[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46894-46896]
[FR Doc No: 2014-18877]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72761; File No. SR-ICEEU-2014-12]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing of Proposed Rule Change to Liquidity Policies Relating to
EMIR

August 5, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 25, 2014, ICE Clear Europe Limited (``ICE Clear Europe'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change described in Items I, II and III below, which
Items have been prepared primarily by ICE Clear Europe. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The principal purpose of the proposed change is to amend and
formalize certain ICE Clear Europe liquidity policies and procedures
(the ``Liquidity Policy Amendments''), including to facilitate
compliance with requirements under the European Market Infrastructure
Regulation (including regulations thereunder, ``EMIR'') \3\ that will
apply to ICE Clear Europe as an authorized central counterparty.
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    \3\ Regulation (EU) No. 648/2012 of the European Parliament and
of the Council of 4 July 2012 on OTC derivatives, central
counterparties and trade repositories.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

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

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

1. Purpose
    ICE Clear Europe proposes to amend its existing Liquidity Risk
Management Framework (``LRMF'') and to adopt a separate Liquidity Plan
that formalizes certain procedures and internal processes relating to
liquidity objectives and monitoring, testing and decision-making
relating to sufficiency of liquidity resources. In ICE Clear Europe's
view, the creation of the Liquidity Plan does not materially change
existing procedures and processes but is intended to formalize them, in
order to be consistent with requirements under EMIR.
    The Liquidity Plan has been drafted in accordance with Article 32
of the Regulatory Technical Standards implementing EMIR.\4\ Consistent
with Article 32, the stated objectives of the Liquidity Plan are to:
(i) Identify sources of liquidity risk; (ii) manage and monitor
liquidity needs across a range of stressed market scenarios; (iii)
maintain sufficient and distinct financial resources to cover liquidity
needs; (iv) assess and value the liquid assets available to the
clearing house and its liquidity needs; (v) assess timescales over
which liquid financial resources should be available; (vi) manage a
liquidity shortfall event; (vi) replace financial resources used in a
liquidity shortfall event; and (vii) assess potential liquidity needs
stemming from Clearing Members ability to swap cash for non-cash
collateral. The Liquidity

Plan also reflects requirements and guidance of the Bank of England.
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    \4\ Commission Delegated Regulation (EU) No. 153/2013 of 9
December 2012 Supplementing Regulation (EU) No. 648/2012 of the
European Parliament and of the Council with regard to Regulatory
Technical Standards on Requirements for Central Counterparties (the
``Regulatory Technical Standards'').
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    The Liquidity Plan contains details about ICE Clear Europe's
liquidity monitoring, stress testing, reporting and management
procedures. With respect to monitoring, various systems and processes
are used by ICE Clear Europe to ascertain the status of settlements at
the start of the day, intra-day and at the end of day, as well as the
status of related investment activity during the day. Any deviation
from established tolerance levels will be escalated in accordance with
the Liquidity Plan. The Liquidity Plan also uses certain Key Risk &
Performance Indicators (``KRPIs'') to ensure the investment policies
are respected in light of ICE Clear Europe's credit and liquidity
requirements, based on a number of investment categories (such as
secured investments, unsecured investments, sovereign investors) and
tenor categories.
    The Liquidity Plan identifies various sources of liquidity risks,
including exposure to settlement banks, custodian banks, liquidity
providers, investment counterparties, payment systems, clearing members
and other service providers, and provides for regular stress testing
based on those risks. The Liquidity Plan also addresses liquidity risk
tolerances and appetite limits established by the Board in connection
with stress testing. Stress testing is conducted using a range of
scenarios, including both historical scenarios and forward-looking
scenarios involving extreme but plausible market events and conditions.
Both types of scenarios simulate extreme but plausible losses arising
from the default of the clearing members with the two largest liquidity
exposures, consistent with EMIR requirements. Scenarios also address
the required level of liquidity resources in a range of other
conditions in the relevant currencies used by ICE Clear Europe,
including defaults of investment counterparties, settlement banks,
Nostro agents, intraday liquidity providers and other service
providers, market infrastructure failures and other systemic events
(and combinations thereof). Historical scenarios are run on a single
day, and a historical trend is kept. Forward-looking scenarios project
these cash flows over the coming eight-day period.
    ICE Clear Europe's Liquidity Plan also specifies procedures for
liquidity management in cases of potential liquidity stress. ICE Clear
Europe has defined a series of liquidity events and stress situations,
ordered by severity, which trigger a notification to the relevant level
of management and, if further escalation is required, the Board. The
Liquidity Plan also outlines actions that may be taken in each
situation to address the liquidity event or stress.
    The Liquidity Plan provides for daily, weekly and monthly reporting
requirements to relevant levels of clearing house management, Board
risk committee, the Board and regulators, as appropriate. In addition,
the Liquidity Plan establishes a protocol for breaches and liquidity
events, which includes reporting and escalation based on the severity
of the event, mitigating actions and replenishment of liquidity. The
Liquidity Plan also provides for periodic testing of liquidity
resources to ensure that they are ``highly reliable'' within the
meaning of Article 44 of EMIR.
    As part of the specified governance process, the Liquidity Plan
will be reviewed by management and must be approved by the Board
annually following consultation with the Board risk committee.
Deviations and interim changes similarly require Board approval
following consultation with the Board risk committee.
    ICE Clear Europe has also revised its LRMF to reflect the adoption
of the new, separate Liquidity Plan (and the two documents together are
intended to reflect the clearing house's approach to liquidity
management). Various sections of the LRMF have also been modified to
improve clarity and readability. As revised, the LRMF specifies the
objectives of liquidity management, and references relevant policies,
including investment policies, collateral management and haircut
policies, stress testing policies and operational risk management
policies. The LRMF also addresses the policies for establishing
liquidity risk tolerances and appetites, the range of relevant stress
scenarios (which are derived from the CPSS-IOSCO Principles for
Financial Market Infrastructures and Regulatory Technical Standards
Article 32.4), reverse stress testing requirements in accordance with
Regulatory Technical Standards Article 49, and the resources the
clearing house will treat as available for liquidity management
purposes. The LRMF specifies further procedures concerning liquidity
shortfalls and replenishment, complementing the provisions set forth in
the Liquidity Plan. The LRMF also specifies procedures for internal
review and governance over the liquidity policies, as well as
procedures for exceptions and breaches of risk tolerance or risk
appetite levels.
2. Statutory Basis
    ICE Clear Europe believes that the proposed rule change is
consistent with the requirements of Section 17A of the Act \5\ and the
regulations thereunder applicable to it, including the standards under
Rule 17Ad-22.\6\ Section 17A(b)(3)(F) of the Act \7\ requires, among
other things, that the rules of a clearing agency be designed to
promote the prompt and accurate clearance and settlement of securities
transactions, and to the extent applicable, derivative agreements,
contracts and transactions and to comply with the provisions of the Act
and the rules and regulations thereunder. The proposed rules are
designed to formalize the clearing house's policies and procedures
relating to liquidity risk management. In particular, the revised
policies address ICE Clear Europe's liquidity resources and procedures
for testing the adequacy of those resources in a range of scenarios,
including extreme but plausible scenarios involving, among other
things, the default of a clearing member, settlement bank, liquidity
provider and other service providers. They also provide further clarity
as to the steps ICE Clear Europe may take when confronted with a
potential liquidity shortfall or similar event. In ICE Clear Europe's
view, the amendments thereby enhance the ability of the clearing house
to assess potential liquidity events that may impact its ability to
conduct settlements for cleared transactions and its ability to avoid
or manage such events and continue clearing house operations. As such,
ICE Clear Europe believes that the changes will promote the prompt and
accurate settlement of securities and derivatives transactions, and
therefore are consistent with the requirements of the Act and the rules
and regulations thereunder applicable to ICE Clear Europe, in
particular, to Section 17(A)(b)(3)(F).
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    \5\ 15 U.S.C. 78q-1.
    \6\ 17 CFR 240.17Ad-22.
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    ICE Clear Europe does not believe the Liquidity Policy Amendments
would have any impact, or impose any burden, on competition not
necessary or appropriate in furtherance of the purposes of the Act. The
amendments formalize certain liquidity management policies and
procedures. ICE Clear Europe does not believe that the revised policies
will materially affect the cost of clearing for clearing members or
their customers, impose additional requirements on clearing members, or
otherwise affect access to clearing. The amendments will promote
liquidity risk

