Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional | RFA FD 26 012

Opportunity Information: Apply for RFA FD 26 012

The FDA funding opportunity titled "Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional" (Funding Opportunity Number RFA-FD-26-012; CFDA 93.103) is a discretionary cooperative agreement program designed to advance how digital health technologies (DHTs) are used to collect data remotely during clinical investigations that support drug and biologic product development. In practical terms, the NOFO is aimed at improving the evidence base, methods, and operational approaches for using tools like connected sensors, wearable devices, mobile apps, and other digitally enabled measurement systems to capture clinically relevant information outside of traditional research sites. The overarching goal is to address key challenges and knowledge gaps that can limit the reliability, interpretability, and regulatory usefulness of remotely acquired digital data in studies intended to inform product development decisions.

This opportunity uses the U01 cooperative agreement mechanism, meaning awardees should expect substantial involvement from the FDA during the project period. Unlike a standard research grant where the funded team largely drives the work independently, a cooperative agreement typically involves close coordination with the agency on technical direction, milestones, and deliverables. The NOFO is labeled "Clinical Trials Optional," which means applicants may propose projects that include clinical trials, but they are not required to do so; projects can also focus on methodological research, validation work, standards development, analytics, protocol design, operational infrastructure, or other study types that strengthen the use of DHTs in clinical investigations.

Eligibility is broad and includes many public and private entities. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education where applicable); for-profit organizations (other than small businesses); and small businesses. This wide eligibility reflects the multidisciplinary nature of digital health work, where progress often depends on collaboration between academia, health systems, technology developers, nonprofit research groups, and industry.

The NOFO sits within the FDA's broader interest in enabling modernized clinical investigations, particularly where remote and decentralized approaches can make studies more efficient, more inclusive, and more reflective of real-world settings. Remote data acquisition using DHTs can reduce the burden of frequent site visits, potentially increase participation from people who live far from research centers or who have mobility and scheduling constraints, and allow for continuous or higher-frequency measurement of outcomes that are difficult to capture during episodic clinic visits. At the same time, the FDA is signaling that important scientific and operational questions remain, such as how to ensure that DHT-derived endpoints are accurate and clinically meaningful, how to manage data quality and missingness in real-world use, how to validate devices and algorithms across diverse populations and settings, and how to maintain privacy, cybersecurity, and appropriate governance over large streams of sensitive health data.

Funding details indicate an award ceiling of $1,100,000, with an expectation of making 2 awards. The original application closing date listed is August 20, 2026, and the opportunity was created on July 20, 2026. The activity category is listed under Agriculture, Consumer Protection, Food and Nutrition, consistent with FDA program classification even though the scientific focus is on digital measurement in clinical research to support drug and biologic development.

In summary, RFA-FD-26-012 is a targeted FDA cooperative agreement opportunity aimed at strengthening the scientific foundations and practical implementation of digital health technologies for remote data capture in clinical investigations. It supports work that can make DHT-generated data more trustworthy and usable for drug and biologic development, while also encouraging approaches that may broaden access to research participation and improve the efficiency and relevance of clinical studies.

• The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
• This funding opportunity was created on 2026-07-20.
• Applicants must submit their applications by 2026-08-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $1,100,000.00 in funding.
• The number of recipients for this funding is limited to 2 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, 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, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses.

Apply for RFA FD 26 012

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