[Federal Register Volume 83, Number 58 (Monday, March 26, 2018)]
[Proposed Rules]
[Pages 12883-12885]
[FR Doc No: 2018-05974]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0219; Airspace Docket No. 17-AGL-23]

Proposed Amendment of Air Traffic Service (ATS) Routes in the
Vicinity of Mattoon and Charleston, IL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify two VHF Omnidirectional Range
(VOR) Federal airways (V-72 and V-429) in the vicinity of Mattoon and
Charleston, IL. The FAA is proposing this action due to the planned
decommissioning of the Mattoon, IL (MTO), VOR/Distance Measuring
Equipment (VOR/DME) navigation aid (NAVAID) which provides navigation
guidance for portions of the affected ATS routes. The Mattoon VOR is
being decommissioned in support of the FAA's VOR Minimum Operational
Network (MON) program.

DATES: Comments must be received on or before May 10, 2018.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2018-0219 and Airspace Docket No. 17-AGL-23 at the beginning of
your comments. You may also submit comments through the internet at
http://www.regulations.gov.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the

agency's authority. This rulemaking is promulgated under the authority
described in Subtitle VII, Part A, Subpart I, Section 40103. Under that
section, the FAA is charged with prescribing regulations to assign the
use of the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would support the route structure in the Mattoon and
Charleston, IL, area as necessary to preserve the safe and efficient
flow of air traffic within the National Airspace System.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2018-0219 and Airspace Docket No. 17-AGL-23) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2018-0219 and Airspace Docket No. 17-AGL-23.''
The postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Operations Support Group, Central
Service Center, Federal Aviation Administration, 10101 Hillwood Blvd.,
Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11B is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

Background

    The FAA is planning to decommission the Mattoon, IL (MTO), VOR/DME
in November 2018. The Mattoon VOR was one of the candidate VORs
identified for discontinuance by the FAA's VOR MON program and listed
in the Final policy statement notice, ``Provision of Navigation
Services for the Next Generation Air Transportation System (NextGen)
Transition to Performance-Based Navigation (PBN) (Plan for Establishing
a VOR Minimum Operational Network),'' published in the Federal Register
of July 26, 2016 (81 FR 48694), Docket No. FAA-2011-1082.
    With the planned decommissioning of the Mattoon, IL, VOR/DME, the
remaining ground-based NAVAID coverage in the area is insufficient to
enable the continuity of the affected airways. As such, proposed
modifications to VOR Federal airways V-72 and V-429 would result in a
gap in the enroute ATS route structure in the Mattoon and Charleston,
IL, area. To overcome the gap in the enroute structure, instrument
flight rules (IFR) traffic could use adjacent VOR Federal airways
(including V-5, V-7, V69, V-171, V-191, V-192, V-262, and V-586) to
circumnavigate the affected area, file point to point through the
affected area using fixes that will remain in place, or receive air
traffic control (ATC) radar vectors through the area. Additionally, the
Mattoon DME facility is planned to be retained and charted as a DME
facility with the ``MTO'' three-letter identifier. Visual flight rules
(VFR) pilots who elect to navigate via the airways through the affected
area could also take advantage of the adjacent VOR Federal airways or
ATC services previously listed.

The Proposal

    The FAA is proposing an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to modify the descriptions of VOR Federal
airways V-72 and V-429. The planned decommissioning of the Mattoon, IL,
VOR has made these actions necessary. The proposed VOR Federal airway
changes are described below.
    V-72: V-72 currently extends between the Razorback, AR, VOR/
Tactical Air Navigation (VORTAC) and the Bloomington, IL, VOR/DME. The
FAA proposes to remove the airway segment between the Bible Grove, IL,
VORTAC and the Bloomington, IL, VOR/DME. The unaffected portions of the
existing airway would remain as charted.
    V-429: V-429 currently extends between the Cape Girardeau, MO, VOR/
DME and the Joliet, IL, VORTAC. The FAA proposes to remove the airway
segment between the Bible Grove, IL, VORTAC and the Champaign, IL,
VORTAC. The unaffected portions of the existing airway would remain as
charted.
    All radials in the route descriptions below are unchanged and
stated in True degrees.
    VOR Federal airways are published in paragraph 6010(a) of FAA Order
7400.11B dated August 3, 2017, and effective September 15, 2017, which
is incorporated by reference in 14 CFR 71.1. The VOR Federal airways
listed in this document would be subsequently published in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed 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
Department of Transportation (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. Since this is a routine matter that will only affect air
traffic procedures and air navigation, it is certified that this
proposed rule, when promulgated, will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B,
Airspace Designations and Reporting Points, dated August 3, 2017 and
effective September 15, 2017, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-72 [Amended]

    From Razorback, AR; Dogwood, MO; INT Dogwood 058[deg] and
Maples, MO, 236[deg] radials; Maples; Farmington, MO; Centralia, IL;
to Bible Grove, IL.
* * * * *

V-429 [Amended]

    From Cape Girardeau, MO; Marion, IL; INT Marion 011[deg] and
Bible Grove, IL, 207[deg] radials; to Bible Grove. From Champaign,
IL; Roberts, IL; to Joliet, IL.

    Issued in Washington, DC, on March 19, 2018.
Rodger A. Dean Jr.,
Manager, Airspace Policy Group.
[FR Doc. 2018-05974 Filed 3-23-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 28, 2008 (Volume 73, Number 61)]
[Rules and Regulations]
[Page 16547-16553]
[DOCID:fr28mr08-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

 [EPA-R04-OAR-2007-0959-200804; FRL-8547-8]

Determination of Nonattainment and Reclassification of the
Memphis, TN/Crittenden County, AR 8-Hour Ozone Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule finalizes EPA's finding of nonattainment and
reclassification of the Memphis, Tennessee and Crittenden County,
Arkansas 8-hour ozone nonattainment area (Memphis TN-AR Nonattainment
Area). EPA finds that the Memphis TN-AR Nonattainment Area has failed
to attain the 8-hour ozone national ambient air quality standard
(``NAAQS'' or ``standard'') by June 15, 2007, the attainment deadline
set forth in the Clean Air Act (CAA) and Code of Federal Regulations
(CFR) for marginal nonattainment areas. As a result, on the effective
date of this rule, the Memphis TN-AR Nonattainment Area will be
reclassified by operation of law as a moderate 8-hour ozone
nonattainment area. The moderate area attainment date for the
reclassified Memphis TN-AR Nonattainment Area would then be ``as
expeditiously as practicable,'' but no later than June 15, 2010. Once
reclassified, Tennessee and Arkansas must submit State Implementation
Plan (SIP) revisions that meet the 8-hour ozone nonattainment
requirements for moderate areas, as required by the CAA. In this
action, EPA is establishing the schedule for the States' submittal of
the SIP revisions required for the

nonattainment area once it is reclassified. EPA determines that the
States must submit these SIP revisions by March 1, 2009.

