[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63809-63812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26753]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Announcement of Requirements and Registration for the National 
Heart, Lung, and Blood Institute ``Novel, Innovative Tools To Increase 
Public Awareness and Knowledge of Sickle Cell Disease Undergraduate 
Challenge''

    Authority: 15 U.S.C. 3719.

SUMMARY: The National Heart, Lung, and Blood Institute (NHBLI), a 
component of the National Institutes of Health (NIH) announces the 
``Novel, Innovative Tools to Increase Public Awareness and Knowledge of 
Sickle Cell Disease Undergraduate Challenge'' to help address the lack 
of awareness about sickle cell disease and its associated complications 
and to improve successful implementation of effective interventions for 
sickle cell disease (SCD) in real world settings. In addition, by 
directing the Challenge at undergraduate students, the Challenge also 
aims to advance the field of implementation science through research 
training, mentoring, and highlighting the contributions of a new 
generation of undergraduate researchers using a systems science 
approach to address multi-faceted problems.

DATES: The Challenge begins October 21, 2015. Submission Period: 
November 30, 2015 to March 7, 2016, 11:59 p.m. PDT, Judging Period: 
March 14, 2016 to March 25, 2016, Winners Notified by email: April 5, 
2016, Winners Announced: April 19, 2016.

FOR FURTHER INFORMATION CONTACT: Helena O. Mishoe, Ph.D., MPH, 
Associate Director for Research Training and Diversity, (email: 
[email protected], 301-451-5081); Joylene John-Sowah, M.D., MPH, 
Medical Officer, (email: [email protected], 301-496-1051); 
Ornela Rutagarama, B.S., (email: [email protected], 301-496-
1051), National Heart, Lung, and Blood Institute, National Institutes 
of Health.

SUPPLEMENTARY INFORMATION: Sickle cell disease is the most common 
genetic disorder in the United States. About 100,000 Americans are 
thought to be living with SCD, and each year another 1,000 babies are 
born with the disease. Sickle cell disease is an inherited disease that 
results in abnormal hemoglobin, the protein in human red blood cells 
that carries oxygen to all tissues in the body. Hemoglobin is essential 
for life. A specific single mutation in the gene (DNA) for hemoglobin, 
when inherited from both parents, causes SCD. The sickle hemoglobin 
distorts the shape of the red blood cell into a `sickle' or crescent 
moon shape that flows poorly through small blood vessels. This can 
cause problems in virtually any organ by reducing the delivery of 
oxygen and inflaming the surrounding tissue. These abnormal sickle 
cells usually die after only about 10 to 20 days (as compared to normal 
red blood cells that live about 120 days). Over time, organ damage 
occurs, possibly resulting in a stroke in the brain, kidney damage, or 
complications in other organ systems. SCD also causes significant pain 
in the affected tissues. This pain, which can begin in childhood, often 
escalates as adulthood approaches, severely affecting the quality of 
life of individuals with SCD. Sickle cell disease not only affects the 
individual but also his or her family and communities.
    There is a lack of awareness about SCD and its associated 
complications among the general public and affected communities. This 
unawareness can contribute to the stigma associated with SCD, the lack 
of understanding of how the disease affects individuals and families' 
daily lives, and to less than optimal care experienced by many 
patients. To help address this problem, the NHLBI is launching the 
``Novel, Innovative Tools to Increase Public Awareness and Knowledge of 
Sickle Cell Disease Undergraduate Challenge'' (the ``Challenge'') to 
incentivize the development of innovative information dissemination 
tools that may be used to (i) increase the general public's awareness 
of SCD; (ii) provide information on SCD and its complications to 
individuals, caregivers, families, and communities affected by SCD in 
an easily comprehensible

