[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Notices]
[Page 52319]
[FR Doc No: 2014-20695]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9016-7]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/compliance/nepa/.

Weekly receipt of Environmental Impact Statements
Filed 08/18/2014 Through 08/22/2014
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.
EIS No. 20140241, Draft Supplement, FHWA, CO, I-70 East, from I-25 to
Tower Road, Comment Period Ends: 10/14/2014, Contact: Chris Horn 720-
963-3017.
EIS No. 20140242, Draft EIS, USFS, CO, Pawnee National Grassland Oil
and Gas Leasing Analysis, Comment Period Ends: 10/14/2014, Contact:
Karen Roth<PHONE_NUMBER>.
EIS No. 20140243, Draft EIS, USFS, NV, Heavenly Mountain Resort Epic
Discovery Project, Comment Period Ends: 10/28/2014, Contact: Matt
Dickinson<PHONE_NUMBER>.

    Dated: August 26, 2014.
Cliff Rader,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2014-20695 Filed 9-2-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Notices]
[Pages 21870-21871]
[FR Doc No: 2020-08223]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4490-DR; Docket ID FEMA-2020-0001]

Missouri; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Missouri (FEMA-4490-DR), dated March 26,
2020, and related determinations.

DATES: The declaration was issued March 26, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated March 26, 2020, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the emergency conditions in the State of
Missouri resulting from the Coronavirus Disease 2019 (COVID-19)
pandemic beginning on January 20, 2020, and continuing, are of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Missouri
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide assistance for emergency
protective measures (Category B), including direct Federal
assistance, under the Public Assistance program throughout the
State. Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Paul Taylor, of FEMA is appointed to
act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Missouri have been designated
as adversely affected by this major disaster:

    Emergency protective measures (Category B) not authorized under
other Federal statutes, including direct Federal assistance, under
the Public Assistance program at 75 percent federal funding for all
areas in the State of Missouri.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-08223 Filed 4-17-20; 8:45 am]
BILLING CODE 9111-23-P


impacts message traffic, data processing and storage.\398\ CAT LLC
explains that it is not feasible to determine the exact cost burden of
each CAT Reporter so trading activity is a reasonable proxy, and that
transaction-based fees for Industry Members are commonly used by
Participants since Industry Members generally effect transactions.\399\
CAT LLC adds that the commenter, FINRA, uses the TAF, a transaction-
based trading activity fee, and that in approving the fee, the
Commission found that transaction volume was sufficiently correlated to
FINRA's regulatory responsibilities.\400\ CAT LLC believes the same
logic should apply to the Executed Share Model.\401\ CAT LLC concludes
that ``executed share volume is an appropriate metric for allocating
CAT costs among CAT Reporters'' \402\ and that the use of executed
share volume would result in reasonable and equitably allocated CAT
fees.\403\
---------------------------------------------------------------------------

    \395\ Id. at 4.
    \396\ See Response Letter at 3.
    \397\ Id.
    \398\ Id.
    \399\ Id.
    \400\ Id. at 4.
    \401\ Id.
    \402\ See Response Letter at 3.
    \403\ Id.
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G. Other Comments

    The Commission also received comments on other topics related to
the funding model.
    One commenter states that the proposed funding model should have
included an explanation of how executed share volume will be calculated
and should explain which ``trade'' event reported by CAT Reporters will
be used to determine executed share volume: MEOT, MEOF, or
allocation.\404\ The commenter recommends that the executed share
volume count only MEOT shares.\405\ The commenter suggests the Proposed
Amendment include a set of ``business rules'' for calculating Executed
Share Volume and that FINRA CAT be required to publish a detailed
specification for calculating volume.\406\ The commenter states that
Industry Members should have an opportunity to review both before the
billing process.\407\
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    \404\ See MMI Letter at 3-4.
    \405\ Id. at 3, n.2.
    \406\ Id. at 3.
    \407\ Id.
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    In response to the comment arguing that the Proposed Amendment
lacks a description of the trades that would be used to calculate
executed share volume,\408\ CAT LLC explains that the Proposed
Amendment states that CAT fees will be assessed for trades reported to
CAT by FINRA via the ADF, the ORF, and the TRF, and by the exchanges,
and that the same transaction data in the CAT Data would be used to
calculate the projected total executed equivalent share volume for the
Fee Rate.\409\ CAT LLC adds that executed share volume would not be
based on other trade-related data in the CAT, like MEOTs, and that
Participant-reported trades, rather than MEOTs and other trade data in
the CAT that is reported by Industry Members would be the ``most
efficient and effective source for calculating executed share volume.''
\410\
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    \408\ Id. at 3-4.
    \409\ See Response Letter at 18.
    \410\ Id.
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    One commenter states that the Proposed Amendment should provide
detail on how the clearing firm for the seller and/or buyer on each
share traded will be determined and how calculations are proposed to be
made if the buyer or seller operates with multiple clearing firms.\411\
The commenter also asks how the Participants would accurately identify
the clearing firm in a transaction, providing as an example a CAT
Reporter with multiple clearing firms.\412\
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    \411\ See MMI Letter at 4.
    \412\ Id. at 3, n.2.
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    In response to the comment asking how clearing firms would be
identified in a transaction, especially when an Industry Member could
have multiple clearing firms,\413\ CAT LLC states that Section
6.4(d)(ii)(A)(2) of the CAT NMS Plan requires the reporting of the SRO-
Assigned Market Participant Identifier of the clearing broker in an
execution and that this information would be provided through the
transaction data in CAT Data to identify the relevant clearing firm in
a transaction.\414\
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    \413\ Id. at 4.
    \414\ See Response Letter at 12-13. CAT LLC also states that it
will adopt policies, procedures, and practices regarding the billing
and collection of fees in compliance with Section 11.1(d) of the CAT
NMS Plan. Id. at 17.
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    Commenters also suggest protocols that would assist clearing firms
and Industry Members in determining and validating CAT fees.\415\ One
commenter recommends that the Operating Committee and FINRA CAT be
required to provide ``detailed data to each clearing firm and to each
CAT reporter so that fees may be validated,'' \416\ and suggests that
the Operating Committee provide estimated fees per CAT Reporter to
allow CAT Reporters to see the impact of the fees, and that these
estimates should ``indicate which clearing firm(s) would be charged for
which portion(s) of the Reporter's traded shares.'' \417\ The commenter
also recommends that the proposed funding model ``set forth parameters
to avoid inefficiencies in the calculation of fees that would result in
a mismatch between fees collected and fees required to cover the cost
of operating the CAT . . . [and] clear procedures to avoid
miscollection of fees.'' \418\
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    \415\ See MMI Letter at 4-5; SIFMA Letter at 10.
    \416\ See MMI Letter at 4-5.
    \417\ Id. at 4.
    \418\ Id. at 4-5.

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Similarly, another commenter states that, because under the Executed
Share Model, clearing firms would be tasked with determining the CAT
fees attributable to each client from a monthly lump sum based on
transaction activity, the CAT should break-out for each clearing firm
the CAT fees attributable to each of the clearing firm's clients.\419\
The commenter also suggests that the CAT break-out and share with each
Industry Member the Industry Member's share of monthly CAT costs.\420\
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    \419\ See SIFMA Letter at 10.
    \420\ Id.
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    In response to the comments suggesting that CAT LLC provide
detailed data to each clearing firm and Industry Member regarding
Industry Member CAT fees and trading activity,\421\ CAT LLC agrees that
this data should be made available to clearing firms and their clients
because ``such data would allow clearing firms to determine which part
of the CAT fees are attributable to their clearing clients and would
facilitate any pass throughs of fees.'' \422\
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    \421\ See MMI Letter at 4-5; SIFMA Letter at 10.
    \422\ See Response Letter at 12.
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    One commenter states that the Proposed Amendment fails to charge
regulators for the costs of filling regulatory queries, which will
result in overuse of the CAT system because regulators will not bear
the costs they impose on the CAT.\423\ The commenter argues that this
failure will make operating the CAT more expensive than it should be
and will result in the inefficient allocation of query resources.\424\
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    \423\ See Harris Letter at 6.
    \424\ Id.
---------------------------------------------------------------------------

    Two commenters state that the Proposed Amendment lacks a cost-
benefit analysis.\425\ One of the commenters argues that the Proposed
Amendment fails to balance the regulatory benefits of CAT with the
costs.\426\ The other commenter states that industry systems are
currently set up to assess fees, such as Section 31 fees, on sellers,
but not purchasers, and as a result, changing the existing industry-
wide systems to charge both purchasers and sellers would ``come not
only at great cost to industry, but also introduce complexity due to
change, without stated benefit.'' \427\ This commenter believes that
the Proposed Amendment should include a cost-benefit analysis of
charging a ``CAT fee on both the purchase and sale of securities, or
alternatively be amended to a fee solely on sellers, to conform to
existing frameworks and business practices.'' \428\
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    \425\ See Virtu Letter at 5; MMI Letter at 3.
    \426\ See Virtu Letter at 4.
    \427\ See MMI Letter at 3.
    \428\ Id.
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    One commenter agrees with the Proposed Amendment's elimination of
tiered pricing and fixed fees.\429\ This commenter states that these
proposed changes would remove a system that is unnecessarily complex,
creates ``perverse incentives'' in tiering and burdens competition
because it increases the cost of entry for new entrants.\430\ This
commenter also recommends two principles that could be used to develop
a fair funding model: the Cost Recovery Principle and the Benefits
Received Principle.\431\
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    \429\ See Harris Letter at 14.
    \430\ Id.
    \431\ Id. at 3.
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    Two commenters argue that the Proposed Amendment's statement that
the Executed Share Model is consistent with existing fees is
irrelevant.\432\ One commenter states that the Participants should have
explained how the existing fees are an appropriate model for CAT
fees.\433\ Another commenter states that similarity to other
transaction-based fees that have been approved by the Commission (e.g.,
TAF, Section 31, ORF) is not an adequate basis to show that the
Executed Share Model is consistent with relevant standards; each
proposed fee must be individually supported.\434\
---------------------------------------------------------------------------

    \432\ See FINRA Letter at 4; SIFMA Letter at 4.
    \433\ See FINRA Letter at 4.
    \434\ See SIFMA Letter at 4.
---------------------------------------------------------------------------

    In response to the comments who disagree with the use of existing
fees as support for the Executed Share Model,\435\ CAT LLC explains
that it cited the other transaction-based regulatory fees to
demonstrate that there is precedent for the use of trading activity as
a metric for calculating fees for a variety of regulatory
activity,\436\ and that the Commission has found that such fees satisfy
the requirements of the Exchange Act.\437\ CAT LLC states that the
proposed CAT fees would operate similar to the precedent.\438\
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    \435\ See FINRA Letter at 3-4; SIFMA Letter at 4.
    \436\ See Response Letter at 4.
    \437\ Id. at 3-4.
    \438\ Id. at 4. CAT LLC also states that the Original Funding
Model relied on a transaction-based CAT fee as the Original Funding
Model based fees for Participants on market share and therefore on
executed transactions. Id. at 5, n.24.
---------------------------------------------------------------------------

H. Past CAT Costs

    In its response, CAT LLC includes discussion and a table that
breaks out the Past CAT Costs into six periods.\439\ The discussion and
tables in this subsection are set forth as substantially prepared by
CAT LLC.
---------------------------------------------------------------------------

    \439\ Id. at 23-28. CAT LLC states that four of the six periods
are the Financial Accountability Milestones (``FAM'') periods set
forth in Section 11.6 of the CAT NMS Plan. Section 11.6 of the CAT
NMS Plan establishes target deadlines for four implementation
milestones (1) July 31, 2020--Initial Industry Member Core Equity
and Option Reporting; (2) December 31, 2020--Full Implementation of
Core Equity Reporting Requirements; (3) December 31, 2021--Full
Availability and Regulatory Utilization of Transactional Database
Functionality; and (4) December 31, 2022--Full Implementation of CAT
NMS Plan Requirements. Id. at 23-24.
---------------------------------------------------------------------------

