Addressing Challenges in Detecting New Drugs: Instrumentation for Alternative Analytical Methods (R41/R42 - Clinical Trials Optional)

The National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA) has announced a funding opportunity (RFA-DA-26-019) aimed at encouraging small business entities to develop affordable, sensitive, and selective instruments capable of detecting both known and novel drugs with minimal training requirements. This funding initiative, titled “Addressing Challenges in Detecting New Drugs: Instrumentation for Alternative Analytical Methods,” is an R41/R42 Small Business Technology Transfer (STTR) grant that supports Phase I projects and includes an optional Fast-Track option for rapid Phase I and Phase II funding. The overarching goal of the grant is to create field-deployable devices that would lower the barriers to drug detection and quantification, providing an alternative to complex, costly methods like liquid chromatography-mass spectrometry (LC-MS), which is currently the standard. The RFA specifically seeks innovative, target-agnostic technologies that do not rely on affinity-based recognition methods, such as antibodies, but rather detect drugs based on physical or chemical properties, such as absorption spectra, Raman scattering, or density. These devices should offer comparable sensitivity and selectivity to LC-MS, while drastically reducing costs and operational complexities. Ideal proposals will include systems that can perform analyses quickly (under one hour) and require minimal consumables, making them viable for use in settings with limited budgets, such as emergency departments, harm reduction centers, and public health labs. Additionally, the devices should enable straightforward updates to add new drugs to detection libraries and possess the capability to analyze samples from various matrices, including urine, blood, saliva, and other biological materials. The STTR Phase I funding available for this opportunity is capped at $306,872, while Phase II funding (for Fast-Track applications) can request up to $2,045,816. The Phase I project period is limited to one year, and Phase II, if pursued, may extend up to two years. NIDA expects to fund between four and seven awards under this RFA, with a total anticipated budget of $3 million, contingent upon the availability of funds and the quality of applications. Small businesses applying for the Phase I award are expected to demonstrate the technical feasibility of the proposed technology, while Fast-Track applications should provide measurable, achievable milestones for both phases, detailing a go/no-go decision for advancing from Phase I to Phase II. Eligibility for this grant is limited to U.S.-based small business concerns (SBCs), which must meet specific ownership and size criteria as outlined by the Small Business Administration. Non-U.S. entities and components are not eligible. Additionally, Phase I applications must show a Phase I to Phase II transition rate benchmark, while Phase II applicants must meet commercialization benchmarks, ensuring the development of products with viable market potential. Applications that focus on traditional affinity-based detection technologies, such as antibody-based testing, will not be considered. The application process requires adherence to NIH’s Small Business Technology Transfer (B) instructions, with all submissions due by 5:00 PM local time on February 19, 2025. Applications should be submitted through NIH ASSIST, institutional system-to-system solutions, or Grants.gov Workspace. Applicants must ensure they meet all required registrations in advance, including those with the System for Award Management (SAM), Small Business Administration (SBA), eRA Commons, and Grants.gov. NIDA encourages early submission to avoid last-minute technical issues. Evaluation criteria for this grant include the significance and commercial potential of the proposed technology, qualifications and expertise of the research team, innovation, and approach. For Fast-Track applications, NIDA will assess whether applicants have articulated clear milestones for both the technical development and commercialization phases, including a comprehensive commercialization plan. Additionally, reviewers will examine the feasibility and resources available to execute the project, as well as any associated risks with achieving technical and commercial viability. Award announcements for successful applicants are expected in December 2025. Following selection, awardees will adhere to NIH’s data management and sharing policies and must report on project performance annually. Additionally, compliance with the NIH Grants Policy Statement, HHS regulations, and the terms and conditions specified in the Notice of Award will be mandatory.