[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48716-48718]
[FR Doc No: 2022-17100]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95424; File No. SR-NYSEAMER-2022-19]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing of Amendment No. 1 and Order Granting Accelerated Approval of
Proposed Rule Change, as Modified by Amendment No. 1, To Add
Subparagraph (f)(4) Regarding Directed Orders to NYSE American Rule
7.31E

August 4, 2022.

I. Introduction

    On April 20, 2022, NYSE American LLC (``NYSE American'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to introduce Directed Orders. The proposed rule
change was published for comment in the Federal Register on May 3,
2022.\3\ On June 16, 2022, the Commission extended to August 7, 2022,
the time period in which to approve the proposal, disapprove the
proposal, or institute proceedings to determine whether to approve or
disapprove the proposal.\4\ On July 28, 2022, the Exchange filed
Amendment No. 1 to the proposed rule change with the Commission and
submitted Amendment No. 1 for inclusion in the public comment file.\5\
The Commission is publishing notice of the filing of Amendment No. 1 to
solicit comment from interested persons, and is approving the proposed
rule change, as modified by Amendment No. 1, on an accelerated
basis.\6\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 94840 (May 3, 2022),
87 FR 27677 (May 9, 2022) (SR-NYSEAMER-2022-19) (``Notice'').
    \4\ See Securities Exchange Act Release No. 95117 (June 16,
2022), 87 FR 37543 (June 23, 2022).
    \5\ In Amendment No. 1, the Exchange: (i) represents that
Directed Orders will not be routed to an ATS with which the Exchange
has a financial arrangement; and (ii) updates the anticipated
implementation date of the proposed rule change from the second
quarter to the third quarter of 2022. See Letter from Martha
Redding, Associate General Counsel, NYSE American LLC, to Secretary,
Commission (July 28, 2022). Amendment No. 1 is available at https://www.sec.gov/comments/sr-nyseamer-2022-19/srnyseamer202219-20135100-306080.pdf.
    \6\ The Commission received one comment letter that is not
germane to the proposal. See https://www.sec.gov/comments/sr-nyseamer-2022-19/srnyseamer202219-289426.htm.
---------------------------------------------------------------------------

II. Self-Regulatory Organization's Description of the Proposal, as
Modified by Amendment No. 1

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

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

1. Purpose
    The Exchange proposes to modify Rule 7.31E (Orders and Modifiers)
to add new subparagraph (f)(4) to provide for Directed Orders and to
make other conforming changes to its Rules in connection with the
addition of this new order type on the Exchange. The Directed Order, as
further defined below, would be an order sent to the Exchange to be
routed directly to an alternative trading system (``ATS'') specified by
an ATP Holder.\7\
---------------------------------------------------------------------------

    \7\ Directed Orders will not be routed to an ATS with which the
Exchange has a financial arrangement.
---------------------------------------------------------------------------

    The Exchange proposes to add Rule 7.31E(f)(4), which would define a
Directed Order as a Limit Order with instructions to route on arrival
at its limit price to a specified ATS with which the Exchange maintains
an electronic linkage. Proposed Rule 7.31E(f)(4) would further provide
that Directed Orders would be available for all securities eligible to
trade on the Exchange. Proposed Rule 7.31E(f)(4) would also provide
that a Directed Order would not be assigned a working time or interact
with interest on the Exchange Book. The Exchange also proposes to
provide in Rule 7.31E(f)(4) that the ATS to which a Directed Order is
routed would be responsible for validating whether the order is
eligible to be accepted, and if such ATS determines to reject the
order, the order would be cancelled.
    Proposed Rule 7.31E(f)(4)(A) would provide that a Directed Order
must be designated for the Exchange's Core Trading Session, as defined
in Rule 7.34E(a)(2).\8\
---------------------------------------------------------------------------

    \8\ Because the Exchange proposes that Directed Orders may only
be designated for the Core Trading Session, the Exchange also
proposes conforming changes to Rule 7.34E (Trading Sessions).
Specifically, the Exchange proposes to modify Rule 7.34E(c)(1)(E) to
provide that Directed Orders designated for the Early Trading
Session would be rejected and Rule 7.34E(c)(3)(C) to provide that
Directed Orders designated for the Late Trading Session would be
rejected. The Exchange also proposes an additional change to correct
a typographical error in Rule 7.34E(c)(1), to update the reference
to ``paragraphs (c)(1)(A)-(E)'' to ``paragraphs (c)(1)(A)-(F)'' to
accurately reflect the number of subparagraphs under Rule
7.34E(c)(1).
---------------------------------------------------------------------------

    Proposed Rule 7.31E(f)(4)(A) would further provide that a Directed
Order must be designated with a Time in Force modifier of IOC \9\ or
Day \10\ and would be routed to the specified ATS with such modifier.
The Exchange proposes that a Directed Order designated IOC would be
traded in whole or in part on the ATS to which it is routed after
receipt of the order, and any untraded quantity would be cancelled. The
Exchange proposes that a Directed Order designated Day would expire at
the end of the Core Trading Session on the day it is entered. Proposed
Rule 7.31E(f)(1)(A) would also provide that a Directed Order may not be
designated with any other modifiers defined in Rule 7.31E.
---------------------------------------------------------------------------

    \9\ See Rule 7.31E(b)(2), which provides that a Limit Order may
be designated with an Immediate-or-Cancel (``IOC'') modifier.
    \10\ See Rule 7.31E(b)(1), which provides that orders may be
designated with a Day modifier, and that an order to buy or sell
designated Day, if not traded, will expire at the end of the
designated session on the day on which it was entered.
---------------------------------------------------------------------------

    Proposed Rule 7.31E(f)(4)(B) would provide that a Directed Order in
a security that is having its initial listing on the Exchange would be
rejected if received before the IPO Auction concludes.
    Proposed Rule 7.31E(f)(4)(C) would provide that, during a trading
halt or pause, an incoming Directed Order would be rejected.
    Proposed Rule 7.31E(f)(4)(D) would provide that a request to cancel
a Directed Order designated Day would be routed to the ATS to which the
order was routed.
    The Exchange also proposes a conforming change to Rule 7.19E (Pre-
Trade Risk Controls). The Exchange proposes to modify Rule 7.19E(a)(5),
which sets forth the definition of Gross Credit Risk Limit and
currently provides that unexecuted orders in the Exchange Book, orders
routed on arrival pursuant to Rule 7.37E(a)(1), and executed orders are
included for purposes of calculating the Gross Credit Risk Limit. The
Exchange proposes to modify Rule 7.19E(a)(5) to specify that orders
routed on arrival pursuant to Rule 7.31E(f)(4) would also be included
for purposes of the Gross Credit Risk Limit calculation.
    The Exchange believes that the proposed rule change would
facilitate additional trading opportunities by

offering ATP Holders the ability to designate orders submitted to the
Exchange to be routed to an ATS of their choosing for execution. The
Exchange believes the proposed change would encourage ATP Holders to
utilize the Exchange as a venue for order entry and further believes
that the proposed change could create efficiencies for ATP Holders by
enabling them to send orders that they wish to route to an alternate
destination through the Exchange, thereby enabling them to leverage
order entry protocols and specifications already configured for their
interactions with the Exchange. The Exchange notes that the Directed
Order, as proposed, would operate similarly to the Primary Only Order
already offered by the Exchange, which is an order that is routed
directly to the primary listing market on arrival, without being
assigned a working time or interacting with interest on the Exchange
Book.\11\ The Exchange also believes that the Directed Order would
offer ATP Holders functionality akin to order types and routing options
that currently exist on other equities exchanges.\12\
---------------------------------------------------------------------------

    \11\ See Rule 7.31E(f)(1). NYSE American also offers variations
of the Primary Only Order, including the Primary Only Until 9:45
Order, which is a Limit or Inside Limit Order that, on arrival and
until 9:45 a.m. Eastern Time, routes to the primary listing market,
and the Primary Only Until 3:55 Order, which is a Limit or Inside
Limit Order entered on the Exchange until 3:55 p.m. Eastern Time,
after which time the order is cancelled on the Exchange and routed
to the primary listing market. See Rules 7.31E(f)(2) and (f)(3). The
Exchange's affiliated exchanges NYSE Arca, Inc. (``NYSE Arca''),
NYSE Chicago, Inc. (``NYSE Chicago''), and NYSE National, Inc.
(``NYSE National'') (collectively, the ``Affiliated Exchanges'')
also offer the Primary Only Order and variations thereof. See NYSE
Arca Rules 7.31-E(f)(1)-(f)(3); NYSE Chicago Rules 7.31(f)(1)-
(f)(3); NYSE National Rules 7.31(f)(1)-(f)(3).
    \12\ See, e.g., Nasdaq Stock Market LLC (``Nasdaq''), Equity 4,
Equity Trading Rules, Rule 4758(a)(ix) (defining the Nasdaq Directed
Order as an order designed to use a routing strategy under which the
order is directed to an automated trading center other than Nasdaq,
as directed by the entering party, without checking the Nasdaq
Book); Cboe EDGX Exchange, Inc. (``EDGX'') Rules 11.8(c)(7)
(defining the Routing/Directed ISO order type as an ISO that
bypasses the EDGX system and is immediately routed by EDGX to a
specified away trading center for execution) and 11.11(g)(2)
(providing for the DRT routing option, in which an order is routed
to an alternative trading system as instructed); Cboe EDGA Exchange,
Inc. (``EDGA'') Rules 11.8(c)(7) (defining the Routing/Directed ISO
order type as an ISO that bypasses the EDGA system and is
immediately routed by EDGA to a specified away trading center for
execution) and 11.11(g)(2) (providing for the DRT routing option, in
which an order is routed to an alternative trading system as
instructed); Cboe BZX Exchange, Inc. (``BZX'') Rules 11.13(b)(3)(D)
(providing for the DRT routing option, in which an order is routed
to an alternative trading system as instructed) and 11.13(b)(3)(F)
(defining the Directed ISO routing option, under which an ISO order
would bypass the BZX system and be sent to a specified away trading
center); Cboe BYX Exchange, Inc. (``BYX'') Rules 11.13(b)(3)(D)
(providing for the DRT routing option, in which an order is routed
to an alternative trading system as instructed) and 11.13(b)(3)(F)
(defining the Directed ISO routing option, under which an ISO order
would bypass the BYX system and be sent to a specified away trading
center). The Exchange also believes that the Directed Order would
provide functionality similar to the C-LNK routing strategy formerly
offered by EDGA, in which C-LNK orders bypassed EDGA's local book
and routed directly to a specified Single Dealer Platform
destination. See Securities Exchange Act Release No. 82904 (March
20, 2018), 83 FR 12995 (March 26, 2018) (SR-CboeEDGA-2018-004)
(Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change To Expand an Offering Known a Cboe Connect To Provide
Connectivity to Single-Dealer Platforms Connected to the Exchange's
Network and To Propose a Per Share Executed Fee for Such Service).
---------------------------------------------------------------------------

    Because of the technology changes associated with this proposed
rule change, the Exchange will announce the implementation date by
Trader Update.\13\ Subject to effectiveness of this proposed rule
change, the Exchange anticipates that the proposed change will be
implemented in the third quarter of 2022.
---------------------------------------------------------------------------

    \13\ The Exchange will also provide information regarding the
ATS(s) to which a Directed Order may be designated to route by
Trader Update.
---------------------------------------------------------------------------

2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934,\14\ in general, and furthers the
objectives of Section 6(b)(5),\15\ in particular, because it is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in facilitating transactions in
securities, to remove impediments to, and perfect the mechanism of, a
free and open market and a national market system and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

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

    The Exchange believes that the proposed rule change is designed to
remove impediments to and perfect the mechanism of a free and open
market and promote just and equitable principles of trade because the
Directed Order would offer ATP Holders access to additional trading
opportunities by permitting them to designate orders submitted to the
Exchange to be routed directly to a specified ATS for execution. The
Exchange further believes that the proposed change would remove
impediments to and perfect the mechanism of a free and open market by
offering ATP Holders the option to send orders that they wish to route
to an alternate destination for execution through the Exchange, which
would create efficiencies to the extent ATP Holders are able to
leverage existing protocols and specifications. Finally, the Exchange
notes that the proposed functionality is not novel, as both the
Exchange and other exchanges offer their members functionality whereby
an exchange routes orders on behalf of a member to a specified trading
center without such order interacting with the exchange's book.\16\
---------------------------------------------------------------------------

    \16\ See notes 11 & 12, supra.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposed rules governing Directed Orders would promote competition
because they would provide for an order type on the Exchange that would
facilitate additional trading opportunities for market participants.
The Exchange further believes that the proposed rules would allow it to
offer ATP Holders functionality similar to order types and routing
options that exist on other equities exchanges, thereby enabling the
Exchange to compete with such exchanges.\17\
---------------------------------------------------------------------------

    \17\ See note 12, supra.
---------------------------------------------------------------------------

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

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

III. Discussion and Commission Findings

    After careful review of the proposal, the Commission finds that the
proposed rule change, as modified by Amendment No. 1, is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\18\ In
particular, the Commission finds that the proposed rule change, as
modified by Amendment No. 1, is consistent with Section 6(b)(5) of the
Act,\19\ which requires, among other things, that the rules of a
national securities exchange be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to

remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general, to protect
investors and the public interest, and that the rules of a national
securities exchange not be designed to permit unfair discrimination
between customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \18\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \19\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission finds that the proposed rule change is reasonably
designed to remove impediments to and perfect the mechanism of a free
and open market and a national market system because it would provide
ATP Holders with additional trading opportunities by providing them
with the option to designate orders to be routed by the Exchange
directly to a specified ATS for execution. The use of Directed Orders
would be voluntary, and the Exchange represents that it would not
direct orders to any ATSs with which the Exchange has a financial
relationship. The Commission also believes that the proposed rule
change would not permit unfair discrimination among customers, brokers,
or dealers because Directed Orders will be available to all ATP Holders
on an equal basis. Finally, the Commission believes that the proposed
changes to Exchange Rule 7.19E(a)(5) will ensure that Directed Orders
are included in the calculation of Gross Credit Risk Limit.

IV. Solicitation of Comments on Amendment No. 1 to the Proposed Rule
Change

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether Amendment No. 1
is consistent with the Act. Comments may be submitted by any of the
following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEAMER-2022-19 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEAMER-2022-19. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street, NE, Washington,
DC 20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting 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-NYSEAMER-2022-19 and should be submitted
on or before August 31, 2022.

