OpenResearch announcementOpportunity PAR-25-032

NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)

National Institutes of Health · Department of Health and Human Services

At a glance

NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional) is an open federal grant opportunity from the National Institutes of Health (Department of Health and Human Services). Applications are due January 7, 2027. Applicant types listed as eligible include state governments, county governments, city or township governments, special district governments, independent school districts and 10 more. Cost sharing is not required. It is funded under Assistance Listing 93.233 (National Center on Sleep Disorders Research) and 4 other listings.

Summary assembled from the official notice's fields. The official notice governs.

Key facts

Dec 18, 2024Posted
Jan 7, 2027Application deadlinenext date
Feb 12, 2027Archived

Posted: Dec 18, 2024
Close date: Jan 7, 2027
Archive date: Feb 12, 2027
Award floor: Not specified
Award ceiling: Not specified
Est. total funding: Not specified
Expected awards: Not specified
Cost sharing: Not required
Funding instrument: Grant
Opportunity category: Discretionary

Typical awards for this program (SAM.gov listing for ALN 93.233, not this notice): Grants: $45 to $2,585,120: $457,671. SBIR Phase I - $319,005; Phase II - up to $301,224; STTR Phase I - $128,047; Phase II – up to $654,527

Who can apply

State governments
County governments
City or township governments
Special district governments
Independent school districts
Public colleges & universities
Federally recognized tribal governments
Public & Indian housing authorities
Native American tribal organizations
501(c)(3) nonprofits
Nonprofits without 501(c)(3) status
Private colleges & universities
For-profit organizations (not small businesses)
Small businesses
Others (see notice)

Additional information on eligibility (from the 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.

Can your organization apply?

A quick check against the listed applicant types — other requirements in the notice still apply.

Based on the published notice. Review the official notice for complete eligibility requirements.

What it funds

Official synopsis as published by the agency, formatted for readability.

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.

Additional information from the agency ↗

Full announcement & documents

The full announcement has the complete rules — page limits, required attachments, evaluation criteria and any letter-of-intent dates. Files download directly from Grants.gov.

PAR-25-032 Full Announcement TextFull Announcement · PAR-25-032-Full-Announcement.htmlHTML · 1 KB

How to apply

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Read the full announcement (NOFO)Eligibility, evaluation criteria, page limits and required attachments are in the full notice on Grants.gov. Open ↗
Confirm eligibility and fitCheck your organization type above; no cost sharing is required.
Register (or renew) in SAM.gov and get a UEIFree. New registrations can take several weeks; registrations must be renewed every year. Open ↗
Set up Grants.gov accessCreate a Grants.gov account and make sure someone has the Authorized Organization Representative (AOR) role. Open ↗
Open the application packageUse opportunity number PAR-25-032 on Grants.gov (Grants.gov Workspace). Open ↗
Prepare narrative, budget and attachmentsFollow the notice's format exactly — page limits and required forms are common reasons applications are rejected.
Ask the agency contact any questions earlyNational Institutes of Health · grantsinfo@nih.gov Open ↗
Submit before January 7, 2027Submit a few days early and keep your Grants.gov confirmation and validation emails.

Assistance Listings

What is an ALN?

Reported obligations under ALN 93.233

Historical data · not a prediction

FY24

$105M

FY25

$116M

FY26

— est.

Source: SAM.gov Assistance Listing 93.233. Program-wide totals, not awards from this specific opportunity.

Who was funded under ALN 93.233

Historical data · not a prediction

Since October 1, 2023, 131 grant awards had funding actions under National Center on Sleep Disorders Research, with 40 sub-awards passed on to other organizations. These are program-wide awards, not awards from this specific notice.

Recipients, states, recent awards and sub-awards →Source: USAspending.gov.

Agency contact (as published)

National Institutes of Health
grantsinfo@nih.gov
301-402-2541

Quick answers

When is the deadline for “NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)”?

According to the official notice, applications are due January 7, 2027. Confirm the deadline and submission time on Grants.gov before applying.

Who is eligible to apply for “NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)”?

The official notice names these applicant types as eligible: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public colleges & universities, Federally recognized tribal governments, Public & Indian housing authorities, Native American tribal organizations, 501(c)(3) nonprofits, Nonprofits without 501(c)(3) status, Private colleges & universities and 3 more. Additional restrictions may apply; review the full notice.

How do I apply for “NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)”?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity PAR-25-032), and review the full announcement and application package. Organizations applying through Grants.gov generally need an active SAM.gov registration and a Grants.gov account, which can take several weeks to set up.

Matched on shared Assistance Listings, agency, categories and eligible applicant types.

OpenResearchALN 93.113, 93.121…