[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60252-60254]
[FR Doc No: 2021-23725]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-E-1817; FDA-2020-E-1818; FDA-2020-E-1820]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ENHERTU

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ENHERTU and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by January 3, 2022.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by May 2, 2022. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 3, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 3, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2020-E-1817; FDA-2020-E-1818; and FDA-2020-E-1820, for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; ENHERTU.'' Received comments, those filed in a timely manner
(see

ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<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 Sec.  10.20 (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>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product ENHERTU
(fam-trastuzumab deruxtecan-nxki). ENHERTU is indicated for the
treatment of adult patients with unresectable or metastatic HER2-
positive breast cancer who have received two or more prior anti-HER2-
based regimens in the metastatic setting. This indication is approved
under accelerated approval based on tumor response rate and duration of
response. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial. Subsequent to this approval, the USPTO received a patent term
restoration application for ENHERTU (U.S. Patent Nos. 9,808,537;
10,155,821; and 10,195,288) from Daiichi Sankyo Company, Limited, and
the USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated October 13,
2020, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of ENHERTU
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ENHERTU is 1,395 days. Of this time, 186 days occurred during the
testing phase of the regulatory review period, while 1,209 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: February
26, 2016. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on February
26, 2016.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): August 29, 2019. FDA has verified the
applicant's claim that the biologics license application (BLA) for
ENHERTU (BLA 761139) was initially submitted on August 29, 2019.
    3. The date the application was approved: December 20, 2019. FDA
has verified the applicant's claim that BLA 761139 was approved on
December 20, 2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 71 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.)

Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket Nos. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD.

    Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23725 Filed 10-29-21; 8:45 am]
BILLING CODE 4164-01-P


                 United States Environmental Protection Agency

                     Docket Index for Proposed Rulemaking
                             EPA-R09-OAR-2022-0306

Air Plan Approval; California; San Diego County Air Pollution Control District; Permits

                                March 24, 2022

Note: Copies of the Federal Register (FR) notices listed in Section D are included in the docket only if they are not publicly accessible in an electronic format. Please follow the hyperlink link provided for all other FR notices; or visit: https://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR.

                              Docket Index Number
                                   Document
                                     Date
                      Section A - SIP Submittal Documents
A.1
State Implementation Plan Submission
                                    2/22/22
A.2
State Implementation Plan Submission
                                    9/21/20
                    Section B  -  Copies of Submitted Rules
B.1
Rule 11, Exemptions from Rule 10 Permit Requirements
                                    7/8/20
B.2
Rule 20.1, New Source Review  -  General Provisions
                                   10/14/21
B.3
Rule 20.3, New Source Review  -  Major Stationary Sources and PSD Stationary Sources
                                   10/14/21
B.4
Rule 20.4, New Source Review  -  Portable Emission Units
                                   10/14/21
             Section C  -  Supporting Material and Other Documents
C.1
Technical Support Document (TSD)
                                    3/29/22
C.2
EPA Region 9 SIP Completeness Checklist
                                    3/29/22
C.3
SIP Approved Rule 11, adopted 5/11/16
                                    10/4/18
C.4
SIP Approved Rule 20.1, adopted 6/26/19
                                    9/16/20
C.5
SIP Approved Rule 20.3, adopted 6/26/19
                                    9/16/20
C.6
SIP Approved Rule 20.4, adopted 6/26/19
                                    9/16/20
C.7
TSD from 2018 NSR Action, 83 FR 50007, 10/4/18
                                   5/23/2018
               Section D  -  Referenced Federal Register Notices
D.1
76 FR 38748
                                    7/1/11
D.2
83 FR 50007
                                    10/4/18
D.3
85 FR 57727
                                    9/16/20
D.4
86 FR 29522
                                    6/2/21
D.5
86 FR 37918
                                    7/19/21


[Federal Register Volume 79, Number 248 (Monday, December 29, 2014)]
[Proposed Rules]
[Pages 77972-77975]
[FR Doc No: 2014-30270]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0928; Directorate Identifier 2014-NM-040-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 all
Airbus Model A330-200 Freighter, A330-200, A330-300, A340-200, A340-
300, A340-500, and A340-600 series airplanes. This proposed AD was
prompted by a report of skin disbonding on a composite side panel of a
rudder installed on an A310 airplane. This proposed AD would require a
review of the maintenance records of the rudder to determine if any
composite side shell panel repair has been done; a thermography
inspection limited to the repair areas or complete side shells, as
applicable, to identify possible in-service rudder repairs, damages, or
fluid ingress; and applicable related investigative and corrective
actions. We are proposing this AD to detect and correct the rudder skin
disbonding, which could affect the structural integrity of the rudder,
and could result in reduced controllability of the airplane.

