[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54300-54301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Announcement of Public Consultation on 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 
will convene a public consultation to seek comments regarding the 
technical criteria and performance characteristics of the diagnostic(s) 
for which the prize(s) will be offered.

DATES: The public consultation will be held on October 7, 2015, 8:30 
a.m. to 3:30 p.m. PDT. Written comments can be submitted to the https://www.challenges.gov Web site for this competition beginning on October 
1 at 8:30 a.m. EDT to October 6, 2015 at 5:00 p.m. EDT.

ADDRESSES: The public consultation will be held at the Marriott Marquis 
San Diego Marina, 333 West Harbor Drive, San Diego, California, 92101.

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 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 
(http://www.gpo.gov/fdsys/pkg/PLAW-111publ358/html/PLAW-111publ358.htm), 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.
    HHS has previously issued a Request for Information (RFI) to obtain 
comments on several topics 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

[[Page 54301]]

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). 
Input received from the RFI and during the 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.
    The agenda of the public consultation meeting will be devoted to 
presentations and discussions on the objectives and criteria for the 
antimicrobial diagnostic challenge competition. Presentations will 
focus on the need for rapid diagnostics to address antimicrobial 
resistance; development and use of rapid diagnostics for drug resistant 
microorganisms; pathogen/resistance markers identification versus 
phenotypic susceptibility; antibiotic stewardship in the clinical 
setting; and regulatory perspectives on rapid diagnostic development.
    Any interested person may submit written comments to be considered 
during the public consultation to the discussion board for this 
Challenge accessible on https://www.challenge.gov. This statement 
should include your name, address, telephone number and when 
applicable, the business or professional affiliation. Written comments 
can be submitted from October 1, 2015 at 8:30 a.m. EDT to October 6, 
2015 at 5:00 p.m. EDT.
    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 public consultation. 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.

    Dated: September 1, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015-22690 Filed 9-8-15; 8:45 am]
 BILLING CODE 4140-01-P