[Federal Register Volume 81, Number 123 (Monday, June 27, 2016)]
[Notices]
[Pages 41619-41625]
[FR Doc No: 2016-15071]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78107; File No. SR-BX-2016-036]

Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Provide a
Process for an Expedited Suspension Proceeding and Adopt a Rule To
Prohibit Disruptive Options Quoting and Trading Activity

June 21, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 17, 2016, NASDAQ BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II and III below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to adopt a new options rule to clearly
prohibit disruptive quoting and trading activity on the Exchange, as
further described below.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxbx.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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange is filing this proposal to adopt an options rule to
clearly prohibit disruptive quoting and trading activity on the
Exchange and to permit the Exchange to take prompt action to suspend
Members or their clients that violate such rule pursuant to Rule 9400.
Background
    As a national securities exchange registered pursuant to Section 6
of the Act, the Exchange is required to be organized and to have the
capacity to enforce compliance by its members and persons associated
with its members, with the Act, the rules and regulations thereunder,
and the Exchange's Rules. Further, the Exchange's Rules are required to
be ``designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade . . . and,
in general, to protect investors and the public interest.'' \3\ In
fulfilling these requirements, the Exchange has developed a
comprehensive regulatory program that includes automated surveillance
of trading activity that is both operated directly by Exchange staff
and by staff of the Financial Industry Regulatory Authority (``FINRA'')
pursuant to a Regulatory Services Agreement (``RSA''). When disruptive
and potentially manipulative or improper quoting and trading activity
is identified, the Exchange or FINRA (acting as an agent of the
Exchange) conducts an investigation into the activity, requesting
additional information from the Member or Members involved. To the
extent violations of the Act, the rules and regulations thereunder, or
Exchange Rules have been identified and confirmed, the Exchange or
FINRA as its agent will commence the enforcement process, which might
result in, among other things, a censure, a requirement to take certain
remedial actions, one or more restrictions on future business
activities, a monetary fine, or even a temporary or permanent ban from
the securities industry.
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    \3\ 15 U.S.C. 78f(b)(1).
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    The process described above, from the identification of disruptive
and potentially manipulative or improper quoting and trading activity
to a final resolution of the matter, can often take several years. The
Exchange believes that this time period is generally necessary and
appropriate to afford the subject Member adequate due process,
particularly in complex cases. However, as described below, the
Exchange believes that there are certain obvious and uncomplicated
cases of disruptive and manipulative behavior or cases where the
potential harm to investors is so large that the Exchange should have
the authority to initiate an expedited suspension proceeding in order
to stop the behavior from continuing on the Exchange.
    In recent years, several cases have been brought and resolved by
the Exchange and other SROs that involved allegations of wide-spread
market manipulation, much of which was ultimately being conducted by
foreign persons and entities using relatively rudimentary technology to
access the markets and over which the Exchange and other SROs had no
direct jurisdiction. In each case, the conduct involved a pattern of
disruptive quoting and trading activity indicative of manipulative
layering \4\ or spoofing.\5\ The Exchange and other SROs were able to
identify the disruptive quoting and trading activity in real-time or
near real-time; nonetheless, in accordance with Exchange Rules and the
Act, the Members responsible for such conduct or responsible for their
customers' conduct were allowed to continue the disruptive quoting and
trading activity on the Exchange and other exchanges during the
entirety of the subsequent lengthy investigation and enforcement
process. The Exchange believes that it should have the authority to
initiate an expedited suspension proceeding in order to stop the
behavior from continuing on the Exchange if a Member is engaging in or
facilitating disruptive quoting and trading activity and the Member has
received sufficient notice with an opportunity to respond, but such
activity has not ceased.
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    \4\ ``Layering'' is a form of market manipulation in which
multiple, non-bona fide limit orders are entered on one side of the
market at various price levels in order to create the appearance of
a change in the levels of supply and demand, thereby artificially
moving the price of the security. An order is then executed on the
opposite side of the market at the artificially created price, and
the non-bona fide orders are cancelled.
    \5\ ``Spoofing'' is a form of market manipulation that involves
the market manipulator placing non-bona fide orders that are
intended to trigger some type of market movement and/or response
from other market participants, from which the market manipulator
might benefit by trading bona fide orders.
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    The following two examples are instructive on the Exchange's
rationale for the proposed rule change.
    In July 2012, Biremis Corp. (formerly Swift Trade Securities USA,
Inc.) (the ``Firm'') and its CEO were barred from the industry for,
among other things, supervisory violations related to a failure by the
Firm to detect and prevent disruptive and allegedly manipulative
trading activities, including layering, short sale violations, and
anti-money laundering violations.\6\ The Firm's sole business was to
provide trade execution services via a proprietary day trading platform
and order management system to day traders located in foreign
jurisdictions. Thus, the disruptive and allegedly manipulative trading
activity introduced by the Firm to U.S. markets originated directly or
indirectly from foreign clients of the Firm. The pattern of disruptive
and allegedly manipulative quoting and trading activity was widespread
across multiple exchanges, and the Exchange, FINRA, and other SROs
identified clear patterns of the behavior in 2007 and 2008. Although
the Firm and its principals were on notice of the disruptive and
allegedly manipulative quoting and trading activity that was occurring,
the Firm took little to no action to attempt to supervise or prevent
such quoting and trading activity until at least 2009. Even when it put
some controls in place, they were deficient and the pattern of
disruptive and allegedly manipulative trading activity continued to
occur. As noted above, the final resolution of the enforcement action
to bar the Firm and its CEO from the industry was not concluded until
2012, four years after the disruptive and allegedly manipulative
trading activity was first identified.
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    \6\ See Biremis Corp. and Peter Beck, FINRA Letter of
Acceptance, Waiver and Consent No.<PHONE_NUMBER>202, July 30, 2012.
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    In September of 2012, Hold Brothers On-Line Investment Services,
Inc. (the ``Firm'') settled a regulatory action in connection with the
Firm's provision of a trading platform, trade software and trade
execution, support and clearing

services for day traders.\7\ Many traders using the Firm's services
were located in foreign jurisdictions. The Firm ultimately settled the
action with FINRA and several exchanges, including the Exchange, for a
total monetary fine of $3.4 million. In a separate action, the Firm
settled with the Commission for a monetary fine of $2.5 million.\8\
Among the alleged violations in the case were disruptive and allegedly
manipulative quoting and trading activity, including spoofing,
layering, wash trading, and pre-arranged trading. Through its conduct
and insufficient procedures and controls, the Firm also allegedly
committed anti-money laundering violations by failing to detect and
report manipulative and suspicious trading activity. The Firm was
alleged to have not only provided foreign traders with access to the
U.S. markets to engage in such activities, but that its principals also
owned and funded foreign subsidiaries that engaged in the disruptive
and allegedly manipulative quoting and trading activity. Although the
pattern of disruptive and allegedly manipulative quoting and trading
activity was identified in 2009, as noted above, the enforcement action
was not concluded until 2012. Thus, although disruptive and allegedly
manipulative quoting and trading was promptly detected, it continued
for several years.
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    \7\ See Hold Brothers On-Line Investment Services, LLC, FINRA
Letter of Acceptance, Waiver and Consent No.<PHONE_NUMBER>0001,
September 25, 2012.
    \8\ In the Matter of Hold Brothers On-Line Investment Services,
LLC, Exchange Act Release No. 67924, September 25, 2012.
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    The Exchange also notes the current criminal proceedings that have
commenced against Navinder Singh Sarao. Mr. Sarao's allegedly
manipulative trading activity, which included forms of layering and
spoofing in the futures markets, has been linked as a contributing
factor to the ``Flash Crash'' of 2010, and yet continued through 2015.
    The Exchange believes that the activities described in the cases
above provide justification for the proposed rule change, which is
described below. In addition, while the examples provided are related
to the equities market, the Exchange believes that this type of conduct
should be prohibited for all Exchange members, equities and options.
The Exchange believes that these patterns of disruptive and allegedly
manipulative quoting and trading activity need to be addressed and the
product should not limit the action taken by the Exchange. For this
reason, the Exchange now proposes a corresponding options rule.

Rule 9400--Expedited Client Suspension Proceeding

    The Exchange adopted Rule 9400 to set forth procedures for issuing
suspension orders, immediately prohibiting a Member from conducting
continued disruptive quoting and trading activity on the Exchange.
Importantly, these procedures provide the Exchange the authority to
order a Member to cease and desist from providing access to the
Exchange to a client of the Member that is conducting disruptive
quoting and trading activity in violation of Rule 2170. Paragraph (a)
of Rule 9400, with the prior written authorization of the Chief
Regulatory Officer (``CRO'') or such other senior officers as the CRO
may designate, the Office of General Counsel or Regulatory Department
of the Exchange (such departments generally referred to as the
``Exchange'' for purposes of Rule 9400) and may initiate an expedited
suspension proceeding with respect to alleged violations of Rule 2170.
Paragraph (a) also sets forth the requirements for notice and service
of such notice pursuant to the Rule, including the required method of
service and the content of notice.
    Paragraph (b) of Rule 9400 governs the appointment of a Hearing
Panel as well as potential disqualification or recusal of Hearing
Officers. The Exchange's Rules provide for a Hearing Officer to be
recused in the event he or she has a conflict of interest or bias or
other circumstances exist where his or her fairness might reasonably be
questioned in accordance with Rules 9233(a). In addition to recusal
initiated by such a Hearing Officer, a party to the proceeding will be
permitted to file a motion to disqualify a Hearing Officer. However,
due to the compressed schedule pursuant to which the process would
operate under Rule 9400, the rule requires such motion to be filed no
later than 5 days after the announcement of the Hearing Panel and the
Exchange's brief in opposition to such motion would be required to be
filed no later than 5 days after service thereof. Pursuant to existing
Rule 9233(c), a motion for disqualification of a Hearing Officer shall
be decided by the Chief Hearing Officer based on a prompt
investigation. The applicable Hearing Officer shall remove himself or
herself and request the Chief Executive Officer to reassign the hearing
to another Hearing Officer such that the Hearing Panel still meets the
compositional requirements described in Rule 9231(b). If the Chief
Hearing Officer determines that the Respondent's grounds for
disqualification are insufficient, it shall deny the Respondent's
motion for disqualification by setting forth the reasons for the denial
in writing and the Hearing Panel will proceed with the hearing.
    Under paragraph (c) of the Rule, the hearing would be held not
later than 15 days after service of the notice initiating the
suspension proceeding, unless otherwise extended by the Chairman of the
Hearing Panel with the consent of the Parties for good cause shown. In
the event of a recusal or disqualification of a Hearing Officer, the
hearing shall be held not later than five days after a replacement
Hearing Officer is appointed. Paragraph (c) also governs how the
hearing is conducted, including the authority of Hearing Officers,
witnesses, additional information that may be required by the Hearing
Panel, the requirement that a transcript of the proceeding be created
and details related to such transcript, and details regarding the
creation and maintenance of the record of the proceeding. Paragraph (c)
also states that if a Respondent fails to appear at a hearing for which
it has notice, the allegations in the notice and accompanying
declaration may be deemed admitted, and the Hearing Panel may issue a
suspension order without further proceedings. Finally, if the Exchange
fails to appear at a hearing for which it has notice, the Hearing Panel
may order that the suspension proceeding be dismissed.
    Under paragraph (d) of the Rule, the Hearing Panel would be
required to issue a written decision stating whether a suspension order
would be imposed. The Hearing Panel would be required to issue the
decision not later than 10 days after receipt of the hearing
transcript, unless otherwise extended by the Chairman of the Hearing
Panel with the consent of the Parties for good cause shown. The Rule
states that a suspension order shall be imposed if the Hearing Panel
finds by a preponderance of the evidence that the alleged violation
specified in the notice has occurred and that the violative conduct or
continuation thereof is likely to result in significant market
disruption or other significant harm to investors.
    Paragraph (d) also describes the content, scope and form of a
suspension order. A suspension order shall be limited to ordering a
Respondent to cease and desist from violating Rule 2170 and/or to
ordering a Respondent to cease and desist from providing access to the
Exchange to a client of Respondent that is causing violations of Rule
2170. Under the rule, a suspension order shall also set forth the
alleged violation and the significant market

disruption or other significant harm to investors that is likely to
result without the issuance of an order. The order shall describe in
reasonable detail the act or acts the Respondent is to take or refrain
from taking, and suspend such Respondent unless and until such action
is taken or refrained from. Finally, the order shall include the date
and hour of its issuance. A suspension order would remain effective and
enforceable unless modified, set aside, limited, or revoked pursuant to
paragraph (e), as described below. Finally, paragraph (d) requires
service of the Hearing Panel's decision and any suspension order
consistent with other portions of the rule related to service.
    Paragraph (e) of Rule 9400 states that at any time after the
Hearing Officers served the Respondent with a suspension order, a Party
could apply to the Hearing Panel to have the order modified, set aside,
limited, or revoked. If any part of a suspension order is modified, set
aside, limited, or revoked, paragraph (e) of Rule 9400 provides the
Hearing Panel discretion to leave the cease and desist part of the
order in place. For example, if a suspension order suspends Respondent
unless and until Respondent ceases and desists providing access to the
Exchange to a client of Respondent, and after the order is entered the
Respondent complies, the Hearing Panel is permitted to modify the order
to lift the suspension portion of the order while keeping in place the
cease and desist portion of the order. With its broad modification
powers, the Hearing Panel also maintains the discretion to impose
conditions upon the removal of a suspension--for example, the Hearing
Panel could modify an order to lift the suspension portion of the order
in the event a Respondent complies with the cease and desist portion of
the order but additionally order that the suspension will be re-imposed
if Respondent violates the cease and desist provisions of the modified
order in the future. The Hearing Panel generally would be required to
respond to the request in writing within 10 days after receipt of the
request. An application to modify, set aside, limit or revoke a
suspension order would not stay the effectiveness of the suspension
order.
    Finally, paragraph (f) provides that sanctions issued under Rule
9400 would constitute final and immediately effective disciplinary
sanctions imposed by the Exchange, and that the right to have any
action under the Rule reviewed by the Commission would be governed by
Section 19 of the Act. The filing of an application for review would
not stay the effectiveness of a suspension order unless the Commission
otherwise ordered.

