Announcement of Requirements and Registration for “Up For A Challenge (U4C)-Stimulating Innovation in Breast Cancer Genetic Epidemiology”, 32168-32172 [2015-13816]
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Subject of Challenge Competition
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Announcement of Requirements and
Registration for ‘‘Up For A Challenge
(U4C)—Stimulating Innovation in
Breast Cancer Genetic Epidemiology’’
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Authority: 15 U.S.C. 3719.
Award Approving Official: Douglas R.
Lowy, Acting Director, National Cancer
Institute.
SUMMARY: The National Cancer
Institute’s (NCI) Division of Cancer
Control and Population Sciences
(DCCPS) announces that they are
partnering with Sage Bionetworks to
launch ‘‘Up For A Challenge (U4C)—
Stimulating Innovation in Breast Cancer
Genetic Epidemiology’’ (the
‘‘Challenge’’) to encourage unique
approaches to more fully decipher the
genomic basis of breast cancer. Utilizing
innovative approaches, the goal of this
Challenge is to identify new genes or
combinations of genes, genetic variants,
or sets of genomic features involved in
breast cancer susceptibility. In addition,
the NCI aims to advance innovation in
the field of genetic epidemiology by
making data more widely available,
increasing the amount and diversity of
minds approaching a difficult scientific
problem, and promoting broader
collaborations. This Challenge is being
launched under the America
COMPETES Reauthorization Act of
2010.
DATES:
Challenge Opens: June 15, 2015
Challenge Entries: Due January 15, 2016
(8 p.m. EST)
Challenge Judging: January 16, 2016–
March 31, 2016
Winners Announced: April 16–20, 2016
The NCI will announce any changes
to the timeline by amending this
Federal Register notice. This Challenge
will be supported by Sage Bionetworks
(https://www.synapse.org/
upforachallenge) on behalf of the NCI.
ADDRESSES: To register for this
Challenge, Challenge participants may
access the registration on the Challenge
Web site (https://www.synapse.org/
upforachallenge). Access to this Web
site may also be found by searching the
www.challenge.gov site for ‘‘Up For A
Challenge.’’
FOR FURTHER INFORMATION CONTACT:
Elizabeth M. Gillanders, Ph.D., NCI,
(240) 276–6764; Leah E. Mechanic,
Ph.D., NCI, (240) 276–6847 or
NCIUpForAChallenge@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
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In order to stimulate innovation, the
National Cancer Institute’s (NCI)
Division of Cancer Control and
Population Sciences (DCCPS) is
launching a prize competition to inspire
novel cross-disciplinary approaches to
more fully decipher the genomic basis
of breast cancer, called ‘‘Up For A
Challenge (U4C)—Stimulating
Innovation in Breast Cancer Genetic
Epidemiology’’ (the ‘‘Challenge’’) using
the America Creating Opportunities to
Meaningfully Promote Excellence in
Technology, Education, and Science
(COMPETES) Reauthorization Act of
2010.
The goal of this Challenge is to use
innovative approaches to identify novel
pathways—including new genes or
combinations of genes, genetic variants,
or sets of genomic features—involved in
breast cancer susceptibility in order to
generate new biological hypotheses.
To that end, several data sets have
been gathered and will be made
available for use in the Challenge; some
of these will be released for the first
time. In addition, Challenge participants
will be free to use any other publicly
available data sets (subject to
compliance with applicable terms and
conditions) for the purposes of
developing and applying methods for
identification of the novel pathways.
Breast cancer is the most commonly
occurring cancer, and the second most
common cause of cancer deaths in
women in the United States. An
estimated 231,840 new cases of invasive
breast cancer are expected to be
diagnosed among women (2,350 in men)
in the U.S. during 2015 with an
estimated 40,730 deaths. Despite
advances in breast cancer therapies,
breast cancer remains a major public
health burden. One approach to reduce
overall occurrence and mortality from
breast cancer is to develop ways of
identifying women who are at increased
risk for breast cancer.
Epidemiologic studies suggest that
genetic factors play a key role in
determining who is at increased risk of
developing breast cancer, as well as
what type of cancer they develop. To
date, genome-wide association studies
(GWAS) have helped researchers
identify more than 90 common genetic
variations. Although GWAS have greatly
increased our understanding of the
genetic components of breast cancer
susceptibility, the results to date explain
only a small proportion of the estimated
genetic contribution to the risk of breast
cancer. However, shifting the focus of
analysis from individual genetic
variants (also known as single
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nucleotide polymorphisms or SNPs) to
pathways (i.e. combinations of genes,
genetic variants, or sets of genomic
features), could lead to the
identification of novel gene sets
involved in breast cancer risk.
This Challenge provides an
opportunity to examine the heritable
contribution to racial disparities, by
facilitating access to GWAS data sets
from African American, Asian,
European, and Latino women. African
American women are known to have a
lower incidence of breast cancer, but
survival is lower for African American
than for non-Hispanic white women at
every stage of diagnosis. Meanwhile,
Asian women have the lowest rates of
breast cancer incidence and mortality
compared with non-Hispanic white,
African American, and Hispanic/Latino
women. Findings from this Challenge
may provide insights into some of these
observed differences.
As more fully described below,
participants are invited to use
innovative approaches to identify novel
pathways—including new genes or
combinations of genes, genetic variants,
or sets of genomic features—involved in
breast cancer susceptibility. Besides
developing a better understanding of
cancer risk assessment, the
identification of breast cancer
susceptibility genes holds promise for
providing therapeutic targets for drug
development.
Statutory Authority
The NCI is authorized and established
by Title IV, Part C, Subpart 1 of the
Public Health Service Act, 42 U.S.C. 285
to conduct and support research,
training, health information
dissemination, and other programs with
respect to the cause, diagnosis,
prevention, and treatment of cancer,
rehabilitation from cancer, and the
continuing care of cancer patients and
the families of cancer patients. Through
this Challenge, the NCI aims to advance
innovation in the field of genetic
epidemiology by making breast cancer
genetic epidemiology data more widely
available, increasing the number and
diversity of researchers addressing a
difficult scientific problem, and
promoting broader collaborations.
Ideally, this would result in insights
into the genetic epidemiology of breast
cancer.
Official Rules:
Eligibility Rules for Participating in the
Challenge and Winning
1. To be eligible to win a prize under
this Challenge, an individual or entity—
a. Shall have registered to participate
in the Challenge under the rules
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promulgated by the National Cancer
Institute (as published in this notice);
b. Shall have complied with all the
requirements under this section;
c. In the case of a private entity, shall
be incorporated in and maintain a
primary place of business in the United
States, and in the case of an individual,
whether participating singly or in a
team, shall be a citizen or permanent
resident of the United States;
d. May not be a Federal entity;
e. May not be a Federal employee
acting within the scope of his or her
employment and further, in the case of
HHS employees may not work on their
Entries during assigned duty hours.
Note: Federal ethical conduct rules may
restrict or prohibit Federal employees
from engaging in certain outside
activities, so any Federal employee not
excluded under the prior paragraph
seeking to participate in this Challenge
outside the scope of employment should
consult his/her agency’s ethics official
prior to developing an Entry;
f. May not be an employee of the NIH,
a judge of the Challenge, or any other
party involved with the design,
production, execution, or distribution of
the Challenge or the immediate family
member of such a party (i.e., spouse,
parent, step-parent, or step-child).
Without limiting the generality of the
foregoing, members of the Evaluation
Panel which will score Entries and the
NIH Judges, as well as their students are
not eligible to participate in the
Challenge.
2. Federal grantees may not use
Federal funds to develop Challenge
Entries unless consistent with the
purpose of their grant award and
specifically requested to do so due to
the Challenge design, and as announced
in the Federal Register.
3. Federal contractors may not use
Federal funds from a contract to develop
Challenge Entries or to fund efforts in
support of a Challenge Entry.
4. An individual, Team, or entity that
is currently on the Excluded Parties List
(https://www.epls.gov/) will not be
selected as a Finalist or prize winner.
5. Whether singly or as part of a team
or entity, each individual participating
in the Challenge must be 18 years of age
or older.
6. An individual shall not be deemed
ineligible to win because the individual
used Federal facilities or consulted with
Federal employees during the Challenge
provided that such facilities and/or
employees, as applicable, are made
available on an equitable basis to all
individuals and Teams participating in
the Challenge.
7. Each individual (whether
competing singly or in a team) or entity
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agrees to follow applicable local, State,
and Federal laws and regulations.
8. Each individual (whether
participating singly or in a team) and
entity participating in this Challenge
must comply with all terms and
conditions of these rules, and
participation in this Challenge
constitutes each such participant’s full
and unconditional agreement to abide
by these rules, which may also be found
on the Challenge Web site (https://
www.synapse.org/upforachallenge).
Winning is contingent upon fulfilling all
requirements herein.
All questions regarding the Challenge
should be directed to Dr. Gillanders or
Dr. Mechanic, identified above or by
emailing NCIUpForAChallenge@
mail.nih.gov and answers will be posted
and updated as necessary at (https://
www.synapse.org/upforachallenge)
under Frequently Asked Questions.
Registration Process for Participants
To register for this Challenge,
Challenge participants may access the
registration on the Challenge Web site
(https://www.synapse.org/
upforachallenge). Access to this Web
site may also be found by searching the
www.challenge.gov site for ‘‘Up For A
Challenge.’’ Individuals may participate
in the Challenge as individuals or as
Teams. Details about participating as a
Team are provided below:
1. After registration, you may
participate alone or on a Team with
other Challenge participants. To work
on a Team, you may either create a new
Team or join a pre-existing Team.
2. There is no maximum Team size.
3. All Teams must designate a Team
Captain. Each individual member of a
Team must be a registered participant in
the Challenge.
4. Individuals may participate on
multiple Teams, and Challenge Teams
may merge (requiring mutual agreement
of Team Captains). Individuals are
allowed to leave a Team to work alone
or join another Team.
Data Access Process
Once registered for the Challenge,
participants must apply for controlled
access to the designated Challenge
genetic datasets following instructions
on the Challenge Web site. Challenge
participants may use any of these dbGaP
datasets or any other datasets available
to anyone (either publically available or
available through controlled access)
such as data from the Cancer Genome
Atlas (TCGA) (https://
cancergenome.nih.gov/) or the
ENCyclopedia Of DNA Elements
(ENCODE) project (https://
www.genome.gov/encode/).
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Data will be requested through
database of Genotypes and Phenotypes
(dbGaP) application process. Details
regarding the process for requesting data
are provided on the Challenge Web site
(https://www.synapse.org/
upforachallenge). Data Access Requests
will be reviewed by the appropriate NIH
Data Access Committees (DAC) to
ensure that the proposed project is
consistent with any Data Use
Limitations for the requested dataset(s).
Note: That any scientific collaborators,
including contractors, who are not at the
same institution as the PI must submit
their own DAR. Data cannot be shared
with collaborators from other
institutions until they have submitted
an application (and explicitly named
this collaborators) to use the dataset(s)
from their institution(s) and have
received approval. If Approved Users
are provided access to NIH genomic
datasets for inter-institutional
collaborative research described in the
research use statement of the DAR, and
all members of the collaboration are also
Approved Users through their home
institution(s), data obtained through this
DAR may be securely transmitted
within the collaborative group.
Challenge participants who obtain
data from dbGaP should note that they
are agreeing to the NIH Genomic Data
User Code of Conduct (https://
gds.nih.gov/pdf/Genomic_Data_User_
Code_of_Conduct.pdf) and they are
agreeing to the terms of specific Data
Use Certificates for each individual
dataset requested (The model Data Use
Certificate can be found here—https://
gds.nih.gov/pdf/Model_DUC.pdf). Note
that individual datasets may have
additional limitations in regards to use
of the data. As the GWAS datasets
obtained from dbGaP are considered
controlled access data, individuals
approved to use these data must abide
by dbGaP security best practices in
regards to the data (https://
www.ncbi.nlm.nih.gov/projects/gap/
pdf/dbgap_2b_security_procedures.pdf).
If submitting a request to dbGaP for use
of data for the Challenge, participants
should be aware that the data requested
should be used solely for the research
purpose described in the Data Access
Request, i.e., solely for the Challenge.
New uses of these data outside this
Challenge will require submission of a
new Data Access Request.
Challenge Entries
As used in this notice, ‘‘Entry’’ is the
information submitted in the manner
and format specified on the Up For A
Challenge (U4C) Web site (https://
www.synapse.org/upforachallenge). All
Entries must be received by the
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applicable deadline. Entries submitted
after a posted Challenge deadline will
not be considered.
Entries may be submitted on behalf of
a Team by any of its participants. It is
up to each Team to organize its
Entry(ies) and to follow the Challenge
submission requirements. On
submission of an Entry, Challenge
participants must include the Team
name under which they are submitting.
All final Entries must be submitted
through the Challenge Web site on
Synapse, following Web site
instructions and should provide
necessary and sufficient detail and
annotation for reproduction of the
submitted results. Information
accompanying each Entry should
include:
1. Title of project
2. Name of Team
3. Names and field of expertise of Team
members
4. List of new pair-wise collaborations
on Team (defined as individuals not
having published together in the
past 5 years)
5. Information about how Team learned
about the Challenge
6. Identification of datasets used (1
page)
7. A description of methods used to
generate the findings (4 pages
maximum)
8. Narrative which addresses the
evaluation criteria (identification of
novel findings, replication of
findings, innovation of approach,
evidence of novel biological
hypothesis(es), and collaboration)
(6 pages maximum)
9. The corresponding source code so
that the Challenge organizers can
re-run and manually review and
verify that the code affiliated with
the top scoring Entries yield the
submitted results.
Only complete Entries, which follow
application instructions, will be
reviewed and eligible to win. Top
performing Entries will be reviewed
thoroughly. The NCI reserves the right
to disqualify any Challenge participants
in instances where cheating or other
misconduct is identified. Details
regarding the dispute resolution process
are provided on the Challenge Web site
(https://www.synapse.org/
upforachallenge).
Warranties
By submitting an Entry to the
Challenge, Challenge participants
represent and warrant that all
information provided in their Entries
and as a result of the Challenge
registration process is true and
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complete, that Challenge participants
have the right and authority to submit
such Entry on their own behalf or on
behalf of the persons and entities
specified within the Entry, and that the
Entry:
1. Is the Challenge participant’s or
Team’s (as applicable) own original
work, or is used by permission with full
and proper credit given within the
Entry;
2. Does not contain confidential
information or trade secrets (the Team’s
or anyone else’s);
3. Does not violate or infringe upon
the patent rights, industrial design
rights, copyrights, trademarks, rights of
privacy, publicity or other intellectual
property or other rights of any person or
entity;
4. Does not contain malicious code,
such as viruses, timebombs, cancelbots,
worms, trojan horses or other
potentially harmful programs or other
material or information;
5. Does not and will not violate any
applicable law, statute, ordinance, rule
or regulation; and
6. Does not trigger any reporting or
royalty obligation to any third party.
Amount of the Prize
The grand prize Entry will be
awarded up to $30,000. The second
place Entry will be awarded a runnerup prize of up to $20,000. Prizes will be
awarded by Sage Bionetworks. The top
5 Entries (grand prize, second place, and
the next three runner-ups) as well as the
People’s Choice Award winner will be
highlighted on the Challenge and
DCCPS EGRP Web sites pending
selection by the NCI Director. The top
5 Entries (grand prize, second place, and
the next three runner-ups) as well as the
People’s Choice Award winner will be
invited to prepare a manuscript for
publication describing their approach
and results with a goal of a special
journal issue highlighting the Challenge.
All Challenge participants will be
acknowledged in the special issue of the
journal, pending acceptance.
The NIH reserves the right to cancel,
suspend, and/or modify this Challenge
at any time through amendment to this
Federal Register notice. In addition, in
the event the Challenge is modified,
Challenge participants registered in the
Challenge will be notified by email and
provided with a copy of the amended
Challenge rules and a listing of the
changes that were made. Any
participant who continues to participate
in the Challenge following receipt of
such a notice of amendment, will be
deemed to have accepted any such
amendment. If a participant does not
wish to continue to participate in the
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Challenge pursuant to the Official Rules,
as amended, such participant may
terminate his/her/participation in the
Challenge by not submitting additional
Entries. The NIH reserves the right to
not award any prizes if no Entries are
deemed worthy.
Basis Upon Which Winner Will Be
Selected
Entries will be scored by the
Challenge Evaluation Panel using the
criteria listed below. After the Challenge
Evaluation Panel provides final scores,
the highest scoring applications will be
evaluated for reproducibility by Sage
Bionetworks’ data scientists. In order to
qualify for a Challenge prize, it must be
possible for Sage Bionetworks’ data
scientists to reproduce Entry results
within 1 month. The NCI Judges will
review scores and reproduction by Sage
and make recommendations to the NCI
Director. The NCI Director will make the
final selection of Entries for award.
Scoring Criteria (100 Points)
1. Identification of Novel Findings (25
points)—Using breast cancer GWAS
data sets available in dbGaP and/or any
other publicly available data sets,
Challenge participants must identify
new genes or combinations of genes,
genetic variants, or sets of genomic
features associated with breast cancer
susceptibility.
a. The National Human Genome
Research Institute’s (NHGRI) Catalog of
Published Genome Wide Association
Studies (https://www.genome.gov/
gwastudies/) or variants/loci identified
in the following publications can be
used to evaluate possible novel findings:
i. Mavaddat et al., 2010, https://
www.ncbi.nlm.nih.gov/pubmed/
?term=20542480;
ii. Ghoussani et al., 2013, https://
www.ncbi.nlm.nih.gov/pubmed/
?term=23973388;
iii. Fachal and Dunning, 2015,
https://www.ncbi.nlm.nih.gov/pubmed/
?term=25727315)
b. The scale for novelty for the
Challenge Evaluation panel to use as a
guide is provided:
i. New variants in well-established
high or moderate penetrance genes (e.g.,
BRCA1/BRCA2; ATM; PALB2) (low).
ii. New variants in GWAS-identified
genes or loci (med).
iii. New combinations of variants
which were previously identified (i.e.,
the combination or combined effect is
new, but the variants were previously
identified) (medium).
iv. New genes or loci (high).
v. New combinations of variants from
genes or loci not identified previously
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(i.e., the combination and some of the
variants are new) (high).
2. Replication of Findings (25
points)—Evidence of the validity of the
proposed novel finding will be
evaluated through replication.
a. There are several different ways
replication can be accomplished. These
may include using data sets as testing
and training data (or discovery in one
data set and replication in another data
set) or dividing the data into several
portions and performing some type of
cross-validation. The Challenge
Evaluation panel will also be open to
other innovative approaches for
replication.
i. The Challenge participant will need
to select criteria for replication and
provide a justification for the selected
criteria. Using the criteria selected by
the Challenge participant, the Challenge
participant must demonstrate
replication of findings.
b. Note: Challenge participants should
provide their criteria for replication in
the narrative portion of their Challenge
Entry.
c. The adequacy of criteria selected by
the Challenge participant and evidence
for replication will be scored by the
Challenge Evaluation Panel.
3. Innovation of Approach (25
points)—Innovation and creativity of
the submitted approach will be
evaluated. Innovation will be defined as
a new or significantly improved
method. The submitted narrative must
describe what is innovative about the
approach, what this approach is
building on, and why the approach is
necessary or how it improves upon
existing approaches. Some criteria for
innovation include the following:
a. Does the Entry seek to shift current
paradigms by utilizing novel theoretical
concepts, approaches, or
methodologies?
b. Are the concepts, approaches, or
methods in the Entry novel to this field
of research or novel in a broader sense?
c. Does the Entry represent a
refinement, improvement, or new
application of theoretical concepts,
approaches, or methodologies?
4. Evidence of Novel Biological
Hypothesis(es) (10 points)—
a. Evaluation of this aspect of
Challenge Entries will be based on
whether findings (i.e., new genes or
combinations of genes, genetic variants,
or sets of genomic features) lead to
novel biological hypotheses. A
description of these hypotheses should
be provided in the final project Entry.
b. Novel biological hypotheses should
be testable, either using computational
or laboratory approaches. Evaluation
will be based on the narrative
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description of the design of testable
experiments, which could examine the
novel biological hypothesis identified
through these new genes or
combinations of genes, genetic variants,
or sets of genomic features associated
with breast cancer. The format should
mirror an outline of grant-specific aims.
Note: The ‘‘Evidence of Novel Biological
Hypothesis(es)’’ criteria (4) is distinct from
the ‘‘Identification of Novel Findings’’
criteria (1). The ‘‘Evidence of Novel
Biological Hypothesis(es)’’ criteria (4) is
based on the narrative description of
hypotheses generated from the findings and
proposed follow up experiments. In contrast,
the ‘‘Identification of Novel Findings’’
criteria (1) are the identification of new genes
or combinations of genes, genetic variants, or
sets of genomic features associated with
breast cancer susceptibility.
5. Collaboration (15 points)—Points
will be awarded based on (a) the
number of different fields represented
on the Team; (b) the number of new
collaborations represented on the Team
(defined as individuals not having
published together in the past 5 years);
and (c) the number of individuals
invited to participate in the Challenge
by Team members resulting in Entries to
the Challenge.
People’s Choice Award
In addition to the main prize, a
People’s Choice Award for the most
interesting strategy may be given to the
Entry that receives the most votes from
the Challenge participants on the
Challenge Web site. Details of how
voting will take place will be posted on
the Challenge Web site.
Additional Information
Intellectual Property
By submitting an Entry, each
Challenge participant warrants that he
or she is the sole author and owner of
any copyrightable works that the Entry
comprises, that the works are wholly
original with the Challenge participant
(or is an improved version of an existing
work that the Challenge participant has
sufficient rights to use and improve),
and that the Entry does not infringe any
copyright or any other rights of any
third party of which Challenge
participant is aware.
To receive an award, Challenge
participants will not be required to
transfer their exclusive intellectual
property rights to the NIH. Each
individual (whether competing singly or
on a team) or entity retains title and full
ownership in and to their Entry and
expressly reserves all intellectual
property rights (e.g., copyright) in their
Entry. However, by participating in the
Challenge each individual (whether
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competing singly or in a team) grants to
the NCI and others acting on behalf of
the NCI, a royalty-free non-exclusive
worldwide license to use, copy for use,
and display publicly all parts of the
Entry for the purposes of the Challenge.
This license may include posting or
linking to the Entry on the official NCI
Challenge Web site and making it
available for research use by the public.
When submitting source code as part
of the Entry package, participants
should provide it to the NCI under an
open-source license of their choice. The
license must permit the NCI contractor,
Sage Bionetworks, to distribute the code
to the public for non-commercial
research and development use via the
Synapse challenge platform.
Participants may keep copyright to their
code Entries. If participants do not
provide information on licensing,
participant’s Entry shall be under the
FreeBSD license.
Challenge participants are free to
discuss their Entry and the ideas or
technologies that it contains with other
parties and are free to contract with any
third parties as long as they do not sign
any agreement or undertake any
obligation that conflicts with any
agreement that they have entered into
(i.e., with Team members) or do enter
into regarding their Entry for the
Challenge. For the purpose of clarity,
Challenge participants acknowledge that
the intent of the Challenge is to
encourage people to collaborate and
share ideas and innovations.
By submitting an Entry, Challenge
participants grant the NCI and the
contractor Sage Bionetworks the limited
rights set forth in these Official Rules.
By submitting an Entry, each participant
(whether competing singly or on a team)
grants to the NCI and Sage Bionetworks
the right to review their Entry and to
have the NCI and their designees review
the Entry.
Liability and Indemnification
By participating in this Challenge,
each Challenge participant (whether
competing singly or on a Team) agrees
to assume any and all risks and waive
claims against the Federal government
and its related entities, including Sage
Bionetworks, the Challenge Evaluation
Panel and the NCI Judges, 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 Challenge,
whether the injury, death, damage, or
loss arises through negligence or
otherwise. By participating in this
Challenge, each Challenge participant
(whether competing singly or on a team)
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agrees to indemnify the Federal
government and the contractor Sage
Bionetworks, against third party claims
for damages arising from or related to
Challenge activities.
Insurance
Based on the subject matter of the
Challenge, the type of work that it will
possibly require, as well as an analysis
of the likelihood of any claims for death,
bodily injury, or property damage, or
loss potentially resulting from
competition participation, Challenge
participants are not required to obtain
liability insurance or demonstrate
financial responsibility in order to
participate in this Challenge.
Challenge Judges
Huann-Sheng Chen; Mathematical
Statistician; Statistical Methodology
and Applications Branch (SMAB);
Surveillance Research Program (SRP);
DCCPS; NCI
Eric J. Feuer; Ph.D.; Chief, SMAB; SRP;
DCCPS; NCI
Leah Mechanic; Ph.D.; Program
Director; Genomic Epidemiology
Branch (GEB); Epidemiology and
Genomics Research Program (EGRP);
DCCPS; NCI
Elizabeth Gillanders; Ph.D.; Chief; GEB;
EGRP; DCCPS; NCI
Carolyn M. Hutter, Ph.D.; Program
Director; Division of Genomic
Medicine; National Human Genome
Research Institute
Margaret A. Tucker, M.D., Director,
Human Genetics Program and Acting
Chief, Laboratory of Translational
Genomics; Division of Cancer
Epidemiology and Genetics; NCI
Dated: May 19, 2015.
Douglas R. Lowy,
Acting Director, National Cancer Institute.
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel; Clinical
Trial Review.
Date: June 24, 2015.
Time: 4:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Christine A. Livingston,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institutes of
Health/NIDCD, 6001 Executive Blvd.—Room
8343, Bethesda, MD 20892, (301) 496–8683,
livingsc@mail.nih.gov.
Name of Committee: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel; Clinical
Trials Review.
Date: July 23, 2015.
Time: 5:00 p.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Christine A. Livingston,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institutes of
Health/NIDCD, 6001 Executive Blvd.—Room
8343, Bethesda, MD 20892, (301) 496–8683,
livingsc@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.173, Biological Research
Related to Deafness and Communicative
Disorders, National Institutes of Health, HHS)
Dated: June 1, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–13816 Filed 6–4–15; 8:45 am]
BILLING CODE 4140–01–P
[FR Doc. 2015–13687 Filed 6–4–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSK5VPTVN1PROD with NOTICES
National Institute on Deafness and
Other Communication Disorders;
Notice of Closed Meetings
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
VerDate Sep<11>2014
18:31 Jun 04, 2015
Jkt 235001
Center For Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
PO 00000
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the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Skin and Autoimmune Diseases.
Date: June 29–30, 2015.
Time: 9:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Rajiv Kumar, Ph.D., Chief,
MOSS IRG, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 4216, MSC 7802, Bethesda, MD
20892, 301–435–1212, kumarra@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA–RM–
14: Science of Behavior Change.
Date: June 29, 2015.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Dana Jeffrey Plude, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3176,
MSC 7848, Bethesda, MD 20892, 301–435–
2309, pluded@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR 13–
109: Mechanistic Insights from Birth Cohorts.
Date: June 30, 2015.
Time: 12:30 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Ellen K. Schwartz, EDD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3144,
Bethesda, MD 20892, 301–828–6146,
schwarel@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Dermatology, Rheumatology and
Inflammation.
Date: July 1, 2015.
Time: 8:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Yanming Bi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214,
MSC 7814, Bethesda, MD 20892, 301–451–
0996, ybi@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: AIDS and AIDS Related Research.
Date: July 7, 2015.
E:\FR\FM\05JNN1.SGM
05JNN1
Agencies
[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Notices]
[Pages 32168-32172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13816]
[[Page 32168]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Announcement of Requirements and Registration for ``Up For A
Challenge (U4C)--Stimulating Innovation in Breast Cancer Genetic
Epidemiology''
Authority: 15 U.S.C. 3719.
Award Approving Official: Douglas R. Lowy, Acting Director,
National Cancer Institute.
SUMMARY: The National Cancer Institute's (NCI) Division of Cancer
Control and Population Sciences (DCCPS) announces that they are
partnering with Sage Bionetworks to launch ``Up For A Challenge (U4C)--
Stimulating Innovation in Breast Cancer Genetic Epidemiology'' (the
``Challenge'') to encourage unique approaches to more fully decipher
the genomic basis of breast cancer. Utilizing innovative approaches,
the goal of this Challenge is to identify new genes or combinations of
genes, genetic variants, or sets of genomic features involved in breast
cancer susceptibility. In addition, the NCI aims to advance innovation
in the field of genetic epidemiology by making data more widely
available, increasing the amount and diversity of minds approaching a
difficult scientific problem, and promoting broader collaborations.
This Challenge is being launched under the America COMPETES
Reauthorization Act of 2010.
DATES:
Challenge Opens: June 15, 2015
Challenge Entries: Due January 15, 2016 (8 p.m. EST)
Challenge Judging: January 16, 2016-March 31, 2016
Winners Announced: April 16-20, 2016
The NCI will announce any changes to the timeline by amending this
Federal Register notice. This Challenge will be supported by Sage
Bionetworks (https://www.synapse.org/upforachallenge) on behalf of the
NCI.
ADDRESSES: To register for this Challenge, Challenge participants may
access the registration on the Challenge Web site (https://www.synapse.org/upforachallenge). Access to this Web site may also be
found by searching the www.challenge.gov site for ``Up For A
Challenge.''
FOR FURTHER INFORMATION CONTACT: Elizabeth M. Gillanders, Ph.D., NCI,
(240) 276-6764; Leah E. Mechanic, Ph.D., NCI, (240) 276-6847 or
NCIUpForAChallenge@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
Subject of Challenge Competition
In order to stimulate innovation, the National Cancer Institute's
(NCI) Division of Cancer Control and Population Sciences (DCCPS) is
launching a prize competition to inspire novel cross-disciplinary
approaches to more fully decipher the genomic basis of breast cancer,
called ``Up For A Challenge (U4C)--Stimulating Innovation in Breast
Cancer Genetic Epidemiology'' (the ``Challenge'') using the America
Creating Opportunities to Meaningfully Promote Excellence in
Technology, Education, and Science (COMPETES) Reauthorization Act of
2010.
The goal of this Challenge is to use innovative approaches to
identify novel pathways--including new genes or combinations of genes,
genetic variants, or sets of genomic features--involved in breast
cancer susceptibility in order to generate new biological hypotheses.
To that end, several data sets have been gathered and will be made
available for use in the Challenge; some of these will be released for
the first time. In addition, Challenge participants will be free to use
any other publicly available data sets (subject to compliance with
applicable terms and conditions) for the purposes of developing and
applying methods for identification of the novel pathways.
Breast cancer is the most commonly occurring cancer, and the second
most common cause of cancer deaths in women in the United States. An
estimated 231,840 new cases of invasive breast cancer are expected to
be diagnosed among women (2,350 in men) in the U.S. during 2015 with an
estimated 40,730 deaths. Despite advances in breast cancer therapies,
breast cancer remains a major public health burden. One approach to
reduce overall occurrence and mortality from breast cancer is to
develop ways of identifying women who are at increased risk for breast
cancer.
Epidemiologic studies suggest that genetic factors play a key role
in determining who is at increased risk of developing breast cancer, as
well as what type of cancer they develop. To date, genome-wide
association studies (GWAS) have helped researchers identify more than
90 common genetic variations. Although GWAS have greatly increased our
understanding of the genetic components of breast cancer
susceptibility, the results to date explain only a small proportion of
the estimated genetic contribution to the risk of breast cancer.
However, shifting the focus of analysis from individual genetic
variants (also known as single nucleotide polymorphisms or SNPs) to
pathways (i.e. combinations of genes, genetic variants, or sets of
genomic features), could lead to the identification of novel gene sets
involved in breast cancer risk.
This Challenge provides an opportunity to examine the heritable
contribution to racial disparities, by facilitating access to GWAS data
sets from African American, Asian, European, and Latino women. African
American women are known to have a lower incidence of breast cancer,
but survival is lower for African American than for non-Hispanic white
women at every stage of diagnosis. Meanwhile, Asian women have the
lowest rates of breast cancer incidence and mortality compared with
non-Hispanic white, African American, and Hispanic/Latino women.
Findings from this Challenge may provide insights into some of these
observed differences.
As more fully described below, participants are invited to use
innovative approaches to identify novel pathways--including new genes
or combinations of genes, genetic variants, or sets of genomic
features--involved in breast cancer susceptibility. Besides developing
a better understanding of cancer risk assessment, the identification of
breast cancer susceptibility genes holds promise for providing
therapeutic targets for drug development.
Statutory Authority
The NCI is authorized and established by Title IV, Part C, Subpart
1 of the Public Health Service Act, 42 U.S.C. 285 to conduct and
support research, training, health information dissemination, and other
programs with respect to the cause, diagnosis, prevention, and
treatment of cancer, rehabilitation from cancer, and the continuing
care of cancer patients and the families of cancer patients. Through
this Challenge, the NCI aims to advance innovation in the field of
genetic epidemiology by making breast cancer genetic epidemiology data
more widely available, increasing the number and diversity of
researchers addressing a difficult scientific problem, and promoting
broader collaborations. Ideally, this would result in insights into the
genetic epidemiology of breast cancer.
Official Rules:
Eligibility Rules for Participating in the Challenge and Winning
1. To be eligible to win a prize under this Challenge, an
individual or entity--
a. Shall have registered to participate in the Challenge under the
rules
[[Page 32169]]
promulgated by the National Cancer Institute (as published in this
notice);
b. Shall have complied with all the requirements under this
section;
c. In the case of a private entity, shall be incorporated in and
maintain a primary place of business in the United States, and in the
case of an individual, whether participating singly or in a team, shall
be a citizen or permanent resident of the United States;
d. May not be a Federal entity;
e. May not be a Federal employee acting within the scope of his or
her employment and further, in the case of HHS employees may not work
on their Entries during assigned duty hours. Note: Federal ethical
conduct rules may restrict or prohibit Federal employees from engaging
in certain outside activities, so any Federal employee not excluded
under the prior paragraph seeking to participate in this Challenge
outside the scope of employment should consult his/her agency's ethics
official prior to developing an Entry;
f. May not be an employee of the NIH, a judge of the Challenge, or
any other party involved with the design, production, execution, or
distribution of the Challenge or the immediate family member of such a
party (i.e., spouse, parent, step-parent, or step-child). Without
limiting the generality of the foregoing, members of the Evaluation
Panel which will score Entries and the NIH Judges, as well as their
students are not eligible to participate in the Challenge.
2. Federal grantees may not use Federal funds to develop Challenge
Entries unless consistent with the purpose of their grant award and
specifically requested to do so due to the Challenge design, and as
announced in the Federal Register.
3. Federal contractors may not use Federal funds from a contract to
develop Challenge Entries or to fund efforts in support of a Challenge
Entry.
4. An individual, Team, or entity that is currently on the Excluded
Parties List (https://www.epls.gov/) will not be selected as a Finalist
or prize winner.
5. Whether singly or as part of a team or entity, each individual
participating in the Challenge must be 18 years of age or older.
6. An individual shall not be deemed ineligible to win because the
individual used Federal facilities or consulted with Federal employees
during the Challenge provided that such facilities and/or employees, as
applicable, are made available on an equitable basis to all individuals
and Teams participating in the Challenge.
7. Each individual (whether competing singly or in a team) or
entity agrees to follow applicable local, State, and Federal laws and
regulations.
8. Each individual (whether participating singly or in a team) and
entity participating in this Challenge must comply with all terms and
conditions of these rules, and participation in this Challenge
constitutes each such participant's full and unconditional agreement to
abide by these rules, which may also be found on the Challenge Web site
(https://www.synapse.org/upforachallenge). Winning is contingent upon
fulfilling all requirements herein.
All questions regarding the Challenge should be directed to Dr.
Gillanders or Dr. Mechanic, identified above or by emailing
NCIUpForAChallenge@mail.nih.gov and answers will be posted and updated
as necessary at (https://www.synapse.org/upforachallenge) under
Frequently Asked Questions.
Registration Process for Participants
To register for this Challenge, Challenge participants may access
the registration on the Challenge Web site (https://www.synapse.org/upforachallenge). Access to this Web site may also be found by
searching the www.challenge.gov site for ``Up For A Challenge.''
Individuals may participate in the Challenge as individuals or as
Teams. Details about participating as a Team are provided below:
1. After registration, you may participate alone or on a Team with
other Challenge participants. To work on a Team, you may either create
a new Team or join a pre-existing Team.
2. There is no maximum Team size.
3. All Teams must designate a Team Captain. Each individual member
of a Team must be a registered participant in the Challenge.
4. Individuals may participate on multiple Teams, and Challenge
Teams may merge (requiring mutual agreement of Team Captains).
Individuals are allowed to leave a Team to work alone or join another
Team.
Data Access Process
Once registered for the Challenge, participants must apply for
controlled access to the designated Challenge genetic datasets
following instructions on the Challenge Web site. Challenge
participants may use any of these dbGaP datasets or any other datasets
available to anyone (either publically available or available through
controlled access) such as data from the Cancer Genome Atlas (TCGA)
(https://cancergenome.nih.gov/) or the ENCyclopedia Of DNA Elements
(ENCODE) project (https://www.genome.gov/encode/).
Data will be requested through database of Genotypes and Phenotypes
(dbGaP) application process. Details regarding the process for
requesting data are provided on the Challenge Web site (https://www.synapse.org/upforachallenge). Data Access Requests will be reviewed
by the appropriate NIH Data Access Committees (DAC) to ensure that the
proposed project is consistent with any Data Use Limitations for the
requested dataset(s). Note: That any scientific collaborators,
including contractors, who are not at the same institution as the PI
must submit their own DAR. Data cannot be shared with collaborators
from other institutions until they have submitted an application (and
explicitly named this collaborators) to use the dataset(s) from their
institution(s) and have received approval. If Approved Users are
provided access to NIH genomic datasets for inter-institutional
collaborative research described in the research use statement of the
DAR, and all members of the collaboration are also Approved Users
through their home institution(s), data obtained through this DAR may
be securely transmitted within the collaborative group.
Challenge participants who obtain data from dbGaP should note that
they are agreeing to the NIH Genomic Data User Code of Conduct (https://gds.nih.gov/pdf/Genomic_Data_User_Code_of_Conduct.pdf) and they are
agreeing to the terms of specific Data Use Certificates for each
individual dataset requested (The model Data Use Certificate can be
found here--https://gds.nih.gov/pdf/Model_DUC.pdf). Note that individual
datasets may have additional limitations in regards to use of the data.
As the GWAS datasets obtained from dbGaP are considered controlled
access data, individuals approved to use these data must abide by dbGaP
security best practices in regards to the data (https://www.ncbi.nlm.nih.gov/projects/gap/pdf/dbgap_2b_security_procedures.pdf). If submitting a request to dbGaP for
use of data for the Challenge, participants should be aware that the
data requested should be used solely for the research purpose described
in the Data Access Request, i.e., solely for the Challenge. New uses of
these data outside this Challenge will require submission of a new Data
Access Request.
Challenge Entries
As used in this notice, ``Entry'' is the information submitted in
the manner and format specified on the Up For A Challenge (U4C) Web
site (https://www.synapse.org/upforachallenge). All Entries must be
received by the
[[Page 32170]]
applicable deadline. Entries submitted after a posted Challenge
deadline will not be considered.
Entries may be submitted on behalf of a Team by any of its
participants. It is up to each Team to organize its Entry(ies) and to
follow the Challenge submission requirements. On submission of an
Entry, Challenge participants must include the Team name under which
they are submitting.
All final Entries must be submitted through the Challenge Web site
on Synapse, following Web site instructions and should provide
necessary and sufficient detail and annotation for reproduction of the
submitted results. Information accompanying each Entry should include:
1. Title of project
2. Name of Team
3. Names and field of expertise of Team members
4. List of new pair-wise collaborations on Team (defined as individuals
not having published together in the past 5 years)
5. Information about how Team learned about the Challenge
6. Identification of datasets used (1 page)
7. A description of methods used to generate the findings (4 pages
maximum)
8. Narrative which addresses the evaluation criteria (identification of
novel findings, replication of findings, innovation of approach,
evidence of novel biological hypothesis(es), and collaboration) (6
pages maximum)
9. The corresponding source code so that the Challenge organizers can
re-run and manually review and verify that the code affiliated with the
top scoring Entries yield the submitted results.
Only complete Entries, which follow application instructions, will
be reviewed and eligible to win. Top performing Entries will be
reviewed thoroughly. The NCI reserves the right to disqualify any
Challenge participants in instances where cheating or other misconduct
is identified. Details regarding the dispute resolution process are
provided on the Challenge Web site (https://www.synapse.org/upforachallenge).
Warranties
By submitting an Entry to the Challenge, Challenge participants
represent and warrant that all information provided in their Entries
and as a result of the Challenge registration process is true and
complete, that Challenge participants have the right and authority to
submit such Entry on their own behalf or on behalf of the persons and
entities specified within the Entry, and that the Entry:
1. Is the Challenge participant's or Team's (as applicable) own
original work, or is used by permission with full and proper credit
given within the Entry;
2. Does not contain confidential information or trade secrets (the
Team's or anyone else's);
3. Does not violate or infringe upon the patent rights, industrial
design rights, copyrights, trademarks, rights of privacy, publicity or
other intellectual property or other rights of any person or entity;
4. Does not contain malicious code, such as viruses, timebombs,
cancelbots, worms, trojan horses or other potentially harmful programs
or other material or information;
5. Does not and will not violate any applicable law, statute,
ordinance, rule or regulation; and
6. Does not trigger any reporting or royalty obligation to any
third party.
Amount of the Prize
The grand prize Entry will be awarded up to $30,000. The second
place Entry will be awarded a runner-up prize of up to $20,000. Prizes
will be awarded by Sage Bionetworks. The top 5 Entries (grand prize,
second place, and the next three runner-ups) as well as the People's
Choice Award winner will be highlighted on the Challenge and DCCPS EGRP
Web sites pending selection by the NCI Director. The top 5 Entries
(grand prize, second place, and the next three runner-ups) as well as
the People's Choice Award winner will be invited to prepare a
manuscript for publication describing their approach and results with a
goal of a special journal issue highlighting the Challenge. All
Challenge participants will be acknowledged in the special issue of the
journal, pending acceptance.
The NIH reserves the right to cancel, suspend, and/or modify this
Challenge at any time through amendment to this Federal Register
notice. In addition, in the event the Challenge is modified, Challenge
participants registered in the Challenge will be notified by email and
provided with a copy of the amended Challenge rules and a listing of
the changes that were made. Any participant who continues to
participate in the Challenge following receipt of such a notice of
amendment, will be deemed to have accepted any such amendment. If a
participant does not wish to continue to participate in the Challenge
pursuant to the Official Rules, as amended, such participant may
terminate his/her/participation in the Challenge by not submitting
additional Entries. The NIH reserves the right to not award any prizes
if no Entries are deemed worthy.
Basis Upon Which Winner Will Be Selected
Entries will be scored by the Challenge Evaluation Panel using the
criteria listed below. After the Challenge Evaluation Panel provides
final scores, the highest scoring applications will be evaluated for
reproducibility by Sage Bionetworks' data scientists. In order to
qualify for a Challenge prize, it must be possible for Sage
Bionetworks' data scientists to reproduce Entry results within 1 month.
The NCI Judges will review scores and reproduction by Sage and make
recommendations to the NCI Director. The NCI Director will make the
final selection of Entries for award.
Scoring Criteria (100 Points)
1. Identification of Novel Findings (25 points)--Using breast
cancer GWAS data sets available in dbGaP and/or any other publicly
available data sets, Challenge participants must identify new genes or
combinations of genes, genetic variants, or sets of genomic features
associated with breast cancer susceptibility.
a. The National Human Genome Research Institute's (NHGRI) Catalog
of Published Genome Wide Association Studies (https://www.genome.gov/gwastudies/) or variants/loci identified in the following publications
can be used to evaluate possible novel findings:
i. Mavaddat et al., 2010, https://www.ncbi.nlm.nih.gov/pubmed/?term=20542480;
ii. Ghoussani et al., 2013, https://www.ncbi.nlm.nih.gov/pubmed/?term=23973388;
iii. Fachal and Dunning, 2015, https://www.ncbi.nlm.nih.gov/pubmed/?term=25727315)
b. The scale for novelty for the Challenge Evaluation panel to use
as a guide is provided:
i. New variants in well-established high or moderate penetrance
genes (e.g., BRCA1/BRCA2; ATM; PALB2) (low).
ii. New variants in GWAS-identified genes or loci (med).
iii. New combinations of variants which were previously identified
(i.e., the combination or combined effect is new, but the variants were
previously identified) (medium).
iv. New genes or loci (high).
v. New combinations of variants from genes or loci not identified
previously
[[Page 32171]]
(i.e., the combination and some of the variants are new) (high).
2. Replication of Findings (25 points)--Evidence of the validity of
the proposed novel finding will be evaluated through replication.
a. There are several different ways replication can be
accomplished. These may include using data sets as testing and training
data (or discovery in one data set and replication in another data set)
or dividing the data into several portions and performing some type of
cross-validation. The Challenge Evaluation panel will also be open to
other innovative approaches for replication.
i. The Challenge participant will need to select criteria for
replication and provide a justification for the selected criteria.
Using the criteria selected by the Challenge participant, the Challenge
participant must demonstrate replication of findings.
b. Note: Challenge participants should provide their criteria for
replication in the narrative portion of their Challenge Entry.
c. The adequacy of criteria selected by the Challenge participant
and evidence for replication will be scored by the Challenge Evaluation
Panel.
3. Innovation of Approach (25 points)--Innovation and creativity of
the submitted approach will be evaluated. Innovation will be defined as
a new or significantly improved method. The submitted narrative must
describe what is innovative about the approach, what this approach is
building on, and why the approach is necessary or how it improves upon
existing approaches. Some criteria for innovation include the
following:
a. Does the Entry seek to shift current paradigms by utilizing
novel theoretical concepts, approaches, or methodologies?
b. Are the concepts, approaches, or methods in the Entry novel to
this field of research or novel in a broader sense?
c. Does the Entry represent a refinement, improvement, or new
application of theoretical concepts, approaches, or methodologies?
4. Evidence of Novel Biological Hypothesis(es) (10 points)--
a. Evaluation of this aspect of Challenge Entries will be based on
whether findings (i.e., new genes or combinations of genes, genetic
variants, or sets of genomic features) lead to novel biological
hypotheses. A description of these hypotheses should be provided in the
final project Entry.
b. Novel biological hypotheses should be testable, either using
computational or laboratory approaches. Evaluation will be based on the
narrative description of the design of testable experiments, which
could examine the novel biological hypothesis identified through these
new genes or combinations of genes, genetic variants, or sets of
genomic features associated with breast cancer. The format should
mirror an outline of grant-specific aims.
Note: The ``Evidence of Novel Biological Hypothesis(es)''
criteria (4) is distinct from the ``Identification of Novel
Findings'' criteria (1). The ``Evidence of Novel Biological
Hypothesis(es)'' criteria (4) is based on the narrative description
of hypotheses generated from the findings and proposed follow up
experiments. In contrast, the ``Identification of Novel Findings''
criteria (1) are the identification of new genes or combinations of
genes, genetic variants, or sets of genomic features associated with
breast cancer susceptibility.
5. Collaboration (15 points)--Points will be awarded based on (a)
the number of different fields represented on the Team; (b) the number
of new collaborations represented on the Team (defined as individuals
not having published together in the past 5 years); and (c) the number
of individuals invited to participate in the Challenge by Team members
resulting in Entries to the Challenge.
People's Choice Award
In addition to the main prize, a People's Choice Award for the most
interesting strategy may be given to the Entry that receives the most
votes from the Challenge participants on the Challenge Web site.
Details of how voting will take place will be posted on the Challenge
Web site.
Additional Information
Intellectual Property
By submitting an Entry, each Challenge participant warrants that he
or she is the sole author and owner of any copyrightable works that the
Entry comprises, that the works are wholly original with the Challenge
participant (or is an improved version of an existing work that the
Challenge participant has sufficient rights to use and improve), and
that the Entry does not infringe any copyright or any other rights of
any third party of which Challenge participant is aware.
To receive an award, Challenge participants will not be required to
transfer their exclusive intellectual property rights to the NIH. Each
individual (whether competing singly or on a team) or entity retains
title and full ownership in and to their Entry and expressly reserves
all intellectual property rights (e.g., copyright) in their Entry.
However, by participating in the Challenge each individual (whether
competing singly or in a team) grants to the NCI and others acting on
behalf of the NCI, a royalty-free non-exclusive worldwide license to
use, copy for use, and display publicly all parts of the Entry for the
purposes of the Challenge. This license may include posting or linking
to the Entry on the official NCI Challenge Web site and making it
available for research use by the public.
When submitting source code as part of the Entry package,
participants should provide it to the NCI under an open-source license
of their choice. The license must permit the NCI contractor, Sage
Bionetworks, to distribute the code to the public for non-commercial
research and development use via the Synapse challenge platform.
Participants may keep copyright to their code Entries. If participants
do not provide information on licensing, participant's Entry shall be
under the FreeBSD license.
Challenge participants are free to discuss their Entry and the
ideas or technologies that it contains with other parties and are free
to contract with any third parties as long as they do not sign any
agreement or undertake any obligation that conflicts with any agreement
that they have entered into (i.e., with Team members) or do enter into
regarding their Entry for the Challenge. For the purpose of clarity,
Challenge participants acknowledge that the intent of the Challenge is
to encourage people to collaborate and share ideas and innovations.
By submitting an Entry, Challenge participants grant the NCI and
the contractor Sage Bionetworks the limited rights set forth in these
Official Rules. By submitting an Entry, each participant (whether
competing singly or on a team) grants to the NCI and Sage Bionetworks
the right to review their Entry and to have the NCI and their designees
review the Entry.
Liability and Indemnification
By participating in this Challenge, each Challenge participant
(whether competing singly or on a Team) agrees to assume any and all
risks and waive claims against the Federal government and its related
entities, including Sage Bionetworks, the Challenge Evaluation Panel
and the NCI Judges, 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 Challenge, whether the injury, death, damage, or loss arises
through negligence or otherwise. By participating in this Challenge,
each Challenge participant (whether competing singly or on a team)
[[Page 32172]]
agrees to indemnify the Federal government and the contractor Sage
Bionetworks, against third party claims for damages arising from or
related to Challenge activities.
Insurance
Based on the subject matter of the Challenge, the type of work that
it will possibly require, as well as an analysis of the likelihood of
any claims for death, bodily injury, or property damage, or loss
potentially resulting from competition participation, Challenge
participants are not required to obtain liability insurance or
demonstrate financial responsibility in order to participate in this
Challenge.
Challenge Judges
Huann-Sheng Chen; Mathematical Statistician; Statistical Methodology
and Applications Branch (SMAB); Surveillance Research Program (SRP);
DCCPS; NCI
Eric J. Feuer; Ph.D.; Chief, SMAB; SRP; DCCPS; NCI
Leah Mechanic; Ph.D.; Program Director; Genomic Epidemiology Branch
(GEB); Epidemiology and Genomics Research Program (EGRP); DCCPS; NCI
Elizabeth Gillanders; Ph.D.; Chief; GEB; EGRP; DCCPS; NCI
Carolyn M. Hutter, Ph.D.; Program Director; Division of Genomic
Medicine; National Human Genome Research Institute
Margaret A. Tucker, M.D., Director, Human Genetics Program and Acting
Chief, Laboratory of Translational Genomics; Division of Cancer
Epidemiology and Genetics; NCI
Dated: May 19, 2015.
Douglas R. Lowy,
Acting Director, National Cancer Institute.
[FR Doc. 2015-13816 Filed 6-4-15; 8:45 am]
BILLING CODE 4140-01-P