[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Proposed Rules]
[Pages 21044-21047]
[FR Doc No: 2022-07618]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0454; Project Identifier MCAI-2021-01124-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2019-03-25, which applies to certain Airbus SAS Model A318 series
airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes; Model A320-211, -212, -214, -216, -231, -232, and -233
airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and
-232 airplanes. AD 2019-03-25 requires repetitive inspections of the
center and outer wing box lower stiffeners and panels at a certain
junction on the left- and right-hand sides for any cracking, and repair
if necessary. AD 2019-03-25 also provides an optional modification,
which would terminate the repetitive inspections. Since the FAA issued
AD 2019-03-25, it has been determined that, for certain airplanes, the
compliance time for the initial inspection is inadequate and must be
revised. This proposed AD continues to require the actions specified in
AD 2019-03-25 with revised compliance times for certain airplanes and
additional actions for certain airplanes, and expands the
applicability, as specified in a European Aviation Safety Agency (EASA)
AD, which is proposed for incorporation by reference. The FAA is
proposing this AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by May 26,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For material that will be incorporated by reference (IBR) in this
AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this material on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket at https://www.regulations.gov by searching for and locating
Docket No. FAA-2022-0454.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0454; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the
mandatory continuing airworthiness information (MCAI), any comments
received, and other information. The street address for Docket
Operations is listed above.

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

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0454; Project Identifier
MCAI-2021-01124-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

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

206-231-3223; email [email protected]. Any commentary that the
FAA receives which is not specifically designated as CBI will be placed
in the public docket for this rulemaking.

Background

    The FAA issued AD 2019-03-25, Amendment 39-19577 (84 FR 8805, March
12, 2019) (AD 2019-03-25), which applies to certain Airbus SAS Model
A318 series airplanes; Model A319-111, -112, -113, -114, -115, -131, -
132, and -133 airplanes; Model A320-211, -212, -214, -216, -231, -232,
and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -
231, and -232 airplanes. AD 2019-03-25 requires repetitive special
detailed inspections (SDIs) of the center and outer wing box lower
stiffeners and panels at a certain junction on the left- and right-hand
sides for any cracking, and repair if necessary. AD 2019-03-25 also
provides an optional modification, which would terminate the repetitive
inspections. The FAA issued AD 2019-03-25 to address the loss of pre-
tension in the fasteners, which could affect the structural integrity
of the airplane.

Actions Since AD 2019-03-25 Was Issued

    Since the FAA issued AD 2019-03-25, it has been determined that,
for certain airplanes, the compliance time for the initial inspection
is inadequate and must be revised and additional actions are required.
Additionally, the applicability is expanded.
    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0228, dated October 12, 2021
(EASA AD 2021-0228) (also referred to as the MCAI), to correct an
unsafe condition for certain Airbus SAS Model A318 series airplanes;
Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes;
Model A320-211, -212, -214, -215, -216, -231, -232, and -233 airplanes;
and Model A321-111, -112, -131, -211, -212, -213, -231, and -232
airplanes. Model A320-215 airplanes are not certificated by the FAA and
are not included on the U.S. type certificate data sheet; this AD
therefore does not include those airplanes in the applicability.
    EASA AD 2021-0228 superseded EASA AD 2018-0218, dated October 11,
2018; corrected October 26, 2018 (which corresponds to FAA AD 2019-03-
25).
    This proposed AD was prompted by a report that taperloks used in
the wing-to-fuselage junction at rib 1 were found to be noncompliant
with the applicable specification, resulting in a loss of pre-tension
in the fasteners; and a determination that, for certain airplanes, the
compliance time for the initial inspection is inadequate and must be
revised. The FAA is proposing this AD to address the loss of pre-
tension in the fasteners, which could affect the structural integrity
of the airplane. See the MCAI for additional background information.

Explanation of Retained Requirements

    Although this proposed AD does not explicitly restate the
requirements of AD 2019-03-25, this proposed AD would retain the
requirements of AD 2019-03-25. Those requirements are referenced in
EASA AD 2021-0228, which, in turn, is referenced in paragraph (g) of
this proposed AD.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0228 specifies procedures for repetitive internal and
external SDIs (ultrasonic inspections) of the center and outer wing box
lower stiffeners and panels at the level of rib 1 junction on the left-
and right-hand sides for any cracking, and repair if necessary; and
additional actions (re-protection of the inspected area at the lower
panel at rib1 junction at the left- and right-hand sides) for airplanes
on which certain service information was used. EASA AD 2021-0228 also
specifies procedures for an optional modification, which would
terminate the repetitive inspections. This material is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.

FAA's Determination

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

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2021-0228 described previously, except for any differences
identified as exceptions in the regulatory text of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2021-0228 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2021-0228 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2021-0228 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2021-
0228. Service information required by EASA AD 2021-0228 for compliance
will be available at https://www.regulations.gov by searching for and
locating Docket No. FAA-2022-0454 after the FAA final rule is
published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 765 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                              Cost per          Cost on U.S.
              Action                      Labor cost         Parts cost        product           operators
----------------------------------------------------------------------------------------------------------------
Retained actions from 2019-03-25..  51 work-hours x $85                $0          $4,335  $25,860 (516
                                     per hour = $4,335.                                     airplanes).

New additional proposed actions...  13 work-hours x $85                 0           1,105  Up to $845,325 (Up to
                                     per hour = $1,105.                                     765 airplanes).
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data that would enable the
agency to provide cost estimates for the repair specified in this
proposed AD.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB Control Number. The OMB
Control Number for this information collection is 2120-0056. Public
reporting for this collection of information is estimated to take
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden, to: Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2019-03-25, Amendment 39-19577
(84 FR 8805, March 12, 2019); and
0
b. Adding the following new AD:

Airbus SAS: Docket No. FAA-2022-0454; Project Identifier MCAI-2021-
01124-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by May 26, 2022.

(b) Affected ADs

    This AD replaces AD 2019-03-25, Amendment 39-19577 (84 FR 8805,
March 12, 2019) (AD 2019-03-25).

(c) Applicability

    This AD applies to Airbus SAS Model A318-111, -112, -121, and -
122 airplanes; Model A319-111, -112, -113, -114, -115, -131, -132,
and -133 airplanes; Model A320-211, -212, -214, -216, -231, -232,
and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -
213, -231, and -232 airplanes; certificated in any category; as
identified in European Aviation Safety Agency (EASA) AD 2021-0228,
dated October 12, 2021 (EASA AD 2021-0228).