    CAT LLC states that Past CAT Costs would include costs related to
the FAM periods as well as costs from prior to the first FAM period,
and potentially costs after the FAM periods depending upon the
effectiveness of the CAT fees pursuant to the Executed Share
Model.\440\
---------------------------------------------------------------------------

    \440\ See Response Letter at 24. See also id. at 29-31
(discussing costs that CAT LLC is seeking to recover during the
first three periods of the FAM). The Commission notes that in May
2020, the Commission adopted amendments to the CAT NMS Plan that
establish four Financial Accountability Milestones and set target
deadlines by which these milestones must be achieved. These
amendments also reduce the amount of any fees, costs, and expenses
that the Participants may recover from Industry Members if the
Participants fail to meet the target deadlines. See supra notes 15-
18 and accompanying text. The Commission believes it is most
appropriate to consider whether the Participants have met the target
deadlines established for each Financial Accountability Milestone in
connection with proposals related to the imposition of CAT fees on
broker-dealers. For that reason, in issuing this Order, the
Commission makes no determinations regarding whether the
Participants have achieved the Financial Accountability Milestones
set forth in Section 1.1 of the CAT NMS Plan or the potential
application of fee reduction provisions set forth in Section 11.6 of
the CAT NMS Plan.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Proposed 1/3
                                                                                Proposed 1/3    Proposed 1/3     allocation to
           Dates cost incurred                         Period                    Total CAT costs *       allocation to   allocation to    participants
                                                                                CBBs *****      CBSs *****     (and previously
                                                                                paid) *****
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prior to June 22, 2020..................  N/A.............................  ** $143,919,521...........     $47,973,174     $47,973,174       $47,973,174
June 22, 2020-July 31, 2020.............  FAM Period 1....................  $6,377,343................       2,125,781       2,125,781         2,125,781
Aug. 1, 2020-Dec. 31, 2020..............  FAM Period 2....................  $42,976,478...............      14,325,493      14,325,493        14,325,493
Jan. 1, 2021-Dec. 31, 2021..............  FAM Period 3....................  $144,415,268..............      48,238,423      48,238,423        48,238,423
Jan. 1, 2022-Dec. 31, 2022..............  FAM Period 4....................  Budgeted $174,766,871 ***.             TBD             TBD               TBD
Post Dec. 31, 2022......................  TBD ****........................  TBD ****..................         *** TBD         *** TBD           *** TBD
--------------------------------------------------------------------------------------------------------------------------------------------------------
* These costs exclude costs of $14,749,362 related to the conclusion of the relationship with the Initial Plan Processor.
** These costs exclude $48,874,937 of Excluded Costs.
*** As 2022 remains in progress, these costs are budgeted costs, not actual. Past CAT Costs, however, would be based on actual costs, and the costs
  included would depend on the effective date of any CAT fees.
**** Depending on the effective date of any CAT fees, costs from the period after December 31, 2022 may also be included in Past CAT Costs.
***** Total of proposed allocated costs may not agree to total CAT Costs due to rounding.

a. Costs Incurred Prior to June 22, 2020
    Past CAT Costs include costs incurred by CAT prior to June 22, 2020
and already funded by the Participants. As noted above, the Past CAT
Costs for the period prior to June 22, 2020 are $143,919,521.
Participants would remain responsible for one-third of this cost (which
they have previously paid), and Industry Members would be responsible
for the remaining two-thirds, with CBBs paying one-third ($47,973,174)
and CBSs paying one-third ($47,973,174). The following provides
additional detail about the costs from this period.
     In accordance with Section 11.1(c) of the CAT NMS Plan,
the Past CAT Costs include ``fees, costs and expenses (including legal
and consulting fees and expenses) incurred by the Participants on
behalf of the Company prior to the Effective Date in connection with
the creation and implementation of the CAT.'' Specifically, Past CAT
Costs include costs incurred from 2012 through November 20, 2016
related to the development of the National Market System Plan Governing
the Process of Selecting a Plan Processor and Developing a Plan for the
Consolidated Audit Trail (``Selection Plan'') and the CAT NMS Plan as
well as the Plan Processor selection process pursuant to the Selection
Plan. The Past CAT Costs incurred during this period are $13,842,881.
Participants would remain responsible for one-third of this cost (which
they have previously paid) ($4,614,294), and Industry Members would be
responsible for the remaining two-thirds, with CBBs paying one-third
($4,614,294) and CBSs paying one-third ($4,614,294).
     The Past CAT Costs for this period include costs incurred
after the formation of the CAT NMS Plan and prior to the selection of
the Initial Plan Processor for the CAT, which covers the period from
November 21, 2016 through April 5, 2017. The Past CAT Costs for this
period are $2,933,869. Participants would remain responsible for one-
third of this cost (which they have previously paid) ($977,956), and
Industry Members would be responsible for the remaining two-thirds,
with CBBs paying one-third ($977,956) and CBSs paying one-third
($977,956).
     The Past CAT Costs include a subset of the total costs
incurred during the period in which Initial Plan Processor for the CAT
was operating, which was April 6, 2017 through March 28, 2019. The
total costs for this period are $106,256,258. The Participants,
however, have determined to exclude from the Past CAT Costs all costs
incurred from November 15, 2017 through November 15, 2018 (``Excluded
Costs'') due to the delay in the start of reporting to the CAT. The
Excluded Costs are $48,874,937. Accordingly, the Past CAT Costs for
this period are $57,381,321.\441\ Participants would remain responsible
for Excluded Costs as well as one-third of these Past CAT Costs (both
of which they have previously paid) ($16,291,646), and Industry Members
would be responsible for the remaining two-thirds, with CBBs paying
one-third ($16,291,646) and CBSs paying one-third ($16,291,646).
---------------------------------------------------------------------------

