[Federal Register Volume 82, Number 84 (Wednesday, May 3, 2017)]
[Notices]
[Pages 20608-20609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08920]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notice of Correction for Announcement of Requirements and
Registration for ``Antimicrobial Resistance Rapid, Point-of-Need
Diagnostic Test'' Challenge
The National Institutes of Health (NIH) is correcting a notice
previously published in the Federal Register on September 8, 2016 (81
FR 62150), 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 competition that 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 NIH is correcting and clarifying several components of Step 2
of the Challenge competition including:
(1) 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.
(2) The prototype in vitro diagnostic device is not to be provided
with the submission. The September 8, 2016, announcement incorrectly
stated that the device was to be included as part of the submission for
Step 2.
(3) 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.
These criteria were defined in the September 8, 2016, announcement;
however, the announcement incorrectly stated that the Panel will
evaluate the solutions based on eight criteria.
(4) A description sufficiently detailed and organized by sections
for evaluation in the technical review and programmatic assessment of
the proposed solution in 15 pages or less including the next 6 bullets,
8.5 x 11 inch page, 10-point or greater Arial, Palatino Linotype, or
Georgia font and one inch margins including:
A title of the proposed solution;
A detailed description of the proposed in vitro
diagnostic, and the development approach, challenges, and risks;
One section addressing each of the 4 criteria listed
above;
One section providing a summary of the data, using the in
vitro diagnostic device and the Standard Operating Procedures described
in Appendix B, 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;
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;
Address the NIH Human Subjects Protections and Inclusion
of Women, Children, and Minorities policies, as well as biohazards
policies (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-078.html), if applicable.
(5) An Appendix A, provide additional data and tables to support
the data summary and performance claims based on the use of the
proposed
[[Page 20609]]
solution testing clinical or contrived samples in 15 pages or less.
(6) An Appendix B with 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 a longer Appendix is
submitted, only the first 10 pages will be considered by the Technical
Evaluation Panel and the Judging Panel.
(7) 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.
(8) 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 11:59 p.m. 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 11:59 p.m. ET.
(9) 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.
(10) A Solver may not be a federal employee of HHS (or any
component of HHS) acting in their personal capacity.
(11) 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.
(12) 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.
(13) 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.
(14) Any Solver is eligible for Step 2 of this Challenge
competition. For example, if a Step 1 ``Solver'' was not identified as
a semifinalist, he/she may still submit for Step 2 of this competition
and those who did not submit a Step 1 proposal may still submit a
proposal for Step 2.
(15) All submissions for Step 2 and 3 must be in English.
For further information about the Antimicrobial Resistance
Diagnostic Challenge competition, please contact Robert W. Eisinger,
Ph.D., NIH, 301-496-2229 or by email [email protected].
Dated: April 27, 2017.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2017-08920 Filed 5-2-17; 8:45 am]
BILLING CODE 4140-01-P