DATES: Effective Date: April 28, 2008.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2007-0959. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Regulatory Development Section, Air Planning Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia
30303-8960 or Air Planning Section, U.S. Environmental Protection
Agency, Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733. EPA
requests that if at all possible, you contact the person listed in the
FOR FURTHER INFORMATION CONTACT section to schedule your inspection.
The Regional Office's official hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m., excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Jane Spann, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, Region 4, U.S. Environmental Protection Agency, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. The telephone number is (404)
562-9029. Mrs. Spann can also be reached via electronic mail at
<EMAIL_ADDRESS>Jeffrey Riley, Air Planning Section, U.S.
Environmental Protection Agency, Region 6, 1445 Ross Avenue, Dallas,
Texas 75202-2733. The telephone number is<PHONE_NUMBER>. Mr. Riley can
also be reached via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. What Is the Background for This Action?
II. Response to Comments
III. What Is the Effect of This Action?
    A. Determination of Nonattainment, Reclassification of Memphis
TN-AR Nonattainment Area and New Attainment Date
    B. When Must Tennessee and Arkansas Submit SIP Revisions
Fulfilling the Requirements for Moderate Ozone Nonattainment Areas
IV. Final Action
V. Statutory and Executive Order Reviews

I. What Is the Background for This Action?

    On October 16, 2007, EPA proposed its finding that the Memphis TN-
AR Nonattainment Area did not attain the 8-hour ozone NAAQS by June 15,
2007, the applicable attainment date (72 FR 58577). The proposed
finding was based upon ambient air quality data from the years 2004,
2005, and 2006. In addition, as explained in the proposed rule, the
Area did not qualify for an attainment date extension under the
provisions of CAA section 181(a)(5) and 40 CFR 51.907, because the 4th
highest daily value in the attainment year of 2006 was greater than
0.084 parts per million (ppm). In the October 16, 2007, proposal, EPA
proposed that the appropriate reclassification of the area was to
``moderate'' nonattainment, in accordance with CAA Section 181(b)(2).

II. Response to Comments

    EPA received comments from the Shelby County Government of
Tennessee (Shelby County), the Arkansas Department of Environmental
Quality (ADEQ), the Sierra Club Chickasaw Group-Tennessee Chapter and
two citizens in response to the proposed reclassification of the
Memphis TN-AR Nonattainment Area from marginal to moderate, published
on October 16, 2007 (72 FR 58577). Comments can be found on the
internet in the electronic docket for this action. To access the
comments, please go to http://www.regulations.gov and search for Docket
No. EPA-R04-OAR-2007-0959, or contact the person listed in the FOR
FURTHER INFORMATION CONTACT paragraph above. A summary of the adverse
comments received and EPA's response to the comments is presented
below.
    Comment: All commenters discussed including DeSoto County,
Mississippi in the 8-hour ozone nonattainment area. Shelby County
commented that the area's failure to meet the attainment date is not
due to a lack of local control measures and regulation of ozone
precursors, but is due to errors made in the original designation and
that EPA's decision to exclude DeSoto County was an error that is
negatively affecting the Area's ability to achieve the standard. Shelby
County also commented that the DeSoto County monitor is exhibiting a
disturbing trend towards violation that should be reversed. Shelby
County and ADEQ suggested that the appropriate action would be to
expand the nonattainment area to include DeSoto County rather than to
reclassify the current area to moderate status.
    Response: The validity of the 2004 designations for DeSoto County
or the Memphis ozone nonattaiment area are not the subject of this
rulemaking, nor is it relevant to EPA's determination of whether the
Memphis area attained the 8-hour ozone NAAQS by its attainment date.
The CAA establishes a process for air quality management for purposes
of attaining and maintaining the NAAQS. After promulgation of a new or
revised NAAQS, section 107(d)(1) of the CAA requires EPA to designate
areas as meeting or not meeting the standard. EPA published the
designations for the 8-hour ozone NAAQS on April 30, 2004. Prior to
April 30, 2004, each State Governor had an opportunity to recommend air
quality designations, including appropriate boundaries, to EPA. One
hundred and twenty days prior to promulgating designations, EPA was
required to notify the States, if EPA disagreed with a State's
recommended designation and intended to modify the recommended
designation. States then had an opportunity to provide a demonstration
as to why the proposed modification was inappropriate. Any issues
concerning the initial designations, including whether a county should
have been included as part of a specific nonattainment area, should
have been raised at that time and any challenges to EPA's final rule
designating areas were required to be filed within 60 days of April 30,
2004. Thus, any claims now that DeSoto County should have been included
as part of the Memphis ozone nonattainment area are not timely. The
time for addressing the validity of the designations is past, and the
appropriateness of the 2004 designations is not at issue in this
rulemaking. As a result, all comments concerning purported deficiencies
in the final designations for these areas are not relevant to this
rulemaking.
    With respect to the commenters' contention that EPA should now
expand the nonattainment area to include DeSoto County, this rulemaking
action, which involves a determination of nonattainment for the Memphis
8-hour ozone nonattainment area pursuant to section 181(b)(2), is not
the appropriate time in which to address a reevaluation of the
designation for the area.
    In its proposed rulemaking EPA noted that DeSoto County is not
included in the Memphis Area, but stated that ``its monitoring data is
regularly considered for potential contributions to the Memphis TN-AR
Nonattainment Area airshed.'' 72 FR 58579. EPA is clarifying

