Supports rigorous development and validation of DHT-derived biomarkers and/or clinical outcome assessments for remote monitoring as future clinical trial endpoints, tested across three or more diseases/conditions, with required PWLE (people with lived experience) input and a staged UG3→UH3 milestone-gated plan.
Eligibility Criteria:
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Applicant types: Higher-ed institutions, nonprofits, small/for-profit businesses, eligible governments/tribal/regional/community organizations; certain federal entities; U.S. territories.
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Foreign organizations: Not eligible. Foreign components of U.S. organizations are allowed.
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PD/PI: eRA Commons account required; multiple PD/PI allowed.
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Key requirements:
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Include ≥3 diseases/conditions and a clear “Contexts of Use.”
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Partner with patient advocacy groups and PWLE.
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Provide Community Engagement Plan, Team Management Plan, Timeline with quantitative Go/No-Go milestones, and DMS Plan.
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Use existing DHT platforms (not device/app invention projects).
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Contact NIH program staff ≥6 weeks before submission if requesting ≥500,000 USD direct costs in any year (excl. consortium F&A).
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Registrations: SAM (UEI/CAGE), eRA Commons, Grants.gov.
Funding Details:
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Activity code: UG3/UH3 phased cooperative agreement; clinical trial optional.
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Budget: Not limited; must reflect actual needs.
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Project period: Up to 5 years total (UG3 1–2 years; UH3 3–4 years).
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Mechanism: Milestone-driven transition from UG3 to UH3 after administrative review.
Deadline:
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Due dates (by 5:00 PM local time):
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February 20, 2026 (Jul 2026; Oct 2026; Dec 2026)
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June 22, 2026 (Nov 2026; Jan 2027; Apr 2027)
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Where to go for further information: