Opportunity Information: Apply for RFA CA 16 004
Apply for RFA CA 16 004
- The HHS-NIH11 in the education, health sector is offering a public funding opportunity titled "Advanced Development and Validation of Emerging Technologies for Cancer-Relevant Biospecimen Science (R33)" 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 09, 2015 and posted on Dec 09, 2015.
- Applicants must submit their applications by Sep 26, 2016. (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 $300,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- 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:
The Advanced Development and Validation of Emerging Technologies for Cancer-Relevant Biospecimen Science (R33) funding opportunity (RFA-CA-16-004) is a National Institutes of Health (NIH) grant program that supports exploratory, later-stage technology work aimed at improving the quality and usefulness of biospecimens used in cancer research and clinical care. The central focus is on emerging tools, methods, and workflows that can either preserve biospecimen integrity or accurately assess biospecimen quality so that downstream analyses (such as molecular profiling, biomarker measurements, and other diagnostics-oriented tests) are more reliable and informative. In practical terms, the opportunity is designed for projects that move beyond an initial concept and into advanced development and validation, where the technology is refined, tested, and demonstrated in ways that show it can meaningfully improve biospecimen-related outcomes.
A key scientific problem the FOA targets is pre-analytical degradation and variability, meaning the kinds of sample changes that happen before the actual analytical test or assay begins. This includes what happens during biospecimen collection, processing, handling, transport, and storage. The FOA is specifically interested in technologies that address degradation or loss of targeted analytes (for example, nucleic acids, proteins, metabolites, or other molecular features) and technologies that can maximize, measure, or otherwise interrogate biospecimen quality and fitness-for-purpose. The intent is to reduce avoidable noise and bias introduced by the way samples are obtained and managed, which is a major barrier to reproducible research and consistent clinical testing.
Because this is an R33 mechanism, the announcement expects applicants to already have proof-of-principle supported by preliminary data. In other words, proposals should not be purely speculative or at the very earliest invention stage. Instead, applicants should be able to show that the approach already works in a meaningful way and now needs advanced development and validation to demonstrate robustness, performance, and real-world utility for cancer-relevant biospecimens. The most competitive projects are those that can plausibly accelerate or improve multiple areas of cancer work, including cancer biology research, early detection and screening, clinical diagnosis, treatment decision-making, cancer control, epidemiology studies, and efforts related to cancer health disparities. The emphasis is on enabling better science and better clinical insight by starting with better, more interpretable samples.
The FOA also draws a clear boundary around what it will not support. Projects that mainly apply established technologies, where the only novelty is the biological or clinical question being studied, are considered non-responsive. Put differently, the innovation is required to be in the biospecimen technology or methodology itself, not simply in how a standard tool is used to answer a new cancer question. Applications that do not meet this expectation are not appropriate for the FOA and are stated to not be reviewed.
Administratively, the opportunity is offered by HHS/NIH (listed as HHS-NIH11) as a discretionary grant in the education and health activity category, associated with CFDA numbers 93.394. The program anticipated a small number of awards (expected awards: 2) with an award ceiling of $300,000. The FOA was posted and created on December 9, 2015, with an original and current closing date of September 26, 2016. Eligibility is broad and includes many types of applicants such as state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; nonprofit organizations with or without 501(c)(3) status; public housing authorities/Indian housing authorities; for-profit organizations (other than small businesses); small businesses; independent school districts; and other entities as specified in the full eligibility details.
Overall, this grant opportunity is best understood as targeted support for technologies that make cancer biospecimens more stable, more standardized, and more diagnostically and scientifically useful, with enough prior evidence to justify a focused push into rigorous development and validation. The goal is to strengthen the foundation of cancer research and clinical testing by reducing pre-analytical failures and by creating better ways to preserve and verify the quality of the samples that everything else depends on.
Frequently Asked Questions (FAQs)
What is the purpose of the Advanced Development and Validation of Emerging Technologies for Cancer-Relevant Biospecimen Science (R33) opportunity?
This NIH funding opportunity supports later-stage, exploratory technology work that improves the quality and usefulness of biospecimens used in cancer research and clinical care. The emphasis is on emerging tools, methods, and workflows that either preserve biospecimen integrity or accurately assess biospecimen quality so downstream analyses (such as molecular profiling, biomarker measurements, and diagnostics-oriented tests) are more reliable and informative.
