Opportunity Information: Apply for PAR 24 304
The NIH National Cancer Institute (NCI) is soliciting revision applications under NOFO PAR-24-304, titled "Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)." The core purpose is to speed up the translation of biomarker-related assays and technologies that were previously developed with NIH support so they can move closer to real clinical use. In practice, this funding is meant to help take an already-developed assay and do the additional adaptation and clinical validation work needed so it can credibly function in clinical settings and be ready for inclusion in future clinical trials as an investigational tool.
The scientific focus is on adapting and clinically validating assays that measure molecular, cellular, or imaging biomarkers relevant to cancer. These biomarkers can be aimed at cancer detection and diagnosis, prognosis, monitoring over time (such as tracking disease burden or recurrence), and predicting response to therapy. The NOFO also includes markers used in cancer control and prevention, not just treatment. The emphasis is not on inventing a brand-new biomarker platform from scratch, but on bringing an existing NIH-supported assay across the gap between promising research performance and clinically meaningful, validated performance.
A key feature of the opportunity is support for obtaining and using well-annotated specimens and datasets to conduct clinical validation. Applicants may propose acquiring samples from NCI-supported clinical trials or from other clinical trials, observational cohorts, or research consortia, as long as the materials are appropriately annotated (for example, with clinical outcomes, patient characteristics, treatment details, and relevant covariates). This reflects the reality that strong validation depends on high-quality specimens and reliable clinical context, and that many assay translation efforts stall because those resources are difficult and expensive to access.
The NOFO strongly encourages team science and a multidisciplinary structure. Competitive projects are expected to involve close coordination among assay developers, disease-focused clinicians, clinical laboratory professionals, and statisticians. The notice explicitly highlights the importance of including clinical laboratory scientist(s) and statistical experts as integral members of the team, which signals that NCI is prioritizing rigorous analytical performance work (such as reproducibility, robustness, and clinical laboratory feasibility) as well as sound study design and analysis plans (such as appropriate endpoints, sample size and power reasoning where applicable, bias control, and handling of confounders).
This is not a mechanism for early-stage technology development, nor is it intended to fund the conduct of clinical trials. The award is positioned for the middle-to-late translational phase: taking an assay that already exists and performing the adaptation and validation steps needed so it could realistically be deployed as an investigational assay, tool, or device within future trials or clinical workflows. Also noted in the title is "Clinical Trial Not Allowed," meaning applicants should not propose a study that meets the NIH definition of a clinical trial under this mechanism; the work should stay within assay adaptation and validation activities rather than interventional clinical testing.
In terms of applicant eligibility, the opportunity is broadly open across many organization types. Eligible applicants include various levels of government (state, county, city/township, special districts), independent school districts, public housing authorities/Indian housing authorities, public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations other than small businesses, small businesses, and certain tribal entities (federally recognized tribal governments and tribal organizations). The NOFO also explicitly calls out additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) organizations.
Administratively, this is an NIH grant opportunity using the R01 activity code as a revision application pathway, with an original closing date listed as 2026-10-14 and a creation date of 2024-10-10. The CFDA (Assistance Listing) number provided is 93.394, and the activity areas are health and education. An award ceiling is not specified in the provided source data, and the expected number of awards is also not listed, which typically means applicants need to rely on the NOFO text and NIH institute funding considerations for budgeting expectations.
Overall, PAR-24-304 is best understood as targeted funding to help mature NIH-supported cancer biomarker assays into clinically credible, analytically and clinically validated tools, using strong specimens and rigorous multidisciplinary methods, without funding early invention work or interventional clinical trial execution.Apply for PAR 24 304
- 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 2024-10-10.
- Applicants must submit their applications by 2026-10-14. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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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Frequently Asked Questions (FAQs) - NIH NCI PAR-24-304 (R01 Revision)
1) What is PAR-24-304?
PAR-24-304 is a National Institutes of Health (NIH) National Cancer Institute (NCI) Notice of Funding Opportunity (NOFO) that solicits revision applications under the R01 activity code. It is titled: "Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)."
2) What is the main goal of this funding opportunity?
The main goal is to accelerate translation of biomarker-related assays and technologies that were previously developed through NIH-supported research grants, so they can move closer to real clinical use. The funding is intended to support additional adaptation and clinical validation work needed for an assay to credibly function in clinical settings and be ready for potential inclusion in future clinical trials as an investigational tool.
3) What kinds of assays and biomarkers are in scope?
The scientific focus is on adapting and clinically validating assays that measure molecular, cellular, or imaging biomarkers relevant to cancer. Biomarkers may be intended for:
- Cancer detection and diagnosis
- Prognosis
- Monitoring over time (for example, tracking disease burden or recurrence)
- Predicting response to therapy
- Cancer control and prevention (not only treatment-related uses)
4) Is this opportunity meant for creating brand-new biomarker platforms?
No. The emphasis is not on inventing a brand-new biomarker platform from scratch. It is focused on bringing an existing NIH-supported assay from strong research performance to clinically meaningful, validated performance.
5) What stage of research is this NOFO intended to support?
This award is positioned for the middle-to-late translational phase: taking an assay that already exists and performing the adaptation and validation work needed so it could realistically be deployed as an investigational assay, tool, or device within future trials or clinical workflows.
6) Does PAR-24-304 fund early-stage technology development?
No. The NOFO is described as not a mechanism for early-stage technology development. It is aimed at validating and adapting assays that have already been developed with NIH support.
7) Are clinical trials allowed under this NOFO?
No. The NOFO title explicitly states "Clinical Trial Not Allowed". Applicants should not propose studies that meet the NIH definition of a clinical trial under this mechanism. The work should remain focused on assay adaptation and validation activities rather than interventional clinical testing.
8) Why is access to specimens and datasets emphasized?
The NOFO supports obtaining and using well-annotated specimens and datasets to conduct clinical validation. This reflects the idea that rigorous validation depends on high-quality materials and reliable clinical context, and that translation often stalls because these resources can be difficult and expensive to access.
9) What kinds of specimen sources can be used for clinical validation?
Applicants may propose acquiring samples from NCI-supported clinical trials or from other sources such as:
- Other clinical trials
- Observational cohorts
- Research consortia
The key requirement is that the specimens/datasets are appropriately annotated.
10) What does "well-annotated" mean in this context?
The NOFO indicates annotation examples such as:
- Clinical outcomes
- Patient characteristics
- Treatment details
- Relevant covariates
11) Does the NOFO encourage team science?
Yes. The NOFO strongly encourages team science and a multidisciplinary project structure. Competitive projects are expected to coordinate closely across multiple areas of expertise.
12) What kinds of expertise are expected on the project team?
Competitive projects are expected to involve close coordination among:
- Assay developers
- Disease-focused clinicians
- Clinical laboratory professionals
- Statisticians
The NOFO explicitly highlights the importance of including clinical laboratory scientist(s) and statistical experts as integral members of the team.
13) What types of performance and rigor does NCI appear to prioritize here?
Based on the NOFO description, NCI is emphasizing rigorous work related to:
- Analytical performance (for example, reproducibility, robustness, and clinical laboratory feasibility)
- Sound study design and analysis planning (for example, appropriate endpoints, sample size and power reasoning where applicable, bias control, and handling confounders)
14) What is the role of clinical laboratory scientists in these projects?
The NOFO signals that clinical laboratory scientist(s) should be integral to the team, reflecting the importance of making sure the assay can perform robustly and feasibly in clinical laboratory contexts (for example, reproducibility and robustness considerations).
15) What is the role of statisticians in these projects?
The NOFO highlights statistical expertise as a priority to ensure rigorous design and analysis plans, including items like endpoints, sample size/power reasoning where applicable, bias control, and approaches to confounders.
16) Who is eligible to apply?
Eligibility is broad and includes many organization types, including:
- State, county, city/township governments, special district governments
- Independent school districts
- Public housing authorities/Indian housing authorities
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Nonprofits (501(c)(3) and non-501(c)(3))
- For-profit organizations other than small businesses
- Small businesses
- Tribal entities (federally recognized tribal governments and tribal organizations)
17) Are specific institution types explicitly called out as eligible?
Yes. The NOFO explicitly calls out eligibility for groups such as:
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISI)
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Faith-based or community-based organizations
- Eligible federal agencies
- Regional organizations
- U.S. territories or possessions
- Non-U.S. (foreign) organizations
18) What is the activity code and application type mentioned?
This is an NIH funding opportunity using the R01 activity code as a revision application pathway.
19) What is the listed closing date and creation date?
The provided details list an original closing date of 2026-10-14 and a creation date of 2024-10-10.
20) What is the Assistance Listing (CFDA) number for this opportunity?
The Assistance Listing (CFDA) number provided is 93.394.
21) What activity areas are associated with this opportunity?
The activity areas listed are health and education.
22) Is there an award ceiling listed?
No award ceiling is specified in the provided source information.
23) Is the expected number of awards listed?
No. The expected number of awards is not listed in the provided source information.
24) If the award ceiling and number of awards are not provided, what does that imply?
