Opportunity Information: Apply for RFA AT 16 001
Apply for RFA AT 16 001
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Phased Innovation Award for Exploratory Clinical Trials of Natural Products in NCCIH High Priority Research Topics (R21/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 $1,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Public and State controlled institutions of higher education For profit organizations other than small businesses Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments County governments City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities State governments Independent school districts Native American tribal governments (Federally recognized).
- 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 Phased Innovation Award for Exploratory Clinical Trials of Natural Products in NCCIH High Priority Research Topics (R21/R33) is a National Institutes of Health (NIH) grant opportunity designed to move promising natural products toward better-quality clinical evidence, but in a careful, staged way. The focus is on pilot testing of natural products such as botanicals, dietary supplements, and probiotics that already have enough early-stage data (for example, preclinical findings, prior human data, or other supportive evidence) to justify stepping into additional clinical testing. A key expectation is that the proposed studies are built to generate results that are scientifically useful regardless of whether outcomes are favorable or not. In other words, the goal is not to chase only positive findings, but to produce clear, decision-making information that helps determine whether the product should advance to larger and more definitive clinical research.
This funding mechanism uses a two-phase structure tied to milestones. The first phase is an R21 (up to two years) and is meant for milestone-driven work that reduces major uncertainties about how the natural product behaves in humans and how it might be working biologically. Typical activities emphasized in this phase include bioavailability and pharmacokinetic testing (how much of the product or its active constituents get into the body, how they are distributed and metabolized, and how long they persist) as well as assessment of a biological signature or mechanism of action (evidence that the product engages a target pathway, produces measurable biological effects, or has a plausible mode of action that can be tracked with biomarkers or other objective measures). The R21 phase is essentially intended to fill key knowledge gaps that commonly block the design of a rigorous, competitive full-scale clinical trial.
If the R21 phase meets its predefined milestones, applicants may transition to the second phase, the R33 (up to three years). The R33 supports additional clinical studies that build on what was learned in the R21. This later phase is meant to further refine clinical feasibility and scientific readiness, such as optimizing dose, confirming target engagement using biomarkers, refining eligibility criteria, improving adherence and retention strategies, strengthening outcome measures, and establishing the operational and scientific foundation needed to justify a future large clinical trial. While the R33 allows for more extensive clinical work than the R21, the overall program is still positioned as exploratory and developmental rather than confirmatory.
A central limitation of this FOA is that it is not meant to fund randomized clinical trials whose main purpose is to test or determine efficacy. The intent is earlier in the translation pipeline: to generate the kinds of human data that clarify whether efficacy testing is warranted and, if so, how to design that later trial properly. In practice, this means the funded studies should prioritize informative endpoints and design features that reduce ambiguity, such as strong characterization of the intervention, clear rationale for dose selection, credible measures of exposure and biological response, and well-justified clinical or physiological outcomes that can guide the next step.
Administrative details from the announcement indicate this is a discretionary grant program in the health research category administered by NIH, tied to CFDA 93.213 (Research and Training in Complementary and Integrative Health). The opportunity listed an estimated total funding level of $1,000,000 and did not require cost sharing or matching. Key dates in the posting show it was posted February 6, 2015, with an original closing date of June 22, 2015, later updated to August 4, 2015, and an archive date of September 4, 2015. The funding opportunity number is RFA-AT-16-001, and the full announcement was hosted through the NIH Grants Guide.
Eligibility was broad across many domestic organization types, including higher education institutions (public and private), nonprofits (including 501(c)(3) organizations), for-profit entities, small businesses, and multiple levels of government (state, county, city/township, special districts), as well as tribal governments and tribal organizations. The announcement also explicitly included eligibility for a range of mission-serving institutions (such as HBCUs, Hispanic-serving institutions, AANAPISIs, and tribally controlled colleges and universities) and faith-based or community-based organizations where applicable. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations were not eligible to apply, although foreign components as defined in NIH policy were allowed. The sponsoring agency was NIH, and technical access issues were routed through the NIH Office of Extramural Research webmaster contact listed in the notice.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
The Phased Innovation Award for Exploratory Clinical Trials of Natural Products in NCCIH High Priority Research Topics (R21/R33) is an NIH grant opportunity intended to move promising natural products toward stronger, higher-quality clinical evidence using a careful, staged approach.
What is the main goal of the R21/R33 phased award?
The main goal is to generate clear, decision-making human data that helps determine whether a natural product should advance to larger and more definitive clinical research, and how that later research should be designed.
