11208 Federal Register / Vol. 80, No. 40 / Monday, March 2, 2015 / Notices 

collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. 

All written comments will be 

available for public inspection on 

Regulations.gov. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. 

Comment Due Date: Your comments 

regarding this information collection are 

best assured of having full effect if 

received within 30 days of the date of 

this publication. 

Dated: February 20, 2015. 

Robert G. McSwain, 

Acting Director, Indian Health Service. 

[FR Doc. 2015–04112 Filed 2–27–15; 8:45 am] 

BILLING CODE 4165–16–P 

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: NonU.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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Federal Register / Vol. 80, No. 40 / Monday, March 2, 2015 / Notices 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/challengeprize 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. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
11210 Federal Register / Vol. 80, No. 40 / Monday, March 2, 2015 / Notices 

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-andsecurity. 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; The Genetic 

Testing Registry 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on November 25, 

2014, page 70194 and allowed 60 days 

for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. The Office 

of the Director (OD), National Institutes 

of Health, may not conduct or sponsor, 

and the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

1995, unless it displays a currently valid 

OMB control number. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: NIH Desk Officer. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments or request more 

information on the proposed project 

contact: Ms. Sarah Carr, Acting Director, 

Office of Clinical Research and 

Bioethics Policy, Office of Science 

Policy, NIH, 6705 Rockledge Dr., Suite 

750, Bethesda, MD 20892, or call nontoll-free number (301) 496–9838, or 

Email your request, including your 

address to: OCRBP-OSP@od.nih.gov. 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

Proposed Collection: The Genetic 

Testing Registry, 0925–0651, 

EXTENSION—Office of the Director 

(OD), National Institutes of Health 

(NIH). 

Need and Use of Information 

Collection: Clinical laboratory tests are 

available for more than 5,000 genetic 

conditions. The Genetic Testing Registry 

(GTR) provides a centralized, online 

location for test developers, 

manufacturers, and researchers to 

voluntarily submit detailed information 

about the availability and scientific 

basis of their genetic tests. The GTR is 

of value to clinicians by providing 

information about the accuracy, 

validity, and usefulness of genetic tests. 

The GTR also highlights evidence gaps 

where additional research is needed. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

5,536. 


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