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

Opportunity snapshot. This Grants.gov announcement - Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional - is cataloged under number RFA-FD-26-012 and tied to CFDA assistance listing 93.103, posted by Food and Drug Administration. Grants.gov currently shows the opportunity as open, first posted on July 20, 2026 and last updated on July 23, 2026. The funding category is Discretionary, delivered as a cooperative agreement.

Award economics. The award range on file is Up to $1,100,000. It expects to issue 2 awards. Cost sharing is not required, so applicants do not need to commit matching funds to be competitive on this opportunity. Federal award ranges are often upper bounds; actual allocations reflect program appropriations, the strength of the applicant pool, and the evaluation committee's scoring.

Deadline and action path. Applications close on August 20, 2026 - roughly 10 days from today. That is a tight window, prioritize SAM.gov registration validation and assemble required documents immediately. Every Grants.gov submission requires an active SAM.gov registration and a Unique Entity ID. Review the Eligibility section below carefully, federal eligibility categories (nonprofit, state or local government, tribal, individual, educational institution, small business) have distinct registration and reporting requirements. Pre-application outreach to the listed agency contact is permitted and often welcomed, it helps clarify scope and scoring priorities. Before acting on the deadline or award figures above, verify them directly on the official Grants.gov listing, amendments can change dates and amounts after this page was last refreshed.