[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Rules and Regulations]
[Pages 6078-6082]
[FR Doc No: 2014-02121]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 121

[Docket No.: FAA-2013-1013; Amdt. No. 121-367]
RIN 2120-AK-35

Use of Additional Portable Oxygen Concentrators on Board Aircraft

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Immediately adopted final rule.

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SUMMARY: This action amends the FAA's rules for permitting use of
portable oxygen concentrator (POC) devices on board aircraft, provided
certain conditions in the SFAR are met. This action is necessary to
allow all POC devices deemed acceptable by the FAA for use in air
commerce to be available to the traveling public in need of oxygen
therapy. Passengers will be able to carry these devices on board the
aircraft and use them with the approval of the aircraft operator.

DATES: Effective February 18, 2014.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action, contact DK Deaderick, Air Transportation Division, AFS-
200, Flight Standards Service, Federal Aviation Administration, 800

Independence Avenue SW., Washington, DC 20591; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>For legal questions concerning this action,
contact Robert H. Frenzel, Manager, Operations Law Branch, Office of
the Chief Counsel, Regulations Division (AGC-220), Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Good Cause for Immediate Adoption

    Section 553 of the Administrative Procedure Act, 5 U.S.C.
553(b)(3)(B), provides that, when an agency for good cause finds that
notice and public procedure are impracticable, unnecessary, or contrary
to the public interest, the agency may issue a rule without providing
notice and an opportunity for public comment. We have determined that
there is good cause for making the rule final without prior proposal
and opportunity for comment because the issues related to the use of
POC devices on board aircraft have already been discussed as part of an
earlier rulemaking. More specifically, on July 14, 2004, the FAA issued
a notice of proposed rulemaking (NPRM) on the use of POC devices on
board aircraft (69 FR 42324). Then, on July 12, 2005, after reviewing
public comments received, the FAA published Special Federal Aviation
Regulation 106 (SFAR 106) entitled, ``Use of Certain Portable Oxygen
Concentrator Devices on Board Aircraft'' (70 FR 40156). Therefore, the
FAA has determined that notice and public comment are unnecessary.
    Moreover, pursuant to 5 U.S.C. 553(d)(3), we find that good cause
exists for making this rule effective in less than 30 days. This rule
is being made effective 15 calendar days after its publication in the
Federal Register to prevent unnecessary delay of additional POC devices
for use on board aircraft by airlines while still providing airlines
adequate notice and time to ensure the devices can be used safely on
board aircraft. We believe, based on information the Department has
received from airlines, that fifteen calendar days is sufficient amount
of time for an airline to ensure that an FAA-approved POC device does
not cause interference with avionics systems on that carrier's aircraft
and convey this information to the appropriate airline personnel in
order to accept these devices on board aircraft for use by passengers
who need medical oxygen therapy for air travel. As such, the FAA
believes that good cause exists for making this rule effective 15
calendar days after its publication in the Federal Register.

Authority for This Rulemaking

    The FAA's authority to issue rules on aviation safety is found in
Title 49 of the United States Code (U.S.C.). This rulemaking is
promulgated under the authority described in 49 U.S.C. 106(f), which
vests final authority in the Administrator for carrying out all
functions, powers, and duties of the administration relating to the
promulgation of regulations and rules, and section 44701(a)(5), which
requires the Administrator to promulgate regulations and minimum
standards for other practices, methods, and procedures necessary for
safety in air commerce and national security.

I. Overview of the Immediately Adopted Final Rule

    This action amends SFAR 106 and permits the use of additional POC
devices on board aircraft. Specifically, the FAA is adding the use of
SeQual Technologies's eQuinox (model 4000) and Oxywell (Model 4000),
and VBOX Inc.'s Trooper on the list of POC devices authorized for use
in air commerce. The FAA has reviewed these devices and accepted the
documentation provided by the manufacturer. After reviewing the
applicable Food and Drug Administration (FDA) safety standards and the
Pipeline and Hazardous Materials Safety Administration (PHMSA)
findings, the devices were determined by the FAA to be acceptable for
use in air commerce.

