Opportunity Information: Apply for RFA OD 22 010
The National Institutes of Health (NIH), through the INCLUDE Project (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE), is offering a grant opportunity focused on moving promising treatments for people with Down syndrome closer to well-designed clinical trials. The overall goal is practical and patient-centered: improve health outcomes and day-to-day quality of life by addressing serious, common, and often interconnected medical conditions that occur alongside Down syndrome across the lifespan. This announcement is specifically built to help research teams do the preparatory work needed to launch a rigorous clinical trial, and then, if the early phase work meets predefined targets, to proceed into an actual clinical trial phase with continued NIH support.
This funding uses a phased award structure called R61/R33, described as an Exploratory/Developmental Phased Innovation mechanism, and it is explicitly a clinical trial required program. In plain terms, the award is designed in two parts. The first part, the R61 phase, can last up to two years and is meant for the key groundwork that must be completed before a clinical trial can responsibly begin. That can include activities such as finalizing the intervention and protocol, establishing feasibility, refining recruitment and retention strategies for individuals with Down syndrome, developing or validating outcome measures, setting up clinical sites and operational infrastructure, addressing regulatory requirements, and completing other planning or pilot activities that de-risk the later trial. The second part, the R33 phase, can last up to three additional years and is intended to support the clinical trial itself, provided the project demonstrates that it has successfully met the R61 milestones and is ready to move forward. Across both phases, the total project period cannot exceed five years.
A central feature of this opportunity is that it is milestone-driven, especially during the R61 phase. Applicants are expected to propose clear, measurable milestones that show whether the project is making the necessary progress to justify transition into the R33 clinical trial phase. These milestones are not optional or vague; they are a required part of the application and function like decision points. The NIH will use them to determine whether the project has achieved enough readiness and feasibility to move from development and planning into full trial execution. This structure is intended to reduce the risk of launching clinical trials that are underprepared, underpowered, or operationally infeasible, while still giving strong projects a defined path into an NIH-supported trial.
The opportunity is listed as a discretionary grant program from NIH and falls within broad activity areas that include health and related social service domains. Multiple CFDA numbers are associated with the announcement, reflecting the cross-institute nature of INCLUDE and the wide range of co-occurring conditions and research topics that may fall under different NIH components. The funding opportunity is identified as "Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trial Required)" with the funding opportunity number RFA-OD-22-010. The posting date in the source data is April 5, 2022, and the original closing date is July 1, 2024.
Eligibility is broad and includes many types of organizations that can credibly plan and run clinical research. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. It also includes Native American tribal governments (federally recognized), tribal organizations (other than federally recognized tribal governments), and public housing authorities/Indian housing authorities. In addition, the announcement highlights 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; U.S. territories or possessions; regional organizations; and even non-U.S. entities (foreign organizations), indicating an openness to a wide set of capable research and community partners.
Taken together, this FOA is best understood as a structured pathway for teams who are not just proposing an idea, but who can map out the practical steps to get from concept to a ready-to-launch trial in Down syndrome populations, and then carry out that trial within a defined five-year window. The NIH is signaling that it wants clinical trials that are thoughtfully designed around Down syndrome-specific needs, that address meaningful co-occurring health conditions, and that are supported by concrete preparatory work and go/no-go milestones rather than aspirational plans.Apply for RFA OD 22 010
- 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): 93.173, 93.233, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.865, 93.866, 93.867.
- This funding opportunity was created on 2022-04-05.
- Applicants must submit their applications by 2024-07-01. (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 this funding opportunity?
This is a National Institutes of Health (NIH) INCLUDE Project funding opportunity titled "Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trial Required)." It supports projects that move promising treatments for people with Down syndrome toward well-designed clinical trials, with an emphasis on improving health outcomes and everyday quality of life.
What is the FOA number and key dates listed?
The funding opportunity number is RFA-OD-22-010. The posting date in the provided information is April 5, 2022, and the original closing date is July 1, 2024.
What is the overall goal of the program?
The goal is to improve practical, patient-centered outcomes for people with Down syndrome by addressing serious, common, and often interconnected co-occurring medical conditions across the lifespan, and by supporting the preparatory work needed to run rigorous clinical trials.
