80_FR_32276 80 FR 32168 - Announcement of Requirements and Registration for “Up For A Challenge (U4C)-Stimulating Innovation in Breast Cancer Genetic Epidemiology”

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]]

-----------------------------------------------------------------------

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

[[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



                                                    32168                            Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices

                                                    DEPARTMENT OF HEALTH AND                                Subject of Challenge Competition                       nucleotide polymorphisms or SNPs) to
                                                    HUMAN SERVICES                                             In order to stimulate innovation, the               pathways (i.e. combinations of genes,
                                                                                                            National Cancer Institute’s (NCI)                      genetic variants, or sets of genomic
                                                    National Institutes of Health                                                                                  features), could lead to the
                                                                                                            Division of Cancer Control and
                                                                                                            Population Sciences (DCCPS) is                         identification of novel gene sets
                                                    Announcement of Requirements and                                                                               involved in breast cancer risk.
                                                    Registration for ‘‘Up For A Challenge                   launching a prize competition to inspire
                                                                                                                                                                      This Challenge provides an
                                                    (U4C)—Stimulating Innovation in                         novel cross-disciplinary approaches to
                                                                                                                                                                   opportunity to examine the heritable
                                                    Breast Cancer Genetic Epidemiology’’                    more fully decipher the genomic basis
                                                                                                                                                                   contribution to racial disparities, by
                                                                                                            of breast cancer, called ‘‘Up For A
                                                                                                                                                                   facilitating access to GWAS data sets
                                                                                                            Challenge (U4C)—Stimulating
                                                       Authority: 15 U.S.C. 3719.                                                                                  from African American, Asian,
                                                                                                            Innovation in Breast Cancer Genetic
                                                                                                                                                                   European, and Latino women. African
                                                       Award Approving Official: Douglas R.                 Epidemiology’’ (the ‘‘Challenge’’) using
                                                                                                                                                                   American women are known to have a
                                                    Lowy, Acting Director, National Cancer                  the America Creating Opportunities to
                                                                                                                                                                   lower incidence of breast cancer, but
                                                    Institute.                                              Meaningfully Promote Excellence in
                                                                                                                                                                   survival is lower for African American
                                                    SUMMARY: The National Cancer                            Technology, Education, and Science
                                                                                                                                                                   than for non-Hispanic white women at
                                                    Institute’s (NCI) Division of Cancer                    (COMPETES) Reauthorization Act of
                                                                                                                                                                   every stage of diagnosis. Meanwhile,
                                                    Control and Population Sciences                         2010.
                                                                                                                                                                   Asian women have the lowest rates of
                                                    (DCCPS) announces that they are                            The goal of this Challenge is to use
                                                                                                                                                                   breast cancer incidence and mortality
                                                    partnering with Sage Bionetworks to                     innovative approaches to identify novel
                                                                                                                                                                   compared with non-Hispanic white,
                                                    launch ‘‘Up For A Challenge (U4C)—                      pathways—including new genes or
                                                                                                                                                                   African American, and Hispanic/Latino
                                                    Stimulating Innovation in Breast Cancer                 combinations of genes, genetic variants,
                                                                                                                                                                   women. Findings from this Challenge
                                                    Genetic Epidemiology’’ (the                             or sets of genomic features—involved in
                                                                                                                                                                   may provide insights into some of these
                                                    ‘‘Challenge’’) to encourage unique                      breast cancer susceptibility in order to
                                                                                                                                                                   observed differences.
                                                    approaches to more fully decipher the                   generate new biological hypotheses.                       As more fully described below,
                                                    genomic basis of breast cancer. Utilizing                  To that end, several data sets have
                                                                                                                                                                   participants are invited to use
                                                    innovative approaches, the goal of this                 been gathered and will be made
                                                                                                                                                                   innovative approaches to identify novel
                                                    Challenge is to identify new genes or                   available for use in the Challenge; some
                                                                                                                                                                   pathways—including new genes or
                                                    combinations of genes, genetic variants,                of these will be released for the first
                                                                                                                                                                   combinations of genes, genetic variants,
