[Federal Register Volume 85, Number 108 (Thursday, June 4, 2020)]
[Proposed Rules]
[Pages 34371-34375]
[FR Doc No: 2020-12025]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0451; Product Identifier 2020-NM-036-AD]
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) 99-
01-19 and AD 2004-25-02, which apply to certain Airbus SAS Model A320
series airplanes. AD 99-01-19 and AD 2004-25-02 require repetitive
inspections to detect fatigue cracking in certain areas of the
fuselage, and corrective action if necessary. AD 2004-25-02 also
provides an optional terminating action for the repetitive inspections.
Since the FAA issued AD 2004-25-02, it has been reported that, during
full scale tests to support the Model A320 structure extended service
goal (ESG) exercise, several cracks were found on both sides of the
overwing emergency exit door cut-outs at fuselage section 15. This
proposed AD would continue to require, for certain airplanes,
repetitive inspections of the fastener holes for any cracking, and
repair if necessary, and would provide an optional terminating action
for the fastener hole inspections. This proposed AD would also expand
the applicable airplanes and require, for all airplanes, inspections of
the emergency exit door structure for any cracking and repair if
necessary; as specified in a European Union Aviation Safety Agency
(EASA) AD, which will be incorporated by reference. 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 July 20,
2020.

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 https://www.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: U.S. Department of Transportation, Docket
Operations, M-

30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    For EASA material that will be incorporated by reference (IBR) in
this AD, contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne,
Germany; telephone +49 221 89990 1000; email<EMAIL_ADDRESS>
internet www.easa.europa.eu. You may find this IBR material on the EASA
website at https://ad.easa.europa.eu. For Airbus service information
identified in this proposed AD, 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
<EMAIL_ADDRESS>internet https://www.airbus.com. You
may view this IBR 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 206-
231-3195. It is also available in the AD docket on the internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-0451.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0451; 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, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
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 the ADDRESSES section. Include ``Docket No. FAA-2020-0451;
Product Identifier 2020-NM-036-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. The FAA will
consider all comments received by the closing date and may amend this
NPRM based on those comments.
    The FAA will post all received comments, without change, to https://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact the agency receives about this NPRM.

Discussion

    The FAA issued AD 2004-25-02, Amendment 39-13889 (70 FR 1184,
January 6, 2005) (``AD 2004-25-02''), which applies to certain Airbus
SAS Model A320 series airplanes. AD 2004-25-02 requires repetitive
inspections to detect fatigue cracking in certain areas of the
fuselage, and corrective action if necessary. AD 2004-25-02 also
provides an optional terminating action for the repetitive inspections.
The FAA issued AD 2004-25-02 to address fatigue cracking of the
fuselage, which could result in reduced structural integrity of the
airplane.
    AD 2004-25-02 specifies that accomplishing the inspection in
paragraph (i) of that AD terminates the repetitive inspection
requirements of that AD. In addition, paragraph (f) of AD 2004-25-02
specifies that accomplishing the inspection in that paragraph
terminates the requirements of AD 99-01-19, Amendment 39-10987 (64 FR
1114, January 8, 1999) (``AD 99-01-19'').

Actions Since AD 2004-25-02 Was Issued

    Since the FAA issued AD 2004-25-02, the agency has determined
additional action is necessary to address the identified unsafe
condition and that additional airplanes are affected by the unsafe
condition.
    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0040, dated February 28, 2020
(``EASA AD 2020-0040'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Airbus SAS Model A319-111, -112, -113, -114, -115, -
131, -132, and -133 airplanes; and Model A320-211, -212, -214, -215, -
216, -231, -232, and -233 airplanes. Model A320-215 airplanes are not
certified by the FAA and are not included on the U.S. type certificate
data sheet; this AD therefore does not include those airplanes in the
applicability. EASA AD 2020-0040 supersedes French AD 2002-259(B),
dated May 15, 2002 (which corresponds to FAA AD 2004-25-12).
    This proposed AD was prompted by a report that during full scale
tests to support the Model A320 structure ESG exercise, several cracks
were found on both sides of the overwing emergency exit door cut-outs
at fuselage section 15. The FAA is proposing this AD to address fatigue
cracking of the fuselage, which could result in reduced structural
integrity of the airplane. See the MCAI for additional background
information.

Explanation of Retained Requirements

    Paragraphs (g), (h), (i), and (j) of this proposed AD restate the
requirements and optional terminating action of AD 2004-25-02, except a
terminating action for repaired areas is removed as of the effective
date of this AD. Paragraph (h) of AD 2004-25-02 (which corresponds to
paragraph (i) of this proposed AD), specifies that accomplishment of
the repair terminates the repetitive inspections for the area repaired.
However, paragraph (3) of EASA AD 2020-0040, specifies that the repair
does not terminate the repetitive inspections. The corresponding FAA
paragraph (paragraph (i) of this proposed AD) specifies the repair does
not terminate the inspections as of the effective date of this AD.
    In addition, the FAA has revised the service information compliance
language for the optional modification. Paragraph (i) of AD 2004-25-02
refers to using Airbus Service Bulletin A320-53-1031, dated December 9,
1994; or Revision 02, dated December 5, 2001, for the optional
modification. However, paragraph (j) of this proposed AD specifies
using Airbus Service Bulletin A320-53-1031, Revision 02, dated December
5, 2001, for the optional modification. The FAA has added paragraph (m)
of this proposed AD to provide credit for the optional modification if
done using Airbus Service Bulletin A320-53-1031, dated December 9,
1994.
    Also, the FAA did not restate paragraph (j) of AD 2004-25-02 in
this proposed AD because that paragraph was informational. If Airbus
Service Bulletin A320-53-1031, dated December 9, 1994; or Revision 02,
dated December 5, 2001; was used for the optional modification while
complying with AD 99-01-19, operators are in compliance with paragraph
(i) of AD 2004-25-02 (which now corresponds to paragraphs (j) and (m)
of this proposed AD).

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0040 describes, among other actions, procedures for
inspections of the emergency exit door structure for any cracking and
repair, and if necessary.
    Airbus has issued Service Bulletin A320-53-1031, Revision 02, dated
December 5, 2001. This service information describes procedures for
repetitive rotating probe inspections of the fasteners holes and repair
if necessary.
    This AD would also require Airbus Service Bulletin A320-53-1032,
Revision 02, dated December 5, 2001, which the Director of the Federal
Register approved for incorporation by reference as of February 10,
2005 (70 FR 1184, January 6, 2005).
    This AD would also require Airbus Service Bulletin A320-53-1032,
Revision 01, dated January 15, 1998, which the Director of the Federal
Register approved for incorporation by reference as of February 12,
1999 (64 FR 1114, January 8, 1999).
    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 and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the agency
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Proposed AD Requirements

    This proposed AD would retain the requirements of AD 2014-25-02.
This proposed AD would also expand the applicability and require
accomplishing the actions specified in EASA AD 2020-0040 described
previously, as incorporated by reference, except for any differences
identified as exceptions in the regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2020-0040
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with EASA AD 2020-0040 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 the EASA AD 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 the EASA AD. Service information specified
in EASA AD 2020-0040 that is required for compliance with EASA AD 2020-
0040 will be available on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2020-0451 after the FAA
final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 800 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 2004-25-  Up to 19 work-hours              $0  Up to $1,615.......  Up to $1,292,000.
 02.                                x $85 per hour =
                                    Up to $1,615.
New proposed actions.............  Up to 23 work-hours               0  Up to $1,955.......  Up to $1,564,000.
                                    x $85 per hour =
                                    Up to $1,955.
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    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: Modification, Repair of Fastener Holes, and Repair of Cracks in the
                              Emergency Exit Door Structure That Are Within Limits
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               Labor cost                          Parts cost                       Cost per product
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Up to 66 work-hours x $85 per hour = Up   Up to $85,000..............  Up to $90,610.
 to $5,610.
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    The FAA has received no definitive data that would enable the
agency to provide cost estimates for the on-condition repair of cracks
in the emergency exit door structure that are not within limits that is
specified in this proposed AD.

                  Estimated Costs for Optional Actions
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                                                             Cost per
              Labor cost                   Parts cost        product
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1 work-hour x $85 per hour = $85......          $4,219           $4,304
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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) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

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 removing Airworthiness Directive (AD)
99-01-19, Amendment 39-10987 (64 FR 1114, January 8, 1999); and AD
2004-25-02, Amendment 39-13889 (70 FR 1184, January 6, 2005); and
adding the following new AD:

Airbus SAS: Docket No. FAA-2020-0451; Product Identifier 2020-NM-
036-AD.

(a) Comments Due Date

    The FAA must receive comments by July 20, 2020.

(b) Affected ADs

    This AD replaces AD 99-01-19, Amendment 39-10987 (64 FR 1114,
January 8, 1999) (``AD 99-01-19''); and AD 2004-25-02, Amendment 39-
13889 (70 FR 1184, January 6, 2005) (``AD 2004-25-02'').

(c) Applicability

    This AD applies to all Airbus SAS Model A319-111, -112, -113, -
114, -115, -131, -132, and -133 airplanes; and Model A320-211, -212,
-214, -216, -231, -232, and -233 airplanes, certificated in any
category.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by a report that, during full scale tests
to support the Model A320 structure extended service goal (ESG)
exercise, several cracks were found on both sides of the overwing
emergency exit door cut-outs at fuselage section 15. The FAA is
issuing this AD to address fatigue cracking of the fuselage, which
could result in reduced structural integrity of the airplane.

(f) Compliance

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

(g) Retained Initial Inspections, with No Changes

    For Airbus SAS Model A320-111, -211, -212, and -231 series
airplanes on which Airbus Modification 21346 has not been done: This
paragraph restates the requirements of paragraph (f) of AD 2004-25-
02, with no changes. At the applicable time specified in paragraph
(g)(1) or (2) of this AD: Do a detailed inspection to find cracking
on the outboard flanges around the fastener holes of frames 38
through 41, between stringers 12 and 21, using Airbus Service
Bulletin A320-53-1032, Revision 02, dated December 5, 2001.
    (1) For airplanes on which the inspection specified in Airbus
Service Bulletin A320-53-1032, Revision 01, dated January 15, 1998;
or Airbus Service Bulletin A320-53-1032, Revision 02, dated December
5, 2001; has been done as of February 10, 2005 (the effective date
of AD 2004-25-02): Do the next inspection within 4,900 flight cycles
after accomplishment of the last inspection, or within 1,100 flight
cycles after February 10, 2005, whichever is later.
    (2) For airplanes on which no inspection specified in Airbus
Service Bulletin A320-53-1032, Revision 01, dated January 15, 1998;
or Airbus Service Bulletin A320-53-1032, Revision 02, dated December
5, 2001; has been done as of February 10, 2005 (the effective date
of AD 2004-25-02): Do the inspection at the earlier of the times
specified in paragraphs (g)(2)(i) and (ii) of this AD.
    (i) Before the accumulation of 30,000 total flight cycles.
    (ii) Before the accumulation of 24,800 total flight cycles, or
within 3,500 flight cycles after February 10, 2005 (the effective
date of AD 2004-25-02), whichever is later.