[[Page 63810]]

manner; and (iii) improve patient care and health outcomes through the 
successful implementation of effective interventions for SCD in real 
world settings.
    Statutory Authority of the Funding Source: The general purpose of 
the NHLBI is the conduct and support of research, training, health 
information dissemination, and other programs with respect to heart, 
blood vessel, lung, and blood diseases and with respect to the use of 
blood and blood products and the management of blood resources. 
Sections 418 and 420 of the Public Health Service Act (42 U.S.C. 285b, 
285b-2). This Challenge is consistent with and advances the mission of 
the NHLBI and its Center for Translation Research and Implementation 
Science. Among other things, this Center (1) plans, fosters, and 
supports an integrated and coordinated program of research to 
understand the multi-level processes and factors that are associated 
with successful integration of evidence-based interventions within 
specific clinical and public health settings such as worksites, 
communities, and schools; and (2) identifies and makes readily 
available to implementation and dissemination practitioners emergent 
knowledge about the late phases of translation research, especially for 
rapid and sustained adoption of effective interventions in real world 
settings. Funds for the Challenge have been provided by contributions 
to the NHLBI Gift Fund that are accepted under the authority 
established in Sections 231, 405(b)(1)(H), and 497 of the Public Health 
Service (PHS) Act, as amended (42 U.S.C. 238, 284(b)(1)(H), and 289f).
    Subject of the Challenge: Through this Challenge, the NHLBI is 
challenging undergraduate students to create novel, innovative 
information dissemination tools that may be used to increase the 
general public's awareness of SCD, provide information on SCD and its 
complications (particularly pain) to individuals, caregivers, families, 
and communities affected by SCD in an easily comprehensible manner, and 
that may lead to rapid and sustained adoption of effective 
interventions for SCD in real world settings.
    More specifically, the goals of the Challenge are to: (1) Generate 
novel, innovative tools that may be used to increase public awareness 
and knowledge of SCD and associated complications that could 
potentially improve patient care; (2) advance the field of 
implementation science through research training, mentoring, and 
highlighting the contributions of a new generation of undergraduate 
researchers using a systems science approach to address multi-faceted 
problems; and (3) encourage ``team science'' by providing undergraduate 
students valuable experiences to pursue science collectively as they 
engage in complex problem solving to improve health outcomes for SCD.
    Rules for Participating in the Challenge: This Challenge is open to 
any ``Student Team'', defined as a group of at least 3 and not more 
than 5 individuals each of whom is at least 18 years of age and 
currently enrolled as a full-time student pursuing a bachelor's or 
associates degree.
    The Student Team must also be trans-disciplinary, that is, composed 
of undergraduate students from diverse disciplines such as fine arts, 
performing arts, humanities, psychology, science, engineering, graphic 
design, IT (hardware, software), mathematics, statistics, environmental 
science, computational modeling and others.
    To participate in and be eligible to win the Challenge, the Student 
Team must also:
    a. Have an individual from the teaching staff at the Academic 
Institution as a mentor to the team. The mentor should hold the 
position as a Professor, Associate Professor, Assistant Professor, 
Instructor, or a Teaching Assistant within the same Academic 
Institution as the Student Team. The teaching staff member can mentor 
only one team; however, a team may have more than one mentor (co-
mentors may be located at a different institution);
    b. Agree to submit only one entry into this Challenge through one 
student member of the Student Team appointed as ``Team Captain'' by 
that Student Team. The Team Captain will carry out all correspondence 
with NHLBI regarding the Student Team's entry. The Team Captain must be 
a citizen or permanent resident of the United States;
    c. On behalf of the Student Team, the Team Captain must certify the 
Student Team's eligibility as part of the online submission process; 
and
    d. Agree that the Student Team's mentor(s) shall not be eligible to 
share in the prize.
    In addition, the following rules apply:
    (1) To be eligible to win a prize under this Challenge, an 
individual or team--
    a. Shall have registered to participate in the Challenge under the 
rules promulgated by the Department of Health and Human Services (HHS), 
National Heart, Lung, and Blood Institute (NHLBI), Center for 
Translation Research and Implementation Science (CTRIS), as published 
in this Notice;
    b. Shall have complied with all the requirements set forth in this 
Notice;
    c. In the case of a private entity, shall be incorporated in and 
maintain a primary place of business in the United States;
    d. In the case of an individual, shall be a citizen or permanent 
resident of the United States. The Student Team Captain must be a 
citizen or permanent resident of the United States. However, the 
Student Team may include undergraduate students who are foreign 
citizens and/or non-permanent U.S. residents who are studying in the 
United States on a valid visa if such students satisfy all the other 
criteria. Foreign students, if part of the winning Student Team, will 
not receive a monetary prize or be reimbursed for any costs associated 
with attending the annual NHLBI/National Sickle Cell Disease meeting 
(August 2016) to present and demonstrate the winning entry. As 
acknowledgement of their participation, however, the names of foreign 
students who are part of a winning Student Team will be listed among 
the winning team members when results are announced and at the annual 
NHLBI/National Sickle Cell Disease meeting;
    e. May not be a Federal entity;
    f. May not be a Federal employee acting within the scope of the 
employee's employment and further, in the case of HHS employees, may 
not work on their submission(s) during assigned duty hours;
    g. 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 of such a party 
(i.e., spouse, parent, step-parent, child, or step-child); and
    h. Agrees to abide by all applicable local, state, and federal 
laws, regulations, and policies.
    (2) Federal grantees may not use Federal funds to develop their 
Challenge submissions unless use of such funds is consistent with the 
purpose of their grant award and specifically requested to do so due to 
the Challenge design.
    (3) Federal contractors may not use Federal funds from a contract 
to develop their Challenge submissions or to fund efforts in support of 
their Challenge submission.
    (4) Submissions must not infringe upon any copyright or any other 
rights of any third party.
    (5) By participating in this Challenge, each individual and team 
agrees to assume any and all risks and waives any and all claims 
against the Federal government and its ``related entities'' (as defined 
in the COMPETES Act), except in the case of willful misconduct, for

[[Page 63811]]

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.
    (6) 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, property damage, or loss 
potentially resulting from Challenge participation, no individual or 
team participating in the Challenge is required to obtain liability 
insurance or demonstrate financial responsibility in order to 
participate in this Challenge.
    (7) By participating in this Challenge, each individual and team 
agrees to indemnify the Federal government against third party claims 
for damages arising from or related to Challenge activities.
    (8) An individual or team shall not be deemed ineligible because 
the individual or team used Federal facilities or consulted with 
Federal employees during the Challenge if the facilities and employees 
are made available to all individuals and team participating in the 
Challenge on an equitable basis.
    (9) By participating in this Challenge, each individual and team 
grants to the NIH and NHLBI an irrevocable, paid-up, royalty-free 
nonexclusive worldwide license to post, link to, share, sublicense, and 
display publicly on the Web the team's submission. Each individual and 
team will retain all other intellectual property rights in their 
submissions, as applicable.
    (10) NIH and the NHLBI reserves the right, in its sole discretion, 
to (a) cancel, suspend, or modify the Challenge, and/or (b) not award 
any prizes if no entries are deemed worthy.
    (11) Each individual (whether participating singly or in a group) 
or entity agrees to follow all applicable federal, state, and local 
laws, regulations, and policies.
    (12) Each individual (whether participating singly or in a group) 
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. Winning is contingent upon fulfilling all 
requirements herein.
    Registration and Submission Process for Student Teams: To register 
and enter a submission for this Challenge, the Team Captain can: Access 
the www.challenge.gov Web site and search for the ``Novel, Innovative 
Tools to Increase Public Awareness and Knowledge of Sickle Cell Disease 
Undergraduate Challenge'' where he or she will be redirected to an 
NHLBI-hosted Web site where:

 Team captain will register Student Team for the Challenge and 
submit its Team's entry in secure environment
 If the ``Tool'', video, written entry, and slides are <25MB 
(total), they can be uploaded with the Team submission form
 If the ``Tool'', video, written entry, and slides are >25MB 
(total), they must be hosted separately but available to Challenge 
Judges
    [cir] Teams can use available storage hosting services (including, 
but not limited to: Dropbox.com, Box.com, iCloud, Google Drive, etc . . 
.)
    [cir] Teams must include a link to hosted files in the Team 
submission (a field will be provided for this link)

