[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36556-36558]
[FR Doc No: 2022-13040]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95088; File No. SR-NYSEArca-2022-34]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Rules
6.40P-O and 6.41P-O

June 13, 2022.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on June 3, 2022, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') 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 self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 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 amend Rules 6.40P-O (Pre-Trade and
Activity-Based Risk Controls) and 6.41P-O (Price Reasonability Checks--
Orders and Quotes). The proposed rule change is available on the
Exchange's website at www.nyse.com, at the principal office of the
Exchange, 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 self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to modify Rules 6.40P-O (Pre-Trade and
Activity-Based Risk Controls) and 6.41P-O (Price Reasonability Checks--
Orders and Quotes) to clarify the application of certain risk checks on
Pillar as set forth below.\4\
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    \4\ Rules 6.40P-O and 6.41P-O describe certain risk checks
available for orders and Market Maker quotes on Pillar. The Exchange
notes that because it has not yet migrated to the Pillar platform,
Rules 6.40-O (Risk Limitation Mechanism), 6.60-O (Price Protection--
Orders) and 6.61-O (Price Protection--Quotes) set forth the
applicable risk checks that continue to apply to orders and Market
Maker quotes, which rules are not being modified by this filing. The
Exchange has announced July 11, 2022 as the planned migration date
for Pillar, as announced here: https://www.nyse.com/trader-update/history#110000421498.
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    First, the Exchange proposes a clarifying change to Rule 6.40P-O
regarding the reference to ``Auction-Only Orders'' as described below.
Rule 6.40P-O describes Activity-Based Risk Controls that are available
to Entering Firms.\5\ Each Entering Firm may apply one of three
activity-based risk limits to its orders and quotes in an options class
based on specified thresholds measured over the course of a specified
time period or Interval.\6\ Rule 6.40P-O(c)(2) sets forth the potential
automated breach action for the Activity-Based Risk Controls that the
Exchange may take should an Entering Firm exceed its established risk
limit. Rule 6.40P-O(d) describes how an Entering Firm's ability to
enter orders, quotes, and related instructions would be reinstated
after certain automated breach actions have been triggered.\7\ And,
Rule 6.40P-O(e) sets forth Kill Switch Action functionality that allows
an Entering Firm to expressly direct the Exchange to take certain bulk
cancel or block actions with respect to orders and quotes in the event
of a breach. The Exchange applies the aforementioned actions to the
quotes and orders submitted by an Entering

Firm, unless otherwise specified in the Rule. In particular, the Rule
explicitly refers to the handling of Auction-Only Orders in the event
of a breach.
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    \5\ See Rule 6.40P-O(a)(1) (defining Entering Firms as all OTP
Holders and OTP Firms (including those acting as Market Makers)).
    \6\ See Rule 6.40P-O(a)(3) (defining Activity-Based Risk
Controls, which controls are not applied to interest represented in
open outcry except for CTB Orders) and Rule 6.40P-O(a)(5) (defining
Interval as the configurable time period during which the Exchange
would determine if an Activity-Based Risk Control is breached).
    \7\ See Rule 6.40P-O(c)(2) (applies in the reinstatement of an
Entering Firm in the event that a ``Block Only'' or ``Cancel and
Block'' Automated Breach Action is triggered).
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    Rule 6.62P-O(c) sets forth the order types that qualify as
``Auction-Only Orders,'' which orders are designated to participate
solely in Auctions held during the opening (or reopening) of option
series.\8\ Subsequent to the adoption of Rule 6.40P-O, the Exchange
adopted Rule 6.91P-O, regarding complex order trading. Rule 6.91P-
O(b)(2)(C) describes ECO GTX Orders. ECO GTX Orders are utilized solely
for a Complex Order Auction or COA, which may only occur once a series
opens or reopens.\9\ As such, for the avoidance of doubt, the Exchange
proposes to specify (by definition) that ``Auction-Only Orders''
referred to throughout Rule 6.40P-O refer to the order types set forth
in Rule 6.62P-O(c) (Orders and Modifiers) and (by extension) do not
include ECO GTX Orders which the Exchange will handle like any other
unexecuted (non-Auction Only) order when an Activity-Based Risk Control
threshold is breached.\10\ The Exchange believes this proposed change
would make clear that Auction-Only Orders do not include ECO GTX Orders
and, as a result would add clarity and transparency to Exchange rules
making them easier to navigate and comprehend.
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    \8\ See Rule 6.62P-O(c)(1)-(3) (defining as Auction-Only Orders:
Limit-on-Open Orders (LOO Orders), Market-on-Open Orders (MOO
Orders), and Imbalance Offset Orders (IO Orders)).
    \9\ See Rule 6.91P-O(f) (providing, in relevant part, that a COA
may only be conducted when a complex strategy is open for trading).
    \10\ See proposed Rule 6.40P-O(a)(6). See, e.g., Rule 6.40P-
O(c)(2)(C)(iii) (providing that for Entering Firms that opt for
``Cancel and Block'' handling upon trigger of an Activity-Based Risk
Control, ``the Exchange will cancel all unexecuted orders and quotes
in the Consolidated Book other than Auction-Only Orders and orders
designated GTC'').
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    Next, the Exchange proposes a clarifying change to Rule 6.41P-O
regarding the application of the ``Price Reasonability Checks'' to
orders and quotes, which include the Arbitrage Check and the Intrinsic
Value Check, when such checks rely on last sale information.\11\ In
particular, the Arbitrage Check will reject or cancel (if resting) a
buy order or quote for call options if the price of the order or quote
``is equal to or greater than the last sale price of the underlying
security on the Primary Market, plus a specified threshold to be
determined by the Exchange and announced by Trader Update.'' \12\
Similarly, for the Intrinsic Value Check, the Exchange deems the
Intrinsic Value of a put option as being ``equal to the strike price
minus the last sale price of the underlying security on the Primary
Market'' and the Intrinsic Value of a call option as being ``equal to
the last sale price of the underlying security on the Primary Market
minus the strike price.'' \13\
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    \11\ See Rule 6.41P-O(b) and (c) (describing the Arbitrage Check
and the Intrinsic Value Check, respectively).
    \12\ See Rule 6.41P-O(b)(2).
    \13\ See Rule 6.41P-O(c)(2)(1)-(2).
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    However, certain trades such as odd-lot transactions are not
considered ``last-sale eligible,'' which means the related pricing data
is not available/reported. As such, when the Exchange does not have
access to such ``last-sale eligible'' information, it cannot perform
the Checks as intended. Therefore, the Exchange proposes to clarify the
impacted sections of the Rule to provide that the applicable Checks
would use as a reference ``the price of the last-sale eligible trade of
the underlying security on the Primary Market.'' \14\ In addition, and
consistent with the aforementioned changes, the Exchange proposes to
add a provision to Rule 6.41P-O(a)(3), regarding the circumstances
under which the Price Reasonability Checks do not apply, to include
``any options series for which there is no last-sale eligible trade in
the underlying security on the Primary Market since the opening of
trading.'' \15\ The Exchange believes these proposed changes add
clarity and transparency to Exchange rules making them easier to
navigate and comprehend.
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    \14\ See proposed Rule 6.41P-O(b)(2), (c)(1)-(2).
    \15\ See proposed Rule 6.41P-O(a)(3)(iv). The Exchange also
proposes to make non-substantive conforming changes to this
paragraph. See proposed Rule 6.41P-O(a)(3)(iii) (removing now-
extraneous and) and (v) (re-numbered existing provision), which
changes add clarity, transparency, and internal consistency to
Exchange rules.
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2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (the ``Act''),\16\ in general, and
furthers the objectives of Section 6(b)(5),\17\ in particular, because
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to, and perfect the
mechanism of, a free and open market and a national market system and,
in general, to protect investors and the public interest.
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    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed rule change to clarify the
``Auction-Only Orders'' covered in Rule 6.40P-O would promote just and
equitable principles of trade and remove impediments to and perfect the
mechanism of a free and open market and a national market system and
protect investors because it would add clarity and transparency to
Exchange rules making them easier to navigate and comprehend. Moreover,
the proposed change would avoid potential confusion regarding the
application of Rule 6.40P-O to ECO GTX Orders (as mentioned in Rule
6.91P-O).
    The Exchange believes that the proposed rule change to clarify that
the Exchange would rely on ``the price of the last-sale eligible trade
of the underlying security on the Primary Market,'' in conducting
certain of the Price Reasonability Checks would promote just and
equitable principles of trade and remove impediments to and perfect the
mechanism of a free and open market and a national market system and
protect investors because it would add clarity and transparency to
Exchange rules making them easier to navigate and comprehend.

