[Federal Register Volume 84, Number 127 (Tuesday, July 2, 2019)]
[Rules and Regulations]
[Pages 31682-31684]
[FR Doc No: 2019-13497]

Vol. 84

Tuesday,

No. 127

July 2, 2019

Part III

Environmental Protection Agency

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40 CFR Part 52

 Air Plan Approval; California; Mojave Desert Air Quality Management
District and Antelope Valley Air Quality Management District; Final
Rules

Federal Register / Vol. 84 , No. 127 / Tuesday, July 2, 2019 / Rules
and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2018-0512; FRL-9994-19-Region 9]

Air Plan Approval; California; Mojave Desert Air Quality
Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve revisions to the Mojave Desert Air Quality Management
District (MDAQMD or ``District'') portion of the California State
Implementation Plan (SIP). These revisions concern emissions of
volatile organic compounds (VOCs) from wood products coating operations
and organic solvent degreasing operations. We are approving local rules
to regulate these emission sources under the Clean Air Act (CAA or the
Act). We are also approving revisions to a definitions rule. Finally,
we are converting the partial conditional approval of the District's
reasonably available control technology (RACT) SIPs for the 1997 and
2008 ozone standards, as it applies to VOC emissions from wood products
coating operations and organic solvent degreasing operations, to a full
approval.

DATES: These rules will be effective on August 1, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2018-0512. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
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 through https://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information.

FOR FURTHER INFORMATION CONTACT: Nancy Levin, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to the EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Proposed Action

    On December 27, 2018 (83 FR 66658), the EPA proposed to approve the
following rules into the California SIP.

----------------------------------------------------------------------------------------------------------------
            Local agency                Rule No.              Rule title              Amended        Submitted
----------------------------------------------------------------------------------------------------------------
MDAQMD.............................            1114  Wood Products Coating             1/22/2018       5/23/2018
                                                      Operations.
MDAQMD.............................            1104  Organic Solvent Degreasing        4/23/2018       7/16/2018
                                                      Operations.
MDAQMD.............................             102  Definition of Terms........       4/23/2018       8/22/2018
----------------------------------------------------------------------------------------------------------------

    We proposed to approve these rules because we determined that they
comply with the relevant CAA requirements. We also proposed to find
that the modifications to rules 1114 and 1104 satisfied the District's
commitment to remedy deficiencies identified in the partial conditional
approval of the District's RACT SIPs for the 1997 and 2008 ozone
standards (83 FR 5921). Our proposed action contains more information
on the rules and our evaluation.

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period
that closed on January 28, 2019. During this period, we received eight
comments. Two comments supported the proposed action, and two comments
discussed issues unrelated to the proposed action. The EPA does not
provide a response to those four comments. The remaining four comments
are summarized below into two separate issues, with EPA responses.
    Comment #1: Three commenters asked whether the revisions to Rule
1114 would result in additional costs to businesses, cause businesses
to move out of state, or reduce California's wood products supply. One
commenter asked whether there is any additional data showing that VOCs
are harmful to the environment.
    Response #1: In this action we are approving into the California
SIP a rule that was drafted and adopted by the MDAQMD. In its RACT SIP
submittal \1\ the District compared its rule with the EPA Control
Techniques Guidelines (CTG) for Control of Volatile Organic Compound
Emissions from Wood Furniture Manufacturing Operations (EPA-453/R-96-
007), and with other district rules in order to determine which control
technologies are reasonably available. The CTG contains the EPA's
analysis regarding which controls were found to be reasonably available
for this source category taking into account various factors for
determining RACT, and it includes an assessment of costs associated
with the recommended RACT options. As explained in our proposal and
technical support document, the EPA's analysis concluded that the
District's rules meet the requirements necessary for RACT. The comments
received do not address or challenge this determination. Moreover,
because Rule 1114 has already been implemented locally, the EPA's
approval of the rule is not expected to result in any additional
compliance costs, or to otherwise affect the local market for wood
products and coatings. The EPA's approval simply makes the existing
locally-implemented rule federally enforceable.
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    \1\ The District's 2015 RACT SIP submittal for the 2008 ozone
NAAQS can be found in the docket for this rulemaking. The EPA's
final action partially approving and partially conditionally
approving the MDAQMD RACT SIP can be found at 83 FR 5921 (February
12, 2018).
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    Volatile Organic Compounds are a precursor to ozone formation,
which is harmful to human health and the environment. Information about
the health and environmental impacts of VOCs and ground-level ozone is
available on the EPA website.\2\ The impacts of ozone exposure are
evaluated by the EPA when setting the national ambient air quality
standards.
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    \2\ For example: https://www.epa.gov/ground-level-ozone-pollution/ground-level-ozone-basics.
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    Comment #2: One commenter states that the use of the phrase
``coatings and adhesives'' is overly broad, and that the EPA should
list the specific VOC compounds and manufacturers affected by the rule
revisions.
    Response #2: District Rule 102 contains a definition of VOC that
applies to Rule 1114. The VOC definition specifies the VOCs that are
regulated in Rule 1114. In addition,

Rule 1114 section (C)(7)(a) provides: ``The manufacturer of Coatings
subject to this Rule shall include a statement of VOC Content as
supplied on data sheets; including Coating components, expressed in
grams per liter or pounds per gallon, excluding water and exempt
Solvents.'' These provisions provide regulated entities with the
information needed to evaluate rule applicability and compliance.

III. EPA Action

    No comments were submitted that change our assessment of the rules
as described in our proposed action. Therefore, as authorized in
section 110(k)(3) of the Act, the EPA is fully approving these rules
into the California SIP. The EPA is also converting the partial
conditional approval of the District's RACT SIPs with respect to Rules
1104 and 1114 into a full approval.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
Mojave Desert rules described in the amendments to 40 CFR part 52 set
forth below. The EPA has made, and will continue to make, these
documents available through www.regulations.gov and at the EPA Region
IX Office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
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 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 Clean Air Act; and
     Does not provide the 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, the SIP is not approved to apply on any Indian
reservation land or in any other area where the 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 and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    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. The 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 Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 3, 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, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: May 14, 2019.
Deborah Jordan,
Acting Regional Administrator, Region IX.
    Part 52, chapter I, title 40 of the Code of Federal Regulations 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 F--California

0
2. Section 52.220 is amended by adding paragraphs (c)(37)(i)(D),
(c)(41)(xiv)(B), (c)(44)(v)(C), (c)(179)(i)(B)(3), (c)(188)(i)(C)(3),
(c)(207)(i)(D)(4), (c)(244)(i)(C)(3), and (c)(518), (519) and (520) to
read as follows:

Sec.  52.220   Identification of plan-in part.

* * * * *
    (c) * * *
    (37) * * *
    (i) * * *
    (D) Previously approved on June 14, 1978 in paragraph (c)(37)(i)(A)
of this section and now deleted with replacement in paragraph
(c)(520)(i)(A)(1) of this section in the Mojave Desert Air Quality
Management District, Rule 102.
* * * * *
    (41) * * *
    (xiv) * * *
    (B) Previously approved on December 19, 1978 in paragraph
(c)(41)(xiv)(A) of

