81_FR_11622 81 FR 11579 - Announcement of Requirements and Registration for the Opioid Overdose Prevention Challenge

81 FR 11579 - Announcement of Requirements and Registration for the Opioid Overdose Prevention Challenge

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration

Federal Register Volume 81, Issue 43 (March 4, 2016)

Page Range11579-11583
FR Document2016-04815

In summarizing the challenge that will be issued by your agency, please answer the following four questions: (1) What action is being taken? The Substance Abuse and Mental Health Services Administration (SAMHSA) has issued a challenge to developers to help support patients in recovery who are receiving medication assisted treatment for opioid use disorder with an innovative app that provides features and information that support their recovery. (2) Why is this action necessary? Addressing the opioid epidemic is a top priority for the U.S. Department of Health and Human Services and the Secretary is committed to evidence-informed interventions to turn the tide against opioid drug-related overdose and misuse. To that end, Substance Abuse and Mental Health Services Administration (SAMHSA) is issuing a three-month challenge to spur developers to create an app that provides additional recovery support to patients receiving outpatient medication-assisted treatment for opioid use disorder. (3) What is the objective of the challenge? To provide support to people in recovery from opioid use disorder receiving medication assisted-treatment so that they can maintain treatment and achieve long-term recovery. (4) What is the intended effect of this action? An increase in the number of individuals with opioid use disorders maintaining recovery; and a reduction in the number of deaths from opioid overdose.

Federal Register, Volume 81 Issue 43 (Friday, March 4, 2016)
[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11579-11583]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04815]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Announcement of Requirements and Registration for the Opioid 
Overdose Prevention Challenge

    Authority: 15 U.S.C. 3719.

AGENCY: SAMHSA, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In summarizing the challenge that will be issued by your 
agency, please answer the following four questions:
    (1) What action is being taken?
    The Substance Abuse and Mental Health Services Administration 
(SAMHSA) has issued a challenge to developers to help support patients 
in recovery who are receiving medication assisted treatment for opioid 
use disorder with an innovative app that provides features and 
information that support their recovery.
    (2) Why is this action necessary?
    Addressing the opioid epidemic is a top priority for the U.S. 
Department of Health and Human Services and the Secretary is committed 
to evidence-informed interventions to turn the tide against opioid 
drug-related overdose and misuse. To that end, Substance Abuse and 
Mental Health Services Administration (SAMHSA) is issuing a three-month 
challenge to spur developers to create an app that provides additional 
recovery support to patients receiving outpatient medication-assisted 
treatment for opioid use disorder.
    (3) What is the objective of the challenge?
    To provide support to people in recovery from opioid use disorder 
receiving medication assisted-treatment so that they can maintain 
treatment and achieve long-term recovery.
    (4) What is the intended effect of this action?
    An increase in the number of individuals with opioid use disorders 
maintaining recovery; and a reduction in the number of deaths from 
opioid overdose.

DATES: The challenge starts on March 4, 2016 10:00 a.m. ET. The 
challenge ends on May 27, 2016 11:59 p.m. ET.

FOR FURTHER INFORMATION CONTACT: Danielle Tarino Rivkin, Health 
Information Technology Team, Center for Substance Abuse Treatment, 
Substance Abuse and Mental Health Services Administration, U.S. 
Department of Health and Human Services, Public Health Advisor, SAMHSA/
CSAT, 5600 Fishers Lane, Rockville, MD 20857, Phone: 240.276.2857, 
Email: [email protected].

SUPPLEMENTARY INFORMATION:
    Subject of Challenge Competition: Opioid Recovery Support.

Eligibility Rules for Participating in the Competition

    To satisfy the mandatory provisions of the COMPETES Act, use the 
following language:
    A. The Competition is open only to:
    (i) Individuals who are at least 18 years of age at the time of 
entry, and are citizens or permanent residents of the United States as 
of the time of entry;
    (ii) teams of eligible individuals where each team member meets the 
eligibility requirements for individual Contestants; and
    (iii) corporations (including not-for-profit corporations and other 
nonprofit organizations), limited liability companies, partnerships, 
and other legal entities that, at the time of entry, are domiciled (or 
incorporated) in the United States, have been duly organized or 
incorporated and validly exist, and employ no more than one hundred 
(100) people (``Organizations'').
    B. Each team or Organization shall appoint one individual (the 
``Representative'') to represent and act, including entering a 
Submission, on behalf of said team or Organization. The Representative 
must meet the eligibility requirements for an individual Contestant and 
must be duly authorized to submit on behalf of the team or 
Organization. The Representative represents and warrants that: (i) He/
she is duly authorized to act on behalf of the team or Organization; 
and (ii) each member of the team (or in the case of Organization, each 
participating member) has read the Official Rules and agrees to abide 
by these Official Rules. The Representative will ensure that each 
member of the team or Organization reads, agrees to, and complies with 
the Official Rules.

[[Page 11580]]

    C. An individual may join more than one team or Organization, and 
an individual who is part of a team or Organization may also enter the 
Competition on an individual basis.
    D. The following individuals, teams, and Organizations are not 
eligible regardless of whether or not they meet the criteria set forth 
above:
    (i) The Sponsor, the Administrator, and any advertising agency, 
contractor or other organization involved with the design, production, 
promotion, execution, or distribution of the Competition (collectively 
``Promotion Entities''); all employees, representatives and agents of 
such Promotion Entities; and all members of any such employee, 
representative or agent's immediate family or household;
    (ii) any individual involved with the design, production, 
promotion, execution, or distribution of the Competition and each 
member of any such individual's immediate family or household;
    (iii) any company or individual that employs any Judge or that 
otherwise has a material business relationship or affiliation with any 
Judge;
    (iv) any parent company, subsidiary, or other affiliate of any 
company described above.
    E. This Challenge falls under the COMPETES Act. As such, if a 
Contestant is a federal grantee, they may not use federal funds to 
develop COMPETES Act challenge applications unless consistent with the 
purpose of their grant award.
    F. If Contestant is a federal contractor, they 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.
    G. For purposes hereof:
    (i) The members of an individual's immediate family include such 
individual's spouse, children and step-children, parents and step-
parents, and siblings and step-siblings; and
    (ii) the members of an individual's household include any other 
person that shares the same residence as such individual for at least 
three (3) months out of the year.
    H. A Contestant will 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 Contestants participating in the competition on an 
equitable basis.

Registration Process for Participants

    (i) Beginning on March 4, 2016 at 10:00 a.m. Eastern Time, visit 
http://samhsaopioidrecoveryapp.devpost.com/ (the ``Competition Web 
site'') and click ``Sign Up'' to create a Devpost account, or click 
``Log In'' and log in with an existing Devpost account. There is no 
charge for creating a Devpost account.
    (ii) After a Contestant signs up on the Competition Web site, a 
confirmation email will be sent to the email address provided by the 
Contestant. The Contestant should use the confirmation email to verify 
their email address.
    (iii) Contestant should indicate their agreement in participating 
by clicking ``Register'' on the Competition Web site in order to 
receive important Competition updates.
    (iv) In the event of a dispute pertaining to this Competition, the 
authorized account holder of the email address used to sign up for the 
Devpost account used to enter the Submission will be deemed to be the 
Contestant (in case of an individual) and the Contestant's 
Representative, in the case of a team or Organization. The ``authorized 
account holder'' is the natural person or legal entity assigned an 
email address by an Internet access provider, online service provider 
or other organization responsible for assigning email addresses for the 
domain associated with the submitted address. Contestants generally and 
potential winners may be required to show proof of being the authorized 
account holder.
    Amount of the Prize: 1st prize: $15,000 cash; 2nd prize: $7,500 
cash; 3rd prize: $5,000 cash.
    Payment of the Prize: Prize payment will be paid by contractor.

Basis Upon Which Winner Will Be Selected

    A. All eligible Submissions will be judged by an expert panel of 
impartial judges (the ``Judges'') selected by the Sponsor. The internal 
panel will judge these Submissions on the criteria identified in these 
Official Rules to select finalist Submissions. Finalist Submissions 
will then be judged by the expert judging panel determined by the 
Sponsor. The judging panel is not required to test the Application and 
may choose to judge based solely on the text description and video 
provided in the Submission. The Sponsor and the Administrator reserve 
the right to divide and assign the criteria identified below in these 
Official Rules among different members of the internal and expert 
judging panels. The Sponsor and the Administrator reserve the right to 
substitute or modify the judging panel at any time for any reason.
    B. All Judges shall be and remain fair and impartial. Any Judge may 
recuse him or herself from judging a Submission if the Judge, the 
Sponsor or the Administrator considers that it is inappropriate, for 
any reason, for the Judge to evaluate a specific Submission or group of 
Submissions.
    C. A Contestant's likelihood of winning will depend primarily on 
the number and quality of all of the Submissions, as determined by the 
Judges using the criteria in these Official Rules. The judging period 
is May 30, 2016 at 10:00 a.m. Eastern Time through July 1, 2016 at 
11:59 p.m. Eastern Time (the ``Judging Period'').
    D. Criteria:

    Judging Criteria:
    a. Quality of Idea (Includes the degree to which the proposed app 
can support patient recovery by addressing the required and optional 
insights, the creativity of the idea and the innovation of the proposed 
app to support recovery).
    b. Implementation of Idea (Includes how well the idea was 
implemented including the user experience, design and technical 
functionality).
    c. Potential Impact (Includes the patient value and potential 
impact the application can have for individuals in recovery).
    E. If deemed necessary by the judging panel, each of the top five 
finalists may be asked to participate in a virtual or in-person meeting 
with federal staff to discuss their Application and demonstrate its 
operation. The purpose of these meetings will be to further evaluate 
the Contestant's product, provide any additional information to SAMHSA, 
and clarify any concerns or questions raised by the review panel.
    F. Tie Breakers. In the event of a tie between two or more 
Submissions, the panel of Judges will vote on the tied submissions.
    G. The Sponsor reserves the right, in its sole discretion, to
    a. cancel, suspend, or modify the Challenge, and/or
    b. not award any prizes if no submissions are deemed worthy.
    H. All decisions made by the Sponsor regarding adherence to contest 
rules are final.
    I. All selection of contest winners is final.

Additional Information

B. Submission

    (i) Contestants must create a working software application. Apps 
must be developed as either:
    a. iOS or Android, as a downloadable app.
    Contestants can submit an app developed for just one operating 
system

[[Page 11581]]

(OS) but the 1st place winner must develop for both iOS and Android 
within six months of winning the prize
    OR
    b. an HTML5 mobile web application accessible via a mobile browser 
(Chrome or Safari) on the device.
    (i) The 1st place winner will need to host the HTML5 mobile web app 
for at least 2 years from delivery of signed affidavit by prizewinner
    c. both a. and b. above.
    (ii) During the Competition Submission Period, Contestant must 
visit the Competition Web site and confirm that he or she has, or if 
Contestant is a Representative, all members of their team or 
Organization have, read and agree to the Official Rules. Then, 
Contestant must submit its Submission by providing the following items 
included in subsections a-n below:
    a. The name of the Application;
    b. a brief text description (no more than 350 words) of the 
Application and how it functions; including a list of the features and 
how they address the insights provided in Attachment A. If any 
additional resources have been provided in the Application by the 
Contestant, the Contestant will submit an Excel or .csv file with a 
list of all the additional resources that includes the title of the 
resource; the source of the resource; and a link to the resource if 
applicable. Additionally, if Application uses any additional 
copyrighted material, contestant must have written consent to use it. 
The Administrator and/or Sponsor reserves the right to request 
additional documentation from Contestants to verify this information.
    c. a text description of testing instructions for the app;
    d. at least one image (screenshot) of the working Application;
    e. a link to a video uploaded to Devpost.com and YouTube.com that 
clearly demonstrates the Application's functionality and features (by 
walking through the Application);
    f. the Application platform (iOS, Android, HTML5 Web);
    g. for Android applications: The Android APK file and any other 
associated files needed to run the app or a link to the app in the 
Google Play store;
    h. for IOS applications:
    If your Application is available on the iTunes App Store provide a 
link in the ``Web site URL'' field on ``Enter a Submission'' form. If 
you charge a fee for downloading your Application, you must provide a 
promo code.
    If your Application is not yet publicly available on the iTunes App 
Store, you must send a test build to the Administrator before the end 
of the Challenge Submission Period using one of the following methods: 
The iOS App file registered to the reviewers unique device ID (UDID), 
the Sponsor will provide UDIDs upon request (see contact info at the 
end of the rules section). For more details see: https://developer.apple.com/library/ios/documentation/IDEs/Conceptual/AppDistributionGuide/TestingYouriOSApp/TestingYouriOSApp.html.
    OR, provide a link to the app in the Apple iTunes store;
    OR contestants can use one of the following options:
    Beta by Crashalytics You may send the Administrator a beta test via 
Crashalytics. Use the Administrator's testing email 
([email protected]) and UDID's (Sponsor will provide UDIDs upon 
request) to provision a build and send the Administrator a link via the 
``Share Links'' button. Add the testing link to the Enter a Submission 
form under ``iOS Build Link''. Beta by Crashalytics is a free service. 
Please review the how-to for their Beta Distribution tool.
    Diawi Send the beta file via Diawi. After uploading your file, 
Diawi creates a unique short URL to access the installation page (for 
ex: aBcDeF). When opened in Safari on the iOS device, the page will 
display a link to install the application. Note that you will need to 
include provisioning for one or more of the UDIDs the Sponsor will 
provide upon request.
    i. for Web or HTML5 mobile Web: A link to a Web site where the 
application can be accessed free of charge;
    j. step-by-step testing instructions including the minimum 
operating system or Web browser version required for testing and login 
instructions, if a login is required;
    k. the submitter type (individual, team, or organization);
    l. the Organization name, if the submitter is an Organization; and
    m. the Contestant Representative's phone number;
    n. the Contestant's email address.
    (Note that items a-n above, are collectively a ``Submission.'')
    (2) For sake of clarity, all parts of the Submission must be 
entered at the same time on the Competition Web site. All Submissions 
must be received by no later than 11:59 p.m. Eastern Time on May 27, 
2016. Applications that cannot be accessed for judging during the 
Judging Period will be disqualified.
    (3) Once a Submission has been submitted and the Competition 
Submission Period has ended, a Contestant may not make any changes or 
alterations to the Submission until the end of the Judging Period. 
Contestants may save draft versions of their Submission before entering 
it on the Competition Web site.
    (4) The Sponsor and/or the Administrator, at their sole discretion, 
may permit a Contestant to modify part of the Submission after the 
Competition Submission Deadline for the purpose of removing material 
that potentially infringes a third party mark or right, discloses 
personally identifiable information, or is otherwise inappropriate or 
deemed not relevant by the administrator. The modified Submission must 
remain substantively the same as the original Submission with the only 
modification being what is permitted by the Sponsor and/or 
Administrator. Any modifications beyond what is permitted may result in 
disqualification.
    (5) Applications cannot be changed after the Competition Submission 
Period and before the end of the Judging Period, unless the Contestant 
has provided an installation file and testing instructions on the Enter 
an Application form on the Competition Web site.
    (6) Upon award the winner must submit a project directory with all 
supporting assets, such as uncompiled code, data, images, etc., 
belonging to the application for review.

5. Submission Requirements

A. Language Requirements

    All Submission materials must be in English.

B. Text Description, Image and Video Requirements

    (i) The text description must describe the Application's key 
features and functionality, and must outline how the features address 
the insights specified by the Administrator in Attachment A.
    (ii) The image(s) must be photographs or screenshots of your 
working Application.
    (iii) The video portion of the Submission:
    a. Should be no longer than five (5) minutes;
    b. must clearly demonstrate the Application's features and 
functionality, especially those that address the required assets and 
insights; and
    c. must not include music or other copyrighted material or use 
third party trademarks unless the Contestant has written permission to 
use such material.
    (iv) If the video is primarily promotional rather than a 
demonstration of the Application's functionality and features (by 
walking through the Application), the

[[Page 11582]]

Submission may be disqualified at the Sponsor's and/or Administrator's 
sole discretion.
    (v) Please provide a description of ideas for how you could promote 
the app if you are a prizewinner (350 words max).

C. Content Requirements

    (i) The Submission must only address insights provided.
    (ii) The Submission must include the required information contained 
in the INSERT ASSET FILE NAME. This includes APIs and resources. The 
ASSET FILE NAME will indicate whether content is optional or required. 
Entries may not substantially alter the meaning, intent, or otherwise 
misrepresent the content in whole or in part. The intention of this 
clause is to ensure that the integrity of the content is maintained.
    (iii) The Submission must target individuals in recovery from 
opioid misuse who are receiving outpatient medication-assisted 
treatment.
    (iv) The submission features should be designed to encourage repeat 
usage of the app.
    (v) A Submission must not include an audio or visual performance, 
including but not limited to music, dance, or other performing art, 
third-party copyrighted material or trademarks, unless the Contestant 
has written permission to use such material.
    (vi) The Submission must not use HHS's or SAMHSA's logos or 
official seals and must not claim endorsement.

D. Application Requirements

    In addition to the requirements described above in Sections 5(A)-
5(C):
    (i) The Application must be able to be successfully installed and 
capable of running consistently as described on the platform for which 
it is intended.
    (ii) Applications may be newly created or existing applications 
modified to meet the requirements of the Competition.
    (iii) Applications must be designed for use with existing modern 
smartphones.
    (iv) Applicants using HTML5 should limit the data burden on users 
and where possible the submissions should leverage local storage and 
client-side cache options.
    (v) Applications must not collect or store personally identifiable 
information (PII) or protected health information (PHI) as defined in 
45 CFR 160.103.
    (vi) Applications must not collect or require input of end user 
email addresses within the Application.
    (vii) The Prizewinners must offer the Application to the public for 
free for a period of at least one (1) year. Each Application must be 
available free of charge for testing, evaluation and use by the 
Competition Sponsor, Administrator and judges during the Competition 
and until the Judging Period ends at 11:59 p.m. Eastern Time on July 1, 
2016. For one year following the prize distribution, prize winners will 
be required to provide to the Sponsor a report of monthly data on the 
number of app downloads.
    (viii) Contestants must acknowledge, as a prerequisite to any 
subsequent acquisition by federal contract or other method, they may be 
required to make their product compliant with Section 508 accessibility 
and usability requirements at their own expense. Any electronic 
information technology that is ultimately obtained by HHS for its use, 
development, or maintenance must meet Section 508 accessibility and 
usability standards. Past experience has demonstrated that it can be 
costly for solution-providers to ``retrofit'' solutions if remediation 
is later needed. The HHS Section 508 Evaluation Product Assessment 
Template, available at www.hhs.gov/od/vendors/index.html, provides a 
useful roadmap for developers to review. It is a simple, Web-based 
checklist utilized by HHS officials to allow vendors to document how 
their products do or do not meet the various Section 508 requirements.
    (ix) Submissions requiring approval from a third party, such as an 
app store, in order to be accessible to the public, must be submitted 
to such third party or app store for review before the end of the 
Competition Submission Period. For any software that is not a web or 
mobile Web Application run on a web browser (tablet and desktop 
Applications), Contestants will be required to provide an installation 
file containing the Application.

E. General Requirements

    (i) Submissions must not:
    a. Violate any law or regulation;
    b. depict hatred;
    c. be in bad taste;
    d. denigrate (or be derogatory towards) any person or group of 
persons or any race, ethnic group or culture;
    e. threaten a specific community in society, including any specific 
race, ethnic group or culture;
    f. incite violence or be likely to incite violence;
    g. contain vulgar or obscene language or excessive violence;
    h. contain pornography, obscenity or sexual activity; or
    i. disparage the Sponsor or Administrator.
    (ii) Submissions must not attempt to duplicate a prior Submission 
already submitted in this Competition. Sponsor or Administrator 
reserves the right in its sole discretion to disqualify any Submission 
that is a duplicate or substantially similar to another Submission.
    (iii) Submissions must be free of malware. Contestant agrees that 
the Sponsor and the Administrator may conduct testing on the 
Application to determine whether malware or other security threats may 
be present. Submission not complying with these requirements may be 
disqualified.
    (iv) Each Application will be tested by the Administrator, the 
Sponsor or their designees. Submissions may be disqualified if the 
Application does not function as depicted in the video or expressed in 
the text description, at the Sponsor's and/or Administrator's sole 
discretion.
    (v) Prizewinners may be required to submit the source code and any 
relevant data of their Application to the Administrator and/or Sponsor 
upon request at any time.
    (vi) A Contestant may submit more than one Submission. However, 
each Submission must be unique, as determined by Sponsor and/or the 
Administrator in their sole discretion. If a Contestant enters two or 
more Submissions that are substantially similar, the Sponsor and 
Administrator reserve the right to disqualify Submissions or require 
the Contestant to choose one Submission to enter into the Competition.
    (vii) Submissions must not include any email addresses, phone 
numbers, addresses, or social security numbers in the Submission name, 
text description, video, or images.
    (viii) Contestants must not imply endorsement of their Application 
by the Sponsor in any of the Submission components or in any 
advertising or media, including Web sites and app stores, featuring the 
Contestant's Application.
    (ix) Submissions must: (a) Be the original work product of the 
Contestant; (b) be solely owned by Contestant and with no other person 
or entity having any right or interest in it; and (c) not violate the 
Intellectual Property rights or other rights including but not limited 
to copyright, trademark, patent, contract, and/or privacy rights, of 
any other person or entity. A Contestant may contract with a third 
party for technical assistance to create the Submission provided the 
Submission components are solely the Contestant's work product and the 
result of the Contestant's ideas

[[Page 11583]]

and creativity, and the Contestant owns all rights to them.
    (x) By entering a Submission, Contestant represents, warrants and 
agrees that the Submission (including, without limitation, the 
Application) is the original work of the Contestant and complies with 
the Official Rules.
    Contestant further represents, warrants and agrees that any use of 
the Submission by the Sponsor, Administrator and/or Judges (or any of 
their respective partners, subsidiaries and affiliates) as authorized 
by these Official Rules, shall not:
    a. Infringe upon, misappropriate or otherwise violate any 
intellectual property right or proprietary right including, without 
limitation, any statutory or common law trademark, copyright or patent, 
nor any privacy rights, moral rights nor any other rights of any person 
or entity; or
    b. constitute or result in any misappropriation or other violation 
of any person's publicity rights or right of privacy.

