National Institutes of Health · Department of Health and Human Services
Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
Key facts
- Deadline
- Due Nov 2, 2028 · 757 days left
- Award size
- Not stated: see the official notice
- Match ?
- Not required · Work out your budget and match
- Who can apply
- City or town government, Tribal organization, School district, Private college or university, Special district (utility, fire, etc.), Nonprofit without 501(c)(3), Larger business, State government, County government, Nonprofit with 501(c)(3), Public college or university, Tribal government, Small business, 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 Tennessee (nationwide program)
- No match required
- Past Tennessee awards on file: 286
Tell us who you are to see whether you're eligible.
Official notice: https://simpler.grants.gov/opportunity/2ea3951b-2890-455c-b746-820bf32f7560 · Printed from grantme.click/grants/02d728c0-d709-4d8e-a016-b0fd84f8527d
View on Grants.gov Add deadline to my calendar
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About this grant
This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or dissemination and implementation science clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, dissemination and implementation science clinical trials and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, participant recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. The application should also describe its approaches to increase community engagement from conceptual design of the intervention through implementation and sustainability, close gaps in health outcomes within the US population, and increase health for all.
Who can apply, from the official notice
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-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.NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.
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 - Oct12
Ask partners for letters of support or commitment
Suggested: partners need about three weeks to write and sign letters. - Oct26
Finish a complete draft for a final review
Suggested: leave about a week for someone else to read the draft. - Oct31
Submit
Grants.gov: submit at least 24–48 hours before the deadline: uploads fail, systems slow down, errors need fixing. Grants.gov blog - Nov2
Deadline
From the funder.
Save this grant to put these dates in My grants and your private calendar.
Who in Tennessee has won this program
78 awards to Tennessee groups in 2 counties since 1977. Largest shown:
| Past winner | Where | Amount | Fiscal year |
|---|---|---|---|
| Vanderbilt University Medical Center | Nashville, Davidson County | $34.7M spent that year | 2025 |
| St Jude Children's Research Hospital Inc | Memphis, Shelby County | $28.2M | 1997 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $24.7M | 2014 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $21.8M | 2012 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $21.6M | 2010 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $19.2M spent that year | 2025 |
| Vanderbilt University | Nashville, Davidson County | $15.5M | 2014 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $12.3M | 2016 |
| University of Tennessee | Memphis, Shelby County | $11.3M | 1977 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $8.1M | 2022 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $7.1M | 2019 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $6.8M | 2007 |
Source: Federal Audit Clearinghouse, USAspending.gov. Past awards show who this program funds. They don't guarantee future awards.
Tennessee groups that got this money through a state agency or another organization
This federal money also reaches local groups as pass-through grants. 208 pass-through grants on file. 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 | 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 | Nashville, Davidson County | Vanderbilt University Medical Center | $1.3M | 2023 |
| Vanderbilt University | Nashville, Davidson County | Purdue University | $1.2M | 2024 |
| Vanderbilt University Medical Center | Nashville, Davidson County | University of Michigan | $1.1M spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Regents of the University of California, San Francisco, the | $1M | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Yale Univ | $938K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Research Triangle Institute | $936K spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | The Children's Hospital of Philadelphia | $810K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | University of Pittsburgh - of the Commonwealth System of Higher Education | $764K | 2026 |
| St Jude Children's Research Hospital Inc | Memphis, Shelby County | Icahn School of Medicine at Mount Sinai | $763K | 2024 |
Source: USAspending.gov pass-through reports (the first recipient reports each one of $30,000 or more).
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
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).