Opportunity Information: Apply for RFA OD 27 004
Apply for RFA OD 27 004
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "INCLUDE Project: Transformative Research Awards for Down syndrome (R01 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, 93.233, 93.242, 93.310, 93.350, 93.351, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.855, 93.865, 93.866, 93.867, 93.879.
- This funding opportunity was created on 2026-05-12.
- Applicants must submit their applications by 2028-06-15.
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- The number of recipients for this funding is limited to 4 candidate(s).
- 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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Opportunity Summary:
The NIH INCLUDE Project Transformative Research Awards for Down syndrome (RFA-OD-27-004) is a discretionary NIH grant opportunity designed to push the field toward major leaps in understanding and improving the health and quality of life of people with Down syndrome across the lifespan. It supports high-impact R01 projects that are intentionally bold and unconventional, aiming for work that could reshape existing scientific thinking, introduce entirely new clinical approaches, or produce genuinely transformative tools or technologies relevant to Down syndrome and conditions that commonly occur alongside it.
The core focus is innovation and potential for paradigm-shifting impact rather than incremental progress. NIH is specifically looking for applications from individual investigators or teams proposing research that is groundbreaking, exceptionally original, and potentially field-defining. A key feature of this NOFO is that preliminary data are not required, which lowers the barrier for proposing ideas that are high-risk but logically compelling. Reviewers will still expect a strong scientific rationale: proposals must make a clear, persuasive case that the underlying logic and approach could plausibly lead to a major advance in Down syndrome-related research or in understanding and addressing co-occurring conditions.
The scientific scope is broad. Applicants can propose projects on essentially any topic that is relevant to Down syndrome or its co-occurring conditions, consistent with the INCLUDE Project mission of studying health and disease across the lifespan. That flexibility allows applicants to bring in diverse disciplines, methods, and model systems, as long as the work is anchored in meaningful relevance to Down syndrome and is positioned to be transformative rather than simply additive.
Administratively, this opportunity uses the NIH R01 mechanism and is explicitly labeled “Clinical Trial Not Allowed,” meaning the proposed project cannot include a clinical trial as defined by NIH. The funding instrument type is a grant, and the activity category is health. The opportunity lists an award ceiling of $500,000 and anticipates making about 4 awards, indicating a competitive program with an emphasis on a small number of standout, high-impact projects rather than broad, incremental funding.
Eligibility is intentionally expansive. A wide range of applicant organizations may apply, including state, county, and city governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations (other than small businesses); small businesses; and other eligible entities. International participation is also explicitly supported: non-U.S. organizations may apply as the primary applicant, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed under NIH policy, making global collaborations and non-U.S.-led projects permissible.
Key timing information included in the listing indicates an original closing date of 2028-06-15, and the opportunity was created on 2026-05-12. The program is administered by the National Institutes of Health, and it is associated with multiple CFDA numbers (including 93.121, 93.173, 93.233, 93.242, 93.310, 93.350, 93.351, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.855, 93.865, 93.866, 93.867, and 93.879), reflecting the cross-NIH, multi-institute nature of INCLUDE-related funding. Overall, this NOFO is best suited for applicants with ambitious, well-reasoned concepts that could materially change what is possible in Down syndrome research, even if those ideas are early-stage and not yet backed by extensive preliminary datasets.
FAQs: NIH INCLUDE Project Transformative Research Awards for Down syndrome (RFA-OD-27-004)
What is the NIH INCLUDE Project Transformative Research Awards for Down syndrome (RFA-OD-27-004)?
This is a discretionary NIH grant opportunity under the NIH INCLUDE Project designed to accelerate major leaps in understanding and improving the health and quality of life of people with Down syndrome across the lifespan. It supports R01 research projects that are intentionally bold and unconventional, with the goal of producing paradigm-shifting advances rather than incremental progress.
What kind of projects is NIH trying to fund through this opportunity?
NIH is looking for high-impact projects that are groundbreaking, exceptionally original, and potentially field-defining. The emphasis is on work that could reshape existing scientific thinking, introduce entirely new clinical approaches (without running a clinical trial), or create transformative tools or technologies relevant to Down syndrome and conditions that commonly co-occur with Down syndrome.
Is this opportunity focused on innovation or on incremental research progress?
The core focus is innovation and the potential for paradigm-shifting impact. The opportunity is intended for proposals that go beyond additive or incremental advances and instead aim for genuinely transformative outcomes.
