Announcement of Requirements and Registration for the 2016 Food and Drug Administration Naloxone App Competition, 64467-64470 [2016-22550]
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Federal Register / Vol. 81, No. 182 / Tuesday, September 20, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Risk Communication Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Risk Communication
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to the
Agency on FDA’s regulatory issues. The
meeting will be open to the public.
DATES: The meeting will be held on
November 7, 2016, from 8:30 a.m. to 5
p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Natasha Facey, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 3354, Silver Spring,
MD 20993–0002, 301–796–5290,
Natasha.Facey@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On November 7, 2016, the
committee will discuss and make
recommendations on FDA’s draft
Strategic Plan for Risk Communication
and Health Literacy. The purpose of the
Strategic Plan for Risk Communication
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and Health Literacy is to clarify how the
Agency can communicate the benefits
and risks of FDA-regulated products to
target audiences more effectively, and so
promote better informed decision
making. The committee will also hear
presentations on some of FDA’s external
communications and how these
communications relate to the draft
Strategic Plan for Risk Communication
and Health Literacy.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before November 1, 2016.
Oral presentations from the public will
be scheduled between approximately
1:30 p.m. to 2:30 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before October
21, 2016. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 25, 2016.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Sheryl Clark at
Sheryl.Clark@fda.hhs.gov or 240–402–
5273 at least 7 days in advance of the
meeting.
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FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 13, 2016.
Janice Soreth,
Acting Associate Commissioner, Special
Medical Programs.
[FR Doc. 2016–22553 Filed 9–19–16; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
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Federal Register / Vol. 81, No. 182 / Tuesday, September 20, 2016 / Notices
FOR FURTHER INFORMATION CONTACT:
Marisa Cruz at naloxoneapp@
fda.hhs.gov, or 240–402–6628.
SUPPLEMENTARY INFORMATION:
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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
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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 https://
www.Challenge.gov.
Interested parties may register for the
Competition at https://
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-athon. 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-athon 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 https://
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 https://
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.
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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 https://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 https://
www.Challenge.gov and https://
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
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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 https://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 https://
www.YouTube.com; and
2. A written summary of the app, not
to exceed three pages, submitted on
https://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 https://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
https://www.Challenge.gov.
VI. Amount of the Prize
At the conclusion of judging after
Phase 2 of the Competition, the highestscoring 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
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64469
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 https://
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
https://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 https://
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 https://
www.samhsa.gov/capt/tools-learningresources/opioid-overdose-preventiontoolkit.
5. U-turn. https://www.u-turntraining.com/
apps/. Accessed September 9, 2016.
6. PulsePoint. https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: 0937–0191–60D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, announces plans
to submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). The ICR is for extending the use
of the approved information collection
assigned OMB control number 0937–
0191, which expires on December 31,
2016. Prior to submitting the ICR to
OMB, OS seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
SUMMARY:
Comments on the ICR must be
received on or before November 21,
2016.
DATES:
Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–5683.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
document identifier 0937–0191–60D for
reference.
Information Collection Request Title:
Information Collection Request Title:
Application packets for Real Property
for Public Health Purposes.
Abstract: The Office of Assistant
Secretary for Administration, Program
Support Center, Federal Property
Assistance Program requesting OMB
approval on a previously approved
information collection, 0937–0191. The
Federal Property and Administrative
Services Act of 1949 (Pub. L. 81–152),
as amended, provides authority to the
Secretary of Health and Human Services
to convey or lease surplus real property
to States and their political subdivisions
and instrumentalities, to tax-supported
institutions, and to nonprofit
institutions which (except for
institutions which lease property to
assist the homeless) have been held
exempt from taxation under Section
501(c)(3) of the 1954 Internal Revenue
Code, and 501(c)(19) for veterans
organizations, for public health and
homeless assistance purposes. Transfers
are made to transferees at little or no
cost.
Need and Proposed Use of the
Information: State and local
governments and non-profit institutions
use these applications to apply for
excess/surplus, underutilized/
unutilized and off-site government real
property. These applications are used to
determine if institutions/organizations
are eligible to purchase, lease or use
property under the provisions of the
surplus real property program.
Likely Respondents: State, local, or
tribal units of government or
instrumentalities thereof; not-for-profit
organizations.
The total annual burden hours
estimated for this ICR are summarized
in the table below.
ADDRESSES:
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TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Applications for surplus Federal real property .................................................
15
1
200
3,000
Total ..........................................................................................................
15
1
200
3,000
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 64468]]
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 https://www.Challenge.gov.
Interested parties may register for the Competition at https://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 https://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 https://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 https://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):
[[Page 64469]]
Shall have registered and entered a submission on https://www.Challenge.gov and https://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 https://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 https://www.YouTube.com; and
2. A written summary of the app, not to exceed three pages,
submitted on https://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 https://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 https://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,
[[Page 64470]]
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 https://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 https://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 https://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 https://www.samhsa.gov/capt/tools-learning-resources/opioid-overdose-prevention-toolkit.
5. U-turn. https://www.u-turntraining.com/apps/. Accessed September
9, 2016.
6. PulsePoint. https://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