Rule 2170--Disruptive Quoting and Trading Activity Prohibited

    The Exchange currently has authority to prohibit and take action
against manipulative trading activity, including disruptive quoting and
trading activity, pursuant to its general market manipulation rules,
including Rules 2110, 2111, 2120 and 2170. The Exchange proposes to
adopt a new rule at Chapter III, Section 16, which would more
specifically define and prohibit disruptive options quoting and trading
activity on the Exchange. As noted above, the Exchange also proposes to
apply the proposed suspension rules to Chapter III, Section 16.
    Proposed Chapter III, Section 16, would prohibit Members from
engaging in or facilitating disruptive options quoting and trading
activity on the Exchange, as described in proposed Chapter III, Section
16(i) and (ii), including acting in concert with other persons to
effect such activity. The Exchange believes that it is necessary to
extend the prohibition to situations when persons are acting in concert
to avoid a potential loophole where disruptive quoting and trading
activity is simply split between several brokers or customers. The
Exchange believes, that with respect to persons acting in concert
perpetrating an abusive scheme, it is important that the Exchange have
authority to act against the parties perpetrating the abusive scheme,
whether it is one person or multiple persons.
    To provide proper context for the situations in which the Exchange
proposes to utilize its authority, the Exchange believes it is
necessary to describe the types of disruptive options quoting and
trading activity that would cause the Exchange to use its authority.
Accordingly, the Exchange proposes to adopt Chapter III, Section 16(i)
and (ii) providing additional details regarding disruptive options
quoting and trading activity. Proposed Chapter III, Section 16(i)(a)
describes disruptive options quoting and trading activity containing
many of the elements indicative of layering. It would describe
disruptive options quoting and trading activity as a frequent pattern
in which the following facts are present: (i) A party enters multiple
limit orders on one side of the market at various price levels (the
``Displayed Orders''); and (ii) following the entry of the Displayed
Orders, the level of supply and demand for the security changes; and
(iii) the party enters one or more orders on the opposite side of the
market of the Displayed Orders (the ``Contra-Side Orders'') that are
subsequently executed; and (iv) following the execution of the Contra-
Side Orders, the party cancels the Displayed Orders. Proposed Chapter
III, Section 16(i)(b) describes disruptive options quoting and trading
activity containing many of the elements indicative of spoofing and
would describe disruptive quoting and trading activity as a frequent
pattern in which the following facts are present: (i) A party narrows
the spread for a security by placing an order inside the national best
bid or offer; and (ii) the party then submits an order on the opposite
side of the market that executes against another market participant
that joined the new inside market established by the order described in
proposed (b)(i) that narrowed the spread. The Exchange believes that
the proposed descriptions of disruptive quoting and trading activity
articulated in the rule are consistent with the activities that have
been identified and described in the client access cases described
above.\9\ The Exchange further believes that the proposed descriptions
will provide Members with clear descriptions of disruptive options
quoting and trading activity that will help them to avoid engaging in
such activities or allowing their clients to engage in such activities.
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    \9\ As previously noted herein, while the examples noted in the
Purpose Section of this 19b4 [sic] are related to the equities
market, the Exchange believes that this type of conduct should be
prohibited for all Exchange members, equities and options. The
Exchange believes that these patterns of disruptive and allegedly
manipulative quoting and trading activity need to be addressed and
the product should not limit the action taken by the Exchange. For
this reason, the Exchange now proposes a corresponding options rule.
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    The Exchange proposes to make clear in proposed Chapter III,
Section 16(ii), unless otherwise indicated, the descriptions of
disruptive options quoting and trading activity do not require the
facts to occur in a specific order in order for the rule to apply. For
instance, with respect to the pattern defined in proposed Chapter III,
Section 16(i)(a) it is of no consequence whether a party first enters
Displayed Orders and then Contra-side Orders or vice-versa. However, as
proposed, supply and demand must change following the entry of the
Displayed Orders. The Exchange also proposes to make clear that
disruptive options quoting and trading activity includes a pattern or
practice in which some portion of the disruptive options quoting and
trading activity is conducted on the Exchange and the other portions of
the disruptive options quoting and trading activity are conducted on
one or more other

exchanges. The Exchange believes that this authority is necessary to
address market participants who would otherwise seek to avoid the
prohibitions of the proposed Rule by spreading their activity amongst
various execution venues. In sum, proposed Chapter III, Section 16
coupled with Rule 9400 would provide the Exchange with authority to
promptly act to prevent disruptive quoting and trading activity from
continuing on the Exchange.
    Below is an example of how the proposed rule would operate.
    Assume that through its surveillance program, Exchange staff
identifies a pattern of potentially disruptive options quoting and
trading activity. After an initial investigation the Exchange would
then contact the Member responsible for the orders that caused the
activity to request an explanation of the activity as well as any
additional relevant information, including the source of the activity.
If the Exchange were to continue to see the same pattern from the same
Member and the source of the activity is the same or has been
previously identified as a frequent source of disruptive options
quoting and trading activity then the Exchange could initiate an
expedited suspension proceeding by serving notice on the Member that
would include details regarding the alleged violations as well as the
proposed sanction. In such a case the proposed sanction would likely be
to order the Member to cease and desist providing access to the
Exchange to the client that is responsible for the disruptive quoting
and trading activity and to suspend such Member unless and until such
action is taken.
    The Member would have the opportunity to be heard in front of a
Hearing Panel at a hearing to be conducted within 15 days of the
notice. If the Hearing Panel determined that the violation alleged in
the notice did not occur or that the conduct or its continuation would
not have the potential to result in significant market disruption or
other significant harm to investors, then the Hearing Panel would
dismiss the suspension order proceeding.
    If the Hearing Panel determined that the violation alleged in the
notice did occur and that the conduct or its continuation is likely to
result in significant market disruption or other significant harm to
investors, then the Hearing Panel would issue the order including the
proposed sanction, ordering the Member to cease providing access to the
client at issue and suspending such Member unless and until such action
is taken. If such Member wished for the suspension to be lifted because
the client ultimately responsible for the activity no longer would be
provided access to the Exchange, then such Member could apply to the
Hearing Panel to have the order modified, set aside, limited or
revoked. The Exchange notes that the issuance of a suspension order
would not alter the Exchange's ability to further investigate the
matter and/or later sanction the Member pursuant to the Exchange's
standard disciplinary process for supervisory violations or other
violations of Exchange rules or the Act.
    The Exchange reiterates that it already has broad authority to take
action against a Member in the event that such Member is engaging in or
facilitating disruptive or manipulative trading activity on the
Exchange. For the reasons described above, and in light of recent cases
like the client access cases described above, as well as other cases
currently under investigation, the Exchange believes that it is equally
important for the Exchange to have the authority to promptly initiate
expedited suspension proceedings against any Member who has
demonstrated a clear pattern or practice of disruptive options quoting
and trading activity, as described above, and to take action including
ordering such Member to terminate access to the Exchange to one or more
of such Member's clients if such clients are responsible for the
activity.
    The Exchange recognizes that its authority to issue a suspension
order is a powerful measure that should be used very cautiously.
Consequently, the rules have been designed to ensure that the
proceedings are used to address only the most clear and serious types
of disruptive quoting and trading activity and that the interests of
Respondents are protected. For example, to ensure that proceedings are
used appropriately and that the decision to initiate a proceeding is
made only at the highest staff levels, the rules require the CRO or
another senior officer of the Exchange to issue written authorization
before the Exchange can institute an expedited suspension proceeding.
In addition, the rule by its terms is limited to violations of Chapter
III, Section 16, when necessary to protect investors, other Members and
the Exchange. The Exchange will initiate disciplinary action for
violations of Chapter III, Section 16, pursuant to Rule 9400. Further,
the Exchange believes that the expedited suspension provisions
described above that provide the opportunity to respond as well as a
Hearing Panel determination prior to taking action will ensure that the
Exchange would not utilize its authority in the absence of a clear
pattern or practice of disruptive options quoting and trading activity.
    The Exchange also notes that that it may impose temporary
restrictions upon the automated entry or updating of orders or quotes/
orders as the Exchange may determine to be necessary to protect the
integrity of the Exchange's systems pursuant to Rule 4611(c).\10\ Also,
pursuant to Rule 9555(a)(2) \11\ if a member, associated person, or
other person cannot continue to have access to services offered by the
Exchange or a member thereof with safety to investors, creditors,
members, or the Exchange, the Exchange's Regulation Department staff
may provide written notice to such member or person limiting or
prohibiting access to services offered by the Exchange or a member
thereof. This ability to impose a temporary restriction upon Members
assists the Exchange in maintaining the integrity of the market and
protecting investors and the public interest.
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    \10\ For example, such temporary restrictions may be necessary
to address a system problem at a particular BX Market Maker, BX ECN
or Order Entry Firm or at the Exchange, or an unexpected period of
extremely high message traffic.
    \11\ See Rule 9555, entitled ``Failure to Meet the Eligibility
or Qualification Standards or Prerequisites for Access to
Services.''
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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 the rules of the
Exchange are designed to prevent fraudulent and manipulative acts and
practices, it is designed to promote just and equitable principles of
trade, to remove impediments to and perfect the mechanism of a free and
open market and a national market system, and, in general to protect
investors and the public interest. Pursuant to the proposal, the
Exchange will have a mechanism to promptly initiate expedited
suspension proceedings in the event the Exchange believes that it has
sufficient proof that a violation of Rule 2170 has occurred and is
ongoing.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
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    Further, the Exchange believes that the proposal is consistent with
Sections 6(b)(1) and 6(b)(6) of the Act,\14\ which require that the
rules of an exchange enforce compliance with, and provide appropriate
discipline for, violations of the Commission and Exchange rules. The
Exchange also believes that the proposal is consistent with the public
interest, the protection of investors, or