    Alternatively, the Team Captain can go directly to 
www.nhlbi.nih.gov or www.nhlbi.nih.gov/news/spotlight/fact-sheet/nhlbis-novel-innovative-tools-increase-public-awareness-and-knowledge-sickle-cell-disease page titled ``Novel, Innovative, Tools to Increase 
Public Awareness and Knowledge of Sickle Cell Disease Undergraduate 
Challenge'' and register for the Challenge and submit its Team's entry 
in the same way as indicated above. The Team Captain will receive 
notification their entry has been received.
    Submission Requirements: Each Student Team must submit a creative 
and innovative information dissemination tool, using any combination of 
media that is designed to reach out to the public to inform and 
increase awareness of sickle cell disease (SCD) and lead to rapid and 
sustained adoption of effective interventions for SCD in real world 
settings. Examples of such information dissemination tools include, but 
are not limited to, a video, a software application, a game, a Web 
site, a marketing campaign, a social media campaign, a grass roots 
campaign, or an exhibit. All materials must be written or composed in 
English. A complete submission is defined as follows:
     The fully functional tool or software application 
(``tool'') developed and tested by the Student Team. The Student Team 
must provide NHLBI with continuous access to the tool after submission 
and until winners are announced. As applicable, include a detailed 
description of the tool, instructions on how to install and operate it, 
and system requirements. The tool must be designed for use with the 
most widely-available computing platforms: including, but not limited 
to: Windows-based Operating Systems; Mac OSX; iOS mobile computing 
platforms, and Android mobile computing platforms.
     A written entry (not to exceed 6 pages) that clearly and 
concisely includes the following:
    [cir] A concise and informative title (150 characters or less).
    [cir] A description of the tool, why it is innovative, the problem 
that the tool addresses, and the expected outcomes (goals) of using the 
tool.
    [cir] A summary of the science and/or technology underlying the 
tool and its development.
    [cir] A description of how the tool was tested among the 
population(s) of interest (e.g., urban/rural/socioeconomic populations, 
patients, clinicians, caregivers and/or researchers). Include a 
description of the study design and why it was selected to test the 
tool.
    [cir] A description of the populations/communities involved in the 
test. Tools that include proposals on how to reach a range of users, 
including those with disabilities and underserved populations are 
encouraged.
    [cir] Preliminary data describing the outcome(s) of testing the 
tool in the population(s) of interest and whether the tool met the 
anticipated goals. Were any outcomes unanticipated and what can be 
learned from them? What challenges or barriers were faced and what 
improvements could be made?
     A video (not to exceed two (2) minutes) that clearly 
articulates the problem and how the Student Team's submission addresses 
the problem. The video must deliver a clear and understandable message 
using non-technical language, have a unified voice, and emphasize new 
methods and insights not provided in the written submission to create a 
novel presentation while telling a compelling story, be visually 
striking, and edited to a high standard. Participants should be aware 
that this short video is required even if the tool described above is 
also a video.
     A set of seven (7) slides in PDF format that describes the 
submission. Address the judging criteria and describe the key features 
of the submission as they relate to the goals of the Challenge.
    In addition, the submission must not use HHS, NIH, or NHLBI logos 
or official seals and must not claim endorsement.
    Student Teams may be required to make their proposed solution 
compliant with Section 508 accessibility and usability requirements at 
their own

[[Page 63812]]