DATES: We must receive comments on this proposed AD by February 12,
2015.

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 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 view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

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-2014-
0928; or in person at the Docket Management Facility 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, WA 98057-3356; telephone<PHONE_NUMBER>;
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-2014-0928;
Directorate Identifier 2014-NM-040-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 2014-0033, dated February 4, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Airbus Model
A330-200 Freighter, A330-200, A330-300, A340-200, A340-300, A340-500,
and A340-600 series airplanes. The MCAI states:

    A case of skin disbonding was reported on a composite side panel
of a rudder installed on an A310 aeroplane.
    The investigation results revealed that this disbonding started
from a skin panel area previously repaired in-service in accordance
with the Structural Repair Manual (SRM).
    The initial damage has been identified as a disbonding between
the core and skin of the repaired area. This damage may not be
visually detectable and likely propagates during normal operation
due to the variation of pressure during ground-air-ground cycles.
    Composite rudder side shell panels are also installed on A330
and A340 aeroplanes, which may have been repaired in-service using a
similar method.
    This condition, if not detected and corrected, could affect the
structural integrity of the rudder, possibly resulting in reduced
control of the aeroplane.
    For the reasons described above, this [EASA] AD requires a one-
time thermography inspection of a repaired rudder or a rudder whose
maintenance records are incomplete and, depending on findings,
accomplishment of applicable corrective and follow-up actions
[including repetitive inspections.

    The related investigative actions in this AD include, as
applicable, an ultrasonic inspection, an elasticity laminate checker
inspection, a tap test inspection, detailed inspections, thermography
inspections, and ventilation of the core. The repetitive inspections
include detailed inspections and thermography inspections. The
corrective actions in this AD include repairs.
    The compliance time for the related investigative actions is before
further flight after accomplishing the applicable inspection required
by paragraph (g)(1) or (g)(2)(ii) of this AD.
    The intervals for the repetitive inspections are either 900 flight
hours or 1,000 flight cycles, depending on the applicable conditions
identified in the service information.
    The compliance times for the corrective actions range, depending on
the applicable conditions identified in the service information, from
before further flight to within 4,500 flight cycles but not to exceed
24 months after accomplishing the applicable inspection required by
paragraphs (g)(1) or (g)(2)(ii) of this AD.
    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0928.

Relevant Service Information

    Airbus has issued the following service information:
     Airbus Service Bulletin A330-55-3043, dated February 7,
2013.
     Airbus Service Bulletin A340-55-4039, dated February 7,
2013.
     Airbus Service Bulletin A340-55-5007, dated February 7,
2013.
    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 these
same type designs.

Costs of Compliance

    We estimate that this proposed AD affects 55 airplanes of U.S.
registry.
    We also estimate that it would take about 45 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. Based on these figures, we estimate the cost of this proposed
AD on U.S. operators to be $210,375, or $3,825 per product.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions 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 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 control
number for the collection of information required by this proposed AD
is 2120-0056. The paperwork cost associated with this proposed AD has
been detailed in the Costs of Compliance section of this document and
includes time for reviewing instructions, as well as completing and
reviewing the collection of information. Therefore, all reporting
associated with this proposed

AD is mandatory. Comments concerning the accuracy of this burden and
suggestions for reducing the burden should be directed to the FAA at
800 Independence Ave. SW., Washington, DC 20591, ATTN: Information
Collection Clearance Officer, AES-200.

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);
    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.

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. Amend Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus: Docket No. FAA-2014-0928; Directorate Identifier 2014-NM-
040-AD.

(a) Comments Due Date

    We must receive comments by February 12, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all airplanes identified in paragraphs (c)(1)
and (c)(2) of this AD, certificated in any category.
    (1) Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F,
-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes,
all manufacturer serial numbers.
    (2) Airbus Model A340-211, -212, -213, -311, -312, -313, -541,
and -642 airplanes, all manufacturer serial numbers.

