Notice Number: NOT-OD-15-104
Release Date: June 2, 2015
Response Date: Friday, July 17, 2015
National Institutes of Health (NIH)
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.
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, 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:
Submission Period begins Tuesday, June 2, 2015, 9:00am EST. Submission Period ends 5:00 pm EST Friday, July 17, 2015.
Comments can be sent to https://www.challenge.gov.
Please direct all inquiries to:
Robert W. Eisinger, Ph.D.,
National Institutes of Health, Division of Program Coordination, Planning, and Strategic Initiatives