[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15155-15157]
[FR Doc No: 2018-07225]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1072]

International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; Cannabis Plant and
Resin; Extracts and Tinctures of Cannabis; Delta-9-
Tetrahydrocannabinol; Stereoisomers of Tetrahydrocannabinol;
Cannabidiol; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is requesting
interested persons to submit comments concerning abuse potential,
actual abuse, medical usefulness, trafficking, and impact of scheduling
changes on availability for medical use of five drug substances. These
comments will be considered in preparing a response from the United
States to the World Health Organization (WHO) regarding the abuse
liability and diversion of these drugs. WHO will use this information
to consider whether to recommend that certain international
restrictions be placed on these drugs. This notice requesting comments
is required by the Controlled Substances Act (the CSA).

DATES: Submit either electronic or written comments by April 23, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 23, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2018-N-1072 for ``International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs; Cannabis
Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9-
Tetrahydrocannabinol (THC); Stereoisomers of THC; Cannabidiol; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug
Evaluation and Research, Controlled Substance Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The United States is a party to the 1971 Convention on Psychotropic
Substances (Psychotropic Convention). Article 2 of the Psychotropic
Convention provides that if a party to the convention or WHO has
information about a substance, which in its opinion may require
international control or change in such control, it shall so notify the
Secretary-General of the United Nations (the U.N. Secretary-General)
and provide the U.N. Secretary-General with information in support of
its opinion.
    Paragraph (d)(2)(A) of the CSA (21 U.S.C. 811) (Title II of the
Comprehensive Drug Abuse Prevention and Control Act of 1970) provides
that when WHO notifies the United States under Article 2 of the
Psychotropic Convention that it has information that may justify adding
a drug or other substances to one of the schedules of the Psychotropic
Convention, transferring a drug or substance from one schedule to
another, or deleting it from the schedules, the Secretary of State must
transmit the notice to the Secretary of Health and Human Services
(Secretary of HHS). The Secretary of HHS must then publish the notice
in the Federal Register and provide opportunity for interested persons
to submit comments that will be considered by HHS in its preparation of
the scientific and medical evaluations of the drug or substance.

II. WHO Notification

    The Secretary of HHS received the following notice from WHO (non-
relevant text removed):

Ref.: C.L.2.2018

    The World Health Organization (WHO) presents its compliments to
Member States and Associate Members and has the pleasure of
informing that the 40th Expert Committee on Drug Dependence (ECDD)
will meet in Geneva from 4 to 8 June 2018. The 40th ECDD will
convene in a special session to review cannabis and cannabis-related
substances on their potential to cause dependence, abuse and harm to
health, and potential therapeutic applications. WHO will make
recommendations to the UN Secretary-General on the need for and
level of international control of these substances. Recommendations
made from the 39th meeting can be found on the ECDD website (https://www.who.int/mason/entity/medicines/news/2017/letter-DG-39thECDDrecommendations.pdf?ua=1).
    At its 126th session in January 2010, the Executive Board
approved the publication ``Guidance on the WHO review of
psychoactive substances for international control'' (EB126/2010/
REC1, Annex 6) which requires the Secretariat to request relevant
information from Ministers of Health in Member States to prepare a
report for submission to the ECDD. For this purpose, a questionnaire
was designed to gather information on the legitimate use, harmful
use, status of national control and potential impact of
international control for each substance under evaluation. Member
States are invited to collaborate, as in the past, in this process
by providing pertinent information as requested in the questionnaire
and concerning substances under review.
    It would be appreciated if a person from the Ministry of Health
could be designated as the focal point responsible for coordinating
answers to the questionnaires. A list of focal points designated by
Member States for the 39th ECDD in November 2017 is attached. It is
requested that if a focal point's contact details including email
address are to be added or amended, that Member States inform the
Secretariat by 26 February 2018. Any additions or amendments to
focal point designations should be emailed to
[email protected].
    If no additions or amendments to focal point details are made by
this date, the focal point from 2017 will be approached by the
Secretariat for questionnaire completion. Where there is a competent
National Authority under the International Drug Control Treaties, it
is kindly requested that the questionnaires be completed in
collaboration with such body.
    Once the Secretariat has received the contact details, focal
points will be given further instructions and direct access to an
online questionnaire. The questionnaires will be analysed by the
Secretariat and prepared as a report that will be published on the
ECDD website (https://www.who.int/medicines/access/controlled-substances/ecdd/en/) prior to the 40th ECDD meeting. The provisional
agenda for the meeting will also be made available in advance on the
ECDD website.
    Member States are also encouraged to provide any additional
relevant information (unpublished or published) that is available on
these substances to: [email protected]. This information will
be an invaluable contribution to the ECDD and all submissions will
be treated as confidential.
    The WHO takes this opportunity to renew to Member States and
Associate Members the assurance of its highest consideration.
GENEVA, 30 January 2018

    FDA has verified the website addresses contained in the WHO notice,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time. Access to view the WHO
questionnaire can be found at https://www.who.int/medicines/access/controlled-substances/ecdd/en/.

III. Substances Under WHO Review

    WHO will convene in a special session to review the following
substances: Cannabis plant and resin; extracts and tinctures of
cannabis; delta-9-tetrahydrocannabinol (THC; stereoisomers of THC; and
cannabidiol (CBD).
    The Committee from the 37th ECDD requested that Secretariat begin
collecting data towards a pre-review of cannabis, cannabis resin,
extracts, and tinctures of cannabis at a future meeting. Subsequent to
this request, WHO commissioned two updates on the scientific literature
for cannabis and cannabis resin, which were prepared and presented to
the 38th ECDD. That Committee noted that the current Schedule I under
the 1961 Convention groups together cannabis and cannabis resin,
extracts, and tinctures of cannabis, that cannabis plant and cannabis
resin are also in Schedule IV of the 1961 Convention, that there are
natural and synthetic cannabinoids in Schedule I and Schedule II of the
1971 Convention, and that cannabis had never been subject to pre-review
or critical review by the ECDD. The Committee also noted an increase in
the use of cannabis and its components for medical purposes and the
emergence of new cannabis-related pharmaceutical preparations for
therapeutic use. From this review, the 38th ECDD Committee recommended
that preparations be made to conduct pre-reviews at a future meeting
dedicated to the following substances: Cannabis plant and cannabis
resin, extracts and tinctures of cannabis, THC, CBD, and stereoisomers
of THC. An excerpt from the report of the 38th ECDD stated that the
purpose of the pre-review was to determine whether current information
justifies an Expert Committee critical review. They noted that the
categories of information for evaluating substances in pre-reviews are
identical to those used in critical reviews and that the pre-review is
a preliminary analysis, and findings should not determine whether the

control status of a substance should be changed.
    Cannabis, also known as marijuana, refers to the dried leaves,
flowers, stems, and seeds from the Cannabis sativa or Cannabis indica
plant. It is a complex plant substance containing multiple cannabinoids
and other compounds, including the psychoactive chemical THC and other
structurally similar compounds. Cannabinoids are defined as having
activity at cannabinoid 1 and 2 (CB1 and CB2 respectively) receptors.
Agonists of CB1 receptors are widely abused and are known to modulate
motor coordination, memory processing, pain, and inflammation, and have
anxiolytic effects. Marijuana is the most commonly used illicit drug in
the United States.
    The principal cannabinoids in the cannabis plant include THC, CBD,
and cannabinol. FDA has not approved any product containing or derived
from botanical marijuana for any indication. These substances are
controlled in Schedule I under the CSA. Synthetic THC (dronabinol) is
the active ingredient in two approved drug products in the United
States, MARINOL capsules (and generics) and SYNDROS oral solution.
MARINOL is controlled in Schedule III, while SYNDROS is controlled in
Schedule II under the CSA. Both MARINOL and SYNDROS are approved to
treat anorexia associated with weight loss in patients with acquired
immunodeficiency syndrome (AIDS), and nausea and vomiting associated
with cancer chemotherapy in patients who have failed to respond
adequately to conventional treatment.
    CBD is another cannabinoid identified in cannabis. CBD has been
tested in experimental animal and laboratory models of several
neurological disorders, including those of seizure and epilepsy. In the
United States, CBD-containing products are in human clinical testing in
several therapeutic areas, but no such products have marketing approval
by FDA for any medical purposes in the United States. CBD is controlled
as a Schedule I substance under the CSA. CBD is not specifically listed
in the schedules of the 1961, 1971, or 1988 International Drug Control
conventions.
    At the 39th (2017) meeting of the ECDD, the committee pre-reviewed
CBD and recommended that extracts or preparations containing almost
exclusively CBD be subject to critical review at the 40th ECDD meeting.

IV. Opportunity To Submit Domestic Information

    As required by paragraph (d)(2)(A) of the CSA, FDA, on behalf of
HHS, invites interested persons to submit comments regarding the five
drug substances. Any comments received will be considered by HHS when
it prepares a scientific and medical evaluation of these drug
substances, responsive to the WHO Questionnaire request for these drug
substances. HHS will forward such evaluation of these drug substances
to WHO, for WHO's consideration in deciding whether to recommend
international control/decontrol of any of these drug substances. Such
control could limit, among other things, the manufacture and
distribution (import/export) of these drug substances and could impose
certain recordkeeping requirements on them.
    Although FDA is, through this notice, requesting comments from
interested persons, which will be considered by HHS when it prepares an
evaluation of these drug substances, HHS will not now make any
recommendations to WHO regarding whether any of these drugs should be
subjected to international controls. Instead, HHS will defer such
consideration until WHO has made official recommendations to the
Commission on Narcotic Drugs, which are expected to be made in mid-
2018. Any HHS position regarding international control of these drug
substances will be preceded by another Federal Register notice
soliciting public comments, as required by paragraph (d)(2)(B) of the
CSA.

    Dated: April 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07225 Filed 4-6-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Notices]
[Pages 13974-13975]
[FR Doc No: 2020-04814]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2019-0007; Notice 2]

Pirelli Tire, LLC, Grant of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition.

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SUMMARY: Pirelli Tire, LLC (Pirelli), has determined that certain
Pirelli P Zero replacement tires do not comply with Federal Motor
Vehicle Safety Standard (FMVSS) No. 139, New Pneumatic Radial Tires for
Light Vehicles. Pirelli filed a noncompliance report dated November 19,
2018, and subsequently petitioned NHTSA on December 14, 2018, for a
decision that the subject noncompliance is inconsequential as it
relates to motor vehicle safety. This notice announces the grant of
Pirelli's petition.

FOR FURTHER INFORMATION CONTACT: Abraham Diaz, Office of Vehicle Safety
Compliance, the National Highway Traffic Safety Administration (NHTSA),
telephone<PHONE_NUMBER>, facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Overview

    Pirelli has determined that certain Pirelli P Zero replacement
tires do not fully comply with paragraphs S5.5(e) and (f) of FMVSS No.
139, New Pneumatic Radial Tires for Light Vehicles (49 CFR 571.139).
Pirelli filed a noncompliance report dated November 19, 2018, pursuant
to 49 CFR part 573, Defect and Noncompliance Responsibility and
Reports, and subsequently petitioned NHTSA on December 14, 2018, for an
exemption from the notification and remedy requirement of 49 U.S.C.
Chapter 301 on the basis that this noncompliance is inconsequential as
it relates to motor vehicle safety, pursuant to 49 U.S.C. 30118(d) and
30120(h) and 49 CFR part 556, Exemption for Inconsequential Defect or
Noncompliance.
    Notice of receipt of Pirelli's petition was published, with a 30-
day public comment period on August 28, 2019, in the Federal Register
(84 FR 45208). No comments were received. To view the petition and all
supporting documents log onto the Federal Docket Management System
(FDMS) website at https://www.regulations.gov/. Then follow the online
search instructions to locate docket number ``NHTSA-2019-0007.''

II. Equipment Involved

    Approximately 28 Pirelli P Zero replacement tires, size 265/45R21
104W, manufactured between July 10, 2018, and August 08, 2018, are
potentially involved.

III. Noncompliance

    Pirelli explains that the noncompliance is due to a mold error and
that as a result, the number of tread plies indicated on the sidewall
of the subject tires does not match the actual number of plies in the
tire construction as required by paragraphs S5.5(e) and (f) of FMVSS
No. 139. Specifically, the tires were marked ``Tread: 2 Polyester 2
Steel 1 Polyamide; Sidewall: 1 Polyamide'' when they should have been
marked ``Tread: 2 Polyester 2 Steel 1 Polyamide; Sidewall: 2
Polyester.''

