[Federal Register: November 20, 2006 (Volume 71, Number 223)]
[Notices]
[Page 67178-67179]
[DOCID:fr20no06-100]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54738; File No. SR-CBOE-2006-91]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by the Chicago Board Options
Exchange, Incorporated To Increase the Class Quoting Limit in the
Option Class Research in Motion

 November 9, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 8, 2006, the Chicago Board Options Exchange, Incorporated
(``CBOE'' 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 CBOE.
The Exchange has designated this proposal as one constituting a stated
policy, practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule under Section
19(b)(3)(A)(i) of the Act,\3\ and Rule 19b-4(f)(1) thereunder,\4\ which
renders the proposal effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(i).
    \4\ 17 CFR 240.19b-4(f)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CBOE proposes to increase the class quoting limit in the option
class Research in Motion (RIMM). The text of the proposed rule change
is available on CBOE's Web site (http://www.cboe.com), at the CBOE's

Office of the Secretary, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the CBOE 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 CBOE 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
    CBOE Rule 8.3A, Maximum Number of Market Participants Quoting
Electronically per Product, establishes class quoting limits (``CQLs'')
for each class traded on the Hybrid Trading System.\5\ A CQL is the
maximum number of quoters that may quote electronically in a given
product and the current levels are established from 25-40, depending on
the trading activity of the particular product.
---------------------------------------------------------------------------

    \5\ See CBOE Rule 8.3A.01.
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    CBOE Rule 8.3A, Interpretation .01(c) provides a procedure by which
the President of the Exchange may increase the CQL for a particular
product. In this regard, the President of the Exchange may increase the
CQL in exceptional circumstances, which are defined in the rule to
include `` * * * substantial trading volume, whether actual or
expected.'' \6\ The effect of an increase in

the CQL is procompetitive in that it increases the number of market
participants that may quote electronically in a product. The purpose of
this filing is to increase the CQL in the option class Research in
Motion (RIMM) from its current limit of 40 to 42.
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    \6\ ``Any actions taken by the President of the Exchange
pursuant to this paragraph will be submitted to the SEC in a rule
filing pursuant to Section 19(b)(3)(A) of the Exchange Act.'' CBOE
Rule 8.3A.01(c).
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    RIMM is one of the most active equity option classes traded on the
Exchange, and consistently ranks among the top classes in national
average daily trading volume. Increasing the CQL in RIMM options will
enable the Exchange to enhance the liquidity offered, thereby offering
deeper and more liquid markets.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations under the Act applicable to a
national securities exchange and, in particular, the requirements of
Section 6(b) of the Act.\7\ Specifically, the Exchange believes the
proposed rule change is consistent with the Section 6(b)(5) \8\
requirements that the rules of an exchange be designed to promote just
and equitable principles of trade, to prevent fraudulent and
manipulative acts and, in general, to protect investors and the public
interest.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Exchange Act.

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

    The Exchange neither received nor solicited written comments on the
proposal.

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

    The foregoing proposed rule change will take effect upon filing
with the Commission pursuant to Section 19(b)(3)(A)(i) of the Act \9\
and Rule 19b-4(f)(1) thereunder,\10\ because it constitutes a stated
policy, practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule.
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    \9\ 15 U.S.C. 78s(b)(3)(A)(i).
    \10\ 17 CFR 240.19b-4(f)(1).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2006-91 on the subject line.

Paper Comments

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

.All submissions should refer to File Number SR-CBOE-2006-91. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the CBOE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-CBOE-2006-91 and should be submitted on or before
December 11, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
[FR Doc. E6-19518 Filed 11-17-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: December 15, 2005 (Volume 70, Number 240)]
[Notices]
[Page 74307-74308]
[DOCID:fr15de05-49]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP00-445-010]

Alliance Pipeline L.P.; Notice of Negotiated Rates

December 7, 2005.
    Take notice that on November 30, 2005, Alliance Pipeline L.P.
(Alliance) tendered for filing as part of its FERC Gas Tariff, the
following tariff sheets, proposed to become effective January 1, 2006:

Original Volume No. 1;
Fifth Revised Sheet No. 11;
Fifth Revised Sheet No. 12;
Fifth Revised Sheet No. 13;
Fifth Revised Sheet No. 14.

    Alliance states that copies of its filing have been mailed to all
customers, state commissions, and other interested parties.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed

docket(s). For assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E5-7358 Filed 12-14-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Notices]
[Pages 63077-63079]
[FR Doc No: 2022-22618]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1298]

Acute Myeloid Leukemia: Developing Drugs and Biological Products
for Treatment; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Acute
Myeloid Leukemia: Developing Drugs

and Biological Products for Treatment.'' This guidance is intended to
assist sponsors in the clinical development of drugs and biological
products for the treatment of acute myeloid leukemia (AML). This
guidance addresses FDA's current thinking regarding the overall
development program and clinical trial designs for the development of
drugs and biological products to support an indication of treatment of
AML, including indications limited to an individual phase of treatment
(for example, maintenance, transplantation preparative regimen, etc.).
The guidance addresses the topics of general drug development, efficacy
endpoints, and exploratory and confirmatory trial considerations for
AML drug development. In addition, the guidance addresses
investigational new drug applications, new drug applications, and
biologics licensing applications for AML drugs. This guidance finalizes
the draft guidance of the same title ``Acute Myeloid Leukemia:
Developing Drugs and Biological Products for Treatment'' issued August
2020.

DATES: The announcement of the guidance is published in the Federal
Register on October 18, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1298 for ``Acute Myeloid Leukemia: Developing Drugs and
Biological Products for Treatment.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002 or Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Donna Przepiorka, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2116, Silver Spring, MD 20993-0002, 301-
796-5358; Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Acute Myeloid Leukemia: Developing Drugs and Biological
Products for Treatment.'' This guidance is intended to assist sponsors
in the clinical development of drugs and biological products for the
treatment of AML. This guidance includes FDA's current thinking
regarding the overall development program and clinical trial designs to
support an indication of treatment of AML, including indications
limited to an individual phase of treatment.
    New classes of drugs are being developed as alternatives to the
standard cytotoxic drugs for the treatment of AML. The following
factors contribute substantially to the complexity of clinical
development programs for such new drugs: the expansion of treatment
intent, broadening of the intended population, and development of a
wide range of new drug classes as alternatives to cytotoxic

drugs. This guidance includes FDA's thinking regarding general drug
development considerations, efficacy endpoints, exploratory and
confirmatory trial considerations, and regulatory submissions for AML
drugs to facilitate the development of new drugs for the treatment of
AML.
    This guidance finalizes the draft guidance entitled ``Acute Myeloid
Leukemia: Developing Drugs and Biological Products for Treatment''
issued August 13, 2020 (85 FR 49383). FDA considered comments received
on the draft guidance as the guidance was finalized. Changes from the
draft to the final guidance include editorial changes, clarifications
of the time frame for marrow sampling and peripheral blood tests to
establish complete remission, the inclusion of marker-negative patients
in studies of targeted therapies, and recommended operating
characteristics for safety-stopping rules.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Acute Myeloid Leukemia: Developing Drugs
and Biological Products for Treatment.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; the collections
of information in 21 CFR part 601 have been approved under 0910-0338;
and the collections of information in 21 CFR 201.56 and 201.57 have
been approved under OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or
https://www.regulations.gov.

    Dated: October 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22618 Filed 10-17-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 11, 2006 (Volume 71, Number 196)]
[Notices]
[Page 59767]
[DOCID:fr11oc06-71]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EG06-70-000]

White Creek Wind I, LLC; Tolling Notice

October 3, 2006.
    White Creek Wind I, LLC (White Creek Wind) filed a notice of self-
certification of exempt wholesale generator (EWG) status in this
proceeding on August 4, 2006. The Commission has determined that
additional information is required to process the notice of self-
certification and therefore cannot process the self-certification
within 60 days from the date of filing, i.e., by October 3, 2006.
Accordingly, the Commission hereby tolls the initial 60-day review
period to allow additional time for submission of the information
within 7 days from the date of this notice. White Creek Wind has
temporary EWG status pursuant to the Commission's regulations. See 18
CFR 366.7(a ) (2006). If the Commission takes no further action within
30 days from the date of this notice, then the self-certification shall
be deemed to have been granted.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-16762 Filed 10-10-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 58 (Monday, March 26, 2018)]
[Rules and Regulations]
[Pages 12856-12857]
[FR Doc No: 2018-06096]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 91

[Docket No. FAA-2018-0243]

``Doors-off'' and ``Open-door'' Flight Prohibition: Emergency
Restriction/Prohibition Order

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notification of Emergency Order of Prohibition.

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SUMMARY: This notification provides Emergency Order of Prohibition No.
FAA-2018-0243, issued March 22, 2018 to all operators and pilots of
flights for compensation or hire with the doors open or removed in the
United States or using aircraft registered in the United States for
doors off flights. The Emergency Order prohibits the use of
supplemental passenger restraint systems that cannot be released
quickly in an emergency in doors off flight operations. It also
prohibits passenger-carrying doors off flight operations unless the
passengers are at all times properly secured using FAA-approved
restraints.

DATES: The Emergency Order of Prohibition is effective March 22, 2018.

FOR FURTHER INFORMATION CONTACT: Jodi Baker, Acting Deputy Director,
Office of Safety Standards, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone:<PHONE_NUMBER>;
email: [email protected].

SUPPLEMENTARY INFORMATION: The full text of Emergency Order of
Prohibition No. FAA-2018-0243, issued March 22, 2018 is as follows:
    This Emergency Order of Prohibition is issued by the Federal
Aviation Administration (FAA) pursuant to 49 U.S.C. 40113(a) and
46105(c). This Order is effective immediately. This order is issued to
all operators and pilots of flights for compensation or hire with the
doors open or removed (hereinafter, ``doors off flights'' or ``doors
off flight operations'') in the United States or using aircraft
registered in the United States for doors off flights. This Order
prohibits the use of supplemental passenger restraint systems (as
defined below) that cannot be released quickly in an emergency in doors
off flight operations. This Order also prohibits passenger-carrying
doors off flight operations unless the passengers are at all times
properly secured using FAA-approved restraints.
    Upon information derived from investigation into a March 11, 2018,
helicopter accident on the East River near New York City, New York, the
Acting Administrator has found that an emergency exists related to
aviation safety and safety in air commerce and requires immediate
action. For more detailed information, see ``Background/Basis for
Order,'' below.

Scope and Effect of This Order

    This order applies to all persons (including, but not limited to,
pilots) conducting doors off flights for compensation or hire in the
United States or using aircraft registered in the United States to
conduct such operations. ``Operate,'' as defined in 14 CFR 1.1, means
to ``use, cause to use or authorize to use'' an aircraft, including the
piloting of an aircraft, with or without right of legal control.
    Supplemental passenger restraint systems, such as the harness
system used by the operator of the helicopter involved in the March 11,
2018, accident, can significantly delay or prevent passengers from
exiting the aircraft in an emergency. Effective immediately, the use of
supplemental passenger restraint systems in doors off flight operations
for compensation or hire is prohibited. The term ``supplemental
passenger restraint system'' means any passenger restraint that is not
installed on the aircraft pursuant to an FAA approval, including (but
not limited to) restraints approved through a Type Certificate,
Supplemental Type Certificate, or as an approved major alteration using
FAA Form 337.
    Persons may operate doors off flights for compensation or hire
involving supplemental passenger restraint systems if the Acting
Administrator has determined that the restraints to be used can be
quickly released by a passenger with minimal difficulty and without
impeding egress from the aircraft in an emergency. The ability of a
passenger to quickly release the restraint with minimal difficulty must
be inherent to the supplemental passenger restraint system. A
supplemental passenger restraint system must not require the use of a
knife to cut the restraint, the use of any other additional tool, or
the assistance of any other person. A supplemental passenger restraint
also must not require passenger training beyond what would be provided
in a pre-flight briefing.
    Applications for a determination as to whether a supplemental
passenger restraint system can be quickly released by a passenger with
minimal difficulty may be submitted to the FAA Aircraft Certification
Service, Policy and Innovation Division, Rotorcraft Standards Branch,
10101 Hillwood Parkway, Ft. Worth, Texas 76177, Attention: Jorge
Castillo, Manager (email: [email protected]; tel:<PHONE_NUMBER>).
The applicant bears the burden of clearly and convincingly
demonstrating that the supplemental passenger restraint system can be
quickly released by a passenger with minimal difficulty and without
impeding egress from the aircraft in an emergency. In reviewing any
such application, the FAA shall consider the design, manufacture,
installation, and operation of the supplemental passenger restraint
system.
    Further, effective immediately, passenger-carrying doors off flight
operations for compensation or hire are

prohibited unless the passengers are at all times properly using FAA-
approved restraints, such as at all times occupying an approved seat or
berth and properly secured with a safety belt and, if installed, a
harness; or at all times secured by an FAA-approved supplemental
passenger restraint system.
    The prohibitions in this Order shall not be construed as
authorizing doors off flight operations without supplemental passenger
restraint systems. The operator of a doors off flight remains
responsible for ensuring the safety of the aircraft and the passengers
on board, and otherwise complying with all statutes, regulations, and
safety standards concerning the flight.

Authority and Jurisdiction

    The FAA Administrator is required to promote the safe flight of
civil aircraft by, among other things, prescribing minimum standards
for practices, methods, and procedures the Administrator finds
necessary for safety in air commerce. 49 U.S.C. 44701(a)(5). The FAA
Administrator has authority to take necessary and appropriate actions
to carry out his aviation safety duties and powers under part A (``Air
Commerce and Safety'') of subtitle VII of Title 49 of the United States
Code, including conducting investigations, issuing orders, and
prescribing regulations, standards, and procedures. 49 U.S.C. 40113(a).
When the Administrator determines that an emergency exists related to
safety in air commerce and requires immediate action, the Administrator
may issue immediately effective orders to meet the emergency. 49 U.S.C.
46105(c).