in this final rulemaking that, while we reviewed the data from the
DeSoto monitor, we are not relying on data from that monitor in
reaching a final determination that the Memphis Area failed to attain
the 8-hour ozone standard by its June 15, 2007, attainment date.
    Notably, for the years 2004-2006, the monitor in DeSoto County
demonstrated attainment. Because this final determination was based
upon the Marion, AR monitor which provided the Area its 2004-2006
design value of .087 ppm, the additional DeSoto County data would not
alter this determination. EPA also notes that preliminary data for 2007
for both the Marion and DeSoto monitors show that, if the data were
quality assured, both monitors would register as nonattainment for
2005-2007. Again, the additional DeSoto County data would not alter the
determination that the Area did not attain the standard.
    Comment: Shelby County and ADEQ commented that EPA has invoked the
legal principle known as ``operation of law'' as justification for
reclassifying the Memphis, TN-AR Nonattainment Area from marginal to
moderate. The commenters believe that the invocation of ``operation of
law'' is, in this instance, a discretionary power. Shelby County
commented that reclassification is not needed and will not serve to
move the Area into attainment of the ozone standard any sooner than is
currently predicted by the extensive computer modeling, and that
reclassification will place an undue and completely unnecessary
administrative cost on the taxpayers of Tennessee and Arkansas without
improving air quality in the Area. ADEQ commented that reclassification
is unmerited at this time and that ``there would be no demonstrable
harm to the public if the EPA Administrator used discretionary
authority to waive the action otherwise the result of operation of
law.'' ADEQ also commented that delays in federal ozone programs were
responsible for higher regional design values, and that ``States and
localities should not be required to take on new regulatory burdens as
a result of programmatic delays over which they had no control. The EPA
has not taken this into account in its deliberations as to whether
redesignation [sic] is appropriate in this instance.''
    Response: EPA disagrees with the assertion that reclassification
upon a determination of failure to attain is a discretionary power, and
that EPA can ``waive'' reclassification after it has determined that
the area has failed to attain by its attainment date. In the October
16, 2007, proposed rule (72 FR 58577), EPA cited section 181(b)(2)(A)
of the CAA, which provides that, for reclassification upon failure to
attain, ``within 6 months following the applicable attainment date
(including any extension thereof) for an ozone nonattainment area, the
Administrator shall determine, based on the area's design value (as of
the attainment date), whether the area attained the standard by that
date. Except for any Severe or Extreme area, any area that the
Administrator finds has not attained the standard by that date shall be
reclassified by operation of law in accordance with table 1 of
subsection (a) (of Section 181) to the higher of--(i) the next higher
classification for the area, or (ii) the classification applicable to
the area's design value as determined at the time of the notice
required under subparagraph (B).'' Pursuant to section 181(b)(2), EPA
has determined that the Memphis TN-AR Nonattainment Area failed to
attain the 8-hour ozone NAAQS by June 15, 2007, the attainment deadline
set forth in the CAA and CFR for marginal nonattainment areas. Because
the Area is not classified as severe or extreme, the area shall be
reclassified by operation of law to the next higher classification. The
next higher classification for the Area (moderate) is higher than the
classification applicable to the Area's design value (marginal).
Therefore, in accordance with the CAA, the Area must be reclassified by
operation of law to a moderate nonattainment area. 72 FR 58579.
    As EPA noted above, under section 181(b)(2)(A), the attainment
determination is made solely on the basis of air quality, and any
reclassification is by operation of law. Thus, the resulting
requirements apply regardless of how the nonattainment came about, and
the CAA does not allow EPA to assess the need, or lack thereof, for
additional local measures. With respect to any perceived burden imposed
by the new planning requirements, EPA notes that the moderate area
requirements are imposed by section 182(b) of the CAA and the impact,
economic or otherwise, of a reclassification is not a consideration in
making the attainment determination under section 181(b)(2).
    Comment: Shelby County and ADEQ commented that if EPA determines
that it has no discretion on reclassification, the public comment
process provides no opportunity for relevant comments on the proposed
action to be considered.
    Response: EPA disagrees that the public comment process provides no
opportunity for relevant comments on the proposed action. The process
allows for an opportunity to ascertain whether EPA's analysis of the
relevant data and CAA requirements is correct. Under section
182(b)(2)(A), the attainment determination is made solely on the basis
of air quality data, and reclassification and the level to which an
area is reclassified is by operation of law. Section 181(b)(2)(B)
requires EPA to publish a notice in the Federal Register identifying
the reclassification status of an area that has failed to attain the
standard by its attainment date. Thus, in making the determinations
required by the CAA, EPA solicits and will consider comments addressing
EPA's determination with respect to whether air quality data show
attainment or nonattainment by the applicable attainment date, and
EPA's identification of any resulting reclassification that occurs by
operation of law. There is, therefore, a meaningful role for public
comments in determinations of attainment, specifically with regard to
the data and EPA's analysis of the data, but this is not inconsistent
with, and does not alter the statutory scheme that provides that
reclassification occurs as a matter of law, and is not within EPA's
discretion.
    Comment: ADEQ commented that for the 2007 ozone season to date, the
fourth highest value in the nonattainment Area had not exceeded 0.084
ppm and that the Area's air quality appears to be improving. ADEQ
further requested that EPA consider calendar year 2007 as an
``extension year'' and grant a one-year extension of the attainment
date as a means of providing relief from the duplication of effort that
will be required in the event that the recently proposed revisions to
the ozone standard are promulgated in the near future.
    Response: Sections 172(a)(2)(C) and 181(a)(5) of the CAA provide
states with an opportunity to apply to extend the attainment date by
one year. Section 181(a)(5) applies to areas classified under Subpart 2
of the CAA, and 40 CFR 51.907 provides EPA's interpretation of section
172(a)(2)(C) and 181(a)(5) for purposes of the 8-hour ozone standard.
For the 8-hour ozone standard, if an area's fourth highest daily
maximum 8-hour average value in the attainment year is 0.084 ppm or
less, the area is eligible for a 1-year extension of the attainment
date (40 CFR 51.907). The attainment year is the year in which the last
full ozone season relied on for purposes of demonstrating attainment
occurs. Because the attainment date for the Memphis Area was June 15,
2007, the last full ozone season preceding the Area's attainment date
was the 2006

