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76362
Federal Register/Vol. 73, No. 242 /Tuesday, December 16, 2008 /Notices
and to provide recommendations on
how to evaluate the safety of these
impurities. Genotoxic compounds,
because of their ability to induce genetic
mutations, chromosomal breaks, and/or
chromosomal rearrangements, have the
potential for being carcinogenic to
humans.
Regulatory issues related to the
presence of genotoxic or carcinogenic
impurities have arisen with greater
frequency because of enhanced
technological capability in identifying
impurities and an increased focus on
their potential for negatively affecting
human health. FDA guidance
documents that address issues related to
impurities and residual solvents include
the following International Conference
on Harmonisation (ICH) guidances for
industry: ‘‘Q3A(R2) Impurities in New
Drug Substances,’’ ‘‘Q3B(R2) Impurities
in New Drug Products,’’ and ‘‘Q3C(R3)
Impurities: Guideline for Residual
Solvents.’’ However, these ICH
guidances do not fully address
situations in which genotoxic or
carcinogenic impurities are present.
This draft guidance describes
acceptable approaches for initially
evaluating the genotoxic potential of
impurities as well as approaches for
handling impurities with known
genotoxic or carcinogenic potential.
These approaches include prevention of
the impurity formation, reduction of the
impurity level to an acceptable
threshold, or additional characterization
of the genotoxic and carcinogenic risk.
The draft guidance also discusses
various factors that should be
considered in the overall risk
assessment based on the drug
indication, duration of use, and the
clinical development stage.
FDA has developed this draft
guidance because these types of
impurities are being identified more
frequently and because FDA has
received a number of questions from
industry regarding acceptable
approaches.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on recommended approaches for
genotoxic and carcinogenic impurities
in drug substances and products. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
Control Numbers 0910–0014 and 0910–
0001, respectively.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES
) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
http://www.fda.gov/cder/guidance/
index.htm or http://
www.regulations.gov.
Dated: December 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29674 Filed 12–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0626]
Draft Guidance for Industry on
Bioequivalence Recommendation for
Vancomycin HCl; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Bioequivalence
Recommendation for Vancomycin HCl.’’
The recommendation provides specific
guidance on the design of
bioequivalence (BE) studies to support
abbreviated new drug applications
(ANDAs) for vancomycin HCl capsules.
DATES:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by February 17, 2009.
ADDRESSES:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION
section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Doan T. Nguyen, Center for Drug
Evaluation and Research (HFD–600),
Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240–
276–9314.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 31,
2007 (72 FR 30388), FDA announced the
availability of a draft guidance for
industry, ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
that would be used to make product-
specific BE recommendations available
to the public on FDA’s Web site at
http://www.fda.gov/CDER/GUIDANCE/
bioequivalence/default.htm. As
described in that draft guidance, FDA
adopted this process as a means to
develop and disseminate product-
specific BE recommendations and
provide a meaningful opportunity for
the public to consider and comment on
those recommendations. This notice
announces the availability of the
agency’s draft BE recommendation for
vancomycin HCl capsules.
Vancocin (vancomycin HCl) oral
capsules, approved by FDA in April
1986, are indicated for the treatment of
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76363
Federal Register/Vol. 73, No. 242 /Tuesday, December 16, 2008 /Notices
1
This PSA was originally assigned Docket No.
2006P–0124. The number was changed to FDA–
2006–P–0007 as a result of FDA’s transition to its
new docketing system (Regulations.gov) in January
2008. This docket also includes a second PSA and
numerous supplements filed by ViroPharma.
enterocolitis caused by Staphylococcus
aureus (including methicillin-resistant
strains) and antibiotic-associated
pseudomembranous colitis caused by
Clostridium difficile. Vancocin oral
capsules are designated the reference
listed drug (RLD) and therefore any
ANDA for generic vancomycin HCl oral
capsules must demonstrate BE to
Vancocin prior to approval. There are
no approved ANDAs for vancomycin
HCl capsules.
