Seeking Products to Address Social Needs impacting Substance Use Disorders (SUD) (R41/R42 Clinical Trial Optional)
ID: RFA-DA-25-047Type: BOTH
Overview

Topic

Seeking Products to Address Social Needs impacting Substance Use Disorders (SUD) (R41/R42 Clinical Trial Optional)

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: STTRPhase: BOTHYear: 2023
Timeline
  1. 1
    Release Sep 28, 2023 12:00 AM
  2. 2
    Open Feb 13, 2024 12:00 AM
  3. 3
    Next Submission Due Mar 13, 2024 12:00 AM
  4. 4
    Close Mar 14, 2026 12:00 AM
Description

The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the development of technologies to address health-related social needs that impact substance use disorders (SUD), excluding alcohol use disorder. The goal is to fill the service gaps that government and the medical community cannot address alone. The technologies should focus on reducing costs, time, and/or increasing access in addressing housing instability, non-medical transportation, food insecurity, utility needs, and personal safety. The products should provide feasible and accessible opportunities for end-users to improve their health-related social needs and SUD outcomes. The solicitation is open for Phase I and Fast-Track (Phase I/Phase II) applications, with a focus on establishing technical feasibility and commercial potential. The application due date is March 13th, 2024, with subsequent due dates in 2025 and 2026. More information can be found on the grants.gov website.

Files
No associated files provided.
Similar Opportunities
Seeking Products to Address Social Needs impacting Substance Use Disorders (SUD) (R41/R42 Clinical Trial Optional)
Active
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the development of technologies to address health-related social needs that impact substance use disorders (SUD), excluding alcohol use disorder. The goal is to fill the service gaps that government and the medical community cannot address alone. The technologies should focus on reducing costs, time, and/or increasing access in addressing housing instability, non-medical transportation, food insecurity, utility needs, and personal safety. The products should provide feasible and accessible opportunities for end-users to improve their health-related social needs and SUD outcomes. The solicitation is open for Phase I and Phase II applications, including Fast-Track applications that combine both phases. The deadline for submission is March 14, 2026. For more information, visit the solicitation agency URL: [link](https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-047.html).
Seeking Products to Address Social Needs impacting Substance Use Disorders (SUD) (R43/R44 Clinical Trial Optional)
Active
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the development of technologies to address health-related social needs that impact substance use disorders (SUD), excluding alcohol use disorder. The goal is to fill the service gaps that government and the medical community cannot address alone. The technologies should focus on reducing costs, time, and/or increasing access in addressing housing instability, non-medical transportation, food insecurity, utility needs, and personal safety. The products should provide feasible and accessible opportunities for end-users to improve their health-related social needs and SUD outcomes. The solicitation is open for Phase I and Phase II applications, including Fast-Track applications. The application due date is March 13th of each year, starting in 2024. For more information, visit the [solicitation link](https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-048.html).
Seeking Products to Address Social Needs impacting Substance Use Disorders (SUD) (R43/R44 Clinical Trial Optional)
Active
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the development of technologies to address health-related social needs that impact substance use disorders (SUD), excluding alcohol use disorder. The purpose of this funding opportunity is to support small business concerns in developing technologies for commercialization that can fill the service gaps in addressing SUD. The research objectives include developing products that reduce costs, time, and increase access in addressing health-related social needs such as housing instability, non-medical transportation, food insecurity, utility needs, and personal safety. The technologies can include physical devices, digital services, software, or non-physical/non-tangible products. The funding opportunity is open for applications until March 14, 2026, and offers both Phase I and Phase II funding options. Phase I focuses on establishing technical merit and feasibility, while Phase II aims to advance technologies towards commercialization. Applicants are encouraged to review the guidelines and adhere to the requirements applicable to their research.
Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R41/R42 Clinical Trial Optional)
Active
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the development of regulated therapeutic and diagnostic solutions for patients affected by opioid and/or stimulants use disorders (OUD/StUD). The current drug crisis surrounding OUD/StUD is a significant issue, with over 100,000 overdose deaths reported in a one-year period. The goal of this solicitation is to offer new medical products that can monitor, diagnose, and treat patients suffering from these disorders. The solicitation is open to small business companies that have developed or are developing FDA-regulated products for different indications and are interested in demonstrating their potential application in the OUD/StUD space. The research and development activities may fall into two areas: pharmacotherapeutics (small molecules and biologics) and medical therapeutic and diagnostic devices, including software as a medical device. The proposed projects should aim to address the needs of patients suffering from OUD/StUD and may include activities such as target identification, lead optimization, preclinical studies, formulation development, and clinical trials. The funding for these projects will be provided through the Small Business Innovation Research (SBIR) program, with Phase I and Phase II funding available. The application due dates are August 15, 2023, February 14, 2024, August 13, 2024, and February 14, 2025. For more information and to apply, interested parties can visit the grants.gov website or the solicitation agency URL provided.
Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R41/R42 Clinical Trial Optional)
Active
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the development of regulated therapeutic and diagnostic solutions for patients affected by opioid and/or stimulant use disorders (OUD/StUD). The current drug crisis surrounding these disorders has resulted in a significant number of deaths and an urgent need for comprehensive solutions. The solicitation is focused on the research and development of medical products regulated by the U.S. Food and Drug Administration (FDA), including pharmacotherapeutics and medical therapeutic and diagnostic devices. In the area of pharmacotherapeutics, the solicitation encourages the development of small or large molecule agents, biologics, natural products, longer-acting formulations of existing addiction medications, advanced drug delivery systems, and the development and characterization of biomarkers. Proposed activities may include target identification, assay development, lead optimization, preclinical studies, formulation development, and process development. The ultimate goal is to file an Investigational New Drug (IND) application and conduct clinical studies to support the filing of a New Drug Application (NDA) or a Biological License Application (BLA). In the area of medical therapeutic and diagnostic devices, the solicitation seeks research and development of imaging technologies, devices for diagnosing and reducing craving and withdrawal symptoms, therapeutic devices, devices for treating pediatric patients, in vitro diagnostic assays, digital therapeutics, devices for detecting and treating opioid-induced respiratory depression, and data science and cloud-based technologies. Proposed activities may include studies supporting an Investigational Device Exemption application, process development, non-clinical safety studies, clinical trials, and engagement with the FDA Center of Devices and Radiological Health. The goal is to successfully file an FDA premarket application for clearance/approval. The solicitation is open for applications and offers funding for Phase I, Phase II, and Fast Track projects. Phase I aims to establish the technical merit and feasibility of the proposed research, while Phase II continues the R&D efforts to advance the technology toward commercialization. Fast Track applications combine Phase I and Phase II into one application to reduce or eliminate the funding gap between phases. Small businesses that have received Phase I STTR awards are eligible to submit Phase II applications as "Renewal" applications.