Opportunity Information: Apply for RFA AT 20 002
The Center of Excellence for Natural Product Drug Interaction Research (U54, Clinical Trial Required) funding opportunity (RFA AT 20 002) was issued by the National Institutes of Health within the Department of Health and Human Services to establish a single, high-impact national center focused on natural product drug interactions. The main idea is to create a coordinated, authoritative program that can move beyond scattered case reports or inconsistent studies and instead produce clear, clinically actionable evidence about how certain natural products affect the way commonly used medications are metabolized and handled by the body. A key emphasis is pharmacokinetic interactions, meaning interactions that change drug absorption, distribution, metabolism, or excretion, often through effects on metabolic enzymes and transporters.
The program has two overarching goals. First, it aims to determine the real clinical relevance of pharmacokinetic interactions for a select set of natural products that are widely used or plausibly risky when taken alongside prescription or over-the-counter drugs. Second, it is meant to serve as a leadership hub for the broader research community by developing and sharing best practices for studying metabolism-mediated drug interactions involving complex natural products, which can be chemically variable, poorly standardized, and difficult to evaluate using conventional drug development approaches.
The Center is expected to carry out a full pipeline of work, beginning with selecting three to five natural products that have credible potential to cause clinically meaningful interactions. This includes identifying and prioritizing candidates based on factors like widespread consumer use, prior signals of interaction risk, biological plausibility, and the likelihood of co-use with medications that have narrow therapeutic windows or serious consequences if blood levels change. After prioritization, the Center must source the natural products and characterize them, which typically implies rigorous authentication, chemical profiling, and attention to batch variability so that any findings can be interpreted and reproduced.
Once candidates are selected and characterized, the Center must perform the necessary preclinical studies to define interaction potential. This includes identifying key mediators of any interaction (for example, specific cytochrome P450 enzymes, UGT enzymes, or drug transporters) and determining the mechanism and magnitude of the effect. The FOA anticipates a careful, stepwise approach where preclinical data guide whether a clinical study is justified, rather than launching human trials without a strong mechanistic and translational foundation. If preclinical evidence indicates a meaningful risk, the Center then conducts rigorously designed clinical studies to quantify the size of the interaction in humans and produce definitive data that clinicians, researchers, and the public can use.
A central deliverable is the creation and ongoing maintenance of a repository for both data and methodology. This repository is intended to house resources generated by the Center as well as information produced by other investigators, with special reference to data coming from related R21 projects funded under a companion announcement (RFA AT 20 001). In practice, this means the Center is not only producing results but also organizing the field by curating datasets, protocols, analytical methods, and other tools that can help standardize how natural product drug interaction studies are performed and interpreted across institutions.
In addition to generating evidence and maintaining shared resources, the Center is expected to provide sustained guidance and leadership to the relevant research communities. That leadership role includes helping define how to design better pharmacokinetic interaction studies for complex natural products, addressing common challenges such as product variability, selection of appropriate probe substrates, endpoint selection, interpretation of mechanistic in vitro findings, and translation to real-world clinical risk. The broader intent is that better science in this area will lead to better-informed decisions about taking natural products and medications together, reducing preventable adverse events and improving patient safety.
From an administrative standpoint, this is a cooperative agreement (U54), meaning the funding agency typically has substantial scientific involvement compared to a standard research project grant. The opportunity falls under the health funding category (CFDA 93.213). Eligibility is broad and includes various government entities, public and private institutions of higher education, tribal governments and organizations, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, among others as clarified in the full announcement. The opportunity was created July 23, 2019, with an original closing date of November 24, 2019. The FOA anticipated one award, reflecting the goal of building a single, centralized center of excellence rather than multiple smaller, disconnected projects. The listed award ceiling is 0, which commonly indicates that the maximum was not specified in that field and applicants needed to consult the FOA for detailed budget expectations and constraints.Apply for RFA AT 20 002
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Center of Excellence for Natural Product Drug interaction Research (U54, Clinical Trial Required)" 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 Jul 23, 2019.
- Applicants must submit their applications by Nov 24, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 1 candidate(s).
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity is the Center of Excellence for Natural Product Drug Interaction Research (U54, Clinical Trial Required), funding opportunity announcement RFA AT 20 002. It was issued by the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services (HHS) to establish a single, high-impact national center focused on natural product-drug interactions.
What is the main purpose of the Center of Excellence?
The purpose is to create a coordinated, authoritative national program that moves beyond scattered case reports or inconsistent studies and instead produces clear, clinically actionable evidence about how selected natural products affect the way commonly used medications are metabolized and handled by the body.
What types of interactions are emphasized?
The emphasis is on pharmacokinetic interactions, meaning interactions that change drug absorption, distribution, metabolism, or excretion. The announcement highlights metabolism- and transporter-related mechanisms, including effects on metabolic enzymes and drug transporters.
What are the two overarching goals of the program?
The program has two overarching goals:
- Determine the real clinical relevance of pharmacokinetic interactions for a select set of natural products that are widely used or plausibly risky when taken with prescription or over-the-counter drugs.