    \441\ Section II(B)(3) below provides further discussion of
costs related to the Initial Plan Processor. The Commission notes
that the section cited is in the Response Letter at 28-29.
---------------------------------------------------------------------------

     The Past CAT Costs include the costs incurred from the
date of FINRA CAT's selection as the Plan Processor on March 29, 2019
through June 21, 2020. The Past CAT Costs for this period are
$69,761,450. These costs are net of costs related to the conclusions of
the relationship with the Initial Plan Processor of $7,337,345.
Participants would remain responsible for costs related to the
conclusion of the relationship with the Initial Plan Processor as well
as one-third of these Past CAT Costs (both of which they have
previously paid) ($23,253,817), and Industry Members would be
responsible for the remaining two-thirds, with CBBs paying one-third
($23,253,817) and CBSs paying one-third ($23,253,817).
    The following table breaks down the Past CAT Costs for the period
prior to June 22, 2020 into the categories set forth in the audited
financial statements for the Company:

------------------------------------------------------------------------
                                                          Total past CAT
                                                             costs for
                    Operating expense                      period prior
                                                            to June 22,
                                                               2020
------------------------------------------------------------------------
Technology Costs *......................................    $105,044,520
Legal...................................................      19,674,463
Consulting..............................................      17,013,414
Insurance...............................................         880,419
Professional and administration.........................       1,082,036
Public relations........................................         224,669
------------------------------------------------------------------------
* Capitalized developed technolgy costs are already included in
  ``Technology Costs'' and therefore the non-cash amortization of these
  capitalized developed technology costs of $2,115,545 incurred during
  the period prior to June 22, 2020 have been appropriately excluded
  from ``Operating Expense.''

b. CAT Costs Incurred in Period 1
    Past CAT Costs include costs incurred by CAT and already funded by
Participants during FAM Period 1, which covers the period from June 22,
2020-July 31, 2020. The Past CAT Costs for Period 1 are $6,377,343.
Participants would remain responsible for one-third of this cost (which
they have previously paid) ($2,125,781), and Industry Members would be
responsible for the remaining two-thirds, with CBBs paying one-third
($2,125,781) and CBSs paying one-third ($2,125,781). The following
table breaks down the Past CAT Costs for Period 1 into the categories
set forth in the audited financial statements for the Company:

------------------------------------------------------------------------
                                                          Total past CAT
                    Operating expense                        costs for
                                                             Period 1
------------------------------------------------------------------------
Technology Costs........................................    * $5,681,670
Legal...................................................         481,687
Consulting..............................................         137,209
Insurance...............................................  ..............
Professional and administration.........................          69,077
Public relations........................................           7,700
------------------------------------------------------------------------
* Capitalized developed technolgy costs are already included in
  ``Technology Costs'' and therefore the non-cash amortization of these
  capitalized developed technology costs of $362,121 incurred during
  Period 1 have been appropriately excluded from ``Operating Expense.''

c. CAT Costs Incurred in Period 2
    Past CAT Costs include costs incurred by CAT and already funded by
Participants during FAM Period 2, which covers the period from August
1, 2020-December 31, 2020. Participants would remain responsible for
one-third of this cost (which they have previously paid) ($14,325,493),
and Industry Members would be responsible for the remaining two-thirds,
with CBBs paying one-third ($14,325,492.70) and CBSs paying one-third
($14,325,492.70). The Past CAT Costs for Period 2 are $42,976,478. The
following table breaks down the Past CAT Costs for Period 2 into the
categories set forth in the audited financial statements for the
Company:

------------------------------------------------------------------------
                                                          Total past CAT
                    Operating expense                        costs for
                                                             Period 2
------------------------------------------------------------------------
Technology Costs *......................................     $38,221,127
Legal...................................................       2,766,644
Consulting..............................................         532,146
Insurance...............................................         976,098
Professional and administration.........................         438,523
Public relations........................................          41,940
------------------------------------------------------------------------
* Capitalized developed technolgy costs are already included in
  ``Technology Costs'' and therefore the non-cash amortization of these
  capitalized developed technology costs of $1,892,505 incurred during
  Period 2 have been appropriately excluded from ``Operating Expense.''

d. CAT Costs Incurred in Period 3
    Past CAT Costs include costs incurred by CAT and already funded by
Participants during FAM Period 3, which covers the period from January
1, 2021-December 31, 2021. The Past CAT Costs for Period 3 are
$144,415,268. Participants would remain responsible for one-third of
this cost (which they have previously paid) ($48,238,423), and Industry
Members would be responsible for the remaining two-thirds, with CBBs
paying one-third ($48,238,423) and CBSs paying one-third ($48,238,423).
The following table breaks down the Past CAT Costs for Period 3 into
the categories set forth in the audited financial statements for the
Company:

------------------------------------------------------------------------
                                                          Total past CAT
                    Operating expense                        costs for
                                                             Period 3
------------------------------------------------------------------------
Technology Costs........................................    $134,402,774
Legal...................................................       6,333,248
Consulting..............................................       1,408,209
Insurance...............................................       1,582,714
Professional and administration.........................         595,923
Public relations........................................          92,400
------------------------------------------------------------------------
* Capitalized developed technolgy costs are already included in
  ``Technology Costs'' and therefore the non-cash amortization of these
  capitalized developoed technology costs of $5,108,044 incurred during
  Period 3 have been appropriately excluded from ``Operating Expense.''

e. CAT Costs Incurred in Period 4
    Past CAT Costs would include CAT costs incurred by CAT and already
funded by Participants (or to be funded by Participants) during FAM
Period 4, which covers the period from January 1, 2022-December 31,
2022 (depending on the completion of the FAM for Period 4), and
incurred prior to the implementation of the CAT fees pursuant to the
Executed Share Model. Participants would remain responsible for one-
third of this cost (which they have previously paid), and Industry
Members would be responsible for the remaining two-thirds, with CBBs
paying one-third and CBSs paying one-third. Given that 2022 remains in
progress, the following table provides budgeted (as opposed to actual)
figures for costs for Period 4. The current budgeted CAT costs for
Period 4 are $174,766,871.

------------------------------------------------------------------------
                                                          Total past CAT
                                                             costs for
                    Operating expense                        Period 4
                                                           through June
                                                               2022
------------------------------------------------------------------------
Technology Costs........................................    $163,609,591
Legal...................................................       7,162,084
Consulting..............................................       1,400,000
Insurance...............................................       1,820,122
Professional and administration.........................         682,674
Public relations........................................          92,400
------------------------------------------------------------------------

    Budgeted CAT costs for 2022 are $174,766,871 and currently
available on the CAT website; \442\ actual CAT costs for 2022 will be
available in audited financial statements for the Company after year
end.
---------------------------------------------------------------------------

    \442\ See Consolidated Audit Trail, LLC 2022 Financial and
Operating Budget, https://www.catnmsplan.com/sites/default/files/2022-04/04.06.22-CAT-2022-Budget.pdf).
---------------------------------------------------------------------------

V. Proceedings To Determine Whether To Approve or Disapprove the
Proposed Amendment

    The Commission is instituting proceedings pursuant to Rule
608(b)(2)(i) of Regulation NMS,\443\ and Rules 700 and 701 of the
Commission's Rules of Practice,\444\ to determine whether to disapprove
the Proposed Amendment or to approve the Proposed Amendment with any
changes or subject to any conditions the Commission deems necessary or
appropriate. Institution of proceedings does not indicate that the
Commission has reached any conclusions with respect to any of the
issues involved. Rather, the Commission seeks and encourages interested
persons to provide additional comment on the Proposed Amendment to
inform the Commission's analysis.
---------------------------------------------------------------------------

    \443\ 17 CFR 242.608.
    \444\ 17 CFR 201.700; 17 CFR 201.701.
---------------------------------------------------------------------------

    Rule 608(b)(2) of Regulation NMS provides that the Commission
``shall approve a national market system plan or proposed amendment to
an effective national market system plan, with such changes or subject
to such conditions as the Commission may deem necessary or appropriate,
if it finds that such plan or amendment is necessary or appropriate in
the public interest, for the protection of investors and the
maintenance of fair and orderly markets, to remove impediments to, and
perfect the mechanisms of, a national market system, or otherwise in
furtherance of the purposes of the Exchange Act.'' \445\ Rule 608(b)(2)
further provides that the Commission shall disapprove a national market
system plan or proposed amendment if it does not make such a
finding.\446\ In the Notice, the Commission sought comment on the
Proposed Amendment, including whether the Proposed Amendment is
consistent with the Exchange Act.\447\ In this order, pursuant to Rule
608(b)(2)(i) of Regulation NMS,\448\ the Commission is providing notice
of the grounds for disapproval under consideration:
---------------------------------------------------------------------------

    \445\ 17 CFR 242.608(b)(2).
    \446\ Id.
    \447\ See Notice, supra note 5.
    \448\ 17 CFR 242.608(b)(2)(i).
---------------------------------------------------------------------------

     Whether, consistent with Rule 608 of Regulation NMS, the
Participants have demonstrated how the Proposed Amendment is necessary
or appropriate in the public interest, for the protection of investors
and the maintenance of fair and orderly markets, to remove impediments
to, and perfect the mechanisms of, a national market

system, or otherwise in furtherance of the purposes of the Exchange
Act; \449\
---------------------------------------------------------------------------

    \449\ 17 CFR 242.608(b)(2).
---------------------------------------------------------------------------

     Whether the Participants have demonstrated how the
Proposed Amendment is consistent with Section 6(b)(4) \450\ and Section
15A(b)(5),\451\ of the Exchange Act, which require that the rules of a
national securities exchange ``provide for the equitable allocation of
reasonable dues, fees, and other charges among its members and issuers
and other persons using its facilities'' and that the rules of a
national securities association ``provide for the equitable allocation
of reasonable dues, fees, and other charges among members and issuers
and other persons using any facility or system which the association
operates or controls;''
---------------------------------------------------------------------------

    \450\ 15 U.S.C. 78f(b)(4).
    \451\ 15 U.S.C. 78o-3(b)(5).
---------------------------------------------------------------------------

     Whether the Participants have demonstrated how the
Proposed Amendment is consistent with Section 6(b)(5) \452\ and Section
15A(b)(6),\453\ of the Exchange Act, which require that the rules of a
national securities exchange or national securities association
``promote just and equitable principles of trade . . . protect
investors and the public interest; and [to be] not designed to permit
unfair discrimination between customers, issuers, brokers, or
dealers;''
---------------------------------------------------------------------------

    \452\ 15 U.S.C. 78f(b)(5).
    \453\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

     Whether the Participants have demonstrated how the
Proposed Amendment is consistent with Section 6(b)(8) \454\ and Section
15A(b)(9) \455\ of the Exchange Act, which require that the rules of a
national securities exchange or national securities association ``do
not impose any burden on competition not necessary or appropriate in
furtherance of the purposes of [the Exchange Act];''
---------------------------------------------------------------------------

    \454\ 15 U.S.C. 78f(b)(8).
    \455\ 15 U.S.C. 78o-3(b)(9).
---------------------------------------------------------------------------

     Whether the Participants have demonstrated how the
Proposed Amendment is consistent with the funding principles of the CAT
NMS Plan that are not proposed to be amended by the Proposed Amendment,
which principles state that the Operating Committee shall seek, among
other things, ``to create transparent, predictable revenue streams for
the Company that are aligned with the anticipated costs to build,
operate and administer the CAT and the other costs of the Company,''
\456\ ``to provide for ease of billing and other administrative
functions,'' \457\ ``to avoid any disincentives such as placing an
inappropriate burden on competition and a reduction in market
quality,'' \458\ and ``to build financial stability to support the
Company as a going concern;'' \459\
---------------------------------------------------------------------------