Vancomycin acts locally in the lower
gastrointestinal (GI) tract. After oral
administration, a vancomycin capsule
releases the drug in the stomach and
upper GI tract, the released drug is
completely solubilized in GI fluids, and
it is transported along with GI fluids to
its site of action in the lower GI tract.
As set forth in the Clinical
Pharmacology section of the approved
product labeling for Vancocin,
vancomycin is poorly absorbed after
oral administration and does not usually
enter the systemic circulation. Thus,
plasma and urine concentrations of
vancomycin are generally undetectable
following oral administration, and
traditional BE studies with
pharmacokinetic (PK) measurements are
of limited utility. Accordingly, in 1996,
FDA recommended an in vivo BE study
with clinical endpoints in patients to
demonstrate BE of generic vancomycin
HCl oral capsules.
In October 2004, FDA asked its
Advisory Committee for Pharmaceutical
Science to consider when dissolution
testing could be used to establish BE for
locally-acting GI drugs. The committee
concluded that dissolution testing along
with PK studies should be acceptable to
establish BE for such products. In light
of the committee’s conclusions, after
obtaining data showing that vancomycin
HCl is highly soluble at pH conditions
encountered in the GI tract and
expected to be in solution long before it
reaches the site of action in the lower GI
tract, the FDA revised its
recommendation in early 2006 to
include in vitro dissolution studies to
demonstrate BE of generic vancomycin
HCl oral capsules. This approach would
provide FDA’s Office of Generic Drugs
with information about drug availability
at the site of action and would be more
sensitive than clinical trials in detecting
differences in product performance. In
accordance with its practice prior to
publication of the draft guidance
‘‘Bioequivalence Recommendations for
Specific Products,’’ FDA provided its
2006 revised BE recommendations to
those parties that had requests pending
with FDA for this information. In March
2006, Viropharma, Inc., the
manufacturer of the RLD Vancocin, filed
a petition for stay of action (PSA)
challenging FDA’s revised
recommendation (Docket No. FDA–
2006–P–0007).
1
In the draft ‘‘Bioequivalence
Recommendation for Vancomycin HCl,’’
FDA further clarifies its
recommendations on the design of BE
studies to support ANDAs for
vancomycin HCl capsules. Because
generic applicants may use different
inactive ingredients, which may affect
the transport, absorption, and/or
effectiveness of the drug, FDA is
currently recommending in vitro
dissolution studies only for test
formulations that are qualitatively (Q1)
and quantitatively (Q2) the same as the
RLD with respect to inactive
ingredients. For test formulations that
are not Q1 and Q2 the same as the RLD
with respect to inactive ingredients,
FDA is recommending in vivo BE
studies with clinical endpoints. The
draft BE recommendation for
vancomycin HCl capsules is consistent
with the 2004 advisory committee’s
conclusion. PK studies are not
appropriate in this case, however,
because vancomycin levels are generally
not detectable in the plasma or urine
due to very limited absorption.
Comments on this draft guidance will
also be considered by FDA as it
addresses the complicated issues raised
in Viropharma, Inc.’s PSAs. FDA will
carefully consider such comments
before responding to the petition and
finalizing its BE recommendation for
vancomycin HCl. Because of the lengthy
history of FDA’s consideration of
bioequivalence methodologies for
vancomycin HCl capsules, the pendency
of the PSAs, and the complexity of the
issues involved, the availability of this
draft guidance is being announced in a
drug product-specific notice, and the
recommendations include a significant
amount of background information and
explanation of the reasons for the
bioequivalence recommendations.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on the design of BE studies to support
ANDAs for vancomycin HCl. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES
) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
http://www.fda.gov/cder/guidance/
index.htm or http://
www.regulations.gov.
Dated: December 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29692 Filed 12–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0614]
Draft Guidance for Industry on
Changes to Approved New Animal
Drug Applications—New Animal Drug
Applications Versus Category II
Supplemental New Animal Drug
Applications; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry
#
191 entitled ‘‘Changes to
Approved NADAs—New NADAs vs.
