80 FR 32168 - Announcement of Requirements and Registration for “Up For A Challenge (U4C)-Stimulating Innovation in Breast Cancer Genetic Epidemiology”

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 108 (June 5, 2015)

Page Range32168-32172
FR Document2015-13816

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.

Federal Register, Volume 80 Issue 108 (Friday, June 5, 2015)
[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Notices]
[Pages 32168-32172]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13816]



[[Page 32168]]

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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 
[email protected].

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 
[email protected] 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) 
(http://cancergenome.nih.gov/) or the ENCyclopedia Of DNA Elements 
(ENCODE) project (http://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 (http://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--http://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 (http://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 (http://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, http://www.ncbi.nlm.nih.gov/pubmed/?term=20542480;
    ii. Ghoussani et al., 2013, http://www.ncbi.nlm.nih.gov/pubmed/?term=23973388;
    iii. Fachal and Dunning, 2015, http://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 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


Current View
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesChallenge 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
ContactElizabeth M. Gillanders, Ph.D., NCI, (240) 276-6764; Leah E. Mechanic, Ph.D., NCI, (240) 276-6847 or [email protected]
FR Citation80 FR 32168 

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