ozone season and 2006 is considered the attainment year. In 2006, the
Area's fourth highest daily maximum 8-hour average was 0.089 ppm. Based
on this information, the Area does not qualify for a 1-year extension
of the attainment date. Under the applicable statutory and regulatory
provisions, EPA is unable to consider 2007 as an extension year. First,
as explained above, the Area did not qualify for an initial 1-year
extension based on its 2006 attainment year. Second, even if the Area
had qualified for a 1-year extension based on 2006 data (which it did
not), it would not qualify for a second 1-year extension based on
preliminary data for 2007. This is because the Area's 4th highest daily
8-hour value, averaged over both 2006 (the original attainment year)
and 2007 (the hypothetical ``first extension year'') is greater than
0.84 ppm. 40 CFR 51.907(b). Finally, preliminary data for 2005-2007
show that the Area is still not attaining the standard.
    Comment: Shelby County commented that air quality in the Memphis
Area has in recent years demonstrated a trend of improvement; that
pollution measures in place are making a positive impact and will lead
to further improvement; and that modeling shows that the Area will soon
attain the standard. Shelby County also commented that reclassification
could ``result in an absurd conclusion since the possibility exists
that, by next year, the only controlling monitor in the area could be
located in a county that is attainment.'' ADEQ commented that for the
2007 ozone season to date, the fourth highest 8-hour ozone value for
any monitor in the Area did not exceed 0.084 ppm; that they are hopeful
ozone levels in 2008 and beyond will continue to show improvement; and
that it is unfortunate that EPA considers it necessary to increase the
severity of the ozone classification from marginal to moderate when it
appears that the Area's air quality is improving. ADEQ also commented
that ``the redesignation [sic] to moderate that is proposed would, in
this instance, result in an absurd conclusion.''
    Response: EPA recognizes the efforts taken by Shelby County, ADEQ,
the Tennessee Department of Environment and Conservation, and the
Memphis Area in general to improve air quality. However, while it is
encouraging that the Area's air quality appears to be improving,
unfortunately, it did not improve enough to meet the June 15, 2007,
deadline for attainment.\1\ The statute requires an assessment of air
quality as of an area's attainment date, and that assessment is the
subject of today's rulemaking. (See also, our responses to previous
comments.) Reclassification of the Area, which occurs by operation of
law, as required by the CAA will lead to additional planning and
emission controls, which will help ensure that the Area attains and
maintains the 8-hour ozone standard.
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    \1\ Moreover, as noted above, preliminary data for 2005-2007
shows that the Area remains in nonattainment.
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III. What Is the Effect of This Action?

A. Determination of Nonattainment, Reclassification of Memphis TN-AR
Nonattainment Area and New Attainment Date

    Pursuant to section 181(b)(2), EPA finds that the Memphis TN-AR
Nonattainment Area failed to attain the 8-hour ozone NAAQS by the June
15, 2007, attainment deadline prescribed under the CAA and 69 FR 23858
(April 30, 2004) for marginal ozone nonattainment areas. When this
finding is effective, the Memphis TN-AR Nonattainment Area will be
reclassified by operation of law from marginal nonattainment to
moderate nonattainment. The reclassification to the next higher
classification is mandated by Section 181(b)(2)(A) of the CAA. Moderate
areas are required to attain the standard ``as expeditiously as
practicable'' but no later than 6 years after designation or June 15,
2010. The ``as expeditiously as practicable'' attainment date will be
determined as part of the action on the required SIP submittal
demonstrating attainment of the 8-hour ozone standard. Also in this
action, EPA is establishing a schedule by which Tennessee and Arkansas
will submit the SIP revisions necessary for the reclassification to
moderate nonattainment of the 8-hour ozone standard.

B. When Must Tennessee and Arkansas Submit SIP Revisions Fulfilling the
Requirements for Moderate Ozone Nonattainment Areas

    EPA must address the schedule by which Tennessee and Arkansas are
required to submit revised SIPs addressing the requirements for the
Memphis TN-AR moderate Nonattainment Area. When an area is
reclassified, EPA has the authority under section 182(i) of the CAA to
adjust the CAA's submittal deadlines for any new SIP revisions that are
required as a result of the reclassification. Pursuant to 40 CFR
51.908(d), for each nonattainment area, a state must provide for
implementation of all control measures needed for attainment no later
than the beginning of the attainment year ozone season. The attainment
year ozone season is the ozone season immediately preceding a
nonattainment area's attainment date, in this case 2009 (40 CFR
51.900(g)). The ozone season is the ozone monitoring season as defined
in 40 CFR part 58, Appendix D, section 4.1, Table D-3 (October 17,
2006, 71 FR 61236). For the purposes of this reclassification of the
Memphis TN-AR Nonattainment Area, March 1, 2009, is the beginning of
the ozone monitoring season. As a result, EPA is requiring that the
necessary SIP revisions be submitted by both Tennessee and Arkansas as
expeditiously as practicable, but no later than March 1, 2009.
    A revised SIP must include all the moderate area requirements in
section 182(b) of the CAA including: (1) An attainment demonstration
(40 CFR 51.908); (2) provisions for reasonably available control
technology and reasonably available control measures (40 CFR 51.912);
(3) reasonable further progress reductions in volatile organic compound
(VOC) emissions (40 CFR 51.910); (4) contingency measures to be
implemented in the event of failure to meet a milestone or attain the
standard (CAA 172(c)(9)); (5) a vehicle inspection and maintenance
program (40 CFR 51.350); and (6) nitrogen oxide and VOC emission
offsets of 1.15 to 1 for major source permits (40 CFR 51.165(a)).

IV. Final Action

    Pursuant to CAA section 181(b)(2), EPA is making a final
determination that the Memphis TN-AR marginal 8-hour Ozone
Nonattainment Area failed to attain the 8-hour ozone NAAQS by June 15,
2007. Upon the effective date of this rule, the Memphis TN-AR marginal
8-hour Ozone Nonattainment Area will be reclassified by operation of
law as a moderate 8-hour ozone nonattainment area. Pursuant to section
182(i) of the CAA, EPA is establishing the schedule for submittal of
the SIP revisions required for moderate areas once the area is
reclassified. The required SIP revisions for Tennessee and Arkansas
shall be submitted as expeditiously as practicable, but no later than
March 1, 2009.

V. Statutory and Executive Order Reviews

A. Executive Order 12866, Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under the Executive

Order. The Agency has determined that the finding of nonattainment
would result in none of the effects identified in the Executive Order.
Under section 181(b)(2) of the CAA, determinations of nonattainment are
based upon air quality considerations and the resulting
reclassifications must occur by operation of law.

B. Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
This action to reclassify the Memphis TN-AR Nonattainment Area as a
moderate ozone nonattainment area and to adjust applicable deadlines
does not establish any new information collection burden. Burden means
the total time, effort, or financial resources expended by persons to
generate, maintain, retain, or disclose or provide information to or
for a Federal agency. This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information. An agency may not conduct or
sponsor, and a person is not required to respond to a collection of
information unless it displays a currently valid Office of Management
and Budget (OMB) control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies the rule
will not have a significant economic impact on a substantial number of
small entities. Small entities include small businesses, small
organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of this action on small
entities, small entity is defined as: (1) A small business that is a
small industrial entity as defined in the U.S. Small Business
Administration (SBA) size standards (see, 13 CFR part 121); (2) a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field. Determinations of nonattainment and the
resulting reclassification of nonattainment areas by operation of law
under section 181(b)(2) of the CAA do not in and of themselves create
any new requirements. Instead, this rulemaking only makes a factual
determination, and does not directly regulate any entities. After
considering the economic impacts of today's action on small entities, I
certify that this rule will not have a significant economic impact on a
substantial number of small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and Tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and Tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation to why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including Tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
    This action does not include a Federal mandate within the meaning
of UMRA that may result in expenditures of $100 million or more in any
one year by either State, local, or Tribal governments in the aggregate
or to the private sector, and therefore, is not subject to the
requirements of sections 202 and 205 of the UMRA. Also, EPA has
determined that this rule contains no regulatory requirements that
might significantly or uniquely affect small governments and therefore,
is not subject to the requirements of sections 203. EPA believes, as
discussed previously in this document, that the finding of
nonattainment is a factual determination based upon air quality
considerations and that the resulting reclassification of the area must
occur by operation of law. Thus, EPA believes that the finding does not
constitute a Federal mandate, as defined in section 101 of the UMRA,
because it does not impose an enforceable duty on any entity.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
    This final rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. This action merely determines
that the Memphis TN-AR Nonattainment Area had not attained by its
applicable attainment date, reclassifies the Memphis TN-AR
Nonattainment Area as a moderate ozone nonattainment area and adjusts
applicable deadlines. Thus, Executive Order 13132 does not apply to
this rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This action does not have
``Tribal implications'' as specified in Executive Order 13175. This
action merely determines that the Memphis TN-AR Nonattainment Area has
not attained by its applicable attainment date, reclassifies the
Memphis TN-AR Nonattainment Area as a moderate ozone nonattainment area
and adjusts applicable deadlines. The CAA and the Tribal Authority Rule
establish the relationship of the Federal government and Tribes in
developing plans to attain the NAAQS, and this rule does nothing to
modify that relationship. Thus, Executive Order 13175 does not apply to
this rule.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    Executive Order 13045, entitled ``Protection of Children From
Environmental Health and Safety Risks'' (62 FR 19885, April 23, 1997)
applies to any rule that (1) is determined to be ``economically
significant'' as defined under Executive Order 12866, and (2) concerns
an environmental health or safety risk that EPA has reason to believe
may have disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency. This action
is not subject to Executive Order 13045 because it is not economically
significant as defined in Executive Order 12866, and because the Agency
does not have reason to believe the environmental health risks or
safety risks addressed by this rule present a disproportionate risk to
children. This action merely determines that the Memphis TN-AR
Nonattainment Area has not attained by its applicable attainment date,
reclassifies the Memphis TN-AR Nonattainment Area as a moderate ozone
nonattainment area and adjusts applicable deadlines.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, entitled
``Actions That Significantly Affect Energy Supply, Distribution, or
Use,'' (66 FR 28355, May 22, 2001) because it is not a significant
regulatory action under Executive Order 12866.

I. National Technology Transfer Advancement Act

    As noted in the proposed rule, Section 12(d) of the National
Technology Transfer Advancement Act of 1995 (NTTAA), Public Law 104-
113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary
consensus standards (VCS) in its regulatory activities unless to do so
would be inconsistent with applicable law or otherwise impractical.
Voluntary consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) that are developed or adopted by VCS bodies. The NTTAA
directs EPA to provide Congress, through OMB, explanations when the
Agency decides not to use available and applicable VCS. This action
merely determines that the Memphis TN-AR Nonattainment Area has not
attained by its applicable attainment date, reclassifies the Memphis
TN-AR ``marginal'' Nonattainment Area as a ``moderate'' ozone
nonattainment area and adjusts applicable deadlines. Therefore, EPA did
not consider the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this rule will not have disproportionately
high and adverse human health or environmental effects on minority or
low-income populations because it does not affect the level of
protection provided to human health or the environment. This action
merely determines that the Memphis TN-AR Nonattainment Area has not
attained by its applicable attainment date, and reclassifies the
Memphis TN-AR Nonattainment Area as a moderate ozone nonattainment area
and adjusts applicable deadlines.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

L. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by May 27, 2008. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action to reclassify the Memphis TN-AR area as a moderate ozone
nonattainment area and to adjust applicable deadlines may not be
challenged later in proceedings to enforce its requirements. (See,
section 307(b)(2).)

List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: March 14, 2008.
J.I. Palmer, Jr.,
Regional Administrator, Region 4.
    Dated: March 19, 2008.
Richard E. Greene,
Regional Administrator, Region 6.

0
40 CFR part 81 is amended as follows:

PART 81--[AMENDED]

0
1. The authority citation for part 81 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart C--Section 107 Attainment Status Designations

0
2. In Sec.  81.304 the table for Arkansas--Ozone (8-hour Standard) is
amended by revising the entry for Memphis, TN-AR and footnote 2 to read
as follows:

Sec.  81.304  Arkansas.

* * * * *

                                                            Arkansas--Ozone (8-Hour Standard)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Designation \a\                                     Category/classification
             Designated area             ---------------------------------------------------------------------------------------------------------------
                                            Date \1\                      Type                      Date \1\                      Type
--------------------------------------------------------------------------------------------------------------------------------------------------------
Memphis, TN-AR: (AQCR 018 Metropolitan    ...........  Nonattainment............................        (\2\)  Subpart 2/Moderate.
 Memphis Interstate) Crittenden County.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is June 15, 2004, unless otherwise noted.
\2\ April 28, 2008.

* * * * *
0
3. In Sec.  81.343 the table for Tennessee--Ozone (8-hour Standard) is
amended by removing footnote 3 and revising the entry for ``Memphis,
TN-AR'' to read as follows:

Sec.  81.343  Tennessee.

* * * * *

                                                           Tennessee--Ozone (8-Hour Standard)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Designation \a\                                      Category/classification
           Designated area            ------------------------------------------------------------------------------------------------------------------
                                           Date \1\                       Type                       Date \1\                      Type
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Memphis, TN-AR: Shelby County........  ...............  Nonattainment..........................   March 28, 2008  Subpart 2/Moderate.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is June 15, 2004, unless otherwise noted.

