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U.S. Food and Drug Administration·United States of America

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

Closes 8/20/2026$1.1MGrants Notice
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Description

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. The opportunity is seeking applications that propose to use DHTs to improve the efficiency and effectiveness of clinical investigations. The scope of work includes the development and validation of DHTs for use in clinical investigations, as well as the evaluation of the impact of DHTs on clinical investigation outcomes. • The opportunity is open to a variety of applicant types, including public and state controlled institutions of higher education, independent school districts, nonprofits, and for-profit organizations. • The award ceiling is $1,100,000, and the award floor is $0. • The opportunity is expected to fund 2 awards. • The application deadline is August 20, 2026.

Attached files

The solicitation documents live at the source — open the bid source above to download them.

Contact

Patrick Johnson(Grants Management Contact)

[email protected]

(301) 827-6802

Key dates

Opened
7/20/2026
Closes
8/20/2026
Duration
2 years

Last updated

Details

Type
Grants Notice
Industry
Healthcare and Medical Services
NAICS
541710
Solicitation №
RFA-FD-26-012

Budget estimate

$0 – $1,100,000

The budget for this opportunity is estimated to be between $0 and $1,100,000, with an expected award of 2 awards. The budget is influenced by the scope of work, which includes the development and validation of digital health technologies for use in clinical investigations, as well as the evaluation of the impact of digital health technologies on clinical investigation outcomes. The award amount is expected to be sufficient to support the proposed research activities.

AI estimate from the solicitation

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