[Federal Register Volume 84, Number 36 (Friday, February 22, 2019)]
[Rules and Regulations]
[Pages 5589-5592]
[FR Doc No: 2019-02930]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0409; Product Identifier 2017-NM-120-AD; Amendment
39-19559; AD 2019-03-07]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2017-16-05,
which applied to certain The Boeing Company Model 737-600, -700, -700C,
-800, -900, and -900ER series airplanes. AD 2017-16-05 required a one-
time detailed visual inspection for discrepancies in the Krueger flap
bullnose attachment hardware, and related investigative and corrective
actions if necessary. This AD adds airplanes and an additional
inspection to determine if any Krueger flap no. 1, 2, 3, or 4 has been
replaced, and related investigative and corrective actions. Since this
is a rotable parts issue, the applicability of this AD has been
expanded beyond the airplanes listed in the related service bulletin to
include all airplanes on which a Krueger flap bullnose may be
installed. This AD was prompted by a report of a Krueger flap bullnose
departing an airplane during taxi, which caused damage to the wing
structure and thrust reverser, and a report of a missing no. 2 Krueger
flap bullnose hinge bolt from an airplane that was not included in the
effectivity of AD 2017-16-05. We are issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective March 29, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 29,
2019.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; phone:<PHONE_NUMBER>; internet: https://www.myboeingfleet.com. You may view this service information 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 on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0409.

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-2018-
0409; 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 (phone: 800-647-
5527) 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: Alan Pohl, Aerospace Engineer,
Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des
Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2017-16-05, Amendment 39-18982 (82 FR39344,
August 18, 2017) (``AD 2017-16-05''). AD 2017-16-05 applied to certain
The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER
series airplanes. The NPRM published in the Federal Register on May 15,
2018 (83 FR22420). The NPRM was prompted by a report of a Krueger flap
bullnose departing an airplane during taxi, which caused damage to the
wing structure and thrust reverser, and a report of a missing no. 2
Krueger flap bullnose hinge bolt from an airplane that was not included
in the effectivity of AD 2017-16-05. The NPRM proposed to continue to
require a one-time detailed visual inspection for discrepancies in the
Krueger flap bullnose attachment hardware, and related investigative
and corrective actions, if necessary. The NPRM also proposed to add
airplanes and an additional inspection to determine if any Krueger flap
no. 1, 2, 3, or 4 has been replaced, and related investigative and
corrective actions. Since this is a rotable parts issue, the
applicability of this AD has been expanded beyond the airplanes listed
in the related service bulletin to include all airplanes on which a
Krueger flap bullnose may be installed. We are issuing this AD to
address missing Krueger flap bullnose hardware. Such missing hardware
could result in the Krueger flap bullnose departing the airplane during
flight, which could damage empennage structure and lead to the
inability to maintain continued safe flight and landing.

Comments

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

Support for the NPRM

    Boeing concurred with the content of the NPRM. Delta Air Lines
(DAL) and American Airlines (AAL) concurred with the intent of the
NPRM.

Effect of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing stated that accomplishing the Supplemental
Type Certificate (STC) ST00830SE does not affect the actions specified
in the NPRM.
    We concur with the commenter. We have redesignated paragraph (c) of
the proposed AD as paragraph (c)(1) of this AD and added paragraph
(c)(2) to this AD to state that installation of STC ST00830SE does not
affect the ability to accomplish the actions required by this AD.
Therefore, for airplanes on which STC ST00830SE is installed, a
``change in product'' alternative method of compliance (AMOC) approval
request is not necessary to comply with the requirements of 14 CFR
39.17.

Request To Remove Airplanes From the Applicability

    All Nippon Airways (ANA) requested that we remove the airplanes
identified in paragraph (c)(3) of the proposed AD. ANA stated that
those airplanes are not required to do the actions specified in
paragraph (g) of the proposed AD.
    We disagree with the request. Although the airplanes identified in
paragraph (c)(1)(iii) of this AD (paragraph (c)(3) of the proposed AD)
are not required to do the actions specified in paragraph (g) of this
AD, those airplanes must still comply with the parts installation
limitation specified in paragraph (i) of this AD. We have not changed
this AD in this regard.

Request for a Different Method of Compliance

    DAL requested that we include an option in paragraph (i) of the
proposed AD to install the Krueger flap before accomplishing the
required actions. DAL mentioned that it has updated its manuals to
inspect after installation on the airplane, not prior to installation.
    We agree that clarification is necessary. The required inspection
of the Krueger flap bullnose can only be accomplished after
installation on the Krueger flap assembly, either prior to or after
installation on the airplane. We have revised paragraph (i) to specify
that the actions required by paragraph (g) of this AD must be
accomplished after installation but prior to further flight.

Request To Clarify Which Krueger Flaps Are Affected

    DAL and AAL requested that we clarify paragraph (i) of the proposed
AD to specify affected Krueger flap(s) and Krueger flap bullnose(s).
DAL stated that not all four positions need to be inspected, only the
Krueger flap(s) and Krueger flap bullnose(s) being installed. AAL
suggested that we reword paragraph (i) of the proposed AD to improve
clarity.
    We agree with the request because it is not necessary to perform
the actions specified in paragraph (i) of this AD on all four Krueger
flap(s) or Krueger flap bullnose(s). Only the Krueger flap(s) or
Krueger flap bullnose(s) being installed must be inspected. We have
revised paragraph (i) of this AD to specify: ``These actions are
required only for the Krueger flap(s) or Krueger flap bullnose(s) being
installed.''

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously, and minor editorial
changes. We have 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.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 737-57A1327, Revision 2,
dated July 25, 2017. This service information describes procedures for
a one-time detailed visual inspection for discrepancies in the Krueger
flap bullnose attachment hardware, and related investigative and
corrective actions; and an inspection to determine if any Krueger flap
no. 1, 2, 3, or 4 has been replaced, and related investigative and
corrective actions. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 1,814 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Inspection of the Krueger flap          3 work-hours x $85 per                $0            $255        $381,225
 bullnose hardware (1,495 airplanes)     hour = $255.
 (retained actions from AD 2017-16-05).
Inspection to determine if any Krueger  3 work-hours x $85 per                 0             255         462,570
 flap no. 1, 2, 3, or 4 has been         hour = $255.
 replaced (1,814 airplanes) (new
 action).
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.
    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all available costs in our
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.
    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.
    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

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

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 removing Airworthiness Directive (AD)
2017-16-05, Amendment 39-18982 (82 FR 39344, August 18, 2017), and
adding the following new AD:

2019-03-07 The Boeing Company: Amendment 39-19559; Docket No. FAA-
2018-0409; Product Identifier 2017-NM-120-AD.

(a) Effective Date

    This AD is effective March 29, 2019.

(b) Affected ADs

    This AD replaces AD 2017-16-05, Amendment 39-18982 (82 FR 39344,
August 18, 2017) (``AD 2017-16-05'').

(c) Applicability

    (1) This AD applies to all The Boeing Company Model 737-600, -
700, -700C, -800, -900, and -900ER series airplanes, certificated in
any category, as specified in paragraphs (c)(1)(i) through
(c)(1)(iii) of this AD.
    (i) Airplanes in Groups 1 and 2 as identified in Boeing Alert
Service Bulletin 737-57A1327, Revision 2, dated July 25, 2017
(``BASB 737-57A1327, R2'').
    (ii) Airplanes in Group 3, as identified in BASB 737-57A1327,
R2, except where this service bulletin specifies the groups as line
numbers 6422 through 6465 inclusive, this AD specifies those groups
as line number 6422 through any line number airplane with an
original Certificate of Airworthiness or an original Export
Certificate of Airworthiness dated on or before the effective date
of this AD.
    (iii) All Model 737-600, -700, -700C, -800, -900 and -900ER
series airplanes with an original Certificate of Airworthiness or an
original Export Certificate of Airworthiness dated after the
effective date of this AD.
    (2) Installation of Supplemental Type Certificate (STC)
ST00830SE does not affect the ability to accomplish the actions
required by this AD. Therefore, for airplanes on which STC ST00830SE
is installed, a ``change in product'' alternative method of
compliance (AMOC) approval request is not necessary to comply with
the requirements of 14 CFR 39.17.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by a report of a Krueger flap bullnose
departing an airplane during taxi, which caused damage to the wing
structure and thrust reverser, and a report of a missing no. 2
Krueger flap bullnose hinge bolt from an airplane that was not
included in the effectivity of AD 2017-16-05. We are issuing this AD
to address missing Krueger flap bullnose hardware. Such missing
hardware could result in the Krueger flap bullnose departing the
airplane during flight, which could damage empennage structure and
lead to the inability to maintain continued safe flight and landing.

(f) Compliance

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

(g) Required Actions

    For airplanes identified in paragraphs (c)(1)(i) and (c)(1)(ii)
of this AD: Except as required by paragraph (h) of this AD, at the
applicable times specified in paragraph 1.E., ``Compliance,'' of
BASB 737-57A1327, R2, do all applicable actions identified as ``RC''

(required for compliance) in, and in accordance with, the
Accomplishment Instructions of BASB 737-57A1327, R2.

(h) Exceptions to Service Information Specifications

    (1) For purposes of determining compliance with the requirements
of this AD: Where BASB 737-57A1327, R2 uses the phrase ``the
original issue date of this service bulletin,'' this AD requires
using September 22, 2017 (the effective date of AD 2017-16-05).
    (2) For purposes of determining compliance with the requirements
of this AD: Where BASB 737-57A1327, R2 uses the phrase ``the
Revision 2 date of this service bulletin,'' this AD requires using
``the effective date of this AD.''

(i) Parts Installation Limitation

    As of the effective date of this AD, no person may install a
Krueger flap or Krueger flap bullnose on any airplane identified in
paragraph (c)(1)(i), (c)(1)(ii), or (c)(1)(iii) of this AD, unless
the actions required by paragraph (g) of this AD have been
accomplished on the Krueger flap bullnose after installation but
prior to further flight. These actions are required only for the
Krueger flap(s) or Krueger flap bullnose(s) being installed.

(j) Credit for Previous Actions

    (1) This paragraph provides credit for the actions specified in
paragraph (g) of this AD, if those actions were performed before
September 22, 2017 (the effective date of AD 2017-16-05), using
Boeing Alert Service Bulletin 737-57A1327, dated May 20, 2016.
    (2) This paragraph provides credit for the actions specified in
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD, using Boeing Alert Service Bulletin 737-
57A1327, Revision 1, dated September 28, 2016.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO 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
manager of the certification office, send it to the attention of the
person identified in paragraph (l)(1) of this AD. Information may be
emailed to<EMAIL_ADDRESS>    (2) 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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO Branch, FAA, to make those findings. To be
approved, the repair method, modification deviation, or alteration
deviation must meet the certification basis of the airplane, and the
approval must specifically refer to this AD.
    (4) AMOCs approved previously for AD 2017-16-05 are approved as
AMOCs for the corresponding provisions of BASB 737-57A1327, R2 that
are required by paragraph (g) of this AD.
    (5) For service information that contains steps that are labeled
as RC, the provisions of paragraphs (k)(5)(i) and (k)(5)(ii) of this
AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Operators may deviate from steps not labeled as RC by using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the RC steps, including substeps and identified figures, can still
be done as specified, and the airplane can be put back in an
airworthy condition.

(l) Related Information

    (1) For more information about this AD, contact Alan Pohl,
Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200
South 216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (m)(3) and (m)(4) of this AD.

(m) 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 the AD specifies otherwise.
    (i) Boeing Alert Service Bulletin 737-57A1327, Revision 2, dated
July 25, 2017.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; phone:<PHONE_NUMBER>; internet: https://www.myboeingfleet.com.
    (4) You may view this service information 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.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on February 7, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-02930 Filed 2-21-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Pages 78629-78630]
[FR Doc No: 2011-32403]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP12-225-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: 12/08/11 Negotiated Rates--Citigroup Energy Inc. to be
effective 12/8/2011.
    Filed Date: 12/8/11.
    Accession Number: 20111208-5102.
    Comments Due: 5 p.m. ET 12/20/11.

    Docket Numbers: RP12-226-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: 12/08/11 Negotiated Rates--Freepoint Commodities, LLC
to be effective 12/8/2011.
    Filed Date: 12/8/11.
    Accession Number: 20111208-5103.
    Comments Due: 5 p.m. ET 12/20/11.

    Docket Numbers: RP12-227-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: 12/08/11 Negotiated Rates--Societe Generale Energy
Corp.--RTS to be effective 12/8/2011.
    Filed Date: 12/8/11.
    Accession Number: 20111208-5104.
    Comments Due: 5 p.m. ET 12/20/11.

    Docket Numbers: RP12-228-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: 12/08/11 Negotiated Rates--United Energy Trading,
LLC--RTS to be effective 12/8/2011.
    Filed Date: 12/8/11.
    Accession Number: 20111208-5105.
    Comments Due: 5 p.m. ET 12/20/11.

    Docket Numbers: RP12-229-000.
    Applicants: Petal Gas Storage, LLC.
    Description: Baseline Filing of Second Revised Volume 1 to be
effective 12/1/2011.
    Filed Date: 12/9/11.
    Accession Number: 20111209-5048.
    Comments Due: 5 p.m. ET 12/21/11.

    Docket Numbers: RP12-230-000.
    Applicants: Petal Gas Storage, LLC.
    Description: Cancel First Revised Volume No. 1 Tariff to be
effective 12/9/2011.
    Filed Date: 12/9/11.
    Accession Number: 20111209-5112.
    Comments Due: 5 p.m. ET 12/21/11.

    Docket Numbers: RP12-231-000.
    Applicants: Viking Gas Transmission Company.
    Description: Part 5.0 Correction to be effective 12/1/2011.

    Filed Date: 12/9/11.
    Accession Number: 20111209-5115.
    Comments Due: 5 p.m. ET 12/21/11.

    Docket Numbers: RP12-232-000.
    Applicants: Tennessee Gas Pipeline Company, LLC.
    Description: Actual Tariff Record Scheduling Provisions (Rate Case
non-rate issues) to be effective 2/1/2012.
    Filed Date: 12/9/11.
    Accession Number: 20111209-5146.
    Comments Due: 5 p.m. ET 12/21/11.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP12-20-001.
    Applicants: Millennium Pipeline Company, LLC.
    Description: Negotiated Rate Service Agreement Compliance Filing to
be effective 11/1/2011.
    Filed Date: 12/8/11.
    Accession Number: 20111208-5107.
    Comments Due: 5 p.m. ET 12/20/11.

    Docket Numbers: RP12-13-001.
    Applicants: Williston Basin Interstate Pipeline Company.
    Description: Compliance Filing--Transfer Language to be effective
11/10/2011.
    Filed Date: 12/9/11.
    Accession Number: 20111209-5047.
    Comments Due: 5 p.m. ET 12/21/11.

    Docket Numbers: RP12-149-001.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Revised Storage Tracker RP12-149-001 to be effective
10/1/2011.
    Filed Date: 12/12/11.
    Accession Number: 20111212-5003.
    Comments Due: 5 p.m. ET 12/27/11.

    Docket Numbers: RP12-150-001.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Revised Storage Tracker RP12-150-001 to be effective
11/1/2011.
    Filed Date: 12/12/11.
    Accession Number: 20111212-5004.
    Comments Due: 5 p.m. ET 12/27/11.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5 p.m. Eastern time on the specified comment
date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: December 12, 2011.
Nathaniel J. Davis, Sr.
Deputy Secretary
[FR Doc. 2011-32403 Filed 12-16-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 242 (Wednesday, December 17, 2014)]
[Notices]
[Pages 75136-75137]
[FR Doc No: 2014-29526]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER14-2373-001.
    Applicants: Avista Corporation.
    Description: Compliance filing per 35: Avista Corp OATT Order 792
Compliance Filing to be effective 12/11/2014.
    Filed Date: 12/10/14.
    Accession Number: 20141210-5151.
    Comments Due: 5 p.m. ET 12/31/14.

    Docket Numbers: ER15-297-001.
    Applicants: LDVF1 TEP LLC.
    Description: Tariff Amendment per 35.17(b): Supplement to MBR
Filing to be effective 1/1/2015.
    Filed Date: 12/8/14.
    Accession Number: 20141208-5349.
    Comments Due: 5 p.m. ET 12/29/14.

    Docket Numbers: ER15-567-001.
    Applicants: NiGen, LLC.
    Description: Tariff Amendment per 35.17(b): Amendment to Baseline
Filing to be effective 1/1/2015.
    Filed Date: 12/10/14.
    Accession Number: 20141210-5112.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-602-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Service
Agreement No. 4063--Queue Position Y2-078 to be effective 11/8/2014.
    Filed Date: 12/10/14.
    Accession Number: 20141210-5005.
    Comments Due: 5 p.m. ET 12/31/14.

    Docket Numbers: ER15-603-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 2827R2
Kansas Power Pool & Westar Meter Agent Agreement to be effective 12/1/
2014.
    Filed Date: 12/10/14.
    Accession Number: 20141210-5043.
    Comments Due: 5 p.m. ET 12/31/14.

    Docket Numbers: ER15-604-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): BPA
Two-Way Operation and Maintenance Agreement 5th Revised to be effective
2/9/2015.
    Filed Date: 12/10/14.
    Accession Number: 20141210-5102.
    Comments Due: 5 p.m. ET 12/31/14.

    Docket Numbers: ER15-605-000.
    Applicants: Solea PJM, LLC.
    Description: Initial rate filing per 35.12 Solea PJM, LLC
Application for MBR Authority to be effective 2/1/2015.
    Filed Date: 12/10/14.
    Accession Number: 20141210-5152.
    Comments Due: 5 p.m. ET 12/31/14.

    Docket Numbers: ER15-606-000.
    Applicants: Palo Duro Wind Interconnection Services.
    Description: Compliance filing per 35: Palo Duro Wind
Interconnection

Services, LLC SFA Compliance Filing to be effective 10/22/2014.
    Filed Date: 12/10/14.
    Accession Number: 20141210-5153.
    Comments Due: 5 p.m. ET 12/31/14.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 10, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-29526 Filed 12-16-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Rules and Regulations]
[Page 81790]
[FR Doc No: 2011-33531]

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

FEDERAL AVIATION ADMINISTRATION

14 CFR Part 23

Airworthiness Standards: Normal, Utility, Acrobatic, and Commuter
Category Airplanes

CFR Correction

    In Title 14 of the Code of Federal Regulations, Parts 1 to 59,
revised as of January 1, 2011, on page 351, in Appendix C to Part 23,
Note (4) to the table is corrected to read as follows:

APPENDIX C TO PART 23--BASIC LANDING CONDITIONS

* * * * *

0
Note (4). L is defined in Sec.  23.725(b).
* * * * *
[FR Doc. 2011-33531 Filed 12-28-11; 8:45 am]
BILLING CODE 1505-01-D


[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)]
[Notices]
[Pages 41944-41945]
[FR Doc No: 2017-18713]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC17-166-000.
    Applicants: Northern States Power Company, a Minnesota corporation,
Benson Power, LLC.
    Description: Joint Application for Authorization under Section 203
of the Federal Power Act, Request for Expedited Treatment, Waivers and
Confidential Treatment of Northern States Power Company, a Minnesota
corporation, et al.
    Filed Date: 8/28/17.
    Accession Number: 20170828-5176.
    Comments Due: 5 p.m. ET 9/18/17.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG17-145-000.
    Applicants: Imperial Valley Solar 3, LLC.
    Description: Notice of Self-Certification of EWG Status of Imperial
Valley Solar 3, LLC.
    Filed Date: 8/28/17.
    Accession Number: 20170828-5134.
    Comments Due: 5 p.m. ET 9/18/17.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER17-1752-002.
    Applicants: Pacific Gas and Electric Company.
    Description: Tariff Amendment: Silicon Valley Power Deficiency
Filing for Grizzly Agreement (RS 248) to be effective 8/1/2017.
    Filed Date: 8/28/17.
    Accession Number: 20170828-5147.
    Comments Due: 5 p.m. ET 9/18/17.

    Docket Numbers: ER17-2364-000.
    Applicants: St. Joseph Energy Center, LLC.
    Description: Baseline eTariff Filing: Application for Market Based
Rate to be effective 10/31/2017.
    Filed Date: 8/28/17.
    Accession Number: 20170828-5119.
    Comments Due: 5 p.m. ET 9/18/17.

    Docket Numbers: ER17-2365-000.
    Applicants: Arizona Public Service Company.

    Description: Sec.  205(d) Rate Filing: Service Agreement No. 318--
NTUA NITS to be effective 8/1/2017.
    Filed Date: 8/28/17.
    Accession Number: 20170828-5148.
    Comments Due: 5 p.m. ET 9/18/17.