Background/Basis for Order

    Based on an initial investigation and the reliable and credible
evidence presently available, the Acting Administrator finds that:
    On March 11, 2018, civil aircraft N350LH, an Airbus Helicopters
AS350B2 helicopter, was operated ``doors off'' on a flight in the
vicinity of New York City, New York. All passengers on the flight wore
harness systems that allowed the passengers to move securely within the
helicopter and sit in the door sill while airborne. The harness systems
were provided by the operator to ensure passengers did not fall out of
the helicopter while moving around. Along with the supplemental
passenger restraint systems, the operator provided knives to be used to
cut through the restraints if necessary, and informed the passengers of
the purpose of the knives.
    During the flight, the aircraft experienced a loss of power,
resulting in the aircraft impacting the East River. The aircraft
subsequently rolled over, and all of the passengers perished. The
supplemental passenger restraint systems worn by the passengers, while
intended as a safety measure when the aircraft was in flight, may have
prevented the passengers' quick egress from the aircraft.
    While the fatalities on March 11, 2018, involved an aircraft
impacting the water, passengers could face a similar hazard in other
emergency situations, such as an aircraft fire on the ground.
    Under 49 U.S.C. 46105(c) the Acting Administrator has determined
that an emergency exists related to safety in air commerce. This
determination is based on the threat to passenger safety presented by
the use of supplemental passenger restraint systems not approved by the
FAA, which may prevent a passenger from exiting the aircraft quickly in
an emergency. Accordingly, this Order is effective immediately.

Duration

    This Order remains in effect until the issuance of an applicable
FAA order rescinding or modifying this Order. The Administrator will
issue a rescission order when there is a change in an applicable
statute or federal regulation that supersedes the requirements of this
Order, or the Administrator otherwise determines that the prohibitions
prescribed above are no longer necessary to address an emergency in air
safety or air commerce.
    While this Order remains in effect, the FAA intends to initiate a
rulemaking that addresses operations using supplemental passenger
restraint systems that have not been approved by the FAA.

Consequences of Failure To Comply With This Order

    Any person failing to comply with this Order is subject to a civil
penalty for each flight on which they are found to be in violation. See
49 U.S.C. 46302(a). Small business concerns and individuals (other than
persons serving as an airman) are subject to a civil penalty of up to
$13,066 per flight. See 49 U.S.C. 46301(a)(5)(A)(ii); 14 CFR 13.301.
Other entities are subject to a civil penalty of up to $32,666 per
flight. See 49 U.S.C. 46301(a)(1)(B); 14 CFR 13.301. A person serving
as an airman on a flight operated in violation of this Order is subject
to a civil penalty of up to $1,437 per flight or a certificate action,
up to and including revocation. See 49 U.S.C. 46301(a)(1)(B),
44709(b)(1)(A); 14 CFR 13.301. An air carrier or commercial operator
violating this Order is subject to certificate action, up to and
including revocation. See id. Air tour operators and other persons are
subject to the rescission of any FAA-issued waiver or letter of
authorization. Any person failing to comply with this Order may be
subject to a cease and desist order or a civil action in a United
States district court to ensure compliance. See 49 U.S.C. 44103(a),
46106.

Right To Review

    Pursuant to 49 U.S.C. 46110(a), a person with a substantial
interest in this order ``may apply for review of the order by filing a
petition for review in the United States Court of Appeals for the
District of Columbia Circuit or in the court of appeals of the United
States in the circuit in which the person resides or has its principal
place of business.'' The petition must be filed within 60 days after
the date of this order. 49 U.S.C. 46110(a).

Emergency Contact Official

    Direct any questions concerning this Emergency Order of
Prohibition, to Jodi Baker, Acting Deputy Director, Office of Safety
Standards, Federal Aviation Administration, 800 Independence Avenue SW,
Washington, DC 20591 (email: [email protected]; Tel:<PHONE_NUMBER>).

    Issued in Washington, DC on March 22, 2018.
Daniel K. Elwell,
Acting Administrator.
[FR Doc. 2018-06096 Filed 3-22-18; 4:15 pm]
BILLING CODE 4910-13-P


on several factors: First, the dose available to the skin tissue
resulting from a topically applied drug product can be much higher than
that from a dose resulting from systemic exposure. In addition,
systemic exposure to the parent drug and metabolites can differ
significantly in topically applied products compared to orally
administered products because the skin has its own metabolic
capability, and the first-pass metabolism, which is available following
oral exposure, is bypassed in the topical route of administration. As
was explained in the 2013 Consumer Wash PR, we reiterate here that
short-term dermal toxicity studies do not meet the chronic duration
requirement for a given drug to cause an increase in the carcinogenic
potential resulting from a lifelong exposure to a drug, such as
triclosan, which is used by consumers from various products over a
lifetime. In addition, we note that the 13-week dermal toxicity study
showed dose-related dermal adverse effects, which further amplifies the
need to evaluate longer term toxicity studies, such as the 2-year
dermal carcinogenicity bioassay. A dermal carcinogenicity study is
currently ongoing at NCTR but has not been completed at this time.
Although this ongoing study may provide important information on
triclosan, there are still other missing data gaps for triclosan for
which information has not been submitted and no interested parties have
committed to filling these data gaps. In sum, no new data or
information were submitted to the docket to fill the dermal
carcinogenicity safety data gap for triclosan.
d. Hormonal Effects
    In the 2013 Consumer Wash PR, we stated that recent studies have
demonstrated that triclosan showed effects on the thyroid, estrogen,
and testosterone systems in several animal species, including mammals,
the implications of which on human health, especially for children, are
still not well understood (78 FR 76444 at 76468).
    (Comment 35) One comment stated that the Organisation for Economic
Co-operation and Development (OECD) TG 443 extended one-generation
reproductive toxicity assay provides an alternative to animal studies
and includes endocrine-sensitive endpoints. The comment asserted that
the OECD TG 443 study design allows for investigation of developmental
toxicity, developmental immunotoxicity, or developmental neurotoxicity
in the same study, and that non-animal methods, when used in an
integrated system, can provide embryotoxicity and teratogenicity
information. The comment also referenced several other non-animal
assays that were conducted to assess the reproductive toxicity
potential for triclosan.

