[Federal Register: March 26, 2008 (Volume 73, Number 59)]
[Notices]
[Page 16021-16022]
[DOCID:fr26mr08-78]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0173]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Appeals of Science-Based Decisions Above the Division
Level at the Center for Veterinary Medicine

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements for appeals of science-based decisions above the division
level at the Center for Veterinary Medicine (CVM).

DATES: Submit written or electronic comments on the collection of
information by May 27, 2008.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the

information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.

Appeals of Science-Based Decisions Above the Division Level at the
Center for Veterinary Medicine--21 CFR Part 10.75 (OMB Control Number
0910-0566)--Extension

    CVM's ``Guidance for Industry 79--Dispute Resolution
Procedures for Science-Based Decisions on Products Regulated by the
Center for Veterinary Medicine'' describes the process by which CVM
formally resolves disputes relating to scientific controversies. A
scientific controversy involves issues concerning a specific product
regulated by CVM related to matters of technical expertise and requires
specialized education, training, or experience to be understood and
resolved. Further, the guidance details information on how the agency
intends to interpret and apply provisions of the existing regulations
regarding internal agency review of decisions. In addition, the
guidance outlines the established recommended procedures for persons
who are applicants, including sponsor applicants or manufacturers, for
animal drugs or other products regulated by CVM, that wish to submit a
request for review of a scientific dispute. When an applicant has a
scientific disagreement and a written decision by CVM, the applicant
may submit a request for review of that decision by following the
established agency channels of supervision for review.
    Respondents to this collection of information are applicants that
wish to submit a request for review of a scientific dispute.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.75                                                                   2                     4                  8                 10                 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    This estimated annual reporting burden is based on CVM's experience
over the past 3 years in handling formal appeals for scientific
disputes. The number of respondents multiplied by the annual frequency
of response equals the total annual responses. The number of hours per
response is based on discussions with industry and may vary depending
on the complexity of the issue(s) involved and the duration of the
appeal process.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.

    Dated: March 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6065 Filed 3-25-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Rules and Regulations]
[Pages 42036-42037]
[FR Doc No: 2018-17921]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-R03-RCRA-2017-0553; FRL-9982-19--Region 3]

District of Columbia: Final Authorization of District Hazardous
Waste Management Program Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final authorization.

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SUMMARY: The EPA is granting the District of Columbia (the District)
final authorization for revisions to its hazardous waste management
program under the Resource Conservation and Recovery Act (RCRA). The
Agency published a proposed rule on June 11, 2018 and provided for
public comment. No comments relevant to the proposed revisions were
received. No further opportunity for comment will be provided.

DATES: This final authorization is effective on August 20, 2018.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R03-RCRA-2017-0553. All documents in the docket are listed in
the www.regulations.gov index. Although listed in the index, some of
the information is not publicly available, e.g., Confidential Business
Information or other information whose disclosure is restricted by
statute. Certain other material, such as copyrighted material, will be
publicly available only in hard copy. Publicly available docket
materials are available either electronically through
www.regulations.gov or in hard copy. You may view and copy the
District's application from 9:00 a.m. to 5:00 p.m., Monday through
Friday at the following locations: District of Columbia Department of
Energy and Environment, Environmental Services Administration,
Hazardous Waste Branch, 1200 First Street NE, 5th Floor, Washington,
DC, Phone number:<PHONE_NUMBER>, Attn: Barbara Williams; and EPA
Region III, Library, 2nd Floor, 1650 Arch Street, Philadelphia, PA
19103-2029, Phone number:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sara Kinslow, U.S. EPA Region III,
RCRA Waste Branch, Mailcode 3LC32, 1650 Arch Street, Philadelphia, PA
19103-2029, phone number:<PHONE_NUMBER>, email: [email protected].

SUPPLEMENTARY INFORMATION:

A. What revisions is EPA authorizing with this action?

    On August 15, 2012, the District submitted a final complete program
revision application (with subsequent corrections) seeking
authorization of revisions to its hazardous waste management program in
accordance with 40 CFR 271.21. EPA now makes a final decision that the
District's hazardous waste management program revisions are equivalent
to, consistent with, and no less stringent than the Federal program,
and therefore satisfy all of the requirements necessary to qualify for
final authorization. For a list of District rules that are being
authorized with this final authorization please see the proposed rule
published in the June 11, 2018 Federal Register at 83 FR 26917.

B. What is codification and is EPA codifying the District of Columbia's
hazardous waste program as authorized in this authorization?

    Codification is the process of placing a state's statutes and
regulations that comprise that state's authorized hazardous waste
program into the Code of Federal Regulations. EPA does this by
referencing the authorized state rules in 40 CFR part 272. EPA is not
codifying the authorization of the District's revisions at this time.
However, EPA reserves the amendment of 40 CFR part 272, subpart J, for
codification of this authorization of the District's hazardous waste
management program until a later date.

C. Statutory and Executive Order Reviews

    This final authorization revises the District's authorized
hazardous waste management program pursuant to section 3006 of RCRA and
imposes no requirements other than those currently imposed by District
law. For further information on how this authorization complies with
applicable executive orders and statutory provisions, please see the
proposed rule published in the June 11, 2018 Federal Register at 83 FR
26917.

List of Subjects in 40 CFR Part 271

    Environmental protection, Administrative practice and procedure,
Confidential business information, Hazardous materials transportation,
Hazardous waste, Indians--lands, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements.

    Authority: This action is issued under the authority of sections
2002(a), 3006 and 7004(b) of the Solid Waste Disposal Act, as
amended, 42 U.S.C. 6912(a), 6926, and 6974(b).

    Dated: July 31, 2018.
Cosmo Servidio,
Regional Administrator, U.S. EPA Region III.
[FR Doc. 2018-17921 Filed 8-17-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31956-31959]
[FR Doc No: 2019-14166]

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SECURITIES AND EXCHANGE COMMISSION

[Release No 34-86226; File No. SR-CFE-2019-001]

Self-Regulatory Organizations; Cboe Futures Exchange, LLC; Notice
of a Filing of a Proposed Rule Change Regarding Trading Conduct

June 27, 2019.
    Pursuant to Section 19(b)(7) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on June 18, 2019 Cboe Futures
Exchange, LLC (``CFE'' or ``Exchange'') filed with the Securities and
Exchange Commission (``SEC'' or ``Commission'') the proposed rule
change described in Items I, II, and III below, which Items have been
prepared by CFE. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons. CFE also
has filed this proposed rule change with the Commodity Futures Trading
Commission (``CFTC''). CFE filed a written certification with the CFTC
under Section 5c(c) of the Commodity Exchange Act (``CEA'') \2\ on June
18, 2019.
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    \1\ 15 U.S.C. 78s(b)(7).
    \2\ 7 U.S.C. 7a-2(c).
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I. Self-Regulatory Organization's Description of the Proposed Rule
Change

    The Exchange proposes to update, clarify, and amend certain CFE
rule provisions primarily relating to trading conduct as well as to the
use of Order

Entry Operator IDs (``OEO IDs''), to Market Participant records
regarding activities in a reference market, and to Clearing Member
requirements with regard to customer records concerning Exchange of
Contract for Related Position (``ECRP'') transactions and Block Trades.
The scope of this filing is limited solely to the application of the
proposed rule amendments to security futures that may be traded on CFE.
Although no security futures are currently listed for trading on CFE,
CFE may list security futures for trading in the future. The text of
the proposed rule change is attached as Exhibit 4 to the filing but is
not attached to the publication of this notice.

