Notice of Information Regarding the "Announcement of Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test Challenge Competition"

Notice Number: NOT-OD-17-063

Key Dates
Release Date:   May 5, 2017

Related Announcements
NOT-OD-16-137

Issued by
National Institutes of Health (NIH)
Biomedical Advances Research and Development Authority (BARDA)

Purpose

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:

Current language:
Eligibility to Win:  The Solver shall submit a letter of intent outlining the proposed in vitro diagnostic assay/assay system and its intended use.

Modified language:
The letter of intent must be submitted by August 3, 2018, at 11:59 p.m. ET, for all “Solvers” planning to submit for the Step 2 (Delivery of Prototype and Analytical Data) stage of the competition.  The letter of intent must be submitted on http://www.cccinnovationcenter.com/challenges/antimicrobial-resistance-diagnostic-challenge/

Current language:
The Technical Evaluation Panel will use the following 8 criteria and rating scales for evaluating proposed Step 2 submissions: a) innovation; b) clinical significance; c) diagnostic performance; d) feasibility; e) setting and ease of use; f) sample matrix; g) throughput; and h) data content.  

Modified language:
The Technical Evaluation Panel will use the following 4 criteria for evaluating the Step 2 submissions including: a) innovation; b) clinical significance; c) diagnostic performance and feasibility; and d) sample matrix/setting and ease of use/throughput.

Additional updates:

The prototype in vitro diagnostic device is not to be provided with the submission. 

Submissions for Step 2 of the Challenge competition can be submitted to http://www.cccinnovationcenter.com/challenges/antimicrobial-resistance-diagnostic-challenge/ beginning June 1, 2018.  Submissions received after the deadline of September 4, 2018, at 11:59 p.m. ET will be disqualified and not evaluated by the Technical Evaluation Panel or Judging Panel.

Solvers may submit corrections or additional materials in support of their Step 2 submissions so long as the NIH receives the materials by the deadline of September 4, 2018, at 11:59pm ET.  Corrections or additional materials for Step 2 will not be accepted or evaluated by the Technical Evaluation Panel or Judging Panel if they are received after September 4, 2018 at 11:59pm ET.

The "Solver" must address the NIH Human Subjects Protections and Inclusion of Women, Children, and Minorities policies, as well as biohazards policies.

The "Solver" must include photographs of the in vitro diagnostic prototype device and a video not to exceed 5 minutes (in accordance with the NIH interim policy for submitting a video as NIH  application materials https://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-141.html) demonstrating the status of the development and actual use of the device in testing contrived or clinical specimens.

The "Solver" must include two appendices with the submission: Appendix A, provide 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 15 pages or less; and Appendix B, provide the Standard Operating Procedures for the use of the solution submitted for Step 2 of the Challenge competition must be limited to 10 pages or less in length.  If Appendices submitted exceed these page limitations, only the designated number of pages will be considered by the Technical Evaluation Panel and the Judging Panel.  

A Solver may not be a federal employee of HHS (or any component of HHS) acting in their personal capacity.

A Solver employed by a federal agency or entity other than HHS (or any component of HHS), should consult with an agency Ethics Official to determine whether the federal ethics rules will limit or prohibit the acceptance of a prize under this challenge.

The NIH will perform an initial review of all submissions to ensure they are complete and within the scope of the Challenge competition.  Submissions that are incomplete will be administratively disqualified and will not be evaluated by 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 2 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 are not eligible to participate in or contribute to any proposal for Step 2 and Step 3 of the Challenge competition.

All submissions for Step 2 and 3 must be in English.

For further information about eligibility requirements, competition rules, and deadlines for submissions, please consult the Federal Register.

Inquiries

Please direct all inquiries to:

Robert W. Eisinger, Ph.D.
Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI)
Telephone: 301-496-2229
Email: robert.eisinger@nih.gov