(d) Subject

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

(e) Reason

    This AD was prompted by a report of skin disbonding on a
composite side panel of a rudder installed on an A310 airplane. We
are issuing this AD to detect and correct the rudder skin
disbonding, which could affect the structural integrity of the
rudder, and could result in reduced controllability of the airplane.

(f) Compliance

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

(g) Review the Maintenance Records

    Within 24 months after the effective date of this AD: Review the
maintenance records of the rudder to determine if any composite side
shell panel repair has been accomplished on the rudder since first
installation on an airplane.
    (1) If, based on the maintenance record review, any repair
identified in Figure A-GBBAA (Sheet 01 and 02) or Figure A-GBCAA
(Sheet 02) of the service information specified in paragraphs
(g)(1)(i) through (g)(1)(iii) of this AD is found: Within 24 months
after the effective date of this AD, do a thermography inspection
for repair, damages, and fluid ingress, limited to the repaired
areas, in accordance with the Accomplishment Instructions of the
applicable service information specified in paragraphs (g)(1)(i)
through (g)(1)(iii) of this AD:
    (i) Airbus Service Bulletin A330-55-3043, dated February 7, 2013
(for Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -
302, -303, -321, -322, -323, -341, -342, and -343 airplanes).
    (ii) Airbus Service Bulletin A340-55-4039, dated February 7,
2013 (for Model A340-211, -212, -213, -311, -312, and -313
airplanes).
    (iii) Airbus Service Bulletin A340-55-5007, dated February 7,
2013 (for Model A340-541 and -642 airplanes).
    (2) For a rudder for which maintenance records are unavailable
or incomplete, do the actions specified in paragraph (g)(2)(i) and
(g)(2)(ii) of this AD:
    (i) No later than 3 months before accomplishment of the
thermography inspection, as required by paragraph (g)(2)(ii) of this
AD, contact Airbus to request related rudder manufacturing reworked
data by submitting the serial number of the rudder to Airbus.
    (ii) Within 24 months after the effective date of this AD: Do a
thermography inspection for any repair on complete side shells to
identify and mark any repair, in accordance with the Accomplishment
Instructions of the applicable service information specified in
paragraphs (g)(1)(i) through (g)(1)(iii) of this AD.

(h) Related Investigative Actions, Corrective Actions, and Repetitive
Inspections

    After the inspection as required by paragraph (g)(1) or (g)(2)
of this AD: At the applicable compliance times specified in
paragraph 1.E., ``Compliance,'' of Tables 3, 4A, 4B, 4C, 4D, and 5
of the applicable service information specified in paragraphs
(g)(1)(i) through (g)(1)(iii) of this AD, accomplish all applicable
related investigative and corrective actions, in accordance with the
Accomplishment Instructions of the applicable service information
specified in paragraphs (g)(1)(i) through (g)(1)(iii) of this AD;
except as provided by paragraphs (i)(1) and (i)(2) of this AD.
Options provided in the service information specified in paragraphs
(g)(1)(i) through (g)(1)(iii) of this AD for accomplishing the
actions are acceptable for the corresponding requirements of this
paragraph provided that the related investigative and corrective
actions are done at the applicable times specified in paragraph
1.E., ``Compliance,'' of the applicable service information
specified in paragraphs (g)(1)(i) through (g)(1)(iii) of this AD,
including applicable repetitive inspection intervals. Thereafter
repeat the inspections of the restored and repaired areas at the
applicable compliance time specified in paragraph 1.E.,
``Compliance,'' of Tables 3, 4A, 4B, 4C, 4D, and 5 of the applicable
service information specified in paragraphs (g)(1)(i) through
(g)(1)(iii) of this AD.

(i) Exceptions to the Service Information

    (1) Where the applicable service information specified in
paragraphs (g)(1)(i) through (g)(1)(iii) of this AD specifies a
compliance time relative to the date of the service information,
this AD requires compliance within the specified compliance time
after the effective date of this AD.
    (2) If the service information in paragraphs (g)(1)(i) through
(g)(1)(iii) of this AD specifies to contact Airbus: At the
applicable

compliance times specified in paragraph 1.E., ``Compliance,'' of the
applicable service information specified in paragraphs (g)(1)(i)
through (g)(1)(iii) of this AD, repair using a method approved by
the Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA; or the European Aviation Safety Agency (EASA); or
Airbus's EASA Design Organization Approval (DOA).

