[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Page 47655]
[FR Doc No: 2014-19255]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0334]

Postmarketing Safety Reports for Human Drug and Biological
Products; Electronic Submission Requirements; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final
rule entitled ``Postmarketing Safety Reports for Human Drug and
Biological Products; Electronic Submission Requirements'' that appeared
in the Federal Register of June 10, 2014 (79 FR 33072). The document
amended FDA's postmarketing safety reporting regulations for human drug
and biological products to require that persons subject to mandatory
reporting requirements submit safety reports in an electronic format
that FDA can process, review, and archive. The document was published
with incorrect information regarding the availability of the
International Conference on Harmonization's (ICH) data elements for
postmarketing safety reports. The document also published with an
incorrect statement regarding the impact of the final rule on small
entities. This document corrects those errors.

FOR FURTHER INFORMATION CONTACT: Jean Chung, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 4466, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:  In the Federal Register of June 10, 2014,
in FR Doc. 2014-13480, the following corrections are made:
    1. On page 33074, in the first column, under ``Introduction'',
footnote 6 is corrected to read: ``ICH data elements for postmarketing
safety reports are provided in the guidance for industry entitled `E2B
Electronic Transmission of Individual Case Safety Reports
Implementation Guide--Data Elements and Message Specification,'
available at http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm.''
    2. On page 33084, in the second column, under ``Analysis of
Impacts'', the first full sentence is corrected to read: ``Because the
average small entity submits few safety reports and the Agency's Web-
based system for submitting reports electronically will require little
additional cost per report, the Agency certifies that this final rule
will not have a significant economic impact on a substantial number of
small entities.''

    Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19255 Filed 8-13-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Pages 3156-3157]
[FR Doc No: 2018-01120]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0045]

Pediatric Advisory Committee and the Endocrinologic and Metabolic
Drugs Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pediatric Advisory Committee
(PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee
(EMDAC). At least one portion of the meeting will be closed to the
public. The general function of the committees is to provide advice and
recommendations to FDA on regulatory issues. FDA is establishing a
docket for public comments on this document.

DATES: The meeting will be held on March 22, 2018, from 8:30 a.m. to
5:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2018-N-0045. The docket will close on March
23, 2018. Submit either electronic or written comments on this public
meeting by that date. Please note that late, untimely comments will not
be considered. The https://www.regulations.gov electronic filing system
will accept comments until midnight Eastern Time at the end of March
23, 2018. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date.
    Comments received on or before March 8, 2018, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA.
    You may submit comments 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 Docket No. FDA-
2018-N-0045 for ``Pediatric Advisory Committee and the Endocrinologic
and Metabolic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA 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 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 the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of the
Commissioner, Food and Drug

Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver
Spring, MD 20993,<PHONE_NUMBER>, email: [email protected], or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in the Washington, DC area). A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's website
at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down
to the appropriate advisory committee meeting link, or call the
advisory committee information line to learn about possible
modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The PAC and EMDAC will meet to discuss the major objectives
of a phase 3 drug development program indicated for the treatment of
children with achondroplasia (ACH). The following elements of a phase 3
program should be considered for discussion: Evidence required to
establish dose-response, study design, e.g., placebo control, study
duration, intended population, e.g., infants and toddlers and/or older
children and adolescents, and endpoints that have a clinically
meaningful impact on the patient's functional or psychological well-
being. Comments about the upcoming advisory committee meeting should be
submitted to Docket No. FDA-2018-N-0045.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: On March 22, 2018, from 10:30 a.m. to 5:30 p.m., the
meeting is open to the public. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committee. Written submissions may be made to the contact person on
or before March 15, 2018. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before March 7, 2018. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by March 8, 2017.
    Closed Committee Deliberations: On March 22, 2018, from 8:30 a.m.
to 10 a.m., the meeting will be closed to permit committee review and
discussion of trade secret and/or confidential commercial information
(5 U.S.C. 552b(c)(4)) included in an Investigational New Drug
application for an investigational product indicated for the treatment
of children with ACH.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Marieann Brill (See, FOR FURTHER INFORMATION CONTACT) at least
7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01120 Filed 1-22-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 51 (Wednesday, March 16, 2011)]
[Notices]
[Page 14413]
[FR Doc No: 2011-6084]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Risk Mitigation Strategies To Address Potential Procoagulant
Activity in Immune Globulin Intravenous Products; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA), in cooperation with the
National Heart, Lung, and Blood Institute, and the Plasma Protein
Therapeutics Association, are jointly cosponsoring a public workshop on
risk mitigation strategies to address procoagulant activity that may be
present in some Immune Globulin Intravenous (IGIV) products. The
purposes of the public workshop are to identify the most likely causes
of IGIV-associated thrombotic events, to determine which procoagulant
proteins may be causative, and to identify relevant, feasible tests
that could be used to assess levels and/or activity of these proteins
in IGIV products. The public workshop will feature presentations by
national and international experts from government, academic
institutions, and industry.
    Dates and Time: The public workshop will be held on May 17, 2011,
from 8:30 a.m. to 5 p.m. and May 18, 2011, from 8 a.m. to 11:30 a.m.
    Location: The public workshop will be held at the Universities at
Shady Grove Conference Center, Building II, Multipurpose Room, 9630
Gudelsky Dr., Rockville, MD 20850. Please visit http://www.shadygrove.umd.edu/about/visit for directions, visitor parking, and
public transportation information.
    Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
e-mail<EMAIL_ADDRESS>    Registration: Mail or fax your registration information (including
name, title, firm name, address, telephone and fax numbers) to the
contact person by April 26, 2011. There is no registration fee for the
public workshop. Early registration is recommended because seating is
limited. Registration on the day of the public workshop will be
provided on a space available basis beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please
contact Rhonda Dawson at least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: The following topics will be discussed at
the public workshop: (1) Epidemiology of thrombotic events in IGIV
recipients; (2) pathophysiology of arterial and venous thrombosis in
this context; (3) research to identify specific procoagulant proteins
that can co-purify with IGIV; (4) partitioning of coagulation factors
during IGIV purification; (5) the role of activated Coagulation Factor
XIa in IGIV-associated thrombosis; (6) test methods for screening IGIV
products; (7) ancillary animal models; and (8) standards development
for thrombin generation tests. On the first day of the public workshop,
the epidemiology and potential causes of historically observed IGIV-
associated thrombotic adverse events, as well as biochemical
identification of procoagulant proteins that co-purify with IGIV will
be discussed. In addition, methods and relevance of both broad and
specific tests to screen IGIV products for procoagulant activity will
be addressed, and limitations in test methodologies and validation
needs will be identified. On the second day of the public workshop,
preliminary results of IGIV product testing for procoagulant activity
will be presented and discussed, followed by a summary of the meeting.
    Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.

