			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on October 20, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST 1997-2073

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  AVIACION COMERCIAL de AMERICA, S.A. de C.V.
    Date Filed:  September 24, 2004

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to continue to conduct passenger charter operations between
Mexico and the United States, and other passenger charters in accordance
with 14 CFR Part 212, using small equipment (see below).

If renewal, date and citation of last action:  October 20, 2003, in this
Docket.

Applicant representative:  Michelle C. Pardo,<PHONE_NUMBER>       DOT
analyst:  Allen Brown,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved
                                            Action date:  October 20,
2004

Effective dates of authority granted:  October 20, 2004, through October
20, 2005

Basis for approval:  United States-Mexico Air Transport Services
Agreement (Agreement).

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:  Standard exemption
conditions (attached).

Special conditions/Remarks:  In the conduct of these operations, the
carrier must adhere to all applicable provisions of the U.S.-Mexico
Agreement.  In the conduct of these operations, the carrier may only use
aircraft capable of carrying no more than 60 passengers and having a
maximum payload capacity of no more than 18,000 pounds (small
equipment).  The above grant includes authority to operate Third and
Fourth Freedom charters.  While we have subjected, consistent with the
provisions of the Agreement, Mexican carriers conducting charter
operations with large aircraft to prior approval or submission of notice
for their Third and Fourth Freedom charters, we determined that any such
requirement was not necessary on public interest grounds in this case of
this carrier, since the carrier will be conducting these operations
solely with small aircraft.  (Other charter operations to/from the
United States under this authority, however, are subject to prior
approval under 14 CFR Part 212.)  Further, we are continuing to allow
Mexican carriers conducting passenger charters using small equipment to
make stopovers in the United States in the conduct of such operations.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

FOREIGN CARRIER EXEMPTION CONDITIONS
                               ATTACHMENT

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

1) Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

2) Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Trans- portation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

3) Comply with the requirements for minimum insurance coverage contained
in 14 CFR Part 205, and, prior to the commencement of any operations
under this authority, file evidence of such coverage, in the form of a
completed OST Form 6411, with the Federal Aviation Administration’s
Program Management Branch (AFS-260), Flight Standards Service (any
changes to, or termination of, insurance also shall be filed with that
office);

4) Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

5) Conform to the airworthiness and airman competency requirements of
its Government for international air services;

6) Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

7) Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: a) based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term “international air transportation” means “international
transportation” as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

9) Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department’s
rules governing charters (including 14 CFR Parts 212 and 380); and

11) Comply with such other reasonable terms, conditions, and limitations
required by the public interest as may be prescribed by the Department,
with all applicable orders or regulations of other U.S. agencies and
courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

         05/2004


[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Proposed Rules]
[Pages 39382-39384]
[FR Doc No: 2018-16638]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0694; Directorate Identifier 2016-SW-068-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Airbus Helicopters Model EC225LP helicopters. This proposed AD would
require repetitive inspections of each life raft inflation cylinder
percussion system bellcrank (bellcrank). This proposed AD is prompted
by reports of jammed bellcranks. The actions of this proposed AD are
intended to prevent an unsafe condition on these products.

DATES: We must receive comments on this proposed AD by October 9, 2018.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0694; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this proposed AD, the European Aviation Safety Agency (EASA) AD, the
economic evaluation, any comments received, and other information. The
street address for Docket Operations (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.
    For service information identified in this proposed rule, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
http://www.helicopters .airbus.com/website/en/ref/Technical-
Support_73.html. You may review the referenced service information at
the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: David Hatfield, Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy

of written comments, or if comments are filed electronically,
commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2016-0200, dated October 11,
2016 (AD 2016-0200), to correct an unsafe condition for Airbus
Helicopters Model EC 225 LP helicopters. EASA advises of a report of
the left-hand and right-hand bellcranks becoming jammed. EASA states an
investigation determined the bellcranks were jammed by the accumulation
of a foreign coating material in the bellcrank hole. EASA further
states that investigation of an additional incident of a jammed
bellcrank determined that corrosion in the bellcrank hole caused the
jam. This condition, according to EASA, could result in failure of the
life rafts to release in an emergency and subsequent injury to
occupants during an otherwise survivable accident. To address this,
EASA AD 2016-0200 requires repetitive cleaning and lubrication of each
bellcrank and pivot link.

