Opportunity Information: Apply for RFA CA 23 005
Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity (RFA-CA-23-005; CFDA 93.394) aimed at improving the quality, reliability, and usability of biospecimens used in cancer research and, where applicable, clinical care. The central problem this FOA targets is pre-analytical variability: the often-unavoidable changes and degradation that can occur in key molecular targets (analytes) while a specimen is being collected, processed, handled, transported, or stored. Because these early steps can distort downstream measurements, even the most advanced genomic, proteomic, metabolomic, or cellular assays can produce misleading or irreproducible results if the input specimens are compromised. This program focuses on technologies that directly reduce those pre-analytical effects or provide credible, standardized ways to detect and quantify specimen quality so researchers and clinicians can trust the data produced from those samples.
The FOA uses the R33 mechanism, which is generally positioned for projects that have already cleared major feasibility hurdles but are not yet ready for broad adoption. In practical terms, applicants are expected to have supportive preliminary data showing the concept works in a meaningful way, and the proposed work should concentrate on further development, optimization, and, most importantly, rigorous validation. The emphasis on validation reflects the goal of moving an emerging tool or method from a promising idea into something that the wider community can confidently implement. The intent is not just to invent something new, but to produce convincing evidence that it performs reliably across realistic conditions, sample types, workflows, and use cases relevant to cancer research.
Projects responsive to this opportunity can include tools, devices, instrumentation, and associated methods that preserve, protect, or stabilize biospecimen integrity, as well as approaches that establish clear verification criteria for quality assessment and quality control (QA/QC). That can mean technologies that prevent degradation of DNA, RNA, proteins, metabolites, or other targets; systems that control temperature, time-to-processing, or other environmental variables; improved collection or storage materials; or analytical and computational methods that can measure or infer specimen quality and flag compromised samples. Importantly, the FOA highlights the need for technologies that work under diverse conditions, recognizing that real-world biospecimen handling varies widely across laboratories, clinics, biobanks, and geographic settings. By reducing pre-analytical variation, these advances are expected to strengthen studies in cancer biology, early detection and screening, clinical diagnosis, treatment and therapeutic decision-making, and cancer epidemiology, while also supporting efforts to address cancer health disparities where sample handling constraints can be more pronounced.
This funding opportunity explicitly does not allow clinical trials, which signals that the supported work should focus on technology and methodology development and validation rather than testing clinical interventions or assigning human participants to intervention arms. While biospecimens may come from clinical settings and may be used to support clinically relevant research questions, the funded activities should remain within the boundaries of tool development, performance characterization, and validation for research and clinical workflow adoption rather than clinical trial execution.
Eligibility is broad, spanning many types of U.S. organizations and also allowing non-U.S. (foreign) entities. Eligible applicants include state, county, city or township, and special district governments; public and state-controlled and private institutions of higher education; independent school districts; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education); for-profit organizations (other than small businesses) as well as small businesses; and additional categories specifically highlighted such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and Indian/Native American tribal governments that are not federally recognized. This wide eligibility aligns with the FOA’s practical aim: improving biospecimen quality requires solutions that can be implemented across many different institutional contexts, including those serving populations affected by cancer disparities.
Key administrative details provided include the NIH as the sponsoring agency, the grant instrument type, and an original closing date of September 1, 2023 (with the FOA created on December 2, 2022). While an award ceiling and expected number of awards are not specified in the provided source text, the program’s overarching purpose is clear: to produce rigorously validated biospecimen science technologies that make cancer research findings more accurate, comparable, and reproducible by ensuring the samples themselves are preserved, characterized, and handled in ways that protect the integrity of the biological signals researchers and clinicians rely on.Apply for RFA CA 23 005
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 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 2022-12-02.
- Applicants must submit their applications by 2023-09-01. (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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FAQs: Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed)
What is this funding opportunity?
This is a National Institutes of Health (NIH) funding opportunity titled "Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed)." It is associated with RFA-CA-23-005 and CFDA 93.394.
What problem is the FOA trying to solve?
The FOA targets pre-analytical variability in biospecimens. This refers to changes or degradation that can occur in important molecular targets (analytes) during specimen collection, processing, handling, transport, or storage, which can compromise downstream measurements and reduce reproducibility.
Why does pre-analytical variability matter for cancer research?
If biospecimens are compromised early in the workflow, even highly advanced genomic, proteomic, metabolomic, or cellular assays can generate misleading or irreproducible results. The FOA is designed to improve trust in the data by improving specimen integrity or enabling credible ways to measure specimen quality.
What is the overall purpose of the program?
The purpose is to improve the quality, reliability, and usability of biospecimens used in cancer research and, where applicable, clinical care by supporting technologies and methods that reduce pre-analytical effects or standardize how specimen quality is assessed.
What grant mechanism does this FOA use?
The FOA uses the R33 mechanism, which is positioned for projects that have already cleared major feasibility hurdles but are not yet ready for broad adoption.
What stage of development is expected for R33 projects under this FOA?
Applicants are expected to have supportive preliminary data showing the concept works in a meaningful way. Proposed work should focus on further development, optimization, and especially rigorous validation to demonstrate reliable performance under realistic conditions.
What does "validation" mean in the context of this FOA?