management and thereby enhance the stability of the clearing house and
its ability to continue to provide clearing services in the case of
liquidity stresses.

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

    Written comments relating to the proposed change to the rules have
not been solicited or received. ICE Clear Europe will notify the
Commission of any written comments received by ICE Clear Europe.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml) or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ICEEU-2014-12 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-ICEEU-2014-12. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filings also will be available
for inspection and copying at the principal office of ICE Clear Europe
and on ICE Clear Europe's Web site at https://www.theice.com/clear-europe/regulation.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-ICEEU-2014-12
and should be submitted on or before September 2, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-18877 Filed 8-8-14; 8:45 am]
BILLING CODE 8011-01-P


Comments on U.S. Environmental Protection Agency Proposed Rule, "Control of Air Pollution from Motor Vehicles: Tier 3 Motor Vehicle Emission and Fuel Standards," RIN 2060-AQ86

   1) Gauging fuel consumption impacts - Suggest EPA assess the overall change to fuel economy within vehicle category.  Did the State of California conduct a similar analysis in support of its LEV III rulemaking?  If so, suggest incorporating by reference, since this proposal discusses essentially the same vehicle/technology/stringency combinations.

We are not projecting any impacts on fuel economy to result from the Tier 3 proposal, although the sulfur reduction may enable lean-burn gasoline technology as another option for manufacturers to use to meet more stringent greenhouse gas and fuel economy standards.

         a. How much will the high oxygen content of the new fuel affect fuel consumption? The Tier 3 proposal is not changing the oxygen content of in-use fuel, and as such will have no impact on in-use fuel economy.  The new certification fuel means a priori lower fuel economy than that of the higher energy-density current certification fuel.  This is solely an issue for certification testing, not in-use fuel economy, which is driven by the quality of fuel actually used by consumers.  As discussed in section IV.D.4 of the preamble, the calculation procedure for determining fuel economy for CAFE purposes already adjusts for changes in the energy content of a test fuel, so the change in energy content associated with the change in test fuel specifications should not impact fuel economy for CAFE purposes.  If there are other aspects of the calculation procedure that need updating, EPA would address that as part of a separate later action.
         b. What additional exhaust control equipment weight will be added to achieve the new emissions limits and what will be the fuel economy penalty be compared to the baseline?  As discussed in Preamble Section IV.A.5.d, our technical assessment of the technologies needed to achieve the proposed standards include changes within the catalyst, engine calibrations, and reduced thermal mass will be the primary technologies manufacturers will use to meet the proposed standards.  None of these technologies will have a significant impact on vehicle weight or fuel economy. (Reduced thermal mass will actually reduce vehicle weight, though the impact is expected to be very small.)

   2) Refinery compliance costs and sulfur disposal

         a. What assumptions has EPA made concerning the by-product use of the sulfur removed from the refinery process?  Elemental sulfur market remains relatively soft, so refiners may be tempted to back the sulfur down to heavier refined grades (a common practice over time) rather than extract it.
         b. Is the only feasible receptacle for this heating oil?  As the recent stringent limits on hoteling emissions in U.S. ports and sulfur control for nonroad diesel have essentially eliminated bunker fuel, the old standby of bygone days, and "red" diesel as candidates.  How did EPA consider the opportunity costs of not being able to use the higher sulfur fuel in these previously available markets?  Please describe the assumptions used, relative differences in value of products, and markets where EPA expects these products to now be used.   As discussed in section VII.B. of the preamble, EPA has projected that Tier 3 will be met through additional hydrotreating of gasoline.  This would result in a very small incremental increase in the amount of elemental sulfur removed by refineries from petroleum fuels and would be sold into the existing market for sulfur.  Due to expansion of the distillate market and contraction of the gasoline market, some refiners are already choosing to undercut the heavy end of their gasoline into diesel fuel, kerosene, and heating oil.  While we have not been able to model it on a refinery-by-refinery basis for the proposal, expansion of this practice in the future would ease the cost of compliance with both the Tier 3 and ultra-low sulfur diesel standards.  This practice would also increase the supply of diesel fuel, which would help supply diesel fuel to ocean going vessels in the emission control areas (ECAs) in lieu of residual fuel.
         c. With respect to increased stringency of gasoline sulfur limits, refiners were already producing or preparing to produce ultra-low sulfur gasoline for the California market; however, this sulfur reduction will not be without added cost in order to comply nationwide.  As discussed in section VII.B. of the preamble, we fully analyze and assess the added cost associated with the Tier 3 sulfur standard.  This includes estimating the compliance costs for gasoline produced by California refineries for sale outside of California.

