Applied Regulatory Science Research to Evaluate Cardiotoxicity of Oncology Therapeutics (U01) Clinical Trial Optional

The U.S. Food and Drug Administration (FDA), through its Oncology Center of Excellence (OCE), is offering funding under the opportunity titled “Applied Regulatory Science Research to Evaluate Cardiotoxicity of Oncology Therapeutics (U01).” This Notice of Funding Opportunity (NOFO), RFA-FD-25-015, aims to support applied regulatory science research that seeks to improve the detection and monitoring of cardiotoxicity associated with oncology therapeutics. This effort is aligned with OCE's mission to foster the development of safe and effective cancer therapies, particularly as many newer treatments, including immunotherapies and targeted agents, carry potential cardiovascular side effects that may not be well understood. The program seeks research proposals that address defined gaps in understanding and mitigating cardiotoxicity. Key focus areas include standardizing definitions and grading for various cardiotoxic effects, developing predictive models, optimizing biomarkers and imaging techniques, and establishing both early and long-term monitoring strategies. Projects that propose novel uses of existing technologies or implementation within observational or interventional trials are encouraged. However, the primary goal should not be the development of a specific therapeutic product or new technology. Collaborative efforts and contributions to public cardiotoxicity data repositories are also encouraged to enhance broader impact. Eligible applicants include a wide range of U.S.-based entities such as higher education institutions, nonprofits, state and local governments, for-profit entities (including small businesses), and tribal organizations. Non-U.S. organizations and foreign components are not eligible. Institutions must ensure compliance with all federal registration requirements (SAM, Grants.gov, eRA Commons, etc.), and principal investigators must have an eRA Commons ID. Individuals proposing the project must demonstrate strong administrative and scientific leadership in the relevant field. Applications must be submitted through one of three methods: NIH’s ASSIST platform, Grants.gov Workspace, or an institutional system-to-system (S2S) submission portal. The application window opens July 23, 2025, and closes August 8, 2025, at 11:59 PM Eastern Time. Late submissions will not be accepted. There is no requirement for a letter of intent or AIDS-specific application window for this opportunity. Conformance to all application instructions outlined in the Research (R) Instructions and the NOFO is mandatory. Funding under this NOFO is provided via a cooperative agreement, which includes substantial FDA involvement throughout the research project. The OCE intends to commit up to $1.5 million in fiscal year 2025, supporting one to three awards. Each project may receive up to $500,000 per year for a period of up to three years, contingent upon annual appropriations, funding availability, and satisfactory performance. No cost-sharing or matching requirements are in place. Scientific merit will be evaluated based on criteria including significance, investigator expertise, alignment with FDA program goals, research approach and innovation, and the strength of the research environment. Reviewers will assess protection of human subjects and vertebrate animals, data sharing, project timeline, budget justification, and any biohazard concerns. Contact for scientific inquiries is Dr. Rebekah Zinn (Rebekah.Zinn@fda.hhs.gov), and grants management contact is Patrick Johnson (patrick.johnson@fda.hhs.gov). Awards will be issued upon successful review, and semi-annual progress reports and final closeout reporting will be required.

Applicants are advised to apply early to allow time to correct any submission errors. Projects must align with regulatory science goals and avoid proposing new therapeutic or technology development.