Opportunity Information: Apply for RFA CA 14 014

  • The National Institutes of Health in the education health sector is offering a public funding opportunity titled "The Early Detection Research Network Biomarker Developmental Laboratories (U01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394 Cancer Detection and Diagnosis Research.
  • This funding opportunity was created on Dec 12, 2014 and posted on Nov 5, 2014.
  • Applicants must submit their applications by Jan 20, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $8,000,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $400,000.00 in funding.
  • The number of recipients for this funding is limited to 16 candidate(s).
  • Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) State governments Public housing authorities/Indian housing authorities County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses City or township governments Private institutions of higher education Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) Independent school districts.
  • 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 Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Apply for RFA CA 14 014

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Opportunity Summary:

The grant opportunity titled "The Early Detection Research Network Biomarker Developmental Laboratories (U01)" (Funding Opportunity Number RFA-CA-14-014) is a National Institutes of Health (NIH) cooperative agreement aimed at strengthening the Early Detection Research Network (EDRN), a national research infrastructure focused on improving how cancers are found and characterized at early stages. The central goal of the EDRN is to discover, develop, and validate biomarkers that can be used for cancer risk assessment, early detection, and molecular diagnosis and prognosis, meaning markers that can help identify who is at risk, detect cancer earlier, and better define the biology and likely course of disease.

This specific announcement solicits applications for Biomarker Developmental Laboratories (BDLs), which represent one of four major scientific units in the EDRN. Under this program, BDLs are expected to do the hands-on scientific work of discovering new biomarkers, improving existing biomarkers, and developing and refining biomarker assays. That includes characterizing biomarkers and testing them in ways that move them closer to practical use in early cancer research settings. In other words, BDLs sit at the front end of the pipeline: they are where promising biological signals are identified and turned into measurable, testable assays that can later be validated in broader clinical contexts.

The BDLs are designed to operate as part of a coordinated network rather than as isolated projects. The FOA emphasizes the broader EDRN structure and how each unit fits into the overall biomarker pipeline. Alongside BDLs, the Biomarker Reference Laboratories (BRLs) function as shared network resources that support clinical and laboratory validation of biomarkers. The Clinical Validation Centers (CVCs) conduct clinical research focused on validating biomarkers and also serve as resource centers by participating in collaborative biomarker validation studies with BDLs and BRLs. The Data Management and Coordinating Center (DMCC) provides the backbone support that makes network-scale work feasible, including statistical and computational analyses, informatics infrastructure, study design, coordination and operational support for EDRN-sponsored biomarker validation studies, and planning and coordination of network-wide meetings and conferences. The overall design is meant to ensure that biomarker discoveries can be efficiently tested, compared, validated, and advanced with consistent data standards and coordinated study designs.

Administratively, this is a discretionary funding opportunity using the cooperative agreement mechanism (U01), which generally means NIH expects substantial involvement in the stewardship and coordination of the funded projects compared with a standard research project grant. The program falls under the Health and Education activity category and is associated with CFDA number 93.394 (Cancer Detection and Diagnosis Research). The opportunity anticipated making about 16 awards, with an estimated total funding level of $8,000,000 and an award ceiling of $400,000. The FOA did not require cost sharing or matching.

Eligibility was broad and included many types of domestic organizations such as state, county, city, and special district governments; independent school districts; public housing authorities; nonprofit organizations (including those with and without 501(c)(3) status, excluding institutions of higher education where specified); for-profit organizations (including small businesses and other than small businesses); and public and private institutions of higher education. It also allowed a range of special categories and community-focused institutions, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American Native American Pacific Islander serving institutions. Importantly, the FOA also permitted non-U.S. entities and foreign institutions to apply, allowed non-domestic components of U.S. organizations, and allowed foreign components as defined by NIH policy.

Key dates show that the opportunity was posted on November 5, 2014, with an original closing date of January 6, 2015, later extended to January 20, 2015, and an archive date of February 20, 2015. For full details, NIH directed applicants to the official FOA page at http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-14-014.html, and provided NIH Office of Extramural Research (OER) webmaster contacts for access or linking issues (FBOWebmaster@OD.NIH.GOV).

In practical terms, the announcement is about building and sustaining a coordinated set of biomarker-focused laboratories that can generate high-quality candidates and assays for early cancer applications, while working in a tightly connected system with validation laboratories, clinical validation centers, and a central data and coordinating hub. This structure is intended to speed up the process from biomarker idea to credible evidence, using shared resources, network standards, and collaborative studies to improve the reliability and real-world relevance of early detection biomarkers.

Frequently Asked Questions (FAQs)

What is the title and funding opportunity number for this grant?

The opportunity is titled "The Early Detection Research Network Biomarker Developmental Laboratories (U01)" and the Funding Opportunity Number is RFA-CA-14-014.

Which federal agency is offering this opportunity?

This is a National Institutes of Health (NIH) funding opportunity.