Based on the information provided, it suggests applicants may need to rely on the NOFO text and NIH institute funding considerations for budgeting expectations, since those specific figures are not included in the provided source data.
25) In plain terms, what is PAR-24-304 best understood as funding?
It is targeted funding to help mature NIH-supported cancer biomarker assays into clinically credible, analytically and clinically validated tools, using strong specimens and rigorous multidisciplinary methods, while not funding early invention work or the execution of interventional clinical trials.
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|---|
| NCI National Clinical Trials Network - Network Lead Academic Participating Sites (UG1 Clinical Trial Not Allowed) Apply for RFA CA 24 033 Funding Number: RFA CA 24 033 Agency: National Institutes of Health Category: Education, Health Funding Amount: $1,700,000 |
| Single Source: NCI National Clinical Trials Network - Canadian Collaborating Clinical Trials Network (U10 Clinical Trial Required) Apply for RFA CA 24 032 Funding Number: RFA CA 24 032 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Interventions to expand cancer screening and preventive services to ADVANCE health in populations that experience health disparities (R01, Clinical Trial Required) Apply for PAR 25 098 Funding Number: PAR 25 098 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed) Apply for PAR 25 075 Funding Number: PAR 25 075 Agency: National Institutes of Health Category: Education, Health Funding Amount: $250,000 |
| Ending the Epidemic: New Models of Integrated HIV/AIDS, Addiction, and Primary Care Services (R34 Clinical Trial Optional) Apply for RFA DA 25 070 Funding Number: RFA DA 25 070 Agency: National Institutes of Health Category: Education, Health Funding Amount: $450,000 |
| Ending the Epidemic: New Models of Integrated HIV/AIDS, Addiction, and Primary Care Services (R01 Clinical Trial required) Apply for RFA DA 25 072 Funding Number: RFA DA 25 072 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed) Apply for PAR 25 074 Funding Number: PAR 25 074 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Screening, Brief Intervention and Referral to Treatment or Prevention (SBIRT/P) for alcohol, tobacco, and other drugs (ATOD) use and misuse in adult populations that experience health disparities (R01, Clinical Trial Required) Apply for PAR 26 001 Funding Number: PAR 26 001 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Co-infection and Cancer (R01 Clinical Trial Not Allowed) Apply for PAR 25 082 Funding Number: PAR 25 082 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Small Grants Program for Cancer Research (NCI Omnibus) (R03 Clinical Trial Optional) Apply for PAR 25 078 Funding Number: PAR 25 078 Agency: National Institutes of Health Category: Education, Health Funding Amount: $50,000 |
| The Metastasis Research Network (MetNet): MetNet Research Projects (U01 Clinical Trial Not Allowed) Apply for PAR 25 130 Funding Number: PAR 25 130 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Targeting Inflammasomes in HIV and Substance Use (R21 Clinical Trial Not Allowed) Apply for RFA DA 25 068 Funding Number: RFA DA 25 068 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Computational Approaches to Curation at Scale for Biomedical Research Assets (R01 Clinical Trial Not Allowed) Apply for PAR 25 131 Funding Number: PAR 25 131 Agency: National Institutes of Health Category: Education, Health Funding Amount: $250,000 |
| Targeting Inflammasomes in HIV and Substance Use (R01 Clinical Trial Not Allowed) Apply for RFA DA 25 069 Funding Number: RFA DA 25 069 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Biomedical Research Environment and Sponsored Programs Administration Development (BRE-SPAD) Program (UC2- Clinical Trial Not Allowed) Apply for PAR 24 268 Funding Number: PAR 24 268 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Mechanistic links between diet, lipid metabolism, and tumor growth and progression (UH2 Clinical Trial Not Allowed) Apply for PAR 25 118 Funding Number: PAR 25 118 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Enhancing Mechanistic Research on Precision Probiotic Therapies (R61/R33 Clinical Trial Optional) Apply for PAR 25 211 Funding Number: PAR 25 211 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Enhancing Mechanistic Research on Precision Probiotic Therapies (R33 Clinical Trial Optional) Apply for PAR 25 210 Funding Number: PAR 25 210 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Mechanistic links between diet, lipid metabolism, and tumor growth and progression (U01 Clinical Trial Not Allowed) Apply for PAR 25 119 Funding Number: PAR 25 119 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Clinical and Translational Exploratory/Developmental Studies (R21 Clinical Trial Optional) Apply for PAR 25 139 Funding Number: PAR 25 139 Agency: National Institutes of Health Category: Education, Health Funding Amount: $275,000 |
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