Summer King,
Statistician.
[FR Doc. 2016-04815 Filed 3-3-16; 8:45 am]
 BILLING CODE 4162-20-P



                                                                                  Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices                                             11579

                                                  II. Significance of Guidance                                  www.fda.gov/AdvisoryCommittees/                 maintaining recovery; and a reduction
                                                    This draft guidance is being issued                         CommitteesMeetingMaterials/                     in the number of deaths from opioid
                                                  consistent with FDA’s good guidance                           MedicalDevices/MedicalDevices                   overdose.
                                                  practices regulation (21 CFR 10.115).                         AdvisoryCommittee/Obstetricsand                 DATES: The challenge starts on March 4,
                                                  The draft guidance, when finalized, will                      GynecologyDevices/                              2016 10:00 a.m. ET. The challenge ends
                                                  represent the current thinking of FDA                         ucm463457.htm.                                  on May 27, 2016 11:59 p.m. ET.
                                                  on ‘‘Labeling for Permanent                               Dated: February 29, 2016.                           FOR FURTHER INFORMATION CONTACT:
                                                  Hysteroscopically-Placed Tubal                          Leslie Kux,                                           Danielle Tarino Rivkin, Health
                                                  Implants Intended for Sterilization.’’ It               Associate Commissioner for Policy.                    Information Technology Team, Center
                                                  does not establish any rights for any                   [FR Doc. 2016–04790 Filed 3–3–16; 8:45 am]            for Substance Abuse Treatment,
                                                  person and is not binding on FDA or the                 BILLING CODE 4164–01–P                                Substance Abuse and Mental Health
                                                  public. You can use an alternative                                                                            Services Administration, U.S.
                                                  approach if it satisfies the requirements                                                                     Department of Health and Human
                                                  of the applicable statutes and                          DEPARTMENT OF HEALTH AND                              Services, Public Health Advisor,
                                                  regulations.                                            HUMAN SERVICES                                        SAMHSA/CSAT, 5600 Fishers Lane,
                                                  III. Electronic Access                                                                                        Rockville, MD 20857, Phone:
                                                                                                          Substance Abuse and Mental Health                     240.276.2857, Email: Danielle.Tarino@
                                                     Persons interested in obtaining a copy               Services Administration                               samhsa.hhs.gov.
                                                  of the draft guidance may do so by
                                                  downloading an electronic copy from                     Announcement of Requirements and                      SUPPLEMENTARY INFORMATION:
                                                  the Internet. A search capability for all               Registration for the Opioid Overdose                   Subject of Challenge Competition:
                                                  Center for Devices and Radiological                     Prevention Challenge                                  Opioid Recovery Support.
                                                  Health guidance documents is available                                                                        Eligibility Rules for Participating in the
                                                  at http://www.fda.gov/MedicalDevices/                     Authority: 15 U.S.C. 3719.
                                                                                                                                                                Competition
                                                  DeviceRegulationandGuidance/                            AGENCY:   SAMHSA, HHS.
                                                  GuidanceDocuments/default.htm.                                                                                   To satisfy the mandatory provisions of
                                                                                                          ACTION:   Notice.
                                                  Guidance documents are also available                                                                         the COMPETES Act, use the following
                                                  at http://www.regulations.gov. Persons                  SUMMARY:   In summarizing the challenge               language:
                                                  unable to download an electronic copy                   that will be issued by your agency,                      A. The Competition is open only to:
                                                  of ‘‘Labeling for Permanent                             please answer the following four                         (i) Individuals who are at least 18
                                                  Hysteroscopically-Placed Tubal                          questions:                                            years of age at the time of entry, and are
                                                  Implants Intended for Sterilization’’                     (1) What action is being taken?                     citizens or permanent residents of the
                                                  may send an email request to CDRH-                        The Substance Abuse and Mental                      United States as of the time of entry;
                                                  Guidance@fda.hhs.gov to receive an                      Health Services Administration                           (ii) teams of eligible individuals
                                                  electronic copy of the document. Please                 (SAMHSA) has issued a challenge to                    where each team member meets the
                                                  use the document number 1500051 to                      developers to help support patients in                eligibility requirements for individual
                                                  identify the guidance you are                           recovery who are receiving medication                 Contestants; and
                                                  requesting.                                             assisted treatment for opioid use                        (iii) corporations (including not-for-
                                                                                                          disorder with an innovative app that                  profit corporations and other nonprofit
                                                  IV. Paperwork Reduction Act of 1995                                                                           organizations), limited liability
                                                                                                          provides features and information that
                                                    This draft guidance refers to                         support their recovery.                               companies, partnerships, and other legal
                                                  previously approved collections of                        (2) Why is this action necessary?                   entities that, at the time of entry, are
                                                  information found in FDA regulations.                     Addressing the opioid epidemic is a                 domiciled (or incorporated) in the
                                                  These collections of information are                    top priority for the U.S. Department of               United States, have been duly organized
                                                  subject to review by the Office of                      Health and Human Services and the                     or incorporated and validly exist, and
                                                  Management and Budget (OMB) under                       Secretary is committed to evidence-                   employ no more than one hundred (100)
                                                  the Paperwork Reduction Act of 1995                     informed interventions to turn the tide               people (‘‘Organizations’’).
                                                  (44 U.S.C. 3501–3520). The collections                  against opioid drug-related overdose                     B. Each team or Organization shall
                                                  of information in 21 CFR part 801,                      and misuse. To that end, Substance                    appoint one individual (the
                                                  regarding labeling have been approved                   Abuse and Mental Health Services                      ‘‘Representative’’) to represent and act,
                                                  under OMB control number 0910–0485.                     Administration (SAMHSA) is issuing a                  including entering a Submission, on
                                                  V. Reference                                            three-month challenge to spur                         behalf of said team or Organization. The
                                                                                                          developers to create an app that                      Representative must meet the eligibility
                                                     The following reference is on display                provides additional recovery support to               requirements for an individual
                                                  in the Division of Dockets Management                   patients receiving outpatient                         Contestant and must be duly authorized
                                                  (see ADDRESSES) and is available for                    medication-assisted treatment for opioid              to submit on behalf of the team or
                                                  viewing by interested persons between                   use disorder.                                         Organization. The Representative
                                                  9 a.m. and 4 p.m., Monday through                         (3) What is the objective of the                    represents and warrants that: (i) He/she
                                                  Friday; it are also available                           challenge?                                            is duly authorized to act on behalf of the
                                                  electronically at http://                                 To provide support to people in                     team or Organization; and (ii) each
                                                  www.regulations.gov. FDA has verified                   recovery from opioid use disorder                     member of the team (or in the case of
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  the Web site address, as of the date this               receiving medication assisted-treatment               Organization, each participating
                                                  document publishes in the Federal                       so that they can maintain treatment and               member) has read the Official Rules and
                                                  Register, but Web sites are subject to                  achieve long-term recovery.                           agrees to abide by these Official Rules.
                                                  change over time.                                         (4) What is the intended effect of this             The Representative will ensure that
                                                  1. Meeting Materials of the Obstetrics                  action?                                               each member of the team or
                                                       and Gynecology Devices Panel                         An increase in the number of                        Organization reads, agrees to, and
                                                       (2015), available at http://                       individuals with opioid use disorders                 complies with the Official Rules.


