[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
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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