[Federal Register Volume 79, Number 167 (Thursday, August 28, 2014)]
[Notices]
[Pages 51340-51341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20428]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Announcement of Requirements and Registration for the Culture-
Independent Straintyping and Characterization Challenge
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
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Authority: 15 U.S.C. 3719.
Award Approving Official: Thomas R. Frieden, MD, MPH, Director,
Centers for Disease Control and Prevention, and Administrator, Agency
for Toxic Substances and Disease Registry.
SUMMARY: The Centers for Disease Control and Prevention (CDC) located
within the Department of Health and Human Services (HHS) launches a
challenge competition for the development of a method or process to
accurately and efficiently identify, subtype, and characterize
pathogenic microorganisms directly from clinical or environmental
samples without the need for culture or culture-based enrichment.
Laboratory-based infectious disease surveillance programs, such as
PulseNet, the National Tuberculosis Surveillance System, and the Active
Bacterial Core Surveillance program, rely on primary culture and
microbiologic testing in community hospital and clinical laboratories.
A new generation of non-culture-based diagnostic tests are now
beginning to enter the marketplace offering physicians faster results
and, in some cases, more types of information than were previously
available. Unfortunately, these new tests do not typically result in
isolates being available for public health purposes, and, as their use
continues to grow, it will likely become increasingly difficult or
impossible to detect and investigate outbreaks or other important
infectious disease trends. New laboratory approaches that do not depend
on isolates or culture for subtyping and characterization of microbes
are needed to maintain and improve important public health activities
across a range of pathogenic organisms.
The Culture-Independent Straintyping and Characterization Challenge
is an opportunity to develop novel approaches to identifying and
characterizing pathogens similar to normal flora in a complex matrix in
a process that does not require any culture, including pre-enrichment.
Straintyping and characterization of the Shiga toxin-producing
Escherichia coli (STEC) from clinical stool samples represents a
significant challenge and has been selected as the target organism for
this challenge. STEC are similar in most respects to the commensal E.
coli that are carried in the intestinal tract of nearly everyone.
Consistent identification, straintyping, and characterization of
pathogenic STEC directly from a complex matrix, such as stool, requires
the consistent identification of both a variable marker that can be
used for subtyping and a second, more stable marker that can be used
for definitive identification.
How To Enter
Sign up for a Challenge.gov account and become a follower
of the Culture-Independent Straintyping and Characterization Challenge
at http://www.cdc.gov/amd/cidtchallenge.
Review the rules and guidelines of this contest listed
below and at http://www.cdc.gov/amd/cidtchallenge.
DATES: Contestants can submit solutions between September 2, 2014 and
November 30, 2014. Judging will take place between December 1 and 10,
2014, during which time additional information, clarification or
documentation may be requested. The winner will be notified and prize
awarded by December 15, 2014.
Contest Prizes: We will choose one winning proposal and award
$200,000 by electronic funds transfer. The winner may need to pay
Federal income taxes on any prize money. We will follow Internal
Revenue Service withholding and reporting requirements, where
applicable.
How Winners Will Be Selected: An expert panel of CDC program staff
with expertise in diagnostic testing, bioinformatics, and biotechnology
who meet the requirements of the America COMPETES Act will evaluate all
entries. The judging panel will use the following criteria to select a
single winning submission:
(1) Resolution and typeability: Ability to accurately straintype
and characterize STEC at high resolution from a stool sample matrix,
without the need for culture-based amplification.
(2) Reproducibility and stability: Ability to return consistent,
unambiguous results from three or more replicate specimens.
(3) Throughput parameters: Proposed solutions should have a
feasible sample-to-answer turnaround time of under 48 hours, and a per-
sample reagent and consumables cost of $100 per sample or less. Methods
should be scalable to accommodate high-throughput testing.
(4) Portability: Data should be objective, based on open or
established standards, and amenable for computerized analysis and
easily disseminated between laboratories.
(5) Generalizability: While the subject organism for this challenge
is STEC, special consideration will be given to proposals that may be
readily adapted to a range of other pathogenic microorganisms.
(6) Epidemiologic concordance: Consistency of the resultant data
with the known epidemiologic context of the specimen.
