[Federal Register Volume 77, Number 170 (Friday, August 31, 2012)]
[Notices]
[Pages 53249-53250]
[FR Doc No: 2012-21542]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Airports
Grants Program

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The FAA collects information from airport sponsors and
planning agencies in order to administer the Airports Grants Program.
Data is

used to determine eligibility, ensure proper use of Federal Funds, and
ensure project accomplishment.

DATES: Written comments should be submitted by October 30, 2012.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0569.
    Title: Airports Grants Program.
    Form Numbers: FAA forms 5100-100, 5100-101, 5100-108, 5100-125,
5100-126, and 5370-1.
    Type of Review: Renewal of an information collection.
    Background: Codification of Certain U.S. Transportation Laws at 49
U.S.C. (Pub. L. 103-272), which is referred to as the ``Act,'' provides
funding for airport planning and development projects at airports
included in the National Plan of Integrated Airport Systems. The Act
also authorizes funds for noise compatibility planning and to carry out
noise compatibility programs. The information required by this program
is necessary to protect the Federal interest in safety, efficiency, and
utility of the Airport. Data is collected to meet report requirements
of 49 CFR part 18 for financial management and performance monitoring.
Information is collected in the application, and grant agreement
amendments; financial management; and performance reporting.
    Respondents: Approximately 1,950 sponsors and planning agencies for
grant projects.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 6.75 hours.
    Estimated Total Annual Burden: 80,569 hours.
ADDRESSES: Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, AES-200, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on August 24, 2012.
Kathy A. DePaepe,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2012-21542 Filed 8-30-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 139 (Monday, July 21, 2014)]
[Rules and Regulations]
[Pages 42211-42214]
[FR Doc No: 2014-16409]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2013-0789; FRL-9913-42-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
West Virginia; Minor New Source Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of West
Virginia. The revision will expedite the processing of certain
preconstruction permits issued under West Virginia's minor New Source
Review (NSR) Program. Notably, the revision will allow, in certain
circumstances, construction prior to obtaining a permit, and will allow
equipment and materials to be delivered and stored onsite prior to
permit issuance. EPA is approving these revisions to West Virginia's
minor NSR Program in accordance with the requirements of the Clean Air
Act (CAA).

DATES: This final rule is effective on August 20, 2014.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2013-0789. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State
submittal are available at the West Virginia Department of
Environmental Protection, Division of Air Quality, 601 57th Street SE.,
Charleston, West Virginia 25304.

FOR FURTHER INFORMATION CONTACT: Gerallyn Duke,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On February 14, 2014 (79 FR 8914), EPA published a notice of
proposed rulemaking (NPR) for the State of West Virginia. In the NPR,
EPA proposed approval of revisions to rule 45CSR13: ``Permits for
Construction, Modification, Relocation and Operation of Stationary
Sources of Air Pollutants, Notification Requirements, Administrative
Updates, Temporary Permits, General Permits, Permission to Commence
Construction, and Procedures for Evaluation.'' The West Virginia
legislature adopted these revisions to rule 45CSR13 in 2008 and West
Virginia submitted the formal SIP revision on July 20, 2009.
    The purpose of this SIP revision is to shorten the time period by
which permits for construction and operation may be issued for sources
subject to minor NSR rules; to allow, in certain instances,
construction prior to obtaining a permit; and to allow equipment and
materials to be delivered and stored onsite prior to minor NSR permit
issuance.

II. Summary of SIP Revision

    The July 20, 2009 SIP revision will (a) reduce the time allotted
for West Virginia Department of Environmental Protection (WVDEP) to
process minor NSR permits from 180 days to 90 days after a permit
application is deemed complete, (b) reduce the time for WVDEP to
process temporary minor NSR permits from 60 days to 45 days after a
complete application is received, and (c) reduce the time for WVDEP to
process Class II general permits from 90 days to 45 days after a
general permit registration application is deemed complete. The SIP
revision also creates a mechanism for the following types of sources to
commence construction prior to obtaining a permit, provided that
operation does not commence until a permit is issued: New and modified
stationary sources which are not major sources, major stationary
sources proposing non-major modifications, and sources subject to
general permits. Sources of hazardous air pollutants subject to CAA
subsections 112(g) or 112(j), sources seeking ``synthetic minor''
permits to avoid otherwise applicable standards, and sources requiring
specific case-by-case emission limits under 45CSR21 or 45CSR27 are
ineligible for permission to commence construction in advance of permit
issuance. Additionally, the SIP revision allows equipment and materials
to be delivered and stored onsite prior to permit issuance and includes
other minor clarifying changes to West Virginia's minor NSR rule.
    If WVDEP determines that any proposed construction, modification,
registration or relocation interferes with attainment or maintenance of
an applicable ambient air quality standard, causes or contributes to a
violation of an applicable air quality increment, or is inconsistent
with the intent and purpose of 45CSR13, WVDEP shall issue an order
denying the proposed activity. No permission to commence construction
in advance of permit issuance is allowed if WVDEP deems it is
inconsistent with any Federal requirement, Federal delegation,
Federally approved requirement in any SIP, or Federally approved
requirement under the title V permitting program.
    Other specific requirements of the regulations and the rationale
for EPA's proposed action are explained in the NPR and will not be
restated here. No public comments were received on the NPR.

III. Final Action

    EPA is approving West Virginia's SIP submission dated July 20,
2009, which consists of a new version of 45CSR13 that revises West
Virginia's minor NSR Program as a revision to the West Virginia SIP.

IV. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
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 Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National

Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with
the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    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).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 19, 2014. Filing a petition for
reconsideration by the Administrator 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
related to West Virginia's minor NSR Program 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, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: June 17, 2014.
W.C. Early,
Acting Regional Administrator, Region III.

    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 XX--West Virginia

0
2. In Sec.  52.2520, the table in paragraph (c) is amended by revising
the table heading and the entries for ``[45 CSR] Series 13'' to read as
follows:

Sec.  52.2520  Identification of plan.

* * * * *
    (c) * * *

                                EPA-Approved Regulations in the West Virginia SIP
----------------------------------------------------------------------------------------------------------------
                                                       State
 State citation  [Chapter 16-20    Title/subject     effective   EPA Approval date     Additional explanation/
           or 45 CSR]                                   date                         citation at 40 CFR 52.2565
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
[45 CSR] Series 13 Permits for Construction, Modification, Relocation and Operation of Stationary Sources of Air
Pollutants, Notification Requirements, Administrative Updates, Temporary Permits, General Permits, Permission to
                               Commence Construction and Procedures for Evaluation
----------------------------------------------------------------------------------------------------------------
Section 45-13-1................  General..........       6/1/09  7-21-14 [Insert
                                                                  Federal Register
                                                                  citation].
Section 45-13-2................  Definitions......       6/1/09  7-21-14 [Insert
                                                                  Federal Register
                                                                  citation].
Section 45-13-3................  Reporting               6/1/09  7-21-14 [Insert
                                  Requirements for                Federal Register
                                  Stationary                      citation].
                                  Sources.
Section 45-13-4................  Administrative          6/1/09  7-21-14 [Insert
                                  Updates to                      Federal Register
                                  Existing Permits                citation].
                                  and General
                                  Permit
                                  Registrations.
Section 45-13-5................  Permit                  6/1/09  7-21-14 [Insert
                                  Application and                 Federal Register
                                  Reporting                       citation].
                                  Requirements for
                                  Construction of
                                  and
                                  Modifications to
                                  Stationary
                                  Sources.
Section 45-13-6................  Determination of        6/1/09  7-21-14 [Insert
                                  Compliance of                   Federal Register
                                  Stationary                      citation].
                                  Sources.
Section 45-13-7................  Modeling.........       6/1/09  7-21-14 [Insert
                                                                  Federal Register
                                                                  citation].
Section 45-13-8................  Public Review           6/1/09  7-21-14 [Insert
                                  Procedures.                     Federal Register
                                                                  citation].
Section 45-13-9................  Public Meetings..       6/1/09  7-21-14 [Insert
                                                                  Federal Register
                                                                  citation].
Section 45-13-10...............  Permit Transfer,        6/1/09  7-21-14 [Insert
                                  Suspension,                     Federal Register
                                  Revocation and                  citation].
                                  Responsibility.
Section 45-13-11...............  Temporary               6/1/09  7-21-14 [Insert
                                  Construction or                 Federal Register
                                  Modification                    citation].
                                  Permits.

Section 45-13-12...............  Permit                  6/1/09  7-21-14 [Insert
                                  Application Fees.               Federal Register
                                                                  citation].
Section 45-13-13...............  Inconsistency           6/1/09  7-21-14 [Insert
                                  Between Rules.                  Federal Register
                                                                  citation].
Section 45-13-14...............  Statutory Air           6/1/09  7-21-14 [Insert    ............................
                                  Pollution.                      Federal Register
                                                                  citation].
Section 45-13-15...............  Hazardous Air           6/1/09  7-21-14 [Insert
                                  Pollutants.                     Federal Register
                                                                  citation].
Section 45-13-16...............  Application for         6/1/09  7-21-14 [Insert    New.
                                  Permission to                   Federal Register
                                  Commence                        citation].
                                  Construction in
                                  Advance of
                                  Permit Issuance.
TABLE 45-13A...................  Potential               6/1/09  7-21-14 [Insert
                                  Emission Rate.                  Federal Register
                                                                  citation].
TABLE 45-13B...................  De Minimus              6/1/09  7-21-14 [Insert
                                  Sources.                        Federal Register
                                                                  citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-16409 Filed 7-18-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Notices]
[Pages 61052-61053]
[FR Doc No: 2019-24566]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER19-465-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Report Filing: 2019-11-01_Order 841 extension request
to be effective N/A.
    Filed Date: 11/1/19.
    Accession Number: 20191101-5279.
    Comments Due: 5 p.m. ET 11/8/19.

    Docket Numbers: ER19-2818-001.
    Applicants: Upper Missouri G. & T. Electric Cooperative, Inc.
    Description: Tariff Amendment: Supplement to Initial Formula Rate
Filing to be effective 11/15/2019.
    Filed Date: 11/5/19.
    Accession Number: 20191105-5069.
    Comments Due: 5 p.m. ET 11/26/19.

    Docket Numbers: ER19-2820-000.
    Applicants: Upper Missouri G. & T. Electric Cooperative, Inc.
    Description: Supplement to September 16, 2019 Upper Missouri G. &
T. Electric Cooperative, Inc. tariff filing.
    Filed Date: 11/5/19.
    Accession Number: 20191105-5100.
    Comments Due: 5 p.m. ET 11/26/19.

    Docket Numbers: ER19-2823-000.
    Applicants: Isabella Wind, LLC.
    Description: Second Supplement to September 17, 2019 Isabella Wind,
LLC tariff filing.
    Filed Date: 11/1/19.
    Accession Number: 20191101-5293.
    Comments Due: 5 p.m. ET 11/15/19.

    Docket Numbers: ER20-301-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of WMPA/SA
No. 4377; Queue No. AB1-040 to be effective 11/12/2019.
    Filed Date: 11/4/19.
    Accession Number: 20191104-5096.
    Comments Due: 5 p.m. ET 11/25/19.

    Docket Numbers: ER20-302-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: First Revised ISA, SA No.
2255, Queue AC1-100 to be effective 10/4/2019.
    Filed Date: 11/4/19.
    Accession Number: 20191104-5099.
    Comments Due: 5 p.m. ET 11/25/19.

    Docket Numbers: ER20-303-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-11-04_CTA Continuous
Improvement Filing to be effective 2/2/2020.
    Filed Date: 11/4/19.
    Accession Number: 20191104-5100.
    Comments Due: 5 p.m. ET 11/25/19.

    Docket Numbers: ER20-304-000.
    Applicants: PPL Electric Utilities Corporation.
    Description: Sec.  205(d) Rate Filing: Service Agreement 941
between MAIT and PPL EU to be effective 11/4/2019.
    Filed Date: 11/4/19.
    Accession Number: 20191104-5103.
    Comments Due: 5 p.m. ET 11/25/19.

    Docket Numbers: ER20-305-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-11-04_CTA Project Cost
Definition Filing to be effective 2/2/2020.
    Filed Date: 11/4/19.
    Accession Number: 20191104-5101.
    Comments Due: 5 p.m. ET 11/25/19.

    Docket Numbers: ER20-306-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to Original WMPA,
SA No. 4951; Queue No. AD1-054 to be effective 2/20/2018.
    Filed Date: 11/4/19.
    Accession Number: 20191104-5104.
    Comments Due: 5 p.m. ET 11/25/19.

    Docket Numbers: ER20-307-000.
    Applicants: C.P. Crane LLC.
    Description: Tariff Cancellation: cancellation tariff to be
effective 1/5/2020.
    Filed Date: 11/5/19.
    Accession Number: 20191105-5066.
    Comments Due: 5 p.m. ET 11/26/19.

    Docket Numbers: ER20-308-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. submits Informational filing for
Qualification in the Forward Capacity Market.
    Filed Date: 11/5/19.
    Accession Number: 20191105-5086.
    Comments Due: 5 p.m. ET 11/20/19.

    Docket Numbers: ER20-310-000.
    Applicants: Tampa Electric Company.
    Description: Compliance filing: Compliance Filing Changes to
Market-Based Rate Tariff to be effective 1/1/2020.
    Filed Date: 11/5/19.
    Accession Number: 20191105-5089.
    Comments Due: 5 p.m. ET 11/26/19.

    Docket Numbers: ER20-311-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. submits Installed Capacity
Requirement, Hydro Quebec Interconnection Capability Credits and
Related Values for the 2023/2024 Capacity Commitment Period.
    Filed Date: 11/5/19.
    Accession Number: 20191105-5112.
    Comments Due: 5 p.m. ET 11/26/19.

    Docket Numbers: ER20-312-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of WMPA/SA
No. 4378; Queue No. AB1-041 to be effective 11/12/2019.
    Filed Date: 11/5/19.
    Accession Number: 20191105-5114.
    Comments Due: 5 p.m. ET 11/26/19.

    Docket Numbers: ER20-313-000.
    Applicants: Sun Streams 2, LLC.
    Description: Baseline eTariff Filing: Certificate of Concurrence
for Shared Facilities Common Ownership Agreement to be effective 11/6/
2019.
    Filed Date: 11/5/19.
    Accession Number: 20191105-5115.
    Comments Due: 5 p.m. ET 11/26/19.

    Docket Numbers: ER20-314-000.
    Applicants: Sun Streams 4, LLC.
    Description: Baseline eTariff Filing: Certificate of Concurrence
for Shared Facilities Common Ownership Agreement to be effective 11/6/
2019.
    Filed Date: 11/5/19.
    Accession Number: 20191105-5116.
    Comments Due: 5 p.m. ET 11/26/19.

    Docket Numbers: ER20-315-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of WMPA/SA
No. 4379; Queue No. AB1-042 to be effective 11/12/2019.
    Filed Date: 11/5/19.
    Accession Number: 20191105-5128.
    Comments Due: 5 p.m. ET 11/26/19.

    Docket Numbers: ER20-316-000.
    Applicants: Sun Streams PVS, LLC.
    Description: Baseline eTariff Filing: Certificate of Concurrence
for Shared Facilities Common Ownership Agreement to be effective 11/6/
2019.
    Filed Date: 11/5/19.
    Accession Number: 20191105-5132.
    Comments Due: 5 p.m. ET 11/26/19.

    Docket Numbers: ER20-317-000.
    Applicants: Sun Streams Expansion, LLC.
    Description: Baseline eTariff Filing: Certificate of Concurrence
for Shared Facilities Common Ownership Agreement to be effective 11/6/
2019.
    Filed Date: 11/5/19.
    Accession Number: 20191105-5133.
    Comments Due: 5 p.m. ET 11/26/19.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES19-25-001.

    Applicants: NSTAR Electric Company.
    Description: Supplement to April 24, 2019 Application under Section
204 of the Federal Power Act for Authorization to Issue Securities of
NSTAR Electric Company.
    Filed Date: 11/1/19.
    Accession Number: 20191101-5316.
    Comments Due: 5 p.m. ET 11/22/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 5, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-24566 Filed 11-8-19; 8:45 am]
BILLING CODE 6717-01-P


                                  Memorandum

To: Robert Stone, Bryan Lincoln, OSHA
From: Chet Fenton, ERG
Date: April 12, 2016
Subject: Benefit estimates for Alternative 1B of the proposed OSHA beryllium rule

Under Alternative 1B of OSHA's proposed beryllium rule, facilities in General Industry who do not meet the 0.1% threshold for beryllium content but would be in-scope under Alternative 1A but would be exempted from the rule if they can provide objective data showing that none of their workers are exposed to beryllium at levels exceeding the action level of 0.1 ug/m[3]. This alternative concerns establishments engaged in primary aluminum smelting and those operating coal-fired power plants, all of whom are in-scope under Alternative 1A. Profile and exposure estimates for these groups are provided below.
Industry Profile and At-Risk Estimates
Coal-Fired Power Plants
Because beryllium occurs as a trace element in coal, workers in coal-fired power plants are at risk of beryllium exposure. Based on data collected by the Department of Energy, Energy Information Administration, ERG estimates that currently 562 such facilities are in operation under OSHA's purview (DOE, 2013). These include 433 operated by utilities and 129 operated by establishments in other industries. Census data indicate that employment for utility facilities averages 52 workers per establishment (US Census Bureau, 2012). Applying this number to the entire set of coal-fired power plants suggests a total employment of 29,417. While reliable exposure information is not available for this sector, ERG believes that potential beryllium exposures are limited to workers engaged in production occupations. Based on data from the BLS Occupational Employment Statistics Survey, ERG estimates that 50.5% of the workers at coal-fired power plant facilities fall into this category (BLS, 2012). These estimates are shown in following table.

                     Employment at Coal-Fired Power Plants

                                     Total
                             Average Per Facility
Total Employment
                                    29,417
                                     52.3
Non Production Occupations
                                    14,558
                                     25.9
All Production Workers
                                    14,859
                                     26.4

Construction and Extraction Occupations
                                     1,108
                                      2.0

Installation, Maintenance, and Repair Occupations
                                     8,864
                                     15.8

Production Occupations  -  Operators
                                     4,405
                                      7.8

Transportation and Material Moving Occupations
                                      482
                                      0.9

Data on the distribution of production workers by beryllium exposure are not available. Exposure to arsenic, which is also a trace contaminant in coal ash, is concomitant with beryllium exposure. OSHA believes that compliance with the arsenic standard ensures that worker beryllium exposures will be below the proposed PEL. For this reason, and given the available evidence, ERG believes the exposure profile shown below best characterizes the beryllium exposures of the affected production workers.

  Estimated Beryllium Exposure Profile for Coal Fired Power Plant Facilities
                              Job Classification

                                     Total
                              Beryllium Exposure

<0.1μg/m[3]
0.1 to 0.2μg/m[3]
>0.2 μg/m[3]
Construction and Extraction Occupations
                                     1,108
                                      831
                                      277
                                       0

                                    100.0%
                                     75.0%
                                     25.0%
                                     0.0%
Installation, Maintenance, and Repair Occupations
                                     8,864
                                     6,648
                                     2,216
                                       0

                                    100.0%
                                     75.0%
                                     25.0%
                                     0.0%
Production Occupations  -  Operators
                                     4,405
                                     3,304
                                     1,101
                                       0

                                    100.0%
                                     75.0%
                                     25.0%
                                     0.0%
Transportation and Material Moving Occupations
                                      482
                                      361
                                      120
                                       0

                                    100.0%
                                     75.0%
                                     25.0%
                                     0.0%

All production workers
                                    14,859
                                    11,144
                                     3,715
                                       0

                                    100.0%
                                     75.0%
                                     25.0%
                                     0.0%

Primary Aluminum Smelters
Based on a review of the primary aluminum smelting industry, ERG found that 10 such smelters are currently operating in the United States, employing 8,750 workers. Of these employees, an estimated 6,956 employees work in production occupations. While comprehensive exposure data are not available, the evidence suggests that some workers in pot room-related jobs are currently exposed to beryllium (from trace amounts in bauxite ore), with some at levels exceeding the proposed PEL. These jobs include pot room workers, pot repair workers, and other maintenance workers involved in cleaning operations in the pot room. Based on data from the BLS Occupational Employment Statistics survey, ERG estimated the numbers of such workers as shown below:
Pot room workers: 805
Pot room maintenance workers: 270
Pot repair workers: 260
Total affected workers: 1,335

Existing exposure data for aluminum smelter workers are only available on an aggregated basis and are not disaggregated by specific job task. ERG, however, believes that the following profile provides a likely approximation of the distribution of beryllium exposures for each of the affected job categories listed above.

                  Primary Aluminum Smelting Exposure Profile
                                 Affected Job
                                     Total
                              Beryllium Exposure

<0.1μg/m[3]
0.1 to 0.2μg/m[3]
>0.2 μg/m[3]
Pot room workers
                                      805
                                      322
                                      241
                                      241

                                    100.0%
                                     40.0%
                                     30.0%
                                     30.0%
Maintenance cleaning workers
                                      270
                                      108
                                      81
                                      81

                                    100.0%
                                     40.0%
                                     30.0%
                                     30.0%
Pot repair workers
                                      260
                                      104
                                      78
                                      78

                                    100.0%
                                     40.0%
                                     30.0%
                                     30.0%

Alternative 1B Assumptions
For the purposes of estimating the costs and benefits associated with this alternative, ERG used estimates of the share of aluminum smelters and coal-fired power plants that would be exempt by use of objective data and reduced the number of affected in-scope facilities and employees accordingly Given the small number of smelters (10) and the complexity of smelter operations, ERG set the smelter share at zero. Because of the relatively low levels of beryllium exposures at coal-fired power plants, ERG set the share of facilities using objective data for this sector at 50%. Thus, the number of affected employees with exposures below the action level and thereby exempted from the rule would equal 50% of the total, or 7,430 employees. Based on these estimates the resultant exposure profile for the remaining at-risk workers is shown below.

           Alternative 1B  -  Additional In-Scope At-Risk Employees
                                    Sector
                                     Total
                              Beryllium Exposure

<0.1μg/m[3]
0.1 to 0.2μg/m[3]
>0.2 μg/m[3]
Primary Aluminum Smelting
                                     1.335
                                      934
                                      133
                                      268

                                    100.0%
                                     70.0%
                                     10.0%
                                     20.0%
Coal-Fired Power plants
                                     7,430
                                     3,715
                                     3,715
                                       0

                                     100.%
                                     50.0%
                                     50.0%
                                     0.0%
Total
                                     8,765
                                     4,649
                                     3,848
                                      268

                                    100.0%
                                     53.0%
                                     43.9%
                                     3.1%

Benefit Estimates
When these at-risk employees are combined with the in-scope at-risk employees for the baseline version of the proposed rule, the following benefit estimates are obtained.

                     Estimated Benefits for Alternative 1B

                             Airborne Factor Only
                         Non-Airborne Factor Included
                                   Midpoint
Annual Cases Avoided

Mortality

Lung Cancer
                                      4.1
                                      4.1
                                      4.1
CBD-related
                                     92.1
                                     109.5
                                     100.8
Total mortality
                                     96.3
                                     113.6
                                     104.9

Morbidity
                                     49.6
                                     59.0
                                     54.3

Monetized Benefits

3% discount rate
                                 $578,011,421
                                 $680,969,358
                                 $629,490,389

7% discount rate
                                 $256,326,075
                                 $301,952,089
                                 $279,139,082

Compared to Alternative 1A, the benefits for Alternative 1B are identical when only the airborne factor is considered. This result is due to the fact that all workers exempt from the standard under 1B are assumed to have exposures below the proposed PEL and therefore enjoyed no benefit from the reduced PEL when they were in-scope under Alternative 1A. When the non-airborne factor is included. the benefits under Alternative 1B are larger, but smaller than the comparable values for Alternative 1A. This difference is due to the fact that the exempted employees under 1B still are at risk of CBD-related mortality and morbidity, despite their relatively low exposures. If exempted, these employees would not benefit from the effect of the standard's ancillary provision in preventing such cases irrespective of employee's exposure level.
References:
BLS, 2012. Occupational Employment Statistics Survey, U.S. Bureau of Labor Statistics. 2012.
DOE, 2013. U.S. Department of Energy, Energy Information Administration. Form EIA-860, Annual Electric Generator Report, 2013.
 US Census Bureau, 2012. County Business Patterns, US. Census Bureau, 2012.


[Federal Register: April 17, 2008 (Volume 73, Number 75)]
[Notices]
[Page 20989-20994]
[DOCID:fr17ap08-105]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57650; File No. SR-CBOE-2008-40]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of a Proposed Rule Change To Provide for
Issuance of Interim Trading Permits

April 11, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'' or ``Exchange Act''),\1\ and Rule 19b-4 thereunder,\2\
notice is hereby given that on April 9, 2008, the Chicago Board Options
Exchange, Incorporated (``CBOE'' 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 CBOE. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CBOE is filing this proposed rule change to provide for the
issuance of up to 50 Interim Trading Permits.\3\ The text of the
proposed rule change is available on CBOE's Web site (http://
www.cboe.org/Legal), at CBOE's Office of the Secretary, and at the
Commission's Public Reference Room.
---------------------------------------------------------------------------

    \3\ Under Sections 2.1(a) and 12.1 of its Constitution, CBOE
must obtain, but has not yet obtained, membership approval for the
issuance of the Interim Trading Permits and the amendments to its
Constitution contemplated in this proposed rule change. Once it has
obtained that membership approval, CBOE plans to file a technical
amendment to this proposed rule change to reflect that approval.
---------------------------------------------------------------------------

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

    In its filing with the Commission, CBOE 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. CBOE 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange is filing this proposed rule change to provide for the
issuance of up to 50 Interim Trading Permits. These permits will grant
the same trading privileges on the Exchange as transferable Exchange
memberships. The Exchange is seeking the authority to issue these
permits to address the demand for trading access to the Exchange to the
extent that a shortage exists from time to time in the number of
transferable Exchange memberships available for lease. Issuances of
Interim Trading Permits under Proposed Rule 3.27(b).
    Under proposed Rule 3.27(b), the Exchange may issue one or more
Interim Trading Permits, subject to the limit on the number of such
permits, to address shortages in the number of transferable memberships
available for lease. Consistent with this purpose, such permits may be
issued only if the Exchange determines in its sole discretion that
there are insufficient transferable Exchange memberships available for
lease at that time at a rate reasonably related to the indicative lease
rate to meet existing demand for such leases,\4\ and that it would be
in the interest of fair and orderly markets to provide additional
trading access under the circumstances (collectively, the ``issuance
findings'').\5\
---------------------------------------------------------------------------

    \4\ The ``indicative lease rate'' will be the highest ``clearing
firm floating monthly rate'' of the Clearing Members that assist in
facilitating at least 10% of the transferable membership leases. The
``clearing firm floating monthly rate'' will be the floating rate
that a Clearing Member designates, in connection with transferable
membership leases that the Clearing Member assisted in facilitating,
for leases that utilize that monthly rate. This is based on the
method the Exchange currently is using to determine the access fee
for persons who are Temporary Members under Interpretation and
Policy .02 of Rule 3.19. See, e.g., Securities Exchange Act Release
No. 57411 (March 3, 2008), 73 FR 12478 (March 7, 2008) (notice of
filing and immediate effectiveness of File No. SR-CBOE-2008-25).
    \5\ The reference to this last finding does not imply that the
Exchange's markets might not be fair and orderly if there were
insufficient permits to satisfy completely the additional demand for
trading access. Instead, this finding ensures that additional
permits are not issued--regardless of the extent of such demand--if
the issuance of such permits would be contrary to the interests of a
fair and orderly market.
---------------------------------------------------------------------------

    In the event that circumstances justify the issuance findings and
the Exchange consequently determines to issue Interim Trading Permits,
the Exchange will announce the number of Interim Trading Permits that
the Exchange determines to make available (limited by the number that
are available for issuance), that the Exchange is taking applications
for such permits, the process the Exchange will follow in issuing such
permits (described in the bullets below), and the beginning and ending
dates during which period of time individuals and organizations must
submit applications for such permits. An individual or organization
must be approved and satisfy all requirements for membership in the
Exchange to be eligible to apply for an Interim Trading Permit to be
issued under proposed Rule 3.27(b). In addition, an individual will be
eligible to receive no more than one Interim Trading Permit in
connection with a particular issuance of Interim Trading Permits
pursuant to proposed Rule 3.27(b), with a maximum of eight such permits
for a member organization and individuals and member organizations
affiliated with the member organization in connection with that
issuance.
    Each issuance of Interim Trading Permits pursuant to proposed Rule
3.27(b) will occur in accordance with one of the following objective
processes:
     Random Lottery Process. After the deadline for
applications has passed, the Exchange, through a random lottery
process, will issue a number of Interim Trading Permits to applicants
equal to the number of Interim Trading Permits that the Exchange
announced it would make available.
     Order in Time Process. After the deadline for applications
has passed, the Exchange will issue an Interim Trading Permit to each
applicant who applied for such a permit in the order in time that such
applicant applied, until the number of Interim Trading Permits that the
Exchange announced it would make available have been issued.
     Other Process. The Exchange will have the authority to
modify the processes described above or to establish any other process
to issue Interim Trading Permits pursuant to a rule filing submitted to
the Commission under Section 19(b) of the Exchange Act.\6\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b).
---------------------------------------------------------------------------

    The Exchange believes that these processes will provide for the
issuance of Interim Trading Permits in an objective manner and
consequently will provide for fair access to the Exchange. At the same
time, the Exchange will have the flexibility to determine which process
it will follow in connection with a particular issuance of permits. The
Exchange believes that this flexibility is needed to allow it to
determine the most efficient way to issue Interim Trading Permits in
any given situation.
    Overall, the Exchange believes that the ability to issue Interim
Trading Permits provides the Exchange with the ability to address, from
time to time, situations in which the demand for full trading access to
the Exchange exceeds the supply of transferable memberships available
for lease. In light of that justification, proposed CBOE Rule 3.27(b)
only allows Interim Trading Permits to be issued in circumstances when
the Exchange is able to make the issuance findings. Increasing the
number of market participants in that situation should promote market
liquidity and help promote the fair and orderly character of CBOE's
markets.
Requirements for Maintaining Interim Trading Permits
    Recipients of Interim Trading Permits and all of their associated
persons must remain in compliance with paragraph (f) of proposed CBOE
Rule 3.27. In particular, subparagraph (f)(ii) of proposed CBOE Rule
3.27 provides that they must remain in good standing and must pay all
applicable fees, dues, assessments and other like charges assessed
against CBOE members. Further, subparagraph (f)(i) of proposed CBOE
Rule 3.27 provides that holders of Interim Trading Permits and all of
their associated persons are subject to the regulatory jurisdiction of
the Exchange under the Exchange Act and the Constitution and Rules of
the Exchange, including the Exchange's disciplinary jurisdiction under
Chapter XVII of the Exchange's Rules.\7\
---------------------------------------------------------------------------

    \7\ In this regard, for instance, Interim Trading Permits may be
suspended or revoked as a result of a disciplinary action under the
amendments proposed for Rule 17.1.
---------------------------------------------------------------------------

    In addition, holders of Interim Trading Permits must pay to the
Exchange a monthly access fee. This monthly access fee will be
established and adjusted through proposed rule change(s) that will be
filed with the Commission under Section 19(b)(3)(A) of the Act.\8\ The
monthly access fee will be due and payable in accordance with the
provisions of the Exchange Fee Schedule and will be the same for all
Interim Trading Permit holders.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).

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

Nature of Rights Under Interim Trading Permits
    As provided in subparagraph (e)(i) of proposed CBOE Rule 3.27, the
holder of an Interim Trading Permit will enjoy the same trading
privileges on the Exchange as the holder of a transferable Exchange
membership. Those rights include the right to trade on the CBOE Stock
Exchange (``CBSX'') and, as provided in Rule 3.29, the trading rights
on the Exchange necessary to become a member of OneChicago, LLC. This
subparagraph also provides that an organization that holds an Interim
Trading Permit or that has an Interim Trading Permit registered for it
shall be treated the same as a ``member organization'' for purposes of
the Rules.\9\ As provided in subparagraph (g)(iii) of proposed CBOE
Rule 3.27, an Interim Trading Permit will be non-transferable, except
that in a form and manner prescribed by the Exchange (1) a member
organization may change the designation of the nominee in respect of
each Interim Trading Permit it holds, and (2) an individual Interim
Trading Permit holder at any time after the issuance of that Interim
Trading Permit may transfer that Interim Trading Permit to a member
organization with which such individual is then associated.
---------------------------------------------------------------------------

    \9\ The Exchange notes that this provision is limited to the
Rules and is subject to the conditions imposed on Interim Trading
Permit holder status in the Constitution and Rules, including
proposed Section 1.1(b) of the Constitution and proposed Rule
3.27(e)(i).
---------------------------------------------------------------------------

    Under proposed Section 2.6 of the Constitution and subparagraph
(g)(i) of proposed CBOE Rule 3.27, Interim Trading Permit holders will
have the same voting and petition rights as regular members, except
that Interim Trading Permit holders will have no right to vote or
petition concerning (1) issues that relate to Exchange ownership
matters, including without limitation those matters related to
demutualization, mergers, consolidations, dissolution, liquidation,
transfer, or conversion of assets of the Exchange, and (2) matters that
relate to Article Fifth(b).\10\ Similarly, under proposed Section
2.1(c) of the Constitution and subparagraph (g)(ii) of proposed CBOE
Rule 3.27, Interim Trading Permit holders will have no interest in the
assets or property of the Exchange, and will have no right to share in
any distribution by the Exchange.\11\
---------------------------------------------------------------------------

    \10\ Under proposed Section 1.1(b) of the Constitution and
proposed Rule 3.27(e)(i), Interim Trading Permit holders in good
standing would be treated the same as members, except as provided in
proposed Sections 2.1(c) and 2.6 of the Constitution, and except for
purposes of paragraph (b) of Article Fifth of the Certificate of
Incorporation, Article Tenth of the Certificate of Incorporation,
proposed Section 4.1(a) of the Constitution, proposed Section 6.1(a)
of the Constitution, and as may be provided in the Rules. Proposed
Rule 3.27(e)(i) further provides that Interim Trading Permit holders
would be treated the same as members (except as described in the
preceding sentence) notwithstanding any references in the Rules
suggesting that Interim Trading Permit holders are members under the
Rules.
    \11\ The Exchange notes that the provisions described in this
paragraph and the following paragraph addressing the voting and
representation rights of Interim Trading Permit holders are
virtually identical to the provisions addressing the voting and
representation rights provided to CBSX Permit holders that were
approved by the Commission in connection with a previous Exchange
rule filing. See Securities Exchange Act Release No. 55326 (February
21, 2007), 72 FR 8816 (February 27, 2007) (order approving File No.
SR-CBOE-2006-107). The Exchange also notes that proposed CBOE Rule
3.27 is similar to the CBSX Permit holder rule, CBOE Rule 3.26,
which the Commission approved in connection with that filing.
---------------------------------------------------------------------------

    To address the fair representation requirements in Section 6(b)(3)
of the Exchange Act,\12\ proposed Section 4.1(a) of the Constitution
provides that an Interim Trading Permit holder, or an officer of an
Interim Trading Permit holder, will be eligible to serve on the
Nominating Committee in one of the six floor member and firm member
positions on the Nominating Committee, notwithstanding the fact that
the holder of an Interim Trading Permit is not a regular member or an
officer of a regular member. In addition, under proposed Section 6.1(a)
of the Constitution, an Interim Trading Permit holder or the executive
officer of an Interim Trading Permit holder will be eligible to serve
in one of the at-large director positions on the Board of Directors of
the Exchange.\13\ To clarify that an Interim Trading Permit holder will
be able to serve only as an at-large director, proposed Rule
3.27(h)(iii) provides that the holding of an Interim Trading Permit
does not satisfy the requirement in Section 6.1(a) of the Constitution
to own and control a membership for purposes of the definitions of
floor director and lessor director in that section. Finally, proposed
Rule 3.27(e)(i) provides that, except as provided in the Constitution,
an Interim Trading Permit holder will be eligible to serve on any
Exchange committee to the same extent that a member can serve on that
committee.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(3).
    \13\ The Exchange also proposes to amend Section 6.1(a) to
remove references to a transitional period that are no longer needed
because that period has passed.
---------------------------------------------------------------------------

Duration of Interim Trading Permits and Transfer of Interim Trading
Permit Holders to Open Leases
    As provided in paragraph (c) of proposed CBOE Rule 3.27, an Interim
Trading Permit will remain in effect until the earlier of one of the
following events: (i) A transaction is consummated pursuant to which
either CBOE is converted into a stock corporation or memberships in
CBOE are converted into stock (collectively, a ``Demutualization
Transaction''), (ii) the holder of the Interim Trading Permit notifies
the Exchange in a form and manner prescribed by the Exchange that the
holder is terminating that Interim Trading Permit, (iii) the Interim
Trading Permit is terminated as a result of a regulatory action by the
Exchange,\14\ or (iv) the Exchange terminates all Interim Trading
Permits through a rule filing approved by the Commission pursuant to
Section 19(b) of the Act.\15\ Subparagraph (e)(ii) of proposed Rule
3.27 provides that, in the event of a Demutualization Transaction,
holders of Interim Trading Permits will be guaranteed to receive
trading permits on the same terms as holders of transferable Exchange
memberships who are eligible to receive trading permits in connection
with that transaction. This guarantee ensures that there is no
disruption in trading access in the event of such a Demutualization
Transaction and thereby helps promote the fair and orderly character of
the Exchange's markets and helps ensure that holders of Interim Trading
Permits are treated fairly in such a transaction and are not unfairly
deprived of trading access to the Exchange.
---------------------------------------------------------------------------

    \14\ For example, an Interim Trading Permit may be revoked as a
result of a disciplinary action under the amendments proposed for
Rule 17.1.
    \15\ 15 U.S.C. 78s(b).
---------------------------------------------------------------------------

    Because Interim Trading Permits can be issued to provide trading
access under specified conditions, those permits should continue to be
available for those purposes if they no longer are being used by their
original recipients. Accordingly, paragraph (c) of proposed Rule 3.27
provides that the Exchange may reissue an Interim Trading Permit that
has been terminated. This paragraph also incentivizes holders to
terminate their permits early in the month so that the Exchange is in a
position to reissue those permits at the end of the month. In
particular, this paragraph requires a holder of an Interim Trading
Permit, if the holder fails to notify the Exchange that the holder is
terminating that Interim Trading Permit by the fifteenth day of the
month, to pay to the Exchange an amount equal to the following month's
monthly access fee for an Interim Trading Permit.
    Under paragraph (d) of proposed Rule 3.27, the Exchange will
endeavor to

facilitate the transfer of holders of Interim Trading Permits to
transferable memberships that are available for lease. In connection
with determining to issue Interim Trading Permits, the Exchange sought
and received oral feedback from the Exchange's Lessors Committee.
Certain participants on that committee expressed the concern that the
issuance of Interim Trading Permits potentially could have a negative
affect on the lease market by reducing the demand for leases. This
transfer provision is designed to address that concern.
    In particular, paragraph (d) of proposed Rule 3.27 will be
triggered if the Exchange is notified by one or more lessors that they
have transferable Exchange memberships available for lease (``open
leases'') at a rate reasonably related to the indicative lease rate, as
determined by the Exchange in its sole discretion. It could distort the
lease market for Interim Trading Permits to be outstanding while open
leases are available at such a rate, so it is appropriate for the
Exchange to endeavor to facilitate the transfer of holders of Interim
Trading Permits to those open leases.
    Accordingly, paragraph (d) of proposed Rule 3.27 provides that, in
the event the Exchange receives notifications from lessors that they
have open leases, the Exchange will notify each Interim Trading Permit
holder of the number of open leases and the names of the lessors with
those open leases. As part of that notification by the Exchange, the
Exchange will advise each Interim Trading Permit holder that the holder
may contact those lessors if the holder is interested in transferring
to an open lease.\16\ The Exchange notes that a transfer to an open
lease is entirely voluntary for Interim Trading Permit holders.\17\
---------------------------------------------------------------------------

    \16\ The Exchange also will provide such a notification to each
person who is a Temporary Member under Interpretation and Policy .02
of Rule 3.19.
    \17\ The Exchange also notes that a transfer to an open lease is
entirely voluntary for Temporary Members.
---------------------------------------------------------------------------

    If, after a reasonable period of time following this process, a
lessor notifies the Exchange that the lessor continues to have an open
lease, the Exchange shall compensate that lessor through a monthly
payment equal to the indicative lease rate, provided that lessor is
offering for lease the transferable membership subject to the open
lease at a rate reasonably related to the indicative lease rate, as
determined by the Exchange in its sole discretion.\18\ If the
indicative lease rate changes, the Exchange may modify that monthly
payment from time to time so that the payment is equal to that rate.
The Exchange has included this compensation provision to address the
potential impact that Interim Trading Permits may have on the lease
market. As mentioned above, certain participants on the Lessors
Committee vocalized concern that Interim Trading Permits potentially
could negatively affect the lease market by reducing demand for leases.
The Exchange believes that this provision is designed to address that
concern.
---------------------------------------------------------------------------

    \18\ The ``indicative lease rate'' will be determined in
accordance with proposed Rule 3.27(b). See supra note 4.
---------------------------------------------------------------------------

    In the event the Exchange compensates a lessor in this situation,
the Exchange will not enter into, nor be deemed to have entered into, a
lease or other agreement with that lessor. Accordingly, the Exchange
will have no rights with respect to that lessor's membership, including
without limitation the right to trade on the Exchange or the right to
vote. The lessor may at any time thereafter lease that membership to
any qualified individual or organization and will be required to notify
the Exchange in the event of such a lease. The Exchange will cease
compensating the lessor if it receives such a notification or otherwise
learns the lessor has leased that membership, and may recoup from the
lessor any compensation paid pursuant to proposed Rule 3.27(d) to the
lessor for any period of time during which the lessor has leased that
membership. The Exchange has added this provision to clarify that it
will have no rights with respect to that membership, and that a lessor
may enter into a lease agreement at any time.
    The Exchange also may cease compensating that lessor if the
Exchange learns an offer to lease that membership at a rate reasonably
related to the indicative lease rate, as determined by the Exchange in
its sole discretion, has been declined by that lessor. This provision
has been added to provide that lessor with an incentive to lease that
membership if the opportunity arises. Consistent with the purpose of
this transfer provision to assist in filling open leases, the Exchange
does not want to be in a position of perpetually compensating certain
lessors in the event they have opportunities to lease their
memberships.
    Finally, in the event that the number of lessors receiving
compensation pursuant to this provision becomes greater than the number
of outstanding Interim Trading Permits, the Exchange will compensate
each such lessor, on a monthly basis, in an amount equal to the current
indicative lease rate, as determined by the Exchange in its sole
discretion, times the number of holders of such permits divided by the
number of such lessors.\19\ The Exchange believes this provision is
necessary to address the scenario in which the number of open leases
exceeds the number of Interim Trading Permits. Under this scenario, the
number of open leases over-and-above the number of outstanding permits
would indicate a lack of demand for trading access to the Exchange
beyond what is being satisfied by Interim Trading Permits. Any
compensation the Exchange may pay pursuant to proposed Rule 3.27(d) is
not intended to be a substitute for that lack of demand for trading
access, and therefore the Exchange has determined in this scenario to
compensate lessors on a pro-rata basis from fees paid by Interim
Trading Permit holders.
---------------------------------------------------------------------------

    \19\ As a corollary to this provision, the Exchange will cease
compensating such lessors during any period when there are no
Interim Trading Permits currently outstanding.
---------------------------------------------------------------------------

Conforming Changes
    The Exchange has made certain conforming changes in its Rules to
ensure that individuals and organizations that receive Interim Trading
Permits under proposed Rule 3.27 can conduct their activities in a
manner similar to holders of Exchange memberships. In particular,
subparagraph (h)(ii) of proposed Rule 3.27 provides that an individual
Interim Trading Permit holder will have the same ability to register
that Interim Trading Permit for a member organization as the holder of
an Exchange membership has to register that membership for a member
organization under Rule 3.8(c). In addition, that same subparagraph
provides that all Rules that apply to an individual member registering
a membership for a member organization, or that apply to a member
organization that has a membership registered for it, shall also be
deemed to apply to an individual Interim Trading Permit holder who has
registered that Interim Trading Permit for a member organization, and
to a member organization that has an Interim Trading Permit registered
for it. Rule 3.8 also has been amended to allow member organizations
holding Interim Trading Permits to designate individual nominees and
inactive nominees with respect to those permits.

    Similarly, subparagraph (h)(i)(A) of proposed Rule 3.27 provides
that an Interim Trading Permit will be counted as one membership for
purposes of the Participation Entitlement provisions in Rule
6.45A(a)(i)(C)(1) and Rule 6.45B(a)(ii)(C)(1). In addition,
subparagraph (h)(i)(B) of proposed Rule 3.27 provides that an Interim
Trading Permit will be counted as one membership for purposes of the
appointment costs provisions in Rule 8.3(c)(v), Rule 8.85(e) and Rule
8.92(d). Notwithstanding the similar treatment of an Interim Trading
Permit and a membership for these purposes, subparagraph (h)(i)(A)-(B)
also provide that an Interim Trading Permit will not satisfy the
requirements in Rule 8.85(e) and Rule 8.92(d) that a DPM or an e-DPM
own at least one membership.\20\ This is consistent with the original
purpose of the DPM and e-DPM membership ownership requirement, which
was to require that DPMs and e-DPMs own, instead of lease, at least one
Exchange membership in order to ensure that they have a long-term
commitment to the Exchange. As discussed above, an Interim Trading
Permit holder will have no interest in the assets or property of the
Exchange, and will have no right to share in any distribution by the
Exchange.
---------------------------------------------------------------------------

    \20\ Proposed Interpretation and Policy .04 of Rule 8.85 and
proposed Interpretation and Policy .01 of Rule 8.92 specifically
provide that an Interim Trading Permit does not satisfy the
membership ownership requirements in those Rules.
---------------------------------------------------------------------------

