[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11720-11722]
[FR Doc No: 2022-04397]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2777]

Expansion Cohorts: Use in First-in-Human Clinical Trials To
Expedite Development of Oncology Drugs and Biologics; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Expansion
Cohorts: Use in First-in-Human Clinical Trials to Expedite Development
of Oncology Drugs and Biologics.'' The purpose of this guidance is to
provide advice to sponsors regarding the design and conduct of first-
in-human (FIH) clinical trials intended to efficiently expedite the
clinical development of oncology drugs, including biological products,
through multiple expansion cohort trial designs. This guidance
finalizes the draft guidance of the same name issued in August 2018.

DATES: The announcement of the guidance is published in the Federal
Register on March 2, 2022.

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 Docket No.
FDA-2018-D-2777 for ``Expansion Cohorts: Use in First-in-Human Clinical
Studies to Expedite Development of Oncology Drugs and Biologics.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Lee Pai-Scherf, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2314, Silver Spring, MD 20993-0002, 240-
402-7911; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Expansion Cohorts: Use in First-in-Human Clinical Trials to
Expedite Development of Oncology Drugs and Biologics.'' The purpose of
this guidance is to provide advice to sponsors regarding the design and
conduct of FIH clinical trials intended to efficiently expedite the
clinical development of oncology drugs, including biological products,
through multiple expansion cohort trial designs. These are trial
designs that employ multiple, concurrently accruing, subject cohorts,
where individual cohorts assess different aspects of the safety,
pharmacokinetics, and antitumor activity of the drug product. This
guidance provides FDA's current thinking regarding (1) characteristics
of drug products best suited for consideration for development under a
multiple expansion cohort trial; (2) information to include in
investigational new drug application submissions to support the use of
individual cohorts; (3) when to interact with FDA on planning and
conducting multiple expansion cohort trials; and (4) safeguards to
protect subjects enrolled in FIH expansion cohort trials.
    This guidance finalizes the draft guidance of the same name issued
August 13, 2018 (83 FR 40055). Changes made to the guidance took into
consideration public comments received. Major changes from the draft to
the final guidance include the following:
     Language added stating that designs other than Simon two-
stage (e.g., Bayesian statistical design) may be used to assess
antitumor activity in a nonrandomized cohort to limit the number of
subjects that could be exposed to a potentially ineffective drug.
     Statement added to indicate that in trials of limited
sample size, a safety assessment committee could be a group within the
sponsor's organization alone that is not otherwise involved in trial
conduct or management or with external representation in lieu of an
independent data monitoring committee.
     Language added to state that development of an age-
appropriate formulation may be necessary for pediatric populations.
     Minor changes added to various sections to clarify
criteria for drug products suitable for investigation in clinical
trials with FIH multiple expansion cohorts, the procedure for obtaining
a risk assessment if an in vitro diagnostic will be used for patient
management, and the information to be submitted to the FDA to support
amendments to expand the protocol.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Expansion Cohorts: Use in First-in-Human
Clinical Trials to Expedite Development of Oncology Drugs and
Biologics.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. 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 21 CFR parts 50 and 56 have been
approved under OMB control number 0910-0130. The collections of
information in 21 CFR part 58 for good laboratory practices for
nonclinical laboratory studies have been approved under OMB control
number 0910-0119. The collections of information in Sec. Sec.  201.56
and 201.57 have been approved under OMB control number 0910-0572. The
collections of information in 21 CFR part 312 that support FDA's
regulations for investigational new drug applications have been
approved under OMB control number 0910-0014. The collections of
information in 21 CFR part 314 have been approved under OMB control
number 0910-0001.
    The collections of information in biologics license applications
submitted under 21 CFR part 601 have been approved under OMB control
number 0910-0338. The collections of information in 21 CFR part 812
have been approved under OMB control number 0910-0078.
    The collections of information in the guidance for industry
entitled ``Oversight of Clinical Investigations--A Risk-Based Approach
to Monitoring'' (available at https://www.fda.gov/media/116754/download) have been approved under OMB control number 0910-0733. The
collections of information in the guidance for industry entitled
``Expedited Programs for Serious Conditions--Drugs and Biologics''
(available at https://www.fda.gov/media/86377/download) have been
approved under OMB control number 0910-0765.
    The collections of information in the International Council for
Harmonisation guidance for industry entitled ``E6(R2) Good Clinical
Practice: Integrated Addendum to ICH E6(R1)'' (available at https://www.fda.gov/media/93884/download) have been approved under OMB control
number 0910-0843. The collections of information in the guidance for
industry entitled ``Formal Meetings Between the FDA and Sponsors or
Applicants of PDUFA Products'' (available at https://www.fda.gov/media/109951/download) have been approved under OMB control number 0910-0429.
    The collections of information regarding evaluation of the program
for enhanced review transparency and communication for new molecular
entity new drug applications and original biologics license
applications in the Prescription Drug User Fee Act have been approved
under OMB control number 0910-0746.
    The collections of information described in the guidance for
industry and review staff entitled ``Formal Dispute Resolution: Sponsor
Appeals Above the Division Level'' (available at https://www.fda.gov/media/126910/download) have been approved under OMB control number
0910-0430.

III. Electronic Access

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

    Dated: February 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04397 Filed 3-1-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: February 1, 2006 (Volume 71, Number 21)]
[Notices]
[Page 5392-5394]
[DOCID:fr01fe06-163]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53176; File No. SR-NYSE-2005-36]

Self-Regulatory Organizations; New York Stock Exchange, Inc.;
Order Approving Proposed Rule Change and Notice of Filing and Order
Granting Accelerated Approval to Amendment No. 1 to the Proposed Rule
Change To Amend Rule 445

January 25, 2006.

