Opportunity Information: Apply for RFA CA 19 001

The grant opportunity "Communication and Decision Making for Individuals with Inherited Cancer Syndromes (U01 Clinical Trial Optional)" is a National Institutes of Health (NIH) cooperative agreement (U01) tied to the Beau Biden Cancer Moonshot Initiative. Its main goal is to speed progress in cancer prevention and early detection by funding projects that improve how cancer risk information is communicated and how medical decisions are made when a person or family has an inherited predisposition to cancer. The focus is not simply on discovering new genes or tests, but on making sure that once hereditary risk is identified, patients, relatives, and clinicians can clearly understand the implications and make informed choices about screening, prevention, and other risk-management steps.

This funding opportunity is aligned with the Cancer Moonshot Blue Ribbon Panel scientific priorities, specifically Recommendation G from the Prevention and Screening Working Group. In practical terms, that recommendation calls for initiatives that strengthen early detection and the broader ecosystem around genetic testing and counseling, while also using implementation science to help proven strategies spread more quickly and equitably. Because of that framing, the FOA emphasizes both intervention development and the real-world adoption of effective approaches. Applicants are encouraged to either create new interventions or adapt existing ones, then rigorously test and evaluate them, including how they can be implemented in clinical settings and scaled across different healthcare environments.

The types of projects this announcement is aiming to support are those that tackle communication breakdowns and decision-making barriers that commonly happen in hereditary cancer care. That can include improving the way genetic risk is explained to patients, strengthening shared decision making between providers and patients, helping families communicate risk information to relatives who may also be affected, and supporting follow-through on recommended clinical actions such as enhanced screening, preventive medications, or risk-reducing surgeries when appropriate. The overall intended outcome is better informed clinical risk management decisions, meaning decisions that reflect accurate understanding of risk, personal values and preferences, and the best available medical evidence.

Mechanistically, the award is a cooperative agreement, which usually means NIH expects to be more actively involved than in a standard research project grant. Projects are still led by the funded institution, but there is typically substantial programmatic interaction with NIH staff around study milestones, coordination, and progress toward shared goals. The FOA is labeled "Clinical Trial Optional," indicating that proposed studies may include clinical trials but do not have to; applicants can propose a range of study designs as long as they are appropriate to developing, testing, evaluating, or implementing communication and decision-support interventions for inherited cancer risk.

Eligibility is broad and spans many sectors. Eligible applicants include state, county, city, and special district governments; independent school districts; public housing authorities; federally recognized Native American tribal governments; other tribal organizations; public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses, among others. The FOA also highlights interest in participation from organizations that serve populations historically underrepresented in research or disproportionately affected by cancer outcomes, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, 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 and community-based organizations and regional organizations. A key boundary is that non-U.S. entities and non-U.S. institutions are not eligible to apply as applicants, and non-domestic components of U.S. organizations are not eligible. However, foreign components, as defined under NIH policy, are allowed, which typically means a U.S. applicant can include certain well-justified international collaborations or activities as part of the project structure even though the primary applicant must be domestic.

From the administrative details provided, the opportunity number is RFA-CA-19-001 and it is categorized as discretionary funding. The activity area is listed under education and health, with CFDA numbers 93.353 and 93.399. The listed award ceiling is $600,000. The original closing date was January 9, 2019, and the opportunity record was created on September 10, 2018. Overall, the FOA is best understood as a Moonshot-supported effort to close the gap between hereditary cancer risk identification and effective action, by improving communication, decision support, and the practical implementation of interventions that can reduce cancer risk and address disparities in access to high-quality genetic services and follow-up care.

  • The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Communication and Decision Making for Individuals with Inherited Cancer Syndromes (U01 Clinical Trial Optional)." and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.353, 93.399.
  • This funding opportunity was created on 2018-09-10.
  • Applicants must submit their applications by 2019-01-09. (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: 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.
Apply for RFA CA 19 001

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Frequently Asked Questions (FAQs)

What is the name of this grant opportunity?

The opportunity is titled "Communication and Decision Making for Individuals with Inherited Cancer Syndromes (U01 Clinical Trial Optional)."

What agency is offering this funding?

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

What type of award mechanism is used?

The funding mechanism is a cooperative agreement (U01). This generally means the funded institution leads the project, but NIH expects substantial programmatic involvement such as interaction on milestones, coordination, and progress toward shared goals.

How is this opportunity connected to the Cancer Moonshot?

