[Federal Register Volume 80, Number 196 (Friday, October 9, 2015)]
[Notices]
[Pages 61217-61220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25406]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Biomedical Imaging and Bioengineering 
(NIBIB) Announcement of Requirements and Registration for the 2015 
Design by Biomedical Undergraduate Teams (DEBUT) Challenge

    Authority: 15 U.S.C. 3719.

SUMMARY: The National Institute of Biomedical Imaging and 
Bioengineering (NIBIB) Design by Biomedical Undergraduate Teams (DEBUT) 
Challenge is open to teams of undergraduate students working on 
projects that develop innovative solutions to unmet health and clinical 
problems. NIBIB's mission is to improve health by leading the 
development and accelerating the application of biomedical 
technologies. The goals of the DEBUT Challenge are to provide 
undergraduate students valuable experiences such as working in teams, 
identifying unmet clinical needs, and designing, building and debugging 
solutions for such open-ended problems; to generate novel, innovative 
tools to improve healthcare, consistent with NIBIB's purpose to support 
research, training, the dissemination of health information, and other 
programs with respect to biomedical imaging and engineering and 
associated technologies and modalities with biomedical applications; 
and to highlight and acknowledge the contributions and accomplishments 
of undergraduate students.

DATES: The competition begins October 9, 2015.
    Submission Period: March 1, 2016 to May 30 2016, 11:59 p.m. EDT.
    Judging Period: June 6, 2016 to August 5, 2016.
    Winners announced: August 22, 2016.
    Award ceremony: October 2016, Biomedical Engineering Society 
Conference, Minneapolis, Minnesota.

ADDRESSES: To submit entries, visit http://www.nibib.nih.gov/training-careers/undergraduate-graduate/design-biomedical-undergraduate-teams-debut-challenge/ or http://venturewell.org/students/debut.

FOR FURTHER INFORMATION CONTACT: [email protected] or (301) 451-4792.

SUPPLEMENTARY INFORMATION:
    Subject of Challenge: NIBIB's mission is to improve health by 
leading the development and accelerating the application of biomedical 
technologies. By challenging undergraduate students to identify unmet 
clinical needs and

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develop innovative solutions for them, NIBIB targets the education of 
biomedical engineers who have the background, skills, and confidence to 
make outstanding contributions to biomedical technologies. Engaging 
undergraduate students to work in teams to design, build and debug 
solutions to real-world problems/needs in healthcare, not only prepares 
them to function effectively in their future work environment, but also 
yields novel, innovative biomedical tools that can transform 
healthcare.
    The NIBIB DEBUT Challenge solicits design projects that develop 
innovative solutions to unmet health and clinical problems. Areas of 
interest for the biomedical engineering projects include, but are not 
limited to: Diagnostics, therapeutics, technologies for underserved 
populations and low resource settings, point-of-care systems, precision 
medicine, preventive medicine, and technologies to aid individuals with 
disabilities. Student Teams participating in capstone design projects 
are especially encouraged to enter the challenge.
    To support and expand the DEBUT Challenge, the NIBIB has joined 
forces with VentureWell, a not-for-profit leader in funding, training, 
coaching and early investment that brings student innovations to 
market. In past years, undergraduate student teams have applied 
separately to NIBIB's DEBUT Challenge and to VentureWell's BMEStart 
competition. The new public-private partnership on DEBUT, allows 
student teams to submit one application and gives teams more chances to 
win a prize in recognition of their technology solution. Student Teams 
entering the Challenge will have the option to have their entries also 
considered for prizes offered by VentureWell. VentureWell prizes will 
be selected and awarded by VentureWell following a separate judging 
process. The rules for the VentureWell prizes and the additional 
submission components that are required to compete for them can be 
found at http://venturewell.org/students/debut/guidelines.