V. Accelerated Approval of Amendment No. 1

    As noted above,\20\ in Amendment No. 1, as compared to the original
proposal,\21\ the Exchange: (i) represents that Directed Orders will
not be routed to an ATS with which the Exchange has a financial
arrangement; and (ii) updates the anticipated implementation date of
the proposed rule change from the second quarter to the third quarter
of 2022. The Commission finds that Amendment No. 1 to the proposal
raises no novel regulatory issues, that it is reasonably designed to
protect investors and the public interest, and that it is consistent
with the requirements of the Act. Accordingly, the Commission finds
good cause, pursuant to Section 19(b)(2) of the Act,\22\ to approve the
proposed rule change, as modified by Amendment No. 1, on an accelerated
basis.
---------------------------------------------------------------------------

    \20\ See supra note 5.
    \21\ See Notice, supra note 3.
    \22\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

VI. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\23\ that the proposed rule change (SR-NYSEAMER-2022-19), as
modified by Amendment No. 1, be, and hereby is, approved on an
accelerated basis.
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78s(b)(2).
    \24\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-17100 Filed 8-9-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 122 (Tuesday, June 25, 2013)]
[Notices]
[Pages 38023-38024]
[FR Doc No: 2013-15068]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL13-74-000]

Demand Response Supporters v. New York Independent System
Operator, Inc.; Notice of Complaint

    Take notice that on June 17, 2013, pursuant to section 206 of the
Federal Power Act, 16 USC 824(e) and Rule 206 of the Rules of Practice
and Procedure of the Federal Energy Regulatory Commission (Commission),
18 CFR 385.206, Demand Response Supporters (Complainant) filed a formal
complaint against New York Independent System Operator, Inc. (NYISO or
Respondents), seeking an order requiring NYISO to amend its tariffs to
allow demand

response facilitated by behind-the-meter generation to be compensated
at full Locational Marginal Price, as more fully discussed in the
complaint.
    The complainant certifies that copies of the complaint were served
on the contacts for the Respondent as listed on the Commission's list
of Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on July 8, 2013.

    Dated: June 18, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-15068 Filed 6-24-13; 8:45 am]
BILLING CODE 6717-01-P


Technical Support Document for EPA Proposal on Oklahoma State
Implementation Plan Revisions for Interstate Transport of Pollution,
Prevention of Significant Deterioration, Nonattainment New Source
Review, Source Registration and Emissions Reporting, and Rules of
Practice and Procedure

Background

Clean Air Act Section 110(a)(2)(D)(i)

On July 18, 1997, EPA promulgated new NAAQS for 8-hour ozone and for
fine particulate matter (PM2.5).  Section 110(a)(1) of the CAA requires
states to submit SIPs to address a new or revised NAAQS within 3 years
after promulgation of such standards, or within such shorter period as
EPA may prescribe.  Section 110(a)(2) lists the elements that such new
SIPs must address, as applicable, including section 110(a)(2)(D)(i),
which pertains to interstate transport of certain emissions.  On August
15, 2006, EPA issued its “Guidance for State Implementation Plan (SIP)
Submission to Meet Current Outstanding Obligations Under Section
110(a)(2)(D)(i) for the 8-Hour Ozone and PM2.5 National Ambient Air
Quality Standards” (2006 Guidance).  EPA developed the 2006 Guidance
to make recommendations to states for making submissions to meet the
requirements of section 110(a)(2)(D)(i) for the 1997 8-hour ozone
standards and the 1997 PM2.5  standards.

As identified in the 2006 Guidance, the “good neighbor” provisions
in section 110(a)(2)(D)(i) require each state to submit a SIP that
prohibits emissions that adversely affect another state in the ways
contemplated in the statute.  Section 110(a)(2)(D)(i) contains four
distinct requirements related to the impacts of interstate transport.
The SIP must prevent sources in the state from emitting pollutants in
amounts which will:  (1) contribute significantly to nonattainment of
the NAAQS in other states; (2) interfere with maintenance of the NAAQS
in other states; (3) interfere with provisions to prevent significant
deterioration of air quality in other states; or (4) interfere with
efforts to protect visibility in other states.

In EPA's November 29, 2005, Phase 2 rule for the 1997 8-hour ozone NAAQS
(70 FR 71612), EPA called for States to modify their Prevention of
Significant Deterioration (PSD) program to address NOx as an ozone
precursor.  The Federal requirements to address NOx as an ozone
precursor and the current CFR citation are as follows:

•	Identify NOx as an ozone precursor (40 CFR 51.166(b)(49)(i)(a))

•	A Major source that is major for NOx shall be major for ozone (40
CFR 51.166(b)(1)(ii))

•	Significant means, in reference to a net emissions increase or
potential to emit, a rate of emissions that equals or exceeds 40 tons
per year of NOx (40 CFR 51.166(b)(23))

•	Any net emissions increase of 100 tons per year of NOx subject to
PSD would require an ambient impact analysis, including the gathering of
air quality data (40 CFR 51.166(i)(5)(i)(e))

In the August 15, 2006 EPA Guidance EPA stated that:

•	States are not required to submit PSD and Nonattainment New Source
Review (NNSR) program SIPs for PM2.5 until EPA completes regulations
establishing the minimum requirements for New Source Review programs for
PM2.5 and finalizes the submission schedule

•	Until the submission date is established in EPA's final PM2.5
implementation rule for New Source Review (NSR), states may continue to
implement interim programs based on PM10 and need not provide PSD or
NNSR program submissions containing rule changes for PM2.5.

Because of Court decisions and EPA decisions on petitions concerning
this issue, EPA requested States such as Oklahoma to clarify how they
are implementing the PM2.5 NAAQS.  (For more information please see the
EPA Order responding to Petition No. IV-2008-3, which concerns the
Louisville Gas and Electric Company Title V/PSD Air Quality Permit.
This order can be found in electronic docket EPA-R06-OAR-2009-0656.)

This TSD addresses the requirement that the Oklahoma SIP prevent sources
in the state from emitting pollutants in amounts which will interfere
with provisions to prevent significant deterioration of air quality in
other states.  Separately, we have proposed to limit the interstate
transport of NOx emissions from Oklahoma that affect the ability of
downwind states to attain and maintain compliance with the 1997 ozone
NAAQS pursuant to CAA 110(a)(2)(D)(i)(I) (75 FR 45210, August 2, 2010).

May 1, 2007 Submittal

On May 1, 2007, we received a SIP revision from the State of Oklahoma
intended to address the interstate transport requirements of section
110(a)(2)(D)(i) for both the 1997 8-hour ozone standards and 1997 PM2.5
standards.  In its submission, the State of Oklahoma stated that its New
Source Review program for major sources satisfies the requirement that
pertains to preventing sources in Oklahoma from emitting pollutants that
will interfere with measures required to prevent significant
deterioration of air quality in other states.

For the PM2.5 NAAQS, Oklahoma stated in its section 110(a)(2)(D)(i)
submission that its NSR program includes an interim PSD permitting
program for PM2.5.  On July 29, 2010 the Oklahoma Department of
Environmental Quality sent a letter to EPA clarifying its implementation
of the implementation the PM2.5 NAAQS.  The letter is further discussed
below.