    \456\ See CAT NMS Plan, supra note 1, at Section 11.2(a).
    \457\ Id. at Section 11.2(d).
    \458\ Id. at Section 11.2(e).
    \459\ Id. at Section 11.2(f).
---------------------------------------------------------------------------

    Under the Commission's Rules of Practice, the ``burden to
demonstrate that a NMS plan filing is consistent with the Exchange Act
and the rules and regulations issued thereunder . . . is on the plan
participants that filed the NMS plan filing.'' \460\ The description of
the NMS plan filing, its purpose and operation, its effect, and a legal
analysis of its consistency with applicable requirements must all be
sufficiently detailed and specific to support an affirmative Commission
finding.\461\ Any failure of the plan participants that filed the NMS
plan filing to provide such detail and specificity may result in the
Commission not having a sufficient basis to make an affirmative finding
that the NMS plan filing is consistent with the Exchange Act and the
applicable rules and regulations thereunder.\462\
---------------------------------------------------------------------------

    \460\ 17 CFR 201.701(b)(3)(ii).
    \461\ Id.
    \462\ Id.
---------------------------------------------------------------------------

VI. Commission's Solicitation of Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
issues identified above, as well as any other concerns they may have
with the Proposed Amendment. In particular, the Commission invites the
written views of interested persons concerning whether the Proposed
Amendment is consistent with Section 11A, Section 6(b)(4), Section
6(b)(5), Section 6(b)(8), Section 15A(b)(5), Section 15A(b)(6), Section
15A(b)(9), or any other provision of the Exchange Act, or the rules and
regulations thereunder, or the funding principles of the CAT NMS Plan.
Although there do not appear to be any issues relevant to approval or
disapproval that would be facilitated by an oral presentation of views,
data, and arguments, the Commission will consider, pursuant to Rule
608(b)(2)(i) of Regulation NMS,\463\ any request for an opportunity to
make an oral presentation.\464\ The Commission asks that commenters
address the sufficiency and merit of the Participants' statements in
support of the Proposed Amendment,\465\ in addition to any other
comments they may wish to submit about the proposed rule changes. In
particular, the Commission seeks comment on the following:
---------------------------------------------------------------------------

    \463\ 17 CFR 242.608(b)(2)(i).
    \464\ Rule 700(c)(ii) of the Commission's Rules of Practice
provides that ``[t]he Commission, in its sole discretion, may
determine whether any issues relevant to approval or disapproval
would be facilitated by the opportunity for an oral presentation of
views.'' 17 CFR 201.700(c)(ii).
    \465\ See Notice, supra note 5.
---------------------------------------------------------------------------

    1. Commenters' views on whether the Executed Share Model is
consistent with the funding principles in the CAT NMS Plan that are not
proposed to be amended by the Proposed Amendment, which principles
state that the Operating Committee shall seek, among other things, ``to
create transparent, predictable revenue streams for the Company that
are aligned with the anticipated costs to build, operate and administer
the CAT and the other costs of the Company,'' \466\ ``to provide for
ease of billing and other administrative functions,'' \467\ ``to avoid
any disincentives such as placing an inappropriate burden on
competition and a reduction in market quality,'' \468\ and ``to build
financial stability to support the Company as a going concern;'' \469\
---------------------------------------------------------------------------

    \466\ See CAT NMS Plan, supra note 1, at Section 11.2(a).
    \467\ Id. at Section 11.2(d).
    \468\ Id. at Section 11.2(e).
    \469\ Id. at Section 11.2(f).
---------------------------------------------------------------------------

    2. Commenters' views on whether the Participants have demonstrated
why it consistent with the Exchange Act and Rule 608 of Regulation NMS
for the Executed Share Model to allocate one-third of Prospective CAT
Costs to Participants, one-third of Prospective CAT Costs to CBS and
one-third of Prospective CAT Costs to CBBs;
    3. Commenters' views on potential alternative allocations of CAT
costs to Industry Members and Participants, including the allocations
considered, but rejected, by the Participants, and the alternative
allocations suggested by commenters as discussed in this order;
    4. Commenters' views on whether a cost-based approach would be
preferable to the proposed Executed Share Model. Commenters' views on
the Operating Committee's statement that ``[i]n light of the many
inter-related cost drivers of the CAT (e.g., storage, message traffic,
processing), determining the precise cost burden imposed by each
individual CAT Reporter on the CAT is not feasible,'' \470\ and that
``trading activity provides a reasonable proxy for cost burden on the
CAT, and therefore is an appropriate metric for allocating CAT costs
among CAT Reporters;'' \471\
---------------------------------------------------------------------------

    \470\ See Notice, supra note 5, 87 FR at 33232.
    \471\ Id.