(j) Provisions for Certain Airplanes

    Airplanes fitted with a rudder having a serial number (S/N) that
is not in the range of S/N TS-1001 through S/N TS-1043 inclusive, S/
N TS-2001 through S/N TS-2074 inclusive, S/N TS-3000 through S/N TS-
3525 inclusive, S/N TS-4001 through S/N TS-4170 inclusive, S/N TS-
6001 through S/N TS-6246 inclusive, or S/N TS-5001 through S/N TS-
5138 inclusive, are not affected by the requirements of paragraphs
(g) and (h) of this AD provided that it is determined that no repair
has been accomplished on the composite side shell panel of that
rudder since first installation on the airplane.

(k) Parts Installation Limitations

    As of the effective date of this AD, no person may install, on
any airplane, a rudder, unless the record review and thermography
inspection specified in paragraph (g) of this AD has been done on
that rudder and thereafter all applicable related investigative
actions, repetitive inspections, and corrective actions are done as
required by paragraph (h) of this AD, except as provided in
paragraph (j) of this AD.

(l) Repair Prohibition

    As of the effective date of this AD, no person may accomplish a
side shell repair on any rudder using a structure repair manual
procedure identified in Figure A-GBBAA (Sheet 01 and 02) or Figure
A-GBCAA (Sheet 02) of the service information specified in
paragraphs (g)(1)(i) through (g)(1)(iii) of this AD, as applicable,
on any airplane.

(m) 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,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA;
or Airbus's EASA DOA. If approved by the DOA, the approval must
include the DOA-authorized signature.
    (3) Reporting Requirements: 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 be approximately 5
minutes per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.
SW., Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2014-0033, dated February 4,
2014, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2014-0928.
    (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 view this service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on December 17, 2014.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-30270 Filed 12-24-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 150 (Friday, August 3, 2012)]
[Notices]
[Page 46432]
[FR Doc No: 2012-19008]

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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: RP12-886-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: 2012-07-26 NC Mieco and CIMA to be effective 7/27/
2012.
    Filed Date: 7/26/12.
    Accession Number: 20120726-5073.
    Comments Due: 5 p.m. ET 8/7/12.
    Docket Numbers: RP12-888-000.
    Applicants: Petal Gas Storage, L.L.C.
    Description: Cash for Fuel to be effective 8/27/2012.
    Filed Date: 7/27/12.
    Accession Number: 20120727-5017.
    Comments Due: 5 p.m. ET 8/8/12.
    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.

Filings in Existing Proceedings

    Docket Numbers: RP12-854-002
    Applicants: Honeoye Storage Corporation
    Description: PNFSS Amendment Sept 1 2012 to be effective 9/1/2012.
    Filed Date: 7/26/12.
    Accession Number: 20120726-5042.
    Comments Due: 5 p.m. ET 8/7/12.

    Docket Numbers: RP12-850-001.
    Applicants: WTG Hugoton, LP.
    Description: Annual Fuel Retention Percentage Filing 2012-2013
(Refile Tariff Record 10.2) to be effective 8/1/2012.
    Filed Date: 7/27/12.
    Accession Number: 20120727-5060.
    Comments Due: 5 p.m. ET 8/3/12.

    Docket Numbers: RP12-870-001.
    Applicants: Petal Gas Storage, L.L.C.
    Description: Amendment to filing in RP12-870-000 to be effective 7/
17/2012.
    Filed Date: 7/27/12.
    Accession Number: 20120727-5016.
    Comments Due: 5 p.m. ET 8/8/12.
    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 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: July 30, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-19008 Filed 8-2-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 83 (Wednesday, April 30, 2014)]
[Rules and Regulations]
[Pages 24328-24329]
[FR Doc No: 2014-09622]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30952; Amdt. No. 3585]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective April 30, 2014. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of April 30, 2014.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to:  http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    Availability--All SIAPs and Takeoff Minimums and ODPs are available
online free of charge. Visit http://www.nfdc.faa.gov to register.
Additionally, individual SIAP and Takeoff Minimums and ODP copies may
be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Richard A. Dunham III, Flight
Procedure Standards Branch (AFS-420), Flight Technologies and Programs
Divisions, Flight Standards Service, Federal Aviation Administration,
Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS.
The complete regulators description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA
Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, in addition
to their complex nature and the need for a special format make
publication in the Federal Register expensive and impractical.
Furthermore, airmen do not use the regulatory text of the SIAPs,
Takeoff Minimums or ODPs, but instead refer to their depiction on
charts printed by publishers of aeronautical materials. The advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP, Takeoff Minimums and ODP listed on
FAA forms is unnecessary. This amendment provides the affected CFR
sections and specifies the types of SIAPs and the effective dates of
the, associated Takeoff Minimums and ODPs. This amendment also
identifies the airport and its location, the procedure, and the
amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as contained in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts. The
circumstances which created the need for some SIAP and Takeoff Minimums
and ODP amendments may require making them effective in less than 30
days. For the remaining SIAPS and Takeoff Minimums and ODPS, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPS contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPS and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedures before adopting these SIAPS, Takeoff Minimums and
ODPs are impracticable and contrary to the public interest and, where
applicable, that good cause exists for making some SIAPs effective in
less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(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); and
(3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference, and
Navigation (air).

