Single Source Competition for Continuation of Understanding and Targeting the Pathophysiology of Youth-Onset Type 2 Diabetes Clinical Centers (U01 Clinical Trial Not Allowed)

The DISCOVERY of Risk Factors for Type 2 Diabetes in Youth Study is a multi-center longitudinal consortium conducted across 19 clinical sites to identify risk factors and biological mechanisms driving progression to youth-onset type 2 diabetes. The study is actively recruiting and following early pubertal youth at high risk for the disease with longitudinal follow-up currently underway. The current Biostatistics Research Center (BRC) serves as the consortium's central coordinating center, managing protocol implementation, data management, quality assurance, statistical design and analysis, and inter-site and consortium-wide coordination. The BRC has established the robust infrastructure and standardized processes required to support the study and preserve the integrity of the longitudinal dataset. The purpose of this single-source solicitation is to support completion of the scientific objectives of the ongoing DISCOVERY clinical consortium.

This is a Single Source competition that will invite application(s) from eligible organization(s) to apply. Please see Eligibility Section for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.

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...