[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62150-62156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21328]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

    Authority:  15 U.S.C. 3719.

SUMMARY: Through the ``Antimicrobial Resistance Rapid, Point-of-Need 
Diagnostic Test'' Challenge (the ``Challenge''), the National 
Institutes of Health (NIH) and the Biomedical Advanced Research and 
Development Authority (BARDA) of the Office of the Assistant Secretary 
for Preparedness and Response (ASPR) are searching for novel and 
innovative in vitro diagnostic tests that would rapidly inform clinical 
treatment decisions and be of potential significant clinical and public 
health utility to combat the development and spread of antibiotic 
resistant bacteria. Tests of interest will provide novel, innovative 
solutions for use in inpatient and/or outpatient settings. The goal of 
the challenge is to identify a diagnostic test that when utilized would 
lead to more rapid clinical decision making such that antibiotic use 
and/or outcomes of patients infected with resistant pathogens are 
fundamentally improved compared to current standard of care, and/or 
reduce transmission of resistant pathogens such that population 
infection rates significantly decrease. The Challenge competition seeks 
to incentivize a broad range of scientists, engineers, and innovators 
to develop diagnostic tests that would enable health care providers to 
make more informed decisions on appropriate antibiotic use and 
infection prevention.
    This Challenge, structured in three steps, will complement existing 
BARDA and NIH research portfolios by reaching

[[Page 62151]]

out to a diverse population of innovators and solvers, including not 
only those from academic institutions, but also those from research and 
development communities in the private sector and others who are 
outside biomedical disciplines. The NIH and the BARDA believe this 
Challenge will stimulate investment from both public and private 
sectors in rapid, point-of-need in vitro diagnostic assay research and 
product development, which, in turn, could lead to the development of 
more sensitive, accurate, robust, and cost-effective assay approaches 
and devices for clinical diagnosis.

DATES: 
Step 1 Submission period begins: September 8, 2016.
Step 1 Submission period ends: January 9, 2017, 11:59 p.m. ET
Step 1 Judging Period: January 10, 2017, to March 26, 2017
Step 1 Up to 20 highest ranked proposals Semi-finalists Announced: 
March 27, 2017
Step 2 Submission period begins: March 28, 2017
Step 2 Submission period ends: September 4, 2018, 11:59 p.m. ET
Step 2 Judging Period: September 5, 2018-November 30, 2018
Step 2 Up to 10 Semi-finalists Announced: December 3, 2018
Step 3 Submission period begins: December 4, 2018
Step 3 Submission period ends: January 3, 2020, 11:59 p.m. ET
Step 3 Judging Period: May 1, 2020-July 1, 2020
Step 3 Winner(s) Announced: July 31, 2020

    The NIH and the BARDA may shorten the submission period for Steps 2 
and 3 and adjust dates for judging and winner(s) announcement if the 
Step 1 winners' feasibility assessments suggest shorter Step 2 and 3 
submission periods are possible. The NIH and the BARDA will announce 
any changes to the timeline by amending this Federal Register notice no 
later than January 3, 2017. Administrative aspects of this Challenge 
will be managed by Capital Consulting Corporation.

FOR FURTHER INFORMATION CONTACT: Robert W. Eisinger, Ph.D., NIH, 301-
496-2229 or by email [email protected].

SUPPLEMENTARY INFORMATION: 
    Statutory Authority to Conduct the Challenge: This Challenge is 
consistent with and advances the mission of the Department of Health 
and Human Services to identify and support research that represents 
important areas of emerging scientific opportunities, rising public 
health challenges, or knowledge gaps that deserve special emphasis. The 
NIH and BARDA are conducting this competition under the America 
COMPETES Reauthorization Act of 2010 (Pub. L. 111-358), codified at 15 
U.S.C. 3719.
    Subject of Challenge: On September 18, 2014, the President issued 
Executive Order 13676 on Combating Antibiotic-Resistant Bacteria, and 
announced the Administration would hold the Antimicrobial Resistance 
Challenge, as described in the accompanying White House Fact Sheet. The 
development and use of rapid, point-of-need, and innovative diagnostic 
tests for identification and characterization of resistant bacteria was 
a goal identified in the National Strategy for Combating Antibiotic-
Resistant Bacteria released in September 2014 and addressed in the 
National Action Plan for Combating Antibiotic-Resistant Bacteria 
released in March 2015.
    In conformance with the above plans and directives, the NIH and the 
BARDA are sponsoring a Challenge competition, with the Food and Drug 
Administration (FDA) and the Centers for Disease Control and Prevention 
(CDC) contributing technical and regulatory expertise to develop the 
award evaluation process.\1\
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    \1\ The NIH has engaged Capital Consulting Corporation to manage 
certain administrative aspects of this challenge, such as 
registration, as described below, under 15 U.S.C. Sec.  3719(l).
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    There are two clinical scenarios in which a diagnostic test is 
expected to have a significant impact on antibiotic stewardship:
    (1) Outpatient setting. Outpatient settings include physician 
offices, clinics, urgent care centers, and emergency rooms, as these 
offer healthcare services without hospital admission. These settings 
are often the first point of contact between patients and providers and 
play an increasingly important role in the delivery of healthcare 
services. Providers in this setting often need to make decisions on the 
use of antibiotics based on immediately observable information. 
Therefore the ability to rapidly determine if a patient needs 
antibiotic therapy, and which antibiotic would be efficacious to treat 
the infection using clinically relevant samples is of primary 
importance.
    (2) Inpatient setting. Inpatient settings include hospitals and 
other settings in which patients are admitted for more than 24 hours. 
Patients admitted with serious infections such as sepsis and pneumonia 
require prompt bacterial detection, identification, and susceptibility 
for selecting appropriate antibiotic treatment. The ability to 
differentiate among many bacterial strains using many different sample 
types is critical. Additionally, hospital-acquired infections are a 
major concern in these settings, and the ability to determine if 
patients are infected with drug resistant microorganisms is critical 
for both treatment and infection control.
    Currently available in vitro diagnostics have not sufficiently 
addressed the needs in each of these settings. Therefore a diagnostic 
that could advance the state-of-the-art in a reliable, cost-effective 
way would provide the healthcare community a significant advantage in 
combating antibiotic resistance. An additional benefit of an in vitro 
diagnostic would be to facilitate clinical trials for new antibacterial 
products by allowing enrollment of patient populations with specific 
infections, thus advancing the development of new antibacterial agents.
    In this Challenge, the NIH and the BARDA are seeking proposals for 
the 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.
    The prize-winning in vitro diagnostic(s) must meet a set of 
predefined technical criteria and performance characteristics based on 
the intended use(s), as described further below. Solutions submitted to 
this Challenge should have the potential to significantly improve 
clinical decision making compared to the current standard of care. 
Solutions also should be novel, innovative, rapid, and appropriate for 
use at the point-of-need. Ultimately the solution should be an in vitro 
diagnostic assay(s) that can:

 Improve antibiotic decision making by health care providers 
and be effective in reducing inappropriate use of antibiotics
 demonstrate a clinically significant advance in diagnostic 
test performance and address gaps or deficiencies in current 
capabilities that may include, but are not limited to:

    [rtarr] Ease of use;
    [rtarr] time to result;
    [rtarr] significant advances in sensitivity and specificity; and
    [rtarr] ability to process a broad range of specimen types.


[[Page 62152]]


    Solutions describing existing, well-established and/or currently 
supported approaches, especially commonly used strategies are not of 
interest unless a compelling case is made that potentially clinically 
significant, quantifiable advances are achievable and/or the methods 
and measures are used in unique combinations that have not been 
previously tested together for the detection/diagnosis of drug 
resistant bacteria. Examples of breakthroughs in this arena could allow 
health care providers to:
    (1) More rapidly identify/detect the specific etiology drawn from a 
differential diagnosis of a particular clinical syndrome caused by any 
of the 18 drug resistant bacteria of highest concern which can be found 
in Table 3 of the National Action Plan for Combating Antibiotic 
Resistant Bacteria released in 2015;
    (2) more rapidly identify/detect, and characterize antibiotic 
susceptibility of at least one of the 18 drug resistant bacteria of 
highest concern which can be found in Table 3; and
    (3) detect biomarkers that would inform patient management 
decisions such as need for antibiotics or severity of infection.

Eligibility Rules for the Challenge

    1. To Participate. This Challenge is open to any ``Solver'' where 
``Solver'' is defined as an individual, a group of individuals (i.e., a 
team), or an entity. Whether singly or as part of a group or entity, 
each individual participating in the Challenge must be 18 years of age 
or older. We welcome solutions from individuals, teams, and entities 
from all U.S. sources, including the public sector, private sector, and 
nonprofit groups.
    Eligibility to participate in Step 2 of the Challenge is not 
dependent on participation in Step 1 of the Challenge and being 
selected as a ``Step 1 Semi-finalist.'' If a ``Solver'' did not 
participate in Step 1, he/she must follow the requirements listed in 
the ``To Win'' section of this announcement in order to submit a 
solution at Step 2. Step 1 Semi-finalists are any individual, team, 
and/or entity whose solution received a meritorious rating based on the 
judging criteria. Eligibility to participate in Step 3 of the challenge 
is conditioned upon participation in Step 2 of the Challenge and being 
selected as a ``Step 2 Semi-finalist.''
    2. Eligibility to Win. To be eligible to win a prize under this 
Challenge, the Solver--

 Shall have registered to participate in the Challenge under 
the rules promulgated by the NIH as published in this Notice.
 Shall submit a letter of intent outlining the proposed in 
vitro diagnostic assay/assay system and its intended use.
 Shall have complied with all the requirements set forth in 
this Notice.
 In the case of a private entity, shall be incorporated in and 
maintain a primary place of business in the United States; and in the 
case of an individual, whether participating singly or in a group, 
shall be a citizen or permanent resident of the United States. Note: 
Individuals who are non-U.S. citizens and nonpermanent residents may 
participate as a member of a team that otherwise satisfies the 
eligibility criteria, but will not be eligible to win a monetary prize 
(in whole or in part); however, their participation as part of a 
winning team, if applicable, may be recognized when results are 
announced.
 In the case of an individual, he/she may not be an employee of 
the NIH, ASPR, CDC, or FDA; an individual involved in formulation of 
the Challenge and/or serving on the technical evaluation panel; any 
other individual involved with the design, production, execution, 
distribution, or evaluation of this Challenge; or members of the 
individual's immediate family (specifically, a parent, step-parent, 
spouse, domestic partner, child, sibling, or step-sibling).
 An individual, team, or entity that is currently on the 
Excluded Parties List (https://www.epls.gov/) will not be selected as a 
Semi-finalist or prize winner.
 In the case of an entity, may not be a federal entity; and in 
the case of an individual, may not be a federal employee acting within 
the scope of his or her employment.
 Federal employees otherwise permitted to participate in the 
Challenge shall not work on their submission during assigned duty 
hours. Note: Federal ethical conduct rules may restrict or prohibit 
federal employees from engaging in certain outside activities, so any 
federal employee not excluded under the prior paragraph seeking to 
participate in this Challenge outside the scope of employment should 
consult his/her agency's ethics official prior to developing a 
submission.
 HHS employees may not work on their applications or 
submissions during assigned duty hours. Commissioned Corps officers are 
excluded from this competition since they are on active duty at all 
times.
 Federal grantees may compete but may not use federal funds to 
develop America COMPETES Act challenge applications unless consistent 
with the purpose of their grant award. If a grantee using federal funds 
wins the competition, the award needs to be treated as program income 
for purposes of the original grant in accordance with applicable 
Uniform Administrative Requirements, Cost Principles, and Audit 
Requirements for Federal Awards.\2\
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    \2\ 2 CFR 200, ``Uniform Administrative Requirements, Cost 
Principles, and Audit Requirements for Federal Awards'' supersedes 
OMB Circular A-21, Cost Principles for Educational Institutions, OMB 
Circular A-87, Cost Principles for State, Local, and Indian Tribe 
Governments, OMB Circular A-110, Uniform Administrative Requirements 
for Grants and Other Agreements with Institutions of Higher 
Education, Hospitals, and Other Non-Profit Organizations, and OMB 
Circular A-122, Cost Principles for Non-Profit Organizations.
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 Federal entities are not eligible to compete in a prize 
competition.
 Federal contractors are eligible to participate, but may not 
use federal funds from a contract to develop submissions for an America 
COMPETES Act prize competition or to fund efforts in support of an 
America COMPETES Act prize competition. Costs associated with such 
activities are unallowable and are not allocable to government 
contracts.
 An individual shall not be deemed ineligible to win because 
the individual used federal facilities or consulted with federal 
employees during the Challenge provided that such facilities and/or 
employees, as applicable, are made available on an equitable basis to 
all individuals and teams participating in the Challenge.

