Opportunity Information: Apply for RFA OD 27 005
The National Institutes of Health (NIH) is offering a discretionary grant opportunity under the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project to advance clinical research that improves health outcomes and quality of life for people with Down syndrome. The funding opportunity is titled "INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)" and is published as RFA-OD-27-005. It uses the Exploratory/Developmental Phased Innovation mechanism, meaning applicants propose a two-stage plan where early work must successfully meet clear, pre-set milestones before moving into the later, larger clinical trial stage.
At the center of this program is the expectation that projects will directly support the development of clinical trials aimed at treating important and often co-occurring health conditions experienced by individuals with Down syndrome. The NOFO is designed for milestone-driven research, so applications should lay out specific, measurable goals and decision points rather than broad exploratory aims. In practice, that means the proposal should explain what must be accomplished in the initial phase to justify launching or expanding into the actual clinical trial phase, and how progress will be judged in an objective way.
The award is structured in two phases over a maximum total project period of five years. The first phase (R61) can last up to two years and is intended for preliminary, developmental, and planning activities that position the team to run a strong clinical trial. This can include activities like finalizing intervention protocols, establishing feasibility, refining study design, building recruitment and retention strategies tailored to Down syndrome populations, confirming outcome measures, strengthening site readiness, or completing other preparatory steps needed to confidently initiate the trial. Transition to the second phase (R33) is not automatic; it is contingent on meeting the required R61 milestones. If those milestones are met, the project may move into the R33 phase, which can provide up to three additional years of support focused on conducting the clinical trial. Even with both phases, the combined duration cannot exceed five years.
A key feature of this NOFO is that measurable R61 milestones are required. Applicants are expected to propose concrete milestones that NIH can use to determine whether the project is ready to proceed into the clinical trial phase. This milestone requirement is central to the phased award design: it creates a go/no-go framework intended to reduce risk and ensure that only projects demonstrating sufficient readiness and feasibility move forward into the more resource-intensive clinical trial stage.
Eligibility is broad and includes many types of domestic applicants such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other organizations. International participation is explicitly allowed: non-U.S. entities (foreign organizations) may apply, non-U.S. components of U.S. organizations are eligible, and foreign components are permitted as defined by NIH Grants Policy. Applicants are directed to the NOFO's eligibility section for any additional conditions or details that may apply.
From an administrative standpoint, the opportunity is run by NIH and is categorized under the health funding activity area, with multiple CFDA numbers listed (93.173, 93.233, 93.310, 93.350, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.865, 93.866), reflecting the multi-institute nature of INCLUDE-related efforts. NIH anticipates making about four awards through this announcement. The posting indicates an original closing date of 2028-06-15, suggesting multiple submission cycles or a longer open window, though applicants should verify application due dates, receipt cycles, and any special submission instructions in the full NOFO. No award ceiling is specified in the provided summary, so budget expectations and limits would need to be confirmed in the full announcement and relevant NIH budget guidance.
Overall, this NOFO is aimed at teams prepared to move beyond basic discovery and into clinical testing, while still acknowledging that meaningful trial-ready preparation work is often needed first. The program is structured to fund that early, practical groundwork (R61) and then, only if milestones show the project is truly ready, support the execution of the clinical trial itself (R33) within a single, integrated five-year plan.Apply for RFA OD 27 005
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (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): 93.173, 93.233, 93.310, 93.350, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.865, 93.866.
- This funding opportunity was created on 2026-05-13.
- Applicants must submit their applications by 2028-06-15.
- 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Frequently Asked Questions (FAQs)
What is this NIH funding opportunity?
This is a discretionary grant opportunity from the National Institutes of Health (NIH) under the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project. The funding opportunity title is "INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)" and it is published as RFA-OD-27-005.
What is the overall goal of this opportunity?
The program is intended to advance clinical research that improves health outcomes and quality of life for people with Down syndrome. It is specifically focused on supporting the development and conduct of clinical trials aimed at treating important and often co-occurring health conditions experienced by individuals with Down syndrome.
What grant mechanism is being used?
The opportunity uses the Exploratory/Developmental Phased Innovation mechanism (R61/R33). Applicants propose a two-stage plan where work in the first stage must successfully meet clear, pre-set milestones before the project can move into the later, larger clinical trial stage.
What does "clinical trial required" mean in this NOFO?
Based on the description provided, this funding opportunity expects projects to directly support the development of clinical trials and, if milestones are met, to conduct the clinical trial in the second phase. In other words, the program is designed around preparing for and then running a clinical trial rather than only conducting early exploratory research.
How is the award structured across phases?
The award is structured in two phases over a maximum total project period of five years:
- R61 phase: Up to 2 years for preliminary, developmental, and planning activities to position the team to run a strong clinical trial.
- R33 phase: Up to 3 additional years to conduct the clinical trial, only if the R61 milestones are met.
The combined duration of both phases cannot exceed five years.
Is transition from the R61 phase to the R33 phase automatic?
No. Transition to the R33 phase is not automatic. It is contingent on successfully meeting the required R61 milestones. The phased design creates a go/no-go decision framework.
What kinds of activities are appropriate for the R61 (first) phase?
The R61 phase supports preparatory work that positions the team to confidently initiate a clinical trial. Examples described include:
- Finalizing intervention protocols
- Establishing feasibility
- Refining study design
- Building recruitment and retention strategies tailored to Down syndrome populations
- Confirming outcome measures
- Strengthening site readiness
- Other preparatory steps needed to initiate the trial
What is expected during the R33 (second) phase?