(h) Retained Repetitive Inspections if No Cracking Is Found, With No
Changes

    This paragraph restates the requirements of paragraph (g) of AD
2004-25-02, with no changes. If no crack is found during the
inspection required by paragraph (g)(1) or (2) of this AD: Repeat
the inspection thereafter at intervals not to exceed 4,900 flight
cycles.

(i) Retained Corrective Actions With New Repetitive Inspections and
Compliance Language

    This paragraph restates the requirements of paragraph (h) of AD
2004-25-02, with new repetitive inspections and compliance language.
If any crack is found during any inspection required by paragraph
(g) of this AD, before further flight, repair using Airbus Service
Bulletin A320-53-1032, Revision 01, dated January 15, 1998; or
Airbus Service Bulletin A320-53-1032, Revision 02, dated December 5,
2001. Accomplishment of a repair using the service bulletin before
the effective date of this AD ends the repetitive inspection
requirements for the area repaired. As of the effective date of this
AD, the repair does not constitute terminating action for the
repetitive inspection. Thereafter, repeat the inspection at
intervals not to exceed 4,900 flight cycles. If any crack is found
during any inspection required by this AD, and the service bulletin
specifies to contact Airbus for appropriate action: Before further
flight, repair using a method approved by the Manager, Large
Aircraft Section, International Validation Branch, FAA.

(j) Retained Optional Terminating Action With Changes to the Service
Information Compliance Language

    This paragraph restates the optional terminating action
specified in paragraphs (i) and (j) of AD 2004-25-02, with changes
to the service information compliance language. Accomplishment of
Airbus Modification 21346 using Airbus Service Bulletin A320-53-
1031, Revision 02, dated December 5, 2001, constitutes terminating
action for the repetitive inspection requirements of paragraphs (h)
and (i) this AD.

(k) New Requirements

    Except as specified in paragraph (l) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2020-0040, dated February 28, 2020 (``EASA AD 2020-0040'').

(l) Exceptions to EASA AD 2020-0040

    (1) Where EASA AD 2020-0040 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where EASA AD 2020-0040 requires the accomplishment of
repetitive inspections and corrective actions as specified in
paragraphs (1) and (2) of the EASA AD, those actions are not
required by this AD as specified in the EASA AD. Those actions are
required by paragraphs (g), (h), and (i) of this AD.

(m) Credit for Previous Actions

    This paragraph provides credit for the optional terminating
action specified in paragraph (j) of this AD, if Airbus Modification
21346 was performed before the effective date of this AD using
Airbus Service Bulletin A320-53-1031, dated December 9, 1994.

(n) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, 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 local Flight
Standards District Office, as appropriate. If sending information
directly to the Large Aircraft Section, International Validation
Branch, FAA, send it to the attention of the person identified in
paragraph (o)(2) of this AD. Information may be emailed to<EMAIL_ADDRESS>    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (ii) AMOCs approved previously for AD 2004-25-02 are approved as
AMOCs for the corresponding provisions of paragraphs (g) through (j)
of this AD.
    (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, Large Aircraft
Section, 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.

(o) Related Information

    (1) For information about EASA AD 2020-0040, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
89990 6017; email<EMAIL_ADDRESS>Internet www.easa.europa.eu.
You may find this EASA AD on the EASA website at https://ad.easa.europa.eu. For Airbus service information identified in this
AD, 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<EMAIL_ADDRESS>
internet https://www.airbus.com. 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>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2020-0451.
    (2) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
    Issued on May 29, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-12025 Filed 6-3-20; 8:45 am]
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[Federal Register: May 1, 2009 (Volume 74, Number 83)]
[Notices]
[Page 20322-20323]
[DOCID:fr01my09-51]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0181]

Draft Guidance for Industry on Label Comprehension Studies for
Nonprescription Drug Products; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Label
Comprehension Studies for Nonprescription Drug Products.'' The draft
guidance provides recommendations on the design of label comprehension
studies, which can be used to assess the extent to which consumers
understand the information conveyed by proposed nonprescription drug
product labeling and then apply that information when making
hypothetical drug product use decisions.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by July 30, 2009.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT:  Laura Shay, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5466, Silver Spring, MD 20993-0002, 301-
796-0994.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Label Comprehension Studies for Nonprescription Drug
Products.'' This draft guidance is intended for individuals or
organizations involved in the development of label comprehension
studies for nonprescription drug products. This draft guidance
discusses general concepts to be considered in the design and conduct
of a label comprehension study. This draft guidance also incorporates
advice obtained from the September 25, 2006, meeting of the
Nonprescription Drug Advisory Committee that considered issues related
to the analysis and interpretation of consumer behavior studies
conducted to support marketing of nonprescription drug products.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on label
comprehension studies for nonprescription drug products. It does not
create or confer any rights for or on any person and does not operate
to bind

FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that 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 parts 312 and 314 have
been approved under OMB Control Numbers 0910-0014 and 0910-0001,
respectively.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
www.regulations.gov.

    Dated: April 22, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-10005 Filed 4-30-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 118 (Tuesday, June 19, 2018)]
[Notices]
[Pages 28479-28481]
[FR Doc No: 2018-13083]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83424; File No. SR-NYSE-2018-27]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Its Price List