                                                    or sets of genomic features involved in                 time. In addition, Challenge participants
                                                                                                                                                                   or sets of genomic features—involved in
                                                    breast cancer susceptibility. In addition,              will be free to use any other publicly
                                                                                                                                                                   breast cancer susceptibility. Besides
                                                    the NCI aims to advance innovation in                   available data sets (subject to
                                                                                                                                                                   developing a better understanding of
                                                    the field of genetic epidemiology by                    compliance with applicable terms and
                                                                                                                                                                   cancer risk assessment, the
                                                    making data more widely available,                      conditions) for the purposes of
                                                                                                                                                                   identification of breast cancer
                                                    increasing the amount and diversity of                  developing and applying methods for
                                                                                                                                                                   susceptibility genes holds promise for
                                                    minds approaching a difficult scientific                identification of the novel pathways.
                                                                                                                                                                   providing therapeutic targets for drug
                                                    problem, and promoting broader                             Breast cancer is the most commonly
                                                                                                                                                                   development.
                                                    collaborations. This Challenge is being                 occurring cancer, and the second most
                                                    launched under the America                              common cause of cancer deaths in                       Statutory Authority
                                                    COMPETES Reauthorization Act of                         women in the United States. An                            The NCI is authorized and established
                                                    2010.                                                   estimated 231,840 new cases of invasive                by Title IV, Part C, Subpart 1 of the
                                                                                                            breast cancer are expected to be                       Public Health Service Act, 42 U.S.C. 285
                                                    DATES:
                                                                                                            diagnosed among women (2,350 in men)                   to conduct and support research,
                                                    Challenge Opens: June 15, 2015
                                                    Challenge Entries: Due January 15, 2016                 in the U.S. during 2015 with an                        training, health information
                                                       (8 p.m. EST)                                         estimated 40,730 deaths. Despite                       dissemination, and other programs with
                                                    Challenge Judging: January 16, 2016–                    advances in breast cancer therapies,                   respect to the cause, diagnosis,
                                                       March 31, 2016                                       breast cancer remains a major public                   prevention, and treatment of cancer,
                                                    Winners Announced: April 16–20, 2016                    health burden. One approach to reduce                  rehabilitation from cancer, and the
                                                       The NCI will announce any changes                    overall occurrence and mortality from                  continuing care of cancer patients and
                                                    to the timeline by amending this                        breast cancer is to develop ways of                    the families of cancer patients. Through
                                                    Federal Register notice. This Challenge                 identifying women who are at increased                 this Challenge, the NCI aims to advance
                                                    will be supported by Sage Bionetworks                   risk for breast cancer.                                innovation in the field of genetic
                                                    (https://www.synapse.org/                                  Epidemiologic studies suggest that                  epidemiology by making breast cancer
                                                    upforachallenge) on behalf of the NCI.                  genetic factors play a key role in                     genetic epidemiology data more widely
                                                                                                            determining who is at increased risk of                available, increasing the number and
                                                    ADDRESSES: To register for this
                                                                                                            developing breast cancer, as well as                   diversity of researchers addressing a
                                                    Challenge, Challenge participants may                   what type of cancer they develop. To
                                                    access the registration on the Challenge                                                                       difficult scientific problem, and
                                                                                                            date, genome-wide association studies                  promoting broader collaborations.
                                                    Web site (https://www.synapse.org/                      (GWAS) have helped researchers
                                                    upforachallenge). Access to this Web                                                                           Ideally, this would result in insights
                                                                                                            identify more than 90 common genetic                   into the genetic epidemiology of breast
                                                    site may also be found by searching the                 variations. Although GWAS have greatly
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    www.challenge.gov site for ‘‘Up For A                                                                          cancer.
                                                                                                            increased our understanding of the                        Official Rules:
                                                    Challenge.’’                                            genetic components of breast cancer
                                                    FOR FURTHER INFORMATION CONTACT:                        susceptibility, the results to date explain            Eligibility Rules for Participating in the
                                                    Elizabeth M. Gillanders, Ph.D., NCI,                    only a small proportion of the estimated               Challenge and Winning
                                                    (240) 276–6764; Leah E. Mechanic,                       genetic contribution to the risk of breast               1. To be eligible to win a prize under
                                                    Ph.D., NCI, (240) 276–6847 or                           cancer. However, shifting the focus of                 this Challenge, an individual or entity—
                                                    NCIUpForAChallenge@mail.nih.gov.                        analysis from individual genetic                         a. Shall have registered to participate
                                                    SUPPLEMENTARY INFORMATION:                              variants (also known as single                         in the Challenge under the rules


