Applied Regulatory Science Research to Evaluate Cardiotoxicity of Oncology Therapeutics (U01) Clinical Trial Optional | RFA FD 25 015

Opportunity Information: Apply for RFA FD 25 015

Applied Regulatory Science Research to Evaluate Cardiotoxicity of Oncology Therapeutics (U01) Clinical Trial Optional (RFA-FD-25-015) is a Food and Drug Administration (FDA) funding opportunity designed to strengthen how cardiotoxicity from cancer drugs is detected and followed over time. The core goal is applied regulatory science research that can produce practical tools, evidence, or approaches that improve monitoring for heart-related side effects tied to oncology therapeutics. Because it is framed as regulatory science, the emphasis is typically on work that can inform evaluation standards, assessment methods, and real-world decision-making around product safety, rather than basic discovery research alone. Clinical trials are allowed but not required, which gives applicants flexibility to propose clinical, translational, computational, or other applied study designs that directly support better cardiotoxicity detection and surveillance.

This opportunity uses a U01 cooperative agreement mechanism, meaning the project is funded as an assistance award with substantial federal programmatic involvement compared with a standard research grant. In practice, that usually translates into closer interaction with the funding agency during the life of the project, including coordination around milestones, deliverables, data sharing expectations, and alignment with regulatory science needs. The funding instrument is listed as a cooperative agreement under a discretionary program, and the activity category is associated with FDA-related areas such as consumer protection and food and nutrition (as categorized in the listing). The NOFO anticipates making around three awards, with an award ceiling of $500,000, indicating a relatively competitive program intended to support a small number of targeted projects.

A wide range of U.S.-based organizations can apply. Eligible applicants include public and private institutions of higher education, nonprofits (both with and without 501(c)(3) status, as long as they are not foreign entities), for-profit organizations (including small businesses and other for-profits), and multiple levels of government such as state, county, and city or township governments. Special district governments, independent school districts, public housing authorities/Indian housing authorities, and tribal governments (both federally recognized and other than federally recognized) are also included, along with certain regional and community-based organizations. Federal agencies are included where eligible. The eligibility rules explicitly exclude non-U.S. entities: foreign organizations are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined in the NIH Grants Policy Statement are not allowed. In other words, the applicant and the work need to be structured to avoid foreign organizational components as part of the proposed project.

The closing date listed for applications is August 8, 2025, and the opportunity was created on July 23, 2025. Applicants are expected to plan ahead for required registrations, which can be a major practical hurdle if started late. The NOFO highlights that registration can take six weeks or more and must be completed before submission, and that delays in registration are not accepted as justification for late applications under HHS policy. Organizations must maintain an active System for Award Management (SAM) registration (renewed at least annually). Domestic organizations may need a CAGE code as part of SAM registration, while foreign organizations would typically obtain an NCAGE code for SAM, although foreign organizations are not eligible to apply here. SAM registration generates the Unique Entity Identifier (UEI), and that same UEI must be used consistently across registrations and on the application.

In addition to SAM and UEI, applicants must be registered in eRA Commons and Grants.gov. eRA Commons registration requires the organization to name at least one Signing Official (SO) and to have at least one Program Director/Principal Investigator (PD/PI) account available for submission. Each PD/PI on the application must have an eRA Commons account, and applicants are advised to coordinate early so that any existing accounts are properly affiliated with the applicant organization. The NOFO also points out a common administrative pitfall: if the PD/PI is also the organization Signing Official, they must hold two separate eRA Commons accounts, one for each role. Since obtaining an individual eRA Commons account can take up to two weeks, the administrative setup should be treated as a project prerequisite rather than something to do near the deadline.

Overall, this NOFO is aimed at organizations capable of delivering applied, regulatorily meaningful research outputs that improve how the cardiotoxic effects of oncology therapies are identified and monitored. With a cooperative agreement structure, limited expected awards, and a defined budget ceiling, strong applications are likely to be those that present a clear, actionable plan, demonstrate the ability to produce credible evidence or tools that can be used in safety evaluation contexts, and show readiness to meet the administrative and coordination requirements tied to a U01 award.

• The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Applied Regulatory Science Research to Evaluate Cardiotoxicity of Oncology Therapeutics (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): 93.103.
• This funding opportunity was created on 2025-07-23.
• Applicants must submit their applications by 2025-08-08. (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 $500,000.00 in funding.
• The number of recipients for this funding is limited to 3 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.

Apply for RFA FD 25 015

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