Contest Rules and Guidelines
Subject of Contest Competition: Your entry for the Culture-
Independent Straintyping and Characterization Challenge should describe
a novel or innovative method to straintype and characterize pathogenic
organisms, such as STEC, directly from a complex clinical sample,
without the need for culture or culture-based amplification.
Eligibility Rules for Participating in the Competition: The contest
is open to everyone, with the exceptions noted below. Participants may
submit individual proposals or work as teams.
To have a chance to win a prize in this contest you must--
(1) Register for the contest at CHALLENGE.GOV and follow posted
contest rules;
(2) Meet all of the requirements in this section;
(3) Enter the contest as an individual or as a team in which a you
or all members of the team are citizen(s) or permanent resident(s) of
the United States; or as an entity where entities are limited to those
that are incorporated and maintain a primary place of business in the
United States; and
(4) Federal employees may not participate in this contest in their
official capacity. Federal employees seeking to participate in this
contest should talk with their ethics official before submitting a
proposal.
(5) Federal grantees cannot use Federal funds to develop COMPETES
Act challenge applications unless consistent with the purpose of their
grant award.
[[Page 51341]]
(6) Federal contractors cannot use Federal funds from a contract to
develop COMPETES Act challenge applications or to fund efforts in
support of a COMPETES Act challenge submission.
You can use Federal facilities (e.g., laboratories) or speak with
Federal employees during the contest only if those same Federal
facilities and employees are equally available to everyone
participating in the contest (for example, such availability could be
announced on a public Web site).
If laboratory work is required to support your submission, all work
should be performed under appropriate biosafety level 2 (BSL2)
conditions, and in accordance with standard precautions for the
handling and processing of clinical specimens.
By participating in this contest, contestants 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 participation
in this prize contest, whether the injury, death, damage, or loss
arises through negligence or otherwise. By participating in this
contest, contestants agree to indemnify the Federal Government against
third party claims for damages arising from or related to contest
activities.
Contestants warrant that their submissions are wholly original and
do not infringe upon any rights of any third party of which Contestants
are aware.
Registration Process for Participants: All participants for the
Culture-Independent Straintyping and Characterization Challenge must
register before submitting a proposal. Registration instructions are
available at http://www.cdc.gov/amd/cidtchallenge. Deadline for
registration is October 1, 2014.
Additional Information: More information on or about CDC's Advanced
Molecular Detection and Response to Outbreaks of Infectious Diseases
initiative can be found at: www.cdc.gov/amd.
Regarding Copyright/Intellectual Property: When you submit your
entry, you must certify that you are the person who developed the
submission and that you maintain intellectual property rights to the
process and solution that you propose. You also must ensure that you
did not use any copyrighted material or affect the rights of any third
party to the best of your knowledge.
Submission Rights: Once you submit your solution, you give HHS/CDC
permission to review and evaluate your submission, and to post and
share information about your solution in the context of the contest,
its participants and its awardee. You cannot take this permission back
or ask us for money to use your submission for these purposes. You can,
however, give other people permission to use your method or solution to
this challenge while the contest is ongoing, and may keep all other
intellectual property rights to your solution and your work.
Compliance With Rules and Contacting Contest Winners: In order to
win the contest, you must meet all terms and conditions of these
Official Rules. You can be named a winner only if you meet all the
requirements. We will contact the winner using the contact information
provided (by email, telephone, or mail after the date of the judging).
You may need to pay Federal income taxes on any prize money. The
Department of Health and Human Services will follow the Internal
Revenue Service withholding and reporting requirements, where
applicable.
Privacy: If you provide personal information to use when you
register for the contest at the Challenge.gov Web site, we will use
that information to contact you about your entry, and to announce
updates and the final contest winner. We will not use the information
for commercial marketing.
General Conditions: HHS/CDC can cancel, suspend, or change the
contest, or any part of it, for any reason.
Dated: August 22, 2014.
Ron A. Otten,
Acting Deputy Associate Director for Science, Centers for Disease
Control and Prevention.
[FR Doc. 2014-20428 Filed 8-27-14; 8:45 am]
BILLING CODE 4163-18-P