Opportunity Information: Apply for RFA CA 19 050
Revision Applications for Mechanisms of Drug Resistance (U01 Clinical Trials Not Allowed) is a National Cancer Institute (NCI) funding opportunity tied to the Beau Biden Cancer Moonshot Initiative, which was created to speed up progress in cancer research. The focus here is not on starting brand-new projects from scratch, but on allowing investigators who already hold an active NCI-funded U01 cooperative agreement to submit a revision application that adds new research aims or shifts the project in new directions. In practical terms, this FOA is meant to help existing teams quickly build on what they have already established so they can dig deeper into why cancers become resistant to treatment and use that knowledge to guide smarter therapy strategies.
The scientific purpose centers on drug resistance and refractory disease, meaning tumors that stop responding or never respond well in the first place. The FOA emphasizes uncovering the underlying mechanisms that drive resistance, improving preclinical study design to better reflect real clinical resistance, and accelerating the development of effective single agents or combination therapies. A major theme is that resistance is not only about tumor cells themselves; it can also be shaped by the tumor microenvironment, so projects that address how the surrounding immune cells, stromal components, signaling factors, or other microenvironmental conditions contribute to treatment failure are aligned with the intent. The end goal is to generate insights and approaches that are relevant at the clinical level, even though the FOA explicitly does not support clinical trials under this mechanism.
Mechanistically, this opportunity uses the U01 cooperative agreement structure, which generally means a more collaborative relationship with NIH/NCI program staff than a standard research project grant. While the FOA details provided do not spell out the specific collaboration expectations, the U01 format typically involves substantial NIH scientific or programmatic involvement to help coordinate efforts, keep projects aligned with program goals, and support timely progress. The opportunity is categorized under Health (CFDA 93.396) and is listed as a discretionary funding program.
Eligibility is broad across U.S.-based organizations and public 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; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; and a wide range of nonprofit organizations (both with and without 501(c)(3) status). It also includes for-profit organizations other than small businesses as well as small businesses. The FOA also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.
At the same time, the opportunity draws a firm line on foreign involvement. Non-domestic (non-U.S.) entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by the NIH Grants Policy Statement are not allowed. In effect, the funded work must be carried out without foreign components and under an eligible U.S.-based applicant organization.
The FOA is specifically for revision applications, meaning it is intended for projects that already have an NCI-funded U01 in place and are seeking support to add new aims that fit the drug resistance emphasis. The provided source details list an award ceiling of $250,000, suggesting that the revision budget is capped at that amount under this announcement. The original closing date shown is June 23, 2021, and the FOA was created on September 5, 2019. The activity is labeled as "U01 Clinical Trials Not Allowed," which signals that proposed work should remain in the mechanistic, translational, and preclinical space rather than interventional human studies, even if the outputs are intended to inform clinical strategies.
Overall, this grant opportunity is designed to help established NCI U01 teams quickly pivot or expand their ongoing research to tackle one of the most stubborn problems in oncology: why therapies fail over time and how to rationally design next-step treatments, including combination approaches, to overcome resistance in tumors and their supportive microenvironments without conducting clinical trials under this particular funding mechanism.Apply for RFA CA 19 050
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Revision Applications for Mechanisms of Drug Resistance (U01 Clinical Trials Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.396.
- This funding opportunity was created on 2019-09-05.
- Applicants must submit their applications by 2021-06-23. (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 $250,000.00 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: Revision Applications for Mechanisms of Drug Resistance (U01 Clinical Trials Not Allowed)
What is the name of this funding opportunity?
The opportunity is titled Revision Applications for Mechanisms of Drug Resistance (U01 Clinical Trials Not Allowed) and is offered by the National Cancer Institute (NCI).
Which NIH institute is associated with this FOA?
This funding opportunity is associated with the National Cancer Institute (NCI).
How is this opportunity connected to the Cancer Moonshot?
This FOA is tied to the Beau Biden Cancer Moonshot Initiative, which was created to accelerate progress in cancer research. The FOA supports faster, targeted expansion of existing work on drug resistance.
