UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF PREVENTION, PESTICIDE
                              AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:		June 18, 2008

SUBJECT:	1,3-Dichloropropene, PC Code 029001, DP Barcode 347278; HED
Component of Response To Comments Document On 1,3-Dichloropropene Phase
5 Fumigant Risk Assessment

PC Code:  029001	DP Barcode:   D347278

Decision No.: 386928	Registration No.: Various

Petition No.: N/A	Regulatory Action: Reregistration

Risk Assessment Type:

Response to Phase 5 Comments	Case No.: N/A

TXR No.:  N/A	CAS No.: 542-75-6

MRID No.:  N/A 	40 CFR: N/A

		              									Ver.Apr.08

FROM:		Jeffrey L. Dawson, Chemist/Risk Assessor

Reregistration Branch 1

Health Effects Division (7509P)

Whang Phang, PhD Toxicologist

Registration Action Branch 3

Health Effects Division (7509P)

THROUGH:		Michael Metzger, Chief

Reregistration Branch 1

Health Effects Division (7509P)

TO:		Andrea Carone, Chemical Review Manager For 1,3-D

		Special Review & Reregistration Division (7508P)

This document serves as the response to those comments received on the
phase 5 risk assessments and initial risk management proposals related
to 1,3-D that are appropriate to be addressed by the Health Effects
Division.  This document will provide the basis for an overarching
Agency response to comments document which will be prepared by SRRD
staff that will be a compilation of the comments received pertaining to
the fumigant effort.  The summary of the comments that has been prepared
by SRRD has been used as the framework for this document (i.e., comment
numbers and SRRD numbers relate to that compilation document).

#	Docket Sent to, Docket #, & Submitter	SRRD

#	Fumigant Addressed	Public Comment	Div. to Review

Toxicology Comments

	7	  HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&d=EPA-HQ-OPP-2005-0124-0164.1"  EPA-HQ-OPP-2005-0124-0164.1

Cal DPR Nov. 2	108	1,3-D	PLEASE SEE THE REVISED DOCUMENT FOR THE
COMMENTS ON THE FOLLOWING:

Acute inhalation NOEL, short-ter  inhalation NOEL, California HEC’s,
Unit risk for cancer effects, and protective nature of the risk
assessment.	On page 17 of the 1,3-Dichloropropene: HED Human Health Risk
Assessment (Phase 5) (4/12/2007), HED presents a concise explanation for
why HED’s approach to inhalation exposure risk is different  from
that of Cal DPR. The basic difference is that Cal DPR  selects the acute
and short-term toxicity endpoints based on the dominant lethal assay in
rats (MRID 44302801).  The selected toxicity endpoint is the  decrease
in body weight at 60 ppm. The NOAEL is 10 ppm.  From the US EPA point of
view, the results of the dominant lethal assay show that  the decrease
in body weight noted in the dominant lethal assay occurred after 7 days
of exposure; therefore, this effect is not the result of a single-dose
exposure. For acute risk assessment, EPA assesses the risk from single
dose exposure and over a single day.

For short-term inhalation exposure, EPA considered all the results of
the subchronic and chronic toxicity studies, developmental toxicity
studies and the dominant lethal assay in rats in establishing the
short-term toxicity endpoint. It was determined that the decrease in
maternal body weight seen in the developmental toxicity study to be
appropriate as the toxicity endpoint with the supporting evidence from
the subchronic and chronic toxicity studies. The NOAEL of 20 ppm as the
point of departure for risk assessment is protective of the decrease in
body weight seen  at  60 ppm in the dominant lethal assay which has been
employed by Cal DPR for establishing the toxicity endpoint for risk
assessment.

24	  HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&d=EPA-HQ-OPP-2005-0123-0430.1"  EPA-HQ-OPP-2005-0123-0430.1

PANNA	38	1,3-D	EPA used unrepresentative use data for 1,3-D to estimate
cancer risks. The data used were from a time period and a location in
California where 1,3-D had severe restrictions placed on its use.	The
Agency used all appropriate, available data at the time to develop the
risk assessment for 1,3-D.  The Agency also recognizes that the data
used in the 1,3-D risk assessment do not completely address all of the
possible situations related to airshed types of exposure related to
1,3-D.  The Agency would use an airshed based estimate of exposure in
any refined approach for evaluating cancer risks from 1,3-D.  For this
reason, the Agency asked for additional monitoring and modeling to
address airshed issues in the 2005 assessment.  Once available, any
resulting data will be used to conduct updated risk assessments.

While DPR has limits (township caps) on 1,3-D use, few townships reached
the limits in 200 and 2001. This indicates that use was not reduced due
to regulatory limits. However, 1,3-D use has increased in recent years
with the continuing phaseout of methyl bromide. CARB conducted
additional air monitoring for 1,3-D in 2005 and 2006. This monitoring is
representative of one of the highest use areas in California, and EPA
has updated its exposure estimates to include the recent data.

33	  HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&d=EPA-HQ-OPP-2005-0123-0430.1"  EPA-HQ-OPP-2005-0123-0430.1

PANNA	38	1,3-D	We are still concerned that the acute and short-term
NOAELs selected by EPA are too high and that EPA is re-defining what
“acute” means, without adequate peer review. The details about the
dominant lethal assay for inhalation in rat are still missing from the
report.	Based on the currently available data,  the acute and short-term
toxicity endpoints established for risk assessment are appropriate, and
the NOAEL’s employed for risk assessment are protective of the
effects seen  with the acute and short-term exposures.(Please also see
HED Response to #7).

The  toxicity endpoint for  “acute” exposure has always been an
adverse effect which can be attributed to a single dose.

The executive summary of the dominant lethal assay  in rats (MRID
44302801) is appended to the end of the Appendix A: Executive summary
for critical studies and Toxicological Profile.

410

Sealing Methods – Water & Soil Seal

	413	 HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&d=EPA-HQ-OPP-2005-0124-0158" \o "EPA-HQ-OPP-2005-0124-0158"
EPA-HQ-OPP-2005-0124-0158

Calvin Oda, Maui Pineapple Company, Ltd. U. of Hawaii	111

	1,3-D	Sealing methods at anthurium farms involve watering-in, then
installing a tarp immediately after application.  The tarp remains in
place for one week.

All pineapple fields treated with 1,3-D are mulched with HDPE mulch
films.  Agricultural mulch films not only help to retain soil fumigants
in treated soil but also conserve soil moisture, elevate soil
temperatures, control weeds under the mulched surface, and provide
planting marks for manual planting operations.

Previous studies indicated the post fumigation irrigation to seal the
soils was not as effective as application at the proper soil depth,
sealing of the chisel trace(s), and use of agricultural mulches.  	The
Agency has used all available emissions data in the development of its
risk assessments.  The Agency has also been very actively pursuing
plausible approaches for using first principles factors and other
approachs for developing a broader understanding of how changing
conditions can influence emissions (D306857).  Additionally, the Agency
has actively pursued information on this issue in a variety of
stakeholder meetings and through the Methyl Bromide Alternative Outreach
conference.  Please refer to the programs for 2006/2007 for more
information (  HYPERLINK "http://www.mbao.org/"  http://www.mbao.org/
).

Modifications to the risk assessment for 1,3-D will be made as
appropriate pending further interpretation of the factors analysis and
as appropriate.

426	  HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&d=EPA-HQ-OPP-2005-0124-0157.1"  EPA-HQ-OPP-2005-0124-0157.1

Schramm Williams & Associates, Inc., California Fresh Carrot (1,3-D)
93.1	1,3-D	Shank injection methods for 1,3-D help reduce offsite
emissions

All fumigants can benefit from compaction sealing.  	As described in the
responses to several comments above, the Agency has used all available
emissions data in the development of its risk assessments.  The Agency
has also been very actively pursuing plausible approaches for using
first principles factors and other approachs for developing a broader
understanding of how changing conditions can influence emissions
(D306857).  Additionally, the Agency has actively pursued information on
this issue in a variety of stakeholder meetings and through the Methyl
Bromide Alternative Outreach conference.  Please refer to the programs
for 2006/2007 for more information (  HYPERLINK "http://www.mbao.org/"
http://www.mbao.org/  ).  The Agency would agree that the design of
certain application implements can reduce emissions.  Also, the Agency
believes that compaction and/or other sealing methods are critical
elements in an overall strategy to reduce emissions.

489

Application Block Limits

	523	  HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&d=EPA-HQ-OPP-2007-0350-0107.2"  EPA-HQ-OPP-2007-0350-0107.2

Kees Weyns, Weyns Farms	69.1	Metam, Pic, Telone	Washington State does
not have the regulatory bodies in place to limit how many acres can be
fumigated in one area at a certain time.  If such limits were forced
onto the region it would be a logistics nightmare between growers,
applicators, and dealers.

