[Federal Register Volume 87, Number 222 (Friday, November 18, 2022)]
[Proposed Rules]
[Pages 69228-69231]
[FR Doc No: 2022-25114]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1475; Project Identifier MCAI-2022-00823-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2022-06-02, which applies to all Airbus SAS Model A318-111, and -112
airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes; Model A320-211, -212, -214, -216, -231, -232, and -233
airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and
-232 airplanes. AD 2022-06-02 requires new repetitive inspections of
the 80 view unit (80VU) rack lower lateral fittings, lower central
support, upper fittings, central post, and shelves attachments for
discrepancies, and corrective actions if necessary. This AD was
prompted by a determination that the compliances times must be revised
to address the unsafe condition. This proposed AD would continue to
require the actions in AD 2022-06-02 with revised compliance times, as
specified in a European Union Aviation Safety Agency (EASA) AD, which
is proposed for incorporation by reference (IBR). The FAA is proposing
this AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by January 3,
2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-1475; 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 NPRM, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For material that is proposed for IBR in this NPRM,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email [email protected]; website easa.europa.eu. You
may find this material on the EASA website at easa.europa.eu. It is
also available at regulations.gov under Docket No. FAA-2022-1475.
     You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, FAA, International Validation Branch, 2200 South
216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-1475; Project Identifier
MCAI-2022-00823-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Dan
Rodina, Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected]. Any commentary that
the FAA receives which is not specifically designated as CBI will be
placed in the public docket for this rulemaking.

Background

    The FAA issued AD 2022-06-02, Amendment 39-21968 (87 FR 16094,
March 22, 2022) (AD 2022-06-02), for all Airbus SAS Model A318-111, and
-112 airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and
-133 airplanes; Model A320-211, -212, -214,

-216, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -
211, -212, -213, -231, and -232 airplanes. AD 2022-06-02 requires new
repetitive inspections of the 80VU rack lower lateral fittings, lower
central support, upper fittings, central post, and shelves attachments
for discrepancies, and corrective actions if necessary. The FAA issued
AD 2022-06-02 to address damage or cracking of the 80VU fittings and
supports, which could lead to possible disconnection of the cable
harnesses to one or more computers, and if occurring during a critical
phase of flight, could result in reduced control of the airplane.

Actions Since AD 2022-06-02 Was Issued

    Since the FAA issued AD 2022-06-02, it's been determined that the
compliance times must be revised to address the unsafe condition.
    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2022-0120R1, dated June 30, 2022
(EASA AD 2022-0120R1) (also referred to as the MCAI), to correct an
unsafe condition for all Airbus SAS Model A318-111, A318-112, A319-111,
A319-112, A319-113, A319-114, A319-115, A319-131, A319-132, A319-133,
A320-211, A320-212, A320-214, A320-215, A320-216, A320-231, A320-232,
A320-233, A321-111, A321-112, A321-131, A321-211, A321-212, A321-213,
A321-231, and A321-232 airplanes. Model A320-215 airplanes are not
certificated by the FAA and are not included on the U.S. type
certificate data sheet; this proposed AD therefore does not include
those airplanes in the applicability.
    This proposed AD was prompted by reports of damaged lower lateral
fittings of the 80VU rack and a determination that the compliance times
must be revised. The FAA is proposing this AD to address damage or
cracking of the 80VU fittings and supports, which could lead to
possible disconnection of the cable harnesses to one or more computers,
and if occurring during a critical phase of flight, could result in
reduced control of the airplane. See the MCAI for additional background
information.

Explanation of Retained Requirements

    Although this proposed AD does not explicitly restate the
requirements of AD 2022-06-02, this proposed AD would retain all of the
requirements of AD 2022-06-02. Those requirements are referenced in
EASA AD 2022-0120R1, which, in turn, is referenced in paragraph (g) of
this proposed AD.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0120R1 specifies procedures for repetitive special
detailed inspections of the 80VU rack lower lateral fittings, lower
central support, upper fittings, central post, and shelves attachments
for discrepancies (referred to as damaged, or parts not found in good
condition in the service information) (including broken fittings,
missing bolts, an electronics rack FIN 80VU that is in contact with
structure, any bush that has migrated, burred material, and cracks),
and corrective action if necessary. Corrective actions include
modification, repair, and replacement. EASA AD 2022-0120R1 also
describes procedures for reporting inspection results to Airbus.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with the State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI referenced above. The FAA is issuing this NPRM after
determining that the unsafe condition described previously is likely to
exist or develop in other products of these same type designs.

Proposed AD Requirements in This NPRM

    This proposed AD would retain all of the requirements of AD 2022-
06-02. This proposed AD would require accomplishing the actions
specified in EASA AD 2022-0120R1 described previously, except for any
differences identified as exceptions in the regulatory text of this
proposed AD. This proposed AD would also revise the compliance times.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2022-0120R1 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2022-0120R1 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2022-0120R1 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2022-
0120R1. Service information required by EASA AD 2022-0120R1 for
compliance will be available at regulations.gov by searching for and
locating Docket No. FAA-2022-1475 after the FAA final rule is
published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 1,528 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
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                                                                                Cost on U.S.
            Action                Labor cost        Parts cost       Cost per product            operators
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Retained actions from AD       Up to 8                       $0   Up to $680............  Up to $1,039,040.
 2022[dash]06[dash]02.          work[dash]hours
                                x $85 per hour
                                = Up to $680.
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* Table does not include estimated costs for reporting.

    The FAA estimates that it would take about 1 work-hour per product
to comply with the reporting requirement in this proposed AD. The
average labor rate is $85 per hour. Based on these figures, the FAA
estimates the cost of reporting the inspection results on U.S.
operators to be $129,880, or $85 per product.
    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need these on-condition actions:

                                     Estimated Costs of On-Condition Actions
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             Action                      Labor cost                 Parts cost              Cost per product
----------------------------------------------------------------------------------------------------------------
Repair..........................  122 work-hours x $85 per  $4,150...................  $14,520.
                                   hour = $10,370.
Replacement.....................  Up to 189 work-hours x    Up to $6,928.............  Up to $22,993.
                                   $85 per hour = Up to
                                   $16,065.
Modification....................  189 work-hours x $85 per  $7,407...................  $23,472.
                                   hour = $16,065.
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Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB Control Number. The OMB
Control Number for this information collection is 2120-0056. Public
reporting for this collection of information is estimated to take
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden, to: Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

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.
    The FAA is 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

    The FAA 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 above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

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:
0
a. Removing Airworthiness Directive (AD) 2022-06-02, Amendment 39-21968
(87 FR 16094, March 22, 2022); and
0
b. Adding the following new AD:

Airbus SAS: Docket No. FAA-2022-1475; Project Identifier MCAI-2022-
00823-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by January 3, 2023.

(b) Affected ADs

    This AD replaces AD 2022-06-02, Amendment 39-21968 (87 FR 16094,
March 22, 2022) (AD 2022-06-02).

(c) Applicability

    This AD applies to all Airbus SAS airplanes, certificated in any
category, identified in paragraphs (c)(1) through (4) of this AD.
    (1) Model A318-111 and -112 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, and -233
airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, and -232
airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

(e) Unsafe Condition

    This AD was prompted by reports of damaged lower lateral
fittings of the 80VU rack and a determination that the compliance
times must be revised. The FAA is issuing this AD to address damage
or cracking of the 80VU fittings and supports, which could lead to
possible disconnection of the cable harnesses to one or more
computers, and if occurring during a critical phase of flight, could
result in reduced control of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2022-0120R1, dated June 30, 2022 (EASA AD 2022-0120R1).

(h) Exceptions to EASA AD 2022-0120R1

    (1) Where EASA AD 2022-0120R1 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where EASA AD 2022-0120R1 refers to the effective date of
EASA AD 2021-0172,

this AD requires using April 26, 2022 (the effective date of AD
2022-06-02).
    (3) Where paragraph (2) of EASA AD 2022-0120R1 specifies ``any
discrepancy,'' for this AD ``any discrepancy'' includes broken
fittings, missing bolts, an electronics rack FIN 80VU that is in
contact with structure, any bush that has migrated, burred material,
and cracks.
    (4) Where the service information referenced in EASA AD 2022-
0120R1 specifies to ``replace the damaged parts with new parts,''
this AD allows replacing damaged parts with new or serviceable
parts.
    (5) The ``Remarks'' section of EASA AD 2022-0120R1 does not
apply to this AD.

(i) Credit for Previous Actions

    This paragraph provides credit for the inspections and
corrective actions required by paragraph (g) of this AD if those
actions were accomplished prior to the effective date of this AD
using Airbus Service Bulletin A320-25-1BKJ, Revision 02, dated April
9, 2020, with corrections referenced in the Airbus Technical
Adaptation 80827186/024/2020, Issue 1, dated September 18, 2020.

(j) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (k)(1) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify
your appropriate principal inspector, or lacking a principal
inspector, the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or EASA; or Airbus SAS's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (j)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(k) Additional Information

    (1) For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected].
    (2) For Airbus service information identified in this AD that is
not incorporated by reference, contact Airbus SAS, Airworthiness
Office--EIAS, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex,
France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
airbus.com">[email protected]airbus.com; website airbus.com. You may view
this service information at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2022-0120R1,
dated June 30, 2022.
    (ii) [Reserved]
    (3) For EASA AD 2022-0120R1, contact EASA, Konrad-Adenauer-Ufer
3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website at ad.easa.europa.eu.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on November 9, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-25114 Filed 11-17-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 94 (Tuesday, May 16, 2023)]
[Notices]
[Page 31256]
[FR Doc No: 2023-10384]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Staff Attendance at North American Electric Reliability
Corporation Standards Committee Meeting

    The Federal Energy Regulatory Commission hereby gives notice that
members of the Commission and/or Commission staff may attend the
following meeting:
    Standards Committee Teleconference WebEx Meeting:

May 17, 2023 (1:00 p.m.-3:00 p.m. eastern time)

    Further information regarding these meetings may be found at:
https://www.nerc.com/Pages/Calendar.aspx.
    The discussions at the meetings, which are open to the public, may
address matters at issue in the following Commission proceeding:

Docket No. RD23-1-000: Extreme Cold Weather Reliability Standards, EOP-
011-3 and EOP-012-1

    For further information, please contact Chanel Chasanov, 202-502-
8569, or [email protected].

    Dated: May 10, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-10384 Filed 5-15-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49382-49384]
[FR Doc No: 2017-23196]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2021]

Deciding When To Submit a 510(k) for a Software Change to an
Existing Device; Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Deciding When to Submit a
510(k) for a Software Change

to an Existing Device.'' FDA is issuing this final guidance document to
clarify when a software change in a legally marketed medical device
would require that a manufacturer submit a premarket notification
(510(k)) to FDA. FDA is correcting an error in the docket number
assigned to the ``Deciding When to Submit a 510(k) for a Software
Change to an Existing Device'' notice of availability when it published
in the Federal Register (81 FR 52441, August 8, 2016). The docket
number currently is FDA-2011-D-0453. FDA is changing the docket number
to FDA-2016-D-2021. This action is administrative in nature and is
being taken to avoid any potential confusion in the docket.

DATES: The announcement of the guidance is published in the Federal
Register on October 25, 2017.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2021 for ``Deciding When to Submit a 510(k) for a Software
Change to an Existing Device.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Deciding When to Submit a 510(k) for a Software Change to an Existing
Device'' to the Office of the Center Director, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002, or the Office of Communication, Outreach, and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Linda Ricci, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G634, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected]; and Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    A 510(k) is required when a legally marketed device subject to
510(k) requirements is about to be significantly changed or modified in
design, components, method of manufacture, or intended use. Significant
changes or modifications are those that could significantly affect the
safety or effectiveness of the device, or major changes or
modifications in the intended use of the device (Sec.  807.81(a)(3) (21
CFR 807.81(a)(3)). This guidance will aid manufacturers of medical
devices who intend to make a software modification to a 510(k)-cleared
device or other device subject to 510(k) requirements, such as a
preamendments device or a device that was granted marketing
authorization via the De Novo classification process under section
513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360c(f)(2)) (also referred to together as ``existing
devices''), during the process of deciding whether the software
modification exceeds the regulatory threshold of Sec.  807.81(a)(3) for
submission and clearance of a new 510(k).

    This guidance specifically addresses software design and technology
modifications, including firmware. This guidance does not apply to
software for which the Agency has stated in guidance that it does not
intend to enforce compliance with applicable regulatory controls (e.g.,
``Mobile Medical Applications: Guidance for Industry and FDA Staff,''
issued February 9, 2015, available on the internet at https://www.fda.gov/downloads/medicaldevices/.../ucm263366.pdf) and software
that does not meet the definition of a medical device at section 201(h)
of the FD&C Act (21 U.S.C. 321(h)).
    In the Federal Register on August 8, 2016, FDA announced the
availability of the draft guidance and interested parties were
requested to comment by November 7, 2016. FDA considered comments
received on the draft guidance and revised the guidance as appropriate.
    This guidance is not intended to implement significant policy
changes to FDA's current thinking on when submission of a new 510(k) is
required for a software change to an existing device. Rather, the
intent of this guidance is to enhance the predictability, consistency,
and transparency of the ``when to submit'' decision-making process by
providing a least burdensome approach, and describing in greater detail
the regulatory framework, policies, and practices underlying such a
decision, specifically as it relates to software changes. The
recommendations discussed in this guidance for evaluating when a
software change to an existing device would trigger the requirement
that a manufacturer submit a new 510(k) to the Agency are consistent
with the least burdensome principles (Refs. 1 and 2). This guidance
applies the least burdensome principles, in part, by reliance on risk
management and the quality system regulation (21 CFR part 820) to
determine whether submission of a new 510(k) is required for a software
change to an existing device.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of the guidance document entitled ``Deciding When to
Submit a 510(k) for a Change to an Existing Device,'' to aid
manufacturers of medical devices who intend to make non-software
changes to an existing device during the process of deciding whether
the modification exceeds the regulatory threshold of Sec.
[thinsp]807.81(a)(3) for submission and clearance of a new 510(k).

