Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional
🏛 Food and Drug Administration (HHS-FDA)
✓ Free, no account · Source: Grants.gov · Last verified Jul 20, 2026
Can you apply?
This grant is for organizations researching digital health technologies in clinical investigations. Eligible applicants typically include research institutions, academic medical centers, biotech companies, and pharmaceutical manufacturers. The grant supports clinical trials using remote data collection and digital health tools for drug and biological product development. Funding is national in scope.
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Program 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.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (Application for Federal Assistance)
- Project Narrative/Research Plan
- Budget and Budget Justification
- Organizational Capability Statement
- Biosketches (key personnel)
- Letters of Support/Commitment
Program contact
- 👤 Stephanie Bogan Grantor
- 📧 patrick.johnson@fda.hhs.gov
- 📞 3018276802
Funding track record
Recent awards under CFDA 93.103 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$121,795,918
-
$76,105,626
-
$50,217,964
-
$47,940,304
-
$36,000,000
-
$35,573,997
-
$35,391,995
-
$30,732,300
-
$23,332,999
-
$21,347,288
Top States by Funding
- AZ 3 awards $131.4M
- MD 7 awards $108.7M
- CA 9 awards $106.5M
- VA 5 awards $96.6M
- PA 10 awards $77.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.103). How funding has trended year over year.
| 2016 | $170,482,435 | |
| 2017 est. | $208,900,832 | |
| 2018 | $173,077,408 | |
| 2019 | $198,507,896 | |
| 2020 | $212,448,590 | |
| 2021 | $218,918,739 | |
| 2022 est. | $255,910,458 | |
| 2023 est. | $246,894,600 |
FAQ
Who can apply for this grant?
Academic institutions, research organizations, biotech/pharma companies, and medical device manufacturers. Organizations must have the capacity to conduct clinical research.
What does the grant fund?
Clinical investigations using digital health technologies for remote data collection. Emphasis is on supporting drug and biological product development efforts.
What is the deadline?
August 20, 2026. Applications must be submitted by this fixed deadline.
What makes an application competitive?
Strong scientific rationale for DHT use, feasibility of remote data collection, relevant preliminary data, and realistic budgets. Clearly defined clinical trial protocols strengthen proposals.
What is the typical award amount?
The grant typically provides around $1.1 million. Budget requests should align with project scope and complexity.
💡 Tips for applicants
- Focus on the innovation of your digital health technology and how it improves data quality in clinical settings.
- Include realistic timelines and milestones for technology implementation and patient enrollment.
- Demonstrate prior experience with remote clinical data collection or pilot testing of your DHT.
- Clearly describe data security, privacy protections, and FDA regulatory compliance.
- Address patient and site burdens; explain how your DHT actually reduces participant burden.
⚠️ Common mistakes
Vague descriptions of DHT functionality or insufficient justification for technology choice. Underestimating data management, IT infrastructure, and regulatory compliance requirements. Failing to address data validation and interoperability with existing clinical systems.
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