    Dated: March 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6084 Filed 3-15-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 22 (Friday, February 3, 2017)]
[Rules and Regulations]
[Pages 9138-9142]
[FR Doc No: 2017-02189]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2016-0620; FRL-9958-28-Region 8]

Approval and Promulgation of Air Quality Implementation Plans;
State of Utah; Revisions to Nonattainment Permitting Regulations

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The EPA is taking final action to conditionally approve all
but one of the State Implementation Plan (SIP) revisions submitted by
the State of Utah on August 20, 2013, with supporting administrative
documentation submitted on September 12, 2013. These submittals revise
the Utah Administrative Code (UAC) that pertain to the issuance of Utah
air quality permits for major sources in nonattainment areas. The EPA
is not taking final action on the portion of the August 20, 2013
submittal that revised rule R307-420 at this time. The EPA is taking
final action to conditionally approve the other revisions because,
while the submitted revisions to Utah's nonattainment permitting rules
do not fully address the deficiencies in the state's program, Utah has
committed to address additional remaining deficiencies in the state's
nonattainment permitting program no later than a year from the EPA
finalizing this conditional approval. Upon the EPA finding of a timely
meeting of this commitment in full, the final conditional approval of
the SIP revisions would convert to a final approval of Utah's plan.
This action is being taken under section 110 of the Clean Air Act (CAA)
(Act).

DATES: This final rule is effective March 6, 2017.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R08-OAR-2016-0620. All documents in the docket are
listed in the www.regulations.gov index. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available either
electronically in www.regulations.gov or in hard copy at the Air
Program, Environmental Protection Agency (EPA), Region 8, 1595 Wynkoop
Street, Denver, Colorado 80202-1129. The EPA requests you contact the
individual listed in the FOR FURTHER INFORMATION CONTACT section to
view the hard copy of the docket. You may view the hard copy of the
docket Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding federal
holidays.

FOR FURTHER INFORMATION CONTACT: Kevin Leone, Air Program, Mailcode 8P-
AR, Environmental Protection Agency, Region 8, 1595 Wynkoop Street,
Denver, Colorado 80202-1129,<PHONE_NUMBER>, or<EMAIL_ADDRESS>
I. Background

    On August 20, 2013, with supporting administrative documentation
submitted on September 12, 2013, Utah sent the EPA revisions to their
nonattainment permitting regulations, specifically to address
deficiencies the EPA identified in their nonattainment permitting
regulations that affected the EPA's ability to approve Utah's
PM10 maintenance plan and that may affect the EPA's ability
to approve Utah's PM2.5 SIP. These revisions addressed R307-
403-1 (Purpose and Definitions), R307-403-2 (Applicability), R307-403-
11 (Actual Plant-wide Applicability Limits (PALs)), and R307-420 (Ozone
Offset Requirements in Davis and Salt Lake Counties). In addition, Utah
moved R307-401-19 (Analysis of Alternatives) to R307-403-10 and moved
R307-401-20 (Relaxation of Limits) to R307-403-2. On June 2, 2016, the
EPA entered into a consent decree with the Center for Biological
Diversity, Center for Environmental Health, and Neighbors for Clean Air
regarding a failure to act, pursuant to CAA sections 110(k)(2)-(4), on
certain complete SIP submissions from states intended to address
specific requirements related to the 2006 PM2.5 national
ambient air quality standard (NAAQS) for certain nonattainment areas,
including the submittal from the Governor of Utah dated August 20,
2013.
    The SIP revisions submitted by the Utah Department of Air Quality
(UDAQ) on August 20, 2013, establish specific nonattainment new source
review (NNSR) permitting requirements. In this revision, the UDAQ has
incorporated federal regulatory language--establishing permitting
requirements for new and modified major stationary sources in a
nonattainment area--from portions of 40 CFR 51.165 and reformatted it
into state-specific requirements for sources in Utah under R307-403-1
(Purpose and Definitions) and R307-403-2 (Applicability), including
provisions relevant to NNSR programs for PM2.5 nonattainment
areas. Additionally, UDAQ incorporated by reference the provisions of
40 CFR 51.165(f)(1)--(f)(14) into 307-403-11 (Actual PALs), and revised
R307-420 to state that the definitions and applicability provisions in
R307-403-1 apply to this section.
    CAA section 110(a)(2)(C) requires each state plan to include ``a
program to provide for . . . regulation of the modification and
construction of any stationary source within the areas covered by the
plan as necessary to assure that [NAAQS] are achieved, including a
permit program as required in parts C and D of this subchapter,'' and
CAA section 172(c)(5) provides that the plan ``shall require permits
for the construction and operation of new or modified major stationary
sources anywhere in the nonattainment area, in accordance with section
[173].'' CAA section 173 lays out the requirements for obtaining a
permit that must be included in a state's SIP-approved permit program.
CAA section 110(a)(2)(A) requires that SIPs contain enforceable
emissions limitations and other control measures. Under section CAA
section 110(a)(2), the enforceability requirement in section
110(a)(2)(A) applies to all plans submitted by a state. CAA section
110(i) (with certain limited exceptions) prohibits states from
modifying SIP requirements for stationary sources except through the
SIP revision process. CAA section 172(c)(7) requires that nonattainment
plans, including NNSR programs required by section 172(c)(5),

