Opportunity Information: Apply for PAR 21 243
The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), is offering a cooperative agreement funding opportunity for organizations to serve as the Clinical Coordinating Center for investigator-initiated, multi-site clinical trials of mind and body interventions. The focus is on complementary and integrative health approaches that include physical and/or psychological therapeutic inputs, and the trials must align with NCCIH areas of high research priority. The intent is to support fully powered studies that can rigorously test these interventions in real-world or near real-world conditions, including efficacy trials, effectiveness trials, or pragmatic trials, depending on the research question.
A key feature of this opportunity is that the applicant proposing the Clinical Coordinating Center is expected to both develop and implement the entire multi-site clinical trial. In practical terms, the application needs to do more than describe a research idea; it must lay out the scientific rationale for the intervention and indication, and it must provide a detailed operational blueprint for how the study will actually run across multiple sites. NCCIH is looking for a complete plan that covers project management structures, coordination across clinical sites, training and quality assurance, and clear procedures to ensure the trial is conducted consistently and with high scientific integrity. Applications are also expected to include robust participant recruitment and retention strategies, since multi-site trials often succeed or fail based on enrollment and adherence. In addition, the proposal should define performance milestones and explain how progress will be monitored, and it should provide a credible plan for disseminating results so findings can inform science, clinical care, and public health.
Funding is provided through a two-phase, milestone-driven UG3/UH3 cooperative agreement mechanism. This structure typically means there is an initial phase (UG3) intended for finalizing start-up activities and demonstrating readiness to launch, followed by a second phase (UH3) that supports full implementation, contingent on meeting predefined milestones. Because it is a cooperative agreement rather than a standard grant, NCCIH program staff are expected to have substantial involvement during the project, particularly around oversight of milestones, coordination expectations, and trial conduct standards.
An important requirement is that a separate but linked Data Coordinating Center (DCC) application must be submitted at the same time as the Clinical Coordinating Center application. The DCC application is submitted under a companion FOA (referenced as PAR-XX-XXX in the text you provided) and must propose the data management and data analysis plan for the same clinical project. NCCIH will consider the Clinical Coordinating Center and DCC applications together, so applicants need to coordinate the scientific design, operational workflow, and data strategy across the two applications to ensure they are fully aligned (for example, on outcomes, data collection schedules, monitoring, analysis methods, and reporting).
Eligibility is broad and includes many types of U.S.-based organizations, such as state, county, and local governments; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; independent school districts; special district governments; public housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The announcement also explicitly highlights additional eligible applicants 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 federal agencies, and U.S. territories or possessions. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible; however, foreign components as defined in NIH policy may be allowed, which generally means certain limited, well-justified international elements could be included when permitted under NIH rules.
From an administrative standpoint, the opportunity is listed as PAR 21-243, categorized as discretionary funding, and uses the cooperative agreement funding instrument. It falls under the health activity category and is associated with CFDA number 93.213. The original closing date shown is March 11, 2024. The announcement encourages applicants to review NCCIHs mission, strategic vision, and research priorities on the NCCIH website and to contact the relevant NCCIH scientific or research program contact before submitting, which is often important for confirming programmatic fit and understanding expectations for trial scope, intervention rationale, and milestone planning.Apply for PAR 21 243
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 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 2021-06-14.
- Applicants must submit their applications by 2024-03-11. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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 NIH/NCCIH funding opportunity?
This opportunity (PAR 21-243) is a cooperative agreement from the National Institutes of Health (NIH), administered through the National Center for Complementary and Integrative Health (NCCIH), to support an organization that will serve as the Clinical Coordinating Center for an investigator-initiated, multi-site clinical trial of a mind and body intervention.
What is the main purpose of the Clinical Coordinating Center under this FOA?
The Clinical Coordinating Center is expected to develop and implement the entire multi-site clinical trial. The application must present both the scientific rationale (why the intervention and indication make sense) and an operational plan (how the study will be run across multiple sites with consistent procedures and high scientific integrity).
What types of interventions are supported?
The focus is on complementary and integrative health approaches that include physical and/or psychological therapeutic inputs, described as mind and body interventions, and that align with NCCIH areas of high research priority.
What kinds of trials are intended to be supported?
The intent is to support fully powered studies designed to rigorously test mind and body interventions in real-world or near real-world conditions. Depending on the research question, this can include efficacy trials, effectiveness trials, or pragmatic trials.
Does the application need to include operational details, or is a research concept enough?
A research concept alone is not sufficient. NCCIH expects a complete plan that includes the scientific rationale plus a detailed operational blueprint for executing a multi-site clinical trial.
What operational elements is NCCIH expecting to see in the application?
Based on the opportunity description, applications are expected to address project management and coordination structures, coordination across clinical sites, training and quality assurance, and clear procedures to ensure consistent trial conduct. The application is also expected to include participant recruitment and retention strategies, performance milestones, progress monitoring plans, and a plan to disseminate results.
Why are recruitment and retention specifically emphasized?
The opportunity notes that multi-site trials often succeed or fail based on enrollment and adherence, so the proposal is expected to include robust participant recruitment and retention strategies.
What are performance milestones, and how are they used in this program?
The program is milestone-driven. Applicants are expected to define performance milestones and explain how progress will be monitored. Milestones are central to moving from the start-up phase to the implementation phase under the UG3/UH3 structure.
What is the UG3/UH3 mechanism described here?
Funding is provided through a two-phase UG3/UH3 cooperative agreement mechanism. The UG3 phase is intended for finalizing start-up activities and demonstrating readiness to launch. The UH3 phase supports full trial implementation, contingent on meeting predefined milestones.
How is a cooperative agreement different from a standard grant in this opportunity?
This opportunity uses a cooperative agreement, which means NCCIH program staff are expected to have substantial involvement during the project. That involvement is described as being particularly related to oversight of milestones, coordination expectations, and trial conduct standards.
Is a Data Coordinating Center (DCC) required?
Yes. A separate but linked Data Coordinating Center (DCC) application must be submitted at the same time as the Clinical Coordinating Center application.
Where is the DCC application submitted?
The DCC application must be submitted under a companion FOA referenced in the provided text as PAR-XX-XXX, and it must cover the data management and data analysis plan for the same clinical project.
How will NCCIH review the Clinical Coordinating Center and DCC applications?
NCCIH will consider the Clinical Coordinating Center and the DCC applications together. Applicants should coordinate across both applications so the scientific design, operational workflow, and data strategy are fully aligned.
What does it mean for the two applications to be "fully aligned"?
The description specifically calls out alignment on outcomes, data collection schedules, monitoring, analysis methods, and reporting, so that the clinical operations plan and the data plan match and work together.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organizations, including state, county, and local governments; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; independent school districts; special district governments; public housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; and other eligible entities.
Are specific types of institutions and organizations explicitly highlighted as eligible?
Yes. The announcement explicitly highlights 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 federal agencies, and U.S. territories or possessions.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible.
Are any international elements allowed at all?
The description notes that foreign components (as defined in NIH policy) may be allowed. This generally refers to limited, well-justified international elements that can be included when permitted under NIH rules.
What is the funding instrument and program category for this opportunity?
The opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument. It falls under the health activity category and is associated with CFDA number 93.213.
What is the closing date listed in the provided information?
The original closing date shown is March 11, 2024.
What does NCCIH recommend applicants do before submitting?
The announcement encourages applicants to review NCCIH's mission, strategic vision, and research priorities on the NCCIH website and to contact the relevant NCCIH scientific or research program contact before submitting to confirm programmatic fit and understand expectations for trial scope, intervention rationale, and milestone planning.
What outcomes does NCCIH want from this program beyond running the trial?
In addition to conducting a rigorous multi-site trial, the proposal is expected to include a credible plan for disseminating results so findings can inform science, clinical care, and public health.
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