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Unsafe Condition

    This AD was prompted by a report that taperloks used in the
wing-to-fuselage junction at rib 1 were found to be non-compliant
with the applicable specification, resulting in a loss of pre-
tension in the fasteners; and a determination that, for certain
airplanes, the compliance time for the initial inspection is
inadequate and must be revised and additional actions are required.
The FAA is issuing this AD to address the loss of pre-tension in the
fasteners, which could affect the structural integrity of the
airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2021-0228.

(h) Exceptions to EASA AD 2021-0228

    (1) Where EASA AD 2021-0228 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where paragraph (3) of EASA AD 2021-0228 specifies to
``contact Airbus for approved repair instructions'' if any damage
(cracking) is found, for this AD, if any cracking is found, the
cracking must be repaired before further flight using a method
approved by the Manager, Large Aircraft Section, International
Validation Branch, FAA; or EASA; or Airbus SAS's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (3) The ``Remarks'' section of EASA AD 2021-0228 does not apply
to this AD.

(i) Additional FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft

Section, International Validation Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or responsible Flight Standards Office,
as appropriate. If sending information directly to the Large
Aircraft Section, International Validation Branch, send it to the
attention of the person identified in paragraph (j)(2). Before using
any approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the responsible Flight
Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2021-0228 that contains paragraphs that are
labeled as RC, the instructions in RC paragraphs, including
subparagraphs under an RC paragraph, must be done to comply with
this AD; any paragraphs, including subparagraphs under those
paragraphs, that are not identified as RC are recommended. The
instructions in paragraphs, including subparagraphs under those
paragraphs, 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
instructions identified as RC can be done and the airplane can be
put back in an airworthy condition. Any substitutions or changes to
instructions identified as RC require approval of an AMOC.

(j) Related Information

    (1) For EASA AD 2021-0228 contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu. You may
view this material at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195. This material may be found in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-
2022-0454.
    (2) For more information about this AD, contact Vladimir
Ulyanov, Aerospace Engineer, Large Aircraft Section, FAA,
International Validation Branch, 2200 South 216th St., Des Moines,
WA 98198; telephone and fax<PHONE_NUMBER>; email
[email protected].

    Issued on April 5, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-07618 Filed 4-8-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 161 (Tuesday, August 20, 2013)]
[Notices]
[Pages 51182-51183]
[FR Doc No: 2013-20160]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP13-527-000]

Sea Robin Pipeline Company, LLC; Notice of Request Under Blanket
Authorization

    Take notice that on July 31, 2013, Sea Robin Pipeline Company, LLC
(Sea Robin), P. O. Box 4967, Houston, Texas 77210, filed in Docket No.
CP13-527-000, a prior notice request, pursuant to sections 157.205(b)
and 157.216 of the Commission's Regulations under the Natural Gas Act
(NGA), and Sea Robin's blanket certificate issued in Docket No. CP82-
429-000, for authorization to abandon in place, two segments of pipe
and to abandon by removal the T-1 Platform and related facilities
located in Vermilion Parish, Louisiana and extending into State and
Federal waters, offshore Louisiana, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection.
    The filing may also be viewed on the web at http://www.ferc.gov
using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Any questions regarding this Application should be directed to
Stephen T. Veatch, Senior Director of Certificates and Tariffs, Sea
Robin Pipeline Company, LLC, 1300 Main Street, Houston, TX, 77002, or
call<PHONE_NUMBER>, facsimile at<PHONE_NUMBER>, or via email:
<EMAIL_ADDRESS>    Any person or the Commission's Staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and, pursuant to section 157.205 of
the Commission's Regulations under the NGA (18 CFR 157.205) a protest
to the request. If no protest is filed within the time allowed
therefore, the proposed activity shall be deemed to be authorized
effective the day after the time allowed for protest. If a protest is
filed and not withdrawn within 30 days after the time allowed for
filing a protest, the instant request shall be treated as an
application for authorization pursuant to section 7 of the NGA.
    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit an original and 5 copies of the protest or
intervention to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. See, 18CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link.

    Dated: August 13, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-20160 Filed 8-19-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 24, 2006 (Volume 71, Number 141)]
[Notices]
[Page 41789-41790]
[DOCID:fr24jy06-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP05-422-016]

El Paso Natural Gas Company; Notice of Compliance Filing

July 14, 2006.
    Take notice that on July 10, 2006, El Paso Natural Gas Company
(EPNG) submitted a compliance filing pursuant to Commission Order dated
June 30, 2006 in the above listed proceeding. EPNG tenders for filing
as part of its FERC Gas Tariff, Second Revised Volume No. 1-A, the
tariff sheets listed in Appendix A to be effective March 20, 2006.

Thirty-Third Revised Sheet No. 20
Tenth Revised Sheet No. 21
Thirty-Second Revised Sheet No. 23
Ninth Revised Sheet No. 25
First Revised Sheet No. 25A
Second Revised Sheet No. 25B
Second Revised Sheet No. 25C
First Revised Sheet No. 25E
First Revised Sheet No. 25F
First Revised Sheet No. 25G
First Revised Sheet No. 25H
Thirty-Third Revised Sheet No. 26
Fourth Revised Sheet No. 27A
Second Revised Sheet No. 374
Second Substitute Original Sheet No. 375
Second Substitute Original Sheet No. 376

    EPNG states that copies of the filing were served on parties on the
official service list in the above-captioned proceedings.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing 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. Such protests
must be filed in accordance with the provisions of Sec.  154.210 of the
Commission's regulations (18 CFR 154.210). Anyone filing a protest must
serve a copy of that document on all the parties to the proceeding.
    The Commission encourages electronic submission of protests 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 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. E6-11664 Filed 7-21-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 157 (Tuesday, August 14, 2012)]
[Proposed Rules]
[Pages 48469-48473]
[FR Doc No: 2012-19887]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0808; Directorate Identifier 2010-NM-170-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Airbus Model A330-200 and A330-300 series airplanes, and Model A340-200
and A340-300 series airplanes. This proposed AD was prompted by reports
of an elevator blocked in the down position due to two independent
failures; first, the inability of a servo control to switch to active
mode because it was not detected by a flight control computer, and
second, an internal hydraulic leak due to the deterioration of an O-
ring seal on a solenoid. This proposed AD would require, depending on
airplane configuration, modifying three flight control primary
computers (FCPCs); modifying two flight control secondary computers
(FCSCs); revising the airplane flight manual (AFM) to include certain
information; replacing certain O-rings; and checking part number, and
replacing certain O-ring seals if needed. We are proposing this AD to
detect and correct O-rings with incorrect part number whose
deterioration could lead to improper sealing of solenoid valves, and to
correct FCPC and FCSC software to allow better control of elevator
positioning; both conditions, if not corrected, could lead to the loss
of elevator control on takeoff, and potentially reduce the
controllability of the airplane.

