Exploratory Clinical Trials and Studies of Natural Products in NCCIH High Priority Research Topics (R33) | PAR 16 419

Opportunity Information: Apply for PAR 16 419

The Exploratory Clinical Trials and Studies of Natural Products in NCCIH High Priority Research Topics (R33) funding opportunity (PAR-16-419) is a National Institutes of Health grant designed to move promising natural products toward stronger, evidence-based clinical development. The focus is specifically on pilot testing natural products such as botanicals, dietary supplements, and probiotics when there is already a strong scientific rationale suggesting they may be worth more rigorous study. The central idea is to fund carefully designed, early-stage clinical studies that can answer practical, decision-driving questions about a product and its use in humans, rather than jumping directly into large, expensive efficacy trials.

A key feature of this FOA is that it is not meant to fund a full randomized controlled trial (RCT) intended to prove clinical efficacy on health outcomes. Instead, the R33 mechanism is being used to generate high-utility data that closes critical knowledge gaps and helps investigators determine whether and how a full-scale clinical trial should be pursued. That means the study design should be optimized to produce clear, interpretable results even if the findings are negative. In other words, an outcome where the product does not perform as hoped should still yield valuable information that influences next steps, such as whether to refine the formulation, adjust dosing, reconsider the target population, improve adherence strategies, select better biomarkers, or decide that additional development is not justified.

The projects supported under this announcement should be positioned as exploratory clinical trials or clinical studies that strengthen the foundation for later confirmatory research. The FOA emphasizes that trials must be designed so the results support concrete decisions about further development or testing. While the notice does not list every allowable study type in the provided excerpt, the intent is consistent with studies that address feasibility and readiness for a future definitive trial, such as evaluating recruitment and retention capability, optimizing dose and regimen, assessing tolerability and safety signals in the intended population, confirming target engagement or biologic activity using credible measures, characterizing variability in response, testing procedures for product standardization and quality control in a clinical setting, and refining outcome measures that would later be used in a larger trial. The overall expectation is that the work will directly inform the design and competitiveness of a subsequent, full-scale clinical trial application.

The sponsoring agency is the NIH (with this program associated with NCCIH priorities), and the activity category is Health under CFDA 93.213. The instrument type is a discretionary grant. The original closing date shown in the source data is December 16, 2016, and the opportunity record was created on September 1, 2016. The excerpted record does not provide an award ceiling or the expected number of awards, so applicants would normally confirm budget limits, project period, and current submission dates in the full FOA text and any related NIH Guide notices.

Eligibility is broad and includes many types of U.S.-based organizations. Eligible applicants listed include state, county, and city/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; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities. The FOA also explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American Tribal Governments other than federally recognized entities, and U.S. territories or possessions.

Foreign eligibility is restricted in a way that is typical for many NIH clinical research opportunities. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and 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. Practically, this means a U.S.-based applicant can include certain international elements or collaborations if they meet NIH definitions and are properly justified, but a foreign organization cannot serve as the primary applicant under this FOA.

Taken together, this R33 opportunity is best understood as a bridge between promising preclinical or early human evidence and the level of preparation needed for a definitive efficacy trial. Competitive applications are likely to be those that pair a well-justified natural product (with credible rationale, product characterization, and quality considerations) with a clinical study plan that is tightly aligned to NCCIH high-priority topics and produces actionable evidence about whether the product is ready for larger-scale testing, and if so, exactly how that next trial should be designed.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Exploratory Clinical Trials and Studies of Natural Products in NCCIH High Priority Research Topics (R33)" 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 2016-09-01.
• Applicants must submit their applications by 2016-12-16. (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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