Opportunity Information: Apply for RFA AT 20 001
The NIH opportunity titled "Preclinical Screening for Natural Product Drug Interactions (Clinical Trial Not Allowed, R21)" (Funding Opportunity Number RFA-AT-20-001) supports early-stage, exploratory research aimed at spotting natural products that could cause drug interactions by changing how the body metabolizes or transports conventional medications. The core scientific goal is to identify natural products that inhibit or induce key Phase I and Phase II drug-metabolizing enzymes, as well as drug transporters, since those mechanisms are a common pathway for pharmacokinetic interactions that can raise drug levels to unsafe ranges or reduce them below effective levels. The work is explicitly preclinical and in vitro, with no clinical trials allowed, and is designed to generate actionable screening data that can help prioritize which natural products need deeper investigation.
Projects are expected to focus on laboratory screening approaches, including medium- to high-throughput assays, to evaluate libraries of complex botanical or natural product extracts and/or purified constituents. A major emphasis is on practical, scalable methods that can flag interaction potential across many samples rather than only studying a single product in depth. The FOA also allows work that goes beyond screening to isolate and chemically identify the specific active constituents responsible for the interaction signal, particularly when the active compounds are novel, not well characterized, or not commercially available. In other words, applicants can propose workflows that start with complex mixtures, detect enzyme or transporter effects, and then perform bioactivity-guided fractionation and identification to pinpoint the interacting molecules.
This announcement is part of a larger NCCIH investment that includes a U54 Center of Excellence for Natural Product Drug Interaction Research. A key expectation is that data generated under these R21 projects will be uploaded to, and shared through, the public data repository maintained by the U54 Center. That requirement signals that the program is building a community resource, not just funding isolated projects, and that applicants should plan for standardized data capture, quality control, and timely data deposition so results can be compared and reused by other researchers and stakeholders.
The award mechanism is the NIH R21 exploratory/developmental grant, and the listed award ceiling is $200,000. The opportunity falls under the Health funding activity category (CFDA 93.213) and is offered by the National Institutes of Health. The original closing date shown for the competition was 2019-11-01, and the FOA creation date is 2019-07-23, which helps situate it historically if someone is using it as a model for similar current opportunities or looking for related reissued announcements.
Eligibility is broad and includes many types of U.S.-based organizations and government entities, such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; and Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments). The FOA also highlights additional eligible applicant categories often emphasized in NIH programs, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.
Foreign eligibility is restricted in a specific way. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as the applicant organization. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant may include certain foreign collaborations or activities if they meet NIH definitions and requirements. This structure supports international scientific expertise when justified, while keeping the primary awardee organization domestic.
Overall, the program is designed to improve understanding of which commonly used or emerging natural products might alter drug exposure through enzyme and transporter pathways, using robust in vitro screening and, when needed, compound isolation and identification. The practical deliverable is a set of publicly shared screening and characterization data that can inform subsequent mechanistic studies, risk assessment, and eventually better guidance for clinicians, patients, and researchers about potential natural product-drug interaction risks.Apply for RFA AT 20 001
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Preclinical Screening for Natural Product Drug Interactions (Clinical Trial Not Allowed, R21)" 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 2019-07-23.
- Applicants must submit their applications by 2019-11-01. (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 $200,000.00 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: Preclinical Screening for Natural Product Drug Interactions (Clinical Trial Not Allowed, R21) - RFA-AT-20-001
What is the purpose of this NIH funding opportunity?
This opportunity supports early-stage, exploratory research to identify natural products that may cause drug interactions by altering how the body metabolizes or transports conventional medications. The intent is to generate actionable screening data that can help prioritize which natural products warrant deeper follow-up studies.
What kinds of drug interactions is the program focused on?
The focus is on pharmacokinetic interaction potential, especially interactions driven by inhibition or induction of key Phase I and Phase II drug-metabolizing enzymes and drug transporters. These mechanisms can increase drug levels into unsafe ranges or decrease them below effective levels.
Is this opportunity clinical or preclinical?
It is explicitly preclinical and in vitro. Clinical trials are not allowed under this funding opportunity.