    Issued in Washington, DC on March 28, 2014.
John Duncan,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,

Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or revoking Standard Instrument
Approach Procedures and/or Takeoff Minimums and/or Obstacle Departure
Procedures effective at 0902 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 1 MAY 2014

Palm Coast, FL, Flagler County, Takeoff Minimums and Obstacle DP, Amdt
1 Hailey, ID, Friedman Memorial, Takeoff Minimums and Obstacle DP, Amdt
2 Russellville, KY, Russellville-Logan County, RNAV (GPS) RWY 6, Orig

Effective 29 MAY 2014

Pilot Point, AK, Pilot Point, RNAV (GPS) RWY 7, Orig-B Pilot Point, AK,
Pilot Point, RNAV (GPS) RWY 25, Orig-B Kremmling, CO, Mc Elroy
Airfield, GPS RWY 27, Orig-A, CANCELED Kremmling, CO, Mc Elroy
Airfield, RNAV (GPS)-B, Orig Kremmling, CO, Mc Elroy Airfield, VOR/DME-
A, Amdt 3 Nashville, GA, Berrien County, Takeoff Minimums and Obstacle
DP, Amdt 1 Nantucket, MA, Nantucket Memorial, RNAV (GPS) RWY 33, Amdt 1
Mandan, ND, Mandan Muni, RADAR-1, Amdt 5 Mandan, ND, Mandan Muni, RNAV
(GPS) RWY 13, Orig Mandan, ND, Mandan Muni, RNAV (GPS) RWY 31, Orig
Mandan, ND, Mandan Muni, Takeoff Minimums and Obstacle DP, Amdt 1
Mandan, ND, Mandan Muni, VOR-A, Amdt 2 Albuquerque, NM, Albuquerque
Intl Sunport, RNAV (RNP) Z RWY 3, Amdt 1 Rochester, NY, Greater
Rochester Intl, ILS or LOC RWY 4, ILS RWY 4 (SA CAT I), ILS RWY 4 (CAT
II), Amdt 21
Rochester, NY, Greater Rochester Intl, ILS or LOC RWY 22, Amdt 8
Rochester, NY, Greater Rochester Intl, ILS or LOC RWY 28, Amdt 31
Rochester, NY, Greater Rochester Intl, RNAV (GPS) RWY 4, Amdt 2
Rochester, NY, Greater Rochester Intl, RNAV (GPS) RWY 7, Amdt 1
Rochester, NY, Greater Rochester Intl, RNAV (GPS) RWY 10, Amdt 1
Rochester, NY, Greater Rochester Intl, RNAV (GPS) RWY 22, Amdt 2
Rochester, NY, Greater Rochester Intl, RNAV (GPS) RWY 25, Amdt 1
Rochester, NY, Greater Rochester Intl, RNAV (GPS) RWY 28, Amdt 2
Rochester, NY, Greater Rochester Intl, VOR RWY 4, Amdt 12 Rochester,
NY, Greater Rochester Intl, VOR/DME RWY 4, Amdt 4 Corpus Christi, TX,
Corpus Christi Intl, RNAV (GPS) Y RWY 36, Amdt 2 Houston, TX, George
Bush Intercontinental/Houston, RNAV (GPS) Z RWY 8R, Amdt 4 Houston, TX,
George Bush Intercontinental/Houston, RNAV (RNP) Y RWY 9, Orig Houston,
TX, George Bush Intercontinental/Houston, RNAV (RNP) Y RWY 26L, Orig
Houston, TX, George Bush Intercontinental/Houston, RNAV (RNP) Y RWY
26R, Orig

