National Institutes of Health · Department of Health and Human Services
INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)
Key facts
- Deadline
- Due Jun 15, 2028 · 617 days left
- Award size
- Not stated: see the official notice
- Total available
- $3M · about 4 awards
- Match ?
- Not required · Work out your budget and match
- Who can apply
- City or town government, School district, County government, Private college or university, Special district (utility, fire, etc.), Public college or university, Nonprofit without 501(c)(3), State government, Tribal government, Nonprofit with 501(c)(3), Small business, Larger business, Tribal organization, and others named in the official notice
- Where
- Anywhere in the U.S., including Tennessee
Before you apply: federal grants require an active SAM.gov registration (Unique Entity ID) and a Grants.gov account. Registration is free but can take weeks, so start now, not when the deadline is close. Get-ready checklist
How this fits you
- Available in Hamilton County (nationwide program)
- No match required
- Past Tennessee awards on file: 1116
Tell us who you are to see whether you're eligible.
Official notice: https://simpler.grants.gov/opportunity/ce88b262-95b3-4f53-942d-41dc3ff2fa7f · Printed from grantme.click/grants/7eedf278-380d-43f4-be8b-90ebf44d92e9
View on Grants.gov Add deadline to my calendar
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About this grant
The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. The purpose of this Notice of Funding Opportunity (NOFO) encourages Exploratory/Developmental Phased Innovation (R61/R33) grant applications to support development of clinical trials to treat critical and co-occurring health conditions in individuals with Down syndrome. The proposed research aims should be milestone-driven. The total project period for an application submitted in response to this NOFO may not exceed five years. This NOFO provides support for up to two years (R61 phase) for preliminary/developmental/planning studies, followed by possible transition to clinical trial support (R33) of up to three years, although the total duration of the award may not exceed five years. This NOFO requires measurable R61 milestones.
Who can apply, from the official notice
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Your schedule, working back from the deadline
- Oct7
Check that your SAM.gov registration is active (or start it now)
Grants.gov: allow up to 10 business days for SAM registration, weeks or months if information isn't verified. It must be renewed every year. Grants.gov - May25
Ask partners for letters of support or commitment
Suggested: partners need about three weeks to write and sign letters. - Jun8
Finish a complete draft for a final review
Suggested: leave about a week for someone else to read the draft. - Jun13
Submit
Grants.gov: submit at least 24–48 hours before the deadline: uploads fail, systems slow down, errors need fixing. Grants.gov blog - Jun15
Deadline
From the funder.
Save this grant to put these dates in My grants and your private calendar.
Writing the need statement? Hamilton County facts with citations.
Who in Tennessee has won this program
279 awards to Tennessee groups in 5 counties since 1975 · 0 in Hamilton County. Largest shown:
| Past winner | Where | Amount | Fiscal year |
|---|---|---|---|
| Vanderbilt University Medical Center | Nashville, Davidson County | $143.7M | 2016 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $118.6M | 2017 |
| St Jude Children's Research Hospital Inc | Memphis, Shelby County | $81.5M | 1993 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $51.7M spent that year | 2025 |
| Meharry Medical College | Nashville, Davidson County | $45.7M | |
| Vanderbilt University Medical Center | Nashville, Davidson County | $44.1M spent that year | 2025 |
| St Jude Children's Research Hospital Inc | Memphis, Shelby County | $41.4M | 1999 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $39.5M spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $37.5M | 2021 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $34.7M spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $32.8M | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $31.4M | 2016 |
Source: USAspending.gov, Federal Audit Clearinghouse. Past awards show who this program funds. They don't guarantee future awards.
Tennessee groups that got this money through Tennessee Department of Education
This federal money also reaches local groups as pass-through grants. In Tennessee, Tennessee Department of Education passes it on: watch that agency for applications, not the federal agency. 837 pass-through grants on file · 0 in Hamilton County. Largest shown:
| Past winner | Where | Through | Amount | Fiscal year |
|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville, Davidson County | Trustees of Boston University | $4.6M | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | University of Vermont & State Agricultural College | $4.4M | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Research Triangle Institute | $3.6M spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Regents of the University of Michigan | $3.4M | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Yale Univ | $3.4M | 2023 |
| St Jude Children's Research Hospital Inc | Memphis, Shelby County | University of Southern California | $2.8M | 2023 |
| Vanderbilt University | Nashville, Davidson County | Vanderbilt University Medical Center | $2.6M | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | University of Wisconsin System | $2.2M | 2023 |
| Vanderbilt University | Nashville, Davidson County | Vanderbilt University Medical Center | $2M | 2024 |
| Vanderbilt University | Nashville | Vanderbilt University Medical Center | $1.9M spent that year | 2025 |
| University of Tennessee | Memphis, Shelby County | Virginia Polytechnic Institute & State University | $1.8M | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Duke Clinical Research Institute | $1.7M spent that year | 2025 |
Source: USAspending.gov pass-through reports (the first recipient reports each one of $30,000 or more).
About the federal program
Research Related to Deafness and Communication Disorders
Program number 93.173 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating applications include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the environment and available resources for the proposed project; (5) the necessity of budget components requested in relation to the proposed project; (6) the relevance and importance to announced program objectives; (7) innovation; (8) risk to human subjects, including inclusion of minorities, inclusion across the lifespan, and animal protection. The following additional criteria will be used in considering the scientific and technical merit of SBIR/STTR grant applications: (1) The technological innovation of the proposed research; (2) the potential of the proposed research for commercial application.