II. Background

A. Statement of the Problem

    When SFAR 106 was published, the FAA committed to establishing a
single performance standard for all POCs so the regulations would not
apply to specific manufacturers and models of device. Whenever
possible, the FAA tries to regulate by creating performance-based
standards. In the case of SFAR 106, the most efficient way to serve
both the passenger and the aircraft operator was to allow the use of
the devices determined to be acceptable by the FAA in SFAR 106 in a
special temporary regulation.
    As the FAA stated in the preamble discussion of the final rule that
established SFAR 106, ``while we are committed to developing a
performance-based standard for all future POCs, we do not want to
prematurely develop standards that have the effect of stifling new
technology of which we are unaware.'' The FAA developed and published
SFAR 106 so passengers who otherwise could not fly could do so with an
affordable alternative to what existed before SFAR 106 was published.
    The FAA continues to pursue the performance-based standard for all
POC devices. This process is time-consuming, and the FAA intends to
publish a notice in the Federal Register and offer the public a chance
to comment on the proposal when it is complete. In the meantime,
manufacturers continue to create new and innovative POC devices, and
manufacturers have requested that their products also be included as
acceptable POC devices in SFAR 106. SeQual Technologies, Inc. and VBOX,
Inc. have submitted requests for approval and addition to SFAR 106,
with all required documentation for their POC devices, to the FAA.

B. Related Actions

    On July 12, 2005, the FAA published SFAR 106 entitled, ``Use of
Certain Portable Oxygen Concentrator Devices Onboard Aircraft'' (70 FR
40156). SFAR 106 is the result of a notice the FAA published on July
14, 2004 (69 FR 42324) to address the needs of passengers who must
travel with medical oxygen. Before publication of SFAR 106, passengers
in need of medical oxygen during air transportation faced many
obstacles when requesting service. Many aircraft operators did not
provide medical oxygen service aboard flights, and those that did often
provided service at a price that travelers could not afford.
Coordinating service between operators and suppliers at airports was
also difficult, and passengers frequently chose not to fly because of
these difficulties.
    SFAR 106 permits passengers to carry-on and use certain POC devices
on board aircraft, if the aircraft operator ensures that the conditions
specified in the SFAR 106 for their use are met. The POC devices
initially determined acceptable for use in SFAR 106, published July 14,
2005, were AirSep Corporation's LifeStyle and Inogen, Inc.'s Inogen
One. SFAR 106 has been amended six times to allow passengers to use
additional devices.

III. Discussion of the Immediately Adopted Rule

    New medical oxygen technologies (POC devices) approved by the FDA
reduce the risks typically associated with compressed oxygen and
provide a safe alternative for passengers who need oxygen therapy.
Numerous manufacturers have developed small POC devices that work by
separating

oxygen from nitrogen and other gases contained in ambient air and
dispensing it in concentrated form to the user with an oxygen
concentration of about 90%. The POC devices operate using either
rechargeable batteries or, if the aircraft operator obtains approval
from the FAA, aircraft electrical power. Additionally, as stated in
Section 2 of SFAR 106, no covered device may contain hazardous
materials as determined by PHMSA (written documentation necessary), and
each device must also be regulated by the FDA.
    This immediately adopted amendment to SFAR 106 is adding three
additional POC devices, thus, increasing the number of options for
aircraft passengers to carry on and use on board aircraft. The FAA is
adding SeQual Technologies, Inc.'s eQuinox Oxygen System (model 4000)
and Oxywell Oxygen System (model 4000), as well as VBOX, Inc.'s Trooper
device to the list of POC devices that may be carried on and used by a
passenger on board an aircraft. Each manufacturer has included
technical specifications for their devices in each request for
approval, as well as the required documentation from PHMSA and the FDA.
    SFAR 106 is an enabling rule, which means that no aircraft operator
is required to allow passengers to operate POC devices on board. If an
aircraft operator chooses to allow a passenger to operate these
devices, SFAR 106 enables such action, provided that the SFAR 106
conditions are met.