[FR Doc. 2014-09622 Filed 4-29-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Rules and Regulations]
[Pages 52414-52416]
[FR Doc No: 2013-19459]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1076; Directorate Identifier 2011-NM-274-AD;
Amendment 39-17556; AD 2013-16-18]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus Model A320-214, -232 and -233 airplanes; and Model A321-211, -
213, and -231 airplanes. This AD was prompted by a report of a missing
fastener between certain stringers of the fuselage frame that connects
the frame to a tee. This AD requires an inspection for a missing
fastener, and a rototest inspection and a modification or repair of the
fuselage frame at the affected area if necessary. We are issuing this
AD to detect and correct cracking in the fuselage that could result in
reduced structural integrity of the airplane.

DATES: This AD becomes effective September 27, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September
27, 2013.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
The NPRM was published in the Federal Register on October 16, 2012 (77
FR 63270). The NPRM proposed to correct an unsafe condition for the
specified products. The European Aviation Safety Agency (EASA), which
is the aviation authority for the Member States of the European
Community, has issued EASA Airworthiness Directive 2011-0229, dated
December 6, 2011 (referred to after this as ``the MCAI''), to correct
an unsafe condition for the specified products. The MCAI states:

    During a quality check in production of an A320 family
aeroplane, it was discovered that a fastener was missing at [frame]
FR 24 between stringer (STRG) 25 and STRG 26 on the right-hand (RH)
side. The purpose of the missing fastener, a 4 [millimeter] mm
diameter aluminum rivet, Part Number (P/N) ASNA2050DXJ040, is to
connect the FR 24 to the FR 24 Tee. The hole where the fastener was
missing was not drilled.
    Further investigations revealed that the drilling was missing on
the milling grid used for frame assembly of a limited group of
aeroplanes.
    This condition, if not corrected, could impair the structural
integrity of the affected aeroplanes.
    For the reasons described above, this [EASA] AD requires a
special detailed inspection (SDI) [rototest inspection for cracking]
of the affected area, and the accomplishment of the associated
corrective actions [modification and/or repair].

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received.

Request To Include Latest Revision of Service Information

    Airbus requested that we revise the NPRM (77 FR 63270, October 16,
2012) to reflect the latest revision of the service information to add
an inspection for a missing fastener that is included in that revised
service information. Airbus stated that the rototest inspection is
required only when it is confirmed that the fastener is missing.
    We agree with the commenter's request. Airbus has issued Airbus
Mandatory Service Bulletin A320-53-1247, Revision 01, dated October 15,
2012. That service bulletin was revised to include procedures for a
general visual inspection for a missing fastener. For airplanes on
which no fastener is missing, the rototest inspection would no longer
be necessary. We have changed paragraph (g) of this final rule to
provide instructions for accomplishing the general visual inspection,
which if accomplished and no fastener is missing, would eliminate the
need for the rototest inspection. We have included the repair and
modification that were part of paragraph (g) of the NPRM (77 FR 63270,
October 16, 2012) as new paragraph (h) of this final rule and changed
subsequent identifiers accordingly.

Conclusion

    We reviewed the available data, including the comment 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 changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 63270, October 16, 2012) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 63270, October 16, 2012).

Costs of Compliance

    We estimate that this AD will affect 111 products of U.S. registry.
We also estimate that it will take about 6 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Required parts will cost about $85 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 parts. 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 this AD to the U.S. operators
to be $66,045, or $595 per product.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD. We
have no way of determining the number of products that may need these
actions.

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 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 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 AD and placed it in the AD docket.

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 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2013-16-18 Airbus: Amendment 39-17556. Docket No. FAA-2012-1076;
Directorate Identifier 2011-NM-274-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective September
27, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A320-214, -232, and -233
airplanes; and Model A321-211, -213, and -231 airplanes;
certificated in any category; manufacturer serial numbers 4338,
4371, 4374, 4375, 4377, 4381 through 4384 inclusive, 4386, 4387,
4388, 4390 through 4402 inclusive, 4404 through 4409 inclusive, 4411
through 4417 inclusive, 4419, 4420, 4421, 4423, 4424, 4426, 4429
through 4436 inclusive, 4438 through 4443 inclusive, 4445 through
4450 inclusive, 4453, 4454, 4456 through 4469 inclusive, 4471, 4472,
4474 through 4481 inclusive, 4483 through 4498 inclusive, 4500,
4504, 4505, 4506, and 4509.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by a report of a missing fastener between
certain stringers of the fuselage frame that connects the frame to a
tee. We are issuing this AD to detect and correct cracking in the
fuselage that could result in reduced structural integrity 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) Inspections