otherwise in furtherance of the purposes of the Act because the
proposal helps to strengthen the Exchange's ability to carry out its
oversight and enforcement responsibilities as a self-regulatory
organization in cases where awaiting the conclusion of a full
disciplinary proceeding is unsuitable in view of the potential harm to
other Members and their customers. Also, the Exchange notes that if
this type of conduct is allowed to continue on the Exchange, the
Exchange's reputation could be harmed because it may appear to the
public that the Exchange is not acting to address the behavior. The
expedited process would enable the Exchange to address the behavior
with greater speed.
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    \14\ 15 U.S.C. 78f(b)(1) and 78f(b)(6).
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    As explained above, the Exchange notes that it has defined the
prohibited disruptive quoting and trading activity by modifying the
traditional definitions of layering and spoofing \15\ to eliminate an
express intent element that would not be proven on an expedited basis
and would instead require a thorough investigation into the activity.
As noted throughout this filing, the Exchange believes it is necessary
for the protection of investors to make such modifications in order to
adopt an expedited process rather than allowing disruptive quoting and
trading activity to occur for several years.
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    \15\ See supra, notes 4 and 5.
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    Through this proposal, the Exchange does not intend to modify the
definitions of spoofing and layering that have generally been used by
the Exchange and other regulators in connection with actions like those
cited above. The Exchange believes that the pattern of disruptive and
allegedly manipulative quoting and trading activity was widespread
across multiple exchanges, and the Exchange, FINRA, and other SROs
identified clear patterns of the behavior in 2007 and 2008 in the
equities markets.\16\ The Exchange believes that this proposal will
provide the Exchange with the necessary means to enforce against such
behavior in an expedited manner while providing Members with the
necessary due process. The Exchange believes that its proposal is
consistent with the Act because it provides the Exchange with the
ability to remove impediments to and perfect the mechanism of a free
and open market and a national market system, and, in general to
protect investors and the public interest from such ongoing behavior.
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    \16\ See Section 3 [sic] herein, the Purpose section, for
examples of conduct referred to herein.
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    Further, the Exchange believes that adopting a rule applicable to
Options Participants is consistent with the Act because the Exchange
believes that this type of behavior should be prohibited for all
members, not just equities members. The type of product should not be
the determining factor, rather the behavior which challenges the market
structure is the primary concern for the Exchange. While this behavior
may not be as prevalent on the options market today, the Exchange does
not believe that the possibility of such behavior in the future would
not have the same market impact and thereby warrant an expedited
process. The Exchange believes that treating all members, equities and
options, in a uniform manner with respect to the type of disciplinary
action that would be taken for violations of manipulative quoting and
trading activity is consistent with the Act.
    The Exchange further believes that the proposal is consistent with
Section 6(b)(7) of the Act,\17\ which requires that the rules of an
exchange ``provide a fair procedure for the disciplining of members and
persons associated with members . . . and the prohibition or limitation
by the exchange of any person with respect to access to services
offered by the exchange or a member thereof.'' Finally, the Exchange
also believes the proposal is consistent with Sections 6(d)(1) and
6(d)(2) of the Act,\18\ which require that the rules of an exchange
with respect to a disciplinary proceeding or proceeding that would
limit or prohibit access to or membership in the exchange require the
exchange to: Provide adequate and specific notice of the charges
brought against a member or person associated with a member, provide an
opportunity to defend against such charges, keep a record, and provide
details regarding the findings and applicable sanctions in the event a
determination to impose a disciplinary sanction is made. The Exchange
believes that each of these requirements is addressed by the notice and
due process provisions included within Rule 9400. Importantly, as noted
above, the Exchange will use the authority only in clear and egregious
cases when necessary to protect investors, other Members and the
Exchange, and in such cases, the Respondent will be afforded due
process in connection with the suspension proceedings.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78f(b)(7).
    \18\ U.S.C. 78f(d)(1).
---------------------------------------------------------------------------

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. To the contrary, the Exchange
believes that each self-regulatory organization should be empowered to
regulate trading occurring on its market consistent with the Act and
without regard to competitive issues. The Exchange is requesting
authority to take appropriate action if necessary for the protection of
investors, other Members and the Exchange. The Exchange also believes
that it is important for all exchanges to be able to take similar
action to enforce their rules against manipulative conduct thereby
leaving no exchange prey to such conduct.
    The Exchange does not believe that the proposed rule change imposes
an undue burden on competition, rather this process will provide the
Exchange with the necessary means to enforce against violations of
manipulative quoting and trading activity in an expedited manner, while
providing Members with the necessary due process. The Exchange believes
that adopting a rule applicable to Options Participants does not impose
an undue burden on competition because this type of behavior should be
prohibited for all members, not just equities members. The Exchange's
proposal would treat all members, equities and options, in a uniform
manner with respect to the type of disciplinary action that would be
taken for violations of manipulative quoting and trading activity.

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)(iii) of the Act \19\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\20\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(a)(iii).
    \20\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file 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.

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

    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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposal 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 No. SR-BX-2016-036 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 No. SR-BX-2016-036. 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 Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-BX-2016-036, and should be
submitted on or before July 18, 2016.

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

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

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-15071 Filed 6-24-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Rules and Regulations]
[Pages 30763-30766]
[FR Doc No: 2021-12045]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0812; Project Identifier MCAI-2020-01317-A;
Amendment 39-21561; AD 2021-10-28]
RIN 2120-AA64

Airworthiness Directives; Pilatus Aircraft Ltd. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Pilatus Aircraft Ltd. (Pilatus) Model PC-24 airplanes. This AD results
from mandatory continuing airworthiness information (MCAI) originated
by an aviation authority of another country to identify and correct an
unsafe condition

on an aviation product. The MCAI identifies the unsafe condition as the
need to revise certain airworthiness limitations and certification
maintenance instructions. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective July 15, 2021.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of July 15,
2021.

