
[Federal Register Volume 81, Number 182 (Tuesday, September 20, 2016)]
[Notices]
[Pages 64467-64470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22550]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2648]


Announcement of Requirements and Registration for the 2016 Food 
and Drug Administration Naloxone App Competition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 2016 
FDA Naloxone App Competition (Competition), a prize competition under 
the America COMPETES Reauthorization Act of 2010 (COMPETES Act). The 
Competition is an effort to help reduce deaths associated with 
prescription opioid and heroin overdose by seeking innovative 
approaches to help reduce preventable harm associated with opioids. 
Specifically, the goal of this Competition is to spur innovation around 
the development of a low-cost, scalable, crowd-sourced mobile phone 
application that helps increase the likelihood that opioid users, their 
immediate personal networks, and first responders are able to identify 
and react to an overdose by administering naloxone, a medication that 
reverses the effects of opioid overdose.

DATES: The Competition begins September 20, 2016.

1. Registration for the Competition: September 23 to October 7, 2016
2. Naloxone App Code-a-Thon: October 19 and October 20, 2016
3. Submission Period: September 23 to November 7, 2016

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FOR FURTHER INFORMATION CONTACT: Marisa Cruz at 
naloxoneapp@fda.hhs.gov, or 240-402-6628.

SUPPLEMENTARY INFORMATION:

I. Background

    In 2014, nearly 2 million Americans aged 12 years or older either 
abused or were dependent on opioid painkillers (Ref. 1). In 2014, 61 
percent of drug overdose deaths involved either an opioid painkiller or 
heroin. Between 2013 and 2014, deaths from any opioid increased 14 
percent (Ref. 2). Naloxone is an antidote for an opioid overdose, 
whether from prescription opioids or heroin. It is a prescription drug, 
with generally minimal side effects, that is frequently used to reverse 
the effects of opioid overdose in emergency rooms and on ambulances. 
Over recent years, many States have taken steps to make it easier for 
both first responders and laypersons, including family and friends of 
opioid users, to carry and administer naloxone (Ref. 3).
    Even with naloxone increasingly available in the community, 
however, persons carrying naloxone may not be on hand when an opioid 
overdose occurs. There is still the practical need to connect the 
individual experiencing the opioid overdose quickly and effectively 
with an individual carrying naloxone. Mobile phone applications (apps) 
have been developed to educate laypersons on opioid overdose and 
administration of naloxone (Refs. 4 and 5), and to connect bystanders 
with individuals in need of other medical services (Ref. 6). In a 
randomized, controlled trial, researchers demonstrated that a mobile-
phone positioning system to dispatch laypersons trained in 
cardiopulmonary resuscitation (CPR) was associated with significantly 
increased numbers of bystander-initiated CPR procedures on persons with 
out-of-hospital cardiac arrest (Ref. 7). To date, however, we are not 
aware of an app that has been developed to connect carriers of naloxone 
with nearby opioid overdose victims.