I. Introduction

    On May 23, 2005, the New York Stock Exchange, Inc. (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or the ``Commission''), pursuant to section 19(b)(1) of the
Securities Exchange Act of 1934 (the ``Exchange Act'') \1\ and Rule
19b-4 thereunder,\2\ a proposed rule change relating to amendments to
NYSE Rule 445. The Commission published the proposed rule change for
comment in the Federal Register on July 6, 2005.\3\ The Commission
received one comment letter on the proposal.\4\ On January 17, 2006,
NYSE filed a response to the comment letter,\5\ as well as Amendment
No. 1 to the proposed rule change.\6\ This order approves the proposed
rule change, grants accelerated approval to Amendment No. 1 to the
proposed rule change, and solicits comments from interested persons on
Amendment No. 1.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 51934 (June 29,
2005), 70 FR 38994 (July 6, 2005).
    \4\ See letter from Alan E. Sorcher, Vice President and
Associate General Counsel, Securities Industry Association
(``SIA''), to Jonathan G. Katz, Secretary, SEC, dated July 27, 2005
(the ``SIA Letter'').
    \5\ See letter from Mary Yeager, Acting Corporate Secretary,
NYSE, to Catherine McGuire, Chief Counsel, Division of Market
Regulation, SEC, dated January 17, 2006 (the ``NYSE Response'').
    \6\ Amendment No. 1 amended the rule text to clarify that notice
to the Exchange, as opposed to approval by the Exchange, is required
if a person holding the AML Officer designation (employed by an
entity that directly or indirectly controls, or is controlled by, or
is under common control with the member or member organization), is
replaced by another person and the structure of the arrangement has
been previously approved by the Exchange.
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II. Description of the Proposed Rule Change

    The proposed rule change consists of amendments to NYSE Rule 445
(the ``Anti-Money Laundering Compliance Rule'') to establish that the
``independent testing'' requirement of the rule must be conducted, at
minimum, on an annual calendar-year basis by members and member
organizations that conduct a public business, or every two years if no
public business is conducted. The amendments also establish a standard
to determine who is adequately qualified and sufficiently independent
to conduct the required testing. Further, they clarify that each person
designated to implement and monitor the Anti-Money Laundering
Compliance Rule must either be an employee of the member or member
organization for which they are designated or, with the prior approval
of the Exchange, an employee of a parent, affiliate, or subsidiary of
the member or member organization. Employees of a parent, affiliate, or
subsidiary of a member or member organization who are designated to
implement and monitor the Anti-Money Laundering Compliance Rule must
consent to the jurisdiction of the Exchange and the member or member
organization must acknowledge their responsibility to supervise them as
employees.

Background and Detail

    NYSE Rule 445, which became effective on April 24, 2002,\7\
requires each member organization and each member not associated with a
member organization to develop and implement an anti-money laundering
(``AML'') program consistent with ongoing obligations pursuant to
Treasury regulation 31 CFR 103.120 under the Bank Secrecy Act,\8\ as
amended by the Uniting and Strengthening America by Providing
Appropriate Tools Required to Intercept and Obstruct Terrorism (USA
PATRIOT ACT) Act of 2001.\9\
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    \7\ See Securities Exchange Act Release No. 45798 (April 22,
2002); 67 FR 20854 (April 26, 2002) (SR-NYSE-2002-10).
    \8\ Currency and Foreign Transactions Reporting Act of 1970
(commonly referred to as the Bank Secrecy Act), 12 U.S.C. 1829b, 12
U.S.C. 1951-1959, and 31 U.S.C. 5311-5330.
    \9\ Public Law No. 107-56, 115 Stat. 272 (2001).
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    The prescribed AML program obligations include the development of
internal policies, procedures and controls; the designation of a person
to implement and monitor the day-to-day operations and internal
controls of the program (commonly referred to as an ``AML Officer'');
ongoing training for appropriate persons; and an independent testing
function for overall compliance.
    Neither the Bank Secrecy Act nor NYSE Rule 445 currently specifies:
(1) Timeframes within which the independent testing function must be
performed, (2) qualification and independence standards for those who
conduct such testing function, or (3) jurisdictional requirements
pertaining to AML Officers. In order to provide

interpretive clarity to the text, the following amendments to NYSE Rule
445 were proposed.

Timeframes for Independent Testing

    The proposed amendments would require that independent testing of
AML programs be conducted, at a minimum, on an annual (calendar-year)
basis by members or member organizations that conduct a public
business, or every two years if no public business is conducted (i.e.,
if the member or member organization engages solely in proprietary
trading, and/or conducts business only with other broker-dealers). The
Exchange believes these timeframes are reasonable in that they require
more frequent testing of AML programs designed to monitor a public
business, which is likely more susceptible to money laundering schemes
than strictly proprietary business. Further, the one-year time frame
for testing is consistent with standard industry practice in that it is
similar to generally accepted guidelines for conducting tests in the
context of, for instance, general audits and branch office visits.
However, the proposed amendments make clear that more frequent testing
should be conducted if circumstances warrant (e.g., should the business
mix of the member or member organization materially change; in the
event of a merger or acquisition; in light of systemic weaknesses
uncovered via testing of the AML program; or in response to any other
``red flags'').

Qualification and Independence Standards for Testing

    With regard to who is adequately qualified and sufficiently
independent to conduct the independent testing function, the proposed
amendments would require that testing be conducted by a designated
person with a working knowledge of applicable requirements under the
Bank Secrecy Act and its implementing regulations. Such person need not
be an employee of the member or member organization since the
responsibility being delegated is essentially an auditing function and,
as such, it would not be unusual or ineffective for it to be performed
by an independent outside party. As noted below, the proposed
amendments require that the day-to-day responsibilities for monitoring
operations and internal controls of AML programs be performed by a
person fully subject to the supervision of the member or member
organization for which they are designated, and to the jurisdiction of
the Exchange.
    The proposed amendments do not preclude an employee of the member
or member organization from conducting the required independent testing
of the AML program; however the proposed ``independence'' standard
would prohibit testing from being conducted by a person who performs
the functions being tested, or by the designated AML Officer, or by a
person who reports to either. This standard is designed to promote the
independence, and thus the integrity, of the testing function by
insulating it from the day-to-day administration of the activities
being tested. It also serves to remove the testing function from the
supervisory structure of the member or member organization, thus
eliminating the possibility that a person might not candidly report
shortcomings in a system designed by their supervisor for fear of
reprisal.

