[Federal Register Volume 88, Number 73 (Monday, April 17, 2023)]
[Notices]
[Pages 23474-23478]
[FR Doc No: 2023-07963]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97284; File No. SR-DTC-2023-003]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Update the Clearing Agency Securities Valuation Framework

April 11, 2023.
    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 March 28, 2023, The Depository Trust Company (``DTC'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II and III below, which Items have
been prepared by the clearing agency. DTC filed the proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6) thereunder.\4\ The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change consists of amendments to the Clearing
Agency Securities Valuation Framework (``Framework'') of DTC and its
affiliates, Fixed Income Clearing Corporation (``FICC'') and National
Securities Clearing Corporation (``NSCC,'' and together with FICC, the
central counterparties or ``CCPs,'' and the CCPs together with DTC, the
``Clearing Agencies''), as described below. The proposed changes to the
Framework would apply to DTC, NSCC, and both of FICC's divisions, the
Government Securities Division and the Mortgage-Backed Securities
Division.

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, the clearing agency included
statements concerning the purpose of and basis for the proposed rule
change and discussed any comments it received on the proposed rule
change. The text of these statements may be examined at the places
specified in Item IV below. The clearing agency 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

1. Purpose
    The proposed rule change consists of modifications to the Framework
to clarify the Clearing Agencies' practices concerning the valuation of
(i) securities eligible for clearance and settlement processing by the
applicable Clearing Agency and (ii) with respect to the CCPs, eligible
securities in their respective Clearing Funds (each, a ``CUSIP'').
Specifically, the proposed rule change would clarify certain aspects of
the Framework concerning (i) the selection of third-party pricing
vendors (``Pricing Vendors''); (ii) the monitoring and review of
Pricing Vendor data; (iii) the processing and use of Pricing Vendor
data; and (iv) other non-substantive aspects of the Framework. The
proposed changes are discussed in detail below.
(i) Background
    The Clearing Agencies maintain a Framework that sets forth the
manner in which each of the Clearing Agencies identifies, measures,
monitors, and manages the risks related to the pricing of securities
processed or otherwise held by such Clearing Agencies, including (i)
CUSIPs eligible for clearance and settlement processing by the
applicable Clearing Agency and (ii) with respect to the CCPs, eligible
CUSIPs in their respective Clearing Funds.\5\ The Framework describes,
among other things, the Clearing Agencies' use of Pricing Vendors and
the monitoring, reviewing and processing of pricing data for end-of-day
and intraday pricing.
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    \5\ See Securities Exchange Act Release No. 82006 (November 2,
2017), 82 FR 51892 (November 8, 2017) (SR-DTC-2017-016; SR-NSCC-
2017-016; SR-FICC-2017-020).
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    The Framework is owned and managed by an officer within the DTCC
Securities Valuation team, which is part of the Group Chief Risk Office
of DTCC, on behalf of the Clearing Agencies.\6\ The processes and
systems described in the Framework, and any policies, procedures, or
other documents created to support those processes, support the
Clearing Agencies' compliance with the requirements of Rule 17Ad-
22(e)(4)(i) \7\ and, with respect to the CCPs, Rule 17Ad-22(e)(6)(iv)
\8\ under the Act.
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    \6\ The parent company of the Clearing Agencies is The
Depository Trust & Clearing Corporation (``DTCC''). DTCC operates on
a shared services model with respect to the Clearing Agencies. Most
corporate functions are established and managed on an enterprise-
wide basis pursuant to intercompany agreements under which it is
generally DTCC that provides a relevant service to a Clearing
Agency.
    \7\ 17 CFR 240.17Ad-22(e)(4)(i).
    \8\ 17 CFR 240.17Ad-22(e)(6)(iv).
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(ii) Proposed Rule Change
    The Clearing Agencies propose to revise the Framework to improve
the accuracy and clarity of the descriptions of the Clearing Agencies'
practices concerning securities valuation. Specifically, the Clearing
Agencies propose to revise the Framework to: (i) clarify certain
aspects of the Pricing Vendor selection process; (ii) clarify the
description of the Clearing Agencies' practices for monitoring and
reviewing Pricing Vendor data; (iii) clarify the description of the
Clearing Agencies' processes concerning the use of end-of day and
intraday CUSIP pricing data; and (iv) make other non-substantive
clarifying and clean-up changes to the Framework. Each of these
categories of changes are discussed in further detail below.
Selection of Pricing Vendors
    Pursuant to the Framework, the Clearing Agencies select Pricing
Vendors based on a review of their services, which includes a review of
their securities coverage, price quality checks, and other due
diligence prior to engagement. Once a Pricing Vendor is engaged, the
Securities Valuation team assesses the reliability of each Pricing
Vendor at least annually.
    The Clearing Agencies propose minor modifications to the Framework
concerning the Pricing Vendor selection process. The Clearing Agencies
propose to revise the Framework to state that Pricing Vendors are
selected based on a ``service review'' as opposed to a ``review of
their service.'' The proposed rule change is not intended to reflect a
material change to the Pricing Vendor selection process, but rather,
would more accurately reflect the scope of any potential review
performed for Pricing Vendors, which may include factors beyond just
the specific service provided (e.g., it may include a review of certain
attributes of the Pricing Vendor itself).
    The Clearing Agencies also propose to revise the Framework to
clarify that when reviewing the reliability of a Pricing Vendor, the
Clearing Agencies would consider whether the Pricing Vendor actually
provides accurate and timely pricing data as opposed to whether the
Pricing Vendor is ``able to provide'' accurate and timely data. The
Clearing Agencies believe the proposed rule change would more clearly
and accurately reflect the expectation that the Pricing Vendor has
actually provided accurate and timely pricing data and thereby further
ensure that the Clearing Agencies' policies and procedures are
reasonably designed to use reliable sources of timely price data.
Monitoring and Review of Pricing Vendor Data
    Pursuant to the Framework, the Securities Valuation team monitors
and reviews each Pricing Vendor's pricing at least once each business
day. This includes a review of whether any CUSIP's price has remained
unchanged for an extended period of time, whether a CUSIP has been
dropped from the Pricing Vendor's file and whether other circumstances
exist that may call into question the reliability of any CUSIP's price.
    The Clearing Agencies propose to make certain non-substantive
clarifying and grammatical corrections to the Framework concerning the
monitoring of Pricing Vendors. The proposed changes would clarify that
the scope of daily monitoring and review includes a determination of
whether (i) an ``eligible'' CUSIP's price has remained unchanged for an
extended period (as opposed to inferring ``all CUSIPS'' for which a
vendor may provide pricing in a given file) and (ii) other ``relevant''
circumstances exist that ``could'' call into question the reliability
of a CUSIP's price. These proposed changes are intended to enhance the
clarity and drafting of the Framework and are not intended to result in
a material change to the monitoring and review processes.
Processing and Use of Pricing Vendor Data
    The Framework currently provides that the Securities Valuation team
assigns each CUSIP a primary source Pricing Vendor and a secondary
source Pricing Vendor and that, in the event that the primary Pricing
Vendor becomes unavailable, unreliable, or otherwise unusable with
respect to a CUSIP, the secondary Pricing Vendor will be designated as
the replacement for the primary Pricing Vendor with