    All questions regarding the Challenge should be directed to Dr. 
Robert Eisinger, identified above, and answers will be posted and 
updated as necessary at the Web site of the Challenge administered for 
NIH by Capital Consulting Corporation at http://www.cccinnovationcenter.com/challenges/antimicrobial-resistance-diagnostic-challenge/ under ``Frequently Asked Questions.'' Questions 
from Solvers that may reveal proprietary information related to 
solutions under development may be addressed in the Capital Consulting 
Corporation project room, an online secure and confidential 
communication forum.
    Submission Requirements: The Challenge has three steps (following 
registration and submission of a Letter of Intent), and specific 
submissions for each step.

[[Page 62153]]

    Step 1 (Theoretical)--Step 1 of the Challenge requires a written 
proposal that describes a potentially clinically significant, new, 
innovative, and cost effective, point-of-need in vitro diagnostic test 
for use in either an inpatient or outpatient setting that could allow 
health care providers to significantly inform clinical treatment 
decisions and be of significant clinical and public health utility to 
combat the development and spread of antibiotic resistant bacteria. For 
example:
    (1) More rapidly identify/detect the specific etiology drawn from a 
differential diagnosis of a particular clinical syndrome caused by any 
of the 18 drug resistant bacteria of highest concern which can be found 
in Table 3 of the National Action Plan for Combating Antibiotic 
Resistant Bacteria released in 2015;
    (2) more rapidly identify/detect, and characterize antibiotic 
susceptibility of at least one of the 18 drug resistant bacteria of 
highest concern which can be found in Table 3; and
    (3) detect biomarkers that would inform patient management 
decisions such as need for antibiotics or severity of infection.
    The Step 1 Submission shall include:
    1. A description sufficiently detailed for evaluation of the 
proposed solution in 10 pages or less including the next 4 bullets, 8.5 
x 11 inch page, 10-point or greater Arial, Palatino Linotype, or 
Georgia font and one inch margins including:

 A one-paragraph executive summary that clearly states the 
clinically significant concern being addressed and the specific 
intended use of the proposed diagnostic device;
 A description of the proposed in vitro diagnostic, and the 
development approach, challenges, and risks;
 A ``State-of-the-Art'' statement that describes: (1) 
Approaches currently in use (if any); (2) clearly explains how the 
methods and measures proposed will outpace/outperform current 
advancements; (3) will provide a useful tool for rapid clinical 
decision making; and (4) potentially quantifiable improvements beyond 
existing capabilities;
 A description of how Solvers plan to complete Step 2, 
including methods and technologies key to implementation. This should 
include estimated timeframe, supporting precedents, and a feasibility 
assessment and description of the Solver's ability to execute the 
proposed solution, including any unique resource(s) that may be needed. 
If relevant, the assessment of feasibility should also address 
Protections for Humans Subjects, compliance with policies related to 
the use of Vertebrate Animals, biosafety issues, and use of methods/
technologies covered by patents or other intellectual property 
protection, as applicable;
 All Step 1 Submitters also will need to provide an Executive 
Summary for public posting on the AMR Diagnostic Test Challenge Web 
site. Proprietary information should not be included in the Executive 
Summary, since this will be accessible to the general public.

    2. Optional Appendices describing existing, unpublished 
experimental data (if available) that support the proposed solution may 
be included. Please note that while a page limit is not placed on 
appendices, it is recommended that applicants be concise and include 
only relevant data in support of the solution. All information that is 
confidential/proprietary should be so indicated.
    Step 2 (Delivery of Prototype and Analytical Data)--All Step 1 
Semi-finalists will be eligible to participate as Step 2 Solvers in the 
second step of the Challenge to produce data generated using their 
solution and may include analytical and clinical data. In addition, 
entries will be accepted for Step 2 from Solvers that have not 
previously entered a submission for Step 1. However, if a Solver did 
not participate in Step 1, he/she must follow the requirements listed 
in the ``To Win'' section of this announcement. Step 2 Solvers will 
develop the proposed diagnostic solution(s) of Step 1 of the Challenge 
and submit (in the Step 2 submission) a prototype device and data 
supporting the ability of the in vitro diagnostic device to meet the 
target product profile (TPP) for analytical and performance 
characteristics in non-clinical testing (i.e., contrived specimens, 
panels, etc.), as well as confirmation of analytical performance (e.g., 
limit of detection, interference, inclusivity, etc.)
    Additional details on submission requirements for Step 2 of the 
Challenge will be available to Step 2 Solvers no later than 30 days 
after the Step 1 Semi-finalists are announced.
    At a minimum, the Step 2 submission shall include:
    1. Execution: Description of the successful generation of a 
prototype diagnostic test(s) that is based on the Step 1 solution, 
which may also include innovations, essential alterations in the 
original proposed plan, and/or technical or analytical challenges 
experienced or anticipated. Any changes from the original design (Step 
1 solution) should be documented and explained.
    2. Data: At a minimum, a summary of the analytical performance 
(limit of detection, inclusivity and exclusivity testing) demonstrated 
by non-clinical testing (i.e., contrived specimens or panels), and 
demonstrated progress or plans to achieving the target product profile.
    3. Detection of New Analyte/Biomarker: The Solvers should provide 
data to the judges that demonstrate the utility or potential utility of 
the test for clinical management. The extent and scope of these data 
are up to the Solver. The judges will assess the strength of these data 
in projecting the potential impact of the diagnostic test.
    Step 3 (Performance testing in CLIA-Certified Laboratories)--All 
Step 2 Semi-finalists will be eligible to participate in Step 3. 
Solvers in the third step of the Challenge will have their solutions 
(prototypes) evaluated in 2 independent CLIA-certified laboratories. 
The cost for the CLIA-certified laboratory testing will be incurred by 
the Challenge Sponsor, not the Solvers. This will permit an assessment 
of the performance of prototype in vitro diagnostics confirmed by 
independent testing. Step 3 Solvers will execute their proposed 
solution(s) to Step 2 of the Challenge and submit (in the Step 3 
submission) sufficient numbers of their solutions (prototype platforms 
and diagnostic test kits/reagents) for testing. The testing in these 
two independent laboratories will ensure the solution(s) demonstrate 
usability, stated time to result, appropriate analytical sensitivity/
specificity by non-clinical and/or clinical testing (i.e., contrived 
specimens or panels of drug resistant bacteria), as well as 
confirmation of analytical performance (e.g., limit of detection, 
interference, inclusivity, reproducibility, etc.) reported in the data 
submitted by solver in Step 2.
    Additional details on submission requirements for Step 3 of the 
Challenge will be available to Step 3 Solvers no later than 30 days 
after the Step 2 Semi-finalists are announced.
    The Step 3 submission requires each semi-finalist to submit:
    1. Project Description: Detailed description of materials, methods, 
personnel, resources, and schedule. Any changes from the original 
design (Step 2 solution) should be documented and explained.
    2. Execution: The Solvers selected for Phase 3 must provide two 
prototype instruments and sufficient numbers of the diagnostic test(s) 
based on the Step 2 solution for testing by the two CLIA-

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laboratories, as well as methodology/protocols to perform diagnostic 
testing using the prototypes.
    Registration and Submission Process for Solvers: To register and 
submit for this Challenge, Solvers may access the registration and 
submission platform from any of the following:

 Access the www.challenge.gov Web site and search for 
``Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test.''
 Access the Antimicrobial Resistance Rapid, Point-of-Need 
Diagnostic Test Web site; a registration link for the Challenge can be 
found on the landing page under ``Challenge Description.''
 Access the Web site of the Challenge administered for NIH by 
Capital Consulting Corporation at http://www.cccinnovationcenter.com/challenges/antimicrobial-resistance-diagnostic-challenge/.