                                               VerDate Sep<11>2014   18:31 Jun 04, 2015   Jkt 235001   PO 00000   Frm 00087   Fmt 4703   Sfmt 4703   E:\FR\FM\05JNN1.SGM   05JNN1


                                                                                     Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices                                             32169

                                                    promulgated by the National Cancer                      agrees to follow applicable local, State,                 Data will be requested through
                                                    Institute (as published in this notice);                and Federal laws and regulations.                      database of Genotypes and Phenotypes
                                                       b. Shall have complied with all the                    8. Each individual (whether                          (dbGaP) application process. Details
                                                    requirements under this section;                        participating singly or in a team) and                 regarding the process for requesting data
                                                       c. In the case of a private entity, shall            entity participating in this Challenge                 are provided on the Challenge Web site
                                                    be incorporated in and maintain a                       must comply with all terms and                         (https://www.synapse.org/
                                                    primary place of business in the United                 conditions of these rules, and                         upforachallenge). Data Access Requests
                                                    States, and in the case of an individual,               participation in this Challenge                        will be reviewed by the appropriate NIH
                                                    whether participating singly or in a                    constitutes each such participant’s full               Data Access Committees (DAC) to
                                                    team, shall be a citizen or permanent                   and unconditional agreement to abide                   ensure that the proposed project is
                                                    resident of the United States;                          by these rules, which may also be found                consistent with any Data Use
                                                       d. May not be a Federal entity;                      on the Challenge Web site (https://                    Limitations for the requested dataset(s).
                                                       e. May not be a Federal employee                     www.synapse.org/upforachallenge).                      Note: That any scientific collaborators,
                                                    acting within the scope of his or her                   Winning is contingent upon fulfilling all              including contractors, who are not at the
                                                    employment and further, in the case of                  requirements herein.                                   same institution as the PI must submit
                                                    HHS employees may not work on their                       All questions regarding the Challenge                their own DAR. Data cannot be shared
                                                    Entries during assigned duty hours.                     should be directed to Dr. Gillanders or                with collaborators from other
                                                    Note: Federal ethical conduct rules may                 Dr. Mechanic, identified above or by                   institutions until they have submitted
                                                    restrict or prohibit Federal employees                  emailing NCIUpForAChallenge@                           an application (and explicitly named
                                                    from engaging in certain outside                        mail.nih.gov and answers will be posted                this collaborators) to use the dataset(s)
                                                    activities, so any Federal employee not                 and updated as necessary at (https://                  from their institution(s) and have
                                                    excluded under the prior paragraph                      www.synapse.org/upforachallenge)                       received approval. If Approved Users
                                                    seeking to participate in this Challenge                under Frequently Asked Questions.                      are provided access to NIH genomic
                                                    outside the scope of employment should                                                                         datasets for inter-institutional
                                                    consult his/her agency’s ethics official                Registration Process for Participants                  collaborative research described in the
                                                    prior to developing an Entry;                              To register for this Challenge,                     research use statement of the DAR, and
                                                       f. May not be an employee of the NIH,                Challenge participants may access the                  all members of the collaboration are also
                                                    a judge of the Challenge, or any other                  registration on the Challenge Web site                 Approved Users through their home
                                                    party involved with the design,                         (https://www.synapse.org/                              institution(s), data obtained through this
                                                    production, execution, or distribution of               upforachallenge). Access to this Web                   DAR may be securely transmitted
                                                    the Challenge or the immediate family                   site may also be found by searching the                within the collaborative group.
                                                    member of such a party (i.e., spouse,                   www.challenge.gov site for ‘‘Up For A                     Challenge participants who obtain
                                                    parent, step-parent, or step-child).                    Challenge.’’ Individuals may participate               data from dbGaP should note that they
                                                    Without limiting the generality of the                  in the Challenge as individuals or as                  are agreeing to the NIH Genomic Data
                                                    foregoing, members of the Evaluation                    Teams. Details about participating as a                User Code of Conduct (http://
                                                    Panel which will score Entries and the                  Team are provided below:                               gds.nih.gov/pdf/Genomic_Data_User_
                                                    NIH Judges, as well as their students are                  1. After registration, you may                      Code_of_Conduct.pdf) and they are
                                                    not eligible to participate in the                      participate alone or on a Team with                    agreeing to the terms of specific Data
                                                    Challenge.                                              other Challenge participants. To work                  Use Certificates for each individual
                                                       2. Federal grantees may not use                      on a Team, you may either create a new                 dataset requested (The model Data Use
                                                    Federal funds to develop Challenge                      Team or join a pre-existing Team.                      Certificate can be found here—http://
                                                    Entries unless consistent with the                         2. There is no maximum Team size.                   gds.nih.gov/pdf/Model_DUC.pdf). Note
                                                    purpose of their grant award and                           3. All Teams must designate a Team                  that individual datasets may have
                                                    specifically requested to do so due to                  Captain. Each individual member of a                   additional limitations in regards to use
                                                    the Challenge design, and as announced                  Team must be a registered participant in               of the data. As the GWAS datasets
                                                    in the Federal Register.                                the Challenge.                                         obtained from dbGaP are considered
                                                       3. Federal contractors may not use                      4. Individuals may participate on                   controlled access data, individuals
                                                    Federal funds from a contract to develop                multiple Teams, and Challenge Teams                    approved to use these data must abide
                                                    Challenge Entries or to fund efforts in                 may merge (requiring mutual agreement                  by dbGaP security best practices in
                                                    support of a Challenge Entry.                           of Team Captains). Individuals are                     regards to the data (http://
                                                       4. An individual, Team, or entity that               allowed to leave a Team to work alone                  www.ncbi.nlm.nih.gov/projects/gap/
                                                    is currently on the Excluded Parties List               or join another Team.                                  pdf/dbgap_2b_security_procedures.pdf).
                                                    (https://www.epls.gov/) will not be                                                                            If submitting a request to dbGaP for use
                                                                                                            Data Access Process
                                                    selected as a Finalist or prize winner.                                                                        of data for the Challenge, participants
                                                       5. Whether singly or as part of a team                 Once registered for the Challenge,                   should be aware that the data requested
                                                    or entity, each individual participating                participants must apply for controlled                 should be used solely for the research
                                                    in the Challenge must be 18 years of age                access to the designated Challenge                     purpose described in the Data Access
                                                    or older.                                               genetic datasets following instructions                Request, i.e., solely for the Challenge.
                                                       6. An individual shall not be deemed                 on the Challenge Web site. Challenge                   New uses of these data outside this
                                                    ineligible to win because the individual                participants may use any of these dbGaP                Challenge will require submission of a
                                                    used Federal facilities or consulted with               datasets or any other datasets available
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                                                                                                                                   new Data Access Request.
                                                    Federal employees during the Challenge                  to anyone (either publically available or
                                                    provided that such facilities and/or                    available through controlled access)                   Challenge Entries
                                                    employees, as applicable, are made                      such as data from the Cancer Genome                      As used in this notice, ‘‘Entry’’ is the
                                                    available on an equitable basis to all                  Atlas (TCGA) (http://                                  information submitted in the manner
                                                    individuals and Teams participating in                  cancergenome.nih.gov/) or the                          and format specified on the Up For A
                                                    the Challenge.                                          ENCyclopedia Of DNA Elements                           Challenge (U4C) Web site (https://
                                                       7. Each individual (whether                          (ENCODE) project (http://                              www.synapse.org/upforachallenge). All
                                                    competing singly or in a team) or entity                www.genome.gov/encode/).                               Entries must be received by the


