Opportunity Information: Apply for PAR 17 319
The NCCIH Natural Product Phase I-IIa Clinical Trial Phased Innovation Award (R61/R33), funding opportunity number PAR 17-319, is a National Institutes of Health (NIH) grant program that supports investigator-initiated, early-stage clinical trials focused specifically on natural products. In this context, natural products include botanicals, dietary supplements, and probiotics. The central goal is to generate high-quality, decision-ready clinical evidence about whether a given natural product is promising enough to justify further development and larger, later-phase clinical testing. A key expectation is that the trial design produces results with strong scientific value regardless of outcome, meaning the study should be built so that both positive and negative findings are interpretable and useful for guiding next steps.
This FOA uses a phased innovation structure (R61/R33) intended to move projects through an initial, milestone-driven stage into a subsequent stage that supports continued clinical evaluation. In practice, this structure is meant to reduce the risk of investing heavily in products that are not ready for broader trials by emphasizing a strong scientific premise up front and requiring that the early trial produce clear, actionable information. The “early phase” framing indicates these studies are not intended to be large, definitive efficacy trials; instead, they generally focus on questions that must be answered before a natural product can responsibly advance, such as feasibility, tolerability, safety signals, adherence, dose selection, target engagement, or preliminary signals that justify a larger Phase IIb or Phase III effort.
The opportunity falls under the NIH health research mission (CFDA 93.213) and is offered as a discretionary grant. The applicant pool is broad and includes many domestic organization types: state, county, city/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 that are not federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); 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, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal government agencies, faith-based or community-based organizations, regional organizations, and applicants located in a U.S. territory or possession.
At the same time, there are clear restrictions related to foreign involvement. 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 by the NIH Grants Policy Statement) are not allowed under this FOA. This means the work, leadership, and supported project components are expected to be entirely within allowable U.S.-based institutional structures.
Key administrative details from the source record include the program’s creation date of June 22, 2017, and an original closing date listed as November 4, 2017. The source information does not specify an award ceiling or the expected number of awards. Overall, the defining feature of this opportunity is its emphasis on carefully designed, early clinical trials of natural products that are rigorous enough to meaningfully inform go/no-go decisions for future clinical development, rather than simply producing exploratory or ambiguous results.Apply for PAR 17 319
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NCCIH Natural Product Phase I-IIa Clinical Trial Phased Innovation Award (R61/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.)
- 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 Phased Innovation Award (R61/R33) - PAR 17-319
What is this funding opportunity?
This is an NIH grant program from the National Center for Complementary and Integrative Health (NCCIH) called the Natural Product Phase I-IIa Clinical Trial Phased Innovation Award (R61/R33). The funding opportunity number is PAR 17-319, and it supports investigator-initiated, early-stage clinical trials focused on natural products.
What is the main purpose of this program?
The central goal is to generate high-quality, decision-ready clinical evidence to determine whether a natural product is promising enough to justify further development and larger, later-phase clinical testing. The program emphasizes producing clear, actionable results that can support go/no-go decisions for future clinical development.
What types of products count as "natural products" under this FOA?
In this context, natural products include botanicals, dietary supplements, and probiotics.
What kinds of studies does this FOA support?
This FOA supports early-stage clinical trials (Phase I through Phase IIa). These studies are not intended to be large, definitive efficacy trials. Instead, they generally focus on questions that need to be answered before a natural product can responsibly advance to larger trials.
What does "early-stage" mean here (what is it not intended to fund)?
The "early phase" framing indicates the studies are not meant to be large, definitive efficacy trials. The emphasis is on generating interpretable information that helps determine readiness for later-phase testing (for example Phase IIb or Phase III), rather than attempting to conclusively prove clinical efficacy in a large population.
What kinds of outcomes or questions are expected in these trials?
The FOA description highlights early clinical questions such as feasibility, tolerability, safety signals, adherence, dose selection, target engagement, and preliminary signals that might justify a larger trial.
What does the R61/R33 "phased innovation" structure mean?
The FOA uses a phased innovation structure (R61/R33) intended to move projects from an initial, milestone-driven stage into a subsequent stage that supports continued clinical evaluation. The first phase emphasizes meeting predefined milestones so the project can transition to the later phase.
Why does this FOA use a phased (R61/R33) approach?
The phased structure is intended to reduce the risk of investing heavily in products that are not ready for broader clinical trials. It does this by emphasizing a strong scientific premise up front and requiring that the early trial generate clear, actionable information before progressing to the next phase.
What is the expectation regarding the interpretability of trial results?
A key expectation is that the trial design produces results with strong scientific value regardless of outcome. That means both positive and negative findings should be interpretable and useful for guiding next steps in development.
Is this opportunity investigator-initiated?
Yes. The program supports investigator-initiated early-stage clinical trials focused specifically on natural products.
Which agency and program area does this opportunity fall under?
It falls under the NIH health research mission and is associated with CFDA 93.213.
What type of funding mechanism is this?
The opportunity is offered as a discretionary grant and uses the R61/R33 phased innovation award structure.
Who is eligible to apply?
The applicant pool described is broad and includes many U.S. domestic organization types. Examples listed include: state, county, city/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 that are not federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations other than small businesses; small businesses; and other eligible entities.
Are specific institution types explicitly highlighted as eligible?
Yes. The FOA explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal government agencies, faith-based or community-based organizations, regional organizations, and applicants located in a U.S. territory or possession.
Are foreign organizations eligible to apply?
No. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply under this FOA.
Can a U.S. organization include a non-U.S. (foreign) component or foreign site?
No. The FOA states that non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed.
Does the FOA allow the project work and leadership to be outside the U.S.?
No. Based on the stated restrictions, the work, leadership, and supported project components are expected to be entirely within allowable U.S.-based institutional structures.
What is the program trying to avoid in natural product clinical development?
The design is meant to avoid ambiguous or purely exploratory results by requiring careful trial design that produces clear, actionable information. It is structured to reduce the risk of advancing or heavily investing in products that are not ready for larger clinical trials.
Are award amounts (ceilings) or the number of awards specified in the provided information?
No. The source information provided does not specify an award ceiling or the expected number of awards.
What are the key dates mentioned for this opportunity?
The source record lists a creation date of June 22, 2017, and an original closing date of November 4, 2017.
What is the overall defining feature of this opportunity?
The defining feature is its emphasis on carefully designed, early clinical trials of natural products that are rigorous enough to meaningfully inform go/no-go decisions for future clinical development, rather than producing exploratory or ambiguous results.
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