Jurisdiction Over AML Officers

    The proposed amendments clarify that the AML Officer designated to
implement and monitor a member's or member organization's AML Program
must either be an employee of the member or member organization for
which they are designated or, with the prior approval of the Exchange,
an employee of a parent, affiliate or subsidiary of the member or
member organization.\10\
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    \10\ If a person holding the AML Officer designation is to be
replaced by another person, and the structure of the arrangement has
been previously approved by the Exchange, then notice to the
Exchange of the designation change would be sufficient if the
previously approved arrangement remained substantively unchanged.
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    The rationale behind the proposal to allow employees of parents,
affiliates and subsidiaries to be designated AML Officers of members
and member organizations is the recognition that AML programs may be
integrated into, and extend throughout, the corporate family.
Accordingly, a person acting as an AML Officer for both a member
organization and the member organization's parent bank would be better
situated to see the ``big picture'' (i.e., to monitor the movements of
funds and securities throughout the corporate structure and, thus, be
better able to identify and understand AML issues across the range of
such structure). The ability to situate AML Officers where they can be
most effective gives members and member organizations the flexibility
to integrate their AML program into the larger corporate structure to
achieve a more global perspective, and thus a more comprehensive and
effective AML program.
    The prior written approval of the Exchange is required if the
designated AML Officer is other than an employee of the member or
member organization. Further, each such person must execute an
attestation, acceptable to the Exchange, consenting to the supervision
of each member or member organization for which they are designated and
to the jurisdiction of the Exchange. A proposed example of such an
attestation is included in Exhibit 3 of the proposed rule change, under
the heading ``AML Officer Consent to Jurisdiction.'' \11\ In addition,
the member or member organization must execute an agreement, acceptable
to the Exchange, acknowledging their responsibility to supervise, as an
employee for all regulatory purposes, each such person designated by
them. A proposed example of such an agreement is included in Exhibit 3
of the proposed rule change under the heading ``Acknowledgement of
Supervisory Responsibility over AML Officer.'' \12\
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    \11\ Exhibit 3 of the proposed rule change is available on the
NYSE's Web site (http://www.NYSE.com), at the NYSE's principal office, and

at the Commission's Public Reference Room.
    \12\ Id.
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III. Summary of Comments Received and NYSE Response

    The Commission received one comment letter from the SIA on the
proposal and a response to the comment letter by NYSE.
    The SIA Letter noted that the ``NYSE proposal provides that the AML
Compliance Person/Officer may be an employee of a parent, affiliate or
subsidiary of the member or member organization with the `prior
approval of the Exchange.' '' \13\ In the SIA's view prior approval
should not be required because it would be impractical to obtain prior
approval for each and every personnel change.\14\
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    \13\ SIA Letter, supra note 4, at 3-4.
    \14\ Id. at 4.
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    The NYSE Response indicated that NYSE ``has a strong regulatory
interest in retaining the right to review `outside' AML Officer
arrangements to make certain practical determinations (e.g., whether
the proposed arrangement is structured such that the AML Officer will
be positioned to effectively implement the member organization's AML
Program, and whether he or she will have sufficient time and resources
to monitor the Program's day-to-day operations and internal
controls).'' \15\ NYSE, however, indicated that its interests rest
primarily in reviewing the structure of the arrangement in which an
``outside'' AML Officer is

employed.\16\ Accordingly, NYSE filed Amendment No. 1 to the proposed
rule change to provide that ``if a person holding the AML Officer
designation is to be replaced by another person, and the structure of
the arrangement has been previously approved by the Exchange, then
notice to the Exchange of the designation change would be sufficient if
the previously approved arrangement remained substantively unchanged.''
\17\
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    \15\ NYSE Response, supra note 5, at 2.
    \16\ Id.
    \17\ Id.
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning Amendment No. 1, 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 e-mail to<EMAIL_ADDRESS>Please include File

Number SR-NYSE-2005-36 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.

All submissions should refer to File Number SR-NYSE-2005-36. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro/shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the NYSE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSE-2005-36 and should be submitted on or before
February 22, 2006.

V. Discussion and Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Exchange Act and the
rules and regulations thereunder applicable to a national securities
exchange, and in particular, with the requirements of sections 6(b)(5)
\18\ of the Exchange Act.\19\ Section 6(b)(5) requires, among other
things, that the rules of an exchange be designed to promote just and
equitable principles of trade, to remove impediments to and perfect the
mechanism of a free and open market and national market system, and in
general, to protect investors and the public interest. The Commission
believes that the proposed rule change is designed to accomplish these
ends by requiring members to conduct periodic tests of their AML
compliance programs, preserve the independence of their testing
personnel, and ensure the accuracy of their AML compliance program.
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    \18\ 15 U.S.C. 78f(b)(5).
    \19\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
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Accelerated Approval of Amendment No. 1

    The Commission finds good cause for approving Amendment No. 1 to
the proposed rule change prior to the thirtieth day after the amendment
is published for comment in the Federal Register pursuant to section
19(b)(2) of the Act. Amendment No. 1 provides that notice to the
Exchange, as opposed to approval by the Exchange, is required if a
person holding the AML Officer designation (employed by an entity that
directly or indirectly controls, or is controlled by, or is under
common control with the member or member organization), is replaced by
another person and the structure of the arrangement has been previously
approved by the Exchange. Permitting Exchange members to submit a
notice instead of seeking prior approval, in circumstances where the
structure of the arrangement in which an outside AML Officer is
employed has not changed, will permit the Exchange to monitor
compliance while minimizing any regulatory burden on members.
Accordingly, the Commission believes that accelerated approval of
Amendment No. 1 is appropriate.