Are clinical trials allowed under this FOA?
No. The opportunity is labeled "Clinical Trial Not Allowed," and the described work is intended to be preclinical and in vitro.
What research approaches are expected for proposed projects?
Projects are expected to use laboratory screening approaches, including medium- to high-throughput assays, to evaluate natural products for enzyme and transporter effects that could indicate interaction potential.
Does the FOA emphasize studying a single natural product deeply, or screening many products?
A major emphasis is on practical, scalable methods that can flag interaction potential across many samples (for example, libraries of extracts or constituents), rather than only studying a single product in depth.
What types of natural product materials can be screened?
The FOA anticipates screening libraries of complex botanical or natural product extracts and/or purified constituents.
Can applicants propose work to identify the specific constituents responsible for an interaction signal?
Yes. The FOA allows work beyond screening to isolate and chemically identify the active constituents responsible for the interaction signal, particularly when active compounds are novel, not well characterized, or not commercially available.
What is an example of an allowed workflow under this opportunity?
An example workflow described by the FOA is: start with complex mixtures, screen for effects on drug-metabolizing enzymes or transporters, then perform bioactivity-guided fractionation and chemical identification to pinpoint the interacting molecules.
What is the expected practical deliverable from funded projects?
The program is intended to produce screening and characterization data that can be used to prioritize natural products for further investigation and inform future risk assessment and guidance related to natural product-drug interaction risks.
Is data sharing required?
Yes. A key expectation is that data generated under these R21 projects will be uploaded to and shared through a public data repository maintained by an associated U54 Center of Excellence for Natural Product Drug Interaction Research.
Where is the data expected to be shared?
Data are expected to be deposited in the public data repository maintained by the U54 Center of Excellence for Natural Product Drug Interaction Research described as part of the larger NCCIH investment.
What does the data repository expectation imply for applicants?
Applicants should plan for standardized data capture, quality control, and timely data deposition so results can be compared and reused by other researchers and stakeholders.
How does this opportunity relate to other NIH/NCCIH efforts?
This R21 announcement is part of a larger NCCIH investment that includes a U54 Center of Excellence for Natural Product Drug Interaction Research. The R21 projects are expected to contribute data to the community resource supported by that U54 Center.
What is the award mechanism for this opportunity?
The award mechanism is the NIH R21 exploratory/developmental grant.
What is the listed award ceiling?
The listed award ceiling is $200,000.
Which agency is offering this funding opportunity?
The opportunity is offered by the National Institutes of Health (NIH).
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-AT-20-001.
What is the title of the funding opportunity?
The title is "Preclinical Screening for Natural Product Drug Interactions (Clinical Trial Not Allowed, R21)."
What is the funding activity category and CFDA number?
The opportunity falls under the Health funding activity category and lists CFDA 93.213.
When was this FOA created and what was the original closing date?
The FOA creation date is 2019-07-23, and the original closing date shown for the competition was 2019-11-01.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organizations and government entities, including state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; and federally recognized Native American tribal governments and other tribal organizations (other than federally recognized tribal governments).
Are U.S. territories or possessions mentioned as eligible?
Yes. The FOA highlights U.S. territories or possessions among eligible applicant categories.
Are certain institution types specifically highlighted as eligible?
Yes. The FOA highlights categories often emphasized in NIH programs, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, and faith-based or community-based organizations, among others.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed as eligible.
Can non-U.S. organizations apply as the applicant organization?
No. Non-domestic (non-U.S.) entities are not eligible to apply as the applicant organization.
Are non-domestic components of U.S. organizations eligible to apply?
No. Non-domestic components of U.S. organizations are not eligible to apply as the applicant organization.
Are foreign components allowed in any form?
Yes. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. This means a U.S. applicant may include certain foreign collaborations or activities if they meet NIH definitions and requirements.
What is the overall long-term intent of building this screening data resource?
The program is designed to improve understanding of which commonly used or emerging natural products might alter drug exposure through enzyme and transporter pathways. By making screening and characterization data publicly available, the results can inform subsequent mechanistic studies, risk assessment, and, eventually, better guidance for clinicians, patients, and researchers.
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