Opportunity Information: Apply for RFA CA 14 015
Apply for RFA CA 14 015
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "The 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): 93.394 Cancer Detection and Diagnosis Research.
- This funding opportunity was created on Dec 12, 2014 and posted on Nov 6, 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 $9,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $600,000.00 in funding.
- The number of recipients for this funding is limited to 8 candidate(s).
- Eligible applicants include: State governments Native American tribal governments (Federally recognized) County governments Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Small businesses Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses City or township governments.
- 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 not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Early Detection Research Network Clinical Validation Centers (U01) opportunity (Funding Opportunity Number RFA-CA-14-015) is a National Institutes of Health (NIH) cooperative agreement designed to build and support the clinical arm of the Early Detection Research Network (EDRN). EDRN is a national, network-based infrastructure focused on improving early cancer outcomes by discovering, developing, and validating biomarkers used for cancer risk assessment, early detection, molecular diagnosis, and prognosis. This particular FOA targets the Clinical Validation Centers (CVCs), which are expected to do the hands-on clinical research needed to determine whether promising biomarkers actually perform well in real-world patient populations and clinical settings.
Under this program, CVCs function as the EDRN's clinical resource centers. Their core role is to lead and participate in collaborative biomarker validation studies, meaning they help move biomarkers from promising laboratory findings toward clinically credible evidence. Because this is a cooperative agreement (U01), awardees are not operating in isolation; they are expected to work closely with NIH and with the other EDRN components in a coordinated, networked way. The emphasis is on team science and shared studies rather than single-investigator projects that run independently.
The FOA places the CVCs inside a larger four-part EDRN structure. Alongside CVCs, the Biomarker Developmental Laboratories (BDLs) focus on creating new biomarkers or refining existing ones, including improving assays and characterization work that prepares biomarkers for broader testing. Biomarker Reference Laboratories (BRLs) serve as network resources that support clinical and laboratory validation, helping to ensure biomarker measurements and validation processes are rigorous and comparable across sites. The Data Management and Coordinating Center (DMCC) provides the backbone for statistics, computation, informatics, study design, and overall coordination, including support for EDRN-sponsored validation studies and the logistics of network-wide meetings and conferences. In practice, the CVCs supply clinical cohorts, patient-facing research workflows, and study execution, while the other units supply assay development, reference-level validation capabilities, and centralized data and coordination support.
From a funding and scale perspective, NIH expected to make about 8 awards, with an estimated total funding amount of roughly $9,000,000 and an award ceiling of $600,000 (per award, per year as typically presented in NIH summaries). There is no cost sharing or matching requirement. The program is listed under CFDA 93.394 (Cancer Detection and Diagnosis Research). Key dates for this archived solicitation include a posted date of November 6, 2014, an original closing date of January 6, 2015, a current closing date of January 20, 2015, and an archive date of February 19, 2015.
Eligibility is broad and includes many types of domestic organizations that can support clinical research infrastructure, such as public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status, other than institutions of higher education), small businesses, and for-profit organizations other than small businesses. Government entities are also eligible, including state, county, city or township governments, special district governments, independent school districts, and certain tribal governments and tribal organizations. The eligibility language also calls out categories like Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies. However, non-U.S. (foreign) organizations and non-U.S. institutions are not eligible to apply directly, and non-domestic components of U.S. organizations are not eligible. At the same time, foreign components, as NIH defines them in its Grants Policy Statement, are allowed, meaning a U.S. applicant can include certain foreign collaborations when justified and compliant with NIH policy.
Overall, this FOA is about strengthening the clinical validation pipeline for early cancer biomarkers by funding centers that can reliably conduct clinical research studies, contribute patients and specimens where appropriate, and operate in a coordinated network that standardizes methods, shares data, and collectively advances biomarkers toward real clinical utility. The full announcement was made available through the NIH grants guide at http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-14-015.html, and technical access issues were directed to the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is the Early Detection Research Network (EDRN) Clinical Validation Centers (U01) funding opportunity?
This opportunity (Funding Opportunity Number RFA-CA-14-015) is an NIH cooperative agreement (U01) intended to build and support the clinical arm of the Early Detection Research Network (EDRN). It supports Clinical Validation Centers (CVCs) that conduct hands-on clinical research to evaluate whether promising cancer biomarkers perform well in real-world patient populations and clinical settings.
What is the main purpose of this program?
The main purpose is to strengthen the clinical validation pipeline for early cancer biomarkers by funding centers that can reliably run clinical research studies, contribute clinical cohorts and patient-facing workflows, and work in a coordinated network to generate clinically credible evidence for biomarker utility.