ADDRESSES: For service information identified in this final rule,
contact Pilatus Aircraft Ltd., Customer Support General Aviation, CH-
6371 Stans, Switzerland; phone: +41 848 24 7 365; email:
exception occurred on : 2021-12045.htm
exception occurred on : 2021-12045.htm
aircraft.com">[email protected]aircraft.com; website: https://www.pilatus-
aircraft.com. You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901 Locust,
Kansas City, MO 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-0812; 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 final rule, the
MCAI, any comments received, and other information. The address for
Docket Operations is 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: Doug Rudolph, Aviation Safety
Engineer, FAA, General Aviation & Rotorcraft Section, International
Validation Branch, 901 Locust, Room 301, Kansas City, MO 64106; phone:
(816) 329-4059; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Pilatus Model PC-24
airplanes. The NPRM published in the Federal Register on March 11, 2021
(86 FR 13838). The NPRM was based on MCAI from the European Union
Aviation Safety Agency (EASA), which is the Technical Agent for the
Member States of the European Union. EASA issued AD 2020-0202, dated
September 22, 2020 (referred to after this as ``the MCAI'') to correct
an unsafe condition for Pilatus Model PC-24 airplanes. The MCAI states:

    The airworthiness limitations and certification maintenance
instructions for Pilatus PC-24 aeroplanes, which are approved by
EASA, are currently defined and published in Pilatus PC-24 AMM
[Aircraft Maintenance Manual] Chapter 04-00-00. These instructions
have been identified as mandatory for continued airworthiness.
    Failure to accomplish these instructions could result in an
unsafe condition.
    Previously, EASA issued AD 2020-0074, [dated March 27, 2020,]
requiring the actions described in the Pilatus PC-24 AMM Chapter 04-
00-00, Document Number 02378 Issue 005 at Revision 14.
    Since that AD was issued, Pilatus published the ALS
[Airworthiness Limitations section, at Issue 005 Revision 19], which
contains the following new and/or more restrictive tasks as
specified in Mandatory Structural Inspection Items data module PC24-
AA04-20-0000-00A-000A-A Issue 005 Revision 00:

--AL-27-00-025 and AL-27-00-026: Control column sprocket gear
assembly, and
--AL-27-00-027: Control wheel column assembly.

    In addition, Airworthiness Limitations Description data module
PC24-A-A04-00-0000-00A-040A-A Issue 008 Revision 00 includes:

--The new limit of validity following the completion of the Full
Scale Fatigue Test, and
--Usage assumptions/conditions for operations on unpaved and grass
runaways.

    EASA AD 2020-0074, dated March 27, 2020, required revising the
Airworthiness Limitations section (ALS) to correct an error in the
horizontal stabilizer primary trim system secondary power source
operational test. The MCAI retains the requirements of EASA AD 2020-
0074, dated March 27, 2020, which the MCAI supersedes, and requires the
additional revisions discussed previously. You may examine the MCAI in
the AD docket at https://www.regulations.gov by searching for and
locating Docket No. FAA-2020-0812.
    In the NPRM, the FAA proposed to require replacing the revised
sections of the ALS described previously into the existing AMM or
instructions for continued airworthiness. The FAA is issuing this AD to
address the unsafe condition on these products.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
our bilateral agreement with this State of Design Authority, it has
notified the FAA of the unsafe condition described in the MCAI and
service information referenced above. The FAA reviewed the relevant
data and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. This AD is adopted as proposed in the
NPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Chapter 04, Airworthiness Limitations, Pilatus PC-
24 Aircraft Maintenance Manual (PC-24 AMM) Report 02378, Issue 005,
Revision 19, dated May 26, 2020. This service information contains the
parent data module and the new limit of validity and updates the usage
assumptions and conditions for operations on unpaved and grass runways.
This document also contains the revised subsections with revised
maintenance actions.
    The FAA also reviewed Horizontal stabilizer primary trim system
secondary power source--Operation test, data module PC24-A-E27-40-0000-
01A-320A-A, dated September 25, 2019, from PC-24 AMM Report 02378,
Issue 005, Revision 19, dated May 26, 2020. This service information
contains revised procedures for task number AL-27-40-022 in the
certification maintenance requirements.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES.

Costs of Compliance

    The FAA estimates that this AD will affect 42 products of U.S.
registry. The FAA also estimates that it will take about 1 work-hour
per product to comply with the requirements of this proposed AD. The
average labor rate is $85 per work-hour.
    Based on these figures, the FAA estimates the cost of this AD on
U.S. operators will be $3,570 or $85 per product.

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

    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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) 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.
    (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.

List of Subjects in 14 CFR Part 39

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

The Amendment

    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 airworthiness
directive:

2021-10-28 Pilatus Aircraft Ltd.: Amendment 39-21561; Docket No.
FAA-2020-0812; Project Identifier MCAI-2020-01317-A.

(a) Effective Date

    This airworthiness directive (AD) is effective July 15, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Pilatus Aircraft Ltd. Model PC-24 airplanes,
all serial numbers, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2740: Stabilizer
Control System.

(e) Reason

    This AD was prompted by the need to revise the Airworthiness
Limitations section (ALS) of the existing aircraft maintenance
manual (AMM) to add new and more restrictive tasks for the control
column sprocket gear assembly and control wheel column assembly, to
address the new limit of validity and update the usage assumptions
and conditions for operations on unpaved and grass runways, and to
correct an error in the horizontal stabilizer primary trim system
secondary power source operational test. The FAA is issuing this AD
to prevent reduction in the structural integrity of the airframe and
components, as well as an unrecognized failure of the manual pitch
trim. These conditions, if not addressed, could result in loss of
airplane control.

(f) Actions and Compliance

    (1) Before further flight, unless already done, revise the ALS
of the existing AMM or instructions for continued airworthiness
(ICA) for your airplane by incorporating the following documents.
    (i) Airworthiness Limitations, AMM data module PC24-A-A04-00-
0000-00A-040A-A, Issue 008, Revision 00, dated May 26, 2020, from
Chapter 04, Airworthiness Limitations, Pilatus PC-24 Aircraft
Maintenance Manual (PC-24 AMM) Report 02378, Issue 005, Revision 19,
dated May 26, 2020.
    (ii) Mandatory structural inspection items, AMM data module
PC24-A-A04-20-0000-00A-000A-A, Issue 005, Revision 00, dated May 26,
2020, from Chapter 04, Airworthiness Limitations, Pilatus PC-24
Aircraft Maintenance Manual (PC-24 AMM) Report 02378, Issue 005,
Revision 19, dated May 26, 2020.
    (iii) Certification maintenance requirements, AMM data module
PC24-A-A04-30-0000-00A-000A-A, Issue 007, Revision 00, dated October
14, 2019, from Chapter 04, Airworthiness Limitations, Pilatus PC-24
Aircraft Maintenance Manual (PC-24 AMM) Report 02378, Issue 005,
Revision 19, dated May 26, 2020.
    (iv) Horizontal stabilizer primary trim system secondary power
source--Operation test, AMM data module PC24-A-E27-40-0000-01A-320A-
A, dated September 25, 2019, from PC-24 AMM Report 02378, Issue 005,
Revision 19, dated May 26, 2020. Your ALS must require this
procedure for task number AL-27-40-022 in the certification
maintenance requirements.