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                                                  11580                           Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices

                                                     C. An individual may join more than                  samhsaopioidrecoveryapp.devpost.com/                  him or herself from judging a
                                                  one team or Organization, and an                        (the ‘‘Competition Web site’’) and click              Submission if the Judge, the Sponsor or
                                                  individual who is part of a team or                     ‘‘Sign Up’’ to create a Devpost account,              the Administrator considers that it is
                                                  Organization may also enter the                         or click ‘‘Log In’’ and log in with an                inappropriate, for any reason, for the
                                                  Competition on an individual basis.                     existing Devpost account. There is no                 Judge to evaluate a specific Submission
                                                     D. The following individuals, teams,                 charge for creating a Devpost account.                or group of Submissions.
                                                  and Organizations are not eligible                         (ii) After a Contestant signs up on the               C. A Contestant’s likelihood of
                                                  regardless of whether or not they meet                  Competition Web site, a confirmation                  winning will depend primarily on the
                                                  the criteria set forth above:                           email will be sent to the email address               number and quality of all of the
                                                     (i) The Sponsor, the Administrator,                  provided by the Contestant. The                       Submissions, as determined by the
                                                  and any advertising agency, contractor                  Contestant should use the confirmation                Judges using the criteria in these Official
                                                  or other organization involved with the                 email to verify their email address.                  Rules. The judging period is May 30,
                                                  design, production, promotion,                             (iii) Contestant should indicate their             2016 at 10:00 a.m. Eastern Time through
                                                  execution, or distribution of the                       agreement in participating by clicking                July 1, 2016 at 11:59 p.m. Eastern Time
                                                  Competition (collectively ‘‘Promotion                   ‘‘Register’’ on the Competition Web site              (the ‘‘Judging Period’’).
                                                  Entities’’); all employees,                             in order to receive important                            D. Criteria:
                                                  representatives and agents of such                      Competition updates.                                     Judging Criteria:
                                                  Promotion Entities; and all members of                     (iv) In the event of a dispute                        a. Quality of Idea (Includes the degree
                                                  any such employee, representative or                    pertaining to this Competition, the                   to which the proposed app can support
                                                  agent’s immediate family or household;                  authorized account holder of the email                patient recovery by addressing the
                                                     (ii) any individual involved with the                address used to sign up for the Devpost               required and optional insights, the
                                                  design, production, promotion,                          account used to enter the Submission                  creativity of the idea and the innovation
                                                  execution, or distribution of the                       will be deemed to be the Contestant (in               of the proposed app to support
                                                  Competition and each member of any                      case of an individual) and the                        recovery).
                                                  such individual’s immediate family or                   Contestant’s Representative, in the case                 b. Implementation of Idea (Includes
                                                  household;                                              of a team or Organization. The                        how well the idea was implemented
                                                     (iii) any company or individual that                 ‘‘authorized account holder’’ is the                  including the user experience, design
                                                  employs any Judge or that otherwise has                 natural person or legal entity assigned               and technical functionality).
                                                  a material business relationship or                     an email address by an Internet access                   c. Potential Impact (Includes the
                                                  affiliation with any Judge;                             provider, online service provider or                  patient value and potential impact the
                                                     (iv) any parent company, subsidiary,                 other organization responsible for                    application can have for individuals in
                                                  or other affiliate of any company                       assigning email addresses for the                     recovery).
                                                  described above.                                        domain associated with the submitted                     E. If deemed necessary by the judging
                                                     E. This Challenge falls under the                    address. Contestants generally and                    panel, each of the top five finalists may
                                                  COMPETES Act. As such, if a                             potential winners may be required to                  be asked to participate in a virtual or in-
                                                  Contestant is a federal grantee, they may               show proof of being the authorized                    person meeting with federal staff to
                                                  not use federal funds to develop                        account holder.                                       discuss their Application and
                                                  COMPETES Act challenge applications                        Amount of the Prize: 1st prize:                    demonstrate its operation. The purpose
                                                  unless consistent with the purpose of                   $15,000 cash; 2nd prize: $7,500 cash;                 of these meetings will be to further
                                                  their grant award.                                      3rd prize: $5,000 cash.                               evaluate the Contestant’s product,
                                                     F. If Contestant is a federal contractor,               Payment of the Prize: Prize payment
                                                                                                                                                                provide any additional information to
                                                  they may not use federal funds from a                   will be paid by contractor.
                                                                                                                                                                SAMHSA, and clarify any concerns or
                                                  contract to develop COMPETES Act                        Basis Upon Which Winner Will Be                       questions raised by the review panel.
                                                  challenge applications or to fund efforts               Selected                                                 F. Tie Breakers. In the event of a tie
                                                  in support of a COMPETES Act                                                                                  between two or more Submissions, the
                                                  challenge submission.                                     A. All eligible Submissions will be
                                                                                                          judged by an expert panel of impartial                panel of Judges will vote on the tied
                                                     G. For purposes hereof:                                                                                    submissions.
                                                     (i) The members of an individual’s                   judges (the ‘‘Judges’’) selected by the
                                                                                                          Sponsor. The internal panel will judge                   G. The Sponsor reserves the right, in
                                                  immediate family include such
                                                                                                          these Submissions on the criteria                     its sole discretion, to
                                                  individual’s spouse, children and step-                                                                          a. cancel, suspend, or modify the
                                                  children, parents and step-parents, and                 identified in these Official Rules to
                                                                                                          select finalist Submissions. Finalist                 Challenge, and/or
                                                  siblings and step-siblings; and                                                                                  b. not award any prizes if no
                                                     (ii) the members of an individual’s                  Submissions will then be judged by the
                                                                                                          expert judging panel determined by the                submissions are deemed worthy.
                                                  household include any other person that
                                                                                                          Sponsor. The judging panel is not                        H. All decisions made by the Sponsor
                                                  shares the same residence as such
                                                                                                          required to test the Application and may              regarding adherence to contest rules are
                                                  individual for at least three (3) months
                                                                                                          choose to judge based solely on the text              final.
                                                  out of the year.
                                                                                                          description and video provided in the                    I. All selection of contest winners is
                                                     H. A Contestant will not be deemed
                                                                                                          Submission. The Sponsor and the                       final.
                                                  ineligible because the individual or
                                                  entity used federal facilities or                       Administrator reserve the right to divide             Additional Information
                                                  consulted with federal employees                        and assign the criteria identified below
                                                                                                                                                                B. Submission
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  during a competition if the facilities and              in these Official Rules among different
                                                  employees are made available to all                     members of the internal and expert                      (i) Contestants must create a working
                                                  Contestants participating in the                        judging panels. The Sponsor and the                   software application. Apps must be
                                                  competition on an equitable basis.                      Administrator reserve the right to                    developed as either:
                                                                                                          substitute or modify the judging panel at               a. iOS or Android, as a downloadable
                                                  Registration Process for Participants                   any time for any reason.                              app.
                                                    (i) Beginning on March 4, 2016 at                       B. All Judges shall be and remain fair                Contestants can submit an app
                                                  10:00 a.m. Eastern Time, visit http://                  and impartial. Any Judge may recuse                   developed for just one operating system