What is the main purpose of this funding opportunity?

The purpose is to strengthen the Early Detection Research Network (EDRN), a national research infrastructure focused on improving how cancers are found and characterized at early stages by advancing biomarker discovery, development, and validation.

What is EDRN and what is its central goal?

The Early Detection Research Network (EDRN) is a national research infrastructure. Its central goal is to discover, develop, and validate biomarkers for cancer risk assessment, early detection, and molecular diagnosis and prognosis.

What specific projects or components does this FOA solicit?

This FOA solicits applications for Biomarker Developmental Laboratories (BDLs), which are one of four major scientific units in the EDRN.

What is a Biomarker Developmental Laboratory (BDL) expected to do?

BDLs are expected to conduct hands-on scientific work to:

  • Discover new biomarkers
  • Improve existing biomarkers
  • Develop and refine biomarker assays
  • Characterize biomarkers and test them in ways that move them closer to practical use in early cancer research settings
Where do BDLs fit in the overall biomarker pipeline described in the FOA?

BDLs sit at the front end of the pipeline, where promising biological signals are identified and turned into measurable, testable assays that can later be validated in broader clinical contexts.

Are BDLs intended to operate independently or as part of a larger network?

BDLs are designed to operate as part of a coordinated EDRN network rather than as isolated projects, using shared resources, network standards, and collaborative studies.

What are the other major scientific units in the EDRN besides BDLs?

In addition to Biomarker Developmental Laboratories (BDLs), the EDRN includes:

  • Biomarker Reference Laboratories (BRLs)
  • Clinical Validation Centers (CVCs)
  • Data Management and Coordinating Center (DMCC)
What do Biomarker Reference Laboratories (BRLs) do in the EDRN structure?

BRLs function as shared network resources that support clinical and laboratory validation of biomarkers.

What do Clinical Validation Centers (CVCs) do in the EDRN structure?

CVCs conduct clinical research focused on validating biomarkers and also serve as resource centers by participating in collaborative biomarker validation studies with BDLs and BRLs.

What does the Data Management and Coordinating Center (DMCC) do?

The DMCC provides backbone support for network-scale work, including:

  • Statistical and computational analyses
  • Informatics infrastructure
  • Study design
  • Coordination and operational support for EDRN-sponsored biomarker validation studies
  • Planning and coordination of network-wide meetings and conferences
What funding mechanism is used for this opportunity?

This opportunity uses the NIH cooperative agreement mechanism (U01).

What does it mean that this is a cooperative agreement (U01)?

Under a cooperative agreement (U01), NIH expects substantial involvement in the stewardship and coordination of funded projects compared with a standard research project grant.

What is the activity category associated with this program?

The program falls under the Health and Education activity category.

What CFDA number is associated with this funding opportunity?

The CFDA number listed is 93.394 (Cancer Detection and Diagnosis Research).

How many awards were anticipated and what was the total estimated funding?

The FOA anticipated making about 16 awards, with an estimated total funding level of $8,000,000.

What was the award ceiling for individual awards?

The award ceiling was $400,000.

Was cost sharing or matching required?

No. The FOA did not require cost sharing or matching.

Who was eligible to apply?

Eligibility was broad and included many types of domestic organizations, including:

  • State, county, city, and special district governments
  • Independent school districts
  • Public housing authorities
  • Nonprofit organizations (including those with and without 501(c)(3) status, excluding institutions of higher education where specified)
  • For-profit organizations (including small businesses and other than small businesses)
  • Public and private institutions of higher education

The FOA also included a range of special categories and community-focused institutions, such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American Native American Pacific Islander serving institutions.

Were non-U.S. or foreign entities allowed to apply?

Yes. The FOA permitted non-U.S. entities and foreign institutions to apply, allowed non-domestic components of U.S. organizations, and allowed foreign components as defined by NIH policy.

When was the opportunity posted and when did it close?

The opportunity was posted on November 5, 2014. The original closing date was January 6, 2015, and it was later extended to January 20, 2015.

When was the opportunity archived?

The archive date was February 20, 2015.

Where can applicants find the official FOA details?

NIH directed applicants to the official FOA page at: http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-14-014.html

Who should be contacted for access or linking issues related to the FOA page?

The NIH Office of Extramural Research (OER) webmaster contact provided for access or linking issues is: FBOWebmaster@OD.NIH.GOV

What is the practical focus of this announcement in plain terms?

In practical terms, the announcement is about building and sustaining a coordinated set of biomarker-focused laboratories that can generate high-quality biomarker candidates and assays for early cancer applications, while working in a tightly connected system with validation laboratories, clinical validation centers, and a central data and coordinating hub.

Why does the FOA emphasize network coordination and shared infrastructure?

The overall design is intended to help biomarker discoveries be efficiently tested, compared, validated, and advanced using consistent data standards and coordinated study designs, improving the reliability and real-world relevance of early detection biomarkers.

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