IV. Regulatory Notices and Analyses

A. Regulatory Evaluation

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 directs that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires
agencies to analyze the economic impact of regulatory changes on small
entities. Third, the Trade Agreements Act of 1979 (Pub. L. 96-39)
prohibits agencies from setting standards that create unnecessary
obstacles to the foreign commerce of the United States. In developing
U.S. standards, this Trade Act requires agencies to consider
international standards and, where appropriate, that they be the basis
of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4) requires agencies to prepare a written assessment of
the costs, benefits, and other effects of proposed or final rules that
include a Federal mandate likely to result in the expenditure by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $100 million or more annually (adjusted for inflation with
base year of 1995). This portion of the preamble summarizes the FAA's
analysis of the economic impacts of this final rule.
    Department of Transportation Order DOT 2100.5 prescribes policies
and procedures for simplification, analysis, and review of regulations.
If the expected cost impact is so minimal that a proposed or final rule
does not warrant a full evaluation, this order permits that a statement
to that effect and the basis for it be included in the preamble if a
full regulatory evaluation of the cost and benefits is not prepared.
Such a determination has been made for this final rule. The reasoning
for this determination follows:
    This action amends SFAR 106 to allow for the use of additional POC
devices on board aircraft, provided certain conditions in the SFAR are
met. This action is necessary to allow additional POC devices deemed
acceptable by the FAA to be available to the traveling public in need
of oxygen therapy, for use in air commerce. As the rule increases the
number of acceptable POC devices on board aircraft, the rule does not
increase costs and provides additional benefits. The FAA has,
therefore, determined that this final rule is not a ``significant
regulatory action'' as defined in section 3(f) of Executive Order
12866, and is not ``significant'' as defined in DOT's Regulatory
Policies and Procedures.

B. Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation. To achieve this principle, agencies are required
to ``solicit and consider flexible regulatory proposals and to explain
the rationale for their actions to assure that such proposals are given
serious consideration.'' The RFA covers a wide-range of small entities,
including small businesses, not-for-profit organizations, and small
governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
    However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify and a regulatory flexibility analysis is not
required. The certification must include a statement providing the
factual basis for this determination, and the reasoning should be
clear.
    As this final rule enables additional POC devices to be carried on
board aircraft, the rule provides benefits at minimal costs for
passengers and minimal implementation costs for all business entities.
    Therefore, as provided in section 605(b), the head of the FAA
certifies that this rulemaking will not result in a significant
economic impact on a substantial number of small entities.

C. International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal
agencies from establishing standards or engaging in related activities
that create unnecessary obstacles to the foreign commerce of the United
States. Pursuant to these Acts, the establishment of standards is not
considered an unnecessary obstacle to the foreign commerce of the
United States, so long as the standard has a legitimate domestic
objective, such the protection of safety, and does not operate in a
manner that excludes imports that meet this objective. The statute also
requires consideration of international standards and, where
appropriate, that they be the basis for U.S. standards. The FAA has
assessed the potential effect of this immediately adopted final rule
and determined that it will have only a domestic impact and therefore
will not create unnecessary obstacles to the foreign commerce of the
United States.

D. Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(in 1995 dollars) in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant regulatory action.'' The FAA currently
uses an inflation-adjusted value of

$143.1 million in lieu of $100 million. This final rule does not
contain such a mandate; therefore, the requirements of Title II of the
Act do not apply.

E. Paperwork Reduction

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that the FAA consider the impact of paperwork and other information
collection burdens imposed on the public. According to the 1995
amendments to the Paperwork Reduction Act (5 CFR 1320.8(b)(2)(vi)), an
agency may not collect or sponsor the collection of information, nor
may it impose an information collection requirement unless it displays
a currently valid Office of Management and Budget (OMB) control number.
    Information collection requirements associated with this final rule
have been approved previously by the Office of Management and Budget
(OMB) under the provisions of the Paperwork Reduction Act of 1995 (44
U.S.C. 3507(d)) and have been assigned OMB Control Number 2120-0702.
This final rule requires that if a passenger carries a POC device on
board the aircraft with the intent to use it during the flight, he or
she must inform the pilot in command of that flight. Additionally, the
passenger who plans to use the device must provide a written statement
signed by a licensed physician that verifies the passenger's ability to
operate the device, respond to any alarms, the extent to which the
passenger must use the POC (all or a portion of the flight), and
prescribes the maximum oxygen flow rate. The Paperwork Reduction Act
paragraph in the final rule that established SFAR 106 still applies to
this amendment. The availability of a new POC device will likely
increase the availability and options for a passenger in need of oxygen
therapy, but the paperwork burden discussed in the original final rule
is unchanged. Therefore, the OMB Control Number associated with this
collection remains 2120-0702.
    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.

F. International Compatibility and Cooperation

    In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to conform to
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA has
determined that there are no ICAO Standards and Recommended Practices
that correspond to these regulations.
    Executive Order 13609, Promoting International Regulatory
Cooperation, promotes international regulatory cooperation to meet
shared challenges involving health, safety, labor, security,
environmental, and other issues and to reduce, eliminate or prevent
unnecessary differences in regulatory requirements. The FAA has
analyzed this action under the policies and agency responsibilities of
Executive Order 13609, and has determined that this action would have
no effect on international regulatory cooperation.

G. Environmental Analysis

    FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion identified in paragraph 312f and involves no extraordinary
circumstances.

V. Executive Order Determinations

A. Executive Order 13132, Federalism

    The FAA has analyzed this immediately adopted final rule under the
principles and criteria of Executive Order 13132, Federalism. The
agency determined that this action will not have a substantial direct
effect on the States, or the relationship between the Federal
Government and the States, or on the distribution of power and
responsibilities among the various levels of government, and,
therefore, does not have Federalism implications.

B. Executive Order 13211, Regulations That Significantly Affect Energy
Supply, Distribution, or Use

    The FAA analyzed this immediately adopted final rule under
Executive Order 13211, Actions Concerning Regulations that
Significantly Affect Energy Supply, Distribution, or Use (May 18,
2001). The agency has determined that it is not a ``significant energy
action'' under the executive order and it is not likely to have a
significant adverse effect on the supply, distribution, or use of
energy.

VI. How To Obtain Additional Information

A. Rulemaking Documents

    An electronic copy of a rulemaking document may be obtained by
using the Internet--
    1. Search the Federal eRulemaking Portal (http://www.regulations.gov);
    2. Visit the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/ or
    3. Access the Government Printing Office's Web page at http://www.gpo.gov/fdsys/.
    Copies may also be obtained by sending a request (identified by
notice, amendment, or docket number of this rulemaking) to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue SW., Washington, DC 20591, or by calling<PHONE_NUMBER>.

B. Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of
1996 requires FAA to comply with small entity requests for information
or advice about compliance with statutes and regulations within its
jurisdiction. A small entity with questions regarding this document,
may contact its local FAA official, or the person listed under the FOR
FURTHER INFORMATION CONTACT heading at the beginning of the preamble.
To find out more about SBREFA on the Internet, visit http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

List of Subjects in 14 CFR Part 121

    Air carriers, Aircraft, Airmen, Reporting and recordkeeping
requirements.

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends SFAR No. 106 to Chapter I of title 14, Code of
Federal Regulations as follows:

PART 121--OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL
OPERATIONS

0
1. The authority citation for part 121 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40113, 40119, 41706,
44101, 44701-44702, 44705, 44709-44711, 44713, 44716-44717, 44722,
46105.

0
2. Amend SFAR 106 by revising sections 2 and 3(a) introductory text to
read as follows:

Special Federal Aviation Regulation 106--Rules for Use of Portable
Oxygen Concentrator Systems on Board Aircraft

* * * * *
    Section 2. Definitions--For the purposes of this SFAR the following
definitions apply: Portable Oxygen

Concentrator: means the AirSep FreeStyle, AirSep LifeStyle, AirSep
Focus, AirSep Freestyle 5, Delphi RS-00400, DeVilbiss Healthcare iGo,
Inogen One, Inogen One G2, Inogen One G3, Inova Labs LifeChoice, Inova
Labs LifeChoice Activox, International Biophysics LifeChoice, Invacare
XPO2, Invacare Solo2, Oxlife Independence Oxygen Concentrator, Oxus RS-
00400, Precision Medical EasyPulse, Respironics EverGo, Respironics
SimplyGo, SeQual Eclipse, SeQual eQuinox Oxygen System (model 4000),
SeQual Oxywell Oxygen System (model 4000), SeQual SAROS and VBOX
Trooper Oxygen Concentrator medical device units as long as those
medical device units: (1) Do not contain hazardous materials as
determined by the Pipeline and Hazardous Materials Safety
Administration; (2) are also regulated by the Food and Drug
Administration; and (3) assist a user of medical oxygen under a
doctor's care. These units perform by separating oxygen from nitrogen
and other gases contained in ambient air and dispensing it in
concentrated form to the user.
    Section 3. Operating Requirements--
    (a) No person may use and no aircraft operator may allow the use of
any portable oxygen concentrator device, except the AirSep FreeStyle,
AirSep LifeStyle, AirSep Focus, AirSep FreeStyle 5, Delphi RS-00400,
DeVilbiss Healthcare iGo, Inogen One, Inogen One G2, Inogen One G3,
Inova Labs LifeChoice, Inova Labs LifeChoice Activox, International
Biophysics LifeChoice, Invacare XPO2, Invacare Solo2, Oxlife
Independence Oxygen Concentrator, Oxus RS-00400, Precision Medical
EasyPulse, Respironics EverGo, Respironics SimplyGo, SeQual Eclipse,
SeQual eQuinox Oxygen System (model 4000), SeQual Oxywell Oxygen System
(model 4000), SeQual SAROS and VBOX Trooper Portable Oxygen
Concentrator units. These units may be carried on and used by a
passenger on board an aircraft provided the aircraft operator ensures
that the following conditions are satisfied:
* * * * *

