Addressing Challenges in Detecting New Drugs: Instrumentation for Alternative Analytical Methods (R43/R44 - Clinical Trials Optional)

The Department of Health and Human Services (HHS), in partnership with the National Institutes of Health (NIH) and the National Institute on Drug Abuse (NIDA), has announced Funding Opportunity Number RFA-DA-26-018 for the development of alternative analytical instrumentation methods to detect emerging drugs with high accuracy and at lower costs than current state-of-the-art methods. This opportunity is aimed at small businesses, encouraging them to develop target-agnostic devices that can detect and quantify both known and unknown drugs with the sensitivity and specificity comparable to liquid chromatography-mass spectrometry (LC-MS), but with significantly reduced initial and operational costs. These devices should ideally be deployable at points of need such as emergency departments, harm reduction centers, and local health departments, which often lack resources for costly, complex LC-MS systems. Eligible projects should focus on creating low-cost, easy-to-use devices that can quickly analyze drug compounds, especially in biological samples like urine, with the potential to extend to matrices such as blood, saliva, and sweat. Possible technologies include, but are not limited to, devices using surface-enhanced Raman scattering (SERS), ion mobility spectrometry, electrochemical detection, or density-based separation. These systems must operate independently of antibody-based recognition, and should facilitate rapid, low-cost analysis while providing quantitative data for unknown drug compounds. The system should also have the capability to integrate new drug detection methods into its existing library as they are identified. This funding is structured through the Small Business Innovation Research (SBIR) program, allowing for various application types, including Phase I, Phase II, Fast-Track, and Direct-to-Phase II. Phase I aims to establish technical feasibility, while Phase II focuses on advancing the technology towards commercialization. Projects may receive up to $306,872 in Phase I and up to $2,045,816 in Phase II, with award periods of 1 year for Phase I and up to 2 years for Phase II. To apply, eligible small businesses must meet specific ownership and operation criteria, including being U.S.-based and primarily owned by U.S. citizens or permanent residents. The primary employment of the Principal Investigator must be with the small business at the time of the award and throughout the project duration. Applicants must also register with SAM.gov, the SBA Company Registry, eRA Commons, and Grants.gov. Phase I applications are limited to businesses with fewer than 500 employees, and those that meet specified commercialization and transition benchmarks may apply for Phase II. Review criteria for the applications include significance, innovation, approach, and commercial potential. NIDA encourages the use of non-stigmatizing language in applications, consistent with person-first language. Awardees must adhere to NIH’s data-sharing and transparency policies, including updated NIH requirements for Data Management and Sharing Plans. Applications are due by February 20, 2025, with an earliest award start date projected for December 2025. For more information, applicants are advised to contact NIH or NIDA program officials.