this section and now deleted with replacement in paragraph
(c)(520)(i)(A)(1) of this section in the Mojave Desert Air Quality
Management District, Rule 102 (except for the definition of
``agricultural burning'').
* * * * *
    (44) * * *
    (v) * * *
    (C) Previously approved on March 28, 1979 in paragraph
(c)(44)(v)(A) of this section and now deleted with replacement in
paragraph (c)(520)(i)(A)(1) of this section in the Mojave Desert Air
Quality Management District, Rule 102, amended November 4, 1977.
* * * * *
    (179) * * *
    (i) * * *
    (B) * * *
    (3) Previously approved on November 27, 1990 in paragraph
(c)(179)(i)(B)(1) of this section and now deleted with replacement in
paragraph (c)(520)(i)(A)(1) of this section, Rule 102 (except fugitive
liquid leak and fugitive vapor leak), amended on December 19, 1988.
* * * * *
    (188) * * *
    (i) * * *
    (C) * * *
    (3) Previously approved on December 20, 1993 in paragraph
(c)(188)(i)(C)(1) of this section and now deleted with replacement in
paragraph (c)(519)(i)(A)(1) of this section in the Mojave Desert Air
Quality Management District, Rule 1171, adopted August 2, 1991.
* * * * *
    (207) * * *
    (i) * * *
    (D) * * *
    (4) Previously approved on April 30, 1996 in paragraph
(c)(207)(i)(D)(2) of this section and now deleted with replacement in
paragraph (c)(519)(i)(A)(1) of this section, Rule 1104, adopted on
September 28, 1994.
* * * * *
    (244) * * *
    (i) * * *
    (C) * * *
    (3) Previously approved on August 18, 1998 in (c)(244)(i)(C)(1) of
this section and now deleted with replacement in (c)(518)(i)(A)(1) of
this section, Rule 1114, amended on November 25, 1996.
* * * * *
    (518) New and amended regulations for the following APCDs were
submitted on May 23, 2018 by the Governor's designee.
    (i) Incorporation by reference. (A) Mojave Desert Air Quality
Management District.
    (1) Rule 1114, ``Wood Products Coating Operations,'' amended on
January 22, 2018.
    (2) [Reserved]
    (B) [Reserved]
    (ii) [Reserved]
    (519) New and amended regulations for the following APCDs were
submitted on July 16, 2018 by the Governor's designee.
    (i) Incorporation by reference. (A) Mojave Desert Air Quality
Management District.
    (1) Rule 1104, ``Organic Solvent Degreasing Operations,'' amended
on April 23, 2018.
    (2) [Reserved]
    (B) [Reserved]
    (ii) [Reserved]
    (520) New and amended regulations for the following APCDs were
submitted on August 22, 2018 by the Governor's designee.
    (i) Incorporation by reference. (A) Mojave Desert Air Quality
Management District.
    (1) Rule 102, ``Definition of Terms,'' amended on April 23, 2018.
    (2) [Reserved]
    (B) [Reserved]
    (ii) [Reserved]

0
3. Section 52.248 is amended by revising paragraph (d) to read as
follows:

Sec.  52.248   Identification of plan--conditional approval.

* * * * *
    (d)(1) The EPA is conditionally approving portions of the
California SIP revisions submitted on July 11, 2007 and September 9,
2015, demonstrating control measures in the Mojave Desert portion of
the Los Angeles-San Bernardino Counties (West Mojave Desert)
nonattainment area implement RACT for the 1997 and 2008 ozone
standards. The conditional approval is based on a commitment from the
state to submit new or revised rules that will correct deficiencies in
the following rules for the Mojave Desert Air Quality Management
District:
    (i) Rule 461, Gasoline Transfer and Dispensing;
    (ii) Rule 462, Organic Liquid Loading;
    (iii) Rule 463, Storage of Organic Liquids;
    (iv)-(v) [Reserved]
    (vi) Rule 1115, Metal Parts and Product Coating Operations;
    (vii) Rule 1157, Boilers and Process Heaters;
    (viii) Rule 1160, Internal Combustion Engines;
    (ix) Rule 1161, Portland Cement Kilns; and
    (x) Rule 1162, Polyester Resin Operations.
    (2) If the State fails to meet its commitment by January 31, 2019,
the conditional approval is treated as a disapproval.
* * * * *
[FR Doc. 2019-13497 Filed 7-1-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 148 (Tuesday, August 2, 2011)]
[Notices]
[Pages 46348-46349]
[FR Doc No: 2011-19461]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64974; File No. SR-C2-2011-016]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Adopt Fees for the Execution of Complex Orders

July 27, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 22, 2011, C2 Options Exchange, Incorporated (the
``Exchange'' or ``C2'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which Items have been prepared by the
Exchange. 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.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to adopt fees for the execution of complex
orders. The text of the proposed rule change is available on the
Exchange's Web site (http://www.cboe.org/legal), at the Exchange's
Office of the Secretary, and at the Commission.

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

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

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

1. Purpose
    In December 2009, the Commission approved adoption of C2's rules,
including the process for the execution of complex orders.\3\ Beginning
on July 25, 2011, C2 intends to permit the execution of complex orders
on the Exchange. To that end, the Exchange hereby proposes to adopt a
set of fees for such executions. The adoption of such fees will allow
the Exchange to equitably assess reasonable fees incurred for
processing such orders.
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    \3\ See Securities Exchange Act Release No. 61152 (December 10,
2009), 74 FR 66699 (December 16, 2009).
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    The complex order fees apply to complex orders in multiply-listed,
equity and ETF options classes. The complex order fees apply to all
components of a complex order itself, but may not apply to both sides
of a transaction involving a complex order. For transactions in which
straight one-sided orders execute against a complex order, each
component of the complex order will be assessed the complex order fees
listed in Section 1B of the Fees Schedule, while the straight one-sided
orders will be assessed the transaction fees listed in Section 1A of
the Fees Schedule. For transactions in which a complex order executes
against another complex order, each component of the complex order will
be assessed the complex order fees listed in Section 1B of the Fees
Schedule. For executions that occur within the Complex Order Auction
(``COA'') against auction responses, the incoming/auctioned order is
considered maker, and auction responses are considered taker.
    The Exchange proposes to offer a maker rebate of $0.25 for complex
orders entered by public customers and assess a maker fee of $0.10 for
complex orders entered by C2 market makers and $0.20 for complex orders
entered from all other market participant origins (professional
customers, firms, broker/dealers, non-C2 market-makers, etc.). The
Exchange proposes to assess taker fees of $0.00 for complex orders
entered by public customers and $0.35 for complex orders entered from
C2 market-makers and all other market participant origins (professional
customers, firms, broker/dealers, non-C2 market-makers, etc.). Listed
rates for the complex order fees are per contract.
    As with straight one-sided orders, the Exchange proposes to charge
no fees and offer no rebates to any market participants for trades on
the open. Trades on the open involve the matching of undisplayed pre-
opening trading interest. As such, there is, in effect, no maker or
taker activity occurring. The Exchange would like to encourage users to
submit pre-opening orders.
    The Exchange also proposes to amend Section 1A of the Fees Schedule
to clarify that the fees therein apply to straight one-sided orders, as
opposed to the new fees listed in Section 1B, which apply to complex
orders.
    The proposed complex order fee structure should encourage public
customers to execute complex orders on the Exchange.
    The proposed rule change will take effect on July 25, 2011.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\4\ in general, and furthers the objectives of Section 6(b)(4) \5\
of the Act in particular, in that it is designed to provide for the
equitable allocation of reasonable dues, fees, and other charges among
C2 Trading Permit Holders and other persons using Exchange facilities.
The Exchange believes that the assessment of transaction fees for
complex orders is an equitable allocation of reasonable fees because
such orders require processing and the assessment of such fees allows
the Exchange to recoup costs incurred processing such orders, as well
as recoup administrative and other costs. The Exchange believes that
the amounts of the proposed fees are reasonable because they are
comparable or favorable to fees assessed by the International
Securities Exchange, LLC (``ISE'') \6\ and NASDAQ OMX PHLX, LLC
(``PHLX'') \7\ for complex order execution.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4).
    \6\ See ISE Schedule of Fees, page 16.
    \7\ See PHLX Fee Schedule, pages 6-8.
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    The Exchange believes that, with respect to complex orders,
offering a maker rebate to public customers (and not other market
participants) and assessing a lower taker fee for public customers than
for other market participants is equitable and not unfairly
discriminatory because it will attract public customer order flow to
the Exchange and incentivize broker-dealers and firms to execute public
customer orders on the Exchange. To the extent that this purpose is
achieved, all of the Exchange's market participants should benefit from
the improved market liquidity and the greater number of public customer
orders with which to trade. Further, the Exchange believes that the
public customer maker rebate and taker fee for complex orders is not
unfairly discriminatory because the same rebates and fees would be
assessed uniformly to all public customers.
    The Exchange believes that assessing a lower maker fee for complex
orders

