Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional

The funding opportunity titled Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional is offered by the Food and Drug Administration within the U.S. Department of Health and Human Services. The FDA is responsible for protecting public health by ensuring the safety and efficacy of drugs, biological products, and medical devices. Through this cooperative agreement program, the agency seeks to advance regulatory science and innovation by supporting research that integrates digital health technologies into clinical investigations. The purpose of this funding opportunity is to address the use of digital health technologies for remote data acquisition in clinical investigations that support drug and biological product development. The program aims to improve the efficiency, quality, and accessibility of clinical trials by leveraging tools such as wearable devices, mobile applications, and remote monitoring systems. These technologies can enable continuous data collection, enhance patient engagement, and reduce the burden of in-person visits, thereby modernizing traditional clinical trial methodologies. Funding is provided through a cooperative agreement mechanism, indicating substantial involvement from the FDA in the funded projects. The expected number of awards is two, with an award ceiling of 1100000 dollars per project. While the total program funding is not specified, the structure suggests significant investment in a small number of high-impact research initiatives. There is no cost sharing or matching requirement, allowing applicants to focus fully on the proposed research activities without needing to secure additional financial contributions. Eligibility for this opportunity is broad and inclusive, encompassing state and local governments, tribal governments and organizations, institutions of higher education, nonprofit organizations with or without 501c3 status, small businesses, and for profit organizations. This wide eligibility scope reflects the interdisciplinary nature of digital health research and encourages collaboration across academic, governmental, and private sector entities. Applications must be submitted through the Grants.gov system by the stated deadline of August 20, 2026. The opportunity was posted on July 20, 2026, providing a one month application window. The notice does not specify pre application requirements such as letters of intent, nor does it outline detailed application components within the summary. However, standard federal grant submission procedures apply, including registration in required systems and completion of all forms within the application package. Evaluation of applications is expected to align with FDA priorities in regulatory science, focusing on the feasibility, innovation, and potential impact of proposed digital health solutions in clinical research. Although specific review criteria are not detailed in the summary, applicants should anticipate rigorous scientific and technical review processes typical of federal research funding opportunities. Award notifications and project timelines are not explicitly stated but are generally consistent with federal grant cycles. For additional information or assistance accessing the full announcement, applicants may contact Patrick Johnson at the Food and Drug Administration. The opportunity is not indicated as recurring, and therefore applicants should treat this as a single cycle funding opportunity with a firm deadline. The archive date of September 19, 2026 indicates when the opportunity will no longer be accessible for application purposes.