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
its AD. We are proposing this AD because we evaluated all known
relevant information and determined that an unsafe condition is likely
to exist or develop on other helicopters of the same type design.

Related Service Information

    We reviewed Airbus Helicopters Emergency Alert Service Bulletin No.
05A050, Revision 0, dated July 22, 2016, which contains procedures for
cleaning and lubricating each bellcrank and pivot link of the life raft
inflation cylinder percussion system and removing any corrosion if
necessary.

Proposed AD Requirements

    This proposed AD would require, before further flight and
thereafter at intervals not exceeding 6 months, cleaning and
lubricating each bellcrank and pivot link.

Costs of Compliance

    We estimate that this proposed AD would affect 5 helicopters of
U.S. Registry.
    At an average labor rate of $85 per work-hour, we estimate that
operators may incur the following costs in order to comply with this
AD. Cleaning and lubricating both bellcranks and pivot links would
require about 16 work-hours, and required materials costs would be
minimal, for a cost of $1,360 per helicopter and $6,800 for the U.S.
fleet per inspection cycle.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):
Airbus Helicopters: Docket No. FAA-2018-0694; Product Identifier
2016-SW-068-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Model EC225 LP helicopters
with a life raft installed, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a jammed bellcrank in a
life raft jettison inflation cylinder percussion system (bellcrank).
This condition could result in failure of a life raft to release in
an emergency and subsequent injury to occupants.

(c) Comments Due Date

    We must receive comments by October 9, 2018.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

 (e) Required Actions

    Before further flight, and thereafter at intervals not to exceed
6 months:
    (1) Clean each bellcrank and pivot link and inspect each
bellcrank hole for corrosion. If there is any corrosion in a
bellcrank hole:
    (i) Remove the corrosion without exceeding a maximum depth of
0.1 millimeter (0.004 inch).
    (ii) Clean each pivot link using 400-grain abrasive paper.
    (iii) Apply corrosion protectant (Alodine 1200 or equivalent) to
each bellcrank hole.
    (2) Lubricate each bellcrank hole with grease before assembling
the bellcrank.

 (f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, FAA, may approve
AMOCs for this AD. Send your proposal to: David Hatfield, Aviation
Safety Engineer, Safety Management Section, Rotorcraft Standards
Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone
(817) 222-5110; email [email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) Airbus Helicopters Emergency Alert Service Bulletin No.
05A050, Revision 0, dated July 22, 2016, which is not incorporated
by reference, contains additional information about the subject of
this AD. For service information identified in this AD, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or
at http://www.helicopters.airbus.com/website/en/ref/Technical-
Support_73.html. You may review the referenced service information
at the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (EASA) AD No. 2016-0200, dated October 11, 2016. You
may view the EASA AD on the internet at http://www.regulations.gov
in the AD Docket.

 (h) Subject

    Joint Aircraft Service Component (JASC) Code: 2564 Life Raft.

    Issued in Fort Worth, Texas, on July 23, 2018.
Scott A. Horn,
Deputy Director for Regulatory Operations, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2018-16638 Filed 8-8-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 76 (Thursday, April 19, 2018)]
[Notices]
[Pages 17467-17472]
[FR Doc No: 2018-08155]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83048; File No. SR-IEX-2018-07]

Self-Regulatory Organizations; Investors Exchange LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Rule 11.190(g) To Incrementally Optimize and Enhance the Effectiveness
of the Quote Instability Calculation in Determining Whether a Crumbling
Quote Exists

April 13, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 3, 2018, the Investors Exchange LLC (``IEX'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and
II, below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Pursuant to the provisions of Section 19(b)(1) under the Act,\3\
and Rule 19b-4 thereunder,\4\ IEX is filing with the Commission a
proposed rule change to amend Rule 11.190(g) to incrementally optimize
and enhance the effectiveness of the quote instability calculation in
determining whether a crumbling quote exists. The Exchange has
designated this proposal as non-controversial and

