Announcement of Requirements and Registration for “A Wearable Alcohol Biosensor: A Second Challenge”, 89119-89122 [2016-29436]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89119-89122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29436]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Announcement of Requirements and Registration for ``A Wearable 
Alcohol Biosensor: A Second Challenge''

    Authority: 15 U.S.C. 3719.

SUMMARY: Through the ``A Wearable Alcohol Biosensor: A Second 
Challenge'' (the ``Challenge''), the National Institute on Alcohol 
Abuse and Alcoholism (NIAAA), a component of the National Institutes of 
Health (NIH), is building upon the success of the previous challenge 
and searching for a wearable or otherwise discreet device capable of 
measuring blood alcohol level in real time. The advent of alcohol 
biosensors that can be worn discreetly and used by individuals in the 
course of their daily lives will advance the mission of the NIAAA in 
the arenas of research, treatment, and rehabilitation. Current 
technological developments in electronics, miniaturization, wireless 
technology, and biophysical techniques of alcohol detection in humans 
increase the likelihood of successful development of a useful alcohol 
biosensor in the near future. The NIH believes that this Challenge will 
further stimulate investment from public and private sectors in the 
development of functional alcohol biosensors that will be appealing to 
individuals, treatment providers, and researchers and will continue to 
further the NIAAA's mission.

DATES: Submission period begins December 9, 2016, 9:00 a.m. ET.
    Submission period ends: May 15, 2017.
    Judging period: May 16, 2017-July 26, 2016.
    Winners announced: On or after August 1, 2017.

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    The NIH will announce any changes to this timeline by amending this 
Federal Register notice.

FOR FURTHER INFORMATION CONTACT: M. Katherine Jung, Ph.D., Acting 
Director, Division of Metabolism and Health Effects, National Institute 
on Alcohol Abuse and Alcoholism, Phone: 301-443-8744, Email 
Kathy.jung@nih.gov. F.L. Dammann, M.P.A., Management Analyst and 
Special Assistant to the Executive, National Institute on Alcohol Abuse 
and Alcoholism, Phone: 301-480-9433, Email: fl.dammann@nih.gov. All 
questions and answers regarding the Challenge will be posted and 
updated as necessary at https://stage.niaaa.nih.gov/research/challenge-prize under Frequently Asked Questions. Questions from Solvers that may 
reveal proprietary information related to solutions under development 
addressed to NIAAA will not be posted on Challenge.gov.

SUPPLEMENTARY INFORMATION:

The NIAAA's Statutory Authority To Conduct the Challenge

    The NIAAA is conducting this challenge under the America Creating 
Opportunities to Meaningfully Promote Excellence in Technology, 
Education, and Science (COMPETES) Reauthorization Act of 2010, 15 
U.S.C. 3719. In addition, this Challenge is consistent with and 
advances the mission of the NIAAA, as described in 42 U.S.C. 285n, to 
conduct and support biomedical and behavioral research, health services 
research, research training, and health information dissemination with 
respect to the prevention of alcohol abuse and the treatment of 
alcoholism, and to conduct a study of alternative approaches for 
alcoholism and alcohol abuse treatment and rehabilitation.

Subject of Challenge

    The winners of the first Wearable Alcohol Biosensor Challenge 
achieved significant improvements in detection of alcohol in sweat and 
sweat vapor, and their products will benefit the mission of the NIAAA 
in multiple ways. Innovators are challenged to design a wearable 
monitoring device based on alternate distinct and inventive methods of 
alcohol detection, specifically using non-invasive technology to detect 
alcohol directly in blood or interstitial fluid. Innovation is 
encouraged.

