National Institutes of Health · Department of Health and Human Services
NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)
In short: A grant from National Institutes of Health. Open to many kinds of groups. See who can apply.
Key facts
- Deadline
- Due Jan 7, 2027 · 90 days left
- Award size
- Not stated: see the official notice
- Match ?
- Not required · Work out your budget and match
- Who can apply
- School district, Small business, Larger business, Special district (utility, fire, etc.), Nonprofit without 501(c)(3), Nonprofit with 501(c)(3), City or town government, Tribal government, Tribal organization, Public college or university, State government, Private college or university, County government, 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 Weakley County (nationwide program)
- No match required
- Past Tennessee awards on file: 286
Tell us who you are to see whether you're eligible.
About this grant
The objective of this funding opportunity is to support investigator-initiated, Phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. In addition to supporting clinical trial start-up and implementation activities, this FOA will provide support for final stage preclinical activities needed for the implementation of the proposed trial. All the activities proposed in the R61 phase must be directly related to the therapeutic/diagnostic in preparation for the clinical trial. The proposed trial can be single or multisite. This NOFO will utilize a bi-phasic, milestone-driven mechanism of award where the first phase can be used to finalize required pre-trial activities such as stability, shipping studies, and site training.
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.
Official notice: https://simpler.grants.gov/opportunity/ea08dd4a-1438-4a0b-a57b-8a393187a141 · Printed from grantme.click/grants/ac56f2a2-705d-434a-b634-1d3ad50f5c11
View on Grants.gov Add deadline to my calendar
Your schedule, working back from the deadline
- Oct9
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.
Writing the need statement? Weakley County facts with citations.
Who in Tennessee has won this program
78 awards to Tennessee groups in 2 counties since 1977 · 0 in Weakley County. 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 · 0 in Weakley 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 | 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).
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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).