provided the Commission with the notice required by Rule 19b-
4(f)(6)(iii) under the Act.\5\
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78s(b)(1).
    \4\ 17 CFR 240.19b-4.
    \5\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
website at www.iextrading.com, at the principal office of the Exchange,
and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of and basis for the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statement [sic] may be examined
at the places specified in Item IV below. The self-regulatory
organization has prepared summaries, set forth in Sections A, B, and C
below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
Overview
    The purpose of the proposed rule change is to amend Rule 11.190(g)
to incrementally optimize and enhance the effectiveness of the quote
instability calculation in determining whether a crumbling quote
exists. The Exchange utilizes real time relative quoting activity of
certain Protected Quotations \6\ and a proprietary mathematical
calculation (the ``quote instability calculation'') to assess the
probability of an imminent change to the current Protected NBB to a
lower price or Protected NBO to a higher price for a particular
security (``quote instability factor''). When the quoting activity
meets predefined criteria and the quote instability factor calculated
is greater than the Exchange's defined quote instability threshold, the
System treats the quote as unstable and the crumbling quote indicator
(``CQI'') is on at that price level for two milliseconds. During all
other times, the quote is considered stable, and the CQI is off. The
System independently assesses the stability of the Protected NBB and
Protected NBO for each security.
---------------------------------------------------------------------------

    \6\ Pursuant to Rule 11.190(g), the Protected Quotations of the
New York Stock Exchange, Nasdaq Stock Market, NYSE Arca, Nasdaq BX,
Bats BZX Exchange, Bats BYX Exchange, Bats EDGX Exchange, and Bats
EDGA Exchange.
---------------------------------------------------------------------------

    When CQI is on, Discretionary Peg orders \7\ and primary peg orders
\8\ do not exercise price discretion to meet the limit price of an
active (i.e., taking) order. Specifically, as set forth in Rule
11.190(b)(10), a Discretionary Peg order pegs to the less aggressive of
the primary quote (i.e., NBB for buy orders and NBO for sell orders) or
the order's limit price, if any, but, will exercise price discretion in
order to meet the limit price of an active order up to the less
aggressive of the Midpoint Price or the order's limit price, if any.
However, a Discretionary Peg order will not exercise such price
discretion when the CQI is on. Similarly, as set forth in Rule
11.190(b)(8), a primary peg order pegs to a price that is the less
aggressive of one (1) minimum price variant (``MPV'') less aggressive
than the primary quote (i.e., one MPV below (above) the NBB (NBO) for
buy (sell) orders) or the order's limit price, if any, but will
exercise price discretion in order to meet the limit price of an active
order up to the NBB (for buy orders) or down to the NBO (for sell
orders), except when the CQI is on or if the order is resting at its
limit price, if any.
---------------------------------------------------------------------------

    \7\ See Rule 11.190(b)(10).
    \8\ See Rule 11.190(b)(8).
---------------------------------------------------------------------------

    In addition, when the CQI is on buy (sell) orders that take
liquidity at prices at or below (above) the NBO (NBB) are subject to
the Crumbling Quote Remove Fee (``CQRF'') for executions that exceed
the CQRF Threshold.
Discretionary Peg Order
    The manner in which Discretionary Peg orders operate is described
in Rule 11.190(b)(10). Specifically, a Discretionary Peg order is a
non-displayed, pegged order that upon entry into the System, the price
of the order is automatically adjusted by the System to be equal to the
less aggressive of the Midpoint Price or the order's limit price, if
any. When unexecuted shares of such order are posted to the Order Book,
the price of the order is automatically adjusted by the System to be
equal to and ranked at the less aggressive of the primary quote or the
order's limit price and is automatically adjusted by the System in
response to changes in the NBB (NBO) for buy (sell) orders up (down) to
the order's limit price, if any. In order to meet the limit price of
active orders on the Order Book, a Discretionary Peg order will
exercise the least amount of price discretion necessary from the
Discretionary Peg order's resting price to its discretionary price
(defined as the less aggressive of the Midpoint Price or the
Discretionary Peg order's limit price, if any), except during periods
of quote instability (i.e., when a crumbling quote exists) as defined
in paragraph Rule 11.190(g).
Primary Peg Orders
    The manner in which primary peg orders operate is described in
Rules 11.190(a)(3) and 11.190(b)(8). Specifically, a primary peg order
is a non-displayed, pegged order that upon entry and when posting to
the Order Book the price of the order is automatically adjusted by the
System to be equal to and ranked at the less aggressive of one (1) MPV
less aggressive than the primary quote (i.e., the NBB for buy orders
and the NBO for sell orders) or the order's limit price, if any. While
resting on the Order Book, the order is automatically adjusted by the
System in response to changes in the NBB (NBO) for buy (sell) orders up
(down) to the order's limit price, if any. In order to meet the limit
price of active orders on the Order Book a primary peg order will
exercise price discretion to its discretionary [sic] (defined as the
primary quote), except during periods of quote instability as defined
in paragraph 11.190(g).
CQRF
    The CQRF is designed to incentivize resting liquidity, including
displayed liquidity, on IEX, and is applicable to orders that remove
resting liquidity when the CQI is on if such orders constitute at least
5% of the Member's volume executed on IEX and at least 1,000,000
shares, on a monthly basis, measured on a per market participant
identifier (``MPID'') basis. Thus, orders that exceed the 5% and
1,000,000 share thresholds are assessed a fee of $0.0030 per each
incremental share executed (or 0.3% of the total dollar value of the
transaction for securities priced below $1.00) that exceeds the
threshold.
Crumbling Quote Calculation
    In determining whether a crumbling quote exists, the Exchange
utilizes real time relative quoting activity of certain Protected
Quotations and a proprietary mathematical calculation (the ``quote
instability calculation'') to assess the probability of an imminent
change to the current Protected NBB to a lower price or Protected NBO
to a higher price for a particular security (``quote instability
factor''). When the quoting activity meets predefined criteria and the
quote instability factor calculated is greater than the Exchange's
defined threshold (``quote instability threshold''), the System treats
the quote as not stable (``quote instability'' or a ``crumbling
quote''). During all other times, the quote is considered stable