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                                                                                  Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices                                            11581

                                                  (OS) but the 1st place winner must                      Administrator before the end of the                   or alterations to the Submission until
                                                  develop for both iOS and Android                        Challenge Submission Period using one                 the end of the Judging Period.
                                                  within six months of winning the prize                  of the following methods: The iOS App                 Contestants may save draft versions of
                                                     OR                                                   file registered to the reviewers unique               their Submission before entering it on
                                                     b. an HTML5 mobile web application                   device ID (UDID), the Sponsor will                    the Competition Web site.
                                                  accessible via a mobile browser (Chrome                 provide UDIDs upon request (see                          (4) The Sponsor and/or the
                                                  or Safari) on the device.                               contact info at the end of the rules                  Administrator, at their sole discretion,
                                                     (i) The 1st place winner will need to                section). For more details see: https://              may permit a Contestant to modify part
                                                  host the HTML5 mobile web app for at                    developer.apple.com/library/ios/                      of the Submission after the Competition
                                                  least 2 years from delivery of signed                   documentation/IDEs/Conceptual/                        Submission Deadline for the purpose of
                                                  affidavit by prizewinner                                AppDistributionGuide/                                 removing material that potentially
                                                     c. both a. and b. above.                             TestingYouriOSApp/                                    infringes a third party mark or right,
                                                     (ii) During the Competition                          TestingYouriOSApp.html.                               discloses personally identifiable
                                                  Submission Period, Contestant must                         OR, provide a link to the app in the               information, or is otherwise
                                                  visit the Competition Web site and                      Apple iTunes store;                                   inappropriate or deemed not relevant by
                                                  confirm that he or she has, or if                          OR contestants can use one of the                  the administrator. The modified
                                                  Contestant is a Representative, all                     following options:                                    Submission must remain substantively
                                                  members of their team or Organization                      Beta by Crashalytics You may send                  the same as the original Submission
                                                  have, read and agree to the Official                    the Administrator a beta test via                     with the only modification being what
                                                  Rules. Then, Contestant must submit its                 Crashalytics. Use the Administrator’s                 is permitted by the Sponsor and/or
                                                  Submission by providing the following                   testing email (challenges@abtassoc.com)               Administrator. Any modifications
                                                  items included in subsections a-n                       and UDID’s (Sponsor will provide                      beyond what is permitted may result in
                                                  below:                                                  UDIDs upon request) to provision a                    disqualification.
                                                     a. The name of the Application;                      build and send the Administrator a link                  (5) Applications cannot be changed
                                                     b. a brief text description (no more                 via the ‘‘Share Links’’ button. Add the               after the Competition Submission
                                                  than 350 words) of the Application and                  testing link to the Enter a Submission                Period and before the end of the Judging
                                                  how it functions; including a list of the               form under ‘‘iOS Build Link’’. Beta by                Period, unless the Contestant has
                                                  features and how they address the                       Crashalytics is a free service. Please                provided an installation file and testing
                                                  insights provided in Attachment A. If                   review the how-to for their Beta                      instructions on the Enter an Application
                                                  any additional resources have been                      Distribution tool.                                    form on the Competition Web site.
                                                  provided in the Application by the                         Diawi Send the beta file via Diawi.                   (6) Upon award the winner must
                                                  Contestant, the Contestant will submit                  After uploading your file, Diawi creates              submit a project directory with all
                                                  an Excel or .csv file with a list of all the            a unique short URL to access the                      supporting assets, such as uncompiled
                                                  additional resources that includes the                  installation page (for ex: aBcDeF). When              code, data, images, etc., belonging to the
                                                  title of the resource; the source of the                opened in Safari on the iOS device, the               application for review.
                                                  resource; and a link to the resource if                 page will display a link to install the
                                                  applicable. Additionally, if Application                application. Note that you will need to               5. Submission Requirements
                                                  uses any additional copyrighted                         include provisioning for one or more of               A. Language Requirements
                                                  material, contestant must have written                  the UDIDs the Sponsor will provide
                                                  consent to use it. The Administrator                    upon request.                                           All Submission materials must be in
                                                  and/or Sponsor reserves the right to                       i. for Web or HTML5 mobile Web: A                  English.
                                                  request additional documentation from                   link to a Web site where the application              B. Text Description, Image and Video
                                                  Contestants to verify this information.                 can be accessed free of charge;                       Requirements
                                                     c. a text description of testing                        j. step-by-step testing instructions
                                                  instructions for the app;                               including the minimum operating                          (i) The text description must describe
                                                     d. at least one image (screenshot) of                system or Web browser version required                the Application’s key features and
                                                  the working Application;                                for testing and login instructions, if a              functionality, and must outline how the
                                                     e. a link to a video uploaded to                     login is required;                                    features address the insights specified
                                                  Devpost.com and YouTube.com that                           k. the submitter type (individual,                 by the Administrator in Attachment A.
                                                  clearly demonstrates the Application’s                  team, or organization);                                  (ii) The image(s) must be photographs
                                                  functionality and features (by walking                     l. the Organization name, if the                   or screenshots of your working
                                                  through the Application);                               submitter is an Organization; and                     Application.
                                                     f. the Application platform (iOS,                       m. the Contestant Representative’s                    (iii) The video portion of the
                                                  Android, HTML5 Web);                                    phone number;                                         Submission:
                                                     g. for Android applications: The                        n. the Contestant’s email address.                    a. Should be no longer than five (5)
                                                  Android APK file and any other                             (Note that items a-n above, are                    minutes;
                                                  associated files needed to run the app or               collectively a ‘‘Submission.’’)                          b. must clearly demonstrate the
                                                  a link to the app in the Google Play                       (2) For sake of clarity, all parts of the          Application’s features and functionality,
                                                  store;                                                  Submission must be entered at the same                especially those that address the
                                                     h. for IOS applications:                             time on the Competition Web site. All                 required assets and insights; and
                                                     If your Application is available on the              Submissions must be received by no                       c. must not include music or other
                                                  iTunes App Store provide a link in the                  later than 11:59 p.m. Eastern Time on                 copyrighted material or use third party
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  ‘‘Web site URL’’ field on ‘‘Enter a                     May 27, 2016. Applications that cannot                trademarks unless the Contestant has
                                                  Submission’’ form. If you charge a fee                  be accessed for judging during the                    written permission to use such material.
                                                  for downloading your Application, you                   Judging Period will be disqualified.                     (iv) If the video is primarily
                                                  must provide a promo code.                                 (3) Once a Submission has been                     promotional rather than a
                                                     If your Application is not yet publicly              submitted and the Competition                         demonstration of the Application’s
                                                  available on the iTunes App Store, you                  Submission Period has ended, a                        functionality and features (by walking
                                                  must send a test build to the                           Contestant may not make any changes                   through the Application), the