    In order further to assure that holders of Interim Trading Permits
can conduct their trading activities in a manner similar to the holders
of Exchange memberships, subparagraph (h)(i)(C) of proposed Rule 3.27
provides that an Interim Trading Permit will be treated as a separate
membership for purposes of the pilot programs referenced in Rule
8.3(c)(vii)(1), Rule 8.3(c)(vii)(2), Rule 8.85(a)(v), Rule 8.93(vii),
and subparagraph (b)(viii) of the Guidelines for Exemptive Relief Under
Rule 8.91(e) for Members Affiliated with DPMs. These pilot programs
allow one Market-Maker affiliated with another Market-Maker, an Off-
Floor DPM or an e-DPM to trade in open-outcry in any specific option
class allocated to that Market-Maker, Off-Floor DPM or e-DPM, provided
such Market-Maker trades on a separate membership. Further,
subparagraph (h)(i)(D) of proposed Rule 3.27 provides that an
individual Interim Trading Permit holder may satisfy the qualification
requirements to be a DPM Designee or SBT DPM Designee as set forth in
Rule 8.81(b)(ii) and Rule 44.11(b)(2) by registering the Interim
Trading Permit for a DPM or SBT DPM or an affiliate of the DPM or SBT
DPM. This subparagraph also provides that a DPM may satisfy the
requirement in Rule 8.81(d) by having DPM Designees who have registered
their Interim Trading Permits for the DPM.
    Other conforming changes have been made to the Rules such that
certain requirements related to the holders of memberships will apply
to the holders of Interim Trading Permits. In particular, under
proposed Rule 3.2(c), individual Interim Trading Permit holders will be
required to have authorized trading functions. In addition, proposed
Rule 3.3(c) provides that the holding of an Interim Trading Permit
satisfies the requirement in that Rule that Clearing Members and order
service firms possess at least one membership. Further, under proposed
Rule 3.19, the membership status of an Interim Trading Permit holder
will automatically terminate at such time that person, among other
things, does not hold an Interim Trading Permit. Under this rule, the
Exchange also will have the authority to permit such a person to retain
that membership status under certain circumstances to enable that
person to obtain, among other things, another Interim Trading Permit
(subject to the requirements in proposed Rule 3.27). Also, individual
Interim Trading Permit holders under proposed Rule 3.24 will be
eligible for the member death benefit.
    Finally, the Rules have been amended to preserve the Exchange's
regulatory authority under the Exchange Act and the Constitution and
Rules of the Exchange. In particular, the Exchange will have the
authority under proposed Rule 2.23 to revoke an Interim Trading Permit
if the holder fails to pay any dues, fees, assessments, charges, fines,
or other amounts due to the Exchange within six months after such
payment is due. In addition, the Exchange will have the authority under
proposed Rules 16.3(c) and 16.4 to suspend or revoke the Interim
Trading Permit of a holder that experiences financial difficulty. The
Exchange also will have the authority under proposed Rule 17.1 to
suspend or revoke an Interim Trading Permit if the holder has been
disciplined by the Exchange.
Clarifying Changes Related to CBOE Stock Exchange Permits
    In amending the Constitution and Rules to provide for the issuance
of Interim Trading Permits, the Exchange determined to make certain
changes to clarify how CBOE Stock Exchange Permits currently are
treated under the Certificate of Incorporation, Constitution, and
Rules. The Exchange believes that these changes are non-substantive in
nature because they make explicit the way CBOE Stock Exchange Permits
and the holders of such permits currently are treated and do not modify
the rights of the holders of such permits.
    In particular, the Exchange has amended Section 1.1 of the
Constitution to specifically provide that, rather than being defined as
members, CBOE Stock Exchange Permit holders will be treated the same as
members, except as provided in Sections 2.1(d) and 2.6 of the
Constitution, and except for purposes of paragraph (b) of Article Fifth
of the Certificate of Incorporation, Article Tenth of the Certificate
of Incorporation, Section 4.1(a) of the Constitution, Section 6.1(a) of
the Constitution, and as may be provided in the Rules. The Exchange
also is proposing a conforming amendment in Rule 3.26(c) to provide
that CBOE Stock Exchange Permit holders are treated the same as members
(except as described above), rather than being ``deemed'' members, for
purposes of the Certificate of Incorporation, Constitution, and Rules.
Similarly, the Exchange is proposing to amend this paragraph to provide
that CBOE Stock Exchange Permit holders shall be treated the same as
members (except as described above) notwithstanding any references in
the Rules suggesting that CBOE Stock Exchange Permit holders are
members under the Rules. In addition, the Exchange is proposing to
amend this paragraph to clarify that an organization that holds a CBSX
Permit or that has a CBSX Permit registered for it shall be treated the
same as a ``member organization'' for purposes of the Rules. Further,
the Exchange is proposing to amend Rule 3.26(e)(i) to clarify that the
holding of a CBSX Permit does not satisfy the requirement in Section
6.1(a) of the Constitution to own and control a membership for purposes
of the definitions of floor director and lessor director in that
section.
    The Exchange also has proposed to amend Rule 2.23 to clarify that
the Exchange has the authority to revoke a CBOE Stock Exchange Permit
if the holder fails to pay any dues, fees, assessments, charges, fines,
or other amounts due to the Exchange within six months after such
payment is due. Similarly, the Exchange has proposed to amend Rules
16.3(c) and 16.4 to clarify that the Exchange has the authority to
suspend or revoke the CBOE Stock Exchange Permit of a holder that
experiences financial difficulty. The Exchange also is clarifying that
it has the authority under proposed Rule 17.1 to suspend or revoke a
CBOE Stock

Exchange Permit if the holder has been disciplined by the Exchange.
    Further, the Exchange is proposing to amend Rule 3.2 to clarify
that individuals holding CBOE Stock Exchange Permits are required to
have authorized trading functions in accordance with Rule 50.3. In
addition, the Exchange is proposing to amend Rule 3.19 to clarify that
the membership status of a CBOE Stock Exchange Permit holder will
automatically terminate at such time that person, among other things,
does not hold a CBOE Stock Exchange Permit. Rule 3.19 also is being
amended to clarify that the Exchange would have the authority to allow
such a person to retain that membership status under certain
circumstances to enable that person to obtain, among other things,
another CBOE Stock Exchange Permit (subject to the requirements in Rule
3.26).
2. Statutory Basis
    For the reasons described above, the Exchange believes that the
proposed rule change is consistent with Section 6(b) of the Exchange
Act, in general, and furthers the particular objectives of Section
6(b)(5) of the Exchange Act.\21\ In particular, the proposed rule
change 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, in general, to protect investors and the public
interest.\22\
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78f(b) and (b)(5).
    \22\ See 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

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

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2008-40 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 20549-1090.

All submissions should refer to File Number SR-CBOE-2008-40. 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, 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 the CBOE. 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-CBOE-2008-40 and should be
submitted on or before May 8, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
 [FR Doc. E8-8278 Filed 4-16-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51322-51323]
[FR Doc No: 2023-16560]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1635]

Prescription Drug User Fee Act Waivers, Reductions, and Refunds
for Fixed-Combinations and Single-Entity Versions of Previously
Approved Antiretrovirals Under the President's Emergency Plan for
Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``PDUFA
Waivers, Reductions, and Refunds for Fixed-Combinations and Single-
Entity Versions of Previously Approved Antiretrovirals under PEPFAR.''
The draft guidance describes circumstances under which an applicant may
be eligible for a barrier-to-innovation waiver under the Prescription
Drug User Fee Act (PDUFA) for certain new drug applications (NDAs) for
single-entity (SE) antiretroviral (ARV) and fixed-combination (FC) ARV
drug products for the treatment or prevention of human immunodeficiency
virus-one (HIV-1). The draft guidance is also intended to help
applicants request a barrier-to-innovation waiver under those
circumstances.

DATES: Submit either electronic or written comments on the draft
guidance by October 2, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1635 for ``PDUFA Waivers, Reductions, and Refunds for Fixed-
Combinations and Single-Entity Versions of Previously Approved
Antiretrovirals under PEPFAR.'' 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, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sophia Park, Division of User Fee
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10001 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-7900, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``PDUFA Waivers, Reductions, and Refunds for Fixed-
Combinations and Single-Entity Versions of Previously Approved
Antiretrovirals under PEPFAR.'' This draft guidance is proposed as a
revision of the guidance for industry entitled ``User Fee Waivers for
FDC and Co-Packaged HIV Drugs for PEPFAR,'' issued February 2007. The
draft guidance describes circumstances under which an applicant may be
eligible for a barrier-to-innovation waiver under PDUFA for certain
NDAs for SE ARV and FC ARV drug products for the treatment of HIV-1.
When final, this guidance will supersede the guidance for industry
entitled ``User Fee Waivers for FDC and Co-Packaged HIV Drugs for
PEPFAR,'' issued February 2007.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``PDUFA
Waivers, Reductions, and Refunds for Fixed-Combinations and Single-
Entity Versions of Previously Approved Antiretrovirals under PEPFAR.''
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 FDA's guidance entitled ``Prescription Drug User Fee
Act Waivers, Reductions, and Refunds for Drug and Biological Products''
associated with requesting waivers of user fees (including PEPFAR
waivers) has been approved under OMB control number 0910-0693. The
collection of information in completing and submitting FDA Form FDA
3397 (Prescription Drug User Fee Coversheet) has been approved under
OMB control number 0910-0297. The collection of information in 21 CFR
part 314 for submission of a new drug application has been approved
under OMB control number 0910-0001.

III. Electronic Access

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

    Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16560 Filed 8-2-23; 8:45 am]
BILLING CODE 4164-01-P