Opportunity Information: Apply for PAR 24 083
The National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH), is offering an R01 grant opportunity (PAR-24-083) to support investigator-initiated, multi-site feasibility clinical trials of complementary and integrative health approaches that use physical and/or psychological therapeutic inputs, often referred to as mind and body interventions. The core purpose is not to run a definitive, fully powered efficacy or effectiveness trial right away, but to generate the specific, practical, and scientifically necessary evidence needed to confidently design and launch a later, larger clinical trial that fits within NCCIHs mission. In other words, applicants are expected to use this R01 to de-risk a future full-scale study by showing that the intervention and trial methods can actually work across multiple locations and populations.
A key expectation is that the application clearly lays out the planned future clinical trial (for example, a fully powered multi-site efficacy trial, effectiveness study, pragmatic trial, or dissemination and implementation trial) and explains why the feasibility work proposed in this R01 is essential to that next step. NCCIH is looking for feasibility data that fill real knowledge gaps and directly inform the design choices of the subsequent trial. The feasibility outcomes can include, but are not limited to, whether the intervention can be delivered with fidelity across different sites (meaning it is implemented consistently and as intended), whether participants can be recruited and enrolled at the needed pace across sites, and whether randomization procedures function smoothly in a multi-site environment. The NOFO also emphasizes demonstrating participant adherence to the intervention and retaining participants through follow-up, since both are common failure points when scaling from single-site studies to multi-site trials.
This opportunity also supports feasibility work for more complex, protocolized multimodal interventions, where multiple components must be delivered in a standardized way. Applicants can use the feasibility trial to refine the intervention protocol, training procedures, quality assurance methods, and cross-site coordination processes so that the later trial is realistically executable. Another major focus is confirming the feasibility of data collection across sites, including the ability to gather comparable measures in consistent ways, maintain data quality, and ensure the study operations are robust enough to support a full-scale multi-site trial later. Overall, NCCIH wants applicants to treat the feasibility trial as a targeted tool: collect the exact information needed to make the later pivotal study competitive, credible, and likely to succeed, rather than simply repeating early-stage pilot work.
Because multi-site feasibility studies are resource-intensive, the NOFO indicates that the need for a multi-site approach should be justified by sufficient preliminary evidence, such as data from earlier single-site feasibility or acceptability studies or strong support from the published literature. The expectation is that applicants are not starting from zero; they should already have reason to believe the intervention is plausible and acceptable, and now need to show it can be standardized and implemented across multiple settings. The end goal is to position a subsequent fully powered multi-site clinical trial that could meaningfully affect public health if successful.
In terms of eligibility, the opportunity is broadly open across many organization types, including state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; and a wide range of nonprofit and for-profit organizations (including small businesses, but excluding the small business-specific mechanisms). The NOFO also explicitly highlights eligibility for organizations such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. However, non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, foreign components (as NIH defines them in the NIH Grants Policy Statement) are allowed, which can matter for specific collaborations or research elements that legitimately require work outside the U.S. while remaining anchored in a U.S.-based applicant organization.
Administrative details from the listing include that it is a discretionary grant program in the health area (CFDA 93.213) administered by NIH, with an original closing date shown as 2026-11-17. The award ceiling is listed as $350,000. (The listing does not specify the number of expected awards.) Taken together, this NOFO is best understood as an NCCIH-supported on-ramp to a larger, high-impact multi-site trial: applicants propose a rigorously designed feasibility clinical trial, justify why multi-site testing is necessary at this stage, and produce concrete evidence that the intervention delivery, recruitment and retention processes, and data collection systems are ready to scale into a definitive, full-scale study.Apply for PAR 24 083
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213.
- This funding opportunity was created on 2023-12-20.
- Applicants must submit their applications by 2026-11-17. (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 $350,000.00 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.
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Frequently Asked Questions (FAQs)
What is this grant opportunity?
This is an NIH National Center for Complementary and Integrative Health (NCCIH) funding opportunity for an R01 grant (PAR-24-083) to support investigator-initiated, multi-site feasibility clinical trials of complementary and integrative health approaches, especially mind and body interventions that use physical and/or psychological therapeutic inputs.
What is the main purpose of this R01?
The main purpose is to generate the specific feasibility evidence needed to confidently design and launch a later, larger, fully powered multi-site clinical trial that fits within NCCIH's mission. The goal is not to immediately conduct a definitive efficacy or effectiveness trial, but to de-risk that future trial by showing the intervention and trial methods can work across multiple sites and populations.
Is this funding intended for a fully powered efficacy or effectiveness trial?
No. The opportunity is focused on feasibility clinical trials conducted across multiple sites. Applicants are expected to use this R01 to collect practical and scientifically necessary feasibility data that inform a subsequent, fully powered trial (such as an efficacy, effectiveness, pragmatic, or dissemination and implementation trial).
