Opportunity Information: Apply for RFA AT 15 001
Apply for RFA AT 15 001
- The 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)" 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 Jun 24, 2014 and posted on Jun 24, 2014.
- Applicants must submit their applications by Dec 4, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,100,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,400,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Special district governments 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 City or township governments County governments Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education Small businesses Public and State controlled institutions of higher education For profit organizations other than small businesses Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Independent school districts State governments.
- 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 Foreign Institutions 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 not allowed.
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Opportunity Summary:
The NIH funding opportunity RFA-AT-15-001, titled "Center of Excellence for Natural Product Drug Interaction Research (U54)," supports the creation of a single national Center of Excellence focused on improving how natural product and prescription medication interactions are studied and interpreted. Structured as a cooperative agreement (U54), this program is designed to be highly collaborative, with the funded Center working closely with NIH staff rather than operating entirely independently. The overall aim is practical and clinical: to build a clear, evidence-based approach for deciding when a natural product causes a pharmacokinetic interaction that actually matters in real-world patient care, not just in theory or in isolated lab findings.
The Center is expected to provide leadership for the field by selecting a small, high-impact set of natural products and then driving them through a rigorous, stepwise research process that closes known evidence gaps. Specifically, the Center must identify, prioritize, and source four to six natural products that have credible potential to cause clinically significant interactions with commonly used medications. These could include widely used botanicals, supplements, or other natural products where existing data suggest possible effects on drug absorption, metabolism, or transport, but where the current literature is incomplete, inconsistent, or not directly clinically actionable.
A central requirement is that the awardee will work collaboratively with NIH to develop and carry out a statement of work for each selected natural product. In practice, this means the Center is not just generating general knowledge, but executing a coordinated research plan designed to answer a specific question for each product: is there a pharmacokinetic interaction, and if so, is it clinically relevant? The focus on "definitive assessment" signals that the intended outputs go beyond exploratory studies. The program is looking for results that can meaningfully inform clinicians, researchers, regulators, and patients about whether concomitant use of certain natural products with medications is safe, risky, or requires monitoring or dose adjustments.
Because natural product research has unique challenges, another major deliverable is the development of best practices tailored to natural product drug-interaction research. This includes addressing issues like variability in product composition, difficulties in standardizing or characterizing complex mixtures, sourcing and authentication of materials, batch-to-batch consistency, and selecting appropriate markers of exposure. It also implies methodological guidance on experimental design across the pipeline of interaction research, such as in vitro screening approaches (for enzymes and transporters), translating those findings into human study designs, and interpreting results in a way that avoids both overwarning and false reassurance. In other words, the Center is expected to help create field-wide standards that improve reproducibility and make future studies more comparable and decision-useful.
The FOA also requires an infrastructure component: the Center must develop and maintain a database and a public access portal containing the data and methodological resources generated by the program. The intent is to make the Center's outputs broadly usable, not locked within a single institution. This public-facing resource is meant to support better study design across the research community and improve decisions about combined use of medications and natural products. By sharing data, methods, and possibly reference materials information, the portal is expected to reduce duplication, clarify what is known versus uncertain, and accelerate higher-quality follow-on research.
Administratively, this is a discretionary health research opportunity offered by the National Institutes of Health, listed under CFDA 93.213 (Research and Training in Complementary and Integrative Health). It anticipated one award with an estimated total funding of about $2.1 million and an award ceiling of $1.4 million, with no cost sharing or matching requirement. The FOA was posted June 24, 2014, with an original and final application due date of December 4, 2014, and it was later archived January 4, 2015. While the dates indicate this particular announcement is no longer active, the summary still reflects how NIH structured the program and what it was aiming to build.
Eligibility was broad across many U.S.-based organization types, including public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), state and local governments, tribal governments and tribal organizations, small businesses, and certain other community-based or regionally focused entities, with explicit inclusion of institutions serving specific populations (for example HBCUs, Hispanic-serving institutions, and tribally controlled colleges and universities). Foreign institutions and non-U.S. components of U.S. organizations were not eligible, and foreign components were not allowed under NIH policy as specified in the announcement. For full details, NIH provided the official announcement link at http://grants.nih.gov/grants/guide/rfa-files/RFA-AT-15-001.html.
FAQs: NIH RFA-AT-15-001 (Center of Excellence for Natural Product Drug Interaction Research, U54)
What is the funding opportunity called?
The opportunity is NIH RFA-AT-15-001, titled "Center of Excellence for Natural Product Drug Interaction Research (U54)."
What is the main purpose of this program?
The program supports creation of a single national Center of Excellence focused on improving how interactions between natural products and prescription medications are studied and interpreted. The practical goal is to establish a clear, evidence-based way to decide when a natural product causes a pharmacokinetic interaction that matters in real-world patient care.