Match
None required (federal program listing).
About the federal program
National Center on Sleep Disorders Research
Program number 93.233 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the importance of the problem the proposed research will address; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation of the proposed research; (5) the potential of the proposed research for commercial application; (6) the appropriateness of the budget requested; (7) the adequacy and suitability of the facilities and research environment; (8) the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will be evaluated; and (9) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or...
Match
None required (federal program listing).
About the federal program
Trans-NIH Research Support, also called “NIH-wide Research Support”
Program number 93.310 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant, training
How applications are judged
Funding decisions are based on scientific merit (42 CFR 52h) and program relevance. Scientific merit review encompasses: the peer review criteria detailed in the specific funding announcement, as well as the significance, approach, and innovation of the proposed research; the competency of the principal investigator; the adequacy of the resources and environment; the proposed budget and requested period of support; and, where applicable, the adequacy of the measures for protecting against adverse effects upon humans, animals, or the environment.
Match
None required (federal program listing).
About the federal program
National Center for Advancing Translational Sciences, also called “NCATS”
Program number 93.350 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Cooperative agreement (a grant with close agency involvement)
How applications are judged
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives and (7) the availability of funds.
Match
None required (federal program listing).
About the federal program
Cancer Treatment Research
Program number 93.395 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Cooperative agreement (a grant with close agency involvement), project grant
How applications are judged
The major elements in evaluating applications include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the...
Match
None required (federal program listing).
About the federal program
Cardiovascular Diseases Research
Program number 93.837 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of: (1) the scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) the soundness and technical merit of the proposed approach; (2) the importance of the problem the proposed research will address; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation of the proposed research; (5) the potential of the proposed research for commercial application; (6) the appropriateness of the budget requested; (7) the adequacy and suitability of the facilities and research environment; and (8) the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will be evaluated; and (9) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or...
Match
None required (federal program listing).
About the federal program
Lung Diseases Research
Program number 93.838 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the importance of the problem the proposed research will address; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the scientific, technical, or technological innovation of the proposed research; (5) the potential of the proposed research for commercial application; (6) the appropriateness of the budget requested; (7) the adequacy and suitability of the facilities and research environment; (8) the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will be evaluated; and (9) where applicable, the adequacy of assurances detailing the proposed means for (a)...
Match
None required (federal program listing).
About the federal program
Blood Diseases and Resources Research, also called “Division of Blood Diseases and Resources (DBDR)”
Program number 93.839 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the importance of the problem the proposed research will address; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation of the proposed research; (5) the potential of the proposed research for commercial application; (6) the appropriateness of the budget requested; (7) the adequacy and suitability of the facilities and research environment; (8) the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will be evaluated; and (9) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or...
Match
None required (federal program listing).
About the federal program
Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
Program number 93.840 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2)the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the importance of the problem the proposed research will address; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation of the proposed research; (5) the potential of the proposed research for commercial application; (6) the appropriateness of the budget requested; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I...
Match
None required (federal program listing).
About the federal program
Arthritis, Musculoskeletal and Skin Diseases Research, also called “NIAMS”
Program number 93.846 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...
Match
None required (federal program listing).
About the federal program
Diabetes, Digestive, and Kidney Diseases Extramural Research
Program number 93.847 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...
Match
None required (federal program listing).
About the federal program
Child Health and Human Development Extramural Research, also called “Child Health and Human Development”
Program number 93.865 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of the significance of the proposed research; approach; innovation; investigators; and environment. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget...
Match
None required (federal program listing).
Examples of funded projects
Fiscal year 2025: The following is a tiny sample of fiscal year 2025 NICHD funded grants within the discretionary award class type. 1) Understanding the role of early life social determinants and sex-specific pubertal pathways in the development of adolescent chronic pain. 2) Improving In Vitro Fertilization Success through Multiplexed Optical Metabolic Imaging. 3) Genetic Studies of Large Palindromes. 4) A Safe, Fast, and Cost-Effective System for Tissue Removal in Laparoscopic Hysterectomy and Other Minimally Invasive Surgery.
The following is a tiny sample of fiscal year 2025 NICHD funded grants within the cooperative agreement award class type. 1) Study of Treatment and Reproductive outcomes. 2) Pediatric HIV/AIDS Cohort Study (PHACS): Research on Immune Aging, Sexual and Reproductive Health, and Perinatal Acquisition: Elucidating Relationships in HIV (RISE). 3) Pelvic Floor Disorders Network Data Coordinating Center. 4) NICHD Maternal-Fetal Medicine Units (MFMU) Network: Data Coordinating Center.
Fiscal year 2026: The following is a tiny sample of fiscal year 2026 NICHD funded grants within the discretionary award class type. 1) Placental Proteins and Prematurity. 2) In...
About the federal program
Aging Research, also called “(Aging)”
Program number 93.866 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of: the scientific merit and general significance of the proposed study and its objectives; the technical adequacy of the experimental design and approach; the competency of the proposed investigator or group to successfully pursue the project; the adequacy of the available and proposed facilities and resources; the necessity of the budget components requested in relation to the proposed project; and the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed...
Match
None required (federal program listing).