    Before the accumulation of 24,000 total flight cycles since
first flight of the airplane, or within 30 days after the effective
date of this AD, whichever occurs later, do the actions specified in
paragraph (g)(1) or (g)(2) of this AD.
    (1) Do a general visual inspection for a missing fastener
between the two fasteners at fuselage frame (FR) 24 between stringer
25 and stringer 26 right-hand side, in accordance with the
Accomplishment Instructions of Airbus Mandatory Service Bulletin
A320-53-1247, Revision 01, dated October 15, 2012.
    (i) If the fastener is not missing, no further action is
required by paragraph (g) of this AD.
    (ii) If the fastener is missing, before further flight, do the
actions required by paragraph (g)(2) of this AD.
    (2) Do a rototest inspection for cracking of the two adjacent
fastener holes at
    fuselage FR 24 between stringer 25 and stringer 26 right-hand
side, in accordance with the Accomplishment Instructions of Airbus
Service Bulletin A320-53-1247, dated July 15, 2011; or Airbus
Mandatory Service Bulletin A320-53-1247, Revision 01, dated October
15, 2012.

(h) Repair

    (1) If, during the rototest inspection specified by paragraph
(g)(2) of this AD, any crack is found, before further flight, repair
using a method approved by the Manager, International Branch, ANM-
116, Transport Airplane Directorate, FAA; or the European Aviation
Safety Agency (EASA) (or its delegated agent).
    (2) If, during the rototest inspection specified by paragraph
(g)(2) of this AD, no crack is found, before the accumulation of
24,000 total flight cycles since first flight of the airplane, or
within 30 days after the effective date of this AD, whichever occurs
later: Modify fuselage FR 24 between stringer 25 and stringer 26
right-hand side, in accordance with the Accomplishment Instructions
of Airbus Service Bulletin A320-53-1247, dated July 15, 2011; or
Airbus Mandatory Service Bulletin A320-53-1247, Revision 01, dated
October 15, 2012.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, 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: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone (425) 227-
1405; fax<PHONE_NUMBER>. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office. 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.

(j) Related Information

    Refer to mandatory continuing airworthiness information (MCAI)
EASA Airworthiness Directive 2011-0229, dated December 6, 2011, for
related information. The MCAI may be viewed on the Internet at
http://ad.easa.europa.eu/ad/2011-0229. EASA ADs are at http://ad.easa.europa.eu/.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Airbus Mandatory Service Bulletin A320-53-1247, Revision 01,
dated October 15, 2012.
    (ii) Airbus Service Bulletin A320-53-1247, dated July 15, 2011.
    (3) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com.
    (4) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.
    (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 Renton, Washington, on August 2, 2013.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-19459 Filed 8-22-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Notices]
[Page 78993]
[FR Doc No: 2013-30961]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4111-DR; Docket ID FEMA-2013-0001]

New York; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for State of New York (FEMA-4111-DR), dated April 23, 2013, and related
determinations.

DATES: Effective Date: December 17, 2013.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, John Long, of
FEMA is appointed to act as the Federal Coordinating Officer for this
disaster.
    This action terminates the appointment of Willie G. Nunn as Federal
Coordinating Officer for this disaster.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-30961 Filed 12-26-13; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 45 (Wednesday, March 8, 2023)]
[Notices]
[Page 14362]
[FR Doc No: 2023-04677]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Staff Attendance at North American Electric Reliability
Corporation Industry Webinar

    The Federal Energy Regulatory Commission hereby gives notice that
members of the Commission and/or Commission staff may attend the
following meeting:
    North American Electric Reliability Corporation Project 2021-07
Extreme Cold Weather Grid Operations, Preparedness, and Coordination
Virtual Industry Webinar on:

March 14, 2023 (1:00 p.m.-2:30 p.m. eastern time)

    Further information regarding these meetings may be found at:
http://www.nerc.com/Pages/Calendar.aspx.
    The discussions at the meetings, which are open to the public, may
address matters at issue in the following Commission proceeding:

Docket No. RD23-1-000 Extreme Cold Weather Reliability Standards EOP-
011-3 and EOP-012-1

    For further information, please contact Chanel Chasanov, 202-502-
8569, or [email protected].