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

    In its filing with the Commission, CFE 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. CFE 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 proposed rule changes update, clarify, and amend certain CFE
rule provisions primarily relating to trading conduct as well as to the
use of OEO IDs, to Market Participant records regarding activities in a
reference market, and to Clearing Member requirements with regard to
customer records concerning ECRP transactions and Block Trades.
    First, CFE is proposing to clarify when an OEO ID must be used for
a front-end trading system utilized by a natural person under CFE Rule
303A (Order Entry Operator ID) which governs the use of OEO IDs in
connection with the submission of orders to CFE's trading system.
Specifically, CFE is proposing to amend Rule 303A to clarify that if a
natural person utilizes a front-end trading system with automated
functionality (such as spreading functionality) and the use of that
functionality is ancillary to the natural person's manual trading, an
OEO ID is not required to be used for that front-end trading system. In
that event, the natural person's OEO ID may be used for the submission
of orders originating from that front-end trading system. If, however,
the automated functionality of the front-end trading system generates a
majority of the natural person's orders, that front-end trading system
will be treated as an Automated Trading System for purposes of Rule
303A and an OEO ID for the front-end trading system must be included in
each order generated by the front-end trading system in order to
differentiate those orders from manual orders submitted by the natural
person. CFE believes that this clarification will enhance CFE's rule
provisions regarding OEO IDs by providing more explicit guidance with
respect to when an OEO ID must be used for a front-end trading system
utilized by a natural person.
    Second, CFE is proposing to amend CFE Rule 308(d) to add CFE Rule
501(c) as a rule that is applicable to Market Participants to the same
extent that it is applicable to CFE Trading Privilege Holders
(``TPHs''). Rule 501(c) provides that if a contract listed on the
Exchange is settled by reference to the price of a contract or
commodity traded in another venue, including a price or index derived
from prices on another designated contract market (``DCM''), TPHs are
required to make available to the Exchange upon request in a form and
manner prescribed by the Exchange and within the time frame designated
by the Exchange information and their books and records regarding their
activities in the reference market. The term ``Market Participant'' is
a new defined term that CFE is implementing under CFE rules which means
any Person subject to CFE Rule 308(c). Rule 308(c) provides that any
Person initiating or executing a transaction on or subject to the Rules
of the Exchange directly or through an intermediary, and any Person for
whose benefit such a transaction has been initiated or executed,
expressly consents to the jurisdiction of the Exchange and agrees to be
bound by and comply with the Rules of the Exchange in relation to such
transactions, including, but not limited to, rules requiring
cooperation and participation in investigatory and disciplinary
processes. CFE believes that making Rule 501(c) applicable to Market
Participants will enhance CFE's ability to conduct regulatory
investigations in relation to CFE's market that may involve activities
by a Market Participant in a reference market.
    Third, CFE is proposing to revise CFE Rule 414 (Exchange of
Contract for Related Position) and CFE Rule 415 (Block Trades) to
clarify certain recordkeeping and reporting requirements relating to
ECRP transactions and Block Trades, respectively. Specifically, the
Exchange is proposing to amend Rules 414(h) and 415(e) to clarify that
each clearing member carrying a customer account for which an ECRP
transaction or Block Trade is executed shall be responsible for
obtaining and submitting to CFE in a timely and complete manner the
records of its customer regarding the ECRP transactions or Block
Trades, as applicable.
    Fourth, CFE is proposing to amend CFE Rule 601 (Fraudulent Acts),
CFE Rule 602 (Fictitious Transactions), CFE Rule 603 (Market
Manipulation), CFE Rule 604 (Adherence to Law), CFE Rule 610 (Priority
of Customers' Orders), CFE Rule 611 (Trading Against Customers'
Orders), CFE Rule 612 (Withholding Orders), CFE Rule 613 (Disclosing
Orders), CFE Rule 614 (Pre-Arranged Trades), CFE Rule 617 (Money
Passes), CFE Rule 618 (Accommodation Trading), CFE Rule 619 (Front-
Running), and CFE Rule 620 (Disruptive Practices) to specifically
reference in those rules that they are applicable to Market
Participants. CFE is proposing to revise the above-referenced rules to
provide that they apply to Market Participants, consistent with the
existing provisions of CFE Rule 308(d) which already provide that any
Person subject to Rule 308(c) that is not a TPH or a Related Party of a
TPH is bound by and required to comply with the above-referenced rules
to the same extent that a TPH or Related Party is bound by and required
to comply with those rules.
    Fifth, CFE is proposing to amend Rule 601, Rule 603, Rule 619 as
well as Policy and Procedure XVIII of the Policies and Procedures
Section of the CFE Rulebook relating to Rule 620 to make clear that
provisions of those rules prohibiting fraudulent acts, market
manipulation, front-running, and disruptive practices in any contract
traded on CFE also apply with respect to any commodity, security,
index, or benchmark that underlies any CFE contract, regardless of the
exchange on or market in which the underlying is transacted, when that
activity has an impact upon or nexus in relation to a CFE contract.
Fraudulent acts, market manipulation, front-running, and disruptive
practices in the underlying for a CFE contract can also impact the
market in the CFE contract or improperly benefit a Person holding that
CFE contract. Accordingly, consistent with similar rules on other DCMs
which encompass activity in the underlying cash market and underlying

