Opportunity Information: Apply for PAR 16 056
Apply for PAR 16 056
- The HHS-NIH11 in the education, health sector is offering a public funding opportunity titled "Revision Applications for Assay Validation For High Quality Markers For NCI-Supported Clinical Trials (U10)" 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 Dec 10, 2015 and posted on Dec 10, 2015.
- Applicants must submit their applications by Oct 06, 2017. (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 (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
Revision Applications for Assay Validation For High Quality Markers For NCI-Supported Clinical Trials (U10) (PAR 16-056) is a National Institutes of Health, National Cancer Institute funding opportunity designed to push promising cancer-related molecular diagnostics across the finish line from late-stage analytical validation into credible clinical validation. The central aim is to strengthen the quality and readiness of assays tied to cancer treatment, cancer control, and cancer prevention, especially when those assays measure biomarkers that could function as prognostic markers (informing likely disease course), predictive markers (indicating who may benefit from a specific therapy), or response markers (reflecting how well a treatment is working). The emphasis is on developing assays to a standard where they are dependable enough to be used in NCI-supported clinical trials and related research settings.
A key requirement is that applicants already have an assay that is essentially through analytical validation in human samples. In practical terms, the assay should be far enough along that only minimal remaining analytical work is needed, and the project can focus on achieving clinical validation without getting bogged down in foundational assay development. The FOA is meant for situations where there is strong justification that the marker and assay matter clinically and are worth advancing into a clinical-grade test. Rather than paying for early discovery work, the program targets the more rigorous stage of confirming that the assay performs reliably in the kinds of real-world human specimens and study contexts that clinical trials require.
This announcement specifically supports “revision applications,” meaning it is structured to add support to an existing, already-funded project or cooperative agreement framework, rather than serving as a typical stand-alone new grant mechanism. Funds can be used to obtain specimens needed for clinical validation, including samples from retrospective or prospective studies, whether those studies come from NCI-supported trials or other clinical trials. That detail matters because access to appropriately collected, well-annotated specimens is often the rate-limiting step in clinical validation, and the FOA explicitly recognizes specimen acquisition as a legitimate and important cost when it is tied to the validation plan.
The FOA also makes clear that clinical laboratory capacity is not an afterthought. Laboratory personnel, technical infrastructure, and other operational needs are expected to be integrated into the proposal, reflecting the reality that clinical validation depends on standardized handling, quality systems, and reproducible workflows. Projects are expected to be multidisciplinary by design, bringing together scientific investigators, clinicians, statisticians, and clinical laboratory scientists and staff. This collaborative structure signals that the program cares not only about whether an assay “works,” but whether it is validated with appropriate clinical context, rigorous statistical planning, and laboratory practices that support consistent performance.
Another important boundary is what the program will not fund. It is not intended to support trials aimed at proving the clinical utility of a marker or assay, meaning it will not primarily pay for studies that test whether using the assay actually improves patient outcomes or changes clinical decision-making in a way that benefits patients. Instead, the goal is to develop and validate the assay to the point where its clinical utility could later be evaluated in separate, appropriately designed trials. In other words, this FOA focuses on the prerequisite step: producing a clinically validated assay that is trustworthy enough to be used as a tool in subsequent clinical utility studies.
From an administrative standpoint, this opportunity is offered by HHS/NIH (AgencyName listed as HHS-NIH11) as a cooperative agreement (FundingInstrumentType: Cooperative Agreement), which typically implies substantial programmatic involvement from the federal funding agency compared to a standard grant. The activity category is listed under Education and Health, and the CFDA numbers include 93.394. Eligible applicants span a wide range of organizations, including various levels of government, public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), and small businesses, along with additional eligible entities as clarified in the full eligibility text. The posted and created dates are December 10, 2015, and the closing date shown is October 6, 2017, with an award ceiling listed at $150,000.