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 change is not
intended to address competition, but rather to clarify the Exchange's
rules regarding certain risk checks and how such checks are applied.
The proposed change would apply to all similarly-situated market
participants.

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 filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \18\ and Rule 19b-4(f)(6) thereunder.\19\
Because the proposed rule change does not: (i) significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on

competition; and (iii) become operative prior to 30 days from the date
on which it was filed, or such shorter time as the Commission may
designate, if consistent with the protection of investors and the
public interest, the proposed rule change has become effective pursuant
to Section 19(b)(3)(A)(iii) of the Act \20\ and subparagraph (f)(6) of
Rule 19b-4 thereunder.\21\
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    \18\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \19\ 17 CFR 240.19b-4(f)(6).
    \20\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \21\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \22\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \22\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEArca-2022-34 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-NYSEArca-2022-34. 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-NYSEArca-2022-34 and should be submitted
on or before July 8, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
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    \23\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-13040 Filed 6-16-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Proposed Rules]
[Pages 8951-8953]
[FR Doc No: 2018-04229]

========================================================================
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. 83, No. 42 / Friday, March 2, 2018 / Proposed
Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0163; Product Identifier 2017-NM-168-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 757 airplanes. This proposed AD was
prompted by an evaluation by the design approval holder (DAH)
indicating that the longitudinal lap splices of the fuselage skin are
subject to widespread fatigue damage (WFD). This proposed AD would
require repetitive inspections of the longitudinal lap splices of the
fuselage skin for cracking and protruding fasteners, and applicable
corrective actions. We are proposing this AD to address the unsafe
condition on these products.

DATES: We must receive comments on this proposed AD by April 16, 2018.

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 Boeing
Commercial Airplanes, Attention: Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may
view this referenced service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>. It
is also available on the internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2018-0163.

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-2016-
0163; 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 proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: David Truong, Aerospace Engineer,
Airframe Section, Los Angeles ACO Branch, FAA, 3960 Paramount
Boulevard, Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; fax: 562-627-
5210; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0163;
Product Identifier 2017-NM-168-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this proposed AD. We will consider
all comments received by the closing date and may amend this proposed
AD 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 proposed AD.

Discussion

    Fatigue damage can occur locally, in small areas or structural
design details, or globally, in widespread areas. Multiple-site damage
is widespread damage that occurs in a large structural element such as
a single rivet line of a lap splice joining two large skin panels.
Widespread damage can also occur in multiple elements such as adjacent
frames or stringers. Multiple-site damage and multiple-element damage
cracks are typically too small initially to be reliably detected with
normal inspection methods. Without intervention, these cracks will
grow, and eventually compromise the structural integrity of the
airplane. This condition is known as widespread fatigue damage. It is
associated with general degradation of large areas of structure with
similar structural details and stress levels. As an airplane ages, WFD
will likely occur, and will certainly occur if the airplane is operated
long enough without any intervention.
    The FAA's WFD final rule (75 FR 69746, November 15, 2010) became
effective on January 14, 2011. The WFD rule requires certain actions to
prevent structural failure due to WFD throughout the operational life
of certain existing transport category airplanes and all of these
airplanes that will be certificated in the future. For existing and
future airplanes subject to the WFD rule, the rule requires that DAHs
establish a limit of validity (LOV) of the engineering data that
support the structural maintenance program. Operators affected by the
WFD rule may not fly an airplane beyond its LOV, unless an extended LOV
is approved.
    The WFD rule (75 FR 69746, November 15, 2010) does not require
identifying and developing maintenance actions if the DAHs can show
that such actions are not necessary to prevent WFD before the airplane
reaches the LOV. Many LOVs, however, do depend on accomplishment of
future maintenance actions. As stated in the WFD rule, any maintenance
actions necessary to reach the LOV will be

mandated by airworthiness directives through separate rulemaking
actions.
    In the context of WFD, this action is necessary to enable DAHs to
propose LOVs that allow operators the longest operational lives for
their airplanes, and still ensure that WFD will not occur. This
approach allows for an implementation strategy that provides
flexibility to DAHs in determining the timing of service information
development (with FAA approval), while providing operators with
certainty regarding the LOV applicable to their airplanes.
    The longitudinal lap splices of the fuselage skin on Model 757
airplanes have been determined to be susceptible to WFD. No cracking
was found on the fatigue test article, but WFD analysis has identified
the need for more frequent repetitive inspections. Existing maintenance
planning data (MPD) inspections are not sufficient to detect widespread
fatigue cracks before they become critical. Currently, there have been
no reports of WFD cracking on airplanes in service. Any fatigue
cracking of the longitudinal lap splices of the fuselage skin could go
undetected and grow in length. This condition could result in reduced
structural integrity of the airplane.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 757-53A0104, dated
November 6, 2017. The service information describes procedures for
visual and eddy current inspections of the longitudinal lap splices of
the fuselage skin for cracking and protruding head fasteners.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

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 require accomplishment of the actions
identified as ``RC'' (required for compliance) in the Accomplishment
Instructions of Boeing Alert Service Bulletin 757-53A0104, dated
November 6, 2017, described previously, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
    For information on the procedures and compliance times, see this
service information at http://www.regulations.gov by searching for and
locating Docket No. FAA-2018-0163.

Costs of Compliance

    We estimate that this proposed AD affects 509 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspections......................  367 work-hours x                 $0  $31,195 per          $15,878,255 per
                                    $85 per hour =                       inspection cycle.    inspection cycle.
                                    $31,195.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition repairs specified in this proposed
AD.

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.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes to the Director of the System Oversight
Division.

Regulatory Findings

    We 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 this 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, 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 adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2018-0163; Product Identifier
2017-NM-168-AD.

(a) Comments Due Date

    We must receive comments by April 16, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 757-200, -200PF, -
200CB, and -300 series airplanes, certificated in any category, as
identified in Boeing Alert Service Bulletin 757-53A0104, dated
November 6, 2017.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by an evaluation by the design approval
holder indicating that the longitudinal lap splices of the fuselage
skin are subject to widespread fatigue damage. We are issuing this
AD to address fatigue cracking of the longitudinal lap splices of
the fuselage skin, which could result in reduced structural
integrity of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Except as required by paragraph (h) of this AD: At the
applicable times specified in paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin 757-53A0104, dated November 6, 2017,
do all applicable actions identified as ``RC'' (required for
compliance) in, and in accordance with, the Accomplishment
Instructions of Boeing Alert Service Bulletin 757-53A0104, dated
November 6, 2017.

(h) Exceptions to Service Information Specifications

    (1) For purposes of determining compliance with the requirements
of this AD, where Boeing Alert Service Bulletin 757-53A0104, dated
November 6, 2017, uses the phrase ``the original issue date of this
service bulletin,'' this AD requires using ``the effective date of
this AD.''
    (2) Where Boeing Alert Service Bulletin 757-53A0104, dated
November 6, 2017, specifies contacting Boeing, and specifies that
action as RC: This AD requires using a method approved in accordance
with the procedures specified in paragraph (i) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles ACO Branch, FAA, has the authority
to approve AMOCs for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your
request to your principal inspector or local Flight Standards
District Office, as appropriate. If sending information directly to
the manager of the certification office, send it to the attention of
the person identified in paragraph (j)(1) of this AD. Information
may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Los Angeles ACO Branch, to make those findings. To be
approved, the repair method, modification deviation, or alteration
deviation must meet the certification basis of the airplane, and the
approval must specifically refer to this AD.
    (4) Except as required by paragraph (h)(2) of this AD: For
service information that contains steps that are labeled as RC, the
provisions of paragraphs (i)(4)(i) and (i)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(j) Related Information

    (1) For more information about this AD, contact David Truong,
Aerospace Engineer, Airframe Section, Los Angeles ACO Branch, FAA,
3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-
5224; fax:<PHONE_NUMBER>; email: [email protected].
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Standards Branch, 2200 South 216th
St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on February 22, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-04229 Filed 3-1-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48636-48639]
[FR Doc No: 2018-20912]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0007]

Animal Generic Drug User Fee Rates and Payment Procedures for
Fiscal Year 2019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the fee rates and payment procedures for fiscal year (FY) 2019 generic
new animal drug user fees. The Federal Food, Drug, and Cosmetic Act
(FD&C Act), as amended by the Animal Generic Drug User Fee Amendments
of 2018 (AGDUFA III), authorizes FDA to collect user fees for certain
abbreviated applications for generic new animal drugs, for certain
generic new animal drug products, and for certain sponsors of such
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs. This notice
establishes the fee rates for FY 2019.