What does EDRN focus on overall?
EDRN is a national, network-based infrastructure focused on improving early cancer outcomes by discovering, developing, and validating biomarkers used for cancer risk assessment, early detection, molecular diagnosis, and prognosis.
What are Clinical Validation Centers (CVCs) expected to do?
CVCs are expected to function as EDRN's clinical resource centers. Their core role is to lead and participate in collaborative biomarker validation studies, helping move biomarkers from promising laboratory findings toward clinically credible evidence by testing performance in patient populations and clinical settings.
What makes this a cooperative agreement (U01) rather than a typical grant?
Because it is a U01 cooperative agreement, awardees are expected to work closely with NIH and with other EDRN components in a coordinated, networked way. The emphasis is on team science and shared studies rather than independent, single-investigator projects operating in isolation.
How does the Clinical Validation Center role fit into the larger EDRN structure?
The FOA describes a four-part EDRN structure: Clinical Validation Centers (CVCs), Biomarker Developmental Laboratories (BDLs), Biomarker Reference Laboratories (BRLs), and the Data Management and Coordinating Center (DMCC). CVCs provide the clinical cohorts and execute patient-facing research workflows, while the other components support assay development, reference-level validation resources, and centralized data/coordination capabilities.
What do Biomarker Developmental Laboratories (BDLs) do?
BDLs focus on creating new biomarkers or refining existing ones. This includes improving assays and conducting characterization work that prepares biomarkers for broader testing.
What do Biomarker Reference Laboratories (BRLs) do?
BRLs serve as network resources that support clinical and laboratory validation. They help ensure biomarker measurements and validation processes are rigorous and comparable across sites.
What does the Data Management and Coordinating Center (DMCC) do?
The DMCC provides centralized support for statistics, computation, informatics, study design, and overall coordination. It also supports logistics for EDRN-sponsored validation studies and network-wide meetings and conferences.
How many awards did NIH expect to make under this FOA?
NIH expected to make about 8 awards under this funding opportunity.
What was the estimated total funding amount for this opportunity?
The estimated total funding amount described for this FOA was roughly $9,000,000.
What is the award ceiling?
The award ceiling is listed as $600,000 per award per year (as typically presented in NIH summaries).
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
What CFDA number is associated with this program?
This program is listed under CFDA 93.394, Cancer Detection and Diagnosis Research.
When was this funding opportunity posted and when did it close?
Key dates included a posted date of November 6, 2014, an original closing date of January 6, 2015, and a current closing date of January 20, 2015. The archive date is February 19, 2015.
Is this funding opportunity still open?
Based on the dates provided (including an archive date of February 19, 2015), this solicitation is archived and its listed submission window has passed.
What types of organizations were eligible to apply?
Eligibility is broad for domestic organizations, including public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status, other than institutions of higher education), small businesses, and for-profit organizations other than small businesses.
Were government entities eligible to apply?
Yes. Eligible government entities include state, county, city or township governments, special district governments, independent school districts, and certain tribal governments and tribal organizations.
Does the FOA specifically encourage applications from certain institution types?
The eligibility language calls out categories such as Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It also mentions faith-based or community-based organizations and eligible federal agencies.
Are non-U.S. (foreign) organizations eligible to apply directly?
No. Non-U.S. (foreign) organizations and non-U.S. institutions are not eligible to apply directly.
Can a U.S. applicant include foreign collaborations?
Yes, foreign components (as NIH defines them in its Grants Policy Statement) are allowed. This means a U.S. applicant can include certain foreign collaborations when justified and compliant with NIH policy.
Are non-domestic components of U.S. organizations eligible?
No. The FOA states that non-domestic components of U.S. organizations are not eligible.
Where can applicants find the full NIH announcement for this FOA?
The full announcement was made available through the NIH grants guide at http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-14-015.html.
Who should be contacted for technical access issues related to the announcement?
Technical access issues were directed to the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
In practical terms, what does "clinical validation" mean in this FOA?
In the context provided, clinical validation refers to the hands-on clinical research needed to determine whether promising biomarkers perform well in real-world patient populations and clinical settings, moving them beyond initial laboratory findings toward clinically credible evidence.
What kind of work culture or approach does this FOA emphasize?
The FOA emphasizes coordinated, network-based team science. CVCs are expected to participate in shared, collaborative validation studies and operate with standardized methods and shared data practices as part of the broader EDRN infrastructure.