Overall, the program is best understood as targeted support for late-stage assay development: taking a biomarker assay that is already largely analytically validated and completing the clinical validation work needed for confident use in cancer clinical trial environments. It prioritizes assay quality, clinical trial readiness, specimen access, and multidisciplinary execution, while deliberately stopping short of funding full-scale clinical utility testing.
FAQs: Revision Applications for Assay Validation For High Quality Markers For NCI-Supported Clinical Trials (U10) (PAR 16-056)
What is this funding opportunity?
This opportunity (PAR 16-056) is a National Institutes of Health (NIH), National Cancer Institute (NCI) funding announcement focused on moving promising cancer-related molecular diagnostic assays from late-stage analytical validation into credible clinical validation so they can be used confidently in NCI-supported clinical trials and related research settings.
What is the main goal of the program?
The central aim is to strengthen assay quality and readiness for clinical trial use by completing the clinical validation work needed to show the assay performs reliably in real-world human specimens and clinical-trial-like contexts.
What types of biomarkers or markers are emphasized?
The program emphasizes assays that measure biomarkers that could function as:
- Prognostic markers (informing likely disease course)
- Predictive markers (indicating who may benefit from a specific therapy)
- Response markers (reflecting how well a treatment is working)
What stage must the assay be at before applying?
A key requirement is that applicants already have an assay that is essentially through analytical validation in human samples. The assay should be far enough along that only minimal remaining analytical work is needed, allowing the project to focus on clinical validation rather than foundational assay development.
Does this program fund early biomarker discovery or initial assay development?
No. The opportunity is not designed to pay for early discovery work or foundational assay development. It targets late-stage work where there is strong justification that the marker and assay are clinically meaningful and ready to be advanced into a clinical-grade test through clinical validation.
What does "revision application" mean in this context?
This announcement specifically supports revision applications, meaning it is structured to add support to an existing, already-funded project or cooperative agreement framework rather than acting as a typical stand-alone new grant mechanism.
What kinds of costs or activities can the funds support?
Funds can support activities needed for clinical validation, including obtaining the human specimens required for validation and supporting clinical laboratory capacity (such as personnel, technical infrastructure, and operational needs) that enable standardized handling, quality systems, and reproducible workflows.
Can the funds be used to obtain specimens for clinical validation?
Yes. The announcement explicitly recognizes specimen acquisition as a legitimate and important cost when it is tied to the clinical validation plan. Specimens may come from retrospective or prospective studies.
Do specimens have to come only from NCI-supported trials?
No. Specimens can be obtained from NCI-supported trials or from other clinical trials, as long as they are appropriate for the proposed clinical validation work.
Is clinical laboratory capacity expected to be part of the proposal?
Yes. Laboratory personnel, technical infrastructure, and other operational needs are expected to be integrated into the proposal. The program reflects that clinical validation depends on standardized handling, quality systems, and reproducible laboratory workflows.
Are multidisciplinary teams expected?
Yes. Projects are expected to be multidisciplinary, bringing together scientific investigators, clinicians, statisticians, and clinical laboratory scientists and staff to ensure the assay is validated with appropriate clinical context, rigorous statistical planning, and consistent laboratory practices.
Does this opportunity fund clinical utility studies?
No. The program is not intended to support trials aimed at proving clinical utility (for example, studies primarily testing whether using the assay improves patient outcomes or changes clinical decision-making to benefit patients). The focus is on producing a clinically validated assay that could later be evaluated for clinical utility in separate studies.
What is the funding instrument type?
The funding instrument type is a cooperative agreement, which typically implies substantial programmatic involvement from the federal funding agency compared with a standard grant.
Which agencies are offering this opportunity?
The opportunity is offered by HHS/NIH, specifically the National Cancer Institute (NCI). The AgencyName is listed as HHS-NIH11.
What activity category is this opportunity listed under?
The activity category is listed under Education and Health.
What CFDA number is associated with this opportunity?
The CFDA number listed includes 93.394.