Rules for Participating in the Challenge

    (1) To be eligible to win a prize under this Challenge, an 
individual must be a member of a ``Student Team'' as described below, 
and each individual of a ``Student Team'':
    (a) Must be an undergraduate student enrolled full-time in an 
undergraduate curriculum during at least one full semester (or quarter 
if the institution is on a quarter system) of the 2015-2016 academic 
year;
    (b) Must form or join a ``Student Team'' with at least two other 
individuals for the purpose of developing an entry for submission to 
this challenge. Each student on the Student Team must satisfy all the 
requirements for competing in this challenge. While at least one 
Student on the Team must be from a biomedical engineering or 
bioengineering department (i.e., majoring in biomedical engineering or 
bioengineering), interdisciplinary teams including students from other 
fields are welcome and encouraged;
    (c) Shall be a citizen or permanent resident of the United States. 
Foreign students who are studying in the United States on a visa are 
eligible to be part of the competing Student Teams. However, they will 
not receive a monetary prize if they are part of a winning Student 
Team. See Prize section below for the distribution of prizes. As 
acknowledgement of their participation, however, the names of foreign 
students who are part of winning Student Teams will be listed among the 
winning team members when results are announced and at the award 
ceremony.
    (d) Must be a member of only one Student Team:
    (e) Must be 13 years of age or older. Individuals who are younger 
than 18 must have their parent or legal guardian complete the Parental 
Consent Form found at https://www.nibib.nih.gov/sites/default/files/Parental%20Consent%20Form.pdf;
    (f) Shall have agreed to be registered by the Team Captain 
(selected by the Student Team) to participate in the Challenge under 
the rules promulgated by the NIH as published in this Notice;
    (g) Shall have complied with all the requirements set forth in this 
Notice;
    (h) May not be a Federal entity;
    (i) 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;
    (j) 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
    (k) Must acknowledge understanding and acceptance of the DEBUT 
challenge rules by signing the NIBIB DEBUT Challenge Certification Form 
found at https://www.nibib.nih.gov/sites/default/files/NIBIB%20DEBUT%20Certification%20Form.pdf. Each entry must include one 
NIBIB DEBUT Challenge Certification Form, completed with: The printed 
names of Student Team members, an indication of whether the team member 
is either a US citizen or permanent resident (as opposed to a foreign 
student on a visa), and be signed and dated by each individual member 
of the Student Team. Entries that do not provide a complete 
Certification Form will be disqualified from the challenge;
    (2) Each entry into this challenge must have been conceived, 
designed, and implemented by the Student Team without any significant 
contribution from other individuals.
    (3) 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, and as announced in the Federal Register.
    (4) 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.
    (5) Submissions must not infringe upon any copyright or any other 
rights of any third party.
    (6) By participating in this Challenge, each individual and entity 
agrees to assume any and all risks and waive claims against the Federal 
government and its related entities (as defined in the COMPETES Act), 
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.
    (7) 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 
participating in the Challenge is required to obtain liability 
insurance or demonstrate financial responsibility in order to 
participate in this Challenge.
    (8) By participating in this Challenge, each individual agrees to 
indemnify the Federal government against third party claims for damages 
arising from or related to Challenge activities.
    (9) An individual shall not be deemed ineligible because the 
individual or entity used Federal facilities or consulted with Federal 
employees during the Challenge if the facilities and employees are made 
available to all individuals and entities participating in the 
Challenge on an equitable basis.

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    (10) By participating in this challenge, such individuals grant to 
NIBIB an irrevocable, paid-up, royalty-free, nonexclusive worldwide 
license to post, link to, share, and display publicly the entry on the 
Web, newsletters or pamphlets, and other information products. It is 
the responsibility of the individuals on the Student Team to obtain any 
rights necessary to use, disclose, or reproduce any intellectual 
property owned by third parties and incorporated in the entry for all 
anticipated uses of the entry.
    (11) NIH 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.
    (12) Each individual agrees to follow all applicable federal, 
state, and local laws, regulations, and policies.
    (13) Each individual 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.
    (14) Each Student Team must appoint a ``Team Captain'' to carry out 
all correspondence regarding the Student Team's entry. The Team Captain 
must be a citizen or permanent resident of the United States.