respect to such CUSIP. The Framework also describes the processing of
end-of-day and intraday pricing from Pricing Vendors. Specifically, the
Framework provides that each CUSIP's price is date stamped (and in the
case of intraday pricing, time-stamped) and identified with its Pricing
Vendor source, and in the event that both primary Pricing Vendor and
secondary Pricing Vendor become unavailable, unreliable, or otherwise
unusable with respect to a CUSIP, the Securities Valuation team assigns
such CUSIP its last available price.
Pricing Vendor Assignments
    The Clearing Agencies propose to revise the Framework to remove the
statement that the Securities Valuation team assigns each CUSIP a
primary and secondary source Pricing Vendor and remove corresponding
references to ``Primary Pricing Vendor'' and ``Secondary Pricing
Vendor'' throughout the Framework. The Clearing Agencies maintain
relationships with more than one Pricing Vendor for the majority of
their products; however, this may not be the case in all circumstances.
For example, the Clearing Agencies may not maintain multiple Pricing
Vendors for products that are cleared based on the pricing of another
similar product for which they also maintain Pricing Vendor
relationships. The Clearing Agencies also may not perform intra-day
pricing for certain asset classes that are not subject to clearance and
netting services. The Clearing Agencies therefore believe the proposed
change would more accurately reflect the Clearing Agencies' practices
for maintaining Pricing Vendors. The proposed changes would further
clarify that the Clearing Agencies may not maintain ``primary'' and
``secondary'' vendors for all CUSIPs, and that the Clearing Agencies
may use whichever Pricing Vendor proves to be available and reliable
for a CUSIP at a given time without relying on such ``primary'' and
``secondary'' designations. The proposed changes would also provide
additional clarity and flexibility for the Clearing Agencies to
maintain more than two Pricing Vendors for a product area/CUSIP or,
where appropriate, reduce the number of Pricing Vendor relationships it
may maintain for any given product area or CUSIP, as governed by
applicable Securities Valuation policies and procedures.
    The Clearing Agencies would also revise the Framework to specify
that in the event a Pricing Vendor becomes unavailable, unreliable, or
otherwise unusable with respect to a CUSIP, back-up pricing would be
utilized to provide accurate and timely pricing data with respect to
such CUSIP. The proposed change would more accurately reflect that
backup pricing may be sourced from an alternative Pricing Vendor, where
applicable, or may also be determined, in the absence of an alternative
Pricing Vendor, pursuant to the Clearing Agencies' applicable policies
and procedures to ensure that timely pricing data is applied.
End-of-Day and Intraday Price Processing
    The Clearing Agencies also propose to clarify their processes for
recording end-of-day and intraday pricing. The Clearing Agencies would
revise the Framework to clarify that, with respect to end-of-day and
intraday pricing, if Pricing Vendor data is unavailable, unreliable, or
otherwise unusable for a CUSIP, the Securities Valuation team does not
``assign'' the last available price to the CUSIP, but rather, the last
available price is recorded in the Clearing Agencies' pricing database,
which is consumable for applicable stakeholders. The proposed rule
change would also further clarify that this process would apply if
pricing data were unavailable, unreliable, or otherwise unusable from
``all'' Pricing Vendors, and not just the primary or secondary Pricing
Vendors, for the reasons discussed above. The Clearing Agencies believe
the proposed changes concerning end-of-day and intraday price
processing would improve the accuracy and clarity of the Framework.
Other Non-Substantive Clean-Up Changes
    Finally, the Clearing Agencies propose to make several non-
substantive changes to the Framework. For example, the Clearing
Agencies would revise a statement that the Securities Valuation team
values each ``applicable'' CUSIP to say each ``eligible'' CUSIP to
align this statement more clearly with the scope of the policy (i.e.,
those securities eligible for clearance and settlement or for each
CCPs' clearing fund). The Clearing Agencies would also revise the
definition of ``Pricing Vendors'' to define them as third-party pricing
``suppliers'' as opposed to ``vendors'' to eliminate redundancy in the
definition and align with other language used in the Framework
concerning their role in supplying prices. Additionally, the Clearing
Agencies would make several non-substantive, grammatical, and
punctuation-related clean-up changes throughout the Framework
(including revisions to a footnote in the policy regarding the
possibility that certain CUSIPs might not be priced as expected). The
proposed changes are not intended to change the meaning or purpose of
the Framework but rather improve the drafting and clarity of the
Framework.
2. Statutory Basis
    The Clearing Agencies believe that the proposed rule change is
consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a registered clearing agency. In
particular, the Clearing Agencies believe the proposed rule change is
consistent with Section 17A(b)(3)(F) of the Act \9\ and Rules 17Ad-
22(e)(4)(i) \10\ and (e)(6)(iv) \11\ under the Act, for the reasons set
forth below.
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    \9\ 15 U.S.C. 78q-1(b)(3)(F).
    \10\ 17 CFR 240.17Ad-22(e)(4)(i).
    \11\ 17 CFR 240.17Ad-22(e)(6)(iv).
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    Section 17A(b)(3)(F) of the Act \12\ requires, in part, that the
rules of a clearing agency be designed to promote the prompt and
accurate clearance and settlement of securities transactions and to
assure the safeguarding of securities and funds which are in the
custody or control of the clearing agency or for which it is
responsible. The proposed rule change would improve descriptions of the
Clearing Agencies' processes for selecting Pricing Vendors, reviewing
the reliability of Pricing Vendors, monitoring and reviewing each
Pricing Vendor's pricing data, and the processing and use of Pricing
Vendor data for securities valuation purposes. The proposed rule change
is designed to improve the accuracy and clarity of the Framework
document. The Framework and the policies and procedures that support
the Framework help assure that each Clearing Agency is using reliable
sources of timely price data for collateral valuation, risk management
and settlement purposes. Since margin and collateral play key roles in
the applicable Clearing Agency's risk management process, having
accurate margin system and collateral valuation facilitates the
Clearing Agencies' ability to continue the prompt and accurate
clearance and settlement of securities transactions and assure the
safeguarding of securities and funds which are in their custody or
control or for which they are responsible. The Clearing Agencies
therefore believe that enhancing the quality and accuracy of the
Framework is consistent with the requirements of Section 17A(b)(3)(F)
of the Act.
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    \12\ 15 U.S.C. 78q-1(b)(3)(F).
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    Rule 17Ad-22(e)(4)(i) \13\ under the Act requires that each covered
clearing

