Opportunity Information: Apply for RFA AT 16 002
Apply for RFA AT 16 002
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Exploratory Clinical Trials 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 Research and Training in Complementary and Integrative Health.
- This funding opportunity was created on Feb 9, 2015 and posted on Feb 6, 2015.
- Applicants must submit their applications by Aug 4, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $450,000.00 in funding.
- Eligible applicants include: Native American tribal governments (Federally recognized) Small businesses Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts State governments For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIH, through the National Center for Complementary and Integrative Health (NCCIH), offered the RFA-AT-16-002 funding opportunity titled "Exploratory Clinical Trials of Natural Products in NCCIH High Priority Research Topics (R33)." This opportunity was built around a very specific purpose: to fund early, exploratory clinical studies of natural products such as botanicals, dietary supplements, and probiotics when there is already enough preliminary or early-stage evidence to justify moving into human testing, but not enough to justify a large, definitive trial. The central idea is to support carefully designed pilot clinical trials that reduce uncertainty, close key knowledge gaps, and generate the kind of data investigators would need to plan a strong, competitive full-scale clinical trial later on.
A defining feature of this announcement is its emphasis on scientific utility regardless of outcome. The trials proposed under this FOA were expected to be informative whether results turned out positive, negative, or mixed. In practice, that means NCCIH wanted studies that are tightly connected to a testable rationale and that produce interpretable results that help decision-making about whether a natural product is worth advancing, how it might work, and what should be measured in subsequent research. Rather than simply asking whether a product "helps," the FOA pushed applicants to design studies that clarify what the product does biologically, how those biological effects relate to meaningful clinical signals, and what the next step should be.
Another core requirement was to strengthen the chain of evidence connecting mechanism to outcomes. NCCIH described this as confirming the link between the natural product and a biological signature, essentially a measurable indicator of mechanism of action, and then demonstrating an association between changes in that biological signature and clinical outcomes. Put simply, the research needed to do more than observe symptom changes; it needed to show that the natural product produces a measurable biological effect consistent with the hypothesized mechanism, and that this biological change tracks with clinical change in a way that supports future, more definitive testing.
This FOA also drew a clear boundary around what it would not support. It explicitly stated that it was not appropriate for randomized clinical trials designed to test or determine efficacy. In other words, the R33 mechanism here was intended for exploratory work, not for the kind of large, confirmatory, efficacy-focused randomized controlled trials that would be used to establish whether a product definitively works. The goal was faster translation from promising basic or preclinical science into well-structured pilot clinical testing, mainly to decide whether continued clinical development is warranted and to ensure that if a larger trial is pursued, it is grounded in strong preliminary human data and mechanistic understanding.
From an administrative and funding standpoint, this was a discretionary grant opportunity in the health category (CFDA 93.213, Research and Training in Complementary and Integrative Health). The estimated total funding available was listed as $500,000, with an award ceiling of $450,000. The opportunity did not require cost sharing or matching. Key dates included a posted date of February 6, 2015, with closing dates shown as June 29, 2015 originally and August 4, 2015 as the updated current closing date, and an archive date of September 4, 2015.
Eligibility was broad across U.S.-based organizations and governments. Eligible applicants included public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities outside higher education), for-profit organizations (including small businesses and other for-profits), and a wide range of government entities such as state governments, county governments, city or township governments, special district governments, and public housing authorities/Indian housing authorities. Federally recognized Native American tribal governments and other tribal organizations were also eligible, along with independent school districts and regional organizations. The announcement also identified additional eligible applicant types such as HBCUs, Hispanic-serving institutions, AANAPISI institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, eligible federal agencies, and faith-based or community-based organizations. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations were not eligible to apply, though foreign components as defined by NIH policy were allowed.
Overall, this R33 opportunity was structured to accelerate smart, mechanism-aware pilot clinical research on natural products in NCCIH priority areas. It aimed to fund studies that produce decisive, high-value evidence about biological activity and early clinical signals, so the field can make better go/no-go decisions and design stronger subsequent trials rather than rushing prematurely into large efficacy studies.
FAQs: NIH NCCIH RFA-AT-16-002 (R33) - Exploratory Clinical Trials of Natural Products
What is the funding opportunity called?
The opportunity is titled "Exploratory Clinical Trials of Natural Products in NCCIH High Priority Research Topics (R33)" and is identified as RFA-AT-16-002. It was offered by the NIH through the National Center for Complementary and Integrative Health (NCCIH).
What is the main purpose of this R33 funding opportunity?