June 24, 2010 Submittal

On June 24, 2010 Oklahoma submitted additional revisions to Subchapter 8
in OAC 252:100 (Permits for Part 70 Sources).  These included revisions
to the Oklahoma PSD regulations necessary to address NOx as a precursor
for the 1997 8-hour ozone NAAQS (PSD Requirements for Attainment Areas,
OAC 252:100-8).  The submittal also includes revisions to: Definitions
(for General Provisions, OAC 252:100-8-1.1), Definitions (for Part 70
Sources, OAC 252:100-8-2), Requirements for construction and operating
permits (OAC 252:100-8-4), Permit applications (OAC 252:100-8-5), Permit
content (OAC 252:100-8-6), General permits (OAC 252:100-8-6.1), Special
provisions for affected (acid rain) sources (OAC 252:100-8-6.3), Permit
review by EPA and affected states (OAC 252:100-8-8), Applicability (OAC
252:100-8-30) and the definition of major stationary source found in OAC
252:100-8-31.  At this EPA is proposing to only act on the portion of
the June 24, 2010 submittal that addresses NOx as an ozone precursor.

February 14, 2002 Submittal

On February 14, 2002 Oklahoma submitted revisions to its State
Implementation Plan (SIP).  The revisions affect Title 252 of the
Oklahoma Administrative Code (OAC 252), the official compilation of
agency rules and executive orders for the State of Oklahoma.

EPA approved portions of the February 14, 2002 submittal on December 29,
2008 (73 FR 79400).  At that time, we took no action on:

•	Chapter 4 (Rules of Practice and Procedure): Subchapters 1 (General
Procedures), Subchapter 7 (Environmental Permit Process), and Appendix C
(Permitting Process Summary);

•	Chapter 100 (Air Pollution Control): Subchapter 5 (Registration,
Emission Inventory and Annual Operating Fees), Subchapter 7 (Permits for
Minor Sources), Subchapter 8 (Permits for Part 70 Sources), Subchapter 9
(Excess Emissions Reporting Requirements), and Appendices H, I and J.

On July 16, 2010 the state submitted a letter to EPA withdrawing their
2002 submittal for Subchapter 9 (Excess Emissions Reporting
Requirements).

The portion of the 2002 revision being considered for approval relate
to:

•	Prevention of Significant Deterioration (PSD) and Nonattainment New
Source Review (NNSR) for major sources (Chapter 100, Subchapter 8,
Permits for Part 70 Sources),

•	Source registration and emissions reporting, (Chapter 100,
Subchapter 5, Registration, Emission Inventory and Annual Operating
Fees), and

•	Other rules of practice and procedure, except for revisions relating
to minor sources (Chapter 4, Subchapter 1 (General Provisions),
Subchapter 7 (Environmental Permit Process) and Appendix C.

We are not proposing action on revisions submitted for Minor Source New
Source Review (NSR) SIP purposes.  These are:

•	The portion of “Availability of a record” found in OAC
252:4-1-5(a), (Chapter 4, Subchapter 1) that relates to minor sources,

•	Portions of Chapter 4, Subchapter 7 (Environmental Permit Process),
Part 1 (The Process, OAC 252:4-7, Part 1) and Part 3 (Air Quality
Division Tiers and Time Lines, OAC 252:4-7, Part 3) that relate to minor
sources),

•	The Tier I minor source category column found in Appendix C of
Chapter 4.

•	The definition for minor facility found in OAC 252:100-5-1.1
(Chapter 100),

•	Chapter 100, Subchapter 7 (Permits for Minor Sources, OAC
252:100-7), and

•	Chapter 100, Appendices H (De Minimis Facilities), I (Insignificant
Activities (Registration) List, and J (Trivial Activities (De Minimis)
List).

We intend to address the revisions related to minor sources at a later
time.

The revisions are further discussed below.

A. OAC 252:4, Rules of Practice and Procedure; and Appendix C.

Oklahoma included a new Chapter 4 (Rules of Practice and Procedure) and
which provides administrative procedures for permit issuance, public
notice, and administrative proceedings.  Chapter 4 was adopted by the
State to meet the requirements of the Oklahoma Administrative Procedures
Act, which requires each agency to adopt rules describing its
organization, method of operation and methods by which the public may
obtain or provide information to the agency.  These rules also specify
the requirements of all formal and informal procedures available,
including a description of forms and instructions.

Subchapter 1 (General Provisions) includes the practices and procedures
of the Environmental Quality Board, Advisory Councils, and the
Department of Environmental Quality; the availability of records; and
fees for copying, faxing, records search and mail services.

Subchapter 7 (Environmental Permit Process) is new and includes Part 1
(The Process) and Part 3 (Air Quality Division Tiers and Time Lines).
Representative sections of Part 1 include 252:4-7-2 (Preamble),
252:4-7-13 (Notices) and 252:4-7-15 (Permit issuance or denial) and are
briefly discussed below.

The Preamble to Subchapter 7 is the introductory section, referencing
the Uniform Environmental Permitting Act (UEPA), which requires that DEQ
fit licenses, permits, certificates, approvals and registrations into a
category, or Tier, established under the uniform environmental
permitting rules. The UEPA was created to streamline the permitting
process and is located in Oklahoma Statute Title 27A Environment and
Natural Resources, Chapter 2 Oklahoma Environmental Quality Code,
Sections 1 through 12.  Tier I, (which are not proposed for approval),
are administrative decisions made by a technical supervisor without
public participation, aside from the landowner. Tier II are
administrative decisions made by the Division Director with little
public participation, including notice to the public, the opportunity
for a public meeting and public comment. Tier III are administrative
decisions made by the Executive Director with extensive public
participation, i.e., an administrative evidentiary hearing.

Appendix C of Chapter 4 is the Permitting Process Summary, which lists
the permit processing steps required under each of the three Tiers.  EPA
is not proposing to approve the Tier I processing steps in the Appendix.

B.  OAC 252:100, Air Pollution Control; and Appendices H, I and J.

Chapter 100 (Air Pollution Control) in part provides details regarding
permitting fees, permitting for minor facilities, permitting for Part 70
Sources, and PSD requirements and major sources.

Subchapter 5 (Registration, Emission Inventory and Annual Operating
Fees) includes three separate revisions.  The first revision to
Subchapter 5 was adopted by Oklahoma in 1998 and includes requirements
to file an emission inventory, formerly located in Subchapter 7;
requirements to pay annual operating fees, formerly located in
Subchapters 7 and 8; and increases to the annual operating fees for
minor facilities and non-Part 70 sources.

The second revision to Subchapter 5 was adopted by Oklahoma in 1999, to
modify the base annual operating fee for minor facilities and the annual
operating fee for Part 70 sources.

The third revision to Subchapter 5 was adopted by Oklahoma in 2000, to
allow the agency to bill annual operating fees on a flexible schedule;
edits define billing dates and identify how errors will be handled.  The
changes allow fees to be based on the most recent emissions data and
require inventories to be submitted prior to March 1.  Miscellaneous
edits delete redundant text and clarify.

EPA is not taking action on Subchapter 7 (Permits for minor facilities).
 A number of revisions to Subchapter 7 were included with the 2002
submission.