What type of award mechanism is used?
This is a cooperative agreement (U54). That means it is designed to be highly collaborative, with the funded Center working closely with NIH staff rather than operating entirely independently.
How many awards were anticipated?
The announcement anticipated one award to support a single national Center of Excellence.
How much funding was expected to be available?
The estimated total funding was about $2.1 million, and the award ceiling was $1.4 million.
Is cost sharing or matching required?
No. The opportunity stated there was no cost sharing or matching requirement.
What does the Center have to do with natural products?
The Center must identify, prioritize, and source four to six natural products with credible potential to cause clinically significant interactions with commonly used medications. These may include widely used botanicals, supplements, or other natural products where existing evidence suggests possible effects on drug absorption, metabolism, or transport, but where the literature is incomplete, inconsistent, or not clinically actionable.
How many natural products must be selected?
The Center is expected to select and work on four to six natural products.
What kinds of interactions are the focus of the research?
The focus is on pharmacokinetic interactions, including potential impacts on drug absorption, metabolism, or transport, and whether those interactions are clinically relevant.
What does "definitive assessment" mean in the context of this FOA?
Based on the description, the program is looking for results that go beyond exploratory or isolated findings. For each selected natural product, the Center is expected to execute a coordinated plan that answers a specific question: whether there is a pharmacokinetic interaction and, if so, whether it is clinically relevant in patient care.
What is the relationship between the awardee and NIH during the project?
The awardee is required to work collaboratively with NIH to develop and carry out a statement of work for each selected natural product. This reflects the cooperative nature of the U54 mechanism, where NIH staff are involved rather than the Center functioning entirely independently.
Does the FOA specify a research approach or pipeline?
Yes, it describes a stepwise process intended to close known evidence gaps. It references a pipeline that can include in vitro screening approaches (for enzymes and transporters), translating findings into human study designs, and interpreting results in a way that supports practical decisions.
Why does the FOA emphasize best practices for natural product drug-interaction research?
Natural product research has unique challenges, and the Center is expected to develop best practices tailored to those challenges. The description highlights issues such as variability in product composition, difficulty standardizing or characterizing complex mixtures, sourcing and authentication, batch-to-batch consistency, and selecting appropriate markers of exposure, along with methodological guidance to improve reproducibility and comparability.
What types of methodological guidance is the Center expected to develop?
The Center is expected to develop best practices covering both product-related challenges (such as sourcing, authentication, characterization, and consistency) and study-design challenges (such as in vitro screening for enzymes/transporters, translation into human studies, and interpretation that avoids both overwarning and false reassurance).
Is the Center required to build any shared infrastructure or public resource?
Yes. The FOA requires the Center to develop and maintain a database and a public access portal that contains the data and methodological resources generated by the program.
What is the intended purpose of the public access portal?
The portal is intended to make the Center's outputs broadly usable across the research community. It is meant to support better study design, reduce duplication, clarify what is known versus uncertain, and accelerate higher-quality follow-on research about combined use of medications and natural products.
Is this opportunity still active?
No. The FOA was posted June 24, 2014, with an original and final application due date of December 4, 2014, and it was later archived January 4, 2015. The dates indicate the specific announcement is no longer active.
Which NIH program category or listing is associated with this opportunity?
The opportunity was listed under CFDA 93.213, "Research and Training in Complementary and Integrative Health."
Who was eligible to apply?
Eligibility was broad across many U.S.-based organization types, including public and private institutions of higher education, nonprofits (with and without 501(c)(3) status), state and local governments, tribal governments and tribal organizations, small businesses, and certain other community-based or regionally focused entities. The FOA also explicitly included institutions serving specific populations such as HBCUs, Hispanic-serving institutions, and tribally controlled colleges and universities.
Were foreign institutions or foreign components allowed?
No. Foreign institutions and non-U.S. components of U.S. organizations were not eligible, and foreign components were not allowed under NIH policy as specified in the announcement.
What is meant by selecting "high-impact" natural products?
In this FOA, "high-impact" refers to choosing a small set of natural products that have credible potential to cause clinically significant interactions with commonly used medications, especially where existing evidence suggests an interaction may exist but is incomplete, inconsistent, or not directly useful for clinical decision-making.
What audiences are the results expected to inform?
The intended outputs are described as being able to meaningfully inform clinicians, researchers, regulators, and patients about whether concomitant use of certain natural products with medications is safe, risky, or requires monitoring or dose adjustments.
Where can the official NIH announcement be found?
The FOA provided the official announcement link: http://grants.nih.gov/grants/guide/rfa-files/RFA-AT-15-001.html
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