Opportunity Information: Apply for RFA CA 09 018
Apply for RFA CA 09 018
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Early Detection Research Network Clinical Validation Centers (U01)" 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.
- This funding opportunity was created on Jul 24, 2009 and posted on Jul 24, 2009.
- Applicants must submit their applications by Oct 29, 2009. (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 $600,000.00 in funding.
- Eligible applicants include: Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Public and State controlled institutions of higher education Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Eligible Agencies of the Federal Government U.S. Territory or Possession.
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Opportunity Summary:
The Early Detection Research Network (EDRN) Clinical Validation Centers (CVCs) opportunity (Funding Opportunity Number RFA-CA-09-018) is a National Institutes of Health (NIH) cooperative agreement grant aimed at strengthening the clinical validation side of a national biomarker consortium focused on cancer. The central goal is to support centers that can run well-designed clinical research studies to validate biomarkers for early cancer detection and cancer risk assessment, along with biomarkers relevant to the molecular diagnosis and prognosis of early-stage disease. In practical terms, this program is about moving promising biomarkers from earlier discovery and development work into real-world clinical testing environments where their performance, reliability, and clinical usefulness can be evaluated in appropriately designed patient and at-risk populations.
Within EDRN, CVCs function as the clinical engine and shared resource for validation studies. These centers are expected to participate in collaborative, multi-site biomarker validation projects across the Network rather than operating in isolation. They also serve as clinical resource hubs, meaning they contribute access to patient cohorts, clinical specimens, expertise in study design and conduct, and the operational capacity to execute validation protocols that can stand up to rigorous scrutiny. The work is inherently team-oriented and depends on coordination with the other EDRN components so that candidate biomarkers, assays, reference methods, and data standards are aligned across sites.
This FOA emphasizes that the CVCs are only one of four coordinated parts of EDRN. Biomarker Developmental Laboratories (BDLs) are responsible for discovering new biomarkers and refining existing biomarkers and assays. Biomarker Reference Laboratories (BRLs) provide network-wide resources for laboratory and clinical validation, including standardized testing capabilities and reference-level performance evaluation. The Data Management and Coordinating Center (DMCC) supports the backbone of the consortium by providing statistical and computational support, data management, protocol development assistance, informatics infrastructure, and coordination of network meetings and conferences. The CVCs fit into this structure by taking candidate biomarkers and helping demonstrate, in clinical settings, whether they meaningfully detect early cancers or stratify risk in ways that can ultimately inform patient care and future implementation.
The funding mechanism is the NIH Cooperative Agreement (U01), which signals that awardees should expect substantial scientific and programmatic involvement from NIH staff compared to a standard research project grant. This is consistent with the consortium model: NIH is not just funding independent projects, but helping coordinate a national network with shared priorities, harmonized protocols, and collaborative deliverables. The FOA also notes parallel companion announcements for the other EDRN components: BDLs under RFA-CA-09-017 (U01), BRLs under RFA-CA-09-019 (U24), and the DMCC under RFA-CA-09-020 (U24), highlighting that these awards are designed to be complementary parts of a single coordinated program.
Administratively, this is a discretionary funding opportunity in the health and education-related research space, tied to CFDA numbers 93.393 (Cancer Cause and Prevention Research) and 93.394 (Cancer Detection and Diagnosis Research). There is no cost sharing or matching requirement. The opportunity was posted on July 24, 2009, with an original and current closing date of October 29, 2009, and an archive date of November 29, 2009. The listed award ceiling is $600,000.
Eligibility is broad and includes public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities), for-profit organizations other than small businesses, small businesses, and certain other applicants as specified in the full announcement. Additional eligible applicants include eligible agencies of the federal government and U.S. territories or possessions. The sponsoring agency is NIH, and the full announcement is available through the NIH grants website at the link provided in the source text. For access or technical issues related to the electronic announcement, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity is the Early Detection Research Network (EDRN) Clinical Validation Centers (CVCs) program, Funding Opportunity Number RFA-CA-09-018. It is a National Institutes of Health (NIH) cooperative agreement designed to strengthen the clinical validation capacity of a national biomarker consortium focused on cancer.
What is the main goal of the EDRN Clinical Validation Centers (CVCs) program?
The main goal is to support centers that can run well-designed clinical research studies to validate biomarkers. These biomarkers are intended for early cancer detection and cancer risk assessment, as well as biomarkers relevant to molecular diagnosis and prognosis of early-stage disease.
What does "clinical validation" mean in the context of this program?
In this context, clinical validation means moving promising biomarkers from earlier discovery and development stages into real-world clinical testing environments. The purpose is to evaluate biomarker performance, reliability, and clinical usefulness in appropriately designed patient and at-risk populations.