Subchapter 8 (Permits for Part 70 Sources) contains the provisions for
NSR and construction permit programs for Part 70 sources.  The State
reasoned that it would be difficult to separate these rules into Title V
and SIP rules without omitting essential requirements, and includes
these rules in the submittal. The February 14, 2002 submittal revises
100-8: Parts 1 (General Provisions), 5 (Permits for Part 70 Sources), 7
(PSD Requirements for Attainment Areas), and 9 (Major Sources Affecting
Nonattainment Areas).   These sections include general information,
including eligibility criteria for general and individual permits;
sources subject to the permit requirements and permit contents;
administrative requirements, including format, transmission of
information, review and petitions; applicability of new sources to NSR
requirements; demonstration of best available control technology and
evaluation of air quality impact.  Finally, Oklahoma is adding a section
for the construction of major sources affecting nonattainment areas.
Oklahoma does not have areas designated as nonattainment at this time.
Should area(s) become designated as nonattainment for a regulated air
pollutant in the future, this part would become applicable.

EPA is not taking action on Appendix H (De Minimis Facilities).  It is
new to the SIP and is referenced in Section 252:100-7-1.1.  Appendix H
lists the facilities that qualify under De Minimis, such as agricultural
(lawn care), woodworking (portable wood chipping operations),
office/janitorial, and cleaning/surface preparation (cold degreasing
operations).  Appendix H meets 40 CFR 51.160.

EPA is not taking action on Appendix I (Insignificant Activities
(Registration) List).  It is new to the SIP and is referenced in Section
252:100-8-2.  Appendix I lists the facilities that qualify under
Insignificant Activities, such as combustion equipment (stationary
reciprocating engines used exclusively for emergency power generation or
peaking power service, not more than 500 hours/year), storage
tanks/distribution (not more than 10,000 gallons capacity that store
volatile organic liquids), and equipment (alkaline/phosphate washers and
associated burners, and cold degreasing operations).   Appendix I meets
40 CFR 51.160.

EPA is not taking action on Appendix J (Trivial Activities (De Minimis)
List).  It is new to the SIP and is referenced in Section 252:100-8-2.
Appendix J lists the facilities that qualify under Trivial Activities
criteria, such as agricultural (non-commercial lawn care), cooling
towers/boiler water (water treatment operations), fugitive emissions
(roof coating, service, and repair), and wastewater (removal of basic
sediment and water from collection or storage systems).  Appendix J
meets 40 CFR 51.160 and strengthens the SIP.

The State also marked rule text for exclusion from the SIP revisions.
These are listed on page 3 of the introduction submitted to EPA.
Generally, the text applied to either:

•	Toxic air pollutants not addressed by the SIP,

•	Rules that do not apply to air matters (i.e. Clean Water Act
permits),

•	Minor permit application fees, and

•	Certain OAC references.

Evaluation of Oklahoma SIP Revisions

Oklahoma SIP for Prevention of Interference with PSD Provisions in Other
States and Revisions to Address NOx as an Ozone Precursor (SIP Revisions
Submitted May 1, 2007 and June 24, 2010 and July 29, 2010 Letter)

As noted above, the third element of section 110(a)(2)(D)(i) requires a
SIP to contain adequate provisions prohibiting emissions that interfere
with any other state's required measures to prevent significant
deterioration of its air quality.  EPA’s 2006 Guidance made
recommendations for SIP submissions to meet this requirement with
respect to both the 1997 8-hour ozone NAAQS and the 1997 PM2.5 NAAQS.

Oklahoma’s May 1, 2007 interstate transport submission is consistent
with the 2006 Guidance, when considered in conjunction with other PSD
program revisions submitted by the State.  The State’s submittal
states:

Oklahoma’s New Source Review (NSR) program for major sources satisfies
the requirement of section 110(a)(2)(D)(i) that the State prohibits any
source or other type of emission activity within the State from emitting
any air pollutant in amounts which will interfere with measures required
to be included in the applicable implementation plan of any other State
to prevent significant deterioration of air quality.  Oklahoma
Administrative Code (OAC) 252:100-8-35(a)(1) requires sources to
demonstrate that allowable emissions increase from a proposed source or
modification, in conjunction with all other applicable emissions
increases or reductions (including secondary emissions) would not cause
or contribute to any increase in ambient concentrations that would
exceed any NAAQS in any air quality control region.

Oklahoma’s regulations for its PSD program were approved by EPA and
made part of the SIP on August 25, 1983 (48 FR 38636).  Oklahoma’s
requirement to demonstrate that an emissions increase would not
interfere with another state’s PSD measures (OAC 252:100-8-35(a)(1))
was previously approved by EPA as Section 1.4.4(f) of Oklahoma
Regulation 1.4 (see the  table at 40 CFR 52.1920(c)).  Oklahoma
submitted OAC 252:100-35 as a SIP revision on February 14, 2002.  The
revision recodified the regulation.  The 2002 submittal is further
discussed below and in Appendix A of this Technical Support Document.

Consistent with EPA's November 29, 2005, Phase 2 rule for the 1997
8-hour ozone NAAQS (70 FR 71612), the State submitted a SIP revision on
June 24, 2009, to modify its PSD program to address NOx as an ozone
precursor (OAC 252:100-8).

The SIP revision submitted by Oklahoma on June 24, 2010 included
revisions to regulate NOx emissions in its PSD permit program as a
precursor to ozone.  The revisions:

•	 include NOx as an ozone precursor in the definition of Regulated
NSR pollutant (OAC 252:100-8-31),

•	 add that a major source that is major for NOx shall be considered
major for ozone in the definition of Major stationary source (OAC
252:100-8-31),

•	 include a NOx emissions rate of 40 tons per year in the definition
of Significant (OAC 252:100-8-31), and

•	 add that any net emissions increase of 100 tons per year or more of
NOx subject to PSD would require an ambient impact analysis, including
the gathering of air quality data (OAC 252:100-8-33).

For the 8-hour ozone NAAQS, the revision to definition of Regulated NSR
pollutant meets the federal definition in 40 CFR 51.166(b)(49) for NOx
as an ozone precursor.  The revision that a major source that is major
for NOx shall be considered major for ozone meets the federal definition
in 40 CFR 51.166(b)(1).  The revision to include a NOx emissions rate of
40 tons per year in the definition of Significant meets the federal
requirement for significant emission rate for NOx emissions in 40 CFR
51.166(b)(23)(i).  The revision that any net emissions increase of 100
tons per year or more of NOx subject to PSD would require an ambient
impact analysis, including the gathering of air quality data meets the
federal requirement for ambient air impact analysis for ozone precursors
under the footnote for 40 CFR 166(i)(5)(i)(e).  Thus, these revisions
meet the requirements of CAA section 110 and 40 CFR 51.166 for
establishing NOx emissions as a precursor for ozone.

The PSD revision for the 1997 8-hour ozone NAAQS taken together with the
interstate transport SIP, satisfies the requirements of the third
element of section 110(a)(2)(D)(i) for the 1997 8-hour ozone NAAQS,
i.e., there will be no interference with any other state’s required
PSD measures.

As noted above, on July 29, 2010 the Oklahoma Department of
Environmental Quality (ODEQ) sent a letter to EPA clarifying their
interpretation of EPA’s interim guidance on use of PM10 as a surrogate
for the PM2.5 NAAQS in the Oklahoma PSD program.  In the letter ODEQ
stated that they would implement the PM2.5 NAAQS consistent with Federal
case law, and EPA Administrator petition decisions.  ODEQ further stated
that: (1) they will not proceed on the general presumption that PM10 is
always a reasonable surrogate for PM2.5, (2) for any permit application
in which the applicant is seeking to rely on the Surrogate Policy, they
will include in the permit record an adequate rationale or demonstration
to support the use of PM10 as a surrogate based on the facts and
circumstances of the specific permit, (3) the permit record will include
an explanation of how the impacts from the proposed source
construction/modification on the PM2.5 levels were determined, and (4)
they will be mindful of the limits provided in the policy itself, such
as the need to identify the technical difficulties that justify the
application of the policy in each specific case.  Because of the
clarifications, EPA believes that Oklahoma’s approach is appropriate.