meet the applicable provisions of section 110(a)(2), including the
requirement in section 110(a)(2)(A) for enforceable emission
limitations and other control measures. CAA section 110(l) provides
that the EPA cannot approve a SIP revision that interferes with any
applicable requirement of the Act.
    Section 51.165 in title 40 of the CFR (Permit Requirements) sets
out the minimum plan requirements states are to meet within each SIP
NNSR permitting program. Generally, 40 CFR 51.165 consists of a set of
definitions, minimum plan requirements regarding procedures for
determining applicability of NNSR and use of offsets, and minimum plan
requirements regarding other source obligations, such as recordkeeping.
    Specifically, subparagraphs 51.165(a)(1)(i) through (xlvi)
enumerate a set of definitions which states must either use or replace
with definitions that a state demonstrates are more stringent or at
least as stringent in all respects. Subparagraph 51.165(a)(2) sets
minimum plan requirements for procedures to determine the applicability
of the NNSR program to new and modified sources. Subparagraph
51.165(a)(3), (a)(9) and (a)(11) set minimum plan requirements for the
use of offsets by sources subject to NNSR requirements. Subparagraphs
(a)(8) and (a)(10) regard precursors, and subparagraphs (a)(6) and
(a)(7) regard recordkeeping obligations. Subparagraph 51.165(a)(4)
allows NNSR programs to treat fugitive emissions in certain ways.
Subparagraph 51.165(a)(5) regards enforceable procedures for after
approval to construct has been granted. Subparagraph 51.165(b) sets
minimum plan requirements for new major stationary sources and major
modifications in attainment and unclassifiable areas that would cause
or contribute to violations of the NAAQS. Finally, subparagraph
51.165(f) sets minimum plan requirements for the use of PALs. Please
refer to docket EPA-R08-OAR-2016-0620 to view a cross-walk table which
outlines how Utah's nonattainment permitting rules correlate with the
requirements of 40 CFR 51.165.
    Clean Air Act section 189(e) requires that state SIPs apply the
same control requirements that apply to major stationary sources of
PM10 to major stationary sources of PM10
precursors, ``except where the Administrator determines that such
sources do not contribute significantly to PM10 levels which
exceed the standard in the area.'' On January 4, 2013, the U.S. Court
of Appeals for the District of Columbia Circuit, in Natural Resources
Defense Council v. EPA, 706 F.3d 428 (D.C. Cir. 2013), issued a
decision that remanded the EPA's 2008 PM2.5 NSR
Implementation Rule (73 FR 28321). The court found that the EPA erred
in implementing the PM2.5 NAAQS in these rules solely
pursuant to the general implementation provisions of subpart 1 of part
D of title I of the CAA, rather than pursuant to the additional
implementation provisions specific to particulate matter nonattainment
areas in subpart 4. In particular, subpart 4 includes section 189(e) of
the CAA, which requires the control of major stationary sources of
PM10 precursors (and hence under the court decision,
PM2.5 precursors) ``except where the Administrator
determines that such sources do not contribute significantly to
PM10 levels which exceed the standard in the area.''
Accordingly, NNSR programs that are submitted for PM2.5
nonattainment areas must regulate all PM2.5 precursors,
i.e., sulfur dioxide (SO2), nitrogen oxides
(NOX), volatile organic compounds (VOC), and ammonia, unless
the Administrator determines that such sources of a particular
precursor do not contribute significantly to nonattainment in the
nonattainment area. The EPA recently finalized a new provision at 40
CFR 51.165(a)(13) that codifies this requirement, as it applies to
PM2.5, in the federal regulations.
    As a result of this court decision, Utah needed to submit further
revisions to address remaining deficiencies in the nonattainment
permitting program in order for the EPA to approve the August 20, 2013,
submittal. Included as part of those deficiencies was that Utah has not
submitted an analysis demonstrating that sources of ammonia, as a
PM2.5 precursor, do not contribute significantly to
PM2.5 levels that exceed the NAAQS in nonattainment areas in
the State. On September 30, 2016, Utah submitted to the EPA a
commitment letter (see docket EPA-R08-OAR-2016-0620) in which Utah
commits to address additional remaining deficiencies in the State's
nonattainment permitting program in R307-403 by December 8, 2017, that
were not addressed in the August 20, 2013, submittal, including
revisions to R307-403-2, R307-403-3, and R307-403-4. In Utah's
commitment letter, Utah specifies that:
    1. UDAQ commits to submit a SIP revision that either regulates
major stationary sources pursuant to Utah's NNSR permitting program,
consistent with all applicable federal regulatory requirements or
demonstrates that sources of ammonia, as a PM2.5 precursor,
do not contribute significantly to PM2.5 levels that exceed
the NAAQS in nonattainment areas in the state, consistent with new
provisions at 40 CFR 51.1006(a)(3);
    2. UDAQ commits to revise R307-403-2 consistent with the new
definitions in 40 CFR 51.165 that the EPA recently finalized in the
PM2.5 SIP Requirements Rules;
    3. UDAQ commits to revise R307-403-3, including R307-403-3(3), to
remove the reference to NNSR determinations being made ``at the time of
the source's proposed start-up date'';
    4. UDAQ commits to revise R307-403-3, including R307-403-3(2) and
R307-403-3(3), to specify that NNSR permit requirements are applicable
to all new major stationary sources or major modifications located in a
nonattainment area that are major for the pollutant for which the area
is designated nonattainment;
    5. UDAQ commits to revise R307-403-3, in addition to the previously
adopted definition of lowest achievable emission rate (LAER) in R307-
403-1, to explicitly state that LAER applies to all major new sources
and major modifications for the relevant pollutants in nonattainment
areas;
    6. UDAQ commits to revise R307-403-4 to incorporate the
requirements from 40 CFR 51.165 to establish that all general offset
permitting requirements apply for all offsets regardless of the
pollutant at issue, and to revise the provision to impose immediate and
direct general offset permitting requirements on all new major
stationary sources or major modifications located in a nonattainment
area that are major for the pollutant for which the area is designated
nonattainment;
    7. UDAQ commits to work with the Utah Air Quality Board to revise
R307-403-4 to reference the criteria discussed in section IV.D. of 40
CFR 51, Appendix S; and
    8. UDAQ will update R307-403 to include a new section that imposes
requirements that address emission offsets for PM2.5
nonattainment areas (as required in 40 CFR 51.165(a)(11)) on NNSR
sources in Utah. UDAQ will revise R307-403-3, including R307-403-
3(3)(c), to cross reference this new section, as well as the
requirements in R307-403-4, R307-403-5, and R307-403-6; and UDAQ
commits to work with the Utah Air Quality Board to revise this section
to include the requirements of CAA Section 173(c)(1) and 40 CFR 51.165
(specifically 40 CFR 51.165(a)(3)) concerning the requirement that
creditable reductions be calculated based on actual emissions for
offset purposes.

    Under CAA section 110(k)(4), the EPA may approve a SIP revision
based on a commitment by the state to adopt specific enforceable
measures by a date certain, but not later than one year after the date
of approval of the plan revision. Under a conditional approval, the
state must adopt and submit the specific revisions it has committed to
within one year of the EPA's finalization. If the EPA fully approves
the submittal of the revisions specified in the commitment letter, the
conditional nature of the approval would be removed and the submittal
would become fully approved. If the state does not submit these
revisions within one year, or if the EPA finds the state's revisions to
be incomplete, or the EPA disapproves the state's revisions, a
conditional approval will convert to a disapproval. If any of these
occur and the EPA's conditional approval converts to a disapproval,
that will constitute a disapproval of a required plan element under
part D of title I of the Act, which starts an 18-month clock for
sanctions, see section 179(a)(2), and a two-year clock for a federal
implementation plan (FIP), see section 110(c)(1)(B).