(``quote stability''). The System independently assesses the stability
of the Protected NBB and Protected NBO for each security.
    When the System determines that a quote, either the Protected NBB
or the Protected NBO, is unstable, the determination remains in effect
at that price level for two (2) milliseconds. The System will only
treat one side of the Protected NBBO as unstable in a particular
security at any given time.\9\ By not permitting resting Discretionary
Peg orders and primary peg orders to exercise price discretion during
periods of quote instability, the Exchange is designed to protect such
orders from unfavorable executions when its probabilistic model
identifies that the market appears to be moving adversely to them.
Similarly, the CQRF is designed to protect liquidity providing orders
by disincentivizing trading strategies that target resting liquidity
during periods of quote instability seeking to trade at prices that are
about to become stale.
---------------------------------------------------------------------------

    \9\ See, Rule 11.190(g).
---------------------------------------------------------------------------

    Quote stability or instability (also referred to as a crumbling
quote) is an assessment that the Exchange System makes on a real-time
basis, based on a pre-determined, objective set of conditions specified
in Rule 11.190(g)(1). Specifically, quote instability, or the presence
of a crumbling quote, is determined by the System when:
    (A) the quote instability factor result from the quote stability
calculation is greater than the defined quote instability threshold.
    (i) Quote Instability Factor. The Exchange's proprietary quote
stability calculation used to determine the current quote instability
factor is defined by the following formula that utilizes the quote
stability coefficients and quote stability variables defined below:

1/(1 + e [supcaret] -(C0 + C1 * N + C2
* F + C3 * NC + C4 * FC + C5 * EPos +
C6 * ENeg + C7 * EPosPrev + C8 *
ENegPrev + C9 * Delta))

(a) Quote Stability Coefficients. The Exchange utilizes the values
below for the quote stability coefficients.

(1) C0 = -1.2867
(2) C1 = -0.7030
(3) C2 = 0.0143
(4) C3 = -0.2170
(5) C4 = 0.1526
(6) C5 = -0.4771
(7) C6 = 0.8703
(8) C7 = 0.1830
(9) C8 = 0.5122
(10) C9 = 0.4645

(b) Quote Stability Variables. The Exchange utilizes the quote
stability variables defined below to calculate the current quote
instability factor.