FOR FURTHER INFORMATION CONTACT: Visit FDA's website at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm, or contact Lisa Kable, Center for Veterinary Medicine
(HFV-10), Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855,<PHONE_NUMBER>, [email protected]. For general questions,
you may also email the Center for Veterinary Medicine (CVM) at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 741 of the FD&C Act (21 U.S.C. 379j-21) establishes three
different types of user fees: (1) Fees for certain types of abbreviated
applications for generic new animal drugs; (2) annual fees for certain
generic new animal drug products; and (3) annual fees for certain
sponsors of abbreviated applications for generic new animal drugs and/
or investigational submissions for generic new animal drugs (21 U.S.C.
379j-21(a)). When certain conditions are met, FDA will waive or reduce
fees for generic new animal drugs intended solely to provide for a
minor use or minor species indication (21 U.S.C. 379j-21(d)).
    For FY 2019 through FY 2023, the FD&C Act establishes a yearly base
revenue amount and percentages for each of these fee categories (21
U.S.C. 379j-21(b)). Base revenue amounts established for fiscal years
after FY 2019 are subject to adjustment for inflation and workload.
Workload increases will be adjusted for excess collections after FY
2020 (21 U.S.C. 379j-21(c)). The target revenue amounts for each fee
category for FY 2019, are as follows: For application fees, the target
revenue amount is $4,584,000; for product fees, the target revenue
amount is $6,876,000; and for sponsor fees, the target revenue amount
is $6,876,000.
    For FY 2019, the generic new animal drug user fee rates are:
$424,444 for each abbreviated application for a generic new animal drug
other than those subject to the criteria in section 512(d)(4) of the
FD&C Act (21 U.S.C. 360b(d)(4)); $212,222 for each abbreviated
application for a generic new animal drug subject to the criteria in
section 512(d)(4); $15,486 for each generic new animal drug product;
$150,098 for each generic new animal drug sponsor paying 100 percent of
the sponsor fee; $112,574 for each generic new animal drug sponsor
paying 75 percent of the sponsor fee; and $75,049 for each generic new
animal drug sponsor paying 50 percent of the sponsor fee. FDA will
issue invoices for FY 2019 product and sponsor fees by December 31,
2018. These fees will be due by January 31, 2019. The application fee
rates are effective for all abbreviated applications for a generic new
animal drug submitted on or after October 1, 2018, and will remain in
effect through September 30, 2019. Applications will not be accepted
for review until FDA has received full payment of related application
fees and any other fees owed under the Animal Generic Drug User Fee
program (AGDUFA program).

II. Revenue Amount for FY 2019

A. Statutory Fee Revenue Amounts

    AGDUFA III, Title II of Public Law 115-234, specifies that the
aggregate revenue amount for FY 2019 for all generic new animal drug
user fee categories is $18,336,000 (rounded to the nearest thousand
dollars) (21 U.S.C. 379j-21(b)(1)).

B. Inflation Adjustment to Fee Revenue Amount

    AGDUFA III specifies that the annual fee revenue amount is to be
adjusted for inflation increases for FY 2020 and subsequent fiscal
years, using two separate adjustments--one for personnel compensation
and benefits (PC&B) and one for non-PC&B costs (see 21 U.S.C. 379j-
21(c)(2)). The component of the inflation adjustment for payroll costs
shall be one plus the average annual percent change in the cost of all
PC&B paid per full-time equivalent position at FDA for the first 3 of
the 4 preceding fiscal years, multiplied by the average proportion of
PC&B costs to total FDA costs for the first 3 of the 4 preceding fiscal
years. The statute specifies that the portion of the inflation
adjustment for non-payroll costs is the average annual percent change
that occurred in the Consumer Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items
less food and energy; annual index) for the first 3 of the preceding 4
years of available data multiplied by the proportion of all costs other
than PC&B costs to total FDA costs. Because the adjustment for
inflation does not take effect until FY 2020, FDA will not adjust the
FY 2019 fee revenue amount for inflation.

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

    The fee revenue amounts established in AGDUFA III for FY 2020 and
subsequent fiscal years are also subject to adjustment to account for
changes in FDA's review workload. A workload adjustment will be applied
to the inflation adjusted fee revenue amount (21 U.S.C. 379j-21(c)(3)).
    AGDUFA III specifies that FDA shall calculate the weighted average
of the change in the total number of each of the four types of
applications and submissions specified in the workload adjustment
provision (abbreviated applications for generic new animal drugs,
manufacturing supplemental abbreviated applications for generic new
animal drugs, investigational generic new animal drug study
submissions, and investigational generic new animal drug protocol
submissions). Because the

adjustment for workload does not take effect until FY 2020, FDA will
not adjust the FY 2019 fee revenue amount for workload changes.

D. Reduction of Workload-Based Increase by Amount of Certain Excess
Collections

    Under section 741(c)(3)(B) of the FD&C Act, for FYs 2021 through
2023, if application of the workload adjustment increases the amount of
fee revenues established for the fiscal year, as adjusted for
inflation, the fee revenue increase will be reduced by the amount of
any excess collections, for the second preceding fiscal year, up to the
amount of the fee revenue increase. Since this provision will not take
effect until FY 2021, FDA will not reduce the FY 2019 fee revenue
amount for excess collections.

E. FY 2019 Fee Revenue Amounts

    AGDUFA III specifies that the revenue amount of $18,336,000
(rounded to the nearest thousand dollars) for FY 2019 is to be divided
as follows: 25 percent, or a total of $4,584,000, is to come from
application fees; 37.5 percent, or a total of $6,876,000, is to come
from product fees; and 37.5 percent, or a total of $6,876,000, is to
come from sponsor fees (21 U.S.C. 379j-21(b)).