II. What are the changes that EPA is taking final action to approve?

    As proposed in our October 31, 2016 proposed action (81 FR 75361),
we are finalizing conditional approval of the following revisions to
the UAC: R307-403-1 (Purpose and Definitions); R307-403-2
(Applicability); R307-403-11 (Actual PALs); and the relocation of R307-
401-19 (Analysis of Alternatives), which was originally approved in 79
FR 7072 on February 6, 2014, to R307-403-10 and R307-401-20 (Relaxation
of Limits) to R307-403-2, which was originally approved in 79 FR 7072
on February 6, 2014.
    In our October 31, 2016 proposed rulemaking (see 81 FR 75361), we
proposed to approve R307-420 (Ozone Offset Requirements in Davis and
Salt Lake Counties.) In that rulemaking, we stated: ``This rule is
being revised to include the definitions and applicability provisions
of R307-403-1. This rule change will ensure that the definitions and
applicability provisions in R307-420 are consistent with related
permitting rules in R307-403.'' However, we are not taking final action
at this time on the revisions to R307-420, as submitted by Utah on
August 20, 2013. Merely approving the phrase ``Except as provided in
R307-420-2, the definitions in R307-403-1 apply to R307-420'' in R307-
420-2 (Definitions), and the phrase ``The applicability provisions in
R307-403-2(1)(a) through (f) and R307-403-2(2) through (7) apply in
R307-420'' in R307-420-3(3) (Applicability) would not meet the
requirements of CAA section 110(a)(2)(A), which requires that SIPs
contain enforceable emissions limitations and other control measures.
The EPA has determined that it should not take action on these
revisions because the rest of R307-420 is not a part of Utah's
federally enforceable SIP, and approving it into the SIP would create
confusion for the regulatory authorities, the sources and the public.
However, once Utah does submit a fully approvable revision
incorporating all of R307-420, the EPA will be able to undertake future
rulemaking action on this section at that time.
    The EPA has determined that these final revisions, when combined
with the changes in Utah's September 30, 2016 commitment letter, create
enforceable obligations for sources and are consistent with the CAA and
EPA regulations, including the requirements of CAA section
110(a)(2)(A), 110(a)(2)(C), 110(i), 110(l), 172(c)(5), 172(c)(7), 173.
While the August 20, 2013, submittal states that ammonia is not a
precursor to PM2.5,\1\ and UDAQ has not submitted an
analysis demonstrating that sources of ammonia, as a PM2.5
precursor, do not contribute significantly to PM2.5 levels
that exceed the NAAQS in nonattainment areas in the State, UDAQ
committed to submit a SIP revision that either (1) regulates major
stationary sources of ammonia pursuant to Utah's NNSR permitting
program, consistent with all applicable federal regulatory
requirements, or (2) demonstrates that sources of ammonia, as a
PM2.5 precursor, do not contribute significantly to
PM2.5 levels that exceed the NAAQS in nonattainment areas in
the State, consistent with new provisions at 40 CFR 51.1006(a)(3).
Therefore, we are conditionally approving the submittal's
PM2.5 precursor provisions.
---------------------------------------------------------------------------

    \1\ R307-403-1(4)(b) states that ``ammonia is not a precursor to
PM2.5 in the Logan, Salt Lake City, and Provo
PM2.5 nonattainment areas as defined in the July 1, 2010
version of 40 CFR 81.345,''
---------------------------------------------------------------------------

    Utah also committed to address additional remaining deficiencies in
the State's nonattainment permitting program in R307-403 by December 8,
2017, that were not addressed in the August 20, 2013, submittal,
including revisions to R307-403-2, R307-403-3, and R307-403-4.
Therefore, the EPA's final conditional approval of these revisions
allows Utah to apply R307-403 as permitting authority in all
nonattainment areas for PM2.5, PM10, and
SO2 as well as maintenance areas for ozone and CO for new
major sources and major modifications.
    We provided a detailed explanation of the basis of our proposed
conditional approval in our proposed rulemaking (see 81 FR 75361). We
invited comment on all aspects of our proposal and provided a 30-day
comment period. The comment period ended on November 30, 2016.

III. Response to Comments

    Comment: We received one (1) comment from Caitlin Whittaker. The
commenter stated the importance of addressing emission offsets in
Utah's SIP, and that it is important for the air quality in Utah.
    Response: The EPA agrees with the commenter that emissions offset
programs for nonattainment areas are an important component for
improving air quality, and we acknowledge the Utah Department of
Environmental Quality's work with the EPA to improve their air quality
regulations, particularly with concern to their nonattainment area
rules.

IV. What action is EPA taking today?

    The EPA is taking final action to conditionally approve Utah's
August 20, 2013, submittal. As discussed in our proposal and this
notice, our action is based on an evaluation of Utah's rules against
the requirements of CAA sections 110(a)(2)(C), 110(a)(2)(A), 110(i),
110(l), 172(c)(5), 172(c)(7), 173, and regulations at 40 CFR 51.165.
    As described in our proposed rulemaking, and in Section II of this
notice, the EPA is conditionally approving the revisions of R307-403-1
(Purpose and Definitions), R307-403-2 (Applicability), R307-403-11
(Actual PALs), and the relocation of R307-401-19 (Analysis of
Alternatives) to R307-403-10 and R307-401-20 (Relaxation of Limits) to
R307-403-2. We are also determining that if the commitments outlined in
Utah's September 30, 2016 commitment letter (see docket EPA-R08-OAR-
2016-0620) are met, those revisions combined with the August 20, 2013,
submittal would address the deficiencies in Utah's nonattainment
permitting program, as identified by the EPA in our proposed rulemaking
for this action.

V. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the UDAQ
rules as described in the amendments to 40 CFR part 52 set forth in
this

document. Therefore, these materials have been approved by the EPA for
inclusion in the State Implementation Plan, have been incorporated by
reference by the EPA into that plan, are fully federally enforceable
under sections 110 and 113 of the CAA as of the effective date of the
final rulemaking of EPA's approval, and will be incorporated by
reference by the Director of the Federal Register in the next update to
the SIP compilation.\2\ The EPA has made, and will continue to make,
these materials generally available through www.regulations.gov and/or
at the EPA Region 8 office (please contact the person identified in the
``For Further Information Contact'' section of this preamble for more
information).
---------------------------------------------------------------------------

    \2\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

VI. Statutory and Executive Orders Review

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable federal regulations 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
in a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where the EPA or an Indian tribe has demonstrated
that a tribe has jurisdiction. In those areas of Indian country, the
rule does not have tribal implications and will not impose substantial
direct costs on tribal governments or preempt tribal law as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by April 4, 2017. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See CAA section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: December 27, 2016.
Shaun L. McGrath,
Regional Administrator, Region 8.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority for citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart TT--Utah

0
2. In Sec.  52.2320, the table in paragraph (c) is amended by:
0
a. Removing, under the center heading ``R307-401. Permit: New and
Modified Sources,'' the entries ``R307-401-19'' and ``R307-401-20.''
0
b. Revising, under the center heading ``R307-403. Permits: New and
Modified Sources in Nonattainment Areas and Maintenance Areas,'' the
entry ``R307-403.''
0
c. Adding, under the center heading ``R307-403. Permits: New and
Modified Sources in Nonattainment Areas and Maintenance Areas,'' the
entries ``R307-403-1,'' ``R307-403-2,'' ``R307-403-10,'' and ``R307-
403-11'' in numerical order.
    The additions and revision read as follows:

Sec.  52.2320  Identification of plan.

