The Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional funding opportunity supports research projects that explore the role of digital health technologies (DHTs) for remote data acquisition in clinical investigations to support drug development.

Overview

This opportunity, issued by the U.S. Food and Drug Administration (FDA), aims to advance the use of DHTs such as actigraphy, photography, and contactless sensors in drug development. Projects may involve engagement with researchers from academia, the biopharmaceutical industry, patient groups, and other stakeholders. The objectives include expanding the ability to capture early manifestations of chronic diseases, determining outcomes in populations with unmet medical needs, and enhancing convenience for trial participants through remote data acquisition.

Research Areas

The scope of this opportunity includes, but is not limited to, projects that focus on:

• Comparing digital measurements to traditional measurements in clinical trials to evaluate drugs
• Developing and evaluating novel endpoints using DHTs to address unmet needs for drug clinical trials (e.g., use of contactless room sensors to capture apnea in pediatric patients)
• Comparing metrics to evaluate continuous measurements (e.g., maximum activity and stamina)
• Capturing early manifestations of chronic diseases (e.g., non-memory related signs of dementia) through the use of DHTs (e.g., tests of balance or slowed reaction time)

Funding and Award Information

Award Ceiling: $1,100,000

Award Floor: $0

Number of Awards: 2

The funding instrument is a cooperative agreement (U01). The assistance listing number is 93.103.

Eligibility

Eligible applicant types include:

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Private institutions of higher education
• Native American tribal governments (Federally recognized)
• Native American tribal organizations (other than Federally recognized tribal governments)
• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
• Small businesses
• For profit organizations other than small businesses
• Public housing authorities/Indian housing authorities

Deadline and Timeline

Posted Date: July 20, 2026

Open Date (Earliest Submission Date): July 20, 2026

Application Due Date: August 20, 2026, by 11:59 PM local time of applicant organization

Expiration Date: August 21, 2026

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. No late applications will be accepted for this Notice of Funding Opportunity.

Application Process

Conformance to all requirements, both in the Research (R) Instructions How to Apply - Application Guide and in the NOFO, is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV of the NOFO. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Contact Information

Grantor: Stephanie Bogan

Contact: Patrick Johnson

Email: patrick.johnson@fda.hhs.gov

Phone: 301-827-6802