III. Abbreviated Application Fee Calculations for FY 2019

A. Application Fee Revenues and Numbers of Fee-Paying Applications

    Each person that submits an abbreviated application for a generic
new animal drug shall be subject to an application fee, with limited
exceptions (21 U.S.C. 379j-21(a)(1)). The term ``abbreviated
application for a generic new animal drug'' means an abbreviated
application for the approval of any generic new animal drug submitted
under section 512(b)(2) (21 U.S.C. 379j-21(k)(1)). The application fees
are to be set so that they will generate $4,584,000 in fee revenue for
FY 2019.
    To set fees for abbreviated applications for generic new animal
drugs to realize $4,584,000, FDA must first make some assumptions about
the number of fee-paying abbreviated applications it will receive
during FY 2019.
    The Agency knows the number of applications that have been
submitted in previous years. That number fluctuates annually. FDA is
making estimates and applying different assumptions for two types of
full fee submissions: Original submissions of abbreviated applications
for generic new animal drugs and ``reactivated'' submissions of
abbreviated applications for generic new animal drugs. Any original
submissions of abbreviated applications for generic new animal drugs
that were received by FDA before July 1, 2008, were not assessed fees
(21 U.S.C. 379j-21(a)(1)(A)). Some of these non-fee-paying submissions
were later resubmitted on or after July 1 because the initial
submission was not approved by FDA (i.e., FDA marked the submission as
incomplete and requested additional non-administrative information) or
because the original submission was withdrawn by the sponsor.
Abbreviated applications for generic new animal drugs resubmitted on or
after July 1, 2008, are subject to user fees. In this notice, FDA
refers to these resubmitted applications as ``reactivated''
applications.
    Also, under AGDUFA III, an abbreviated application for an animal
generic drug subject to the criteria in section 512(d)(4) of the FD&C
Act and submitted on or after October 1, 2013, shall be subject to 50
percent of the fee applicable to all other abbreviated applications for
a generic new animal drug (21 U.S.C. 379j-21(a)(1)(C)(ii)).
    Regarding original submissions of abbreviated applications for
generic new animal drugs, FDA is assuming that the number of
applications for which fees will be paid in FY 2019 will equal the
average number of submissions over the five most recently completed
years of the AGDUFA program (FY 2013-FY 2017).
    The average number of original submissions of abbreviated
applications for generic new animal drugs over the five most recently
completed years is 9.2 applications not subject to the criteria in
section 512(d)(4) of the FD&C Act and 3.2 submissions subject to the
criteria in section 512(d)(4). Each of the submissions described under
section 512(d)(4) of the FD&C Act pays 50 percent of the fee paid by
the other applications and will be counted as one half of a fee. Adding
all of the applications not subject to the criteria in section
512(d)(4) of the FD&C Act and 50 percent of the number that are subject
to such criteria results in a total of 10.8 anticipated full fees.
    In prior years, FDA had estimated the number of reactivations of
abbreviated applications for generic new animal drugs that had been
originally submitted prior to July 1, 2008. Over the years, that number
has decreased to the point that FDA no longer expects to receive any
reactivations of applications initially submitted prior to July 1,
2008, and will include no provision for them in its fee estimates.
Should such a submission be made, the submitter will be expected to pay
the appropriate fee.
    Based on the previous assumptions, FDA is estimating that it will
receive a total of 10.8 fee-paying generic new animal drug applications
in FY 2019 (9.2 original applications paying a full fee and 3.2
applications paying a half fee).

B. Application Fee Rates for FY 2019

    FDA must set the fee rates for FY 2019 so that the estimated 10.8
abbreviated applications that pay the fee will generate a total of
$4,584,000. To generate this amount, the fee for a generic new animal
drug application will have to be $424,444 and for those applications
that are subject to the criteria set forth in section 512(d)(4) of the
FD&C Act, 50 percent of that amount, or $212,222.

IV. Generic New Animal Drug Product Fee Calculations for FY 2019

A. Product Fee Revenues and Numbers of Fee-Paying Products

    The generic new animal drug product fee must be paid annually by
the person named as the applicant in an abbreviated application or
supplemental abbreviated application for a generic new animal drug
product submitted for listing under section 510 of the FD&C Act (21
U.S.C. 360), and who had an abbreviated application or supplemental
abbreviated application for a generic new animal drug product pending
at FDA after September 1, 2008 (see 21 U.S.C. 379j-21(a)(2)). The term
``generic new animal drug product'' means each specific strength or
potency of a particular active ingredient or ingredients in final
dosage form marketed by a particular manufacturer or distributor, which
is uniquely identified by the labeler code and product code portions of
the national drug code, and for which an abbreviated application for a
generic new animal drug or supplemental abbreviated application for a
generic new animal drug has been approved (21 U.S.C. 379j-21(k)(6)).
The product fees are to be set so that they will generate $6,876,000 in
fee revenue for FY 2019.
    To set generic new animal drug product fees to realize $6,876,000,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2019. FDA gathered data on all generic
new animal drug products that have been submitted for listing under
section 510 of the FD&C Act and matched this to the list of all persons
who FDA estimated would have an abbreviated new animal drug application
or supplemental abbreviated

application pending after September 1, 2008. As of June 2018, FDA
estimates a total of 448 products submitted for listing by persons who
had an abbreviated application for a generic new animal drug or
supplemental abbreviated application for a generic new animal drug
pending after September 1, 2008. Based on this, FDA believes that a
total of 448 products will be subject to this fee in FY 2019.
    In estimating the fee revenue to be generated by generic new animal
drug product fees in FY 2019, FDA is estimating that one percent of the
products invoiced, or four products, will qualify for minor use/minor
species fee waiver (see 21 U.S.C. 379j-21(d)). FDA has made this
estimate at one percent this year, based on historical data over the
past five completed years of the AGDUFA program.
    Accordingly, the Agency estimates that a total of 444 (448 minus 4)
products will be subject to product fees in FY 2019.

B. Product Fee Rates for FY 2019

    FDA must set the fee rates for FY 2019 so that the estimated 444
products that pay fees will generate a total of $6,876,000. To generate
this amount will require the fee for a generic new animal drug product,
rounded to the nearest dollar, to be $15,486.

