[Federal Register Volume 80, Number 234 (Monday, December 7, 2015)]
[Notices]
[Pages 76064-76066]
[FR Doc No: 2015-30803]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0326]

Parts and Accessories Necessary for Safe Operation; Denial of an
Exemption Application From Atwood Forest Products, Inc.

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Denial of exemption application.

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SUMMARY: FMCSA denies an exemption application from Atwood Forest
Products, Inc. (Atwood) to allow the use of a camera system installed
at the sides and rear of up to 15 of its commercial motor vehicles
(CMV) in lieu of rear-vision mirrors as specified in the Federal Motor
Carrier Safety Regulations (FMCSR). Section 393.80 of the FMCSRs
requires every bus, truck, and truck tractor to be equipped with two
rear-vision mirrors, one at each side, firmly attached to the outside
of the motor vehicle, and so located as to reflect to the driver a view
of the highway to the rear along both sides of the vehicle. All such
mirrors must, at a minimum, meet the requirements of Federal Motor
Vehicle Safety Standard (FMVSS) No. 111, ``Rearview mirrors,'' in
effect at the time the vehicle was manufactured. While Atwood wanted to
install the camera system on its vehicles for use in an evaluation
study to evaluate the safety and economic benefits of eliminating
outside mirrors, it did not provide evidence to enable the Agency to
conclude that motor carriers operating vehicles without any rear-vision
mirrors could achieve a level of safety that is equivalent to, or
greater than, the level of safety that would be obtained by complying
with the regulation.

FOR FURTHER INFORMATION CONTACT: Mr. Mike Huntley, Vehicle and Roadside
Operations Division, Office of Carrier, Driver, and Vehicle Safety, MC-
PSV,<PHONE_NUMBER>; Federal Motor Carrier Safety Administration, 1200
New Jersey Avenue SE., Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

Background

    Section 4007 of the Transportation Equity Act for the 21st Century
(TEA- 21) [Pub. L. 105-178, June 9, 1998, 112 Stat. 401] amended 49
U.S.C. 31315 and 31136(e) to provide authority to grant exemptions from
the FMCSRs. On August 20, 2004, FMCSA published a final rule (69 FR
51589) implementing section 4007. Under this rule, FMCSA must publish a
notice of each exemption request in the Federal Register (49 CFR
381.315(a)). The Agency must provide the public with an opportunity to
inspect the information relevant to the application, including any
safety analyses that have been conducted. The Agency must also provide
an opportunity for public comment on the request.
    The Agency reviews the safety analyses and the public comments and
determines whether granting the exemption would likely achieve a level
of safety equivalent to or greater than the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)). If the Agency denies the request, it must state the reason
for doing so. If the decision is to grant the exemption, the notice
must specify the person or class of persons receiving the exemption and
the regulatory provision or provisions from which an exemption is
granted. The notice must specify the effective period of the exemption
(up to 2 years) and explain the terms and conditions of the exemption.
The exemption may be renewed (49 CFR 381.315(c) and 49 CFR 381.300(b)).

Atwood Application for Exemption

    Atwood applied for an exemption from 49 CFR 393.80 to allow the use
of a camera system installed at the sides and rear of CMVs in lieu of
rear-vision mirrors as specified in the FMCSRs. A copy of the
application is included in the docket referenced at the beginning of
this notice.
    Section 393.80 of the FMCSRs currently requires every bus, truck,
and truck tractor to be equipped with two rear-vision mirrors, one at
each side, firmly attached to the outside of the motor vehicle, and so
located as to reflect to the driver a view of the highway to the rear
along both sides of the vehicle. All such mirrors must, at a minimum,
meet the requirements of FMVSS No. 111 in effect at the time the
vehicle was manufactured. The purpose of FMVSS No. 111 is to reduce the
number of deaths and injuries that occur when the driver of a motor
vehicle does not have a clear and reasonably unobstructed view to the
rear.
    In its application, Atwood states:

    Atwood Forest Products, Inc. is making this request because we
are coordinating device development and installation of rear cameras
in up to fifteen (15) commercial motor vehicles and trailers. The
camera equipment to be installed is going to be located at rear of
trailers and at sides of motor vehicles. A monitor is to be located
in the cab . . . Regulations currently require that mirrors be
installed on each side of [a] tractor. Our system will remove
outside mirrors and install cameras at the rear of trailers and cabs
and motor vehicles with monitors inside the cabs of tractors.

    Atwood contends that without the proposed temporary exemption, it
will not be able to deploy cameras and monitors in its vehicles because
they will be fined for violating the current

regulation, which requires rear-vision mirrors. With the exemption,
Atwood states that it ``will be able to install the camera systems in a
location which will offer the best opportunity to optimize the data and
evaluate the benefits of such a system'' which would eliminate the need
for the currently required outside mirrors.

Public Comments

    On August 28, 2014, FMCSA published a notice of the Atwood
application and asked for public comment (79 FR 51391). The Agency
received four comments.
    Advocates for Highway and Auto Safety (``Advocates'') opposed the
exemption application, stating:

    Atwood provides absolutely no analysis of the safety impacts the
exemption may have. Atwood provides no actual data regarding safety
performance at all. In fact, the applicant failed to provide even a
rudimentary study to confirm that the proposed systems would provide
performance in accordance with FMVSS 111.
    Atwood has provided no evidence that their proposed exemption
would ensure safety and mitigate the concerns regarding rearview
visibility which spurred the FMCSR requirement and the underlying
FMVSS. Likewise, the applicant fails to cite any research on the
performance of the proposed systems, the visibility coverage
offered, the possibility of driver distraction, or even usability
studies to confirm that the proposed monitor and camera systems
would allow a driver to operate a vehicle as safely as while using
traditional, compliant, mirrors.
    The Application is, therefore, insufficient on its face, as
Atwood neither performed nor included any form of safety analysis in
their application nor provided any form of explanation as to how the
applicant would ensure that the proposed exemption will achieve an
equivalent level of safety as required by both the statute and
regulation. The requirement for a safety analysis is part of the
statute and regulations governing the granting of exemptions
precisely to ensure that exemptions which increase risk and decrease
safety are not permitted.

