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

The purpose of this Notice of Funding Opportunity (NOFO) is to address topics related to the use of digital health technologies (DHTs) for remote data acquisition in clinical investigations to support drug development.

Program Details

Food and Drug Administration is a federal agency that offers the Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional grant program to support eligible programs and projects. This funding opportunity is available nationally and is administered by Food and Drug Administration through Grants.gov. Organizations seeking funding for eligible programs and projects should review the details below and confirm their eligibility before preparing an application.

Eligibility

Eligible applicants include government agencies and municipalities, eligible organizations, for-profit businesses, and nonprofit organizations. Organizations that meet the eligibility criteria are encouraged to apply and to review the full program guidelines before submission. Because eligibility rules and funding priorities can change between cycles, applicants should always confirm the current requirements with Food and Drug Administration or on Grants.gov before investing time in an application.

Funding and Timeline

Funding available: $0 – $1.1M. The application deadline is August 20, 2026 (30 days remaining). Applicants should allow sufficient time to gather required documentation, including organizational information, project descriptions, budgets, and supporting materials as specified in the program guidelines. Submitting a complete application well ahead of the deadline reduces the risk of disqualification on technical or administrative grounds.

Program Focus

This grant supports eligible programs and projects. This grant is associated with NAICS industry classifications: 541714, 325412. Organizations operating in these sectors are encouraged to review eligibility. Funded projects are expected to demonstrate measurable outcomes aligned with the program's stated objectives. Grant recipients may be required to submit progress reports and final evaluations as a condition of the award, and to retain records for audit and compliance purposes.

How to Apply

Eligible organizations can apply through Grants.gov. Create a free organization profile on GrantRegister to see whether this grant matches your organization's NAICS code, entity type, location, and focus area, and to receive a weekly digest of every open grant you qualify for.

GrantRegister maintains a complete, authoritative registry of US federal, state, and foundation grant opportunities — matched automatically to your organization profile and delivered every Monday.

Eligibility

• Funded by FDA

Award details

Award range: $0 – $1.1M. Applications close on August 20, 2026 (30 days remaining).

Categories

Not categorized