(1) N = the number of Protected Quotations on the near side of the
market, i.e. Protected NBB for buy orders and Protected NBO for sell
orders.
(2) F = the number of Protected Quotations on the far side of the
market, i.e. Protected NBO for buy orders and Protected NBB for sell
orders.
(3) NC = the number of Protected Quotations on the near side of the
market minus the maximum number of Protected Quotations on the near
side at any point since one (1) millisecond ago or the most recent
PBBO change, whichever happened more recently.
(4) FC = the number of Protected Quotations on the far side of the
market minus the minimum number of Protected Quotations on the far
side at any point since one (1) millisecond ago or the most recent
PBBO change, whichever happened more recently.
(5) EPos = a Boolean indicator that equals 1 if the most recent
quotation update was a quotation of a protected market joining the
near side of the market at the same price.
(6) ENeg = a Boolean indicator that equals 1 if the most recent
quotation update was a quotation of a protected market moving away
from the near side of market that was previously at the same price.
(7) EPosPrev = a Boolean indicator that equals 1 if the second most
recent quotation update was a quotation of a protected market
joining the near side of the market at the same price AND the second
most recent quotation update occurred since one (1) millisecond ago
or the most recent PBBO change, whichever happened more recently.
(8) ENegPrev = a Boolean indicator that equals 1 if the second most
recent quotation update was a quotation of a protected market moving
away from the near side of market that was previously at the same
price AND the second most recent quotation update occurred since one
(1) millisecond ago or the most recent PBBO change, whichever
happened more recently.
(9) Delta = the number of these three (3) venues that moved away
from the near side of the market on the same side of the market and
were at the same price at any point since one (1) millisecond ago or
the most recent PBBO change, whichever happened more recently: XNGS,
EDGX, BATS.

    (ii) Quote Instability Threshold. The Exchange utilizes a quote
instability threshold of 0.39 for securities whose current spread is
less than or equal to $0.01; 0.45 for securities for which the current
spread (i.e., the Protected Best Offer minus Protected Best Bid) is
greater than $0.01 and less than or equal to $0.02; 0.51 for securities
for which the current spread is greater than $0.02 and less than or
equal to $0.03; and 0.39 for securities for which the current spread is
greater than $0.03.
    Rule 11.190(g)(1)(D)(iii) provides that the Exchange reserves the
right to modify the quote instability coefficients or quote instability
threshold at any time, subject to a filing of a proposed rule change
with the SEC. The Exchange is proposing such changes in this rule
filing.
Changes To Quote Instability Coefficients and Quote Instability
Threshold
    IEX conducted an analysis of the effectiveness of the existing
factors in predicting whether a crumbling quote would occur, by
reviewing market data from randomly selected days in the period from
October 2016 through October 2017. These results were then validated by
testing different randomly selected dates from the same time period.
Based on this analysis, the Exchange has determined that further
optimization of the methodology and existing factors would
incrementally increase the accuracy of the formula in predicting
whether a crumbling quote will occur. The following describes the
proposed changes:
    1. Rule 11.190(g)(1) provides in part that when the System
determines that a quote, either the Protected NBB or the Protected NBO
is unstable, the determination remains in effect at that price level
for two (2) milliseconds. The Exchange proposes to revise the time
limitation on how long each determination remains in effect, and
reorganize certain existing rule text for clarity. As proposed, when
the System determines that either the Protected NBB or the Protected
NBO in a particular security is unstable, the determination remains in
effect at that price level for two (2) milliseconds, unless a new
determination is made before the end of the two (2) millisecond period.
Only one determination may be in effect at any given time for a
particular security. A new determination may be made after at least 200
microseconds has elapsed since a preceding determination, or a price
change on either side of the Protected NBBO occurs, whichever is first.
If a new determination is made, the original determination is no longer
in effect. A new determination can be at either the Protected NBB or
the Protected NBO and at the same or different price level as the
original determination.\10\ Based

upon our analysis of market data, as described above, the Exchange
believes that changes to the time limitation would provide for a more
dynamic methodology for quote instability determinations thereby
incrementally increasing the accuracy of the formula in predicting a
crumbling quote by expanding the scope of the model to additional
situations where a crumbling quote exists at a different price point,
or again at the same price point within two (2) milliseconds. For
example, suppose that the NBBO is currently $10.03 by $10.04 in a
particular security, and the System determines that the NBB is
unstable. This determination goes into effect, with an expiration time
set two (2) milliseconds in the future. Now suppose that one (1)
millisecond later, the NBB falls to $10.02 and the System determines
that this new NBB is unstable. As proposed once the System makes a new
determination that the NBB of $10.02 is unstable, even though the prior
determination at $10.03 has not expired, the new determination will
overwrite the old determination, and its expiration time will be set to
two (2) milliseconds in the future from the time of this determination.
---------------------------------------------------------------------------