Is this FOA meant for brand-new projects?
No. This FOA is designed for revision applications, meaning it supports investigators who already hold an active NCI-funded U01 cooperative agreement and want to add new research aims or shift the project in new directions aligned with drug resistance.
What does "revision application" mean in this context?
It means an applicant proposes changes or additions to an existing, active NCI-funded U01 project, such as adding new research aims or expanding the project scope to address additional questions about mechanisms of resistance.
What is the main scientific focus of the FOA?
The focus is on mechanisms of drug resistance and refractory disease, including tumors that stop responding to treatment over time or do not respond well from the start. The goal is to understand why therapies fail and to use those insights to guide smarter therapeutic strategies.
What types of resistance-related problems does the FOA emphasize?
The FOA emphasizes understanding the drivers of treatment failure, including both acquired resistance (loss of response after initial benefit) and refractory disease (limited or no response to therapy).
Does the FOA encourage work on the tumor microenvironment?
Yes. The FOA explicitly highlights that resistance can be influenced not only by tumor cells, but also by the tumor microenvironment, including immune cells, stromal components, signaling factors, and other local conditions that can contribute to treatment failure.
What kinds of research approaches are aligned with the FOA?
Based on the description provided, aligned approaches include efforts to (1) uncover underlying mechanisms that drive resistance, (2) improve preclinical study design to better reflect clinically relevant resistance, and (3) accelerate development of effective single-agent or combination therapeutic strategies, while staying outside the clinical trial space.
Are clinical trials allowed under this funding mechanism?
No. The activity is labeled "U01 Clinical Trials Not Allowed", and the FOA explicitly does not support clinical trials under this mechanism.
If clinical trials are not allowed, how should applicants think about clinical relevance?
The FOA aims for outputs that are relevant at the clinical level, even though it does not fund interventional human studies. The intent is to generate mechanistic and preclinical insights that can inform future therapy strategies.
What funding mechanism is used?
This opportunity uses the U01 cooperative agreement mechanism.
What does a U01 cooperative agreement generally imply?
In general terms, a U01 cooperative agreement implies a more collaborative relationship with NIH/NCI program staff than a standard research grant, with substantial NIH scientific or programmatic involvement typically used to help coordinate efforts and keep projects aligned with program goals. The specific collaboration expectations are not detailed in the provided summary.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations and public entities, including (as listed in the provided information): state/county/local governments; 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; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (including small businesses and other than small businesses); and additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.
Are non-U.S. (foreign) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply under this opportunity.
Can a U.S. organization include a foreign component in the proposed work?
No. The FOA draws a firm line on foreign involvement: 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 this mean all work must be conducted in the United States?
Yes, based on the provided information. The funded work must be carried out without foreign components and under an eligible U.S.-based applicant organization.
Is this a discretionary funding program?
Yes. The opportunity is listed as a discretionary funding program.
What is the program category and CFDA number?
The opportunity is categorized under Health with CFDA 93.396.
What is the maximum award amount indicated in the provided details?
The provided source details list an award ceiling of $250,000, indicating the revision budget is capped at that amount under this announcement.
When was the FOA created?
The FOA was created on September 5, 2019.
What is the closing date shown in the provided information?
The original closing date shown is June 23, 2021.
What is the overarching goal of the FOA?
The overarching goal is to help established NCI U01 teams quickly expand or pivot existing research to address why cancer therapies fail over time, including developing mechanistic insights and preclinical approaches that can support more rational next-step treatments and combination strategies, without conducting clinical trials under this mechanism.
Does the FOA emphasize single agents, combinations, or both?
Both. The FOA emphasizes accelerating development of effective single agents or combination therapies informed by resistance mechanisms.
Does the FOA address improving how resistance is modeled preclinically?
Yes. A stated emphasis is improving preclinical study design so it better reflects real clinical resistance, supporting more clinically relevant conclusions while remaining non-clinical-trial research.
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