V. Generic New Animal Drug Sponsor Fee Calculations for FY 2019

A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors

    The generic new animal drug sponsor fee must be paid annually by
each person who: (1) Is named as the applicant in an abbreviated
application for a generic new animal drug, except for an approved
application for which all subject products have been removed from
listing under section 510 of the FD&C Act, or has submitted an
investigational submission for a generic new animal drug that has not
been terminated or otherwise rendered inactive and (2) had an
abbreviated application for a generic new animal drug, supplemental
abbreviated application for a generic new animal drug, or
investigational submission for a generic new animal drug pending at FDA
after September 1, 2008 (see 21 U.S.C. 379j-21(k)(7) and 379j-21(a)(3),
respectively). A generic new animal drug sponsor is subject to only one
such fee each fiscal year (see 21 U.S.C. 379j-21(a)(3)(C)). Applicants
with more than six approved abbreviated applications will pay 100
percent of the sponsor fee; applicants with more than one and fewer
than seven approved abbreviated applications will pay 75 percent of the
sponsor fee; and applicants with one or fewer approved abbreviated
applications will pay 50 percent of the sponsor fee (see 21 U.S.C.
379j-21(a)(3)(C)). The sponsor fees are to be set so that they will
generate $6,876,000 in fee revenue for FY 2019.
    To set generic new animal drug sponsor fees to realize $6,876,000,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2019. Based on the number of firms that meet this
definition and the average number of firms paying fees at each level
over the five most recently completed years of the AGDUFA program (FY
2013 through FY 2017), FDA estimates that in FY 2019, 14 sponsors will
pay 100 percent fees, 19 sponsors will pay 75 percent fees, and 37
sponsors will pay 50 percent fees. That totals the equivalent of 46.75
full sponsor fees (14 x 100 percent or 14, plus 19 x 75 percent or
14.25, plus 37 x 50 percent or 18.5).
    FDA estimates that about two percent of all of these sponsors, or
0.94, may qualify for a minor use/minor species fee waiver (see 21
U.S.C. 379j-21(d)). FDA has made the estimate of the percentage of
sponsors that will not pay fees at two percent this year, based on
historical data over the past five completed years of the AGDUFA
program.
    Accordingly, the Agency estimates that the equivalent of 45.81 full
sponsor fees (46.75 minus 0.94) are likely to be paid in FY 2019.

B. Sponsor Fee Rates for FY 2019

    FDA must set the fee rates for FY 2019 so that the estimated
equivalent of 45.81 full sponsor fees will generate a total of
$6,876,000. To generate this amount will require the 100 percent fee
for a generic new animal drug sponsor, rounded to the nearest dollar,
to be $150,098. Accordingly, the fee for those paying 75 percent of the
full sponsor fee will be $112,574, and the fee for those paying 50
percent of the full sponsor fee will be $75,049.

VI. Fee Schedule for FY 2019

    The fee rates for FY 2019 are summarized in table 1.

                       Table 1--FY 2019 Fee Rates
------------------------------------------------------------------------
                                                           Fee rate for
        Generic new animal drug user fee category             FY 2019
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal Drug         $424,444
 except those subject to the criteria in section
 512(d)(4)..............................................
Abbreviated Application Fee for Generic New Animal Drug          212,222
 subject to the criteria in section 512(d)(4)...........
Generic New Animal Drug Product Fee.....................          15,486
100 Percent Generic New Animal Drug Sponsor Fee \1\.....         150,098
75 Percent Generic New Animal Drug Sponsor Fee \1\......         112,574
50 Percent Generic New Animal Drug Sponsor Fee \1\......          75,049
------------------------------------------------------------------------
\1\ An animal drug sponsor is subject to only one fee each fiscal year.

VII. Fee Waiver or Reduction; Exemption From Fees

    The types of fee waivers and reductions that applied last fiscal
year still exist for FY 2019. However, a new exemption from fees was
established by AGDUFA III, as follows:
    Fees will not apply to any person who not later than September 30,
2023, submits to CVM a supplemental abbreviated application relating to
a generic new animal drug approved under section 512 of the FD&C Act,
solely to add the application number to the labeling of the drug in the
manner specified in section 502(w)(3) of the FD&C Act (21 U.S.C.
352(w)(3)), if that person otherwise would be subject to user fees
under AGDUFA based only on the submission of the supplemental
abbreviated application (21 U.S.C. 379j-21(d)(2).

VIII. Procedures for Paying FY 2019 Generic New Animal Drug User Fees

A. Abbreviated Application Fees and Payment Instructions

    The FY 2019 fee established in the new fee schedule must be paid
for an abbreviated new animal drug application subject to fees under
AGDUFA III that is submitted on or after October 1, 2018. The payment
must be made in U.S. currency from a U.S. bank