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Deciding When to Submit a 510(k) for a
Software Change to an Existing Device.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Persons unable to
download an electronic copy of ``Deciding When to Submit a 510(k) for a
Software Change to an Existing Device'' may send an email request to
[email protected] to receive an electronic copy of the
document. Please use the document number 1500055 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 820 are approved under OMB
control number 0910-0073; the collections of information in 21 CFR part
807, subpart E are approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 803 are approved under OMB
control number 0910-0437; and the collections of information in 21 CFR
parts 801 are approved under OMB control number 0910-0485.

V. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. ``The Least Burdensome Provisions of the FDA Modernization Act of
1997: Concept and Principles,'' dated October 4, 2002, available at:
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085999.pdf.
2. ``Suggested Format for Developing and Responding to Deficiencies
in Accordance with the Least Burdensome Provisions of FDAMA,'' dated
November 2, 2000, available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073680.pdf.

    Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23196 Filed 10-24-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 115 (Wednesday, June 15, 2011)]
[Notices]
[Pages 34979-34982]
[FR Doc No: 2011-14765]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0014; FRL-8876-1]

Product Cancellation Order for Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces EPA's order for the cancellations,
voluntarily requested by the registrants and accepted by the Agency, of
the products listed in Table 1 of Unit II., pursuant to section 6(f)(1)
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as
amended. This cancellation order follows a November 10, 2010 Federal
Register Notice of Receipt of Requests from the registrants listed in
Table 2 of Unit II. to voluntarily cancel these product registrations.
In the November 10, 2010 notice, EPA indicated that it would issue an
order implementing the cancellations, unless the Agency received
substantive comments within the 180-day comment period that would merit
its further review of these requests, or unless the registrants
withdrew their requests. The Agency did not receive any comments on the
notice. Further, the registrants did not withdraw their requests.
Accordingly, EPA hereby issues in this notice a cancellation order
granting the requested cancellations. Any distribution, sale, or use of
the products subject to this cancellation order is permitted only in
accordance with the terms of this order, including any existing stocks
provisions.

DATES: The cancellations are effective June 15, 2011.

FOR FURTHER INFORMATION CONTACT: Maia Tatinclaux, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0014. Publicly available
docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

II. What action is the agency taking?

    This notice announces the cancellation, as requested by
registrants, of 48 products registered under FIFRA section 3. These
registrations are listed in sequence by registration number in Table 1
of this unit.

                                         Table 1--Product Cancellations
----------------------------------------------------------------------------------------------------------------
     EPA registration number            Product name                         Active ingredients
----------------------------------------------------------------------------------------------------------------
000264-00499....................  Rootone F Brand Rooting  1-Naphthaleneacetamide
                                   Hormone.                Thiram
000432-01454....................  Merit 240 SC             Imidacloprid
                                   Insecticide.
000707-00302....................  Cunilate 2002..........  Copper, bis(8-quinolinolato-N1, O8)-
001475-00159....................  Willert Mosquito Coils.  Bioallethrin
001529-00054....................  Nuosept 91T............  Grotan
002517-00006....................  Double Duty Cat Flea &   Pyrethrins
                                   Tick Spray.             Piperonyl butoxide
                                                           MGK 264
002517-00034....................  Sergeant's Foam 'N Comb  Pyrethrins
                                   Dry Shampoo for Dogs    Piperonyl butoxide
                                   and Cats.
002517-00099....................  Pyrethroid W.B.          Permethrin
                                   Concentrate.
002517-00104....................  Preventic L.A. Flea and  Permethrin
                                   Tick Spray for Dogs.
002517-00105....................  Natura Flea & Tick       Permethrin
                                   Collar for Dogs and
                                   Cats.
002517-00108....................  Permethrin- IGR 1 Flea and Tick       Pyriproxyfen
                                   Spray for Dogs.
002517-00113....................  Permethrin-Pyriproxifen  Permethrin
                                   Residual Shampoo for    Pyriproxyfen
                                   Dogs 2.
002829-00042....................  Socci 3500 WP..........  Copper, bis(8-quinolinolato-N1, O8)-
002829-00044....................  Cunilate 2174-NO.......  Copper, bis(8-quinolinolato-N1, O8)-
002829-00049....................  Socci 3500.............  Copper, bis(8-quinolinolato-N1, O8)-
002829-00082....................  Vinyzene BP-5..........  10, 10'-Oxybisphenoxarsine
002829-00112....................  Cunilate 2419-75.......  Copper, bis(8-quinolinolato-N1, O8)-
002829-00135....................  Nytek 10WP.............  Copper, bis(8-quinolinolato-N1, O8)-
002829-00136....................  Nytek 10...............  Copper, bis(8-quinolinolato-N1, O8)-
002829-00137....................  Nytek WD...............  Copper, bis(8-quinolinolato-N1, O8)-
005905-00066....................  MSMA Plus..............  MSMA (and salts)
005905-00162....................  Helena Brand MSMA High   MSMA (and salts)
                                   Concentrate.
005905-00164....................  MSMA Plus* H.C.........  MSMA (and salts)
006218-00041....................  Summit Sumithrin         Phenothrin
                                   Greenhouse Spray.
006218-00046....................  Summit Sumithrin         MGK 264
                                   Greenhouse Aerosol.     Phenothrin
009630-00004....................  6% Copper Nap-All......  Copper naphthenate
009630-00005....................  M-Gard S120............  Copper naphthenate
009630-00006....................  8% Zinc Nap-All........  Zinc naphthenate
009630-00007....................  Zinc Hydro-Nap.........  Zinc naphthenate
009630-00010....................  M-Gard W550............  Zinc naphthenate
009630-00012....................  M-Gard S520............  Copper naphthenate
009630-00021....................  M-Gard S550............  Zinc naphthenate
040849-00069....................  Scorcher Total           Prometon
                                   Vegetation Killer.
043437-00003....................  8% Zinc Naphthenate....  Zinc naphthenate
043437-00004....................  8% Copper Naphthenate..  Copper naphthenate
044446-00072....................  Areo Blast.............  Piperonyl butoxide
                                                           Tetramethrin
                                                           Permethrin
053853-00002....................  Black Flag Fogging       Permethrin
                                   Insecticide Formula 2.  Piperonyl butoxide
                                                           Tetramethrin
066330-00313....................  Bifenthrin 98%           Bifenthrin
                                   Technical.
066330-00322....................  Sulfometuron Methyl      Sulfometuron
                                   Technical.
066330-00326....................  Sulfometuron 75EG        Sulfometuron
                                   Herbicide.
074530-00024....................  Helm Diquat AG.........  Diquat dibromide
083071-00001....................  Activ-Ox 20............  Sodium chlorite
                                                           Sodium hypochlorite

084456-00001....................  Abamectin Technical....  Abamectin
084456-00003....................  Abamectin 2% Ornamental  Abamectin
                                   Miticide/Insecticide.
084456-00004....................  Abamectin 2% Miticide/   Abamectin
                                   Insecticide.
AR980003........................  Dylox 80 Turf and        Trichlorfon
                                   Ornamental Insecticide.
OR050018........................  Prometryne 4L Herbicide  Prometryn
WA040010........................  Warrior Insecticide      lambda-Cyhalothrin
                                   with Zenon Technology.
----------------------------------------------------------------------------------------------------------------

    Table 2 of this unit includes the names and addresses of record for
all registrants of the products in Table 1 of this unit, in sequence by
EPA company number. This number corresponds to the first part of the
EPA registration numbers of the products listed in Table 1 of this
unit.