                                               VerDate Sep<11>2014   18:31 Jun 04, 2015   Jkt 235001   PO 00000   Frm 00088   Fmt 4703   Sfmt 4703   E:\FR\FM\05JNN1.SGM   05JNN1


                                                    32170                            Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices

                                                    applicable deadline. Entries submitted                  complete, that Challenge participants                  Challenge pursuant to the Official Rules,
                                                    after a posted Challenge deadline will                  have the right and authority to submit                 as amended, such participant may
                                                    not be considered.                                      such Entry on their own behalf or on                   terminate his/her/participation in the
                                                       Entries may be submitted on behalf of                behalf of the persons and entities                     Challenge by not submitting additional
                                                    a Team by any of its participants. It is                specified within the Entry, and that the               Entries. The NIH reserves the right to
                                                    up to each Team to organize its                         Entry:                                                 not award any prizes if no Entries are
                                                    Entry(ies) and to follow the Challenge                     1. Is the Challenge participant’s or                deemed worthy.
                                                    submission requirements. On                             Team’s (as applicable) own original
                                                                                                            work, or is used by permission with full               Basis Upon Which Winner Will Be
                                                    submission of an Entry, Challenge
                                                                                                            and proper credit given within the                     Selected
                                                    participants must include the Team
                                                    name under which they are submitting.                   Entry;                                                    Entries will be scored by the
                                                       All final Entries must be submitted                     2. Does not contain confidential                    Challenge Evaluation Panel using the
                                                    through the Challenge Web site on                       information or trade secrets (the Team’s               criteria listed below. After the Challenge
                                                    Synapse, following Web site                             or anyone else’s);                                     Evaluation Panel provides final scores,
                                                    instructions and should provide                            3. Does not violate or infringe upon                the highest scoring applications will be
                                                    necessary and sufficient detail and                     the patent rights, industrial design                   evaluated for reproducibility by Sage
                                                    annotation for reproduction of the                      rights, copyrights, trademarks, rights of              Bionetworks’ data scientists. In order to
                                                    submitted results. Information                          privacy, publicity or other intellectual               qualify for a Challenge prize, it must be
                                                    accompanying each Entry should                          property or other rights of any person or              possible for Sage Bionetworks’ data
                                                    include:                                                entity;                                                scientists to reproduce Entry results
                                                                                                               4. Does not contain malicious code,                 within 1 month. The NCI Judges will
                                                    1. Title of project
                                                                                                            such as viruses, timebombs, cancelbots,                review scores and reproduction by Sage
                                                    2. Name of Team
                                                                                                            worms, trojan horses or other                          and make recommendations to the NCI
                                                    3. Names and field of expertise of Team
                                                                                                            potentially harmful programs or other                  Director. The NCI Director will make the
                                                         members
                                                                                                            material or information;                               final selection of Entries for award.
                                                    4. List of new pair-wise collaborations                    5. Does not and will not violate any
                                                         on Team (defined as individuals not                applicable law, statute, ordinance, rule               Scoring Criteria (100 Points)
                                                         having published together in the                   or regulation; and
                                                         past 5 years)                                                                                               1. Identification of Novel Findings (25
                                                                                                               6. Does not trigger any reporting or                points)—Using breast cancer GWAS
                                                    5. Information about how Team learned                   royalty obligation to any third party.
                                                         about the Challenge                                                                                       data sets available in dbGaP and/or any
                                                    6. Identification of datasets used (1                   Amount of the Prize                                    other publicly available data sets,
                                                         page)                                                 The grand prize Entry will be                       Challenge participants must identify
                                                    7. A description of methods used to                     awarded up to $30,000. The second                      new genes or combinations of genes,
                                                         generate the findings (4 pages                     place Entry will be awarded a runner-                  genetic variants, or sets of genomic
                                                         maximum)                                           up prize of up to $20,000. Prizes will be              features associated with breast cancer
                                                    8. Narrative which addresses the                        awarded by Sage Bionetworks. The top                   susceptibility.
                                                         evaluation criteria (identification of             5 Entries (grand prize, second place, and                a. The National Human Genome
                                                         novel findings, replication of                     the next three runner-ups) as well as the              Research Institute’s (NHGRI) Catalog of
                                                         findings, innovation of approach,                  People’s Choice Award winner will be                   Published Genome Wide Association
                                                         evidence of novel biological                       highlighted on the Challenge and                       Studies (http://www.genome.gov/
                                                         hypothesis(es), and collaboration)                 DCCPS EGRP Web sites pending                           gwastudies/) or variants/loci identified
                                                         (6 pages maximum)                                  selection by the NCI Director. The top                 in the following publications can be
                                                    9. The corresponding source code so                     5 Entries (grand prize, second place, and              used to evaluate possible novel findings:
                                                         that the Challenge organizers can                  the next three runner-ups) as well as the                i. Mavaddat et al., 2010, http://
                                                         re-run and manually review and                     People’s Choice Award winner will be                   www.ncbi.nlm.nih.gov/pubmed/
                                                         verify that the code affiliated with               invited to prepare a manuscript for                    ?term=20542480;
                                                         the top scoring Entries yield the                  publication describing their approach                    ii. Ghoussani et al., 2013, http://
                                                         submitted results.                                 and results with a goal of a special                   www.ncbi.nlm.nih.gov/pubmed/
                                                       Only complete Entries, which follow                  journal issue highlighting the Challenge.              ?term=23973388;
                                                    application instructions, will be                       All Challenge participants will be                       iii. Fachal and Dunning, 2015,
                                                    reviewed and eligible to win. Top                       acknowledged in the special issue of the               http://www.ncbi.nlm.nih.gov/pubmed/
                                                    performing Entries will be reviewed                     journal, pending acceptance.                           ?term=25727315)
                                                    thoroughly. The NCI reserves the right                     The NIH reserves the right to cancel,                 b. The scale for novelty for the
                                                    to disqualify any Challenge participants                suspend, and/or modify this Challenge                  Challenge Evaluation panel to use as a
                                                    in instances where cheating or other                    at any time through amendment to this                  guide is provided:
                                                    misconduct is identified. Details                       Federal Register notice. In addition, in                 i. New variants in well-established
                                                    regarding the dispute resolution process                the event the Challenge is modified,                   high or moderate penetrance genes (e.g.,
                                                    are provided on the Challenge Web site                  Challenge participants registered in the               BRCA1/BRCA2; ATM; PALB2) (low).
                                                    (https://www.synapse.org/                               Challenge will be notified by email and                  ii. New variants in GWAS-identified
                                                                                                            provided with a copy of the amended                    genes or loci (med).
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    upforachallenge).
                                                                                                            Challenge rules and a listing of the                     iii. New combinations of variants
                                                    Warranties                                              changes that were made. Any                            which were previously identified (i.e.,
                                                      By submitting an Entry to the                         participant who continues to participate               the combination or combined effect is
                                                    Challenge, Challenge participants                       in the Challenge following receipt of                  new, but the variants were previously
                                                    represent and warrant that all                          such a notice of amendment, will be                    identified) (medium).
                                                    information provided in their Entries                   deemed to have accepted any such                         iv. New genes or loci (high).
                                                    and as a result of the Challenge                        amendment. If a participant does not                     v. New combinations of variants from
                                                    registration process is true and                        wish to continue to participate in the                 genes or loci not identified previously