    Docket Numbers: ER17-2366-000.
    Applicants: West Penn Power Company, PJM Interconnection, L.L.C.,
The Potomac Edison Company.
    Description: Sec.  205(d) Rate Filing: West Penn submits Borderline
Agreement, Service Agreement No. 4692 with Potomac to be effective 9/1/
2017.
    Filed Date: 8/29/17.
    Accession Number: 20170829-5094.
    Comments Due: 5 p.m. ET 9/19/17.

    Docket Numbers: ER17-2367-000.
    Applicants: GenOn Holdco 1, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization and Request for Waivers to be effective 10/1/2017.
    Filed Date: 8/29/17.
    Accession Number: 20170829-5095.
    Comments Due: 5 p.m. ET 9/19/17.

    Docket Numbers: ER17-2368-000.
    Applicants: GenOn Holdco 3, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization and Request for Waivers to be effective 10/1/2017.
    Filed Date: 8/29/17.
    Accession Number: 20170829-5097.
    Comments Due: 5 p.m. ET 9/19/17.

    Docket Numbers: ER17-2369-000.
    Applicants: GenOn Holdco 4, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization and Request for Waivers to be effective 10/1/2017.
    Filed Date: 8/29/17.
    Accession Number: 20170829-5099.
    Comments Due: 5 p.m. ET 9/19/17.

    Docket Numbers: ER17-2370-000.
    Applicants: GenOn Holdco 2, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization and Request for Waivers to be effective 10/1/2017.
    Filed Date: 8/29/17.
    Accession Number: 20170829-5101.
    Comments Due: 5 p.m. ET 9/19/17.

    Docket Numbers: ER17-2371-000.
    Applicants: GenOn Holdco 5, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization and Request for Waivers to be effective 10/1/2017.
    Filed Date: 8/29/17.
    Accession Number: 20170829-5102.
    Comments Due: 5 p.m. ET 9/19/17.

    Docket Numbers: ER17-2372-000.
    Applicants: GenOn Holdco 6, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization and Request for Waivers to be effective 10/1/2017.
    Filed Date: 8/29/17.
    Accession Number: 20170829-5104.
    Comments Due: 5 p.m. ET 9/19/17.

    Docket Numbers: ER17-2373-000.
    Applicants: GenOn Holdco 7, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization and Request for Waivers to be effective 10/1/2017.
    Filed Date: 8/29/17.
    Accession Number: 20170829-5105.
    Comments Due: 5 p.m. ET 9/19/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 29, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-18713 Filed 9-1-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: September 8, 2010 (Volume 75, Number 173)]
[Proposed Rules]
[Page 54536-54540]
[DOCID:fr08se10-20]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0852; Directorate Identifier 2010-NM-005-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A330-200 and -300 and
A340-200 and -300 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above that would supersede an existing AD. This
proposed AD results from mandatory continuing airworthiness information
(MCAI) originated by an aviation authority of another country to
identify and correct an unsafe condition on an aviation product. The
MCAI describes the unsafe condition as:

    A debonding area was detected on the RH [right-hand] elevator of
an A340 in-service aeroplane during a scheduled maintenance task
inspection.
    Investigation has revealed that this debonding may have been
caused by water ingress and, if not detected and corrected, might
compromise the structural integrity of the elevators [and could
result in reduced controllability of the airplane].

    The proposed AD would require actions that are intended to address
the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by October 25,
2010.

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 W12-40, 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; e-mail<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; telephone (425)
227-1138; fax<PHONE_NUMBER>.

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-2010-0852;
Directorate Identifier 2010-NM-005-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 have lengthened the 30-day comment period for proposed ADs that
address MCAI originated by aviation authorities of other countries to
provide adequate time for interested parties to submit comments. The
comment period for these proposed ADs is now typically 45 days, which
is consistent with the comment period for domestic transport ADs.
    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

    On September 29, 2005, we issued AD 2005-20-32, Amendment 39-14329
(70 FR 59263, October 12, 2005). That AD required actions intended to
address an unsafe condition on the products listed above.
    Since we issued AD 2005-20-32, we have determined that the existing
inspection of the upper and lower elevator skin panels needs to be a
repetitive inspection in order to adequately address the identified
unsafe condition. We have also added airplane models to the
applicability of this proposed AD, and we have identified additional
affected elevators in Table 1 of this proposed AD. The European
Aviation Safety Agency (EASA), which is the Technical Agent for the
Member States of the European Community, has issued EASA Airworthiness
Directive 2009-0255, dated December 1, 2009 (referred to after this as
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    A debonding area was detected on the RH [right-hand] elevator of
an A340 in-service aeroplane during a scheduled maintenance task
inspection.
    Investigation has revealed that this debonding may have been
caused by water ingress and, if not detected and corrected, might
compromise the structural integrity of the elevators [and could
result in reduced controllability of the airplane].
    DGAC [Direction G[eacute]n[eacute]rale de l'Aviation Civile]
France AD F-2004-118 R1 (EASA approval N. 2004-10125) required a
one-time inspection of elevators skin panels installed on MSN up to
091, to detect potential liquid ingress and repair as necessary, in
accordance with Airbus inspection service bulletins (ISB) A330-55-
3032 and A340-55-4029.
    Following the AD issuance, further in-service experience has
shown that in order to ensure the structural integrity of all A330/
A340 elevators skin panels with sandwich construction (excluding
A340-500/-600), it is necessary to perform the same elevators panels
inspection and to repair as necessary, but in a repetitive manner.
    The aim of this AD, which supersedes DGAC France AD F-2004-118
R1, is to require this additional inspection program in order to
maintain the structural integrity of the elevators.

The required actions include repetitive special detailed inspections
and repetitive re-protection of the elevator assembly. The special
detailed inspections consist of the following actions:

     Repetitive endoscopic inspections for damage (such as a
scratch, disbonding, or a tear) of the inner skin of the upper and
lower elevator panels on both sides of the airplane, and if any damage
is found, contacting Airbus for instructions and doing the
instructions.
     Repetitive tap tests for debonding in the inner side of
the upper and lower elevator panels on both sides, and if any debonding
is found, contacting Airbus for instructions and doing the
instructions.
     Repetitive thermographic inspections for indications of
trapped water in the upper and lower elevator panels on both sides of
the airplane, and if any indications of trapped water are found, doing
applicable corrective actions (including, but not limited to, repeating
the thermographic inspection to determine the size of the damaged area,
doing a general visual inspection to determine if there is an existing
repair, contacting Airbus for instructions and doing the instructions,
re-protecting the affected surfaces, and repairing holes).
     Repetitively re-protect the elevator assembly (including
doing a general visual inspection to determine damage and repair if
necessary, a general visual inspection to determine if the drainage
holes are clean and not obstructed and cleaning the drainage holes if
necessary, a general visual inspection to determine the status of the
static discharges contour and sealing the static discharges contour if
necessary, and installing front spar access hole covers).
    You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Airbus has issued Mandatory Service Bulletins A330-55-3039 and
A340-55-4035, both including Appendix 1, both dated August 7, 2009. The
actions described in the service information are intended to correct
the unsafe condition identified in the MCAI.