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

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend its Price List to (1) add a new
incentive for member organizations and Supplemental Liquidity Providers
(``SLP'') in Tape A securities when adding liquidity in securities
traded pursuant to Unlisted Trading Privileges (``UTP'') (Tapes B and
C) on the Pillar Trading Platform; (2) add a new Tier 4 for SLPs; and
(3) make non-substantive changes to eliminate obsolete footnotes. The
Exchange proposes to implement these changes to its Price List
effective June 1, 2018. The proposed rule change is available on the
Exchange's website at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend its Price List to (1) add a new
incentive for member organizations and SLPs on Tape A when adding
liquidity in UTP Securities (Tapes B and C) on the Pillar Trading
Platform; (2) add a new Tier 4 for SLPs; and (3) make non-substantive
changes to eliminate obsolete footnotes.
    The Exchange proposes to implement these changes to its Price List
effective June 1, 2018.
New Cross Tape Incentive
    The Exchange proposes an additional incentive to member
organizations and SLPs in Tape A securities that add liquidity to the
Exchange in UTP Securities, as follows.
    As proposed, member organizations that meet the current
requirements for the Non-Tier Adding Credit, Tier 3 Adding Credit, and
Tier 4 Adding Credit on Tape A would be eligible to receive an
additional $0.0001 per share if the member organization adds liquidity,
excluding liquidity added as an SLP, in UTP Securities of at least
0.20% of Tape B and Tape C consolidated average daily volume (``CADV'')
combined.
    Similarly, SLPs that (1) meet the current requirements for SLP Tier
3, SLP Tier 2 and SLP Tier 1A credits, and (2) add liquidity in UTP
Securities of at least 0.30% of Tape B and Tape C CADV combined, would
be eligible for an additional $0.0001 per share in securities with a
per share price of $1.00 or more that meet the 10% average or more
quoting requirement in an assigned security pursuant to Rule 107B
(quotes of an SLP-Prop and an SLMM of the same member organization
would not be aggregated).
New SLP Tier 4
    The Exchange proposes a new, fifth SLP Tier designated ``4'' that
would provide that an SLP that either (1) is in the first two calendar
months as an SLP, or (2) adds liquidity for all assigned SLP securities
in the aggregate (including shares of both an SLP-Prop and an SLMM \4\
of the same or an affiliated member organization) of an ADV of more
than 0.03% of NYSE CADV after averaging less an adding ADV \5\ of than
0.01% in each of the prior 3 months, after a discount of the percentage
for the prior quarter of NYSE CADV in DMM assigned securities as of the
last business day of the prior month, would receive a credit of
$0.0029, or $0.00105 if a Non-Displayed Reserve Order, if the SLP meets
the 10% average or more quoting requirement in an assigned security
pursuant to Rule 107B when adding liquidity to the NYSE with orders,
other than Mid-Point Liquidity (``MPL'') orders, in securities with a
per share price of $1.00 or more. For

purposes of qualifying for the proposed Tier, quotes of an SLP-Prop and
an SLMM of the same member organization would not be aggregated. The
Exchange believes that the new tier will provide greater incentives for
newer and less active SLPs to add liquidity to the Exchange.
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    \4\ Under Rule 107B, an SLP can be either a proprietary trading
unit of a member organization (``SLP-Prop'') or a registered market
maker at the Exchange (``SLMM''). For purposes of the 10% average or
more quoting requirement in assigned securities pursuant to Rule
107B, quotes of an SLP-Prop and an SLMM of the same member
organization are not aggregated. However, for purposes of adding
liquidity for assigned SLP securities in the aggregate, shares of
both an SLP-Prop and an SLMM of the same member organization are
included.
    \5\ The phrase ``Adding ADV'' in the proposed tier would have a
citation to footnote 4 in the current Price List, which provides
``For purposes of transaction fees and Supplemental Liquidity
Provider liquidity credits, ADV calculations exclude early closing
days.'' The text of current footnote 4 would remain unchanged.
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Non-Substantive Changes
    Currently, as reflected in footnote * to the section of the Price
List setting forth adding tiers for trading UTP Securities,\6\ the
Exchange waives the Tier 1 adding tier requirement and the remove tier
requirements for securities priced at or above $1.00 until June 1,
2018. Similarly, as reflected in footnote ** of the section of the
Price List setting forth the SLP Provide Tiers for trading in UTP
Securities, the Exchange also currently waives the provide volume
component of the SLP Tier requirements for securities priced at or
above $1.00 until June 1, 2018. Because the waivers set forth in
footnotes * and ** expire on June 1, 2018, and the Exchange does not
propose to extend the waivers, the Exchange accordingly proposes to
delete footnotes * and ** as obsolete.
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    \6\ The term ``UTP Security'' means a security that is listed on
a national securities exchange other than the Exchange and that
trades on the Exchange pursuant to unlisted trading privileges. See
Rule 1.1(ii).
---------------------------------------------------------------------------

* * * * *
    The proposed changes are not otherwise intended to address any
other issues, and the Exchange is not aware of any problems that member
organizations would have in complying with the proposed change.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\7\ in general, and furthers the
objectives of Sections 6(b)(4) and 6(b)(5) of the Act,\8\ in
particular, because it provides for the equitable allocation of
reasonable dues, fees, and other charges among its members, issuers and
other persons using its facilities and does not unfairly discriminate
between customers, issuers, brokers or dealers.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4) & (5).
---------------------------------------------------------------------------