Amount of the Prize

Step 1: Up to $50,000 per semi-finalist (maximum of 20 semi-finalists)
Step 2: up to $100,000 per semi-finalist (maximum of 10 semi-finalists)
Step 3: equal to or greater than $18,000,000 to be divided among a 
maximum of 3 awardees based on the number of prizes awarded to Step 1 
and 2 semi-finalists from a total pool of $20,000,000.
    As determined by the judges, the number of prizes will be 
determined for the Step 1 and 2 Semi-finalists and Step 3 winner(s) 
from a total pool of $20,000,000.
    The NIH and the BARDA reserve the right to cancel, suspend, and/or 
modify this Challenge at any time through amendment to this Federal 
Register notice. In addition, the NIH and the BARDA reserve the right 
to not award any prizes if no solutions are deemed worthy. The award 
approving official for Step 3 of this Challenge is the Secretary, 
Department of Health and Human Services (HHS).
    Basis upon Which Winners Will Be Evaluated: Solutions for all steps 
of the Challenge will be evaluated by a Technical Evaluation Panel 
using the criteria and rating scales describe below. Additionally, the 
BARDA scientific staff and the NIH scientific staff from the various 
NIH Institutes and Centers (ICs), including the Division of Program 
Coordination, Planning, and Strategic Initiatives (DPCPSI) of the NIH 
Office of the Director, will review highly rated solutions for 
scientific alignment with the National Action Plan for Combating 
Antibiotic Resistant Bacteria goal for a rapid, point-of-need 
diagnostic test that has the ability or potential to improve clinical 
decision making such that antibiotic use and/or outcomes of patients 
infected with drug resistant pathogens are fundamentally improved 
compared to current standard of care and/or reduce transmission of drug 
resistant pathogens. Specific examples could include allowing health 
care providers to: (1) Rapidly identify/detect one or more of the 18 
drug resistant bacteria of highest concern which can be found in Table 
3 of the National Action Plan for Combating Antibiotic Resistant 
Bacteria or (2) detect biomarkers that would inform patient management 
decisions, such as need for antibiotics or severity of infection.
    The Judging Panel will determine which of the diagnostic test 
solutions are of relevance to the BARDA's and NIH's missions, and the 
degree of innovation advancing existing clinical diagnostics. Three 
judges, comprising senior leadership from the BARDA and the NIH, will 
use the technical and programmatic evaluations to determine the Step 1 
semi-finalists, those Solvers in Step 1 who are deemed meritorious; the 
Step 2 semifinalists, those Solvers in Step 2 who are deemed 
meritorious; and the Step 3 prize winner(s). Prizes will be approved by 
the Secretary, Department of Health and Human Services.
    Step 1 (Theoretical)--The Technical Evaluation Panel will use the 
following criteria and rating scales for evaluating proposed solutions 
with high scores reflecting the mostly highly rated solutions:
    1. Innovation. Clearly demonstrates novel and innovative technology 
and/or approaches outpacing the current state-of-the-science.
    2. Clinical significance. Implementation of the proposed in vitro 
diagnostic test supports improved clinical decision making and thus 
decreases antibiotic resistance.
    3. Diagnostic Performance. The proposed in vitro diagnostic test is 
anticipated to have performance characteristics (e.g., sensitivity, 
specificity) relevant to its intended use and consistent with and 
support by proposed approaches and prior evidence.
    4. Feasibility. Likelihood, based on scientific concept, existing 
data, technological capability, and resources that the proposed in 
vitro diagnostic test can be successful as a commercial diagnostic 
system.
    5. Time to test result. The proposed in vitro diagnostic test 
produces actionable results (from the time that a sample is collected 
from a patient to the time that the result is available to the 
healthcare provider) relevant to its intended use (inpatient, 
outpatient, reduction in time compared to existing methods).
    6. Setting and Ease of Use. The proposed in vitro diagnostic test 
is intended for use in inpatient and/or outpatient settings. The 
proposed solution should account for: A settings particular 
availability of equipment and personnel, that will affect what 
specimens can be collected (i.e., sample matrix), stored, processed, 
and analyzed; what level of training is required to operate the device; 
what disposable materials are required; and how dependent the test will 
be on other types of equipment. These factors may affect an in vitro 
diagnostic test's ease of use or otherwise limit its utility. Plan for 
advancing to Step 2 of the competition.
    Step 2 (Delivery of Prototype and Analytical Data)--Additional 
details on evaluation criteria will be provided later. Step 2 
submissions must provide a clear description of how experiments were 
conducted (including use of appropriate controls, instrument 
calibration, etc.), how the data were collected, and how analytical 
performance was assessed. Step 2 submissions must include all requisite 
scientific and technical details including materials, methods, 
protocols, and devices to demonstrate successful execution of the 
proposed solution. Has test reproducibility been demonstrated? What 
improvements and/or innovations were implemented above and beyond what 
was proposed in Step 1?
    The Technical Evaluation Panel will use the following criteria and 
rating scales for evaluating proposed Step 2 solutions, with high 
scores reflecting the mostly highly rated solutions.
    1. Innovation. Must be clearly novel and innovative technology 
representing an advance beyond the current state-of-the-science.
    2. Clinical significance. Clinical significance of the diagnostic 
use and likelihood that implementation would contribute to decreasing 
antibiotic resistance.
    3. Diagnostic Performance. The performance characteristics (e.g., 
sensitivity, specificity, positive predictive value, and negative 
predictive value) required of the proposed in vitro diagnostic test in 
order for it to have significant utility in combating antibiotic 
resistance.
    4. Feasibility. Likelihood, based on scientific concept, existing 
data, technological capability, and resources that the proposal can be 
successful at the end of Step 3 of this competition. Time to test 
result. The development of an effective in vitro diagnostic test that 
rapidly produces results (from the time