On the basis of the analysis presented above we believe that the
Oklahoma SIP as revised with respect to PSD program requirements,
satisfactorily addresses the requirement of CAA section
110(a)(2)(D)(i)(II) that emissions from Oklahoma sources do not
interfere with PSD measures in other any other State for the 1997 8-hour
ozone NAAQS and 1997 PM2.5 NAAQS.

Emissions Inventory Requirements Submitted February 14, 2002 (OAC
252:100-5-2.1)

The revisions require certain stationary sources of air pollution to
report annual emissions (an emissions inventory) to the State by March 1
of each year, with the provision for an extension of up to 60 days (OAC
252:100-5-2.1).  The emission inventory requirements were previously in
OAC 252:100, Subchapter 7 (Permits).

Specifically, the Emissions Inventory requirements at OAC 252:100-5-2.1
read:

Emission inventory

(a) Requirement to file an emission inventory. The owner or operator of
any facility that is a source of air emissions shall submit a complete
emission inventory annually on forms obtained from the division.

(1) The inventory shall cover operations during a calendar year and
shall be submitted prior to March 1 of the following year, unless a
30-day extension has been granted by the Division. An additional 30-day
extension may be granted for good cause shown.

(2) De minimis facilities as defined in 252:100-7-1.1 are not required
to submit an annual emission inventory.

(b) Content. All inventories submitted to the Division shall include,
but shall not be

limited to, the following:

(1) For those emissions subject to a permit, the permit number and the
permitted allowable emissions as set forth therein.

(2) The amount of the actual emissions, including quantifiable excess
emissions, and the basis for such determination.

(3) If the actual emissions vary from the allowable or from the previous
year's actual by more than 30%, an explanation for the difference.

(4) For those emissions not the subject of a permit and when requested
by the AQD, a list of all 252:100 rules setting forth emission
limitations applicable to the facility in question and the maximum
yearly allowable for the facility.

(c) Documentation. All calculations and assumptions must be verified by
proper documentation.  All supporting data, including actual production,
throughput and measurement records along with engineering calculations
and other data utilized in accordance with 252: 100-5-2.1(d), below,
must be maintained for at least 5 years by the current owner or operator
at the facility in conjunction with facility records of the emission
inventory. This information must either be submitted to the Division or
made available for inspection upon request.

(d) Method of calculation. The best available data at the time the
emission inventory is or should have been prepared shall be used to
determine emissions. It shall be the burden of the owner or operator to
select the best available data, based on an acceptable method of
calculation.  The method of calculation used to determine emissions
shall be binding upon the owner or operator and the Division for the
purpose of calculating fees under 252:100-5-2.2 unless challenged by the
owner or operator prior to September 1 of the year the inventory is due
or by the Division within

six (6) months after the date the inventory is received.  Acceptable
methods of calculation for determining actual emissions are:

(1) Emission factors utilized in the issuance of a relevant Oklahoma Air
Quality permit(s) for the facility.

(2) Stack tests using appropriate EPA test methods, with advance
notification and opportunity for observation by the Air Quality
Division.

(3) Stack tests using appropriate EPA test method may be used for
determining the emissions of identical equipment (i.e., same model, same
location, and same operating conditions and parameters) when:

(A) Tests are performed by persons qualified by training and experience
to perform said tests.

(B) Copies of the tests results and methods are available for review by
the Air Quality Division.

(4) Continuous emissions monitoring data, when supported by required
certification and calibration data.

(5) Current AP-42 factors or other factors acceptable to the Division.

(6) Manufacturer's test data, when approved by the Division as reliable.

(7) EPA and EPA-contracted industry-specific emission study data when it
can be shown to be applicable to the facility in question and approved
for use in the emission inventory by the Division.

(8) Fuel usage and other mass-balance methods when supported by specific
records applicable to the materials on which the calculations are based
and approved for use in the emission inventory by the Division.

(9) Any other method that can be shown to be reasonably accurate when
supported by engineering data and calculations, and approved for use in
the emission inventory by the Division.

(e) Methods of verification. Emission inventories determined by the
division to be

substantially incomplete or substantially incorrect shall, upon the
request of the

Division, be subject to verification if not satisfactorily completed or
corrected within a reasonable time. Verification shall be accomplished
by an appropriate stack test using EPA approved methods, installation of
continuous monitoring equipment, or other methods acceptable to the
Division.

These requirements are consistent with EPA’s Air Emissions Reporting
Requirements, (40 CFR 51, Subpart A), which calls for States to report
emissions from stationary sources.

Other Revisions Submitted on February 14, 2002

The other revisions submitted on February 14, 2002 are discussed further
in Appendix A of this document.  We have reviewed the revisions being
proposed for approval and believe they are consistent with the
applicable requirements of the CAA.  The majority of the revisions are
administrative in nature, stemming from the State’s initiative to
repeal or otherwise modify redundant or incorrect language within the
OAC.  The variety of revisions include recodified portions of the
Oklahoma SIP, deletions of duplicative and outdated rules, and edits
that simplify text and correct errors.

The revisions also incorporate requirements of the Oklahoma Uniform
Environmental Permitting Act (UEPA), which requires that the Oklahoma
Department of Environmental Quality (ODEQ) fit licenses, permits,
certificates, approvals and registrations into a category, or Tier,
established under the uniform environmental permitting rules. The UEPA
was created to streamline the permitting process and is located in
Oklahoma Statute Title 27A Environment and Natural Resources, Chapter 2
Oklahoma Environmental Quality Code, Sections 1 through 12.  Tier I are
administrative decisions made by a technical supervisor without public
participation, aside from the landowner.  Tier II are administrative
decisions made by the Division Director with little public
participation, including notice to the public, the opportunity for a
public meeting and public comment.  Tier III are administrative
decisions made by the Executive Director with extensive public
participation, i.e., an administrative evidentiary hearing.

CAAA 110(l) Analysis

Section 110(l) of the Clean Air Act requires:

Each revision to an implementation plan submitted by a State under this
Act shall be adopted by such State after reasonable notice and public
hearing. The Administrator shall not approve a revision of a plan if the
revision would interfere with any applicable requirement concerning
attainment and reasonable further progress (as defined in section 171),
or any other applicable requirement of this Act.  We have reviewed the
revisions proposed for approval and find that they are consistent with
the Clean Air Act.

 There is no Part 2 for Chapter 4, Subchapter 7.  Parts 5 and 7 do not
apply to air matters and were not submitted to EPA for approval as a SIP
revision.


[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Rules and Regulations]
[Page 52348]
[FR Doc No: 2016-18682]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2013-0696; FRL-9950-26-OAR]
RIN 2060-AS86

 Technical Amendments to Performance Specification 18 and
Procedure 6

AGENCY: Environmental Protection Agency (EPA).

ACTION: Partial withdrawal of direct final rule.