New Cross Tape Incentive
    The Exchange believes that providing an additional incentive in
Tape A securities for member organizations that add liquidity in UTP
Securities is reasonable because it would further contribute to
incenting member organizations to provide additional liquidity to a
public exchange in UTP Securities, thereby promoting price discovery
and transparency and enhancing order execution opportunities for member
organizations. The Exchange believes that that the proposal is
reasonable and not unfairly discriminatory because it would apply to
all member organizations eligible for the relevant Tape A tier credits
equally. The Exchange further believes that limiting the additional
credit to Non-Tier, Adding Tier 3 and Adding Tier 4 is reasonable
because members qualifying for Adding Tier 1 and Adding Tier 2 would
already receive a higher credit for such executions. Similarly, the
Exchange believes that limiting the additional credit to SLP Tier 3,
SLP Tier 2 and SLP Tier 1A is reasonable because SLPs qualifying for
SLP Tier 1 would already receive a higher credit for such executions.
New SLP Tier 4
    The Exchange believes that the proposal to introduce a new SLP Tier
4 is reasonable because it provides SLPs as well as SLPs that are also
DMMs with an additional way to qualify for a rebate, thereby providing
SLPs with greater flexibility and creating an added incentive for SLPs
to bring additional order flow to a public market. In particular, as
noted above, the Exchange believes that the new tier will provide
greater incentives for newer and less active SLPs to add liquidity to
the Exchange, to the benefit of the investing public and all market
participants. Moreover, offering a higher credit for the first two
months would provide an incentive for new and less active SLPs to add
liquidity and meet the SLP quoting requirements, thereby contributing
to additional levels of liquidity at the Exchange, which benefits all
market participants. The Exchange also believes that the two-month
period for new SLPs and inactive SLPs to qualify for the new tier is
reasonable because it will allow newer and less active SLPs more time
to meet the SLP volume requirements while building up the SLPs'
liquidity providing activities during the first two months. Finally,
the Exchange believes that the proposed tier is equitable and not
unfairly discriminatory because it would apply equally to all SLPs and
because there are two ways to qualify for the proposed tier.
Non-Substantive Changes
    The Exchange believes that the proposed deletion of footnotes * and
** removes impediments to and perfects the mechanism of a free and open
market by adding clarity as to whether waivers are operative and when,
thereby reducing potential confusion, and making the Exchange's rules
easier to navigate. The Exchange also believes that eliminating
obsolete material from its rulebook also removes impediments to and
perfects the mechanism of a free and open market by removing confusion
that may result from having obsolete material in the Exchange's
rulebook. The Exchange believes that eliminating such obsolete material
would not be inconsistent with the public interest and the protection
of investors because investors will not be harmed and in fact would
benefit from increased transparency, thereby reducing potential
confusion.
    Finally, the Exchange believes that it is subject to significant
competitive forces, as described below in the Exchange's statement
regarding the burden on competition.
    For the foregoing reasons, the Exchange believes that the proposal
is consistent with the Act.

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

    In accordance with Section 6(b)(8) of the Act,\9\ the Exchange
believes that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. Instead, the Exchange believes that the proposed
change would foster liquidity provision and stability in the
marketplace, thereby promoting price discovery and transparency and
enhancing order execution opportunities for member organizations. In
this regard, the Exchange believes that the transparency and
competitiveness of attracting additional executions on an exchange
market would encourage competition. The Exchange also believes that the
proposed rule change is designed to provide the public and investors
with a Price List that is clear and consistent, thereby reducing
burdens on the marketplace and facilitating investor protection.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    Finally, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive or rebate opportunities available at other venues to be more
favorable. In such an environment, the Exchange must continually adjust
its fees and rebates to remain competitive with other exchanges and
with alternative trading systems that have been exempted from
compliance with the statutory standards applicable to exchanges.
Because competitors are free to modify their own fees and credits in

response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited. As a result of all of these considerations, the
Exchange does not believe that the proposed changes will impair the
ability of member organizations or competing order execution venues to
maintain their competitive standing in the financial markets.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \10\ of the Act and subparagraph (f)(2) of Rule
19b-4 \11\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \12\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSE-2018-27 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2018-27. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSE-2018-27 and should be submitted on
or before July 10, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-13083 Filed 6-18-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 128 (Tuesday, July 3, 2018)]
[Notices]
[Pages 31198-31201]
[FR Doc No: 2018-14297]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83537; File No. SR-CboeBZX-2018-042]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to Rule
11.9, Orders and Modifiers

June 28, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 18, 2018, Cboe BZX Exchange, Inc. (the ``Exchange'' or ``BZX'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Exchange has designated this
proposal as a ``non-controversial'' proposed rule change pursuant to
Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\
which renders it effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange filed a proposal to add a new optional order type
modifier to be known as Non-Displayed Swap. The proposed amendments are
substantively identical to the rules of Cboe EDGX Exchange, Inc.
(``EDGX'') \5\ and substantially similar to the rules of the Nasdaq
Stock Market LLC (``Nasdaq'') \6\ and NYSE Arca, Inc. (``Arca'').\7\
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    \5\ See EDGX Rules 11.6(n)(7), 11.8(b)(7) and 11.8(d)(5); see
also Securities Exchange Act Release No. 80841 (June 1, 2017), 82 FR
26559 (June 7, 2017), (Notice of Filing and Immediate Effectiveness
To Add a New Optional Order Instruction Known as Non-Displayed
Swap).
    \6\ See Nasdaq Rule 4703(m) (defining the Trade Now order
modifier); see also Securities Exchange Act Release No. 79282
(November 10, 2016), 81 FR 81219 (November 17, 2016) (Notice of
Filing and Immediate Effectiveness of Proposed Rule change to Amend
Rule 4702 and Rule 4703 to Add a ``Trade Now'' Instruction to
Certain Order Types).
    \7\ See Arca Rule 7.31-E(d)(2)(B) (describing the Non-Display
Remove Modifier); see also Securities Exchange Act Release No. 76267
(October 26, 2015), 80 FR 66951 (October 30, 2015) (Order Approving
Proposed Rule change Adopting New Equity Trading Rules Relating to
Orders and Modifiers and Retail Liquidity Program To Reflect the
Implementation of Pillar, the Exchange's New Trading Technology
Platform).
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
website at

www.markets.cboe.com, at the Exchange's principal office and at the
Public Reference Room of the Commission.

