The U.S. Food and Drug Administration (FDA) is offering funding opportunities through its Drug Development Tools Research Grants (U01) program, with the aim of supporting the advancement of drug development tools (DDTs). These tools are methods, materials, or measures that can accelerate drug development and improve regulatory reviews. The program seeks to fill unmet needs in drug development by making qualified DDTs publicly available for broader use. The opportunity is open to projects that have an accepted or reviewable Letter of Intent (LOI) under the FDA’s DDT Qualification Program, managed by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

The purpose of this funding is to assist researchers in advancing their DDT projects, focusing on achieving specific milestones such as submitting a Qualification Plan (QP) or Full Qualification Package (FQP) to the FDA. Applicants are encouraged to target gaps in their development plans to ensure timely progress toward FDA qualification. Examples of DDTs include biomarkers for clinical trials, clinical outcome assessments, or animal models for testing under regulatory frameworks. Qualified DDTs can be used without further validation in investigational or new drug applications, thereby optimizing the drug development process and benefiting public health through faster access to effective treatments.

Funding for this opportunity will be provided as cooperative agreements, which means that the FDA will play a significant role in guiding and monitoring the funded projects. Awards will cover a one-year project period with a budget of up to $250,000 per year, with a potential two-year extension if well-justified. The total project budget should not exceed $500,000 for two years. The FDA expects to award up to six grants annually, subject to available funding and the quality of applications. Applicants must tailor their project scope to fit the grant’s limited timeframe and funding, focusing on achievable objectives like addressing FDA feedback or completing essential components of the statistical analysis plan.

Eligibility is open to a broad range of organizations, including public and private higher education institutions, nonprofits, for-profit entities, and various levels of government. The program encourages participation from minority-serving institutions, such as Historically Black Colleges and Universities (HBCUs), and community-based organizations. However, foreign organizations are not eligible. Applicants must have an active registration with the System for Award Management (SAM) and other required federal systems, including eRA Commons and Grants.gov.

Applications are due by May 13, 2024, with another opportunity to apply in 2025. Submissions must be made through the NIH ASSIST system, institutional system-to-system solutions, or Grants.gov Workspace. Compliance with the detailed application instructions is critical, and errors or non-compliance may lead to delays or rejection of the application. Additionally, applicants must use the correct DDT submission number in the project title.

The evaluation of applications will focus on several key criteria: public health impact, alignment with the FDA’s DDT Qualification Program, the feasibility of the research approach, and the qualifications of the investigative team. Projects will also be assessed for their potential to overcome existing barriers in drug development and regulatory review. While the program does not require cost-sharing, applicants must ensure that their project budget aligns with the outlined funding limits and policies.

Funding decisions will be based on scientific merit, alignment with program priorities, and the availability of funds. The earliest start date for projects funded under this opportunity will be July 2024.