    Two anonymous commenters opposed the exemption application, citing
concerns that the camera-based system may be prone to operational
failure in the event of electrical outages. One of the commenters
stated that the camera-based system could be used ``IN ADDITION to
rearview mirrors, but not IN LIEU of'' the required mirrors.
    The Owner-Operator Independent Drivers Association (OOIDA) stated
``This system quite possibly could have additional safety benefits when
utilized by a well-trained driver. However, there are significant
questions regarding this application, both in terms of the technology
proposed by Atwood, and the method that Atwood and Safety Track would
use to evaluate the performance of the camera systems. As such, OOIDA
urges the FMCSA to only move forward with granting the exemption
request under significant restrictions.''
    OOIDA--like the anonymous commenters--noted concerns regarding the
reliability of the camera-based system due to its reliance on
electronic components. OOIDA encouraged FMCSA to consider mandating
some type of redundancy in the system if the exemption application is
granted. OOIDA stated:

    Mandating the inclusion of one external mirror on each side of
the cab (even if smaller than current standards) could provide a
level of protection against electronics failure. Requiring
redundancy in the electronics system might provide an acceptable
level of protection. Rather than one monitor, two monitors with
independent wiring systems may accomplish a lower risk of failure.
    While current mirrors are susceptible to environmental
conditions that lessen their effectiveness (rain, road, spray, fog)
they never fail completely. We encourage the consideration of this
exemption request to utilize appropriate technology, but caution
against complete reliance on technology (without redundancy)--at
least until a suitable time where the technology has proven
reliability in the very harsh conditions that a CMV operates within.

    In addition, OOIDA echoed Advocates' concerns that Atwood had
failed to provide ``any detailed description of the proposed analysis
of the effectiveness of the system.''

FMVSS No. 111; NHTSA Rulemaking

    Specifically with respect to CMVs, FMVSS No. 111 requires vehicles
with a GVWR of more than 10,000 pounds (excluding trailers) to have
mirrors installed on both sides of the vehicle, located so as to
provide the driver a view to the rear along both sides of the vehicle
and adjustable both in the horizontal and vertical directions to view
the rearward scene. On April 7, 2014, and to satisfy the mandate of the
Cameron Gulbransen Kids Transportation Safety Act of 2007 (``K.T.
Safety Act''), the National Highway Traffic Safety Administration
(NHTSA) published a final rule amending FMVSS No. 111 to expand the
required field of view for all passenger cars, trucks, multipurpose
passenger vehicles, buses, and low-speed vehicles with a GVW of less
than 10,000 pounds (79 FR 19178). Specifically, the rule specifies an
area behind the vehicle which must be visible to the driver when the
vehicle is placed into reverse and other related performance
requirements. NHTSA noted that it anticipates vehicle manufacturers
will use rearview video systems and in-vehicle visual displays in the
near term to meet the requirements of the rule.
    However, the K.T. Safety Act specifically excluded all vehicles
with a GVWR greater than 10,000 pounds, motorcycles, and trailers.
NHTSA declined to extend scope of the rule in response to public
comments recommending that the rule cover larger vehicles not
contemplated by the K.T. Safety Act. NHTSA stated:

    Finally, we also decline to extend today's final rule to cover
trailers, garbage trucks, and other vehicles not contemplated by the
K.T. Safety Act. While we acknowledge that many of these vehicles
may also have significant blind zones, we have concentrated our
research and rulemaking efforts on the vehicles mandated by
Congress. We believe that, by focusing on the vehicles types covered
in the K.T. Safety Act, this rulemaking is able to more
appropriately address the types of crashes that Congress sought to
avoid. To include and accommodate vehicles with a GVWR of 10,000 lbs
or more (many of which are used for commercial purposes), the agency
may be required to utilize a significantly different approach with
different requirements and test procedures that may not be as
closely tailored to avoiding the types of crashes contemplated by
the K.T. Safety Act. Further, we note that backover crashes
involving vehicles with a GVWR less than 10,000 lbs represent a
significant majority of both fatalities and injuries. As this
rulemaking has continuously focused exclusively on vehicles covered
by the K.T. Safety Act, to introduce requirements regarding other
vehicles in today's final rule would raise questions regarding the
sufficiency of the scope of notice of this rulemaking. Thus, today's
final rule declines to introduce such requirements at this time.

FMCSA Decision

    The purpose of FMVSS No. 111 is to reduce the number of deaths and
injuries that occur when the driver of a motor vehicle does not have a
clear and reasonably unobstructed view to the rear. While both
Advocates and OOIDA note that the use of camera-based technology for
rear visibility may have merit for use in CMVs, and such technologies
will be used by light vehicle manufacturers to meet the newly adopted
requirements of FMVSS No. 111, the Atwood application did not provide
sufficient evidence to demonstrate that the use of a camera system
installed at the sides and rear of CMVs in lieu of rear-vision mirrors
as specified in the FMCSRs would be able to provide an equivalent level
of safety when compared to a compliant vehicle.
    Based on the above, FMCSA denies the Atwood exemption application.
FMCSA is unable to determine--as required for an exemption by 49 CFR

381.305(a)--that Atwood would be able to maintain a level of safety
equivalent to, or greater than, the level achieved without the
exemption.
    FMCSA notes that while Atwood's use of the camera-based system in
lieu of the rear vision mirrors required via Sec.  393.80 is denied,
Sec.  393.3 of the FMCSRs expressly permits the use of additional
equipment and accessories (such as the camera-based rear vision
system), not inconsistent with or prohibited by the FMCSRs, provided
that such equipment and accessories do not decrease the safety of
operation of the motor vehicles on which they are used.

    Issued on: November 30, 2015.
T.F. Scott Darling, III,
Acting Administrator.
[FR Doc. 2015-30803 Filed 12-4-15; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 85, Number 59 (Thursday, March 26, 2020)]
[Notices]
[Pages 17146-17148]
[FR Doc No: 2020-06390]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88460; File No. SR-Phlx-2020-10]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Options
4A, Section 12, Terms of Option Contracts

March 23, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 18, 2020, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II 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 amend Options 4A, Section 12, Terms of
Option Contracts.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqphlx.cchwallstreet.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 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 Options 4A, Section 12, Terms of
Option Contracts. Specifically, the Exchange proposes to amend Options
4A, Section 12(b) and (b)(2) to change the number of expirations that
the Exchange may open for trading in series of options related to Long-
Term Options Series of index options. The Exchange also proposes to
change the title of Options 4A, Section 12 from ``Terms of Option
Contracts'' to ``Terms of Index Options Contracts.''
Long-Term Options Series
    The current rule text provides within Phlx Options 4A, Section
12(b):

    After a particular class of stock index options has been
approved for listing and trading on the Exchange, the Exchange shall
from time to time open for trading series of options therein. Within
each approved class of stock index options, the Exchange shall open
for trading a minimum of one expiration month and series for each
class of approved stock index options and may also open for trading
series of options having not less than nine and up to 60 months to
expiration (long-term options series) as provided in subparagraph
(b)(2). Prior to the opening of trading in any series of stock index
options, the Exchange shall fix the expiration month and exercise
price of option contracts included in each such series.

    The Exchange proposes to also amend the current text of Phlx
Options 4A, Section 12(b)(2) which states the below with respect to
Long-term \3\ Option Series:
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    \3\ The Exchange proposes to amend this title to capitalize
``Term.''

    The Exchange may list, with respect to any class of stock index
options, series of options having not less than nine and up to 60
months to expiration, adding up to ten expiration months. Such
series of options may be opened for trading simultaneously with
series of options trading pursuant to this rule. Strike price
interval, bid/ask differential and continuity rules shall not apply
to such options series until the time to expiration is less than
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nine months.

