National Institutes of Health · Department of Health and Human Services
NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
Key facts
- Deadline
- Due Jan 7, 2027 · 92 days left
- Award size
- Not stated: see the official notice
- Match ?
- Not required · Work out your budget and match
- Who can apply
- Private college or university, County government, City or town government, School district, Larger business, Tribal government, Nonprofit without 501(c)(3), State government, Special district (utility, fire, etc.), Public college or university, Tribal organization, Small business, Nonprofit with 501(c)(3), 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/abd15dbe-3891-47eb-b1e1-31c03f8ea731 · Printed from grantme.click/grants/a3ec937f-ebf6-4a72-95ea-7dc6d30eebd0
View on Grants.gov Add deadline to my calendar
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About this grant
This Notice of Funding Opportunity Announcement (NOFO) intends to supports studies that are both necessary and sufficient to inform the planning of a Phase II-IV clinical trial within NHLBI's mission. The NHLBI expects that applications to this NOFO will describe the planned clinical trial and in so doing demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent trial. Furthermore, this NOFO will support research projects that are designed to provide results that will be sufficient to inform the future trial without further studies. The planned Phase II, III, or IV trial must be primarily intended to test the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and/or treatment of heart, lung, blood, and sleep disorders. In contrast to the study start up or preparation phase of NHLBI funding opportunities for clinical trials (as described at https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/clinical-trials-optimization), the R34 mechanism is intended to provide new information that answers a scientific or operational question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial. Regardless of the results of the R34, support of the proposed future clinical trial will require a new application.
Who can apply, from the official notice
Other Eligible Applicants include the following:
Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not 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 - Dec17
Ask partners for letters of support or commitment
Suggested: partners need about three weeks to write and sign letters. - Dec31
Finish a complete draft for a final review
Suggested: leave about a week for someone else to read the draft. - Jan5
Submit
Grants.gov: submit at least 24–48 hours before the deadline: uploads fail, systems slow down, errors need fixing. Grants.gov blog - Jan7
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).