The FY2025 Notice of Funding Opportunity (NOFO), Time-Sensitive Evaluation of Policies Affecting Health Behaviors and Chronic Disease Risk (R01 - Clinical Trial Not Allowed), issued by the National Institutes of Health (NIH), seeks proposals for evaluating imminent policies or programs expected to influence diet, physical activity, sleep, or weight, with the potential to reduce chronic disease rates. The NOFO targets research where immediate action is required to capture baseline data and assess policy/program effects, particularly in populations experiencing health disparities. The program emphasizes the use of rigorous, time-sensitive methodologies to generate meaningful, evidence-based conclusions. Applications must highlight a unique scientific opportunity that will be lost without expedited research initiation. Awards are anticipated to begin within four months of submission due to the time-sensitive nature of the research.

The program is supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Cancer Institute (NCI), with co-funding possible from the NIH Office of Disease Prevention (ODP). Proposals must align with these Institutes' missions, such as addressing obesity, metabolic disorders, or environmental influences on health behaviors. A focus on diversity and inclusion is critical, requiring applicants to submit a Plan for Enhancing Diverse Perspectives (PEDP) to outline strategies for advancing inclusivity throughout the project.

Eligible applicants include public and private higher education institutions, nonprofits with or without 501(c)(3) status, for-profit organizations, state and local governments, tribal organizations, and other entities within the U.S. and its territories. Foreign entities or projects outside the U.S. are not eligible. The maximum project period is five years, and application budgets should reflect actual project needs without predefined limits. Key dates include an earliest submission date of January 14, 2025, and rolling deadlines on the 9th or 10th of each subsequent month through January 2028.

Proposals should evaluate policies or programs that are independent of NIH funding and already in place, with examples such as food or beverage taxes, urban planning for active transportation, or workplace health initiatives. They must focus on objectively measured outcomes like dietary changes, physical activity, or weight management, using methods such as actigraphy for sleep or BMI assessments. Secondary outcomes, including barriers to implementation and unintended policy consequences, should also be considered.

Applicants must submit through NIH’s ASSIST system, Grants.gov, or an institutional system-to-system solution. Applications require comprehensive documentation, including a research strategy, detailed budget, and a data management plan. Proposals exceeding $500,000 in direct costs annually require prior approval from NIH contacts. Non-compliance with requirements, such as failing to submit a PEDP, will result in administrative withdrawal.

Applications are reviewed based on significance, scientific rigor, feasibility, and alignment with the program’s goals. Successful projects will demonstrate innovative approaches to time-sensitive research, strong partnerships with diverse institutions, and actionable outcomes. Awardees must comply with NIH’s data sharing policies, progress reporting requirements, and ethical standards.

For further details, applicants are encouraged to consult the NOFO and NIH resources, including a pre-application webinar. Agency contacts are available to address scientific, peer review, and financial management queries. This funding opportunity represents a critical pathway to advance public health by evaluating policies that address chronic disease risk and health disparities.