The Focused Technology Research and Development (R01 Clinical Trial Not Allowed) program, issued by the National Institute of General Medical Sciences (NIGMS), seeks innovative projects that focus on the development of tools and technologies with the potential to advance biomedical research. This funding opportunity is not for clinical trials but supports creating and validating working prototypes for novel technologies. Applications must demonstrate proof-of-concept and focus on overcoming significant technical hurdles to develop tools with broad utility in biomedical research.

The program supports the development of laboratory instruments, algorithms, software, chemical reagents, or biological systems modified for research purposes. It emphasizes innovation over incremental improvements and encourages technologies that promise transformative impacts on biomedical research. Applicants are required to demonstrate the potential utility of their technologies in broad scientific contexts without addressing specific biological questions, as such proposals will be administratively withdrawn.

NIGMS anticipates funding projects of varying scope, with budgets reflecting actual needs. While there is no budget cap, applications requiring more than $500,000 in direct costs annually must secure prior approval. The maximum project period is five years, although most awards will be limited to four years. The program prioritizes early-stage investigators and includes a single renewal opportunity for funded projects. Submission cycles occur three times annually, with deadlines on February 5, June 5, and October 5 through January 2028.

Eligible applicants include higher education institutions, nonprofits, for-profits, state and local governments, and other entities, though foreign institutions are not eligible. Collaborative projects with diverse expertise are encouraged. Applicants must adhere to NIH data management and sharing policies, ensuring transparency and accessibility of generated data and resources. Compliance with all registration and submission requirements, including SAM.gov and eRA Commons, is mandatory.

The review process evaluates significance, innovation, approach, and feasibility, with a focus on the transformative potential of the proposed technology. Applicants are encouraged to consult NIGMS contacts before submission to confirm project alignment with program goals. Applications are reviewed for scientific merit by NIH peer review panels, with funding decisions based on priority scores, program relevance, and availability of funds.

The program supports transformative technological advancements in biomedical research, fostering tools and methods that expand scientific inquiry. Applicants with innovative ideas aligned with NIGMS priorities are encouraged to apply and leverage this opportunity to contribute significantly to the scientific community.