    (Response 35) We reviewed all available data on the hormonal
effects of triclosan, including those generated from the extended one-
generation reproductive toxicity assay mentioned previously in this
document. We also reviewed the previously conducted studies for
triclosan (general toxicity and reproductive toxicity) where
reproductive toxicity endpoints were evaluated; however, we note that
the previously conducted studies were not designed to investigate
specific endpoints for evaluating the hormonal effects of triclosan,
especially with respect to the thyroid findings. In terms of the
alternative animal model argument, it is possible that in some
instances that non-animal assays, such as those referenced in comment
35, can be used to explore potential DART findings for a new chemical
entity. However, in the case of triclosan, there are many in vivo
studies that have assessed DART endpoints, thus making the reliance on
findings from the referenced non-animal assays unnecessary.
    (Comment 36) Several other comments asserted that the existing
database of in vitro and in vivo animal and human studies does not
support a conclusion that triclosan causes hormonal effects in humans
at actual relevant exposure concentrations. The comments asserted that
the reports of high throughput screening and animal studies showing
thyroid or other hormonal activity demonstrated conflicting results for
the effects of triclosan on various hormonal endpoints (androgen-,
estrogen-, and thyroid-related toxicity). One comment also argued that
additional testing for potential hormonal effects is not justified
because of the existence of adequate reproductive toxicity data that,
given the doses used, endpoints measured and study duration, should
have detected a potential for the indication of biologically
significant androgen-, estrogen-, or thyroid-related toxicity if such
toxicity occurred. The comment maintained that available in vitro high
throughput screen information on these endpoints fails to indicate a
justifiable level of concern.
    (Response 36) We agree that some data for hormonal effects for
triclosan can be gleaned from previously conducted studies (chronic
toxicity, DART, and multigenerational studies). Although we concur that
the previously conducted toxicology and reproductive studies can be
useful, we note that the previously conducted studies were not designed
to investigate specific endpoints for evaluating the hormonal effects
of triclosan. In particular, the effects of triclosan on the thyroid
gland during critical windows of growth and development when subtle
functional and/or histopathologic changes are taking place could result
in disturbing the normal homeostasis of the organism; for example,
whether long-term exposure to triclosan is associated with an adverse
impact on the growth or neurobehavioral aspects of animals treated
during critical windows of development is currently unknown.
    We have evaluated the recently published articles in the literature
reporting on the endocrine effects of triclosan in mammalian species.
Data available to date do not provide conclusive evidence regarding the
effects of triclosan on the levels of estrogen, androgen, and thyroid
hormones and whether a link between the hormonal effects and the
biologically relevant outcomes on the tested animal model can be drawn.
Although no significant findings were noted for reproductive endpoints,
the thyroid gland may be a potential target for triclosan in animals
exposed to high doses of triclosan. The reported findings in the
thyroid included a dose dependent decrease in the levels of some
thyroid hormones in the rat model (T3 & T4) (Ref.
69). This observation was seen in pubertal males and females, in
pregnant dams and their pre-weaned exposed pups, as well as in young
male and female rats (up to day 53 postpartum age). It is also
important to note that the available rat studies for which the thyroid
effects were investigated in detail only covered a short duration (up
to 30 days of exposure). These changes seen in thyroid hormone levels
in the rat do not necessarily predict a similar scenario in humans
because of differences in the physiology and metabolic characteristics
that triclosan imparts on the hormonal homeostasis in the two species.
Based on the available data, a conclusion regarding the significance of
the thyroid findings in the rat to that in humans cannot be made. Using
a weight-of-evidence approach for the thyroid findings, we find that no
further nonclinical data are recommended for the characterization of
potential hormonal effects of triclosan in humans. Available in vitro
and in vivo animal studies cannot be used to predict a potential human
hormonal signal. Clinical studies may be better able to evaluate the
effects of triclosan on the endocrine system in humans.
e. Resistance
    (Comment 37) Comments from a manufacturer of consumer antiseptic
products containing triclosan asserted that there is no proof of
triclosan resistance or confirmation that triclosan/antibiotic cross-
resistance is becoming a problem in the real world. The comment also
noted that although bacteria can develop reduced susceptibilities to
triclosan in the laboratory, the level of sensitivity is still well
below the at-use concentration. However, other comments disagreed and
argued that recent studies provide evidence of the development of
resistance to triclosan (Refs. 29 and 30).
    (Response 37) We agree that currently there is no evidence of
bacterial resistance to actual-use concentrations of triclosan.
However, bacterial exposure to triclosan is not limited to actual-use
concentrations. In a natural setting, bacteria are exposed to sublethal
concentrations of the antiseptic active ingredient that can trigger the
expression of bacterial resistance mechanisms. The European
Commission's Subcommittee on Consumer Safety noted that there are
environmental concentrations of triclosan in a number of geographically
distinct areas that were high enough to suggest that this triggering of
bacterial resistance could occur (Ref.70). Furthermore, as previously
discussed, there are data that document the existence of numerous
bacterial resistance mechanisms to triclosan, and there is some
expression of these mechanisms in the natural microbial populations.
Although the available studies do not prove definitively that
triclosan/antibiotic resistance currently poses a public health risk,
they do suggest that susceptibility to triclosan may be decreasing.
Data are not currently available to assess the magnitude of this risk
that triclosan poses for the development of resistance. As we stated in
the in the 2013 Consumer Wash PR, data to clarify the relevance of
antimicrobial resistance laboratory findings to the consumer setting
would be necessary to determine the GRAS status of triclosan.
f. Other Issues
    (Comment 38) Several comments expressed concern that antiseptic
chemicals, including triclosan, are contaminating waterways and aquatic
wildlife, and are having a negative impact on the wastewater treatment
process and the environment. The comments supported restrictions on the
use of triclosan in consumer antiseptic washes and urged FDA and EPA to
coordinate their evaluation of chemicals like triclosan to better
protect human health and the environment, as well as protect the
wastewater treatment process.

    (Response 38) We do not address these comments in this final rule
because they are outside the scope of this rulemaking. We note,
however, that we have conferred with EPA, wherever there were issues in
common between the two Agencies (e.g., some of the animal toxicology
studies were independently reviewed by both EPA and FDA), at various
stages of the antiseptic proceedings on matters applicable to these
rulemakings.
    In sum, the total available data regarding the safety profile of
triclosan do not contain sufficient information to find that triclosan
is GRAS for use in consumer antiseptic wash products. Moreover, we
reviewed studies submitted in the comments to support efficacy for
triclosan. These studies are not designed as adequate and well-
controlled clinical outcome studies and are not sufficient to determine
the GRAE status of triclosan as a topical antiseptic. Moreover, these
studies lack an adequate vehicle or placebo controls, which makes it
difficult to determine the contribution of antiseptic hand wash
implementation to reduction of methicillin-resistance Staphylococcus
aureus infections. Thus, we find that insufficient data were submitted
to the docket to demonstrate the effectiveness of triclosan for use as
a consumer antiseptic wash product. Therefore, triclosan is not GRAS/
GRAE for use in consumer antiseptic wash products.

F. Comments on the Preliminary Regulatory Impact Analysis and FDA
Response

    (Comment 39) Several comments raised issues concerning the
preliminary regulatory impact analysis and the Agency's assessment of
the net benefit of the rulemaking.
    (Response 39) Our response is provided in the full discussion of
economic impacts, available in the docket for this rulemaking (Docket
No. 1975-N-0012, http://www.regulations.gov) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

IV. Ingredients Not Generally Recognized as Safe and Effective

    In addition to the individual active ingredients discussed in
section III.E, no additional safety or effectiveness data have been
submitted to support a GRAS/GRAE determination for the remaining
consumer antiseptic wash active ingredients. Thus, the following active
ingredients are not GRAS/GRAE for use as a consumer antiseptic wash:

 Cloflucarban
 Fluorosalan
 Hexachlorophene
 Hexylresorcinol
 Iodophors (Iodine-containing ingredients)
    [cir] Iodine complex (ammonium ether sulfate and polyoxyethylene
sorbitan monolaurate)
    [cir] Iodine complex (phosphate ester of alkylaryloxy polyethylene
glycol)
    [cir] Nonylphenoxypoly (ethyleneoxy) ethanoliodine
    [cir] Poloxamer--iodine complex
    [cir] Povidone-iodine 5 to 10 percent
    [cir] Undecoylium chloride iodine complex
 Methylbenzethonium chloride
 Phenol (greater than 1.5 percent)
 Phenol (less than 1.5 percent)
 Secondary amyltricresols
 Sodium oxychlorosene
 Tribromsalan
 Triclocarban
 Triclosan
 Triple dye

    Accordingly, OTC consumer antiseptic wash drug products containing
these active ingredients are misbranded, and are new drugs for which
approved new drug applications are required for marketing.