What role do CVCs play within the Early Detection Research Network (EDRN)?
CVCs serve as the clinical engine and shared resource for validation studies across EDRN. They are expected to participate in collaborative, multi-site biomarker validation projects rather than operating independently, and they provide clinical resources needed to execute rigorous validation protocols.
Are CVCs expected to work independently or as part of a network?
CVCs are expected to work as part of the EDRN consortium. The program is inherently team-oriented and depends on coordination across EDRN components so candidate biomarkers, assays, reference methods, and data standards are aligned across sites.
What types of resources are CVCs expected to contribute?
CVCs are described as clinical resource hubs. They are expected to contribute access to patient cohorts, clinical specimens, expertise in clinical study design and conduct, and operational capacity to execute biomarker validation protocols.
What kinds of biomarker studies are intended to be supported?
The program supports clinical research studies aimed at validating biomarkers for early cancer detection and cancer risk assessment, along with biomarkers relevant to molecular diagnosis and prognosis of early-stage disease, within appropriately designed patient and at-risk populations.
How does this CVC program fit into the overall EDRN structure?
The FOA emphasizes that CVCs are one of four coordinated EDRN components. The other components are Biomarker Developmental Laboratories (BDLs), Biomarker Reference Laboratories (BRLs), and the Data Management and Coordinating Center (DMCC). CVCs focus on testing candidate biomarkers in clinical settings to determine whether they meaningfully detect early cancers or stratify risk.
What are Biomarker Developmental Laboratories (BDLs) and how are they different from CVCs?
BDLs are responsible for discovering new biomarkers and refining existing biomarkers and assays. In contrast, CVCs focus on clinical validation of candidate biomarkers by testing them in clinical research studies and populations appropriate for validation.
What are Biomarker Reference Laboratories (BRLs) and how do they relate to CVCs?
BRLs provide network-wide resources for laboratory and clinical validation, including standardized testing capabilities and reference-level performance evaluation. CVCs run the clinical studies and rely on coordinated alignment of assays and standards across the network, which is supported by the BRL role described in the FOA.
What is the Data Management and Coordinating Center (DMCC) and what does it do?
The DMCC provides statistical and computational support, data management, protocol development assistance, informatics infrastructure, and coordination of network meetings and conferences. It supports the backbone operations of the consortium and helps enable coordinated multi-site work.
What is the funding mechanism for this opportunity?
The funding mechanism is an NIH Cooperative Agreement (U01).
What does a U01 cooperative agreement imply for awardees?
A U01 cooperative agreement indicates substantial scientific and programmatic involvement from NIH staff compared to a standard research project grant. This aligns with EDRN being a coordinated national consortium with shared priorities, harmonized protocols, and collaborative deliverables.
Is this opportunity connected to other related EDRN funding announcements?
Yes. The FOA notes parallel companion announcements for other EDRN components: BDLs under RFA-CA-09-017 (U01), BRLs under RFA-CA-09-019 (U24), and the DMCC under RFA-CA-09-020 (U24). These are designed to function as complementary parts of a single coordinated program.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What are the CFDA numbers associated with this funding opportunity?
The CFDA numbers listed are 93.393 (Cancer Cause and Prevention Research) and 93.394 (Cancer Detection and Diagnosis Research).
Is there a cost sharing or matching requirement?
No. The opportunity states there is no cost sharing or matching requirement.
What is the award ceiling listed for this opportunity?
The listed award ceiling is $600,000.
When was this opportunity posted?
The opportunity was posted on July 24, 2009.
What are the closing date and archive date?
The original and current closing date is October 29, 2009. The archive date is November 29, 2009.
What types of organizations are eligible to apply?
Eligibility includes public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities), for-profit organizations other than small businesses, small businesses, and certain other applicants as specified in the full announcement. Additional eligible applicants include eligible agencies of the federal government and U.S. territories or possessions.
Are small businesses eligible?
Yes. Small businesses are listed among the eligible applicants.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also listed as eligible.
Are nonprofit organizations eligible?
Yes. Both 501(c)(3) nonprofits and non-501(c)(3) nonprofits are listed as eligible applicants.
Are colleges and universities eligible?
Yes. Both public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible.
Are federal agencies eligible to apply?
Yes. Eligible agencies of the federal government are included among eligible applicants.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are included in the eligible applicant categories described.
Where can applicants find the full announcement?
The full announcement is available through the NIH grants website at the link provided in the source text for the opportunity.
Who should be contacted for access or technical issues related to the electronic announcement?
For access or technical issues related to the electronic announcement, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Is this a discretionary funding opportunity?
Yes. It is described as a discretionary funding opportunity in the health and education-related research space.
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