    Issued under authority provided by 49 U.S.C. 106(f) and
44701(a)(5) in Washington, DC, on December 23, 2013.
Michael P. Huerta,
Administrator.
[FR Doc. 2014-02121 Filed 1-31-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 101 (Wednesday, May 25, 2016)]
[Notices]
[Pages 33283-33284]
[FR Doc No: 2016-12396]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77876; File No. SR-MIAX-2016-08]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Order Granting Approval of Proposed Rule Change to Amend
the Exchange's Amended and Restated By-Laws Relating to the Removal of
a Board Restriction

May 20, 2016.

I. Introduction

    On March 29, 2016, Miami International Securities Exchange LLC (the
``Exchange'' or ``MIAX'') filed with the Securities and Exchange
Commission (the ``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934

(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
amend the Exchange's Amended and Restated By-Laws (``By-Laws'') in
order to remove a restriction prohibiting a Director, Observer or
committee member of the Exchange's Board of Directors (``Board'') from
simultaneously serving as a member of the governing body of a
competitor. The proposed rule change was published for comment in the
Federal Register on April 8, 2016.\3\ The Commission received no
comments on the proposed rule change. This order approves the proposed
rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 77507 (April 4,
2016), 81 FR 20716 (April 8, 2016) (``Notice'').
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II. Description of the Proposed Rule Change