    \10\ The Exchange also proposes a nonsubstantive change to the
text of subparagraph (g)(1) of Rule 11.190 to remove the sentence
stating that ``[t]he System will only treat one side of the
Protected NBBO as unstable in a particular security at any give
time.'' which is redundant of proposed new text that provides that
``[o]nly one determination may be in effect at any given time for a
particular security.''. [sic]
---------------------------------------------------------------------------

    2. The Exchange proposes to revise five of the quote stability
variables currently specified in subparagraph (1)(A)(i)(b) of Rule
11.190(g). Specifically, the Exchange proposes to revise variables NC,
EPosPrev, ENegPrev and Delta to be calculated over a time window
looking back from the time of calculation to one (1) millisecond ago or
the most recent PBBO change on the near side (rather than on either
side), whichever happened more recently. Based on our analysis of
market data, as described above, the Exchange identified that for each
variable, considering the maximum change over the time window defined
in this manner is a more accurate indicator of a crumbling quote than
the current approach. Similarly, the Exchange proposes to revise
variable FC to be calculated over a time window looking back from the
time of calculation to one (1) millisecond ago or the most recent PBBO
change on the far side (rather than on either side), whichever happened
more recently. Based on our analysis of market data, as described
above, the Exchange identified that for this variable, considering the
maximum change over the time window described in this manner is a more
accurate indicator of a crumbling quote than the current approach.
    3. The Quote Stability Coefficients specified in subparagraph
(1)(A)(i)(a) of Rule 11.190(g) are proposed to be modified to take into
account the recent market data analysis, as well as the changes to the
quote stability variables as described above. The Exchange believes
that the modifications, as proposed, will increase the accuracy of the
quote instability calculation.
    4. The Exchange proposes to modify and re-optimize the Quote
Instability Threshold specified in subparagraph (1)(A)(ii) of Rule
11.190(g) based on the recent market data analysis and the changes to
the quote stability variables. Specifically, the threshold size would
continue to vary based on the spread of the Protected NBBO,\11\ but the
values would be revised. Based on its data analysis, as described
above, the Exchange believes that the revised values, as proposed, will
increase the accuracy of the quote instability calculation.
---------------------------------------------------------------------------

    \11\ The spread is defined in proposed paragraph (1)(D)(ii) as
the Protected Best Offer minus Protected Best Bid.
---------------------------------------------------------------------------

    5. Finally, the Exchange proposes to conform terminology within
Rule 11.190(g) by replacing the use of the term ``quote stability'' in
two instances--within subparagraph (1)(A) and subparagraph (1)(A)(i) of
11.190(g)--with ``quote instability'' for clarity and consistency. The
Exchange notes that in context, both instances mean ``quote
instability'' so no substantive change is proposed in this respect.
    The Exchange will announce the implementation date of the proposed
rule change by Trading Alert at least five business days in advance of
such implementation date and within 90 days of effectiveness of this
proposed rule change.
2. Statutory Basis
    IEX believes that the proposed rule change is consistent with
Section 6(b) \12\ of the Act in general, and furthers the objectives of
Section 6(b)(5) of the Act,\13\ in particular, in that it is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system and, in general, to
protect investors and the public interest. Specifically, and as
discussed above, the proposal is designed to optimize and enhance the
effectiveness of the quote instability calculation in determining
whether a crumbling quote exists. As discussed in the Purpose section,
each of the proposed changes are based on the Exchange's analysis of
market data, which supports that the proposed changes would increase
the accuracy of the Exchange's quote instability calculation.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f.
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed changes are designed to
protect investors and the public interest by incrementally enhancing
the accuracy of the Exchange's quote instability calculation in
determining whether a crumbling quote exists, thereby increasing the
Exchange's protection of Discretionary Peg orders, primary peg orders
and other liquidity providing orders. Specifically, the Exchange
believes that the proposed rule change will enhance the extent to which
Discretionary Peg orders and primary peg orders will be protected from
unfavorable executions by increasing the instances in which such orders
will be prevented from exercising price discretion during periods of
quote instability when the Exchange's probabilistic model identifies
that the market appears to be moving adversely to them. Similarly, the
Exchange believes that the proposed rule change will incrementally
enhance the extent to which liquidity providing orders will be
protected from liquidity taking orders targeting them at prices that
are likely to move adversely from the perspective of the liquidity
providing order.
    The Exchange also believes that application of the proposed rule
change to the CQRF is equitable and not unfairly discriminatory,
because it will continue to be narrowly tailored to disincentivize all
Members from deploying trading strategies designed to chase short-term
price momentum during periods when the CQI is on and thus potentially
adversely impact liquidity providing orders. Further, although the
incremental enhancements to the accuracy of the crumbling quote formula
may result in a corresponding increase in executions that remove
resting liquidity when the CQI is on, the Exchange believes that
Members are able to adjust their trading on IEX to reduce or eliminate
the imposition of fees pursuant to the CQRF. Moreover, based on its
review of market data during February 2018, the Exchange estimates that
while approximately 10% more trades would be impacted by the proposed
rule change, only one additional Member would potentially be subject to
the CQRF. However, a review of this Member's trading activity since

