Opportunity Information: Apply for RFA CA 19 017
The grant opportunity "Approaches to Identify and Care for Individuals with Inherited Cancer Syndromes (U01 Clinical Trial Required)" (RFA-CA-19-017) is a National Cancer Institute (NCI) cooperative agreement announcement under the U.S. Department of Health and Human Services and the NIH. It sits within the Beau Biden Cancer Moonshot initiative, a national effort designed to speed up progress in cancer research and translate that progress into real-world benefits. The central idea behind this FOA is practical and prevention-focused: more people who carry inherited genetic risks for cancer need to be identified, connected to the right follow-up care, and supported over time so they actually receive evidence-based screening, prevention, and early detection services.
The program is framed around a specific Cancer Moonshot Blue Ribbon Panel scientific priority (Recommendation G), which emphasized strengthening early detection, genetic testing, genetic counseling, and the broader knowledge base around mechanisms and biomarkers related to cancer development. In other words, the FOA is not simply asking for more genetic discoveries in the lab. It is asking applicants to build and test workable approaches that improve how healthcare systems find individuals and families with hereditary cancer syndromes, confirm risk through appropriate genetic evaluation, and then ensure those individuals receive recommended surveillance and preventive care. The emphasis on "demonstration projects" signals that NCI is looking for practical models that can be implemented, evaluated, and potentially scaled, with outcomes that matter to patients and health systems, such as lives saved, quality of life improvements, and reduced healthcare costs through prevention and earlier detection.
The announcement specifically invites applications using a multi-Program Director/Principal Investigator structure, reflecting how complex hereditary cancer care is across real clinical settings. These projects are expected to bring together the expertise needed to solve problems that often span multiple domains: oncology, primary care, genetics, genetic counseling, public health, health services research, informatics, and community engagement. The goal is to identify and validate best practices for both case ascertainment (finding the right people, including those who may not realize they are at high risk) and follow-up care (making sure identified individuals actually get guideline-based management, such as appropriate screening intervals, risk-reducing options when indicated, and cascade testing or outreach to family members where appropriate).
A key structural feature is that this is a cooperative agreement (U01), meaning awardees should expect substantial scientific and programmatic involvement from NIH/NCI staff compared with a typical investigator-initiated grant. Cooperative agreements are commonly used when the funder anticipates that close coordination, shared standards, or active oversight will help align projects with program goals, promote harmonization across sites, and generate results that are comparable and useful beyond a single institution. The title also indicates "Clinical Trial Required," which generally means applicants must include a clinical trial component as defined by NIH, such as prospective testing of an intervention or strategy related to identifying at-risk individuals and improving their care pathways, with measurable outcomes.
In terms of who can apply, eligibility is broad and includes many types of organizations positioned to influence hereditary cancer identification and care. Eligible applicants include state, county, and local governments; tribal governments and tribal organizations; public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; public housing authorities/Indian housing authorities; for-profit organizations (other than small businesses) as well as small businesses; and other entities as described in the FOA. This wide eligibility list aligns with the reality that improving identification and follow-up for inherited cancer risk may require partnerships that extend beyond academic medical centers, including public health infrastructure, community-based health systems, payers, and organizations serving populations that have historically had limited access to genetic services.
Administratively, the FOA was created on August 10, 2018, with an original closing date of January 9, 2019. It is listed under CFDA numbers 93.393 and 93.399, which are commonly associated with NCI research support mechanisms. The announcement anticipated making about four awards. The award ceiling is listed as 0, which typically indicates that a specific cap was not provided in the summary field and that applicants should rely on the detailed FOA instructions or NCI guidance for budget expectations and project scope.
Overall, the opportunity is best understood as an implementation and care-delivery improvement initiative focused on hereditary cancer syndromes. It prioritizes improving real-world pathways: identifying individuals and families at inherited risk, connecting them to genetic evaluation and counseling as appropriate, and ensuring that evidence-based prevention and early detection practices are actually delivered and sustained. The bigger-picture aim is to demonstrate approaches that not only improve clinical outcomes for high-risk individuals, but also create replicable models that health systems can adopt to reduce preventable cancer burden and associated costs.Apply for RFA CA 19 017
- The Department of Health and Human Services, National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Approaches to Identify and Care for Individuals with Inherited Cancer Syndromes (U01 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393, 93.399.
- This funding opportunity was created on Aug 10, 2018.
- Applicants must submit their applications by Jan 09, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 4 candidate(s).
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled "Approaches to Identify and Care for Individuals with Inherited Cancer Syndromes (U01 Clinical Trial Required)" and is referenced as RFA-CA-19-017.
Which agency is offering this funding opportunity?
This is a National Cancer Institute (NCI) funding opportunity under the U.S. Department of Health and Human Services and the National Institutes of Health (NIH).
What type of grant mechanism is this?
The mechanism is a cooperative agreement (U01). In a U01, NIH/NCI staff typically have substantial scientific and programmatic involvement compared with a standard investigator-initiated grant.
What does "cooperative agreement" mean for applicants and awardees?
