Opportunity Information: Apply for PAR 17 318
The NCCIH Natural Product Phase I-IIa Clinical Trial Award (R33) (Funding Opportunity Number PAR-17-318) is a National Institutes of Health grant opportunity focused on supporting investigator-initiated, early-phase clinical trials of natural products. The program is administered through the NIH, with the activity area in health (CFDA 93.213), and it is specifically intended for clinical studies that evaluate natural products such as botanicals, dietary supplements, and probiotics. The central goal is to fund trials that are rigorous and informative enough to guide real development decisions, meaning the study design and outcomes should be useful even if the results are negative. In practice, this puts emphasis on trials that can clearly answer important questions about whether a natural product is promising, safe enough, and sufficiently supported by science to justify larger or later-stage clinical testing.
A key feature of this FOA is its insistence on a strong scientific premise. Applicants are expected to make a convincing case, based on prior data and rationale, that the natural product being tested warrants further clinical investigation. The funded trials must also be structured so that the resulting evidence has high scientific utility. That typically means well-defined objectives, meaningful endpoints, and a design capable of producing interpretable outcomes that can reduce uncertainty about the product's potential. The intent is not simply to run a small exploratory study, but to produce results that can credibly support a go/no-go decision about next steps in development or additional testing.
The award mechanism is an R33 grant, positioned to support Phase I through Phase IIa-type clinical trial work. While the opportunity description does not spell out every operational requirement in the excerpt provided, the framing makes clear that this FOA targets early clinical testing where questions like feasibility, dosing, safety, tolerability, early signals of efficacy, and outcome measurement strategy are commonly central. The emphasis on decision-making utility signals that NCCIH expects thoughtful planning around what will be learned, how it will be interpreted, and how it will inform whether the natural product should advance to more definitive trials.
Eligibility is broad across many U.S.-based organizational types. Eligible applicants include state, county, city or township, and 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 other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities as allowed by NIH policy. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), tribally controlled colleges and universities (TCCUs), regional organizations, eligible federal agencies, Indian/Native American tribal governments other than federally recognized ones, and U.S. territories or possessions.
At the same time, the FOA draws a firm boundary around foreign involvement in the application structure. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined under the NIH Grants Policy Statement) are not allowed. In other words, applicants must be U.S.-based and structured without foreign components in the way NIH defines and regulates them, which is an important compliance consideration for institutions with international affiliates, overseas sites, or planned research activities outside the United States.
From the funding details provided, the opportunity is a discretionary grant with an award ceiling listed at $750,000. The source data also notes an original closing date of 2017-11-04 and a creation date of 2017-06-22, indicating the posted cycle and timeframe for that particular announcement record. Overall, the program is best understood as a targeted NIH/NCCIH pathway for advancing well-justified natural products into early clinical testing, with a strong preference for trials designed to produce clear, decision-grade evidence about whether and how a natural product should move forward in the clinical development pipeline.Apply for PAR 17 318
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NCCIH Natural Product Phase I-IIa Clinical Trial Award (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 2017-06-22.
- Applicants must submit their applications by 2017-11-04. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $750,000.00 in funding.
- 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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FAQs: NCCIH Natural Product Phase I-IIa Clinical Trial Award (R33) (PAR-17-318)
What is this grant opportunity?
The NCCIH Natural Product Phase I-IIa Clinical Trial Award (R33) (Funding Opportunity Number PAR-17-318) is a National Institutes of Health (NIH) funding opportunity administered by the National Center for Complementary and Integrative Health (NCCIH). It supports investigator-initiated, early-phase clinical trials of natural products.
What kinds of studies does this FOA support?
This FOA supports early-phase clinical trials (Phase I through Phase IIa-type work) that evaluate natural products. The trials are expected to be rigorous and designed to produce interpretable results that can guide real development decisions.
What types of products are considered "natural products" under this opportunity?
The opportunity is specifically intended for clinical studies evaluating natural products such as botanicals, dietary supplements, and probiotics.
What is the main goal of the program?