What does "INCLUDE" stand for?
INCLUDE stands for INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE.
What is meant by "co-occurring conditions" in this context?
Based on the provided description, co-occurring conditions are medical conditions that occur alongside Down syndrome and may be serious, common, and interconnected across different life stages.
What award mechanism is being used?
This opportunity uses the NIH R61/R33 phased award structure, described as an Exploratory/Developmental Phased Innovation mechanism.
Is a clinical trial required under this opportunity?
Yes. The opportunity is explicitly described as a "clinical trial required" program, and the second phase (R33) is intended to support the clinical trial itself if readiness targets are met.
How do the two phases (R61 and R33) work?
The award is split into two parts. The R61 phase supports early work to prepare for a clinical trial. If predefined milestones are met, the project can transition to the R33 phase, which supports the execution of the clinical trial with continued NIH funding.
How long can the R61 phase last?
The R61 phase can last up to two years.
How long can the R33 phase last?
The R33 phase can last up to three additional years.
What is the maximum project period across both phases?
The total project period across both phases cannot exceed five years.
What kinds of activities are supported during the R61 (pre-trial) phase?
The R61 phase supports key groundwork needed before a clinical trial can responsibly begin. Examples listed include finalizing the intervention and protocol, establishing feasibility, refining recruitment and retention strategies for individuals with Down syndrome, developing or validating outcome measures, setting up clinical sites and operational infrastructure, addressing regulatory requirements, and completing other planning or pilot activities that reduce risk for the later trial.
What happens during the R33 phase?
The R33 phase is intended to support the clinical trial itself, provided the project has successfully met the R61 milestones and is ready to proceed.
What does "milestone-driven" mean for this FOA?
It means applicants are expected to propose clear, measurable milestones (especially for the R61 phase) that function as decision points. NIH uses these milestones to determine whether the project has demonstrated enough readiness and feasibility to transition from R61 planning/development into the R33 clinical trial phase.
Are milestones required in the application?
Yes. The description states that milestones are a required part of the application and are not meant to be optional or vague.
What role do milestones play in transitioning from R61 to R33?
Milestones serve as predefined targets NIH will use to determine whether the project is prepared to move into the R33 clinical trial phase. Transition depends on demonstrating successful completion of R61 readiness and feasibility goals.
Why does NIH use a phased, milestone-based structure here?
The structure is intended to reduce the risk of launching clinical trials that are underprepared, underpowered, or operationally infeasible, while still providing strong projects a defined path into an NIH-supported trial once readiness is demonstrated.
What type of grant program is this described as?
It is described as a discretionary grant program from NIH and falls within broad activity areas that include health and related social service domains.
What are CFDA numbers, and how are they represented here?
The information notes that multiple CFDA numbers are associated with the announcement, reflecting the cross-institute nature of INCLUDE and the wide range of co-occurring conditions and research topics that may fall under different NIH components.
Who is eligible to apply?
Eligibility is broad and includes many types of organizations that can credibly plan and run clinical research, including various government entities, educational institutions, nonprofits, for-profits (other than small businesses), small businesses, tribal governments and organizations, public housing authorities/Indian housing authorities, and additional categories of institutions and organizations highlighted in the announcement.
Are state and local governments eligible?
Yes. Eligible applicants include state governments, county governments, and city or township governments, as well as special district governments.
Are universities and colleges eligible?
Yes. Eligible applicants include public and state-controlled universities and private institutions of higher education. The eligibility list also highlights specific institution types such as HBCUs, TCCUs, and other designated serving institutions.
Are nonprofit organizations eligible?
Yes. Nonprofit organizations with or without 501(c)(3) status are listed as eligible, with the note that these categories apply as long as they are not institutions of higher education within those nonprofit categories.
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 tribal entities eligible?
Yes. Eligibility includes Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments), as well as Tribally Controlled Colleges and Universities (TCCUs).
Are U.S. territories and regional organizations eligible?
Yes. The eligibility list includes U.S. territories or possessions and regional organizations.
Are foreign (non-U.S.) organizations eligible?
Yes. The information explicitly indicates that non-U.S. entities (foreign organizations) are included among eligible applicants.
Does the FOA encourage participation from community-based or faith-based organizations?
Yes. The eligibility description highlights faith-based or community-based organizations among other eligible applicants.
What kinds of projects does NIH appear to be looking for under this FOA?
The description emphasizes teams that can map out practical steps from concept to a trial-ready plan for Down syndrome populations, propose meaningful go/no-go milestones, address Down syndrome-specific needs, and focus on co-occurring health conditions, with the ability to execute the clinical trial within the defined five-year window if milestones are achieved.
Is this FOA mainly for generating new ideas or for preparing and running a trial?
Based on the description, it is designed as a structured pathway for teams to do the preparatory work needed to launch a rigorous trial (R61) and then to carry out the clinical trial (R33) if readiness milestones are met.
What does "patient-centered" mean in the context provided?
In the provided description, "patient-centered" is tied to improving health outcomes and day-to-day quality of life for people with Down syndrome by addressing serious and common co-occurring medical conditions across the lifespan.
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| Funding Opportunity |
|---|
| Transformative Research Award for the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndrome) Project (R01 Clinical Trial Not Allowed) Apply for RFA OD 22 009 Funding Number: RFA OD 22 009 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $6,000,000 |
| INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed) Apply for RFA OD 22 007 Funding Number: RFA OD 22 007 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $275,000 |
| Small Research Grants for Analysis, Curation, and/or Sharing of Down syndrome-related Research Data for the INCLUDE Project (R03 Clinical Trial Not Allowed) Apply for RFA OD 22 008 Funding Number: RFA OD 22 008 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $1,000,000 |
| HEAL Initiative: Team Research for Initial Translational Efforts in Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed) Apply for RFA NS 22 052 Funding Number: RFA NS 22 052 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $1,500,000 |
| BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP (U19 Clinical Trial Not Allowed) Apply for RFA NS 22 040 Funding Number: RFA NS 22 040 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Basic Experimental Studies with Humans Required) Apply for RFA NS 22 041 Funding Number: RFA NS 22 041 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP (U19 Basic Experimental Studies with Humans Required) Apply for RFA NS 22 039 Funding Number: RFA NS 22 039 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Transformative Brain Non-invasive Imaging Technology Development (UG3/UH3 Clinical Trial Not Allowed) Apply for RFA EB 22 001 Funding Number: RFA EB 22 001 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL): Resource Center (U24- Clinical Trial Optional) Apply for RFA DA 23 042 Funding Number: RFA DA 23 042 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $1,500,000 |
| HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL) (R01 Clinical Trial Required) Apply for RFA DA 23 041 Funding Number: RFA DA 23 041 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $750,000 |
| Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATCH-IN) Clinical Research Centers (UG1 Clinical Trial Optional) Apply for RFA HD 23 013 Funding Number: RFA HD 23 013 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| PATC3H Implementation Science Network (PATC3H-IN) Coordination, Translation and Advanced Methods and Analytics Center (UM2 Clinical Trial Optional) Apply for RFA HD 23 014 Funding Number: RFA HD 23 014 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $25,000,000 |
| NIH HEAL Initiative: Coordinated Approaches to Pain Care in Health Care Systems (UG3/UH3 - Clinical Trial Optional) Apply for RFA NS 22 053 Funding Number: RFA NS 22 053 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Brain Behavior Quantification and Synchronization (R61/R33 Clinical Trial Optional) Apply for RFA MH 22 240 Funding Number: RFA MH 22 240 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R33 Clinical Trial Optional) Apply for RFA DA 23 054 Funding Number: RFA DA 23 054 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $750,000 |
| HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional) Apply for RFA DA 23 053 Funding Number: RFA DA 23 053 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $750,000 |
| HEAL Initiative: Translational Development of Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed) Apply for RFA EB 22 002 Funding Number: RFA EB 22 002 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $750,000 |
| HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R01 Clinical Trial Not Allowed) Apply for RFA HD 23 030 Funding Number: RFA HD 23 030 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R21 Basic Experimental Studies with Humans Required) Apply for RFA HD 23 033 Funding Number: RFA HD 23 033 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R21 Clinical Trial Not Allowed) Apply for RFA HD 23 031 Funding Number: RFA HD 23 031 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
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