V. Effective Date

    In the 2013 Consumer Wash PR, we recognized, based on the scope of
products subject to this final rule, that manufacturers would need time
to comply with this final rule. Thus, as proposed in the 2013 Consumer
Wash PR (78 FR 76444 at 76470), this final rule will be effective 1
year after the date of the final rule's publication in the Federal
Register. On or after that date, any OTC consumer antiseptic wash drug
product containing an ingredient that we have found in this final rule
to be not GRAS/GRAE or to be misbranded, cannot be initially introduced
or initially delivered for introduction into interstate commerce unless
it is the subject of an approved new drug application.

VI. Economic Analysis of Impacts

    The summary analysis of benefits and costs included in this final
rule is drawn from the detailed Regulatory Impact Analysis that is
available at http://www.regulations.gov, Docket No. FDA-1975-N-0012
(formerly Docket No. 1975N-0183H).

A. Introduction

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The Office of Management and
Budget (OMB) has determined that this final rule is a significant
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because a majority of firms that will be affected by this
rule are defined as small businesses, we find that the final rule will
have a significant economic impact on a substantial number of small
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $146
million, using the most current (2015) Implicit Price Deflator for the
Gross Domestic Product. This final rule would result in an expenditure
in any year that meets or exceeds this amount.

B. Summary of Costs and Benefits

    As discussed in the preamble of this final rule, this rule
establishes that 19 active ingredients, including triclosan and
triclocarban, are not generally recognized as safe and effective and
are misbranded for use in OTC consumer antiseptic washes. Regulatory
action is being deferred on three active ingredients that were included
in the 2013 Consumer Wash PR: Benzalkonium chloride, benzethonium
chloride, and chloroxylenol. The costs and benefits of the final rule
are summarized in table 3, entitled Economic Data: Costs and Benefits
Statement. As table 3 shows, the primary estimated benefits come from
reduced exposure to antiseptic active ingredients by 2.2 million pounds
per year. We note that triclosan and triclocarban, are the most widely
used OTC consumer antiseptic wash active ingredients on the market,
based on available data, thus, our analysis focuses

on these two products. Using the primary estimates, the combined total
consists of a reduction in triclosan exposure by 799,426 pounds per
year, and triclocarban exposure by 1.4 million pounds per year.
Limitations in the available data characterizing the health effects
resulting from widespread long-term exposure to these ingredients
prevent us from translating the estimated reduced exposure into
monetary equivalents of health effects.
    The primary estimate of costs annualized over 10 years is
approximately $23.6 million at a 3 percent discount rate and $27.6
million at a 7 percent discount rate. These costs consist of total one-
time costs of relabeling and reformulation ranging from $106.3 to
$402.8 million. Under the final rule, we estimate that each pound of
reduced exposure to antiseptic active ingredients will cost $12.97 to
$14.28 at a 3 percent discount rate and $16.36 to $18.02 at a 7 percent
discount rate.

                                                  Table 3--Economic Data: Costs and Benefits Statement
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Economic Data: Costs and Benefits Statement
---------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Primary                                                      Discount rate
             Category                 estimate      Low  estimate  High  estimate   Year  dollars        (%)        Period covered          Notes
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Benefits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Monetized $millions/    ..............  ..............  ..............  ..............               7  Annual.
 year.                             ..............  ..............  ..............  ..............               3  Annual.........
Annualized Quantified............       2,197,737         989,856       3,405,619  ..............               7  Annual.........  Reduced antiseptic
                                        2,197,737         989,856       3,405,619  ..............               3  Annual.........   active ingredient
                                                                                exposure (in
                                                                                pounds).
Qualitative                        ..............  ..............  ..............  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Monetized $millions/              27.6            14.1            53.6            2014               7  Annual.........  Annualized costs of
 year.                                       23.6            12.1            45.8            2014               3  Annual.........   relabeling and
                                                                                reformulation.
                                                                                Range of estimates
                                                                                captures
                                                                                uncertainty.
Annualized Quantified............  ..............  ..............  ..............  ..............               7
                                   ..............  ..............  ..............  ..............               3
Qualitative                        ..............  ..............  ..............  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Transfers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federal Annualized Monetized       ..............  ..............  ..............  ..............               7  ...............  None.
 $millions/year.                   ..............  ..............  ..............  ..............               3  ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To..........................  From:
                                   To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Annualized Monetized         ..............  ..............  ..............  ..............               7
 $millions/year.                   ..............  ..............  ..............  ..............               3
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To..........................  From:
                                   To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                        State, Local, or Tribal Government: Not applicable.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Small Business
--------------------------------------------------------------------------------------------------------------------------------------------------------
     Annual cost per affected small entity estimated as $0.11-$0.41 million, which will represent 0.28-1.10 percent of annual
                                                            shipments.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Wages: No estimated effect.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Growth: No estimated effect.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The full analysis of economic impacts is available in the docket
for this final rule (Docket No. FDA-1975-N-0012) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore,
clearance by OMB under the Paperwork Reduction Act of 1995 is not
required.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.31(a) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an

environmental impact statement is required.

IX. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires agencies to ``construe . . . a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' The sole statutory provision giving preemptive
effect to the final rule is section 751 of the FD&C Act (21 U.S.C.
379r). We have complied with all of the applicable requirements under
the Executive order and have determined that the preemptive effects of
this rule are consistent with Executive Order 13132.

X. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified all Web site addresses as of the date of this document, but
Web sites are subject to change over time.

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Nonprescription Drugs and Anti-Infective Drugs Advisory Committees,
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2. Comment submitted in Docket No. FDA-1975-N-0012, available at
http://www.regulations.gov with Comment No. FDA-1975-N-0012-0081.
3. Transcript of the March 23, 2005, Nonprescription Drugs Advisory
Committee. Available at http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4184T1.pdf.
4. Transcript of the October 20, 2005, Meeting of the
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5. Summary Minutes of the November 14, 2008, Feedback Meeting with
Personal Care Products Council and Soap and Detergent Association,
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6. Transcript of the September 3, 2014, Meeting of the
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25. Buffet-Bataillon, S., et al., ``Molecular Mechanisms of Higher
MICs of Antibiotics and Quaternary Ammonium Compounds for
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26. Guo, W., et al., ``Resistant Mechanism Study of Benzalkonium
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27. Bore, E., et al., ``Adapted Tolerance to Benzalkonium Chloride
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28. Morrissey, I., et al., ``Evaluation of Epidemiological Cut-Off
Values Indicates that Biocide Resistant Subpopulations are Uncommon
in Natural Isolates of Clinically-Relevant Microorganisms,'' PLOS
One, 9(1): p. e86669, 2014. Available at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0086669.
29. Copitch, J. L., R. N. Whitehead, and M. A. Webber, ``Prevalence
of Decreased Susceptibility to Triclosan in Salmonella enterica
Isolates from Animals and Humans and Association with Multiple Drug
Resistance,'' International Journal of Antimicrobial Agents, 36(3):
p. 247-51, 2010. Available at http://www.ncbi.nlm.nih.gov/pubmed/20541914.
30. Skovgaard, S., et al., ``Staphylococcus epidermidis Isolated in
1965 Are More Susceptible to Triclosan than Current Isolates,'' PLOS
One, 8(4): p. e62197, 2013. Available at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0062197.
31. Cole, E. C. et al., ``Investigation of Antibiotic and
Antibacterial Susceptibility and Resistance in Staphylococcus from
the Skin of Users and Non-users of Antibacterial Wash Products in
Home Environments,'' International Journal of Microbiology Research
3 (2): p 90-96, 2003. Available at http://www.bioinfopublication.org/files/articles/3_2_4_IJMR.pdf.
32. Lear, J. C., ``Chloroxylenol- and Triclosan-Tolerant Bacteria
from Industrial Sources--Susceptibility to Antibiotics and Other
Biocides,'' International Biodeterioration and Biodegradation, 2006.
Available at http://www.sciencedirect.com/science/article/pii/S096483050500137X.
33. Lear, J. C., et al., ``Chloroxylenol- and Triclosan-Tolerant
Bacteria from Industrial Sources,'' Journal of Industrial
Microbiology and Biotechnology, 29(5): p. 238-42, 2002. Available at
http://link.springer.com/article/10.1038/sj.jim.7000320#page-1.
34. Aiello, A. E., et al., ``Relationship Between Triclosan and
Susceptibilities of Bacteria Isolated from Hands in the Community,''
Antimicrobial Agents and Chemotherapy, 48(8): p. 2973-9, 2004.
Available at http://aac.asm.org/content/48/8/2973.full.pdf+html.
35. Aiello, A. E., et al., ``Antibacterial Cleaning Products and
Drug Resistance,'' Emerging Infectious Diseases, 11(10): p. 1565-70,
2005. Available at http://www.thelancet.com/pdfs/journals/laninf/PIIS1473-3099(03)00723-0.pdf.
36. Cole, E. C., et al., ``Investigation of Antibiotic and
Antibacterial Agent Cross-Resistance in Target Bacteria From Homes
of Antibacterial Product Users and Nonusers,'' Journal of Applied
Microbiology, 95(4): p. 664-676, 2003. Available at http://www.ncbi.nlm.nih.gov/pubmed/12969278.
37. Marshall, B. M., et al., ``The Frequency of Antibiotic-Resistant
Bacteria in Homes Differing in Their Use of Surface Antibacterial
Agents,'' Current Microbiology, 65(4): p. 407-15, 2012. Available at
http://www.ncbi.nlm.nih.gov/pubmed/22752336.
38. Carson, R. T., et al., ``Use of Antibacterial Consumer Products
Containing Quaternary Ammonium Compounds and Drug Resistance in the
Community,'' Journal of Antimicrobial Chemotherapy, 62(5): p. 1160-
2, 2008. Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Carson+RT%2C+Larson+E%2C+Levy+SB%2C+Marshall+BM%2C+Aiello+AE.
39. Coelho, J. R., et al., ``The Use of Machine Learning
Methodologies to Analyse Antibiotic and Biocide Susceptibility in
Staphylococcus aureus,'' PLOS One, 8(2): p. e55582, 2013. Available
at http://www.ncbi.nlm.nih.gov/pubmed/?term=Coelho+JR%2C+Carri%C3%A7o+JA%2C+Knight+D%2C+Mart%C3%ADnez+JL%2C+Morrissey+I%2C+Oggioni+MR%2C+Freitas+AT.
40. Braoudaki, M. and A. C. Hilton, ``Adaptive Resistance to
Biocides in Salmonella enterica and Escherichia coli O157 and Cross-
Resistance to Antimicrobial Agents,'' Journal of Clinical
Microbiology, 42(1): p. 73-8, 2004. Available at http://www.ncbi.nlm.nih.gov/pubmed/14715734.
41. Brenwald, N. P. and A. P. Fraise, ``Triclosan Resistance in
Methicillin-Resistant Staphylococcus aureus (MRSA),'' Journal of
Hospital Infections, 55(2): p. 141-4, 2003. Available at http://www.ncbi.nlm.nih.gov/pubmed/14529640.
42. Langsrud, S., G. Sundheim, and A. L. Holck, ``Cross-Resistance
to Antibiotics of Escherichia coli Adapted to Benzalkonium Chloride
or Exposed to Stress-Inducers,'' Journal of Applied Microbiology,
96(1): p. 201-8, 2004. Available at http://www.ncbi.nlm.nih.gov/pubmed/14678175.
43. Birosova, L. and M. Mikulasova, ``Development of Triclosan and
Antibiotic Resistance in Salmonella enterica serovar Typhimurium,''
Journal of Medical Microbiology, 58(Pt. 4): p. 436-41, 2009.
Available at http://www.ncbi.nlm.nih.gov/pubmed/19273638.
44. Joynson, J. A., B. Forbes, and R. J. Lambert, ``Adaptive
Resistance to Benzalkonium Chloride, Amikacin and Tobramycin: The
Effect on Susceptibility to Other Antimicrobials,'' Journal of
Applied Microbiology, 93(1): p. 96-107, 2002. Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Joynson+JA%2C+Forbes+B%2C+Lambert+RJ.
45. International Conference on Harmonization S1B. Available at
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S1B/Step4/S1B_Guideline.pdf.
46. Guidance for IndustryS1B Testing for Carcinogenicity of
Pharmaceuticals. Available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm074916.pdf.
47. Citizen Petition submitted by Comprehensive Technology Center,
FDA Docket No. 1996-P-0205-005, Aug. 9, 1996. Available at https://www.regulations.gov/document?D=FDA-1996-P-0205-0001.
48. ``NTP Toxicology and Carcinogenesis Studies of 4-Hexylresorcinol
(CAS No. 136-77-6) in F344/N Rats and B6C3F1 Mice (Gavage
Studies),'' National Toxicology Program Technical Rep Series, 330:
p. 1-166, 1988. Available at http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr300399/abstracts/tr330/index.html.
49. Schreier, H., et al., ``Molecular Effects of Povidone-Iodine on
Relevant Microorganisms: An Electron-Microscopic and Biochemical
Study,'' Dermatology, 195 Suppl 2: p. 111-6, 1997. Available at
http://www.ncbi.nlm.nih.gov/pubmed/9403268.
50. Reimer, K., et al., ``Antimicrobial effectiveness of povidone-
iodine and consequences for new application areas,'' Dermatology,
204 Suppl 1: p. 114-20, 2002. Available at http://www.ncbi.nlm.nih.gov/pubmed/12011534.
51. Durani, P. and D. Leaper, ``Povidone-Iodine: Use in Hand
Disinfection, Skin Preparation and Antiseptic Irrigation,''
International Wound Journal, 5(3): p. 376-87, 2008. Available at
http://www.ncbi.nlm.nih.gov/pubmed/18593388.
52. Barabas, E. G. and H. G. Brittain., ``Povidone-Iodine in 25
Analytical Profiles and Excipients--Volume 25,'' Academic Press,
Inc., 25: p. 341-387, 1998. Available at https://books.google.com/books?id=kia7bq8EM9IC&pg=PA341&lpg=PA341&dq=Barabas;+Povidone-
Iodine+in+25+Analytical+Profiles+and+