Similar, in part, to Cboe Exchange, Inc. (``Cboe'') Rule 4.13(b),\4\
the Exchange proposes to amend the current rule text to provide ``the
Exchange shall open for trading a minimum of one expiration month and
series for each class of approved stock index options and may also open
for trading series of options having not less than twelve and up to 60
months to expiration (long-term options series) within Options 4A,
Section 12(b) and, similarly, within Options 4A, Section 12(b)(2) amend
the language to provide, ``[t]he Exchange may list, with respect to any
class of stock index options, series of options

having not less than twelve and up to 60 months to expiration . . .''.
This would change Phlx's current expiration for index options from
those series not having less than nine and up to 60 months to
expirations to a number of expirations not having less than twelve and
up to 60 months to expiration with respect to Long-Term Options Series.
The Exchange is aligning its Rules, in part, to match those of Cboe
with respect to the lower monthly limit of acceptable months for Long-
Term Option Series in index options.
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    \4\ Cboe Rule 4.13(b) provide for Long-Term Index Option Series,
``Notwithstanding the provisions of subparagraph (a)(2) above, the
Exchange may list long-term index option series that expire from 12
to 180 months from the date of issuance.''
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    In addition, the Exchange proposes to internally harmonize its
Rules with respect to Long-Term Options Series. In 2013, Phlx amended
Rule 1101(A), currently Options 4A, Section 12, to make its rule
consistent with Cboe's rule.\5\ The 2013 Rule Change amended the Phlx
rule text at then Rule 1101A(b)(iii) from a maximum term of up to 60
months to expiration to an established minimum term of not less than
nine months to expiration for long-term options series. The 2013 Rule
Change established a floor for long-term options series which was not
identical to CBOE Rule 24.9; Cboe's minimum floor was twelve months
while Phlx established the floor at nine months. The Exchange noted in
that filing that the intent of the 2013 Rule Change was to harmonize
the Exchange's rules internally with Phlx Rule 1012,\6\ which is
currently Phlx Options 4, Section 5, (regarding long-term equity and
exchange traded fund options) as well as with the rules of another
options exchange, namely CBOE. The 2013 Rule Change stated, ``The
Exchange believes this would eliminate potential confusion about
competitive long term-index options listing opportunities on the
Exchange, would allow better hedging and trading opportunities and
efficiency, and would be beneficial to the Exchange and its traders,
market participants, and public investors in general.'' \7\
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    \5\ See Securities Exchange Act Release No. 69031 (March 4,
2013), 78 FR 15073 (March 8, 2013) (SR-Phlx-2013-18) (``2013 Rule
Change''). The 2013 Rule Change stated that, ``The purpose of the
proposed rule change is to amend subsection (b) of Rule 1101A to
clarify that long-term options series must have a term of not less
than nine months to expiration, and to reflect that certain rules
will not apply to such long-term options series until the time to
expiration is less than nine months. These changes are proposed to
the limited extent needed to make subsection (b) regarding long-term
options series consistent with the established rule language of
Chicago Board Options Exchange, Inc. (``CBOE'') (e.g., CBOE Rule
24.9 regarding LEAPS), as well as with the established rule language
of the Exchange (e.g., Rule 1012 regarding long-term equity and
exchange traded fund (``ETF'') options).''
    \6\ Phlx Rule 1012(a)(i)(D) contained language that was being
harmonized. The Exchange noted that intervals, differentials, and
continuity rules are equally not germane to long-term index options
as to long-term equity and ETF options. That is, index options are
no different from equity and ETF options in respect of the non-
applicability of these three items until expiration time is less
that nine months, and should, therefore, have similar rules. Phlx
Rule 1012 was since relocated to current Options 4A, Section 5.
    \7\ Id.
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    Subsequent to the 2013 Rule Change, Phlx amended then Rule
1012(a)(i)(D) \8\ to change the expiration timeframe to twelve to
thirty-nine months until expiration stating that this change was
consistent with the proposed rule change filings which adopted it.\9\
The Rule 1012 Rule Change resulted in current Phlx Options 4, Section
5(a)(i)(D) Long-Term Option Series having an expiration timeframe of
twelve to thirty-nine months while the 2013 Rule Change resulted in
current Phlx Options 4A, Section 12 having an expiration of nine to 60
months. At this time, the Exchange proposes to harmonize Phlx Options
4, Section 12 to Phlx Option 4, Section 5(a)(i)(D) and also mirror the
lower monthly limit within Cboe's Rule 4.13(b).
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    \8\ See Securities Exchange Act Release No. 80769 (June 1,
2017), 82 FR 25472 (May 25, 2017) (SR-Phlx-2017-41) (``Rule 1012
Rule Change'').
    \9\ See Securities Exchange Act Release Nos. 28910 (February 22,
1991), 56 FR 9032 (March 4, 1991) (SR-Phlx-90-38) (adopting Rule
1012 Commentary .03), and 29103 (April 18, 1991), 56 FR 19132 (April
25, 1991) (SR-Phlx-91-18). The provision was subsequently relocated
to subsection (a)(i)(D) of Rule 1012. See Securities Exchange Act
Release No. 63700 (January 11, 2011), 76 FR 2931 (January 18, 2011)
(SR-Phlx-2011-04).
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Rulebook Correction
    In addition, the Exchange proposes to correct rule text which was
not correctly copied into the Phlx Rulebook from a prior rule
change.\10\ Specifically, the Prior Rule Change adopted a new section
(a)(2) which was not properly copied into the Rulebook before it was
relocated into the new Rulebook as part of the Phlx Rulebook Relocation
Rule Change.\11\ The rule text, as adopted, stated, ``The Exchange
shall determine fixed point intervals of exercise prices for index
options (options on indexes). Generally, except as provided in
Commentary .04 below, the exercise (strike) price intervals will be no
less than $5, provided that the Exchange may determine to list strike
prices at no less than $2.50 intervals for options on the following
indexes (which may also be known as sector indexes):''. At this time,
the Exchange proposes to restore the correct rule text into Phlx
Options 4A, Section 12(a)(2) and amend the term ``Commentary'' to
reflect the new term ``Supplementary Material'' as stated within the
Phlx Rulebook Relocation Rule Change.
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    \10\ See Securities Exchange Act Release No. 85210 (February 27,
2019), 84 FR 7958 (March 5, 2019) (SR-Phlx-2019-02) (``Prior Rule
Change'').
    \11\ See Securities Exchange Act Release No. 88213 (February 14,
2020), 85 FR 9859 (February 20, 2020) (SR-Phlx-2020-03) (``Phlx
Rulebook Relocation Rule Change'').
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\12\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\13\ in particular, in that it is designed to
promote just and equitable principles of trade and to protect investors
and the public interest by amending its rules, in part, to align them
to Cboe's Rule,\14\ as well Phlx Rules at Options 4, Section
12(a)(i)(D) with respect to Long-Term Option Series in index options.
Harmonizing Phlx's index options and equity and ETF options rules, with
respect to Long-Term Option Series in index options, will allow Phlx to
list these options in the same manner. The Exchange notes that this
rule change will allow Phlx to list more non-Long-Term Option Series
expirations as the front-months for Long-Term Options expirations would
begin with month twelve instead of month nine. The Exchange believes
that there is greater customer demand for a greater number of non-Long-
Term Option Series expirations.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
    \14\ See Cboe Rule 4.13(b).
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    The remainder of the Rulebook changes are intended to restore the
proper rule text from a prior rule change \15\ into the Rulebook and
other non-substantive amendments.
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    \15\ See note 10 above.
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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 not necessary or appropriate in
furtherance of the purposes of the Act. Specifically, the Exchange does
not believe the proposal will impose any burden on intra-market
competition as all market participants will be treated in the same
manner with respect to expirations of Long-Term Options Series in index
options. Additionally, the Exchange does not believe the proposal will
impose any burden on inter-market competition as market participants
are welcome to become Phlx Members and trade at Phlx if they determine
that this proposed rule change has made Phlx more attractive or
favorable. Finally, all options exchanges are free to compete by
listing and trading their own broad-