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

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

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

1. Purpose
    The Exchange proposes to add a new optional order type modifier to
be known as Non-Displayed Swap. The proposed amendments are
substantively identical to the rules of EDGX \8\ and substantially
similar to the rules of Nasdaq and Arca.\9\
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    \8\ See supra note 5.
    \9\ See supra notes 6 and 7.
---------------------------------------------------------------------------

    The proposed Non-Displayed Swap (``NDS'') instruction would provide
resting limit orders that are not displayed on the Exchange \10\ and
Mid-Point Peg Orders resting on the BZX Book \11\ with a greater
ability to receive an execution when that resting order is locked by an
incoming order (e.g., the price of the resting non-displayed order is
equal to the price of the incoming order that is to be placed on the
BZX Book). The NDS instruction would be an optional order instruction
that would allow Users \12\ to have their resting non-displayed orders
execute against an incoming order with a Post Only instruction rather
than have it be locked by the incoming order. NDS would be defined as
an instruction on an order resting on the BZX Book that, when locked by
an incoming order with a Post Only instruction that does not remove
liquidity pursuant to paragraph (c)(6) of Exchange Rule 11.9,\13\
causes such order to be converted to an executable order that removes
liquidity against such incoming order. An NDS instruction would only be
eligible for inclusion on a non-displayed limit order or a Mid-Point
Peg Order. An order with a NDS instruction would not be eligible for
routing pursuant to Exchange Rule 11.13, Order Execution and Routing.
The proposed NDS instruction assists in the avoidance of an internally
locked BZX Book (though such lock would not be displayed by the
Exchange) \14\ by facilitating the execution of orders that would
otherwise lock each other.
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    \10\ See Exchange Rule 11.9(c)(11).
    \11\ See Exchange Rule 1.5(e).
    \12\ See Exchange Rule 1.5(cc).
    \13\ Under Exchange Rule 11.9(c)(6), a BZX Post Only Order will
remove contra-side liquidity from the BZX Book if the order is an
order to buy or sell a security priced below $1.00 or if the value
of such execution when removing liquidity equals or exceeds the
value of such execution if the order instead posted to the BZX Book
and subsequently provided liquidity, including the applicable fees
charged or rebates provided. To determine at the time of a potential
execution whether the value of such execution when removing
liquidity equals or exceeds the value of such execution if the order
instead posted to the BZX Book and subsequently provided liquidity,
the Exchange will use the highest possible rebate paid and highest
possible fee charged for such executions on the Exchange.
    \14\ See Exchange Rule 11.13(a)(4)(C).
---------------------------------------------------------------------------

    The following example illustrates the operation of an order with a
NDS instruction. Assume the National Best Bid and Offer is $10.00 by
$10.04. There is a non-displayed limit order to buy resting on the BZX
Book at $10.03. A BZX Post Only Order to sell priced at $10.03 is
entered. Under current behavior, the incoming sell order marked as Post
Only would post to the BZX Book because it would not receive sufficient
price improvement.\15\ This would result in the BZX Book being
internally locked.\16\ As proposed, if the non-displayed limit order to
buy also included a NDS instruction, the orders would instead execute
against each other at $10.03, with the resting buy order with the NDS
instruction becoming the remover of liquidity and the incoming BZX Post
Only Order to sell becoming the liquidity provider.
---------------------------------------------------------------------------

    \15\ Id. [sic]
    \16\ In the event the incoming order with a Post Only
instruction was to be displayed, it would post and display at $10.03
and the resting buy order with a Non-Displayed instruction would not
execute against it or subsequent incoming sell orders at $10.03 for
so long as the sell order was displayed on the Exchange. See
Exchange Rule 11.13(a)(4)(C) and (D).
---------------------------------------------------------------------------

    Assume the same facts as above, but that a non-displayed limit
order to buy at $10.03 (``Order A'') is also resting on the BZX Book
with time priority ahead of the non-displayed limit order mentioned
above (``Order B''). Like above, a BZX Post Only Order to sell priced
at $10.03 is entered. Under current behavior, the incoming BZX Post
Only Order to sell would post to the BZX Book because the value of such
execution against the resting buy interest when removing liquidity does
not equal or exceed the value of such execution if the order instead
posted to the BZX Book and subsequently provided liquidity, including
the applicable fees charged or rebates provided. As proposed, if Order
B also included a NDS instruction, the incoming sell order would
execute against Order B and such order would become the remover of
liquidity and the BZX Post Only Order to sell would become the
liquidity provider. In such case, Order A cedes time priority to Order
B because Order A did not also include a NDS instruction and thus the
User that submitted Order A did not indicate the preference to be
treated as the remover of liquidity in favor of an execution; instead,
by not using NDS, a User indicates the preference to remain posted on
the BZX Book as a liquidity provider.\17\ However, if the incoming sell
order was priced at $10.02, it would receive sufficient price
improvement to execute upon entry against all resting buy limit orders
in time priority at $10.03.\18\
---------------------------------------------------------------------------

    \17\ Should the limit order to buy at $10.03 with time priority
(i.e., Order A) be displayed on the BZX Book, the incoming BZX Post
Only Order to sell at $10.03 will not execute against the non-
displayed buy order with a NDS instruction because displayed orders
have priority over non-displayed orders. In such a case, the
incoming limit order would be handled as it is today in accordance
with existing Exchange rules. See, e.g., Exchange Rules 11.9 and
11.13(a).
    \18\ The execution occurs here because the value of the
execution against the buy order when removing liquidity exceeds the
value of such execution if the order instead posted to the BZX Book
and subsequently provided liquidity, including the applicable fees
charged or rebates provided. See supra note 13.
---------------------------------------------------------------------------

