Opportunity Information: Apply for PAR 24 047
The NIH, through the National Cancer Institute (NCI), is offering a grant opportunity (PAR-24-047) that supports revision applications to existing NIH-funded research grants, with the goal of moving promising, NCI-supported biomarker assays closer to real clinical use. The central purpose is to speed up translation of methods, assays, and related technologies that have already been developed under NIH support so they can be adapted and clinically validated for cancer-focused applications. The program is aimed at bridging the common gap between a biomarker assay that works well in a research setting and one that is solid enough, standardized enough, and validated enough to be used as an investigational tool in a clinical trial setting later on.
The scientific focus is on adapting and validating assays tied to molecular, cellular, or imaging biomarkers relevant to cancer. These biomarkers can be intended for cancer detection or diagnosis, for prognosis and risk stratification, for monitoring disease over time, or for predicting treatment response. The NOFO also explicitly includes biomarkers related to cancer control and prevention, which broadens the scope beyond treatment-response markers alone. In practical terms, the work supported here is about demonstrating that the assay performs reliably with clinically relevant samples and under conditions that reflect how it would be used in real-world clinical research workflows.
A key feature of the opportunity is support for obtaining and using well-annotated human specimens, especially from NCI-supported clinical trials and other clinical research resources such as observational cohorts or consortia. The point of using these sample sets is to perform clinical validation in a way that is statistically credible and clinically meaningful. That typically means the specimens have strong associated metadata (for example, diagnosis, stage, treatment, outcomes, timepoints, collection procedures) so the assay results can be evaluated against real clinical endpoints and contexts. The emphasis is not simply on generating more exploratory data, but on producing evidence that the assay is ready to be integrated into clinical research as an investigational assay, tool, or device.
The NOFO strongly encourages multidisciplinary teams and expects applicants to bring together the right expertise to do rigorous validation. Assay developers and basic scientists are expected to work closely with clinicians, clinical laboratory professionals, and statisticians. Clinical laboratory scientists are highlighted because moving an assay toward clinical readiness often requires attention to analytical performance, reproducibility, quality control, pre-analytic variables, and operational workflow considerations. Statistical experts are highlighted because validation depends on sound study design, power calculations, predefined performance metrics, and clear interpretation standards that can withstand scrutiny and support downstream clinical use.
This funding opportunity is not meant for early-stage technology development, and it is not meant to fund the conduct of clinical trials. The work sits in the middle ground: taking something that already exists from NIH-supported research and doing the adaptation and validation steps needed so it can later be used within clinical trials. Importantly, the FOA title specifies "Clinical Trial Not Allowed" for the R01 mechanism in this context, reinforcing that the funded activities should be validation-oriented rather than interventional trial execution.
From an administrative and eligibility standpoint, it is a discretionary NIH grant opportunity within the education and health activity category (CFDA 93.394). A wide range of applicants can apply, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other categories. The opportunity also calls out additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, US territories or possessions, and non-US entities (foreign organizations). This broad eligibility is designed to encourage participation from many sectors that contribute to biomarker development and validation, including organizations with access to unique patient populations, specimen resources, or specialized laboratory expertise.
Key logistical details include an original closing date of 2026-10-13 and an award ceiling listed as $150,000. The opportunity was created on 2023-10-10. Overall, the program is best understood as targeted support for strengthening and clinically validating cancer biomarker assays that have already emerged from NIH-funded research, so they can credibly progress into clinical research pipelines and, ultimately, into settings where they can influence patient care decisions.Apply for PAR 24 047
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394.
- This funding opportunity was created on 2023-10-10.
- Applicants must submit their applications by 2026-10-13. (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 $150,000.00 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: NIH/NCI Grant Opportunity PAR-24-047 (Clinical Trial Not Allowed)
What is PAR-24-047?
PAR-24-047 is a National Institutes of Health (NIH) funding opportunity offered through the National Cancer Institute (NCI). It supports revision applications to existing NIH-funded research grants to help move promising, NCI-supported biomarker assays closer to real clinical use by adapting and clinically validating them for cancer-focused applications.
What is the main goal of this funding opportunity?
The main goal is to speed up translation of methods, assays, and related technologies that were already developed with NIH support so they can be adapted, standardized, and clinically validated for use as investigational tools in clinical research settings (for example, later use in clinical trials).
What problem is this program trying to solve?
This program is designed to bridge the common gap between a biomarker assay that performs well in a research environment and one that is robust, reproducible, standardized, and validated enough to be used credibly in clinical research workflows, including as an investigational assay in a clinical trial setting later on.
What types of projects does this opportunity support?
It supports projects focused on adapting and validating biomarker assays tied to molecular, cellular, or imaging biomarkers relevant to cancer. The work is meant to demonstrate reliable performance with clinically relevant samples under conditions that reflect real-world clinical research workflows.
What kinds of biomarkers are within scope?
