NIH Research Program Projects (Parent P01 Clinical Trial Optional) | PA 27 061

FAQs: NIH Research Program Projects (Parent P01 Clinical Trial Optional) - PA-27-061

What is the NIH P01 (Program Project) grant mechanism?

The P01 (Program Project) mechanism supports a coordinated, multi-project research program that is broader in scope and more scientifically integrated than a single-project grant. Under PA-27-061, NIH is seeking investigator-initiated P01 applications where multiple complementary projects work together around one overarching scientific objective or unifying theme.

What is the funding opportunity number and title for this grant?

The funding opportunity is titled "NIH Research Program Projects (Parent P01 Clinical Trial Optional)" and the funding opportunity number is PA-27-061.

Is this a one-time competition or an ongoing NIH opportunity?

This is described as a standing (ongoing) NIH grant opportunity. The public record shows an original closing date of 2029-05-25, which indicates it is intended to remain active over multiple years and use standard NIH receipt cycles rather than operating as a single, one-time competition.

What does it mean that this NOFO is a "parent" announcement?

"Parent" means the NOFO provides a general entry point for submitting P01 applications across multiple participating NIH Institutes, Centers, and Offices (ICOs). The science is investigator-initiated, but applications still need to align with the missions and programmatic interests of at least one participating ICO.

Does NIH allow investigator-initiated topics under PA-27-061?

Yes. The NOFO supports investigator-initiated P01 applications. However, the proposed program still needs to fit within the priorities and mission of at least one participating NIH ICO, so applicants should shape the theme and aims accordingly.

What kind of scientific structure is NIH looking for in a P01 application?

NIH is looking for applications organized around one clearly defined overarching scientific objective or unifying theme. The P01 should include multiple related research projects that are complementary and coordinated, where collaboration produces added value beyond what separate, parallel projects would achieve.

How is a P01 different from multiple independent projects submitted separately?

Based on the description provided, a P01 is intended to be more than several projects grouped together. The component projects should be logically connected and interdependent under a central theme, designed to reinforce one another through shared strategy, coordinated leadership, and collaboration that increases scientific value.

What components are expected within the P01 structure?

A defining feature described for P01s is a set of multiple related research projects organized around a common theme, supported by an Administrative Core. The Administrative Core is responsible for leadership, coordination, governance, communication, and overall program management.

What is an Administrative Core and what does it do?

The Administrative Core is the coordinating hub of the P01. As described, it handles leadership and program coordination, including governance, communication among projects, and management of the overall program so the projects function as an integrated research effort.

Are shared resource cores allowed, and what are they used for?

Yes. The NOFO allows optional shared resource cores (often referred to as "Core(s)"). These cores can provide centralized services, facilities, data support, specialized methods, or other shared resources used across the component projects. Their purpose is to improve efficiency and scientific integration by reducing duplication and enabling shared infrastructure and expertise.

Are shared cores required for a P01 under this NOFO?

No. Shared resource cores are described as optional. The Administrative Core is described as a defining feature, while additional shared cores may be included when they strengthen integration and efficiency across projects.

Is this opportunity intended for multidisciplinary team science?

Yes. The structure is described as designed for multidisciplinary teams where progress depends on close interaction among projects, not simply parallel studies under the same umbrella.

What does "Clinical Trial Optional" mean in this NOFO?

"Clinical Trial Optional" means the opportunity can accommodate applications that include clinical trials, but clinical trials are not required. Applicants may propose basic, translational, clinical, or mixed research, as long as the overall program remains cohesive and organized around the central theme.

Does PA-27-061 require that a clinical trial be included?

No. The description states clinical trials are optional, not required.

Can a P01 include a mix of basic, translational, and clinical research?

Yes. The opportunity can support programs that are purely basic, purely translational, purely clinical, or a mix, provided the program is cohesive and the component projects are logically connected under the unifying theme.

How should applicants think about alignment with NIH Institutes, Centers, and Offices (ICOs)?

Even though the science is investigator-initiated, applicants are expected to align the program's theme and aims with the programmatic interests and missions of at least one participating NIH ICO. In practice, that means not treating the mechanism as completely open-ended.

What types of organizations are eligible to apply?

Eligibility is described as broad and includes many domestic organization types, including 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; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions where applicable); for-profit organizations other than small businesses; and small businesses.

Are nonprofit organizations eligible, including those without 501(c)(3) status?

Yes. The description states nonprofit organizations with or without 501(c)(3) status are eligible (excluding higher education institutions where applicable).

Are for-profit organizations eligible to apply?

Yes. The eligibility list includes for-profit organizations other than small businesses, and it also separately lists small businesses as eligible.

Are small businesses eligible to apply?

Yes. Small businesses are explicitly listed among eligible applicants.

Are tribal governments eligible applicants?

Yes. Federally recognized Native American tribal governments are listed as eligible. The opportunity also explicitly notes Native American tribal governments other than federally recognized entities as additional eligible applicants.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are explicitly noted as additional eligible applicants.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly listed among additional eligible applicants.

Are foreign (non-U.S.) institutions eligible to apply?

Yes. The opportunity explicitly notes that non-domestic (non-U.S.) entities (foreign institutions) are eligible. This can be relevant for programs requiring international cohorts, field sites, specialized populations, or infrastructure outside the United States.

Which federal agency issues this grant opportunity?

The issuing agency is NIH, under the U.S. Department of Health and Human Services (HHS). The grant mechanism is described as discretionary.

What is the funding activity category?

The funding activity category is Health.

Are there specific Assistance Listing (CFDA) numbers tied to this opportunity?

Yes. The opportunity is associated with multiple Assistance Listing (CFDA) numbers, reflecting participation across a wide set of NIH programs.

Is there an award ceiling or an expected number of awards listed?

The public record provided does not specify an award ceiling or the expected number of awards. This is described as common for NIH parent announcements where budgets and award counts can vary widely depending on institute, topic area, and the scale of the proposed program.

What kind of application is this NOFO best suited for?

Based on the description, this NOFO is best suited for well-developed, theme-driven team science proposals where multiple strong projects are intentionally designed to reinforce one another, supported by a clear management approach (via the Administrative Core) and, when helpful, shared cores that strengthen the program as a whole.