The Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional, offered by the U.S. Food and Drug Administration (FDA), supports research projects that explore the role of digital health technologies (DHTs) for remote data acquisition in clinical investigations to support drug development. The overarching goal is to advance DHTs for clinical drug development, expand the ability to capture early manifestations of chronic diseases, determine outcomes in populations with unmet medical needs, and enhance convenience for trial participants by allowing for remote data acquisition.

Overview

This funding opportunity is issued under the Prescription Drug User Fee Act VII (PDUFA VII) commitment letter, which includes goals relating to the use of DHTs to support drug development and review. A DHT is a system that uses computing platforms, connectivity, software, and/or sensors for health care and related uses. Projects may involve engagement with researchers from academia, the biopharmaceutical industry, patient groups, and other stakeholders. The participating organizations are the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).

Research Areas and Activities

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 Benefits

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:

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

Application Process

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 program-specific instructions deviate from those in the How to Apply - Application Guide, applicants must follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review. A Letter of Intent is not applicable.

Deadline and Timeline

Posted Date: July 20, 2026

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

Application Due Date: August 20, 2026

All applications are due by 11:59 PM local time of the applicant organization. No late applications will be accepted. The expiration date for this opportunity is August 21, 2026.

Contact Information

Grantor: Stephanie Bogan

Contact: Patrick Johnson

Email: patrick.johnson@fda.hhs.gov

Phone: 301-827-6802