[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Page 17181]
[FR Doc No: 2011-7177]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: SWIFT Customer
Satisfaction Survey

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. This collection of information is necessary to determine
how satisfied applicants are with the automated staffing solution. The
information enables the FAA to improve and enhance its automated
staffing process.

DATES: Written comments should be submitted by May 27, 2011.

FOR FURTHER INFORMATION CONTACT: Carla Scott on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0699.
    Title: SWIFT Customer Satisfaction Survey.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: The information will be collected via an online form.
It is part of the automated SWIFT staffing tool. The data collected is
analyzed by Information Systems Division, AHP-100 to determine the
quality of our service to our users and customers, to address any
problems or issues found as a result of the data analysis.
    Respondents: Approximately 50,000 applicants.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 3 minutes.
    Estimated Total Annual Burden: 2,500 hours.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Scott, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on March 21, 2011.
Carla Scott,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2011-7177 Filed 3-25-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 182 (Tuesday, September 20, 2016)]
[Notices]
[Pages 64467-64470]
[FR Doc No: 2016-22550]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: The Competition begins September 20, 2016.

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

FOR FURTHER INFORMATION CONTACT: Marisa Cruz at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

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

II. Subject of Competition

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

III. Eligibility Rules for Participating in the Competition

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

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

IV. Registration Process for Participants

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

V. Submission Requirements

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

VI. Amount of the Prize

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

VII. Payment of the Prize

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

VIII. Basis Upon Which Winner Will Be Selected

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

IX. Additional Information

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

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

X. Statutory Authority To Conduct the Challenge

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

XI. References

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

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

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


[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Page 18919]
[FR Doc No: 2016-07355]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Rule 17a-8. OMB Control No. 3235-0235, SEC File No. 270-225.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange
Commission (the ``Commission'') has submitted to the Office of
Management and Budget (``OMB'') a request for extension of the
previously approved collection of information discussed below.
    Rule 17a-8 (17 CFR 270.17a-8) under the Investment Company Act of
1940 (the ``Act'') (15 U.S.C. 80a) is entitled ``Mergers of affiliated
companies.'' Rule 17a-8 exempts certain mergers and similar business
combinations (``mergers'') of affiliated registered investment
companies (``funds'') from prohibitions under section 17(a) of the Act
(15 U.S.C. 80a-17(a)) on purchases and sales between a fund and its
affiliates. The rule requires fund directors to consider certain issues
and to record their findings in board minutes. The rule requires the
directors of any fund merging with an unregistered entity to approve
procedures for the valuation of assets received from that entity. These
procedures must provide for the preparation of a report by an
independent evaluator that sets forth the fair value of each such asset
for which market quotations are not readily available. The rule also
requires a fund being acquired to obtain approval of the merger
transaction by a majority of its outstanding voting securities, except
in certain situations, and requires any surviving fund to preserve
written records describing the merger and its terms for six years after
the merger (the first two in an easily accessible place).
    The average annual burden of meeting the requirements of rule 17a-8
is estimated to be 7 hours for each fund. The Commission staff
estimates that each year approximately 766 funds rely on the rule. The
estimated total average annual burden for all respondents therefore is
5,362 hours.
    The average cost burden of preparing a report by an independent
evaluator in a merger with an unregistered entity is estimated to be
$15,000. The average net cost burden of obtaining approval of a merger
transaction by a majority of a fund's outstanding voting securities is
estimated to be $100,000. The Commission staff estimates that each year
approximately 0 mergers with unregistered entities occur and
approximately 15 funds hold shareholder votes that would not otherwise
have held a shareholder vote. The total annual cost burden of meeting
these requirements is estimated to be $1,500,000.
    The estimates of average burden hours and average cost burdens are
made solely for the purposes of the Paperwork Reduction Act, and are
not derived from a comprehensive or even a representative survey or
study. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

    Dated: March 29, 2016.
 Robert W. Errett,
 Deputy Secretary.
[FR Doc. 2016-07355 Filed 3-31-16; 8:45 am]
 BILLING CODE 8011-01-P