[Federal Register Volume 84, Number 19 (Tuesday, January 29, 2019)]
[Notices]
[Pages 464-466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00218]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Notice To Announce of Requirements and Registration for 
``Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test'' 
Challenge

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) is supplementing and 
amending a Notice previously published in the Federal Register on 
September 8, 2016 titled ``Announcement of Requirements and 
Registration for ``Antimicrobial Resistance Rapid, Point-of-Need 
Diagnostic Test'' Challenge.'' This Notice serves to provide additional 
details to Step 2 Semi-finalists of the submission requirements and 
review criteria for Step 3 (Performance Testing in CLIA-certified 
Laboratories) of this Challenge.

DATES: On or before Monday, November 4, 2019, 11:59 p.m. ET: Step 3 
Letter of Intent is due. Only Step 2 Semi-finalists are eligible to 
submit a Letter of Intent. On or before Friday, January 3, 2020, 5:00 
p.m. ET: The submissions from the Step 2 Semi-finalists for Step 3 are 
due. Submissions received after the deadline of January 3, 2020, at 
5:00 p.m. ET will be disqualified and not evaluated by the CLIA-
certified laboratories, the Technical Evaluation Panel, or Judging 
Panel.
    Important note: The Step 3 submission must be received by January 
3, 2020. Plan to send the submission so it arrives on or before January 
3, 2020. In effect, a post-mark date of January 3, 2020, is not 
sufficient; the submission must be received by that date.

ADDRESSES: The Letter of Intent and Step 3 submission must be submitted 
to Capital Consulting Corporation no later than the due dates cited 
above. The letter of intent must be submitted on http://www.cccinnovationcenter.com/challenges/antimicrobial-resistance-diagnostic-challenge/.

FOR FURTHER INFORMATION CONTACT: Robert W. Eisinger, Ph.D., NIH, 301-

[[Page 465]]

496-2229 or by email <a href="/cdn-cgi/l/email-protection#55073a373027217b303c263c3b323027153b3c3d7b323a23"><span class="__cf_email__" data-cfemail="0f5d606d6a7d7b216a667c6661686a7d4f61666721686079">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: On September 8, 2016, the National 
Institutes of Health (NIH) published a Notice in the Federal Register 
titled ``Announcement of Requirements and Registration for 
``Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test'' 
Challenge.'' The Notice announced the Antimicrobial Resistance Rapid, 
Point-of-Need Challenge may result in the awarding of $20 million 
dollars for the successful development of new, innovative, accurate, 
and cost-effective in vitro diagnostic tests that would rapidly inform 
clinical treatment decisions and be of significant clinical and public 
health utility to combat the development and spread of antibiotic 
resistant bacteria and improve antibiotic stewardship. The Notice 
provided information on submission requirements for Step 3 of the 
Challenge and indicated that additional details on submission 
requirements for Step 3 will be made available after the Step 2 Semi-
finalists are announced. This Notice serves to provide additional 
details to Step 2 Semi-finalists of the submission requirements and 
review criteria for Step 3 (Performance Testing in CLIA-certified 
Laboratories) of this Challenge.
    The NIH is supplementing and amending several components of Step 3 
of the Challenge including:
    (1) The letter of intent must be submitted by Monday, 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 Challenge. A list of Step 2 Semi-finalists 
can be found at http://www.cccinnovationcenter.com/challenges/antimicrobial-resistance-diagnostic-challenge/.
    (2) The Technical Evaluation Panel will use the following 4 
criteria for evaluating the Step 3 submissions 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. These criteria were 
defined in the September 8, 2016, announcement; however, the 
announcement incorrectly stated that the Panel will evaluate the in 
vitro diagnostics (solution) based on six criteria.
    (3) 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.
    (4) Step 2 Semi-finalists will submit:
    a. Sufficient numbers of their diagnostic tests based on the Step 2 
solutions for independent testing by both 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. At a future date, the NIH 
will provide additional information about the specific number of test 
kits that each Step 2 Semi-finalist will need to provide for CLIA-
certified laboratory testing. Submissions received after the deadline 
of January 3, 2020, at 5:00 p.m. ET will be disqualified and not 
evaluated by the CLIA-certified laboratories, the Technical Evaluation 
Panel, or the Judging Panel.
    b. A description sufficiently detailed and organized by sections 
for evaluation in the technical evaluation and programmatic assessment 
of the proposed solution in 10 pages or less including the next 8 
bullets, 8.5'' x 11'' inch page, 10-point or greater Arial, Palatino 
Linotype, or Georgia font and one-inch margins including:
    <bullet> A title of the proposed solution;
    <bullet> A one-paragraph executive summary that will be posted on 
the Challenge website after the ``Winners'' are announced in July 2020. 
The Executive Summary must not contain any proprietary information 
since the website is open to the public;
    <bullet> A statement as to the source of funds that were used to 
develop their solution submitted for Step 3 of the Challenge;
    <bullet> A detailed description of the proposed in vitro diagnostic 
and the claims of performance using specific types of biospecimens/
samples;
    <bullet> A description of any changes from the original design 
(Step 2 solution) must be documented and explained;
    <bullet> One section providing a summary of the data, using the in 
vitro diagnostic device and the Standard Operating Procedures described 
in Appendix A, generated with either clinical or contrived samples 
compared to existing standard techniques demonstrating the performance 
characteristics (e.g., limits of detection, sensitivity, specificity, 
and other characteristics that demonstrate test performance to support 
detection of biomarkers or analytes). The September 8, 2016, 
announcement incorrectly stated that diagnostic performance 
characteristics included positive predictive value and negative 
predictive value;
    <bullet> 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;
    <bullet> A section addressing applicable 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.
    (5) An Appendix A with the standard operating procedures for the 
use of the solution submitted for Step 3 of the Challenge must include 
all steps to prepare test specimen/sample, perform the assay, and 
interpret the results.
    (6) An Appendix B 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 5 pages of less.
    (7) Each Step 2-Semi-finalist may submit corrections in support of 
their Step 3 submission within the page limitations cited above as 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.
    (8) 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 of 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. Disqualified submissions will not be 
returned to the Step 2 Semi-finalist.
    (9) 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.
    (10) Members of the Technical Evaluation Panel for Step 1 or Step 2 
are not eligible to participate in or

[[Page 466]]

contribute to any proposal for Step 3 of the Challenge.
    (11) Only Step 2 Semi-finalists are eligible for Step 3 of this 
Challenge.
    (12) All submissions for Step 3 must be in English.
    (13) No submissions will be returned to the submitters.
    (14) The remainder of the provisions from the September 8, 2016, 
Federal Register Notice (81 FR 62150) not amended here still apply.

    Dated: January 11, 2019.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2019-00218 Filed 1-28-19; 8:45 am]
 BILLING CODE 4140-01-P


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