DATES: We must receive comments on this proposed AD by September 28,
2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 45 80; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, Washington. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: (425) 227-
1138; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-0808;
Directorate Identifier 2010-NM-170-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2010-0081, dated April 27, 2010 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:
    This [EASA] AD deals with the two following points:

     Case of an elevator blocked in down position due to two
independent failures one of which is hidden:
    Each elevator is controlled by two servo controls. In normal
operation:

--One servo control in active mode controlled by PRIM 1 (Green servo
control),
--One servo control in damping mode (Yellow or Blue servo control)
monitored by PRIM 2.

    Change from active mode to damped mode is obtained by means of a
mode selector which is controlled by two identical solenoid valves
housed on the servo control. The sealing of each solenoid valve is
ensured by four O-ring seals.
    During pre-flight control checks, the flight crew of an A330-200
aeroplane observed that one of the elevators was blocked in down
position, the ECAM screen displaying ``F/CTL PRIM 1 PITCH FAULT''.

    This condition was due to two independent failures, one of which
was dormant, which occurred on one of the elevators.
    Investigations revealed that the origin of the elevator
malfunction was due to the inability of the Yellow servo control to
switch to active mode.
    This inability:
--Was caused by an internal hydraulic leak due to the deterioration
of an O-ring seal on a solenoid valve,
--Was not detected by the PRIM 2 computer nor announced to the
flight crew.
     Incorrect Part Number (P/N) for solenoid valve O-ring
seals in IPC [illustrated parts catalog]:
    An incorrect O-ring seal P/N in IPC 27-34-51-1 could have led to
the installation of O-ring seals incompatible with the hydraulic
fluid, causing them to deteriorate.
    These conditions if not detected could lead to the loss of
elevator [control] on takeoff and, potentially reduce the
controllability of the aeroplane.
    The aim of EASA AD 2007-0009 was to:
--Take over the requirements of AD F-2004-158, and
--Require the terminating action for Sec.  (1), (2) and (4) of this
AD by introducing new capped seals on solenoid valves for A330-200
only.
    This new [EASA] AD * * * requires the embodiment of the latest
software standard on the three Flight Control Primary Computers
(FCPC) and on the two Flight Control Secondary Computers (FCSC) [by
modifying the FCPCs and FCSCs] * * *.

    The modification is accomplished either by replacing the FCPCs and
FCSCs with new FCPCs and FCSCs, or by replacing or reprogramming the
on-board replaceable modules in the FCPCs and FCSCs. Required actions
also include, depending on airplane configuration, the following
actions: revising the airplane flight manual (AFM) to include certain
information; replacing certain O-rings; and checking part number, and
replacing certain O-ring seals if needed. You may obtain further
information by examining the MCAI in the AD docket.

Relevant Service Information

    Airbus has issued the following service information:
     Airbus All Operators Telex (AOT) A330-27A3129, Revision
01, dated July 16, 2004.
     Airbus Mandatory Service Bulletin A330-27-3136, Revision
01, dated July 19, 2006.
     Airbus Mandatory Service Bulletin A330-27-3146, Revision
01, dated September 3, 2008.
     Airbus Mandatory Service Bulletin A330-27-3148, Revision
01, including Appendix 1, dated October 9, 2008.
     Airbus Mandatory Service Bulletin A330-27A3131, Revision
01, including Appendix 01, dated March 3, 2005.
     Airbus Mandatory Service Bulletin A340-27-4144, including
Appendix 1, dated October 19, 2009.
     Airbus Mandatory Service Bulletin A340-27-4146, dated June
1, 2007.
     Airbus Mandatory Service Bulletin A340-27-4148, including
Appendix 1, dated June 13, 2008.
     Airbus Mandatory Service Bulletin A340-27A4130, Revision
01, including Appendix 01, dated March 3, 2005.
     Airbus Service Bulletin A330-27-3134, Revision 01, dated
May 12, 2006.
     Airbus Service Bulletin A330-27-3144, Revision 01,
including Appendix 1, dated July 16, 2009.
     Airbus Service Bulletin A330-27-3145, dated December 16,
2008.
     Airbus Service Bulletin A340-27-4145, dated December 16,
2008.
     Airbus Temporary Revision TR4, Issue 1.0, ``TR 4.02.00/25
Issue 2--Undetected Elevator Control Loss in Case of Dual Failure,''
dated November 26, 2009, to the Airbus A330/A340 Airplane Flight
Manual.
     Airbus Temporary Revision TR22, Issue 1.0, ``TR 4.02.00/40
Issue 2--Undetected Elevator Control Loss in Case of Dual Failure,''
dated November 26, 2009, to the Airbus A330/A340 Airplane Flight
Manual.

The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    EASA AD 2010-0081, dated April 27, 2010, contains additional
requirements to modify the four elevator servo controls installed on
Model A330-200 series airplanes, as specified in Airbus Service
Bulletin A330-27-3134. This AD does not contain those requirements
because those actions are already mandated by FAA AD 2008-06-07,
Amendment 39-15419 (73 FR 13103, March 12, 2008; as corrected on April
15, 2008 (73 FR 20367), and must be accomplished within 17 months after
April 16, 2008 (the effective date of AD 2008-06-07, Amendment 39-
15419). EASA AD 2010-0081, dated April 27, 2010, also contains
additional requirements to amend the airplane flight manual to include
the operational procedure specified in paragraph (n) of this proposed
AD. This proposed AD does not include that requirement, because that
information is already contained in the U.S. operators' AFMs.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 41 products of U.S. registry. We also estimate that
it would take about 5 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $0 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these costs.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $17,425, or $425 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Airbus: Docket No. FAA-2012-0808; Directorate Identifier 2010-NM-
170-AD.

(a) Comments Due Date

    We must receive comments by September 28, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus airplanes, certificated in any
category, specified in paragraphs (c)(1) and (c)(2) of this AD.
    (1) Model A330-201, -202, -203, -223, -243, -301, -302, -303, -
321, -322, -323, -341, -342, and -343 airplanes, all manufacturer
serial numbers (MSN).
    (2) Model A340-211, -212, -213, -311, -312, and -313 airplanes,
all MSN.