Within this FOA, validation emphasizes producing convincing evidence that a tool, technology, or method performs reliably across realistic conditions, sample types, workflows, and use cases relevant to cancer research, so that the broader community can confidently implement it.
Is this FOA mainly about inventing brand-new technologies?
The stated intent is not only to invent something new, but to move an emerging tool or method from a promising idea into something that can be credibly implemented by others, supported by rigorous validation.
What kinds of projects are considered responsive?
Responsive projects can include tools, devices, instrumentation, and associated methods that preserve, protect, or stabilize biospecimen integrity, as well as approaches that establish verification criteria for quality assessment and quality control (QA/QC).
What types of biospecimen integrity improvements are included?
The FOA includes technologies that prevent or reduce degradation of DNA, RNA, proteins, metabolites, or other molecular targets, as well as systems that control environmental variables such as temperature and time-to-processing.
Are collection and storage materials within scope?
Yes. The FOA explicitly mentions improved collection or storage materials as potential areas of interest.
Are computational or analytical approaches allowed?
Yes. The FOA includes analytical and computational methods that can measure or infer specimen quality and flag compromised samples.
Does the FOA focus only on lab-ideal conditions?
No. The FOA highlights the need for technologies that work under diverse conditions, acknowledging that real-world biospecimen handling can vary widely across laboratories, clinics, biobanks, and geographic settings.
What is meant by QA/QC in this FOA?
QA/QC refers to quality assessment and quality control. In this FOA, it includes establishing clear verification criteria and standardized ways to detect and quantify specimen quality so that compromised samples can be identified and data can be trusted.
What research and clinical areas could benefit from these technologies?
The FOA indicates that reducing pre-analytical variation can strengthen cancer biology studies, early detection and screening research, clinical diagnosis, treatment and therapeutic decision-making, and cancer epidemiology.
How does this FOA relate to cancer health disparities?
The FOA notes that sample handling constraints can be more pronounced in settings affected by cancer health disparities. Technologies that work under diverse and variable conditions may help support research and care contexts where handling limitations are more common.
Are clinical trials allowed under this opportunity?
No. The FOA explicitly does not allow clinical trials.
If clinical trials are not allowed, what kind of work is expected instead?
The funded work should focus on technology and methodology development and validation, including performance characterization and validation for research and clinical workflow adoption, rather than testing clinical interventions or assigning participants to intervention arms.
Can biospecimens come from clinical settings?
Yes. The FOA states that biospecimens may come from clinical settings and may support clinically relevant research questions, as long as the activities remain focused on tool development, performance characterization, and validation rather than conducting a clinical trial.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. organizations as well as non-U.S. (foreign) entities.
Which U.S. government entities are eligible?
Eligible government applicants include state, county, city or township, and special district governments, as well as U.S. territories or possessions and eligible federal agencies. The FOA also includes Indian/Native American tribal governments (federally recognized) and tribal governments that are not federally recognized.
Are colleges and universities eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education. The FOA also highlights several institution types such as HBCUs, TCCUs, and other designated serving institutions.
Are minority-serving and specialized institutions specifically mentioned?
Yes. The FOA specifically highlights Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are nonprofits eligible?
Yes. Eligible applicants include nonprofits with and without 501(c)(3) status (excluding institutions of higher education).
Are for-profit organizations eligible?
Yes. Eligibility includes for-profit organizations (other than small businesses) and also small businesses.
Are community-based or faith-based organizations eligible?
Yes. The FOA specifically mentions faith-based or community-based organizations as eligible applicant types.
Are school districts or housing authorities eligible?
Yes. Independent school districts are listed as eligible, as are public housing authorities/Indian housing authorities.
Are foreign (non-U.S.) entities eligible to apply?
Yes. The FOA states that non-U.S. (foreign) entities are allowed.
What is the FOA identifier and CFDA number?
The FOA identifier is RFA-CA-23-005 and the CFDA number is 93.394.
When was the FOA created and when was it originally due?
The FOA was created on December 2, 2022, and the original closing date provided is September 1, 2023.
Does the provided information specify an award ceiling or number of awards?
No. Based on the information provided, an award ceiling and the expected number of awards are not specified.
What is the key outcome NIH is aiming for through this program?
The stated goal is to produce rigorously validated biospecimen science technologies that improve accuracy, comparability, and reproducibility of cancer research findings by ensuring specimens are preserved, characterized, and handled in ways that protect the biological signals used for research and, where applicable, clinical care.
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| Revision Applications for Incorporation of Novel NCI-Supported Technology to Accelerate Cancer Research (P50 Clinical Trial Optional) Apply for RFA CA 23 010 Funding Number: RFA CA 23 010 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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| Revision Applications for Incorporation of Novel NCI-Supported Technology to Accelerate Cancer Research (R01 Clinical Trial Optional) Apply for RFA CA 23 006 Funding Number: RFA CA 23 006 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Revision Applications for Incorporation of Novel NCI-Supported Technology to Accelerate Cancer Research (U2C Clinical Trial Optional) Apply for RFA CA 23 011 Funding Number: RFA CA 23 011 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Small Grants Program for Cancer Research for Years 2023, 2024, and 2025 (NCI Omnibus) (R03 Clinical Trial Optional) Apply for PAR 23 058 Funding Number: PAR 23 058 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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