[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Pages 31402-31404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13113]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Announcement for Request for Comment for: Antimicrobial 
Resistance Rapid, Point-of-Care Diagnostic Test Challenge

    Authority: 15 U.S.C. 3719

SUMMARY: The U.S. Department of Health and Human Services (HHS) intends 
to hold a prize competition in which up to $20 million will be made 
available, subject to the availability of funds, for the delivery of 
one or more successful rapid point-of-care diagnostics that may be used 
by health care providers to identify bacterial infections. The National 
Institutes of Health (NIH) and the Biomedical Advanced Research and 
Development Authority (BARDA) are sponsoring the prize competition, and 
seek public comments regarding the technical criteria and performance 
characteristics of the diagnostic(s) for which the prize(s) will be 
offered.

DATES: Submission Period begins June 2, 2015, 9:00 a.m. EST. Submission 
Period ends 5 p.m. EST July 17, 2015.

ADDRESSES: Comments can be sent to https://www.challenge.gov.

FOR FURTHER INFORMATION CONTACT: Robert W. Eisinger, Ph.D., National 
Institutes of Health, Division of Program Coordination, Planning, and 
Strategic Initiatives, Telephone: 301-496-2229, 
Email:[email protected].

SUPPLEMENTARY INFORMATION: On September 18, 2014, the President issued 
Executive Order 13676 on Combating Antibiotic-Resistant Bacteria 
(https://www.whitehouse.gov/the-press-office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria) and the Antimicrobial 
Resistance Challenge was called for in the accompanying White House 
Fact Sheet https://www.whitehouse.gov/the-press-office/2014/09/18/fact-sheet-obama-administration-takes-actions-combat-antibiotic-resistan). 
The development and use of rapid, point-of-care, and innovative 
diagnostic tests for

[[Page 31403]]

