NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required) | PAR 21 118

Opportunity Information: Apply for PAR 21 118

The NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required) funding opportunity (PAR-21-118) is an NIH/NHLBI grant mechanism designed to support investigator-initiated phase I clinical trials that test new or early-stage therapeutic and/or diagnostic interventions relevant to heart, lung, blood, and sleep (HLBS) disorders. The emphasis is on first-in-human or other early clinical testing focused on initial safety, tolerability, feasibility, and other early signals appropriate for phase I work, and it applies to studies in both adult and pediatric populations. Trials may be structured as single-site or multisite projects, giving applicants flexibility to match the design to recruitment needs, specialized procedures, or the nature of the intervention or diagnostic.

A defining feature of this FOA is its expectation of immediate trial readiness. Applicants are expected to be able to initiate the clinical trial within the first quarter of the project period, which effectively means the project should be poised to start right after award rather than using early months for major startup tasks. In practical terms, NHLBI is looking for applications where key startup elements are already in place or will be in place by the time the award is made. This includes having regulatory and oversight pathways well underway or completed, and having operational details sufficiently mature that participant enrollment and study procedures can begin quickly.

Because this is a clinical trial-required R33, the FOA expects that major regulatory and administrative prerequisites will be ready by award. That includes, as applicable, FDA-related interactions and submissions (for example, IND or IDE and any necessary communications), Institutional Review Board (IRB) review and approval, and Data and Safety Monitoring Board (DSMB) planning and approvals when required. In addition, applicants are expected to have drug supply logistics settled, including placebo when relevant, and to have any essential third-party agreements arranged (such as contracts with manufacturers, central labs, imaging core facilities, clinical sites, or other vendors). The overall message is that this FOA is not intended to fund lengthy preclinical development or extended trial setup; it is intended to fund the conduct of the phase I trial itself when the team is ready to move.

For teams that are not yet at that level of readiness, NHLBI points applicants to a companion opportunity that uses an R61/R33 phased approach. The purpose of the phased mechanism is to support remaining preclinical and trial-readiness activities first (R61) and then transition into the clinical trial phase (R33) once milestones are met. In other words, PAR-21-118 is the better fit when the intervention is ready for early clinical testing now, while the R61/R33 companion is the better fit when additional time and support are still needed to finalize critical enabling work before launching the trial.

Eligibility is broad and spans many organization types, reflecting NIH norms for investigator-initiated research. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal government agencies, regional organizations, and U.S. territories or possessions.

Foreign eligibility is more limited and follows a specific structure. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement. This distinction means a U.S.-based applicant may include certain foreign activities or collaborators as part of the project when justified, but a foreign institution cannot serve as the primary applicant.

In the source details provided, the opportunity is categorized as a discretionary grant within the health funding activity category, administered by the National Institutes of Health. The CFDA numbers associated with this FOA include 93.233 and 93.837 through 93.840, reflecting NHLBI-related funding streams. The record indicates an original closing date of 2024-01-07 and a creation date of 2021-01-15, with award ceiling and expected awards not specified in the provided extract. Overall, this FOA is best understood as a fast-start mechanism for investigators who already have their phase I HLBS clinical trial positioned to begin promptly, with regulatory, supply, and operational foundations substantially completed by the time the award is issued.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840.
• This funding opportunity was created on 2021-01-15.
• Applicants must submit their applications by 2024-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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