agency establish, implement, maintain and enforce written policies and
procedures reasonably designed to effectively identify, measure,
monitor, and manage its credit exposures to participants and those
arising from its payment, clearing, and settlement processes by
maintaining sufficient financial resources to cover its credit exposure
to each participant fully with a high degree of confidence. The
Framework describes how the Clearing Agencies identify, measure,
monitor, and manage the risks related to the pricing of securities
processed or otherwise held by the Clearing Agencies. The processes,
systems, and controls used by the Clearing Agencies to identify,
measure, monitor, and manage such risks, as described in the Framework,
and the policies and procedures that support these activities, help
assure that each Clearing Agency is using (i) reliable sources of
timely price data when pricing securities processed or otherwise held
by the applicable Clearing Agency and (ii) procedures and sound
valuation models when pricing data are not readily available or
reliable. The proposed rule change would enhance the Framework by
providing additional clarity and accuracy concerning the Clearing
Agencies' securities valuation practices, and specifically, its
processes for selecting Pricing Vendors, reviewing the reliability of
Pricing Vendors, monitoring and reviewing each Pricing Vendor's pricing
data, and the processing and use of Pricing Vendor data. By
appropriately pricing securities, the Clearing Agencies can more
accurately calculate the value of the securities that the Clearing
Agencies monitor or hold for risk management purposes. The proposed
changes are therefore intended to facilitate the maintenance of
policies and procedures that are reasonably designed to effectively
identify, measure, monitor and manage the Clearing Agencies' credit
exposures to participants and those arising from its payment, clearing,
and settlement processes and determine the amount of financial
resources required to cover its credit exposure to each participant
with a high degree of confidence in accordance with the requirements of
Rule 17Ad-22(e)(4)(i).
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    \13\ 17 CFR 240.17Ad-22(e)(4)(i).
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    Rule 17Ad-22(e)(6)(iv) \14\ under the Act requires each covered
clearing agency that is a CCP to establish, implement, maintain and
enforce written policies and procedures reasonably designed to cover
its credit exposures to its participants by establishing a risk-based
margin system that, at a minimum, uses reliable sources of timely price
data and uses procedures and sound valuation models for addressing
circumstances in which pricing data are not readily available or
reliable. The Framework describes how the CCPs identify, measure,
monitor, and manage the risks related to the pricing of securities
processed or otherwise held by the CCPs. As noted above, the proposed
rule change would enhance the Framework by providing additional clarity
and accuracy concerning the Clearing Agencies' securities valuation
practices, and specifically, its processes for selecting Pricing
Vendors, reviewing the reliability of Pricing Vendors, monitoring and
reviewing each Pricing Vendor's pricing data, and the processing and
use of Pricing Vendor data. The processes, systems, and controls used
by the CCPs to identify, measure, monitor, and manage such risks, as
described in the Framework, and the policies and procedures that
support these activities, help assure that each CCP is using reliable
sources of timely price data as well as procedures and sound valuation
models when pricing data are not readily available or reliable. The
Clearing Agencies therefore believe the proposed changes to the
Framework are consistent with the requirements of Rule 17Ad-
22(e)(6)(iv).
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    \14\ 17 CFR 240.17Ad-22(e)(6)(iv).
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(B) Clearing Agency's Statement on Burden on Competition

    The Clearing Agencies do not believe that the proposed rule change
would have any impact, or impose any burden, on competition. The
proposed changes would enhance the Framework by providing additional
clarity and accuracy concerning the Clearing Agencies' securities
valuation processes. The Framework itself, and the proposed rule
changes described herein, would not advantage or disadvantage any
particular participant or user of the Clearing Agencies' services or
unfairly inhibit access to the Clearing Agencies' services. The
Clearing Agencies therefore do not believe that the proposed rule
change would have any impact, or impose any burden, on competition.

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

    The Clearing Agencies have not received or solicited any written
comments relating to this proposal. If any written comments are
received, they will be publicly filed as an Exhibit 2 to this filing,
as required by Form 19b-4 and the General Instructions thereto.
    Persons submitting comments are cautioned that, according to
Section IV (Solicitation of Comments) of the Exhibit 1A in the General
Instructions to Form 19b-4, the Commission does not edit personal
identifying information from comment submissions. Commenters should
submit only information that they wish to make available publicly,
including their name, email address, and any other identifying
information.
    All prospective commenters should follow the Commission's
instructions on how to submit comments, available at https://www.sec.gov/regulatory-actions/how-to-submit-comments. General
questions regarding the rule filing process or logistical questions
regarding this filing should be directed to the Main Office of the
Commission's Division of Trading and Markets at
[email protected] or<PHONE_NUMBER>.
    The Clearing Agencies reserve the right not to respond to any
comments received.

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

    Because the foregoing proposed rule change does not:
    (i) significantly affect the protection of investors or the public
interest;
    (ii) impose any significant burden on competition; and
    (iii) become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, it has
become effective pursuant to Section 19(b)(3)(A) of the Act \15\ and
Rule 19b-4(f)(6) thereunder.\16\
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    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-DTC-2023-003 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-DTC-2023-003. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of DTC and on DTCC's website
(http://dtcc.com/legal/sec-rule-filings.aspx). 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-DTC-2023-003 and should be submitted on
or before May 8, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-07963 Filed 4-14-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: April 29, 2009 (Volume 74, Number 81)]
[Rules and Regulations]
[Page 19421]
[DOCID:fr29ap09-7]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2009-0210]

Drawbridge Operation Regulations; Hackensack River, Jersey City,
NJ, Maintenance

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Witt Penn Bridge across the Hackensack River at mile 3.1, and the Lower
Hack Bridge at mile 3.4, across the Hackensack River, at Jersey City,
New Jersey. Under this temporary deviation the Lower Hack Bridge will
be allowed to provide a maximum opening of only 110 feet at mean high
water for a period of 30-days and both bridges will be allowed to
remain in the closed position for a period of 45-days to facilitate
major bridge maintenance. Vessels that can pass under the draws without
a bridge opening may do so at all times.

DATES: This deviation is effective from May 9, 2009 through July 22,
2009.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2009-0210 and are available online
at www.regulations.gov, selecting the Advanced Docket Search Option on
the right side of the screen, inserting USCG-2009-0210 in the Docket ID
box, pressing Enter, and then clicking on the item in the Docket ID
column. This material is also available for inspection or copying at
the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call Zachary Strauss, Project Officer, First Coast Guard District,
telephone<PHONE_NUMBER>. If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION: The Witt Penn Bridge, across the Hackensack
River at mile 3.1 has a vertical clearance in the closed position of 35
feet at mean high water and 40 feet at mean low water.
    The Lower Hack Bridge at mile 3.4 has a vertical clearance in the
closed position of 40 feet above mean high water and 45 feet above low
water. The existing drawbridge operation regulations are listed at 33
CFR 117.723.
    The waterway has seasonal recreational vessels, and commercial
vessels of various sizes.
    The owner of the bridges, New Jersey Department of Transportation,
(Witt Penn Bridge) and New Jersey Transit (Lower Hack Bridge) requested
a temporary deviation to facilitate the replacement of sheaves and wire
ropes at both the Witt Penn and Lower Hack bridges and asbestos removal
at the Lower Hack Bridge only.
    The asbestos removal at the Lower Hack Bridge will prevent the
bridge from fully opening during the removal process.
    The asbestos removal is scheduled to commence 30-days before the
bridge closures to replace the sheaves and wire ropes at the bridges.
    The Lower Hack Bridge will only be able to open to 110 feet above
mean high water and 115 feet at mean low water from May 9, 2009 through
June 7, 2009, during the asbestos removal.
    Therefore, under this temporary deviation the Lower Hack Bridge may
open to only 110 feet above mean high water instead of the normal 135
feet above mean high water from May 9, 2009 through June 7, 2009. From
June 8, 2009 through July 22, 2009, the Witt Penn Bridge, mile 3.1, and
the Lower Hack Bridge, mile 3.4, across the Hackensack River may remain
in the closed position for bridge maintenance. Vessels that can pass
under the bridge without a bridge opening may do so at all times.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: April 13, 2009.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. E9-9717 Filed 4-28-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 74, Number 102 (Friday, May 29, 2009)]
[Proposed Rules]
[Pages 25686-25689]
[FR Doc No: E9-12557]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2005-KY-0003-200616; FRL-8911-3]

Approval and Promulgation of Implementation Plans; Kentucky;
NOX SIP Call Phase II

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve the State Implementation Plan
(SIP) revisions submitted by the Commonwealth of Kentucky on September
12, 2005, and March 24, 2006. The first revision provides Kentucky's
response to EPA's regulations entitled, ``Finding of Significant
Contribution and Rulemaking for Certain States in Ozone Transport
Assessment Group Region for Purposes of Reducing Regional Transport of
Ozone,'' otherwise known as the ``Nitrogen Oxides (NOX) SIP
Call Phase I.'' The second revision responds to EPA's regulations
entitled, ``Interstate Ozone Transport: Response to Court Decisions on
the NOX SIP Call, NOX SIP Call Technical
Amendments, and Section 126 Rules,'' otherwise known as the ``
NOX SIP Call Phase II.'' The NOX SIP Call Phase
II revision satisfies EPA's rule that requires Kentucky to submit Phase
II revisions necessary to achieve applicable, incremental reductions of
NOX. The intended effect of the Phase II SIP revision is to
reduce emissions of NOX originating in the Commonwealth of
Kentucky to help attain and maintain the national ambient air quality
standard for ozone. The March 24, 2006, final submittal stopped the
federal implementation plan clock that started on February 8, 2006,
when EPA made a finding that Kentucky failed to submit the required SIP
for Phase II of the NOX SIP Call by April 1, 2005.