originating from C2 market-makers than for those originating from all
other origins (except Public Customers) is equitable and not unfairly
discriminatory because C2 market-makers have affirmative obligations
(such as quoting) to the Exchange that other market participants do not
have. Further, assessing different complex order fee amounts to
different types of market participants on C2 is equitable and not
unfairly discriminatory because ISE and PHLX assess different complex
order fee amounts to different types of market participants in
connection with complex order executions.\8\ Finally, assessing
different fee levels based on order origin type is a longstanding
practice in the options market.\9\
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    \8\ See ISE Schedule of Fees, page 16 and PHLX Fee Schedule,
pages 6-8.
    \9\ See the Fee Schedules of the BATS Exchange, Inc., BATS Y-
Exchange, Inc., Chicago Board Options Exchange, Incorporated, ISE,
NASDAQ OMX BX, Inc., PHLX, NYSE Amex, LLC, and NYSE Arca, Inc. In
the Fee Schedules of all of these exchanges, these respective
exchanges assess different fee levels based on order origin type in
a variety of circumstances.
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    The Exchange believes that the complex order fees being assessed to
C2 market-makers are equitable and not unfairly discriminatory because
the same fees would be assessed uniformly to all C2 market-makers. The
Exchange also believes that the fees being assessed to complex orders
entered by all origins other than public customers and C2 market-makers
are equitable and not unfairly discriminatory because the same fees
would be assessed to all complex orders entered from origins other than
public customers and C2 market-makers.
    The Exchange believes that, with respect to complex orders,
assessing a fee of $0.00 for trades on the open is reasonable because
it is in line with the fee assessed for straight one-sided trades on
the open \10\ and is equitable and not unfairly discriminatory because
the same fee is assessed to all market participants.
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    \10\ See Exchange Fees Schedule, Section 1A.
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    Finally, the Exchange believes that amending Section 1A of the Fees
Schedule to clarify that the section applies to straight one-sided
orders (as opposed to complex orders) furthers the objectives of
Section 6(b)(5) \11\ of the Act, in that it is designed to avoid
investor confusion, thereby removing impediments to and perfecting the
mechanism of a free and open market and a national market system. The
Exchange operates in a highly competitive market comprised in which
[sic] sophisticated and knowledgeable market participants readily can,
and do, send order flow to competing exchanges if they deem fee levels
at a particular exchange to be excessive. The Exchange believes that
the proposed complex order fees it assesses must be competitive with
fees assessed on other options exchanges. The Exchange believes that
this competitive marketplace impacts the fees present on the Exchange
today and influences the proposals set forth above.
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    \11\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    C2 does not believe that the proposed rule change will impose any
burden on competition 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

    The Exchange has designated the proposed rule change as
establishing or changing a due, fee, or other charge imposed by the
Exchange, thereby qualifying the proposal for effectiveness on filing
pursuant to Section 19(b)(3)(A)(ii) of the Act \12\ and Rule 19b-
4(f)(2) \13\ thereunder. 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.
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    \12\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \13\ 17 CFR 240.19b-4(f)(2).
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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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-C2-2011-016 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-C2-2011-016. 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 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 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
Exchange. 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-C2-
2011-016 and should be submitted on or before August 23, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-19461 Filed 8-1-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 18, 2010 (Volume 75, Number 222)]
[Notices]
[Page 70702-70703]
[DOCID:fr18no10-44]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2010-0045]

Advisory Committee on Construction Safety and Health (ACCSH)

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Announcement of a meeting of the Advisory Committee on
Construction Safety and Health (ACCSH) and ACCSH Work Group meetings.

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

SUMMARY: ACCSH will meet December 9 and 10, 2010 in Washington, DC. In
conjunction with the ACCSH meeting, ACCSH Work Groups will meet
December 7 and 8, 2010.

DATES:
    ACCSH: ACCSH will meet from 8 a.m. to 4 p.m., Thursday, December 9,
2010, and from 8 a.m. to noon, Friday, December 10, 2010.
    ACCSH Work Groups: ACCSH Work Groups will meet Tuesday, December 7,
and Wednesday, December 8, 2010. (For Work Group meeting times and
locations, see the Work Group Schedule information in the SUPPLEMENTARY
INFORMATION section of this notice.)
    Written comments, requests to speak, speaker presentations, and
requests for special accommodation: Comments, requests to address the
ACCSH meeting, written or electronic speaker presentations, and
requests for special accommodations for the ACCSH and ACCSH Work Group
meetings must be submitted (postmarked, sent, transmitted) by November
24, 2010.

ADDRESSES: ACCSH and ACCSH Work Group: ACCSH and ACCSH Work Group
meetings will be held in Room N-3437 A-C, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington DC 20210.
    Submission of comments, requests to speak, and speaker
presentations: Interested persons may submit comments, requests to
speak at the ACCSH meeting, and speaker presentations using any one of
the following methods:
    Electronically: You may submit materials, including attachments,
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the on-line instructions for submissions or
comments.
    Facsimile (Fax): If your submission, including attachments, does
not exceed 10 pages, you may fax it to the OSHA Docket Office at (202)
693-1648.
    Mail, hand delivery, express mail, messenger, or courier service:
You may submit a copy of your comments, request to speak, and speaker
presentation to the OSHA Docket Office, Docket No. OSHA-2010-0045, Room
N-2625, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Washington, DC 20210; telephone<PHONE_NUMBER> (TTY<PHONE_NUMBER>).
Deliveries (hand deliveries, express mail, messenger, and courier
service) are accepted during the Department of Labor's and OSHA Docket
Office's normal business hours, 8:15 a.m.-4:45 p.m., e.t., weekdays.
Because of security-related procedures, submissions by regular mail may
experience significant delays.
    Requests for special accommodations: Please submit requests for
special accommodation to attend the ACCSH and ACCSH Work Group meetings
to Ms. Veneta Chatmon, OSHA, Office of Communications, Room N-3647,
U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC
20210; telephone<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Ms. MaryAnn Garrahan, OSHA, Office of
Communications, Room N-3647, U.S. Department of Labor, 200 Constitution
Avenue, NW., Washington, DC 20210; telephone<PHONE_NUMBER>.
    For general information about ACCSH and ACCSH meetings: Mr. Francis
Dougherty, OSHA, Directorate of Construction, Room N-3468, U.S.
Department of Labor, 200 Constitution Avenue, NW., Washington, DC
20210; telephone<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

ACCSH Meeting

    ACCSH will meet Thursday, December 9, 2010, and Friday, December
10, 2010, in Washington DC. The meeting is open to the public.
    ACCSH is authorized to advise the Secretary of Labor and Assistant
Secretary of Labor for Occupational Safety and Health (Assistant
Secretary) in the formulation of standards affecting the construction
industry and on policy matters arising in the administration of the
safety and health provisions under the Contract Work Hours and Safety
Standards Act (Construction Safety Act) (40 U.S.C. 3701 et seq.) and
the Occupational Safety and Health Act of 1970 (29 U.S.C. 651 et
seq.)(see also 29 CFR 1911.10 and 1912.3).
    The agenda topics for this meeting include:
     Welcome/Remarks from the Office of the Assistant
Secretary;
     Remarks from the Directorate of Construction;
     Mast Climbing Work Platform presentation;
     Update on the Injury and Illness Prevention Program
rulemaking;
     Update on the Severe Violator Enforcement Program;
     Update on Cooperative and State Programs;
     Work Group Reports, Work Group and Committee
Administration;
     Public Comment Period.
    ACCSH meetings are transcribed and detailed minutes of the meetings
are prepared. The transcript and minutes are placed in the public
docket for the meeting. The docket also includes ACCSH Work Group
reports, speaker presentations, comments, and other materials and
requests submitted to the Committee.

ACCSH Work Group Meetings

    In conjunction with the ACCSH meeting, the following ACCSH Work
Groups will meet December 7-8, 2010:

Tuesday, December 7

     Multilingual Issues in Construction--8 to 10 a.m.;
     Power Fastening Tools (Nailguns)--10:10 a.m. to 12:10
p.m.;
     Residential Fall Protection--1 to 3 p.m.;
     Green Jobs in Construction--3:10 to 5:10 p.m.

Wednesday, December 8

     Diversity--Women in Construction--8 to 10 a.m.;
     Silica and Other Construction Health Hazards--10:10 a.m.
to 12:10 p.m.;
     Prevention by Design--1 to 3 p.m.;
     Education and Training (OTI)--3:10 to 5:10 p.m.
    For additional information on ACCSH Work Group meetings or
participating in them, please contact Mr. Dougherty or look on the
ACCSH page on OSHA's Web page at http://www.osha.gov.

Public Participation

    ACCSH Meetings and ACCSH Work Group Meetings: ACCSH and ACCSH Work
Group meetings are open to the public. Individuals needing special
accommodations to attend the ACCSH and ACCSH Work Group meetings should
contact Ms. Chatmon (see ADDRESSES section).
    Submission of written comments, requests to address ACCSH, and
speaker presentations: Interested persons may submit comments, requests
to address ACCSH, and speaker presentations (1) electronically, (2) by
fax, or (3) by hard copy (mail, hand delivery, express mail, messenger,
and courier). All submissions must include the Agency name and docket
number for this ACCSH meeting (Docket No. OSHA-2010-0045). OSHA will
provide copies of submissions to ACCSH members.
    Because of security-related procedures, submissions by regular mail
may experience significant delays. For information about security
procedures for submitting materials by hand delivery, express mail,
messenger, or courier service, contact the OSHA Docket Office.
    Requests to address ACCSH: Individuals who want to address ACCSH at
the meeting must submit their requests to speak and their written or
electronic presentations (e.g., PowerPoint) by November 24, 2010. The
request must state the amount of time desired to speak, the interest
the presenter represents (e.g., business, organization, affiliation),
if any, and a brief outline of the presentation. PowerPoint
presentations and other electronic materials must be compatible with
PowerPoint 2003 and other Microsoft Office 2003 formats. Alternately,
at the ACCSH meeting, individuals may request to address ACCSH by
signing the public comment request sheet and listing the interests they
represent, if any, and the topic(s) to be addressed. In addition, they
must provide 20 hard copies of any materials, written or electronic,
that they want to present to ACCSH.
    Requests to address the Committee may be granted at the ACCSH
Chair's discretion and as time and circumstances permit.
    Public docket of the ACCSH meeting: Comments, requests to speak and
speaker presentations, including any personal information you provide,
will be placed in the public docket of this ACCSH meeting without
change and may be available online at http://www.regulations.gov.
Therefore, OSHA cautions you about submitting certain personal
information such as social security numbers and birthdates.
    The meeting transcript, meeting minutes, documents presented at the
ACCSH meeting, Work Group reports, and other documents pertaining to
involving this ACCSH meeting also are placed in the public docket and
may be available online at http://www.regulations.gov.
    Access to the public record of ACCSH meetings, including Work Group
reports: To read or download documents in the public docket of this
ACCSH meeting, including the transcript, meeting minutes, Work Group
reports and other submissions, go to Docket No. OSHA-2010-0045 at
http://www.regulations.gov. The meeting record and all submissions for
this meeting are listed in the http://www.regulations.gov index;
however, some documents (e.g., copyrighted materials) are not publicly
available through the Web page. The record and all submissions,
including materials not available through http://www.regulations.gov
are available for inspection and copying in the OSHA Docket Office (see
ADDRESSES). Please contact the OSHA Docket Office for assistance making
submissions to or obtaining materials from the public docket.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this notice
under the authority granted by section 7 of the Occupational Safety and
Health Act of 1970 (29 U.S.C. 656), section 107 of the Contract Work
Hours and Safety Standards Act (Construction Safety Act) (40 U.S.C.
3704), the Federal Advisory Committee Act (5 U.S.C. App. 2), 29 CFR
Parts 1911 and 1912, 41 CFR Part 102, and Secretary of Labor's Order
No. 4-2010 (75 FR 55355 (9/10/2010)).

    Signed at Washington, DC, this 15th day of November 2010.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2010-29124 Filed 11-17-10; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 83, Number 222 (Friday, November 16, 2018)]
[Notices]
[Pages 57755-57756]
[FR Doc No: 2018-24985]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84567; File No. SR-CboeEDGX-2018-054]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating To Modify its Fee Schedule

November 9, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 6, 2018, Cboe EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. 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 EDGX Exchange, Inc. (the ``Exchange'' or ``EDGX'') is filing
with the Securities and Exchange Commission (``Commission'') a proposed
rule change to modify its fee schedule.
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

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

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

Exchange 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
    The Exchange proposes to amend its Fees Schedule to correct an
inadvertent oversight to update an amended transaction fee in a
footnote. Specifically, on August 8, 2018, the Exchange filed a rule
filing, SR-CboeEDGX-2018-032, which proposed, among other things, to
increase the standard rate for Bats Auction Mechanism (``BAM'') Contra
orders (i.e., yields fee code BB) from $0.04 per contract to $0.05 per
contract, effective August 1, 2018.\3\ The Exchange notes that although
it reflected the rate increase in the Fee Codes and Associated Fees
table, it mistakenly failed to update the rate referenced under
Footnote 6 of the Fees Schedule, which includes a table setting forth
BAM Pricing. Accordingly, the Exchange proposes to update the listed
BAM Contra Rate under Footnote 6 from $0.04 per contract to $0.05 per
contract. No substantive changes are being made by the proposed rule
change.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 83846 (August 14,
2018), 83 FR 42175 (August 20, 2018) (SR-CboeEDGX-2018-032).
---------------------------------------------------------------------------

2. Statutory Basis

    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\4\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \5\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes the proposed rule change to update an
inaccurate rate under a footnote of the Fees Schedule, will alleviate
potential confusion, thereby removing impediments to and perfecting the
mechanism of a free and open market and a national market system and
protecting investors and the public interest. As noted above, the
proposed filing does not substantively change any transaction fees, but
merely corrects an inadvertent oversight from a previous rule filing to
update the rate under a footnote.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change
does not address competitive issues, but rather, as discussed above, is
merely intended to correct an inadvertent marking omission relating to
a rate change made in a previous rule filing, which will alleviate
potential confusion.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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 \6\ and paragraph (f) of Rule 19b-4 \7\
thereunder. 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 will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
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    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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-CboeEDGX-2018-054 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-CboeEDGX-2018-054. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeEDGX-2018-054 and should be
submitted on or before December 7, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-24985 Filed 11-15-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Notices]
[Pages 51601-51603]
[FR Doc No: 2019-21196]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0007]

Fee for Using a Tropical Disease Priority Review Voucher in
Fiscal Year 2020

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rates for using a tropical disease priority review
voucher for fiscal year (FY) 2020. The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended by the Food and Drug Administration
Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect
priority review user fees for certain applications for review of drug
and biological products when those applications use a tropical disease
priority review voucher. These vouchers are awarded to the sponsors of
certain tropical disease product applications, submitted after
September 27, 2007, upon FDA approval of such applications. The amount
of the fee submitted to FDA with applications using a tropical disease
priority review voucher is determined each fiscal year based on the
difference between the average cost incurred by FDA to review a human
drug application designated as priority review in the previous fiscal
year and the average cost incurred in the review of an application that
is not subject to priority review in the previous fiscal year. This
notice establishes the tropical disease priority review fee rate for FY
2020.

FOR FURTHER INFORMATION CONTACT: Melissa Hurley, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
61075, Beltsville, MD 20705-4304,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 1102 of FDAAA (Pub. L. 110-85) added section 524 to the
FD&C Act (21 U.S.C. 360n). In section 524, Congress encouraged
development of new drug and biological products for prevention and
treatment of tropical diseases by offering additional incentives for
obtaining FDA approval of such products. Under section 524, the sponsor
of an eligible human drug application submitted after September 27,
2007, for a tropical disease (as defined in section 524(a)(3) of the
FD&C Act) shall receive a priority review voucher upon approval of the
tropical disease product application (assuming other criteria are met).
The recipient of a tropical disease priority review voucher may either
use the voucher with a future submission to FDA under section 505(b)(1)
of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351(a) of the Public
Health Service Act (42 U.S.C. 262), or transfer (including by sale) the
voucher to another party. The voucher may be transferred (including by
sale) repeatedly until it ultimately is used for a human drug
application submitted to FDA under section 505(b)(1) of the FD&C Act or
section 351(a) of the Public Health Service Act. A priority review is a
review conducted with a Prescription Drug User Fee Act (PDUFA) goal
date of 6 months after the receipt or filing date, depending upon the
type of application. Information regarding the PDUFA goals is available
at: https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
    The sponsor that uses a priority review voucher is entitled to a
priority review but must pay FDA a priority review user fee in addition
to any other fee required by PDUFA. FDA published guidance on its
website about how this tropical disease priority review voucher program
operates (available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080599.pdf).
    This notice establishes the tropical disease priority review fee
rate for FY 2020 as $2,167,116 and outlines FDA's process for
implementing the collection of the priority review user fees. This rate
is effective on October 1, 2019, and will remain in effect through
September 30, 2020, for applications submitted with a tropical disease
priority review voucher. The payment of this priority review user fee
is required in addition to the payment of any other fee that would
normally apply to such an application under PDUFA before FDA will
consider the application complete and acceptable for filing.

II. Tropical Disease Priority Review User Fee for FY 2020

    FDA interprets section 524(c)(2) of the FD&C Act as requiring that
FDA determine the amount of the tropical disease priority review user
fee each fiscal year based on the difference between the average cost
incurred by FDA in the review of a human drug application subject to
priority review in the previous fiscal year and the average cost
incurred by FDA in the review of a human drug application that is not
subject to priority review in the previous fiscal year.
    A priority review is a review conducted with a PDUFA goal date of 6
months after the receipt or filing date, depending on the type of
application. Under the PDUFA goals letter, FDA has committed to
reviewing and acting on 90 percent of the applications granted priority
review status within this expedited timeframe. Normally, an application
for a human drug or biological product will qualify for priority review
if the product is intended to treat a serious condition and, if
approved, would provide a significant improvement in safety or
effectiveness. An application that does not receive a priority
designation receives a standard review. Under the PDUFA goals letter,
FDA committed to reviewing and acting on 90 percent of standard
applications within 10 months of the receipt or filing date, depending
on the type of application. A priority review involves a more intensive
level of effort and a higher level of resources than a standard review.
    FDA is setting fees for FY 2020, which is to be based on standard
cost data from the previous fiscal year, FY 2019. However, the FY 2019
submission cohort has not been closed out yet, thus the cost data for
FY 2019 are not complete. The latest year for which FDA has complete
cost data is FY 2018. Furthermore, because FDA has never tracked the
cost of reviewing applications that get priority review as a separate
cost subset, FDA estimated this cost based on other data that the
Agency has tracked. The Agency expects all applications that received
priority review would contain clinical data. The application categories
with clinical data for which FDA tracks the cost of review are: (1) New
drug applications (NDAs) for a new molecular entity (NME) with clinical
data and (2) biologics license applications (BLAs).
    The total cost for FDA to review NME NDAs with clinical data and
BLAs in FY 2018 was $335,338,639. There was a total of 74 applications
in these two categories (53 NME NDAs with clinical data and 21 BLAs).
(Note: These numbers exclude the President's Emergency Plan for AIDS
Relief NDAs; no investigational new drug review costs are included in
this amount.) Of these applications, 48 (35 NDAs and 13 BLAs) received
priority review and the remaining 26 received standard reviews. Because
a priority review compresses a review that ordinarily takes 10 months
into 6 months, FDA estimates that a multiplier of 1.67 (10 months
divided by 6 months) should be applied to non-priority review costs in
estimating the effort and cost of a priority review as compared to a
standard review. This multiplier is consistent with published research
on this subject, which supports a priority review multiplier in the
range of 1.48 to 2.35 (Ref. 1). Using FY 2018 figures, the costs of a
priority and standard review are estimated using the following formula:

(48 [alpha] x 1.67) + (26 [alpha]) = $335,338,639

where ``[alpha]'' is the cost of a standard review and ``[alpha]
times 1.67'' is the cost of a priority review.

    Using this formula, the cost of a standard review for NME NDAs and
BLAs is calculated to be $3,158,804 (rounded to the nearest dollar) and
the cost of a priority review for NME NDAs and BLAs is 1.67 times that
amount, or $5,275,203 (rounded to the nearest dollar). The difference
between these two cost estimates, or $2,116,399, represents the
incremental cost of conducting a priority review rather than a standard
review.
    For the FY 2020 fee, FDA will need to adjust the FY 2018
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2019, to adjust the FY 2018 amount
for cost increases in FY 2019. That adjustment, published in the
Federal Register on August 2, 2019 (84 FR 37882), setting FY 2020 PDUFA
fees, is 2.3964 percent for the most recent year, not compounded.
Increasing the FY 2018 incremental priority review cost of $2,116,399
by 2.3964 percent (or 0.023964) results in an estimated cost of
$2,167,116 (rounded to the nearest dollar). This is the tropical
disease priority review user fee amount for FY 2020 that must be
submitted with a priority review voucher for a human drug application
in FY 2020, in addition to any PDUFA fee that is required for such an
application.

III. Fee Schedule for FY 2020

    The fee rate for FY 2020 is set out in table 1:

     Table 1--Tropical Disease Priority Review Schedule for FY 2020
------------------------------------------------------------------------
                                                         Fee rate for FY
                      Fee category                             2020
------------------------------------------------------------------------
Application submitted with a tropical disease priority       $2,167,116
 review voucher in addition to the normal PDUFA fee....
------------------------------------------------------------------------

IV. Implementation of Tropical Disease Priority Review User Fee

    Under section 524(c)(4)(A) of the FD&C Act, the priority review
user fee is due upon submission of a human drug application for which
the priority review voucher is used. Section 524(c)(4)(B) of the FD&C
Act specifies that the application will be considered incomplete if the
priority review user fee and all other applicable user fees are not
paid in accordance with FDA payment procedures. In addition, FDA may
not grant a waiver, exemption, reduction, or refund of any fees due and
payable under section 524 of the FD&C Act (see section 524(c)(4)(C)),
and FDA may not collect priority review voucher fees ``except to the
extent provided in advance in appropriation Acts.'' (Section
524(c)(5)(B) of the FD&C Act.)
    The tropical disease priority review fee established in the new fee
schedule must be paid for any application that is received on or after
October 1, 2019, and submitted with a priority review voucher. This fee
must be paid in addition to any other fee due under PDUFA. Payment
should be made in U.S. currency by electronic check, check, bank draft,
wire transfer, credit card, or U.S. postal money order payable to the
order of the Food and Drug Administration. The preferred payment method
is online using electronic check (Automated Clearing House (ACH) also
known as eCheck). Secure electronic payments can be submitted using the
User Fees Payment Portal at https://userfees.fda.gov/pay. (Note: Only
full payments are accepted. No partial payments can be made

online). Once you search for your invoice, select ``Pay Now'' to be
redirected to Pay.gov. Note that electronic payment options are based
on the balance due. Payment by credit card is available for balances
that are less than $25,000. If the balance exceeds this amount, only
the ACH option is available. Payments should be made using U.S bank
accounts as well as U.S. credit cards.
    FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA website after the
user fee identification (ID) number is generated.
    If paying by paper check, the user fee ID number should be included
on the check, followed by the words ``Tropical Disease Priority
Review.'' All paper checks should be in U.S. currency from a U.S. bank
made payable and mailed to: Food and Drug Administration, P.O. Box
979107, St. Louis, MO 63197-9000.
    If checks are sent by a courier that requests a street address, the
courier can deliver the checks to: U.S. Bank, Attention: Government
Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only.) If you have any
questions concerning courier delivery, contact the U.S. Bank at 314-
418-4013. (This telephone number is only for questions about courier
delivery.) The FDA post office box number (P.O. Box 979107) must be
written on the check. If needed, FDA's tax identification number is 53-
0196965.
    If paying by wire transfer, please reference your unique user fee
ID number when completing your transfer. The originating financial
institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required to add that
amount to the payment to ensure that the invoice is paid in full. The
account information is as follows: U.S. Dept. of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY 10045, Account Number: 75060099,
Routing Number: 021030004, SWIFT: FRNYUS33.

V. Reference

    The following reference is on display with the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is not
available electronically at https://www.regulations.gov as this
reference is copyright protected. FDA has verified the website address,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time.

1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, ``Developing Drugs
for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313-
324, 2006, available at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.25.2.313.

    Dated: September 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21196 Filed 9-27-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Rules and Regulations]
[Pages 28662-28664]
[FR Doc No: 2011-12308]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 60 and 63

[EPA-HQ-OAR-2002-0058; EPA-HQ-2003-0119; FRL-9308-6]
RIN 2060-AQ25; 2060-AO12

Industrial, Commercial, and Institutional Boilers and Process
Heaters and Commercial and Industrial Solid Waste Incineration Units

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rules; Delay of effective dates.

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

SUMMARY: The EPA is delaying the effective dates for the final rules
titled ``National Emission Standards for Hazardous Air Pollutants for
Major Sources: Industrial, Commercial, and Institutional Boilers and
Process Heaters'' and ``Standards of Performance for New Sources and
Emission Guidelines for Existing Sources: Commercial and Industrial
Solid Waste Incineration Units'' under the authority of the
Administrative Procedure Act (APA) until the proceedings for judicial
review of these rules are completed or the EPA completes its
reconsideration of the rules, whichever is earlier.

DATES: The effective dates of the final rules published in the Federal
Register on March 21, 2011 (76 FR 15608 and 76 FR 15704), are delayed
until such time as judicial review is no longer pending or until the
EPA completes its reconsideration of the rules, whichever is earlier.
The Director of the Federal Register has reviewed certain

publications listed in these final rules for incorporation by reference
approval. That approval is delayed until such time as the proceedings
for judicial review of these rules are completed or the EPA completes
its reconsideration of the rules, whichever is earlier. The EPA will
publish in the Federal Register announcing the effective dates and the
incorporation by reference approvals once delay is no longer necessary.

ADDRESSES: Docket: The final rules, the petitions for reconsideration,
and all other documents in the record for the rulemakings are in Docket
ID. No. EPA-HQ-OAR-2002-0058 and EPA-HQ-OAR-2003-0119. All documents in
the dockets are listed in the http://www.regulations.gov index.
Although listed in the index, some information is not publicly
available, e.g., Confidential Business Information or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the EPA's Docket
Center, Public Reading Room, EPA West Building, Room 3334, 1301
Constitution Avenue, NW., Washington, DC 20004. This Docket Facility is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Public Reading Room is
(202) 566-1744, and the telephone number for the Air Docket is (202)
566-1741.

FOR FURTHER INFORMATION CONTACT: ``National Emission Standards for
Hazardous Air Pollutants for Major Sources: Industrial, Commercial, and
Institutional Boilers and Process Heaters'': Mr. Brian Shrager, Energy
Strategies Group, Sector Policies and Programs Division, Office of Air
Quality Planning and Standards (D243-01), U.S. Environmental Protection
Agency, Research Triangle Park, NC 27711, telephone<PHONE_NUMBER>, fax
number<PHONE_NUMBER>, e-mail address<EMAIL_ADDRESS>
``Standards of Performance for New Sources and Emission Guidelines for
Existing Sources: Commercial and Industrial Solid Waste Incineration
Units'': Ms. Toni Jones, Fuels and Incineration Group, Sector Policies
and Programs Division, Office of Air Quality Planning and Standards
(E143-03), U.S. Environmental Protection Agency, Research Triangle
Park, NC 27711, telephone<PHONE_NUMBER>, fax number<PHONE_NUMBER>, e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On March 21, 2011, the EPA issued a final rule to regulate
emissions of hazardous air pollutants (HAP) from industrial,
commercial, and institutional boilers and process heaters located at
major sources of HAP emissions (the ``Major Source Boiler MACT''). On
the same date, the EPA issued a final rule to regulate emissions of
certain air pollutants from commercial and industrial solid waste
incineration units (the ``CISWI Rule''). For further information on the
Major Source Boiler MACT, see 76 FR 15608 (March 21, 2011). For further
information on the CISWI Rule, see 76 FR 15704 (March 21, 2011). In the
March 21 notices, the EPA established an effective date of May 20,
2011, for each rule.
    On the same day the rules were issued, the EPA also published a
notice explaining that the Agency was in the process of developing a
notice proposing reconsideration of certain aspects of both rules. 76
FR 15267. In that notice, the EPA explained that the proposed
reconsideration would address issues on which the EPA believes further
opportunity for public comment is appropriate, as well as any
provisions of the rules that the EPA believes warrant modification
after further consideration of the data and comments already received.
The EPA has received petitions from a number of interested parties
seeking reconsideration of both rules. The petitions identify specific
issues that the EPA is being asked to reconsider. The EPA intends to
initiate a reconsideration process for both rules, as explained above.
The EPA will issue a notice of proposed reconsideration of each rule
that identifies the specific issue or issues raised in the petitions on
which the Agency is granting reconsideration. The EPA understands that
members of the public may wish to submit additional data and
information to inform the EPA's proposed reconsideration, and the
Agency will consider any additional information submitted in time to do
so. Given the anticipated schedule for the reconsideration process, we
request that any additional data and information be provided to the EPA
by July 15, 2011, to allow the Agency to fully consider it.
    The EPA has also received petitions for judicial review of the
Major Source Boiler MACT from the United States Sugar Corporation as
well as from a coalition of industry groups. The EPA has received a
petition for judicial review of the CISWI Rule from a coalition of
industry groups as well. Under section 705 of the APA, ``an agency * *
* may postpone the effective date of [an] action taken by it pending
judicial review.'' The provision requires that the Agency find that
justice requires postponing the action, that the action has not gone
into effect, and that litigation is pending. As described above,
neither the Major Source Boiler MACT nor the CISWI Rule has gone into
effect and petitions for judicial review of both rules have been filed.
    We find that justice requires postponing the effectiveness of these
rules. As explained in the March 21, 2011, notice, EPA has identified
several issues in the final rules which it intends to reconsider
because we believe the public did not have a sufficient opportunity to
comment on certain revisions EPA made to the proposed rules. These
issues include revisions to the proposed subcategories and revisions to
some of the proposed emissions limits. In addition, EPA received data
before finalizing both rules but was unable to incorporate that data
into the final rules given the court deadline for issuing the rules,
which the Agency was unable to extend. EPA also notes thousands of
facilities across multiple, diverse industries will need to begin to
make major compliance investments soon, in light of the pressing
compliance deadlines. These investments may not be reversible if the
standards are in fact revised following reconsideration and full
evaluation of all relevant data.
    Finally, the EPA notes that it is delaying the effective date of
the Major Source Boiler MACT and the CISWI Rule pursuant to the APA,
rather than section 307(d)(7)(B) of the Clean Air Act. As explained
above, the APA authorizes the EPA to find that justice requires
postponing the effective date of a rule when litigation is pending. In
contrast, the Clean Air Act authorizes the EPA to stay the
effectiveness of a rule for three months if the Administrator has
convened a proceeding to reconsider the rule. The EPA further notes
that section 307(d) of the Act expressly states that it is intended to
replace only sections 553-557 of the APA (except as otherwise provided
in section 307(d)), and does not state that it replaces section 705 of
the APA. Therefore, the EPA has the discretion to decide whether it is
appropriate to delay the effective date of a rule under either
provision, based on the specific facts and circumstances before the
Agency. Since petitions for judicial review of both the Major Source
Boiler MACT and the CISWI Rule have been filed, and, as explained
above, justice requires a delay of the effective

dates, it is reasonable for the EPA to exercise its authority to delay
the effective dates of the Major Source Boiler MACT and the CISWI Rule
under the APA for a period that exceeds three months.