The central goal is to fund trials that are informative enough to support clear development decisions (for example, whether a natural product is promising, safe enough, and scientifically supported enough to justify larger or later-stage clinical testing). The FOA emphasizes that the study design and outcomes should remain useful even if the results are negative.
What does NCCIH mean by "decision-grade" evidence?
Based on the description provided, NCCIH is looking for evidence that reduces uncertainty and can credibly support a go/no-go decision about next steps. This implies a design with well-defined objectives, meaningful endpoints, and results that can be interpreted in a way that informs whether further development is justified.
Is this meant for exploratory pilot studies?
The FOA description indicates the intent is not simply to run a small exploratory study. Instead, applicants are expected to design trials that can clearly answer important questions and produce outcomes with high scientific utility for decision-making.
What is the award mechanism?
The award mechanism is an R33 grant.
Which clinical trial phases are targeted?
The R33 mechanism here is positioned to support Phase I through Phase IIa-type clinical trial work.
What kinds of questions should the clinical trial be designed to answer?
The description highlights early clinical testing priorities, including feasibility, dosing, safety, tolerability, early signals of efficacy, and outcome measurement strategy. The overarching expectation is that the trial will be designed to yield interpretable results that inform next-step decisions.
How important is prior evidence or rationale for the natural product?
A strong scientific premise is described as a key feature of this FOA. Applicants are expected to make a convincing case, based on prior data and rationale, that the natural product warrants further clinical investigation.
Why does the FOA emphasize that negative results should still be useful?
The FOA aims to fund trials whose design and outcomes can guide development decisions regardless of outcome direction. This means the trial should be structured so that even a negative result is still interpretable and informative for deciding whether to stop, revise, or continue development.
What is the activity area and CFDA number associated with this opportunity?
The activity area is health, and the CFDA number listed is 93.213.
Who can apply?
Eligibility is broad across many U.S.-based organizational types. Eligible applicants include various levels of government (state, county, city or township, special district), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized Native American tribal governments, tribal organizations other than federally recognized tribal governments, public housing authorities and Indian housing authorities, nonprofits (with or without 501(c)(3) status, as long as they are not institutions of higher education), for-profit organizations (other than small businesses), small businesses, and other entities as allowed by NIH policy.
Are any specific institution categories explicitly highlighted as eligible?
Yes. The FOA explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), tribally controlled colleges and universities (TCCUs), regional organizations, eligible federal agencies, Indian/Native American tribal governments other than federally recognized ones, and U.S. territories or possessions.
Can a foreign organization apply?
No. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply.
Can a U.S. organization include a non-U.S. (foreign) component in the project?
No. The FOA states that non-domestic components of U.S. organizations are not eligible, and foreign components (as defined under the NIH Grants Policy Statement) are not allowed.
Why is the foreign component restriction important?
The description emphasizes this as a compliance consideration for institutions with international affiliates, overseas sites, or planned research activities outside the United States. Applicants must be U.S.-based and structured without foreign components as NIH defines them.
What type of funding is this?
The opportunity is described as a discretionary grant.
What is the maximum award amount listed?
The award ceiling listed is $750,000.
What are the key dates mentioned for this announcement record?
The source data notes a creation date of 2017-06-22 and an original closing date of 2017-11-04 for that particular announcement record.
What does "investigator-initiated" mean in this context?
Based on the provided description, the trials are investigator-initiated, meaning the study is proposed and driven by the applicant investigators rather than being a pre-specified protocol dictated by the funding agency.
What is NCCIH looking for in trial design and endpoints?
The FOA emphasizes high scientific utility, which typically implies well-defined objectives, meaningful endpoints, and a design capable of producing interpretable outcomes that reduce uncertainty about the product's potential.
How does this FOA fit into the broader clinical development pipeline?
It is described as a targeted NIH/NCCIH pathway for advancing well-justified natural products into early clinical testing, with a strong preference for trials that produce clear evidence to determine whether and how a natural product should move forward to larger or later-stage testing.
Which NIH institute/center is associated with this opportunity?
The opportunity is administered through NIH and specifically associated with the National Center for Complementary and Integrative Health (NCCIH).
What is the funding opportunity number?
The funding opportunity number provided is PAR-17-318.
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