The purpose is to fund early, exploratory clinical studies (pilot clinical trials) of natural products when there is enough preliminary evidence to justify human testing, but not enough evidence to justify a large, definitive clinical trial. The intent is to reduce uncertainty, close key knowledge gaps, and generate data that would support planning a strong, competitive full-scale clinical trial later.
What kinds of interventions are considered "natural products" under this opportunity?
The opportunity focuses on natural products such as botanicals, dietary supplements, and probiotics.
What stage of clinical research is this FOA designed to support?
It is designed to support carefully designed, early-stage exploratory or pilot clinical trials, not large confirmatory trials.
Is this opportunity intended to determine whether a natural product is efficacious?
No. The announcement explicitly states it is not appropriate for randomized clinical trials designed to test or determine efficacy. The focus is on exploratory work that informs next-step decisions and future trial design rather than establishing definitive effectiveness.
What does NCCIH mean by studies being scientifically useful "regardless of outcome"?
Trials were expected to be informative whether results are positive, negative, or mixed. That means studies should be grounded in a testable rationale and designed to produce interpretable results that help decide whether the natural product is worth advancing, how it might work, and what should be measured next.
What is meant by connecting "mechanism" to outcomes in these trials?
A central requirement was strengthening the evidence chain from a hypothesized mechanism of action to observable outcomes. Applicants were expected to confirm a link between the natural product and a measurable biological signature (a biological indicator consistent with the mechanism), and then demonstrate an association between changes in that signature and clinical outcomes.
What is a "biological signature" in the context of this FOA?
In this FOA, a biological signature is described as a measurable indicator of the product's mechanism of action. The study is expected to show the natural product produces a measurable biological effect consistent with the hypothesized mechanism.
Does the FOA require researchers to measure more than symptom changes?
Yes. The research needed to do more than observe symptom changes. It needed to demonstrate a measurable biological effect consistent with the hypothesized mechanism and show that this biological change is associated with clinical change.
What are the expected outputs or benefits of an R33 project under this FOA?
The expected outputs include high-value, decision-enabling evidence about biological activity and early clinical signals, helping investigators and the field make better go/no-go decisions and design stronger subsequent trials rather than moving prematurely into large efficacy studies.
What is the funding mechanism used in this announcement?
The mechanism is an R33, described here as supporting exploratory clinical trials.
Which NIH institute/center sponsored this opportunity?
The opportunity was offered by NIH through the National Center for Complementary and Integrative Health (NCCIH).
What is the CFDA number and program category?
The CFDA is 93.213, under "Research and Training in Complementary and Integrative Health." The opportunity is described as a discretionary grant opportunity in the health category.
How much total funding was estimated to be available?
The estimated total funding available was listed as $500,000.
What was the maximum award amount (award ceiling)?
The award ceiling was $450,000.
Was cost sharing or matching required?
No. The opportunity did not require cost sharing or matching.
When was the opportunity posted?
The posted date was February 6, 2015.
What were the closing date(s) for applications?
The closing date was originally shown as June 29, 2015, and the updated current closing date was August 4, 2015.
When was the opportunity archived?
The archive date was September 4, 2015.
What types of organizations were eligible to apply?
Eligibility was broad across U.S.-based organizations and governments. Eligible applicants included public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities outside higher education); for-profit organizations (including small businesses and other for-profits); and multiple government entities.
Which government entities were eligible?
Eligible government applicants included state governments, county governments, city or township governments, special district governments, and public housing authorities/Indian housing authorities.
Are tribal governments or tribal organizations eligible?
Yes. Federally recognized Native American tribal governments and other tribal organizations were eligible.
Are school districts or regional organizations eligible?
Yes. Independent school districts and regional organizations were listed as eligible.
Were certain institution types explicitly called out as eligible?
Yes. The announcement identified additional eligible applicant types such as HBCUs, Hispanic-serving institutions, AANAPISI institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, eligible federal agencies, and faith-based or community-based organizations.
Are non-U.S. (foreign) institutions eligible to apply?
No. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations were not eligible to apply.
Are foreign components allowed in any form?
Yes. While foreign institutions and non-U.S. components of U.S. organizations were not eligible to apply, foreign components (as defined by NIH policy) were allowed.
What is the overall goal of this FOA for the research field?
The overall goal is to accelerate smart, mechanism-aware pilot clinical research on natural products in NCCIH priority areas, producing decisive early human and mechanistic evidence to inform whether continued clinical development is warranted and to improve the design of subsequent trials.
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