identification and characterization of resistant bacteria was a goal 
identified in the National Strategy for Combating Antibiotic-Resistant 
Bacteria released in September 2014 (https://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf) and addressed in the 
National Action Plan for Combating Antibiotic-Resistant Bacteria 
released in March 2015 (https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf).
    In conformance to the above documents, the NIH and BARDA are 
sponsoring a prize competition, and the Food and Drug Administration 
(FDA) and the Centers for Disease Control and Prevention (CDC) are 
contributing technical and regulatory expertise to develop the award 
evaluation process.
    The aim of the prize competition is to incentivize the development 
of one or more in vitro diagnostic tests that would be of significant 
clinical and public health utility to combat the development and spread 
of antibiotic resistant bacteria. For example, such a diagnostic test 
could be used by health care providers to identify bacterial infections 
in patients to help guide their decisions about the necessity of 
prescribing antibiotics, and if so, which antibiotics may be 
effective--thus promoting antibiotic stewardship. Another important 
diagnostic use could be to facilitate clinical trials for new 
antibacterial products by allowing for the enrichment of patient 
populations with specific infections, thus advancing the development of 
new antibacterial agents. The prize-winning diagnostic(s) must exhibit 
a set of predefined technical criteria and performance characteristics 
based on the intended use(s).
    When exercising prize authority under the America COMPETES Act, 
agencies are to ``consult widely both within and outside the federal 
Government'' when developing prize competitions. As such, HHS is 
seeking input from the medical, public health, and scientific 
communities; the pharmaceutical and medical diagnostic sectors; 
patients and other advocacy groups; and the public at-large in order to 
receive broad input on the type(s) of diagnostic(s) that may be 
developed in an appropriate time frame to be of significant utility in 
combating the development and spread of antibiotic resistant bacteria.
    At this time, HHS is seeking comments on the topics identified 
below as they pertain to a rapid, point-of-care diagnostic test(s) that 
could be developed in an appropriate time frame to be of significant 
clinical and public health utility in combating the development and 
spread of antibiotic resistant bacteria. A prioritized list of 18 
bacteria of highest concern can be found in Table 3 of the National 
Action Plan (https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf). 
The comment period will be open for 45 days from the publication of 
this request for information (RFI). Input received during this 45-day 
comment period and during the subsequent public consultation will be 
used by HHS to develop the technical criteria and performance 
characteristics of the diagnostic(s) for which the prize(s) will be 
offered. The design of the Challenge will take into account previous 
guidance obtained in the aforementioned National Strategy and National 
Action Plan to combat antibiotic resistant bacteria. Comments can be 
submitted to the discussion board for this Challenge accessible on 
https://www.challenge.gov.
    This web-based discussion board also provides an open forum for 
discussion of this prize competition. The online community is open to 
the public and will allow for a broad and interactive discussion of the 
topics covered by this RFI. This platform will allow users to submit 
ideas about a desired diagnostic test and to comment on the ideas that 
have been submitted by others.
    Comments may include, but are not limited to, the following topic 
areas:
    1. Purpose. The purpose(s) or function(s) a rapid, point-of-care in 
vitro diagnostic test that would be of significant utility to the 
clinical and public health communities in combating antibiotic 
resistance. Comments may reflect considerations about in vitro 
diagnostic tests that distinguish between bacterial and viral 
infections, or that identify specific bacterial pathogens and/or their 
drug susceptibility in patients.
    2. Characterizing drug susceptibility. The development of an 
effective in vitro diagnostic test that can identify whether bacterial 
pathogens are resistant and/or sensitive to certain clinically relevant 
antibiotics, and thus would be of significant utility in combating 
antibiotic resistance. Examples may be provided.
    3. Sample matrix. The development of an effective in vitro 
diagnostic test that identifies pathogens by testing human samples 
(e.g., blood, urine, sputum, tissue fluid, multiple or other sample 
specimens). Comments may include what type or types of samples would be 
most relevant in identifying pathogens and/or antibiotic 
susceptibility.
    4. Speed. The development of an effective in vitro diagnostic test 
that rapidly produces results. Comments may reflect considerations 
about 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).
    5. Setting. The settings or venues in which the proposed point-of-
care in vitro diagnostic test may be most needed for combating 
antibiotic resistance.
    6. Ease-of-use. 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, 
comments also may include considerations about how such specialized 
equipment may affect an in vitro diagnostic test's ease of use or 
otherwise limit its utility. Comments also may include considerations 
about the nature and extent of training that would be necessary to 
operate and obtain results from the proposed in vitro diagnostic test.
    7. 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 combatting antibiotic 
resistance.
    8. Tradeoffs. Any inherent tradeoffs associated with the 
performance characteristics/parameters described in connection with 
your previous comments and priority of the characteristics/parameters, 
if applicable.
    9. Cost. The development of an effective in vitro diagnostic test 
that is not cost prohibitive for its intended purpose. Cost and cost 
considerations may include what price or price range would be desirable 
to support the widespread adoption of an in vitro diagnostic test that 
will be effective in combating antibiotic resistant bacteria.
    10. Other characteristics. Additional characteristics of the 
proposed in vitro diagnostic test that would be of significant value.
    11. Key technologies. The specific technologies or disciplines, 
current or nascent, which would lend themselves to the development of a 
successful in vitro diagnostic test including, for example, what 
special considerations, advantages, and disadvantages may be associated 
with each technology/discipline. Comments on what timeframe would be 
considered reasonable for the development and licensure of a successful 
in vitro diagnostic test are also welcome.

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    12. Interest. Major factors that may influence a person's decision 
to compete in the prize competition described in this information 
request.
    13. Use. Identification of who is likely to purchase and/or use the 
type of in vitro diagnostic tests being targeted by this prize 
competition and how or where such a purchaser or user is most likely to 
use the in vitro diagnostic test. Examples may be provided (e.g., 
patient/self-diagnosis, guiding prescriptive decisions, etc.).
    14. Barriers. Major barriers that may impede development of the 
proposed in vitro diagnostic test (e.g., technical or research driven; 
financial or regulatory; infrastructure or resource based). Comments 
may reflect considerations about what potential solutions, if any, may 
be available to overcome such barriers and the level of difficulty 
associated with implementing any such solution in the U.S. and/or 
globally.

    Dated: May 26, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015-13113 Filed 6-1-15; 8:45 am]
 BILLING CODE 4140-01-P