    Note 1 to paragraph (f)(1) of this AD: Pilatus PC-24 Aircraft
Maintenance Manual, Airworthiness Limitations, AMM data module PC24-
A-A04-00-0000-00A-040A-A, Issue 008, Revision 00, dated May 26,
2020, is the parent data module for Chapter 04 of the PC-24 AMM and
consists of four subsections (sub-data modules). The parent data
module and four sub-data modules comprise the complete ALS of
Chapter 04, Airworthiness Limitations, Pilatus PC-24 Aircraft
Maintenance Manual (PC-24 AMM) Report 02378, Issue 005, Revision 19,
dated May 26, 2020. Incorporating Pilatus PC-24 Aircraft Maintenance
Manual, Airworthiness Limitations, AMM data module PC24-A-A04-00-
0000-00A-040A-A, Issue 008 Revision 00, dated May 26, 2020, and all
four subsections listed in Section 1 General, is acceptable, but not
required, for compliance with this AD.

    (2) As of the effective date of this AD, except as provided in
paragraph (g) of this AD, no alternative replacement times,
inspection intervals, or tasks may be approved for the affected
parts.
    (3) The actions required by paragraph (f)(1) of this AD may be
performed by the owner/operator (pilot) holding at least a private
pilot certificate and must be entered into the aircraft records
showing compliance with this AD in accordance with 14 CFR 43.9(a)(1)
through (4), and 14 CFR 91.417(a)(2)(v). The record must be
maintained as required by 14 CFR 91.417, 121.380, or 135.439.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to Doug Rudolph,
Aviation Safety Engineer, FAA, General Aviation & Rotorcraft
Section, International Validation Branch, 901 Locust, Room 301,
Kansas City, MO 64106; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>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. Before using any approved
AMOC, notify your appropriate principal inspector, or lacking a
principal inspector, the manager of the local flight standards
district office/certificate holding district office.

(h) Related Information

    Refer to European Union Aviation Safety Agency (EASA) AD 2020-
0202, dated September 22, 2020, for more information. You may
examine the EASA AD at https://www.regulations.gov by searching for
and locating Docket No. FAA-2020-0812.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Chapter 04, Airworthiness Limitations, Pilatus PC-24
Aircraft Maintenance Manual

(PC-24 AMM) Report 02378, Issue 005, Revision 19, dated May 26,
2020.
    (ii) Horizontal stabilizer primary trim system secondary power
source--Operation test, AMM data module PC24-A-E27-40-0000-01A-320A-
A, dated September 25, 2019, from PC-24 AMM Report 02378, Issue 005,
Revision 19, dated May 26, 2020.
    (3) For Pilatus Aircraft Ltd. service information identified in
this AD, contact Pilatus Aircraft Ltd., Customer Support General
Aviation, CH-6371 Stans, Switzerland; phone: +41 848 24 7 365;
exception occurred on : 2021-12045.htm
exception occurred on : 2021-12045.htm
email: aircraft.com">[email protected]aircraft.com; website: https://
www.pilatus-aircraft.com.
    (4) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 901 Locust, Kansas
City, MO 64106. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 7, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-12045 Filed 6-9-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 56 (Friday, March 22, 2013)]
[Rules and Regulations]
[Pages 17595-17598]
[FR Doc No: 2013-06126]

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

Food and Drug Administration

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

[Docket No. FDA-2013-N-0002]

New Animal Drugs; Changes of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for 21 approved new
animal drug applications (NADAs) and 43 approved abbreviated new animal
drug applications (ANADAs) from Teva Animal Health, Inc., to Bayer
HealthCare LLC.

DATES: This rule is effective March 22, 2013.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855;<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Teva Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503 has informed FDA that it has
transferred ownership of, and all rights and interest in, the following
21 approved NADAs and 43 approved ANADAs to Bayer HealthCare LLC,
Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201:

                    Table 1--Applications Transferred
------------------------------------------------------------------------
       Application No.                         Trade name
------------------------------------------------------------------------
6-391........................  S.Q. (sulfaquinoxaline) 40% Type A
                                Medicated Article.
6-677........................  S.Q. (sulfaquinoxaline) 20% Solution.
7-087........................  Sulfaquinoxaline Solubilized.
33-157.......................  SPECTAM (spectinomycin) Scour Halt.
40-040.......................  SPECTAM (spectinomycin) Injectable
                                Solution.
45-416.......................  TEVCODYNE (phenylbutazone) Injectable
                                Solution.
48-287.......................  Oxytetracycline-50 Injectable Solution.
55-002.......................  TEVCOCIN (chloramphenicol) Injection.
65-110.......................  PEN-G-MAX (penicillin G procaine)
                                Injectable Suspension.
65-498.......................  DUAL-CILLIN (penicillin G benzathine and
                                penicillin G procaine).
91-818.......................  Phenylbutazone Tablets, USP 1 gram.
93-483.......................  SPECTAM (spectinomycin) Injectable
                                Solution.
94-170.......................  Phenylbutazone Tablets, USP 100 or 200
                                mg.
99-169.......................  Oxytocin Injection.
119-142......................  PVL Iron Dextran Injectable (iron
                                hydrogenated dextran injection).
123-815......................  Dexamethasone Sodium Phosphate Injection.
124-241......................  PVL (oxytocin) Injectable.
128-089......................  ZONOMETH (dexamethasone) Solution.
140-270......................  SULFASURE (sulfamethazine) SR Cattle
                                Bolus.
141-070......................  RAPINOVET (propofol) Injectable Emulsion.
141-245......................  TRIBUTAME (embutramide, chloroquine, and
                                lidocaine) Euthanasia Solution.
200-042......................  Ketamine Hydrochloride Injection, USP.
200-068......................  Oxytetracycline Hydrochloride Injection
                                100.
200-069......................  FERTELIN (gonadorelin diacetate
                                tetrahydrate) Injection.
200-108......................  Dexamethasone Solution.
200-118......................  Neomycin Oral Solution.
200-123......................  MAXIM-200 (oxytetracycline hydrochloride)
                                Injection.
200-124......................  Flunixin Meglumine Injection.
200-126......................  Phenylbutazone 20% Injection.
200-137......................  Gentamicin Sulfate Solution (IU).
200-147......................  Gentamicin Sulfate Injection.
200-153......................  NEO 200 (neomycin sulfate) Oral Solution.
200-162......................  Tripelennamine Hydrochloride Injection.
200-174......................  Gentamicin Sulfate Pig Pump Oral
                                Solution.
200-177......................  Sulfadimethoxine Injection 40%.
200-178......................  Amikacin Sulfate Injection.
200-181......................  Amikacin Sulfate Solution.
200-192......................  Sulfadimethoxine 12.5% Oral Solution.
200-193......................  Clindamycin Hydrochloride Oral Liquid.
200-202......................  PHOENECTIN (ivermectin) Oral Solution.
200-219......................  Ivermectin Pour-On for Cattle.
200-228......................  PHOENECTIN (ivermectin) Injectable
                                Solution.
200-230......................  Guaifenesin Injection.
200-246......................  Pyrantel Pamoate Oral Suspension (OTC and
                                Rx).
200-248......................  Pyrantel Pamoate Oral Suspension.
200-253......................  PROSTAMATE (dinoprost tromethamine)
                                Injectable Solution.
200-254......................  Iron Dextran Injection--100.
200-256......................  Iron Dextran Injection--200.
200-265......................  Praziquantel Tablets (OTC and Rx).
200-286......................  PHOENECTIN (ivermectin) Paste 1.87%.
200-287......................  GBC (gentamicin sulfate, betamethasone
                                valerate, and clotrimazole) Ointment.
200-293......................  Furosemide Injection 5%.
200-297......................  Ivermectin Chewable Tablets.
200-298......................  Clindamycin Hydrochloride Capsules.
200-319......................  Acepromazine Maleate Injection.