DATES: Comments must be received on or before June 29, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2005-KY-0003, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: EPA-R04-OAR-2005-KY-0003, 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.
    5. Hand Delivery or Courier: Lynorae Benjamin, Chief, 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. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The Regional Office's official hours of business are Monday through
Friday, 8:30 to 4:30, excluding federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2005-KY-0003. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
Online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit through http://www.regulations.gov or e-mail, information that you consider to be CBI
or otherwise protected. The http://www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI 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 in http://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. 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 to 4:30, excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Nacosta C. Ward, 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. The telephone number
is<PHONE_NUMBER>. Ms. Ward can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Analysis of State's Submittal
III. Proposed Action
IV. Statutory and Executive Order Reviews

I. Background

    On October 27, 1998, EPA published a final rule known as the
``NOX SIP Call'' (63 FR 57356), and later known as the
``NOX SIP Call Phase I.'' The NOX SIP Call Phase
I required 22 states, including the Commonwealth of Kentucky, to meet
NOX emission budgets during the ozone season (March through
September) to reduce the amount of ground level ozone that is
transported across the eastern United States. EPA identified
NOX emission reductions by source category when they could
be achieved by using cost-effective measures. These source categories
include electric generating units (EGUs), non-EGUs, internal combustion
engines (ICEs) and cement kilns. For each affected jurisdiction, EPA
determined NOX emission budgets based on the implementation
of cost effective controls. The budgets were to be met by the year
2007. Phase I of the NOX SIP Call gave states the
flexibility to decide which source categories to regulate to meet its
statewide budget. During Phase I, Kentucky regulated EGUs, non-EGUs and
cement kilns, but chose not to address ICEs. See, 67 FR 17624, 17625
(April 11, 2002) (Approval and Promulgation of Implementation Plans:
Kentucky: Nitrogen Oxides Budget and Allowance Trading Program).
    A number of parties, including certain states as well as industry
and labor groups, challenged Phase I of the NOX SIP Call
rule. On March 2, 2000, EPA published additional technical amendments
to the NOX SIP Call in the Federal Register (64 FR 26298 and
65 FR 11222, respectively). On March 3, 2000, the United States Court
of Appeals for the District of Columbia Circuit Court (D.C. Circuit
Court) issued its decision on the NOX SIP Call, ruling in
favor of EPA on all the major issues. Michigan v. EPA, 213 F.3d 663
(D.C. Cir. 2000). However, the D.C. Circuit Court remanded four
specific elements to EPA for further action: The definition of EGU; the
level of control for stationary internal combustion engines; the
geographic extent of the NOX SIP Call for Georgia and
Missouri; and the inclusion of Wisconsin. On January 31, 2002, the
Kentucky Environmental and Public Protection Cabinet (KEPPC) submitted
final revisions to its SIP that complied with the requirements of Phase
I of the NOX SIP Call. EPA approved the revisions on April
11, 2002, 67 FR 17624, which became effective on June 10, 2002.
    On April 21, 2004, EPA published a final rule, addressing the
remanded portion of the NOX SIP Call Rule. This rule is
entitled, ``Interstate Ozone Transport: Response to Court Decisions on
the NOX SIP Call, NOX SIP Call Technical
Amendments, and Section 126 Rules,'' and is otherwise known as the
``NOX SIP Rule Phase II'' (69 FR 21604). The action
promulgated specific changes in response to the Court's ruling on Phase
I of the Rule. Specifically, it finalized certain aspects of the
definitions of EGU and non-EGU, and the control level assumed for large
stationary ICEs. For large, natural gas fired, stationary ICEs the
control level was set at 82 percent, because the vast majority of large
natural gas-fired ICEs are lean burn. For diesel and dual fuel
stationary ICEs the control level was set at 90 percent since on
average they are rich burn, diesel and dual fuel ICEs. The April 21,
2004, rule also finalized partial state budgets for Georgia, Missouri,
Alabama, and Michigan, changes to statewide NOX budgets, the
SIP submittal dates for the required states to address the Phase II
portion of the budget, the SIP submittal dates for Georgia and
Missouri, the compliance date for all covered sources, and the
exclusion of Wisconsin from the NOX SIP Call (69 FR 21604,
April 21, 2004). The final rule also required states that submitted
NOX SIP Call Phase I revisions, to submit by April 1, 2005,
Phase II SIP revisions as needed to achieve the necessary incremental
reductions of NOX. Phase II requires emissions reductions
that are relatively small, representing less than 10 percent of the
total reductions required by Phase I of the NOX SIP Call.
    Phase II of the NOX SIP Call required Kentucky to reduce
the Phase I NOX emissions originating in the Commonwealth
from 165,075 tons (Phase I budget) to 162,519 tons (Phase II budget) of
NOX emissions. (69 FR 21604, 2162, April 21, 2004). This
represents a 4,224 ton reduction of NOX emissions in
Kentucky. The budget numbers for Phase II for each affected state were
based on the Phase I emission inventory as revised in the ``Technical
Amendment to the Finding of Significant Contribution and Rulemaking for
Certain States for Purposes of Reducing Regional Transport of Ozone,''
which was published on March 2, 2000. However, EPA approved a revised
Phase I Budget for Kentucky in a revision to the NOX SIP
Call submitted on April 11, 2002 (67 FR 17624). Therefore, the final
Kentucky Phase II Budget in the April 21, 2004, notice is inaccurate
because it is based on the previous Phase I Budget.
    On January 23, 2004, EPA wrote a letter to KEPPC clarifying that
based on current rules and regulations, including 63 FR 57356, 57416
(October 27, 1998), and 40 CFR 96.2, EPA was allowing each state with
one or more carbon monoxide (CO) boiler combusting CO from fluidized
catalytic cracking units (FCCUs) to determine whether all of the
Commonwealth's FCCU-CO boilers were covered by the NOX SIP
Call trading program. There is currently only one facility in Kentucky
with FCCU-CO boilers (the Ashland Oil facility, located in Ashland,
Kentucky). Kentucky elected to exclude all FCCU-CO boilers in the
Commonwealth from the NOX trading program. Today's action
removes the requirement from the Kentucky SIP that such units comply
with the NOX SIP Call Phase I by exempting them from the
non-EGU portion of the Kentucky NOX budget. However,
Kentucky is still able to meet the phase II budgets through other
reductions. For more information regarding the specifics of Phase I
source categories and budgets, see 67 FR 17624 (April 11, 2002).
    Kentucky is achieving the Phase II goal by setting the control
level for large, stationary ICEs at 82 percent, and for diesel and dual
fuel stationary ICEs at 90 percent. The application of control levels
to ICEs represents a reduction in NOX emissions originating
in Kentucky. Therefore, the large stationary ICE portion of Kentucky's
non-EGU NOX trading budget is being reduced by 2,491 tons of
NOX emissions.
    On September 12, 2005, the KEPPC submitted a draft of its SIP
regulation revisions, intended to meet the requirements of the
NOX SIP Call Phase II. A public hearing was conducted on
October 21, 2005. On March 24, 2006,

SIP revisions were submitted in their final form. The March 24, 2006,
submittal stopped the federal implementation plan clock that started
under the Clean Air Act (CAA) following EPA's February 8, 2006, finding
that Kentucky failed to submit the required SIP revisions for Phase II
of the NOX SIP Call by April 1, 2005 (71 FR 6347, February
8, 2006).

