Opportunity Information: Apply for RFA CA 14 006

  • The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Validation and Advanced Development of Emerging Technologies for Biospecimen Science (R33)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393 Cancer Cause and Prevention Research 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research.
  • This funding opportunity was created on Dec 20, 2013 and posted on Dec 20, 2013.
  • Applicants must submit their applications by Sep 18, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $700,000.00 to eligible and selected applicants.
  • 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: Small businesses Public and State controlled institutions of higher education City or township governments Public housing authorities/Indian housing authorities State governments Independent school districts For profit organizations other than small businesses Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
Apply for RFA CA 14 006

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Opportunity Summary:

The NIH grant opportunity titled "Validation and Advanced Development of Emerging Technologies for Biospecimen Science (R33)" (Funding Opportunity Number RFA-CA-14-006) supports late-stage feasibility projects that move promising biospecimen technologies from proof-of-principle into rigorous validation and advanced development. The core focus is on cancer-relevant technologies that directly tackle pre-analytical variation, meaning the real-world differences and inconsistencies that can be introduced before an assay ever begins, during biospecimen collection, processing, handling, shipping, and storage. Because these upstream factors can strongly influence downstream molecular and cellular measurements, the FOA is aimed at tools and methods that either interrogate biospecimen quality (so researchers can determine whether a sample is fit-for-purpose) or actively maximize and preserve the integrity and utility of specimens and specimen-derived materials.

The opportunity is specifically intended for projects where the technology concept has already been demonstrated and where applicants can provide supportive preliminary data. In other words, this is not an early ideation or basic discovery mechanism; it is meant for groups that have already established proof of principle and are ready to validate performance, robustness, and practical use under conditions that reflect how biospecimens are actually managed across clinical and research settings. Technologies of interest can include new or improved devices, instruments, analytical tools, and associated protocols that help assess sample quality, preserve or protect sample integrity, or define clear verification criteria for quality assessment and quality control. A key theme is reproducibility and standardization: enabling consistent specimen handling and reliable downstream analyses even when samples are collected and processed in diverse environments.

The FOA also draws a firm boundary around what it will not support. Applications that mainly apply established technologies, where the only novelty is the biological or clinical question being studied, are considered out of scope and will not be reviewed. The innovation must be in the technology, methodology, or validation approach that improves biospecimen science itself, not simply in how an existing tool is used to answer a new biomedical question.

Administratively, this is a discretionary NIH grant using the R33 activity code, and it sits within cancer-related research areas reflected in CFDA numbers 93.393 (Cancer Cause and Prevention Research), 93.394 (Cancer Detection and Diagnosis Research), and 93.395 (Cancer Treatment Research). The announcement anticipated approximately 2 awards, with an estimated total funding amount of about $700,000 and an award ceiling of $300,000. There is no cost sharing or matching requirement.

Eligibility is broad and includes small businesses, for-profit organizations (including those other than small businesses), nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), public and private institutions of higher education, federal agencies, state, county, city/township, and special district governments, public housing authorities, independent school districts, and a wide range of tribal governments and tribal organizations. It also explicitly includes many mission-serving and community-based institutions and organizations (for example HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions), as well as non-U.S. entities and regional organizations, and U.S. territories or possessions. The program was posted and created on December 20, 2013, with an original and current closing date of September 18, 2014, and an archive date of October 19, 2014.

In practical terms, a strong application under this FOA would typically center on a technology that can be validated against real sources of pre-analytical variability, demonstrate measurable improvements in specimen quality or interpretability, and produce defensible, transferable QC metrics or verification criteria that other sites could adopt. The best fit is work that bridges engineering or method development with biospecimen handling realities, showing not just that a technology works in ideal conditions, but that it performs reliably across the kinds of conditions that routinely challenge cancer biospecimen research.

Full details were made available through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-14-006.html.

Frequently Asked Questions (FAQs)

What is the NIH funding opportunity described here?

This opportunity is the NIH grant titled "Validation and Advanced Development of Emerging Technologies for Biospecimen Science (R33)" under Funding Opportunity Number (FON) RFA-CA-14-006. It supports late-stage feasibility projects that move promising biospecimen technologies from proof-of-principle into rigorous validation and advanced development, with a core emphasis on cancer-relevant biospecimen science.

What is the main purpose of this R33 FOA?

The main purpose is to validate and advance technologies that address pre-analytical variation in biospecimens. This includes real-world differences introduced before an assay begins during collection, processing, handling, shipping, and storage. The FOA aims to improve how biospecimens are assessed and preserved so downstream molecular and cellular measurements are more reliable and interpretable.

What does "pre-analytical variation" mean in this context?