    Currently, the By-Laws restrict an individual who is a Director,\4\
Observer,\5\ or committee member of the Exchange from also serving as a
member of the board of directors or similar governing body of a
``Specified Entity.'' The term ``Specified Entity'' generally refers to
any U.S. securities option exchange (or facility thereof) or U.S.
alternative trading system on which securities options are traded which
competes with the Exchange.\6\ The By-Laws specify that upon any
individual who is a Director, Observer, or committee member of the
Exchange becoming a member of the board of directors or similar
governing body of a Specified Entity, such individual immediately would
cease being a Director, Observer or committee member, as applicable, of
the Board (``Board Restriction'').\7\
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    \4\ The term ``Director'' means the persons elected or appointed
to the Board from time to time in accordance with the LLC Agreement
of the Exchange and the By-Laws in their capacity as managers of the
Exchange. See By-Laws, Article I (j).
    \5\ The term ``Observer'' means a person invited to attend
meetings of the Board in a nonvoting observer capacity as further
described in Article II, Section 2.2(g)(i)-(iii) of the By-Laws. See
By-Laws, Article II, Section 2.2(g).
    \6\ Specifically, the term ``Specified Entity'' is defined in
the By-Laws to mean (i) any U.S. securities option exchange (or
facility thereof) or U.S. alternative trading system on which
securities options are traded (other than the Exchange or any of its
affiliates) that lists for trading any option contract that competes
with an Exchange Contract, (ii) any person that owns or controls
such U.S. securities option exchange or U.S. alternative trading
system, and (iii) any affiliate of a person described in clause (i)
or (ii) above. See By-Laws, Article I (oo).
    \7\ The Board Restriction was adopted by the Exchange in 2014.
See Securities Exchange Act Release Nos. 71172 (December 23, 2013),
78 FR 79530 (December 30, 2013); and 71541 (February 12, 2014), 79
FR 9572 (February 19, 2014) (SR-MIAX-2013-58).
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    The Exchange states that the Board Restriction was added to the By-
Laws in connection with the Equity Rights Program (``ERP''),\8\ and was
intended to prevent potential conflicts of interest that might arise
due to an Exchange Director, Observer or committee member also serving
a similar role on the governing body of a competitor.\9\ As more fully
described in the Notice, the Exchange now proposes to amend the By-Laws
to eliminate the Board Restriction.\10\ The Exchange states that it has
found the Board Restriction to be unnecessarily restrictive, that it
unduly limits the availability of qualified candidates from serving on
the Exchange Board (or other governing body), and that the potential
conflicts of interest that the restriction was designed to address can
be more effectively and more efficiently addressed by other means.\11\
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    \8\ Pursuant to the ERP, units representing the right to acquire
equity in the Exchange's parent holding company, Miami International
Holdings, Inc., were issued to participating Members in exchange for
payment of an initial purchase price or the prepayment of certain
transaction fees and the achievement of certain liquidity addition
volume thresholds on the Exchange over a fixed period of time. The
By-Laws were also then amended to incorporate rights granted to
Members participating in the ERP to appoint representation on the
MIAX Board. See Securities Exchange Act Release No. 70498 (September
25, 2013), 78 FR 60348 (October 1, 2013) (SR-MIAX-2013-43) and
Securities Exchange Act Release No. 71172 (December 23, 2013), 78 FR
79530 (December 30, 2013) (SR-MIAX-2013-58).
    \9\ See Notice, supra note 3, at 20717.
    \10\ Specifically, the Exchange proposes to remove the last
sentence of Article II, Section 2.2(d), Article II, Section
2.2(g)(ii), and Article IV, Section 4.2(b) regarding the Board
Restriction, and remove the defined terms ``Exchange Contract'' and
``Specified Entity,'' set forth in Article I (p) and (oo),
respectively, which are used only in connection with the Board
Restriction. See Notice, supra note 3, at 20717-18.
    \11\ See Notice, supra note 3, at 20717.
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III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange
and, in particular, with Section 6(b) of the Act.\12\ In particular,
the Commission finds that the proposal is consistent with Section
6(b)(1) of the Act,\13\ which requires that an exchange be organized
and have the capacity to be able to carry out the purposes of the Act
and to comply, and to enforce compliance by its members and persons
associated with its members, with the provisions of the Act, the rules
and regulations thereunder, and the rules of the Exchange.
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    \12\ 15 U.S.C. 78f(b). In approving this proposed rule change,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \13\ 15 U.S.C. 78f(b)(1).
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    The Exchange represents that its proposed removal of the Board
Restriction from the By-Laws is designed to enable MIAX to engage the
best suited and most qualified leaders to serve in the capacity of
Director, Observer or committee member of the Exchange and will
facilitate a Board structure and composition that will strengthen the
Exchange's ability to comply with the provisions of the Act and enforce
compliance by its members with the provisions of the Act. The Exchange
also notes that most of its competing option exchanges do not restrict
their board members from sitting on the board of directors or other
governing body of another options exchange.\14\ Further, the Commission
notes that it has previously considered and approved the Exchange's
Board structure without the Board Restriction, and determined that the
Exchange's governance provisions were designed to enable the Exchange
to carry out its functions and responsibilities under the Act.\15\ For
these reasons, the Commission finds that the proposed rule change is
consistent with the Act.
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    \14\ See Notice, supra note 3, at 20717.
    \15\ See Securities Exchange Act Release No. 68341 (December 3,
2012), 77 FR 73065, 73070 (December 7, 2012) (File No. 10-207)
(order approving MIAX's application for registration as a national
securities exchange).
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IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\16\ that the proposed rule change (SR-MIAX-2016-08) be, and hereby
is, approved.
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    \16\ 15 U.S.C. 78f(b)(2).
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    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

    \17\ 17 CFR 200.30-3(a)(12).

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-12396 Filed 5-24-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Notices]
[Pages 15848-15850]
[FR Doc No: 2018-07545]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1030]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Allergen
Labeling and Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 14,
2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0792.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD

20852,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Food Allergen Labeling and Reporting