Rules for Participating in the Challenge

    This Challenge is open to any ``Solver,'' where ``Solver'' is 
defined as an individual, a group of individuals (i.e., a team), or an 
entity. Whether singly or as part of a group or entity, individuals 
younger than 18 participating in the Challenge as Solvers must provide 
parental consent. By allowing individuals younger than 18 to 
participate in the Challenge as Solvers, the NIH is not condoning or 
encouraging underage alcohol consumption, but is rather encouraging 
innovation in a manner that is consistent with all applicable laws.
    1. To be eligible to win a prize under this Challenge, the Solver--
    a. Shall have registered to participate in the Challenge under the 
rules as promulgated by the NIH as published in this Notice and 
www.challenge.gov;
    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; and in the 
case of an individual, whether participating singly or in a group, 
shall be a citizen or permanent resident of the United States. Note: 
Non-U.S. citizens and nonpermanent residents can participate as a 
member of a team that otherwise satisfies the eligibility criteria but 
will not be eligible to win a monetary prize (in whole or in part); 
however, their participation as part of a winning team, if applicable, 
may be recognized when results are announced;
    d. May not be a federal entity;
    e. May not be a federal employee acting within the scope of the 
employee's employment and further, in the case of the Department of 
Health and Human Services (HHS) employees, may not work on their 
submission(s) 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 otherwise 
excluded who seeks to participate in this Challenge should consult his/
her agency's ethics official prior to developing a submission; and
    f. May not be an employee of the NIH, a judge of the challenge, a 
member of the technical evaluation panel, or any other party involved 
with the design, production, execution, or distribution of the 
Challenge or the immediate family (specifically, a parent, stepparent, 
spouse, domestic partner, child, sibling, or step-sibling).
    2. Federal grantees may not use federal funds to develop Challenge 
submissions.
    3. Federal contractors may not use federal funds from a contract to 
develop Challenge submissions or to fund efforts in support of a 
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 (whether 
competing singly or in a group) 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.
    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, individuals 
(whether competing singly or in a group) or entities participating in 
the Challenge are not required to obtain liability insurance or 
demonstrate financial responsibility in order to participate in this 
Challenge.
    7. By participating in this Challenge, each individual (whether 
competing singly or in a group) and entity agrees to indemnify the 
federal government against third party claims for damages arising from 
or related to Challenge activities.
    8. An individual or entity 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.
    9. By submitting the Submission, each Solver warrants that he or 
she is the sole author and owner of any copyrightable works or 
patentable inventions that the Submission comprises, that the works are 
wholly original with the Solver (or is an improved version of an 
existing work that the Solver has sufficient rights to use and 
improve), and that the Submission does not infringe on any copyright, 
patent or any other rights of any third party of which Solver is aware. 
To receive an award, Solvers will not be required to transfer their 
exclusive intellectual property rights to the NIH. Instead, Solvers 
will grant to the federal government a nonexclusive license to practice 
their solutions and use the materials that describe them. To 
participate in the Challenge, each Solver must warrant that there are 
no legal obstacles to providing a nonexclusive license of Solver's 
rights to the federal government, where such license need be provided 
only if the Solver wins the award. This license will be a condition

[[Page 89121]]

of the award and will grant to the United States government a 
nonexclusive, nontransferable, irrevocable, paid-up license to practice 
or have practiced for or on behalf of the United States throughout the 
world any invention made by the Solvers that covers the Submission. In 
addition, the license will grant to the federal government and others 
acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide 
license in any copyrightable works that the Submission comprises, 
including the right to reproduce, prepare derivative works, distribute 
copies to the public, and perform publicly and display publicly said 
copyrightable works.
    10. The 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.
    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. Except where prohibited, participation in the Challenge 
constitutes consent by the Solvers to allow NIAAA or its contractors to 
the use or display the Solvers' names, likenesses, photographs, 
prototype images, and/or hometowns and states for publications and 
publicity purposes in any media, worldwide, without further payment or 
consideration.
    13. 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.
    14. An individual, team, or entity that is currently on the 
Excluded Parties List (https://oig.hhs.gov/exclusions/) will not be 
selected as a Finalist or prize winner.

Registration and Submission Process for Participants

    Solvers must register and submit their Solutions on 
www.challenge.gov Web site under the link for ``A Wearable Alcohol 
Biosensor: A Second Challenge.''

Amount of the Prize

    First Prize: $200,000.
    Second Prize: $100,000.
    The award approving official for this Challenge is the NIAAA 
Director.

Payment of the Prize

    Prizes awarded under this competition will be paid by electronic 
funds transfer and may be subject to Federal income taxes. The NIAAA 
will comply with the Internal Revenue Service withholding and reporting 
requirements, where applicable.