Excipients%E2%80%94Volume+25,%E2%80%9D+Academic+Press,+Inc&source=bl&
ots=ba5Vqlsbem&sig=z87Vk2drikzKZ9cVuO4ZhAxoZYI&hl=en&sa=X&ved=0ahUKEw
iz177BtYfOAhWCGT4KHTQ7BSoQ6AEIHjAA#v=onepage&q=Barabas%3B%20Povidone-
Iodine%20in%2025%20Analytical%20Profiles%20and%20Excipients%E2%80%94V
olume%2025%2C%E2%80%9D%20Academic%20Press%2C%20Inc&f=false.
53. Michel, D. and G. A. Zach, ``Antiseptic Efficacy of Disinfecting
Solutions in Suspension Test in vitro Against Methicillin-Resistant
Staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli
in Pressure Sore Wounds After Spinal Cord Injury,'' Dermatology, 195
Suppl 2: p. 36-41, 1997. Available at http://www.karger.com/Article/PDF/246028.
54. Block, C., et al., ``Evaluation of Chlorhexidine and Povidone
Iodine Activity Against Methicillin-Resistant Staphylococcus aureus
and Vancomycin-Resistant Enterococcus faecalis Using a Surface
Test,'' Journal of Hospital Infections, 46(2): p. 147-52, 2000.
Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Evaluation+of+chlorhexidine+and+povidone+iodine+activity+against+methicillin-resistant+Staphylococcus+aureus+and+vancomycin-resistant+Enterococcus+faecalis+using+a+surface+test.
55. Block, S. S., ``Disinfection, Sterilization, and Preservation,''
Philadelphia: Lippincott Williams & Wilkins, 2001. Available at.
Available at https://books.google.com/books?id=3f-kPJ17_TYC&printsec=frontcover&dq=Disinfection,+Sterilization,+and+Preservation&hl=en&sa=X&ved=0ahUKEwiNxurX6JHOAhWTix4KHVcKDKcQ6AEIHjAA#v=onepage&q=Disinfection%2C%20Sterilization%2C%20and%20Preservation&f=false.
56. Houang, E. T., et al., ``Absence of Bacterial Resistance to
Povidone Iodine,'' Journal of Clinical Pathology, 29(8): p. 752-5,
1976. Available at http://jcp.bmj.com/content/29/8/752.long.
57. Prince, H. N., et al., ``Drug resistance studies with topical
antiseptics,'' Journal of Pharmaceutical Sciences, 67(11): p. 1629-
31, 1978. Available at http://www.ncbi.nlm.nih.gov/pubmed/712607.
58. Panlilio, A. L., et al., ``Infections and pseudoinfections due
to povidone-iodine solution contaminated with Pseudomonas cepacia,''
Clinical Infectious Diseases, 14(5): p. 1078-83, 1992. Available at
http://www.jstor.org/stable/4456469?seq=1#page_scan_tab_contents.
59. Jarvis, W. R., ``Nosocomial Outbreaks: The Centers for Disease
Control's Hospital Infections Program Experience, 1980-1990.
Epidemiology Branch, Hospital Infections Program,'' American Journal
of Medicine, 91(3B): p. 101S-106S, 1991. Available at http://www.ncbi.nlm.nih.gov/pubmed/1656744.
60. Prevention, CDC, ``Contaminated Povidone-Iodine Solution--
Texas,'' in Morbidity and Mortality Weekly Report, p. 133-4, 1989.
Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/00001358.htm.
61. Berkelman, R. L., et al., ``Pseudobacteremia Attributed to
Contamination of Povidone-Iodine with Pseudomonas cepacia,'' Annals
of Internal Medicine, 95(1): p. 32-6, 1981. Available at http://annals.org/article.aspx?articleid=694897.
62. Craven, D. E., et al., ``Pseudobacteremia Caused by Povidone-
Iodine Solution Contaminated with Pseudomonas cepacia,'' New England
Journal of Medicine, 305(11): p. 621-3, 1981. Available at http://www.nejm.org/doi/full/10.1056/NEJM198109103051106.
63. Triclocarban (TCC) Consortium, Soap and Detergent Association.
IUCLID Data Set: Triclocarban. December 12, 2002. Available at
http://www.aciscience.org/docs/Triclocarban_HPV_Robust_Study_Summaries.pdf.
64. Sutherland, V., ``NTP Research Concept: Triclocarban.''
Available at http://ntp.niehs.nih.gov/ntp/about_ntp/bsc/2014/june/triclocarban_concept_508.pdf, 2014.
65. Scientific Committee on Consumer Products (SCCP) opinion on
Triclosan COLIPA n[deg] P32. Available at http://ec.europa.eu/health/archive/ph_risk/committees/04_sccp/docs/sccp_o_166.pdf.
66. Addendum to the SCCP Opinion on Triclosan. Available at http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_054.pdf.
67. Registered substances. Available at http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances.
68. Fang, J. L., et al., ``Absorption and Metabolism of Triclosan
After Application to the Skin of B6C3F1 Mice,'' Environmental
Toxicology, 2014. Avilable at http://www.ncbi.nlm.nih.gov/pubmed/?term=Absorption+and+metabolism+of+triclosan+after+application+to+the+skin+of+B6C3F1+mice.
69. Crofton, K. M., et al., ``Short-Term in vivo Exposure to the
Water Contaminant Triclosan: Evidence for Disruption of Thyroxine,
'' Environmental Toxicology and Pharmacology, 24(2): p. 194-7, 2007.
Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Short-term+in+vivo+exposure+to+the+water+contaminant+triclosan%3A+Evidence+for+disruption+of+thyroxine.
70. European Commission Scientific Committee on Consumer Safety,
Final Opinion on Triclosan (Antimicrobial Resistance), cited March
24, 2016, available at http://ec.europa.eu/health/scientific_committees/consumer_safety/index_en.htm.

List of Subjects in 21 CFR Part 310

    Administrative practice and procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
310 is amended as follows:

PART 310--NEW DRUGS

0
1. The authority citation for part 310 is revised to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f,
360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-l; 42 U.S.C.
216, 241, 242(a), 262.

0
2. In Sec.  310.545, add paragraphs (a)(27)(iii) and (iv) and (d)(41),
and remove from paragraph (d) introductory text the number ``(39)'' and
add in its place the number ``(41)'' to read as follows:

Sec.  310.545  Drug products containing certain active ingredients
offered over-the-counter (OTC) for certain uses.

    (a) * * *
    (27) * * *
    (iii) Consumer antiseptic hand wash drug products. Approved as of
September 6, 2017.

Cloflucarban
Fluorosalan
Hexachlorophene
Hexylresorcinol
Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan
monolaurate)
Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
Methylbenzethonium chloride
Nonylphenoxypoly (ethyleneoxy) ethanoliodine
Phenol (greater than 1.5 percent)
Phenol (less than 1.5 percent)
Poloxamer iodine complex
Povidone-iodine (5 to 10 percent)
Secondary amyltricresols
Sodium oxychlorosene
Tribromsalan
Triclocarban
Triclosan
Triple Dye
Undecoylium chloride iodine complex

    (iv) Consumer antiseptic body wash drug products. Approved as of
September 6, 2017.

Cloflucarban
Fluorosalan
Hexachlorophene
Hexylresorcinol
Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
Iodine tincture
Methylbenzethonium chloride
Nonylphenoxypoly (ethyleneoxy) ethanoliodine
Phenol (greater than 1.5 percent)

Phenol (less than 1.5 percent)
Poloxamer iodine complex
Povidone-iodine (5 to 10 percent)
Secondary amyltricresols
Sodium oxychlorosene
Tribromsalan
Triclocarban
Triclosan
Triple Dye
Undecoylium chloride iodine complex
* * * * *
    (d) * * *
    (41) September 6, 2017, for products subject to paragraph
(a)(27)(iii) or (iv) of this section.

    Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21337 Filed 9-2-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 80 (Friday, April 24, 2020)]
[Proposed Rules]
[Pages 22970-22972]
[FR Doc No: 2020-08644]

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

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0411; Product Identifier 2018-SW-061-AD]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Leonardo S.p.a. (Leonardo) Model A119 and AW119MKII
helicopters. This proposed AD would require repetitive borescope
inspections of the tail rotor gearbox (TGB) and depending on the
inspection results, removing the TGB from service. This proposed AD was
prompted by reports of corrosion on the internal surface of the 90-
degree TGB output shaft. The actions of this proposed AD are intended
to address an unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by June 23,
2020.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to https://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0411; 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 proposed AD, the European Union Aviation Safety Agency (previously
European Aviation Safety Agency) (EASA) AD, any comments received, and
other information. The street address for Docket Operations is listed
above. Comments will be available in the AD docket shortly after
receipt.
    For service information identified in this proposed rule, contact
Leonardo S.p.a. Helicopters, Emanuele Bufano, Head of Airworthiness,
Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone
+39-0331-225074; fax +39-0331-229046; or at https://www.leonardocompany.com/en/home. You may view the referenced service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Rao Edupuganti, Aviation Safety
Engineer, Regulations and Policy Section, Rotorcraft Standards Branch,
FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone 817-222-
5110; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to participate in this rulemaking by submitting
written comments, data, or views. The FAA also invites comments
relating to the economic, environmental, energy, or federalism impacts
that might result from adopting the proposals in this document. The
most helpful comments reference a specific portion of the proposal,
explain the reason for any recommended change, and include supporting
data. To ensure the docket does not contain duplicate comments,
commenters should send only one copy of written comments, or if
comments are filed electronically, commenters should submit only one
time.
    The FAA will file in the docket all comments received, as well as a
report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal,
the FAA will consider all comments received on or before the closing
date for comments. The FAA will consider comments filed after the
comment period has closed if it is possible to do so without incurring
expense or delay. The FAA may change this proposal in light of the
comments received.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2018-0156, dated July 24, 2018
(EASA AD 2018-0156) to correct an unsafe condition for Leonardo
(formerly Finmeccanica S.p.A., AgustaWestland S.p.A., Agusta S.p.A.;
and AgustaWestland Philadelphia Corporation, formerly Agusta Aerospace
Corporation) Model A119 and AW119MKII helicopters with 90-degree TGB
part number (P/N) 109-0440-06-101 or P/N 109-0440-06-105 having serial
number 167, 169 through 172 inclusive, 215 through 225 inclusive, 227,
230, 232, 233, AW268, K3, K16, M47, or L29, installed. EASA advises of
two reported occurrences of corrosion on the internal surface of the
90-degree TGB shaft installed on Model A119 helicopters. Further
analysis identified a specific batch of parts that may be susceptible
to similar conditions. Due to design similarity, Model AW119MKII
helicopters are also affected.
    EASA states that this condition, if not detected and corrected,
could lead to failure of the tail rotor, possibly resulting in reduced
control of the helicopter. Accordingly, EASA AD 2018-0156 requires
performing repetitive endoscope inspections on the internal surface of
the 90-degree TGB output shaft for corrosion and depending on the
findings, replacing the TGB. EASA further states EASA AD 2018-0156 is
considered an interim action and further AD action may follow.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA is proposing this AD
after evaluating all known relevant information and determining that an
unsafe condition is

likely to exist or develop on other helicopters of the same type
designs.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Leonardo Helicopters Alert Service Bulletin No.
119-090, dated July 23, 2018, for Model A119 and AW119MKII helicopters,
which contains procedures for conducting an endoscope inspection of the
internal surface of the 90-degree TGB output shaft for corrosion. This
service information also specifies replacing the TGB if corrosion is
found.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Proposed AD Requirements

    This proposed AD would require compliance with certain procedures
described in the manufacturer's service bulletin. For helicopters with
an affected 90-degree TGB output shaft installed, this proposed AD
would require within 25 hours time-in-service (TIS) or 3 months,
whichever comes first, and thereafter at intervals not to exceed 100
hours TIS or 6 months, whichever occurs first, borescope inspecting the
internal surface of the 90-degree TGB output shaft for corrosion. If
there is corrosion, this proposed AD would require removing the TGB
from service before further flight.

Interim Action

    The FAA considers this proposed AD to be an interim action. An
investigation is ongoing and if final action is later identified, the
FAA might consider further rulemaking then.

Costs of Compliance

    The FAA estimates that this proposed AD would affect 96 helicopters
of U.S. Registry. The FAA also estimates that operators may incur the
following costs in order to comply with this proposed AD. Labor costs
are estimated at $85 per work-hour.
    Borescope inspecting the 90-degree TGB output shaft would take
about 3 work-hours for an estimated cost of $255 per helicopter and
$24,480 for the U.S. fleet per inspection cycle.
    Replacing a (overhauled) TGB would take about 18 work-hours and
parts would cost about $49,000 (overhauled) for an estimated cost of
$50,530 per helicopter.
    According to Leonardo's service information, some of the costs of
this proposed AD may be covered under warranty, thereby reducing the
cost impact on affected individuals. The FAA does not control warranty
coverage by Leonardo. Accordingly, the FAA has included all costs in
the cost estimate.

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Leonardo S.p.a.: Docket No. FAA-2020-0411; Product Identifier 2018-
SW-061-AD.

(a) Applicability

    This AD applies to Leonardo S.p.a. Model A119 and AW119MKII
helicopters, certified in any category, with 90-degree tail rotor
gearbox (TGB) part number (P/N) 109-0440-06-101 or 109-0440-06-105
having serial number 167, 169 through 172 inclusive, 215 through 225
inclusive, 227, 230, 232, 233, AW268, K3, K16, M47, or L29,
installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as corrosion on the
internal surface of the 90-degree TGB output shaft. This condition
could result in failure of the 90-degree TGB output shaft and
reduced control of the helicopter.

(c) Comments Due Date

    The FAA must receive comments by June 23, 2020.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) Within 25 hours time-in-service (TIS) or 3 months, whichever
occurs first, and thereafter at intervals not to exceed 100 hours
TIS or 6 months, whichever occurs first, borescope inspect the
entire internal surface of the 90-degree TGB output shaft for
corrosion. Refer to Figure 3 of Leonardo Helicopters Alert Service
Bulletin No. 119-090, dated July 23, 2018, for a depiction of the
entry point for the borescope. If there is corrosion, before further
flight, remove from service the TGB.
    (2) After the effective date of this AD, do not install on any
helicopter any 90-degree TGB P/N 109-0440-06-101 or 109-0440-06-105
that has serial number 167, 169 through 172 inclusive, 215 through
225 inclusive, 227, 230, 232, 233, AW268, K3, K16, M47, or L29,
unless the actions required by paragraph (e)(1) of this AD have been
done.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
Rao Edupuganti, Aviation Safety Engineer, Regulations and Policy
Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy.,
Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggests
that you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office before

operating any aircraft complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in European Union Aviation
Safety Agency (previously European Aviation Safety Agency) (EASA) AD
No. 2018-0156, dated July 24, 2018. You may view the EASA AD on the
internet at https://www.regulations.gov in the AD Docket.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 62, Tail Rotor
Gearbox.

    Issued on April 20, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-08644 Filed 4-23-20; 8:45 am]
 BILLING CODE 4910-13-P