-24.
- Applicants must submit their applications by 2022-11-03. (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 INCLUDE Exploratory/Developmental Research Grant (R21, Clinical Trial Not Allowed) - RFA-OD-21-007
What is this funding opportunity?
This is an NIH discretionary grant funding opportunity titled "INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Exploratory/Developmental Research Grant Award (R21 Clinical Trial Not Allowed)." The Funding Opportunity Number is RFA-OD-21-007.
What is the main goal of this FOA?
The goal is to support early-stage, high-impact exploratory or developmental research that advances the goals of the NIH INCLUDE Project. The focus is on Down syndrome research, especially research that helps explain, prevent, or better manage health conditions that commonly co-occur with Down syndrome across the lifespan.
What kind of grant mechanism is being used?
The FOA uses the NIH R21 mechanism, which is intended for exploratory/developmental projects that may be at a formative stage. Preliminary data may be limited, but the scientific premise should be strong and the potential impact should be significant.
What types of projects are most appropriate for an R21 under this announcement?
This FOA emphasizes innovative, sometimes higher-risk concepts that can open new research directions rather than simply extending established work. Examples described include feasibility studies, testing novel research questions or emerging experimental systems, and applying existing methods in unique ways to answer new scientific questions relevant to Down syndrome and co-occurring conditions.
Is the FOA looking for incremental extensions of existing research programs?
The FOA is oriented toward ideas that could open new directions and seed new exploratory or developmental studies, rather than projects that mainly extend established work.
Does the FOA support development of tools or resources?
Yes. The FOA highlights potential outputs such as new tools and resources for the field, including novel models, agents, methods, technologies, or analytical approaches that could be broadly useful for biomedical, behavioral, or clinical research related to Down syndrome.
Can projects be clinically relevant under this FOA?
Yes. The FOA notes that projects can still be clinically relevant and may involve human data or clinical populations when appropriate, as long as the work is not structured as a prohibited clinical trial under NIH policy for this announcement.
Are clinical trials allowed?
No. This is an "R21 Clinical Trial Not Allowed" announcement. Applicants cannot propose a clinical trial as defined by NIH policy under this FOA.
What does "Clinical Trial Not Allowed" mean in practical terms?
It means the project must not be designed as an interventional clinical trial intended to prospectively assign participants to an intervention in order to study health-related outcomes. The FOA positions this mechanism as a way to build foundational knowledge, develop or validate methods, generate preliminary evidence, or establish feasibility that could support larger studies later through other mechanisms.
What is the focus area within Down syndrome research?
The emphasis is on co-occurring conditions associated with Down syndrome across the lifespan and on research that can improve understanding, prevention, or management of those conditions.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organizations and governmental entities. The FOA lists eligible applicants such as state, county, city or township governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; and federally recognized Native American tribal governments. It also includes public/state controlled and private institutions of higher education, nonprofits with or without 501(c)(3) status (that are not institutions of higher education), for-profit organizations other than small businesses, and small businesses.
Are small businesses eligible?
Yes. Small businesses are explicitly included among eligible applicants.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also listed as eligible.
Are nonprofit organizations eligible even if they do not have 501(c)(3) status?
Yes. The FOA states that nonprofits with or without 501(c)(3) status are eligible, as long as they are not institutions of higher education.
Are institutions of higher education eligible?
Yes. Both public/state controlled institutions of higher education and private institutions of higher education are eligible.
Which types of government entities are eligible?
Eligible government entities listed include state governments, county governments, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities.
Are tribal governments eligible?
Yes. Federally recognized Native American tribal governments are eligible. The FOA also highlights Indian/Native American Tribal Governments that are not federally recognized among "other eligible applicants."
Are certain minority-serving or mission-focused institutions called out as eligible?
Yes. The FOA highlights categories 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), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are specifically mentioned among the "other eligible applicants."
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are included among the "other eligible applicants."
Can a foreign (non-U.S.) organization apply as the main applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization under this FOA.
Can a non-domestic component of a U.S. organization apply?
No. Non-domestic components of U.S. organizations are also not eligible to apply as the applicant organization.
Are any international activities allowed at all?
Yes. The FOA states that "foreign components" are allowed as defined in the NIH Grants Policy Statement. In general terms, a U.S. applicant may include certain elements involving international collaboration or performance sites when scientifically justified and appropriately documented, even though a foreign institution cannot be the direct applicant.
Which federal agency is offering this opportunity?
The opportunity is offered by the National Institutes of Health (NIH).
How is this opportunity connected to the INCLUDE Project?
The FOA is explicitly designed to advance the goals of the NIH INCLUDE Project by seeding new exploratory or developmental studies addressing critical needs in Down syndrome research, especially around co-occurring conditions across the lifespan.
When was the opportunity created and what closing date is listed?
The administrative details provided indicate the opportunity was created on 2021-09-24, and the original closing date listed is 2022-11-03.
What are the CFDA/Assistance Listing numbers for this opportunity?
The source information indicates that multiple CFDA (now often referred to as Assistance Listing) numbers are associated with the opportunity, reflecting the multi-institute and cross-cutting nature of INCLUDE and the range of NIH programs that may support aligned Down syndrome research.
What is the expected value of applying to this FOA if a project is still early?
The FOA is positioned as an entry point for creative, development-focused projects that can quickly test promising ideas, establish feasibility, develop methods, or generate early evidence that could build momentum toward larger future studies through other mechanisms.
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