[Federal Register Volume 84, Number 98 (Tuesday, May 21, 2019)]
[Rules and Regulations]
[Pages 22984-22985]
[FR Doc No: 2019-10563]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2018-0064; FRL-9993-89-Region 4]

Air Plan Approval; Georgia: Permit Exemption for Fire Fighting
Equipment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve two revisions to the Georgia State Implementation
Plan (SIP), submitted by the State of Georgia, through the Georgia
Environmental Protection Division (Georgia EPD), with two letters dated
November 13, 2017, and July 31, 2018. Specifically, EPA is approving
changes that revise existing exemptions for firefighting equipment. EPA
is approving these SIP revisions because the Agency believes that they
are consistent with the Clean Air Act (CAA or Act).

DATES: This rule will be effective June 20, 2019.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R04-OAR-2018-0064. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information or other information whose disclosure is restricted by
statute. Certain other material, such as copyrighted material, is not
placed on the internet and will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically through www.regulations.gov or in hard copy at the Air
Regulatory Management Section, Air Planning and Implementation Branch,
Air and Radiation Division (formerly the Air, Pesticides and Toxics
Management Division), U.S. Environmental Protection Agency, Region 4,
61 Forsyth Street SW, Atlanta, Georgia 30303-8960. EPA requests that if
at all possible, you contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to schedule your inspection. The Regional
Office's official hours of business are Monday through Friday 8:30 a.m.
to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Andres Febres, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, Region 4, U.S. Environmental Protection Agency, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-8966. Mr. Febres can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Through a letter dated November 13, 2017, Georgia EPD submitted a
SIP revision for EPA's approval that included several miscellaneous
rule amendments.\1\ Specifically, the November 13, 2017, SIP revision
included changes to Georgia's Air Quality Control Rule 391-3-1-.01--
``Definitions,'' Rule 391-3-1-.02(4)--``Ambient Air Standards,'' Rule
391-3-1-.02(7)--``Prevention of Significant Deterioration of Air
Quality,'' Rule 391-3-1-.03(6)--``Exemptions,'' Rule 391-3-1-.03(8)--
``Permit Requirements,'' and Rule 391-3-1-.03(10)--``Title V Operating
Permits.''
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    \1\ EPA notes that the Agency received this submittal on
November 29, 2017.
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    Through an additional letter dated July 31, 2018, Georgia EPD
submitted several SIP revisions that included some miscellaneous rule
amendments.\2\ Specifically, the July 31, 2018, SIP revisions included
changes to Georgia's Air Quality Control Rule 391-3-1-.01--
``Definitions,'' Rule 391-3-1-.02(2)(c)--``Incinerators,'' Rule 391-3-
1-.02(4)--``Ambient Air Standards,'' Rule 391-3-1-.02(12)--``Cross
State Air Pollution Rule NOX Annual Trading Program,'' Rule
391-3-1-.02(13)--``Cross State Air Pollution Rule SO2 Annual
Trading Program,'' Rule 391-3-1-.02(14)--``Cross State Air Pollution
Rule NOX Ozone Season Trading Program,'' Rule 391-3-
1-.03(6)--``Exemptions,'' Rule 391-3-1-.03(11)--``Permit by Rule,''
Rule 391-3-1-.03(10)--``Title V Operating Permits,'' Rule 391-3-1-.11--
``Small Business Assistance Administration,'' and Rule 391-3-1-.12--
``Duties of the Small Business Ombudsman Office.''
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    \2\ EPA notes that the Agency received this submittal on August
2, 2018.
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    In a notice of proposed rulemaking (NPRM) published on February 1,
2019, (84 FR 1037), EPA proposed to approve revisions to the Georgia's
Rule 391-3-1-.03(6), which addresses exemptions for firefighting
equipment from minor new source review (NSR) requirements. EPA provided
further analysis of these revisions, as well as the Agency's rationale
for approving the changes, in its NPRM. Comments on the NPRM were due
on or before March 4, 2019. EPA received no adverse comments on the
proposed action. EPA is now taking final action to approve the above-
referenced revision.

II. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of Georgia EPD's
Rule 391-3-1-.03(6)--``Exemptions,'' which became state effective July
23, 2018. EPA has made, and will continue to make, these materials
generally available through www.regulations.gov and at the EPA Region 4
Office (please contact the person identified in the For Further
Information Contact section of this preamble for more information).
Therefore, these materials have been approved by EPA for inclusion in
the SIP, have been incorporated by reference by EPA into that plan, are
fully federally enforceable under sections 110 and 113 of the CAA as of
the effective date of the final rulemaking of EPA's approval, and will
be incorporated by reference in the next update to the SIP
compilation.\3\
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    \3\ See 62 FR 27968 (May 22, 1997).
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III. Final Action

    EPA is approving Georgia EPD's November 13, 2017, and July 31,
2018, SIP revisions. Specifically, EPA is approving these SIP revisions
that modify Georgia's Rule 391-3-1-.03(6). The changes at Georgia Rule
391-3-1-.03(6)(b)(13) exempt fire pumps and other equipment used by
firefighters and other emergency personnel to fight fires from the
Act's preconstruction review requirement. As discussed in further
detail in EPA's February 1, 2019, (84 FR 1037) NPRM, the Agency
believes that any air quality impacts from these activities are de
minimis and will often lead to net emissions reductions by mitigating
or eliminating the air quality impacts of uncontrolled fires. EPA is
approving these SIP revisions because the Agency has determined that
they are consistent with the CAA and will not interfere with attainment
or maintenance of any NAAQS, reasonable further progress, or any other
applicable 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 that 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);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     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 July 22, 2019. 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: May 6, 2019.
Mary S. Walker,
Acting Regional Administrator, Region 4.
    40 CFR part 52 is amended 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, the table in paragraph (c) is amended by revising
the entry ``391-3-1-.03(6)'' to read as follows:

Sec.  52.570  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Georgia Regulations
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                                                            State
          State citation               Title/subject      effective    EPA approval  date        Explanation
                                                             date
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----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
                                                     Permits
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
391-3-1-.03(6)...................  Exemptions..........    7/23/2018  5/21/2019, [insert
                                                                       Federal Register
                                                                       citation].

                                                  * * * * * * *
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* * * * *
[FR Doc. 2019-10563 Filed 5-20-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16289-16291]
[FR Doc No: 2023-05335]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97104; File No. SR-FINRA-2023-004]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Revise the Research Analyst (Series 86/87)
Examination

March 10, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 28, 2023, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. FINRA has
designated the proposed rule change as ``constituting a stated policy,
practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule'' under Section
19(b)(3)(A)(i) of the Act \3\ and Rule 19b-4(f)(1) thereunder,\4\ which
renders the proposal effective upon receipt of this filing by 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)(i).
    \4\ 17 CFR 240.19b-4(f)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing revisions to the content outline and selection
specifications for the Research Analyst (Series 86/87) exam program,
including a reduction of the number of scored questions on the Series
86 exam. The proposed revisions update the material to incorporate the
functions and associated tasks currently performed by a Research
Analyst and to reflect the laws, rules, and regulations most relevant
to these functions and associated tasks. FINRA is also proposing to
make changes to the format of the content outline to reflect these
revisions. FINRA is not proposing any textual changes to the By-Laws,
Schedules to the By-Laws, or Rules of FINRA.
    The revised content outline appears in Exhibit 3a. The Series 86/87
exam selection specifications have been submitted to the Commission
under separate cover with a request for confidential treatment pursuant
to Exchange Act Rule 24b-2.\5\
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    \5\ 17 CFR 240.24b-2; FINRA also is proposing corresponding
revisions to the Series 86/87 question bank. Based on instruction
from the Commission, FINRA is submitting this filing for immediate
effectiveness pursuant to Section 19(b)(3)(A) of the Act and Rule
19b-4(f)(1) thereunder, and FINRA is not filing the question bank
for review. See Letter from Belinda Blaine, Associate Director,
Division of Market Regulation, SEC, to Alden S. Adkins, Senior Vice
President and General Counsel, NASD Regulation Inc., dated July 24,
2000. The question bank is available for the Commission's review.
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    The text of the proposed rule change is available on FINRA's
website at http://www.finra.org, at the principal office of FINRA 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, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA 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
    Section 15A(g)(3) of the Exchange Act \6\ authorizes FINRA to
prescribe standards of training, experience, and competence for persons
associated with FINRA members. In accordance with this provision, FINRA
has developed exams that are designed to establish that persons
associated with FINRA members have attained specified levels of
competence and knowledge, consistent with applicable registration
requirements under FINRA rules. FINRA periodically reviews the content
of the exams to determine whether revisions are necessary or
appropriate in view of changes pertaining to the subject matter covered
by the exams.
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    \6\ 15 U.S.C. 78o-3(g)(3).
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    FINRA Rule 1220(b)(6) (``Research Analyst'') requires an associated
person whose primary job function is to provide investment research and
who is primarily responsible for the preparation of the substance of an
equity research report,\7\ or whose name appears on an equity research
report, to be registered and qualified as a Research Analyst.\8\ An
associated person registering as Research Analyst after October 1,
2018, shall, prior to or concurrent with such registration, pass the
general knowledge co-requisite Securities Industry Essentials (SIE)
Exam and the Series 86/87 exam, or obtain a waiver.\9\ Rather than pass
both the Series 86 and Series 87 exams, an associated person may obtain
a waiver from the analytical portion (Series 86 exam) upon written
request (pursuant to the FINRA Rule 9600 Series) and verification that
the applicant has passed:
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    \7\ See Rule 2241(a)(11).
    \8\ See Rule 1220(b)(6).
    \9\ See Rule 1220(b)(6)(B) (``Qualifications'').
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    (i) Levels I and II of the CFA Examination; or
    (ii) if the applicant functions as a research analyst who prepares
only technical research reports as defined in paragraph (b)(6) of Rule
1220, Levels I and II of the Chartered Market Technician (``CMT'')
Examination; and
    (iii) has either functioned as a research analyst continuously
since having passed the Level II CFA or CMT

Examination or applied for registration as a Research Analyst within
two years of having passed the Level II CFA or CMT Examination.\10\
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    \10\ See Rule 1220(b)(6)(B) (``Qualifications'').
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    FINRA has created Qualification Exam Content Committees to advise
FINRA's Testing and Continuing Education Department regarding the
content of all qualification exams. Committee members are drawn from
the industry and self-regulatory organization staff.\11\ In
consultation with the appropriate committee of industry
representatives, FINRA recently reviewed the Series 86/87 exam program.
As a result of this review, FINRA is proposing to revise the content
outline to incorporate the functions and associated tasks currently
performed by a Research Analyst and to reflect the laws, rules, and
regulations most relevant to these functions and associated tasks.
FINRA is also proposing to make changes to the format of the content
outline to reflect these revisions.
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    \11\ More information about the Qualification Exam Content
Committees can be found on FINRA's website at https://www.finra.org/about/governance/ad-hoc-committees.
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Current Outline
    The current content outline is divided into two parts, with each
part divided further into major functions performed by a Research
Analyst. The following reflects the two parts, total number of
questions associated with each part, and major job functions, including
the allocation of questions among the major job functions:
    Part I. Series 86 (100 questions):
    Function 1: Information and Data Collection (10 questions); and
    Function 2: Analysis, Modeling and Valuation (90 questions).
    Part II. Series 87 (50 questions):
    Function 3: Preparation of Research Reports (32 questions); and
    Function 4: Dissemination of Information (18 questions).
    The current outline describes each function, including specific
tasks and activities associated with performing that function. The
current outline also includes a preface addressing the purpose,
structure, administration and scoring of the exams.
Proposed Revisions
    FINRA is proposing to divide the Series 86 exam into three major
job functions and to reduce the length of the Series 86 exam from 100
questions to 85 questions. The Series 87 exam will remain divided into
two functions with 50 questions total, though the number of questions
will be reallocated between the two functions of the Series 87 exam.
The following reflects the proposed revisions:
    Part I. Series 86 (85 questions):
    Function 1: Information and Data Collection (18 questions);
    Function 2: Data Verification and Analysis (28 questions); and
    Function 3: Valuation and Forecasting (39 questions).
    Part II. Series 87 (50 questions):
    Function 4: Preparation of Research Reports (36 questions); and
    Function 5: Dissemination and Marketing of Information (14
questions).
    Each function includes specific tasks describing activities
associated with performing that function. There are two tasks (1.1-1.2)
associated with Function 1; one task (2.1) associated with Function 2;
three tasks (3.1-3.3) associated with Function 3; two tasks (4.1-4.2)
associated with Function 4; and two tasks (5.1-5.2) associated with
Function 5.\12\ For example, one such task (3.3) is ``forecast the
future valuation of the company and determine any recommendation by
identifying key catalysts that may alter the price of a stock and
identifying patterns or events (macro, political, or company-specific)
that move stock prices and create investment opportunities.'' \13\
Further, the content outline lists the knowledge required to perform
each function and associated tasks (e.g., characteristics of markets,
factors that could impact the perceived risk of an investment,
technical analysis, large shareholder exposure, activist investors,
valuation considerations).\14\ Additionally, where applicable, the
content outline lists the laws, rules and regulations a candidate is
expected to know to perform each function and associated tasks. These
include the applicable FINRA rules (e.g., FINRA Rule 2241) and SEC
rules and regulations (e.g., Regulation AC under the Exchange Act).\15\
FINRA conducted a job analysis study of Research Analysts,\16\ which
included the use of a survey, to develop each function and associated
tasks and update the required knowledge set forth in the revised
content outline. These functions and associated tasks reflect the day-
to-day activities of a Research Analyst.
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    \12\ See Exhibit 3a, Outline Pages 3-9.
    \13\ See Exhibit 3a, Outline Page 6.
    \14\ See Exhibit 3a, Outline Pages 3-9.
    \15\ See Exhibit 3a, Outline Page 7.
    \16\ FINRA periodically conducts job analysis studies to help
ensure exams test current job functions and required knowledge of
registered representatives to perform associated tasks. This is an
internal process that may include conducting focus panels,
consulting with the appropriate committees, or surveying registered
representatives to determine current job functions and associated
tasks of registered representatives so that FINRA may update exams
accordingly.
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    In reviewing the results of the survey and the changes to the tasks
and knowledge required to function as a Research Analyst, FINRA
believes an 85-question Series 86 exam can sufficiently sample the
requisite knowledge domain. FINRA looked at the impact of shorter test
forms on key psychometric properties of the test, including decision
agreement (the probability that the 85-item version of the test and the
100-item version yield the same pass-fail result for a given examinee).
The results show that the move to 85-item test forms will have minimal
impact on the effectiveness of the Series 86 exam in assessing the
level of proficiency required of an entry-level Research Analyst.
Therefore, the 85-question Series 86 exam can reliably assess the level
of proficiency required of an entry-level Research Analyst. The time
given to complete the Series 86 exam will remain at four hours and 30
minutes to continue to ensure candidate performance is not affected by
time constraints.\17\
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    \17\ The time given to complete the Series 87 exam will also
remain the same, at one hour and 45 minutes.
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    As noted above, FINRA is also proposing to revise the content
outline to reflect the laws, rules, and regulations most relevant to
the functions and associated tasks of a Research Analyst, including
incorporating FINRA Rule 5280 (``Trading Ahead of Research Reports'')
in the content outline.\18\
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    \18\ The proposed revisions to the content outline will also
reflect the removal of FINRA Rule 2220 (``Options Communications'')
from the content outline because, based on discussions with the
appropriate committee of industry representatives, this rule is not
relevant to the functions and associated tasks currently performed
by Research Analysts.
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    Finally, FINRA is proposing corresponding changes to the Series 86/
87 selection specifications and question bank.
Availability of Content Outline
    The current Series 86/87 exam content outline is available on
FINRA's website, at www.finra.org/brokerqualifications/exams. The
revised Series 86/87 exam content outline will replace the current
content outline on FINRA's website.
    FINRA is filing the proposed rule change for immediate
effectiveness. FINRA will announce the implementation date of the
proposed rule change in a Regulatory Notice to be published following
Commission notice of the filing of the proposed rule change for
immediate effectiveness.

2. Statutory Basis
    FINRA believes that the proposed revisions to the Series 86/87 exam
program are consistent with the provisions of Section 15A(b)(6) of the
Exchange Act,\19\ which requires, among other things, that FINRA rules
must be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, and, in
general, to protect investors and the public interest, and Section
15A(g)(3) of the Exchange Act,\20\ which authorizes FINRA to prescribe
standards of training, experience, and competence for persons
associated with FINRA members. FINRA believes that the proposed
revisions will further these purposes by updating the exam program to
incorporate the functions and associated tasks currently performed by a
Research Analyst and to reflect the most relevant laws, rules and
regulations covered by the exams.
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    \19\ 15 U.S.C. 78o-3(b)(6).
    \20\ 15 U.S.C. 78o-3(g)(3).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed revisions will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Exchange Act. The updated exam
program aligns with the functions and associated tasks currently
performed by Research Analysts and tests knowledge of the most relevant
laws, rules, regulations and skills relevant to those functions and
tasks. As such, the proposed revisions would make the exams more
efficient and effective.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \21\ and paragraph (f)(1) of Rule 19b-4
thereunder.\22\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act. If
the Commission takes such action, the Commission shall institute
proceedings to determine whether the proposed rule should be approved
or disapproved.
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    \21\ 15 U.S.C. 78s(b)(3)(A).
    \22\ 17 CFR 240.19b-4(f)(1).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-FINRA-2023-004 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-FINRA-2023-004. 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 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of FINRA. 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-
FINRA-2023-004 and should be submitted on or before April 6, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
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    \23\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-05335 Filed 3-15-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: September 9, 2009 (Volume 74, Number 173)]
[Notices]
[Page 46430-46432]
[DOCID:fr09se09-62]

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

Food and Drug Administration

[Docket No. FDA-2009-N-0372]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Environmental Impact Considerations

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
contained in FDA regulations entitled ``Environmental Impact
Considerations.''

DATES:  Submit written or electronic comments on the collection of
information by November 9, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Environmental Impact Considerations--21 CFR Part 25 (OMB Control Number
0910-0322)--Extension

    FDA is requesting OMB approval for the reporting requirements
contained in the FDA regulation ``Environmental Impact
Considerations.'' The National Environmental Policy Act (NEPA) (42
U.S.C. 4321-4347) states national environmental objectives and imposes
upon each Federal agency the duty to consider the environmental effects
of its actions. Section 102(2)(C) of NEPA requires the preparation of
an environmental impact statement (EIS) for every major Federal action
that will significantly affect the quality of the human environment.
The FDA NEPA regulations are in part 25 (21 CFR part 25). All
applications or petitions requesting agency action require the
submission of a claim for a categorical exclusion or an environmental
assessment (EA). A categorical exclusion applies to certain classes of
FDA-regulated actions that usually have little or no potential to cause
significant environmental effects and are excluded from the
requirements to prepare an EA or EIS. Section 25.15(a) and (d)
specifies the procedures for submitting to FDA a claim for a
categorical exclusion. Extraordinary circumstances (Sec.  25.21), which
may result in significant environmental impacts, may exist for some
actions that are usually categorically excluded. An EA provides
information that is used to determine whether an FDA action could
result in a significant environmental impact. Section 25.40(a) and (c)
specifies the content requirements for EAs for nonexcluded actions.
    This collection of information is used by FDA to assess the
environmental impact of agency actions and to ensure that the public is
informed of environmental analyses. Firms wishing to manufacture and
market substances regulated under statutes for which FDA is responsible
must, in most instances, submit applications requesting approval.
Environmental information must be included in such applications for the
purpose of determining whether the proposed action may have a
significant impact on the environment. Where significant adverse
effects cannot be avoided, the agency uses the submitted information as
the basis for preparing and circulating to the public an EIS, made
available through a Federal Register document also filed for comment at
the Environmental Protection Agency. The final EIS, including the
comments received, is reviewed by the agency to weigh environmental
costs and benefits in determining whether to pursue the proposed action
or some alternative that would reduce expected environmental impact.
    Any final EIS would contain additional information gathered by the
agency's after the publication of the draft EIS, a copy of or a summary
of the comments received on the draft EIS, and

the agency's responses to the comments, including any revisions
resulting from the comments or other information. When the agency finds
that no significant environmental effects are expected, the agency
prepares a finding of no significant impact (FONSI).

Estimated Annual Reporting Burden for Human Drugs (including biologics
in the Center for Drug Evaluation and Research)

    Under Sec.  312.23(a)(7)(iv)(e) (21 CFR 312.23(a)(7)(iv)(e)), 21
CFR 314.50(d)(1)(iii), and 21 CFR 314.94(a)(9)(i), each investigational
new drug application (IND), new drug application (NDA), and abbreviated
new drug application (ANDA) must contain a claim for categorical
exclusion under Sec.  25.30 or Sec.  25.31 or an EA under Sec.  25.40.
In 2008, FDA received 2,550 INDs from 2,026 sponsors; 106 NDAs from 88
applicants; 2,856 supplements to NDAs from 615 applicants; 13 biologics
license applications (BLAs) from 9 applicants; 206 supplements to BLAs
from 64 applicants; 835 ANDAs from 165 applicants; and 4,143
supplements to ANDAs from 224 applicants. FDA estimates that it
receives approximately 10,689 claims for categorical exclusions as
required under Sec.  25.15(a) and (d), and 20 EAs as required under
Sec.  25.40(a) and (c). Based on information provided by the
pharmaceutical industry, FDA estimates that it takes sponsors or
applicants approximately 8 hours to prepare a claim for a categorical
exclusion and approximately 3,400 hours to prepare an EA.
    FDA estimates the burden of this collection of information as
follows:

                         Table 1.--Estimated Annual Reporting Burden for Human Drugs\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and                3,171                  3.37             10,686                  8             85,488
 (d)
----------------------------------------------------------------------------------------------------------------
25.40(a) and                   20                     1                 20              3,400             68,000
 (c)
----------------------------------------------------------------------------------------------------------------
Total                                                                                153,488
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Estimated Annual Reporting Burden for Human Foods

    Under 21 CFR 71.1, 171.1, 170.39, and 170.100, food additive
petitions, color additive petitions, requests for exemption from
regulation as a food additive, and submission of a food contact
notification (FCN) for a food contact substance must contain either a
claim of categorical exclusion under Sec.  25.30 or Sec.  25.32, or an
EA under Sec.  25.40. In 2008, FDA received 112 industry submissions.
FDA received an annual average of 67 claims of categorical exclusions
as required under Sec.  25.15(a) and (d), and 45 EAs as required under
Sec.  25.40(a) and (c). FDA estimates that, on average, it takes
petitioners, notifiers, or requestors approximately 3 hours to prepare
a claim of categorical exclusion and approximately 210 hours to prepare
an EA.

                         Table 2.--Estimated Annual Reporting Burden for Human Foods\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and                   40                   1.7                 68                  3                204
 (d)
----------------------------------------------------------------------------------------------------------------
25.40(a) and                   24                   1.9                 45                210              9,450
 (c)
----------------------------------------------------------------------------------------------------------------
Total                                                                                9,654
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Estimated Annual Reporting Burden for Medical Devices

    Under 21 CFR 814.20(b)(11), premarket approvals (PMAs) (original
PMAs and supplements) must contain a claim for categorical exclusion
under Sec.  25.30 or Sec.  25.34 or an EA under Sec.  25.40. In 2008,
FDA received approximately 39 claims (original PMAs and supplements)
for categorical exclusions as required under Sec.  25.15(a) and (d),
and 0 EAs as required under Sec.  25.40(a) and (c). Based on
information provided by less than 10 sponsors, FDA estimates that it
takes approximately 6 hours to prepare a claim for a categorical
exclusion and an unknown number of hours to prepare an EA.

                       Table 3.--Estimated Annual Reporting Burden for Medical Devices\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and                   39                     1                 39                  6                234
 (d)
----------------------------------------------------------------------------------------------------------------
25.40(a) and                    1                     1                  1                  1                  1
 (c)
----------------------------------------------------------------------------------------------------------------
Total                                                                                235
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Estimated Annual Reporting Burden for Biological Products in the Center
for Biologics Evaluation and Research

    Under Sec.  312.23(a)(7)(iv)(e) and 601.2(a), INDs and BLAs must
contain a claim for categorical exclusion under Sec.  25.30 or Sec.
25.31 or an EA under Sec.  25.40. In 2008, FDA received 245 INDs from
180 sponsors, 28 BLAs from 13 applicants, and 972 BLA supplements to
license applications from 173 applicants. FDA estimates that
approximately 10 percent of these supplements would be submitted with a
claim for categorical exclusion or an EA.
    FDA estimates that it received approximately 370 claims for
categorical exclusion as required under Sec.  25.15(a) and (d), and 2
EAs as required under Sec.  25.40(a) and (c). Based on information
provided by industry, FDA estimates that it takes sponsors and
applicants approximately 8 hours to prepare a claim for categorical
exclusion and approximately 3,400 hours to prepare an EA for a
biological product.

                     Table 4.--Estimated Annual Reporting Burden for Biological Products\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and                  210                  1.76                370                  8              2,960
 (d)
----------------------------------------------------------------------------------------------------------------
25.40(a) and                    2                  1                     2              3,400              6,800
 (c)
----------------------------------------------------------------------------------------------------------------
Total                                                                                9,760
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Estimated Annual Reporting Burden for Animal Drugs

    Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and
abbreviated new animal drug applications (ANADAs); 21 CFR 514.8(a)(1)
supplemental NADAs and ANADAs; 21 CFR 511.1(b)(10) investigational new
animal drug applications (INADs); and 21 CFR 571.1(c) food additive
petitions must contain a claim for categorical exclusion under Sec.
25.30 or Sec.  25.33 or an EA under Sec.  25.40. In 2008, FDA's Center
for Veterinary Medicine received approximately 676 claims for
categorical exclusion as required under Sec.  25.15(a) and (d), and 8
EAs as required under Sec.  25.40(a) and (c). FDA estimates that it
takes sponsors/applicants approximately 5 hours to prepare a claim for
a categorical exclusion and an average of 2,160 hours to prepare an EA.

                         Table 5.--Estimated Annual Reporting Burden for Animal Drugs\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and                   65                  10.4                676                  5              3,380
 (d)
----------------------------------------------------------------------------------------------------------------
25.40(a) and                    6                   1.3                  8              2,160             17,280
 (c)
----------------------------------------------------------------------------------------------------------------
Total                                                                                20,660
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

 Table 6.--Combined Estimated Annual Total Burden Hours for All Centers
Total                                                            193,797
------------------------------------------------------------------------
------------------------------------------------------------------------

    Dated: August 28, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21724 Filed 9-8-09; 8:45 am]

BILLING CODE 4160-01-S