- Serve as a leadership hub for the research community by developing and sharing best practices for studying metabolism-mediated drug interactions involving complex, chemically variable natural products.
How many centers does NIH expect to fund under this FOA?
The FOA anticipated one award. This reflects the intent to build a single, centralized center of excellence rather than multiple smaller, disconnected projects.
What grant mechanism is used, and what does it imply?
The mechanism is a cooperative agreement (U54). This typically means NIH will have substantial scientific involvement compared to a standard research project grant, reflecting a more collaborative, coordinated relationship between the awardee and the funding agency.
Are clinical trials required?
Yes. The opportunity is explicitly labeled "Clinical Trial Required." The Center is expected to conduct rigorously designed clinical studies when preclinical evidence supports a meaningful interaction risk.
Is the program expected to follow a stepwise approach before launching human studies?
Yes. The FOA anticipates a careful, stepwise pipeline where preclinical data guide whether a clinical study is justified, rather than initiating human trials without a strong mechanistic and translational foundation.
What is the expected research pipeline or workflow for the Center?
The Center is expected to carry out a full pipeline of work that includes:
- Selecting and prioritizing three to five natural products with credible potential for clinically meaningful interactions.
- Sourcing and characterizing the selected natural products (including authentication, chemical profiling, and accounting for batch variability).
- Conducting preclinical studies to define interaction potential, identify mediators (such as specific enzymes or transporters), and determine mechanism and magnitude.
- Conducting clinical studies in humans to quantify the size of interactions when preclinical evidence indicates meaningful risk.
- Creating and maintaining a data and methodology repository to support standardization and sharing across the field.
How many natural products should the Center prioritize for study?
The Center is expected to select and prioritize three to five natural products that have credible potential to cause clinically meaningful interactions.
What factors should be used to prioritize which natural products to study?
The FOA describes prioritization factors including widespread consumer use, prior signals of interaction risk, biological plausibility, and the likelihood of co-use with medications where changes in blood levels could have serious consequences (for example, drugs with narrow therapeutic windows).
What does "natural product" characterization involve in this FOA?
Characterization is described as rigorous sourcing and evaluation so results can be interpreted and reproduced. This typically implies authentication, chemical profiling, and explicit attention to batch variability and chemical variability in complex natural products.
What kinds of preclinical studies are expected?
Preclinical studies are expected to define interaction potential and identify key mediators of any interaction. The FOA gives examples such as cytochrome P450 enzymes, UGT enzymes, and drug transporters, and indicates that studies should determine both mechanism and magnitude of effects.
What is meant by "clinically actionable evidence" in this context?
Within the description provided, "clinically actionable evidence" refers to definitive, human-relevant findings that clarify whether an interaction is real and meaningful, how large the effect is, and how that information can be used by clinicians, researchers, and the public when considering co-use of natural products with medications.
What is the repository deliverable, and what is it supposed to contain?
A central deliverable is the creation and ongoing maintenance of a repository for both data and methodology. It is intended to house resources generated by the Center as well as information produced by other investigators, including datasets, protocols, analytical methods, and other tools that help standardize natural product-drug interaction research.
How does this Center relate to the companion R21 projects mentioned?
The repository is intended to include information produced by other investigators, with special reference to data from related R21 projects funded under a companion announcement, RFA AT 20 001. In other words, the Center is expected to help curate and organize outputs not only from its own work but also from aligned projects in the broader program.
What leadership role is the Center expected to play beyond running studies?
The Center is expected to provide sustained guidance and leadership to relevant research communities. This includes helping define best practices for pharmacokinetic interaction studies involving complex natural products and addressing common challenges like product variability, selection of appropriate probe substrates, endpoint selection, interpretation of mechanistic in vitro findings, and translation to real-world clinical risk.
Why does the FOA emphasize complex natural products as a special challenge?
The FOA notes that natural products can be chemically variable, poorly standardized, and difficult to evaluate using conventional drug development approaches. These characteristics can make it harder to generate reproducible, comparable interaction evidence without shared standards and robust characterization methods.
Which agency issued the FOA?
The FOA was issued by the National Institutes of Health (NIH) within the Department of Health and Human Services (HHS).
What is the funding category and CFDA number?
The opportunity falls under the health funding category and lists CFDA 93.213.
Who is eligible to apply based on the description provided?
Eligibility is described as broad and includes various government entities, public and private institutions of higher education, tribal governments and organizations, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, among others as clarified in the full announcement.
When was this opportunity created and when did it close?
The opportunity was created on July 23, 2019. The original closing date listed is November 24, 2019.
What does it mean that the listed award ceiling is 0?
The listed award ceiling is shown as 0, which commonly indicates that a maximum award amount was not specified in that field. Applicants would be expected to consult the full FOA for detailed budget expectations and constraints.
What kinds of medications are particularly important when assessing interaction risk?
The description highlights concern for co-use with medications where changes in blood levels could have serious consequences, including drugs with narrow therapeutic windows.
What is the overall public health intent of establishing this Center?
The intent is to improve decision-making about taking natural products and medications together by strengthening the evidence base, reducing preventable adverse events, and improving patient safety through clearer, standardized, clinically relevant interaction science.
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