* * * * *
 [FR Doc. E8-6287 Filed 3-27-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 157 (Wednesday, August 18, 2021)]
[Notices]
[Pages 46290-46292]
[FR Doc No: 2021-17671]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92652; File No. SR-ICEEU-2021-014]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing of Proposed Rule Change, as Modified by Partial Amendment No.
1, Relating to the ICE Clear Europe Clearing Membership Policy and
Clearing Membership Procedures

August 12, 2021.
    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 August 2, 2021, ICE Clear Europe Limited (``ICE Clear Europe'' or
the ``Clearing House'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule changes described in
Items I, II and III below, which Items have been prepared primarily by
ICE Clear Europe. On August 11, 2021, ICE Clear Europe filed Partial
Amendment No. 1 to the proposed rule change.\3\ The Commission is
publishing this notice to solicit comments on the proposed rule change,
as modified by Partial Amendment No. 1 (hereafter referred to as the
``proposed rule change''), from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Partial Amendment No. 1 amended the filing to delete from
the filed Exhibit 5B, Clearing Membership Procedures, certain
statements in sections 2.4.1 and 2.4.2 of such Procedures concerning
the termination of clearing membership by a Clearing Member.
Specifically, ICE Clear Europe proposes to remove the statements
that it will define a minimum notice period and may publish a
Circular confirming that a Termination Notice has been issued,
because the appropriate minimum notice period and requirements for
publishing a Circular are set forth in existing Clearing Rule 209,
which is not proposed to be amended.
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    ICE Clear Europe proposes to adopt a new Clearing Membership Policy
(the ``Policy'') and new Clearing Membership Procedures (the
``Procedures'', and collectively with the Policy, the ``Documents'').
The revisions would not involve any changes to the ICE Clear Europe
Clearing Rules.\4\
---------------------------------------------------------------------------

    \4\ Capitalized terms used but not defined herein have the
meanings specified in the ICE Clear Europe Clearing Rules (the
``Rules'').
---------------------------------------------------------------------------

II. Clearing Agency'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 such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(a) Purpose
    ICE Clear Europe is proposing to adopt the new Policy and
Procedures to consolidate and summarize its existing clearing
membership criteria and to document certain existing processes and
procedures concerning the membership application process.
Clearing Membership Policy
    ICE Clear Europe is proposing to adopt the new Policy which would
describe its clearing membership criteria (which are set forth in full
detail in the Rules). The Policy would not change existing membership
criteria. The Policy would also address related processes for assessing
applicants for membership, variations of permissions and termination of
membership.
    The Policy would describe clearing membership criteria, starting
with a description of the objectives, which accounts for membership
risk and ensures that such risks are properly managed and that
admission criteria is non-discriminatory, transparent and objective to
ensure fair and open access, as well as consistent with relevant
regulatory requirements. The Policy would describe how these objectives
are met through setting and monitoring appropriate membership criteria,
establishing a due diligence process and requiring notifications
regarding changes to Clearing Member business. The core clearing
membership criteria, including holding sufficient capital, being a
party to a Clearing Membership Agreement and others, would be
summarized in the Policy (with the full criteria set out in Rule 201
and the CDS Procedures).
    The Policy would provide that ICE Clear Europe has established
processes for clearing membership application, permission variations
and clearing membership termination which are set out in further detail
in the Procedures. The Policy would also address monitoring in respect
of membership criteria, including periodic in-depth counterparty
reviews, periodic review of financial positions and use of its

counterparty rating system, maintenance of a watch list, requiring an
annual member return, and other operational monitoring.
    The Policy would also provide arrangements for breach management,
ongoing reviews and exception handling. This section is consistent with
other ICE Clear Europe policies and governance processes. In
particular, it would provide that (i) the document owner would be
responsible for ensuring that documents remain up-to-date and are
reviewed in accordance with the Clearing House's governance processes,
(ii) the document owner would report material breaches or unapproved
deviations from the Framework to their Head of Department, the Chief
Risk Officer and the Head of Compliance (or their delegates) who would
determine if further escalation would be made to relevant senior
executives, the Board and/or competent authorities, and (iii)
exceptions to the Policy would be approved in accordance with the
Clearing House's governance process for the approval of changes to such
document.
Procedures
    The Procedures would describe in further detail the processes for
reviewing applications for clearing membership, variations of
membership permissions, on-going monitoring and membership termination.
The objective would be to establish a due diligence process to ensure
applicants meet ICE Clear Europe membership criteria and, once members,
provide notifications of any changes to their business that could
impact their ability to meet the criteria.
    The Procedures would describe the Clearing Member application
process, the consideration by relevant ICE Clear Europe departments,
the process for approval or rejection of applications by the Executive
Risk Committee under authority delegated by the Board and the right to
appeal to the Board, additional membership conditions or criteria that
the Clearing House may, at its discretion, require prior to approval
and additional information requests that ICE Clear Europe may make
during the application process. The Procedures would also describe the
process for a Clearing Member to obtain membership to a different
membership class and the procedure through which a Clearing Member may
resign or be terminated by the Clearing House (both of which would be
in accordance with Rule 209).
    The Procedures would detail the core membership requirements, which
would include minimum capital requirements as well as a description of
additional financial requirements ICE Clear Europe may impose and of
certain aspects of the calculation of member capital, including the use
of subordinated debt and controller guarantees where approved by ICE
Clear Europe and the disallowance of certain assets from the
calculation. The Procedures also reference Guaranty Fund contributions
for CDS and F&O clearing services, including replenishments in the
event of application of the funds; the margin-to-capital ratio
requirement; (iv) default management capabilities; and (v) EOD price
submissions (for CDS Clearing Members only) as required by the CDS EOD
Price Discovery Policy.
    The Procedures would further provide for a description of ongoing
monitoring which would include: (i) Periodic review of the financial
position and compliance with the relevant membership requirements of
each Clearing Member; (ii) quarterly review of Clearing Member capital
situation and monthly review of FCM/BD Clearing Members; (iii) the
quarterly counterparty rating system report, which aggregates risk
factors covering credit, market price, liquidity and operational risk
for each Clearing Member; (iv) the watch list highlighting Clearing
Members with special risk situations; (v) annual member returns
pursuant to which Clearing Members must provide certain information to
ICE Clear Europe; (vi) daily monitoring of Clearing Member performance
in relation to fulfilment of obligations to cover cash payments, margin
collateral and Guaranty Fund contributions as well as delivery
obligations.
    The Procedures would also set out the same governance requirements
as those described above with respect to the Policy.
(b) Statutory Basis
    ICE Clear Europe believes that the proposed amendments are
consistent with the requirements of Section 17A of the Act \5\ and the
regulations thereunder applicable to it. In particular, Section
17A(b)(3)(F) of the Act \6\ 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, the safeguarding of securities and funds in the custody
or control of the clearing agency or for which it is responsible, and
the protection of investors and the public interest. The proposed
Documents are intended generally to more clearly document and
consolidate the Clearing House's criteria for admitting and monitoring
Clearing Members. In ICE Clear Europe's view the new documentation
would facilitate implementation of the Clearing House's existing
membership criteria as well as ongoing risk management with respect to
Clearing Members by the Clearing House through monitoring of their
particular situations. These amendments would therefore promote overall
Clearing House risk management and facilitate the prompt and accurate
clearing of cleared contracts and protect investors and the public
interest in the sound operations of the Clearing House, consistent with
the requirements of Section 17A(b)(3)(F).\7\ Further, the amendments
will not affect the safeguarding of securities and funds in the custody
or control of the Clearing House or for which it is responsible, within
the meaning of Section 17A(b)(3)(F).
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1.
    \6\ 15 U.S.C. 78q-1(b)(3)(F).
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The proposed amendments to the Documents are further consistent
with the risk management requirements of Rule 17Ad-22(e)(3)(i) \8\ as
they relate to clearing membership. As noted above, the amendments
would formalize and consolidate membership application and monitoring
processes to ensure that Clearing Members meet admission criteria upon
initial membership and continue to meet such criteria throughout their
membership. The amendments will facilitate the Clearing House's ability
to manage the potential risks posed by such Clearing Members.
---------------------------------------------------------------------------

