The NIH's Leveraging Extant Data to Understand Developmental Trajectories of Late Talking Children initiative (R21 Clinical Trial Not Allowed) seeks to advance understanding of late language emergence by promoting the use of existing data. Late talking is identified when children older than 18 months fail to meet expressive language milestones. This funding opportunity aims to identify developmental patterns, risk factors, and potential mechanisms underlying late talking, leveraging data to build shared resources for further research. Investigators are encouraged to analyze existing datasets, improve data utility, and make resources openly available, fostering advancements in the field and alignment with the NIH Strategic Plan for Data Science.

The initiative prioritizes data sharing, secondary analysis, and methods to enhance the discoverability and usability of data related to late talking children. Eligible projects may focus on data integration, developing tools for data analysis, or harmonizing existing datasets. Activities must align with FAIR data principles (Findable, Accessible, Interoperable, Reusable) and meet ethical and confidentiality standards. Proposals must include a Data Management and Sharing Plan and a Plan for Enhancing Diverse Perspectives (PEDP), detailing strategies to include underrepresented populations and perspectives in research.

The R21 funding mechanism supports up to $275,000 in direct costs over two years, with a maximum of $200,000 per year. The total project period is limited to two years. The program encourages applications from higher education institutions, nonprofits, for-profits, governments, and foreign entities. Proposals must exclude de novo data collection and clinical trials but may involve data re-consent or additional coding of existing datasets. Applications from underserved or underrepresented communities and studies addressing longitudinal data are especially welcome.

Key deadlines include application due dates on February 3, June 2, and October 2, 2025, with the earliest project start date anticipated in December 2025. Applications must be submitted electronically through NIH ASSIST, Grants.gov, or institutional systems. Applicants should complete required registrations (SAM, eRA Commons, Grants.gov) well in advance. Proposals must conform to NIH policies, and incomplete or non-compliant submissions will not be reviewed.

Evaluation will consider the significance, innovation, approach, and environment, as well as the inclusion of diverse perspectives and populations. Successful applications will demonstrate scientific rigor, feasibility, and alignment with NIH priorities. Proposals must advance understanding of late talking trajectories, integrate existing data, and support open science practices. Budget and timelines must be justified and achievable.

Applicants are encouraged to consult program contacts for guidance on alignment with NIH priorities. Awardees are expected to adhere to NIH grant policies, including ethical considerations, data-sharing commitments, and progress reporting. Additional resources and support are available through NIH’s eRA service desk and designated scientific contacts. For full program details and requirements, applicants should reference the complete Notice of Funding Opportunity.