The award is tied to the Beau Biden Cancer Moonshot Initiative and is aligned with the Cancer Moonshot Blue Ribbon Panel scientific priorities, specifically Recommendation G from the Prevention and Screening Working Group.

What is the main purpose of this funding opportunity?

The main goal is to speed progress in cancer prevention and early detection by supporting projects that improve how hereditary cancer risk information is communicated and how medical decisions are made when individuals or families have an inherited predisposition to cancer.

What problem is this FOA trying to solve?

The focus is on closing the gap between identifying hereditary cancer risk and taking effective action. The FOA targets communication breakdowns and decision-making barriers that can prevent patients, families, and clinicians from understanding hereditary risk and following through on appropriate screening, prevention, and other risk-management steps.

Is this grant focused on discovering new cancer genes or new genetic tests?

No. The emphasis is not simply on discovering new genes or tests. The FOA prioritizes improving understanding and use of hereditary risk information after risk is identified, including communication, decision support, and implementation of effective approaches in real-world settings.

What types of projects are encouraged under this FOA?

Projects are encouraged to create new interventions or adapt existing ones, then rigorously test and evaluate them. This includes evaluating how interventions can be implemented in clinical settings and scaled across different healthcare environments.

What kinds of interventions does this FOA appear to support?

Based on the description, supported interventions may include efforts to improve how genetic risk is explained to patients, strengthen shared decision making between providers and patients, help families communicate risk information to relatives, and support follow-through on recommended clinical actions such as enhanced screening, preventive medications, or risk-reducing surgeries when appropriate.

What outcomes is this program aiming for?

The intended outcome is better-informed clinical risk management decisions. In this context, that means decisions that reflect accurate understanding of risk, personal values and preferences, and the best available medical evidence.

Does the FOA require a clinical trial?

No. The FOA is labeled "Clinical Trial Optional," meaning studies may include clinical trials but do not have to. Applicants may propose a range of study designs as long as they are appropriate for developing, testing, evaluating, or implementing communication and decision-support interventions related to inherited cancer risk.

What does "Clinical Trial Optional" mean in practice for applicants?

It indicates applicants are not required to include a clinical trial. However, a clinical trial may be proposed if it fits the goals of developing, testing, evaluating, or implementing interventions that improve communication and decision making for inherited cancer syndromes.

What is the opportunity number for this FOA?

The opportunity number is RFA-CA-19-001.

What is the funding type/category listed for this opportunity?

The opportunity is categorized as discretionary funding.

What activity areas are associated with this opportunity?

The activity area is listed under education and health.

What CFDA numbers are associated with this grant?

The CFDA numbers listed are 93.353 and 93.399.

What is the award ceiling?

The listed award ceiling is $600,000.

When was the opportunity record created?

The opportunity record was created on September 10, 2018.

What was the original closing date for applications?

The original closing date was January 9, 2019.

Who is eligible to apply?

Eligibility is broad and includes state, county, city, and special district governments; independent school districts; public housing authorities; federally recognized Native American tribal governments and other tribal organizations; public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses, among others.

Are there specific organizations the FOA encourages to participate?

Yes. The FOA highlights interest in participation from organizations serving populations historically underrepresented in research or disproportionately affected by cancer outcomes. Examples include HBCUs, Hispanic-serving Institutions, TCCUs, Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, as well as faith-based, community-based, and regional organizations.

Are non-U.S. entities eligible to apply as the applicant organization?

No. Non-U.S. entities and non-U.S. institutions are not eligible to apply as applicants.

Can a U.S. organization include international work or collaborators?

Yes, foreign components are allowed as defined under NIH policy. This generally means a U.S. applicant may include certain well-justified international collaborations or activities, even though the primary applicant must be domestic.

Are non-domestic components of U.S. organizations eligible?

No. Non-domestic components of U.S. organizations are not eligible.

What is the role of implementation science in this FOA?

The FOA emphasizes not only developing and testing interventions, but also studying real-world adoption. It encourages use of implementation science to help proven strategies spread more quickly and equitably across clinical settings and healthcare environments.

What does the FOA suggest about scaling interventions?

Applicants are encouraged to evaluate how effective approaches can be implemented in clinical settings and scaled across different healthcare environments, consistent with the goal of broader, more equitable adoption.

What is the overall theme of the opportunity in one sentence?

It is a Moonshot-supported effort to improve communication and decision support in hereditary cancer care so that identification of inherited cancer risk leads to informed, evidence-based, and actionable prevention and early-detection decisions.

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