OMB Control Number 0910-0792--Extension

    This information collection supports third-party disclosure
requirements of food allergen labeling, as well as the reporting
associated with the submission of petitions and notifications seeking
exemptions from the labeling requirements for ingredients derived from
major food allergens under section 403(w)(6) and (7) of the FD&C Act
(21 U.S.C. 343(w)(6) and (7)). The Food Allergen Labeling and Consumer
Protection Act of 2004 (FALCPA) (Title II, Pub. L. 108-282) amended the
FD&C Act by defining the term ``major food allergen'' and stating that
foods regulated under the FD&C Act are misbranded unless they declare
the presence of each major food allergen on the product label using the
name of the food source from which the major food allergen is derived.
Section 403(w)(1) of the FD&C Act sets forth the requirements for
declaring the presence of each major food allergen on the product
label. Section 201(qq) of the FD&C Act (21 U.S.C. 321(qq)) defines a
major food allergen as ``[m]ilk, egg, fish (e.g., bass, flounder, or
cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts
(e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans'' and
also as a food ingredient that contains protein derived from such
foods. The definition excludes any highly refined oil derived from a
major food allergen and any ingredient derived from such highly refined
oil.
    In some cases, the production of an ingredient derived from a major
food allergen may alter or eliminate the allergenic proteins in that
derived ingredient to such an extent that it does not contain
allergenic protein. In addition, a major food allergen may be used as
an ingredient or as a component of an ingredient such that the level of
allergenic protein in finished food products does not cause an allergic
response that poses a risk to human health. Therefore, FALCPA provides
two mechanisms through which such ingredients may become exempt from
the labeling requirement of section 403(w)(1) of the FD&C Act. An
ingredient may obtain an exemption through submission and approval of a
petition containing scientific evidence that demonstrates that the
ingredient ``does not cause an allergic response that poses a risk to
human health'' (section 403(w)(6) of the FD&C Act). Alternately, an
ingredient may become exempt through submission of a notification
containing scientific evidence showing that the ingredient ``does not
contain allergenic protein'' or that there has been a previous
determination through a premarket approval process under section 409 of
the FD&C Act (21 U.S.C. 348) that the ingredient ``does not cause an
allergic response that poses a risk to human health'' (section
403(w)(7) of the FD&C Act).

A. Third-Party Disclosure

    The labeling requirements of section 403(w)(1) of the FD&C Act
apply to all packaged foods sold in the United States that are
regulated under the FD&C Act, including both domestically manufactured
and imported foods. As noted, section 403(w)(1) of the FD&C Act
requires that the label of a food product declare the presence of each
major food allergen. We estimate the information collection burden of
the third-party disclosure associated with food allergen labeling under
section 403(w)(1) of the FD&C Act as the time needed for a manufacturer
to review the labels of new or reformulated products for compliance
with the requirements of section 403(w)(1) of the FD&C Act and the time
needed to make any needed modifications to the labels of those
products.
    The primary user of the allergen information disclosed on the label
or labeling of food products is the consumer that purchases the food
product. Consumers will use the information to help them make choices
concerning their purchase of a food product, including choices related
to substances that the consumer wishes to avoid due to their potential
to cause adverse reactions. Additionally, we intend to use the
information to determine whether a manufacturer or other supplier of
food products is meeting its statutory obligations. Failure of a
manufacturer or other supplier of food products to label its products
in compliance with section 403(w)(1) of the FD&C Act may result in a
product being misbranded under the FD&C Act and the manufacturer or
packer and the product subject to regulatory action.

B. Reporting

    Under section 403(w)(6) and (7) of the FD&C Act, interested parties
may request from us a determination that an ingredient is exempt from
the labeling requirement of section 403(w)(1) of the FD&C Act. An
ingredient may obtain an exemption through submission and approval of a
petition containing scientific evidence that demonstrates that the
ingredient ``does not cause an allergic response that poses a risk to
human health'' (section 403(w)(6) of the FD&C Act). This section also
states that the burden shall be on the petitioner to provide scientific
evidence (including the analytical method used to produce the evidence)
that demonstrates that such food ingredient, as derived by the method
specified in the petition, does not cause an allergic response that
poses a risk to human health. Alternately, an ingredient may become
exempt through submission of a notification containing scientific
evidence showing that the ingredient ``does not contain allergenic
protein'' or that there has been a previous determination through a
premarket approval process under section 409 of the FD&C Act that the
ingredient ``does not cause an allergic response that poses a risk to
human health'' (section 403(w)(7) of the FD&C Act).
    Our document entitled ``Food Allergen Labeling Exemption Petitions
and Notifications: Guidance for Industry,'' sets forth our
recommendations with regard to the information that an interested party
should submit in such a petition or notification. The guidance states
that to evaluate these petitions and notifications, we will consider
scientific evidence that describes: (1) The identity or composition of
the ingredient; (2) the methods used to produce the ingredient; (3) the
methods used to characterize the ingredient; (4) the intended use of
the ingredient in food; and (5) either (a) for a petition--data and
information, including the expected level of consumer exposure to the
ingredient, that demonstrate that the ingredient, when manufactured and
used as described, does not cause an allergic response that poses a
risk to human health; or (b) for a notification, data and information
that demonstrate that the ingredient, when manufactured as described,
does not contain allergenic protein, or documentation of a previous
determination under a process under section 409 of the FD&C Act that
the ingredient does not cause an allergic response that poses a risk to
human health.
    We use information submitted in petitions and notifications to
determine whether the ingredient satisfies the criteria of section
403(w)(6) and (7) of the FD&C Act for granting the exemption.
    In the Federal Register of December 12, 2017 (82 FR 58407), we
published a