commodities or securities,\3\ it is important that CFE be able to bring
disciplinary action for such activity by those subject to CFE
disciplinary jurisdiction under CFE Rule 308 if warranted under the
circumstances. In particular:
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    \3\ See, e.g., Chicago Mercantile Exchange Inc. Rule 432H, The
Board of Trade of the City of Chicago, Inc. Rule 432H, New York
Mercantile Exchange, Inc. Rule 432H, and Commodity Exchange, Inc.
Rule 432H.
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     CFE is proposing to amend Rule 601 to make clear that
fraudulent acts and attempted fraudulent acts encompassed by Rule 601
may be committed in connection with or related to any CFE contract,
either directly through activity in the market for that CFE contract,
or indirectly through activity in the market of any commodity,
security, index, or benchmark underlying that CFE contract, regardless
of the exchange on or market in which the underlying is transacted.
     CFE is proposing to amend Rule 603 to make clear that no
TPH, Related Party, or Market Participant shall (i) manipulate, or
attempt to manipulate, the price of any CFE contract, either directly
by engaging in activity in the market for that contract, or indirectly
by engaging in activity in the market of any commodity, security,
index, or benchmark underlying that contract, regardless of the
exchange on or market in which the underlying is transacted; (ii)
purchase or sell, or offer to purchase or sell, any CFE contract, or
any commodity, security, index, or benchmark that underlies any CFE
contract, regardless of the exchange on or market in which the
underlying is transacted, for the purpose of creating a condition in
which prices of the contract do not or will not reflect fair market
values; or (iii) intentionally or recklessly use or employ, or attempt
to use or employ, any manipulative device, scheme, or artifice to
defraud, relating to any CFE contract either directly by engaging in
activity in the market for that contract, or indirectly by engaging in
activity in the market of any commodity, security, index, or benchmark
underlying that contract, regardless of the exchange on or market in
which the underlying is transacted. The rules of other DCMs \4\ and
CFTC Regulation 180.1 \5\ also include a prohibition on the employment,
or attempted employment, of manipulative and deceptive devices.
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    \4\ See, e.g., ICE Futures U.S., Inc. Rule 4.02(d) and the rules
cited in footnote 3 above.
    \5\ 17 CFR 180.1.
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     CFE is proposing to amend Rule 619 to make clear that no
TPH, Related Party, or Market Participant shall take a position in a
CFE contract based upon non-public information regarding an impending
transaction by another person in the same or a related CFE contract, or
in any commodity, security, index, or benchmark underlying that CFE
contract regardless of the exchange on or market in which the
underlying is transacted, subject to certain existing exceptions
enumerated in Rule 619. These existing enumerated exceptions include
activity permitted under CFE Rule 407 (Crossing Trades), Rule 414, Rule
415, and Rule 611 or under any policies and procedures for pre-
execution discussions from time to time adopted by the Exchange.
     CFE is proposing to amend Policy and Procedure XVIII to
make clear that prohibited activity under Rule 620 may occur directly
or indirectly. In particular, prohibited activity encompassed by Rule
620 in relation to any CFE contract may occur directly through any
trading, practice, or conduct in the market for that contract that is
prohibited by Rule 620. Additionally, the proposed rule change makes
clear that prohibited activity encompassed by Rule 620 in relation to
any CFE contract may also occur indirectly through any trading,
practice, or conduct in the market of any commodity, security, index,
or benchmark underlying that contract, regardless of the exchange on or
market in which the underlying is transacted, that would be prohibited
by Rule 620 if it were done in that contract and that has an impact in
relation to that contract or the market in that contract.
    Sixth, the Exchange proposes to amend Rule 610 to delete
superfluous references to the qualifier that actions in violation of
Rule 610 must be ``knowingly'' committed. Rule 610 describes various
circumstances under which priority must be given to customer orders.
Rule 610(d) already provides for more detailed safe harbors from those
provisions making this qualifier unnecessary. In particular, Rule
610(a) currently prohibits knowingly buying (selling) a contract for a
personal or proprietary account when holding an order to buy (sell) the
same contract for any other person at the same price or at the market
price. Rule 610(b) also currently prohibits knowingly executing a
discretionary order for an immediate family member or for a personal or
proprietary account when holding a customer market order for the same
contract open as to time and price. The qualifier that these
prohibitions be knowingly committed is already addressed by the safe
harbors under Rule 610(d) that there is not a violation of these
prohibitions when appropriate ``firewall'' or separation of function
procedures are in place or an individual has no direct knowledge of the
other relevant order.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\6\ in general, and furthers the
objectives of Sections 6(b)(1) \7\ and 6(b)(5) \8\ in particular, in
that it is designed:
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(1).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