VI. Conclusions

    It is therefore ordered, pursuant to section 19(b)(2) of the
Act,\20\ that the proposed rule change, as amended (SR-NYSE-2005-36),
be, and hereby is, approved.
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    \20\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\21\
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    \21\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
[FR Doc. E6-1227 Filed 1-31-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: April 10, 2006 (Volume 71, Number 68)]
[Notices]
[Page 18126-18127]
[DOCID:fr10ap06-96]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53587; File No. SR-CHX-2006-11]

Self-Regulatory Organizations; Chicago Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Change To
Amend the Bylaws of CHX Holdings, Inc.

April 3, 2006.
    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 27, 2006, the Chicago Stock Exchange, Inc. (``CHX'' or
``Exchange'') 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 CHX. The CHX has
filed this proposal pursuant to Section 19(b)(3)(A)(iii) of the Act \3\
and Rule 19b-4(f)(6) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. 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)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    On behalf of its parent company, CHX Holdings, Inc. (``CHX
Holdings''), the CHX proposes to amend the CHX Holdings Bylaws to
confirm that CHX Holdings will take steps necessary to ensure that
directors, officers, and employees of CHX Holdings consent to the
applicability of the requirements of Article III, Sections 3 and 5 of
the CHX Holdings Bylaws with respect to activities related to the
Exchange. The text of this proposed rule change is available on the
Exchange's Web site at http://www.chx.com/rules/proposed_rules.htm and

at the Commission's Public Reference Room.

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

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

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

1. Purpose
    As a result of its demutualization in February 2005, the Exchange
became the wholly-owned subsidiary of CHX Holdings, a Delaware
corporation.\5\ The Demutualization Approval Order confirmed that the
Exchange's staff had agreed to submit to the CHX Holdings Board of
Directors a change to the Bylaws of CHX Holdings that would require CHX
Holdings to take such action as is necessary to ensure that officers,
directors, and employees of CHX Holdings consent to the applicability
of two specific provisions of the CHX Holdings Bylaws.\6\ In general,
these two CHX Holdings Bylaws confirm that: (1) To the extent that they
are related to the activities of the CHX, CHX Holdings' officers,
directors, and employees are deemed to be officers, directors, and
employees of the CHX for the purposes of the Act; and (2) CHX Holdings'
officers, directors, and employees, by virtue of their acceptance of
such positions, are deemed to submit to the jurisdiction of the United
States federal courts, the Commission, and the CHX for the purposes of
securities law-related proceedings that arise out of, or are related
to, the activities of the Exchange. The proposed Bylaws change that is
the subject of this filing is designed to meet the requirement set out
in the Demutualization Approval Order.\7\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 51149 (February 9,
2005), 70 FR 7531 (February 14, 2005) (order approving File No. SR-
CHX-2004-26) (``Demutualization Approval Order'').
    \6\ See Demutualization Approval Order, supra note 5, at note 4.
    \7\ This proposal mirrors a similar proposal submitted by
Pacific Exchange, Inc. in the context of a series of similar
corporate changes. See Securities Exchange Act Release No. 51389
(March 17, 2005), 70 FR 15374 (March 25, 2005) (notice of filing and
immediate effectiveness of File No. SR-PCX-2005-17) (relating to the
Bylaws of PCX Holdings, Inc.).
---------------------------------------------------------------------------

2. Statutory Basis
    The CHX believes that the proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\8\ In particular, the
CHX believes that the proposal is consistent with Section 6(b)(5) of
the Act \9\ in that it is designed to promote just and equitable
principles of trade, 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 by ensuring
that the directors, officers, and employees of CHX Holdings consent to
the applicability of the requirements Article III, Sections 3 and 5 of
the CHX Holdings Bylaws with respect to activities related to the
Exchange.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition.

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

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Changes 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 \10\ and Rule 19b-
4(f)(6) thereunder.\11\ At any time within 60 days of the filing of the
proposed rule change, the Commission may summarily abrogate 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.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). As required by Rule 19b-
4(f)(6)(iii) of the Act, the CHX provided the Commission with
written notice of its intent to file the proposed rule change, along
with a brief description of the text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change.
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal 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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CHX-2006-11 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-CHX-2006-11. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule changes 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 inspection and
copying in the Commission's Public Reference Room. Copies of such
filing will also be available for inspection and copying at the
principal office of the CHX. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File No. SR-CHX-2006-11 and should be submitted on or before May 1,
2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Nancy M. Morris,
Secretary.
[FR Doc. E6-5183 Filed 4-7-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Page 62500]
[FR Doc No: 2016-21769]

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

[ER-FRL-9028-9]

Environmental Impact Statements; Notice of Availability

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

Weekly receipt of Environmental Impact Statements (EISs)
Filed 08/29/2016 Through 09/02/2016
Pursuant to 40 CFR 1506.9.

    Notice: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

EIS No. 20160201, Final Supplement, NRC, IL, Generic--License Renewal
on Nuclear Plants, Supplement 57, Regarding LaSalle County Station,
Units 1 and 2, Review Period Ends: 10/11/2016, Contact: William Ford
301-415-1263.
EIS No. 20160202, Final, NPS, WY, Moose-Wilson Corridor Final
Comprehensive Management Plan, Review Period Ends: 10/11/2016, Contact:
Daniel Noon<PHONE_NUMBER>.
EIS No. 20160203, Final, FERC, OH, Leach XPress and Rayne XPress
Expansion Projects, Review Period Ends: 10/11/2016, Contact: Juan Polit
202-502-8652.
EIS No. 20160204, Final, USFS, BLM, ID, Rasmussen Valley Mine, Review
Period Ends: 10/11/2016, Contact: Bill Volk<PHONE_NUMBER>.