based index options with similar expirations. This proposal will
harmonize Phlx's index options and equity and ETF options rules, with
respect to Long-Term Option Series in index options.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \16\ and Rule 19b-
4(f)(6) thereunder.\17\
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    \16\ 15 U.S.C. 78s(b)(3)(A).
    \17\ 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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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \18\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \19\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has requested that the Commission waive the 30-day operative delay so
that the proposed rule change may become operative upon filing. As the
proposed rule change raises no novel issues and allows Phlx, with
respect to Long-Term Option Series in index options, to harmonize its
index options and equity and ETF options rules, the Commission believes
that waiver of the 30-day operative delay is consistent with the
protection of investors and the public interest. Accordingly, the
Commission hereby waives the operative delay and designates the
proposed rule change operative upon filing.\20\
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    \18\ 17 CFR 240.19b-4(f)(6).
    \19\ 17 CFR 240.19b-4(f)(6)(iii).
    \20\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2020-10 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-Phlx-2020-10. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10 a.m. and 3 p.m.
Copies of 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-
Phlx-2020-10, and should be submitted on or before April 16, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-06390 Filed 3-25-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 179 (Friday, September 16, 2022)]
[Notices]
[Pages 56994-56995]
[FR Doc No: 2022-20020]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-265, OMB Control No. 3235-0273]

Proposed Collection; Comment Request; Extension: Rule 17Ad-10

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 17Ad-10, (17 CFR
240.17Ad-10), under the Securities Exchange Act of 1934 (15 U.S.C. 78a
et seq.). The Commission plans to submit this existing collection of
information to the Office of Management and Budget (``OMB'') for
extension and approval.
    Rule 17Ad-10 generally requires registered transfer agents to: (1)
create and maintain current and accurate securityholder records; (2)
promptly and accurately record all transfers, purchases, redemptions,
and issuances, and notify their appropriate regulatory agency if they
are unable to do so; (3) exercise diligent and continuous attention in
resolving record inaccuracies; (4) disclose to the issuers for whom
they perform transfer agent functions and to their appropriate

regulatory agency information regarding record inaccuracies; (5) buy-in
certain record inaccuracies that result in a physical over issuance of
securities; and (6) communicate with other transfer agents related to
the same issuer. These requirements assist in the creation and
maintenance of accurate securityholder records, enhance the ability to
research errors, and ensure the transfer agent is aware of the number
of securities that are properly authorized by the issuer, thereby
avoiding over issuance.
    The rule also has specific recordkeeping requirements. It requires
registered transfer agents to retain certificate detail that has been
deleted for six years and keep current an accurate record of the number
of shares or principal dollar amount of debt securities that the issuer
has authorized to be outstanding. These mandatory requirements ensure
accurate securityholder records and assist the Commission and other
regulatory agencies with monitoring transfer agents and ensuring
compliance with the rule. This rule does not involve the collection of
confidential information.
    There are approximately 401 registered transfer agents. We estimate
that the average number of hours necessary for each transfer agent to
comply with Rule 17Ad-10 is approximately 80 hours per year, which
generates an industry-wide annual burden of approximately 32,080 hours
(401 times 80 hours). This burden is primarily of a recordkeeping
nature but also includes a small amount of third-party disclosure. At
an average staff cost of $50 per hour, the industry-wide internal labor
cost of compliance (a monetization of the burden hours) is
approximately $1,604,000 per year (32,080 x $50). In addition, we
estimate that each transfer agent will incur an annual external cost
burden of approximately $18,000 resulting from the collection of
information. Therefore, the total annual external cost on the entire
transfer agent industry is approximately $7,218,000 ($18,000 times
401). This cost primarily reflects ongoing computer operations and
maintenance associated with generating, maintaining, and disclosing or
providing certain information required by the rule.
    The amount of time any particular transfer agent will devote to
Rule 17Ad-10 compliance will vary according to the size and scope of
the transfer agent's business activity. We note, however, that at least
some of the records, processes, and communications required by Rule
17Ad-10 would likely be maintained, generated, and used for transfer
agent business purposes even without the rule.
    Written comments are invited on: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted by
November 15, 2022.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549, or send an email to:
[email protected].

    Dated: September 12, 2022.
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-20020 Filed 9-15-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 26 (Tuesday, February 8, 2022)]
[Proposed Rules]
[Pages 7062-7065]
[FR Doc No: 2022-02520]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0091; Project Identifier MCAI-2021-01123-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Airbus SAS Model A318 series airplanes; Model A319-111, -
112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-211,
-212, -214, -216, -231, -232, and -233 airplanes; and Model A321-111, -
112, -131, -211, -212, -213, -231, and -232 airplanes. This proposed AD
was prompted by reports that during inspections accomplished in
accordance with certain airworthiness limitation items (ALIs), cracks
were detected in double joggle areas at frame (FR) 16 and FR20, right
hand and left hand sides. This proposed AD would require repetitive
special detailed inspections of certain areas and applicable on-
condition actions, as specified in a European Union Aviation Safety
Agency (EASA) AD. The FAA is proposing this AD to address the unsafe
condition on these products.

DATES: The FAA must receive comments on this proposed AD by March 25,
2022.