     To enable the Exchange to enforce compliance by its TPHs
and persons associated with its TPHs with the provisions of the rules
of the Exchange,
     to prevent fraudulent and manipulative acts and practices,
     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.
    The Exchange believes that the proposed rule change would
strengthen CFE's ability to carry out its responsibilities as a self-
regulatory organization by providing further clarity and guidance with
regard to provisions of the Exchange's rules that relate to trading
conduct by TPHs, their related parties, and Market Participants. In
particular, the proposed rule change would update, clarify, and augment
CFE rules that prohibit abusive trading practices on CFE's market by
TPHs, their related parties, and Market Participants, including CFE
rules that address fraudulent acts, fictitious transactions, market
manipulation, adherence to law, priority of customer orders, trading
ahead of customer orders, withholding orders, disclosing orders, pre-
arranged trades, simultaneous buying and selling orders, money passes,
accommodation trading, front-running, and disruptive practices.
    The proposed rule change would also clarify the application of CFE
requirements relating to the use of OEO IDs when a natural person
utilizes a front-end trading system with automated functionality, which
would contribute to the accuracy of CFE's audit trail. Additionally,
the proposed rule change would contribute to CFE's ability to obtain
information in connection with the regulation of CFE's market by
requiring clearing members carrying customer accounts to obtain and
submit to CFE customer records

regarding ECRP transactions and Block Trades by providing that Market
Participants are required to make available to CFE upon request
information and their books and records regarding their activities in a
reference market.

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

    CFE 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, in that the proposed rule change will enhance
CFE's ability to carry out its responsibilities as a self-regulatory
organization. The Exchange believes that the proposed rule change is
equitable and not unfairly discriminatory in that the rule amendments
included in the proposed rule change would apply equally to all TPHs,
their related parties, and Market Participants.

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

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

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

    The proposed rule change will become operative on July 2, 2019. At
any time within 60 days of the date of effectiveness of the proposed
rule change, the Commission, after consultation with the CFTC, may
summarily abrogate the proposed rule change and require that the
proposed rule change be refiled in accordance with the provisions of
Section 19(b)(1) of the Act.\9\
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    \9\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

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-CFE-2019-001 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-CFE-2019-001. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street, NE, Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. 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-CFE-2019-001, and should be submitted on
or before July 24, 2019.

For the Commission, by the Division of Trading and Markets, pursuant
to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(73).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-14166 Filed 7-2-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Rules and Regulations]
[Pages 68169-68171]
[FR Doc No: 2010-27972]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-1082; Directorate Identifier 2009-SW-041-AD;
Amendment 39-16491; AD 2010-23-02]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France (Eurocopter) Model
SA-365N, SA-365N1, AS-365N2, and AS 365 N3 Helicopters

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; request for comments.

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SUMMARY: This amendment adopts a new airworthiness directive (AD) for
the

specified Eurocopter model helicopters. This action requires amending
the Limitations section of the Rotorcraft Flight Manual (RFM) to limit
the never-exceed velocity (VNE) to 150 Knots Indicated Air Speed (KIAS)
and to add a 1,500 ft/minute rate of descent (R/D) limitation beyond
140 KIAS. This action also requires installing one or more placards on
the cockpit instrument panel in full view of the pilot and co-pilot.
This amendment is prompted by failures of the horizontal stabilizers on
recently delivered Model AS 365 N3 helicopters. Tests indicate that the
failures were due to a vibration phenomenon that may arise during the
descent flight phases at high speed regardless of the stabilizer
installed. The actions specified in this AD are intended to restrict
the VNE, to prevent failure of the horizontal stabilizer, and
subsequent loss of control of the helicopter.

