The National Institutes of Health (NIH) is seeking applications for the Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD).
Donor Name: National Institutes of Health (NIH)
State: All States
County: All Counties
Type of Grant: Grant
Deadline: 02/14/2025
Size of the Grant: $320,000 – $2,500,000
Grant Duration: 3 years
Details:
This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) proposing research projects, directed towards commercialization, for the development of novel, evidence-based, FDA-regulated medical products addressing the needs of patients suffering from opioid use disorders (OUD) and/or stimulant use disorders (StUD). Applications received under this FOA may fall within two scientific areas, namely: (1) pharmacotherapeutics (small molecules and biologics) and (2) medical therapeutic and diagnostic devices, including software as a medical device. This FOA strives to contribute to the effort against the national opioid and psychostimulant emergency and offer new medical products for individuals, families, and communities affected by this devastating crisis. Small business companies that developed currently marketed technologies or are developing technologies for different indications and are interested in demonstrating that their FDA-regulated product has a potential application in the OUD/StUD space are encouraged to apply.
- OUD/StUD pharmacotherapeutics – Projects proposed under Area 1 may include but are not limited to developing the following categories of pharmacotherapeutics for OUD/StUD
- Small or large molecule agents.
- Biologics, including antibodies and therapeutic vaccines.
- Natural products.
- Longer-acting formulations of existing addiction medications.
- Longer-acting formulations of agonists or antagonists, e.g., longer-lasting naloxone formulations and new medications.
- Advanced drug delivery systems.
- Development and characterization of biomarkers.
- Medical therapeutic and diagnostic devices, including software as a medical device – Projects proposed under Area 2 may include, but are not necessarily limited to, research and development of the following categories of medical devices:
- Imaging technologies for investigating brain function and enhancing the diagnosis of OUD/StUD.
- Devices that directly diagnose and reduce craving and withdrawal symptoms or increase retention in outpatient therapies.
- Therapeutic devices (e.g., neuromodulation) are intended to improve OUD/StUD treatment outcomes and recurrence prevention.
- Devices, including digital therapeutics, intended to identify and treat newborns exposed to opioids and stimulants, along with other drugs, to improve both short- and long-term developmental outcomes; novel approaches to managing neonatal abstinence syndrome (NAS).
- Devices intended for the treatment of pediatric patients (e.g., neonates, infants, adolescents) including use of extrapolation methods to treat pediatric patients following FDA’s pediatric extrapolation guidance
- Devices, including digital therapeutics, with treatment indications for pregnant mothers suffering from OUD/StUD.
- In vitro diagnostic assays such as Point-of-Care analytical tools for blood, saliva, or urine (e.g., lab-on-a-chip biosensors that allow remote performance of chemical or biological assays outside of a laboratory environment).
- Stand-alone or adjunctive digital therapeutics (e.g., Software as a Medical Device, Software in Medical Device) focused on behavioral health interventions to diagnose, treat, prevent, and mitigate OUD/StUD.
- Devices, including wearables and connected digital therapeutics at point-of-care, intended to detect, diagnose, and treat opioid-induced respiratory depression.
- Data science and cloud-based technologies empowered by artificial intelligence intended to collect, integrate, analyze, and visualize multimodal data related to diagnosis/treatment of OUD/StUD, including disorder progression and risk of recurrence.
- Technologies that integrate sensors, wearables, environmental and social factors to analyze behavior patterns, social interactions, ecological momentary assessment of triggers, and identifying stress responses to personalize just-in-time treatment interventions.
Funding Information
- Total funding support (direct costs, indirect costs, fees) may not exceed $320,000 for Phase I awards and $2,500,000 for Phase II awards.
Period of Performance
- Award periods may not exceed 1 year for Phase I and 3 years for Phase II.
Eligibility Criteria
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:
- Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials, or labor;
- Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture;
- SBIR and STTR. Be a concern that is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), an Indian tribe, ANC or NHO (or a wholly-owned business entity of such tribe, ANC or NHO), or any combination of these; OR
- SBIR-only. Be a concern that is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern, unless that single venture capital operating company, hedge fund, or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States; OR
- SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraphs 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements.
- Has, including its affiliates, not more than 500 employees.
- The hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
- A portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm.
- Private equity firm has the meaning given the term “private equity fund” in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
- Venture capital operating company means an entity described in § 121.103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
- ANC means Alaska Native Corporation.
- NHO means Native Hawaiian Organization.
For more information, visit Grants.gov.