What activity mechanism does this funding opportunity use?
This opportunity uses the NIH R01 mechanism.
Are clinical trials allowed under this funding opportunity?
No. The opportunity is explicitly labeled "Clinical Trial Not Allowed," meaning the proposed project cannot include a clinical trial as defined by NIH.
Are preliminary data required to apply?
No. A key feature of this NOFO is that preliminary data are not required, which is meant to lower the barrier for proposing high-risk but logically compelling ideas.
If preliminary data are not required, what will reviewers expect instead?
Reviewers will still expect a strong scientific rationale. Applications need to make a clear and persuasive case that the underlying logic and approach could plausibly lead to a major advance in Down syndrome-related research or in understanding and addressing co-occurring conditions.
How broad is the scientific scope of eligible research topics?
The scientific scope is broad. Applicants can propose projects on essentially any topic relevant to Down syndrome or its co-occurring conditions, consistent with the INCLUDE Project mission of studying health and disease across the lifespan. The key requirement is that the work is meaningfully anchored to Down syndrome relevance and positioned to be transformative.
Does the opportunity support research across the lifespan?
Yes. The INCLUDE Project mission referenced in the opportunity emphasizes studying health and disease across the lifespan, and the program seeks advances that can improve health and quality of life for people with Down syndrome across life stages.
Can projects involve multiple disciplines, methods, or model systems?
Yes. The opportunity is intentionally flexible and can accommodate diverse disciplines, methods, and model systems, as long as the project is meaningfully relevant to Down syndrome (or co-occurring conditions) and is designed to be transformative.
Who is the ideal applicant for this NOFO?
This NOFO is best suited for individual investigators or teams with ambitious, well-reasoned concepts that could materially change what is possible in Down syndrome research, including early-stage ideas that may not yet have extensive supporting datasets.
What is the maximum award amount (award ceiling) listed for this opportunity?
The opportunity lists an award ceiling of $500,000.
How many awards does NIH expect to make?
The listing anticipates making about 4 awards, signaling a competitive program focused on a small number of standout, high-impact projects.
What is the funding instrument type and activity category?
The funding instrument type is a grant, and the activity category is health.
Which agency is administering this program?
The program is administered by the National Institutes of Health (NIH).
Who is eligible to apply?
Eligibility is expansive and includes many organization types, such as state, county, and city governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations (other than small businesses); small businesses; and other eligible entities.
Are international (non-U.S.) organizations allowed to apply as the primary applicant?
Yes. International participation is explicitly supported, including non-U.S. organizations applying as the primary applicant.
Can a U.S. organization include a non-U.S. component on the project?
Yes. Non-U.S. components of U.S. organizations are eligible.
Are foreign components permitted under NIH policy for this opportunity?
Yes. Foreign components are allowed under NIH policy, which supports global collaborations and non-U.S.-led projects.
What is the application closing date listed in the opportunity?
The listing indicates an original closing date of 2028-06-15.
When was this opportunity created?
The opportunity was created on 2026-05-12.
What does it mean that this is a "discretionary" NIH grant opportunity?
Based on the listing, it is identified as a discretionary NIH grant opportunity. In practical terms within this description, it is positioned as a targeted program designed to push for transformative, high-impact advances in Down syndrome research rather than routine or incremental funding.
What types of outcomes does NIH describe as "transformative" for this award?
Examples described include work that could reshape existing scientific thinking, introduce entirely new clinical approaches (without conducting a clinical trial), or deliver genuinely transformative tools or technologies relevant to Down syndrome and co-occurring conditions.
Are projects required to focus only on Down syndrome, or can they include related conditions?
Projects can focus on Down syndrome and also on conditions that commonly occur alongside Down syndrome, as long as the work is meaningfully relevant to Down syndrome and aligned with the INCLUDE mission across the lifespan.
What CFDA numbers are associated with this opportunity?
The opportunity is associated with multiple CFDA numbers, including 93.121, 93.173, 93.233, 93.242, 93.310, 93.350, 93.351, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.855, 93.865, 93.866, 93.867, and 93.879. This reflects the cross-NIH, multi-institute nature of INCLUDE-related funding.
What does the long list of CFDA numbers imply about the program?
It indicates the opportunity is associated with multiple NIH programs and reflects a cross-NIH, multi-institute structure for INCLUDE-related funding.
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