200-322......................  Butorphanol Tartrate Injection.
200-342......................  Pyrantel Pamoate Paste.
200-351......................  Lincomycin Injectable, USP.
200-360......................  TIAGARD (tiamulin) Liquid Concentrate.
200-365......................  ROBINUL-V (glycopyrrolate) Injectable.
200-382......................  Furosemide Syrup 1%.
200-389......................  Amprolium 9.6% Oral Solution.
200-408......................  Butorphanol Tartrate Injection.
200-463......................  Amprolium-P 9.6% Oral Solution.
------------------------------------------------------------------------

    Accordingly, the Agency is amending the regulations in 21 CFR parts
510, 520, 522, 524, 529, and 558 to reflect these transfers of
ownership. Following these changes of sponsorship, Teva Animal Health,
Inc., is no longer the sponsor of an approved application. As such, 21
CFR 510.600 is being amended to remove the entries for this firm.
    This rule 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.

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 and
redelegated to the Center for Veterinary Medicine, 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 21 CFR part 510 continues to read as
follows:

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

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry
for ``Teva Animal Health, Inc.''; and in the table in paragraph (c)(2),
remove the entry for ``059130''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as
follows:

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

Sec.  520.100  [Amended]

0
4. In paragraph (b)(3) of Sec.  520.100, remove ``059130'' and in its
place add ``000859''.

Sec.  520.446  [Amended]

0
5. In paragraph (b)(1) of Sec.  520.446, remove ``059130'' and in its
place add ``000859''.

Sec.  520.447  [Amended]

0
6. In paragraph (b) of Sec.  520.447, remove ``000009, 051311, 058829,
and 059130'' and in its place add ``000009, 000859, 051311, and
058829''.

Sec.  520.1010  [Amended]

0
7. In paragraph (b)(3) of Sec.  520.1010, remove ``058829 and 059130''
and in its place add ``000859 and 058829''.

Sec.  520.1044b  [Amended]

0
8. In paragraph (b) of Sec.  520.1044b, remove ``059130'' and in its
place add ``000859''.

Sec.  520.1192  [Amended]

0
9. In paragraph (b)(2) of Sec.  520.1192, remove ``051311, 054925,
059130, and 061623'' and in its place add ``000859, 051311, 054925, and
061623''.

Sec.  520.1193  [Amended]

0
10. In paragraph (b)(2) of Sec.  520.1193, remove ``051311 and 059130''
and in its place add ``000859 and 051311''.

Sec.  520.1195  [Amended]

0
11. In paragraph (b)(1) of Sec.  520.1195, remove ``050604, 054925, and
059130'' and in its place add ``000859, 050604, and 054925''.

Sec.  520.1484  [Amended]

0
12. In paragraph (b)(3) of Sec.  520.1484, remove ``000009, 054925,
058005, and 059130'' and in its place add ``000009, 000859, 054925, and
058005''.

Sec.  520.1720a  [Amended]

0
13. In paragraph (b)(2) of Sec.  520.1720a, remove ``059130'' and in
its place add ``000859''.

Sec.  520.1870  [Amended]

0
14. In paragraph (b)(2) of Sec.  520.1870, remove ``059130'' and in its
place add ``000859''.

Sec.  520.2043  [Amended]

0
15. In paragraph (b)(1) of Sec.  520.2043, remove ``000069, 058829, and
059130'' and in its place add '' 000069, 000859, and 058829''.

Sec.  520.2044  [Amended]

0
16. In paragraph (b)(2) of Sec.  520.2044, remove ``059130'' and in its
place add ``000859''.

Sec.  520.2123c  [Amended]

0
17. In paragraph (b) of Sec.  520.2123c, remove ``059130'' and in its
place add ``000859''.

Sec.  520.2220a  [Amended]

0
18. In paragraph (a)(1) of Sec.  520.2220a, remove ``000010, 000069,
054925, 057561, and 059130'' and in its place add ``000010, 000069,
000859, 054925, and 057561''.

Sec.  520.2260b  [Amended]

0
19. In paragraph (f)(1) of Sec.  520.2260b, remove ``059130'' and in
its place add ``000859''.

Sec.  520.2325a  [Amended]

0
20. In paragraph (a)(1) of Sec.  520.2325a, remove ``059130'' and in
its place add ``000859''.

0
21. In Sec.  520.2455, revise paragraph (b)(2) and add paragraph (b)(3)
to read as follows:

Sec.  520.2455  Tiamulin.

* * * * *
    (b) * * *
    (2) No. 066104 for the product described in paragraph (a)(1) of
this section.
    (3) No. 000859 for the product described in paragraph (a)(3) of
this section.
* * * * *

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

0
22. The authority citation for 21 CFR part 522 continues to read as
follows:

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

Sec.  522.23  [Amended]

0
23. In paragraph (b)(2) of Sec.  522.23, remove ``059130'' and in its
place add ``000859''.

Sec.  522.56  [Amended]

0
24. In paragraph (b) of Sec.  522.56, remove ``059130'' and in its
place add ``000859''.

Sec.  522.246  [Amended]

0
25. In Sec.  522.246, in paragraphs (b)(2) and (b)(3), remove
``059130'' and in its place add ``000859''.

Sec.  522.390  [Amended]

0
26. In paragraph (b) of Sec.  522.390, remove ``059130'' and in its
place add ``000859''.

Sec.  522.540  [Amended]

0
27. In Sec.  522.540, in paragraphs (a)(2)(i), (d)(2)(i), and (e)(2),
remove ``059130'' and in its place add ``000859''; in paragraphs
(b)(3)(i), (b)(3)(ii), (c)(3)(i), and (c)(3)(ii), remove the footnote
reference ``1''; and remove the text of footnote 1.

Sec.  522.810  [Amended]

0
28. In paragraph (b) of Sec.  522.810, remove ``059130'' and in its
place add ``000859''.

Sec.  522.1010  [Amended]

0
29. In paragraph (b)(3) of Sec.  522.1010, remove ``059130'' and in its
place add ``000859''.

Sec.  522.1044  [Amended]

0
30. In paragraph (b)(4) of Sec.  522.1044, remove ``059130'' and in its
place add ``000859''.

Sec.  522.1066  [Amended]

0
31. In paragraph (b) of Sec.  522.1066, remove ``059130'' and in its
place add ``000859''.

Sec.  522.1086  [Amended]

0
32. In paragraph (b) of Sec.  522.1086, remove ``037990 and 059130''
and in its place add ``000859 and 037990''.

Sec.  522.1182  [Amended]

0
33. In Sec.  522.1182, in paragraph (b)(1), remove ``042552 and
059130'' and in its place add ``000859 and 042552''; in paragraph
(b)(6), remove ``058005 and 059130'' and in its place add ``000859 and
058005''; and in paragraph (b)(7), remove ``042552 and 059130'' and in
its place add ``000859 and 042552''.

Sec.  522.1192  [Amended]

0
34. In paragraph (b)(2) of Sec.  522.1192, remove ``055529, 058005,
059130, and 061623'' and in its place add ``000859 055529, 058005, and
061623''.

Sec.  522.1222a  [Amended]

0
35. In paragraph (b) of Sec.  522.1222a, remove ``059130'' and in its
place add ``000859''.

Sec.  522.1260  [Amended]

0
36. In paragraph (b)(2) of Sec.  522.1260, remove ``058005 and 059130''
and in its place add ``000859 and 058005''.

