NCI Outstanding Investigator Award (R35 Clinical Trial Optional) | RFA CA 22 045

Opportunity Information: Apply for RFA CA 22 045

The NCI Outstanding Investigator Award (R35 Clinical Trial Optional), announced by the National Institutes of Health through the National Cancer Institute under funding opportunity number RFA-CA-22-045, is designed to provide long-term, stable support for highly accomplished cancer researchers who have already demonstrated exceptional productivity and impact. Rather than emphasizing a narrow, short-term project plan, this award is meant to back investigators with a strong track record who are positioned to pursue especially promising and potentially high-impact directions in cancer research. NCI frames the award as a way to give outstanding investigators enough time and flexibility to push boundaries, take scientific risks, explore more adventurous ideas, and invest effort into developing new techniques or approaches that might be difficult to support under more traditional, tightly scoped grant mechanisms.

A key feature of the program is that applications are submitted by an institution nominating an established Program Director/Principal Investigator (PD/PI). In practice, that means the institution is putting forward a proven investigator for sustained support, with the expectation that this stability will enable bolder, longer-range research that could open new fields, significantly extend earlier discoveries into new applications, or produce breakthrough advances. The research can be in any area of cancer research and may span biomedical, behavioral, or clinical domains, with the overarching expectation that the work is exceptional in vision and potential impact. As indicated by the title, clinical trials are optional, meaning proposed work may involve a clinical trial but is not required to do so.

The funding opportunity is categorized as discretionary support using a grant funding instrument and is listed under activity categories related to education and health. It is associated with multiple CFDA numbers (93.393 through 93.399), reflecting the broader NCI program landscape that can intersect with this mechanism. The stated award ceiling is $600,000, which typically signals the maximum annual direct cost level permitted under the announcement (though applicants should always confirm the exact budget rules and any exclusions in the full FOA and NIH policy documents). The original closing date provided for this opportunity is 2024-11-07.

Eligibility is broad across many types of U.S.-based organizations. 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 and certain tribal organizations; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions when specified); for-profit organizations (other than small businesses); and small businesses. The opportunity also highlights specific eligible institution types 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 or community-based organizations, regional organizations, and eligible federal agencies.

At the same time, the FOA draws clear boundaries around foreign involvement. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations are also not eligible. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, which generally means a U.S. applicant organization may include certain well-justified foreign elements within the project structure when permitted by NIH policy and when they are necessary to achieve the scientific aims.

Overall, this R35 mechanism is best understood as NCI making a long-term investment in investigators rather than only in a single, tightly constrained project. The intent is to reward and empower established leaders in cancer research to pursue ambitious lines of inquiry with the flexibility needed to generate transformative advances, including potentially groundbreaking discoveries or new applications that significantly move cancer science, prevention, diagnosis, treatment, survivorship, or related behavioral and clinical research forward.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "NCI Outstanding Investigator Award (R35 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393, 93.394, 93.395, 93.396, 93.397, 93.398, 93.399.
• This funding opportunity was created on 2022-07-26.
• Applicants must submit their applications by 2024-11-07. (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 22 045

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