* * * * *
    (c) * * *

----------------------------------------------------------------------------------------------------------------
                                                         State       Final rule citation,
          Rule No.                 Rule title       effective date           date                 Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
             R307-403 Permits: New and Modified Sources in Nonattainment Areas and Maintenance Areas
----------------------------------------------------------------------------------------------------------------
R307-403...................  Permits: New and            9/15/1998  71 FR 7679, 2/14/06..  Except for R307-403-
                              Modified Sources in                                           1, R307-403-2, R307-
                              Nonattainment Areas                                           403-10, R307-403-11.
                              and Maintenance
                              Areas.
R307-403-1.................  Purpose and                  7/1/2013  [insert Federal        Conditionally
                              Definitions.                           Register citation],    approved through 2/5/
                                                                     2/3/2017.              2018.
R307-403-2.................  Applicability........        7/1/2013  [insert Federal        Conditionally
                                                                     Register citation],    approved through 2/5/
                                                                     2/3/2017.              2018.
R307-403-10................  Analysis of                  7/1/2013  [insert Federal        Conditionally
                              Alternatives.                          Register citation],    approved through 2/5/
                                                                     2/3/2017.              2018.
R307-403-11................  Actuals PALS.........        7/1/2013  [insert Federal        Conditionally
                                                                     Register citation],    approved through 2/5/
                                                                     2/3/2017.              2018.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-02189 Filed 2-2-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: June 26, 2007 (Volume 72, Number 122)]
[Proposed Rules]
[Page 35022]
[DOCID:fr26jn07-8]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2007-0457; FRL-8330-6]

Approval and Promulgation of Implementation Plans; State of Iowa

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA proposes to approve a revision to the Iowa State
Implementation Plan (SIP). The purpose of this revision is to update
the Polk County Board of Health Rules and Regulations, Chapter V, Air
Pollution. These revisions reflect updates to the Iowa statewide rules
previously approved by EPA and will ensure consistency between the
applicable local agency rules and Federally-approved rules.

DATES: Comments on this proposed action must be received in writing by
July 26, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2007-0457 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Mail: Heather Hamilton, Environmental Protection Agency, Air
Planning and Development Branch, 901 North 5th Street, Kansas City,
Kansas 66101.
    4. Hand Delivery or Courier: Deliver your comments to: Heather
Hamilton, Environmental Protection Agency, Air Planning and Development
Branch, 901 North 5th Street, Kansas City, Kansas 66101. Such
deliveries are only accepted during the Regional Office's normal hours
of operation. The Regional Office's official hours of business are
Monday through Friday, 8 a.m. to 4:30 p.m., excluding legal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Heather Hamilton at<PHONE_NUMBER>, or
by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of the Federal
Register, EPA is approving the state's SIP revision as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial revision amendment and anticipates no relevant adverse
comments to this action. A detailed rationale for the approval is set
forth in the direct final rule. If no relevant adverse comments are
received in response to this action, no further activity is
contemplated in relation to this action. If EPA receives relevant
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed action. EPA will not institute a second comment
period on this action. Any parties interested in commenting on this
action should do so at this time. Please note that if EPA receives
adverse comment on part of this rule and if that part can be severed
from the remainder of the rule, EPA may adopt as final those parts of
the rule that are not the subject of an adverse comment. For additional
information, see the direct final rule which is located in the rules
section of this Federal Register.

    Dated: June 8, 2007.
John B. Askew,
Regional Administrator, Region 7.
 [FR Doc. E7-12238 Filed 6-25-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 170 (Friday, September 2, 2022)]
[Notices]
[Page 54270]
[FR Doc No: 2022-18981]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-405, OMB Control No. 3235-0462]

Submission for OMB Review; Comment Request; Extension: Display of
Customer Limit Orders (17 CFR 242.604)

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) (``PRA''), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in Rule 604
(17 CFR 242.604) under the Securities Exchange Act of 1934 (17 U.S.C.
78a et seq.) (``Exchange Act'').
    Rule 604 requires specialists and market makers to publish customer
limit orders that are priced superior to the bids or offers being
displayed by each such specialist or market maker.\1\ Customer limit
orders that match the bid or offer being displayed by a specialist or
market maker must be published if the limit price also matches the
national best bid or offer (``NBBO'') and the size of the customer
limit order is more than de minimis (i.e., more than 10% of the
specialist's or market maker's displayed size).
---------------------------------------------------------------------------

    \1\ See Securities Exchange Act Release No. 37619A (September 6,
1996), 61 FR 48290 (September 12, 1996).
---------------------------------------------------------------------------

    The information collected pursuant to Rule 604 is necessary to
facilitate the establishment of a national market system for
securities. The publication of trading interests that improve
specialists' and market makers' quotes presents investors with improved
execution opportunities and improved access to the best available
prices when they buy or sell securities.
    The Commission estimates that approximately 318 respondents will
respond to the collection of information requirements each time they
receive a displayable customer limit order. The Commission further
estimates that a respondent will receive a customer limit order, on
average, 15,136.767 times per trading day with an estimate average time
of 0.1 second per quote update. Accordingly, assuming 252 days in a
trading year, an average 105.957 hours per year per respondent, the
Commission estimates that the total annual burden for all respondents
is 33,694 hours.
    The collection of information in Rule 604 is mandatory for all
respondents, but does not require the collection of confidential
information.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: >www.reginfo.gov<. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent by October 3, 2022 to (i)
>[email protected] < and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o John Pezzullo, 100 F Street NE, Washington, DC 20549, or by sending
an email to: [email protected].

    Dated: August 29, 2022.
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-18981 Filed 9-1-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Notices]
[Page 27791]
[FR Doc No: 2018-12740]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4367-DR; Docket ID FEMA-2018-0001]

Maine; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Maine (FEMA-4367-DR), dated May 30, 2018, and
related determinations.

DATES: The declaration was issued May 30, 2018.

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: Notice is hereby given that, in a letter
dated May 30, 2018, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Maine resulting from a severe storm and flooding during the
period of March 2-8, 2018, is of sufficient severity and magnitude
to warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the State of Maine.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, James N. Russo, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Maine have been designated as
adversely affected by this major disaster:

    York County for Public Assistance.
    All areas within the State of Maine are eligible for assistance
under the Hazard Mitigation Grant Program.

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.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-12740 Filed 6-13-18; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 78, Number 55 (Thursday, March 21, 2013)]
[Rules and Regulations]
[Pages 17294-17297]
[FR Doc No: 2013-05589]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0597; Directorate Identifier 2012-NM-054-AD;
Amendment 39-17377; AD 2013-05-05]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 777-200, -200LR, -300, and -300ER series
airplanes. This AD was prompted by reports of in-service events related
to electrical power system malfunctions resulting in damage to
electrical load management system (ELMS) P200 and P300 power panels and
the surrounding area. This AD requires installing enclosure trays to
contain debris in certain ELMS panels, and replacing certain ELMS
contactors. We are issuing this AD to prevent contactor failures, which
could result in uncontained hot debris flow due to ELMS contactor
breakdown, consequent smoke and heat damage to airplane structure and
equipment during ground operations, and possible injuries to passengers
and crew.