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 https://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 EASA material that will be incorporated by reference (IBR) in
this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this material on the EASA website at
https://ad.easa.europa.eu.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0091; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the
mandatory continuing airworthiness information (MCAI), any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0091; Project Identifier
MCAI-2021-01123-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Sanjay Ralhan, Aerospace Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des Moines,
WA 98198; telephone and fax<PHONE_NUMBER>; email [email protected].
Any commentary that the FAA receives which is not specifically
designated as CBI will be placed in the public docket for this
rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0227, dated October 11, 2021
(EASA AD 2021-0227) (also referred to as the MCAI), to correct an
unsafe condition for certain Airbus SAS Model A318 series airplanes;
Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes;
Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes; and
Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes.
    This proposed AD was prompted by reports that during inspections
accomplished in accordance with ALI tasks 531153 and 531155, cracks
were detected in the double joggle areas at FR16 and FR20, right hand
and left hand sides. The FAA is proposing this

AD to address cracks in these areas, which, if not detected and
corrected, could reduce the structural integrity of the fuselage. See
the MCAI for additional background information.

Other Relevant Rulemaking

    AD 2020-20-05, Amendment 39-21261 (85 FR 65197, October 15, 2020)
(AD 2020-20-05) applies to Model A318-111, -112, -121, and -122
airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, -133, -
151N, and -153N airplanes; Model A320-211, -212, -214, -216, -231, -
232, -233, -251N, -252N, -253N, -271N, -272N, and -273N airplanes; and
Model A321-111, -112, -131, -211, -212, -213, -231, -232, -251N, -
251NX, -252N, -252NX, -253N, -253NX, -271N, -271NX, -272N, and -272NX
airplanes. AD 2020-20-05 requires incorporating new or more restrictive
airworthiness limitations. Accomplishment of the proposed actions would
terminate ALI Tasks 531153-02-1, 531153-02-2, 531155-02-1 and 531155-
02-2, as required by paragraph (i) of AD 2020-20-05 for Model A318
series airplanes; Model A319-111, -112, -113, -114, -115, -131, -132,
and -133 airplanes; Model A320-211, -212, -214, -216, -231, -232, and -
233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231,
and -232 airplanes only.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0227 specifies procedures for repetitive special
detailed inspections (rototest inspections) of double joggle areas at
FR16 and FR20, right hand and left hand sides for cracking, applicable
on-condition actions (repair) and an optional modification of the
double joggle area, which terminates the repetitive inspections. The
modification includes a rotating probe inspection of certain fastener
holes for cracks, a check of the fastener holes for a minimum diameter,
and applicable on-condition actions (repair and oversizing holes). This
material 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

    These products have been approved by the aviation authority of
another country and is approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with the State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI referenced above. The FAA is issuing this NPRM after
determining that the unsafe condition described previously is likely to
exist or develop in other products of these same type designs.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2021-0227 described previously, except for any differences
identified as exceptions in the regulatory text of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2021-0227 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2021-0227 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2021-0227 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2021-
0227. Service information required by EASA AD 2021-0227 for compliance
will be available at https://www.regulations.gov by searching for and
locating Docket No. FAA-2022-0091 after the FAA final rule is
published.

Costs of Compliance

    The FAA estimates that this proposed AD would affect 1,549
airplanes of U.S. registry. The FAA estimates the following costs to
comply with this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
               Labor cost                   Parts cost         Cost per product         Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 55 work-hours x $85 per hour =                  $0  Up to $4,675..............  Up to $7,241,575.
 $4,675.
----------------------------------------------------------------------------------------------------------------

                  Estimated Costs for Optional Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
60 work-hours x $85 per hour = $5,100.          $1,624           $6,724
------------------------------------------------------------------------

    The FAA has received no definitive data on which to base the 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.
    The FAA is 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

    The FAA 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) Would not affect intrastate aviation in Alaska, and
    (3) Would 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:

Airbus SAS: Docket No. FAA-2022-0091; Project Identifier MCAI-2021-
01123-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by March 25, 2022.

(b) Affected ADs

    This AD affects AD 2020-20-05, Amendment 39-21261 (85 FR 65197,
October 15, 2020) (AD 2020-20-05).

(c) Applicability

    This AD applies to Airbus SAS Model airplanes specified in
paragraphs (c)(1) through (4) of this AD, certificated in any
category, as identified in European Union Aviation Safety Agency
(EASA) AD 2021-0227, dated October 11, 2021 (EASA AD 2021-0227).
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, and -233
airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, and -232
airplanes.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by reports that, during inspections
accomplished as specified in certain airworthiness limitation items
(ALIs), cracks were detected in the double joggle areas at frame
(FR) 16 and FR20 in the nose forward fuselage. The FAA is issuing
this AD to address cracks in these areas, which, if not detected and
corrected, could reduce the structural integrity of the fuselage.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2021-0227.

(h) Exceptions to EASA AD 2021-0227

    (1) Where EASA AD 2021-0227 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2021-0227 does not apply
to this AD.
    (3) Where paragraph (2) of EASA AD 2021-0227 specifies to
``contact Airbus for approved repair instructions and, within the
compliance time specified therein, accomplish those instructions
accordingly'' if any cracks are detected, for this AD if any
cracking is detected, the cracking must be repaired before further
flight using a method approved by Airbus SAS's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (4) Where paragraphs (3) and (4) of EASA AD 2021-0227 specify
``Airbus approved repair instructions,'' or ``post-repair inspection
instructions approved by Airbus,'' for this AD, to be acceptable for
credit, the repair instructions must be approved by Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2021-0227
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

 (j) Terminating Action for Certain Requirements in AD 2020-20-05

    Accomplishing the initial inspections required by this AD
terminates ALI Tasks 531153-02-1, 531153-02-2, 531155-02-1 and
531155-02-2, as required by paragraph (i) of AD 2020-20-05 only for
the airplanes identified in paragraph (c) of this AD.

 (k) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation 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 responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (l)(2) of
this AD. Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraphs (h)(3), (i), and (k)(2) of this AD, if any service
information contains procedures or tests that are identified as RC,
those procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's existing maintenance or inspection program without
obtaining approval of an AMOC, provided the procedures and tests
identified as RC can be done and the airplane can be put back in an
airworthy condition. Any substitutions or changes to procedures or
tests identified as RC require approval of an AMOC.

(l) Related Information

    (1) For EASA AD 2021-0227, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; Internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu. You may
view this material at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195. This material may be found in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-
2022-0091.
    (2) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email [email protected].

    Issued on February 2, 2022.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-02520 Filed 2-7-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 28, 2008 (Volume 73, Number 230)]
[Notices]
[Page 72496]
[DOCID:fr28no08-97]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2008-1059]

Random Drug Testing Rate for Covered Crewmembers

AGENCY: Coast Guard, DHS.

ACTION: Notice of minimum random drug testing rate.

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SUMMARY: The Coast Guard has set the calendar year 2009 minimum random
drug testing rate at 50 percent of covered crewmembers.

DATES: The minimum random drug testing rate is effective January 1,
2009, through December 31, 2009. Marine employers must submit their
2008 Management Information System (MIS) reports no later than March
15, 2009.