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

    5. Commenters' views on how fees would be passed on to Industry
Members and investors if all CAT costs were allocated to Participants;
views on how this outcome would be different than under the
Participants' proposal; views on whether such an approach would benefit
or harm efficiency, competition, and capital formation; and any views
on whether there are other benefits or costs of adopting such an
approach;
    6. Commenters' views on whether the proposed assessment of a CAT
fee on FINRA would indirectly impose FINRA's CAT fee on Industry
Members, and therefore increase Industry Members' share of CAT fees. If
so, commenters' views on whether this would result in a burden on
competition for FINRA and for Industry Members, particularly those who
trade OTC Equity Securities. Additionally, commenters' views on whether
FINRA should be assessed a CAT fee in the same manner as the national
securities exchanges;
    7. Commenters' views on whether equities Participants and Industry
Members that transact in equities would subsidize the activity of
options Participants and Industry Members that transact in options
under the proposal; views on how this subsidization would benefit or
harm efficiency, competition, and capital formation; views on whether
there are other benefits or costs of adopting such an approach; and any
views (in detail) on whether there is an alternative approach that
would be more beneficial to efficiency, competition, or capital
formation;
    8. Commenters' views on whether the Participants have demonstrated
why imposing CAT fees only on clearing brokers, instead of on all
Industry Members is consistent with the Exchange Act and Rule 608 of
Regulation NMS, and whether such allocation is an unreasonable burden
on competition; commenters' views on the proposed imposition of the
Industry Member portion of the CAT fee on both buy- and sell-side
clearing brokers instead of solely on sell-side clearing brokers;
    9. Commenters' views on whether the Participants should be required
to change the Fee Rate when the budget or projected executed equivalent
share volume changes;
    10. Commenters' views on whether the Fee Rate should be permitted
to be recalculated if the budgeted CAT costs or the projected total
executed equivalent share volume of transactions change more than once
in a year;
    11. Commenters' views on whether it is necessary or appropriate in
the public interest for the Proposed Amendment to permit the Fee Rate
to potentially remain in effect even if the budget or projected
executed equivalent share volume changes (both would be used to
calculate the Fee Rate under the Executed Share Model) or if the Fee
Rate should sunset after a year. For example, if the Commission
temporarily suspends and institutes proceedings to determine whether to
approve or to disapprove a Section 19(b) fee filing to institute a new
Fee Rate, the old Fee Rate could remain in effect during the
proceedings;
    12. Commenters' views on whether the Proposed Amendment's statement
that the Participants do not intend to file a new separate amendment to
the CAT NMS Plan for Participants each time a new Fee Rate is approved
by the Operating Committee is consistent with the Exchange Act;
    13. Commenters' views on whether the Proposed Amendment provides
sufficient clarity and detail regarding the content and process
relating to the fee filing pursuant to Section 19(b) and Rule 19b-4
thereunder with regard to Fee Rate changes applicable to Industry
Members;
    14. Commenters' views on the proposed Participant CAT fee,
including views on its calculation; any views on whether the proposed
fee raises any competitive issues; and any views on whether the
proposed fee is consistent with the funding principles expressed in the
CAT NMS Plan;
    15. Commenters' views on the Proposed Amendment's methods of
counting executed equivalent shares for NMS Stocks, Listed Options, and
OTC Equity Securities, including the appropriateness of the discount to
1% for OTC Equity Security share volume;
    16. Commenters' views on the Proposed Amendment's use of total
executed equivalent share volume from the prior six months to determine
a projected total for the year instead of using the past year's total
executed equivalent share volume;
    17. Commenters' views on the calculation of the Past CAT Costs Fee
Rate, including any views on the relevant period to be used by the
Operating Committee to calculate the Fee Rate for Past CAT Costs;
    18. Commenters' views on whether it is appropriate to allocate one-
third of Past CAT Costs to CBBs and one-third of Past CAT Costs to
CBSs. Commenters' views on the composition and transparency of Past CAT
Costs to be so allocated;
    19. Commenters' views on whether the Participants have demonstrated
why allowing the Participants to be responsible for one-third of Past
CAT Costs and to collect two-thirds of Past CAT Costs from clearing
brokers on a pro rata basis, rather than based on the executed
equivalent share volume of transactions in Eligible Securities, is
consistent with the Exchange Act and Rule 608 of Regulation NMS;
    20. Commenters' views on whether the Proposed Amendment contains
sufficient detail on how CAT fees for Past CAT Costs would be allocated
to Participants on a pro rata basis;
    21. Commenters' views on whether it is appropriate to use
transaction activity from the past month to determine the CAT fee for
Past CAT Costs (that were incurred months or years before);
    22. Commenters' views on the Proposed Amendment's requirement that
CAT fees related to Past CAT Costs would be collected from current
Industry Members and not Industry Members that were active at the time
when the Past CAT Costs were incurred;
    23. Commenters' views on the transparency of the Proposed Amendment
and the level of detail made available into Past CAT Costs and
Prospective CAT Costs;
    24. Commenters' views on the costs that would be included in the
proposed definition of Budgeted CAT Costs in the Proposed Participant
Fee Schedule; commenters' views on whether the Proposed Amendment needs
a discussion of how the budget will be reconciled to fees;
    25. Commenters' views on the decision to use total budgeted costs
for the CAT for the relevant year to calculate fees related to
Prospective CAT Costs for Participants and Industry Members, rather
than costs already incurred; and views on the treatment of any
surpluses;
    26. Commenters' views on how any inherent conflicts of interest may
be addressed in the Proposed Amendment;
    27. Commenters' views on whether, and if so how, the Proposed
Amendment would affect efficiency, competition or capital formation;
    28. Commenters' views on whether modifications to the Proposed
Amendment, or conditions to its approval, would be necessary or
appropriate in the public interest, for the protection of investors and
the maintenance of fair and orderly markets, to remove impediments to,
and perfect the mechanisms of, a national market system, or otherwise
in furtherance of the purposes of the Exchange Act;
    29. Commenters' views on the proposed changes to the funding
principle in Section 11.2(b) of the CAT NMS Plan to eliminate the
requirement that the Operating Committee shall seek to take into
account distinctions in the

securities trading operations of Participants and Industry Members and
their relative impact upon Company resources and operations;
    30. Commenters' views on the proposed changes to the funding
principle in Section 11.2(c) of the CAT NMS Plan, including the
elimination of requirements related to a tiered fee structure in which
the fees charged are based on market share for Participants and
Industry Members based on message traffic, and comparability between or
among CAT Reporters;
    31. Commenters' views on the proposed changes to Section 11.1(d) of
the CAT NMS Plan to remove references to the assignment of tiers in
order to conform the Plan to the Executed Shares Model; and
    32. Commenters' views on the proposed changes to Section 11.3 of
the CAT NMS Plan in order to conform the Plan to the Executed Shares
Model by revising the manner in which fees to recover costs will be
assessed on Participants and Industry Members.
    The Commission also requests that commenters provide analysis to
support their views, if possible.
    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposals should be approved or
disapproved by September 27, 2022. Any person who wishes to file a
rebuttal to any other person's submission must file that rebuttal
October 11, 2022. 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. Please include File Number 4-698 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 4-698. 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 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the Participants' principal offices. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number 4-698 and should be submitted on or before
September 27, 2022.
---------------------------------------------------------------------------

    \472\ 17 CFR 200.30-3(a)(85).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\472\
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-19111 Filed 9-2-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 246 (Tuesday, December 23, 2014)]
[Rules and Regulations]
[Page 76888]
[FR Doc No: 2014-29920]

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

Food and Drug Administration

21 CFR Part 316

[Docket No. FDA-2011-N-0583]

Policy on Orphan-Drug Exclusivity; Clarification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; clarification on policy.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing this
document to clarify its policy regarding certain aspects of orphan-drug
exclusivity. This document is being published because of a recent court
decision interpreting provisions of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as amended by the Orphan Drug Act.