We have such a brief time period transitioning the fields from
harvesting previous crops to preparing a field for fumigation.  Here’s
one example: field corn planted in the Columbia Basin on the 15th of
April can be dry enough to harvest by the 15th of October.  A 125-acre
circle will take two days to combine with one machine.  Then over the
course of three more days, two tractors will shred and disc the stalks
thoroughly into the soil.  Then soil samples can effectively be pulled
to determine the nematode threat for that particular field.  It can take
up to ten days before the sample results are received from the lab
during the busy fumigation season, since we only have one dependable
nematology lab for the some 170,000 acres of potatoes and onions grown
in the basin.  After the grower sees the nematode levels, he consults
with varies crop advisors to see what they recommend and how much its
going to cost.  Then they call me to see if I can start on their field
“first thing in the morning.”  Since I work with about 15 growers,
10 crop advisors, and 7 dealers, the answer to his question is usually
“no, but maybe the day after, if it doesn’t freeze up first.”  I
don’t think having to get clearance from a governing body on whether
or not I can fumigate a field, that I might get started on in a couple
of days, is going to streamline this process any.  Let alone if we can
only run our $350,000 applicators during the 8-10 daylight hours of
October and November.

I do not believe the data concerning higher emissions from night time
applications is correct.  If the data showed increased emissions from
night applications, then one could conclude that less chemical is fuming
the soil during that same period.  Of all the fields I have fumigated, I
have never seen a pattern that would correlate to decreased efficacy
from night applications.  My family has invested over $750,000, and
countless hours of work and stress into our fumigation operation.  The
only way we can make positive returns to our investment is to run these
tractors 18 to 24 hours a day during the short time period ideal for
fumigation. By limiting the amount and times we can fumigate, the agency
will place undue economic stress on the growers, dealers, consultants,
and especially the applicators.	Most of this comment has been addressed
separately in responses developed by risk managers.

With regard to the nighttime emissions.  All data were used in the risk
assessments.  At one point there was consideration of placing
limitations on the time of day during which applications could be made.
The point of this was to possibly eliminate the co-occurrence of peak
emissions with calmer atmospheric conditions that would lead to
potentially higher exposure concentrations.  The Agency is not going to
implement this approach because so many factors influence peak emissions
and it places very difficult logistical restrictions on users.

937

Risk Management Comments

	1045	  HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&d=EPA-HQ-OPP-2005-0123-0430.1"  EPA-HQ-OPP-2005-0123-0430.1

PANNA	38	1,3-D	(page 10) EPA is still underestimating the cancer risks
from use of 1,3-dichloropropene, because the data from which exposure
was estimated was collected when California’s township caps and other
use restrictions for 1,3-D were in effect. Under these conditions,
EPA’s exposure estimates are not accurate for other states where there
are no such restrictions, nor will they be accurate if township caps are
lifted in California and use continues to increase. In response to this
concern, EPA indicates they “used the best available data.” However,
additional information is available to modify the assessment to provide
a more accurate picture of exposure. EPA failed to use this information.
Thus, EPA’s conclusion that their assessment is representative of
high-end exposure is not correct. The upper end cancer risks are likely
to be higher than predicted by EPA, and the number of people exposed to
levels above the unit risk are higher than estimated by EPA. The
appearance of increased rates of pancreatic cancer in human populations
living in areas of high 1,3-D use for 20 years  should not be dismissed
by EPA.	The Agency calculated risks from ambient sources of 1,3-D using
all available data and the best available data.  In Section 5.2 of the
comment PANNA indicates that “additional information is available to
modify the assessement to provide a more accurate picture of
exposure.”  However, these data, to the best knowledge of the Agency
were not submitted or cited in conjunction with the comment.

Additionally, the Agency concurs with PANNA  that in areas where 1,3-D
township caps are not in place that it is possible ambient levels could
exceed those defined in the available monitoring data.  In fact, the
Agency acknowledged this uncertainty in its characterization of the
ambient risk estimates for 1,3-D on page 56 of the risk assessment
available at   HYPERLINK "http://www.regulations.gov"
www.regulations.gov  (EPA-HQ-OPP-2005-0124-0052).  In this document it
was indicated “It is clear from the characterization of the data
provided by CARB that some data represent highly targeted monitoring in
a region during the season of use and others represent urban background
levels.  Because of these criteria, the results should be considered
representative for the state of California in the context that
California has a number of restrictions and systems in place where the
overall goal is to reduce environmental emissions from fumigant use.  As
such, it is difficult to quantify how the results above may apply to
other regions of the country that do not have these types of
programs.”

It is also clear that 1,3-D is used extensively in other states as
illustrated by the fumigant use summary document (page 16 for 1,3-D of
“Overview of the Use and Usage of Soil Fumigants, Becker et al,
6/15/2005). For this reason, the Agency is asking that additional data
be required of 1,3-D registrants to provide information on ambient air
concentrations in areas of high use other than California in order to
better address this issue.

 PAGE

Page   PAGE  1  of   NUMPAGES  6


[Federal Register Volume 82, Number 163 (Thursday, August 24, 2017)]
[Notices]
[Page 40148]
[FR Doc No: 2017-17949]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER16-1832-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Midcontinent Independent System Operator, Inc. submits
tariff filing per 35.19a(b): Refund Report (ER16-1832-000, 001, 002 and
003) to be effective N/A.
    Filed Date: 8/17/17.
    Accession Number: 20170817-5136.
    Comments Due: 5 p.m. ET 9/7/17.

    Docket Numbers: ER17-210-002.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Midcontinent Independent System Operator, Inc. submits
tariff filing per 35.19a(b): Refund Report (ER17-210-002 and 004) to be
effective N/A.
    Filed Date: 8/17/17.
    Accession Number: 20170817-5135.
    Comments Due: 5 p.m. ET 9/7/17.

    Docket Numbers: ER17-2324-000.
    Applicants: NSTAR Electric Company.
    Description: Initial rate filing: LCC Services and Telemetering
Services Agreements--RMLD to be effective 8/17/2017.
    Filed Date: 8/18/17.
    Accession Number: 20170818-5003.
    Comments Due: 5 p.m. ET 9/8/17.

    Docket Numbers: ER17-2325-000.
    Applicants: Colonial Eagle Solar, LLC.
    Description: Compliance filing: Order No. 819 Compliance Filing to
be effective 10/18/2017.
    Filed Date: 8/18/17.
    Accession Number: 20170818-5030.
    Comments Due: 5 p.m. ET 9/8/17.

    Docket Numbers: ER17-2326-000.
    Applicants: Conetoe II Solar, LLC.
    Description: Compliance filing: Order No. 819 Compliance Filing to
be effective 10/18/2017.
    Filed Date: 8/18/17.
    Accession Number: 20170818-5031.
    Comments Due: 5 p.m. ET 9/8/17.

    Docket Numbers: ER17-2327-000.
    Applicants: New York Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 205 filing re: cost recovery
for regulated transmission facilities to be effective 10/18/2017.
    Filed Date: 8/18/17.
    Accession Number: 20170818-5034.
    Comments Due: 5 p.m. ET 9/8/17.

    Docket Numbers: ER17-2328-000.
    Applicants: Duke Energy Kentucky, Inc.
    Description: Compliance filing: Order No. 819 Compliance Filing to
be effective 10/18/2017.
    Filed Date: 8/18/17.
    Accession Number: 20170818-5035.
    Comments Due: 5 p.m. ET 9/8/17.

    Docket Numbers: ER17-2329-000.
    Applicants: Duke Energy Ohio, Inc.
    Description: Compliance filing: Order No. 819 Compliance Filing to
be effective 10/18/2017.
    Filed Date: 8/18/17.
    Accession Number: 20170818-5036.
    Comments Due: 5 p.m. ET 9/8/17.

    Docket Numbers: ER17-2330-000.
    Applicants: Laurel Hill Wind Energy, LLC.
    Description: Compliance filing: Order No. 819 Compliance Filing to
be effective 10/18/2017.
    Filed Date: 8/18/17.
    Accession Number: 20170818-5038.
    Comments Due: 5 p.m. ET 9/8/17.

    Docket Numbers: ER17-2331-000.
    Applicants: North Allegheny Wind, LLC.
    Description: Compliance filing: Order No. 819 Compliance Filing to
be effective 10/18/2017.
    Filed Date: 8/18/17.
    Accession Number: 20170818-5042.
    Comments Due: 5 p.m. ET 9/8/17.

    Docket Numbers: ER17-2332-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Revisions to OATT Schedule
RE: New Black Start Unit Revenue Requirements Process to be effective
11/16/2017.
    Filed Date: 8/18/17.
    Accession Number: 20170818-5044.
    Comments Due: 5 p.m. ET 9/8/17.

    Docket Numbers: ER17-2333-000.
    Applicants: Duke Energy Beckjord Storage, LLC.
    Description: Compliance filing: Order No. 819 Compliance Filing to
be effective 10/18/2017.
    Filed Date: 8/18/17.
    Accession Number: 20170818-5059.
    Comments Due: 5 p.m. ET 9/8/17.