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                                                  11582                           Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices

                                                  Submission may be disqualified at the                   period of at least one (1) year. Each                   (ii) Submissions must not attempt to
                                                  Sponsor’s and/or Administrator’s sole                   Application must be available free of                 duplicate a prior Submission already
                                                  discretion.                                             charge for testing, evaluation and use by             submitted in this Competition. Sponsor
                                                    (v) Please provide a description of                   the Competition Sponsor, Administrator                or Administrator reserves the right in its
                                                  ideas for how you could promote the                     and judges during the Competition and                 sole discretion to disqualify any
                                                  app if you are a prizewinner (350 words                 until the Judging Period ends at 11:59                Submission that is a duplicate or
                                                  max).                                                   p.m. Eastern Time on July 1, 2016. For                substantially similar to another
                                                                                                          one year following the prize                          Submission.
                                                  C. Content Requirements
                                                                                                          distribution, prize winners will be                     (iii) Submissions must be free of
                                                     (i) The Submission must only address                 required to provide to the Sponsor a                  malware. Contestant agrees that the
                                                  insights provided.                                      report of monthly data on the number of               Sponsor and the Administrator may
                                                     (ii) The Submission must include the                 app downloads.                                        conduct testing on the Application to
                                                  required information contained in the                      (viii) Contestants must acknowledge,               determine whether malware or other
                                                  INSERT ASSET FILE NAME. This                            as a prerequisite to any subsequent                   security threats may be present.
                                                  includes APIs and resources. The                        acquisition by federal contract or other              Submission not complying with these
                                                  ASSET FILE NAME will indicate                           method, they may be required to make                  requirements may be disqualified.
                                                  whether content is optional or required.                their product compliant with Section                    (iv) Each Application will be tested by
                                                  Entries may not substantially alter the                 508 accessibility and usability                       the Administrator, the Sponsor or their
                                                  meaning, intent, or otherwise                           requirements at their own expense. Any                designees. Submissions may be
                                                  misrepresent the content in whole or in                 electronic information technology that                disqualified if the Application does not
                                                  part. The intention of this clause is to                is ultimately obtained by HHS for its                 function as depicted in the video or
                                                  ensure that the integrity of the content                use, development, or maintenance must                 expressed in the text description, at the
                                                  is maintained.                                          meet Section 508 accessibility and                    Sponsor’s and/or Administrator’s sole
                                                     (iii) The Submission must target                     usability standards. Past experience has              discretion.
                                                  individuals in recovery from opioid                     demonstrated that it can be costly for                  (v) Prizewinners may be required to
                                                  misuse who are receiving outpatient                     solution-providers to ‘‘retrofit’’                    submit the source code and any relevant
                                                  medication-assisted treatment.                          solutions if remediation is later needed.             data of their Application to the
                                                     (iv) The submission features should                  The HHS Section 508 Evaluation                        Administrator and/or Sponsor upon
                                                  be designed to encourage repeat usage of                Product Assessment Template, available                request at any time.
                                                  the app.                                                at www.hhs.gov/od/vendors/index.html,                   (vi) A Contestant may submit more
                                                     (v) A Submission must not include an                 provides a useful roadmap for                         than one Submission. However, each
                                                  audio or visual performance, including                  developers to review. It is a simple,                 Submission must be unique, as
                                                  but not limited to music, dance, or other               Web-based checklist utilized by HHS                   determined by Sponsor and/or the
                                                  performing art, third-party copyrighted                 officials to allow vendors to document                Administrator in their sole discretion. If
                                                  material or trademarks, unless the                      how their products do or do not meet                  a Contestant enters two or more
                                                  Contestant has written permission to                    the various Section 508 requirements.                 Submissions that are substantially
                                                  use such material.                                         (ix) Submissions requiring approval                similar, the Sponsor and Administrator
                                                     (vi) The Submission must not use                     from a third party, such as an app store,             reserve the right to disqualify
                                                  HHS’s or SAMHSA’s logos or official                     in order to be accessible to the public,              Submissions or require the Contestant to
                                                  seals and must not claim endorsement.                   must be submitted to such third party or              choose one Submission to enter into the
                                                  D. Application Requirements                             app store for review before the end of                Competition.
                                                    In addition to the requirements                       the Competition Submission Period. For                  (vii) Submissions must not include
                                                  described above in Sections 5(A)–5(C):                  any software that is not a web or mobile              any email addresses, phone numbers,
                                                    (i) The Application must be able to be                Web Application run on a web browser                  addresses, or social security numbers in
                                                  successfully installed and capable of                   (tablet and desktop Applications),                    the Submission name, text description,
                                                  running consistently as described on the                Contestants will be required to provide               video, or images.
                                                  platform for which it is intended.                      an installation file containing the                     (viii) Contestants must not imply
                                                    (ii) Applications may be newly                        Application.                                          endorsement of their Application by the
                                                  created or existing applications                        E. General Requirements                               Sponsor in any of the Submission
                                                  modified to meet the requirements of                                                                          components or in any advertising or
                                                  the Competition.                                          (i) Submissions must not:                           media, including Web sites and app
                                                    (iii) Applications must be designed                     a. Violate any law or regulation;                   stores, featuring the Contestant’s
                                                  for use with existing modern                              b. depict hatred;                                   Application.
                                                  smartphones.                                              c. be in bad taste;                                   (ix) Submissions must: (a) Be the
                                                    (iv) Applicants using HTML5 should                      d. denigrate (or be derogatory                      original work product of the Contestant;
                                                  limit the data burden on users and                      towards) any person or group of persons               (b) be solely owned by Contestant and
                                                  where possible the submissions should                   or any race, ethnic group or culture;                 with no other person or entity having
                                                  leverage local storage and client-side                    e. threaten a specific community in                 any right or interest in it; and (c) not
                                                  cache options.                                          society, including any specific race,                 violate the Intellectual Property rights or
                                                    (v) Applications must not collect or                  ethnic group or culture;                              other rights including but not limited to
                                                                                                            f. incite violence or be likely to incite           copyright, trademark, patent, contract,
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  store personally identifiable information
                                                  (PII) or protected health information                   violence;                                             and/or privacy rights, of any other
                                                  (PHI) as defined in 45 CFR 160.103.                       g. contain vulgar or obscene language               person or entity. A Contestant may
                                                    (vi) Applications must not collect or                 or excessive violence;                                contract with a third party for technical
                                                  require input of end user email                           h. contain pornography, obscenity or                assistance to create the Submission
                                                  addresses within the Application.                       sexual activity; or                                   provided the Submission components
                                                    (vii) The Prizewinners must offer the                   i. disparage the Sponsor or                         are solely the Contestant’s work product
                                                  Application to the public for free for a                Administrator.                                        and the result of the Contestant’s ideas


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                                                                                  Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices                                              11583

