NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R61/R33 Clinical Trial Required) | PAR 21 119

Frequently Asked Questions (FAQs)

What is the NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R61/R33 Clinical Trial Required) opportunity?

It is an NIH/NHLBI funding opportunity (PAR-21-119) designed to move promising heart, lung, blood, and sleep (HLBS) innovations into first-in-human testing. It specifically supports investigator-initiated Phase I clinical trials for therapeutic and/or diagnostic interventions relevant to adults and/or children.

What is the main goal of this program?

The central goal is to support projects that are ready to transition from late preclinical development into a tightly planned early clinical study and to help overcome common last-step barriers that prevent otherwise strong Phase I concepts from starting.

What kinds of clinical trials does this program support?

This program is built to support Phase I clinical trials, including first-in-human testing, for both therapeutic and diagnostic interventions within the NHLBI mission areas (heart, lung, blood, and sleep).

Are both therapeutic and diagnostic projects eligible?

Yes. The opportunity explicitly supports Phase I clinical trials for therapeutic interventions and diagnostic interventions.

Does the opportunity apply to adult studies, pediatric studies, or both?

Both. The funded work may be relevant to adults and/or children.

What does “R61/R33” mean in this funding opportunity?

The FOA uses a two-stage NIH grant mechanism. The R61 phase is a time-limited launch period focused on completing essential final pre-trial tasks. The R33 phase supports start-up and implementation of the Phase I clinical trial itself.

What is the purpose of the R61 phase?

The R61 phase is intended to complete specific final preparation activities that directly enable the proposed Phase I clinical trial. It is meant to remove the last practical barriers to starting the clinical trial rather than support broad exploratory research.

What kinds of activities are appropriate in the R61 phase?

R61 activities must be tied to the specific therapeutic or diagnostic being advanced and must be necessary preparation for clinical trial execution. Examples highlighted include stability testing, shipping and handling studies, and site training activities that ensure protocol consistency and participant safety.

Is the R61 phase intended for exploratory or discovery research?

No. The FOA is explicit that the R61 phase is not meant for broad exploratory research. It is intended for targeted, essential final tasks required to begin the proposed Phase I clinical trial.

Why does the FOA emphasize activities like stability testing or shipping and handling studies?

The FOA recognizes that many Phase I concepts stall because key preparatory work is not fully supported elsewhere. Practical readiness items like stability confirmation and shipping/handling studies can be critical, especially for biologics, cell-based products, devices, or temperature-sensitive diagnostics.

What is the purpose of the R33 phase?

The R33 phase supports the actual start-up and implementation of the Phase I clinical trial. This includes the operational work required to initiate the study and complete the planned trial activities.

What kinds of activities are supported in the R33 phase?

The R33 phase can include initiating clinical sites, enrolling participants, collecting and managing clinical data, conducting safety monitoring, and completing the planned Phase I trial activities.

Can the Phase I trial be single-site or multi-site?

Yes. The FOA allows flexibility for a single-site or multi-site Phase I clinical trial design, depending on recruitment needs, specialized clinical capabilities, and the complexity of the intervention/diagnostic and required assessments.

How does a project move from the R61 phase to the R33 phase?

The overall award is milestone-based. Progression from R61 to R33 is expected to depend on meeting predefined readiness criteria, supporting realistic planning and clear go/no-go decision points.

What does “milestone-driven” mean in this context?

It means the project is structured around predefined milestones and readiness criteria, and advancement into the clinical trial implementation stage (R33) is tied to achieving the launch-stage (R61) objectives needed to start the Phase I trial.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S.-based organizations, such as state/county/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; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status, excluding institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other organizations.

Are minority-serving institutions and similar entities included in the eligible applicant types?

Yes. The FOA calls out eligibility for organizations such as HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs.

Are faith-based or community-based organizations eligible to apply?

Yes. The FOA lists faith-based or community-based organizations among eligible applicant types.

Are federal agencies eligible to apply?

Yes. The FOA includes eligible federal agencies among additional eligible applicant types.

Can organizations in U.S. territories or possessions apply?

Yes. U.S. territories or possessions are included among eligible applicant types.

Are foreign (non-U.S.) institutions eligible to apply as the primary applicant?

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as applicant organizations under this opportunity.

Are any foreign activities allowed under this opportunity?

Yes, with limitations. Non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined by the NIH Grants Policy Statement, meaning certain parts of the work can occur outside the U.S. when justified and structured under NIH rules.

What does it mean that “foreign components” are allowed?

Based on the provided information, it means that while the primary applicant organization must be domestic, some portion of the project work may be conducted outside the U.S. if it meets NIH’s definition of a foreign component and is handled consistent with NIH policy.

Which NIH institute is associated with this funding opportunity?

This opportunity is associated with the National Heart, Lung, and Blood Institute (NHLBI), part of the NIH.

What subject areas does this opportunity fall under?

It is categorized under health and is focused on innovations relevant to heart, lung, blood, and sleep (HLBS) conditions and research areas.

Is this a discretionary grant program?

Yes. The listing describes it as a discretionary grant program under NIH.

What are the CFDA numbers associated with this opportunity in the provided listing?

The listing includes CFDA numbers 93.233 and 93.837 through 93.840.

When was this opportunity created?

The listing notes the opportunity was created on 2021-01-15.

What is the closing date shown in the provided information?

The listing notes an original closing date of 2024-01-07.

Are the award ceiling and expected number of awards provided?

No. The provided source excerpt does not specify the award ceiling or the expected number of awards.

Where should applicants look for budget guidance and current dates if they are not listed here?

Based on the provided information, applicants would need to consult the full FOA text and any related NHLBI funding policy pages for budget guidance, project period constraints, and the most current submission dates or reissue status.

What types of projects are the best fit for this FOA?

This FOA is best suited for teams that already have a well-defined therapeutic or diagnostic candidate and a Phase I clinical trial concept that is close to execution but still needs targeted final preclinical and/or operational work to ensure the study can begin safely and smoothly.

What problem is this FOA trying to solve for Phase I clinical trials?

It is designed to address the common gap between “almost ready” development and an actual first-in-human trial by funding both final preparation (R61) and trial implementation (R33) in a connected, milestone-governed pathway.

Does the FOA require a clinical trial?

Yes. The opportunity title explicitly states “Clinical Trial Required,” and the described structure supports the preparation for and implementation of a Phase I clinical trial.