by one of the following methods: Wire transfer, electronically, check,
bank draft, or U.S. postal money order made payable to the Food and
Drug Administration. The preferred payment method is online using an
electronic check (Automated Clearing House (ACH), also known as eCheck)
or credit card (Discover, VISA, MasterCard, American Express). Secure
electronic payments can be submitted using the User Fees Payment Portal
at https://userfees.fda.gov/pay or the Pay.gov. payment option is
available to you after you submit a cover sheet. (Note: only full
payments are accepted. No partial payments can be made online.) Once
you have found your invoice, select ``Pay Now'' to be redirected to
Pay.gov. Electronic payment options are based on the balance due.
Payment by credit card is available only for balances less than
$25,000. If the balance exceeds this amount, only the ACH option is
available. Payments must be made using U.S. bank accounts as well as
U.S. credit cards.
    When paying by check, bank draft, or U.S. postal money order,
please write your application's unique Payment Identification Number,
beginning with the letters ``AG'', on the upper right-hand corner of
your completed Animal Generic Drug User Fee Cover Sheet. Also write the
FDA post office box number (P.O. Box 979033) on the enclosed check,
bank draft, or money order. Mail the payment and a copy of the
completed Animal Generic Drug User Fee Cover Sheet to: Food and Drug
Administration, P.O. Box 979033, St. Louis, MO 63197-9000.
    When paying by wire transfer, it is required that the invoice
number is included; without the invoice number the payment may not be
applied. If the payment amount is not applied, the invoice amount would
be referred to collections. 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. Use the following account
information when sending a wire transfer: U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Account Name:
Food and Drug Administration, Account No.: 75060099, Routing No.:
021030004, Swift No.: FRNYUS33.
    To send a check by a courier such as Federal Express, the courier
must deliver the check and printed copy of the cover sheet to: U.S.
Bank, Attn: Government Lockbox 979033, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This address is for courier delivery only. If
you have any questions concerning courier delivery, contact U.S. Bank
at<PHONE_NUMBER>. This phone number is only for questions about courier
delivery.)
    It is important that the fee arrives at the bank at least a day or
two before the abbreviated application arrives at FDA's CVM. FDA
records the official abbreviated application receipt date as the later
of the following: The date the application was received by CVM, or the
date U.S. Bank notifies FDA that your payment in the full amount has
been received, or when the U.S. Department of the Treasury notifies FDA
of payment. U.S. Bank and the United States Treasury are required to
notify FDA within 1 working day, using the Payment Identification
Number described previously.
    The tax identification number of FDA is 53-0196965. (Note: In no
case should the payment for the fee be submitted to FDA with the
application.)

B. Application Cover Sheet Procedures

    Step One--Create a user account and password. Log onto the AGDUFA
website at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm and scroll down the
page until you find the link ``Create AGDUFA User Fee Cover Sheet.''
Select that link and follow the directions. For security reasons, each
firm submitting an application will be assigned an organization
identification number, and each user will also be required to set up a
user account and password the first time you use this site. Online
instructions will walk you through this process.
    Step Two--Create an Animal Generic Drug User Fee Cover Sheet,
transmit it to FDA, and print a copy. After logging into your account
with your user name and password, complete the steps required to create
an Animal Generic Drug User Fee Cover Sheet. One cover sheet is needed
for each abbreviated animal drug application. Once you are satisfied
that the data on the cover sheet is accurate and you have finalized the
cover sheet, you will be able to transmit it electronically to FDA and
you will be able to print a copy of your cover sheet showing your
unique Payment Identification Number.
    Step Three--Send the payment for your application as described in
section VIII.A.
    Step Four--Please submit your application and a copy of the
completed Animal Generic Drug User Fee Cover Sheet to the following
address: Food and Drug Administration, Center for Veterinary Medicine,
Document Control Unit (HFV-199), 7500 Standish Pl., Rockville, MD
20855.

C. Product and Sponsor Fees

    By December 31, 2018, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2019 using this fee
schedule. Fees will be due by January 31, 2019. FDA will issue invoices
in November 2019 for any products and sponsors subject to fees for FY
2019 that qualify for fees after the December 2018 billing.

    Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20912 Filed 9-25-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 99 (Monday, May 23, 2022)]
[Notices]
[Pages 31251-31252]
[FR Doc No: 2022-10982]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2022-0151]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number 1625-0096

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting an extension
of its approval for the following collection of information: 1625-0096,
Report of Oil or Hazardous Substance Discharge; and Report of
Suspicious Maritime Activity; without change. Our ICR describes the
information we seek to collect from the public. Review and comments by
OIRA ensure we only impose paperwork burdens commensurate with our
performance of duties.

DATES: You may submit comments to the Coast Guard and OIRA on or before
June 22, 2022.

ADDRESSES: Comments to the Coast Guard should be submitted using the
Federal eRulemaking Portal at https://www.regulations.gov. Search for
docket number [USCG-2022-0151]. Written comments and recommendations to
OIRA for the proposed information collection should be sent within 30
days of publication of this notice to https://www.reginfo.gov/public/do/PRAMain.
    Find this particular information collection by selecting
``Currently under 30-day Review--Open for Public Comments'' or by using
the search function.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-6P), Attn: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE, Stop 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: A.L. Craig, Office of Privacy
Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>, for questions
on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. 3501 et seq., chapter 35, as amended. An ICR is an
application to OIRA seeking the approval, extension, or renewal of a
Coast Guard collection of information (Collection). The ICR contains
information describing the Collection's purpose, the Collection's
likely burden on the affected public, an explanation of the necessity
of the Collection, and other important information describing the
Collection. There is one ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. These comments
will help OIRA determine whether to approve the ICR referred to in this
Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2022-0151], and must be received by June 22,
2022.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at

https://www.regulations.gov and can be viewed by following that
website's instructions. Additionally, if you go to the online docket
and sign up for email alerts, you will be notified when comments are
posted.
    We accept anonymous comments. All comments to the Coast Guard will
be posted without change to https://www.regulations.gov and will
include any personal information you have provided. For more about
privacy and submissions to the Coast Guard in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020). For more about privacy and submissions to OIRA in
response to this document, see the https://www.reginfo.gov, comment-
submission web page. OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each
ICR. An OMB Notice of Action on each ICR will become available via a
hyperlink in the OMB Control Number: 1625-0096.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (87 FR 13740, March 10, 2022)
required by 44 U.S.C. 3506(c)(2). That notice elicited no comments.
Accordingly, no changes have been made to the Collection.

