[Federal Register Volume 80, Number 40 (Monday, March 2, 2015)]
[Notices]
[Pages 11208-11210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-04254]
-----------------------------------------------------------------------
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
[email protected]. 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: [email protected].
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,
[[Page 11209]]
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 http://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.
[[Page 11210]]
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: http://www.hhs.gov/ocr/privacy/index.html.
Summary of the HIPAA Privacy Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html.
Summary of the HIPAA Security Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html.
Human Subjects--HHS
Office for Human Research Protections: http://www.hhs.gov/ohrp/index.html.
Protection of Human Subjects Regulations: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
Policy & Guidance: http://www.hhs.gov/ohrp/policy/index.html.
Institutional Review Boards &Assurances: http://www.hhs.gov/ohrp/assurances/index.html.
Human Subjects--FDA
Clinical Trials: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.
Office of Good Clinical Practice: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018191.
Consumer Protection--Federal Trade Commission
Bureau of Consumer Protection: http://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]
BILLING CODE 4140-01-P