DATES: Effective November 22, 2010.
    Comments for inclusion in the Rules Docket must be received on or
before January 4, 2011.

ADDRESSES: Use one of the following addresses to submit comments on
this AD:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may get the service information identified in this AD from
American Eurocopter Corporation, 2701 Forum Drive, Grand Prairie, TX
75053-4005, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or at http://www.eurocopter.com.
    Examining the Docket: You may examine the docket that contains the
AD, any comments, and other information on the Internet at http://www.regulations.gov, or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The Docket Operations office (telephone<PHONE_NUMBER>) is
located in Room W12-140 on the ground floor of the West Building at the
street address stated in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Gary Roach, Aviation Safety Engineer,
FAA, Rotorcraft Directorate, Regulations and Guidance Group, 2601
Meacham Blvd., Fort Worth, Texas 76137, telephone<PHONE_NUMBER>, fax
(817) 222-5961.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Emergency AD No. 2008-0204-E, dated December 4, 2008, to correct an
unsafe condition for the specified Eurocopter model helicopters. EASA
advises that Eurocopter has received reports of failed horizontal
stabilizers on recently delivered AS 365 N3 helicopters. The failures
occurred during acceptance test and training flights as part of the
demonstration of the VNE and resulted in in-flight separation and loss
of the failed sections. In each case, the helicopters succeeded in
returning to base with no further problems. Tests conducted on the
helicopter and in the laboratory have revealed the reported incidents
were due to a vibration phenomenon that may arise in the descent flight
phases at high speed ``regardless of the stabilizer definition.''
Although EASA AD 2008-0110-E, dated June 6, 2008, which is superseded
by EASA AD 2008-0204-E, dated December 4, 2008, applied to the Model
SA-336G1, EASA states that the stabilizer assembly procedure on SA-
366G1 helicopters modifies the dynamic behavior of the stabilizer.
Since an unsafe condition does not exist on that helicopter, the SA-
366G1 has been deleted from the EASA AD applicability.

Related Service Information

    Eurocopter has issued an Emergency Alert Service Bulletin (EASB)
with 3 numbers (01.00.60, 01.00.16, and 01.28), Revision 1, dated
December 2, 2008. EASB No. 01.00.60 applies to U.S. type-certificated
Model SA-365N, SA-365N1, AS-365N2, and AS 365 N3 helicopters and also
to military Model AS365F, Fs, Fi, and K helicopters that are not type
certificated in the United States. EASB No. 01.00.16 applies to
military Model AS565AA, MA, MB, SA, SB, and UB helicopters that are not
type certificated in the United States. EASB 01.28 applies to the Model
SA-366G1 helicopter. The EASB specifies bonding one or more locally-
produced labels to the instrument panel stating that the VNE is limited
to 150 KIAS and the R/D must not exceed 1,500 ft/min beyond 140 KIAS.
Eurocopter states in the EASB that it is working on an enhanced
definition that will be proposed as soon as possible. EASA classified
this EASB as mandatory and issued Emergency AD No. 2008-0204-E, dated
December 4, 2008, to ensure the continued airworthiness of these
helicopters.

FAA's Evaluation and Unsafe Condition Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, their technical
representative, has notified us of the unsafe condition described in
the MCAI AD. We are issuing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of these same
type designs.

Differences Between This AD and the EASA AD

    This AD uses a compliance time of before further flight rather than
before next flight after June 7, 2008, as stated in the EASA AD.

FAA's Determination and Requirements of This AD

    This unsafe condition is likely to exist or develop on other
helicopters of these same type designs. Therefore, this AD is being
issued to restrict the VNE to prevent failure of the horizontal
stabilizer and subsequent loss of control of the helicopter. This AD
requires amending the Limitations section of the RFM to limit the VNE
to 150 KIAS and to add a 1,500 ft/minute R/D limitation for airspeeds
beyond 140 KIAS. This action also requires installing one or more
placards on the cockpit instrument panel in full view of the pilot and
co-pilot stating the limitations. The change to the Operating
limitation section of the RFM may be made in pen and ink or a copy of
this AD may be filed in the Limitations section of the RFM.
    The short compliance time involved is required because the
previously described critical unsafe condition can adversely affect the
controllability and structural integrity of the helicopter. Amending
the Limitations section of the RFM to limit the VNE to 150 KIAS and
adding a 1,500 ft/minute R/D limitation beyond 140 KIAS are required
before further flight and installing one or more placards on the
cockpit instrument panel is required. Therefore, this AD must be issued
immediately.
    Since a situation exists that requires the immediate adoption of
this

regulation, it is found that notice and opportunity for prior public
comment hereon are impracticable, and that good cause exists for making
this amendment effective in less than 30 days.