    If the order with a NDS instruction is only partially executed, the
unexecuted portion of that order remains on the BZX Book and maintains
its priority, as is the case today for an order that is partially
executed and not cancelled by the User.\19\ The Exchange is proposing
to make the NDS instruction available to limit orders \20\ that are not
displayed on the Exchange \21\ and MidPoint Peg Orders.\22\ Because the
NDS instruction would be only available to limit orders not displayed
on the Exchange and to MidPoint Peg Orders, the NDS instruction would
not be available to other order types provided by the Exchange under
its Rule 11.9, such as BZX Market Orders, Reserve Orders, and Market
Maker Peg Orders,\23\ as the NDS instruction would be inconsistent with
the use of those order types. The NDS instruction could, however, be
combined with other instructions also

available to non-displayed limit orders, such as the Minimum Quantity
Order instruction, the Primary Pegged Order instruction, the Market
Pegged Order instruction or the Discretionary Order instruction.\24\
---------------------------------------------------------------------------

    \19\ See Exchange Rule 11.12(a)(5).
    \20\ See Exchange Rule 11.9(a)(1).
    \21\ See Exchange Rule 11.9(c)(11).
    \22\ See Exchange Rule 11.9(c)(9).
    \23\ See Exchange Rules 11.9(a)(2), 11.9(c)(1) and 11.9(c)(16),
respectively.
    \24\ See Exchange Rules 11.9(c)(5), 11.9(c)(8)(A), 11.9(c)(8)(B)
and 11.9(c)(10), respectively.
---------------------------------------------------------------------------

    The Exchange notes that similar functionality exists on Nasdaq and
Arca. Nasdaq refers to their functionality as the ``Trade Now''
instruction \25\ and Arca refers to their functionality as the ``Non-
Display Remove Modifier''.\26\ On Arca, a Limit Non-Displayed Order may
be designated with a Non-Display Remove Modifier. If so designated, a
Limit Non-Displayed Order to buy (sell) will trade as the remover of
liquidity with an incoming Adding Liquidity Only Order (``ALO Order'')
to sell (buy) that has a working price equal to the working price of
the Limit Non-Displayed Order.\27\ On Nasdaq, Trade Now is an order
attribute that allows a resting order that becomes locked by an
incoming Displayed Order to execute against the available size of the
contra-side locking order as a liquidity taker, and any remaining
shares of the resting order will remain posted on the Nasdaq Book with
the same priority.\28\ Nasdaq requires the contra-side order to be
display eligible, while the Exchange proposes to enable an order with a
NDS instruction to remove liquidity regardless of whether the incoming
order would have ultimately been eligible for display consistent with
Arca's Non-Display Remove Modifier.
---------------------------------------------------------------------------

    \25\ See Nasdaq Rule 4703(m). See also Securities and Exchange
Act Release No. 79282 (November 10, 2016), 81 FR 81219 (November 17,
2016) (SR-Nasdaq-2016-156) (Notice of Filing and Immediate
Effectiveness of Proposed Rule Change to Amend Rule 4703 and Rule
4703 to add a ``Trade Now'' Instruction to Certain Order Types).
    \26\ See Arca Rule 7.31-E(d)(2)(B). See also Securities and
Exchange Act Release No. 76267 (October 26, 2015), 80 FR 66951
(October 30, 2015) (SR-NYSEArca-2015-56) (Order Approving Proposed
Rule Change, and Notice of Filing and Order Granting Accelerated
Approval of Amendment Nos. 1 and 2 Thereto, Adopting New Equity
Trading Rules Relating to Orders and Modifiers and the Retail
Liquidity Program To Reflect the Implementation of Pillar, the
Exchange's New Trading Technology Platform) (including the Non-
Display Remove Modifier).
    \27\ See Arca Rule 7.31-E(d)(2)(b).
    \28\ Arca provides their Non-Display Remove Modifier to their
Mid-Point Liquidity Orders (``MPL Orders'') designated Day and MPL-
ALO Orders and Arca Only Orders. Nasdaq's Trade Now functionality is
available to Price to Comply Orders, Price to Display Orders, Non-
Displayed Orders, Post-Only Orders, Midpoint Peg Post-Only Orders,
and Market Maker Peg Orders. To the extent the NDS instruction is
only available to non-displayed limit orders and MidPoint Peg
Orders, the Exchange notes that the NDS instruction will apply to
different order types than Arca's Non-Display Remove Modifier and
Nasdaq's Trade Now functionality.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \29\ in general, and furthers the objectives of Section
6(b)(5) of the Act \30\ in particular, in that it is designed to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system and, in general, to
protect investors and the public interest by offering Users optional
functionality that will facilitate the execution of orders that would
otherwise remain unexecuted, thereby increasing the efficient
functioning of the Exchange. The NDS instruction is an optional feature
that is intended to reflect the order management practices of various
market participants. The proposed NDS instruction assists in the
avoidance of an internally locked BZX Book by facilitating the
execution of orders that would otherwise post, or remain posted, to the
BZX Book.
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    \29\ 15 U.S.C. 78f(b).
    \30\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. On
the contrary, the Exchange believes the proposed rule change promotes
competition because it will enable the Exchange to offer functionality
substantially similar to that offered by Nasdaq and Arca (in addition
to the fact that such functionality is identical to that already
offered by the Exchange's affiliate, EDGX).\31\ Therefore, the Exchange
does not believe the proposed rule change will result in any burden on
intermarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act. As the NDS feature will be
equally available to all Users, the Exchange does not believe the
proposed rule change will result in any burden on intramarket
competition that is not necessary or appropriate in furtherance of the
purposes of the Act.
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    \31\ See supra notes 5-7.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No comments were solicited or received on the proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \32\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\33\
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    \32\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \33\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of the filing. However,
Rule 19b-4(f)(6)(iii) \34\ permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. In its filing, BZX requested that
the Commission waive the 30-day operative delay so that the Exchange
can implement the proposed rule change promptly after filing. The
Exchange noted that the proposed functionality is optional, may lead to
increased order interaction on the Exchange, and is identical to
functionality already provided on EDGX. The Commission believes that
waiver of the 30-day operative delay is consistent with the protection
of investors and the public interest, as such waiver will permit the
Exchange to update its rule without delay so that it provides the same
optional NDS functionality as is available on EDGX and potentially
increase order interaction on the Exchange. Accordingly, the Commission
waives the 30-day operative delay and designates the proposed rule
change operative upon filing.\35\
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    \34\ 17 CFR 240.19b-4(f)(6)(iii).
    \35\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the