Submission Requirements

    1. Each Student Team may submit only one entry into this challenge 
through the Team Captain. The Team Captain will submit a Student Team's 
entry on behalf of the Student Team by following the links and 
instructions at http://venturewell.org/students/debut/guidelines and 
certify that the entry meets all the challenge rules. At this time, 
teams will have the option to indicate that they wish to have their 
entries considered also for prizes sponsored by VentureWell. For a 
description of these prizes and rules of participation, see http://venturewell.org/students/debut/guidelines.
    2. Each entry must comply with Section 508 standards that require 
federal agencies' electronic and information technology be accessible 
to people with disabilities, http://www.section508.gov/.
    3. Each entry must be submitted as a single pdf file including the 
following 4 components:
    i. The NIBIB DEBUT Challenge Certification Form (downloadable from 
https://www.nibib.nih.gov/sites/default/files/NIBIB%20DEBUT%20Certification%20Form%202015.pdf completed with project 
title and team member information, printed names, indication of U.S. 
citizenship or permanent residency, dates, and signatures of each 
individual member of the Student Team.
    ii. Project Narrative (not to exceed 6 pages using Arial font and a 
font size of at least 11 points) that includes the following 6 
sections:
    (1) Abstract.
    (2) Description of clinical need or problem, including background 
and current methods available. When the submitted entry is part of a 
bigger/ongoing project, the specific components designed and 
implemented by the competing Student Team must be clarified and 
distinguished from those accomplished by others (e.g. other students, 
advisor, collaborators).
    (3) Project objective statement, describing the approach to address 
the problem, including a discussion of the innovative aspects.
    (4) Documentation of the design, providing sufficient detail.
    (5) Documentation of the prototype of the final design, with 
photographs, graphical representations, or link to a video, as 
appropriate.
    (6) Proof that the design is functional and will solve the problem, 
providing a discussion of how the efficacy of the device was evaluated, 
including test results, graphics obtained with the designed solution 
and comparison to existing device outputs. A link to a 3-min video 
demonstrating the successful operation of the device developed is 
required. This link may be provided in this section, and will be 
requested separately during the online submission process.
    The 6-page limit includes any graphics, but excludes the 
certification form, parental consent form, and any references. 
Submissions exceeding 6 pages for the Project Narrative will not be 
accepted.
    Optional supporting material: The following optional supporting 
material may be submitted as a separate pdf file and will not count 
towards the 6-page limit: Up to three support letters from stakeholders 
(patients, healthcare providers, industry, etc.); up to three 
supporting articles, reports, etc that present background information 
for your project; and up to 3 links to videos and/or Web sites. 
However, the judges will mainly review the required components of your 
application and may consider the optional material at their discretion.
    iii. Sponsor letter, on department letterhead, from a faculty 
member from the Biomedical Engineering, Bioengineering or similar 
department of the institution in which the Student Team members are 
enrolled, verifying (a) that the entry was achieved by the named 
Student Team, (b) that each member of the team was enrolled full-time 
in an undergraduate curriculum during at least one semester or quarter 
of the academic year 2015-2016, and (c) describing clearly any 
contribution from the advisor or any other individual outside the 
Student Team (especially when the submitted entry is part of a bigger/
ongoing project, the specific components designed and implemented by 
the competing Student Team must be clarified and distinguished from 
those accomplished by others).
    iv. A completed Parental Consent Form, downloadable from https://www.nibib.nih.gov/sites/default/files/Parental%20Consent%20Form.pdf, 
for each individual on the Student Team who is under the age of 18.
    Amount of the Prize; Award Approving Official: The 1st, 2nd, and 
3rd place prizes will be $20,000, $15,000, and $10,000, respectively, 
to be distributed only among the members of the winning Student Team 
eligible to win a prize in this challenge. The prize will be 
distributed equally among the prize-eligible Student Team members, 
i.e., students who are either citizens or permanent residents of the 
United States. Each prize-eligible member of the winning Student Teams 
must provide his/her bank information to enable electronic transfer of 
funds. Five honorable mentions will also be awarded, without an 
accompanying monetary prize.
    Winning Student Teams will be honored at the NIBIB DEBUT Award 
Ceremony during the 2016 Annual Meeting of the Biomedical Engineering 
Society (BMES) in Minneapolis, Minnesota in October 2016. Updated 
information on the BMES annual meeting can be found at http://bmes.org/annualmeeting. NIBIB will not provide financial support for winning 
Student Teams or Honorable Mention awardees to attend the award 
ceremony. However they are welcome and encouraged to attend the award 
ceremony, or designate a representative to attend on their behalf. 
NIBIB reserves the right to cancel, suspend, modify the challenge, and/
or not award a prize if no entries are deemed worthy. The NIBIB prize-
approving official will be the Director of NIBIB.
    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.

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    Basis upon Which Winner Will Be Selected: The winning entries will 
be selected based on the following criteria:
     Significance of the problem addressed--Does the entry 
address an important problem or a critical barrier to progress in 
clinical care or research?
     Impact on potential users and clinical care--How likely is 
it that the entry will exert a sustained, powerful influence on the 
problem and medical field addressed?
     Innovative design (creativity and originality of 
concept)--Does the entry utilize novel theoretical concepts, approaches 
or methodologies, or instrumentation?
     Working prototype that implements the design concept and 
produces targeted results--Has evidence been provided (in the form of 
results, graphs, photographs, films, etc.) that a working prototype has 
been achieved?
    Additional Information: For more information and to submit entries, 
visit http://www.nibib.nih.gov/training-careers/undergraduate-graduate/design-biomedical-undergraduate-teams-debut-challenge/ or http://venturewell.org/students/debut.

    Dated: September 30, 2015.
Jeffrey D. Domanski,
Executive Officer, National Institute of Biomedical Imaging and 
Bioengineering.
[FR Doc. 2015-25406 Filed 10-8-15; 8:45 am]
BILLING CODE 4140-01-P