Funder: National Institutes of Health
Due Dates: July 14, 2025 (Earliest submission) | August 13, 2025 (Application) | December 18, 2025 (Application) | August 13, 2026 (Application)
Funding Amounts: Up to $500,000 direct costs/year for UG3 phase (2 years); UH3 phase (up to 3 years) not limited but must reflect project needs.
Summary: Supports phased development and testing of device-based treatments for Substance Use Disorders, advancing toward FDA approval.
Key Information: UG3/UH3 phased award; clear, quantifiable milestones required; clinical trial optional; broad eligibility including foreign organizations.
Description
This opportunity, offered by the National Institute on Drug Abuse (NIDA) at NIH, aims to accelerate the development of neuromodulatory or neurophysiological devices as treatments for Substance Use Disorders (SUDs). The program supports both pre-clinical and clinical research, including the adaptation of existing devices or the development of new ones, with the ultimate goal of progressing these devices toward FDA approval for SUD indications.
The funding mechanism is a phased UG3/UH3 cooperative agreement. The UG3 phase (up to 2 years) supports milestone-driven early development, while the UH3 phase (up to 3 years) provides additional support for projects that meet UG3 milestones, enabling further clinical validation and regulatory advancement.
Due Dates
- Earliest Submission Date: July 14, 2025
- Letter of Intent: 30 days prior to application due date (recommended, not required)
- Application Deadlines:
- August 13, 2025 (New, Renewal, Resubmission, Revision)
- December 18, 2025 (New, Renewal, Resubmission, Revision)
- August 13, 2026 (New, Renewal, Resubmission, Revision)
- Expiration Date: August 14, 2026
All applications are due by 5:00 PM local time of the applicant organization.
Funding Amount
- UG3 Phase: Up to $500,000 direct costs per year, for up to 2 years.
- UH3 Phase: Up to 3 additional years; no specific budget cap, but budgets must be justified by project needs.
- Project Duration: Maximum 5 years (2 years UG3 + 3 years UH3).
- Funding Instrument: Cooperative Agreement (substantial NIH programmatic involvement).
Eligibility
Eligible applicants include:
- Public/State and Private Institutions of Higher Education
- Nonprofits (with or without 501(c)(3) status)
- For-profit organizations (including small businesses)
- State, county, city, township, and special district governments
- Independent school districts
- Public housing authorities/Indian housing authorities
- Native American tribal governments and organizations (federally recognized and other)
- Faith-based and community-based organizations
- Regional organizations
- U.S. territories and possessions
- Eligible agencies of the federal government
- Non-domestic (non-U.S.) entities (foreign organizations) and foreign components of U.S. organizations
Note: Applicant organizations may submit more than one application, provided each is scientifically distinct.
Application Process
- Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
- Required Registrations: All applicant organizations must have active registrations in SAM, Grants.gov, and eRA Commons. PDs/PIs must have an eRA Commons account.
- Letter of Intent: Email to NIDALetterofIntent@mail.nih.gov (optional but encouraged).
- Application Forms: Use the SF424 (R&R) forms and follow the NIH Research Application Guide.
- Page Limits: Follow the NIH Table of Page Limits.
- Milestones: Applications must include clear, quantifiable milestones for the UG3 phase and a plan for transition to UH3.
- Clinical Trials: Optional; both clinical trial and non-clinical trial applications are accepted.
Additional Information
- Scope: Research may focus on new devices or repurposing existing devices for SUDs, including mechanistic studies.
- Device Types: Includes, but is not limited to, transcranial magnetic stimulation, direct current stimulation, vagal stimulation, deep-brain stimulation, focused ultrasound, and other neuromodulatory or neurophysiological devices.
- Regulatory Pathway: Applicants must address the FDA regulatory pathway, including plans for IDE (Investigational Device Exemption) if applicable.
- Data Management: All applications must include a Data Management and Sharing Plan.
- Non-Responsive Applications: Projects that do not propose a device-based intervention for SUDs, lack quantifiable milestones, or focus solely on alcohol use disorder are not responsive.
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