60-day notice inviting public comment on the proposed extension of this
collection of information. One comment was received that expressed
support for the information collection but did not otherwise respond to
the topics solicited, nor did the comment suggest we revise our burden
estimate. We therefore retain the currently approved estimate of the
associated burden for the information collection, which is as follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual       Average
    FD&C act section/activity       respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
----------------------------------------------------------------------------------------------------------------
403(w)(1); review labels for              77,500               1          77,500               1          77,500
 compliance with food allergen
 labeling requirements..........
403(w)(1); redesign labels to              3,875               1           3,875              16          62,000
 comply with food allergen
 labeling requirements..........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         139,500
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Using a labeling cost model to estimate the number of new or
reformulated products sold in the United States, annually, that are
affected by the requirements of section 403(w)(1) of the FD&C Act, we
estimate there are 690,000 Universal Product Codes (UPCs) of FDA-
regulated foods and approximately 85,000 UPCs of FDA-regulated dietary
supplements for a total of 775,000 UPCs. We assume an annual entry rate
of 10 percent for new or reformulated UPCs (77,500), and assume 5
percent of labels may be redesigned (3,875). We estimate an average
burden for the review of labels for compliance with the food allergen
labeling requirements under section 403(w)(1) of the FD&C Act to be 1
hour, and we estimate 16 hours for the redesign of a label. Together we
estimate a total annual hourly burden of 139,500 in third-party
disclosure.

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    FD&C act section/activity        Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
403(w)(6); petition for                        5               1               5             100             500
 exemption......................
403(w)(7); notification.........               5               1               5              68             340
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             840
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on the number of petitions and notifications received in
recent years, we assume that we will receive five petitions and five
notifications annually, over the next 3 years. Assuming an association
of one respondent to each petition or notification, we estimate that
five respondents will each submit one petition and five respondents
will each submit one notification, as reported in table 2, rows 1 and
2.
    We base our estimate of the average burdens per response reported
in table 2 on our experience with other petition processes. We estimate
that a petition would take, on average, 100 hours to develop and
submit. Therefore, we estimate that the burden associated with
petitions will be 500 hours annually (5 petitions x 100 hours per
petition).
    The burden of a notification involves collecting documentation that
a food ingredient does not pose an allergen risk. Either we can make a
determination that the ingredient does not cause an allergic response
that poses a risk to human health under a premarket approval or
notification program under section 409 of the FD&C Act, or the
respondent would submit scientific evidence demonstrating that the
ingredient when manufactured as described does not contain allergenic
protein. We estimate that it would take a respondent 20 hours to
prepare and submit a notification based on our determination under a
process under section 409 of the FD&C Act that the ingredient does not
cause an allergic response. We estimate that it would take a respondent
approximately 100 hours to prepare a notification submitting scientific
evidence (including the analytical method used) that demonstrates that
the food ingredient (as derived by the method specified in the
notification, where applicable) does not contain allergenic protein. We
have no data on how many notifications would be based on our
determination that the ingredient does not cause an allergic response
or based on scientific evidence that demonstrates that the food
ingredient does not contain allergenic protein. Therefore, we estimate
that three of the five notifications would be based on scientific
evidence, and two of the five notifications would be based on our
determination. The average time per notification is then estimated to
be 68 hours (2 x 20 hours + 3 x 100 hours)/5). Therefore, we estimate
that the burden associated with notifications will be 340 hours
annually (5 notifications x 68 hours per notification), as reported in
table 2. The burden estimate has not increased since the initial OMB
approval.

    Dated: April 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07545 Filed 4-11-18; 8:45 am]
 BILLING CODE 4164-01-P