the January 2018 implementation of the CQRF indicates that the Member
has been able to adjust its trading on IEX to reduce and then eliminate
its liability for the CQRF. Thus, the Exchange believes that
application of the rule change with respect to the CQRF is equitable
and not unfairly discriminatory.
    The Exchange further believes that the conforming changes to
terminology are consistent with the Act because they are designed to
provide enhanced clarity within Rule 11.190(g) and thereby avoid any
potential confusion on the part of market participants.
    Finally, the Exchange notes that, as proposed, the new quote
instability calculation will continue to be a fixed formula specified
transparently in IEX's rules. The Exchange is not proposing to add any
new functionality, but merely to revise the fixed formula based on
market data analysis designed to increase the accuracy of the formula
in predicting a crumbling quote, and as contemplated by the rule.

B. Self-Regulatory Organization's Statement on Burden on Competition

    IEX does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. With regard to intra-market
competition, the proposed change will apply equally to all IEX Members.
The Commission has already considered the Exchange's Discretionary Peg
order type in connection with its grant of IEX's application for
registration as a national securities exchange under Sections 6 and 19
of the Act \14\ and approved the Exchange's primary peg order type.\15\
The Commission has also considered the CQRF,\16\ and the Exchange does
not believe that the incremental increase in the number of executions
that remove resting liquidity when the CQI is on as a result of the
proposed enhancements to the accuracy of the quote instability
calculation specified in Rule 11.190(g) will create a burden on
competition with respect to application to the CQRF. As discussed in
the Statutory Basis section, the proposed rule change will apply
equally to all Members, and the Exchange believes that Members who may
be subject to potential increased fees will be able to adjust their
trading on IEX to reduce or eliminate any additional fees pursuant to
the CQRF.
---------------------------------------------------------------------------

    \14\ See Securities Exchange Act Release 78101 (June 17, 2016),
81 FR 41142 (June 23, 2016) (File No. 10-222).
    \15\ See Securities Exchange Act Release No. 80223 (March 13,
2017), 82 FR 14240 (March 17, 2017).
    \16\ See Securities Exchange Act Release No. 81484 (August 25,
2017), 82 FR 41446 (August 31, 2017).
---------------------------------------------------------------------------

    The Exchange also believes that the proposed rule change will not
result in any burden on inter-market competition that is not necessary
or appropriate in furtherance of the purposes of the Act. In this
regard, the Exchange notes that NYSE American LLC has adopted a rule
copying an earlier iteration of the Exchange's Discretionary Peg Order
and quote stability calculation.\17\
---------------------------------------------------------------------------

    \17\ See NYSE American Rule 7.31E(h)(3)(D).
---------------------------------------------------------------------------

    As discussed in the Purpose and Statutory Basis sections, the
proposed rule change is designed to merely enhance the accuracy of the
quote instability calculation; therefore, no new burdens are being
proposed.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \18\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\19\
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \19\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of the filing. However,
Rule 19b-4(f)(6)(iii) \20\ permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. In its filing, IEX requests that the
Commission waive the 30-day operative delay. IEX represented that the
proposed rule change would optimize the methodology by which the
Exchange determines whether a crumbling quote exists. Specifically, IEX
stated that its proposed changes to the quote stability variables, the
quote stability coefficients, and the quote instability threshold were
based on a recent market data analysis and would increase the accuracy
of the quote instability calculation. IEX similarly believed that its
proposed changes to the current time limitation would provide a more
dynamic and expansive methodology that would increase the accuracy of
quote instability determinations.\21\ IEX further indicated that the
proposed changes to the quote instability calculation would enhance the
Exchange's ability to protect Discretionary Peg orders, primary peg
orders, and other liquidity providing orders from unfavorable
executions, because such changes would better prevent such orders from
exercising price discretion during periods when the market appears to
be moving adversely to them.
---------------------------------------------------------------------------