    The U.S. Department of Agriculture's Forest Service and the U.S.
Department of the Interior's Bureau of Land Management are joint lead
agencies for the above project.

EIS No. 20160205, Draft Supplement, USACE, WV, Bluestone Dam Safety
Modification, Comment Period Ends: 10/24/2016, Contact: Rebecca
Rutherford<PHONE_NUMBER>.

    Dated: September 6, 2016.
Dawn Roberts,
Management Analyst, NEPA Compliance Division, Office of Federal
Activities.
[FR Doc. 2016-21769 Filed 9-8-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 43 (Monday, March 8, 2021)]
[Rules and Regulations]
[Pages 13191-13196]
[FR Doc No: 2021-04413]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2019-0661; FRL-10019-92-Region 4]

Air Plan Approval; GA: Non-Interference Demonstration and
Maintenance Plan Revision for the Removal of Transportation Control
Measures in the Atlanta Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by Georgia, through the
Georgia Environmental Protection Division (GA EPD), on September 16,
2019, for the purpose of removing certain transportation control
measures (TCMs) from the SIP for the thirteen counties in the Atlanta,
Georgia, area. EPA is also approving Georgia's update to the 2008 8-
hour ozone maintenance plan that was submitted in the September 16,
2019, SIP revision. Specifically, EPA is approving the updated mobile
emissions inventory,

the associated 2030 motor vehicle emissions budgets (MVEBs), and the
measures offsetting the potential emissions increases due to removal of
the TCMs from the Georgia SIP. This approval is based on the
determination that this SIP revision will not interfere with attainment
or maintenance of any national ambient air quality standards (NAAQS or
standards) or any other Clean Air Act (CAA or Act) requirements.

DATES: This rule is effective April 7, 2021.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R04-OAR-2019-0661. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information may not be publicly available, i.e., Confidential Business
Information or other information whose disclosure is restricted by
statute. Certain other material, such as copyrighted material, is not
placed on the internet and will be publicly available only in hard copy
form. Publicly available docket materials can either be retrieved
electronically via www.regulations.gov or in hard copy at the Air
Regulatory Management Section, Air Planning and Implementation 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 possible, you contact the person
listed in the FOR FURTHER INFORMATION CONTACT section to schedule your
inspection. The Regional Office's official hours of business are Monday
through Friday 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Dianna Myers, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. Ms. Myers can be reached via telephone at<PHONE_NUMBER> or
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What is the background for this action?

    On November 6, 1991 (56 FR 56694), EPA designated and classified
the following counties in the Atlanta Area as a Serious ozone
nonattainment area for the 1-hour ozone national ambient air quality
standards (NAAQS): Cherokee, Clayton, Cobb, Coweta, DeKalb, Douglas,
Fayette, Forsyth, Fulton, Gwinnett, Henry, Paulding, and Rockdale (the
Atlanta 1979 1-hour ozone Area). TCMs were implemented in the 13
counties comprising the Atlanta 1979 1-hour ozone Area. Because the
Atlanta 1979 1-hour ozone Area failed to attain the 1-hour ozone NAAQS
by November 15, 1999, EPA issued a final rulemaking action (68 FR
55469) on September 26, 2003, to reclassify the area to a Severe ozone
nonattainment area. Subsequently, the Atlanta 1979 1-hour ozone Area
attained the 1-hour ozone NAAQS, and thus EPA redesignated the
nonattainment area to attainment for the 1-hour ozone NAAQS. See 70 FR
34660 (June 15, 2005). The 1979 1-hour ozone NAAQS was revoked,
effective June 15, 2005. See 69 FR 23951 (April 30, 2004).
    On April 30, 2004 (69 FR 23858), EPA designated the following 20
counties in the Atlanta Area as a Marginal nonattainment area for the
1997 8-hour ozone NAAQS: Barrow, Bartow, Carroll, Cherokee, Clayton,
Cobb, Coweta, DeKalb, Douglas, Fayette, Forsyth, Fulton, Gwinnett,
Hall, Henry, Newton, Paulding, Rockdale, Spalding, and Walton (Atlanta
1997 8-hour ozone Area). The Atlanta 1979 1-hour ozone Area is a subset
of this 20-county area. EPA reclassified the Atlanta 1997 8-hour ozone
Area as a Moderate nonattainment area on March 6, 2008, because the
area failed to attain the 1997 8-hour ozone NAAQS by the required
attainment date of June 15, 2007. See 73 FR 12013. Subsequently, the
Atlanta 1997 8-hour ozone Area attained the 1997 8-hour ozone standard,
and on December 2, 2013, EPA redesignated the-Atlanta 1997 8-hour ozone
Area to attainment for the 1997 8-hour ozone NAAQS. See 78 FR 72040.
The 1997 8-hour ozone NAAQS was revoked, effective April 6, 2015. See
80 FR 12264 (March 6, 2015).
    On May 21, 2012 (77 FR 30088), EPA designated the following 15
counties as Marginal nonattainment for the 2008 8-hour ozone NAAQS:
Bartow, Cherokee, Clayton, Cobb, Coweta, DeKalb, Douglas, Fayette,
Forsyth, Fulton, Gwinnett, Henry, Newton, Paulding, and Rockdale
(Atlanta 2008 8-hour ozone Area). The Atlanta 1979 1-hour ozone Area is
a subset of the Atlanta 2008 8-hour ozone Area. The Atlanta 2008 8-hour
ozone Area did not attain the 2008 8-hour ozone NAAQS by the attainment
date of July 20, 2015, and therefore on May 4, 2016, EPA reclassified
the area from a Marginal nonattainment area to a Moderate nonattainment
area for the 2008 8-hour ozone standard. See 81 FR 26697. Subsequently,
on July 14, 2016, EPA determined that the Atlanta 2008 8-hour ozone
Area attained the 2008 8-hour ozone standard. See 81 FR 45419
(determination that the area attained the standard, also known as a
Clean Data Determination). EPA redesignated the Atlanta 2008 8-hour
ozone Area to attainment for the 2008 8-hour ozone NAAQS. See 82 FR
25523.
    On October 26, 2015 (80 FR 65292), EPA revised the 8-hour ozone
standard from 0.075 parts per million (ppm) to 0.070 ppm. Subsequently,
on June 4, 2018 (83 FR 25776), EPA designated the following seven
Atlanta counties as Marginal nonattainment for the 2015 8-hour ozone
NAAQS: Bartow, Clayton, Cobb, Dekalb, Fulton, Gwinnett, and Henry
(Atlanta 2015 8-hour ozone Area). The seven counties comprising the
Atlanta 2015 8-hour ozone Area were also part of the 13-county Atlanta
1979 1-hour ozone Area. Areas designated as Marginal nonattainment must
attain the standard by August 3, 2021. Although the attainment date is
August 3, 2021, Marginal areas must show attainment using air quality
data for years 2018 through 2020. Preliminary data indicates that the
Atlanta Area will be able to attain the 2015 8-hour ozone NAAQS by the
August 3, 2021, attainment deadline.\1\
---------------------------------------------------------------------------