Which NIH grant mechanism is used for this program?
The program uses the NIH R33 mechanism, which is intended for advanced development and validation activities rather than early invention or purely conceptual work.
What types of projects are a strong fit for this FOA?
Projects that move beyond an initial concept into advanced development and validation. Competitive proposals typically refine a technology, test it, and demonstrate robust performance and real-world utility for cancer-relevant biospecimens, especially where the work can meaningfully improve biospecimen-related outcomes.
Does this FOA require preliminary data?
Yes. Because this is an R33 opportunity, applicants are expected to already have proof-of-principle supported by preliminary data. Proposals should not be purely speculative or at the earliest invention stage.
What scientific problem is this FOA trying to address?
A central problem is pre-analytical degradation and variability: changes to samples that occur before the analytical test or assay begins. This includes effects introduced during biospecimen collection, processing, handling, transport, and storage.
What does "pre-analytical" mean in the context of biospecimens?
In this context, "pre-analytical" refers to everything that happens to a biospecimen before the actual measurement or test is performed, including collection, processing, handling, transport, and storage, all of which can introduce degradation or variability.
What kinds of analytes or molecular targets does the FOA mention?
The FOA highlights degradation or loss of targeted analytes such as nucleic acids, proteins, metabolites, or other molecular features, and encourages technologies that preserve these analytes or help assess their condition.
What does "fitness-for-purpose" mean here?
It refers to whether a biospecimen is suitable for a specific intended downstream use (for example, molecular profiling, biomarker measurement, or other diagnostics-oriented tests). The FOA is interested in technologies that can measure, maximize, or interrogate biospecimen quality in a way that supports this determination.
What outcomes is the program trying to improve in cancer research and clinical care?
The goal is to reduce avoidable noise and bias caused by how samples are obtained and managed, which is a major barrier to reproducible research and consistent clinical testing. By improving biospecimen stability, standardization, and quality assessment, downstream results are intended to become more reliable and informative.
What downstream analyses are specifically mentioned?
Examples mentioned include molecular profiling, biomarker measurements, and other diagnostics-oriented tests.
Which areas of cancer work could benefit from supported technologies?
The FOA describes potential impact across multiple areas, including cancer biology research, early detection and screening, clinical diagnosis, treatment decision-making, cancer control, epidemiology studies, and efforts related to cancer health disparities.
What types of projects are considered non-responsive and not reviewed?
Projects that mainly apply established technologies where the only novelty is the biological or clinical question being studied are considered non-responsive. The innovation must be in the biospecimen technology or methodology itself, not simply using a standard tool to answer a new cancer question. Applications that do not meet this expectation are stated to not be reviewed.
Who is offering this funding opportunity?
The opportunity is offered by HHS/NIH (listed as HHS-NIH11).
What is the FOA identifier for this opportunity?
The funding opportunity is identified as RFA-CA-16-004.
What is the CFDA number associated with this program?
The opportunity is associated with CFDA number 93.394.
How many awards are expected?
The program anticipated a small number of awards, with expected awards listed as 2.
What is the award ceiling?
The award ceiling is listed as $300,000.
When was this FOA posted and what was the closing date?
The FOA was posted and created on December 9, 2015. The original and current closing date is listed as September 26, 2016.
What is the general funding category and type of grant?
It is listed as a discretionary grant in the education and health activity category.
Who is eligible to apply?
Eligibility is broad and includes state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; nonprofit organizations with or without 501(c)(3) status; public housing authorities/Indian housing authorities; for-profit organizations (other than small businesses); small businesses; independent school districts; and other entities as specified in the full eligibility details.
Are for-profit organizations eligible under this FOA?
Yes. The eligibility description includes for-profit organizations (other than small businesses) and also separately includes small businesses.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized tribal governments and other tribal organizations are included in the eligibility description.
Are nonprofits without 501(c)(3) status eligible?
Yes. The eligibility description includes nonprofit organizations with or without 501(c)(3) status.
What is the central theme that ties responsive projects together?
Responsive projects are centered on biospecimen-focused technology innovation that reduces pre-analytical degradation and variability, preserves analyte integrity, and/or provides credible methods to assess biospecimen quality so cancer-related downstream analyses and decisions can be more dependable.
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