No. PAR-25-032 · National Institutes of Health
NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
Not reimbursement-only
“Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.” — From the announcement
- Award range
- Not specified
- Expected awards
- Not specified
- Application deadline
- Jan 7, 2027
- Posted
- Dec 18, 2024
- Last verified
- 4 days ago
At a glance
AI summaryThis program funds pilot studies that fill information gaps needed to complete the protocol for a future Phase II to IV clinical trial for heart, lung, blood, or sleep disorders. It can support work such as refining the study population, intervention, outcomes, statistical methods, adherence, training tools, or feasibility, but it does not support first-in-human studies, animal studies, purely mechanistic studies, protocol writing, infrastructure development, or malignancy-related research. Eligible applicants include many U.S. organizations such as nonprofits, universities, governments, tribal entities, small businesses, and faith-based or community-based organizations; foreign organizations are not eligible, though foreign components of U.S. organizations are allowed. Applications may request up to $450,000 in direct costs over 3 years, with no more than $225,000 in direct costs in any single year, and no cost sharing is required.
AI-generated summary — verify against the announcement
What it funds
Official description from grants.gov
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
- City or township governments
- County governments
- For-profit organizations other than small businesses
- Independent school districts
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized)
- Nonprofits with 501(c)(3) status (other than higher education)
- Nonprofits without 501(c)(3) status (other than higher education)
- Others
- Private institutions of higher education
- Public and State controlled institutions of higher education
- Public housing authorities / Indian housing authorities
- Small businesses
- Special district governments
- State governments
Program history
USASpending.govAssistance listing 93.233 · National Center on Sleep Disorders Research
Real awards this federal program has made — the whole assistance listing (93.233), not just this notice.
No grants-family awards recorded for this program since FY 2021 — it may be new, renamed, or not yet reported to USASpending.
Source: USASpending.gov · refreshed Aug 22, 2026
Assistance listing 93.837 · Cardiovascular Diseases Research
Real awards this federal program has made — the whole assistance listing (93.837), not just this notice.
| Fiscal year | Awards | Median award | Middle half |
|---|---|---|---|
| FY 2026 (so far) | 910 | $406,108 | $121,423 – $769,962 |
| FY 2025 | 1,358 | $638,002 | $257,444 – $1,262,955 |
| FY 2024 | 1,513 | — | — |
| FY 2023 | 1,478 | — | — |
| FY 2022 | 1,536 | — | — |
| FY 2021 | 1,389 | — | — |
Dollar figures are based on the 1,000 most recent awards we store, not all 8,184 — award counts are complete.
- CHILDRENS HOSPITAL MEDICAL CENTER $6,452,040 · FY 2026
- KAISER FOUNDATION HOSPITALS $3,918,561 · FY 2025
- ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI $3,605,083 · FY 2026
- UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION $3,229,552 · FY 2026
- NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC. $3,002,716 · FY 2026
Source: USASpending.gov · refreshed Aug 22, 2026
Assistance listing 93.838 · Lung Diseases Research
Real awards this federal program has made — the whole assistance listing (93.838), not just this notice.
No grants-family awards recorded for this program since FY 2021 — it may be new, renamed, or not yet reported to USASpending.
Source: USASpending.gov · refreshed Aug 23, 2026
Assistance listing 93.839 · Blood Diseases and Resources Research
Real awards this federal program has made — the whole assistance listing (93.839), not just this notice.
No grants-family awards recorded for this program since FY 2021 — it may be new, renamed, or not yet reported to USASpending.
Source: USASpending.gov · refreshed Aug 23, 2026
Assistance listing 93.840 · Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
Real awards this federal program has made — the whole assistance listing (93.840), not just this notice.
| Fiscal year | Awards | Median award | Middle half |
|---|---|---|---|
| FY 2026 (so far) | 0 | — | — |
| FY 2025 | 0 | — | — |
| FY 2024 | 1 | $1,998,060 | $1,998,060 – $1,998,060 |
| FY 2023 | 8 | $718,015 | $520,326 – $1,181,909 |
| FY 2022 | 0 | — | — |
| FY 2021 | 0 | — | — |
- MICHIGAN PUBLIC HEALTH INSTITUTE $1,332,220 · FY 2023
- INDIANA DEPARTMENT OF HEALTH $1,304,518 · FY 2023
- MINNESOTA DEPARTMENT OF HEALTH $1,141,039 · FY 2023
- SOUTHERN NEVADA HEALTH DIST $762,811 · FY 2023
- COUNTY OF CHARLESTON $673,219 · FY 2023
Source: USASpending.gov · refreshed Aug 23, 2026