    \1\ States are not required to certify their air quality data
until May 1st of the following year.
---------------------------------------------------------------------------

    On September 16, 2019, Georgia submitted a SIP revision requesting
removal of certain TCMs from the Georgia SIP. The following TCMs have
been approved into the Georgia SIP: High Occupancy Vehicle (HOV) Lanes;
High Occupancy Toll Lanes; Atlantic Station; Express Bus Routes;
Improvements/Expansion of Bus Service; Park and Ride Lots; Transit
Signal Preemption; Clean Fuel Buses; Clean Fuels Revolving Loan
Program; Intersection Upgrade, Coordination and Computerization; ATMS/
Incident Management; Regional Commute Options & HOV Marketing;
Transportation Management Associations; Transit Incentives; and
University Rideshare Programs. See 63 FR 23387 (April 29, 1998), 63 FR
34300 (June 24, 1998), 64 FR 13348 (March 18, 1999), 64 FR 20186 (April
26, 1999), 65 FR 52028 (August 28, 2000), 77 FR 24397 (April 24, 2012),
and Table 1, Appendix A, Table 2-1 and Table 2-2 of Georgia's September
16, 2019, SIP revision. Georgia is requesting removal of all the TCMs
that are approved into the SIP except for Intersection Upgrade,
Coordination and Computerization.
    Georgia's September 16, 2019, SIP revision includes a demonstration
that two offset measures--school bus replacements and rail locomotive

conversions--obtain the necessary emissions reductions to make up for
the increases in nitrogen oxides (NOX) and volatile organic
compounds (VOC) emissions resulting from the TCM removals. Removing the
TCMs will not worsen air quality because Georgia's offsets provided
compensating, equivalent, and contemporaneous emissions reductions to
negate the increases in emissions from NOX and VOC. More
information on the offsets is provided below.
    The Georgia Environmental Protection Division (GA EPD) has a school
bus early replacement program and a locomotive conversion program.
School bus replacement projects that were completed in 2018 using
Diesel Emissions Reduction Act funding have resulted in NOX
emissions reductions. Specifically, eighty-five older school buses
(built in 1999-2005) in Fulton County were replaced with 2018 engine
model year school buses. The Locomotive Conversion Program consists of
two components in the Atlanta Area: (1) The conversion of three older
Norfolk Southern Railway, Inc., traditional switcher locomotives into
newly-available low emissions engine technology and (2) Norfolk
Southern Railway, Inc.'s conversion of two switchers into ``slugs''
which are driven by electrical motors whose electricity is received
from companion ``mother'' locomotives. The offsets available from both
the school bus replacements and locomotive conversions total 38.85 tons
per year (tpy) of NOX. As there are 31.99 tpy of equivalent
NOX associated with removing the TCMs, the annual
NOX decreases from the school bus replacements and
locomotive conversions will offset the removal of the TCMs with 6.86
tpy excess NOX emissions offset that will remain available.
As further detailed in EPA's June 30, 2020, notice of proposed
rulemaking (NPRM), the school bus replacements and locomotive
conversions were more than what was needed to compensate for the amount
of NOX and VOC increases associated with removing the TCMs.
    Georgia's September 16, 2019, SIP revision also included an update
to the on-road emissions inventory and associated 2030 MVEBs due to the
removal of the TCMs. The on-road emissions inventory and safety margin
allocation for the year 2030 were updated but the MVEB totals
themselves remained unchanged. See Table 1 below.

                       Table 1--Updated MVEBs for the Atlanta 2008 8-Hour Ozone Area (tpd)
----------------------------------------------------------------------------------------------------------------
                                                             2014 \2\                          2030
                                                 ---------------------------------------------------------------
                                                        NOX             VOC             NOX             VOC
----------------------------------------------------------------------------------------------------------------
On-Road Emissions...............................          170.15           81.76           39.63           36.01
Safety Margin Allocation \3\....................  ..............  ..............           18.37           15.99
MVEBs with Safety Margin........................          170.15           81.76              58              52
----------------------------------------------------------------------------------------------------------------

    In the June 30, 2020, NPRM (85 FR 39135), EPA proposed to approve
the September 16, 2019, SIP revision. The details of Georgia's
submittal and the rationale for EPA's action are further explained in
the NPRM.
---------------------------------------------------------------------------

    \2\ The 2014 on-road emissions and MVEBs in this chart are shown
for illustration purposes only, as no changes were made to the 2014
attainment year emissions inventory due to removing the TCMs.
    \3\ The safety margin is the difference between the attainment
level of emissions (from all sources) and the projected level of
emissions (from all sources) in the maintenance plan. The
transportation conformity rule provides for establishing safety
margins for use in transportation conformity determinations. See 40
CFR 93.124(a).
---------------------------------------------------------------------------

II. Response to Comments

    EPA received three comments on the proposal. Overall, the
commenters disagreed with EPA's proposal to approve removal of the TCMs
from the Georgia SIP. EPA has summarized and responded to these adverse
comments below.
    Comment 1: A Commenter disagrees with EPA's proposal, asserting
that Georgia EPD does not have ``a very good reason for its request,''
making the request seem ``very arbitrary and capricious.'' The
Commenter goes on to discuss the expense to install the TCMs and the
usable lifespans of the TCMs and questions the State's objective in
removing the TCMs, while also acknowledging that EPA has ``no purview''
over the monetary costs of the TCMs. The Commenter mentions that there
is not enough analysis to determine whether removal of the TCMs ``will
allow the state to meet [the] NAAQS'' and questions the use of school
bus fleets to offset the potential increase in emissions as a result of
removal of certain TCMs from the SIP. Additionally, the Commenter
mentions that the State failed to consider the increases in other
pollutants such as carbon monoxide (CO) as a result of the retirement
of the express bus fleets.
    Response 1: EPA disagrees with the Commenter's assertions that this
action is arbitrary and capricious and that there is not enough
analysis to determine whether removal will allow the state to meet the
NAAQS. With respect to the Commenter's assertion that Georgia EPD
``does not have a very good reason for its request,'' EPA notes that,
with respect to SIPs, ``each State is given wide discretion in
formulating its plan,'' so long as the revision is consistent with the
applicable requirements of the CAA, including section 110(l). See Union
Elec. Co. v. EPA, 427 U.S. 246, 250 (1976); see also Alabama Envtl.
Council v. EPA, 711 F.3d 1277, 1280 (11th Cir. 2013), Sierra Club v.
EPA, 939 F.3d 649, 673 (5th Cir. 2019), and Alaska Dep't of Envtl.
Conservation v. EPA, 540 U.S. 461, 470 (2004). CAA section 110(l)
provides that the Administrator cannot approve a revision of a plan if
the revision would interfere with any applicable requirement concerning
attainment and reasonable further progress, or any other applicable
requirement of the CAA. Pursuant to section 110(k), EPA must approve a
SIP revision that meets all applicable CAA requirements, including
section 110(l).
    In EPA's June 30, 2020, NPRM, the Agency provided specific analysis
and rationale supporting its proposed approval of Georgia's September
16, 2019, SIP revision that demonstrates compliance with the CAA,
including section 110(l). As Georgia is in nonattainment only for the
2015 8-hour ozone NAAQS, Georgia was only required to obtain offsets to
ensure that the TCM removals would not affect attainment of the 2015 8-
hour ozone NAAQS. Georgia provided a technical analysis including
modeling showing that removal of the TCMs would not impact attainment
or maintenance of any NAAQS, and that Georgia secured offsetting,
contemporaneous, compensating, equivalent, emissions reductions for the
2015 8-hour ozone NAAQS. EPA reviewed Georgia's analysis and agrees
with the methodology and the results. EPA is not

aware of any information, and the Commenter did provide a demonstration
or other information, that is contrary to EPA's analysis and proposed
finding that Georgia's September 16, 2019, SIP revision complies with
CAA section 110(l).
    With respect to the offsets related to school buses, Georgia
provided data and calculations regarding emission reductions
attributable to school bus replacements in the September 16, 2019, SIP
submittal, which was included in Georgia's 110(l) demonstration, and
the Commenter did not provide any information indicating that these
data and calculations are erroneous.\4\ As discussed above and further
in the June 30 2020, NPRM, the school buses are only a part of the
emissions reductions that Georgia used to offset the increase in
emissions due to the removal of the TCMs, and between the locomotive
and school bus offsets, Georgia has secured more than enough offsets to
support removal of the TCMs.
---------------------------------------------------------------------------

    \4\ Data and calculations related to school bus offsets are
available in the docket to this action at Appendix F, documents EPA-
R04-OAR-2019-0661-0015, EPA-R04-OAR-2019-0661-0020, and EPA-R04-OAR-
2019-0661-0021.
---------------------------------------------------------------------------

    Although the Commenter asserts that Georgia failed to consider the
increases in other pollutants due to the retirement of the express bus
fleets, the Atlanta Regional Commission's (ARC) \5\ activity-based
modeling and Georgia's motor vehicle emissions modeling calculated the
emissions associated with the removal of the TCMs pertaining to transit
buses. Further, Georgia considered all pollutants in its analysis, but
provided more detail with respect to pollutants that are likely to be
increased due to the removal of the TCMs, specifically ozone and ozone
precursors (NOX and VOCs). Additional discussion regarding
VOCs, NOX, and particulate matter (PM) was included because
VOC and NOX emissions are also precursors for PM, and
NOX is also a precursor for nitrogen dioxide. The TCMs were
not designed to reduce emissions of sulfur dioxide (SO2),
CO, and PM10, and do not reduce SO2, CO, and
PM10 emissions. See the June 30, 2020, NPRM for more detail.
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    \5\ The Atlanta Regional Commission (ARC) is the federally
designated Metropolitan Planning Organization (MPO) and is
responsible for developing a multi-modal, financially constrained
transportation plan that meets all federal transportation and Clean
Air Act planning requirements.
---------------------------------------------------------------------------