(d) Subject

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

(e) Reason

    This AD was prompted by reports of an elevator blocked in the
down position due to two independent failures; first, the inability
of a servo control to switch to active mode because it was not
detected by a flight control computer, and second, an internal
hydraulic leak due to the deterioration of an O-ring seal on a
solenoid. We are issuing this detect and correct O-rings with
incorrect part number whose deterioration could lead to improper
sealing of solenoid valves, and to correct FCPC and FCSC software to
allow better control of elevator positioning; both conditions, if
not corrected, could lead to the loss of elevator control on
takeoff, and potentially reduce the controllability of the airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Replace O-ring Seals For Elevator Servo Controls Installed in
Damping Position on Model A330-200 Series Airplanes Only

    For all Airbus Model A330-200 series airplanes, except those on
which Airbus modifications 53969 and 54833 have been embodied in
production: At the later of the times specified in paragraphs (g)(1)
and (g)(2) of this AD, replace the O-ring seals installed on the two
solenoid valves of each servo control using new O-ring seals, in
accordance with Airbus All Operators Telex (AOT) A330-27A3129,
Revision 01, dated July 16, 2004.
    (1) Before the accumulation of 3,000 flight cycles by the servo
control since first installation on an airplane, or 3,000 flight
cycles since the installation of the solenoid valve on the servo
control.
    (2) Within 700 flight hours after the effective date of this AD.

(h) Replace O-ring Seals on Spare Elevator Servo Controls Whose O-ring
Seals Were Not Replaced as Required by Paragraph (g) of This AD

    For all Airbus Model A330-200 series airplanes, except those on
which Airbus modifications 53969 and 54833 have been embodied in
production: As of the effective date of this AD, before the
installation of an elevator servo control on an Airbus Model A330-
200 airplane, replace the O-ring seals installed on the two spare
servo control solenoid valves using new O-ring seals, in accordance
with Airbus AOT A330-27A3129, Revision 01, dated July 16, 2004.

(i) Replace O-ring Seals with Part Number (P/N) MS28775-XXX or a Part
Number That Cannot Be Identified

    For Model A330-200 series airplanes which have been modified as
specified in Airbus AOT A330-27A3129, dated June 24, 2004, but which
have not been modified as specified in Airbus AOT A330-27A3129,
Revision 01, dated July 16, 2004; except those airplanes on which
Airbus modifications 53969 and 54833 have been embodied in
production: Within 15 days after the effective date of this AD,
check the (P/N) of the seals installed on the solenoid valve of the
servo control of the elevator in the damping position. If the seals
installed have P/N MS28775-XXX or a part number that cannot be
identified, before further flight, replace the seals with new seals
using a part number listed in paragraph (i)(1), (i)(2), or (i)(3) of
this AD, in accordance with Airbus AOT A330-27A3129, Revision 01,
dated July 16, 2004.
    (1) IPC 27-34-51-1 item 130: NAS1611-011 or NAS1611-011A;
    (2) IPC 27-34-51-1 item 140: NAS1611-012 or NAS1611-012A; or
    (3) IPC 27-34-51-1 item 150: NAS1611-013 or NAS1611-013A.

(j) Replace O-ring Seals on Model A330-200, A330-300, A340-200, and
A340-300 Series Airplanes

    For Model A330-200, A330-300, A340-200, and A340-300 series
airplanes equipped with elevator servo controls P/N SC4800-2/-4/-7/-
8 or SC4800-7/-8 modified into P/N SC4800-7A/-9, as specified in
Airbus Service Bulletin A340-27-4083 or Airbus Service Bulletin
A330-27-3076: Within 1,400 flight hours after the effective date of
this AD, replace the O-ring seals installed on the two solenoid
valves of each elevator servo control in damping position (except
for Model A330-200 series airplanes which have to comply with
paragraph (g) of this AD), and in active position, using a new O-
ring seal P/N NAS1611-XXX or P/N NAS1611-XXXA, in accordance with
the Accomplishment Instructions of Airbus Mandatory Service Bulletin
A330-27A3131, Revision 01, excluding Appendix 01, dated March 3,
2005 (for Model A330 series airplanes); or Airbus Mandatory Service
Bulletin A340-27A4130, Revision 01, excluding Appendix 01, dated
March 3, 2005 (for Model A340 series airplanes).

(k) Replace O-ring Seals on Spare Elevator Servo Controls on Model
A330-200, A330-300, A340-200, and A340-300 Series Airplanes

    For the spare elevator servo controls P/N SC4800-2/-4/-7/-8 or
SC4800-7/-8 modified into P/N SC4800-7A/-9, as specified in Airbus
Service Bulletin A340-27-4083 or Airbus Service Bulletin A330-27-
3076: Before the installation of a spare elevator servo control on
an airplane, replace the O-ring seals installed on the two spare
servo control solenoid valves using a new O-ring seal P/N NAS1611-
XXX or P/N NAS1611-XXXA, in accordance with the Accomplishment
Instructions of Airbus Mandatory Service Bulletin A330-27A3131,
Revision 01, excluding Appendix 01, dated March 3, 2005 (for Model
A330 series airplanes); or Airbus Mandatory Service Bulletin A340-
27A4130, Revision 01, excluding Appendix 01, dated March 3, 2005
(for Model A340 series airplanes).

(l) Modify the Flight Control Primary Computers (FCPCs)

    For all Airbus Model A330-200 and A330-300 series airplanes,
except those on which both Airbus modifications 53468 and 55697 have
been embodied in production; and for all Airbus Model A340-200 and
A340-300 series airplanes, except those on which both modifications
55879 and 55697 have been embodied in production: Within 24 months
after the effective date of this AD, modify the three FCPCs in
accordance with the Accomplishment Instructions of the applicable
service bulletin identified in paragraphs (l)(1) or (l)(2) of this
AD.
    (1) Airbus Service Bulletin A330-27-3144, Revision 01, excluding
Appendix 1, dated July 16, 2009; or Airbus Mandatory Service
Bulletin A330-27-3148, Revision 01, excluding Appendix 1, dated
October 9, 2008 (for Model A330 series airplanes).
    (2) Airbus Mandatory Service Bulletin A340-27-4144, excluding
Appendix 1, dated October 19, 2009; or Airbus Mandatory Service
Bulletin A340-27-4148, excluding Appendix 1, dated June 13, 2008
(for Model A340 series airplanes).

(m) Modify the Flight Control Secondary Computers (FCSCs)

    For all Airbus Model A330-200 and A330-300 series airplanes,
except those on which both Airbus modifications 53468 and 55697 have
been embodied in production, and for all Airbus Model A340-200 and
A340-300 series airplanes, except those on which both modifications
55879 and 55697 have been embodied in production: Within 24 months
after the effective date of this AD, modify both FCSCs, in
accordance with the Accomplishment Instructions of the applicable
service bulletin identified in paragraphs (m)(1) or (m)(2) of this
AD.
    (1) Airbus Mandatory Service Bulletin A330-27-3146, Revision 01,
dated September 3, 2008; or Airbus Service Bulletin A330-27-3145,
dated December 16, 2008 (for Model A330 airplanes).
    (2) Airbus Mandatory Service Bulletin A340-27-4146, June 1,
2007; or Airbus Service Bulletin A340-27-4145, dated December 16,
2008 (for Model A340 airplanes).

(n) Revise the Airplane Flight Manual

    Before further flight, after doing the applicable actions
required by both paragraphs (l) and (m) of this AD, remove the
following procedure from the airplane flight manual, if inserted, in
accordance with the instructions contained in Airbus Temporary
Revision TR4, Issue 1.0, ``TR 4.02.00/25 Issue 2--Undetected
Elevator Control Loss in Case of Dual Failure,'' dated November 26,
2009, to the Airbus A330/A340 Airplane Flight Manual; and Airbus
Temporary Revision TR22, Issue 1.0, ``TR 4.02.00/40 Issue 2--
Undetected Elevator Control Loss in Case of Dual Failure,'' dated
November 26, 2009, to the Airbus A330/A340 Airplane Flight Manual.

Undetected Elevator Control Loss in Case of Dual Failure

    On ground, before takeoff until takeoff power thrust setting,
apply the following procedure.
     In the case of a F/CTL PRIM 1 FAULT, or F/CTL PRIM 1
PITCH FAULT: Turn off PRIM 1, then back on to perform a FCPC PRIM 1
reset.
     If successful: Perform the normal pre-flight Flight
Control check.
     If unsuccessful: Return to the gate and require
appropriate maintenance actions.
     In the case of a F/CTL ELEV SERVO FAULT: Return to the
gate and require appropriate maintenance actions.

(o) Credit for Previous Actions

    This paragraph provides credit for certain actions described in
the following paragraphs.
    (1) This paragraph provides credit for replacements of the O-
ring seals, as required by paragraphs (j) and (k) of this AD, if
those actions were performed before the effective date of this AD
using Airbus Service Bulletin A330-27A3131, dated September 22, 2004
(for Model A330 airplanes); or Airbus Service Bulletin 340-27A4130,
dated September 22, 2004 (for Model A340 airplanes).
    (2) This paragraph provides credit for modifications of the
FCPC, as required by paragraph (l) of this AD, if those actions were
performed before the effective date of this AD using Airbus Service
Bulletin A330-27-3144, dated April 2, 2009 (for Model A330
airplanes); or Airbus Service Bulletin A340-27-3148, dated July 17,
2008 (for Model A340 airplanes).
    (3) This paragraph provides credit for modifications of the
FCSCs, as required by paragraph (m) of this AD, if those actions
were performed before the effective date of this AD using Airbus
Mandatory Service Bulletin A330-27-3146, dated June 1, 2007 (for
Model A330 airplanes).

(p) Terminating Action

    Installation of modified servo-controls at all positions on
Model A330-200 airplanes in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A330-27-3134, Revision 01,
dated May 12, 2006; and Airbus Mandatory Service Bulletin A330-27-
3136, Revision 01, dated July 19, 2006; terminates the actions
required by paragraphs (g), (h), and (i) and of this AD.

(q) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 Branch, send it to Attn: Vladimir
Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
Washington 98057-

3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. 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. The
AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(r) Related Information

    (1) Refer to MCAI European Aviation Safety Agency (EASA)
Airworthiness Directive 2010-0081, dated April 27, 2010, and the
service information specified in paragraphs (r)(1)(i) through
(r)(1)(xv) of this AD, for related information.
    (i) Airbus AOT A330-27A3129, Revision 01, dated July 16, 2004.
    (ii) Airbus Mandatory Service Bulletin A330-27-3136, Revision
01, dated July 19, 2006.
    (iii) Airbus Mandatory Service Bulletin A330-27-3146, Revision
01, dated September 3, 2008.
    (iv) Airbus Mandatory Service Bulletin A330-27-3148, Revision
01, excluding Appendix 1, dated October 9, 2008.
    (v) Airbus Mandatory Service Bulletin A330-27A3131, Revision 01,
excluding Appendix 01, dated March 3, 2005.
    (vi) Airbus Mandatory Service Bulletin A340-27-4144, excluding
Appendix 1, dated October 19, 2009.
    (vii) Airbus Mandatory Service Bulletin A340-27-4146, dated June
1, 2007.
    (viii) Airbus Mandatory Service Bulletin A340-27-4148, excluding
Appendix 1, dated June 13, 2008.
    (ix) Airbus Mandatory Service Bulletin A340-27A4130, Revision
01, excluding Appendix 01, dated March 3, 2005.
    (x) Airbus Service Bulletin A330-27-3134, Revision 01, dated May
12, 2006.
    (xi) Airbus Service Bulletin A330-27-3144, Revision 01,
excluding Appendix 1, dated July 16, 2009.
    (xii) Airbus Service Bulletin A330-27-3145, dated December 16,
2008.
    (xiii) Airbus Service Bulletin A340-27-4145, dated December 16,
2008.
    (xiv) Airbus Temporary Revision TR4, Issue 1.0, ``TR 4.02.00/25
Issue 2--Undetected Elevator Control Loss in Case of Dual Failure,''
dated November 26, 2009, to the Airbus A330/A340 Airplane Flight
Manual.
    (xv) Airbus Temporary Revision TR22, Issue 1.0, ``TR 4.02.00/40
Issue 2--Undetected Elevator Control Loss in Case of Dual Failure,''
dated November 26, 2009, to the Airbus A330/A340 Airplane Flight
Manual.
    (2) For service information identified in this AD, contact
Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, Washington. For
information on the availability of this material at the FAA, call
425-227-1221.

    Issued in Renton, Washington, on August 3, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-19887 Filed 8-13-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 14, 2010 (Volume 75, Number 198)]
[Notices]
[Page 63222-63225]
[DOCID:fr14oc10-122]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 29458; 812-13657]

Claymore Exchange-Traded Fund Trust, et al.; Notice of
Application

October 7, 2010.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of application to amend a prior order under section 6(c)
of the Investment Company Act of 1940 (``Act'') granting an exemption
from sections 2(a)(32), 5(a)(1), 22(d), 22(e) and 24(d) of the Act and
rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act
granting an exemption from sections 17(a)(1) and (a)(2) of the Act, and
under section 12(d)(1)(J) granting an exemption from sections
12(d)(1)(A) and (B) of the Act (``Prior Order'').\1\

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

    \1\ Claymore Exchange-Traded Fund Trust, et al., Investment
Company Act Release Nos. 27469 (Aug. 28, 2006) (notice) and 27483
(Sept. 18, 2006) (order), as amended by Investment Company Act
Release Nos. 27982 (Sept. 26, 2007) (notice) and 28019 (Oct. 23,
2007) (order).

Summary of Application:  The Prior Order permits: (a) Open-end
management investment companies, whose series are based on certain
equity or fixed-income securities indexes (each, an ``Underlying
Index''), to issue shares of limited redeemability; (b) secondary
market transactions in the shares of the series to occur at negotiated
prices; (c) dealers to sell shares to purchasers in the secondary
market unaccompanied by a prospectus when prospectus delivery is not
required by the Securities Act of 1933 (``Securities Act''); (d)
certain affiliated persons of the series to deposit securities into,
and receive securities from, the series in connection with the purchase
and redemption of aggregations of the series' shares; (e) under certain
circumstances, certain series to pay redemption proceeds more than
seven days after the tender of shares; and (f) certain registered
management investment companies and unit investment trusts outside of
the same group of investment companies as the series to acquire shares
of the series. Applicants seek to amend the Prior Order to: (a) Permit
certain Funds (as defined below) to track an Underlying Index that is
created, compiled, sponsored, or maintained by an index provider
(``Index Provider'') that is an affiliated person, or an affiliated
person of an affiliated person, of the Fund, its investment adviser,
distributor, promoter, or any sub-adviser to the

Fund; (b) delete the relief granted from the requirements of section
24(d) of the Act in the Prior Order and revise the applications on
which the Prior Order was issued (``Prior Applications'') to reflect
such deletion; (c) modify the 80%/90% investment requirement in the
Prior Applications; (d) revise the discussion of depositary receipts
(``Depositary Receipts'') in the Prior Applications; and (e) permit the
personnel of the Adviser (as defined below) or any sub-adviser who are
responsible for the designation and dissemination of the securities to
be used for creations (``Deposit Securities'') or redemptions (``Fund
Securities'') to also select securities for purchase or sale by
---------------------------------------------------------------------------
actively-managed accounts of the Adviser or any sub-adviser.

Applicants:  Claymore Exchange-Traded Fund Trust, Claymore Exchange-
Traded Fund Trust 2, Claymore Exchange-Traded Fund Trust 3 (each, a
``Trust'' and together, the ``Trusts''), Guggenheim Funds Investment
Advisors, LLC (``Adviser''), and Guggenheim Funds Distributors, Inc.
(``Distributor'').

Filing Dates:  The application was filed on May 5, 2009, and amended on
November 23, 2009, September 3, 2010, and October 1, 2010. Applicants
have agreed to file an amendment during the notice period, the
substance of which is reflected in the notice.

Hearing or Notification of Hearing:  An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on November 1, 2010, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549-1090. Applicants, 2455 Corporate West
Drive, Lisle, IL 60532.

FOR FURTHER INFORMATION CONTACT: Courtney S. Thornton, Senior Counsel,
at<PHONE_NUMBER>, or Mary Kay Frech, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Office of Investment Company
Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's website by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/
search.htm, or by calling<PHONE_NUMBER>.

Applicants' Representations

    1. Each Trust is organized as a Delaware statutory trust and is
registered under the Act as an open-end management investment company.
Each Trust offers one or more series (each a ``Fund''), each of which
operates as an exchange-traded fund (``ETF''). The Adviser, a Delaware
limited liability company, is registered as an investment adviser under
the Investment Advisers Act of 1940 (the ``Advisers Act''). The Adviser
serves as investment adviser to each of the Funds and may retain sub-
advisers (``Sub-Advisers'') to manage the assets of one or more of the
Funds. Any Sub-Adviser will be registered under the Advisers Act. The
Distributor, a broker-dealer registered under the Securities Exchange
Act of 1934 (``Exchange Act''), serves as principal underwriter and
distributor for each of the Funds.
    2. Applicants currently are permitted to offer Funds that operate
in reliance on the Prior Order and seek to track the performance of
Underlying Indexes from Index Providers that are not ``affiliated
persons'' (as such term is defined in section 2(a)(3) of the Act), or
affiliated persons of affiliated persons, of a Trust, the Adviser, any
Sub-Adviser to a Fund, the Distributor or a promoter of a Fund. Certain
Funds rely on the Prior Order and track an Underlying Index provided by
either AlphaShares, LLC (``AlphaShares'') or Delta Global Indices, LLC
(``Delta Global'') (collectively, the ``Affected Funds'').\2\
Currently, neither AlphaShares nor Delta Global is an affiliated
person, nor an affiliated person of an affiliated person, of a Trust,
the Adviser, or any Sub-Adviser to a Fund, the Distributor or promoter
of a Fund.
---------------------------------------------------------------------------

    \2\ AlphaShares is the Index Provider for Guggenheim China Real
Estate ETF, Guggenheim China Small Cap ETF, Guggenheim China All-Cap
ETF, and Guggenheim China Technology ETF. Delta Global is the Index
Provider for Guggenheim Shipping ETF.
---------------------------------------------------------------------------

    3. Applicants seek to amend the Prior Order to permit an Affected
Fund to track an Underlying Index that is created, compiled, sponsored,
or maintained by an Index Provider that is an affiliated person, as
defined in section 2(a)(3) of the Act, or an affiliated person of an
affiliated person, of a Trust, the Adviser, the Distributor, promoter,
or any Sub-Adviser to the Affected Fund solely because the Index
Provider serves as a Sub-Adviser to a Subadvised Fund (as defined
below).\3\ The Adviser proposes to offer a closed-end fund (``Closed-
End Fund'') for which AlphaShares would serve as Sub-Adviser. In
reliance on an order granting relief with respect to the offering of
actively managed Future Funds,\4\ the Adviser and Claymore Exchange-
Traded Fund Trust 3 propose to offer three actively managed ETFs for
which Delta Global would serve as Sub-Adviser. Because the Adviser
serves or will serve as investment adviser to each, the Affected Funds
and each Subadvised Fund could be deemed to be under common control for
purposes of section 2(a)(3). In addition, section 2(a)(3)(E) provides
that any investment adviser to an investment company is deemed to be an
affiliated person of such company. Accordingly, by serving as Sub-
Adviser to a Subadvised Fund, each of AlphaShares and Delta Global
could be deemed to be an affiliated person of an affiliated person of
the Adviser and/or the Fund(s) for which it serves as Index Provider.
As a result, applicants would not be permitted to retain either
AlphaShares or Delta Global as Sub-Adviser to a Subadvised Fund, absent
further exemptive relief.
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    \3\ Applicants request that the requested order apply to any
future series of the Trusts or other registered investment company
advised by the Adviser or a person controlling, controlled by, or
under common control with the Adviser that operates as an ETF (a
``Future Fund'') for which the Index Provider also serves as Sub-
Adviser to another Fund or Future Fund or other registered
investment company advised by the Adviser, or a person controlling,
controlled by, or under common control with the Adviser
(collectively ``Subadvised Funds'').
    \4\ Claymore Exchange-Traded Fund Trust 3, et al., Investment
Company Act Release No. 29256 (Apr. 23, 2010) (notice) and 29271
(May 18, 2010) (order).
---------------------------------------------------------------------------

    4. Applicants state that the conflicts of interest that could
result if an Index Provider has a proscribed relationship with a Trust,
the Adviser, any Sub-Adviser, the Distributor, or promoter of a Fund
include the ability of an affiliated person to manipulate the
Underlying Index to the benefit or detriment of the Fund, as well as
conflicts that may also arise with respect to the personal trading
activity of personnel of the affiliated person who may have access to,
or knowledge of, changes to an Underlying Index's composition
methodology or the constituent securities in an Underlying Index prior
to the time that information is publicly disseminated. Applicants
believe that these conflicts of interest are not applicable to the
Affected Funds because the Adviser is not part of the

same organization as either Index Provider. Accordingly, the Adviser
will not be informed of any additions to or deletions from an
Underlying Index tracked by an Affected Fund (each, an ``Applicable
Underlying Index'') prior to other market participants or the general
public. Applicants state that the Adviser therefore will not have any
ability to manipulate the components of the Applicable Underlying
Indexes for its own benefit, nor will it have an informational
advantage over other market participants with regard to additions to or
deletions from the Applicable Underlying Indexes. Applicants further
state that the Adviser will not have any role in the (a) modification
of an Applicable Underlying Index's methodology, (b) selection of an
Applicable Underlying Index's constituents, or (c) calculation or
dissemination of an Applicable Underlying Index's value, and shall have
no access to the information involved with items (a)-(c) or any changes
thereto prior to their public dissemination in advance of the
rebalancing of an Applicable Underlying Index or any interim
modification arising from any corporate action.
    5. Applicants also state that the Adviser and the Index Providers
have adopted policies and procedures designed to prevent the
dissemination and improper use of non-public information in a manner
similar to firewalls. Each of the Adviser, AlphaShares, and Delta
Global has adopted written policies and procedures in accordance with
rule 206(4)-7 under the Advisers Act, that contains: (a) A section that
sets forth the applicable entity's insider trading policy and that
includes the applicable entity's procedures to prevent and detect the
misuse of material non-public information; and (b) the applicable
entity's code of ethics which was adopted pursuant to rule 17j-1 under
the Act and rule 204A-1 under the Advisers Act, which contains
provisions reasonably necessary to prevent Access Persons (as defined
in rule 17j-1) of the applicable entity from trading on the basis of,
improperly disseminating or otherwise engaging in any improper use of
nonpublic information.
    6. Applicants further state that they will adopt, and will require
AlphaShares and Delta Global to adopt, policies and procedures that
require the Applicable Underlying Indexes to be transparent. Each of
AlphaShares and Delta Global will maintain a publicly available Web
site on which it will publish the basic concept of each Applicable
Underlying Index and disclose (a) the composition methodology for each
such Applicable Underlying Index (``Index Composition Methodology'')
and (b) the components and weightings of the components of each
Applicable Underlying Index (as of each rebalancing or interim
modification arising from a corporate action). Applicants note that the
identity and weightings of the component securities of the Applicable
Underlying Index will be readily ascertainable by a third party because
the Index Composition Methodology will be publicly available. Although
each of AlphaShares and Delta Global reserves the right to modify its
Index Composition Methodology in the future, such modifications would
not take effect until the applicable Index Provider has given the
Calculation Agent (as defined below) and the investing public at least
60 days' prior written notice, disclosed on the publicly available Web
site of such Index Provider, that such changes are being planned to
take effect.\5\ Each Underlying Index will be reconstituted or
rebalanced no more frequently than on a monthly basis.
---------------------------------------------------------------------------

    \5\ The ``Calculation Agent'' is the entity that will implement
the Index Composition Methodology, calculate and maintain the
Applicable Underlying Indexes, and calculate and disseminate the
Applicable Underlying Index values. The Calculation Agent is not and
will not be an affiliated person within the meaning of section
2(a)(3) of the Act, or an affiliated person of an affiliated person,
of a Trust, the Adviser, any Sub-Adviser, the Distributor, or a
promoter of a Fund. The Calculation Agent will be instructed not to
communicate any non-public information about the Applicable
Underlying Indexes to anyone, but specifically not to the personnel
of the Adviser with responsibility for the portfolio management of
the Affected Funds. The Calculation Agent will be instructed to
disseminate information about the daily constituents of the
Applicable Underlying Indexes to the Adviser (on behalf of the
Affected Funds) and the public at the same time.
---------------------------------------------------------------------------

    7. Applicants represent that any Index Provider to an existing Fund
or a Future Fund that enters into a similar arrangement to serve as
Sub-Adviser to a Subadvised Fund will be subject to the same policies
and procedures as proposed herein with respect to AlphaShares and Delta
Global. Applicants further represent that any relief granted pursuant
to the application will only apply to an Index Provider whose
affiliation with a Trust, the Adviser or any Sub-Adviser to a Fund,
Distributor or promoter of a Fund arises from relationships such as
those described in the application. Applicants acknowledge that Index
Providers whose affiliation arises from relationships other than those
described in the application may not serve as Index Provider to a Fund
without additional exemptive relief.

Additional Changes to Prior Order

    1. Applicants seek to amend the Prior Order to delete the relief
granted from section 24(d) of the Act. Applicants believe that the
deletion of the exemption from section 24(d) is warranted because the
adoption of the summary prospectus should supplant any need by a Fund
to use a product description (``Product Description'').\6\ The deletion
of the relief granted with respect to section 24(d) of the Act from the
Prior Order will also result in the deletion of related discussions in
the Prior Applications, revision of the Prior Applications to delete
references to Product Descriptions, including in the conditions, and
the deletion of condition 5 to the Prior Order.\7\
---------------------------------------------------------------------------

    \6\ Investment Company Act Release No. 28584 (Jan. 13, 2009)
(the ``Summary Prospectus Rule'').
    \7\ Condition 5 states: Before a Fund may rely on the order, the
Commission will have approved, pursuant to rule 19b-4 under the
Exchange Act, an Exchange rule requiring Exchange members and member
organizations effecting transactions in Fund Shares to deliver a
Product Description to purchasers of Fund Shares.
---------------------------------------------------------------------------

    2. The Prior Applications state that a Fund will hold, in the
aggregate, at least 80 percent or 90 percent of its total assets in the
securities that comprise the relevant Underlying Index (``Component
Securities''), and investments that have economic characteristics that
are substantially identical to the economic characteristics of the
Component Securities of its Underlying Index. Applicants seek to amend
the Prior Order to require a Fund to hold at least 80 percent of its
total assets in Component Securities of its Underlying Index or in
Depositary Receipts or to-be-announced transactions (``TBAs'')
representing Component Securities (or underlying securities
representing Depositary Receipts, if Depositary Receipts are themselves
Component Securities).
    3. Applicants wish to amend the Prior Order to revise certain
representations regarding a Fund's ability to invest in Depositary
Receipts. The Prior Applications state, among other things, that a Fund
will invest only in Depositary Receipts listed on a national securities
exchange as defined in section 2(a)(26) of the Act and that all
Depositary Receipts in which a Fund invests will be sponsored by the
issuers of the underlying security, except in certain circumstances.
Applicants seek to amend the Prior Applications to state that
Depositary Receipts include American Depositary Receipts (``ADRs'') and
Global Depositary Receipts (``GDRs''). With respect to ADRs, the
depositary is typically a U.S. financial institution, and the
underlying

securities are issued by a foreign issuer. The ADR is registered under
the Securities Act on Form F-6. ADR trades occur either on an Exchange
or off-exchange. Rule 6620 of the Financial Industry Regulatory
Authority (``FINRA'') requires all off-exchange transactions in ADRs to
be reported within 90 seconds and ADR trade reports to be disseminated
on a real-time basis. With respect to GDRs, the depositary may be
foreign or a U.S. entity, and the underlying securities may have a
foreign or a U.S. issuer. All GDRs are sponsored and trade on a foreign
exchange. No affiliated persons of applicants will serve as the
depositary for any Depositary Receipts held by a Fund. A Fund will not
invest in any Depositary Receipts that the Adviser deems to be illiquid
or for which pricing information is not readily available.
    4. Applicants also seek to amend the terms and conditions of the
Prior Applications to provide that all representations and conditions
contained in the Prior Applications that require a Fund to disclose
particular information in the Fund's prospectus and/or annual report
shall remain effective with respect to the Fund until the time the Fund
complies with the disclosure requirements adopted by the Commission in
the Summary Prospectus Rule. Applicants believe that the proposal to
supersede the representations and conditions requiring certain
disclosures in the Prior Applications is warranted because the
Commission's amendments to Form N-1A with respect to ETFs as part of
the Summary Prospectus Rule reflect the Commission's view with respect
to the appropriate types of prospectus and annual report disclosures
for an ETF.
    5. Applicants also wish to amend the Prior Order to permit the
personnel of the Adviser or any Sub-Adviser who are responsible for the
designation and dissemination of Deposit Securities or Fund Securities
to also select securities for purchase or sale by actively-managed
accounts of the Adviser or Sub-Adviser. The Prior Applications
currently state that such personnel will have no responsibilities for
the selection of securities for purchase or sale by any actively-
managed accounts of the Adviser or Sub-Adviser. Applicants state that
the Codes of Ethics adopted by the Adviser and Distributor, among other
procedures, adequately address any conflicts of interest. Applicants
also note that the Commission more recently has granted exemptive
relief with respect to index-based ETFs that does not contain the
prohibition on adviser personnel designating securities for a creation
or redemption with respect to such ETFs and also managing actively-
managed accounts for the adviser.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the same conditions as those imposed by the Prior Order,
except for condition 5 to the Prior Order, which will be deleted.\8\
---------------------------------------------------------------------------

    \8\ As noted above, all representations and conditions contained
in the application and the Prior Applications that require a Fund to
disclose particular information in the Fund's prospectus and/or
annual report shall remain effective with respect to the Fund until
the time that the Fund complies with the disclosure requirements
adopted by the Commission in the Summary Prospectus Rule.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-25819 Filed 10-13-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 96 (Thursday, May 18, 2023)]
[Notices]
[Pages 31763-31764]
[FR Doc No: 2023-10604]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidance for Ethinyl Estradiol; Segesterone
Acetate; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Draft
Guidance for Ethinyl Estradiol; Segesterone Acetate.'' The draft
guidance, when finalized, will provide product-specific recommendations
on, among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs) for ethinyl
estradiol; segesterone acetate vaginal ring.

DATES: Submit either electronic or written comments on the draft
guidance by July 17, 2023, to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2007-D-0369 for ``Draft Guidance for Ethinyl Estradiol; Segesterone
Acetate.'' 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 the draft 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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Christine Le, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 301-
796-2398, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific
guidances available to the public on FDA's website at: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
    As described in that guidance, FDA adopted this process to develop
and disseminate product-specific guidances and to provide a meaningful
opportunity for the public to consider and comment on the guidances.
This notice announces the availability of a draft guidance for ethinyl
estradiol; segesterone acetate vaginal ring.
    FDA initially approved new drug application (NDA) 209627 ANNOVERA
(ethinyl estradiol; segesterone acetate) in August 2018. We are now
issuing a draft guidance for industry on, among other things, BE
recommendations for generic ethinyl estradiol; segesterone acetate
vaginal ring (``Draft Guidance for Ethinyl Estradiol; Segesterone
Acetate'').
    In March 2021, TherapeuticsMD, Inc. (``TherapeuticsMD'') submitted
a citizen petition requesting, among other things, that FDA refuse to
receive and refuse to approve any ANDAs seeking approval to market a
generic version of ANNOVERA unless certain BE criteria are met.

(Docket No. FDA-2021-P-0293, available at https://www.regulations.gov).
FDA is separately responding to TherapeuticsMD's citizen petition today
as well.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the design of
BE studies to support ANDAs for ethinyl estradiol; segesterone acetate.
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

    FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

III. Electronic Access

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

    Dated: May 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10604 Filed 5-17-23; 8:45 am]
BILLING CODE 4164-01-P