   3) In what respects is the Tier 3 rule not aligned with the CARB LEV III rule?
         a. Will auto manufacturers be required to perform additional test procedures for the Tier 3 rule, that are not required under LEV III? If so, what are the costs to auto manufacturers of purchasing the equipment and/or running the tests that are required under Tier 3 but not required under LEV III?
         We have worked extensively with CARB and the auto manufacturers to harmonize the Tier 3 proposal and the LEV III programs.  As a result, we and the automakers believe that we have developed Tier 3 in such a way as to allow manufacturers to design and test one vehicle for sale nationwide.  There are some differences between Tier 3 and LEV III, and these are highlighted in Section IV of the preamble.  These include, for example, historical differences carried over to Tier 3, such as our need in a national program for 20 degree F and high altitude testing vs CARB's need for 50 degree F testing.   The Tier 3 proposal accounts for costs associated with additional test burden resulting from Tier 3.  We don't expect Tier 3 to require new tests that are not otherwise required by LEV III, except for the evaporative leak test, which California has already stated it intends to adopt after Tier 3 is finalized.

   4) How does EPA account for the increased costs to manufacturers and consumers for repairing emissions control systems? As manufacturers are forced to add more intricate technologies to achieve more stringent emissions standards, the likelihood and frequency of problems that would require repair would presumably increase as well. Where does EPA address this issue in the rule?  Discussion of the costs projected for the Tier 3 standards is contained in Section VII.A of the preamble.

The technologies we expect to be added or changed to comply with the proposed standards should not require any additional maintenance beyond that already required.  In other words, none of the technologies are expected to deteriorate more rapidly than today and, in fact, we would expect them to become more durable.  A key aspect of the Tier 3 standards is requiring more focus on extended durability (e.g., the 150,000 mile useful life standards and the evaporative leak test). Hence, if anything, we would expect manufacturers to increase maintenance intervals rather than decrease them.  For the Tier 3 technologies, we can see no technology that would incur higher maintenance costs.

We do not agree that the new technologies required to comply with the proposed Tier 3 standards would increase the likelihood and frequency of problems that would require repair.  Vehicles are far more complex today than only 10 years ago yet are more reliable and durable.  In the 2012 final rule establishing light-duty vehicle greenhouse gas emissions and CAFE standards for 2017 and later, we looked at the issue of repair costs and have a lengthy write-up of our findings in Section <IP_ADDRESS> of EPA's final RIA.

   5) Certification fuel revisions  -  Will EPA explain the rationale for the proposed change to the specifications of vehicle emission/fuel economy certification fuel?  As discussed in Section IV.D. of the preamble, in-use gasoline has changed significantly since the certification test fuel specifications were established.  Section 206(h) of the CAA requires that EPA revise the regulations as necessary "to insure that vehicles are tested under circumstances which reflect the actual current driving conditions under which motor vehicles are used, including conditions related to fuel, temperature, acceleration, and altitude." The table below highlights key changes to the certification fuel specs:

                     Proposed Gasoline Emissions Test Fuel
                                   Property
                                     Unit
                                 SPECIFICATION
                           ASTM Reference Procedure

                                    General
                                    Testing
                            Low-Temperature Testing
                             High Altitude Testing

Antiknock Index (R+M)/2
                                       -
                                  87.0 - 88.4
                                 87.0 Minimum
D2699-11 and D2700-11
Sensitivity (R-M)
                                       -
                                  7.5 Minimum

Dry Vapor Pressure Equivalent (DVPE)
                                   kPa (psi)
                                   60.0-63.4
                                   (8.7-9.2)
                                  77.2-81.4
                                  (11.2-11.8)
                                   52.4-55.2
                                   (7.6-8.0)
D5191-10b
Distillation
                                                                 10% evaporated
                                   °C (°F)
                                     49-60
                                   (120-140)
                                     43-54
                                   (110-130)
                                     49-60
                                   (120-140)
D86-10a
                                                                 50% evaporated
                                   °C (°F)
                                77-88 (170-190)

                                                                 90% evaporated
                                   °C (°F)
                               154-166 (310-330)

                                                 Evaporated final boiling point
                                   °C (°F)
                               193-216 (380-420)

Residue
                                  Milliliter
                                  2.0 Maximum

Total Aromatic Hydrocarbons
                                    vol. %
                                   19.5-24.5
D5769-10
                                                         C6 Aromatics (benzene)
                                    vol. %
                                    0.6-0.8

                                                         C7 Aromatics (toluene)
                                    vol. %
                                    4.4-5.5

                                                                   C8 Aromatics
                                    vol. %
                                    5.5-6.9

                                                                   C9 Aromatics
                                    vol. %
                                    5.0-6.2

                                                                 C10+ Aromatics
                                    vol. %
                                    4.0-5.0

Olefins
                                     mass %
                                    4.5-11.5
D6550-10
Ethanol
                                    vol. %
                                   14.6-15.0
D5599-00 (Reapproved 2010)
Total Content of Oxygenates Other than Ethanol
                                    vol. %
                                  0.1 Maximum