    With respect to the Commenter's assertions specific to CO, EPA
disagrees. Removing the fleet of express buses as a TCM from the
Georgia SIP will not cause a violation of the CO NAAQS. The transit bus
fleet in the Atlanta area is mostly comprised of compressed natural gas
and diesel, which have low CO emissions. Further, there has never been
a designated CO nonattainment area in Georgia. Additionally, the
current level of the CO NAAQS is 9 ppm on an 8-hour average and 35 ppm
on a 1-hour average; the Atlanta Area's current design values for 2018-
2019 are 2.0 ppm for the 8-hr average and 2.2 ppm for the 1-hour
average, which equates to 78 percent and 94 percent below the standard,
respectively.
    Comment 2: A Commenter states that EPA should not remove the TCMs
from the Georgia SIP, that removal of the controls will create an
inconsistent regulatory environment that is contrary to the CAA, and
that removal of the TCMs would give Georgia an unfair advantage. The
Commenter also notes that the Georgia Department of Transportation
(GDOT) issued a draft environmental impact statement (EIS) ``for the
Georgia SIPs'' but that it was ``delayed because of legal reasons.''
    Response 2: EPA disagrees with the Commenter's assertions and is
not clear on how the removal of the TCMs creates an inconsistent
regulatory environment or gives Georgia an unfair advantage. The Agency
notes that TCMs were adopted into the SIP as part of the State's
discretion to implement measures to attain and maintain the NAAQS. The
CAA requires each state to have a SIP, which is a federally-enforceable
plan that identifies how the state will attain and maintain the NAAQS.
As discussed previously, states have wide discretion in determining the
control measures they choose to utilize in achieving and maintaining
the NAAQS. A state has the option of revising its SIP so long as state
and Federal requirements governing SIPs are met.
    It is unclear from the comment how an EIS relates to this action or
what draft EIS the Commenter is referring to. To the extent the
Commenter suggests that the SIP or this SIP revision should have gone
through an EIS process, EPA also disagrees. Generally, actions taken
under the CAA are exempted from the National Environmental Policy Act
of 1969 (NEPA), including this SIP action. See 15 U.S.C. 793(c)(1).
    Comment 3: A Commenter contends that EPA cannot remove the TCMs
from the Georgia SIP without ``input and concurrence'' from GDOT and
the Georgia Department of Environmental Management. The Commenter goes
on to assert that the SIP must be amended to ensure compliance with all
Federal and state laws that address the construction of new facilities,
the application of engineering standards, procedures or practices for
new facilities, and must ensure the ``highest level of protection,''
specifically referencing the ``Georgia Environmental Protection Act, as
revised,'' the CAA, and Federal requirements from the ``Federal
Aviation Act and Federal Motor Carrier Safety Improvement Act, as
revised.''
    Response 3: EPA agrees with the Commenter's assertion that
Georgia's removal of the TCMs is subject to ``input'' from various
agencies such as GDOT, and notes that the environmental agency for
Georgia is GA EPD, the author of the September 16, 2019, SIP revision.
Specifically, 40 CFR part 93 governs transportation conformity
requirements pursuant to CAA section 176(c) and requires interagency
consultation for certain actions. The interagency consultation process,
set forth in 40 CFR 93.105, is a process in which Federal, state, and
local jurisdictions consult on the status of air quality and
transportation projects. The Atlanta interagency consultation group
consists of transportation and air quality partners such as the Federal
Highway Administration-GA Division, US EPA Region 4, GA EPD, GDOT, the
ARC, Metropolitan Atlanta Rapid Transit Authority (MARTA), the Georgia
Regional Transportation Authority, and several others. Before
submitting the September 16, 2019, SIP revision requesting removal of
the TCMs from the Georgia SIP, GA EPD consulted with the Atlanta
interagency consultation group (which includes GDOT). None of the
Atlanta Interagency Consultation partners expressed objection to the
removal of the TCMs from the Georgia SIP.
    In addition, EPA disagrees with the Commenter's other assertions.
The removal of TCMs from Georgia's SIP does not involve the
construction of new facilities. EPA's review and approval of SIPs is
restricted to compliance with the CAA, rather than compliance with the
Georgia Environmental Protection Act or the Federal Aviation Act and
Federal Motor Carrier Safety Improvement Act. As discussed in more
detail above and in the NPRM, states have discretion as to the contents
of their plans, EPA must approve SIPs that meet the CAA requirements,
and Georgia's September 16, 2019, SIP revision meets CAA requirements.

III. Final Action

    EPA is taking final action to approve Georgia's September 16, 2019,
SIP revision to remove certain TCMs from the Georgia SIP that are
applicable within the Atlanta Area. This approval

updates Georgia's 2008 8-hour ozone standard Maintenance Plan,
specifically the on-road emissions inventory and the associated 2030
MVEBs, and measures offsetting the emissions increases due to removal
of the TCMs. EPA is also determining that this SIP revision will not
interfere with any requirement concerning attainment or any other
applicable CAA requirement.

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. See 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 they meet the criteria of the CAA. This 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 action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by May 7, 2021. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

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

    Dated: February 25, 2021.
John Blevins,
Acting Regional Administrator, Region 4.

    For the reasons stated in the preamble, EPA amends 40 CFR part 52
as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart L--Georgia

0
2. In Sec.  52.570, amend paragraph (e) by adding an entry for ``2008
8-hour ozone Maintenance Plan for the Atlanta Area, Revision for the
Removal of Transportation Control Measures'' at the end of the table to
read as follows:

Sec.  52.570  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Georgia Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                                             State
    Name of nonregulatory SIP           Applicable      submittal date/
            provision                 geographic or        effective     EPA approval date       Explanation
                                    nonattainment area       date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
2008 8-hour ozone Maintenance      Bartow, Cherokee,         9/16/2019  3/8/2021, [Insert    ...................
 Plan for the Atlanta Area,         Clayton, Cobb,                       citation of
 Revision for the Removal of        Coweta, DeKalb,                      publication].
 Transportation Control Measures.   Douglas, Fayette,
                                    Forsyth, Fulton,
                                    Gwinnett, Henry,
                                    Newton, Paulding,
                                    and Rockdale
                                    Counties.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-04413 Filed 3-5-21; 8:45 am]
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