II. Analysis of State Submittal

    The September 12, 2005, and March 24, 2006, proposed revisions to
the Kentucky SIP include changes to regulation 401 KAR 51:150, which
are consistent with EPA requirements for Phase II of the NOX
SIP Call. In addition, the proposed revisions included a change to
regulation 401 KAR 51:160, which is consistent with EPA requirements
for Phase I of the NOX SIP Call. The Phase II revisions
require the Cabinet to set NOX emission levels for large
stationary ICEs, including large utility and industrial boilers (i.e.,
engines emitting more than one ton of NOX per average ozone
season day in 1997), except FCCU-CO boilers, at 82 percent. The
combination of the Kentucky regulations addressing NOX
emissions from large utility and industrial boilers, cement kilns and
ICEs achieve all the necessary NOX reductions required to
meet NOX Phase II requirements for Kentucky. In light of
these reductions, the projected 2007 control period NOX
emissions for the various categories are as follows in tons per year:
     Total EGU NOX Budget--36,504.
     Total Non-EGU NOX--Budget 26,259.
     Total NOX Budget for Stationary Area Sources--
31,807.
     Total NOX Budget for Nonroad Mobile Sources--
15,025.
     Total NOX Budget for Highway Mobile Sources--
53,268.\1\
---------------------------------------------------------------------------

    \1\ This NOX Budget is not intended for the purposes
of implementing transportation conformity requirements. Refer to the
attainment demonstration, maintenance plan or reasonable further
progress plan for the particular nonattainment and/or maintenance
area(s) for the appropriate motor vehicle emissions budget for an
area for transportation conformity purposes.
---------------------------------------------------------------------------

     Total NOX Budget for Kentucky--162,863.
    The revised non-EGU NOX budget was 28,750 tons in the
January 31, 2002, SIP revision and revised to 26,259 tons in the
September 2005 SIP Revision. The large boilers/turbines were reduced
from 179 to 64 NOX ozone season tons due to FCCU-CO boilers
being exempted from that category. The large cement kilns remained the
same at 1,091 NOX ozone season tons. The large ICEs went
from 3,083 to 577 NOX ozone season tons by applying the
appropriate Phase II reductions. Small and other sources increased from
24,397 to 24,527 tons due to moving Ashland Oil from the large boilers/
turbines to this portion of the non-EGU budget. Additionally, there was
an error in Kentucky's original inventory for units at the Texas Gas-
Jeffersontown facility, resulting in eight more units than initially
included in the small/other sources budget. The chart below summarizes
the budgets:

                 Summary of Non-EGU NOX Emissions Budget
------------------------------------------------------------------------
                                     January 31, 2002    March 24, 2006
                                     NOX SIP Call SIP   NOX SIP Call SIP
    Portion of the non-EGU NOX           revision           revision
         emissions budget             submittal (NOX     submittal (NOX
                                      ozone  season      ozone  season
                                          tons)              tons)
------------------------------------------------------------------------
Large Boilers/Turbines*...........                179                 64
Large Cement Kilns................               1091               1091
Large ICEs........................               3083                577
Small/Other Sources...............             24,397             24,527
                                   -------------------------------------
    Total Non-EGU Emissions.......             28,750            26,259
------------------------------------------------------------------------
* Non-EGU budget that is part of the NOX SIP Call cap and trade program.

III. Proposed Action

    EPA is proposing to approve the aforementioned changes to the SIP,
including Kentucky's NOX SIP Call Phase II budget. This SIP
revision is consistent with section 110 of the CAA.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249,

November 9, 2000), because the SIP is not approved to apply in Indian
country located in the state, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Incorporation by reference, Air pollution
control, Carbon monoxide, Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Volatile organic compounds.

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

    Dated: May 18, 2009.
Beverly H. Banister,
Acting Regional Administrator, Region 4.
[FR Doc. E9-12557 Filed 5-28-09; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Rules and Regulations]
[Pages 74298-74302]
[FR Doc No: 2016-25851]

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

Food and Drug Administration

21 CFR Part 2

[Docket No. FDA-2015-N-1355]
RIN 0910-AH36

Use of Ozone-Depleting Substances

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
amending its regulation on uses of ozone-depleting substances (ODSs),
including chlorofluorocarbons (CFCs), to remove the designation for
certain products as ``essential uses'' under the Clean Air Act.
Essential-use products are exempt from the ban by FDA on the use of
CFCs and other ODS propellants in FDA-regulated products and from the
ban by the Environmental Protection Agency (EPA) on the use of ODSs in
pressurized dispensers. The products that will no longer constitute an
essential use are: Sterile aerosol talc administered intrapleurally by
thoracoscopy for human use and metered-dose atropine sulfate aerosol
human drugs administered by oral inhalation. FDA is taking this action
because alternative products that do not use ODSs are now available and
because these products are no longer being marketed in versions that
contain ODSs.