II. Issuance of a Stay and Delay of Effective Date

    Pursuant to section 705 of the APA, the EPA hereby postpones the
effectiveness of the Major Source Boiler MACT and the CISWI Rule until
the proceedings for judicial review of these rules are complete or the
EPA completes its reconsideration of the rules, whichever is earlier.
By this action, we are delaying the effective date of both rules,
published in the Federal Register on March 21, 2011 (76 FR 15608 and 76
FR 15704). The delay of the effective date of the CISWI Rule applies
only to those provisions issued on March 21, 2011, and not to any
provisions of 40 CFR part 60, subparts CCCC and DDDD, in place prior to
that date. This delay of effectiveness will remain in place until the
proceedings for judicial review are completed or the EPA completes its
reconsideration of the rules, whichever is earlier, and the Agency
publishes a notice in the Federal Register announcing that the rules
are in effect.

List of Subjects

40 CFR Part 60

    Environmental protection, Administrative practice and procedure,
Air pollution control, Incorporation by reference, Intergovernmental
relations, Reporting and recordkeeping requirements.

40 CFR Part 63

    Environmental protection, Administrative practice and procedure,
Air pollution control, Hazardous substances, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements.

    For the reasons set forth above, under the authority at 7 U.S.C.
705, the effective dates of FRL 9272-8, 76 FR 15608 (March 21, 2011),
and FRL 9273-4, 76 FR 15704 (March 21, 2011) are delayed until further
notice.

    Dated: May 16, 2011.
Lisa P. Jackson,
Administrator.
[FR Doc. 2011-12308 Filed 5-17-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Proposed Rules]
[Pages 77411-77413]
[FR Doc No: 2014-30194]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1100; Directorate Identifier 2009-NE-37-AD]
RIN 2120-AA64

Airworthiness Directives; International Aero Engines AG Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede airworthiness directive (AD) 2012-09-
09 that applies to all International Aero Engines AG (IAE) V2500-A1,
V2525-D5, and V2528-D5 turbofan engines, and certain serial numbers (S/
Ns) of IAE V2522-A5, V2524-A5, V2527-A5, V2527E-A5, V2527M-A5, V2530-
A5, and V2533-A5 turbofan engines. AD 2012-09-09 currently requires
cleaning, eddy current inspection (ECI) or fluorescent penetrant
inspection (FPI), and initial and repetitive ultrasonic inspections
(USIs) of certain high-pressure compressor (HPC) stage 3 to 8 drums, as
well as replacement of the drum attachment nuts. Since we issued AD
2012-09-09, we discovered that additional attachment nuts for certain
HPC stage 3 to 8 drums are affected. This proposed AD would expand the
affected population for initial and repetitive USIs of the HPC stage 3
to 8 drum, revise the inspection intervals, require removal of the
affected attachment nuts and any HPC stage 3 to 8 drum found cracked,
and require a mandatory terminating action. We are proposing this AD to
prevent failure of the HPC stage 3 to 8 drum, which could result in
uncontained drum failure, damage to the engine, and damage to the
airplane.

DATES: We must receive comments on this proposed AD by February 23,
2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact
International Aero Engines AG, 400 Main Street, East Hartford, CT
06118; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Internet: https://www.iaeworld.com. You may view
this service information at the FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2009-
1100; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Office (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Martin Adler, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this NPRM. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2009-1100;
Directorate Identifier 2009-NE-37-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. We will
consider all comments received by the closing date and may amend this
NPRM because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    On May 2, 2012, we issued AD 2012-09-09, Amendment 39-17044 (77 FR
30371, May 23, 2012), (``AD 2012-09-09''), for all IAE V2500-A1, V2525-
D5, and V2528-D5 turbofan engines, and certain S/Ns of IAE V2522-A5,
V2524-A5, V2527-A5, V2527E-A5, V2527M-A5, V2530-A5, and V2533-A5
turbofan engines. AD 2012-09-09 requires cleaning, ECI or FPI, and
initial and repetitive USIs of certain HPC stage 3 to 8 drums, as well
as replacement of the drum attachment nuts. AD 2012-09-09 resulted from
inspections that found 50 HPC drums with cracks and reports that
indicated that the required inspection intervals were not adequate. We
issued AD 2012-09-09 to prevent uncontained failure of the HPC stage 3
to 8 drum, which could result in damage to the airplane.

Actions Since AD 2012-09-09 Was Issued

    Since we issued AD 2012-09-09, we discovered that partially silver-
plated nuts for certain HPC stage 3 to 8 drums cause the drum to
corrode and crack. IAE has also developed a new nut design without
silver plating.

Relevant Service Information

    We reviewed IAE Alert Non-Modification Service Bulletin (NMSB) No.
V2500-ENG-72-0615, Revision 6, dated September 4, 2014; IAE NMSB No.
V2500-ENG-72-0625, dated September 20, 2011; and IAE NMSB No. V2500-
ENG-72-0637, dated May 2, 2013. IAE Alert NMSB No. V2500-ENG-72-0615
describes procedures for performing a USI of the HPC stage 3 to 8 drum.
IAE NMSB No. V2500-ENG-72-0625 provides guidance on performing an ECI
that will improve the ability to detect cracked HPC stage 3 to 8 drums.
IAE NMSB No. V2500-ENG-72-0637 describes procedures for

performing an FPI of the HPC stage 3 to 8 drum.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would expand the affected population for initial
and repetitive USIs of the HPC stage 3 to 8 drum, revise the inspection
intervals, require removal of affected attachment nuts, and require
removal of any HPC stage 3 to 8 drums found cracked. As mandatory
terminating action, this proposed AD would require installation of an
HPC stage 3 to 8 drum that has never operated with silver-plated nuts
using silver-free nuts to attach the HPC stage 3 to 8 drum to the HPC
stage 9 to 12 drum.

Costs of Compliance

    We estimate that this proposed AD affects 956 engines installed on
airplanes of U.S. registry. We estimate that it would take about 3
hours per engine to perform the USI and about 2 hours per engine to
perform the FPI or ECI of the HPC stage 3 to 8 drum. We also estimate
that removing silver residue from the HPC stage 3 to 8 drum would cost
about $2,600 per engine, and required parts would cost about $1,060 per
engine. We estimate the pro-rated replacement cost to replace an HPC
stage 3 to 8 drum to be $52,014. Based on these figures, we estimate
the cost of this proposed AD on U.S. operators to be $53,630,644.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2012-09-09, Amendment 39-17044 (77 FR 30371, May 23, 2012), and adding
the following new AD:

International Aero Engines AG: Docket No. FAA-2009-1100; Directorate
Identifier 2009-NE-37-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by February 23,
2015.

(b) Affected ADs

    This AD replaces AD 2012-09-09, Amendment 39-17044 (77 FR 30371,
May 23, 2012).

(c) Applicability

    This AD applies to:
    (1) All International Aero Engines AG (IAE) V2500-A1 turbofan
engines; and
    (2) All IAE V2525-D5 and V2528-D5 turbofan engines; and
    (3) IAE V2522-A5, V2524-A5, V2527-A5, V2527E-A5, V2527M-A5,
V2530-A5, and V2533-A5 turbofan engines with serial numbers (S/Ns)
V10001 through V13190, and V15001 through V16728, excluding V16707.

(d) Unsafe Condition

    This AD was prompted by the discovery that additional attachment
nuts for certain HPC stage 3 to 8 drums cause the drum to corrode
and crack. We are issuing this AD to prevent failure of the HPC
stage 3 to 8 drum, which could result in uncontained drum failure,
damage to the engine, and damage to the airplane.

