Notice Number: NOT-OD-19-046
Release Date: January 9, 2019
The purpose of this Notice is to inform the community about updates and clarifications of several components of the Challenge competition posted within the Federal Register including:
Eligibility to Win: The Solver shall submit a letter of intent outlining the proposed in vitro diagnostic assay/assay system and its intended use.
The letter of intent must be submitted on or before November 4, 2019, at 11:59 p.m. ET, for all Step 2 Semi-finalists planning to submit for the Step 3 (Performance Testing in CLIA-certified Laboratories) stage of the competition. The letter of intent must be submitted on http://www.cccinnovationcenter.com/challenges/antimicrobial-resistance-diagnostic-challenge/
The Technical Evaluation Panel will use the following 6 criteria and rating scales for evaluating proposed Step 3 solutions: a) novel and innovation technology; b) likelihood of improving the use of antibiotics in patients; c) diagnostic performance; d) sample matrix; e) time to test result; and f) setting and ease of use prototypes.
The Technical Evaluation Panel will use the following 4 criteria for evaluating the submissions for Step 3 and the test results from the two CLIA-certified laboratories' analysis of the Step 3 prototype submissions including: a) innovation; b) clinical significance; c) diagnostic performance and feasibility; and d) sample matrix/setting and ease of use/throughput.
Only Step 2 Semi-finalists are eligible to compete for Step 3 of this Challenge.
Step 2 Semi-finalists will submit sufficient numbers of their in vitro diagnostic tests (solutions) based on the Step 2 solutions for independent testing by two CLIA-certified laboratories, as well as methodology/protocols to perform diagnostic testing using the prototypes. These materials must be received on or before January 3, 2020, at 5:00 p.m. ET by Capital Consulting Corporation, Suite 100, 11821 Parklawn Drive, Rockville MD 20852. Submissions received after the deadline of January 3, 2020, will be disqualified and not evaluated by the CLIA-certified laboratories, the Technical Evaluation Panel, or the Judging Panel. At a future date, the NIH will provide additional information about the specific number of test kits each Step 2 Semi-finalist will need to provide for CLIA-certified laboratory testing.
Each solution will be tested by two CLIA-certified laboratories against standard FDA-approved in vitro assays using a panel of reference (or well-characterized) pathogens, clinical specimens, and/or contrived samples to demonstrate usability, stated time to result, appropriate analytical sensitivity/specificity, as well as confirmation of analytical performance (e.g., limit of detection, interference, inclusivity, reproducibility, etc.) reported in the data submitted by the Step 2 Semi-finalist.
Each Step 2 Semi-finalist must provide a description sufficiently detailed and organized by sections in 10 pages or less for evaluation in the technical evaluation and programmatic assessment of the proposed solution including: 1) a detailed description of the proposed in vitro diagnostic and claims of performance using specific types of biospecimens/samples; 2) a description of any changes from the original design (Step 2 solution) must be documented and explained; and 3) a summary of supporting data relevant to the evaluation criteria.
Each Step 2 Semi-finalist must include two appendices with the submission: Appendix A, with the standard operating procedure for the use of the solution submitted for Step 3 of the competition including all steps to prepare the specimen, perform the assay, and interpret the results; and Appendix B providing additional data and tables to support the data summary and performance claims based on the use of the proposed solution testing clinical or contrived samples in 5 pages or less.
Each Step 2 Semi-finalist must include a video not to exceed 15 minutes demonstrating the status of the development and actual use of the device in testing contrived or clinical specimens.
Each Step 2 Semi-finalist must provide a one-paragraph executive summary that will be posted on the Challenge website after the “Winners” are announced in July 2020. The Executive Summary should not contain any proprietary information since the website is open to the public.
Each Step 2 Semi-finalist must provide a statement as to the source of funds that were used to develop their solution submitted for Step 3 of the Challenge;
Step 2 Semi-finalists may submit corrections in support of their Step 3 submissions within the page limitations cited above so long as Capital Consulting Corporation receives the materials by the deadline of January 3, 2020, at 5:00 p.m. ET. Corrections for Step 3 will not be accepted or evaluated by the CLIA-certified laboratories, Technical Evaluation Panel or Judging Panel if they are received after January 3, 2020, at 5:00 p.m. ET.
Each Step 2 Semi-finalist needs to address the HHS Human Subjects Protections regulations and NIH Inclusion of Women, Children, and Minorities policies, as well as biohazards policies (https://grants.nih.gov/grants/guide/notice-files?NOT-OD-12-141.html) , if applicable.
The NIH will perform an initial review of all submissions to ensure they are complete and within the scope of the Challenge. Submissions that are incomplete or outside the scope of the Challenge will be administratively disqualified and will not be evaluated by the CLIA-certified laboratories, the Technical Evaluation Panel or the Judging Panel.
The NIH and Assistant Secretary for Preparedness and Response/Biomedical Advanced Research and Development Authority may determine that based on the number of submissions received for Step 3 that less competitive submissions will not be discussed by the Technical Evaluation Panel during the Panel’s meeting.
Members of the Technical Evaluation Panel for Step 1 or Step 2 are not eligible to participate in or contribute to any proposal for Step 3 of the Challenge.
No submissions will be returned to the submitters.
All submissions for Step 3 must be in English.
The remainder of the provisions from the September 8, 2016, Federal Register Notice (81 FR 62150) not amended here still apply.
Please direct all inquiries to:
Robert W. Eisinger, Ph.D.
Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI)