[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Notices]
[Pages 57110-57112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22682]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1287]


Announcement of Requirements and Registration for the 2014 Food 
and Drug Administration Food Safety Challenge

    Authority:  15 U.S.C. 3719.

AGENCY: Food and Drug Administration, HHS.
    Award Approving Official: Erik Mettler, Deputy Associate 
Commissioner, Food and Drug Administration/Office of Foods and 
Veterinary Medicine.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 2014 
FDA Food Safety Challenge, a prize competition under the America 
COMPETES Reauthorization Act of 2010. The 2014 FDA Food Safety 
Challenge is an effort to advance breakthroughs in foodborne pathogen 
detection, specifically with the goal of accelerating the detection of 
Salmonella in fresh produce. As FDA's food safety program incorporates 
preventive control measures through the implementation of the FDA Food 
Safety Modernization Act, quicker detection of these harmful bacteria 
will help to prevent foodborne illnesses.

DATES: 
    1. Phase I submission period: September 23 to November 9, 2014.
    2. Phase II judging of submissions and selection of finalists: 
November 10, 2014, to January 6, 2015.
    3. Phase III field accelerator, inclusive of finalist mentorship, 
boot camp, and demo day: January 8 to March 5, 2015.
    4. Phase IV final judging: March 5 to March 11, 2015.
    5. Winner(s) announced: March 12, 2015.

FOR FURTHER INFORMATION CONTACT: Chad P. Nelson, Office of Foods and 
Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 301-796-4643.

SUPPLEMENTARY INFORMATION:

I. Background

    While the American food supply is among the safest in the world, 
the Centers for Disease Control and Prevention (CDC) estimates that 1 
in 6 Americans is sickened by foodborne illness annually, resulting in 
about 3,000 deaths each year. It is estimated that the overall negative 
economic impact of foodborne illness in the United States, including 
medical costs, quality-of-life losses, lost productivity, and lost-life 
expectancy, may be as high as $77 billion per year. Salmonella 
represents the leading cause of deaths and of hospitalizations related 
to foodborne illness. Contaminated produce is responsible for nearly 
half of foodborne illnesses and almost a quarter of foodborne-related 
deaths.
    The 2014 FDA Food Safety Challenge is a call to scientists, 
academics, entrepreneurs, and innovators from all disciplines to submit 
concepts applying novel and/or advanced methodologies to foster 
revolutionary improvements in foodborne pathogen detection.

[[Page 57111]]

Specifically, concepts should apply cutting-edge techniques to achieve 
significant improvements in the speed of the FDA's detection methods 
for Salmonella with identification to the subtype/serovar level in 
minimally processed fresh produce. FDA is most interested in concepts 
that explore the acceleration or elimination of sample preparation and/
or enrichment in the testing process, and/or those that employ novel or 
revolutionary techniques to achieve pathogen detection. Concepts may 
combine new techniques with existing methodologies, such as polymerase 
chain reaction, and must describe where time savings are achieved in 
the testing process as well as the expected time from unprepared food 
sample to verifiable result.
    The statutory authority for this challenge competition is section 
105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-
358).

II. Subject of the Challenge Competition

    The primary goal of the challenge is to advance breakthroughs in 
foodborne pathogen detection, specifically to significantly accelerate 
detection of Salmonella in produce, in order to support FDA's effort to 
ensure the safety of America's food supply.
    The secondary goals of the challenge are:
     To bring new innovators to FDA's foodborne pathogen 
testing processes;
     To increase public awareness about food safety, foodborne 
pathogen testing, and FDA's role in those areas; and
     To promote open government and citizen participation to 
improve innovation in the Federal Government.
    This challenge is designed to solicit breakthrough solutions from 
advanced scientific and research areas, such as, but not limited to 
metagenomics (or other next-generation sequencing methods), 
spectroscopy, application of nanotubes/nanotechnology, quantum 
detection methods, and electrical detection methods. Although concepts 
must specifically be able to address the detection of Salmonella, with 
identification to the subtype/serovar level, in minimally processed 
fresh produce, the ability of the solution to address testing for other 
microbial pathogens and in other foods or complex matrices is 
encouraged. Submissions must describe how the technique would increase 
speed of pathogen detection efforts (starting from an unprepared food 
sample, through verification of pathogen(s)) without sacrificing 
specificity and sensitivity or comparability reference methods. FDA is 
most interested in methods that would accelerate or eliminate sample 
preparation and/or enrichment in the testing process. Submitted 
concepts can be targeted at any point in the food system (i.e. harvest, 
packaging, distribution, point of sale, etc.), however concepts should 
specify which point(s) they are targeting and how the technique would 
be implemented. Though submissions may be theoretical in terms of 
application to food safety, all entries must be able to demonstrate a 
path to practical development of their concept and a plan to move to 
proof of concept over the course of the challenge. Submissions should 
include relevant data with reference to use of the concept/technique, 
such as any initial verification results, any available proof of 
concept, or relevant data from the technique's use in adjacent 
industries. During the field accelerator phase, which will include a 
live boot camp, finalists will refine their submissions with the 
assistance of FDA food safety and pathogen testing experts. Feedback 
will focus on helping finalists to clarify their concepts and ensure 
they are in line with FDA's needs and capabilities, maximize impact on 
food safety, and can be reasonably executed. At the end of the field 
accelerator phase, finalists will present their refined concepts to the 
judges at a demo day and provide a final report describing how their 
submission was modified based on the feedback from FDA subject matter 
experts.

III. Eligibility Rules for Participating in the Competition

    To be eligible to win a prize under this challenge, an individual 
or entity:
     Must have entered a submission on 
www.foodsafetychallenge.com under the rules promulgated by FDA.
     Must have complied with all the requirements under this 
section.
     Must be (1) an individual or team of U.S. citizens or 
permanent residents of the United States each of whom are 18 years of 
age and over or (2) an entity incorporated in and maintaining a primary 
place of business in the United States. Foreign citizens can 
participate as employees of an entity that is properly incorporated in 
the United States and maintains a primary place of business in the 
United States.
     May not be a Federal entity or Federal employee acting 
within the scope of their employment. An individual or entity shall not 
be deemed ineligible because the individual or entity used Federal 
facilities or consulted with Federal employees during a competition if 
the facilities and employees are made available to all individuals and 
entities participating in the competition on an equitable basis.
    Federal grantees may not use Federal funds to develop COMPETES Act 
challenge applications unless consistent with the purpose of their 
grant award. Federal contractors may not use Federal funds from a 
contract to develop COMPETES Act challenge applications or to fund 
efforts in support of a COMPETES Act challenge submission.
    Employees of FDA, the U.S. Department of Agriculture's Food Safety 
and Inspection Service, the CDC, Luminary Labs, LLC, each of their 
affiliates, and/or any other individual or entity associated with the 
development, evaluation, or administration of the challenge as well as 
members of such persons' immediate families (spouses, children, 
siblings, parents), and persons living in the same household as such 
persons, whether or not related, are not eligible to participate in the 
challenge.
    Entrants must agree to assume any and all risks and waive claims 
against the Federal Government and its related entities, except in the 
case of willful misconduct, for any injury, death, damage, or loss of 
property, revenue, or profits, whether direct, indirect, or 
consequential, arising from their participation in a competition, 
whether the injury, death, damage, or loss arises through negligence or 
otherwise.
    Entrants must also agree to indemnify the Federal Government 
against third-party claims for damages arising from or related to 
competition activities.
    Entrants are not required to obtain liability insurance or 
demonstrate financial responsibility in order to participate in the 
challenge.
    By participating in the challenge, each entrant who works with 
pathogenic organisms such as Salmonella in support of its submission 
agrees to follow the requirements for Biosafety Level II laboratory 
operations, as outlined in the 5th edition of ``Biosafety in 
Microbiological and Biomedical Laboratories,'' available at http://www.cdc.gov/biosafety/publications/bmbl5/.