II. Subject of Competition

    The Competition encourages computer programmers, public health 
advocates, clinical researchers, entrepreneurs, and innovators from all 
disciplines to create teams focused on the development of innovative 
strategies to combat the rising epidemic of opioid overdose. 
Specifically, the Competition invites submissions for an app that 
increases the likelihood of timely naloxone administration by 
connecting opioid users experiencing an overdose with nearby naloxone 
carriers. FDA is most interested in concepts that are readily scalable, 
free or low-cost to the end-user, and take advantage of existing 
systems for naloxone distribution and use. FDA's expectation is that 
any app developed through the Competition will be used with FDA-
approved naloxone products. For additional background information on 
the Competition, participants can access http://www.Challenge.gov.
    Interested parties may register for the Competition at http://www.Challenge.gov beginning on September 23, 2016; participants are 
highly encouraged to register as teams, but individual applicants will 
also be accepted. The Competition will be conducted in two phases. 
Phase 1 will consist of a code-a-thon hosted at the FDA campus in 
Silver Spring, Maryland, for registered entrants to develop their 
concepts and initial prototypes for an app that alerts carriers of 
naloxone to a nearby opioid overdose. Entrants are encouraged, but not 
required, to participate in the code-a-thon. The code-a-thon will occur 
on October 19 and October 20, 2016. All code developed through the 
code-a-thon will be made open-source and publicly accessible on the 
GitHub platform, a Web-based code repository. The code-a-thon event 
space is limited to the first 50 individuals who indicate interest in 
onsite participation during the registration process (see Section IV). 
There will be a virtual component to the code-a-thon for the first 100 
individuals who indicate interest in remote participation during the 
registration process. In Phase 2, all registered entrants will refine 
their concepts and develop a functional prototype, a video of which 
will be submitted on http://www.YouTube.com by the submission deadline. 
The video will be accompanied by a short summary of the prototype, as 
detailed in this document, which will be submitted on http://www.Challenge.gov.
    Federal Agency subject matter experts will provide background and 
technical information to entrants on topics including, but not limited 
to, the opioid epidemic, uses of approved formulations of naloxone, and 
regulatory science considerations. During all phases of app 
development, all entrants should consider strategies to minimize legal 
risk and maximize regulatory compliance, including for the developer 
and the end-user. To ensure adequate consideration of potential 
liability, privacy, and regulatory concerns, FDA strongly encourages 
all entrants to obtain independent legal counsel.
    FDA is sponsoring the Competition and will be providing entrants 
with technical expertise from the National Institute on Drug Abuse 
(NIDA) and the Substance Abuse and Mental Health Services 
Administration (SAMHSA). Specifically, NIDA and SAMHSA will each 
provide one judge with experience in relevant fields including drug use 
and misuse, clinical trial design, development of mobile medical 
applications, and public health. Additionally, NIDA and SAMHSA will 
provide information to Competition entrants at the code-a-thon on key 
issues, including (1) patterns of opioid use and misuse, (2) 
characteristics of populations at risk of opioid overdose, and (3) data 
collection and evaluation considerations.
    Entrants may not test or evaluate their app using real people, 
including opioid users and naloxone carriers, during the Competition. 
Following the Competition, entrants may consider seeking grant funding 
from the NIDA Small Business Innovation Research (SBIR) program to 
further develop and bring to scale Competition concepts through testing 
and evaluation. As with all other National Institutes of Health (NIH) 
funding applications, NIDA staff will provide dedicated assistance and 
guidance about the NIH grant submission process, including submissions 
for the NIDA SBIR grants. The SBIR grant program is open to all small 
businesses (which may include Competition entrants) that meet 
applicable eligibility requirements set forth in the SBIR funding 
opportunity announcement. More information is available at http://grants.nih.gov/grants/guide/pa-files/PA-16-302.html. For Competition 
entrants and projects that meet all applicable SBIR requirements, the 
NIDA SBIR program may provide the opportunity to further develop 
Competition concepts through field testing and evaluation.
    The primary goal of the Competition is to reduce death from opioid 
overdoses by expanding access to naloxone, in support of the Federal 
Government's mission to protect and advance public health. The 
secondary goals of the Competition are:
     To increase public awareness about naloxone and its role 
in reducing death from opioid overdoses; and
     To promote open government and citizen participation to 
improve innovation in the Federal Government.

III. Eligibility Rules for Participating in the Competition

    To be eligible to win a prize under this Competition, an entrant 
(individual or entity):

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     Shall have registered and entered a submission on http://www.Challenge.gov and http://www.YouTube.com under the rules 
promulgated by FDA;
     Shall have complied with all the requirements under this 
section;
     Shall be (1) an individual or team of U.S. citizens or 
lawful permanent residents of the United States, each of whom is 18 
years of age and over; or (2) an entity incorporated in and maintaining 
a primary place of business in the United States. Foreign citizens can 
participate as employees of an entity that is properly incorporated in 
the United States and maintains a primary place of business in the 
United States;
     May not be a Federal entity or Federal employee acting 
within the scope of their employment. An individual or entity shall not 
be deemed ineligible because the individual or entity used Federal 
facilities or consulted with Federal employees during a competition if 
the facilities and employees are made available to all individuals and 
entities participating in the competition on an equitable basis.
     Federal grantees may not use Federal funds to develop 
COMPETES Act challenge applications unless consistent with the purpose 
of their grant award. Federal contractors may not use Federal funds 
from a contract to develop COMPETES Act challenge applications or to 
fund efforts in support of a COMPETES Act challenge submission.
     Employees of FDA, NIDA, SAMHSA, and/or any other 
individual or entity associated with the development, evaluation, or 
administration of the Competition as well as members of such persons' 
immediate families (spouses, children, siblings, parents), and persons 
living in the same household as such persons, whether or not related, 
are not eligible to participate in the Competition.
     Entrants must agree 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 their participation in the Competition, 
whether the injury, death, damage, or loss arises through negligence or 
otherwise.
     Entrants must also agree to indemnify the Federal 
Government against third party claims for damages arising from or 
related to competition activities. Entrants are not required to obtain 
liability insurance or demonstrate financial responsibility in order to 
participate in the Competition.
     By participating in the Competition, each entrant agrees 
to comply with and abide by the rules of the Competition and the 
decisions of FDA and/or the individual judges, which shall be final and 
binding in all respects.
     Each entrant agrees to follow all applicable local, State, 
and Federal laws and regulations.

IV. Registration Process for Participants

    Registration for this Competition will open on September 23, 2016. 
To register, visit http://www.Challenge.gov, search for the 2016 FDA 
Naloxone App Competition, and follow the instructions. Entrants will 
receive an email confirming registration and participation in the code-
a-thon, if applicable.

V. Submission Requirements

    All written, digital, or recorded materials must be in English.
    Submissions are required to include:
    1. A video of the functional app prototype, not more than 5 minutes 
in duration, uploaded to http://www.YouTube.com; and
    2. A written summary of the app, not to exceed three pages, 
submitted on http://www.Challenge.gov. This document should detail:
     A description of the entrant(s), including relevant fields 
of expertise;
     A summary of the concept for the app, including 
identification of the target audience;
     A general description of the proposed technical design, 
including an explanation of any planned interfaces between the app and 
existing systems or datasets; and
     The URL for the uploaded YouTube video.
    To submit the written summary of the app, visit http://www.Challenge.gov, search for the 2016 FDA Naloxone App Competition, 
click on Submit Solution, and follow the instructions. For additional 
detail on required components of a submission, and the minimum 
requirements for the proposed app, participants may access the rules 
for the Competition posted at http://www.Challenge.gov.