    Dated: March 1, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-04677 Filed 3-7-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 20 (Wednesday, January 30, 2013)]
[Notices]
[Pages 6361-6362]
[FR Doc No: 2013-01936]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 248.30; OMB Control No. 3235-0610, SEC File No. 270-549.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Rule 248.30 (17 CFR 248.30), under Regulation S-P is titled
``Procedures to Safeguard Customer Records and Information; Disposal of
Consumer Report Information.'' Rule 248.30 (the ``safeguard rule'')
requires brokers, dealers, investment companies, and investment
advisers registered with the Commission (``registered investment
advisers'') (collectively ``covered institutions'') to adopt written
policies and procedures for administrative, technical, and physical
safeguards to protect customer records and information. The safeguards
must be reasonably designed to ``insure the security and
confidentiality of customer records and information,'' ``protect
against any anticipated threats or hazards to the security and
integrity'' of those records, and protect against unauthorized access
to or use of those records or information, which ``could result in
substantial harm or inconvenience to any customer.'' The safeguard
rule's requirement that covered institutions' policies and procedures
be documented in writing constitutes a collection of information and
must be maintained on an ongoing basis. This requirement eliminates
uncertainty as to required employee actions to protect customer records
and information and promotes more systematic and organized reviews of
safeguard policies and procedures by institutions. The information
collection also assists the Commission's examination staff in assessing
the existence and adequacy of covered institutions' safeguard policies
and procedures.
    We estimate that as of the end of 2011, there are 4,695 broker-
dealers, 4,203 investment companies, and 11,658 investment advisers
currently registered with the Commission, for a total of 20,556 covered
institutions. We believe that all of these covered institutions have
already documented their safeguard policies and procedures in writing
and therefore will incur no hourly burdens related to the initial
documentation of policies and procedures.
    Although existing covered institutions would not incur any initial
hourly burden in complying with the safeguards rule, we expect that
newly registered institutions would incur some hourly burdens
associated with documenting their safeguard policies and procedures. We
estimate that approximately 1,500 broker-dealers, investment companies,
or investment advisers register with the Commission annually. However,
we also expect that approximately 70% of these newly registered covered
institutions (1,050) are affiliated with an existing covered
institution, and will rely on an organization-wide set of previously
documented safeguard policies and procedures created by their
affiliates. We estimate that these affiliated newly registered covered
institutions will incur a significantly reduced hourly burden in
complying with the safeguards rule, as they will need only to review
their affiliate's existing policies and procedures, and identify and
adopt the relevant policies for their business. Therefore, we expect
that newly registered covered institutions with existing affiliates
will incur an hourly burden of approximately 15 hours in identifying
and adopting safeguard policies and procedures for their business, for
a total hourly burden for all affiliated new institutions of 15,750
hours.
    Finally, we expect that the 450 newly registered entities that are
not affiliated with an existing institution will incur a significantly
higher hourly burden in

reviewing and documenting their safeguard policies and procedures. We
expect that virtually all of the newly registered covered entities that
do not have an affiliate are likely to be small entities and are likely
to have smaller and less complex operations, with a correspondingly
smaller set of safeguard policies and procedures to document, compared
to other larger existing institutions with multiple affiliates. We
estimate that it will take a typical newly registered unaffiliated
institution approximately 60 hours to review, identify, and document
their safeguard policies and procedures, for a total of 27,000 hours
for all newly registered unaffiliated entities.
    Therefore, we estimate that the total annual hourly burden
associated with the safeguards rule is 42,750 hours. We also estimate
that all covered institutions will be respondents each year, for a
total of 20,556 respondents.
    These estimates of average burden hours are made solely for the
purposes of the Paperwork Reduction Act. An agency may not conduct or
sponsor, and a person is not required to respond to a collection of
information unless it displays a currently valid control number. The
safeguard rule does not require the reporting of any information or the
filing of any documents with the Commission. The collection of
information required by the safeguard rule is mandatory.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Thomas Bayer, Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312; or send an
email to<EMAIL_ADDRESS>
    Dated: January 24, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-01936 Filed 1-29-13; 8:45 am]
BILLING CODE 8011-01-P