Costs of Compliance

    We estimate that this AD will affect about 39 helicopters of U.S.
registry. We also estimate that it will take about \l/2\ work-hour per
helicopter to make copies to include in the RFM and to make and install
the placards. The average labor rate is $85 per work-hour. The parts
costs are minimal. Based on these figures, we estimate the cost of this
AD on U.S. operators is $1,658 for the fleet.

Comments Invited

    This AD is a final rule that involves requirements that affect
flight safety and was not preceded by notice and an opportunity for
public comment; however, we invite you to submit any written data,
views, or arguments regarding this AD. Send your comments to an address
listed under ADDRESSES. Include ``Docket No. FAA-2010-1082; Directorate
Identifier 2009-041-SW-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of the AD. We will consider all
comments received by the closing date and may amend the AD in light of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this AD. Using the search function of the
docket web site, you can find and read the comments to any of our
dockets, including the name of the individual who sent the comment. You
may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477-78).

Regulatory Findings

    We have determined that 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 the regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); 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.
    We prepared an economic evaluation of the estimated costs to comply
with this AD. See the AD docket to examine the economic evaluation.

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 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.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (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. Section 39.13 is amended by adding a new airworthiness directive to
read as follows:

2010-23-02 Eurocopter France: Amendment 39-16491; Docket No. FAA-
2010-1082; Directorate Identifier 2009-SW-041-AD.

    Applicability: Model SA-365N, SA-365N1, AS-365N2, and AS 365 N3-
helicopters, with a horizontal stabilizer, part number 365A13-3030-
1901, -1902, -1903, -1904, -1905, -1906, -1908, -1909; 365A13-3036-
00, -0001, -0002, -0003; or 365A13-3038-00, installed, certificated
in any category.
    Compliance: Before further flight, unless accomplished
previously.
    To restrict the never-exceed velocity (VNE) to prevent failure
of the horizontal stabilizer, and subsequent loss of control of the
helicopter, do the following:
    (a) Revise the airspeed operating limitation in the Limitations
section of the Rotorcraft Flight Manual (RFM) by making pen and ink
changes or by inserting a copy of this AD into the RFM stating:
``The never-exceed speed (VNE) is limited to 150 knots indicated
airspeed (KIAS),'' and ``The rate-of-descent (R/D) must not exceed
1,500 ft/min when the airspeed is beyond 140 KIAS.''
    (b) Install one or more self-adhesive placards, with 6
millimeter red letters on white background, on the cockpit
instrument panel in full view of the pilot and co-pilot to read as
follows:
    ``VNE LIMITED TO 150 KIAS''
    ``R/D MUST NOT EXCEED 1,500 ft/min when airspeed is beyond 140
KIAS''
    (c) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Contact the Manager Safety Management Group: ATTN: Gary Roach,
Aerospace Engineer, FAA, Regulations and Policy Group, 2601 Meacham
Blvd., Fort Worth, Texas 76137; telephone:<PHONE_NUMBER>; fax: 817-
222-5961, for information about previously approved alternative
methods of compliance.
    (d) The Joint Aircraft System/Component (JASC) Code is 5510:
Horizontal Stabilizer Structure.
    (e) This amendment becomes effective on November 22, 2010.

    Note: The subject of this AD is addressed in European Aviation
Safety Agency Emergency AD No. 2008-0204-E, dated December 4, 2008,
and in Eurocopter Emergency Alert Service Bulletin No. 01.00.60,
Revision 1, dated December 2, 2008, for the Model AS365N series
helicopters.

    Issued in Fort Worth, Texas, on October 15, 2010.
Mark R. Schilling,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2010-27972 Filed 11-4-10; 8:45 am]
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