Opportunity Information: Apply for RFA CA 22 040
The funding opportunity titled "The Early Detection Research Network: Biomarker Characterization Centers (U2C Clinical Trial Not Allowed)" (RFA-CA-22-040) is a National Institutes of Health (NIH) cooperative agreement designed to support a key set of research hubs within the Early Detection Research Network (EDRN). EDRN functions as a national, coordinated infrastructure focused on improving early cancer detection and cancer risk assessment by advancing biomarkers and imaging approaches. In practical terms, this FOA is aimed at building and sustaining specialized centers that can move promising biomarker ideas from early discovery and assay development toward readiness for larger-scale validation work across the Network.
The specific centers being solicited are Biomarker Characterization Centers (BCCs), which represent one of the three main scientific units that make up the continuing EDRN program. The BCC role is centered on the scientific and technical work needed to get biomarkers into a form that can be credibly tested and validated in broader clinical contexts. These centers are expected to discover new biomarkers, further develop and characterize them, and test their performance in well-controlled research settings. They may also refine existing biomarkers that show promise but need more work to improve sensitivity, specificity, robustness, or overall usability. A major emphasis is placed on assay-related capabilities: BCCs are expected to develop, refine, and/or standardize biomarker assays so results are reliable and comparable across laboratories and studies. Beyond their own biomarker pipeline work, BCCs are also expected to provide tangible resources and support that enable validation of EDRN-developed biomarkers, and to participate actively in collaborative projects with other EDRN laboratories and centers, rather than operating as isolated, single-lab efforts.
BCCs are positioned within a broader EDRN ecosystem that is designed to cover the full arc from biomarker development to validation at scale. The second scientific unit is the Clinical Validation Centers (CVCs). CVCs lead the clinical research needed to validate biomarkers and also serve as resource centers for the Network by working jointly with BCCs and the Data Management and Coordinating Center (DMCC) on collaborative validation studies. The third unit, the DMCC, provides the backbone for statistical and computational analysis, data and informatics infrastructure, and study design support. The DMCC also handles coordination and management of EDRN-sponsored biomarker validation studies and organizes Network-wide meetings and workshops, which is important because EDRN is structured around coordinated, multi-site collaboration and shared standards.
This FOA uses the U2C cooperative agreement mechanism, which generally means funded centers should expect substantial NIH programmatic involvement compared with a standard research grant. The title also makes clear that clinical trials are not allowed under this announcement, signaling that the supported work should focus on biomarker discovery, characterization, assay development, and related preparatory or enabling research activities rather than interventional clinical trial conduct.
In terms of eligibility, the opportunity is broadly open to a wide range of U.S.-based organizations and government entities, reflecting the infrastructure-building nature of EDRN. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education when applying under those nonprofit categories); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, it draws clear boundaries around foreign participation: non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as the applicant organization. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant may include certain defined international elements within the project when justified and compliant with NIH policy.
Key administrative details from the source data include the sponsoring agency (NIH), the opportunity category (discretionary), the funding instrument type (cooperative agreement), the activity area (education and health), and the CFDA number 93.394. The FOA was created on July 18, 2022, and the original closing date listed is September 8, 2022. The provided record does not specify an award ceiling or expected number of awards in the excerpt, so applicants would typically need to consult the full FOA text for budget limits, project period expectations, and other application requirements.
Overall, the central idea of this grant opportunity is to fund centers that can do the heavy-lift scientific and technical work of turning candidate cancer biomarkers into rigorously characterized, well-assayed tools that are ready for network-supported validation efforts. Success in this program is inherently collaborative: BCCs are expected to contribute not only through their own biomarker and assay development outputs, but also by supporting EDRN-wide validation activities and working in close coordination with CVCs and the DMCC to ensure methods, data, and results can be compared and integrated across the Network.Apply for RFA CA 22 040
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "The Early Detection Research Network: Biomarker Characterization Centers (U2C 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 2022-07-18.
- Applicants must submit their applications by 2022-09-08. (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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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 Characterization Centers (U2C Clinical Trial Not Allowed)" and is identified as RFA-CA-22-040.
Which federal agency is sponsoring this funding opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What is the main purpose of this funding opportunity?
This FOA is designed to support Biomarker Characterization Centers (BCCs) within the Early Detection Research Network (EDRN). The overall goal is to strengthen a national, coordinated infrastructure for improving early cancer detection and cancer risk assessment by advancing biomarkers and imaging approaches, with BCCs specifically focused on moving promising biomarkers toward readiness for larger-scale validation across the Network.
What is the Early Detection Research Network (EDRN)?
EDRN is a national, coordinated infrastructure focused on improving early cancer detection and cancer risk assessment by advancing biomarkers and imaging approaches. It is structured around multi-site collaboration and shared standards so that methods and results can be compared and integrated across the Network.
What are Biomarker Characterization Centers (BCCs)?
BCCs are specialized research hubs within EDRN that perform key scientific and technical work to advance cancer biomarkers. Their role includes discovering and further developing biomarkers, characterizing biomarker performance in well-controlled research settings, and getting biomarkers into a form that can be credibly tested and validated in broader clinical contexts.