VI. Amount of the Prize

    At the conclusion of judging after Phase 2 of the Competition, the 
highest-scoring entrant will receive an award of $40,000.
    The award approving official for this Competition is the FDA 
Associate Commissioner for Public Health Strategy and Analysis (Peter 
Lurie). Following the Competition, all entrants eligible for SBIR 
grants may also apply for a NIDA SBIR award, as announced in the NIH 
SBIR funding opportunity announcement, in order to research, develop, 
and evaluate app performance and utility.

VII. Payment of the Prize

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

VIII. Basis Upon Which Winner Will Be Selected

    A panel of judges with experience in the fields of mobile medical 
application development, public health, and/or regulatory science 
chosen by FDA will select the highest-performing entrant from the pool 
of eligible submissions.
    Judging of eligible submissions will be fair and impartial, and 
based upon the following evaluation criteria, with equal weighting.
     Innovation: Uniqueness and innovation in use of software 
and data analytics to fulfill the mandatory requirements; variety and 
value of additional features (weight 25 percent).
     Usability: Use of design elements to increase utilization 
among both people at risk of opioid overdose and naloxone carriers; 
ease of navigation; appropriate use of an interface to support the app 
in achieving desired outcome (weight 25 percent).
     Functionality: Potential to enhance the frequency and 
speed of naloxone administration by the carriers to the overdose 
victims (weight 25 percent).
     Adaptability: Potential for app to be tailored to the 
practical environment (e.g., urban, rural) of an individual community 
(weight 25 percent).

IX. Additional Information

    FDA reserves the right to suspend, postpone, terminate, or 
otherwise modify the Competition, or any entrant's participation in the 
Competition, at any time at the discretion of the Agency. FDA also 
reserves the right to not award a prize if no submission is deemed 
worthy. All decisions by FDA regarding adherence to Competition rules 
are final.
    To receive the prize, entrants will not be required to transfer 
their intellectual property rights to FDA. Each entrant retains any 
applicable intellectual property rights to their submission. By 
participating in the Competition, each entrant hereby grants to FDA, 
and any third-parties acting on FDA's behalf an irrevocable, paid up, 
non-exclusive,

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royalty-free, worldwide license and right to reproduce, publicly 
perform, publicly display, and use the entrant's submission for 
government purposes, and to publicly perform and publicly display the 
entrant's submission video, including, without limitation, for 
advertising and promotional purposes relating to the Competition.
    Additionally, each participant at the code-a-thon will be required 
to provide FDA with an open source version of the code written by the 
participant at the code-a-thon to be posted on the GitHub source code 
repository and made publicly available under the Creative Commons 
license, CCO 1.0 Universal (CCO 1.0, Public Doman Dedication). For a 
summary and full text of the CCO 1.0 Universal license, see https://creativecommons.org/publicdomain/zero/1.0/. The GitHub source code 
repository is accessible at https://github.com.

X. Statutory Authority To Conduct the Challenge

    FDA is conducting this Challenge under section 105 of the America 
COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).

XI. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at http://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

1. Centers for Disease Control and Prevention. ``Prescription Drug 
Overdose Data.'' Accessed September 9, 2016, at http://www.cdc.gov/drugoverdose/data/overdose.html.
2. Rudd, R.A., N. Aleshire, J.E. Zibbell, and R.M. Gladden. 
``Increases in Drug and Opioid Overdose Deaths--United States, 2000-
2014.'' Morbidity and Mortality Weekly Report, 2015;64: 1-5. 
Accessed September 9, 2016, at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm64e1218a1.htm.
3. Network for Public Health Law. ``Legal Interventions to Reduce 
Overdose Mortality: Naloxone Access and Overdose Good Samaritan 
Laws.'' Accessed September 9, 2016, at https://www.networkforphl.org/_asset/qz5pvn/network-naloxone-10-4.pdf.
4. Substance Abuse and Mental Health Services Administration. 
``Opioid Overdose Prevention Toolkit.'' Accessed September 9, 2016, 
at http://www.samhsa.gov/capt/tools-learning-resources/opioid-overdose-prevention-toolkit.
5. U-turn. http://www.u-turntraining.com/apps/. Accessed September 
9, 2016.
6. PulsePoint. http://www.pulsepoint.org. Accessed September 9, 
2016.
7. Ringh, M., M. Rosenqvist, J., Hollenberg, et al. ``Mobile-Phone 
Dispatch of Laypersons for CPR in Out-of-Hospital Cardiac Arrest.'' 
New England Journal of Medicine, 2015; 372:2316-2325.


    Dated: September 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22550 Filed 9-19-16; 8:45 am]
 BILLING CODE 4164-01-P