What kinds of products are in scope?
The FOA focuses on natural products such as botanicals, dietary supplements, and probiotics.
What level of prior evidence is expected before applying?
Projects should involve natural products that already have enough early-stage support to justify additional clinical testing, such as preclinical findings, prior human data, or other supportive evidence.
Does this FOA require positive results to be valuable?
No. A key expectation is that studies are designed to produce scientifically useful results regardless of whether outcomes are favorable or not, so the findings still inform next-step decisions.
How is the award structured?
This mechanism uses two phases tied to predefined milestones: an initial R21 phase (up to two years) followed by an R33 phase (up to three years) if milestones are met.
How long is the R21 phase?
The R21 phase can last up to two years.
What is the purpose of the R21 phase?
The R21 phase is intended to reduce major uncertainties about how the natural product behaves in humans and how it might be working biologically, filling key knowledge gaps that often block the design of a rigorous, competitive larger clinical trial.
What types of activities are emphasized during the R21 phase?
Typical R21 activities include bioavailability and pharmacokinetic testing (exposure, distribution, metabolism, persistence) and assessing a biological signature or mechanism of action (for example, evidence of target engagement or measurable biological effects using biomarkers or other objective measures).
What does "bioavailability and pharmacokinetic testing" mean in this context?
It refers to understanding how much of the natural product (or its active constituents) gets into the body, how it is distributed and metabolized, and how long it remains detectable or active.
What does "biological signature" or "mechanism of action" mean here?
It means generating evidence that the product engages a target pathway or produces measurable biological effects that can be tracked using biomarkers or other objective measures.
Can an application automatically move from R21 to R33?
No. Transition to the R33 phase is contingent on meeting the predefined R21 milestones.
How long is the R33 phase?
The R33 phase can last up to three years.
What is the purpose of the R33 phase?
The R33 phase supports additional clinical studies that build on R21 findings to further refine feasibility and scientific readiness for a future larger clinical trial.
What kinds of activities are supported in the R33 phase?
Examples include optimizing dose, confirming target engagement using biomarkers, refining eligibility criteria, improving adherence and retention strategies, strengthening outcome measures, and establishing the operational and scientific foundation for a later large clinical trial.
Is this FOA intended to fund full efficacy trials?
No. A central limitation is that it is not meant to fund randomized clinical trials whose main purpose is to test or determine efficacy.
If the FOA is not for efficacy trials, what should studies prioritize?
Studies should prioritize informative endpoints and design features that reduce ambiguity, such as strong characterization of the intervention, a clear rationale for dose selection, credible measures of exposure and biological response, and well-justified clinical or physiological outcomes to guide next steps.
Is the overall program confirmatory or exploratory?
The program is positioned as exploratory and developmental rather than confirmatory, even though the R33 phase can support more extensive clinical work than the R21.
Who administers this grant program?
The sponsoring agency is the National Institutes of Health (NIH).
What is the funding opportunity number?
The funding opportunity number is RFA-AT-16-001.
What is the CFDA number and program area?
The opportunity is tied to CFDA 93.213, Research and Training in Complementary and Integrative Health.
What is the estimated total funding level listed?
The estimated total funding level listed in the announcement is $1,000,000.
Is cost sharing or matching required?
No cost sharing or matching was required according to the posting.
When was the opportunity posted and when did it close?
It was posted on February 6, 2015. The original closing date was June 22, 2015, later updated to August 4, 2015.
Is this opportunity still active?
No. The archive date listed is September 4, 2015.
Which types of organizations were eligible to apply?
Eligibility was broad across many domestic organization types, including public and private higher education institutions, nonprofits (including 501(c)(3) organizations), for-profit entities, small businesses, state and local governments (including counties, cities/townships, and special districts), tribal governments, and tribal organizations.
Were mission-serving institutions included in eligibility?
Yes. The announcement explicitly included a range of mission-serving institutions, such as HBCUs, Hispanic-serving institutions, AANAPISIs, and tribally controlled colleges and universities.
Were faith-based or community-based organizations eligible?
Yes, where applicable, faith-based or community-based organizations were included as eligible.
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 any foreign elements allowed at all?
Yes. Foreign components, as defined in NIH policy, were allowed.
Where was the full announcement hosted?
The full announcement was hosted through the NIH Grants Guide.
Who was listed for technical access issues?
Technical access issues were routed through the NIH Office of Extramural Research webmaster contact listed in the notice.
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