                                               VerDate Sep<11>2014   18:31 Jun 04, 2015   Jkt 235001   PO 00000   Frm 00089   Fmt 4703   Sfmt 4703   E:\FR\FM\05JNN1.SGM   05JNN1


                                                                                     Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices                                             32171

                                                    (i.e., the combination and some of the                  description of the design of testable                  competing singly or in a team) grants to
                                                    variants are new) (high).                               experiments, which could examine the                   the NCI and others acting on behalf of
                                                       2. Replication of Findings (25                       novel biological hypothesis identified                 the NCI, a royalty-free non-exclusive
                                                    points)—Evidence of the validity of the                 through these new genes or                             worldwide license to use, copy for use,
                                                    proposed novel finding will be                          combinations of genes, genetic variants,               and display publicly all parts of the
                                                    evaluated through replication.                          or sets of genomic features associated                 Entry for the purposes of the Challenge.
                                                       a. There are several different ways                  with breast cancer. The format should                  This license may include posting or
                                                    replication can be accomplished. These                  mirror an outline of grant-specific aims.              linking to the Entry on the official NCI
                                                    may include using data sets as testing                    Note: The ‘‘Evidence of Novel Biological             Challenge Web site and making it
                                                    and training data (or discovery in one                  Hypothesis(es)’’ criteria (4) is distinct from         available for research use by the public.
                                                    data set and replication in another data                the ‘‘Identification of Novel Findings’’                  When submitting source code as part
                                                    set) or dividing the data into several                  criteria (1). The ‘‘Evidence of Novel                  of the Entry package, participants
                                                    portions and performing some type of                    Biological Hypothesis(es)’’ criteria (4) is            should provide it to the NCI under an
                                                    cross-validation. The Challenge                         based on the narrative description of                  open-source license of their choice. The
                                                    Evaluation panel will also be open to                   hypotheses generated from the findings and             license must permit the NCI contractor,
                                                                                                            proposed follow up experiments. In contrast,           Sage Bionetworks, to distribute the code
                                                    other innovative approaches for
                                                                                                            the ‘‘Identification of Novel Findings’’
                                                    replication.                                            criteria (1) are the identification of new genes
                                                                                                                                                                   to the public for non-commercial
                                                       i. The Challenge participant will need               or combinations of genes, genetic variants, or         research and development use via the
                                                    to select criteria for replication and                  sets of genomic features associated with               Synapse challenge platform.
                                                    provide a justification for the selected                breast cancer susceptibility.                          Participants may keep copyright to their
                                                    criteria. Using the criteria selected by                  5. Collaboration (15 points)—Points                  code Entries. If participants do not
                                                    the Challenge participant, the Challenge                                                                       provide information on licensing,
                                                                                                            will be awarded based on (a) the
                                                    participant must demonstrate                                                                                   participant’s Entry shall be under the
                                                                                                            number of different fields represented
                                                    replication of findings.                                                                                       FreeBSD license.
                                                                                                            on the Team; (b) the number of new                        Challenge participants are free to
                                                       b. Note: Challenge participants should
                                                                                                            collaborations represented on the Team                 discuss their Entry and the ideas or
                                                    provide their criteria for replication in
                                                                                                            (defined as individuals not having                     technologies that it contains with other
                                                    the narrative portion of their Challenge
                                                                                                            published together in the past 5 years);               parties and are free to contract with any
                                                    Entry.
                                                                                                            and (c) the number of individuals                      third parties as long as they do not sign
                                                       c. The adequacy of criteria selected by
                                                                                                            invited to participate in the Challenge                any agreement or undertake any
                                                    the Challenge participant and evidence
                                                                                                            by Team members resulting in Entries to                obligation that conflicts with any
                                                    for replication will be scored by the
                                                                                                            the Challenge.                                         agreement that they have entered into
                                                    Challenge Evaluation Panel.
                                                       3. Innovation of Approach (25                        People’s Choice Award                                  (i.e., with Team members) or do enter