IV. Rule Requirements

    Paragraphs S5.5(e) and (f) of FMVSS No. 139 provide the
requirements relevant to this petition. Each tire must be marked on
each sidewall with the information specified in paragraphs S5.5(a)
through (d) and on one sidewall with the information specified in
S5.5(e) through (i) according to the phase-in schedule specified in
paragraph S7 of FMVSS No. 139. Specifically, each tire should be marked
with the generic name of each cord material used in the plies (both
sidewall and tread area) of the tire and the actual number of plies in
the sidewall, and the actual number of plies in the tread area, if
different.

V. Summary of Petition

    Pirelli described the subject noncompliance and stated its belief
that the noncompliance is inconsequential as it relates to motor
vehicle safety.
    In support of its petition, Pirelli submitted the following
reasoning:
    1. The subject tires comply with the performance requirements and
all other marking requirements of FMVSS No. 139.
    2. The tire construction information for the subject tires has been
corrected in Pirelli's centralized R&D system that creates the drawings
used in manufacturing the tire molds. Pirelli is in the process of
correcting the subject molds before they are used for future
production.
    3. Pirelli cited the Agency as saying that it ``believes that one
measure of inconsequentiality to motor vehicle safety, in this case, is
that there is no effect of the noncompliance on the operational safety
of vehicles on which these tires are mounted. The safety of people
working in the tire retread, repair, and recycling industries must also
be considered and is a measure of inconsequentiality.'' See 83 FR 36668
(July 30, 2018) (Grant of petition for determination of inconsequential
noncompliance for Continental tires, for tires marked with the
incorrect number of tread plies.
    4. Pirelli stated that the subject tires were manufactured as
designed and meet or exceed all applicable FMVSS No. 139 performance
standards. Furthermore, all of the sidewall markings related to tire
service (load capacity, corresponding inflation pressure, etc.) are
correct and the tires correctly show that they contain tread plies.
Pirelli does not believe the mislabeling of these tires presents a
safety concern for consumers or for the retreading and recycling
personnel.
    5. Pirelli says that NHTSA has granted similar petitions involving
tires manufactured by Cooper Tire and Goodyear (Dunlop). See 74 FR
10804 (March 12, 2009), grant of petition submitted by Goodyear where
tires were marked ``Tread 3 Polyester + 2 Steel,'' whereas the correct
marking should have been ``Tread 2 Polyester + 2 Steel + 2 Polyamide;''
82 FR 17075 (April 7, 2017). See 82 FR 17075 (April 7, 2017) grant of
petition submitted by Cooper Tire & Rubber Company where tires were
marked ``TREAD 1 PLY NYLON + 2 PLY STEEL + 2 PLY POLYESTER,'' whereas
the correct marking should have been ``TREAD 1 PLY NYLON + 2 PLY STEEL
+ 1 PLY POLYESTER.'' See 83 FR 13002 (March 26, 2018), grant of
petition submitted by Sumitomo Rubber Industries Ltd. where tires were
marked ``TREAD 5 PLIES STEEL'' whereas the correct marking should have
been ``TREAD 4 PLIES STEEL.''
    6. Pirelli is not aware of any warranty claims, field reports,
customer complaints, legal claims, or any incidents or injuries related
to the subject condition.

VI. NHTSA's Analysis

    NHTSA has evaluated the merits of the inconsequential noncompliance
petition submitted by Pirelli and agrees that this particular
noncompliance is inconsequential to motor vehicle safety. NHTSA
believes that the true measure of inconsequentiality to motor vehicle
safety, in this case, is that there is no effect of the noncompliances
on the operational safety of vehicles on which these tires are mounted.
    Although tire construction affects the strength and durability,
neither the Agency nor the tire industry provides information relating
tire strength and durability to the ply cord material in the

tread and sidewall. Therefore, tire dealers and customers should
consider the tire construction information along with other information
such as load capacity, maximum inflation pressure, and tread wear,
temperature, and traction ratings, to assess the performance
capabilities of various tires.
    The Agency also believes the noncompliance will have no measurable
effect on the safety of the tire retread, repair, and recycling
industries. The use of steel cord construction in the sidewall and
tread is the primary safety concern of these industries. In this case,
because the sidewall marking indicates that some steel plies exist in
the tire tread, this potential safety concern does not exist.
    In the Agency's judgment, the incorrect labeling of the tire
construction information will have an inconsequential effect on motor
vehicle safety because most consumers do not base tire purchases or
vehicle operation parameters on the ply material in a tire.

VII. NHTSA's Decision

    In consideration of the foregoing, NHTSA finds that Pirelli has met
its burden of persuasion that the FMVSS No. 139 noncompliance is
inconsequential as it relates to motor vehicle safety. Accordingly,
Pirelli's petition is hereby granted and Pirelli is exempted from the
obligation of providing notification of, and a remedy for, the
noncompliance under 49 U.S.C. 30118 and 30120.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, this decision
only applies to the subject equipment that Pirelli no longer controlled
at the time it determined that the noncompliance existed. However, the
granting of this petition does not relieve equipment distributors and
dealers of the prohibitions on the sale, offer for sale, or
introduction or delivery for introduction into interstate commerce of
the noncompliant equipment under their control after Pirelli notified
them that the subject noncompliance existed.

    Authority: (49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8)

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2020-04814 Filed 3-9-20; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Notices]
[Page 10506]
[FR Doc No: 2012-4071]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM11-9-000]

Locational Exchanges of Wholesale Electric Power; Notice
Terminating Proceeding

    1. On February 17, 2011, the Commission issued a Notice of Inquiry
(NOI) concerning the regulatory treatment of locational exchanges of
wholesale electric power. The Commission sought guidance as to the
circumstances under which locational exchanges of wholesale electric
power should be permitted generically and circumstances under which the
Commission should consider locational exchanges of wholesale electric
power on a case-by-case basis. The Commission received 17 comments from
interested parties addressing various issues presented in the NOI. The
Commission has determined that there is no basis for continuing this
proceeding through the initiation of a rulemaking process and, instead,
addresses related issues in an order issued contemporaneously with this
order.\1\ Therefore, the Commission is terminating this proceeding.
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    \1\ 138 FERC ] 61,121 (2012).
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    The Commission orders:
    The Notice of Inquiry issued by the Commission in this proceeding
is hereby terminated.

    By direction of the Commission.
    Issued: February 16, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-4071 Filed 2-21-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Rules and Regulations]
[Pages 54490-54492]
[FR Doc No: 2019-22131]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0194; Product Identifier 2019-NM-009-AD; Amendment
39-19750; AD 2019-19-14]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Airbus SAS Model A350-941 and -1041 airplanes. This AD was prompted by
reports of cracks within the ring gears of a slat geared rotary
actuator (SGRA) resulting from a change in the raw material
manufacturing process. This AD requires replacement of affected parts
with serviceable parts, as specified in a European Aviation Safety
Agency (EASA) AD, which is incorporated by reference. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective November 14, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 14,
2019.

ADDRESSES: For the material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 89990 1000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available in the AD docket on the internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2019-0194.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0194; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations is U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Aerospace
Engineer, International Section, Transport Standards Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0020, dated January 31, 2019
(``EASA AD 2019-0020'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Airbus SAS Model A350-941 and -1041 airplanes.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Airbus SAS Model
A350-941 and -1041 airplanes. The NPRM published in the Federal
Register on April 9, 2019 (84 FR 14038). The NPRM was prompted by
reports of cracks within the ring gears of an SGRA resulting from a
change in the raw material manufacturing process. The NPRM proposed to
require replacement of affected parts with serviceable parts.
    The FAA is issuing this AD to address cracking of SGRA ring gears.
This condition, if not detected and corrected, could, in combination
with an independent failure on the second SGRA of the same slat
surface, lead to detachment of the slat surface, possibly resulting in
reduced control of the airplane and injury to persons on the ground.
See the MCAI for additional background information.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The following presents the comments
received on the NPRM and the FAA's response to each comment.

Support for the NPRM

    The Air Line Pilots Association, International; Stephanie Lok; and
an anonymous commenter indicated their support for the NPRM.

Request To Clarify Requirements for Group 1 Airplanes

    Delta Air Lines (Delta) requested that a statement be added to
paragraph (g) of this AD to clarify that the installation of affected
parts was prohibited for Group 1 airplanes before 15,000 flight hours.
Delta asserted that the AD could be interpreted as allowing the
installation of affected parts on those airplanes during that time
period.
    The FAA does not agree that an additional statement to paragraph
(g) of this AD is necessary. The FAA has confirmed with EASA that since
the safety assessment was performed on the life of the airplane and not
the life of the affected part, a restriction to limit the affected
parts prior to 15,000 flight hours is not necessary. Therefore, the
commenter's interpretation that installation of affected parts could be
allowed prior to 15,000 flight hours is correct. This AD has not been
changed in this regard.

Request To Modify Serial Number Table

    Delta requested that the serial numbers of final assembly line
units be removed from Table 1 of certain Liebherr service information
instead of noting that they are to be excluded.
    The FAA does not agree with the commenter's request. Although the
proposal may provide a more straightforward presentation of the serial
numbers, obtaining new service information with revised serial number
tables from the manufacturer would delay publication of this AD. This
delay would be inappropriate since the FAA has determined that an
unsafe condition exists and that the required actions must be
accomplished to ensure continued safety. The FAA also has determined
that the serial number table in the Liebherr service information
provides the information necessary to comply with this AD. Therefore,
this AD has not been changed in this regard.

Request To Clarify Location of Identification Mark

    Delta requested that certain Airbus service information be updated
to clarify the location of a certain marking on the identification
plate. Delta noted that the Liebherr service information refers to the
specified marking, but does not show the marking's location, while the
Airbus service information does not refer to the marking at all.
    The FAA disagrees with obtaining revised service information
because it would delay publication of this AD, which would be
inappropriate for the reasons stated previously. However, the FAA
agrees to clarify the location of the specified marking on the
identification plate. The FAA has confirmed with EASA that the marking
will be on both ``A'' faces of the identification plate, as depicted in
Figure 1 of the Liebherr service information. This AD has not been
changed in this regard.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety and the public interest
require adopting this final rule as proposed, except for minor
editorial changes. The FAA has determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2019-0020 describes procedures for replacing the affected
SGRAs. This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 12 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
25 work-hours x $85 per hour = $2,125........................           (*) $         * $2,125        * $25,500
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data that would enable the agency to provide cost estimates for the parts
  specified in this AD.

    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. The FAA does not control warranty coverage for
affected individuals. As a result, the FAA has included all known 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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) 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.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2019-19-14 Airbus SAS: Amendment 39-19750; Docket No. FAA-2019-0194;
Product Identifier 2019-NM-009-AD.

(a) Effective Date

    This AD is effective November 14, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus SAS Model A350-941 and -1041
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
controls.

(e) Reason

    This AD was prompted by reports of cracks within the ring gears
of a slat geared rotary actuator (SGRA), resulting from a change in
the raw material manufacturing process. The FAA is issuing this AD
to address cracking of SGRA ring gears. This condition, if not
detected and corrected, could, in combination with an independent
failure on the second SGRA of the same slat surface, lead to
detachment of the slat surface, possibly resulting in reduced
control of the airplane and injury to persons on the ground.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Aviation Safety Agency (EASA) AD 2019-
0020, dated January 31, 2019 (``EASA AD 2019-0020'').

(h) Exceptions to EASA AD 2019-0020

    (1) For purposes of determining compliance with the requirements
of this AD: Where EASA AD 2019-0020 refers to its effective date,
this AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2019-0020 does not apply
to this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (j) of this AD. Information may
be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2019-0020 that contains RC procedures and
tests: Except as required by paragraph (i)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(j) Related Information

    For more information about this AD, contact Kathleen Arrigotti,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Aviation Safety Agency (EASA) AD 2019-0020, dated
January 31, 2019.
    (ii) [Reserved]
    (3) For EASA AD 2019-0020, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 89990 6017; email
<EMAIL_ADDRESS>Internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this material at the FAA, Transport Standards
Branch, 2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. EASA AD
2019-0020 may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2019-0194.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on September 23, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-22131 Filed 10-9-19; 8:45 am]
 BILLING CODE 4910-13-P