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

    Dated: August 18, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-17949 Filed 8-23-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Rules and Regulations]
[Pages 62466-62470]
[FR Doc No: 2015-26119]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Parts 2, 5, 11, 107, 113, 114, 117, 125, 159, 162, 175, and
180

[Docket No. USCG-2015-0867]

Shipping; Technical, Organizational, and Conforming Amendments

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: This final rule makes non-substantive technical,
organizational, and conforming amendments to existing regulations
throughout Title 46 of the Code of Federal Regulations. This rule will
have no substantive effect on the regulated public.

DATES: This final rule is effective October 16, 2015.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2015-0867, which is available at
http://regulations.gov.

FOR FURTHER INFORMATION CONTACT: If you have questions on this final
rule, call or email Mr. Paul Crissy, Coast Guard; telephone 202-372-
1093, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Abbreviations
II. Regulatory History
III. Basis and Purpose
IV. Discussion of the Rule
V. Regulatory Analyses
    A. Regulatory Planning and Review
    B. Small Entities
    C. Assistance for Small Entities
    D. Collection of Information
    E. Federalism
    F. Unfunded Mandates Reform Act
    G. Taking of Private Property
    H. Civil Justice Reform
    I. Protection of Children
    J. Indian Tribal Governments
    K. Energy Effects
    L. Technical Standards
    M. Environment

I. Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
E.O. Executive Order
FR Federal Register
OMB Office of Management and Budget
Pub. L. Public Law
Sec.  Section symbol
U.S.C. United States Code

II. Regulatory History

    We did not publish a notice of proposed rulemaking for this rule.
Under 5 U.S.C. 553(b)(A), the Coast Guard finds that this rule is
exempt from notice and comment rulemaking requirements, because these
changes involve rules of agency organization, procedure, or practice.
In addition, the Coast Guard finds that notice and comment procedures
are unnecessary under 5 U.S.C. 553(b)(B), as this rule consists only of
corrections and editorial, organizational, and conforming amendments,
and that these changes will have no substantive effect on the public.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that, for the same
reasons, good cause exists for making this final rule effective upon
publication in the Federal Register.

III. Basis and Purpose

    On the 1st of October each year, the printed editions of Titles 46
and 49 of the Code of Federal Regulations (CFR) are re-codified. This
rule, which becomes effective October 16, 2015, makes technical and
editorial corrections throughout Title 46. There are no technical or
editorial corrections for Title 49 this year. This rule does not create
or change any substantive requirements.

IV. Discussion of the Rule

    Each year, the Coast Guard issues technical, organizational, and
conforming amendments to existing regulations in Titles 46 and 49 of
the CFR. These annual ``technical amendments'' provide the public with
more accurate and current regulatory information, but do not change the
impact on the public of any Coast Guard regulations. This rule makes no
changes to Title 49.
    This rule makes changes in the following sections of Title 46 in
the CFR:
    Section 2.75-25(c)(3): Change ``in the Federal Register'' to ``on
the Coast Guard's Maritime Information eXchange Web site at http://cgmix.uscg.mil/equipment'' to reflect the accurate location where the
Coast Guard publishes the approval and listing of recognized
laboratories. The change updates an outdated location.
    Section 5.903(b): Change the mailing address to reflect the U.S.
Coast Guard Office of Investigations and Analysis as the office for
submitting applications.
    Section 11.329(e): Remove the table in Sec.  11.329(e) that is
titled ``Table 1 to Sec.  11.327(d).'').'' The same Table 1 correctly
appears in Sec.  11.327(d), but it has been erroneously duplicated in
Sec.  11.329(e). Table 1 to Sec.  11.329(e) remains unchanged.
    Sections 107.111, 114.400(b), 125.160, 159.005-13(a)(4), 175.400:
Change the reference to the location where the Coast Guard publishes a
listing of current and formerly approved equipment and materials. The
change updates an outdated location.
    Section 113.25-9(a): Change the term ``windless'' to ``windlass.''
The change corrects a typographical error.
    Sections 117.68(a)(1), 117.68(b)(1), 117.68(c)(2)(ii),
117.68(c)(2)(iii), 117.70(b)(1), 117.70(d)(1), 117.71(c), 180.68(a)(1),
180.68(c)(2)(ii), 180.68(c)(2)(iii), 180.70(b)(1), 180.70(d)(1),
180.71(c), 180.75(a): Add a reference to the relevant approval standard
for equipment carried on vessels subject to the International
Convention for the Safety of Life at Sea (SOLAS), 1974, as an option
for compliance. The SOLAS standards have already routinely been
approved by the Coast Guard as an ``other standard specified by the
Commandant.'' The change will provide clarity for the regulated public,
eliminating duplicative approval requests.
    Section 162.060-10(b)(1): Change ``manufacturer'' to ``manufacturer
or independent laboratory'' to reflect the fact that the independent
laboratory is typically the entity that submits requests for approval
of alternatives as equivalent to the regulatory requirements.
    Section 162.060-42(a)(2): Change the reference from ``requirements
in paragraph (b) of this section'' to ``requirements in paragraph
(a)(1) of this section.'' Section 162.060-42(a)(2) discusses the
ability of an independent laboratory to reject a manufacturer's
proposed ballast water management system if the system does not meet
the requirements listed in another paragraph in that section. Paragraph
(b) is an incorrect reference paragraph because it does not list
requirements for the manufacturer's system; instead, it is a
requirement for the independent laboratory. Paragraph (a)(1) is the
correct reference paragraph because it lists the relevant requirements.
The change corrects a typographical error.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders (E.O.s) related to rulemaking. Below we summarize our
analyses based on these statutes or E.O.s.

A. Regulatory Planning and Review

    Executive Orders 13563 and 12866 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has not been designated a ``significant
regulatory action,'' under section 3(f) of Executive Order 12866.
Accordingly, the rule has not been reviewed by the Office of Management
and Budget. Because this rule involves non-substantive changes and
internal agency practices and procedures, it will not impose any
additional costs on the public. The benefit of the non-substantive
changes is increased clarity of regulations.

B. Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), rules
exempt from the notice and comment requirements of the Administrative
Procedure Act are not required to examine the impact of the rule on
small entities. Nevertheless, we have considered whether this rule
would have a significant economic impact on a substantial number of
small entities. The term ``small entities'' comprises small businesses,
not-for-profit organizations that are independently owned and operated
and are not dominant in their fields, and governmental jurisdictions
with populations of less than 50,000.
    There is no cost to this final rule, and we do not expect it will
have an impact on small entities because the provisions of this rule
are technical and non-substantive. It will have no substantive effect
on the public and will impose no additional costs. Therefore, the Coast
Guard certifies under 5 U.S.C. 605(b) that this final rule will not
have a significant economic impact on a substantial number of small
entities.

C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule so that they can better evaluate
its effects on them and participate in the rulemaking. If the rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please consult Mr. Paul Crissy by phone at 202-
372-1093 or via email at<EMAIL_ADDRESS>The

Coast Guard will not retaliate against small entities that question or
complain about this rule or any policy or action of the Coast Guard.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247).

D. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

E. Federalism

    A rule has implications for federalism under E.O. 13132
(``Federalism'') if it has 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. We have analyzed this rule under that order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in E.O. 13132.

F. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any 1 year. Though this final rule will not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

G. Taking of Private Property

    This final rule will not cause a taking of private property or
otherwise have taking implications under E.O. 12630 (``Governmental
Actions and Interference with Constitutionally Protected Property
Rights'').

H. Civil Justice Reform

    This final rule meets applicable standards in sections 3(a) and
3(b)(2) of E.O. 12988 (``Civil Justice Reform''), to minimize
litigation, eliminate ambiguity, and reduce burden.

I. Protection of Children

    We have analyzed this final rule under E.O. 13045 (``Protection of
Children from Environmental Health Risks and Safety Risks''). This
final rule is not an economically significant rule and would not create
an environmental risk to health or risk to safety that might
disproportionately affect children.

J. Indian Tribal Governments

    This final rule does not have tribal implications under E.O. 13175
(``Consultation and Coordination with Indian Tribal Governments''),
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

K. Energy Effects

    We have analyzed this final rule under E.O. 13211 (``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use''). We have determined that it is not a
``significant energy action'' under that order because it is not a
``significant regulatory action'' under E.O. 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of OMB's Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under E.O. 13211.

L. Technical Standards

    The National Technology Transfer and Advancement Act (15 U.S.C. 272
note) directs agencies to use voluntary consensus standards in their
regulatory activities unless the agency provides Congress, through the
OMB, with an explanation of why using these standards would be
inconsistent with applicable law or otherwise impractical. Voluntary
consensus standards are technical standards (e.g., specifications of
materials, performance, design, or operation; test methods; sampling
procedures; and related management systems practices) that are
developed or adopted by voluntary consensus standards bodies.
    This final rule does not use technical standards. Therefore, we did
not consider the use of voluntary consensus standards.

M. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have concluded that this
action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded under section 2.B.2 and figure 2-1,
paragraph (34)(a) of the Instruction. This final rule involves
amendments to regulations that are editorial or procedural. An
environmental analysis checklist and a categorical exclusion
determination are available in the docket for this final rule where
indicated under ADDRESSES.

List of Subjects

46 CFR Part 2

    Marine safety, Reporting and recordkeeping requirements, Vessels.

46 CFR Part 5

    Administrative practice and procedure, Alcohol abuse, Drug abuse,
Investigations, Seamen.

46 CFR Part 11

    Penalties, Reporting and recordkeeping requirements, Schools,
Seamen.

46 CFR Part 107

    Marine safety, Oil and gas exploration, Reporting and recordkeeping
requirements, Vessels.

46 CFR Part 113

    Communications equipment, Fire prevention, Vessels.

46 CFR Part 114

    Marine safety, Passenger vessels, Reporting and recordkeeping
requirements.

46 CFR Parts 117 and 180

    Marine safety, Passenger vessels.

46 CFR Part 125

    Administrative practice and procedure, Cargo vessels, Hazardous
materials transportation, Marine safety, Seamen.

46 CFR Part 159

    Business and industry, Laboratories, Marine safety, Reporting and
recordkeeping requirements.

46 CFR Part 162

    Fire prevention, Marine safety, Oil pollution, Reporting and
recordkeeping requirements.

46 CFR Part 175

    Marine safety, Passenger vessels, Reporting and recordkeeping
requirements.
    For the reasons discussed in the preamble, the Coast Guard amends
46 CFR parts 2, 5, 11, 107, 113, 114, 117, 125, 159, 162, 175, and 180
to read as follows:

PART 2--VESSEL INSPECTIONS

0
1. The authority citation for part 2 continues to read as follows:

    Authority:  Sec. 622, Pub. L. 111-281; 33 U.S.C. 1903; 43 U.S.C.
1333; 46 U.S.C. 2103, 2110, 3306, 3703; E.O. 12234, 45 FR 58801, 3
CFR, 1980 Comp., p. 277, sec. 1-105; Department of Homeland Security
Delegation No. 0170.1(II)(77), (90), (92)(a), (92)(b).

Sec.  2.75-25  [Amended]

0
2. In Sec.  2.75-25(c)(3), remove the text ``in the Federal Register''
and add, in its place, the text ``on the Coast Guard's Maritime
Information eXchange Web site at http://cgmix.uscg.mil/equipment''.

PART 5--MARINE INVESTIGATION REGULATIONS--PERSONNEL ACTION

0
3. The authority citation for part 5 continues to read as follows:

    Authority:  46 U.S.C. 2103, 7101, 7301, 7701; Department of
Homeland Security Delegation No. 0170.1.

0
4. Revise Sec.  5.903(b) to read as follows:

Sec.  5.903  Application procedures.

* * * * *
    (b) The completed application and letter must be addressed to the
U.S. Coast Guard Office of Investigations and Analysis, Commandant (CG-
INV-1), U.S. Coast Guard Stop 7501, 2703 Martin Luther King Jr. Avenue
SE., Washington, DC 20593-7501, and must be delivered in person to the
nearest Officer in Charge, Marine Inspection.
* * * * *

PART 11--REQUIREMENTS FOR OFFICER ENDORSEMENTS

0
5. The authority citation for part 11 continues to read as follows:

    Authority:  14 U.S.C. 633; 31 U.S.C. 9701; 46 U.S.C. 2101, 2103,
and 2110; 46 U.S.C. chapter 71; 46 U.S.C. 7502, 7505, 7701, 8906,
and 70105; E.O. 10173; Department of Homeland Security Delegation
No. 0170.1. Section 11.107 is also issued under the authority of 44
U.S.C. 3507.

Sec.  11.329  [Amended]

0
6. In Sec.  11.329(e), remove Table 1 to Sec.  11.327(d).

PART 107--INSPECTION AND CERTIFICATION

0
7. The authority citation for part 107 continues to read as follows:

    Authority:  43 U.S.C. 1333; 46 U.S.C. 3306, 3307; 46 U.S.C.
3316; Department of Homeland Security Delegation No. 0170.1; Sec.
107.05 also issued under the authority of 44 U.S.C. 3507.

Sec.  107.111  [Amended]

0
8. In Sec.  107.111 in the definition of ``Approval series'' following
the text ``A listing of'', remove the text ``approved equipment,
including all of the approval series, is published periodically by the
Coast Guard in Equipment Lists (COMDTINST M16714.3 series), available
from the Superintendent of Documents.'' and add, in its place, the text
``current and formerly approved equipment and materials may be found on
the Internet at: http://cgmix.uscg.mil/equipment.''.

PART 113--COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT

0
9. The authority citation for part 113 continues to read as follows:

    Authority:  46 U.S.C. 3306, 3703; Department of Homeland
Security Delegation No. 0170.1.

Sec.  113.25-9  [Amended]

0
10. In Sec.  113.25-9(a) following the words ``passageways in cargo
areas, steering gear rooms,'' remove the word ``windless'' and add, in
its place, the word ``windlass''.

PART 114--GENERAL PROVISIONS

0
11. The authority citation for part 114 continues to read as follows:

    Authority:  46 U.S.C. 2103, 3306, 3703; Pub. L. 103-206, 107
Stat. 2439; 49 U.S.C. App. 1804; Department of Homeland Security
Delegation No. 0170.1; Sec.  114.900 also issued under 44 U.S.C.
3507.

Sec.  114.400  [Amended]

0
12. In Sec.  114.400(b), in the definition of ``Approval series''
following the text ``A listing of'', remove the text ``approved
equipment, including all of the approval series, is published
periodically by the Coast Guard in Equipment Lists (COMDTINST M16714.3
series), available from the Superintendent of Documents.'' and add, in
its place, the text ``current and formerly approved equipment and
materials may be found on the Internet at: http://cgmix.uscg.mil/equipment.''.

PART 117--LIFESAVING EQUIPMENT AND ARRANGEMENTS

0
13. The authority citation for part 117 continues to read as follows:

    Authority:  46 U.S.C. 2103, 3306; E.O. 12234, 45 FR 58801, 3
CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation
No. 0170.1.

Sec.  117.68  [Amended]

0
14. Amend Sec.  117.68 as follows:
0
a. In paragraphs (a)(1), (b)(1), and (c)(2)(ii) following the text
``specified by the Commandant'' add the text ``, including, but not
limited to, approval series 160.121''; and
0
b. In paragraph (c)(2)(iii), following the text ``specified by the
Commandant'' add the text ``, including, but not limited to, approval
series 160.122''.

Sec.  117.70  [Amended]

0
15. Amend Sec.  117.70 as follows:
0
a. In paragraph (b)(1) following the text ``specified by the
Commandant'', add the text ``, including, but not limited to, approval
series 160.150''; and
0
b. In paragraph (d)(1) following the text ``specified by the
Commandant'', add the text ``, including, but not limited to, approval
series 160.110''.

Sec.  117.71  [Amended]

0
16. In Sec.  117.71(c), following the text ``specified by the
Commandant'', add the text ``, including, but not limited to, approval
series 160.155 or 160.176''.

PART 125--GENERAL

0
17. The authority citation for part 125 continues to read as follows:

    Authority:  46 U.S.C. 2103, 3306, 3307; 49 U.S.C. App. 1804;
sec. 617, Pub. L. 111-281, 124 Stat. 2905; Department of Homeland
Security Delegation No. 0170.1.

Sec.  125.160  [Amended]

0
18. In Sec.  125.160 in the definition of ``Approval series'' following
the text ``A listing of'', remove the text ``approved equipment,
including all of the approval series, is published periodically by the
Coast Guard in Equipment Lists (COMDTINST M16714.3 series), available
from the Superintendent of Documents.'' and add, in its place, the text
``current and formerly approved equipment and materials may be found on
the Internet at: http://cgmix.uscg.mil/equipment.''.

PART 159--APPROVAL OF EQUIPMENT AND MATERIALS

0
19. The authority citation for part 159 continues to read as follows:

    Authority:  46 U.S.C. 3306, 3703; 49 CFR 1.45, 1.46; Section
159.001-9 also issued under the authority of 44 U.S.C. 3507.

0
20. Revise Sec.  159.005-13(a)(4) to read as follows:

Sec.  159.005-13  Equipment or material: Approval.

    (a) * * *
    (4) Publishes a record of the approval in the Coast Guard Maritime
Information Exchange (CGMIX). A listing of current and formerly
approved equipment and materials may be found on the Internet at:
http://cgmix.uscg.mil/equipment.
* * * * *

PART 162--ENGINEERING EQUIPMENT

0
21. The authority citation for part 162 continues to read as follows:

    Authority:  33 U.S.C. 1321(j), 1903; 46 U.S.C. 3306, 3703, 4104,
4302; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; Department of
Homeland Security Delegation No. 0170.1.