                                                  and creativity, and the Contestant owns                 reviewed for suitability for use to assist            Notice showing it as either suitable/
                                                  all rights to them.                                     the homeless. The properties were                     available or suitable/unavailable.
                                                     (x) By entering a Submission,                        reviewed using information provided to                   For properties listed as suitable/
                                                  Contestant represents, warrants and                     HUD by Federal landholding agencies                   unavailable, the landholding agency has
                                                  agrees that the Submission (including,                  regarding unutilized and underutilized                decided that the property cannot be
                                                  without limitation, the Application) is                 buildings and real property controlled                declared excess or made available for
                                                  the original work of the Contestant and                 by such agencies or by GSA regarding                  use to assist the homeless, and the
                                                  complies with the Official Rules.                       its inventory of excess or surplus                    property will not be available.
                                                     Contestant further represents,                       Federal property. This Notice is also
                                                  warrants and agrees that any use of the                 published in order to comply with the                    Properties listed as unsuitable will
                                                  Submission by the Sponsor,                              December 12, 1988 Court Order in                      not be made available for any other
                                                  Administrator and/or Judges (or any of                  National Coalition for the Homeless v.                purpose for 20 days from the date of this
                                                  their respective partners, subsidiaries                 Veterans Administration, No. 88–2503–                 Notice. Homeless assistance providers
                                                  and affiliates) as authorized by these                  OG (D.D.C.).                                          interested in a review by HUD of the
                                                  Official Rules, shall not:                                 Properties reviewed are listed in this             determination of unsuitability should
                                                     a. Infringe upon, misappropriate or                  Notice according to the following                     call the toll free information line at 1–
                                                  otherwise violate any intellectual                      categories: Suitable/available, suitable/             800–927–7588 for detailed instructions
                                                  property right or proprietary right                     unavailable, and suitable/to be excess,               or write a letter to Ann Marie Oliva at
                                                  including, without limitation, any                      and unsuitable. The properties listed in              the address listed at the beginning of
                                                  statutory or common law trademark,                      the three suitable categories have been               this Notice. Included in the request for
                                                  copyright or patent, nor any privacy                    reviewed by the landholding agencies,                 review should be the property address
                                                  rights, moral rights nor any other rights               and each agency has transmitted to                    (including zip code), the date of
                                                  of any person or entity; or                             HUD: (1) Its intention to make the                    publication in the Federal Register, the
                                                     b. constitute or result in any                       property available for use to assist the              landholding agency, and the property
                                                  misappropriation or other violation of                  homeless, (2) its intention to declare the            number.
                                                  any person’s publicity rights or right of               property excess to the agency’s needs, or                For more information regarding
                                                  privacy.                                                (3) a statement of the reasons that the               particular properties identified in this
                                                                                                          property cannot be declared excess or                 Notice (i.e., acreage, floor plan, existing
                                                  Summer King,
                                                                                                          made available for use as facilities to               sanitary facilities, exact street address),
                                                  Statistician.                                                                                                 providers should contact the
                                                                                                          assist the homeless.
                                                  [FR Doc. 2016–04815 Filed 3–3–16; 8:45 am]                                                                    appropriate landholding agencies at the
                                                                                                             Properties listed as suitable/available
                                                  BILLING CODE 4162–20–P
                                                                                                          will be available exclusively for                     following addresses: GSA: Mr. Flavio
                                                                                                          homeless use for a period of 60 days                  Peres, General Services Administration,
                                                                                                          from the date of this Notice. Where                   Office of Real Property Utilization and
                                                  DEPARTMENT OF HOUSING AND                               property is described as for ‘‘off-site use           Disposal, 1800 F Street NW., Room 7040
                                                  URBAN DEVELOPMENT                                       only’’ recipients of the property will be             Washington, DC 20405, (202) 501–0084;
                                                                                                          required to relocate the building to their            NASA: Mr. Frank T. Bellinger, Facilities
                                                  [Docket No. FR–5907–N–10]
                                                                                                          own site at their own expense.                        Engineering Division, National
                                                  Federal Property Suitable as Facilities                 Homeless assistance providers                         Aeronautics & Space Administration,
                                                  To Assist the Homeless                                  interested in any such property should                Code JX, Washington, DC 20546, (202)
                                                                                                          send a written expression of interest to              358–1124; NAVY: Mr. Steve Matteo,
                                                  AGENCY:  Office of the Assistant                        HHS, addressed to: Ms. Theresa M.                     Department of the Navy, Asset
                                                  Secretary for Community Planning and                    Ritta, Chief Real Property Branch, the                Management; Division, Naval Facilities
                                                  Development, HUD.                                       Department of Health and Human                        Engineering Command, Washington
                                                  ACTION: Notice.                                         Services, Room 5B–17, Parklawn                        Navy Yard, 1330 Patterson Ave. SW.,
                                                                                                          Building, 5600 Fishers Lane, Rockville,               Suite 1000, Washington, DC 20374;
                                                  SUMMARY:    This Notice identifies                      MD 20857, (301) 443–2265 (This is not                 (202) 685–9426; (These are not toll-free
                                                  unutilized, underutilized, excess, and                  a toll-free number.) HHS will mail to the             numbers).
                                                  surplus Federal property reviewed by                    interested provider an application                      Dated: February 25, 2016.
                                                  HUD for suitability for use to assist the               packet, which will include instructions
                                                  homeless.                                                                                                     Brian P. Fitzmaurice,
                                                                                                          for completing the application. In order              Director, Division of Community Assistance,
                                                  FOR FURTHER INFORMATION CONTACT:                        to maximize the opportunity to utilize a              Office of Special Needs Assistance Programs.
                                                  Juanita Perry, Department of Housing                    suitable property, providers should
                                                  and Urban Development, 451 Seventh                      submit their written expressions of                   TITLE V, FEDERAL SURPLUS PROPERTY
                                                  Street SW., Room 7266, Washington, DC                   interest as soon as possible. For                     PROGRAM FEDERAL REGISTER REPORT
                                                  20410; telephone (202) 402–3970; TTY                                                                          FOR 03/04/2016
                                                                                                          complete details concerning the
                                                  number for the hearing- and speech-                     processing of applications, the reader is             Suitable/Available Properties
                                                  impaired (202) 708–2565 (these                          encouraged to refer to the interim rule               Land
                                                  telephone numbers are not toll-free), or                governing this program, 24 CFR part
                                                  call the toll-free Title V information line                                                                   New Jersey
                                                                                                          581.
                                                  at 800–927–7588.                                           For properties listed as suitable/to be            49 Acres
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  SUPPLEMENTARY INFORMATION: In                           excess, that property may, if                         Woodbridge Avenue
                                                                                                                                                                Edison NJ 08817
                                                  accordance with 24 CFR part 581 and                     subsequently accepted as excess by
                                                                                                                                                                Landholding Agency: GSA
                                                  section 501 of the Stewart B. McKinney                  GSA, be made available for use by the                 Property Number: 54201610006
                                                  Homeless Assistance Act (42 U.S.C.                      homeless in accordance with applicable                Status: Excess
                                                  11411), as amended, HUD is publishing                   law, subject to screening for other                   GSA Number: NJ–0944–AA
                                                  this Notice to identify Federal buildings               Federal use. At the appropriate time,                 Comments: 49 acres, contact GSA for more
                                                  and other real property that HUD has                    HUD will publish the property in a                      information.



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Document Created: 2018-02-02 15:05:19
Document Modified: 2018-02-02 15:05:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe challenge starts on March 4, 2016 10:00 a.m. ET. The challenge ends on May 27, 2016 11:59 p.m. ET.
ContactDanielle Tarino Rivkin, Health Information Technology Team, Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services, Public Health Advisor, SAMHSA/ CSAT, 5600 Fishers Lane, Rockville, MD 20857, Phone: 240.276.2857, Email: [email protected]
FR Citation81 FR 11579 

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