Because this is a cooperative agreement, awardees should expect active involvement from NIH/NCI staff. This often includes closer coordination, shared expectations or standards, and programmatic oversight intended to align projects with the overall goals and to support results that are useful beyond a single institution or site.
Is a clinical trial required?
Yes. The title specifies "Clinical Trial Required," meaning applications must include a clinical trial component as defined by NIH. This generally involves prospective testing of an intervention or strategy with measurable outcomes related to identifying at-risk individuals and improving their care pathways.
What is the main goal of the funding opportunity?
The goal is to develop and test practical, prevention-focused approaches to (1) identify more people with inherited genetic risks for cancer and (2) connect them to appropriate follow-up care and long-term support so they actually receive evidence-based screening, prevention, and early detection services.
How is this opportunity connected to the Beau Biden Cancer Moonshot?
The FOA sits within the Beau Biden Cancer Moonshot initiative, which is intended to accelerate cancer research progress and translate that progress into real-world benefits.
What Cancer Moonshot priority does this program align with?
It is framed around a Cancer Moonshot Blue Ribbon Panel scientific priority (Recommendation G), which emphasized strengthening early detection, genetic testing, genetic counseling, and building knowledge related to cancer development mechanisms and biomarkers.
Is this opportunity focused on basic genetic discovery research?
No. The focus is on building and testing workable, real-world approaches that improve how healthcare systems find individuals and families with hereditary cancer syndromes, confirm risk through appropriate genetic evaluation, and ensure that people receive guideline-based surveillance and preventive care.
What does NCI mean by "demonstration projects" in this context?
"Demonstration projects" signals that NCI is looking for practical models that can be implemented and evaluated in real settings and that have potential to be scaled. The emphasis is on outcomes that matter to patients and health systems, such as improvements in health and quality of life and potential reductions in costs through prevention and earlier detection.
What kinds of approaches or activities are these projects expected to address?
Projects are expected to improve both case ascertainment (finding individuals and families at inherited risk, including those who may not realize they are at high risk) and follow-up care (ensuring identified individuals receive evidence-based management such as recommended screening and prevention/early detection services over time).
What is meant by "case ascertainment" in this FOA?
Case ascertainment refers to identifying the right people in real-world settings who may have hereditary cancer syndromes or inherited cancer risk, including individuals who may not yet know they are at higher risk.
What is meant by "follow-up care" in this FOA?
Follow-up care refers to connecting identified individuals to appropriate genetic evaluation and counseling as appropriate and ensuring they receive guideline-based management. The FOA emphasizes sustained delivery of evidence-based screening, prevention, and early detection services.
Does the FOA emphasize family-based approaches?
Yes. The FOA notes the importance of identifying individuals and families with hereditary cancer syndromes and mentions cascade testing or outreach to family members where appropriate.
Why does the FOA encourage a multi-Program Director/Principal Investigator (multi-PD/PI) structure?
The FOA specifically invites a multi-PD/PI structure to reflect the complexity of hereditary cancer identification and care in real clinical settings, which often requires coordinated expertise across multiple disciplines and operational domains.
What disciplines or partner areas are expected to be involved in these projects?
The FOA anticipates multidisciplinary teams spanning areas such as oncology, primary care, genetics, genetic counseling, public health, health services research, informatics, and community engagement.
Who is eligible to apply?
Eligibility is broad and includes state, county, and local governments; tribal governments and tribal organizations; public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; public housing authorities/Indian housing authorities; for-profit organizations (other than small businesses) and small businesses; and other entities as described in the FOA.
Why is eligibility so broad for this program?
The eligibility list reflects the idea that improving identification and follow-up care for inherited cancer risk may require partnerships beyond academic medical centers, including public health infrastructure, community-based health systems, payers, and organizations serving populations that have historically had limited access to genetic services.
How many awards were anticipated?
The announcement anticipated making about four awards.
What are the key administrative dates mentioned?
The FOA was created on August 10, 2018, and had an original closing date of January 9, 2019.
What CFDA numbers are associated with this opportunity?
The opportunity is listed under CFDA numbers 93.393 and 93.399.
Is there a stated maximum award amount (budget cap)?
The award ceiling is listed as 0 in the summary field, which typically indicates that a specific cap was not provided there. The description indicates applicants should rely on the detailed FOA instructions or NCI guidance for budget expectations and project scope.
What kinds of outcomes does the FOA care about?
The FOA emphasizes outcomes that matter to patients and health systems, including improved delivery of evidence-based screening, prevention, and early detection services, and the potential for improved quality of life and reduced healthcare costs through prevention and earlier detection.
What is the overall theme of this opportunity?
This opportunity is best understood as an implementation and care-delivery improvement initiative focused on hereditary cancer syndromes, with an emphasis on identifying at-risk individuals and families and ensuring sustained, guideline-based preventive care and early detection in real-world settings.
What does it mean that the results should be "replicable" or "scalable"?
The FOA emphasizes developing approaches that can be evaluated and potentially adopted by other health systems or organizations to reduce preventable cancer burden and associated costs, rather than solutions that only work in one institution.
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