                                                    points)—Innovation and creativity of                                                                           into regarding their Entry for the
                                                                                                              In addition to the main prize, a
                                                    the submitted approach will be                                                                                 Challenge. For the purpose of clarity,
                                                                                                            People’s Choice Award for the most
                                                    evaluated. Innovation will be defined as                                                                       Challenge participants acknowledge that
                                                                                                            interesting strategy may be given to the
                                                    a new or significantly improved                                                                                the intent of the Challenge is to
                                                                                                            Entry that receives the most votes from
                                                    method. The submitted narrative must                                                                           encourage people to collaborate and
                                                                                                            the Challenge participants on the
                                                    describe what is innovative about the                                                                          share ideas and innovations.
                                                                                                            Challenge Web site. Details of how                        By submitting an Entry, Challenge
                                                    approach, what this approach is                         voting will take place will be posted on
                                                    building on, and why the approach is                                                                           participants grant the NCI and the
                                                                                                            the Challenge Web site.                                contractor Sage Bionetworks the limited
                                                    necessary or how it improves upon
                                                    existing approaches. Some criteria for                  Additional Information                                 rights set forth in these Official Rules.
                                                    innovation include the following:                                                                              By submitting an Entry, each participant
                                                                                                            Intellectual Property                                  (whether competing singly or on a team)
                                                       a. Does the Entry seek to shift current
                                                    paradigms by utilizing novel theoretical                   By submitting an Entry, each                        grants to the NCI and Sage Bionetworks
                                                    concepts, approaches, or                                Challenge participant warrants that he                 the right to review their Entry and to
                                                    methodologies?                                          or she is the sole author and owner of                 have the NCI and their designees review
                                                       b. Are the concepts, approaches, or                  any copyrightable works that the Entry                 the Entry.
                                                    methods in the Entry novel to this field                comprises, that the works are wholly
                                                                                                            original with the Challenge participant                Liability and Indemnification
                                                    of research or novel in a broader sense?
                                                       c. Does the Entry represent a                        (or is an improved version of an existing                 By participating in this Challenge,
                                                    refinement, improvement, or new                         work that the Challenge participant has                each Challenge participant (whether
                                                    application of theoretical concepts,                    sufficient rights to use and improve),                 competing singly or on a Team) agrees
                                                    approaches, or methodologies?                           and that the Entry does not infringe any               to assume any and all risks and waive
                                                       4. Evidence of Novel Biological                      copyright or any other rights of any                   claims against the Federal government
                                                    Hypothesis(es) (10 points)—                             third party of which Challenge                         and its related entities, including Sage
                                                       a. Evaluation of this aspect of                      participant is aware.                                  Bionetworks, the Challenge Evaluation
                                                    Challenge Entries will be based on                         To receive an award, Challenge                      Panel and the NCI Judges, except in the
                                                    whether findings (i.e., new genes or                    participants will not be required to                   case of willful misconduct, for any
                                                    combinations of genes, genetic variants,                transfer their exclusive intellectual                  injury, death, damage, or loss of
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    or sets of genomic features) lead to                    property rights to the NIH. Each                       property, revenue, or profits, whether
                                                    novel biological hypotheses. A                          individual (whether competing singly or                direct, indirect, or consequential, arising
                                                    description of these hypotheses should                  on a team) or entity retains title and full            from participation in this Challenge,
                                                    be provided in the final project Entry.                 ownership in and to their Entry and                    whether the injury, death, damage, or
                                                       b. Novel biological hypotheses should                expressly reserves all intellectual                    loss arises through negligence or
                                                    be testable, either using computational                 property rights (e.g., copyright) in their             otherwise. By participating in this
                                                    or laboratory approaches. Evaluation                    Entry. However, by participating in the                Challenge, each Challenge participant
                                                    will be based on the narrative                          Challenge each individual (whether                     (whether competing singly or on a team)