DATES: This AD is effective April 25, 2013.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of April 25,
2013.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced service
information at the FAA, 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 Management Facility
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 address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
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: Georgios Roussos, Aerospace Engineer,
Systems and Equipment Branch, ANM-130S, Seattle Aircraft Certification
Office (ACO), FAA, 1601 Lind Avenue SW., Renton, Washington 98057-3356;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
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.
That NPRM published in the Federal Register on June 18, 2012 (77 FR
36206). That NPRM proposed to require installing enclosure trays to
contain debris in certain ELMS panels, and replacing certain ELMS
contactors in the P200 and P300 ELMS panels.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
(77 FR 36206, June 18, 2012) and the FAA's response to each comment.

Request To Allow Certain Installations of Removed Contactors

    Cathay Pacific Airways (Cathay) and All Nippon Airways (All Nippon)
requested that we clarify the proposed requirement to discard the
removed contactors. The commenters requested that we identify certain
inspection criteria that would allow further use of these contactors on
non-AD-affected locations and ease the financial burden of discarding
removed but serviceable power contactors.
    We partially agree with the request. The note in paragraphs 3.B.3
and 3.B.4 of the Accomplishment Instructions of Boeing Special
Attention Service Bulletin 777-24-0112, Revision 2, dated December 14,
2011, specifies discarding these parts. We agree that power contactors
that have been appropriately overhauled to the manufacturer's original
specifications may meet criteria for safe operation in non-AD-affected
locations. But this AD applies to the affected airplanes, not the
contactors; the AD therefore cannot mandate the disposition of
contactors removed from

the airplane. Further, power contactors that are removed from the AD-
affected ELMS panel location are considered compromised parts and may
not be installed ``as is'' in other non-AD-affected locations. We have
added new paragraph (j)(2) in this final rule to provide for the re-
installation of the contactors, provided they are first inspected and
tested, and repaired if necessary, in accordance with a method approved
by the Seattle Aircraft Certification Office (ACO).

Concern for Effect of Ongoing Maintenance on AD Compliance

    Cathay was concerned that operators would have difficulty ensuring
compliance with the proposed requirements in ongoing maintenance.
According to Cathay, operators are unable to purge the stock with part
number (P/N) ELM827-1 contactors still installed on the P100 panel.
    We acknowledge Cathay's concern for allowing installation of the P/
N ELM827-1 contactors within the P100 ELMS panel. We disagree, however,
with Cathay's inference that this is difficult to accomplish on the
other panel, because proper maintenance documentation and personnel
training can secure ongoing compliance with the AD requirements.
Furthermore, we are not aware of any issues associated with these power
contactors within the P100 ELMS panel that would warrant any regulatory
action against this panel installation. We have not changed the final
rule regarding this issue.

Request To Allow Contactor Replacement as Optional

    Korean Air Lines and Air France requested that we reconsider the
proposed requirement to replace the power contactors. Korean Air Lines
stated that Boeing introduced, in addition to the tray installation,
certain improvements to the ELMS panel, such as the installation of a
cooling duct and internal inspection of the panel. Korean Air Lines
considered these additional improvements sufficient to provide safety
for the passengers. Korean Air Lines requested that the power contactor
replacement become optional if the tray enclosures and the cooling duct
were installed. Air France explained its choice to replace the power
contactor within the P300 ELMS panel because inspections revealed a
number of panels and contactors with evidence of overheating and/or
silver deposits. Air France further pointed to inspections on the P200
ELMS panel that did not identify any damage. Air France asserted that
there is no technical or reliability benefit to the requirement to
replace the power contactors, and requested that we reconsider the
requirement.
    We disagree. Our data indicate a number of in-service failures of
power contactors installed within the P200 and P300 ELMS panels. While
installation of the tray enclosures may limit the extent of the damage
within the affected power panel, power contactor failures nevertheless
generate excessive heat and smoke that may lead to aircraft emergency
evacuation and potential passenger injuries. While the cooling duct
provides a better operating environment for the power contactors, its
installation does not necessarily address the kind of internal
contactor failures that may result from operating at power levels so
near the rated capacity and could lead to thermal degradation of
materials, which further reduce contactor protection and can lead to
loose parts within the contactor that may increase the probability of
arcing. We have not changed the final rule regarding this issue.

Request To Clarify Cost Estimate

    United Airlines questioned the high cost of the replacement parts
relative to parts outsourcing and liability concerns. Air France
considered that the cost of the replacement is not justified by any
technical or reliability benefit, and offered two solutions: (1) a
substantially reduced contactor price or (2) use of P/N ELM827-1 as
spares, provided certain preventive measures were taken.
    We partially agree. We have been informed that Boeing is
negotiating certain price reductions with its contactor supplier.
However, we have determined that replacement of these parts is
necessary for continued safe flight, and we have therefore not changed
the final rule regarding this issue. Regarding use of P/N ELM827-1 as
spares, as discussed previously, we have added new paragraph (j)(2) in
this final rule to provide for re-installation of the contactors, if
done using a method approved by the Seattle ACO.

Request To Allow Credit for Certain Revised Service Information

    Boeing requested that we revise Note 1 to paragraph (g) of the NPRM
(77 FR 36206, June 18, 2012) to include prior revisions of the
specified Smiths service information. Boeing added that Boeing Special
Attention Service Bulletin 777-24-0106, dated July 20, 2007 (referenced
in the NPRM as the appropriate source of service information for the
tray installation), does not identify a specific revision level of the
Smiths service information. Boeing reported that the next revision of
Boeing Service Bulletin 777-24-0106 will include the revision levels
per the proposed AD, but that the subsequent changes, which are related
to ease of installation only, were not necessary to ensure safety.
    We agree that the changes introduced to the referenced revised GE
Aviation (Smiths) service information are not necessary to ensure
safety. We have determined that the information in Note 1 to paragraph
(g) of the NPRM (77 FR 36206, June 18, 2012), as well as Note 2 to
paragraph (h) of the NPRM, is unnecessary; these notes have been
removed from the AD.

Concern Regarding Quality Oversight

    Recognizing the proposed requirement to upgrade to the more robust
contactors, as specified in the NPRM (77 FR 36206, June 18, 2012), and
noting the benefits of containment trays, United Airlines expressed its
hope that the NPRM addressed all compromised areas of concern regarding
the equipment. The commenter also expressed concern about contactor
quality oversight.
    We infer that the commenter agrees with the requirements of this
final rule. We also recognize the importance of parts quality oversight
to prevent failures on high-power contactors that could potentially
cause significant airplane damage. We understand that both Boeing and
the parts supplier have increased their quality oversight of the
contactors. There is no need to change the final rule regarding this
issue.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the 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 (77 FR 36206, June 18, 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 36206, June 18, 2012).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects 128 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
----------------------------------------------------------------------------------------------------------------
Tray installation.....................  3 work-hours x $85 per            $1,729          $1,984        $253,952
                                         hour = $255.
Contactor replacement.................  6 work-hours x $85 per            49,317          49,827       6,377,856
                                         hour = $510.
----------------------------------------------------------------------------------------------------------------

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

    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 adding the following new airworthiness
directive (AD):

2013-05-05 The Boeing Company: Amendment 39-17377; Docket No. FAA-
2012-0597; Directorate Identifier 2012-NM-054-AD.

