NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional) | PAR 21 079

Opportunity Information: Apply for PAR 21 079

The NHLBI Clinical Trial Pilot Studies funding opportunity (PAR-21-079) is a National Institutes of Health (NIH) discretionary grant program designed to support early, pilot-stage clinical trial work in areas aligned with the National Heart, Lung, and Blood Institute (NHLBI) mission. It uses the R34 mechanism, which is commonly intended to help investigators plan, refine, and generate key preliminary evidence needed to launch a larger, definitive clinical trial. The notice is a reissue of an earlier opportunity (PAR-19-155), indicating it continues an established NHLBI pathway for building feasibility and readiness for subsequent, larger-scale trial funding. Importantly, the announcement is labeled "Clinical Trial Optional," meaning applicants may propose either a pilot clinical trial or a related preparatory project that may not itself meet NIH's definition of a clinical trial, depending on the aims and design.

The program sits within the NIH health funding category and is associated with multiple CFDA numbers (93.233, 93.837, 93.838, 93.839, 93.840), reflecting the breadth of NHLBI research domains across heart, lung, blood, and sleep-related conditions. The overall intent is to enable smaller, time-limited, and tightly scoped studies that can test practical and scientific uncertainties before committing the resources required for a full-scale clinical trial. Typical pilot-study goals under an R34 often include demonstrating feasibility of recruitment and retention strategies, assessing intervention delivery and adherence, refining trial protocols and outcome measures, validating data collection procedures, establishing operational workflows across sites (if multi-site), and generating initial safety or signal-of-effect data where appropriate. These awards are generally used to reduce risk, clarify design choices, and create a stronger foundation for a later application for a larger efficacy or effectiveness trial.

The award information provided indicates an award ceiling of $225,000. While the listing does not specify the exact budget structure (for example, whether the ceiling is per year or total direct costs across the project period), the ceiling communicates that the program is oriented toward modestly sized pilot work rather than large, resource-intensive trials. The listing also shows an original closing date of 2023-11-17, which is the deadline information as presented in the source data. The opportunity was created on 2020-11-18, underscoring that it is part of an ongoing NHLBI pilot-trial support track rather than a one-time solicitation.

A wide range of U.S.-based applicant organizations are eligible. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; and Native American tribal organizations that are not federally recognized tribal governments. Both nonprofit organizations (with and without 501(c)(3) status) and for-profit organizations (other than small businesses), as well as small businesses, are listed as eligible. The announcement also explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible agencies of the federal government, and U.S. territories or possessions. This emphasis signals a clear interest in broad institutional participation, including organizations that serve historically underrepresented or priority populations and community-rooted entities that may strengthen recruitment, relevance, and implementation planning.

Foreign eligibility is limited in a way that is typical for many NIH opportunities. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the primary applicant organization. However, non-domestic components of U.S. organizations are eligible to apply, and foreign components are allowed as defined by the NIH Grants Policy Statement. In practical terms, that means a U.S. applicant can include certain international collaborations or activities as part of the project when well-justified, but the main applicant organization must be domestic.

In summary, PAR-21-079 is an NHLBI R34 pilot-study grant opportunity intended to help investigators and organizations conduct focused preliminary work that de-risks and strengthens the case for a future full-scale clinical trial in heart, lung, blood, and related areas. It offers a relatively small budget (ceiling $225,000), supports clinical trial activities on an optional basis, is open to a broad set of U.S. organizations including many institution types specifically serving diverse communities, and restricts foreign institutions from serving as the primary applicant while still permitting certain foreign components within a U.S.-led application.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)" 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 2020-11-18.
• Applicants must submit their applications by 2023-11-17. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $225,000.00 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 21 079

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