ADDRESSES: Annual MIS reports may be submitted to Commandant (CG-545),
U.S. Coast Guard Headquarters, 2100 Second Street, SW., Room 2404,
Washington, DC 20593-0001 or by electronic submission to the following
Internet address: http://homeport.uscg.mil/Drugtestreports.

FOR FURTHER INFORMATION CONTACT: For questions about this notice,
please contact Mr. Robert C. Schoening, Drug and Alcohol Program
Manager, Office of Investigations and Casualty Analysis (CG-545), U.S.
Coast Guard Headquarters, telephone<PHONE_NUMBER>. If you have questions
on viewing or submitting material to the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under 46 CFR 16.230, the Coast Guard
requires marine employers to establish random drug testing programs for
covered crewmembers on inspected and uninspected vessels.
    Every marine employer is required by 46 CFR 16.500 to collect and
maintain a record of drug testing program data for each calendar year,
and submit this data by 15 March of the following year to the Coast
Guard in an annual MIS report. Marine employers may either submit their
own MIS reports or have a consortium or other employer representative
submit the data in a consolidated MIS report.
    The purpose of setting a minimum random drug testing rate is to
assist the Coast Guard in analyzing its current approach for deterring
and detecting illegal drug abuse in the maritime industry. The testing
rate for calendar year 2009 is 50 percent.
    The Coast Guard may lower this rate if, for two consecutive years,
the drug test positive rate is less than 1.0 percent, in accordance
with 46 CFR 16.230(f)(2).
    Since 2007 MIS data indicates that the positive rate is greater
than one percent industry-wide (1.33 percent), the Coast Guard
announces that the minimum random drug testing rate will continue at 50
percent of covered employees for the period of January 1, 2009, through
December 31, 2009, in accordance with 46 CFR 16.230(e).
    Each year, the Coast Guard will publish a notice reporting the
results of random drug testing for the previous calendar year's MIS
data and the minimum annual percentage rate for random drug testing for
the next calendar year.

    Dated: November 14, 2008.
Francis J. Sturm,
Captain, U.S. Coast Guard, Deputy Director of Prevention Policy.
[FR Doc. E8-28133 Filed 11-26-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register: March 11, 2009 (Volume 74, Number 46)]
[Rules and Regulations]
[Page 10469-10471]
[DOCID:fr11mr09-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0671; Directorate Identifier 2008-NM-017-AD;
Amendment 39-15796; AD 2009-02-06]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-300, -400, and -500
Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Boeing Model 737-300, -400, and -500 series airplanes. This AD requires
repetitive high frequency eddy current inspections for cracking of the
1.04-inch nominal diameter wire penetration hole in the frame and frame
reinforcement, between stringers S-20 and S-21, on both the left and
right sides of the airplane, and related investigative and corrective
actions if necessary. This AD results from reports of cracking in the
frame, or in the frame and frame reinforcement, common to the 1.04-inch
nominal diameter wire penetration hole intended for wire routing. We
are issuing this AD to detect and correct cracking in the fuselage
frames and frame reinforcements, which could reduce the structural
capability of the frames to sustain limit loads, and result in cracking
in the fuselage skin and subsequent rapid depressurization of the
airplane.

DATES: This AD is effective April 15, 2009.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 15,
2009.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1, fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; 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 AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Wayne Lockett, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6447; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
certain Boeing Model 737-300, -400, and -500 series airplanes. That
NPRM was published in the Federal Register on June 24, 2008 (73 FR
35598). That NPRM proposed to require repetitive high frequency eddy
current (HFEC) inspections for cracking of the 1.04-inch nominal
diameter wire penetration hole in the frame and frame reinforcement,
between stringers S-20 and S-21, on both the left and right sides of
the airplane, and related investigative and corrective actions if
necessary.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received from the single commenter.

Request To Revise Paragraph (h) To Correct References to Parts of the
Service Bulletin

    KLM Royal Dutch Airlines (KLM) requests that we revise paragraph
(h) of the NPRM to correct the references to certain parts of Boeing
Alert Service Bulletin 737-53A1279, dated December 18, 2007 (``the
service bulletin''), for doing certain actions. KLM points out that
paragraph (h) of the NPRM refers to Part 3 of the service bulletin for
doing the repair and to Part 4 of the service bulletin for doing the
preventative modification. KLM further points out that Part 4 of the
service bulletin concerns repeat inspections, not the preventative
modification. The preventative modification is provided in Part 5 of
the service bulletin.
    We agree with the commenter. It was our intention to refer to Part
5 of the service bulletin for doing the preventative modification
provided in paragraph (h) of the NPRM. Therefore, we have revised
paragraph (h) of this AD to refer to Part 5 of the service bulletin for
doing the preventative modification.

Request To Revise Paragraph (e) To Clarify Compliance Times

    KLM requests that we revise paragraph (e) of the NPRM to refer to
paragraph 1.E., ``Compliance,'' of the service bulletin. KLM asserts
that adding a reference to the location of the compliance times in the
service bulletin would be helpful.
    We do not agree to revise paragraph (e) of this AD. A reference to
paragraph 1.E., ``Compliance,'' of Boeing Service Bulletin 737-53A1279,
dated December 18, 2007, is already provided in paragraph (g) of this
AD.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the change described previously. We also determined that
this change will not increase the economic burden on any operator or
increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects 616 airplanes of U.S. registry.
The following table provides the estimated costs for U.S. operators to
comply with this AD. The average labor rate is $80 per work hour.

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Number of
                                                                                U.S.-
             Action                  Work hours        Parts    Cost per  product  registered      Fleet cost
                                                                                airplanes
----------------------------------------------------------------------------------------------------------------
Inspection.....................  Between 6 and 8            $0  Between $480 and          616  Between $295,680
                                  (depending on                  $640, per                      and $394,240,
                                  airplane                       inspection cycle.              per inspection
                                  configuration),                                               cycle.
                                  per inspection
                                  cycle.
----------------------------------------------------------------------------------------------------------------

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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, (2) Is not a ``significant rule'' under DOT Regulatory
Policies and Procedures (44 FR 11034, February 26, 1979), and

    (3) 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.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 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 AD:

2009-02-06 Boeing: Amendment 39-15796. Docket No. FAA-2008-0671;
Directorate Identifier 2008-NM-017-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective April 15,
2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 737-300, -400, and -500
series airplanes, certificated in any category; as identified in
Boeing Alert Service Bulletin 737-53A1279, dated December 18, 2007.

Unsafe Condition

    (d) This AD results from reports of cracking in the frame, or in
the frame and frame reinforcement, common to the 1.04-inch nominal
diameter wire penetration hole intended for wire routing. We are
issuing this AD to detect and correct cracking in the fuselage
frames and frame reinforcements, which could reduce the structural
capability of the frames to sustain limit loads, and result in
cracking in the fuselage skin and subsequent rapid depressurization
of the airplane.