Explanation of Change to This AD

    We have removed the ``Service Bulletin Reference'' paragraph from
the ``Restatement of Requirements of AD 2005-20-32'' section of this
AD. That paragraph was identified as paragraph (f) in AD 2005-20-32.
Instead, we have provided the full service bulletin citations
throughout this AD.

Change to Existing AD

    This proposed AD would retain the requirements of AD 2005-20-32.
Since AD 2005-20-32 was issued, the AD format has been revised, and
certain paragraphs have been rearranged. As a result, the corresponding
paragraph identifiers have changed in this proposed AD, as listed in
the following table:

                      Revised Paragraph Identifiers
------------------------------------------------------------------------
                                      Corresponding  requirement in this
    Requirement in AD 2005-20-32                 proposed AD
------------------------------------------------------------------------
          paragraph (f)(1)                        paragraph (g)
          paragraph (f)(2)                        paragraph (h)
             paragraph (g)                        paragraph (i)
             paragraph (h)                        paragraph (j)
             paragraph (i)                        paragraph (k)
------------------------------------------------------------------------

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

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 56 products of U.S. registry.
    The actions that are required by AD 2005-20-32 and retained in this
proposed AD take about 1 work-hour per product, at an average labor
rate of $85 per work hour. Based on these figures, the estimated cost
of the currently required actions is $85 per product.
    We estimate that it would take about 14 work-hours per product to
comply with the new basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of the proposed AD on U.S. operators to be $66,640, or $1,190
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 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); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared 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 removing Amendment 39-14329 (70 FR
59263, October 12, 2005) and adding the following new AD:

Airbus: Docket No. FAA-2010-0852; Directorate Identifier 2010-NM-
005-AD.

Comments Due Date

    (a) We must receive comments by October 25, 2010.

Affected ADs

    (b) This AD supersedes AD 2005-20-32, Amendment 39-14329.

Applicability

    (c) This AD applies to Airbus Model A330-201, -202, -203, -223,
-243, -301, -302, -303, -321, -322, -323, -341, -342, and -343
airplanes, and A340-211, -212, -213, -311, -312, and -313 airplanes;
certificated in any category; all manufacturer serial numbers, if
equipped with any of the elevator part numbers (P/N) identified in
Table 1 of this AD (``ZZ'' indicates a number from 00 up to 99
inclusive).

                     Table 1--Elevator Part Numbers
------------------------------------------------------------------------
    For the left-hand  elevator          For the right-hand  elevator
------------------------------------------------------------------------
P/N F55280000000ZZ                   P/N F55280000001ZZ
P/N F55280000002ZZ                   P/N F55280000003ZZ
P/N F55280000004ZZ                   P/N F55280000005ZZ
P/N F55280000006ZZ                   P/N F55280000007ZZ
P/N F55280000008ZZ                   P/N F55280000009ZZ
P/N F55280000012ZZ                   P/N F55280000013ZZ
P/N F55280002000ZZ                   P/N F55280002001ZZ
P/N F55280005000ZZ                   P/N F55280005001ZZ
P/N F55280005002ZZ                   P/N F55280005003ZZ
P/N F55280005004ZZ                   P/N F55280005005ZZ
------------------------------------------------------------------------

Subject

    (d) Air Transport Association (ATA) of America Code 55:
Stabilizers.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    A debonding area was detected on the RH [right-hand] elevator of
an A340 in-service aeroplane during a scheduled maintenance task
inspection.
    Investigation has revealed that this debonding may have been
caused by water ingress and, if not detected and corrected, might
compromise the structural integrity of the elevators [and could
result in reduced controllability of the airplane].

Compliance

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

Restatement of Requirements of AD 2005-20-32

Service Bulletin Exceptions for Airbus Service Bulletin A330-55-
3032 and Airbus Service Bulletin A340-55-4029

    (g) Where Airbus Service Bulletin A330-55-3032 and Airbus
Service Bulletin A340-55-4029, both dated December 22, 2003,
recommend contacting Airbus for appropriate action: Before further
flight, repair the condition according to a method approved by the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA; or the Direction G[eacute]n[eacute]rale de
l'Aviation Civile (or its delegated agent), or EASA (or its
delegated agent).
    (h) Although Airbus Service Bulletin A330-55-3032 and Airbus
Service Bulletin A340-55-4029, both dated December 22, 2003, specify
to submit certain information to the manufacturer, this AD does not
include that requirement.

Determining Part Number, Serial Number

    (i) For Model A330-201, -202, -203, -223, -243, -301, -321, -
322, -323, -341, -342, and -343 airplanes; and Model A340-211, -212,
-213, -311, -312, and -313 airplanes: At the later of the times
specified in paragraphs (i)(1) and (i)(2) of this AD, perform an
inspection to determine the part number and serial number of the
left- and right-hand elevator assemblies. A review of airplane
maintenance records is acceptable in lieu of this inspection if the
part number and serial number of each elevator assembly can be
conclusively determined from that review. If neither elevator
assembly has a part number and serial number combination identified
in Table 2 of this AD, no further action is required by this
paragraph. If either elevator assembly has a part number and serial
number combination identified in Table 2 of this AD, do paragraph
(j) of this AD. Doing the actions in paragraph (k) of this AD
terminates the requirements of paragraph (i) of this AD.
    (1) Within 10 years after the date of the first flight of the
airplane, or before the accumulation of 12,000 total flight cycles,
whichever is first.
    (2) Within 18 months after the November 16, 2005 (the effective
date of AD 2005-20-32).

Table 2--Affected Elevator Part Numbers and Serial Numbers in AD 2005-20-
                                   32
------------------------------------------------------------------------
                                     Affected part      Affected serial
              Part                      numbers             numbers
------------------------------------------------------------------------
Left-hand elevator assembly.....  F55280000000,       CG1002 through
                                   F55280000004.       CG1091 inclusive,
                                                       CG1093, CG1094,
                                                       CG2001.
Right-hand elevator assembly....  F55280000001,       CG1002 through
                                   F55280000005.       CG1094 inclusive,
                                                       CG2001.
------------------------------------------------------------------------