Sec.  162.060-10  [Amended]

0
22. Sec.  162.060--10(b)(1), after the text ``practicable or
applicable, a manufacturer'', add the text ``or independent
laboratory''.

Sec.  162.060-42  [Amended]

0
23. In Sec.  162.060-42(a)(2) following the text ``requirements in
paragraph'', remove the text ``(b)'' and add, in its place, the text
``(a)(1)''.

PART 175--GENERAL PROVISIONS

0
24. The authority citation for part 175 continues to read as follows:

    Authority:  46 U.S.C. 2103, 3205, 3306, 3703; Pub. L. 103-206,
107 Stat. 2439; 49 U.S.C. App. 1804; Department of Homeland Security
Delegation No. 0170.1; Sec.  175.900 also issued under 44 U.S.C.
3507.

Sec.  175.400  [Amended]

0
25. In Sec.  175.400 in the definition of ``Approval series'' following
the text ``A listing of'', remove the text ``approved equipment,
including all of the approval series, is published periodically by the
Coast Guard in Equipment Lists (COMDTINST M16714.3 series), available
from the Superintendent of Documents.'' and add, in its place, the text
``current and formerly approved equipment and materials may be found on
the Internet at: http://cgmix.uscg.mil/equipment.''.

PART 180--LIFESAVING EQUIPMENT AND ARRANGEMENTS

0
26. The authority citation for part 180 continues to read as follows:

    Authority:  46 U.S.C. 2104, 3306; E.O. 12234, 45 FR 58801, 3
CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation
No. 0170.1.

Sec.  180.68  [Amended]

0
27. Amend Sec.  180.68 as follows:
0
a. In paragraph (a)(1), following the text ``specified by the
Commandant'' add the text ``, including, but not limited to, approval
series 160.121'';
0
b. In paragraph (c)(2)(ii), after the text ``specified by the
Commandant'', add the text ``, including, but not limited to, approval
series 160.121''; and
0
c. In paragraph (c)(2)(iii), after the text ``or other standard
specified by the Commandant'', add the text ``, including, but not
limited to, approval series 160.122''.

Sec.  180.70  [Amended]

0
28. Amend Sec.  180.70 as follows:
0
a. In paragraph (b)(1), following the text ``specified by the
Commandant'' add the text ``, including, but not limited to, approval
series 160.150''; and
0
b. In paragraph (d)(1), following the text ``specified by the
Commandant'' add the text ``, including, but not limited to, approval
series 160.110''.

Sec.  180.71  [Amended]

0
29. In Sec.  180.71(c), following the text ``specified by the
Commandant'' add the text ``, including, but not limited to, approval
series 160.155 or 160.176''.

Sec.  180.75  [Amended]

0
30. In Sec.  180.75(a), following the text ``specified by the
Commandant'' add the text ``, including, but not limited to, approval
series 160.112''.

Katia Kroutil,
Chief, Office of Regulations and Administrative Law, U.S. Coast Guard.
[FR Doc. 2015-26119 Filed 10-15-15; 8:45 am]
BILLING CODE 9110-04--P


only, it would never receive a Floor broker parity allocation for
proprietary trading. As such, the Exchange does not consider the
proposed parity allocation model for UTP Securities as a Floor broker
``benefit,'' but rather as an allocation model choice for customers.
    This choice remains relevant in today's more electronic market. As
broker-dealers and institutional investors have reduced the number of

natural persons on their own off-Floor trading desks, Floor brokers
have come to serve as an extension of the more thinly staffed trading
desks of other broker-dealers or institutional investors, but at a
variable cost. This is an important function that the Floor brokers
play as an agency broker without conflicts and fills a void for firms
that have chosen to allocate resources away from trading desks. In
addition to this role, Floor brokers provide services for more illiquid
securities, which upstairs trading desks may not be staffed to manage.
Importantly, when providing such agency trading services, a Floor
broker is unconflicted because he or she is not trading for his own
account and does not sell research to customers. Floor brokers
therefore can focus on price discovery and volume discovery on behalf
of their customers, while at the same time managing their customers'
order flow to ensure that it does not impact pricing on the market
(e.g., executing large positions on behalf of a customer). As discussed
above, when managing such customer order flow, Floor brokers trading in
UTP Securities would continue to be subject to Exchange rules that are
unique to Floor brokers, including Rules 95, 122, 123, and paragraphs
(d)-(j) of Rule 134.
    Fourth, any member organization can choose to have a Floor broker
operation and thus have direct access to Floor broker parity
allocations on behalf of its customers. The Exchange does not charge
member organizations for the use of booth space on the Floor, and
therefore there would be minimal to no extra cost for a member
organization to have a Floor business. Indeed, a smaller firm that
moves its entire operation to the NYSE Floor could have reduced costs
as compared to a firm that needs to pay for office space. Because there
is fair access to any member organization to engage in a Floor broker
operation, the differences between how an order is allocated to a Floor
Broker Participant and Book Participant would not unfairly discriminate
among Exchange member organizations.
    Finally, customers relying on agency broker-dealers to represent
their orders on the Exchange can choose whether to use a Floor broker
or a member organization that only uses off-exchange order entry
methods.\49\ In some cases, customers choose to use a member
organization that offers both order entry methods. But the different
allocation models are available to all customers that use a member
organization to enter orders on the Exchange; having such choice would
not unfairly discriminate among customers.
---------------------------------------------------------------------------

    \49\ Floor broker customers are generally other broker-dealers
or institutional investors. Retail investors generally do not
interact directly with either Floor brokers or the trade desks of
member organizations that route orders to the Exchange.
---------------------------------------------------------------------------

    The Exchange also believes that its proposal to make its existing
parity allocation model, as modified for the Pillar trading platform,
available for UTP Securities would remove impediments to and perfect
the mechanism of a free and open market because it would extend the
Exchange's choice-based allocation model to all securities that would
trade on the Exchange in a manner that is consistent with its Trading
Floor model. For market participants other than DMMs, the Exchange does
not believe that there is an inherent benefit of one method of
allocation on the Exchange over another. Market participants that are
latency sensitive--whether for proprietary or agency-based trading--may
choose to use the off-exchange order entry method because of the
relative speed of that order entry path as compared to Floor broker
order entry and availability of Setter Priority allocation. By
contrast, market participants that are not as latency sensitive or are
seeking an unconflicted agent to manage their order flow and
potentially negotiate a large crossing transaction may choose to use a
Floor broker.
    The Exchange believes that intra-day trading volume entered by
Floor brokers in NYSE-listed securities, which are subject to the
Exchange's existing parity allocation model, demonstrates how customers
have already exercised this choice. In October 2017, orders from Floor
brokers represented approximately 5.5% of the intra-day liquidity-
providing volume on the Exchange in NYSE-listed securities (the parity
allocation model is only applicable to provide volume).\50\ The
Exchange believes that this volume demonstrates that there is still a
value to the end customer--who has a choice--to use a Floor broker. As
discussed above, Floor brokers can be distinguished from off-Floor
agency member organizations because they operate a pure agency business
and do not trade for their own accounts. There are customers that value
that conflict-free model. In addition, Floor brokers distinguish
themselves by providing high-touch service to their customers. Floor
brokers that attract liquidity-providing orders promote the display of
liquidity on the Exchange.
---------------------------------------------------------------------------

    \50\ Over 75% of Floor broker traded volume in NYSE-listed
securities is for auctions. However, because the Exchange would not
be conducting auctions in UTP Securities, the relative benefits of a
parity allocation to a Floor broker in an auction would not be
applicable.
---------------------------------------------------------------------------

    That volume of Floor broker intra-day trading also demonstrates
that customers have similarly exercised their choice not to use Floor
brokers. If there were an inherent benefit to the Floor broker parity
allocation that distinguishes it as superior to the Book Participant
allocation, it would likely follow that there would be greater
proportion of intra-day order flow directed to Floor brokers in NYSE-
listed securities. But that is not the case. In sum, the current NYSE-
listed intra-day Floor broker provide volume demonstrates that using a
Floor broker has value to certain customers, but also demonstrates that
the parity allocation to a Floor broker is not the only component of a
customer's decision about how to send its orders to the Exchange. With
this filing, the Exchange proposes to extend that choice to UTP
Securities, thereby benefiting the ultimate customer of the Floor
broker.
    The Exchange further believes that its proposed parity allocation
model for UTP Securities would remove impediments to and perfect the
mechanism of a free and open market and a national market system
because it is a competitive offering vis-[agrave]-vis other exchange
competitors, which offer variations on a price-time priority models,
and over-the-counter trading. The Exchange is currently the only
registered exchange that does not trade non-Exchange listed securities
on a UTP basis. Additionally, the Exchange currently is the only
registered exchange that makes available Floor-based trading for cash
equity securities. The Exchange proposes to extend the availability of
this feature by maintaining Floor-based crossing transactions when it
launches trading in UTP Securities. The Exchange believes that trading
UTP Securities is a natural extension of its current offering of
trading Exchange-listed securities, which also trade on a parity
allocation model. The Exchange believes it would promote competition to
offer this allocation model for all securities that would trade on the
Exchange, thereby providing an alternative allocation model for UTP
Securities. Conversely, Floor brokers on the Exchange would be able to
expand the services they provide to customers by being able to manage
order flow in UTP Securities in addition to Exchange-listed securities.
The Exchange also believes that this proposed allocation model would
promote intra-market competition by offering a menu of choices to
market participants of how their orders in UTP Securities would be
allocated on the Exchange.