Biomarkers relevant to cancer are within scope, including those intended for:
- Cancer detection or diagnosis
- Prognosis and risk stratification
- Monitoring disease over time
- Predicting treatment response
- Cancer control and prevention (explicitly included)
Does the NOFO focus only on treatment-response biomarkers?
No. While predicting treatment response is included, the scope is broader and explicitly includes biomarkers for detection/diagnosis, prognosis/risk stratification, monitoring, and cancer control and prevention.
What does “adapting and validating” a biomarker assay mean in this context?
In this context, it means taking an assay that already exists from NIH-supported research and performing the steps needed to make it clinically ready as an investigational tool. This includes showing the assay performs reliably with clinically relevant specimens and under practical workflow conditions, with attention to standardization, reproducibility, and validation against meaningful clinical context.
What is the role of human specimens in this program?
A key feature is support for obtaining and using well-annotated human specimens, especially from NCI-supported clinical trials and other clinical research resources (such as observational cohorts or consortia), to enable statistically credible and clinically meaningful clinical validation.
What does “well-annotated” specimens mean here?
Well-annotated specimens are sample sets with strong associated metadata that make clinical validation meaningful, such as diagnosis, stage, treatment details, outcomes, timepoints, and collection procedures. This metadata helps evaluate assay results against real clinical endpoints and contexts.
Why is metadata (like stage, outcomes, and timepoints) emphasized?
Because the program aims for clinically meaningful validation rather than exploratory findings. Rich metadata allows the assay’s performance to be evaluated against real clinical endpoints and under the clinical conditions in which the assay would be used.
Is this funding meant for exploratory biomarker discovery?
No. The emphasis is not on generating more exploratory data. The focus is on producing evidence that an existing NIH-supported assay is ready to be integrated into clinical research as an investigational assay, tool, or device.
Is early-stage technology development supported?
No. The opportunity is not meant for early-stage technology development. It is intended for the middle stage of translation: adapting and validating something already developed under NIH support.
Are clinical trials allowed under this opportunity?
No. The FOA title specifies “Clinical Trial Not Allowed” for the R01 mechanism in this context. Funded activities should be validation-oriented rather than the conduct of interventional clinical trials.
If clinical trials are not allowed, what type of work is expected?
The expected work is clinical validation and readiness activities: demonstrating assay reliability, reproducibility, standardization, and performance using clinically relevant specimens and workflows so the assay can later be used in clinical trials or other clinical research pipelines as an investigational tool.
Why does the program encourage multidisciplinary teams?
Because rigorous validation requires multiple types of expertise. The NOFO encourages teams that bring together assay developers and basic scientists with clinicians, clinical laboratory professionals, and statisticians to ensure the assay is validated in a way that is scientifically rigorous and clinically meaningful.
What roles are highlighted as especially important?
Clinical laboratory scientists and statisticians are highlighted. Clinical laboratory professionals are important for analytical performance, reproducibility, quality control, pre-analytic variables, and workflow considerations. Statistical experts are important for sound study design, power calculations, predefined performance metrics, and interpretation standards that can withstand scrutiny.
What types of assays/technologies are relevant?
The NOFO focuses on methods, assays, and related technologies tied to molecular, cellular, or imaging biomarkers relevant to cancer, where the key need is adaptation and clinical validation to support later use in clinical research settings.
What is the application type supported by this opportunity?
This opportunity supports revision applications to existing NIH-funded research grants, specifically to advance promising NCI-supported biomarker assays toward clinical readiness.
Who is eligible to apply?
A broad range of organizations are eligible, including:
- State, county, and local governments
- Public and private institutions of higher education
- Independent school districts
- Special district governments
- Federally recognized tribal governments
- Tribal organizations (not federally recognized)
- Public housing authorities/Indian housing authorities
- Nonprofits (with or without 501(c)(3) status)
- For-profit organizations (other than small businesses) and small businesses
- Other categories noted in the opportunity
Are specific institution types explicitly encouraged or called out?
Yes. The opportunity explicitly calls out additional eligible applicant types such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, US territories or possessions, and non-US entities (foreign organizations).
Are non-US organizations eligible?
Yes. Non-US entities (foreign organizations) are included among the eligible applicant types as described in the opportunity information provided.
What is the NIH activity category and CFDA number listed?
The opportunity is described as a discretionary NIH grant opportunity within the education and health activity category, with CFDA 93.394.
What is the award ceiling?
The listed award ceiling for this opportunity is $150,000.
What is the original closing date?
The original closing date listed is 2026-10-13.
When was this opportunity created?
The opportunity was created on 2023-10-10.
How does this program fit into the biomarker pipeline?
It targets the translation stage between research success and clinical research readiness. The intent is to strengthen and clinically validate cancer biomarker assays that already emerged from NIH-funded work so they can credibly progress into clinical research pipelines and ultimately toward use in settings that can influence patient care decisions.
What is the expected outcome of a successful project?
Based on the description provided, a successful project would produce rigorous, clinically meaningful validation evidence showing that a previously NIH-supported biomarker assay is robust and standardized enough to be used as an investigational assay, tool, or device in clinical research workflows later on.
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