(a) Effective Date

    This AD is effective April 25, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-200, -200LR, -
300, and -300ER series airplanes; certificated in any category; as
identified in Boeing Special Attention Service Bulletin 777-24-0106,
dated July 20, 2007; and Boeing Special Attention Service Bulletin
777-24-0112, Revision 2, dated December 14, 2011.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 24, Electrical power.

(e) Unsafe Condition

    This AD was prompted by reports of in-service events related to
electrical power system malfunctions resulting in damage to
electrical load management system (ELMS) P200 and P300 power panels
and the surrounding area. We are issuing this AD to prevent
contactor failures, which could result in uncontained hot debris
flow due to ELMS contactor breakdown, consequent smoke and heat
damage to airplane structure and equipment during ground operations,
and possible injuries to passengers and crew.

(f) Compliance

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

(g) Tray Installation

    For airplanes identified in Boeing Special Attention Service
Bulletin 777-24-0106, dated July 20, 2007: Within 36 months after
the effective date of this AD, install enclosure trays to contain
debris in the ELMS panels, in accordance with the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 777-24-
0106, dated July 20, 2007.

(h) Contactor Replacement

    For airplanes identified in Boeing Special Attention Service
Bulletin 777-24-0112, Revision 2, dated December 14, 2011: Within 60
months after the effective date of this AD, replace specified
electrical power contactors in the ELMS P200 and P300 power panels
with new contactors, in accordance with the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 777-24-
0112, Revision 2, dated December 14, 2011, except as provided by
paragraph (j)(2) of this AD.

(i) Credit for Previous Actions

    This paragraph provides credit for the replacement of the ELMS
contactors required by paragraph (h) of this AD, if those actions
were performed before the effective date of this AD using Boeing
Special Attention Service Bulletin 777-24-0112, dated February 19,
2009; or Revision 1, dated June 30, 2011. These service bulletins
are not incorporated by reference in this AD.

(j) Parts Installation

    (1) Except as required by paragraph (j)(2) of this AD: As of the
effective date of this AD, no person may install, on any airplane, a
contactor having part number ELM827-1 in the ELMS panels and
locations identified in this AD, except as required by paragraph
(j)(2) of this AD.
    (2) This paragraph provides operators with the option not to
discard the removed power contactors, in contrast with the note in
steps 3.B.3 and 3.B.4 of the Accomplishment Instructions of Boeing
Special Attention Service Bulletin 777-24-0112, Revision 2, dated
December 14, 2011. This AD allows re-installation of removed power
contactors, if done using a method approved in accordance with the
procedures specified in paragraph (k) of this AD.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
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 ACO, send it to the
attention of the person identified in the Related Information
section 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.

(l) Related Information

    (1) For more information about this AD, contact Georgios
Roussos, Aerospace Engineer, Systems and Equipment Branch, ANM-130S,
Seattle Aircraft Certification Office (ACO), FAA, 1601 Lind Avenue
SW., Renton, Washington 98057-3356; phone:<PHONE_NUMBER>; fax: 425-
917-6590; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.

(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 Special Attention Service Bulletin 777-24-0106, dated
July 20, 2007.
    (ii) Boeing Special Attention Service Bulletin 777-24-0112,
Revision 2, dated December 14, 2011.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, Washington. For
information on the availability of this material at the FAA, call
425-227-1221.
    (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 February 28, 2013.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-05589 Filed 3-20-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Rules and Regulations]
[Pages 63850-63852]
[FR Doc No: 2013-24937]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0881; Directorate Identifier 2013-SW-056-AD;
Amendment 39-17628; AD 2013-20-51]
RIN 2120-AA64

Airworthiness Directives; AgustaWestland S.p.A. (Agusta)
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for Agusta
Model A109A, A109A II, A109C, A109E, A109K2, A109S, AW109SP, A119, and
AW119 MKII helicopters. The emergency AD was sent previously to all
known U.S. owners and operators of these helicopters. This AD requires,
before further flight, inspecting certain Thomas coupling nuts on the
tail rotor drive shaft line for a crack and replacing all the nuts if
any nut is cracked. Also this AD requires replacing all affected Thomas
coupling nuts within 10 hours time-in-service (TIS) or 30 days,
whichever occurs first. This AD was prompted by two incidents of
cracking on the nuts that connect the flexible disc coupling (Thomas
coupling) with the splined adapter on the tail rotor drive shaft. We
are issuing this AD to correct the unsafe condition on these
helicopters.

DATES: This AD is effective October 25, 2013 to all persons except
those persons to whom it was made immediately effective by Emergency AD
2013-20-51, issued on October 3, 2013, which contained the requirements
of this amendment.
    We must receive comments on this AD by December 24, 2013.

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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at 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 foreign authority's AD,
the economic evaluation, any comments received, and other information.
The street address for the Docket Operations Office (phone: 800-647-
5527) is in the ADDRESSES section.
    For service information identified in this AD, contact Agusta
Westland, Customer Support & Services, Via Per Tornavento 15, 21019
Somma Lombardo (VA) Italy, ATTN: Giovanni Cecchelli; telephone 39-0331-
711133; fax 39 0331 711180; or at http://www.agustawestland.com/technical-bullettins. You may review the referenced service information
at the FAA, Office of the Regional Counsel, Southwest Region, 2601
Meacham Blvd., Room 663, Fort Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Gary Roach, Aviation Safety Engineer,
Regulations and Policy Group, Rotorcraft Directorate, FAA, 2601 Meacham
Blvd., Fort Worth, TX 76137; telephone:<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On October 3, 2013, we issued Emergency AD 2013-20-51, which
requires, before further flight, inspecting certain Thomas coupling
nuts on the tail rotor drive shaft line for a crack and replacing all
the nuts if any nut is cracked. Also the emergency AD requires
replacing all affected Thomas coupling nuts within 10 hours TIS or 30
days, whichever occurs first. This emergency AD was sent previously to
all known U.S. owners and operators of these helicopters. This action
was prompted by two incidents of cracking on the nuts that connect the
flexible disc coupling (Thomas coupling) with the splined adapter on
the tail rotor drive shaft.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
No. 2013-

0225-E, dated September 20, 2013, to correct an unsafe condition for
certain Agusta Model A109A, A109A II, A109C, A109E, A109K2, A109S,
AW109SP, A119, and AW119 MKII helicopters. The EASA advises that during
scheduled inspection on the tail rotor drive shaft line of two in-
service Model AW109SP helicopters, one part-numbered nut that connects
the Thomas coupling with the splined adapter was cracked. The
subsequent investigation identified that the reported cracks of the
nuts are the results of a production deficiency (hydrogen
embrittlement) at the nut supplier.

