NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required) | PAR 24 172

Opportunity Information: Apply for PAR 24 172

The NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required) opportunity (PAR 24-172) is an NIH grant program designed to fund investigator-initiated Phase I clinical trials that test new or early-stage diagnostic tools and therapeutic interventions aimed at heart, lung, blood, and sleep (HLBS) disorders. The intent is to move promising HLBS innovations into first-in-human or other early clinical evaluations, including studies in both adult and pediatric populations. Trials may be conducted at a single site or across multiple sites, giving applicants flexibility to match the design to the target population, enrollment needs, and operational realities of the intervention being tested.

A major emphasis of this announcement is trial readiness at the time of award. Applicants are expected to be in a position to launch the clinical trial within the first quarter of the project period, meaning key operational and regulatory steps should not be treated as future milestones but rather as prerequisites for funding. By the time an award is made, the program expects that applicants will have already engaged in the necessary discussions and submissions and have approvals or clear paths in place for the relevant oversight bodies and requirements. This includes, as applicable, FDA interactions and regulatory positioning, Institutional Review Board (IRB) review and approval, and establishment of an appropriate Data and Safety Monitoring Board (DSMB) or equivalent safety monitoring plan. It also includes practical trial-startup needs such as having drug supply (and placebo supply where relevant) secured and ready, as well as having any required third-party agreements in place (for example, manufacturing, distribution, site contracts, laboratories, device vendors, or data coordinating arrangements). If an applicant is not yet at that stage and still needs time or support for preclinical package completion, IND/IDE-enabling work, manufacturing scale-up, final protocol refinement, or other readiness activities, the announcement points them toward a companion funding opportunity that uses an R61/R33 phased approach, which is structured to support preparatory work followed by the clinical trial phase.

In terms of who can apply, the eligibility is broad and covers many common U.S.-based research and community entities. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses) as well as small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) and certain tribal organizations. The announcement also highlights additional categories of eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, non-domestic (non-U.S.) entities are not eligible to apply as applicant organizations, although non-domestic components of U.S. organizations may participate, and foreign components are allowed as defined under the NIH Grants Policy Statement. In practice, this means a U.S. applicant can include certain foreign activities or collaborators when justified and structured in accordance with NIH policy, but a foreign organization cannot be the primary applicant.

Operationally, this is a discretionary grant mechanism under NIH, with the activity centered on health and aligned with CFDA numbers 93.233, 93.837, 93.838, and 93.839. The opportunity is administered by the National Institutes of Health, with an application window that runs through an original closing date of January 7, 2027. The listed award ceiling is $1,515,000, signaling that projects are expected to be early phase and tightly scoped around Phase I objectives such as initial safety, tolerability, feasibility, and early performance signals for diagnostics, rather than large efficacy trials. Overall, the program is best suited for teams that already have a well-developed clinical protocol, a credible operational plan, and near-complete regulatory and supply chain readiness, and who are prepared to move quickly from award to first participant enrollment.

• 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 (R33 CT 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.
• This funding opportunity was created on 2024-04-01.
• Applicants must submit their applications by 2027-01-07.
• Each selected applicant is eligible to receive up to $1,515,000.00 in funding.
• 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 24 172

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