DATES: Effective December 23, 2014.

FOR FURTHER INFORMATION CONTACT: Gayatri R. Rao, Office of Orphan
Products Development, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5271, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    After a designated orphan drug is approved, section 527 of the FD&C
Act (21 U.S.C. 360cc) generally prohibits the Food and Drug
Administration (FDA or the Agency) from approving another such drug for
the same disease for 7 years. Regulations interpreting this provision
were proposed in 1991 (January 29, 1991, 56 FR 3338) and made final in
1992 (December 29, 1992, 57 FR 62076). In 2011, FDA issued a proposed
rule (October 19, 2011, 76 FR 64868) to amend these regulations to
clarify certain regulatory language and propose areas of minor
improvement regarding orphan-drug designation and orphan-drug
exclusivity; these were finalized in 2013 (June 12, 2013, 78 FR 35117).
These regulations are codified under part 316 (21 CFR part 316).
    FDA has interpreted section 527 of the FD&C Act and its regulations
such that the Agency will not recognize orphan-drug exclusivity for a
drug when it has previously approved the same drug for the same use or
indication in a rare disease or condition. Sec. Sec.  316.3(b)(12);
316.31(a). A drug will not be considered the same as a previously
approved drug if, at the time of approval, the sponsor has provided
evidence that its drug is ``clinically superior'' to the previously
approved drug, that is, the drug is more effective, safer, or makes a
major contribution to patient care. Sec.  316.3(b)(3). Accordingly, the
sponsor of an orphan-designated drug that is the same as a previously
approved drug, as defined in Sec.  316.3(b)(14), is required to
demonstrate that its drug is clinically superior to the previously
approved drug in order for its drug to be eligible for orphan-drug
exclusivity upon approval.
    The Agency's interpretation of section 527 of the FD&C Act has been
the subject of legal action in Depomed v. HHS et al., Civil Action No.
12-1592 (KBJ) (D.D.C. September 5, 2014). Depomed has not demonstrated
that GRALISE (gabapentin) is clinically superior to a previously
approved drug, Pfizer's NEURONTIN (gabapentin). Accordingly, under the
relevant regulations, GRALISE is the same drug as NEURONTIN, because it
contains the same active moiety (gabapentin), was approved for the same
use (post-herpetic neuralgia), and was not demonstrated to be
clinically superior to NEURONTIN. Nevertheless, the Depomed court held
that FDA must recognize orphan-drug exclusivity for GRALISE for the
treatment of post-herpetic neuralgia. Following the Depomed decision,
under the court's order, FDA recognized orphan-drug exclusivity for
GRALISE for the treatment of post-herpetic neuralgia.

II. Orphan-Drug Exclusivity

    In consideration of any uncertainty created by the court's decision
in Depomed, the Agency is issuing this statement. It is the Agency's
position that, given the limited terms of the court's decision to
GRALISE, FDA intends to continue to apply its existing regulations in
part 316 to orphan-drug exclusivity matters. FDA interprets section 527
of the FD&C Act and its regulations (both the older regulations that
still apply to original requests for designation made on or before
August 12, 2013, as well as the current regulations) to require the
sponsor of a designated drug that is the ``same'' as a previously
approved drug to demonstrate that its drug is ``clinically superior''
to that drug upon approval in order for the subsequently approved drug
to be eligible for orphan-drug exclusivity.

    Dated: December 17, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29920 Filed 12-22-14; 8:45 am]
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[Federal Register Volume 77, Number 100 (Wednesday, May 23, 2012)]
[Proposed Rules]
[Pages 30453-30454]
[FR Doc No: 2012-12509]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2011-0347; FRL-9677-2]

Approval and Promulgation of Air Quality Implementation Plans;
Wisconsin; Milwaukee-Racine Nonattainment Area; Determination of
Attainment for the 2006 24-Hour Fine Particle Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of public comment period.

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SUMMARY: EPA is extending the comment period for a proposed rule
published April 24, 2012 (77 FR 24436). On April 24, 2012, EPA proposed
to approve a determination of attainment for the Milwaukee-Racine,
Wisconsin area for the 2006 24-hour fine particle National Ambient Air
Quality Standard submitted by the State of Wisconsin on March 7, 2011.
In response to a May 1, 2012, request from David C. Bender, EPA is
extending the comment period for 30 days.

DATES: The comment period for the proposed rule published April 24,
2012 (77 FR 24436) is being extended for 30 days to June 25, 2012.

ADDRESSES: Submit comments, identified by Docket ID No. EPA-R05-OAR-
2011-0347, to: Douglas Aburano, Chief, Attainment Planning and
Maintenance Section, Air Programs Branch (AR-18J), U.S. Environmental
Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago,
Illinois 60604<EMAIL_ADDRESS>Additional instructions to
comment can be found in the notice of proposed rulemaking published
April 24, 2012 (77 FR 24436).

FOR FURTHER INFORMATION CONTACT: Gilberto Alvarez, Environmental
Scientist, Attainment Planning and Maintenance Section, Air Programs
Branch (AR-18J), U.S. Environmental Protection Agency, Region 5, 77
West

Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
    Dated: May 11, 2012.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2012-12509 Filed 5-22-12; 8:45 am]
BILLING CODE 6560-50-P