Related Service Information

    Agusta has issued the following service information:
     Alert Bollettino Tecnico (ABT) No. 109K-58 for all Model
A109K2 helicopters;
     ABT No. 109-136, for all Model A109A, A109A II, and A109C
helicopters;
     ABT No. 109EP-130, for Model A109E helicopters up to and
including serial number (S/N) 11832, except S/N 11796, from 11808 to
11810, and from 11812 to 11829;
     ABT No. 109L-066 for all Model A109LUH helicopters;
     ABT No. 109S-055, for all Model A109S helicopters;
     ABT No. 109SP-069, for Model AW109SP helicopters up to
including S/N 22316, except S/N 22284, 22286, 22307, and 22308; and
     ABT No. 119-061 for Model A119 and AW119 MKII helicopters
up to and including S/N 14811, except S/N 14805 and 14807.
    All the ABTs are dated September 20, 2013, and specify a one-time
inspection of the Thomas coupling nuts, part number (P/N) MS21042L4. If
any nut is cracked, the ABTs specify replacing all nuts with nuts, P/N
NAS1805-4.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Italy and are approved for operation in the United States. Pursuant to
our bilateral agreement with Italy, EASA, its technical representative,
has notified us of the unsafe condition described in their AD. We are
issuing this AD because we evaluated all information provided by EASA
and determined the unsafe condition exists and is likely to exist or
develop on other helicopters of these same type designs.

AD Requirements

    This AD requires, before further flight, visually inspecting each
Thomas coupling nut, P/N MS2104L4, along the tail rotor drive shaft
line for a crack. If any nut is cracked, replacing all the nuts with
nuts, P/N NAS1805-4, is required before further flight. Replacing all
nuts, P/N MS21042L4, with nuts, P/N NAS1805-4, is required within 10
hours TIS or 30 days, whichever occurs first. Finally, this AD
prohibits installing a Thomas coupling nut, P/N MS21042L4, on any tail
rotor drive shaft line.

Differences Between This AD and the EASA AD

    This AD differs from the EASA AD in that we include all model
helicopters rather than limiting the applicability to specific serial-
numbered helicopters, and we do not include Model A109LUH helicopters
as they do not have a U.S. type certificate.

FAA's Justification and Determination of the Effective Date

    Providing an opportunity for public comments prior to adopting
these AD requirements would delay implementing the safety actions
needed to correct this known unsafe condition. Therefore, we find that
the risk to the flying public justifies waiving notice and comment
prior to adoption of this rule because inspecting for and replacing a
cracked nut must be done before further flight, and replacing all nuts
is required within 10 hours TIS or 30 days, whichever occurs first,
which is a very short time period based on the average flight-hour
utilization rate of these helicopters.
    Since an unsafe condition exists that requires the immediate
adoption of this AD, we determined that notice and opportunity for
prior public comment are impracticable and that good cause exists for
making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send any written data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include the Docket Number FAA-2013-0881 and
Directorate Identifier 2013-SW-056-AD at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this AD. We will
consider all comments received by the closing date and may amend this
AD because of 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 AD.

Costs of Compliance

    We estimate that this AD will affect 222 helicopters of U.S.
Registry. We estimate the following costs to comply with this AD. Labor
costs are estimated at $85 per hour. We estimate 2 work hours to
inspect each nut and 16 work hours to replace all nuts at a cost of
$1,530 per helicopter and a total fleet cost of $339,600.
    According to the manufacturer, the costs of this AD may be covered
under warranty, thereby reducing the cost to affected individuals. We
do not control warranty coverage for affected individuals. As a result,
we have included all 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 helicopters identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) 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 to the extent
that it justifies making a regulatory distinction; 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 an economic evaluation of the estimated costs to comply
with this 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.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2013-20-51 Agusta S.p.A: Amendment 39-17628; Docket No. FAA-2013-
0881; Directorate Identifier 2013-SW-056-AD.

(a) Applicability

    This AD applies to the following Agusta S.p.A. (Type certificate
currently held by AgustaWestland S.p.A) (Agusta) helicopters, with a
tail rotor drive shaft flexible disc coupling (Thomas coupling) nut,
part number (P/N) MS21042L4, certificated in any category:
    (i) Model A109A, A109A II, A109C, A109E, A109S, A109K2, AW109SP
helicopters; and
    (ii) Model A119 and AW119 MKII helicopters.

(b) Unsafe Condition

    This AD defines the unsafe condition as a production deficiency
in a certain Thomas coupling nut. This condition could result in
failure of the Thomas coupling, failure of the tail drive shaft, and
subsequent loss of control of the helicopter.

(c) Effective Date

    This AD is effective October 25, 2013 to all persons except
those persons to whom it was made immediately effective by Emergency
AD 2013-20-51, issued on October 3, 2013, which contained the
requirements of this amendment.

(d) Compliance

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

(e) Required Actions

    (1) Before further flight, using a borescope or light source and
mirror, inspect each Thomas coupling nut for a crack. If any Thomas
coupling nut is cracked, before further flight, replace all the
Thomas coupling nuts with nuts, P/N NAS1805-4, torqueing each nut to
5.6-7.9 Nm.
    (2) Within 10 hours time-in-service or 30 days, whichever occurs
first, replace each Thomas coupling nut, P/N MS21042L4, with a nut,
P/N NAS1805-4, torqueing each nut to 5.6-7.9 Nm.
    (3) After the effective date of this EAD, do not install a nut,
P/N MS21042L4, on any Thomas coupling.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to Gary Roach, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, TX 76137; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) Agusta Alert Bollettino Tecnico (ABT) No. 109K-58, ABT No.
109-136, ABT No. 109EP-130, ABT No. 109L-066, ABT No. 109S-055, ABT
No. 109SP-069, and ABT No. 119-061, all dated September 20, 2013,
which are not incorporated by reference, contain additional
information about the subject of this AD. For service information
identified in this AD, contact: Agusta Westland, Customer Support &
Services, Via Per Tornavento 15, 21019 Somma Lombardo (VA) Italy,
ATTN: Giovanni Cecchelli; telephone 39-0331-711133; fax 39 0331
711180; or at http://www.agustawestland.com/technical-bullettins.
You may review a copy of the service information at the FAA, Office
of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room
663, Fort Worth, Texas 76137.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (EASA) Emergency Airworthiness Directive 2013-0225-E,
effective September 21, 2013. You may view the EASA AD at http://www.regulations.gov in Docket No. FAA-2013-0881.

(h) Subject

    Joint Aircraft Service Component (JASC): 6400 Tail rotor system.

    Issued in Fort Worth, Texas, on October 16, 2013.
Kim Smith,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2013-24937 Filed 10-24-13; 8:45 am]
BILLING CODE 4910-13-P