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RFA-FD-26-012

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)

Up to $1,100,000
Due Aug 20, 2026(30d left)
At a glance
Moderate Complexity

This grant is for projects that explore how digital health technologies can be used to collect data remotely in clinical trials, which helps in the development of new drugs and biological products. It's about using tech to make drug development more efficient and effective.

Who it's for: This grant is open to a wide range of applicants, including government entities, nonprofits, for-profit organizations, educational institutions, and individuals. If you're involved in clinical research or digital health technology, this could be for you.

More details

Likely Disqualifiers

  • Ineligible organization type
  • Incomplete application
  • Missing required documents
  • Application submitted after the deadline
  • Non-compliance with grant guidelines

What You May Need

  • Detailed project proposal
  • Budget plan
  • Proof of eligibility
  • Organizational background
  • Letters of support or collaboration
  • CVs of key personnel
  • Data management plan
  • Ethical approval documentation
  • Registration in federal grant systems
  • Past performance documentation

Cautions

  • Ensure all parts of the application are complete
  • Adhere to the budget limitations
  • Follow ethical guidelines for clinical research
  • Be clear about the use of digital technologies
  • Submit before the deadline

Generated from official source details for readability

Eligibility

Eligible Applicant Types

Individuals
Tribal Gov
County Gov
Tribal Org
School Districts
Private Higher Ed
Nonprofit
For-Profit
City/Township
Special District
Public Higher Ed
State Gov
501(c)(3)

Additional Criteria

Eligible applicants include city or township governments, nonprofits without 501(c)(3) status, for-profit organizations, other Native American tribal organizations, county governments, independent school districts, public and state institutions of higher education, nonprofits with 501(c)(3) status, state governments, individuals, private institutions of higher education, special district governments, and federally recognized Indian tribal governments.

Overview

This grant is open to a wide range of applicants, including government entities, nonprofits, for-profit organizations, educational institutions, and individuals. If you're involved in clinical research or digital health technology, this could be for you.

Likely Disqualifiers

  • Ineligible organization type
  • Incomplete application
  • Missing required documents
  • Application submitted after the deadline
  • Non-compliance with grant guidelines

Use of Funds

The funds can be used to support research projects that utilize digital health technologies for data collection in clinical trials. This includes costs related to technology development, data management, personnel, and other research-related expenses.

Expected Awards

2

Cost Sharing

Not Required

Important Dates

Posted
Jul 20, 2026
Deadline
Aug 20, 2026(30 days)
Archive Date
Sep 19, 2026

Application Checklist

0/8 complete
  • Register in federal grant systems (e.g., SAM, Grants.gov)
  • Prepare a detailed project proposal
  • Develop a comprehensive budget plan
  • Gather letters of support or collaboration
  • Compile CVs of key personnel
  • Draft a data management plan
  • Obtain ethical approval documentation
  • Submit application before the deadline

Award Range

$0 - $1,100,000

Deadline

Aug 20, 2026

Official Source

Always review the official grant listing for the most accurate and up-to-date information.

View Official Listing

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