[[Page 62155]]

that a sample is collected from a patient to the time that the result 
is available to the healthcare provider) relevant to its intended use 
(inpatient, outpatient, reduction in time compared to existing 
methods). It is anticipated that all proposals will have a maximum 
result time of 90 minutes.
    5. Setting and Ease of Use. The settings or venues in which the 
proposed point-of-need in vitro diagnostic test may be most needed for 
combating antibiotic resistance. The development of an effective in 
vitro diagnostic test that is easy to use in either an inpatient and/or 
outpatient setting. The proposed solution should require limited, if 
any, specimen processing. Test complexity, as assessed by applicability 
for over-the-counter, outpatient (i.e., CLIA-waived), or hospital-based 
settings (i.e., moderately complex CLIA laboratories) will be 
considered. Recognizing that diagnostics often require specialized 
equipment for sample storage, processing and/or analysis, 
considerations about how such specialized equipment may affect an in 
vitro diagnostic test's ease of use or otherwise limit its utility.
    6. Sample matrix. The development of an effective in vitro 
diagnostic test that uses human samples (e.g., blood, urine, sputum, 
tissue fluid, multiple or other sample specimens).
    7. Throughput. Methods that describe the ability to process more 
than one specimen simultaneously.
    8. Data Content. Methods that promote the collection and 
integration of multiple types of data (e.g., biochemical, physiologic, 
morphological, or `omics-level analyses) on diagnostics for one or more 
of the 18 drug resistant bacteria referenced previously or 
differentiates between viral and bacterial infections will be rated 
more favorably.
    Step 3 (Performance testing)--Step 3 submitters must provide the 
diagnostic device(s), any ancillary devices, procedure for using the 
device and interpreting the results, and controls for testing. Specimen 
panels will be provided by the Challenge sponsors.
    The Technical Evaluation Panel will use the following criteria and 
rating scales for evaluating proposed Step 3 solutions, with high 
scores reflecting the mostly highly rated solutions:
    1. Must be clearly novel and innovative technology representing an 
advance beyond the current state-of-the-science.
    2. Likelihood of improving the use of antibiotics in patients.
    3. Diagnostic performance. The performance characteristics (e.g., 
sensitivity, specificity, positive predictive value, and negative 
predictive value) of the in vitro diagnostic test using the prototype 
and likely impact of the performance on utility in combating antibiotic 
resistance.
    4. Sample matrix. The development of an effective in vitro 
diagnostic test that uses human samples (e.g., blood, urine, sputum, 
tissue fluid, multiple or other sample specimens).
    5. Time to test result. The development of an effective in vitro 
diagnostic test that rapidly produces results. Specifically, what would 
be the maximum acceptable time-to-result for an in vitro diagnostic 
test to be of significant utility (i.e., from the time that a sample is 
collected from a patient to the time that the result is available to 
the healthcare provider).
    6. Setting and Ease of Use. The settings or venues in which the 
proposed point-of-need in vitro diagnostic test may be most needed for 
combating antibiotic resistance. The development of an effective in 
vitro diagnostic test that is easy to use. Recognizing that diagnostics 
often require specialized equipment for sample storage, processing and/
or analysis, considerations about how such specialized equipment may 
affect an in vitro diagnostic test's ease of use or otherwise limit its 
utility.
    As part of the evaluation process, the panel may request a 
demonstration of the technology.