expense. It can be costly to ``retrofit'' Section 508 accessibility 
standards if remediation is later needed. The HHS Section 508 
Evaluation Product Assessment Template, available at http://www.hhs.gov/web/508/contracting/technology/vendors.html, provides a 
useful roadmap for developers. It is a simple, web-based checklist 
utilized by HHS officials to allow vendors to document how their 
products do or do not meet the various Section 508 requirements.
    Amount of the Prize; Award Approving Official: The Award Approving 
Official will be the Director of the NHLBI. The NHLBI may select up to 
three winners to receive a monetary prize. Any money awarded to a 
winning Student Team will be distributed equally among the Student 
Team's eligible undergraduate students. The Student Team Captain must 
be a citizen or permanent resident of the United States. Mentors and 
any team members that do not meet the applicable citizenship/residency 
requirements will not be eligible to receive any monetary prize award 
and will not be reimbursed for meeting registration or travel expenses 
to the annual NHLBI/National Sickle Cell Disease meeting (August 2016), 
as discussed below.
     1st Prize--$7,000 with up to an additional $2,000 to 
reimburse the Student Team for eligible expenses to register for and 
travel to the annual NHLBI/National Sickle Cell Disease meeting to 
present and demonstrate its winning entry.
     2nd Prize--$5,000 with up to an additional $2,000 to 
reimburse the Student Team for eligible expenses to register and travel 
to the annual NHLBI/National Sickle Cell Disease meeting to present and 
demonstrate its winning entry.
     3rd Prize--$3,000 with up to an additional $2,000 to 
reimburse the Student Team for eligible expenses to register and travel 
to the annual NHLBI/National Sickle Cell Disease meeting to present and 
demonstrate its winning entry.
     Up to three Student Teams may also receive ``Honorable 
Mentions'' but no monetary prize, or support to register and travel to 
the annual NHLBI/National Sickle Cell Disease meeting will be provided. 
``Honorable Mentions'' winning entries will be recognized on the NHLBI 
Web site and/or other media venues.
    Payment of the Prize: Prizes awarded under this Challenge will be 
paid by electronic funds transfer and may be subject to Federal income 
taxes. HHS/NIH will comply with the Internal Revenue Service 
withholding and reporting requirements, where applicable.
    Basis upon Which Submissions Will be Evaluated: Five to seven 
Federal employees will serve as judges. They could include members from 
any NHLBI Extramural Division/Office/Center, the Division of Intramural 
Research, and other NIH Federal employees. Each submission will be 
rated on the following criteria:
    Significance (20 points): Potential impact and significance of the 
submission to improve public awareness and knowledge about SCD and 
associated complications and the successful implementation of effective 
interventions for SCD in real world settings. This must include 
scientifically accurate information.
    Innovation (25 points): Submission is an innovative and creative 
information management tool that is:

a. Different from existing technologies
b. Designed for use on the most widely-available computing platforms: 
Including, but not limited to: Windows-based Operating Systems; Mac 
OSX; iOS mobile computing platforms; and Android mobile computing 
platforms and
c. Widely available to end-users (ease and breadth of dissemination)

    Usability and design (25 points): User friendliness and user 
comprehension

a. Appropriateness of user level and efficiency of use
b. Tool generates the expected output leading to user satisfaction
c. Evidence of co-design with and support from users of proposed tool 
(e.g., patient, family, caregivers, community, and healthcare 
providers)
d. Appropriateness of images/messaging for the intended audience
e. Clear, concise, and well-organized message
f. Clarity of image and/or audio
    Quality of pilot test and outcomes (30 points): Assess approach and 
feasibility

Approach

a. Research Objectives/Research Question/Literature Review
b. Study Methods/Study Design
c. Study participants, allocation of study participants, and 
intervention (information management tool)
d. Variables/Data Collection
e. Statistical Analysis and Sample Size
f. Outreach and Dissemination plan employed
g. Results and discussion of pilot test outcomes

Feasibility

a. Dissemination plan employed likely to result in widespread use
b. Based on the outcomes of the pilot, assess likelihood of full 
implementation to succeed

    The NHLBI reserves the right to disqualify a submission if the tool 
fails to function as expressed in the description provided by the 
submitting Student Team or if the tool provides inaccurate or 
incomplete information. Submissions must be free of malware. The NHLBI 
may test the tool to determine whether malware or other security 
threats may be present and reserves the right to disqualify the 
submission if, in NHLBI's judgment, the tool may damage government or 
others' equipment or operating environment.

Challenge Judges

Senior Advisor, Division of Blood Diseases and Resources, National 
Heart, Lung, and Blood Institute
Clinical Trials Specialist, Division of Cardiovascular Sciences, 
National Heart, Lung, and Blood Institute
Program Director, Division of Lung Diseases, National Heart, Lung, and 
Blood Institute
Deputy Director, Office of Translational Alliances and Coordination, 
Division of Extramural Research Activities, National Heart, Lung, and 
Blood Institute
Staff member, Office of Science Policy, Engagement, Education and 
Communications, National Heart, Lung, and Blood Institute
Staff member, Center for Translation Research and Implementation 
Science, National Heart, Lung, and Blood Institute
Deputy Chief, Education and Community Involvement Branch, National 
Human Genome Research Institute

    Dated: October 2, 2015.
Gary H. Gibbons,
Director, National Heart, Lung, and Blood Institute.
[FR Doc. 2015-26753 Filed 10-20-15; 8:45 am]
BILLING CODE 4140-01-P