    \20\ 17 CFR 240.19b-4(f)(6)(iii).
    \21\ The Exchange also proposed several non-substantive changes
to Rule 11.190(g) that were designed to increase the clarity and
consistency of the rule.
---------------------------------------------------------------------------

    The Commission believes that a partial waiver of the 30-day
operative delay is consistent with the protection of investors and the
public interest as it will allow IEX to optimize the functionality of
its quote instability calculation in order to allow the crumbling quote
functionality to better meet its intended purpose to protect certain
liquidity-providing orders. At the same time, a partial operative delay
will afford the public time to review and comment upon the proposed
changes before they become operative. Accordingly, the Commission
waives the 30-day operative delay and designates that the proposed rule
change will become operative on April 24, 2018.\22\
---------------------------------------------------------------------------

    \22\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act.

Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-IEX-2018-07 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-IEX-2018-07. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-IEX-2018-07, and should be submitted on
or before May 10, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12) and (59).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-08155 Filed 4-18-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Notices]
[Pages 11994-11995]
[FR Doc No: 2021-04144]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP21-505-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Florida Gas Transmission Company, LLC submits tariff
filing per 154.204: Curtailment Priority Filing to be effective 3/25/
2021 under RP21-505.

    Filed Date: 02/22/2021.
    Accession Number: 20210222-5067.
    Comment Date: 5 p.m. ET 3/8/21.

    Docket Numbers: RP21-506-000.
    Applicants: Viking Gas Transmission Company.
    Description: Viking Gas Transmission Company submits tariff filing
per 154.204: Negotiated Rate PAL Agreement--World Fuel VR1048 Amend 2
Extension to be effective 2/22/2021 under RP21-506.
    Filed Date: 02/22/2021.
    Accession Number: 20210222-5140.
    Comment Date: 5 p.m. ET 3/8/21.

    Docket Numbers: RP21-507-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: El Paso Natural Gas Company, L.L.C. submits tariff
filing per 154.601: Negotiated Rate Agreement Update (Pioneer Apr-Jun
2021) to be effective 4/1/2021 under RP21-507.
    Filed Date: 02/22/2021.
    Accession Number: 20210222-5163.
    Comment Date: 5 p.m. ET 3/8/21.

    Docket Numbers: RP21-508-000.
    Applicants: Cimarron River Pipeline, LLC.
    Description: Cimarron River Pipeline, LLC submits tariff filing per
154.403(d)(2): Fuel Tracker 2021--Summer Season Rates to be effective
4/1/2021 under RP21-508.
    Filed Date: 02/22/2021.
    Accession Number: 20210222-5169.
    Comment Date: 5 p.m. ET 3/8/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 23, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-04144 Filed 2-26-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 86 (Friday, May 3, 2019)]
[Notices]
[Pages 19085-19086]
[FR Doc No: 2019-09005]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1262]

Notice of Approval of Product Under Voucher: Rare Pediatric
Disease Priority Review Voucher

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of approval of a product redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the
Food and Drug Administration Safety and Innovation Act (FDASIA),
authorizes FDA to award priority review vouchers to sponsors of
approved rare pediatric disease product applications that meet certain
criteria. FDA is required to publish notice of the issuance of vouchers
as well as the approval of products redeeming a voucher. FDA has
determined that ULTOMIRIS (ravulizumab-cwvz) approved December 21,
2018, meets the redemption criteria.

FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax: 301-
796-9858, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA, FDA will report the issuance of rare
pediatric disease priority review vouchers and the approval of products
for which a voucher was redeemed. FDA has determined that ULTOMIRIS
(ravulizumab-cwvz) approved December 21, 2018, meets the redemption
criteria.
    For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about ULTOMIRIS (ravulizumab-cwvz) go to the ``[email protected]''
website at https://

www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: April 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09005 Filed 5-2-19; 8:45 am]
BILLING CODE 4164-01-P