[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