Compliance

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

Service Bulletin Reference Paragraph

    (f) The term ``service bulletin,'' as used in this AD, means the
Accomplishment Instructions of Boeing Alert Service Bulletin 737-
53A1279, dated December 18, 2007.
    (1) The ``condition'' column of paragraph 1.E. of Boeing Alert
Service Bulletin 737-53A1279, dated December 18, 2007, refers to
total flight cycles ``at the date given on this service bulletin.''
This AD applies to the airplanes with the specified total flight
cycles as of the effective date of this AD.
    (2) Where the service bulletin specifies to contact Boeing for
instructions for removing damage and repairing cracking: Before
further flight, remove the damage or repair the cracking using a
method approved in accordance with the procedures specified in
paragraph (i) of this AD.
    (3) Although the service bulletin referenced in this AD
specifies to submit information to the manufacturer, this AD does
not include that requirement.

Inspections, Related Investigative and Corrective Actions

    (g) At the applicable time specified in paragraph 1.E.,
``Compliance,'' of the service bulletin, except as specified by
paragraph (f)(1) of this AD: Do a high frequency eddy current (HFEC)
surface inspection or an HFEC hole/edge inspection for cracking of
the 1.04-inch nominal diameter wire penetration hole in the frame
and frame reinforcement, between stringer S-20 and S-21; and do all
applicable related investigative and corrective actions; by
accomplishing all the actions specified in the Accomplishment
Instructions of the service bulletin, except as specified by
paragraphs (f)(2) and (f)(3) of this AD. Do all applicable related
investigative and corrective actions before further flight.
Thereafter, repeat the inspections at the applicable intervals
specified in paragraph 1.E. of the service bulletin.

Terminating Action

    (h) Doing the repair in Part 3 or the preventative modification
in Part 5 of the service bulletin terminates the repetitive
inspection requirements of this AD.

Alternative Methods of Compliance (AMOCs)

    (i)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, ATTN: Wayne Lockett, Aerospace Engineer, Airframe Branch, ANM-
120S, 1601 Lind Avenue, SW., Renton, Washington 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who has been authorized
by the Manager, Seattle ACO, to make those findings. For a repair
method to be approved, the repair must meet the certification basis
of the airplane, and the approval must specifically refer to this
AD.

Material Incorporated by Reference

    (j) You must use Boeing Alert Service Bulletin 737-53A1279,
dated December 18, 2007, to do the actions required by this AD,
unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1, fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (3) You may review copies of the service information
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For
information on the availability of this material at the FAA, call
425-227-1221 or<PHONE_NUMBER>.
    (4) You may also review copies of the service information at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html.

    Issued in Renton, Washington, on January 9, 2009.
Stephen P. Boyd,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.
[FR Doc. E9-4734 Filed 3-10-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Rules and Regulations]
[Pages 58554-58557]
[FR Doc No: 2017-26753]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529, and 558

[Docket No. FDA-2017-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for a
new animal drug application (NADA) and abbreviated new animal drug
applications (ANADAs) during May and June 2017. FDA is informing the
public of the availability of summaries of the basis of approval and of
environmental review documents, where applicable. The animal drug
regulations are also being amended to make technical amendments to
improve the accuracy of the regulations.

DATES: This rule is effective December 13, 2017.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval
actions for a NADA and ANADAs during May and June 2017, as listed in
table 1. In addition, FDA is informing the public of the availability,
where applicable, of documentation of environmental review required
under the National Environmental Policy Act (NEPA) and, for actions
requiring review of safety or effectiveness data, summaries of the
basis of approval (FOI Summaries) under the Freedom of Information Act
(FOIA). These public documents may be seen in the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through
Friday. Persons with access to the internet may obtain these documents
at the CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be
accessed in FDA's publication, Approved Animal Drug Products Online
(Green Book) at: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                                  Table 1--Original and Supplemental NADAs and ANADAs Approved During May and June 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Effect of the
       Approval date          File No.         Sponsor            Product name              Species                 action           Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
May 23, 2017..............      055-099  Zoetis Inc., 333     CLAVAMOX             Dogs and cats...........  Supplemental         FOI Summary.
                                          Portage St.,         (amoxicillin and                               approval of a
                                          Kalamazoo, MI        clavulanate                                    chewable tablet
                                          49007.               potassium tablets)                             form of the
                                                               Chewables.                                     approved tablet.
June 21, 2017.............      141-338  Elanco US Inc.,      INTERCEPTOR          Dogs....................  Supplemental         FOI Summary.
                                          2500 Innovation      SPECTRUM                                       approval for the
                                          Way, Greenfield,     (milbemycin oxime/                             treatment and
                                          IN 46140.            praziquantel)                                  control of adult
                                                               Chewable Tablets.                              tapeworm
                                                                                (Dipylidium
                                                                                caninum)
                                                                                infections in dogs
                                                                                and puppies 2
                                                                                pounds of body
                                                                                weight or greater
                                                                                and 6 weeks of age
                                                                                and older.

May 25, 2017..............      200-610  Modern Veterinary    Medetomidine HCl     Dogs....................  Original approval    FOI Summary.
                                          Therapeutics, LLC,   (medetomidine                                  as a generic copy
                                          14343 SW 119th       hydrochloride)                                 of NADA 140-999.
                                          Ave., Miami, FL      Injectable
                                          33186.               Solution.
June 23, 2017.............      200-618  Virbac AH, Inc.,     ZOLETIL (tiletamine  Dogs and cats...........  Original approval    FOI Summary.
                                          3200 Meacham         HCl and zolazepam                              as a generic copy
                                          Blvd., Ft. Worth,    HCl) for Injection.                            of NADA 106-111.
                                          TX 76137.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Following the approval of ANADA 200-610, Modern Veterinary
Therapeutics, LLC, will now be included in the lists of sponsors of
approved applications in Sec.  510.600(c) (21 CFR 510.600(c)).

II. Technical Amendments

    We are making several technical amendments in 21 CFR part 558,
which was amended on December 27, 2016 (81 FR 94991), and February 24,
2017 (82 FR 11510), as part of the FDA Center for Veterinary Medicine's
(CVM's) Judicious Use Initiative. We are also making several technical
amendments to the regulations for dosage form drugs to reflect revised
labeling. These actions are being taken to improve the accuracy of the
regulations.

III. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(i)), which
requires Federal Register publication of ``notice[s] . . . effective as
a regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 524, and 529

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 520, 522, 524, 529, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), alphabetically
add an entry for ``Modern Veterinary Therapeutics, LLC''; and in the
table in paragraph (c)(2), numerically add an entry for ``015914.'' The
additions read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                 Firm name and address                         code
------------------------------------------------------------------------

                              * * * * * * *
Modern Veterinary Therapeutics, LLC, 14343 SW 119th              015914
 Ave., Miami, FL 33186.................................