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

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-CboeBZX-2018-042 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-CboeBZX-2018-042. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeBZX-2018-042, and should be
submitted on or before July 24, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\36\
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    \36\ 17 CFR 200.30-3(a)(12) and (59).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-14297 Filed 7-2-18; 8:45 am]
 BILLING CODE 8011-01-P


TABLE 1. AVERAGE ANNUAL EPA RESOURCE REQUIREMENT FOR FACILITIES SUBJECT TO THE NSPS SUBPART VVV: POLYMERIC COATING OF SUPPORTING SUBSTRATES ( A) ( B) ( C) ( D= BXC) ( E) b EPA hrs/ EPA hrs/ lines/ EPA hrs/ Cost/

Occurrence line/ yr year year year a ACTIVITY New Affected Facilities Initial Performance Tests ( b+ c) 12 12 6.4 d 76.8 2,840.1 Repeat Performance e Tests 12 12 0.2 f 2.4 88.8 Notification of construction 2 2 6 12 443.8 Notification of actual startup 2 2 6 12 443.8 Notification of initial test ( b+ c+ g) 2 2 7.5 15 554.7 Notification of VOC use at the end of the initial year g 2 2 1 h 2 f 74.0 Review test results ( b+ c) 8 8 5 40 1,479.2 New and Existing Affected Facilities Quarterly reports of 8 32 i 11.2 j 358.4 13,253.6 monitoring exceedances and i periods of non compliance Semiannual reports of 2 4 i 44.8k 179.2 6,626.8 no excess emissions d Report when 1st projected VOC use exceeds the applicable cutoff 2 2 0l 0 0 Report when 1st actual 12 month VOC use exceeds the applicable cutoff 2 2 0l 0 0 Notification of changes 2 2 2.5g 5 184.9 TOTAL ANNUAL HOURS 702.8 25,989.5 Travel Expenses m ( 1 person x 4.1 lines/ yr x 1.5 day/ plant x $ 85 per diem/ day/ person) + ($ 350 round trip/ plant x 4.1 plants/ yr) = $ 1,957.8 TOTAL ANNUAL COST= $ 27,947.3 a This cost is based on the annual wage of a government employee at a grade of GS12, step 1 ($ 23.11) plus 60 percent overhead for a total of $ 36.98. This amount was multiplied by the hours per year in Column D.

b There are a total of 51 existing plants subject to this NSPS, according to AIRS. Assume that each existing plant has one solvent borne coating operation subject to this NSPS. Assume that a total of 5 new coating lines per year will be installed at existing plants. Of these 5 lines per year, 4 are expected to be solvent borne lines with annual VOC usage greater than 95 Mg/ yr and 1 a water borne line.

This assumption is based on the fact that the growth in this industry is expected in lines with annual VOC usage greater that 95 Mg per year, according to the economic impact analysis done for the development of this rule. Water borne lines will not have to be tested.

c Assume one additional solvent borne coating operation with VOC usage greater than 95Mg/ yr per year will be installed at a new plant and will become subject to the standard in the next three years.

d A total of 5 new solvent borne lines per year and 3 modified solvent borne lines perform initial performance test. EPA personnel attend 80 percent of these tests, or 6.4 tests per year.

e Assume 20 percent of initial performance tests must be repeated due to failure ( 8 solvent borne coating lines x 0.20 = 1.6).

f Ten percent of the initial performance retests are attended by EPA personnel ( 0.1 x 1.6= 0.16, rounded to 0.2)

g Assume that changes constituting modification or reconstruction making an existing coating operation and/ or a coating mix preparation equipment ( e. g., changes to an existing coating mix preparation equipment such as the replacement of a coating applicator or the oven and installing a new part), subject to this NSPS will not occur frequently. Therefore, we assume that only 5 percent of the existing polymeric coating plants will undertake a change that constitute modification over the next three years ( 0.05 X 51= 2.5 per year).

h An affected facility claiming to use less than 95Mg per year or less than 130 Mg per year of VOC in the first year of operation shall submit actual VOC records at the end of the initial year. As stated in ( b)

and ( c) above, there is one new water borne line( which uses less than 95 Mg of VOC per year) being installed at existing plants over the year period. This existing plant would be required to submit a notification of VOC use at the end of the initial year of operation of its new coating line. Also we assume that all of the 5 new solvent borne lines being installed use at least 130 Mg of VOC per year and are not required to notified actual VOC use at the end of the initial year.

i ( A) x number of reports required annually.

j Assume that 20 percent of the affected facilities ( either complying with the emission reduction standard,

the alternative standard and/ or coating mix preparation equipment standard) report monitoring exceedances or periods of noncompliance quarterly. Since the average number of solvent borne lines with recurrent annual burden is 56 ( 51 existing lines + 5 additional new lines per year over the three year period= 56 lines), then 20 percent of that number equals 11.2 ( 0.2 x 56= 11.2). Rounded to 11.

k Assume 80 percent of the solvent borne lines report no excess emissions semiannually.

( 0.8 x 56 = 44.8). Rounded to 45.

l No lines with projected VOC consumption of less than 95 Mg/ yr or less than 130 Mg of VOC are expected to exceed the cutoff value in the future.

m Tests attended = 4 ( initial tests) + 0.1 ( repeat tests)= 4.1 tests.