                                               VerDate Sep<11>2014   18:31 Jun 04, 2015   Jkt 235001   PO 00000   Frm 00090   Fmt 4703   Sfmt 4703   E:\FR\FM\05JNN1.SGM   05JNN1


                                                    32172                            Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices

                                                    agrees to indemnify the Federal                         confidential trade secrets or commercial               the discussions could disclose
                                                    government and the contractor Sage                      property such as patentable material,                  confidential trade secrets or commercial
                                                    Bionetworks, against third party claims                 and personal information concerning                    property such as patentable material,
                                                    for damages arising from or related to                  individuals associated with the grant                  and personal information concerning
                                                    Challenge activities.                                   applications, the disclosure of which                  individuals associated with the grant
                                                                                                            would constitute a clearly unwarranted                 applications, the disclosure of which
                                                    Insurance
                                                                                                            invasion of personal privacy.                          would constitute a clearly unwarranted
                                                       Based on the subject matter of the                      Name of Committee: National Institute on            invasion of personal privacy.
                                                    Challenge, the type of work that it will                Deafness and Other Communication                         Name of Committee: Center for Scientific
                                                    possibly require, as well as an analysis                Disorders Special Emphasis Panel; Clinical             Review Special Emphasis Panel; Member
                                                    of the likelihood of any claims for death,              Trial Review.                                          Conflict: Skin and Autoimmune Diseases.
                                                    bodily injury, or property damage, or                      Date: June 24, 2015.                                  Date: June 29–30, 2015.
                                                    loss potentially resulting from                            Time: 4:00 p.m. to 6:00 p.m.                          Time: 9:00 a.m. to 2:00 p.m.
                                                    competition participation, Challenge                       Agenda: To review and evaluate grant                  Agenda: To review and evaluate grant
                                                    participants are not required to obtain                 applications.                                          applications.
                                                                                                               Place: National Institutes of Health,                 Place: National Institutes of Health, 6701
                                                    liability insurance or demonstrate
                                                                                                            Neuroscience Center, 6001 Executive                    Rockledge Drive, Bethesda, MD 20892
                                                    financial responsibility in order to                    Boulevard, Rockville, MD 20852 (Telephone              (Virtual Meeting).
                                                    participate in this Challenge.                          Conference Call).                                        Contact Person: Rajiv Kumar, Ph.D., Chief,
                                                    Challenge Judges                                           Contact Person: Christine A. Livingston,            MOSS IRG, Center for Scientific Review,
                                                                                                            Ph.D., Scientific Review Officer, Division of          National Institutes of Health, 6701 Rockledge
                                                    Huann-Sheng Chen; Mathematical                          Extramural Activities, National Institutes of          Drive, Room 4216, MSC 7802, Bethesda, MD
                                                      Statistician; Statistical Methodology                 Health/NIDCD, 6001 Executive Blvd.—Room                20892, 301–435–1212, kumarra@csr.nih.gov.
                                                      and Applications Branch (SMAB);                       8343, Bethesda, MD 20892, (301) 496–8683,                Name of Committee: Center for Scientific
                                                      Surveillance Research Program (SRP);                  livingsc@mail.nih.gov.                                 Review Special Emphasis Panel; RFA–RM–
                                                      DCCPS; NCI                                               Name of Committee: National Institute on            14: Science of Behavior Change.
                                                    Eric J. Feuer; Ph.D.; Chief, SMAB; SRP;                 Deafness and Other Communication                         Date: June 29, 2015.
                                                      DCCPS; NCI                                            Disorders Special Emphasis Panel; Clinical               Time: 9:00 a.m. to 5:00 p.m.
                                                    Leah Mechanic; Ph.D.; Program                           Trials Review.                                           Agenda: To review and evaluate grant
                                                                                                               Date: July 23, 2015.                                applications.
                                                      Director; Genomic Epidemiology                                                                                 Place: National Institutes of Health, 6701
                                                                                                               Time: 5:00 p.m. to 6:30 p.m.
                                                      Branch (GEB); Epidemiology and                           Agenda: To review and evaluate grant                Rockledge Drive, Bethesda, MD 20892.
                                                      Genomics Research Program (EGRP);                     applications                                             Contact Person: Dana Jeffrey Plude, Ph.D.,
                                                      DCCPS; NCI                                               Place: National Institutes of Health,               Scientific Review Officer, Center for
                                                    Elizabeth Gillanders; Ph.D.; Chief; GEB;                Neuroscience Center, 6001 Executive                    Scientific Review, National Institutes of
                                                      EGRP; DCCPS; NCI                                      Boulevard, Rockville, MD 20852 (Telephone              Health, 6701 Rockledge Drive, Room 3176,
                                                    Carolyn M. Hutter, Ph.D.; Program                       Conference Call).                                      MSC 7848, Bethesda, MD 20892, 301–435–
                                                      Director; Division of Genomic                            Contact Person: Christine A. Livingston,            2309, pluded@csr.nih.gov.