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

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                              * * * * * * *
015914..................  Modern Veterinary Therapeutics, LLC, 14343 SW
                           119th Ave., Miami, FL 33186.

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

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for part 520 continues to read as follows:

    Authority: 21 U.S.C. 360b.

0
4. In Sec.  520.88g, revise the section heading and paragraphs (a) and
(b) to read as follows:

Sec.  520.88g  Amoxicillin trihydrate and clavulanate potassium
tablets.

    (a) Specifications. Each tablet or chewable tablet contains
amoxicillin trihydrate and clavulanate potassium equivalent to 50
milligrams (mg) of amoxicillin and 12.5 mg clavulanic acid, 100 mg of
amoxicillin and 25 mg clavulanic acid, 200 mg amoxicillin and 50 mg
clavulanic acid, or 300 mg amoxicillin and 75 mg clavulanic acid.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (1) No. 054771 for use of tablets and chewable tablets as in
paragraph (c) of this section.
    (2) No. 026637 for use of tablets as in paragraph (c) of this
section.
* * * * *

0
5. In Sec.  520.1445, revise paragraph (c)(1)(ii) to read as follows:

Sec.  520.1445  Milbemycin oxime and praziquantel.

* * * * *
    (c) * * *
    (1) * * *
    (ii) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis and for the treatment and control of
adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm
(Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult
tapeworm (Taenia pisiformis, Echinococcus multilocularis, E.
granulosus, and Dipylidium caninum) infections in dogs and puppies 2
pounds of body weight or greater and 6 weeks of age and older.
* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for part 522 continues to read as follows:

    Authority: 21 U.S.C. 360b.

Sec.  522.1335  [Amended]

0
7. In Sec.  522.1335, in paragraph (b), remove ``052483'' and in its
place add ``Nos. 015914 and 052483''.

0
8. In Sec.  522.2470, revise paragraphs (b), (c)(1)(i) and (ii), and
(c)(2) to read as follows:

Sec.  522.2470  Tiletamine and zolazepam for injection.

* * * * *
    (b) Sponsors. See Nos. 026637, 051311, and 054771 in Sec.
510.600(c) of this chapter.
    (c) * * *
    (1) * * *
    (i) Healthy dogs. An initial intramuscular dosage of 3 to 4.5
milligrams per pound (mg/lb) of body weight for diagnostic purposes;
4.5 to 6 mg/lb of body weight for minor procedures of short duration
such as repair of lacerations and wounds, castrations, and other
procedures requiring mild to moderate analgesia. Supplemental doses
when required should be less than the initial dose and the total dose
given should not exceed 12 mg/lb of body weight. The maximum total safe
dose is 13.6 mg/lb of body weight.
    (ii) Healthy cats. An initial intramuscular dosage of 4.4 to 5.4
mg/lb of body weight is recommended for such procedures as dentistry,
treatment of abscesses, foreign body removal, and related types of
surgery; 4.8 to 5.7 mg/lb of body weight for minor procedures requiring
mild to moderate analgesia, such as repair of lacerations, castrations,
and other procedures of short duration. Initial dosages of 6.5 to 7.2
mg/lb of body weight are recommended for ovariohysterectomy and
onychectomy. When supplemental doses are required, such individual
supplemental doses should be given in increments that are less than the
initial dose, and the total dose given (initial dose plus supplemental
doses) should not exceed the maximum allowable safe dose of 32.7 mg/lb
of body weight.
    (2) Indications for use. For restraint or for anesthesia combined
with muscle relaxation in cats and in dogs for restraint and minor
procedures of short duration (30 minutes average) requiring mild to
moderate analgesia.
* * * * *

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for part 524 continues to read as follows:

    Authority: 21 U.S.C. 360b.

Sec.  524.1580a  [Amended]

0
10. In Sec.  524.1580a, in paragraph (d)(3), in the second sentence,
remove ``in'' and in its place add ``on''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
11. The authority citation for part 529 continues to read as follows:

    Authority: 21 U.S.C. 360b.

0
12. Amend 529.1030 as follows:
0
a. Revise paragraph (d)(1)(ii);
0
b. In the table in paragraph (d)(2)(i), revise footnote 1;
0
c. In paragraph (d)(2)(ii), in the table, in the heading of the
``Administer in earthen ponds indefinitely ([mu]L/L or ppm)'' column,
remove ``indefinitely'' and in its place add ``single treatment''; and
0
d. Revise paragraphs (d)(2)(iii) and (d)(3).
    The revisions read as follows:

Sec.  529.1030  Formalin.

* * * * *
    (d) * * *
    (1) * * *
    (ii) All finfish. For control of external protozoa Ichthyophthirius
spp., Chilodonella spp., Ichthyobodo spp., Ambiphrya spp., Epistylis
spp., and Trichodina spp., and the monogeneans Cleidodiscus spp.,
Gyrodactylus spp., and Dactylogyrus spp.
* * * * *
    (2) * * *
    (i) * * *
    \1\ Treat for up to 4 hours daily. Treatment may be repeated daily
until parasite control is achieved. Use the lower concentration when
tanks or raceways are heavily loaded with phytoplankton or shrimp, to
avoid oxygen depletion due to the biological oxygen demand created by
decay of dead phytoplankton. Alternatively, a higher concentration
might be used if dissolved oxygen is strictly monitored.
* * * * *
    (iii) For control of fungi of the family Saprolegniaceae on finfish
eggs: Eggs of all finfish except Acipenseriformes, 1,000 to 2,000
[mu]L/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to 1,500
[mu]L/L (ppm) for 15 minutes. A preliminary bioassay should be
conducted on a small subsample of fish eggs to determine sensitivity
before treating an entire group. This is necessary for all species
because egg sensitivity can vary with species or strain and the unique
conditions at each facility.
    (3) Limitations. Fish tanks and raceways may be treated daily until
parasite control is achieved. Pond treatment may be repeated in 5 to 10
days if needed. However, pond treatments for Ichthyophthirius spp.
should be made at 2-day intervals until control is achieved. Egg tanks
may be

treated as often as necessary to prevent growth of fungi. Do not use
formalin which has been subjected to temperatures below 40 [deg]F, or
allowed to freeze. Treatments in tanks and raceways should never exceed
1 hour for fish or 4 hours for penaeid shrimp (even if they show no
sign of distress), nor should it exceed 15 minutes for fish eggs. Do
not apply formalin to ponds with water warmer than 27 [deg]C (80
[deg]F), when a heavy bloom of phytoplankton is present, or when the
concentration of dissolved oxygen is less than 5 milligrams per liter.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
13. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

Sec.  558.58  [Amended]

0
14. In Sec.  558.58, remove paragraphs (f)(4) and (5).

Sec.  558.366  [Amended]

0
15. In Sec.  558.366, remove paragraph (e).

    Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26753 Filed 12-12-17; 8:45 am]
BILLING CODE 4164-01-P