    While the parity allocation model is a competitive offering, its
origins are derived from the Floor-based trading model of the Exchange.
Accordingly, the Exchange believes that it would remove impediments to
and perfect the mechanism of a free and open market and a national
market system to provide for Floor-based crossing transactions and to
extend existing requirements relating to Floor brokers for orders in
UTP Securities that seek to be eligible to be included in the Floor
Broker Participant. First, as noted above, the Floor broker must trade
on an agency-only basis and would continue to be subject to rules that
are unique to a Floor broker, including requirements specified in Rules
95, 122, 123, and 134(d)-(j). Second, consistent with current Rule 70
requirements, for orders in UTP Securities to be eligible to be
included in the Floor Broker Participant, such orders must be entered
by a Floor broker while on the Trading Floor.
    In addition, because the parity allocation model is based on the
history of the Exchange as a Floor-based model, the Exchange believes
that for orders in UTP Securities to be eligible to be included in the
Floor Broker Participant, the Floor broker representing such orders
must also be engaged in a Floor broker business in Exchange-listed
securities. Trading in UTP Securities on the Trading Floor is designed
to complement a Floor broker's existing role in representing orders in
Exchange-listed securities because it would enable such Floor brokers
to trade additional securities on behalf of their customers. For
example, a Floor broker would be better positioned to process baskets
of securities that include Tape A, B, and C securities and enter all
such orders on the Exchange. By offering the parity allocation model
for UTP Securities, a Floor broker would not need to segregate its
orders in UTP Securities into different trading strategies than what
would be offered for Exchange-listed securities. Because Floor broker
trading in UTP Securities is designed to function in tandem with
trading in Exchange-listed securities, the Exchange believes that it
would remove impediments to and perfect the mechanism of a free and
open market and a national market system to require such nexus because
it would ensure that member organizations would not seek to conduct a
stand-alone Floor broker business in only UTP Securities.
    The Exchange believes that proposed Rules 7.10, 7.11, 7.16, 7.18,
7.31, 7.34, 7.38, and 7.46 would remove impediments to and perfect the
mechanism of a free and open market and a national market system
because they are based on the rules of NYSE Arca and NYSE American. The
proposed substantive differences to the Exchange's rules would be
because the Exchange would not be offering the full suite of orders and
modifiers available on NYSE Arca and NYSE American. In addition, the
Exchange proposes substantive differences to these rules consistent
with the Exchange's proposed parity allocation model. The Exchange
believes that the proposed substantive differences for these rules
would remove impediments to and perfect the mechanism of a free and
open market and a national market system because they would provide
transparency of which orders, modifiers and instructions would be
available on the Exchange when it begins trading UTP Securities on the
Pillar trading platform, and how the Pillar rules would function with a
parity allocation model.
    The Exchange believes that the proposed substantive differences to
Rule 7.34 to offer Early and Core Trading Sessions, but not a Late
Trading Session, would remove impediments to and perfect the mechanism
of a free and open market and a national market system because it is
consistent with the Exchange's current hours, described in Rule 51,
that the Exchange is not open for business after 4:00 p.m. Eastern
Time. The Exchange further believes that adding a trading session
before 9:30 a.m. Eastern Time would provide additional time for
Exchange member organizations to trade UTP Securities on the Exchange
consistent with the trading hours of other exchanges, including NYSE
American, which also will begin trading at 7:00 a.m. Eastern Time.
    The Exchange believes that the proposed amendments to Rules 103B
and 107B would remove impediments to and perfect the mechanism of a
free and open market and a national market system because they would
provide transparency that the Exchange would not be assigning UTP
Securities to DMMs and that member organizations would be eligible to
register as a Supplemental Liquidity Providers in UTP Securities. The
Exchange further believes that not assigning DMMs to UTP Securities is
consistent with just and equitable principles of trade because the
Exchange would not be conducting auctions in UTP Securities and
therefore the Exchange would not need DMMs assigned to such securities
to facilitate auctions. Not having DMMs registered in UTP Securities is
also consistent with how NYSE Arca and NYSE American function on
Pillar, in that neither lead market makers (on NYSE Arca) nor
electronic designated market makers (on NYSE American) are assigned
securities not listed on those exchanges. The Exchange further believes
that it would remove impediments to and perfect the mechanism of a free
and open market and a national market system for member organizations
to be eligible to register as Supplemental Liquidity Providers in UTP
Securities as this would provide an incentive for displayed liquidity
in UTP Securities.
    The Exchange further believes that it would remove impediments to
and perfect the mechanism of a free and open market and a national
market system to specify which current rules would not be applicable to
trading UTP Securities on the Pillar trading platform. The Exchange
believes that the following legend, which would be added to existing
rules, ``This Rule is not applicable to trading UTP Securities on the
Pillar trading platform,'' would promote transparency regarding which
rules would govern trading UTP Securities on the Exchange on Pillar.
The Exchange has proposed to add this legend to rules that would be
superseded by proposed rules or rules that would not be applicable
because they relate to auctions or Floor-based point-of-sale trading.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed change is
designed to propose rules to support trading of UTP Securities on the
Exchange's new Pillar trading platform. The Exchange operates in a
highly competitive environment in which its unaffiliated exchange
competitors operate multiple affiliated exchanges that operate under
common rules. By adding trading of UTP Securities on the Exchange, the
Exchange believes that it will be able to compete on a more level
playing field with its exchange competitors that similarly trade all
NMS Stocks. In addition, by basing certain rules on those of NYSE Arca
and NYSE American, the Exchange will provide its members with
consistency across affiliated exchanges, thereby enabling the Exchange
to compete with unaffiliated exchange competitors that similarly
operate multiple exchanges on the same trading platforms.
    More specifically, the Exchange does not believe that the proposal
to extend

the Exchange's existing parity allocation model, as modified for
Pillar, to UTP Securities would impose a burden on competition that is
not necessary or appropriate in furtherance of the purposes of the Act.
To the contrary, the Exchange believes that the proposal would promote
inter-market competition by providing market participants with the
choice of a parity allocation model together with Floor crossing
transactions for trading UTP Securities, which is not available on any
other exchange. For the Exchange's listed securities, its competitive
offering includes not only its parity allocation model, but also its
auctions. Designed as a complement to existing Floor broker operations
in Exchange-listed securities and consistent with the Exchange's
current trading model, the Floor Broker Participant parity allocation
for UTP Securities would be available only to Floor brokers that engage
in Floor trading of Exchange-listed securities, and such Floor brokers
would be eligible to engage in manual transactions under Rule 76 for
UTP Securities. In addition, to be eligible for a parity allocation,
Floor brokers must enter such orders on the Trading Floor and could
only trade on an agency basis. Moreover, any trading in UTP Securities
by Floor brokers would be subject to existing rules that apply only to
Floor brokers, such as Rules 95, 122, 123, and 134(d)-(j).
    The Exchange further believes that the proposal would promote
intra-market competition because it would provide a choice to customers
of how their orders in UTP Securities would be allocated on the
Exchange. For certain customers, entering orders via the Book
Participant may serve their trading strategies. For other customers,
using a Floor broker for intra-day trading may serve their trading
strategies. Importantly, the results of a Floor broker allocation would
always accrue to the customer, and whether to use a Floor broker is the
customer's choice. Accordingly, this proposed market structure is not
about providing a ``benefit'' to a Floor broker, but rather providing
customers with a choice of how an order would be allocated.