Inspections

    (j) For Model A330-201, -202, -203, -223, -243, -301, -321, -
322, -323, -341, -342, and -343 airplanes; and Model A340-211, -212,
-213, -311, -312, and -313 airplanes: If the left- or right-hand
elevator assembly has a part number and serial number combination
identified in Table 2 of this AD, before further flight after
accomplishing paragraph (i) of this AD, do the actions in paragraphs
(j)(1), (j)(2), and (j)(3) of this AD, as applicable. Doing the
actions in paragraph (k) of this AD terminates the requirements of
paragraph (j) of this AD.
    (1) Perform an endoscopic inspection to detect damage (such as a
scratch, disbonding, or a tear), and a tap test and a thermographic
inspection to detect signs of moisture penetration, to the upper and
lower elevator panels on both sides of the airplane, in accordance
with the Accomplishment Instructions of Airbus Service Bulletin
A330-55-3032 (for Model A330-201, -202, -203, -223, -243, -301, -
321, -322, -323, -341, -342, and -343 airplanes), or Airbus Service
Bulletin A340-55-4029 (for Model A340-211, -212, -213, -311, -312,
and -313 airplanes), both dated December 22, 2003, as applicable,
except as provided by paragraphs (g) and (h) of this AD.
    (2) If any damage is found, before further flight, do all
applicable corrective actions (including, but not limited to,
repeating the thermographic inspection to determine the size of the
damaged area, and performing a tap test around the areas where
moisture is indicated), in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A330-55-3032 (for Model
A330-201, -202, -203, -223, -243, -301, -321, -322, -323, -341, -
342, and -343 airplanes), or Airbus Service Bulletin A340-

55-4029 (for Model A340-211, -212, -213, -311, -312, and -313
airplanes) both dated December 22, 2003, as applicable, except as
provided by paragraphs (g) and (h) of this AD.
    (3) Re-protect the elevator assembly (including performing a
general visual inspection to determine if the drainage holes are
clean, a general visual inspection to determine the condition of the
sealant covering the static discharges contour, and applicable
corrective actions), in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A330-55-3032 (for Model
A330-201, -202, -203, -223, -243, -301, -321, -322, -323, -341, -
342, and -343 airplanes), or Airbus Service Bulletin A340-55-4029
(for Model A340-211, -212, -213, -311, -312, and -313 airplanes),
both dated December 22, 2003, as applicable, except as provided by
paragraphs (g) and (h) of this AD.

    Note 1: For the purposes of this AD, a general visual inspection
is: ``A visual examination of an interior or exterior area,
installation, or assembly to detect obvious damage, failure, or
irregularity. This level of inspection is made from within touching
distance unless otherwise specified. A mirror may be necessary to
ensure visual access to all surfaces in the inspection area. This
level of inspection is made under normally available lighting
conditions such as daylight, hangar lighting, flashlight, or
droplight and may require removal or opening of access panels or
doors. Stands, ladders, or platforms may be required to gain
proximity to the area being checked.''

New Requirements of This AD

Repetitive Inspection

    (k) Within the applicable time in paragraph (k)(1) or (k)(2) of
this AD, do a special detailed inspection for discrepancies
(scratches, debonding, tears, and indications of trapped water), on
the elevator upper and lower skin panels, in accordance with the
Accomplishment Instructions of Airbus Mandatory Service Bulletin
A330-55-3039 (for Model A330-201, -202, -203, -223, -243, -301, -
302, -303, -321, -322, -323, -341, -342, and -343 airplanes), or
A340-55-4035 (for Model A340-211, -212, -213, -311, -312, and -313
airplanes), both dated August 7, 2009. Repeat the inspections
thereafter at intervals not to exceed 72 months from the date of the
elevator's first flight after the last inspection. Doing the special
detailed inspection specified in this paragraph terminates the
requirements of paragraphs (i) and (j) of this AD.
    (1) For elevators identified in Table 1 of this AD that have not
been inspected in accordance with Airbus Service Bulletin A330-55-
3032 (for Model A330-201, -202, -203, -223, -243, -301, -302, -303,
-321, -322, -323, -341, -342, and -343 airplanes), or Airbus Service
Bulletin A340-55-4029 (for Model A340-211, -212, -213, -311, -312,
and -313 airplanes): Within 144 months since the date of the
elevator's first flight on any airplane, or within 24 months after
the effective date of this AD, whichever occurs later.
    (2) For elevators identified in Table 1 of this AD that have
been inspected in accordance with Airbus Service Bulletin A330-55-
3032 (for Model A330-201, -202, -203, -223, -243, -301, -302, -303,
-321, -322, -323, -341, -342, and -343 airplanes), or Airbus Service
Bulletin A340-55-4029 (for Model A340-211, -212, -213, -311, -312,
and -313 airplanes): Within 72 months since the date of the
elevator's first flight on any airplane after accomplishing Airbus
Service Bulletin A330-55-3032, or Airbus Service Bulletin A340-55-
4029, or within 24 months after the effective date of this AD,
whichever occurs later.

Corrective Action

    (l) If any discrepancy is found during any inspection required
by paragraph (k) of this AD, before further flight, do all
applicable corrective actions (including applicable inspections and
repair), in accordance with the Accomplishment Instructions of
Airbus Mandatory Service Bulletin A330-55-3039 (for Model A330-201,
-202, -203, -223, -243, -301, -302, -303, -321, -322, -323, -341, -
342, and -343 airplanes) or A340-55-4035 (for Model A340-211, -212,
-213, -311, -312, and -313 airplanes), both dated August 7, 2009; or
contact Airbus for instructions and follow their corrective actions.

Re-Protection

    (m) For elevators on which any action required by paragraph (k)
or (l) of this AD is done: Before the elevator's next flight, do a
re-protection (including all applicable inspections and corrective
actions), in accordance with the Accomplishment Instructions of
Airbus Mandatory Service Bulletin A330-55-3039 (for Model A330-201,
-202, -203, -223, -243, -301, -302, -303, -321, -322, -323, -341, -
342, and -343 airplanes), or A340-55-4035 (for Model A340-211, -212,
-213, -311, -312, and -313 airplanes), both dated August 7, 2009.

Reporting

    (n) Submit a report of the findings (both positive and negative)
of the inspection required by paragraph (k) of this AD to Airbus, as
specified in Appendix 1 of Airbus Mandatory Service Bulletin A330-
55-3039, dated August 7, 2009; or Airbus Mandatory Service Bulletin
A340-55-4035, dated August 7, 2009; as applicable; at the applicable
time specified in paragraph (n)(1) or (n)(2) of this AD. The report
must include the information identified in Appendix 1 of Airbus
Mandatory Service Bulletin A330-55-3039, dated August 7, 2009; or
Airbus Mandatory Service Bulletin A340-55-4035, dated August 7,
2009; as applicable.
    (1) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.
    (2) If the inspection was done before the effective date of this
AD: Submit the report within 30 days after the effective date of
this AD.
    (o) As of the effective date of this AD, do not install any
elevator identified in Table 1 of this AD on any airplane, unless
the elevator has been inspected in accordance with paragraph (l) of
this AD and all applicable corrective actions have been done.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (p) 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. Send information 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 on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards 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.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (q) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2009-0255, dated December 1, 2009; and the service
bulletins listed in Table 3 of this AD, for related information.

                       Table 3--Service Bulletins
------------------------------------------------------------------------
              Document                               Date
------------------------------------------------------------------------
Airbus Mandatory Service Bulletin     August 7, 2009.
 A330-55-3039, including Appendix 1.
Airbus Mandatory Service Bulletin     August 7, 2009.
 A340-55-4035, including Appendix 1.