Additional Requirements

    Each individual (whether participating singly or in a group) or 
entity agrees to follow all applicable federal, state, and local laws, 
regulations, and policies.
    Each individual (whether participating singly or in a group) or 
entity participating in this Challenge must comply with all terms and 
conditions of these rules, and participation in this Challenge 
constitutes each such participant's full and unconditional agreement to 
abide by these rules. Winning is contingent upon fulfilling all 
requirements herein.
    Intellectual Property: By submitting the Submission, each Solver 
warrants that he or she is the sole author and owner of any 
copyrightable works that the Submission comprises, that the works are 
wholly original with the Solver (or is an improved version of an 
existing work that the Solver has sufficient rights to use and 
improve), and that the Submission does not infringe any copyright or 
any other rights of any third party of which Solver is aware.
    To receive an award, Solvers will not be required to transfer their 
exclusive intellectual property rights to the NIH or ASPR. Instead, 
Solvers must grant to the federal government a nonexclusive license to 
practice their solutions and use the materials that describe them. To 
participate in the Challenge, each Solver must warrant that there are 
no legal obstacles to providing a nonexclusive license of Solver's 
rights to the federal government. This license must grant to the United 
States government a nonexclusive, nontransferable, irrevocable, paid-up 
license to practice or have practiced for or on behalf of the United 
States throughout the world any invention made by the Solvers that 
covers the Submission. In addition, the license must grant to the 
federal government and others acting on its behalf, a fully paid, 
nonexclusive, irrevocable, worldwide license in any copyrightable works 
that the Submission comprises, including the right to reproduce, 
prepare derivative works, distribute copies to the public, and perform 
publicly and display publicly said copyrightable works.
    Liability and Indemnification: By participating in this Challenge, 
each Solver agrees to assume any and all risks and waive claims against 
the federal government and its related entities, except in the case of 
willful misconduct, for any injury, death, damage, or loss of property, 
revenue, or profits, whether direct, indirect, or consequential, 
arising from participation in this Challenge, whether the injury, 
death, damage, or loss arises through negligence or otherwise. By 
participating in this Challenge, each Solver agrees to indemnify the 
federal government against third party claims for damages arising from 
or related to Challenge activities.
    Insurance: Based on the subject matter of the Challenge, the type 
of work that it will possibly require, as well as an analysis of the 
likelihood of any claims for death, bodily injury, or property damage, 
or loss potentially resulting from competition participation, Solvers 
are not required to obtain liability insurance or demonstrate financial 
responsibility in order to participate in this Challenge.
    Privacy, Data Security, Ethics, and Compliance: Solvers are 
required to identify and address privacy and security issues in their 
proposed projects and describe specific solutions for meeting them. In 
addition to complying with appropriate policies, procedures, and 
protections for data that ensures all privacy requirements and 
institutional policies are met, use of data should not allow the 
identification

[[Page 62156]]

of the individual from whom the data was collected.
    Solvers are responsible for compliance with all applicable federal, 
state, local, and institutional laws, regulations, and policies. These 
may include, but are not limited to, Health Information Portability and 
Accountability Act (HIPAA) protections, Department of Health and Human 
Services (HHS) Protection of Human Subjects regulations, and Food and 
Drug Administration (FDA) regulations. If approvals (e.g., from an 
Institutional Review Board) will be required to initiate project 
activities in Step 2, it is recommended that Solvers apply for approval 
at or before the Step 1 submission deadline. The following links are 
intended as a starting point for addressing potentially applicable 
regulatory requirements but should not be interpreted as a complete 
list of resources on these issues:

HIPAA

    Main link: http://www.hhs.gov/ocr/privacy/index.html.
    Summary of the HIPAA Privacy Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html.
    Summary of the HIPAA Security Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html.

Human Subjects--HHS

    Office for Human Research Protections: http://www.hhs.gov/ohrp/index.html.
    Protection of Human Subjects Regulations: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
    Policy & Guidance: http://www.hhs.gov/ohrp/policy/index.html.
    Institutional Review Boards & Assurances: http://www.hhs.gov/ohrp/assurances/index.html.

Human Subjects--FDA

    Clinical Trials: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.
    Office of Good Clinical Practice: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018191.

Consumer Protection--Federal Trade Commission

    Bureau of Consumer Protection: http://business.ftc.gov/privacy-and-security.
    Challenge Judges: Senior leadership of the DPCPSI of the Office of 
the Director of NIH; the National Institute of Allergy and Infectious 
Diseases (NIAID), NIH; and BARDA, ASPR.

Acknowledgements

    The Antimicrobial Resistance Diagnostic Working Group would like to 
thank the following Subject Matter Experts for providing guidance as 
BARDA and NIH staff developed this Challenge.
    NIAID staff including Ann Eakin, Ph.D. and Randall Kincaid, Ph.D.
    FDA staff including Steven Gitterman, M.D., Ph.D. and Jennifer 
Ross, Ph.D., J.D.
    CDC staff including Jean Patel, Ph.D., D (ABMM).

    Dated: August 3, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-21328 Filed 9-7-16; 8:45 am]
 BILLING CODE 4140-01-P