Mechanism for Time-Sensitive Substance Use Research (R21 Clinical Trial Optional)

The National Institute on Drug Abuse (NIDA) has issued the FY2025 Notice of Funding Opportunity (NOFO) for the Mechanism for Time-Sensitive Substance Use Research (R21), an exploratory/developmental grant program to support research in priority areas addressing time-sensitive substance use issues. This funding opportunity (PAR-24-298) is designed to facilitate pilot and feasibility studies on emergent substance use topics, particularly those that require an accelerated review and funding process. Specific areas of interest include responses to sudden and severe drug use issues (e.g., spikes in opioid overdoses), shifts in drug policies, time-sensitive healthcare or criminal justice system changes related to substance misuse, early implementation of new substance use policies or payment models, and the impacts of natural disasters on drug markets and substance use outcomes. Applicants must demonstrate that their proposed research meets the “time-sensitive” criterion, meaning it addresses an issue that cannot wait for the typical NIH funding cycle due to urgency, such as imminent policy changes or rapidly emerging substance use crises. Projects that are responsive to this NOFO must focus on immediate needs that can contribute to broader substance use understanding beyond a single locality. Collaborative projects involving researchers and public partners, such as local health departments, community health centers, criminal justice settings, and school systems, are encouraged to ensure relevance and practicality in real-world settings. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, government entities (local, state, tribal), and other eligible U.S.-based entities. However, foreign institutions and components are not eligible. Applicants may request up to $275,000 in direct costs over a two-year period, with a maximum of $200,000 allowed in any single year. This NOFO does not require cost-sharing, and organizations may submit multiple applications, provided each is scientifically distinct. To apply, organizations must be registered in SAM.gov, Grants.gov, eRA Commons, and comply with NIH’s new FORMS-I requirements, which will be available 30 days before the first due date of May 5, 2025. Letters of intent, while optional, are recommended 30 days prior to the application due date. Applications must include a Resource Sharing Plan and comply with NIH data sharing policies, ensuring that scientific data generated is accessible to the public. Human subjects or clinical trials must be detailed in the PHS Human Subjects and Clinical Trials Information Form if applicable. Applications will be reviewed based on criteria including the significance and innovation of the research, the rigor and feasibility of the approach, and the expertise and resources of the investigators. Additional review will consider protections for human subjects, plans for data sharing, and relevance to NIDA’s mission. The peer review process will determine the scientific merit, followed by a second review by NIDA’s Advisory Council. Funding decisions will be based on scientific merit, availability of funds, and relevance to NIDA’s priorities, with a goal of issuing awards within six months of the due date for eligible applications. Applicants seeking more information on submission and program-specific details are advised to contact NIDA’s Scientific, Peer Review, and Grants Management contacts provided in the NOFO. Compliance with NIH’s administrative policies, data management, and reporting requirements are expected upon award.