Airbus Service Bulletin A330-55-3032  December 22, 2003.
Airbus Service Bulletin A340-55-4029  December 22, 2003.
------------------------------------------------------------------------

    Issued in Renton, Washington, on August 30, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-22275 Filed 9-7-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Notices]
[Pages 22451-22453]
[FR Doc No: 2023-07767]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1188]

Over-the-Counter Monograph Order Requests: Format and Content;
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 ``Over-the-
Counter Monograph Order Requests (OMORs): Format and Content.'' This
draft guidance provides recommendations on the format and content of
the information that a requestor should provide in an over-the-counter
(OTC) monograph order request (OMOR) and identifies relevant guidance
documents to assist requestors in preparing their OMORs.

DATES: Submit either electronic or written comments on the draft
guidance by June 12, 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-2023-D-1188 for ``Over-the-Counter Monograph Order Requests
(OMORs): Format and Content.'' 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, 240-
402-7500.
     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: Trang Tran, Center for Drug Evaluation
and Research (HFD-600), Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Over-the-Counter Monograph Order Requests (OMORs): Format
and Content.'' This draft guidance is intended to assist requestors in
preparing OMORs for submission to FDA under section 505G of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h). This draft
guidance provides recommendations on the format and content of the
information that a requestor should provide in an OMOR and identifies
relevant guidance documents to assist requestors in preparing their
OMORs.
    Section 505G of the FD&C Act was added by the Coronavirus Aid,
Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136), which
was enacted on March 27, 2020. As required by section 505G(l) of the
FD&C Act, this draft guidance, when finalized, will discuss the format
and content of data submissions, specifically OMORs, to FDA.
    In support of the CARES Act, FDA agreed to specific performance
goals and procedures described in the document ``Over-the-Counter
Monograph User Fee Program Performance Goals and Procedures--Fiscal
Years 2018-2022,'' commonly referred to as the OMUFA Commitment Letter
(the document can be accessed at https://www.fda.gov/media/106407/download and the document with updated goal dates for fiscal years
2021-2025 can be accessed at https://www.fda.gov/media/146283/download). In the OMUFA Commitment Letter, FDA committed to issuing
this draft guidance under specific timelines.
    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 ``Over-the-
Counter Monograph Order Requests (OMORs): Format and Content.'' 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

    Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act
of 1995 (chapter 35 of title 44, United States Code) does not apply to
collections of information made under section 505G of the FD&C Act. The
information collections described in this guidance implement the
following provisions of section 505G:
    (1) Section 505G(b)(5) of the FD&C Act, which allows submission of
administrative orders, OMORs, initiated at the request of a requestor.
    (2) Section 505G(b)(6) of the FD&C Act, which allows requestors to
provide certain information regarding safe nonprescription product
marketing and use as a condition for filing a generally recognized as
safe and effective request.
    (3) Section 505G(d) of the FD&C Act confidentiality of information
submitted to the Secretary, which requires FDA to make information
submitted in support of an OMORs available to the public no later than
the date of the proposed order unless it meets certain limitations on
public availability.
    (4) Section 505G(j) of the FD&C Act, which requires that all
submissions under section 505G must be in electronic format.
    (5) Section 505G(l)(1) of the FD&C Act, which requires FDA to issue
guidance that specifies the procedures and principles for formal
meetings between the Secretary and sponsors or requestors for drugs
subject to section 505G.
    (6) Section 505G(1)(2) of the FD&C Act, which requires FDA to issue
guidance that specifies the format and content of data submissions to
the Secretary under section 505G.
    (7) Section 505G(1)(3) of the FD&C Act, which requires FDA to issue
guidance that specifies the format of electronic submissions to the
Secretary under section 505G.
    Therefore, clearance by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521)
is not required for these collections of information. In addition, this
guidance refers to previously approved FDA collections of information.
The previously approved collections of information are subject to
review by OMB under the PRA. The collections of

information for OTC monograph products, OTC monograph order requests,
and the OTC Monograph User Fee Program have been approved under OMB
control number 0910-0340. The information collections for submission of
new drug applications and abbreviated new drug applications in 21 CFR
part 314 are approved under OMB control number 0910-0001. The
collections of information used by FDA to assess the environmental
impact of Agency actions and to ensure that the public is informed of
environmental analyses under 21 CFR part 25 have been approved under
OMB control number 0910-0322.

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: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07767 Filed 4-12-23; 8:45 am]
BILLING CODE 4164-01-P


In a 1-generation range-finding reproduction study in rats (Nonguideline study, MRID 44014241) CGA 245704 Technical (97.9% a.i.; Batch No. P.303011) was administered to groups of 15 male and 15 female Tif: RAT f (SPF), hybrids of RTTI 1 x P11/2 (Sprague-Dawley derived) rats at dietary concentrations of 0, 2000, 4000, or 8000 ppm for one generation (MRID 44681301). In this range- finding study, F0 adults were administered test or control diet for two weeks prior to mating. Premating doses were 199.4, 382.0, and 700.1 mg/kg/day, respectively, for F0 males and 208.7, 409.9, and 727.8 mg/kg/day, respectively, for F0 females. Males were terminated at the end of mating and females were terminated at weaning of their pups. All offspring, except five litters per dose group, were necropsied at weaning. After weaning, five litters per dose group were retained on treatment for an additional three weeks and then necropsied.  The only clinical sign of toxicity in the parental animals was perineal hemorrhage during late gestation in five high-dose females. Gross necropsy was unremarkable. Absolute body weights, body weight gains, and food consumption values for the low- and mid-dose males and low-dose females were similar to the controls throughout the study. High-dose males had significantly (p > 0.01; 88-91% of control) lower body weights than the controls beginning on day 8 and continuing until study termination. Overall weight gain by the high-dose males was 69% of the control level. Body weights and body weight gains of the high-dose females were significantly (p > 0.01; body weights 88-90% of controls) Tess than the controls during the premating interval. Overall body weight gain by the high- dose group was only 30% of the control group level. Mid-dose females had significantly (p > 0.05) lower body weight gains than the controls during days 1-8. Reduced body weight gains in the high- dose males and females and mid-dose females correlated with significantly (p > 0.05 or 0.01) reduced food consumption by these treated groups during study days 1-8. Lower body weights, body weight gains, and food consumption continued for the mid- and high-dose females during gestation and lactation. Body weights of the high-dose group were significantly (p > 0.05 or 0.01) lower than the controls throughout gestation with overall weight gain by the high-dose females during gestation 27% (p > 0.01) of the control group level. Mid-dose females had significantly (p > 0.05 or 0.01) lower body weights than the controls on GD 21 and on lactation days 7, 14, and 21. Weight gains by the mid-dose group during gestation and lactation were 92% and 83%, respectively of the control group levels. Food consumption by the high-dose group was significantly (p > 0.05 or 0.01) less than the controls throughout gestation. Food consumption by the mid-dose group was significantly (p > 0.01) less than the controls throughout lactation. Therefore, the LOAEL for parental toxicity is 4000 ppm based on reduced food consumption and lower body weight gains in F0 females. The parental toxicity NOAEL is 2000 ppm.  Mating and fertility indices, mean precoital interval, mean gestation length, and mean numbers of corpora lutea and implantation sites per dam were similar between the treated and control groups. Mating and fertility indices for the high-dose group were similar to the control group, but no live lifters were produced by the high-dose group (i.e. all pregnancies were lost). Live births and pup survival were similar between the low- and mid-dose groups and the control group. Therefore, the LOAEL for reproductive toxicity is 8000 ppm based on total resorptions in all dams. The reproductive toxicity NOAEL is 4000 ppm.  No treatment-related clinical signs of toxicity were observed in the pups during lactation. Absolute body weights of pups in the low-dose group were similar to the controls throughout lactation. Body weights of the mid-dose pups were significantly (p > 0.05 or 0.01; 76-89% of controls) less than the controls beginning on lactation day 7 and continuing throughout lactation and postweaning. The lower body weights of the mid-dose pups were a result of significantly (p > 0.05 or 0.01; 69-89% of controls) lower body weight gains from postnatal day 4 through postnatal day 28. Recovery of body weight gains occurred during the postweaning intervals of days 28-35 and 35-42. Therefore, the LOAEL for developmental toxicity is 4000 ppm based on reduced pup body weight gains and lower pup body weights during lactation and early postweaning. The developmental toxicity NOAEL is 2000 ppm.