               Table 2--Registrants of Cancelled Products
------------------------------------------------------------------------
        EPA company number                Company name and address
------------------------------------------------------------------------
264...............................  Bayer CropScience LP, 2 T.W.
                                     Alexander Drive, P.O. Box 12014,
                                     Research Triangle Park, NC 27709.
432...............................  Bayer Environmental Science, 2 T.W.
                                     Alexander Drive, P.O. Box 12014,
                                     Research Triangle Park, NC 27709.
707...............................  Rohm & Hass Co., 100 Independence
                                     Mall West, Philadelphia, PA 19106-
                                     2399.
1475..............................  Willert Home Products, 4044 Park
                                     Ave., St Louis, MO 63110.
1529..............................  International Specialty Products,
                                     1361 Alps Rd., Wayne, NJ 07470.
2517..............................  Sergeant's Pet Care Products, Inc.,
                                     2625 South 158th Plaza, Omaha, NE
                                     68130-1703.
2829..............................  Rohm & Hass Co., 100 Independence
                                     Mall West, Ste. 1A, Philadelphia,
                                     PA 19106-2399.
5905..............................  Helena Chemical Company, 7664 Moore
                                     Road, Memphis, TN 38120.
6218..............................  Summit Chemical Co., 235 S Kresson
                                     St., Baltimore, MD 21224.
9630..............................  OMG Americas Inc., 811 Sharon Drive,
                                     Westlake, OH 44145.
40849.............................  ZEP Commercial Sales & Service, 1310
                                     Seaboard Industrial Blvd., NW.,
                                     Atlanta, GA 30318.
43437.............................  OMG Belleville Limited, 811 Sharon
                                     Drive, Cleveland, OH 44145-1522.
44446.............................  QuestVaptco Corporation, P.O. Box
                                     624, Brenham, TX 77834.
53853.............................  The Fountainhead Group, Inc., 23
                                     Garden Street, New York Mills, NY
                                     13417.
66330.............................  Arysta Lifescience North America,
                                     LLC, 15401 Weston Parkway, Suite
                                     150, Cary, NC 27513.
74530.............................  Helm Agro US, Inc., Agent: Ceres
                                     International LLC, 1087 Heartsease
                                     Drive, West Chester, PA 19382.
83071.............................  Feedwater Limited, 1415 Crystal
                                     Court, Naperville, IL 60563-0142.
84456.............................  Hebei Veyong Bio-Chemical Company,
                                     Ltd., Agent Name: Wagner Regulatory
                                     Associates, Inc., 7460 Lancaster
                                     Pike, Suite 9, P.O. Box 640,
                                     Hockessin, DE 19707-0640.
AR980003..........................  Arkansas Bait and Ornamental Fish
                                     Growers Assn, P.O. Box 509, Lonoke,
                                     AR 72086.
OR050018..........................  Loveland Products, Inc., P.O. Box
                                     1286, Greeley, CO 80632-1286.
WA040010..........................  Syngenta Crop Protection, Inc., P.O.
                                     Box 18300, Greensboro, NC 27419-
                                     8300.
------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

    During the public comment period provided, EPA received no comments
in response to the November 10, 2010 Federal Register notice (75 FR
69070) (FRL-8851-9) announcing the Agency's receipt of the requests for
voluntary cancellations of products listed in Table 1 of Unit II.

IV. Cancellation Order

    Pursuant to FIFRA section 6(f), EPA hereby approves the requested
cancellations of the registrations identified in Table 1 of Unit II.
Accordingly, the Agency hereby orders that the product registrations
identified in Table 1 of Unit II are cancelled. The effective date of
the cancellations that are the subject of this notice is June 15, 2011.
Any distribution, sale, or use of existing stocks of the products
identified in Table 1 of Unit II. in a manner inconsistent with any of
the provisions for disposition of existing stocks set forth in Unit VI.
will be a violation of FIFRA.

V. What is the agency's authority for taking this action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be cancelled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the EPA Administrator may approve
such a request. The notice of receipt for this action was published for
comment in the Federal Register issue of November 10, 2010. The comment
period closed on May 9, 2011.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action. The existing stocks provisions for the products
subject to this order are as follows.
    The registrants may continue to sell and distribute existing stocks
of products listed in Table 1 of Unit II. until June 15, 2012, which is
1 year after the publication of the Cancellation Order in the Federal
Register. Thereafter, the registrants are prohibited from selling or
distributing products listed in Table 1, except for export in
accordance with FIFRA section 17, or proper disposal. Persons other
than the registrants may sell, distribute, or use existing stocks of
products listed in Table 1 of Unit II. until existing stocks are
exhausted, provided that such sale,

distribution, or use is consistent with the terms of the previously
approved labeling on, or that accompanied, the cancelled products.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: June 7, 2011.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2011-14765 Filed 6-14-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)]
[Proposed Rules]
[Pages 59165-59167]
[FR Doc No: 2016-20653]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0032; FRL-9950-22]

Receipt of Several Pesticide Petitions Filed for Residues of
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing of petitions and request for comment.

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

SUMMARY: This document announces the Agency's receipt of several
initial filings of pesticide petitions requesting the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before September 28, 2016.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number and the pesticide petition number (PP) of
interest as shown in the body of this document, by one of the following
methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://

www.epa.gov/dockets/contacts.html. Additional instructions on
commenting or visiting the docket, along with more information about
dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (BPPD) (7511P), main telephone number:
(703) 305-7090, email address<EMAIL_ADDRESS>or Michael
Goodis, Registration Division (RD) (7505P), main telephone number:
(703) 305-7090, email address<EMAIL_ADDRESS>The mailing address
for each contact person is: Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001. As part of the mailing address, include the contact person's
name, division, and mail code. The division to contact is listed at the
end of each pesticide petition summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
    [emsp14]Crop production (NAICS code 111).
    [emsp14]Animal production (NAICS code 112).
    [emsp14]Food manufacturing (NAICS code 311).
    [emsp14]Pesticide manufacturing (NAICS code 32532).
    If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT for the division listed at the end of the
pesticide petition summary of interest.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What action is the agency taking?

    EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, requesting the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. The Agency is taking public comment on
the requests before responding to the petitioners. EPA is not proposing
any particular action at this time. EPA has determined that the
pesticide petitions described in this document contain the data or
information prescribed in FFDCA section 408(d)(2), 21 U.S.C.
346a(d)(2); however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data support granting of the
pesticide petitions. After considering the public comments, EPA intends
to evaluate whether and what action may be warranted. Additional data
may be needed before EPA can make a final determination on these
pesticide petitions.
    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this document, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA
is publishing notice of the petitions so that the public has an
opportunity to comment on these requests for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petitions may be obtained
through the petition summaries referenced in this unit.
New Tolerances
    1. PP 5E8432. (EPA-HQ-OPP-2016-0299). Dow AgroSciences LLC, 9330
Zionsville Road, Indianapolis, IN 46268, requests to establish an
import tolerance in 40 CFR part 180 for residues of the cloquintocet-
mexyl (acetic acid [(5-chloro-8-quniolinyl)oxyl]-1-methylhexyl ester)
(CAS Reg. No. 99607-70-2) and its acid metabolite (5-chloro-8-
quinlinoxyacetic acid) for use as an inert ingredient (safener) in
combination with the herbicide pyroxsulam in or on teff, forage at 0.2
parts per million (ppm); teff, grain at 0.1 ppm; teff hay at 0.5 ppm;
teff straw at 0.1 ppm. The High Performance Liquid Chromatography with
Ultraviolet Detection (HPLC-UV) method REM 138.01 is used to measure
and evaluate residues of the cloquintocet-mexyl (parent) and the HPLC-
UV Method RED 138.10 allows determination of its acid metabolite (also
known as CGA-153433) for the proposed uses. Contact: RD.
    2. PP 5E8433. (EPA-HQ-OPP-2016-0143). Syngenta Crop Protection,
LLC, 410 Swing Road, P.O. Box 18300, Greensboro, NC 27419-8300,
requests to establish a tolerance in 40 CFR part 180.654 for residues
of the fungicide, isopyrazam in or on tomato at 0.5 parts per million
(ppm), pepper, bell at 0.6 ppm, and cucurbit crop subgroup 9A at 0.3
ppm. The GRM006.01B validation method is used to measure and evaluate
the chemical isopyrazam, analyzed as the isomers SYN534968 and
SYN534969. Contact: RD.
    3. PP 5E8366. (EPA-HQ-OPP-2016-0380). BASF Corporation, 26 Davis
Drive, Research Triangle Park, NC 27709-3528, requests to establish
tolerances in 40 CFR part 180 for residues of the fungicide,
fluxapyroxad in or on banana at 3.0 parts per million (ppm); coffee,
green bean at 0.2 ppm; mango at 0.7 ppm; and papaya at 0.6 ppm.
Independently validated methods have been used to measure and evaluate
parent fluxapyroxad, BAS 700F plus metabolites M700F008, M700F048, and
M700F002. Contact: RD.
    4. PP 5F8381. (EPA-HQ-OPP-2015-0722). Bayer CropScience, P.O. Box

12014, 2 T.W., Alexander Drive, Research Triangle Park, NC 27709,
requests to establish a tolerance in 40 CFR part 180.626 for residues
of the fungicide, prothioconazole in or on cotton, gin by-products at
4.0 parts per million (ppm). The liquid chromatography/mass
spectrometry (LC/MS/MS) is used to measure and evaluate the chemical
prothioconazole. Contact: RD.
    5. PP 6F8461. (EPA-HQ-OPP-2016-0255). Bayer CropScience, P.O. Box
12014, Research Triangle Park, NC 27709, requests to establish a
tolerance in 40 CFR part 180 for residues of the insecticide
spirotetramat in or on sugar beet, root at 0.15 ppm; and sugar beet,
molasses at 0.20 ppm. The high pressure liquid chromatography/triple
stage quadrupole mass spectrometry (LC/MS/MS) analytical method is used
to measure and evaluate the chemical spirotetramat. Contact: RD.
Amended Tolerances
    1. PP 5F8400. (EPA-HQ-OPP-2015-0695). Isagro S.P.A. (d/b/a Isagro
USA, Inc.), 430 Davis Drive, Suite 240, Morrisville, NC 27560, requests
to amend the tolerances in 40 CFR 180.557 for residues of the fungicide
tetraconazole in or on beet sugar, dried pulp at 0.20 parts per million
(ppm), beet sugar, molasses at 0.25 ppm, and beet sugar, root at 0.15
ppm. The capillary gas chromatography with electron capture detector
(GC/ECD)) as well as a QuEChERS multi-residue method (LC/MS-MS
detection) is used to measure and evaluate the chemical tetraconazole.
Contact: RD.
    2. PP 6F8465. (EPA-HQ-OPP-2016-0307). Nichino America, Inc., 4550
New Linden Hill Road, Suite 501, Wilmington, DE 19808, requests to
amend the tolerances in 40 CFR 180.566 for residues of the insecticide
fenpyroximate in or on fruit, citrus, Group 10-10 at 1.0 parts per
million (ppm), citrus dried pulp at 4.0 ppm, and citrus oil at 14 ppm.
The high performance liquid chromatography using tandem mass
spectrometric detection (LC/MS/MS) is used to measure and evaluate the
chemical fenpyroximate and the M-1 Metabolite. Contact: RD.
New Tolerance Exemptions
    1. PP 6F8444. (EPA-HQ-OPP-2016-0348). Marrone Bio Innovations, 1540
Drew Ave., Davis, CA 95618, requests to establish an exemption from the
requirement of a tolerance in 40 CFR part 180 for residues of the
bactericide and fungicide Bacillus amyloliquefaciens strain F727 in or
on all food commodities. The petitioner believes no analytical method
is needed because when used as proposed, Bacillus amyloliquefaciens
strain F727 would not result in residues that are of toxicological
concern. Contact: BPPD.
    2. PP 6F8459. (EPA-HQ-OPP-2016-0259). Spring Trading Co., 203
Dogwood Trl., Magnolia, TX 77354 (on behalf of CH Biotech R&D Co. Ltd.,
No. 121 Xian An Rd., Xianxi Township, Changhua County 50741 Taiwan
R.O.C.), requests to establish an exemption from the requirement of a
tolerance in 40 CFR part 180 for residues of the plant regulator 1-
Triacontanol in or on raw agricultural commodity growing crops on in
products to treat animals. The petitioner believes no analytical method
is needed because the 10X standard safety factor is unnecessary for 1-
Triacontanol since it is a compound found in plant cuticle waxes and
beeswax. Contact: BPPD.
    3. PP IN-10851. (EPA-HQ-OPP-2016-0378). Technology Sciences Group,
1150 18th Street, Suite 1000, Washington, DC 20036, on behalf of Jeneil
Biosurfactant Company, 400 N. Dekora Woods Blvd., Saukville, WI 53080,
requests to establish an exemption from the requirement of a tolerance
for residues of isoamyl acetate (CAS Reg. No. 123-92-2) when used as an
inert ingredient (solvent) in pesticide formulations applied to growing
crops and raw agricultural commodities after harvest under 40 CFR
180.910. The petitioner believes no analytical method is needed because
the request is for an exemption from the requirements of a pesticide
tolerance. Contact: RD.

    Authority: 21 U.S.C. 346a.