Sulfur
                                     mg/kg
                                   8.0-11.0
D2622-10, D5453-09 or D7039-07
Lead
                                    g/liter
                                0.0026 Maximum
D3237-06
Phosphorus
                                    g/liter
                                0.0013 Maximum
D3231-11
Copper Corrosion
                                       -
                                 No. 1 Maximum
D130-10
Solvent-Washed Gum Content
                                   mg/100 ml
                                  3.0 Maximum
D381-09
Oxidation Stability
                                    Minute
                                 1,000 Minimum
D525-05

   6) Ethanol by % volume - Will EPA explain the rationale for jumping from the expected choice of a 10%-by-volume ethanol fuel, now common throughout the U.S., to E15?  This is explained in Section IV.D. of the preamble.  We do not change certification test fuel parameters often due to the level of effort involved in such a new regulation.  Thus, it is important for us to be forward looking with respect to the fuel anticipated to be in-use during the years the Tier 3 vehicle standards will be in effect (MY2017-2025 and later).  Knowing that E15 has been shown to be less likely to volatilize its gasoline blendstock than E10, how does EPA anticipate this impacting ozone or other emissions?  The volatility of the certification test fuel as listed above is the same as that for the current certification test fuel.  Thus, this will have no impact on emissions during vehicle certification.  In-use emissions are a function of what fuels are actually used by consumers.  Has EPA conducted a sensitivity analysis to see what the implications on vehicle emissions and air quality impacts are for using E10 versus E15?  An assessment of the in-use emission impacts of E15 compared to E10 was performed as part of the E15 waiver decisions (January 26, 2011, 76 FR 4662).  What does EPA project concerning the penetration of E15 in gasoline blendstock?  Is there a particular date by which EPA expects E15 to be commonly used like E10 is today?  Please explain.  For the purposes of establishing a reference case for the analysis of the emission impacts of Tier 3, EPA projected E15 penetration rates over time as shown in chapter 7 of the RIA.

   7) Will EPA also explain why aromatics and olefin percentages are adjusted?  Is it in anticipation of higher oxygenate content and/or octane rating?  Please explain.  As explained in RIA Chapter 3, these changes are to reflect the levels of these parameters in today's in-use gasoline as well as their expected continued decline with the expanded blending of ethanol in the future.

   8) Will EPA explain under what circumstances vehicle manufacturers may request approval for an alternative certification fuel such as a high-octane 30 percent ethanol by volume (E30) blend for vehicles?  This is detailed in 40 CFR 86.113 of the regulations.  The vehicles must be designed to run on such fuels and not on the primary certification test fuels.

Responses to comments directly inserted in the preamble:

      A. Pages 18-19: EPA may want to reconsider proposing E15 as the certification fuel given the significant number of issues that face early market acceptance for E15.  Proposing E10 as the certification fuel and seeking comment on E15 may be more appropriate given that almost all gasoline is now E10 and the issues concerning vehicle warranties, refueling station compatibility for E15 blends, the gasoline blendstock production, transportation and refueling infrastructure limitations, potential refueling retail resistance to eliminating higher margin products (mid-grade and premium E10) for potentially lower margin E15 grade of fuel with significant investment of new refueling equipment and tanks.  As discussed above, our reasons for this change in test fuel are explained in Section IV.D. of the preamble.  We do not change certification test fuel parameters often due to the level of effort involved in such a new regulation.  Thus, it is important for us to be forward looking with respect to the fuel anticipated to be in-use during the years the Tier 3 vehicle standards will be in effect (MY2017 and later).   We are aware of the challenges facing E15, and we will carefully consider what to finalize, with the benefit of public comment.  In addition, it is impractical to make the suggested change in the proposal.  For example, were we to change our proposal to E10, we would then also likely have to consider raising the certification test fuel RVP to 10 psi in order to reflect the in-use volatility of E10.  This would have significant impacts on the stringency of the evaporative emissions standards that we have harmonized with CARB and coordinated with the vehicle manufacturers.  We have added language to the proposal's discussion (in Section IV.D) to ensure that it is clear and robust enough to encourage public comment and allow us to finalize either E10 or E15 cert fuel.
      B. Page 121:  Why does EPA calculate that manufacturers opting to certify vehicles for a 120,000 mile useful life would have to meet 0.85 of the standard for a certification to a 150,000 mile useful life? Isn't the proper ratio 0.80?
         To establish an equivalent standard at 120k useful life vs. a 150k useful life, we looked at relative emission control system deterioration rates for Tier 1 and Tier 2 vehicles based on Inspection and Maintenance (I/M) data.  This data was used to project the relative deterioration rates for Tier 3 vehicles.  The final ratio between the two useful life projections was determined to be 0.85.
         Page 216:  Note the proposed specifications do not align with alternative fuel specifications in 49 USC Section 32901. Definitions
(a) General. - In this chapter -
     (1) "alternative fuel" means -
(D) except as provided in subsection (b) of this section, a mixture containing at least 85 percent of methanol, denatured ethanol, and other alcohols by volume with gasoline or other fuels;
(2) "alternative fueled automobile" means an automobile that is a - (A) dedicated automobile; or (B) dual fueled automobile.
(8) "dedicated automobile" means an automobile that operates only on alternative fuel.
(9) "dual fueled automobile" means an automobile that - (A) is capable of operating on alternative fuel....

This should be reconciled. Note that the DOT has authority to change the specification, but has not revised the specification yet.
49 USC Section 32901. Definitions
(b) Authority To Change Percentage. - The Secretary may prescribe regulations changing the percentage referred to in subsection (a)(1)(D) of this section to not less than 70 percent because of requirements relating to cold start, safety, or vehicle functions.

Our current regulations require that the manufacturers certify FFVs on E0 and E85.  The E85 is produced using denatured ethanol, resulting in an ethanol concentration of E83.  In the Tier 3 proposal we are merely being more explicit on the rest of the chemical makeup of this fuel and providing a blending tolerance for the ethanol concentration.  Thus, our use of a concentration less than 85 percent is not new with the Tier 3 proposal.  Furthermore, we specifically selected the level of 83 percent to be consistent with ASTM specifications for in-use fuel for use in FFVs, which has an ethanol concentration ranging from 51% to 83%.  Since the CAA requires that we certify the emission performance of vehicles under circumstances which reflect the actual current driving conditions under which motor vehicles are used, including conditions related to fuel, it is only appropriate that we not require them to be tested at ethanol levels higher than that experienced in-use.  Nevertheless, it is also clear that the definition in 49 USC Section 32901 (a)(2)(9) only requires that the vehicle be "capable" of operating on the alternative fuel.  Even though we only require that the emissions testing for FFVs be performed on ethanol levels up to 83 percent, that does not mean that the vehicles are not capable of operating on 85 percent and therefore fully qualify with the definition of Alternative fueled automobile.
D.	Page 218:  While NHTSA establishes the fuel economy standards for the CAFE program, EPA is responsible for vehicle testing and compliance calculations.  We have revised to say "While NHTSA establishes the fuel economy standards for the CAFE program, EPA is responsible for vehicle testing and calculation of fuel economy values used by manufacturers for compliance with the CAFE standards."
E.	Page 241:  As such, it can be is less costly per gallon for some larger refineries to get down to 10 ppm than for smaller refineries, as discussed in Chapter 5 of the draft RIA.  We accept these edits.
F.	Page 271:  Same as C., above and same response
G.	Page 273:  Same as C., above and same response


[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Notices]
[Pages 55788-55790]
[FR Doc No: 2023-17609]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98111; File No. SR-NYSE-2023-30]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Its Price List To Adopt a Fee for Directed Orders Routed Directly
by the Exchange to an Alternative Trading System

August 11, 2023.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that on August 9, 2023, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend its Price List to adopt a fee for
Directed Orders routed directly by the Exchange to an alternative
trading system (``ATS''). The proposed rule change is available on the
Exchange's website at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend the NYSE Price List to adopt a fee
for Directed Orders routed directly by the Exchange to an ATS. The
Exchange proposes to implement the fee change effective August 9,
2023.\4\
---------------------------------------------------------------------------

    \4\ The Exchange originally filed to amend the Fee Schedule on
July 31, 2023 (SR-NYSE-2023-28). SR-NYSE-2023-28 was subsequently
withdrawn and replaced by this filing.
---------------------------------------------------------------------------

Background
    The Exchange operates in a highly competitive market. The
Securities and Exchange Commission (``Commission'') has repeatedly
expressed its preference for competition over regulatory intervention
in determining prices, products, and services in the securities
markets. In Regulation NMS, the Commission highlighted the importance
of market forces in determining prices and SRO revenues and, also,
recognized that current regulation of the market system ``has been
remarkably successful in promoting market competition in its broader
forms that are most important to investors and listed companies.'' \5\
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    \5\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005) (File No. S7-10-04) (Final
Rule) (``Regulation NMS'').
---------------------------------------------------------------------------

    While Regulation NMS has enhanced competition, it has also fostered
a ``fragmented'' market structure where trading in a single stock can
occur across multiple trading centers. When multiple trading centers
compete for order flow in the same stock, the Commission has recognized
that ``such competition can lead to the fragmentation of order flow in
that stock.'' \6\ Indeed, cash equity trading is currently dispersed
across 16 exchanges,\7\ numerous alternative trading systems,\8\ and
broker-dealer internalizers and wholesalers, all competing for order
flow. Based on publicly available information, no single exchange
currently has more than 17% market share.\9\ Therefore, no exchange
possesses significant pricing power in the execution of cash equity
order flow. More specifically, the Exchange's share of executed volume
of equity trades in Tapes A, B and C securities is currently has less
than 10%.\10\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 61358, 75 FR 3594,
3597 (January 21, 2010) (File No. S7-02-10) (Concept Release on
Equity Market Structure).
    \7\ See Cboe U.S Equities Market Volume Summary, available at
https://markets.cboe.com/us/equities/market_share. See generally
https://www.sec.gov/fast-answers/divisionsmarketregmrexchangesshtml.html.
    \8\ See FINRA ATS Transparency Data, available at https://otctransparency.finra.org/otctransparency/AtsIssueData. A list of
alternative trading systems registered with the Commission is
available at https://www.sec.gov/foia/docs/atslist.htm.
    \9\ See Cboe Global Markets U.S. Equities Market Volume Summary,
available at http://markets.cboe.com/us/equities/market_share/.
    \10\ See id.
---------------------------------------------------------------------------

    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
move order flow, or discontinue or reduce use of certain categories of
products. While it is not possible to know a firm's reason for shifting
order flow, the Exchange believes that one such reason is because of
fee changes at any of the registered exchanges or non-exchange venues
to which a firm routes order flow. Accordingly, competitive forces
constrain exchange transaction fees because market participants can
readily trade on competing venues if they deem pricing levels at those
other venues to be more favorable.
Proposed Rule Change
    Pursuant to Commission approval, the Exchange adopted a new order
type known as Directed Orders.\11\ Under Exchange rules, the ATS to
which a Directed Order is routed is responsible for validating whether
the order is eligible to be accepted, and if such ATS determines to
reject the order, the order would be cancelled. Directed Orders that
are the subject of this proposed rule change are those that are routed
to OneChronos LLC (``OneChronos'').
---------------------------------------------------------------------------

    \11\ A Directed Order is a Limit Order with instructions to
route on arrival at its limit price to a specified ATS with which
the Exchange maintains an electronic linkage. See Rule 7.31(f)(1).
See also Securities Exchange Act Release No. 95423 (August 4, 2022),
87 FR 48741 (August 10, 2022) (SR-NYSE-2022-20).
---------------------------------------------------------------------------

    The Exchange implemented the routing functionality to OneChronos on
September 9, 2022,\12\ and introduced the functionality at that time
without charging a fee.\13\ The Exchange now proposes to adopt a fee of
$0.0015 per share for Directed Orders routed to OneChronos. To reflect
the proposed fee, the Exchange proposes to amend the current table
under the section titled

Transaction Fees. Specifically, under ``Routing Fee--per share'', the
Exchange proposes to amend the current rule text to state ``$0.0015 for
a Directed Order, as defined in Rule 7.31(f)(1), routed to OneChronos
LLC'' for securities priced at or above $1.00. Additionally, the
Exchange proposes to adopt similar rule text under the section titled
Transaction Fees and Credits For Tape B and C Securities. Specifically,
the Exchange proposes to amend the first bullet under ``Routing Fees''.
As proposed, the first bullet would state:
---------------------------------------------------------------------------

    \12\ See https://www.nyse.com/publicdocs/nyse/notifications/trader-update/110000456275/OneChronos_August_2022_Trader_Update_Final.pdf.
    \13\ See Securities Exchange Act Release No. 95798 (September
15, 2022), 87 FR 57741 (September 21, 2022) (SR-NYSE-2022-43).
---------------------------------------------------------------------------

     For securities at or above $1.00, $0.0015 per share for a
Directed Order, as defined in Rule 7.31(f)(1), routed to OneChronos
LLC; $0.0005 per share in a NYSE American Auction; $0.0010 per share
execution in an Away Market Auction at venues other than NYSE American;
$0.0035 per share for all other executions, or $0.0030 if the member
organization has adding ADV in Tapes A, B, and C combined that is at
least 0.20% of Tapes A, B and C CADV combined.
    Since its implementation, the Directed Order functionality has
facilitated additional trading opportunities by offering member
organizations the ability to designate orders submitted to the Exchange
to be routed to OneChronos for execution. The functionality has also
created efficiencies for member organizations that choose to use the
functionality by enabling them to send orders that they wish to route
to OneChronos through the Exchange by leveraging order entry protocols
already configured for their interaction with the Exchange. Routing
functionality offered by the Exchange is completely optional and member
organizations can readily select between various providers of routing
services, including other exchanges and non-exchange venues. Member
organizations that choose not to utilize Directed Orders would continue
to be able to trade on the Exchange as they currently do.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\14\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\15\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78f(b).
    \15\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    As discussed above, the Exchange operates in a highly fragmented
and competitive market. The Commission has repeatedly expressed its
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. Specifically,
in Regulation NMS, the Commission highlighted the importance of market
forces in determining prices and SRO revenues and, also, recognized
that current regulation of the market system ``has been remarkably
successful in promoting market competition in its broader forms that
are most important to investors and listed companies.'' \16\
---------------------------------------------------------------------------

    \16\ See supra note 5.
---------------------------------------------------------------------------

    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
shift order flow, or discontinue or reduce use of certain categories of
products, in response to fee changes. Accordingly, changes to exchange
transaction fees can have a direct effect on the ability of an exchange
to compete for order flow.
    The routing of orders to OneChronos is provided by the Exchange on
a voluntary basis and no rule or regulation requires that the Exchange
offer it. Nor does any rule or regulation require market participants
to send orders to an ATS generally, let alone to OneChronos. The
routing of orders to OneChronos operates similarly to the Primary Only
Order offered by the Exchange's affiliates NYSE American LLC (``NYSE
American''), NYSE Arca, Inc. (``NYSE Arca''), NYSE Chicago, Inc.
(``NYSE Chicago'') and NYSE National, Inc. (``NYSE National'')
(``collectively, the ``Affiliated Exchanges''). On the Affiliated
Exchanges, a Primary Only Order is an order that is routed directly to
the primary listing market on arrival, without being assigned a working
time or interacting with interest on the order book of the exchange to
which it was submitted.\17\
---------------------------------------------------------------------------

    \17\ See NYSE American Rule 7.31E(f)(1); NYSE Arca Rule 7.31-
E(f)(1); NYSE Chicago Rule 7.31(f)(1); NYSE National Rule
7.31(f)(1).
---------------------------------------------------------------------------

    The Exchange believes its proposal equitably allocates its fees
among market participants. The Exchange believes that the proposal
represents an equitable allocation of fees because it would apply
uniformly to all member organizations, in that all member organizations
will have the ability to designate orders submitted to the Exchange to
be routed to OneChronos, and each such member organization would be
charged the proposed fee when utilizing the functionality. Without
having a view of member organizations' activity on other exchanges and
off-exchange venues, the Exchange has no way of knowing whether the
proposed fee would result in any member organization from reducing or
discontinuing its use of the routing functionality. While the Exchange
has no way of knowing whether this proposed rule change would serve as
a disincentive to utilize the order type, the Exchange believes that a
number of member organizations will continue to utilize the
functionality because of the efficiencies created for member
organizations that enables them to send orders that they wish to route
to OneChronos through the Exchange by leveraging order entry protocols
already configured for their interactions with the Exchange.
    The Exchange reiterates that the routing functionality offered by
the Exchange is completely optional and that the Exchange operates in a
highly competitive market in which market participants can readily
select between various providers of routing services with different
product offerings and different pricing. The Exchange believes that the
proposed flat fee structure for orders routed to away venues is a fair
and equitable approach to pricing, as it will provide certainty with
respect to execution fees.
    The Exchange believes that the proposal is not unfairly
discriminatory. The Exchange believes it is not unfairly discriminatory
as the proposal to charge a fee would be assessed on an equal basis to
all member organizations that use the Directed Order functionality.
Moreover, this proposed rule change neither targets nor will it have a
disparate impact on any particular category of market participant. The
Exchange believes that this proposal does not permit unfair
discrimination because the changes described in this proposal would be
applied to all similarly situated member organizations. Accordingly, no
member organization already operating on the Exchange would be
disadvantaged by the proposed allocation of fees. The Exchange further
believes that the proposed rule change would not permit unfair
discrimination among member organizations because the Directed Order
functionality would remain available to all member organizations on an
equal basis and each such participant would be charged the same fee for
using the functionality.
    Finally, the submission of orders to the Exchange is optional for
member organizations in that they could choose

whether to submit orders to the Exchange and, if they do, the extent of
its activity in this regard. The Exchange believes that it is subject
to significant competitive forces, as described below in the Exchange's
statement regarding the burden on competition.
    For the foregoing reasons, the Exchange believes that the proposal
is consistent with the Act.

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

    In accordance with Section 6(b)(8) of the Act,\18\ the Exchange
believes that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The Exchange believes that the proposed change
furthers the Commission's goal in adopting Regulation NMS of fostering
integrated competition among orders, which promotes ``more efficient
pricing of individual stocks for all types of orders, large and
small.'' \19\ The Exchange does not believe that the proposed fee
change represents a significant departure from previous pricing offered
by the Exchange or pricing offered by the Exchange's competitors.
Member organizations may opt to disfavor the Exchange's pricing if they
believe that alternatives offer them better value. Accordingly, the
Exchange does not believe that the proposed change will impair the
ability of member organizations or competing venues to maintain their
competitive standing in the financial markets.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78f(b)(8).
    \19\ See supra note 5.
---------------------------------------------------------------------------

    Intramarket Competition. The Exchange believes the proposed
amendment to its Price List would not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act. The Directed Order functionality is available to all member
organizations and all member organizations that use the functionality
to route their orders to OneChronos would be charged the proposed fee.
The routing of orders to OneChronos is provided by the Exchange on a
voluntary basis and no rule or regulation requires that the Exchange
offer it. Member organizations have the choice whether or not to use
the Directed Order functionality and those that choose not to utilize
it will not be impacted by the proposed rule change. The Exchange also
does not believe the proposed rule change would impact intramarket
competition as the proposed fee would apply to all member organizations
equally that choose to utilize the Directed Order functionality, and
therefore the proposed change would not impose a disparate burden on
competition among market participants on the Exchange.
    Intermarket Competition. The Exchange operates in a highly
competitive market in which market participants can readily choose to
send their orders to other exchange and off-exchange venues if they
deem fee levels at those other venues to be more favorable. As noted
above, the Exchange's market share of intraday trading is currently
less than 10%. In such an environment, the Exchange must continually
adjust its fees and rebates to remain competitive with other exchanges
and with off-exchange venues. Because competitors are free to modify
their own fees and credits in response, and because market participants
may readily adjust their order routing practices, the Exchange does not
believe its proposed fee change can impose any burden on intermarket
competition.

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

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

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

    The foregoing rule change has become effective upon filing pursuant
to Section 19(b)(3)(A) \20\ of the Act and paragraph (f) thereunder. At
any time within 60 days of the filing of the proposed rule change, the
Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78s(b)(3)(A).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-NYSE-2023-30 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-2023-30. 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 (https://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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-NYSE-2023-30 and should be
submitted on or before September 6, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-17609 Filed 8-15-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Proposed Rules]
[Pages 2093-2095]
[FR Doc No: 2022-00475]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2021-N-1326]

Scientific Data and Information Related to the Residue of
Carcinogenic Concern for the New Animal Drug Carbadox; Public Hearing;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public hearing on scientific data and information related
to the residue of carcinogenic concern for the new animal drug
carbadox, a carcinogenic new animal drug used in swine feed.

DATES: The public hearing will be held virtually on March 10, 2022,
from 1 p.m. to 5 p.m., Eastern Time. Persons interested in attending
this public hearing must register no later than 11:59 p.m. Eastern Time
on March 9, 2022. Persons interested in making oral presentations and
comments at the public hearing must submit requests by February 18,
2022. Submit either electronic or written comments on this hearing by
April 11, 2022. See the SUPPLEMENTARY INFORMATION section for
registration dates and 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 April 11, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 11, 2022. 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-2021-N-1326 for ``Scientific Data and Information Related to the
Residue of Carcinogenic Concern for the New Animal Drug Carbadox;
Public Hearing; Request for Comments.'' 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,<PHONE_NUMBER>.
     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 our consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.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: Kelly Covington, Center for Veterinary
Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, [email protected], 240-402-
5661.

SUPPLEMENTARY INFORMATION:

I. Background and Purpose of Hearing

    Under the Delaney Clause (section 512(d)(1)(I) (21 U.S.C.
360b(d)(1)(I)) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)),
FDA generally cannot approve a new animal drug application (NADA) if
the drug that is the subject of that application induces cancer in
humans or animals. An exception to this general rule is commonly known
as the Diethylstilbestrol ``DES'' Proviso, which allows for the
approval of a carcinogenic new animal drug where FDA finds that under
the approved conditions of use: (1) The drug will not adversely affect
the animals treated with the drug and (2) no residues of the drug will
be found by an approved regulatory method in any edible tissues of, or
in any foods yielded by, the animal (section 512(d)(1)(I) of the FD&C
Act).
    On July 20, 2020, the Agency published a notice in the Federal
Register proposing an order to revoke the approved method for detecting
residues of carbadox, a carcinogenic new animal drug used in swine
feed. (85 FR 43853, July 20, 2020; Docket No. FDA-2020-N-0955, ``Phibro
Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of
Approved Method.'') The currently approved method measures quinoxaline-
2-carboxylic acid (QCA) as a marker residue to detect the presence of
the residue of carcinogenic concern. (Determination of Carbadox (as
Quinoxaline-2-Carboxylic [QCA]) Residues in Swine Liver and Muscle
Tissues After Drug Withdrawal, https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room.) The proposal to
revoke the approved method for carbadox is based on CVM's determination
that the method is inadequate to monitor residue of carcinogenic
concern in compliance with FDA's regulations in part 500, subpart E (21
CFR part 500, subpart E). These regulations set out the requirements
for demonstrating that no residues of the drug will be found by an
approved regulatory method in any edible tissues of or in any foods
obtained from the animal, as required to meet the requirements of the
DES Proviso. The purpose of the public hearing is to gather additional
data and information related to the residue of carcinogenic concern for
the new animal drug carbadox.

II. Notice of Hearing Under 21 CFR Part 15

    This public hearing will be held in accordance with part 15 (21 CFR
part 15). Pursuant to Sec.  15.1(a) and authority delegated from the
Commissioner of Food and Drugs as referenced in the FDA Staff Manual
Guide 1410.21(1)(B)(6) and (1)(D), the FDA Acting Chief Scientist
concludes, as a matter of discretion, that it is in the public interest
to permit persons to present information and views at a public hearing
on this matter. The hearing will be conducted by a presiding officer,
who will be accompanied by other United States Government employees
serving as a panel in conducting the hearing. Under Sec.  15.30(f), the
hearing is informal, and the rules of evidence do not apply. Only the
presiding officer and panel members can pose questions; they can
question any person during or at the conclusion of each presentation.
To the extent that the conditions for the hearing, as described in this
notice, conflict with any provisions set out in part 15, this notice
acts as a waiver of those provisions as specified in Sec.  15.30(h).