    \8\ 17 CFR 240.17Ad-22(e)(3)(i)-(ii). The rule states that
``[e]ach covered clearing agency shall establish, implement,
maintain and enforce written policies and procedures reasonably
designed to, as applicable: [m]aintain a sound risk management
framework for comprehensively managing legal, credit, liquidity,
operational, general business, investment, custody, and other risks
that arise in or are borne by the covered clearing agency, which:
    (i) Includes risk management policies, procedures, and systems
designed to identify, measure, monitor, and manage the range of
risks that arise in or are borne by the covered clearing agency,
that are subject to review on a specified periodic basis and
approved by the board of directors annually;''
---------------------------------------------------------------------------

    Rule 17Ad-22(b)(7) \9\ requires clearing agencies to provide the
ability to obtain

membership to persons that maintain net capital equal to or greater
than $50 million, providing such persons can comply with other
reasonable membership standards and that any net capital requirements
be scalable so that they are proportional to the risks posed by the
member's activities to the clearing agency. The Procedures do not
change ICE Clear Europe's existing membership and minimum capital
standards in this regard, but more clearly document those requirements
and the process for monitoring compliance. The amendments are thus
consistent with Rule 17Ad-22(b)(7).\10\
---------------------------------------------------------------------------

    \9\ 17 CFR 240.17 Ad-22(b)(7). The rule states that ``[a]
registered clearing agency that performs central counterparty
services shall establish, implement, maintain and enforce written
policies and procedures reasonably designed to:
    . . .
    (7) Provide a person that maintains net capital equal to or
greater than $50 million with the ability to obtain membership at
the clearing agency, provided that such persons are able to comply
with other reasonable membership standards, with any net capital
requirements being scalable so that they are proportional to the
risks posed by the participant's activities to the clearing agency;
provided, however, that the clearing agency may provide for a higher
net capital requirement as a condition for membership at the
clearing agency if the clearing agency demonstrates to the
Commission that such a requirement is necessary to mitigate risks
that could not otherwise be effectively managed by other measures
and the Commission approves the higher net capital requirement as
part of a rule filing or clearing agency registration application.''
    \10\ 17 CFR 240.17 Ad-22(b)(7).
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(2)(i) and (v) \11\ requires clearing agencies to
establish reasonably designed policies and procedures to provide for
governance arrangements that are clear and transparent and specify
clear and direct lines of responsibility. The proposed Documents
clearly define the roles and responsibilities of the document owner,
the Head of Department, the senior members of the Risk Oversight
Department and the senior members of the Compliance Department,
consistent with governance arrangement for other ICE Clear Europe
policies and procedures. ICE Clear Europe believes that the amendments
to the Documents are therefore consistent with the requirements of Rule
17Ad-22(e)(2)(i) and (v).\12\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.17 Ad-22(e)(2). The rule states that ``[e]ach
covered clearing agency shall establish, implement, maintain and
enforce written policies and procedures reasonably designed to, as
applicable:
    (2) Provide for governance arrangements that:
    (i) Are clear and transparent . . .
     (v) Specify clear and direct lines of responsibility . . .''
    \12\ 17 CFR 240.17 Ad-22(e)(2).
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed Documents would have
any impact, or impose any burden, on competition not necessary or
appropriate in furtherance of the purposes of the Act. The Documents
are not changing existing membership criteria and would apply uniformly
to all Clearing Members. As a result, ICE Clear Europe does not believe
the amendments would affect the cost of clearing for Clearing Members
or other market participants, the market for cleared services generally
or access to clearing by Clearing Members or other market participants,
or otherwise affect competition among Clearing Members or market
participants in a manner not necessary or appropriate in furtherance of
the purposes of the Act.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

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

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-2021-014 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-2021-014. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filings will also be available for inspection
and copying at the principal office of ICE Clear Europe and on ICE
Clear Europe's website at https://www.theice.com/clear-europe/regulation. All comments received will be posted without change.
Persons submitting comments are cautioned that we do not redact or edit
personal identifying information from comment submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ICEEU-2021-014 and should be
submitted on or before September 8, 2021.

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

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

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-17671 Filed 8-17-21; 8:45 am]
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[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88623-88625]
[FR Doc No: 2023-28210]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-5259]

Master Protocols for Drug and Biological Product Development;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Master
Protocols for Drug and Biological Product Development.'' The draft
guidance addresses the design and analysis of trials conducted under a
master protocol as well as the submission of documentation to support
regulatory review. The primary focus is on randomized umbrella and
platform trials that are intended to contribute to a demonstration of
safety and substantial evidence of effectiveness. The considerations in
this guidance apply to a range of therapeutic areas. The draft guidance
is intended to clarify the Agency's thinking on the use of master
protocols in drug and biological product development, which was
previously addressed in FDA's guidance entitled ``COVID-19: Master
Protocols Evaluating Drugs and Biological

Products for Treatment or Prevention.'' FDA is also announcing the
withdrawal of the guidance entitled ``COVID-19: Master Protocols
Evaluating Drugs and Biological Products for Treatment or Prevention.''