    Dated: August 16, 2016.
Michael Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2016-20653 Filed 8-26-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 195 (Friday, October 7, 2016)]
[Notices]
[Pages 69878-69881]
[FR Doc No: 2016-24284]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79030; File No. SR-NYSE-2016-62]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Partial Amendment No. 2 and Order Granting
Accelerated Approval of a Proposed Rule Change, as Modified by Partial
Amendment No. 2, To Amend Rule 67 Relating to the Tick Size Pilot
Program

October 3, 2016.

I. Introduction

    On August 25, 2016, New York Stock Exchange LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``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: (1) Change system functionality to implement
the Plan to Implement a Tick Size Pilot Program (``Plan'' or ``Pilot'')
\3\ submitted to the Commission pursuant to Rule 608 of Regulation NMS
\4\ under the Act; (2) clarify the operation of certain exceptions to
the Trade-at Prohibition \5\ on Pilot Securities in Test Group Three;
(3) amend the Limit Up/Limit Down (``LULD'') price controls set forth
in Exchange Rule 80C regarding the Regulation NMS Plan to Address
Extraordinary Market Volatility (``LULD Plan''); \6\ and (4) amend the
Exchange's trading collar calculation in Exchange Rule 1000. The
proposed rule change was published for comment in the Federal Register
on September 15, 2016.\7\ The Commission received two comments letter
on the proposal.\8\ On September 27, 2016, the Exchange filed Partial
Amendment No. 1 to the proposed rule change (``Amendment No. 1''). On
September 30, 2016, the Exchange withdrew Amendment No. 1 and filed
Partial Amendment No. 2 to the proposed rule change (``Amendment No.
2'').\9\
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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. 74892 (May 6, 2015),
80 FR 27513 (May 13, 2015) (``Approval Order''). Unless otherwise
specified, capitalized terms used in this order are defined as set
forth in the Plan.
    \4\ 17 CFR 242.608.
    \5\ Exchange Rule 67(e)(4)(A) defines the ``Trade-at
Prohibition'' as the prohibition against executions by a Trading
Center of a sell order for a Pilot Security at the price of a
Protected Bid or the execution of a buy order for a Pilot Security
at the price of a Protected Offer during regular trading hours. See
also Plan Section I(LL) and Plan Section VI(D).
    \6\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (File No. 4-631).
    \7\ See Securities Exchange Act Release No. 78802 (September 9,
2016), 81 FR 63515.
    \8\ See Letters from Eric Swanson, EVP, General Counsel, Bats
Global Markets, Inc., Elizabeth K. King, General Counsel and
Corporate Secretary, New York Stock Exchange; and Thomas A. Wittman,
EVP, Global Head of Equities, Nasdaq, Inc., dated September 9, 2016
(``Comment Letter No. 1''); and Eric Swanson, EVP, General Counsel,
Bats Global Markets, Inc., dated September 12, 2016 (``Comment
Letter No. 2'').
    \9\ In Amendment No. 2, the Exchange proposes to: (1) Specify
that in all Pilot Securities, d-Quotes to buy (sell) would not
exercise discretion if (A) exercising discretion would result in an
execution equal to or higher (lower) than the price of a protected
offer (bid) or (B) the price of a protected bid (offer) is equal to
or higher (lower) than the filed price of the d-Quote; and (2)
correct cross references.
---------------------------------------------------------------------------

    This order provides notice of Amendment No. 2, and approves the
proposal, as modified by Amendment No. 2, on an accelerated basis.

II. Description of the Amended Proposal

    The Exchange proposes to amend Exchange Rule 67 to: (1) Change
system functionality to implement the Plan; (2) clarify the operation
of certain exceptions to the Trade-at Prohibition on Pilot Securities
in Test Group Three; (3) amend the LULD price controls set forth in
Exchange Rule 80C; and (4) amend the Exchange's trading collar
calculation set forth in Exchange Rule 1000.

A. Amendments to Exchange Systems Functionality To Implement the Plan

1. Trade-at Intermarket Sweep Order \10\
---------------------------------------------------------------------------

    \10\ See proposed Exchange Rule 67(f)(1).
---------------------------------------------------------------------------

    The Exchange proposes to accept Trade-at Intermarket Sweep Orders
(``TAISO'') in all securities, and that TAISOs must be designated as
immediate or cancel (``IOC''), may include a minimum trade size, and do
not route. The Exchange would immediately and automatically execute a
TAISO against the displayed and non-displayed bid (offer) up to its
full size in accordance with and to the extent provided by Exchange
Rules 1000--1004 and will then sweep the Exchange's book as provided in
Rule 1000(e)(iii), and the portion not so executed will be immediately
and automatically cancelled. The Exchange would accept TAISOs before
the Exchange opens and would allow TAISOs to be eligible to participate
in the opening transaction at its limit price, but would not be accept
TAISOs during a trading halt or pause for participation in a reopening
transaction. Finally, the Exchange would not allow TAISOs to be entered
as e-Quotes, d-Quotes, or g-Quotes.

2. Pilot Securities in Test Groups One, Two, and Three \11\
---------------------------------------------------------------------------

    \11\ See proposed Exchange Rule 67(f)(2).
---------------------------------------------------------------------------

    The Exchange proposes that references in Exchange rules to the
minimum price variation (``MPV'') would mean the quoting minimum price
variation as specified in Exchange Rule 67 (c), (d), and (e). Pre-
opening indications \12\ would be published in $0.05 pricing increments
for Pilot Securities in Test Groups One, Two, and Three. Mid-Point
Passive Liquidity (``MPL'') Orders, which are undisplayed limit orders
that automatically execute at the mid-point of the protected best bid
(``PBB'') and the protected best offer (``PBO'') (``PBBO''),\13\ must
be entered with a limit price in a $0.05 pricing increment. Trading
collars that are not in the trading MPV for the security would be moved
to the nearest price in the trading MPV for that security.
---------------------------------------------------------------------------

    \12\ See Exchange Rule 15(a) (providing that pre-opening
indications will include the security and the price range within
which the opening price is anticipated to occur and will be
published via the securities information processor and proprietary
data feeds).
    \13\ See Exchange Rule 13(d)(1)(A).
---------------------------------------------------------------------------

3. Retail Price Improvement Orders in Test Groups Two and Three \14\
---------------------------------------------------------------------------

    \14\ See proposed Exchange Rule 67(f)(3).
---------------------------------------------------------------------------

    The Exchange proposes that Retail Price Improvement orders must be
entered with a limit price and an offset in a $0.005 increment.
4. Pilot Securities in Test Group Three
    The Exchange proposes procedures for handling, executing, re-
pricing and displaying of certain order types and order type
instructions applicable to Pilot Securities in Test Group Three.
a. Change in Priority \15\
---------------------------------------------------------------------------

    \15\ See proposed Exchange Rule 67(f)(4)(A).
---------------------------------------------------------------------------

    The Exchange proposes that incoming automatically executing order
to sell (buy) will trade with displayable bids (offers) and route to
protected bids (offers) before trading with an unexecuted Market Order
held undisplayed at the same price. After trading or routing, or both,
any remaining balance of such an incoming automatically executing order
would satisfy any unexecuted Market Orders in time priority before
trading with non-displayable interest on parity.
b. ISOs \16\
---------------------------------------------------------------------------