DATES: This direct final rule is effective February 23, 2017. Submit
either electronic or written comments on the direct final rule by
December 27, 2016. If FDA receives no significant adverse comments
within the specified comment period, the Agency will publish a document
confirming the effective date of the final rule in the Federal Register
within 30 days after the comment period on this direct final rule ends.
If timely significant adverse comments are received, the Agency will
publish a document in the Federal Register withdrawing this direct
final rule before its effective date.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2015-N-1355 for ``Use of Ozone-Depleting Substances.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     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 http://www.regulations.gov. Submit both copies to the Division of
Dockets Management. 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: http://www.gpo.gov/fdsys/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 http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6246, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Production of ODSs has been phased out worldwide under the terms of
the Montreal Protocol on Substances that Deplete the Ozone Layer
(Montreal Protocol) (September 16, 1987, S. Treaty Doc. No. 10, 100th
Cong., 1st sess., 26 I.L.M. 1541 (1987)). In accordance with the
provisions of the Montreal Protocol, under authority of Title VI of the
Clean Air Act (section 601 et seq.), the manufacture of ODSs, including
CFCs, in the United States was generally banned as of January 1, 1996.
To receive permission to manufacture CFCs in the United States after
the phase-out date, manufacturers must obtain an exemption from the
phase-out requirements from the parties to the Montreal Protocol.
Procedures for securing an essential-use exemption under the Montreal
Protocol are described in a request by EPA for applications for
exemptions (60 FR 54349, October 23, 1995).
    Firms that wish to use ODSs manufactured after the phase-out date
in medical devices (as defined in section 601(8) of the Clean Air Act)
(42 U.S.C. 7671(8)) covered under section 610 of the Clean Air Act (42
U.S.CC. 7671i) must receive exemptions for essential uses under the
Montreal Protocol. EPA regulations implementing the provisions of
section 610 of the Clean Air Act contain a general ban on the use of
ODSs in pressurized dispensers, such as metered-dose inhalers (MDIs)
(40 CFR 82.64(c) and 82.66(d)). These EPA regulations exempt from the
general ban ``medical devices'' that FDA considers essential and that
are listed in Sec.  2.125(e) (21 CFR 2.125(e)). Section 601(8) of the
Clean Air Act defines ``medical device'' as any device (as defined in
the Federal Food, Drug and Cosmetic Act (the FD&C Act) (21 U.S.C.
321)), diagnostic product, drug (as defined in the FD&C Act), and drug
delivery system, if such device, diagnostic product, drug, or drug
delivery system uses a class I or class II ODS for which no safe and
effective alternative has been developed (and where necessary, has been
approved by the Commissioner of Food and Drugs), and if such device,
diagnostic product, drug, or drug delivery system has, after notice and
opportunity for public comment, been approved and determined to be
essential by the Commissioner in consultation with the Administrator of
EPA. Class I substances include CFCs, halons, carbon tetrachloride,
methyl chloroform, methyl bromide, and other chemicals not relevant to
this document (see 40 CFR part 82, appendix A to subpart A). Class II
substances include hydrochlorofluorocarbons (see 40 CFR part 82,
appendix B to subpart A).
    A drug, device, cosmetic, or food contained in an aerosol product
or other pressurized dispenser that releases a CFC or other ODS
propellant is generally not considered an essential use of the ODS
under the Clean Air Act except as provided in Sec.  2.125(c) and (e).
This prohibition is based on scientific research indicating that CFCs
and other ODSs reduce the amount of ozone in the stratosphere and
thereby increase the amount of ultraviolet radiation reaching the
Earth. An increase in ultraviolet radiation will increase the incidence
of skin cancer and produce other adverse effects of unknown magnitude
on humans, animals, and plants (80 FR 36937, June 29, 2015). Section
2.125(c) and (e) provide exemptions for essential uses of ODSs for
certain products containing ODS propellants that FDA determines provide
unique health benefits that would not be available without the use of
an ODS.
    Faced with the statutorily mandated phase-out of the production of
ODSs, drug manufacturers have developed alternatives to MDIs and other
self-pressurized drug dosage forms that do not contain ODSs. Examples
of these alternative dosage forms are MDIs that use non-ODSs as
propellants and dry-powder inhalers. The availability of alternatives
to ODSs means that certain drug products listed in Sec.  2.125(e) are
no longer essential uses of ODSs. Therefore, due to lack of marketing
of approved products containing ODSs, and the availability of
alternative products that do not contain ODSs, FDA is amending its
regulations to remove essential-use designations for sterile aerosol
talc administered intrapleurally by thoracoscopy for human use (Sec.
2.125(e)(4)(ix)) and for metered-dose atropine sulfate aerosol human
drugs administered by oral inhalation (Sec.  2.125(e)(4)(vi)).
    There is currently one sterile aerosol talc product containing ODSs
that is approved for administration intrapleurally by thoracoscopy for
human use for the treatment of recurrent malignant pleural effusion in
symptomatic patients. Section 2.125(g) sets forth standards for
determining whether the use of an ODS in a medical product is no longer
essential. Under Sec.  2.125(g)(3), an essential-use designation for
individual active moieties marketed as ODS products and represented by
one new drug application may no longer be essential if:
     At least one non-ODS product with the same active moiety
is marketed with the same route of administration, for the same
indication, and with approximately the same level of convenience of use
as the ODS product containing that active moiety;
     Supplies and production capacity for the non-ODS
product(s) exist or will exist at levels sufficient to meet patient
need;
     Adequate U.S. postmarketing-use data are available for the
non-ODS product(s); and
     Patients who medically require the ODS product are
adequately served by the non-ODS product(s) containing that active
moiety and other available products (Sec.  2.125(g)(3)).
    On June 29, 2015, FDA published a notice and request for comment
concerning its tentative conclusion that sterile aerosol talc
administered intrapleurally by thoracoscopy for human use no longer
constitutes an essential use under the Clean Air Act under the criteria
in Sec.  2.125(g)(3). FDA requested comment on its findings that
sterile aerosol talc is currently marketed for intrapleural
administration in two non-ODS formulations and on its

finding that the route of administration, indications, and level of
convenience appear to be the same for the ODS and non-ODS formulations
of sterile aerosol talc. FDA also requested comment on its finding that
the non-ODS products are available in sufficient quantities to serve
the current patient population. FDA received no comments on these
findings or on its tentative conclusion that sterile aerosol talc
administered intrapleurally by thoracoscopy for human use no longer
constitutes an essential use of ODSs under the Clean Air Act.
    In the same document published on June 29, 2015, FDA requested
comments concerning its tentative conclusion that metered-dose atropine
sulfate aerosol human drugs administered by oral inhalation no longer
constitute an essential use under the Clean Air Act under the criteria
in Sec.  2.125(g)(1). FDA requested comment concerning its finding that
metered-dose atropine sulfate aerosol human drugs administered by oral
inhalation are no longer marketed in an approved ODS formulation. Under
Sec.  2.125(g)(1), an active moiety may no longer constitute an
essential use (Sec.  2.125(e)) if it is no longer marketed in an
approved ODS formulation. The failure to market indicates
nonessentiality because the absence of a demand sufficient for even one
company to market the product is highly indicative that the use is not
essential. FDA received no comments concerning its finding that
metered-dose atropine sulfate aerosol human drugs administered by oral
inhalation are no longer marketed in an ODS formulation or concerning
its tentative conclusion that these drugs no longer constitute an
essential use of ODSs under the Clean Air Act.
    Accordingly, FDA is amending its regulation to remove sterile
aerosol talc administered intrapleurally by thoracoscopy for human use
(Sec.  2.125(e)(4)(ix)) and to remove metered-dose atropine sulfate
aerosol human drugs administered by oral inhalation (Sec.
2.125(e)(4)(vi)) as essential uses under the Clean Air Act.

II. Direct Final Rulemaking

    FDA has determined that the subject of this rulemaking is suitable
for a direct final rule. FDA is amending Sec.  2.125 to remove
essential-use designations for sterile aerosol talc administered
intrapleurally by thoracoscopy for human use and for metered-dose
atropine sulfate aerosol human drugs administered by oral inhalation.
This rule is intended to make noncontroversial changes to existing
regulations. The Agency does not anticipate receiving any significant
adverse comment on this rule.
    Consistent with FDA's procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
proposed rule. The companion proposed rule and this direct final rule
are substantively identical. The companion proposed rule provides the
procedural framework within which the proposed rule may be finalized in
the event the direct final rule is withdrawn because of any significant
adverse comment. The comment period for this direct final rule runs
concurrently with the comment period of the companion proposed rule.
Any comments received in response to the companion proposed rule will
also be considered as comments regarding this direct final rule.
    FDA is providing a comment period for the direct final rule of 60
days after the date of publication in the Federal Register. If we
receive any significant adverse comment, we intend to withdraw this
direct final rule before its effective date by publishing a notice in
the Federal Register within 30 days after the comment period ends. A
significant adverse comment explains why the rule either would be
inappropriate, including challenges to the rule's underlying premise or
approach, or would be ineffective or unacceptable without a change. In
determining whether an adverse comment is significant and warrants
withdrawing a direct final rule, the Agency will consider whether the
comment raises an issue serious enough to warrant a substantive
response in a notice-and-comment process in accordance with section 553
of the Administrative Procedure Act (5 U.S.C. 553).
    Comments that are frivolous, insubstantial, or outside the scope of
the direct final rule will not be considered significant or adverse
under this procedure. For example, a comment recommending a regulation
change in addition to the changes in the direct final rule would not be
considered a significant adverse comment unless the comment states why
the rule would be ineffective without the additional change. In
addition, if a significant adverse comment applies to an amendment,
paragraph, or section of this rule and that provision can be severed
from the remainder of the rule, FDA may adopt as final the provisions
of the rule that are not the subject of a significant adverse comment.
    If FDA does not receive any significant adverse comment in response
to the direct final rule, the Agency will publish a document in the
Federal Register confirming the effective date of the final rule. The
Agency intends to make the direct final rule effective 30 days after
publication of the confirmation document in the Federal Register.
    A full description of FDA's policy on direct final rule procedures
may be found in a guidance for FDA and industry entitled ``Direct Final
Rule Procedures'' (available on http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm) that was announced in
the Federal Register of November 21, 1997 (62 FR 62466).

III. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the direct final rule under
Executive Order 12866, Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us
to assess all costs and benefits of available regulatory alternatives
and, when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). We have developed a comprehensive Economic Analysis of
Impacts that assesses the impacts of the proposed rule. We believe that
this final rule is not a significant regulatory action as defined by
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. We certify that the direct final rule will not have a
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $146
million, using the most current (2015) Implicit Price Deflator for the
Gross Domestic Product. This direct final rule would not result in an
expenditure in any year that meets or exceeds this amount.

B. Need for the Regulation

    This rule is necessary to comply with the Montreal Protocol under
authority of

Title VI of the Clean Air Act (section 601 et seq.), which banned the
manufacture of ODSs, including CFCs, to reduce the depletion of the
ozone layer in the United States as of January 1, 1996. EPA regulations
exempted from the ban medical devices, diagnostic products, drugs, and
drug delivery systems that FDA considered essential and that are listed
in Sec.  2.125(e) when they use a class I or class II ODS for which no
safe and effective alternative has been developed. The direct final
rule would remove the exemptions for sterile aerosol talc products and
for metered-dose atropine sulfate aerosol human drugs containing ODSs.
    There is currently at least one sterile aerosol talc product not
containing ODSs approved for the administration intrapleurally by
thoracoscopy for human use that is a safe and effective alternative,
and which meets the criteria outlined in Sec.  2.125(g)(3).
Accordingly, the sterile aerosol talc product containing ODSs no longer
meets the requirements for an essential use and should no longer be
exempted from the ban.
    Metered-dose atropine sulfate aerosol human drugs administered by
oral inhalation are no longer available in the product market in an
approved ODS formulation. The current absence of the product in the
market indicates both a lack of demand for the product and that the
product is nonessential, under Sec.  2.125(g)(1). With the adoption of
this direct final rule, the manufacturer of the sterile aerosol talc
with ODSs and any potential future manufacturers of metered-dose
atropine sulfate aerosols will have notice of the requirements to
comply with the ban of products from containing ODSs.

C. Benefits and Costs

1. Number of Affected Entities
    The affected entities covered by this direct final rule are the
manufacturing facilities of the products that would have exemptions
from the ban removed. Only one manufacturer, the Bryan Corporation that
manufactures the sterile aerosol talc product containing ODSs at a
single facility, would be affected. Currently, there are no
manufacturers of metered-dose atropine sulfate aerosols.
2. Costs
    The potential social costs from removing the exemptions are (1) the
costs to patient consumers or to their insurers for paying a higher
price for alternative non-ODS formulations of sterile aerosol talc
products and (2) the costs for disposing of and destroying any
remaining product inventory that remains after the effective date of
the direct final rule. We lack data about the remaining stocks of
product inventory that are likely to remain after the effective date of
the direct final rule and the relative price that consumers or their
insurers would pay. Because significant notice has been given to the
manufacturer about the impending removal of the exemptions, we do not
believe a significant stock of inventory will remain for the sterile
aerosol talc product. The most recent publically available information
shows that the annual revenues for Bryan Corporation are about $10
million (Ref. 1). Public information about this company shows that it
manufactures three different surgical and medical instruments including
the talc. If total profits for the exempt talc product are 10 percent
of the total annual revenues, and if total revenues are exclusively
from the exempt talc, then $1 million represents an upper bound for the
total social cost of removing the sterile aerosol talc product from the
market. Because it is unlikely that their total profits are exclusively
from the sterile aerosol talc, it is more likely that the foregone
profits are at most one-third of the $1 million; in fact, the true
social cost could be significantly less than the total foregone profit
of this product.
    Metered-dose atropine sulfate aerosol human drugs that would be
affected by this rule are no longer marketed; consequently, removal of
the exemption for this product would not present the public, consumers,
insurers, or producers with any costs.
3. Health Benefits
    The direct final rule implements the requirements of the Clean Air
Act that ban the use of products containing ODSs that no longer meet
the requirements for essential use. The social benefits of the direct
final rule derive from greater compliance with the Clean Air Act. The
ODSs that either would have been emitted by sterile aerosol talcs that
contain them, or from potential market entrants that would have
manufactured metered-dose atropine sulfate aerosols that contain ODSs
will no longer be emitting them, which will help reduce the depletion
of the ozone layer and the ultraviolet radiation reaching the Earth. We
lack the ability to quantify the health benefits from the reduced
exposure to and from the reduced risk associated with ultraviolet light
that result from removing the exemptions to the ban. Because the change
in exposure and resulting risk from the final rule is likely to be
small, the incremental health impact is likely to be too small to
measure.

D. Economic Summary

    The direct final rule will remove the exemptions for sterile
aerosol talc products and for metered-dose atropine sulfate aerosol
human drugs containing ODSs. The primary public health benefit from
adoption of the direct final rule is to reduce the depletion of the
ozone layer to decrease human exposure to ultraviolet radiation. The
reduction in exposure to ultraviolet radiation because of the direct
rule is likely to be too small to measure. The potential social costs
of the direct final rule would occur if patient consumers or their
health care insurers would have to pay more for otherwise comparable
products and if the product manufacturers would have to safely destroy
any remaining product inventories after the effective date of the rule.
We estimate that the social cost of the direct final rule is likely to
be significantly less than $1 million but no more than the upper bound
estimate of the foregone annual profit of the company that manufactures
the sterile aerosol talc or $1 million. Because the metered-dose
atropine sulfate aerosol is not currently in the market, there would be
no social cost for removing its exemption from the ban.
    Imposing no new federal requirement is the baseline for a
regulatory analysis. With no new regulation, there are no compliance
costs or benefits to the direct final rule. However, because sterile
aerosol talc is no longer an essential use of ODSs, under the Clean Air
Act, there is no longer a pathway for sterile aerosol talc products
containing ODSs to remain on the market.

IV. Final Regulatory Flexibility Analysis

    FDA has examined the economic implications of the direct final rule
as required by the Regulatory Flexibility Act. If a rule will have a
significant economic impact on a substantial number of small entities,
the Regulatory Flexibility Act requires Agencies to analyze regulatory
options that would lessen the economic effect of the rule on small
entities. We certify that the direct final rule will not have a
significant economic impact on a substantial number of small entities.
This analysis, together with other relevant sections of this document,
serves as the final regulatory flexibility analysis, as required under
the Regulatory Flexibility Act.

V. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

    FDA concludes that this direct final rule contains no collection of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.

VII. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that this final
rule does not contain policies 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. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

VIII. References

    The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at http://www.regulations.gov. FDA has
verified the Web site address as of the date this document publishes in
the Federal Register, but Web sites are subject to change over time.

