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

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

What is this funding opportunity?

This is an NIH (NHLBI) discretionary grant program that supports investigator-initiated Phase I clinical trials for new or early-stage therapeutic interventions and/or diagnostic tools addressing heart, lung, blood, and sleep (HLBS) disorders.

Which NIH institute is running this program?

The program is administered by the National Institutes of Health (NIH) through the National Heart, Lung, and Blood Institute (NHLBI).

What type of clinical trial does this opportunity fund?

It is designed to fund Phase I clinical trials (early clinical evaluations), including first-in-human studies or other early-stage clinical testing.

What kinds of technologies or interventions are in scope?

Projects that test early-stage diagnostic tools and therapeutic interventions for HLBS disorders are in scope. The emphasis is on moving promising innovations into early clinical evaluation.

Are both adult and pediatric studies allowed?

Yes. The announcement indicates that studies may include both adult and pediatric populations.

Can a trial be single-site, or does it have to be multi-site?

Either approach is allowed. Trials may be conducted at a single site or across multiple sites, depending on the target population, enrollment needs, and practical operational considerations.

What is the major emphasis of this funding announcement?

A major emphasis is trial readiness at the time of award. Applicants are expected to be positioned to launch the clinical trial within the first quarter of the project period.

What does "trial readiness at the time of award" mean in practical terms?

It means key operational and regulatory steps should be treated as prerequisites for funding rather than future milestones. By award time, applicants are expected to have already engaged in needed discussions and submissions and to have approvals in place, or clear paths established, for required oversight and startup elements.

How quickly does the program expect the trial to start after award?

The program expects applicants to be able to launch the clinical trial within the first quarter of the project period.

What kinds of regulatory and oversight elements are expected to be addressed by the time of award?

As applicable, expectations include FDA interactions and regulatory positioning, Institutional Review Board (IRB) review and approval, and establishment of an appropriate Data and Safety Monitoring Board (DSMB) or an equivalent safety monitoring plan.

Does this opportunity require IRB approval before an award is made?

The announcement emphasizes being ready at award, including having IRB review and approval addressed, with approvals or clear paths in place by the time an award is made.

Does this opportunity involve FDA interactions (for example, IND/IDE positioning)?

Yes, where applicable. The announcement specifically calls out FDA interactions and regulatory positioning as part of the readiness expected by the time of award.

Is a DSMB required?

The announcement expects establishment of an appropriate Data and Safety Monitoring Board (DSMB) or an equivalent safety monitoring plan, as applicable to the study.

What operational items should be in place to be considered "ready"?

Examples listed include having drug supply secured and ready (and placebo supply where relevant) and having required third-party agreements in place (such as manufacturing, distribution, site contracts, laboratories, device vendors, or data coordinating arrangements).

Does the program expect manufacturing and supply chain readiness?

Yes. The announcement highlights having drug supply (and placebo supply where relevant) secured and ready, along with necessary third-party agreements related to manufacturing and distribution, where applicable.

What if a team is not ready to launch a Phase I trial shortly after award?

If more time or support is still needed for activities like completing the preclinical package, IND/IDE-enabling work, manufacturing scale-up, or final protocol refinement, the announcement points applicants toward a companion funding opportunity that uses an R61/R33 phased approach (preparatory work followed by the clinical trial phase).

What is the difference between this R33 opportunity and the companion R61/R33 approach (as described here)?

This R33 opportunity emphasizes being ready to start the clinical trial quickly after award. The companion R61/R33 approach is described as supporting preparatory work first and then transitioning to the clinical trial phase.

Who is eligible to apply?

Eligibility is broad and includes many U.S.-based organizations, such as state/county/city/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) and small businesses; public housing authorities/Indian housing authorities; and federally recognized Native American tribal governments and certain tribal organizations.

Are community-based and faith-based organizations eligible?

Yes. The announcement highlights faith-based or community-based organizations among the eligible applicant categories.

Are minority-serving institutions specifically mentioned as eligible?

Yes. The announcement highlights eligibility for categories including HBCUs, TCCUs, Hispanic-serving institutions, AANAPISI institutions, and Alaska Native and Native Hawaiian Serving Institutions.

Can for-profit organizations apply?

Yes. For-profit organizations (other than small businesses) and small businesses are included among eligible applicants.

Can non-U.S. (foreign) organizations apply as the primary applicant?

No. Non-domestic (non-U.S.) entities are not eligible to apply as applicant organizations.

Can a U.S. applicant include foreign collaborators or activities?

Yes. The announcement states that non-domestic components of U.S. organizations may participate and that foreign components are allowed as defined under the NIH Grants Policy Statement. 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.

What is the award ceiling for this opportunity?

The listed award ceiling is $1,515,000.

What does the award ceiling suggest about the size and scope of supported trials?

It signals 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.

What are the key goals or endpoints typically aligned with this program (as described)?

The description emphasizes Phase I objectives including safety, tolerability, feasibility, and (for diagnostics) early performance signals.

When is the application deadline?

The application window runs through an original closing date of January 7, 2027.

What are the CFDA numbers associated with this opportunity?

The opportunity references CFDA numbers 93.233, 93.837, 93.838, and 93.839.

What is this program best suited for?

It 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.