    \16\ See proposed Exchange Rule 67(f)(4)(B).
---------------------------------------------------------------------------

    The Exchange proposes that on entry, Day ISOs will be eligible for
the TAISO exception to the Trade-at Prohibition. In addition, an IOC
ISO to buy (sell) would not trade with non-displayed interest to sell
(buy) that is the same price as a protected offer (bid) unless the
limit price of such IOC ISO is higher (lower) than the price of the
protected offer (bid).
c. Non-Displayed Resting Orders \17\
---------------------------------------------------------------------------

    \17\ See proposed Exchange Rule 67(f)(4)(C).
---------------------------------------------------------------------------

    The Exchange proposes restrictions applicable to resting non-
displayed interest, i.e., a resting order to buy (sell) that is not
displayed at the price at which it is eligible to trade. Resting non-
displayed interest on the Exchange could include Non-Display Reserve
Orders,\18\ Non-Display Reserve e-Quotes,\19\ the reserve interest of
Minimum Display Reserve Orders and Minimum Display Reserve e-
Quotes,\20\ and pegging interest that is not displayed.\21\ The
proposed rule changes are intended to assure that these orders would
not price match a protected quotation.
---------------------------------------------------------------------------

    \18\ A ``Non Displayed Reserve Order'' is a Limit Order that is
not displayed, but remains available for potential execution against
all incoming automatically executing orders until executed in full
or cancelled. See Rule 13(d)(1)(A).
    \19\ See Rule 70(f)(ii).
    \20\ A ``Minimum Display Reserve Order'' is a Limit Order that
will have a portion of the interest displayed when the order is or
becomes the Exchange BBO and a portion of the interest (``reserve
interest'') that is not displayed. See Rules 13(d)(2)(C) and
70(f)(i).
    \21\ See Rule 13(f)(1)(A) (Pegging interest includes non-
displayable interest to buy or sell at a price to track the same-
side PBBO). d-Quotes enable Floor brokers to enter discretionary
instructions as to the price at which the d-Quote may trade and the
number of shares to which the discretionary price instructions
apply. Executions of d-Quotes within a discretionary pricing
instruction range are considered non-displayable interest for
purposes of Rule 72. See Rule 70.25(a)(ii).
---------------------------------------------------------------------------

    First, the Exchange proposes that a resting non-displayed order to
buy (sell) will not trade at the price of a protected offer (bid).
Second, a resting non-displayed order to buy (sell) will not trade at
the price of a protected bid (offer) unless the incoming order to sell
(buy) is a TAISO, Day ISO, or IOC ISO that has a limit price lower
(higher) than the price of the non-displayed orders. Finally, the
Exchange proposes that resting non-displayed interest will be either
routed, cancelled, or re-priced, consistent with the terms of the
order.
d. Block Size Exception to the Trade-at Prohibition \22\
---------------------------------------------------------------------------

    \22\ See proposed Exchange Rule 67(f)(4)(E).
---------------------------------------------------------------------------

    The Exchange proposes that only buy and sell orders that are
entered into the Cross Function pursuant to Supplementary Material .10
to Exchange Rule 76 and that satisfy the Block Size definition would be
eligible for the Block Size exception to the Trade-at Prohibition.
e. Self-Trade Prevention Modifiers \23\
---------------------------------------------------------------------------

    \23\ See proposed Exchange Rule 67(f)(4)(F).
---------------------------------------------------------------------------

    The Exchange proposes that incoming orders designated with a
certain self-trade prevention (``STP'') Modifier, STPN, would cancel
before routing or trading with non-displayed orders if the opposite-
side resting interest marked with an STP modifier with the same market
participant identifier (``MPID'') is a displayed order.
f. g-Quotes and Buy Minus/Zero Plus Orders \24\
---------------------------------------------------------------------------

    \24\ See proposed Exchange Rule 67(f)(4)(G).
---------------------------------------------------------------------------

    The Exchange proposes that g-Quotes and Buy Minus/Zero Plus Orders
would be rejected.
5. d-Quotes \25\
---------------------------------------------------------------------------

    \25\ See proposed Exchange Rule 67(f)(5). See also Amendment No.
2.
---------------------------------------------------------------------------

    The Exchange proposes that in all Pilot Securities, d-Quotes to buy
(sell) would not exercise discretion if (i) exercising discretion would
result in an execution equal to or higher (lower) than the price of a
protected offer (bid), or (ii) the price of a protected bid (offer) is
equal to or higher (lower) than the filed price of the d-Quote.

B. Operation of Certain Exceptions to the Trade-At Prohibition on Pilot
Securities in Test Group Three

1. Trade-At Intermarket Sweep Orders \26\
---------------------------------------------------------------------------

    \26\ See proposed Exchange Rule 67(a)(1)(D) and proposed
Exchange Rule 67(e)(4)(C)(x).
---------------------------------------------------------------------------

    The Exchange proposes to add phrase ``or Intermarket Sweep Orders''
(``ISO'') to the definition of TAISO as well as to the TAISO exception
to the Trade-At Prohibition to clarify that ISOs may be routed to
execute against the full displayed size of the Protected Quotation that
was traded at.\27\
---------------------------------------------------------------------------

    \27\ The Exchange also proposes to add the word ``display'' to
Exchange Rule 67(a)(1)(D) to correct a previous omission.
---------------------------------------------------------------------------

2. Block Size Exception to the Trade-At Prohibition \28\
---------------------------------------------------------------------------

    \28\ See proposed Exchange Rule 67(e)(4)(C)(iii).
---------------------------------------------------------------------------

    The Exchange proposes to amend the Block Size Exception to the
Trade-at Prohibition to allow execution on multiple Trading Centers to
comply with Regulation NMS.

C. LULD Price Bands \29\
---------------------------------------------------------------------------

    \29\ See proposed Exchange Rule 80C(a)(8).
---------------------------------------------------------------------------

    The Exchange proposes that after the Exchange opens or reopens an
Exchange-listed security but before receiving Price Bands from the
Securities Information Processor (``SIP'') under the LULD Plan, the
Exchange would calculate Price Bands based on the first Reference Price
provided to the

SIP and, if such Price Bands are not in the MPV for the security, round
such Price Bands to the nearest price at the applicable MPV.

D. Trading Collars Rounding \30\
---------------------------------------------------------------------------

    \30\ See proposed Exchange Rule 1000(c)(i).
---------------------------------------------------------------------------

    The Exchange proposes that Trading Collars for both buy and sell
orders that are not in the MPV for the security would be rounded down
to the nearest price at the applicable MPV.

III. Summary of Comment Letters

    Both comment letters express support for the proposed rule change
and suggest that the Commission should approve the proposal. In Comment
Letter No. 1, the commenters stated that if the proposal is approved as
proposed, then NYSE would be able to meet the October 3, 2016
implementation date. Further, in Comment Letter No. 1, the commenters
stated their belief that the requirements from the Commission have been
unclear. In Comment Letter No. 2, the commenter questioned Commission
staff's authority.

