Announcement of Requirements and Registration for “A Wearable Alcohol Biosensor” Challenge, 11208-11210 [2015-04254]

Agencies

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

[Federal Register Volume 80, Number 40 (Monday, March 2, 2015)]
[Notices]
[Pages 11208-11210]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04254]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

    Authority: 15 U.S.C. 3719.

    Award Approving Official: Dr. Lawrence A. Tabak, Principal Deputy 
Director, National Institutes of Health (NIH).

SUMMARY: Through the ``A Wearable Alcohol Biosensor'' Challenge (the 
``Challenge''), the National Institute on Alcohol Abuse and Alcoholism 
(NIAAA), a component of the National Institutes of Health (NIH), is 
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 NIAAA in the 
arenas of research, treatment, and rehabilitation. NIAAA has supported 
academic and small business grants and contracts to advance the 
development and use of alcohol biosensors in the past. 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 
stimulate investment from public and private sectors in the development 
of functional alcohol biosensors that will be appealing to individuals, 
treatment providers, and researchers.

DATES: 
    Submission period begins March 2, 2015, 9:00 a.m. ET.
    Submission period ends: December 1, 2015.
    Judging period: January 2016.
    Winners announced: On or after February 15, 2016.
    The NIH will announce any changes to this timeline by amending this 
Federal Register notice.

FOR FURTHER INFORMATION CONTACT: M. Katherine Jung, Ph.D., Program 
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.

SUPPLEMENTARY INFORMATION: 

Subject of Challenge

    Current technologies for real time monitoring of alcohol 
consumption, used in criminal justice applications, have performed 
adequately, but have disadvantages for broader use.
    NIAAA seeks the design and production of a wearable device to 
monitor blood alcohol levels in real time. The device should be 
inconspicuous, low profile, and appealing to the wearer. The design can 
take the form of jewelry, clothing, or any other format located in 
contact with the human body. A non-invasive technology is preferred.
    Current technology for continuous alcohol monitoring takes a 
reading every 30 minutes. We are seeking a solution that improves on 
this interval and most closely approximates real time monitoring and 
data collection. The device should be able to quantitate blood alcohol 
level, interpret and store the data, or transmit it to a smartphone or 
other device by wireless transmission. Data storage and transmission 
must be completely secure in order to protect the privacy of the 
individual. The device should have the ability to verify 
standardization at regular intervals and to indicate loss of 
functionality. The power source should be dependable and rechargeable. 
A form of subject identification would be an added benefit. The device 
can be removable.
    This is a reduction to practice challenge that requires written 
documentation and a working prototype of the submitted solution.
    NIAAA is open to a range of design forms which can accomplish the 
above tasks.

Statutory Authority of the Funding Source

    This Challenge is consistent with and advances the mission of 
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.

Eligibility Rules for the Challenge

1. To Participate

    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 must provide parental 
consent and must abide by the Children's Online Privacy Protection Act.

2. To Win

    To be eligible to win a prize under this Challenge, the Solver--
    1. Shall have registered to participate in the Challenge at 
www.challenge.gov.
    2. Shall have complied with all the requirements under this section 
on Eligibility.
    3. 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.
    4. In the case of an individual, he/she may not be an employee of 
the NIH; an individual involved in formulation of the Challenge and/or 
serving on the technical evaluation panel; any other individual 
involved with the design,

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production, execution, distribution, or evaluation of this Challenge; 
or members of the individual's immediate family (specifically, a 
parent, stepparent, spouse, domestic partner, child, sibling, or step-
sibling).
    5. 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.
    6. In the case of an entity, may not be a federal entity; and in 
the case of an individual, may not be a federal employee acting within 
the scope of his or her employment.
    7. Federal employees otherwise permitted to participate in the 
Challenge shall not work on their submission 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 a 
submission.
    8. Federal grantees may not use federal funds to develop Challenge 
submissions.
    9. Federal contractors may not use federal funds from a contract to 
develop Challenge submissions or to fund efforts in support of a 
Challenge submission.
    10. 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. All questions regarding the 
Challenge should be directed to Dr. Jung or Mr. Dammann, identified 
above, and answers will be posted and updated as necessary at https://www.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 be held in strictest confidence.

Submission Requirements

    The submission to the Challenge should include the following:
    (1) The final solution set for challenge award must include 
reduction to practice of a working prototype of a wearable alcohol 
biosensor.
    (2) Solutions should also include written evidence of successful 
data storage and retrieval, of consistent function, reliability and 
robust reproducibility of alcohol quantification. 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.
    (3) Image or images of the proposed wearable, to include overall 
dimensions.
    (4) A video demonstrating the wearable's required capabilities.

Registration and Submission Process for Solvers

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

Amount of the Prize

First Prize: $200,000
Second Prize: $100,000

    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, the NIH reserves the right to not award any prizes 
if no solutions are deemed worthy. The award approving official for 
this Challenge is the NIH Principal Deputy 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. NIAAA will 
comply with the Internal Revenue Service withholding and reporting 
requirements, where applicable.

Basis Upon Which Winners Will Be Evaluated

    Submissions will be judged by a qualified panel selected by NIAAA. 
The panel will evaluate submissions based on the following judging 
criteria:

1. Accuracy, reliability, and frequency of blood alcohol measurement
2. Functionality, accuracy, and integration of data collection, data 
transmission and data storage
3. Safeguards for privacy protection and data integrity
4. Plans for process of manufacture
5. Marketability and likelihood of bringing the product to market
6. Appeal and acceptability to wearers
7. Feasibility

    The award is contingent upon experimental validation of the 
submitted Solution by the Seeker. During the judging period, the expert 
panel may request additional information or clarification in order to 
evaluate the entry.

Challenge Judges

Director, National Institute on Alcohol Abuse and Alcoholism
A senior staff member from the National Institute of Biomedical Imaging 
and Bioengineering
One or more members from the National Advisory Council of the National 
Institute on Alcohol Abuse and Alcoholism
Program Staff from the National Institute on Alcohol Abuse and 
Alcoholism

    The challenge judges will be advised by a technical panel 
consisting of individuals with expertise in the following areas:

    Chemistry
    Engineering
Information Technology and Information System Security
Behavioral and Social Sciences
Development of vehicular alcohol detection systems

Additional Information

    Intellectual Property: By submitting the Submission, each Solver 
warrants that he or she is the sole author and owner of any patentable 
works 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. This license 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.

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    Liability and Indemnification: By participating in this Challenge, 
each Solver agrees to assume any and all risks and waive claims against 
the federal government and its related entities, 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 Solver agrees to indemnify the 
federal government 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. Solvers 
are not required to obtain liability insurance or demonstrate financial 
responsibility in order to participate in this Challenge.
    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 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, Department of Health and Human 
Services (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/ocr/privacy/.
Summary of the HIPAA Privacy Rule: https://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/.
Summary of the HIPAA Security Rule: https://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html.

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.
Policy & Guidance: https://www.hhs.gov/ohrp/policy/.
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://business.ftc.gov/privacy-and-security.

    Dated: February 23, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015-04254 Filed 2-27-15; 8:45 am]
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