1. Bryan Corporation (http://listings.findthecompany.com/l/12165972/Bryan-Corporation-in-Woburn-MA, accessed on February 24, 2016).

List of Subjects in 21 CFR Part 2

    Administrative practice and procedure, Cosmetics, Drugs, Foods.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
2 is amended as follows:

PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

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

    Authority: 15 U.S.C. 402, 409; 21 U.S.C. 321, 331, 335, 342,
343, 346a, 348, 351, 352, 355, 360b, 361, 362, 371, 372, 374; 42
U.S.C. 7671 et seq.

Sec.  2.125   [Amended]

0
2. In Sec.  2.125, remove and reserve paragraphs (e)(4)(vi) and (ix).

    Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25851 Filed 10-25-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Proposed Rules]
[Pages 10886-10888]
[FR Doc No: 2021-02480]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-1188; Airspace Docket No. 20-ANE-10]
RIN 2120-AA66

Proposed Amendment of Class D and Class E Airspace, and Proposed
Establishment of Class E Airspace; Worcester, MA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class D airspace, Class E
surface airspace, and Class E airspace extending upward from 700 feet
above the surface for Worcester Regional Airport, Worcester, MA, as an
airspace evaluation of the area determined additional airspace is
necessary. Also, this action proposes to establish Class E airspace
extending upward from 700 feet above the surface for UMass Memorial
Medical Center-University Campus Heliport, to accommodate new area
navigation (RNAV) global positioning system (GPS) standard instrument
approach procedures (SIAPs) serving this heliport. Controlled airspace
is necessary for the safety and management of instrument flight rules
(IFR) operations in the area.

DATES: Comments must be received on or before April 9, 2021.

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 20590-0001;
Telephone:<PHONE_NUMBER>, or<PHONE_NUMBER>. You must identify the
Docket No. FAA-2020-1188; Airspace Docket No. 20-ANE-10, at the
beginning of your comments. You may also submit comments through the
internet at https://www.regulations.gov.
    FAA Order 7400.11E Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://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 7400.11E at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; Telephone<PHONE_NUMBER>.

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
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 amend Class D and Class E airspace, and establish Class E
airspace in Worcester, MA, to support IFR operations in the area.

Comments Invited

    Interested persons are invited to comment on 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 (Docket No. FAA-
2020-1188 and Airspace Docket No. 20-ANE-10) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for the
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Persons 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-2020-1188; Airspace Docket No. 20-ANE-10.'' The postcard
will be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this document may be changed in light of the
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 https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://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 the 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 between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays at the office
of the Eastern Service Center, Federal Aviation Administration, Room
350, 1701 Columbia Avenue, College Park, GA 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11E, Airspace
Designations and Reporting Points, dated July 21, 2020, and effective
September 15, 2020. FAA Order 7400.11E is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11E lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA proposes an amendment to 14 CFR part 71 to amend Class D
and Class E surface airspace, for Worcester Regional Airport (formerly
Worcester Municipal Airport), Worcester, MA. An airspace evaluation of
the area determined the Class D and Class E surface area radii required
an increase to 5.1 miles (from 4.2 miles). Also, the airport's Class E
airspace extending upward from 700 feet above the surface would be
increased to a 7.6-mile radius (from 6.7 miles). This action would also
update the airport's name. In addition, the FAA proposes to establish
Class E airspace extending upward from 700 feet above the surface for
UMass Memorial Medical Center-University Campus Heliport, Worcester,
MA, providing the controlled airspace required to support the new RNAV
(GPS) standard instrument approach procedures for IFR operations at the
heliport. This action would also replace the outdated term Airport/
Facility Directory with the term Chart Supplement in the legal
description of associated Class D and Class E airspace.
    Class D and E airspace designations are published in Paragraphs
5000, 6002, and 6005, respectively of FAA Order 7400.11E, dated July
21, 2020, and effective September 15, 2020, which is incorporated by
reference in 14 CFR 71.1. The Class E airspace designations listed in
this document will be published subsequently in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

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 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.

Lists 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 Federal Aviation
Administration Order 7400.11E, Airspace Designations and Reporting
Points, dated July 21, 2020, and effective September 15, 2020, is
amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ANE MA D Worcester, MA [Amended]

Worcester Regional Airport, MA
    (Lat. 42[deg]16'02'' N, long. 71[deg]52'32'' W)
Spencer Airport, MA
    (Lat. 42[deg]17'26'' N, long. 71[deg]57'53'' W)

    That airspace extending upward from the surface to and including
3,500 feet MSL within a 5.1-mile radius of Worcester Regional
Airport, excluding that airspace from the surface up to but not
including 1,900 feet MSL within a 1-mile radius of the Spencer
Airport. This Class D airspace area is effective during the specific
dates and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Chart Supplement.

Paragraph 6002 Class E Surface Airspace.

* * * * *

ANE MA E2 Worcester, MA [Amended]

Worcester Regional Airport, MA
    (Lat. 42[deg]16'02'' N, long. 71[deg]52'32'' W)

    That airspace extending upward from the surface within a 5.1-
mile radius of Worcester Regional Airport. This Class E airspace
area is effective during the specific dates and times established in
advance by a Notice to Airmen. The effective date and time will
thereafter be continuously published in the Chart Supplement.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANE MA E5 Worcester, MA [Amended]

Worcester Regional Airport, MA
    (Lat. 42[deg]16'02'' N, long. 71[deg]52'32'' W)
UMass Memorial Medical Center-University Campus Heliport
    (Lat. 42[deg]16'30'' N, long. 71[deg]45'36'' W)

    That airspace extending upward from 700 feet above the surface
within a 7.6-mile radius of Worcester Regional Airport, and within a
6-mile radius of UMass Memorial Medical Center-University Campus
Heliport.

    Issued in College Park, Georgia, on February 2, 2021.
Andreese C. Davis,
Manager, Airspace & Procedures Team South, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2021-02480 Filed 2-22-21; 8:45 am]
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[Federal Register Volume 87, Number 216 (Wednesday, November 9, 2022)]
[Notices]
[Pages 67680-67681]
[FR Doc No: 2022-24441]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD22-10-000]

Reliability Technical Conference; Third Supplemental Notice of
Technical Conference

    As announced in the Notices of Technical Conference issued in this

proceeding on August 23, 2022, October 4, 2022, and October 28, 2022,
the Federal Energy Regulatory Commission (Commission) will convene its
annual Commissioner-led Reliability Technical Conference in the above-
referenced proceeding on Thursday, November 10, 2022, from
approximately 12:00 p.m. to 5:00 p.m. Eastern time. The conference will
be held in-person at the Commission's headquarters at 888 First Street
NE, Washington, DC 20426 in the Commission Meeting Room.
    The purpose of this conference is to discuss policy issues related
to the reliability and security of the Bulk-Power System.
    The conference will be open for the public to attend, and there is
no fee for attendance. Information about this technical conference can
be found on the Events Calendar on the Commission's website,
www.ferc.gov. The conference will also be transcribed. Transcripts will
be available for a fee from Ace Reporting,<PHONE_NUMBER>.
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to [email protected], call toll-free<PHONE_NUMBER>
(voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER> with
the required accommodations.
    For more information about this technical conference, please
contact Lodie White at [email protected] or<PHONE_NUMBER>. For
information related to logistics, please contact Sarah McKinley at
[email protected] or<PHONE_NUMBER>.

    Dated: November 3, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-24441 Filed 11-8-22; 8:45 am]
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