Pre-analytical variation refers to inconsistencies and real-world differences that occur before testing or analysis starts. For biospecimens, it can be introduced during specimen collection, processing steps, handling practices, shipping conditions, and storage duration/conditions. These upstream factors can strongly influence downstream measurements, which is why this FOA targets technologies that either measure or reduce these sources of variation.

What types of projects are a strong fit for this FOA?

Strong-fit projects generally involve a biospecimen technology that has already shown proof-of-principle and now needs rigorous validation and advanced development under realistic conditions. Competitive projects typically validate performance, robustness, and practical utility across real sources of pre-analytical variability, and they generate defensible quality control (QC) metrics or verification criteria that could be adopted by other sites.

Is this opportunity meant for early-stage ideas or basic discovery?

No. The FOA is specifically intended for projects where the technology concept has already been demonstrated and applicants can provide supportive preliminary data. It is not positioned as an early ideation or basic discovery mechanism.

What kinds of technologies are of interest?

Technologies of interest can include new or improved devices, instruments, analytical tools, and associated protocols that help:

  • Interrogate biospecimen quality (determine whether a sample is fit-for-purpose)
  • Maximize, preserve, or protect specimen integrity and utility
  • Define clear verification criteria for quality assessment and quality control

A recurring theme is improving reproducibility and standardization across diverse clinical and research environments.

What does "fit-for-purpose" mean for biospecimen quality in this FOA?

Within the FOA framing, "fit-for-purpose" means a biospecimen is of sufficient quality and integrity for its intended downstream molecular or cellular measurements. The FOA supports tools and methods that help determine whether a specimen meets usable quality thresholds and/or that help preserve integrity so it remains suitable for analysis.

What is the role of validation in this R33 program?

Validation is central. The FOA is aimed at moving technologies from proof-of-principle into rigorous validation and advanced development. This includes demonstrating performance and robustness under conditions that reflect how biospecimens are actually managed across clinical and research settings, not only in idealized laboratory scenarios.

Does the FOA prioritize reproducibility and standardization?

Yes. A key theme is reproducibility and standardization, enabling consistent specimen handling and reliable downstream analyses even when samples are collected and processed in different environments and institutions.

What kinds of applications are explicitly out of scope?

Applications that mainly apply established technologies, where the only novelty is the biological or clinical question being studied, are out of scope and will not be reviewed. The innovation must be in the technology, methodology, or validation approach that improves biospecimen science itself, not simply a new use of an existing tool for a new biomedical question.

What grant mechanism/activity code is used?

This is a discretionary NIH grant using the R33 activity code.

Is this opportunity tied to cancer-related research areas?

Yes. The FOA sits within cancer-related research areas reflected in CFDA numbers:

  • 93.393 (Cancer Cause and Prevention Research)
  • 93.394 (Cancer Detection and Diagnosis Research)
  • 93.395 (Cancer Treatment Research)

How many awards were anticipated and what funding levels were described?

The announcement anticipated approximately 2 awards. The estimated total funding amount was about $700,000, and the award ceiling was $300,000.

Is cost sharing or matching required?

No. There is no cost sharing or matching requirement stated for this FOA.

Who is eligible to apply?

Eligibility is broad and includes:

  • Small businesses
  • For-profit organizations (including those other than small businesses)
  • Nonprofits (including 501(c)(3) and certain non-501(c)(3) entities)
  • Public and private institutions of higher education
  • Federal agencies
  • State, county, city/township, and special district governments
  • Public housing authorities
  • Independent school districts
  • Tribal governments and tribal organizations (including a wide range of types)

Are mission-serving and community-based institutions explicitly included?

Yes. The FOA explicitly includes many mission-serving and community-based institutions and organizations, including (as examples) HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and related organizations.

Are non-U.S. organizations eligible?

Yes. The eligibility statement explicitly includes non-U.S. entities and regional organizations, as well as U.S. territories or possessions.

What were the key dates for this funding opportunity?

The program was posted and created on December 20, 2013. The original and current closing date was September 18, 2014. The archive date was October 19, 2014.

What kind of evidence would typically strengthen an application under this FOA?

Based on the description, a strong application would typically show:

  • Supportive preliminary data demonstrating the technology concept (proof-of-principle)
  • Validation plans that test the technology against real sources of pre-analytical variability
  • Measurable improvements in specimen quality or interpretability
  • Defensible, transferable QC metrics or verification criteria that other sites could adopt
  • Performance that holds up across conditions commonly encountered in clinical and research biospecimen handling

Where can applicants find the full FOA details?

Full details were made available through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-14-006.html

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Next opportunity: Validation and Advanced Development of Emerging Molecular Analysis Technologies for Cancer Research (R33)

Previous opportunity: Early Stage Development of Innovative Technologies for Biospecimen Science (R21)

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