Who is eligible to apply?
Eligible applicants include a wide range of organizations, including various levels of government, public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), and small businesses, along with additional eligible entities as clarified in the full eligibility text.
What is the award ceiling?
The award ceiling listed for this opportunity is $150,000.
When was this opportunity posted and when did it close?
The posted and created dates are December 10, 2015, and the closing date shown is October 6, 2017.
What is this program best suited for?
This program is best suited for late-stage assay development efforts where a biomarker assay is already largely analytically validated and needs targeted support to complete clinical validation so it can be used with confidence in cancer clinical trial environments.
What are the key priorities highlighted by the announcement?
The announcement prioritizes assay quality, clinical trial readiness, access to appropriately collected and well-annotated specimens, and multidisciplinary execution, while drawing a clear line that it is not funding full-scale clinical utility testing.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 16 056) also looked into and applied for these:
| Funding Opportunity |
|---|
| Innovative Questions in Symptom Science and Genomics (R01) Apply for PA 16 024 Funding Number: PA 16 024 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Global Noncommunicable Diseases and Injury Across the Lifespan: Exploratory Research (R21) Apply for PAR 16 052 Funding Number: PAR 16 052 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $125,000 |
| Integration of Infectious Diseases and Substance Abuse Intervention Services for Individuals Living with HIV (R01) Apply for RFA DA 16 011 Funding Number: RFA DA 16 011 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Innovative Questions in Symptom Science and Genomics (R21) Apply for PA 16 023 Funding Number: PA 16 023 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $200,000 |
| Research Projects to Enhance Applicability of Mammalian Models for Translational Research (R01) Apply for PAR 16 059 Funding Number: PAR 16 059 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $450,000 |
| Applying Metabolomics to Drive Biomarker Discovery in Symptom Science (R01) Apply for PA 16 030 Funding Number: PA 16 030 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Innovative Molecular and Cellular Analysis Technologies for Basic and Clinical Cancer Research (R21) Apply for RFA CA 16 001 Funding Number: RFA CA 16 001 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $200,000 |
| Applying Metabolomics to Drive Biomarker Discovery in Symptom Science (R21) Apply for PA 16 029 Funding Number: PA 16 029 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $200,000 |
| Effects of Drugs of Abuse on Latent HIV Reservoirs in the CNS (R01) Apply for RFA DA 16 014 Funding Number: RFA DA 16 014 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| NCI Research Specialist Award (R50) Apply for PAR 16 025 Funding Number: PAR 16 025 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Drug Discovery For Nervous System Disorders (R01) Apply for PAR 16 041 Funding Number: PAR 16 041 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| HIV/AIDS High Priority Drug Abuse Research (R01) Apply for PAS 16 018 Funding Number: PAS 16 018 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Exploring Epigenomic or Non-Coding RNA Regulation in HIV/AIDS and Substance Abuse (R01) Apply for RFA DA 16 012 Funding Number: RFA DA 16 012 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Genomic Data Analysis Network: Visualization Genomic Data Center (U24) Apply for RFA CA 15 019 Funding Number: RFA CA 15 019 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $660,000 |
| The NCI Predoctoral to Postdoctoral Fellow Transition Award (F99/K00) Apply for RFA CA 16 005 Funding Number: RFA CA 16 005 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Behavioral and Integrative Treatment Development Program (R03) Apply for PA 16 074 Funding Number: PA 16 074 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $50,000 |
| Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R21) Apply for PA 16 075 Funding Number: PA 16 075 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Behavioral and Integrative Treatment Development Program (R34) Apply for PA 16 073 Funding Number: PA 16 073 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $225,000 |
| Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R01) Apply for PA 16 076 Funding Number: PA 16 076 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $500,000 |
| Behavioral Science Track Award for Rapid Transition (B/Start)(R03) Apply for PAR 16 071 Funding Number: PAR 16 071 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $75,000 |
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