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. Summary of Comments Received

    The Commission received one comment letter, which opposes NYSE's
proposal to provide floor brokers with parity allocation and the
exclusive use of certain order types (i.e., pegged orders).\51\ The
commenter asserts that providing floor brokers with preferential
treatment in a fully electronic trading environment, the market for UTP
Securities, unfairly discriminates against market participants who do
not submit orders through a Floor Broker.\52\ According to the
commenter, parity provides floor brokers with a distinct unfair
competitive advantage over other market participants, such as customers
and broker-dealers.\53\
---------------------------------------------------------------------------

    \51\ See Cboe Letter, supra note 9.
    \52\ See id. at 1-2.
    \53\ Id. at 2.
---------------------------------------------------------------------------

    The commenter states that floor brokers do not have the
restrictions of time priority when they receive parity and can ``skip
the line.'' \54\ According to the commentor, floor brokers can insert
themselves into the parity wheel and buy and sell during price
disparities to liquidate or acquire positions at beneficial prices.\55\
The commentor asserts that this would disadvantage customers and
broker-dealers, even though, like the floor brokers, they add liquidity
to the market.\56\ The commenter further assert that this would also
disadvantages other members and their orders, including orders routed
from other trading centers, which are aggregated into one participant
and receive one slot on the parity wheel.\57\
---------------------------------------------------------------------------

    \54\ Id.
    \55\ Id.
    \56\ Id.
    \57\ Id.
---------------------------------------------------------------------------

    According to the commenter, many entities cannot, as a practical
matter, take advantage of the floor brokers' parity allocations, and
that those that can use the services of floor brokers may route more
orders through them to get the advantage of parity.\58\ The commenter
believes that floor brokers could take advantage of this by charging
higher transaction fees to customers.\59\ The commenter asserts that
orders submitted by the floor broker do not represent manual interest,
but are the byproduct of the floor broker reselling algorithms or other
electronic access to their privileged position on the parity wheel.\60\
---------------------------------------------------------------------------

    \58\ Id.
    \59\ Id.
    \60\ Id. at 2-3.
---------------------------------------------------------------------------

    The commenter also states that providing floor brokers with the
exclusive use of pegged orders provides them an unjustified competitive
advantage over customers and broker-dealers when trading securities
electronically.\61\ The commenter explains that pegged orders
automatically repriced to a new price level and that, therefore, pegged
orders have a time advantage over all other orders that seek to be
entered at the revised price.\62\
---------------------------------------------------------------------------

    \61\ Id. at 3.
    \62\ Id.
---------------------------------------------------------------------------

IV. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change, as modified by Amendment No. 1, is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to a national securities exchange.\63\ In particular, the
Commission finds that the proposed rule change is consistent with
Section 6(b)(5) of the Act \64\--which requires, among other things,
that the rules of a national securities exchange be designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general, to protect
investors and the public interest, and that the rules not be designed
to permit unfair discrimination between customers, issuers, brokers, or
dealers--and with Section 6(b)(8) of the Act,\65\ which requires that
the rules of a national securities exchange not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The Commission further finds that the proposed
rule change is consistent with Section 12(f) of the Act,\66\ which
permits a national securities exchange to trade securities it does not
list, pursuant to unlisted trading privileges, as long as the
securities are listed on another national securities exchange.
---------------------------------------------------------------------------

    \63\ In approving this proposed rule change, as modified by
Amendment No. 1, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. See 15
U.S.C. 78c(f).
    \64\ 15 U.S.C. 78f(b)(5).
    \65\ 15 U.S.C. 78f(b)(8).
    \66\ 15 U.S.C. 78l(f).
---------------------------------------------------------------------------

    The Exchange proposes to trade, for the first time, securities that
it does not list, and it proposes to do so using a new technology
platform--the Pillar platform that has been deployed to date on the
Exchange's affiliated exchanges NYSE Arca and NYSE American. The
proposed rules for UTP trading would govern clearly erroneous
executions, limit-up-limit-down plan compliance, short sales, trading
halts, orders and

modifiers, order ranking and display, order execution and routing, odd
and mixed lots trading, and tick-size pilot plan compliance, and the
proposal would also designate the current Exchange rules that are not
applicable to UTP Securities.
    Trading of UTP Securities on the Exchange would differ in two
significant respects from trading in NYSE-listed securities.\67\ First,
the Exchange would not conduct auctions in UTP Securities. And second,
the Exchange would not assign UTP securities to DMMs, which have
affirmative obligations to support a fair and orderly market, and to
facilitate auctions, in their assigned securities.\68\ The Commission
believes that these distinctions between NYSE-listed securities and UTP
Securities are consistent with UTP trading of securities generally, and
that these distinctions are consistent with the requirements of the
Act.
---------------------------------------------------------------------------

    \67\ NYSE represents that it will continue to trade NYSE-listed
securities on its current trading platform. The Exchange intends to
migrate trading in NYSE-listed securities to Pillar at a later date.
See supra note 17.
    \68\ See NYSE Rule 104(a) (stating that ``DMMs registered in one
or more securities trading on the Exchange must engage in a course
of dealings for their own account to assist in the maintenance of a
fair and orderly market insofar as reasonably practicable.'').
---------------------------------------------------------------------------

    The Commission also notes that, while the proposed trading rules
are similar in most respects to previously approved rules of NYSE Arca
and NYSE American--which also use the Pillar trading platform \69\--
they differ in certain material ways. Most notably, the Exchange will
extend its current parity allocation model to the execution of trades
in UTP Securities, rather than using the strict price-time priority
allocation of NYSE Arca and NYSE American, and this parity allocation
model would allow each floor broker's orders to trade on parity with
orders on the Exchange book. Only floor brokers engaged in a floor-
broker business for NYSE-listed securities would be eligible for parity
allocation. Additionally, Exchange floor brokers would only be able to
enter orders for parity allocation while physically on the floor of the
Exchange, and they could not engage in proprietary trading using parity
allocation. Finally, there would also be a floor-based point of sale,
supervised by Exchange employees, where floor brokers would be able
cross trades in UTP securities.
---------------------------------------------------------------------------

    \69\ See supra notes 12 and 13.
---------------------------------------------------------------------------

    When instituting proceedings to determine whether the Exchange's
proposal was consistent with Section 6(b)(5) and Section 6(b)(8) of the
Act,\70\ the Commission specifically requested comments concerning the
role of floor brokers in trading UTP Securities on the Exchange; \71\
on the benefits and costs of floor-broker activities with respect to
trading of UTP Securities; \72\ and on whether providing floor brokers
with parity allocation in UTP Securities, or providing floor brokers
with exclusive use of certain order instructions, would unfairly
discriminate or impose an unfair burden on competition that is not
necessary or appropriate.\73\ The one comment letter received opposes
the proposal, arguing that parity allocation in a fully electronic
market would provide floor brokers, by allowing them to ``skip the
line,'' with an unfair advantage vis-[agrave]-vis other market
participants that also add liquidity to the market, and that floor
brokers might take advantage of their preferential treatment on the
parity wheel by charging higher transaction fees. The commenter also
argues that the exclusive use of pegged orders by floor brokers would
similarly provide them with an unfair competitive advantage.
---------------------------------------------------------------------------

    \70\ See Order Instituting Proceedings, supra note 7, at 52761.
    \71\ Id.
    \72\ Id.
    \73\ Id.
---------------------------------------------------------------------------

    The Commission notes that, in Amendment No. 1 to its proposal, the
Exchange has responded to the questions raised by the Commission, and
the concerns expressed by the commenter, by modifying its proposal to
require that floor brokers be engaged in a floor-broker business in
NYSE-listed securities in order to be eligible for parity allocation in
UTP Securities; to expressly require that orders in UTP Securities be
entered from the Exchange floor in order to be eligible for parity
\74\; and to provide for a floor-based point of sale for crossing
transactions.\75\ Additionally, the Exchange has added substantial
further explaination of the role that floor brokers play as agency
brokers on behalf of their customers.
---------------------------------------------------------------------------

    \74\ See Proposed NYSE Rule 7.36(a)(5).
    \75\ As explained above, NYSE proposes to permit floor brokers
to enter into crossing transactions pursuant to NYSE Rule 76.
---------------------------------------------------------------------------

    The Exchange argues that the parity allocation model for UTP
Securities is based on the historically floor-based model of the
Exchange and that trading in UTP Securities is designed to complement
the floor broker's existing role in NYSE-listed securities, which
includes both parity allocation and the use of pegging orders. The
Exchange argues that the proposed parity allocation model in UTP
Securities would benefit competition by providing market participants
with a choice as to how their orders are executed, asserting that
market participants who do not wish to invest in speed-related
technology, who have a thinly staff trading desk, or who would like to
execute a large crossing transaction could utilize the services of a
floor broker. According to the Exchange, trading UTP Securities using a
parity model would also benefit competition by providing an alternative
trading model for trading those securities. The Exchange asserts that
floor brokers serve an important role as an agency broker without
conflicts, especially for illiquid securities. The Exchange also notes
that any member organization can choose to become a floor broker and
that the Exchange does not charge member organizations for the use of
space on the trading floor.
    The Commission believes that the changes to the proposal in
Amendment No. 1 have sufficiently addressed the Commission's and the
commenter's concerns regarding the proposal's consistency with the Act.
The proposal, as amended, represents a measured extension of the
Exchange's existing market model (including the potential for floor-
based trading added by Amendment No. 1) to trading in UTP Securities,
while ensuring that the ability of floor brokers to obtain parity
allocation is limited to those floor brokers who are engaged in a bona
fide agency business while physically on the trading floor of the
Exchange, with the benefit of parity allocations flowing to the
customers of the floor brokers. Floor brokers, as agency-only market
participants, would not be able to use either parity allocations or
pegging orders to liquidate or acquire their own proprietary positions.
Finally, with respect to concerns regarding competition, the Exchange
has representated that, in October 2017, floor-broker orders receiving
parity executions (all of which are liquidity-providing orders)
represented only about 5.5% of the intraday liquidity-providing volume
on the Exchange in NYSE-listed securities.\76\ Given that parity
allocation and the exclusive use of pegging orders do not appear to
have burdened competition in NYSE-listed securities, the Commission
does not have a reason to believe that permitting the Exchange to trade
UTP Securities with a similar intraday role for floor brokers will
provide those floor brokers with an unfair competitive advantage.
---------------------------------------------------------------------------