IV. Discussion and Commission's Findings

    After careful review of the proposed rule change, as modified by
Amendment No. 2, and the comment letters, the Commission finds that the
proposal, as modified by Amendment No. 2, is consistent with the
requirements of the Act, Rule 608 of Regulation NMS,\31\ and the rules
and regulations thereunder that are applicable to a national securities
exchange.\32\ Specifically, the Commission finds that the rule change
is consistent with Section 6(b)(5) of the Act, which requires that the
rules of a national securities exchange be designed, among other
things, to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and to protect investors and the public interest; and
are not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \31\ 17 CFR 242.608.
    \32\ In approving this rule change, the Commission has
considered the rule's impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    As noted in the Approval Order, the Plan is by design, an
objective, data-driven test to evaluate how a wider tick size would
impact trading, liquidity, and market quality of securities of smaller
capitalization companies. In addition, the Plan is designed with three
Test Groups and a Control Group, to allow analysis and comparison of
incremental market structure changes on the Pilot Securities and is
designed to produce empirical data that could inform future policy
decisions. As such, any proposed changes targeted at particular Test
Groups during the Pilot Period should be necessary for compliance with
the Plan.
    The Exchange proposes changes to modify how the Exchange will
handle orders during the Pilot Period. Specifically, the Exchange
proposes to accept TAISOs in all securities. In addition, the Exchange
proposes to make changes to d-Quotes for all Pilot Securities by
limiting instances when d-Quotes would exercise discretion.\33\
Further, for Pilot Securities in the Test Groups, the Exchange proposes
to specify references to the MPV, provide that pre-opening indications
would be published in $0.05 increments, require that MPL Orders with a
limit price must be entered in a $0.05 increment, and clarify how
Trading Collars that are not in the trading MPV would be handled. The
Exchange also proposes to specify that Retail Price Improvement Orders
must be entered with a limit price and an offset in a $0.005 pricing
increment in Test Groups Two and Three.
---------------------------------------------------------------------------

    \33\ See Amendment No. 2. The Exchange originally proposed to
limit d-Quotes from exercising discretion only in Test Group Three.
In Amendment No. 2, the Exchange proposes to apply the proposed
limitation of discretion to all Pilot Securities. The Commission
believes that the amendment to apply the proposed changes to the
exercise of discretion by d-Quotes to all Pilot Securities modifies
the proposal so that it does not have an unnecessary disparate
impact on the different Test Groups and the Control Group. Thus, the
Commission believes that the Exchange's proposal is consistent with
the Pilot. The Exchange has committed to make the systems changes
necessary to implement Amendment No. 2 no later than November 7,
2016. See Email from Clare Saperstein, Exchange to Kelly Riley, SEC
date October 2, 2016.
---------------------------------------------------------------------------

    The Exchange proposes changes for Pilot Securities in Test Group
Three to comply with the Trade-at Prohibition, including a different
priority for execution of resting orders, how certain ISOs would be
handled in Test Group Three, how resting non-displayed orders would
trade, how order with a STPN Modifier would be handled, and that g-
Quotes and Buy Minus/Zero Plus orders will be rejected. The Exchange
proposes to only permit buy and sell orders that are entered into the
Cross Function pursuant to Supplementary Material .10 to Rule 76 to be
eligible for the Block Size order exception to the Trade-at
Prohibition.\34\
---------------------------------------------------------------------------

    \34\ The Commission notes that the orders entered into the Cross
Function for purposes of relying on the Block Size exception must
satisfy the provisions of the exception, including that it may not
be an aggregation of non-block orders, or broken into orders smaller
than Block Size prior to submitting the order the Trading Center for
execution. See Exchange Rule 67(e)(4)(C)(iii).
---------------------------------------------------------------------------

    In addition, the Exchange proposes to amend provisions related to
two exceptions to the Trade-at Prohibition. First, the Exchange
proposes amend the TAISO definition to reflect that ISOs may be routed
to the full displayed size of a Protected Quotation that is traded-at
and to make the corresponding change to the specific trade-at
exception. Second, the Exchange proposes to amend the exception for
Block Size orders to allow an order of Block Size to be executed on
multiple Trading Centers.
    The Commission believes that these changes are reasonably designed
to comply with the Plan. Further, the Commission believes that the
proposed changes that are targeted at particular Test Groups are
necessary for compliance with the Plan. Accordingly, the Commission
finds that these changes are consistent with Section 6(b)(5) of the Act
\35\ and Rule 608 of Regulation NMS \36\ because they implement the
Plan and clarify Exchange Rules.
---------------------------------------------------------------------------

    \35\ 15 U.S.C. 78f(b)(5).
    \36\ 17 CFR 242.608.
---------------------------------------------------------------------------

    In addition, the Exchange proposes to adopt a rule to specify how
the Exchange will calculate LULD Price Bands after the Exchange opens
or reopens. The Commission believes that this change should help to
ensure that trading does not occur outside of Price Bands when LULD is
in effect.
    Finally, the Exchange proposes to specify that Trading Collars that
are not in the MPV would be rounded down to the nearest price. The
Commission believes that this change should provide clarity in the
Exchange's rules.
    For these reasons, the Commission finds that the proposed rule
change, as modified by Amendment No. 2, is consistent with the
requirements of the Act and Rule 608 of Regulation NMS.

V. Solicitation of Comments on Amendment No. 2

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether Amendment No. 2
is consistent with the Exchange 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_ADDRESS>Please include
File Number SR-NYSE-2016-62 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-NYSE-2016-62. 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 Web site (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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549-1090, on official business days between the hours
of 10:00 a.m. and 3:00 p.m. Copies of such filing will also be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSE-2016-62 and should be submitted on or before October 28, 2016.

VI. Accelerated Approval of Proposed Rule Change, as Modified by
Amendment No. 2

    The Commission finds good cause to approve the proposed rule
change, as modified by Amendment No. 2, prior to the thirtieth day
after the date of publication of notice of Amendment No. 2 in the
Federal Register. As described above, the Exchange proposes to amend
its rules to comply with the Plan and clarify other rules related to
LULD and Trading Collars.
    The Commission believes that the proposals related to LULD Price
Bands and Trading Collars should provide clarity on instances where
they are not in the MPV. The Commission believes that the proposals
related to the Pilot are designed to ensure compliance with the Plan.
The Commission notes that the Pilot is scheduled to start on October 3,
2016, and accelerated approval would ensure that the rules of the
Exchange would be in place for the start of the Pilot. Accordingly, the
Commission finds good cause, pursuant to Section 19(b)(2) of the
Act,\37\ to approve the proposed rule change, as modified by Amendment
No. 2, on an accelerated basis.
---------------------------------------------------------------------------

    \37\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

VII. Conclusion

    It is therefore ordered that, pursuant to Section 19(b)(2) of the
Act,\38\ the proposed rule change (SR-NYSE-2016-62), as modified by
Amendment No. 2, be and hereby is approved on an accelerated basis.
---------------------------------------------------------------------------

    \38\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\39\
---------------------------------------------------------------------------

    \39\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-24284 Filed 10-6-16; 8:45 am]
 BILLING CODE 8011-01-P