870.6200b Subchronic Neurotoxicity

In a subchronic neurotoxicity study (MRID 45713601), CGA-245704 (Acibenzolar, 97.9% a.i., Batch No. P.303011) was administered in the diet to 10 Sprague-Dawley derived rats/sex/group at dose levels of 0, 400, 2000, or 8000 ppm (equivalent to 0/0, 24/26, 126/143, and 575/628 mg/kg/day [M/F], respectively) for at least 90 days.  Neurobehavioral assessment (functional observational battery [FOB] and motor activity testing) was performed using all rats at pre-dosing and Weeks 4, 8, and 13.  At study termination, 5 rats/sex/group were anesthetized and perfused in situ for neuropathological examination.  The tissues from the perfused animals in the control and 8000 ppm groups were subjected to histopathological evaluation of brain and peripheral nervous system tissues.  Positive control data were not provided.No compound-related effects were observed in mortality, clinical signs of toxicity, FOB, motor activity, or gross or neuropathology.  At 8000 ppm, body weights were generally decreased throughout the study in the males (decreased 11-14%, not statistically significant) and females (decreased 8-13%, attaining statistical significance at Weeks 2-5, 7 and 8, and 11-13).  Also at this dose, cumulative body weight gains were decreased throughout the study in the males (decreased 19-35%, attaining statistical significance at Weeks 2-4 and 6-9), and in the females (decreased 24-40%).  A decreasing trend (p<0.01) in body weight and body weight gain was also generally noted in both sexes at this dose.  These decreases in body weight gain corresponded with decreases in food consumption which was sporadically decreased in the 8000 ppm males (decreased 9-21% at Weeks 1-3, 5-7, and 11, but only attaining statistical significance during Week 1), and females (decreased 14-18%, p<0.01 at Weeks 1 and 3).  A decreasing trend (p<0.01) in food consumption was also generally noted in the males at 8000 ppm during the weeks reported above. No neurological effects were observed at any dose in either sex.

The LOAEL was 8000 ppm (equivalent to 575/628 mg/kg/day, M/F) based on decreased body weights, body weight gains, and food consumption.  The NOAEL is 2000 ppm (equivalent to 126/143 mg/kg/day, M/F).

The subchronic neurotoxicity study in rats (MRID 45713601) on Acibenzolar had been reviewed and is classified as acceptable/non-guideline.

870.5100, 870-5300, 870.5375, 870.5900  Mutagenicity

Five acceptable mutagenicity studies on technical grade acibenzolar-S-methyl are available:

1. 	Reverse gene mutation, S. typhimuriumlE. Coli (MRID 44014247)
2. 	Forward gene mutation, Chinese hamster V79 lung cells in culture/HGPRT locus (MRID
	44014246)
3. 	Chromosome aberration, Chinese hamster ovary (CHO) cells in culture (MRID 44014245)
4. 	Unscheduled DNA synthesis assay, primary rat hepatocytes in culture (MRID 44014248)
5. 	In vivo cytogenetics, micronucleus assay in mice (MRID 44014244)
	Results in all five studies were negative for genotoxicity. The five studies on the technical grade product satisf' the new revised mutagenicity guideline requirements for a new chemical (published in 1991).

Three additional acceptable mutagenicity studies on a) an isomer (CGA-362020) of acibenzolar S-methyl, b) a by-product (NOA 419191) of acibenzolar-S-methyl, and c) a plain metabolite (CGA-323060) of acibenzolar-S-methyl are also available.

1. 	Reverse gene mutation, S. typhimuriumlE. Coli; Test Material: CGA-362020 (MRID
	44537025). This study was POSITIVE for evidence of induced mutant colonies over background in S. typhimurium strain TA1537 at concentrations of 277.8 and higher in the absence of 59-mix.
2. 	Reverse gene mutation, S. typhimuriumlE. Coli; Test Material: NOA 419191 (MRID
	44537024). This study was negative.
3. 	Reverse gene mutation, S. typhimuriumfE. Coli; Test Material: CGA-323060 (MRlD
	44537026). This study was negative

APPENDIX B.  Chemical Names And Structures Of Metabolites

APPENDIX C. Physical/Chemical Properties

Physicochemical Properties of Acibenzolar-S-Methyl.
Parameter
Value
Reference
Melting point/range
133 ºC
DP# 250963, 2/10/99, H. Podall
pH
7.9 (1% solution in water) at 25 ºC

Density
1.54 g/cc at 22 ºC (bulk density)

Water solubility
0.0077 g/L

Solvent solubility
Methanol	  4.2 g/L
Acetone		  28 g/L
Toluene		  36 g/L
n-Octanol	  5.4 g/L
n-Hexane	  1.3 g/L
Ethyl acetate	   25 g/L
Dichloromethane   160 g/L
European Commission, 6506/VI/99-final, 5/21/02
Vapor pressure
3.6 x 10[-6] Torr at 25 ºC
DP# 250963, 2/10/99, H. Podall
Dissociation constant, pKa
No dissociation constant in an
accessible pH range (1.0 - 9.0)
European Commission, 6506/VI/99-final, 5/21/02
Octanol/water partition coefficient, Log(KOW)
Log (POW) 3.1 at 25 ºC
DP# 250963, 2/10/99, H. Podall
UV/visible absorption spectrum
253 nm ε : 14.7 10[3] l mol[-1] cm[-1]
288 nm ε : 5.4 10[3]
324 nm ε : 7.2 10[3]
European Commission, 6506/VI/99-final, 5/21/02

APPENDIX D.  Studies Reviewed for Ethical Conduct

The PHED Task Force, 1995.  The Pesticide Handlers Exposure Database, Version 1.1.  Task Force members Health Canada, U.S. Environmental Protection Agency, and the National Agricultural Chemicals Association, released February, 1995.

Agricultural Re-entry Task Force (ARTF) data base (SOP #3.1)