What kinds of activities are BCCs expected to perform under this FOA?
Based on the provided description, BCCs are expected to:
- Discover new biomarkers.
- Further develop and characterize biomarkers.
- Test biomarker performance in well-controlled research settings.
- Refine existing biomarkers to improve sensitivity, specificity, robustness, and usability.
- Develop, refine, and/or standardize biomarker assays to ensure results are reliable and comparable across labs and studies.
- Provide tangible resources and support that enable validation of EDRN-developed biomarkers.
- Participate actively in collaborative projects with other EDRN laboratories and centers.
Why is assay development and standardization emphasized for BCCs?
A major emphasis is placed on assay-related capabilities so that biomarker results are reliable and comparable across laboratories and studies. The FOA describes BCCs as centers expected to develop, refine, and/or standardize biomarker assays to support credible downstream validation work across EDRN.
Are clinical trials allowed under this funding opportunity?
No. The FOA title explicitly states "Clinical Trial Not Allowed," indicating the supported work should focus on biomarker discovery, characterization, assay development, and related preparatory or enabling research activities rather than conducting interventional clinical trials.
What funding mechanism is used for this opportunity?
This FOA uses the U2C cooperative agreement mechanism.
What does it mean that this is a cooperative agreement (U2C)?
The U2C cooperative agreement mechanism generally indicates substantial NIH programmatic involvement compared with a standard research grant. Funded centers should expect a more collaborative relationship with NIH as part of the cooperative agreement structure.
How do BCCs fit into the broader EDRN program structure?
The continuing EDRN program includes three main scientific units:
- Biomarker Characterization Centers (BCCs): Focus on biomarker discovery, development, characterization, and assay standardization to prepare biomarkers for broader validation.
- Clinical Validation Centers (CVCs): Lead the clinical research needed to validate biomarkers and serve as Network resource centers, working jointly with BCCs and the DMCC on collaborative validation studies.
- Data Management and Coordinating Center (DMCC): Provides statistical and computational analysis, data and informatics infrastructure, study design support, and coordinates EDRN-sponsored validation studies and Network-wide meetings/workshops.
What is the role of Clinical Validation Centers (CVCs) in EDRN?
CVCs lead clinical research to validate biomarkers and serve as resource centers for the Network. They work jointly with BCCs and the DMCC on collaborative validation studies.
What is the role of the Data Management and Coordinating Center (DMCC)?
The DMCC provides the backbone for statistical and computational analysis, data and informatics infrastructure, and study design support. It also coordinates and manages EDRN-sponsored biomarker validation studies and organizes Network-wide meetings and workshops.
Is this opportunity intended for single-lab projects or collaborative centers?
It is intended for collaborative centers. The description emphasizes that BCCs should participate actively in collaborative projects with other EDRN laboratories and centers, rather than operating as isolated, single-lab efforts.
What is the opportunity category and funding instrument type?
The opportunity category is discretionary, and the funding instrument type is a cooperative agreement.
What activity area is associated with this opportunity?
The activity area listed is education and health.
What is the CFDA number for this program?
The CFDA number provided is 93.394.
When was this funding opportunity created and what is the closing date listed?
The FOA record indicates it was created on July 18, 2022, and lists an original closing date of September 8, 2022.
Is the award ceiling or expected number of awards provided in the information shown?
No. The excerpt provided does not specify an award ceiling or the expected number of awards. Applicants would typically need to consult the full FOA text for budget limits, expected project period, and other application requirements.
Who is eligible to apply?
Eligibility is broadly open to many U.S.-based organizations and government entities. Eligible applicants include:
- State, county, and local governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Tribal organizations (including those other than federally recognized tribal governments)
- Public housing authorities/Indian housing authorities
- Nonprofits with or without 501(c)(3) status (when applying under those nonprofit categories and not as institutions of higher education)
- For-profit organizations (other than small businesses)
- Small businesses
Are any additional applicant types explicitly highlighted as eligible?
Yes. The FOA explicitly highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
Can a non-U.S. (foreign) organization apply as the applicant?
No. Non-domestic (non-U.S.) entities are not eligible to apply as the applicant organization under this FOA.
Can a U.S. organization include a non-domestic component as part of its project?
Non-domestic components of U.S. organizations are not eligible to apply as the applicant organization. However, "foreign components" (as defined by the NIH Grants Policy Statement) are allowed, meaning a U.S. applicant may include certain defined international elements within the project when justified and compliant with NIH policy.
What is the central outcome this program is trying to achieve through BCC funding?
The central idea is to fund centers that can do the scientific and technical work of turning candidate cancer biomarkers into rigorously characterized, well-assayed tools that are ready for Network-supported validation efforts.
How does collaboration show up in day-to-day expectations for BCCs?
The description emphasizes that success is inherently collaborative. BCCs are expected to contribute through their own biomarker and assay development outputs, provide resources that support EDRN-wide validation activities, and coordinate closely with CVCs and the DMCC so methods, data, and results can be compared and integrated across the Network.
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