    \76\ See supra note 50 and accompanying text.
---------------------------------------------------------------------------

    The Commission also finds that the proposed rule change is
consistent with Section 12(f) of the Act. Section 12(a) of

the Act \77\ generally prohibits trading on an exchange of any security
that is not registered (listed) on that exchange. Section 12(f) of the
Act,\78\ however, allows a national securities exchange to extend
unlisted trading privileges--i.e., to allow trading in a security that
is not listed and registered on that exchange--to securities that are
registered on another national securities exchange. When an exchange
extends unlisted trading privileges to a security, the exchange allows
its members to trade the security as if the security were listed on
that exchange.\79\
---------------------------------------------------------------------------

    \77\ 15 U.S.C. 78l(a).
    \78\ 15 U.S.C. 78l(f).
    \79\ Over-the-counter (``OTC'') dealers are not subject to the
Section 12(a) registration requirement because they do not transact
business on an exchange.
---------------------------------------------------------------------------

    The UTP Act of 1994 \80\ substantially amended Section 12(f) of the
Act. Before 1994, national securities exchanges had to apply to the
Commission for approval before extending unlisted trading privileges to
a particular security. The UTP Act removed the application, notice, and
Commission approval process from Section 12(f) of the Act, except in
cases of Commission suspension of unlisted trading privileges in a
particular security on an exchange. Accordingly, under Section 12(f) of
the Act, exchanges may immediately extend unlisted trading privileges
to a security listed on another exchange. Pursuant to Rule 12f-5 under
the Act,\81\ a national securities exchange shall not extend unlisted
trading privileges to any security, unless the national securities
exchange has in effect a rule or rules providing for transactions in
the class or type of security to which the exchange extends unlisted
trading privileges.
---------------------------------------------------------------------------

    \80\ Pub. L. 103-389, 108 Stat. 4081 (1994).
    \81\ 17 CFR 240.12f-5.
---------------------------------------------------------------------------

    The proposal would establish Exchange rules providing for
transactions on securities that are listed on other national securities
exchanges. As a national securities exchange, the Exchange is permitted
under Section 12(f) of the Act \82\ to extend unlisted trading
privileges to securities listed and registered on other national
securities exchanges, subject to Rule 12f-5 under the Act. The
Commission notes that the Exchange's current rules would allow the
Exchange to extend unlisted trading privileges to any security that is
an NMS Stock listed on another national securities exchange.\83\
---------------------------------------------------------------------------

    \82\ 15 U.S.C. 78l.
    \83\ See NYSE Rule 5.1 (``Notwithstanding the requirements for
listing set forth in these Rules, the Exchange may extend unlisted
trading privileges (``UTP'') to any security that is an NMS Stock
(as defined in Rule 600 of Regulation NMS under the Act) that is
listed on another national securities exchange or with respect to
which unlisted trading privileges may otherwise be extended in
accordance with Section 12(f) of the Act. Any such security will be
subject to all Exchange trading rules applicable to securities
trading on the Pillar trading platform, unless otherwise noted.'').
---------------------------------------------------------------------------

    The proposed rules provide for transactions in the class or type of
security to which the Exchange intends to extend unlisted trading
privileges. Together with the existing Exchange rules for trading on
Pillar--NYSE Rules 1P to 13P--the Exchange would have rules providing
for transactions in the class or type of security to which the exchange
proposes to extend unlisted trading privileges, and, therefore, the
proposal is consistent with Section 12(f) of the Act.
    Because the proposal, as amended, is consistent with Sections
6(b)(5), 6(b)(8), and 12(f) of the Act, the Commission finds good
cause, pursuant to Section 19(b)(2) of the Act,\84\ to approve the
proposed rule change on an accelerated basis.
---------------------------------------------------------------------------

    \84\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

V. Solicitation of Comments on Amendment No. 1

    Interested persons are invited to submit written data, views, and
arguments concerning whether Amendment No. 1 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-2017-36 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-2017-36. 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 comment 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-2017-36, and should be submitted on
or before April 19, 2018.

VI. Accelerated Approval of the Proposed Rule Change, as Modified by
Amendment No. 1

    The Commission finds good cause to approve the proposed rule
change, as modified by Amendment No. 1, prior to the thirtieth day
after the date of publication of Amendment No. 1 in the Federal
Register. In Amendment No. 1, among other changes, the Exchange: (i)
Responds to the Commission's concerns in the Order Instituting
Proceedings relating to the extension of parity to floor brokers in UTP
Securities by (a) proposing additional requirements for floor broker
orders to be eligible for parity, (b) proposing to permit floor brokers
to engage in floor-based point-of-sale trading and crossing
transactions in UTP Securities, and (c) providing additional
justification for providing floor brokers with parity in UTP
Securities; (ii) amends the definition of Aggressing Order to include
that a resting order may become an Aggressing Order if its working
price change, the PBBO or NBBO is updated, when there are changes to
other orders on the Exchange Book, or when processing inbound messages;
(iii) amends the rules relating to the MPL Order and MTS Modifier to
reflect those of NYSE Arca and NYSE American and sets forth additional
rules relating setting forth how orders with an MTS Modifier would
trade in a parity-based model; (iv) makes changes to the list of rules
that are not applicable for parity; (v) makes changes to proposed NYSE
Rules 7.37 and 7.46 to refer to an order with an MTS as an order with
an ``MTS Modifier''; (vi) changes cross-references to NYSE Arca's rules
to reflect the merger of NYSE Arca and NYSE Arca Equities, and (vii)
makes changes to

reflect the renaming of NYSE MKT to NYSE American.
    As discussed above, Amendment No.1 addresses the Commission's
concerns and the comment letter received. The definitions of Aggressing
Order, the MPL Order, and the MTS Modifier are similar to the rules of
NYSE Arca, which have been approved by the Commission previously, with
adaptions for the Exchange's parity allocation model. The remaining
changes are non-substantive. Accordingly, the Commission finds good
cause, pursuant to Section 19(b)(2) of the Act,\85\ to approve the
proposed rule change, as modified by Amendment No. 1, on an accelerated
basis.
---------------------------------------------------------------------------

    \85\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

VII. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\86\ that the proposed rule change (SR-NYSE-2017-36), as modified
by Amendment No. 1, be, and hereby is, approved on an accelerated
basis.
---------------------------------------------------------------------------

    \86\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\87\
---------------------------------------------------------------------------

    \87\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2018-06339 Filed 3-28-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33307-33308]
[FR Doc No: 2021-13411]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-E-1281]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ZOLGENSMA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ZOLGENSMA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by August 23, 2021.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by December 21, 2021. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 23, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 23, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2020-E-1281 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ZOLGENSMA.'' Received comments, those
filed in a timely manner (see ADDRESSES), 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, 240-
402-7500.
     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 Sec.
10.20 (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.govinfo.gov/content/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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product ZOLGENSMA
(onasemnogene abeparvovec-xioi). ZOLGENSMA is indicated for treatment
of pediatric patients less than 2 years of age with spinal muscular
atrophy with bi-allelic mutations in the survival motor neuron 1 gene.
Subsequent to this approval, the USPTO received a patent term
restoration application for ZOLGENSMA (U.S. Patent No. 7,906,111) from
REGENXBIO, Inc., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated May 26, 2020, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of ZOLGENSMA represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ZOLGENSMA is 2,088 days. Of this time, 1,852 days occurred during the
testing phase of the regulatory review period, while 236 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: September
6, 2013. The applicant claims September 7, 2013, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was September 6, 2013,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): October 1, 2018. FDA has verified the
applicant's claim that the biologics license application (BLA) for
ZOLGENSMA (BLA 125694) was initially submitted on October 1, 2018.
    3. The date the application was approved: May 24, 2019. FDA has
verified the applicant's claim that BLA 125694 was approved on May 24,
2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,162 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: June 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13411 Filed 6-23-21; 8:45 am]
BILLING CODE 4164-01-P