Notice of Intent to Publish a Funding Opportunity Announcement for Single Source for Continuation of the Environmental Determinants of Diabetes in The Young Study (TEDDY) Data Coordinating Center (U01 Clinical Trial Not Allowed)

This is a non-competitive funding opportunity intended to fund a single award. The National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) is announcing its intent to issue a single source cooperative agreement award to University of South Florida for of the current Data Coordinating Center (DCC) for The Environmental Determinants of Diabetes in the Young (TEDDY) study, an ongoing epidemiological study. This DCC has been involved in study design and data and bio sample acquisition and management since the inception of the TEDDY Consortium. The DCC has initiated a second case-control analysis of the TEDDY cohort. This NOFO provides support for the TEDDY DCC to continue to complete the ongoing analysis of the samples from the second case control cohort and allow funding for closeout of the study. This NOFO is associated with the Special Diabetes Program (https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/type-1-diabetes-special-statutory-funding-program/about-special-diabetes-program) which funds research on the prevention, treatment, and cure of type 1 diabetes and its complications, including unique, innovative, and collaborative research consortia and clinical trials networks.

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...