NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required) | PAR 24 173

Opportunity Information: Apply for PAR 24 173

The NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required), PAR-24-173, is a National Institutes of Health funding opportunity designed to move promising heart, lung, blood, and sleep (HLBS) interventions into first-in-human testing. Its core purpose is to support investigator-initiated Phase I clinical trials in both adults and children, covering either therapeutic candidates (for example, drugs, biologics, devices, or other interventions) or diagnostic approaches. The program is built to help researchers bridge the common gap between late preclinical readiness and actual trial launch, so it supports not only trial start-up and execution but also the final practical preclinical steps needed to safely and successfully begin the proposed Phase I study.

A defining feature of this opportunity is its two-stage, milestone-driven structure using the R61/R33 mechanism. The R61 phase functions as a short, focused preparation period where applicants complete the last required steps that directly enable the clinical trial. The announcement is explicit that everything proposed in the R61 phase must be directly tied to the specific therapeutic or diagnostic being advanced and must be in preparation for the trial itself. Examples of the kinds of activities that fit in the R61 phase include stability testing, shipping and handling studies, final logistics that ensure the intervention can be delivered consistently at the clinical site(s), and site training. In other words, this phase is not meant for broad discovery work; it is meant to finish the practical readiness items that can otherwise delay a Phase I launch. Progress is evaluated against predefined milestones, and successful completion of those milestones is what enables transition into the R33 phase.

The R33 phase is the clinical trial phase, supporting start-up and implementation of the Phase I clinical trial. The trial may be designed as a single-site study or a multisite study, giving applicants flexibility depending on recruitment needs, specialized procedures, or the distribution of the target patient population. Because the FOA requires a clinical trial, applicants should expect that the application will need to clearly describe the Phase I protocol concept, operational approach, and how the project will meet the milestones that trigger movement from the R61 preparatory stage into the R33 trial stage.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding higher education institutions when specified); for-profit organizations other than small businesses; small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) as well as tribal organizations that are not federally recognized. The announcement also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

On the non-U.S. participation rules, the FOA draws an important distinction. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components (as defined by the NIH Grants Policy Statement) are allowed. Practically, that means the applicant must be a domestic eligible organization, but certain work or collaborations can involve foreign components if they meet NIH policy requirements and are justified within the project.

Administratively, this is a discretionary grant opportunity under NIH, with an activity category in health and associated CFDA numbers including 93.233 and several 93.83x listings (93.837, 93.838, 93.839, 93.840), reflecting NHLBI-relevant programs. The opportunity lists an original closing date of 2027-01-07, indicating that applications may be accepted across multiple receipt dates until that end date under the standing announcement schedule. The award ceiling and expected number of awards are not specified in the provided listing, so applicants would need to consult the full NOFO text and NIH budget guidance for any limits, typical award sizes, and current NHLBI expectations.

Overall, PAR-24-173 is aimed at teams that have a specific HLBS therapeutic or diagnostic that is close to clinical readiness and need targeted support to complete final enabling activities and then run a Phase I trial. The structure is designed to reduce avoidable delays by explicitly funding the “last mile” work (like stability and shipping validation and site readiness) while keeping the project accountable through clear go/no-go milestones before advancing into the clinical trial implementation phase.

• 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 for HLBS Disorders (R61/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 2024-04-02.
• Applicants must submit their applications by 2027-01-07.
• 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.

Apply for PAR 24 173

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