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

SUMMARY: Because the Environmental Protection Agency (EPA) received
adverse comment, we are withdrawing a portion of the May 19, 2016,
direct final rule that made several minor technical amendments to the
performance specifications and test procedures for hydrogen chloride
(HCl) continuous emission monitoring systems (CEMS). The adverse
comments related to revisions to Procedure 6 and thus the EPA is
withdrawing the portion of the direct final rule that revised Procedure
6.

DATES: Effective August 8, 2016, the EPA withdraws the revisions to
Procedure 6, sections 4.1.5, <IP_ADDRESS>, <IP_ADDRESS>, and <IP_ADDRESS>, published
at 81 FR 31515, on May 19, 2016.

FOR FURTHER INFORMATION CONTACT: Ms. Candace Sorrell, U.S. EPA, Office
of Air Quality Planning and Standards, Air Quality Assessment Division,
Measurement Technology Group (Mail Code: E143-02), Research Triangle
Park, NC 27711; telephone number:<PHONE_NUMBER>; fax number: (919)
541-0516; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On May 19, 2016, the EPA published a direct
final rule that makes minor technical amendments to the performance
specifications and test procedures for hydrogen chloride (HCl)
continuous emission monitoring systems (CEMS). 81 FR 31515. In the
direct final rule, the EPA stated that if we received adverse comment
by July 5, 2016, the EPA would publish a timely withdrawal and address
the comments in a subsequent final rule based on the proposed rule also
published on May 19, 2016 (81 FR 31577). The May 19, 2016, direct final
rule noted that if the EPA received adverse comment on an amendment,
paragraph, or section of this rule and, if that provision may be
severed from the remainder of the rule, the EPA may adopt as final
those provisions of the rule that are not the subject of an adverse
comment.
    In this instance, the EPA received an adverse comment on an
amendment to the quality assurance provision in Procedure 6, related to
above span requirements. 81 FR 31517. The portions of the direct final
rule revising Performance Standard 18 are severable from the revisions
to Procedure 6. Thus, the EPA is only withdrawing the revisions to
Procedure 6. The EPA will address the comment in a subsequent final
action, which will be based on the parallel proposed rule also
published on May 19, 2016 (81 FR 31515). As stated in the parallel
proposal, we will not institute a second comment period on this
proposed action. The revisions to Performance Standard 18 in the May
19, 2016, direct final rule are not affected and will become effective
on August 17, 2016, as provided in the direct final rule.

List of Subjects in 40 CFR Part 60

    Environmental protection, Administrative practice and procedure,
Air pollution control, Continuous emission monitoring systems, Hydrogen
chloride, Performance specifications, Test methods and procedures.

    Dated: July 28, 2016.
Janet G. McCabe,
Acting Assistant Administrator.

    Accordingly, amendatory instruction 3 in the direct final rule
published in the Federal Register on May 19, 2016, at 81 FR 31520, is
withdrawn as of August 8, 2016.

[FR Doc. 2016-18682 Filed 8-5-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39048-39051]
[FR Doc No: 2021-15649]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1136 and FDA-2020-D-1137]

Guidance Documents Related to Coronavirus Disease 2019;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidances have been implemented without prior comment, but they
remain subject to comment in accordance with the Agency's good guidance
practices.

DATES: The announcement of the guidances is published in the Federal
Register on July 23, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the name of the
guidance document that the comments address and the docket number for
the guidance (see table 1). Received comments will be placed in the
docket(s) and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))). Submit written requests for single
copies of these guidances to the address noted in table 1. Send two
self-addressed adhesive labels to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Center for Drug
Evaluation and Research (CDER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
796-2357, or Stephen Ripley, Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, the
Secretary of Health and Human Services, pursuant to the authority under
section 319 of the Public Health Service Act (42 U.S.C. 247d),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, there was a Presidential declaration
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
---------------------------------------------------------------------------

    \1\ Secretary of Health and Human Services, ``Determination that
a Public Health Emergency Exists'' (originally issued on January 31,
2020, and subsequently renewed), available at: https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at: https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. On February 24, 2021, there
was a Presidential Declaration continuing the national emergency
concerning the COVID-19 pandemic beyond March 1, 2021. See
Continuation of the National Emergency Concerning the Coronavirus
Disease 2019 (COVID-19) Pandemic (February 24, 2021), available at
https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.
---------------------------------------------------------------------------

    In the Federal Register of March 25, 2020 (85 FR 16949) (the March
25, 2020, notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making
available FDA guidances related to the COVID-19 PHE. These procedures,
which operate within FDA's established good guidance practices
regulations, are intended to allow FDA to rapidly disseminate Agency
recommendations and policies related to COVID-19 to industry, FDA
staff, and other stakeholders. The March 25, 2020, notice stated that
due to the need to act quickly and efficiently to respond to the COVID-
19 PHE, FDA believes that prior public participation will not be
feasible or appropriate before FDA implements COVID-19-related
guidances. Therefore, FDA will issue COVID-19-related guidances for
immediate implementation without prior public comment (see section
701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
371(h)(1)(C)) and Sec.  10.115(g)(2)). The guidances are available on
FDA's web pages entitled ``COVID-19-Related Guidance Documents for
Industry, FDA Staff, and Other Stakeholders'' (available at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders)
and ``Search for FDA Guidance Documents'' (available at https://
www.fda.gov/regulatory-

information/search-fda-guidance-documents).
    The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance, FDA
intends to publish periodically a consolidated NOA announcing the
availability of certain COVID-19-related guidances that FDA issued
during the relevant period, as included in table 1. This notice
announces COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

    Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidances:

                       Table 1--Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
                                                                                Contact information to
             Docket No.                        Center              Title of guidance      request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1136.....................  CDER....................  Manufacturing, Supply<EMAIL_ADDRESS>                                                                 Chain, and Drug and      Please include the
                                                                 Biological Product       docket number FDA-2020-
                                                                 Inspections During       D-1136 and complete
                                                                 COVID-19 Public Health   title of the guidance
                                                                 Emergency Questions      in the request.
                                                                 and Answers (Updated
                                                                 May 2021).
FDA-2020-D-1137.....................  CBER....................  Emergency Use            Office of
                                                                 Authorization for        Communication,
                                                                 Vaccines to Prevent      Outreach and
                                                                 COVID-19 (Updated May    Development, 10903 New
                                                                 2021).                   Hampshire Ave., Bldg.
                                                                                71, Rm. 3128, Silver
                                                                                Spring, MD 20993-0002,
                                                                                1-800-835-4709 or 240-
                                                                                402-8010; email
<EMAIL_ADDRESS>----------------------------------------------------------------------------------------------------------------

    Although these guidances have been implemented immediately without
prior comment, FDA will consider all comments received and revise the
guidances as appropriate (see Sec.  10.115(g)(3)).
    These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec.  10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

A. CDER Guidance

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information (listed in
table 2). Therefore, clearance by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations and
guidances have been approved by OMB as listed in the following table:

                                     Table 2--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                       Another guidance title
       COVID-19  guidance title           CFR cite referenced in       referenced in COVID-19       OMB control
                                            COVID-19 guidance                 guidance                 Nos.
----------------------------------------------------------------------------------------------------------------
Manufacturing, Supply Chain, and Drug   21 CFR 314.50, 314.94,     --Prioritization of the             0910-0001
 and Biological Product Inspections      314.95, 314.125,           Review of Original ANDAs,          0910-0014
 During COVID-19 Public Health           314.127; 21 CFR 601.2      Amendments, and Supplements.       0910-0338
 Emergency Questions and Answers         and 601.20.               --Requests for Expedited            0910-0045
 (Updated May 2021).                                                Review of New Drug                 0910-0139
                                                                    Application and Biologics          0910-0759
                                                                    License Application Prior
                                                                    Approval Supplements
                                                                    Submitted for Chemistry,
                                                                    Manufacturing, and Controls
                                                                    Changes.
                                                                   --Administrative Processing
                                                                    of Original Biologics
                                                                    License Applications (BLA)
                                                                    and New Drug Applications
                                                                    (NDA).
                                                                   --Changes to an Approved
                                                                    Application for Specified
                                                                    Biotechnology and Specified
                                                                    Synthetic Biological
                                                                    Products.
                                                                   --Changes to an Approved
                                                                    Application: Biological
                                                                    Products.
                                                                   --Changes to an Approved NDA
                                                                    or ANDA; Questions and
                                                                    Answers.
                                                                   --Changes to an Approved NDA
                                                                    or ANDA.
                                                                   --CMC Postapproval
                                                                    Manufacturing Changes To Be
                                                                    Documented in Annual Reports.
                                                                   --Changes to an Approved
                                                                    Application: Biological
                                                                    Products: Human Blood and
                                                                    Blood Components Intended
                                                                    for Transfusion or for
                                                                    Further Manufacture.
                                                                   --CMC Postapproval
                                                                    Manufacturing Changes for
                                                                    Specified Biological
                                                                    Products To Be Documented in
                                                                    Annual Reports.
                                                                   --Chemistry, Manufacturing,
                                                                    and Controls Changes to an
                                                                    Approved Application:
                                                                    Certain Biological Products.
                                                                   --Immediate Release Solid
                                                                    Oral Dosage Forms; Scale-Up
                                                                    and Postapproval Changes:
                                                                    Chemistry, Manufacturing,
                                                                    and Controls, In Vitro
                                                                    Dissolution Testing, and In
                                                                    Vivo Bioequivalence
                                                                    Documentation.
                                                                   --SUPAC-IR: Questions and
                                                                    Answers about SUPAC-IR
                                                                    Guidance.

                                                                   --SUPAC-SS: Nonsterile
                                                                    Semisolid Dosage Forms;
                                                                    Scale-Up and Postapproval
                                                                    Changes: Chemistry,
                                                                    Manufacturing, and Controls;
                                                                    In Vitro Release Testing and
                                                                    In Vivo Bioequivalence
                                                                    Documentation.
                                                                   --SUPAC-MR: Modified Release
                                                                    Solid Oral Dosage Forms;
                                                                    Scale-Up and Postapproval
                                                                    Changes: Chemistry,
                                                                    Manufacturing, and Controls;
                                                                    In Vitro Dissolution Testing
                                                                    and In Vivo Bioequivalence
                                                                    Documentation.
                                                                   --SUPAC: Manufacturing
                                                                    Equipment Addendum.
                                                                   --Remote Interactive
                                                                    Evaluations of Drug
                                                                    Manufacturing and
                                                                    Bioresearch Monitoring
                                                                    Facilities During the COVID-
                                                                    19 Public Health Emergency.
----------------------------------------------------------------------------------------------------------------

B. CBER Guidance

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information (listed in
table 3). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations and
guidance have been approved by OMB as listed in the following table:

                                     Table 3--CBER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                        Another guidance title
         COVID-19 guidance title            CFR cite referenced in      referenced in COVID-19      OMB control
                                               COVID-19 guidance               guidance                Nos.
----------------------------------------------------------------------------------------------------------------
Emergency Use Authorization for Vaccines  21 CFR 314.420............  Emergency Use                    0910-0001
 to Prevent COVID-19 (Updated May 2021).  21 CFR part 312...........   Authorization of Medical        0910-0014
                                          21 CFR parts 210, 211, and   Products and Related            0910-0139
                                           610.                        Authorities.
                                          21 CFR part 600...........                                   0910-0308
                                          21 CFR part 601...........                                   0910-0338
                                                                                0910-0595
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

    Persons with access to the internet may obtain COVID-19-related
guidances at:
     FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders.
     FDA web page entitled ``Search for FDA Guidance
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.

    Dated: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15649 Filed 7-22-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Page 64279]
[FR Doc No: 2022-22975]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-404, OMB Control No. 3235-0461]

Proposed Collection; Comment Request; Extension: Rule 602

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 602 of Regulation NMS
(17 CFR 240.602), under the Securities Exchange Act of 1934 (15 U.S.C.
78a et seq.). The Commission plans to submit this existing collection
of information to the Office of Management and Budget (``OMB'') for
extension and approval.
    Rule 602 of Regulation NMS, Dissemination of Quotations in NMS
securities, contains two related collections. The first collection of
information is found in Rule 602(a).\1\ This third-party disclosure
requirement obligates each national securities exchange and national
securities association to make available to quotation vendors for
dissemination to the public the best bid, best offer, and aggregate
quotation size for each ``subject security,'' as defined under the
Rule. The second collection of information is found in Rule 602(b).\2\
This disclosure requirement obligates any exchange member and over-the-
counter (``OTC'') market maker that is a ``responsible broker or
dealer,'' as defined under the Rule, to communicate to an exchange or
association its best bids, best offers, and quotation sizes for subject
securities.\3\
---------------------------------------------------------------------------

    \1\ 17 CFR 242.602(a).
    \2\ 17 CFR 242.602(b).
    \3\ Under Rule 602(b)(5), electronic communications networks
(``ECNs'') have the option of reporting to an exchange or
association for public dissemination, on behalf of customers that
are OTC market makers or exchange market makers, the best-priced
orders and the full size for such orders entered by market makers on
the ECN, to satisfy such market makers' reporting obligation under
Rule 602(b). Since this reporting requirement is an alternative
method of meeting the market makers' reporting obligation, and
because it is directed to nine or fewer persons (ECNs), this
collection of information is not subject to OMB review under the
Paperwork Reduction Act (``PRA'').
---------------------------------------------------------------------------

    It is anticipated that 25 respondents, consisting of 24 national
securities exchanges and one national securities association, will
collectively respond approximately 19,093,763,801,315 times per year
pursuant to Rule 602(a) at 18.22 microseconds per response, resulting
in a total annual time burden of approximately 96,625 hours. It is
anticipated that no respondents will have a reporting burden pursuant
to Rule 602(b).\4\
---------------------------------------------------------------------------

    \4\ For the reporting obligation under Rule 602(b), the
respondents are exchange members and OTC market makers. The
Commission believes that communication of quotations through an
exchange's electronic trading system effectively means that exchange
members currently have no reporting burden under Rule 602(b) for
these quotations. The Commission also believes that there are
presently no OTC market makers that quote other than on an exchange.
---------------------------------------------------------------------------

    Thus, the aggregate third-party disclosure burden under Rule 602 is
approximately 96,625 hours annually which is comprised of 96,625 hours
relating to Rule 602(a) and 0 hours relating to Rule 602(b).
    Written comments are invited on: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted by
December 23, 2022.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549, or send an email to:
[email protected].

    Dated: October 18, 2022.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2022-22975 Filed 10-21-22; 8:45 am]
BILLING CODE 8011-01-P