                                                      Medicine; National Human Genome                       Ph.D., Scientific Review Officer, Division of            Name of Committee: Center for Scientific
                                                      Research Institute                                    Extramural Activities, National Institutes of          Review Special Emphasis Panel; PAR 13–
                                                                                                            Health/NIDCD, 6001 Executive Blvd.—Room                109: Mechanistic Insights from Birth Cohorts.
                                                    Margaret A. Tucker, M.D., Director,
                                                                                                            8343, Bethesda, MD 20892, (301) 496–8683,                Date: June 30, 2015.
                                                      Human Genetics Program and Acting                     livingsc@mail.nih.gov.                                   Time: 12:30 p.m. to 2:00 p.m.
                                                      Chief, Laboratory of Translational                                                                             Agenda: To review and evaluate grant
                                                                                                            (Catalogue of Federal Domestic Assistance
                                                      Genomics; Division of Cancer                          Program Nos. 93.173, Biological Research               applications.
                                                      Epidemiology and Genetics; NCI                        Related to Deafness and Communicative                    Place: National Institutes of Health, 6701
                                                      Dated: May 19, 2015.                                  Disorders, National Institutes of Health, HHS)         Rockledge Drive, Bethesda, MD 20892
                                                                                                                                                                   (Telephone Conference Call).
                                                    Douglas R. Lowy,                                          Dated: June 1, 2015.                                   Contact Person: Ellen K. Schwartz, EDD,
                                                    Acting Director, National Cancer Institute.             Melanie J. Gray,                                       Scientific Review Officer, Center for
                                                    [FR Doc. 2015–13816 Filed 6–4–15; 8:45 am]              Program Analyst, Office of Federal Advisory            Scientific Review, National Institutes of
                                                    BILLING CODE 4140–01–P                                  Committee Policy.                                      Health, 6701 Rockledge Drive, Room 3144,
                                                                                                            [FR Doc. 2015–13687 Filed 6–4–15; 8:45 am]             Bethesda, MD 20892, 301–828–6146,
                                                                                                                                                                   schwarel@mail.nih.gov.
                                                                                                            BILLING CODE 4140–01–P
                                                    DEPARTMENT OF HEALTH AND                                                                                         Name of Committee: Center for Scientific
                                                    HUMAN SERVICES                                                                                                 Review Special Emphasis Panel; Small
                                                                                                                                                                   Business: Dermatology, Rheumatology and
                                                                                                            DEPARTMENT OF HEALTH AND                               Inflammation.
                                                    National Institutes of Health                           HUMAN SERVICES                                           Date: July 1, 2015.
                                                    National Institute on Deafness and                                                                               Time: 8:00 a.m. to 5:30 p.m.
                                                                                                            National Institutes of Health                            Agenda: To review and evaluate grant
                                                    Other Communication Disorders;
                                                                                                                                                                   applications.
                                                    Notice of Closed Meetings                               Center For Scientific Review; Notice of                  Place: Residence Inn Bethesda, 7335
                                                                                                            Closed Meetings                                        Wisconsin Avenue, Bethesda, MD 20814.
                                                      Pursuant to section 10(d) of the
                                                    Federal Advisory Committee Act, as                        Pursuant to section 10(d) of the                       Contact Person: Yanming Bi, Ph.D.,
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                                                                                                                                   Scientific Review Officer, Center for
                                                    amended (5 U.S.C. App.), notice is                      Federal Advisory Committee Act, as                     Scientific Review, National Institutes of
                                                    hereby given of the following meetings.                 amended (5 U.S.C. App.), notice is                     Health, 6701 Rockledge Drive, Room 4214,
                                                      The meetings will be closed to the                    hereby given of the following meetings.                MSC 7814, Bethesda, MD 20892, 301–451–
                                                    public in accordance with the                             The meetings will be closed to the                   0996, ybi@csr.nih.gov.
                                                    provisions set forth in sections                        public in accordance with the                            Name of Committee: Center for Scientific
                                                    552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              provisions set forth in sections                       Review Special Emphasis Panel; Member
                                                    as amended. The grant applications and                  552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,             Conflict: AIDS and AIDS Related Research.
                                                    the discussions could disclose                          as amended. The grant applications and                   Date: July 7, 2015.



                                               VerDate Sep<11>2014   18:31 Jun 04, 2015   Jkt 235001   PO 00000   Frm 00091   Fmt 4703   Sfmt 4703   E:\FR\FM\05JNN1.SGM   05JNN1



Document Created: 2015-12-15 15:20:12
Document Modified: 2015-12-15 15:20:12
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 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR