Opportunity Information: Apply for PAR 18 697
This opportunity is a National Institutes of Health (NIH) cooperative agreement (U24) focused on supporting the Data Coordinating Center (DCC) for an investigator-initiated, multi-site clinical trial of a natural product. It is specifically tied to late-stage clinical testing, meaning Phase III and beyond, and it is designed to be submitted as a paired application alongside a separate but connected Clinical Coordinating Center (CCC) application. In other words, NIH is not looking for a stand-alone data center proposal; the DCC must be built around, and tailored to, a particular multi-site clinical trial that is being proposed at the same time through the companion clinical trial funding announcement (PAR-18-124). Both the DCC and CCC applications have to be submitted simultaneously to be considered.
The main purpose of the DCC under this FOA is to serve as the operational and analytical backbone of the trial. Applicants are expected to propose a comprehensive, end-to-end coordination plan that covers overall project coordination and administration, centralized data management, and biostatistical support. In practical terms, that typically means building and maintaining the trial data systems, standardizing data collection across sites, ensuring data quality and integrity, overseeing data flow and timelines, supporting randomization and statistical analysis plans, and producing the reports and deliverables needed for trial monitoring and decision-making. Because this is a cooperative agreement, recipients should also expect substantial NIH program involvement during the project period compared to a standard research grant, with NIH staff playing an active role in oversight and coordination.
The scientific scope is anchored in the mission of the National Center for Complementary and Integrative Health (NCCIH). The multi-site trial being supported must be relevant to NCCIH priorities and considered high priority by the Center, so applicants need to ensure the proposed natural product intervention and clinical question fit squarely within NCCIHs strategic vision and research portfolio. The announcement strongly encourages prospective applicants to review NCCIHs mission and research priorities on the NCCIH website and to contact the appropriate NIH scientific or research program contact before submitting, which is often important for confirming fit, clarifying expectations, and avoiding misalignment with NCCIH program goals.
Eligibility is broad across many U.S.-based organization types. Eligible applicants include state, county, and 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 that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits (including both 501(c)(3) and non-501(c)(3) entities) that are not institutions of higher education; for-profit organizations other than small businesses; and small businesses, among others. The FOA also calls out additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.
Foreign participation is restricted in a way that is common for NIH opportunities but can be confusing at first glance. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are not eligible to apply as the applicant organization. Non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant organization may include certain foreign elements or collaborations when appropriately justified and structured under NIH policy, even though the primary applicant itself must be domestic.
Key administrative details included in the listing are the FOA number PAR-18-697, the funding instrument type (cooperative agreement), the broad activity area (health), and the CFDA number 93.213. The posting indicates an original closing date of November 4, 2019, and it does not specify an award ceiling or expected number of awards in the excerpt provided. The essential takeaway is that this FOA is meant for groups with strong clinical trial coordination, data infrastructure, and biostatistics capability who are partnering tightly with a CCC to run a high-priority, NCCIH-relevant, Phase III or later multi-site natural product clinical trial, with both applications developed as a single, integrated trial package and submitted together.Apply for PAR 18 697
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Natural Product, Multi-Site, Clinical Trial, Data Coordinating Center (Collaborative U24 - 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 2018-03-05.
- Applicants must submit their applications by 2019-11-04. (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 funding opportunity?
This is a National Institutes of Health (NIH) cooperative agreement (U24) to support a Data Coordinating Center (DCC) for an investigator-initiated, multi-site clinical trial of a natural product. The funding announcement number is PAR-18-697.
What does "cooperative agreement (U24)" mean in this context?
The award mechanism is a cooperative agreement, which means NIH staff are expected to have substantial involvement during the project period compared to a standard research grant. In practical terms, NIH program staff may play an active role in oversight and coordination of the supported trial and coordinating center activities.
Is this opportunity for a stand-alone data coordinating center?
No. NIH is not seeking a stand-alone DCC proposal. The DCC application must be built around and tailored to a specific multi-site clinical trial that is being proposed at the same time through the companion Clinical Coordinating Center (CCC) funding announcement (PAR-18-124).
Do the DCC and CCC applications have to be submitted together?
Yes. The DCC and CCC applications must be submitted simultaneously to be considered.
What trial stage is this FOA intended to support?
This FOA is focused on late-stage clinical testing, meaning Phase III and beyond.
What kind of clinical trial is being supported?
The supported effort is an investigator-initiated, multi-site clinical trial of a natural product intervention.
What is the primary purpose of the Data Coordinating Center (DCC) under this FOA?
The DCC is intended to serve as the operational and analytical backbone of the trial, providing an end-to-end coordination plan covering overall project coordination and administration, centralized data management, and biostatistical support.
What activities and responsibilities are typically expected of the DCC?
Based on the description provided, expected DCC responsibilities commonly include building and maintaining trial data systems, standardizing data collection across sites, ensuring data quality and integrity, overseeing data flow and timelines, supporting randomization and statistical analysis plans, and producing reports and deliverables needed for trial monitoring and decision-making.
How does this DCC relate to the Clinical Coordinating Center (CCC)?
The DCC is designed to partner tightly with the CCC as part of a single, integrated multi-site trial package. The DCC application should be tailored to the specific trial being proposed via the companion CCC opportunity (PAR-18-124), and both applications must be developed and submitted together.
Which NIH Center is associated with the scientific scope of this opportunity?
The scientific scope is anchored in the mission of the National Center for Complementary and Integrative Health (NCCIH).
How important is alignment with NCCIH priorities?
Alignment is central. The multi-site trial must be relevant to NCCIH priorities and considered high priority by the Center. Applicants are expected to ensure that the natural product intervention and the clinical question fit squarely within NCCIH's strategic vision and research portfolio.
Does the FOA suggest contacting NIH staff before submitting?
Yes. Prospective applicants are strongly encouraged to review NCCIH's mission and research priorities and to contact the appropriate NIH scientific or research program contact before submitting to confirm fit and clarify expectations.
Who is eligible to apply?
Eligibility is broad across many U.S.-based organization types. Eligible applicants include, among others: state, county, and 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; non-federally recognized tribal organizations; public housing authorities and Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)) that are not institutions of higher education; for-profit organizations other than small businesses; and small businesses.
Are specific institution types explicitly mentioned as eligible?
Yes. The listing calls out additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.
Can a foreign organization apply as the applicant?
No. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are not eligible to apply as the applicant organization for this opportunity.
Are non-domestic components of U.S. organizations eligible to apply?
No. Non-domestic components of U.S. organizations are not eligible to apply.
Is any foreign participation allowed at all?
Yes, in a limited way. The opportunity allows foreign components (as defined by the NIH Grants Policy Statement) to be included under a U.S. applicant organization when appropriately justified and structured under NIH policy, even though the primary applicant must be a domestic (U.S.) organization.
What is the activity area and CFDA number listed for this opportunity?
The activity area is health, and the CFDA number listed is 93.213.
What is the original closing date shown in the listing excerpt?
The excerpt indicates an original closing date of November 4, 2019.
Does the excerpt specify an award ceiling or the expected number of awards?
No. The excerpt provided does not specify an award ceiling or the expected number of awards.
What kinds of capabilities are implied for a competitive DCC applicant team?
The description implies applicants should have strong clinical trial coordination capacity, robust data infrastructure and centralized data management capabilities, and biostatistical expertise to support randomization, analysis planning, reporting, and ongoing trial monitoring needs.
What is the most important "must-do" requirement highlighted in the description?
The central requirement is that the DCC application must be paired with, and submitted simultaneously alongside, a companion CCC application for the same specific Phase III (or later) multi-site natural product clinical trial (PAR-18-124). A stand-alone DCC submission is not responsive to the intent described.
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