Browse more opportunities from the same category: Education Health
Next opportunity: Fiscal Year 2015 Department of Defense Research and Education Program for Historically Black Colleges and Universities and Minority Serving Institutions (HBCU/MI)
Previous opportunity: The Early Detection Research Network Biomarker Developmental Laboratories (U01)
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Applicants also applied for:
Applicants who have applied for this opportunity (RFA CA 14 015) also looked into and applied for these:
| Funding Opportunity |
|---|
| The Early Detection Research Network Biomarker Reference Laboratories (U24) Apply for RFA CA 14 016 Funding Number: RFA CA 14 016 Agency: National Institutes of Health Category: Education Health Funding Amount: $300,000 |
| The Early Detection Research Network Data Management and Coordinating Center (U24) Apply for RFA CA 14 017 Funding Number: RFA CA 14 017 Agency: National Institutes of Health Category: Education Health Funding Amount: $4,500,000 |
| Cancer Prevention, Control, Behavioral Sciences, and Population Sciences Career Development Award (K07) Apply for PAR 15 033 Funding Number: PAR 15 033 Agency: National Institutes of Health Category: Education Health Funding Amount: $130,000 |
| Research Aimed at Novel Behavioral Targets to Improve Adolescent Substance Abuse Treatment and Prevention Interventions (R01) Apply for PA 15 036 Funding Number: PA 15 036 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Research Aimed at Novel Behavioral Targets to Improve Adolescent Substance Abuse Treatment and Prevention Interventions (R34) Apply for PA 15 035 Funding Number: PA 15 035 Agency: National Institutes of Health Category: Education Health Funding Amount: $450,000 |
| Cancer Detection, Diagnosis, and Treatment Technologies for Global Health (UH2/UH3) Apply for RFA CA 15 001 Funding Number: RFA CA 15 001 Agency: National Institutes of Health Category: Education Health Funding Amount: $1,000,000 |
| Exploratory Grant Award to Promote Workforce Diversity in Basic Cancer Research (R21) Apply for PAR 15 053 Funding Number: PAR 15 053 Agency: National Institutes of Health Category: Education Health Funding Amount: $275,000 |
| NCI Mentored Clinical Scientist Research Career Development Award to Promote Diversity (K08) Apply for PAR 15 060 Funding Number: PAR 15 060 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| NCI Mentored Patient Oriented Research Career Development Award to Promote Diversity (K23) Apply for PAR 15 062 Funding Number: PAR 15 062 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| NCI Transition Career Development Award to Promote Diversity (K22) Apply for PAR 15 063 Funding Number: PAR 15 063 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| NCI Mentored Research Scientist Development Award to Promote Diversity (K01) Apply for PAR 15 064 Funding Number: PAR 15 064 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| The NCI Transition Career Development Award (K22) Apply for PAR 15 056 Funding Number: PAR 15 056 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Building on High Impact Basic Neurobiology Through Assay Development Advancing Tools for Therapeutic Discovery (R01) Apply for PAR 15 066 Funding Number: PAR 15 066 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Academic Industrial Partnerships for Translation of Technologies for Cancer Diagnosis and Treatment (R01) Apply for PAR 15 075 Funding Number: PAR 15 075 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Integration of Infectious Diseases and Substance Abuse Intervention Services for Individuals Living with HIV (R01) Apply for RFA DA 15 013 Funding Number: RFA DA 15 013 Agency: National Institutes of Health Category: Education Health Funding Amount: $3,000,000 |
| Cutting Edge Basic Research Awards (CEBRA) (R21) Apply for PAR 15 079 Funding Number: PAR 15 079 Agency: National Institutes of Health Category: Education Health Funding Amount: $125,000 |
| Innovative Molecular Analysis Technologies for Cancer Research (R21) Apply for RFA CA 15 002 Funding Number: RFA CA 15 002 Agency: National Institutes of Health Category: Education Health Funding Amount: $2,000,000 |
| Innovative Technologies for Cancer Relevant Biospecimen Science (R21) Apply for RFA CA 15 004 Funding Number: RFA CA 15 004 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Advanced Development and Validation of Emerging Molecular Analysis Technologies for Cancer Research (R33) Apply for RFA CA 15 003 Funding Number: RFA CA 15 003 Agency: National Institutes of Health Category: Education Health Funding Amount: $300,000 |
| Advanced Development and Validation of Emerging Technologies for Cancer Relevant Biospecimen Science (R33) Apply for RFA CA 15 005 Funding Number: RFA CA 15 005 Agency: National Institutes of Health Category: Education Health Funding Amount: $300,000 |
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