Sec.  522.1660a  [Amended]

0
37. In paragraph (b) of Sec.  522.1660a, remove ``000010, 000069,
048164, 055529, 057561, 059130, and 061623'' and in its place add
``000010, 000069, 000859, 048164, 055529, 057561, and 061623''.

Sec.  522.1662a  [Amended]

0
38. In paragraph (i)(2) of Sec.  522.1662a, remove ``059130'' and in
its place add ``000859''.

Sec.  522.1680  [Amended]

0
39. In paragraph (b) of Sec.  522.1680, remove ``000010, 000856,
059130, 059130, and 061623'' and in its place add ``000010, 000856,
000859, and 061623''.

Sec.  522.1696a  [Amended]

0
40. In paragraph (b)(2) of Sec.  522.1696a, remove ``055529, 059130,
and 061623'' and in its place add ``000859, 055529, and 061623''.

Sec.  522.1696b  [Amended]

0
41. In Sec.  520.1696b:
0
a. In paragraph (b)(1), remove ``053501, 055529, and 059130'' and in
its place add ``000859, 053501, and 055529''.
0
b. In paragraph (d)(2)(i)(A), remove ``053501, 055529, 059130, and
061623'' and in its place add ``000859, 053501, 055529, and 061623''.
0
c. In paragraph (d)(2)(iii)(B), remove ``055529 and 059130'' and in its
place add ``000859 and 055529''.

Sec.  522.1720  [Amended]

0
42. In paragraph (b)(1) of Sec.  522.1720, remove ``059130'' and in its
place add ``000859''.

Sec.  522.2005  [Amended]

0
43. In paragraph (b)(1) of Sec.  522.2005, remove ``059130'' and in its
place add ``000859''.

Sec.  522.2120  [Amended]

0
44. In paragraph (b) of Sec.  522.2120, remove ``059130'' and in its
place add ``000859''.

Sec.  522.  2220 [Amended]

0
45. In paragraph (a)(2)(iii) of Sec.  522.2220, remove ``059130'' and
in its place add ``000859''.

Sec.  522.2615  [Amended]

0
46. In paragraph (b) of Sec.  522.2615, remove ``053501 and 059130''
and in its place add ``000859 and 053501''.

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

0
47. The authority citation for 21 CFR part 524 continues to read as
follows:

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

Sec.  524.1044g  [Amended]

0
48. In paragraph (b)(3) of Sec.  524.1044g, remove ``059130'' and in
its place add ``000859''.

Sec.  524.1193  [Amended]

0
49. In paragraph (b)(2) of Sec.  524.1193, remove ``054925, 059130, and
066916'' and in its place add ``000859, 054925, and 066916''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
50. The authority citation for 21 CFR part 529 continues to read as
follows:

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

Sec.  529.56  [Amended]

0
51. In paragraph (b) of Sec.  529.56, remove ``059130'' and in its
place add ``000859''.

Sec.  529.1044a  [Amended]

0
52. In paragraph (b) of Sec.  529.1044a, remove ``000010, 000061,
000856, 057561, 058005, 059130, and 061623'' and in its place add
``000010, 000061, 000856, 000859, 057561, 058005, and 061623''.

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

0
53. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.586  [Amended]

0
54. In paragraph (b) of Sec.  558.586, remove ``059130'' and in its
place add ``000859''.

    Dated: March 12, 2013.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2013-06126 Filed 3-21-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: October 18, 2007 (Volume 72, Number 201)]
[Notices]
[Page 59087-59088]
[DOCID:fr18oc07-40]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2007-0045; FRL-8483-9]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NSPS for Phosphate Rock Plants
(Renewal); EPA ICR Number 1078.08, OMB Control Number 2060-0111

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before November 19,
2007.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2007-0045, to (1) EPA online using http://www.regulations.gov (our preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:

EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
2201T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street,
NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Compliance Assessment
and Media Programs Division, Office of Compliance, Mail Code 2223A,
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On March 9, 2007 (72 FR 10735), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2007-0045, which is available for public viewing
online at http://www.regulations.gov, or in person viewing at the

Enforcement and Compliance Docket and Information Center in the EPA
Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue,
NW., Washington, DC. The EPA Docket Center Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Reading Room is<PHONE_NUMBER>,
and the telephone number for the Enforcement and Compliance Docket is
(202) 566-1752.
    Use EPA's electronic docket and comment system at http://www.regulations.gov
, to submit or view public comments, access the

index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA

receives them and without change, unless the comment contains
copyrighted material, confidential business information (CBI) or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://www.regulations.gov
.

    Title: NSPS for Phosphate Rock Plants (Renewal).
    ICR Numbers: EPA ICR Number 1078.08, OMB Control Number 2060-0111.
    ICR Status: This ICR is scheduled to expire on November 30, 2007.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR

part 9, and displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
in certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: The New Source Performance Standards (NSPS) for Phosphate
Rock Plants were proposed on September 21, 1979, and promulgated on
April 16, 1982. These standards apply to the new facilities at
phosphate rock plants with capacities greater than 4 tons per hour:
dryers, calciners, grinders, and ground rock handling and storage
facilities, except those facilities producing or preparing phosphate
rock solely for consumption in elemental phosphorus production. These
standards rely on the capture of particulate emissions by a baghouse or
wet scrubber. This information is being collected to determine
compliance with 40 CFR part 60, subpart NN. In general, all NSPS
standards require initial notifications, performance tests, and
periodic reports. Owners or operators are also required to maintain
records of the occurrence and duration of any startup, shutdown, or
malfunction in the operation of an affected facility, or any period
during which the monitoring system is inoperative. These notifications,
reports, and records are essential in determining compliance and are
required of all sources subject to NSPS.
    Any owner or operator subject to the provisions of this part shall
maintain a file of these measurements and retain the file for at least
two years following the date of such measurements, maintenance reports
and records. All reports are sent to the delegated state or local
authority. In the event that there is no such delegated authority, the
reports are sent directly to the EPA regional office. This information
is being collected to assure compliance with 40 CFR part 60, subpart
NN, as authorized in section 112 and 114(a) of the Clean Air Act. The
required information consists of emissions data and other information
that have been determined to be private.
    An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB Control Number. The OMB Control Number for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 55.2
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Phosphate rock plants.
    Estimated Number of Respondents: 13.
    Frequency of Response: Initially and semiannually.
    Estimated Total Annual Hour Burden: 1,602.
    Estimated Total Annual Cost: $226,427, which includes $12,210
annualized Capital Startup (CSU) costs, $111,972 annualized Operating
and Maintenance (O&M) costs, and $102,245 annualized Labor costs.
    Changes in the Estimates: There is no change in the labor hours in
this ICR compared to the previous ICR. This is due to two
considerations. First, the regulations have not changed over the past
three years and are not anticipated to change over the next three
years. Secondly, the growth rate for the industry is very low, negative
or non-existent, so there is not significant change to the overall
labor hours.
    There is however, a change in the cost estimate. The previous ICR
used a total cost figure of $124,000 for Capital Startup (CSU) costs
and Operating and Maintenance (O&M) costs. This ICR uses the exact cost
figure of $124,182, resulting in a small cost increase.
    Since there are no changes in the regulatory requirements and there
is no significant industry growth, the labor hours in the previous ICR
are used in this ICR and there is no change in the labor hours to
industry.

    Dated: October 11, 2007.
Sara Hisel-McCoy,
Acting Director, Collection Strategies Division.
 [FR Doc. E7-20566 Filed 10-17-07; 8:45 am]

BILLING CODE 6560-50-P