DATES: Submit either electronic or written comments on the draft
guidance by February 20, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-5259 for ``Master Protocols for Drug and Biological Product
Development.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<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
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.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>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Scott N. Goldie, Center for Drug
Evaluation and Research, Office of Biostatistics, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3557, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Anne Taylor, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Master Protocols for Drug and Biological Product
Development.'' The draft guidance addresses the design and analysis of
trials conducted under a master protocol as well as the submission of
documentation to support regulatory review. The primary focus of this
guidance is on randomized umbrella and platform trials that are
intended to contribute to a demonstration of safety and substantial
evidence of effectiveness. The concepts discussed may also be useful to
consider for early-phase or exploratory umbrella and platform trials as
well as those conducted to satisfy post-marketing commitments or
requirements. The considerations in this draft guidance apply to a
range of therapeutic areas.
    Well-designed and -conducted trials using master protocols can
accelerate drug development by maximizing the amount of information
obtained from the research effort. Compared with stand-alone trials
under separate protocols, a master protocol may offer certain
advantages by leveraging a shared control arm and other shared protocol
elements (e.g., visit schedule, measurement procedures), shared
infrastructure (e.g., network of clinical sites, central facilities,
central randomization system, data management systems), and shared
oversight (e.g., steering committee, data review committee). At the
same time, master protocols add elements of complexity, which can
increase startup time and can lead to design challenges such as
ensuring adequate blinding to treatment assignment. Additionally,
master protocols involving multiple stakeholders will require a high
degree of coordination.

    FDA provided recommendations on master protocols for COVID-19 drug
and biological products in the guidance entitled ``COVID-19: Master
Protocols Evaluating Drugs and Biological Products for Treatment or
Prevention,'' which posted May 2021 and was announced in the Federal
Register on June 24, 2021 (86 FR 33309) (hereafter ``2021 COVID-19
Master Protocols Guidance''). FDA issued the guidance to communicate
its policy for the duration of the COVID-19 public health emergency
(PHE) declared by the Secretary of Health and Human Services (HHS) on
January 31, 2020, including any renewals made by the HHS Secretary in
accordance with section 319(a)(2) of the Public Health Service Act (42
U.S.C. 247d(a)(2)). Furthermore, in the Federal Register of March 13,
2023 (88 FR 15417), FDA listed the guidance documents that will no
longer be effective with the expiration of the PHE declaration,
guidances that FDA was revising to continue in effect for 180 days
after the expiration of the PHE declaration to provide a period for
stakeholder transition and then would no longer be in effect, and
guidances that FDA was revising to continue in effect for 180 days
after the expiration of the PHE declaration during which time FDA
planned to further revise the guidances. The 2021 COVID-19 Master
Protocols Guidance is included in the latter category. The 2021 COVID-
19 Master Protocols Guidance was revised to remain in effect for 180
days post expiration of the PHE declaration, and then revised again to
remain in effect until March 7, 2024, so that FDA could further revise
the 2021 guidance.
    FDA is issuing this draft guidance because many of the issues
addressed in the 2021 guidance arise outside the context of the COVID-
19 PHE. The recommendations in this draft guidance apply to a range of
therapeutic areas, not just COVID-19. The draft guidance also provides
a more comprehensive discussion of many of the design and analysis
topics covered in the 2021 COVID-19 Master Protocols Guidance. For
example, the draft guidance provides more detailed considerations
related to randomization, the choice of control group, informed
consent, blinding to treatment assignment, adaptive design,
multiplicity, comparisons between drugs, and the evaluation of drug
safety. The draft guidance also expands on considerations for trial
oversight, data sharing, dissemination of information, and submissions
to support regulatory review. The draft guidance, when finalized, will
represent the Agency's current thinking on the use of master protocols
in drug and biological product development.
    FDA is issuing this guidance to satisfy, in part, a mandate under
section 3607(b)(2)(C-F) of the Food and Drug Omnibus Reform Act of 2022
(FDORA). Consistent with the FDORA mandate, this guidance discusses
recommendations for clinical trials to streamline logistics and
facilitate the efficient collection and analysis of data, as well as
important principles for the evaluation of effectiveness,
recommendations for communication between sponsors and FDA, and
considerations related to ensuring participant safety and data
integrity in such trials.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Master
Protocols for Drug and Biological Product Development.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
    FDA is also announcing that the 2021 COVID-19 Master Protocols
Guidance will be withdrawn upon publication of this draft guidance. FDA
has determined that the 2021 COVID-19 Master Protocols Guidance is no
longer needed because this new draft is available and its
recommendations, when finalized, will be applicable outside the context
of the COVID-19 PHE.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 312 for the submission of investigational new drug
applications (INDs), including protocols, protocol amendments, and
information amendments, have been approved under OMB control number
0910-0014. The information collections for new drug application (NDA)
regulations (including abbreviated new drug applications (ANDAs)) (21
CFR part 314) and related guidances are approved under OMB control
number 0910-0001, and our biological licensing applications (BLA)
regulations (21 CFR part 601) are approved under OMB control number
0910-0338. The collections of information in 21 CFR parts 50 and 56 for
the protection of human subjects and institutional review boards have
been approved under OMB control number 0910-0130. The collections of
information related to the protection of human subjects under 45 CFR
part 46 and to IRB recordkeeping under 45 CFR 46.115 have been approved
under OMB control number 0990-0260. The collections of information in
21 CFR part 11, Electronic Records; Electronic Signatures, have been
approved under OMB control number 0910-0303. The information collection
requirements in FDA's guidance for industry entitled ``Establishment
and Operation of Clinical Trial Data Monitoring Committees'' have been
approved under OMB control number 0910-0581. The information collection
requirements in FDA's guidance for industry entitled ``Oversight of
Clinical Investigations--A Risk-Based Approach to Monitoring'' and
FDA's final guidance for industry entitled ``A Risk-Based Approach to
Monitoring of Clinical Investigations'' have been approved under OMB
control number 0910-0733. The information collections in FDA's guidance
for industry entitled ``Expedited Programs for Serious Conditions--
Drugs and Biologics'' have been approved under OMB control number 0910-
0765.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28210 Filed 12-21-23; 8:45 am]
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