Single Source for the Continuation of the Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Scientific and Data Research Center (U01 Clinical Trial Required)

Applications for a 3-year extension/renewal of the Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) clinical trial consortium are requested to fully meet the enrollment targets, complete participant follow-up, and finalize data analysis and dissemination of study findings. This Notice of Funding Opportunity (NOFO) invites a Single Source application for the eligible organization, the Scientific and Data Research Center (SDRC) already involved in the Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Consortium. Please see Section III. Eligibility 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.There is currently no standard of care for patients after hospitalization with acute kidney injury (AKI). Successful completion of the COPE-AKI study will provide key insights that are expected to directly inform improved clinical management strategies and the development of standard of care for Stage 2 and 3 AKI survivors.

As this NOFO is a Single Source application, only the current recipient under RFA-DK-20-012 is eligible to apply under this announcement. Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

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...

This program has no statutory formula. Matching requirements are not applicable to this assistance listing. MOE requirements are not applicable to this assistance listing.

Not Applicable.