IV. Registration Process for Participants

    To register for the 2014 FDA Food Safety Challenge, participants 
can access http://foodsafetychallenge.com/ and click on Submission 
Form.

V. Amount of the Prize

    The total prize pool for the 2014 FDA Food Safety Challenge is 
$500,000. From the $500,000 prize pool, up to 5 finalists will be 
awarded $20,000 each following the open submission phase and judging of 
submissions. After the field accelerator phase and final

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judging, the winner(s) will receive the remainder of the prize money.

VI. Payment of the Prize

    Prizes awarded under this competition will be paid by electronic 
funds transfer and may be subject to Federal income taxes. FDA will 
comply with the Internal Revenue Service withholding and reporting 
requirements, where applicable.

VII. Basis Upon Which Winner(s) Will Be Selected

    A panel of expert judges will select up to five finalist teams from 
the pool of eligible entries. These finalists will then refine their 
concepts during the field accelerator phase and will present the 
concept at demo day. The judging will be based and scored upon the 
judges' own discretion as to the quality of each entry according to the 
following finalist evaluation criteria, with equal weighting (i.e., 20 
percent for each).

A. Finalist Evaluation Criteria

     Speed: Proposed reduction in time from unprepared food 
sample to verified pathogen to subtype/serovar level for Salmonella in 
fresh, minimally processed produce. The ability of the solution to also 
address testing in other foods and other complex matrices is 
encouraged. The ability of the technique to also address additional 
pathogens such as Shiga toxin-producing Escherichia coli is encouraged.
     Improved detection and path to impact: Strength of 
evidence, data, and/or argumentation regarding the application of 
submission's technique to create impactful acceleration and improvement 
of foodborne pathogen detection, inclusive of improvements in 
specificity and sensitivity for Salmonella and possibly other 
pathogens.
     Applicability: Applicability of solution to FDA testing 
processes.
     Revolutionary: Whether the concept would be a 
revolutionary improvement over the FDA's current testing procedures 
with potential to make a major impact on food testing.
     Execution: Perceived ability of submitting team or 
individual to execute and develop their concept.

B. Winner Selection Criteria

    Winner selection criteria will include finalist evaluation criteria 
plus the following criterion: Demonstration of team's/individual's 
ability to effectively iterate and improve their concept over the 
course of the field accelerator phase.

VIII. Additional Information

    FDA reserves the right to suspend, postpone, terminate, or 
otherwise modify the challenge, or any entrant's participation in the 
challenge, at any time at FDA's discretion.

IX. Intellectual Property

    Entrants retain ownership of their concepts, including any 
software, research, or other intellectual property that they develop in 
connection therewith, subject to the license granted to FDA to use 
publicly posted materials as set forth herein. By participating in the 
challenge, each entrant hereby irrevocably grants to FDA and Luminary 
Labs, LLC, a limited, non-exclusive, royalty free, worldwide license 
and right to reproduce, publicly perform, publicly display, and use the 
submission to the extent necessary to administer the challenge, and to 
publicly perform and publicly display the submission abstract, 
including, without limitation, for advertising and promotional purposes 
relating to the challenge.
    Entrants retain all rights in the submission and any invention or 
work, including any software, submitted as part of the submission, 
subject to the following:
     A nonexclusive, nontransferrable, irrevocable, paid-up 
license to practice or have practiced for or on behalf of the United 
States any such invention or work throughout the world, should the 
submission win; and
     A license in the submission or work submitted as part of 
the submission for the United States to use, disclose, reproduce, 
prepare derivative works, distribute copies to the public, and perform 
publicly and display publicly, in any manner and for any purpose, and 
to have or permit others to do so, should the submission win.

    Dated: September 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22682 Filed 9-23-14; 8:45 am]
BILLING CODE 4164-01-P