Do applicants need to describe the future full-scale trial in the application?
Yes. A key expectation is that the application clearly lays out the planned future clinical trial (for example, a fully powered multi-site efficacy trial, effectiveness study, pragmatic trial, or dissemination and implementation trial) and explains why the feasibility work proposed under this R01 is essential to that next step.
What kinds of interventions are in scope?
The opportunity supports complementary and integrative health approaches that use physical and/or psychological therapeutic inputs, often referred to as mind and body interventions. It also supports feasibility work for more complex, protocolized multimodal interventions with multiple components that must be delivered in a standardized way.
Why does NCCIH emphasize multi-site feasibility studies?
Multi-site feasibility studies are intended to show that an intervention and study procedures can be standardized and implemented consistently across different locations and populations. Because scaling from a single site to multiple sites often introduces new challenges, NCCIH is looking for feasibility evidence that directly informs design choices for a later multi-site pivotal trial.
What feasibility outcomes does NCCIH expect applicants to address?
The feasibility outcomes can include (but are not limited to) whether the intervention can be delivered with fidelity across sites, whether recruitment and enrollment can occur at the needed pace across sites, and whether randomization procedures function smoothly in a multi-site environment.
What does "intervention fidelity" mean in this context?
Intervention fidelity refers to whether the intervention is implemented consistently and as intended at each participating site, including whether delivery is standardized and aligned with the protocol across locations and personnel.
Why are adherence and retention highlighted as important feasibility topics?
The NOFO emphasizes demonstrating participant adherence to the intervention and retaining participants through follow-up because both are common failure points when moving from smaller or single-site studies to larger multi-site trials.
Can this feasibility trial be used to refine a complex or multimodal intervention?
Yes. The opportunity supports feasibility work to refine protocolized multimodal interventions, including improving and standardizing the intervention protocol, training procedures, quality assurance methods, and cross-site coordination processes so that the later full-scale trial is realistically executable.
What expectations are there around data collection across sites?
A major focus is confirming the feasibility of data collection across sites. This includes demonstrating the ability to gather comparable measures in consistent ways, maintain data quality, and ensure study operations are robust enough to support a later full-scale multi-site trial.
How should applicants think about the role of the feasibility trial?
NCCIH expects applicants to treat the feasibility trial as a targeted tool to collect the exact information needed to make the later pivotal study competitive, credible, and likely to succeed, rather than simply repeating early-stage pilot work.
Do applicants need preliminary evidence before proposing a multi-site feasibility study?
Yes. Because multi-site feasibility studies are resource-intensive, the need for a multi-site approach should be justified by sufficient preliminary evidence, such as data from earlier single-site feasibility or acceptability studies or strong support from the published literature.
Is this opportunity intended for projects starting from scratch?
No. The expectation is that applicants are not starting from zero. Applicants should already have reason to believe the intervention is plausible and acceptable and now need to show it can be standardized and implemented across multiple settings.
What is the long-term goal NCCIH is trying to support?
The end goal is to position a subsequent fully powered multi-site clinical trial that could meaningfully affect public health if successful, by establishing that the intervention delivery, recruitment and retention processes, and data collection systems are ready to scale.
Who is eligible to apply?
Eligibility is broad and includes many organization types such as state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; and a wide range of nonprofit and for-profit organizations (including small businesses, but excluding small business-specific mechanisms).
Are specific institution types explicitly noted as eligible?
Yes. The NOFO explicitly highlights eligibility for 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; eligible federal agencies; regional organizations; and U.S. territories or possessions.
Are non-U.S. (non-domestic) entities eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply.
Are foreign components allowed at all?
Yes. Foreign components (as NIH defines them in the NIH Grants Policy Statement) are allowed, which can be relevant when certain collaborations or research elements legitimately require work outside the U.S., while the applicant organization remains U.S.-based.
What agency is administering this opportunity?
The opportunity is administered by the National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH).
What is the CFDA number and program type listed?
The listing describes this as a discretionary grant program in the health area with CFDA 93.213.
What is the application closing date shown in the listing?
The listing shows an original closing date of 2026-11-17.
What is the award ceiling listed for this opportunity?
The award ceiling is listed as $350,000.
Does the listing state how many awards will be made?
No. The listing does not specify the number of expected awards.
How should applicants justify using a multi-site design at the feasibility stage?
Applicants should justify the need for a multi-site feasibility approach by pointing to sufficient preliminary evidence (for example, prior single-site feasibility or acceptability data or strong published literature support) and by explaining what multi-site-specific uncertainties the feasibility trial will resolve for the later full-scale study.
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