If the project meets the R61 milestones, the R33 phase can provide up to three additional years of support focused on conducting the clinical trial.
What are R61 milestones and why are they important?
Measurable R61 milestones are required and are central to this NOFO. Applicants are expected to propose concrete, objective milestones that NIH can use to determine whether the project is ready to proceed into the clinical trial phase. These milestones function as decision points for a go/no-go transition into the R33 stage.
How should an application describe milestones?
Applications are expected to lay out specific, measurable goals and decision points rather than broad exploratory aims. The proposal should clearly explain what must be accomplished in the initial phase to justify launching or expanding into the clinical trial phase and how progress will be judged in an objective way.
What types of organizations are eligible to apply?
Eligibility is broad and includes many types of domestic applicants, including:
- State, county, and local governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized tribal governments and other tribal organizations
- Public housing authorities/Indian housing authorities
- Nonprofits with or without 501(c)(3) status (other than institutions of higher education)
- For-profit organizations (other than small businesses)
- Small businesses
- Other organizations
Are non-U.S. (foreign) organizations allowed to apply?
Yes. International participation is explicitly allowed. Non-U.S. entities (foreign organizations) may apply, non-U.S. components of U.S. organizations are eligible, and foreign components are permitted as defined by NIH Grants Policy.
Who is running and funding this opportunity?
The opportunity is run by the National Institutes of Health (NIH) and is categorized under the health funding activity area.
Is this opportunity connected to multiple NIH institutes or programs?
Yes. Multiple CFDA numbers are listed (93.173, 93.233, 93.310, 93.350, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.865, 93.866), reflecting the multi-institute nature of INCLUDE-related efforts.
How many awards does NIH expect to make?
NIH anticipates making about four awards through this announcement.
What is the closing date listed for this opportunity?
The posting indicates an original closing date of 2028-06-15. The summary suggests there may be multiple submission cycles or a longer open window, but applicants should verify application due dates, receipt cycles, and any special submission instructions in the full NOFO.
Is there a maximum award amount (budget ceiling) stated in the summary?
No award ceiling is specified in the provided summary. Budget expectations and limits would need to be confirmed in the full announcement and relevant NIH budget guidance.
What makes this NOFO different from a typical single-phase research grant?
This NOFO is explicitly milestone-driven and uses a phased structure. It funds early, practical groundwork (R61) and then supports the execution of the clinical trial (R33) only if pre-specified milestones show the project is truly ready, all within an integrated five-year plan.
What kind of projects is this opportunity best suited for?
It is aimed at teams prepared to move beyond basic discovery and into clinical testing, while recognizing that meaningful trial-ready preparation work is often needed first.
Browse more opportunities from the same category: Health
Previous opportunity: Community-Partnered Nursing Research Centers (P20 Clinical Trial Optional)
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA OD 27 005
Applicants also applied for:
Applicants who have applied for this opportunity (RFA OD 27 005) also looked into and applied for these:
| Funding Opportunity |
|---|
| INCLUDE Project: Transformative Research Awards for Down syndrome (R01 Clinical Trial Not Allowed) Apply for RFA OD 27 004 Funding Number: RFA OD 27 004 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| Discovery of in vivo Chemical Probes for the Nervous System (R01 Clinical Trial Not Allowed) Apply for PAR 27 081 Funding Number: PAR 27 081 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21) Apply for RFA OH 26 015 Funding Number: RFA OH 26 015 Agency: Centers for Disease Control and Prevention - ERA Category: Health Funding Amount: $365,000 |
| Coccidioidomycosis Collaborative Research Centers (P01 Clinical Trial Not Allowed) Apply for RFA AI 27 012 Funding Number: RFA AI 27 012 Agency: National Institutes of Health Category: Health Funding Amount: $1,200,000 |
| Garrett Lee Smith State/Tribal Youth Suicide Prevention and Early Intervention Program Apply for SM 26 010 Funding Number: SM 26 010 Agency: Substance Abuse and Mental Health Services Adminis Category: Health Funding Amount: $735,000 |
| Community Programs for Youth and Young Adults at Clinical High Risk for Psychosis Apply for SM 26 012 Funding Number: SM 26 012 Agency: Substance Abuse and Mental Health Services Adminis Category: Health Funding Amount: $650,000 |
| Enhancing Understanding of and Preparedness for Public Health Threats Through Research in Kenya Apply for RFA JG 26 034 Funding Number: RFA JG 26 034 Agency: Centers for Disease Control and Prevention - ERA Category: Health Funding Amount: $6,000,000 |
| Tuberculosis Research Advancement Centers (TRACs) (P30 Clinical Trial Not Allowed) Apply for RFA AI 27 016 Funding Number: RFA AI 27 016 Agency: National Institutes of Health Category: Health Funding Amount: $600,000 |
| Providers Clinical Support System – Substance Use Disorder Treatment (PCSS-SUD Treatment) Apply for TI 26 002 Funding Number: TI 26 002 Agency: Substance Abuse and Mental Health Services Adminis Category: Health Funding Amount: $3,000,000 |
| Disaster Distress Helpline (Short Title: DDH) Apply for SM 26 011 Funding Number: SM 26 011 Agency: Substance Abuse and Mental Health Services Adminis Category: Health Funding Amount: $1,953,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA OD 27 005", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.