III. Topics for the Public Hearing

    We encourage public comments and presentations at the public
hearing. We are particularly interested in receiving comments, data,
and information about the topics listed below. In submitting comments,
data, and information to the docket, please identify available
references for the data and information, as well as the specific item
number listed below, if applicable. Please reference, but do not
resubmit, any information already contained in Docket No. FDA-2020-N-
0955, ``Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed;
Revocation of Approved Method.''
    1. Data to inform our knowledge of the residue of carcinogenic
concern not summarized in the Freedom of Information summary for the
1998 supplemental approvals, including additional data regarding the
fraction of noncarcinogenic residues in the total radiolabeled residues
of carbadox.
    2. For any given concentration of a marker residue, the
corresponding concentration of the residue of carcinogenic concern.
    3. Additional information not already contained in Docket No. FDA-
2020-N-0955, ``Phibro Animal Health Corp.; Carbadox in Medicated Swine
Feed; Revocation of Approved Method'' related to the adequacy of the
current approved method to measure QCA as a marker residue for the
residue of carcinogenic concern for the new animal drug carbadox.
    4. Any method, other than the current approved method, that
demonstrates ``no residue'' for the new animal drug carbadox in
conformance with part 500, Subpart E.
    5. Detailed information on the conduct and quality of studies
providing data to support the points above, including information on
the extraction process and the stability of residues being analyzed.

IV. Participating in the Public Hearing

    Registration: To register to attend the virtual public hearing, on
``Scientific Data and Information Related to the Residue of
Carcinogenic Concern for the New Animal Drug Carbadox; Public Hearing;
Request for Comments'' please register at https://fda.zoomgov.com/j/1600135012?pwd=MFdjMW9FRXg4RGllc3FHWVhkWVAyZz09 by March 9, 2022. If
you have any questions, you can contact
[email protected] (See DATES and ADDRESSES). Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone.
    Request for Oral Presentations: During online registration, you may
indicate if you wish to make a formal presentation (with accompanying
slide deck) or present oral comments during the public hearing session
(with no slide deck). If you decide you wish to make a presentation
after registering online, you may submit a request to
[email protected]. All requests to make
presentations must be received by February 18, 2022. FDA will do its
best to accommodate requests to make public presentations. Individuals
and organizations with common interests are urged to consolidate or
coordinate their presentations. FDA will determine the amount of time
allotted to each presenter and the approximate time each presentation
is to begin and will select and notify participants by February 23,
2022.
    If selected for a formal oral presentation (with a slide deck),
each presenter must submit an electronic copy of their presentation
(PowerPoint or PDF) to [email protected] with the
subject line ``Scientific Data and Information Related to the Residue
of Carcinogenic Concern for the New Animal Drug Carbadox; Public
Hearing; Request for Comments'' on or before March 4, 2022. No
commercial or promotional material will be permitted to be presented or
distributed at the public hearing.
    Persons notified that they will be presenters are encouraged to be
online early. Actual presentation times may vary based on how the
hearing progresses in real time. An agenda for the hearing and any
other background materials will be made available no later than 5 days
before the hearing at https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/part-15-public-hearing-scientific-data-and-information-related-residue-carcinogenic-concern-new.
    Transcripts: Please be advised that as soon as a transcript of the
public hearing is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the transcript will also be available
on the Agency's website at https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/part-15-public-hearing-scientific-data-and-information-related-residue-carcinogenic-concern-new.

    Dated: January 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00475 Filed 1-12-22; 8:45 am]
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Comment Info: =================

General Comment:A 75 day comment period is insufficient time for the vaping industry and the wider vaping community to comment on the proposed deeming regulations. I would respectfully request that the period for comment be extended to 180 days. We need time to voice our opinion about this do to the huge impact it will have on the vaping community and businesses.


[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Rules and Regulations]
[Pages 17116-17117]
[FR Doc No: 2017-06752]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31126; Amdt. No. 3740]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule amends, suspends, or removes Standard Instrument
Approach Procedures (SIAPs) and associated Takeoff Minimums and
Obstacle Departure Procedures for operations at certain airports. These
regulatory actions are needed because of the adoption of new or revised
criteria, or because of changes occurring in the National Airspace
System, such as the commissioning of new navigational facilities,
adding new obstacles, or changing air traffic requirements. These
changes are designed to provide for the safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective April 10, 2017. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of April 10, 2017.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001;
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center online at nfdc.faa.gov
to register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedure
Standards Branch (AFS-420) Flight Technologies and Procedures Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20.
The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained on FAA form documents is
unnecessary.
    This amendment provides the affected CFR sections, and specifies
the SIAPs and Takeoff Minimums and ODPs with their applicable effective
dates. This amendment also identifies the airport and its location, the
procedure and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPs, Takeoff
Minimums and ODPs as identified in the amendatory language for part 97
of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on the
criteria contained in the U.S. Standard for Terminal Instrument
Procedures (TERPS). In developing these changes to SIAPs and Takeoff
Minimums and ODPs, the TERPS criteria were applied only to specific
conditions existing at the affected airports. All SIAP amendments in
this rule have been previously issued by the FAA in a FDC NOTAM as an
emergency action of immediate flight safety relating directly to
published aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    Because of the close and immediate relationship between these
SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find
that notice and public procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest and, where
applicable, under 5 U.S.C. 553(d), good cause exists for making these
SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866;(2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on March 10, 2017.
John S. Duncan,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal regulations, Part 97, (14 CFR part 97), is amended by
amending Standard Instrument Approach Procedures and Takeoff Minimums
and ODPs, effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

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            AIRAC date                  State              City                 Airport            FDC No.        FDC date              Subject
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27-Apr-17.........................  AK            Kenai................  Kenai Muni..........          7/9573         2/28/17  RNAV (GPS) RWY 20R, Amdt
                                                                                3.
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[FR Doc. 2017-06752 Filed 4-7-17; 8:45 am]
 BILLING CODE 4910-13-P