(e) Compliance

    Comply with this AD within the compliance times specified,
unless already done. Use paragraph 3.A. of IAE Alert Non-
Modification Service Bulletin (NMSB) No. V2500-ENG-72-A0615,
Revision 6, dated September 4, 2014, to do the ultrasonic inspection
(USI) required by this AD. You may use the inspections listed in
paragraph (g)(3) of this AD instead of a USI for the initial
inspection required by paragraphs (e)(1) through (e)(5) of this AD.
If cracks are found during any of the inspections required by this
AD, remove the drum from service before further flight.
    (1) Initial USI of the HPC stage 3 to 8 drum--Group ``A'' and
Group ``B'':
    For IAE V2500-A1 turbofan engines with S/Ns listed in ``Group
A'' or ``Group B'' in paragraph 1.E. in IAE Alert NMSB No. V2500-
ENG-72-A0615, Revision 6, dated September 4, 2014, perform an
initial USI of the HPC stage 3 to 8 drum within 200 cycles of
accumulating 8,000 cycles-since-new (CSN) or within 200 cycles from
the effective date of this AD, whichever occurs later.
    (2) Initial USI of the HPC stage 3 to 8 drum--Group ``C'':
    For IAE V2500-A5 turbofan engines with S/Ns listed in ``Group
C'' in paragraph 1.E. in IAE Alert NMSB No. V2500-ENG-72-A0615,
Revision 6, dated September 4, 2014, perform an initial USI of the
HPC stage 3 to 8 drum within 200 cycles of accumulating 6,250 CSN or
within 200 cycles from the effective date of this AD, whichever
occurs later.
    (3) Initial USI of the HPC stage 3 to 8 drum--Group ``D'':
    For IAE V2500-A5 turbofan engines with S/Ns listed in ``Group
D'' in paragraph 1.E. in IAE Alert NMSB No. V2500-ENG-72-A0615,
Revision 6, dated September 4, 2014, perform an initial USI of the
HPC stage 3 to 8 drum within 200 cycles of accumulating 3,750 CSN or
within 200 cycles from the effective date of this AD, whichever
occurs later.
    (4) Initial USI of the HPC stage 3 to 8 drum--Group ``E'':
    For IAE V2500-A1, -A5, and -D5 turbofan engines not listed in
``Group A,'' ``Group B,'' ``Group C,'' or ``Group D,'' and with drum
assembly part numbers (P/Ns) listed in ``Group E'' in paragraph 1.E.
in IAE Alert NMSB No. V2500-ENG-72-A0615, Revision

6, dated September 4, 2014, perform an initial USI of the HPC stage
3 to 8 drum within 200 cycles of accumulating 12,500 CSN or within
200 cycles from the effective date of this AD, whichever occurs
later.
    (5) Initial USI of the HPC stage 3 to 8 drum--Group ``F'':
    For IAE V2500-A1, -A5, and -D5 turbofan engines not listed in
``Group A,'' ``Group B,'' ``Group C,'' or ``Group D,'' and with drum
assembly P/Ns listed in ``Group F'' in paragraph 1.E. in IAE Alert
NMSB No. V2500-ENG-72-A0615, Revision 6, dated September 4, 2014,
perform an initial USI of the HPC stage 3 to 8 drum within 200
cycles of accumulating 9,000 CSN or within 200 cycles from the
effective date of this AD, whichever occurs later.

(f) Repetitive USIs of the HPC Stage 3 to 8 Drum

    (1) For engines included in ``Group A,'' ``Group B,'' ``Group
C,'' ``Group E,'' or ``Group F,'' as defined in paragraph (e) of
this AD, perform repetitive USIs of the HPC stage 3 to 8 drum within
every 750 cycles of the last USI.
    (2) For engines included in ``Group D,'' as defined in paragraph
(e) of this AD, perform repetitive USIs of the HPC stage 3 to 8 drum
within every 500 cycles of the last USI.
    (3) If you inspect the HPC stage 3 to 8 drum at shop visit, you
may delay the next USI as shown in the ``Grace Periods Table'' for
each compliance group listed in paragraph 1.E. in IAE Alert NMSB No.
V2500-ENG-72-A0615, Revision 6, dated September 4, 2014.

(g) Removal of Silver-Plated Nuts

    Unless already done, at the next piece-part exposure of the HPC
stage 3 to 8 drum after the effective date of this AD, do the
following before returning any HPC stage 3 to 8 drum to service:
    (1) Remove from service all silver-plated nuts (fully or
partially-plated), P/Ns AS44862 or AS64367, that attach the HPC
stage 3 to 8 drum to the HPC stage 9 to 12 drum.
    (2) Remove the silver residue from the HPC stage 3 to 8 drum.
    (3) Perform an inspection of the HPC stage 3 to 8 drum using at
least one of the following methods:
    (i) Fluorescent penetrant inspection (FPI) of the HPC stage 3 to
8 drum for cracks, or
    (ii) Eddy current inspection (ECI) of the HPC stage 3 to 8 drum
for cracks.

(h) Installation Prohibition

    After the effective date of this AD, do not install any silver-
plated nuts, P/N AS44862 or AS64367, into any engine.

(i) Mandatory Terminating Action

    Within 9,450 cycles after the effective date of this AD,
install:
    (1) an HPC stage 3 to 8 drum that has never operated with
silver-plated nuts (fully or partially plated) to attach the HPC
stage 3 to 8 drum to the HPC stage 9 to 12 drum, with
    (2) silver-free nuts to attach the HPC stage 3 to 8 drum to the
HPC stage 9 to 12 drum.

(j) Definition

    For the purpose of this AD, ``piece-part exposure'' is removal
of the HPC stage 3 to 8 drum from the engine, removal of all blades
from the drum, and separation of the HPC stage 3 to 8 drum from the
stage 9 to 12 drum.

(k) Credit for Previous Actions

    If you performed an inspection of the HPC stage 3 to 8 drum
before the effective date of this AD using one of the following IAE
NMSBs, you met the initial inspection requirement of paragraph (e)
of this AD:
    (i) IAE NMSB No. V2500-ENG-72-0594, Revision 3, dated August 7,
2009, through Revision 6, dated April 12, 2010.
    (ii) IAE NMSB No. V2500-ENG-72-0603, Revision 2, dated March 17,
2010, or earlier revisions.
    (iii) IAE NMSB No. V2500-ENG-72-0608, Revision 3, dated
September 20, 2011, or earlier revisions.
    (iv) IAE NMSB No. V2500-ENG-72-0615, Revision 5, dated August 5,
2014, or earlier revisions.
    (v) IAE NMSB No. V2500-ENG-72-0638, Initial Issue, dated April
11, 2013.

(l) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
for this AD. Use the procedures found in 14 CFR 39.19 to make your
request. You may email your request to<EMAIL_ADDRESS>
(m) Related Information

    (1) For more information about this AD, contact Martin Adler,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) IAE NMSB No. V2500-ENG-72-0637, dated May 2, 2013; IAE NMSB
No. V2500-ENG-72-0625, dated September 20, 2011; IAE Engine Manual
Task 72-41-11-200-001; and IAE Engine Manual Task 72-41-11-110-001,
which are not incorporated by reference in this AD, can be obtained
from IAE, using the contact information in paragraph (m)(3) of this
proposed AD. IAE NMSB No. V2500-ENG-72-0637 and IAE Engine Manual
Task 72-41-11-200-001 provide guidance on performing the FPI.
Guidance on performing the ECI can be found in IAE NMSB No. V2500-
ENG-72-0625. IAE Engine Manual Task 72-41-11-110-001 provides
guidance on cleaning the HPC stage 3 to 8 drum.
    (3) For service information identified in this AD, contact
International Aero Engines AG, 400 Main Street, East Hartford, CT
06118; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Internet: https://www.iaeworld.com.
    (4) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on December 16, 2014.
Colleen M. D'Alessandro,
Assistant Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2014-30194 Filed 12-23-14; 8:45 am]
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