Information Collection Request

    Title: Report of Oil or Hazardous Substance Discharge; and Report
of Suspicious Maritime Activity.
    OMB Control Number: 1625-0096.
    Summary: Any discharge of oil or a hazardous substance must be
reported to the National Response Center (NRC) so that the pre-
designated on-scene coordinator can be informed and appropriate spill
mitigation action carried out. The NRC also receives suspicious
activity reports from the public and disseminates this information to
appropriate entities.
    Need: 33 CFR 153.203, 40 CFR 263.30 and 264.56, and 49 CFR 171.15
mandate that the NRC be the central place for the public to report all
pollution spills. 33 CFR 101.305 mandates that owners or operators of
those vessels or facilities required to have security plans, report
activities that may result in a Transportation Security Incident (TSI)
or breaches of security to the NRC. Voluntary reports are also
accepted.
    Forms: None.
    Respondents: Persons-in-charge of a vessel or onshore/offshore
facility; owners or operators of vessels or facilities required to have
security plans; and the public.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from 1,980
hours to 3,683 hours a year, due primarily to an increase in the
estimated hour burden per response. The Coast Guard revised the hour
burden per response from 5 minutes to 8.5 minutes per response. Based
on recent NRC data, the change more accurately reflect the time per
response.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. et seq.,
chapter 35, as amended.

    Dated: May 17, 2022.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S. Coast Guard.
[FR Doc. 2022-10982 Filed 5-20-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: November 6, 2008 (Volume 73, Number 216)]
[Notices]
[Page 66085-66086]
[DOCID:fr06no08-81]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58890; File No. SR-CBOE-2008-98]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Increase the Maximum Term for FLEX Options

October 30, 2008.
    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 October 24, 2008, the Chicago Board Options Exchange,
Incorporated (``Exchange'' or ``CBOE'') filed with the Securities and
Exchange Commission (the ``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
the Exchange. The Exchange filed the proposal as a ``non-
controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rules 24A.4 and 24B.4 to increase
the maximum term for Flexible Exchange Options (``FLEX Options'') \5\
to fifteen years. The text of the proposed rule change is available on
the Exchange's Web site (http://www.cboe.org/Legal), at the Office of
the Secretary, CBOE and at the Commission.
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    \5\ FLEX Options provide investors with the ability to customize
basic option features including size, expiration date, exercise
style, and certain exercise prices.
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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
    The purpose of the proposed rule change is to increase the maximum
term for FLEX Options. Currently, the term for a FLEX Options varies
based upon the type of underlying. For example, for FLEX Equity
Options, the maximum term is currently 3 years, provided a member may
request a longer term to a maximum of 5 years (and upon assessment by
the FLEX Official that sufficient liquidity exists, such request will
be granted). For FLEX Index Options, the maximum term is currently 5
years, provided a member may request a longer term to a maximum of 10
years (and upon assessment by the FLEX Official that sufficient
liquidity exists, such request will be granted).\6\ For FLEX Credit
Options, the maximum term is currently 10.25 years.\7\
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    \6\ See Rules 24A.4(a)(4)(i) and 24B.4(a)(5)(i).
    \7\ See Rule 29.18.
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    We are proposing to increase the maximum term for all FLEX Options
to fifteen years and to eliminate the requirement that a FLEX Official
make a liquidity assessment. The changes are being proposed to simplify
the process and in response to numerous member requests that we expand
the maximum term in order to accommodate their desire to bring trades
that are otherwise conducted in the over-the-counter (``OTC'') market
to an exchange environment. Though we want to accommodate these
requests, we are not able to do so under the existing term limitations
imposed in our rules.
    CBOE believes that expanding the eligible term for FLEX Options as
proposed is important and necessary to the Exchange's efforts to create
a product and market that provides members and investors interested in
FLEX-type options with an improved but comparable alternative to the
OTC market in customized options, which can take on contract
characteristics similar FLEX Options but are not subject to the same
maximum term restriction. By expanding the eligible term for FLEX
Options, market participants will now have greater flexibility in
determining whether to execute their customized options in an exchange
environment or in the OTC market. CBOE believes market participants
benefit from being able to trade these customized options in an
exchange environment in several ways, including, but not limited to the
following: (1) Enhanced efficiency in initiating and closing out
positions; (2) increased market transparency; and (3) heightened
contra-party creditworthiness due to the role of The Options Clearing
Corporation (``OCC'') as issuer and guarantor of FLEX Options. Finally,
the Exchange has confirmed with the OCC that OCC can configure its
systems to support FLEX Options that have a maximum expiration of
fifteen years.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act \8\ and the rules and regulations under the Act applicable to
national securities exchanges and, in particular, the requirements of
Section 6(b) of the Act.\9\ Specifically, the Exchange believes the
proposed rule change is consistent with the Section 6(b)(5) \10\
requirements that the rules of an exchange be designed to promote just
and equitable principles of trade, to prevent fraudulent and
manipulative acts, to remove impediments to and to perfect the
mechanism for a free and open market and a national market system, and,
in general, to protect investors and the public interest. The proposed
rule change will provide members and investors with additional
opportunities to trade customized options in an exchange environment,
and investors will benefit as a result.
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    \8\ 15 U.S.C. 78s(b)(1).
    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

    Because the foregoing proposed rule change does not: (1)
Significantly affect the protection of investors or the public
interest; (2) impose any significant burden on competition; and (3)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \11\ and Rule 19b-
4(f)(6) thereunder.\12\ At any time within 60 days of the filing of
such proposed rule change, the Commission may summarily abrogate such
rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6). In addition, when filing a proposed
rule change pursuant to Rule 19b-4(f)(6) under the Act, an Exchange
is required to give the Commission written notice of its intent to
file the proposed rule change, along with a brief description and
text of the proposed rule change, at least five business days prior
to the date of filing of the proposed rule change, or such shorter
time as designated by the Commission. The Exchange provided such
notice to the Commission.
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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-CBOE-2008-98 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-CBOE-2008-98. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the CBOE. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2008-98 and should be
submitted on or before November 28, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-26481 Filed 11-5-08; 8:45 am]

BILLING CODE 8011-01-P