Basis Upon Which Winners Will Be Evaluated

Solution Desired

    Solvers are asked to produce a prototype of an appealing, 
inconspicuous, low profile, wearable technology capable of monitoring 
blood alcohol non-invasively. The design can take the form of jewelry, 
clothing, or any other format located in contact with the human body. 
Highest priority will be given to devices that use non-invasive 
technologies to measure alcohol concentration in blood or interstitial 
fluid, as opposed to the detection of alcohol exuded through the skin 
in sweat or vapor. Functionally, the solution must:
     Achieve real time-monitoring and quantification of blood 
alcohol level.
     Collect and interpret data, eliminating as much of the 
biological and device-related delays as possible through innovative, 
validated, and verifiable techniques.
     Store or transmit data to a smartphone or other device by 
wireless transmission. It is desirable that the technology permits 
subject identification. Data storage and transmission must be 
completely secure in order to protect the privacy of the individual.
     Verify standardization at regular intervals and indicate 
loss of functionality. Operate from a dependable and rechargeable power 
source.
     Be removable.
    NIAAA is open to a range of design forms which can accomplish the 
above tasks.

What To Submit

    This is a reduction to practice Challenge that requires written 
documentation and a working prototype of the submitted solution. The 
submission to the Challenge must be in English and include the 
following:
    1. A working prototype of a wearable alcohol biosensor including 
all accessories necessary for functionality.
    2. Written evidence of successful data storage and retrieval, of 
consistent function, reliability and robust reproducibility of alcohol 
quantification. The submitted device and the written documentation must 
be free of any Personally Identifiable Information (PII) accrued during 
prototype development. A detailed description of the proposed Solution 
must include an instructive account of the method of alcohol detection, 
interval of data sampling, the means of subject identification, 
proposed process of manufacture, verification of data security and 
integrity, and standardization of measurements. Upon receipt of the 
written documentation, NIAAA will provide an address for the shipment 
of the prototypes to NIAAA for evaluation.
    3. Image or images of the proposed wearable, to include overall 
dimensions.
    4. A video not to exceed 10 minutes demonstrating the wearable's 
required capabilities.
    Submissions will be judged by a qualified panel of federal 
employees selected by the NIAAA. The award is primarily contingent upon 
experimental validation of the submitted Solution by the NIAAA. The 
panel will evaluate submissions based on the following judging 
criteria:
     Accuracy, reliability, and frequency of blood alcohol 
levels as validated by the NIAAA.
     Functionality, accuracy, and integration of data 
collection, data transmission and data storage.
     Safeguards for data integrity and privacy protection for 
the wearer.
     Plans for process of manufacture.
     Marketability and likelihood of bringing the product to 
market.
     Appeal and acceptability to wearers.
    During the judging period, the expert panel may request additional 
information or clarification from the Solver in order to evaluate the 
entry. The judges will be assisted by a panel of technical experts in 
the following areas: Alcohol pharmacokinetics, chemistry, engineering, 
information technology and information system security, behavioral and 
social sciences, development of vehicular alcohol detection systems, 
and wearables. Depending on the nature of the entries, additional 
expertise may be sought to advise the judges.

Additional Information

    Privacy, Data Security, Ethics, and Compliance: Solvers are 
required to identify and address privacy and security issues in their 
proposed projects and describe specific solutions for meeting them. In 
addition to complying with appropriate policies, procedures, and 
protections for data that ensures all privacy requirements and 
institutional policies are met, use of data should not allow the 
identification

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of the individual from whom the data was collected. Solvers are 
responsible for compliance with all applicable federal, state, local, 
and institutional laws, regulations, and policies. These may include, 
but are not limited to, Health Information Portability and 
Accountability Act (HIPAA) protections, HHS Protection of Human 
Subjects regulations, and Food and Drug Administration (FDA) 
regulations. It is the responsibility of the Solver to obtain approvals 
(e.g., from an Institutional Review Board), if required. The following 
links are intended as a starting point for addressing regulatory 
requirements but should not be interpreted as a complete list of 
resources on these issues:

HIPAA

    Main link: https://www.hhs.gov/hipaa/.
    Summary of the HIPAA Privacy Rule: https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/.
    Summary of the HIPAA Security Rule: https://www.hhs.gov/hipaa/for-professionals/security/laws-regulations/.

Human Subjects--HHS

    Office for Human Research Protections: https://www.hhs.gov/ohrp/.
    Protection of Human Subjects Regulations: https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
    Institutional Review Boards &Assurances: https://www.hhs.gov/ohrp/assurances/.

Human Subjects--FDA

    Clinical Trials: https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.
    Office of Good Clinical Practice: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018191.

Consumer Protection--Federal Trade Commission

    Bureau of Consumer Protection: https://www.ftc.gov/tips-advice/business-center/privacy-and-security.

    Dated: December 2, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-29436 Filed 12-8-16; 8:45 am]
 BILLING CODE 4140-01-P