Category II Supplemental NADAs’’. This
guidance is intended to assist sponsors
who wish to apply for approval of
changes to approved new animal drugs
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[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Rules and Regulations]
[Pages 21641-21645]
[FR Doc No: 2021-08574]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0317; Project Identifier MCAI-2021-00175-R;
Amendment 39-21520; AD 2021-09-07]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2019-17-
02, which applied to certain Airbus Helicopters Deutschland GmbH
(Airbus Helicopters) Model EC135P1, EC135P2, EC135P2+, EC135P3,
EC135T1, EC135T2, EC135T2+, and EC135T3 helicopters. AD 2019-17-02
required inspecting certain part-numbered actuators for corrosion,
removing them as necessary, and reporting certain information. This new
AD continues to require inspecting certain part-numbered actuators,
removing them as necessary, and reporting; and extends the compliance
time for the initial inspection, expands the applicability, and
includes new requirements for repetitive replacement of affected
actuators; as specified in a European Union Aviation Safety Agency
(EASA) AD, which is incorporated by reference. This AD was prompted by
a hard landing of a helicopter and the discovery of a ruptured and
displaced tie bar inside the piston of the longitudinal single-axis
actuator of the main rotor actuator (MRA). The FAA is issuing this AD
to address the unsafe condition on these products.

DATES: This AD becomes effective May 10, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 10,
2021.
    The FAA must receive comments on this AD by June 7, 2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material incorporated by reference (IBR) in this AD, contact
the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49
221 8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu.
You may find this material on the EASA website at https://ad.easa.europa.eu. You may view this material at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2021-0317.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0317; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Hal Jensen, Aerospace Engineer,
Operational Safety Branch, Compliance & Airworthiness Division, FAA,
950 L'Enfant Plaza N SW, Washington, DC 20024; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued AD 2019-17-02, Amendment 39-19722 (84 FR 47410,
September 10, 2019) (AD 2019-17-02), which applied to Airbus
Helicopters Deutschland GmbH Model EC135P1, EC135P2, EC135P2+, EC135P3,
EC135T1, EC135T2, EC135T2+, and EC135T3 helicopters with certain
longitudinal, collective, and lateral single-axis actuators installed
having accumulated 6 or more years since manufacturing date or last
overhaul, whichever occurred later. AD 2019-17-02 required visually
inspecting for corrosion on all external surfaces of the longitudinal,
collective, and lateral single-axis actuators, and based on the
inspection outcome, removing the single-axis actuators from service at
different compliance times. AD 2019-17-02 also required reporting
certain information, along with photos of any corrosion, to Airbus
Helicopters. The FAA issued AD 2019-17-02 to address corrosion in
certain MRA components, which could result in failure of the component,
failure of the MRA, and loss of control of the helicopter.

Actions Since AD 2019-17-02 Was Issued

    Since the FAA issued AD 2019-17-02, the agency has determined the
unsafe condition affects all longitudinal, collective, and lateral
single-axis actuators that have accumulated 4 or more years since
manufacturing date or last overhaul. Also, Airbus Helicopters has
developed repetitive replacement and repetitive inspection procedures
for the tie bar located in the affected single-axis actuators and
addresses affected actuators with a manufacturing date or last overhaul
of more than 4 years and less than 6 years, in addition to the affected
actuators with a manufacturing date or last overhaul of more than 6
years.
    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0105, dated May 11, 2020 (EASA
AD 2020-0105) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Airbus Helicopters Deutschland GmbH Model EC135 P1, EC135 P2,
EC135 P2+, EC135 P3, EC135 T1, EC135 T2, EC135 T2+, EC135 T3, EC635
P2+, EC635 P3, EC635 T1, EC635 T2+ and EC635 T3 helicopters, all
variants, all serial numbers. Model EC635 P2+, EC635 P3, EC635 T1,
EC635 T2+, and EC635 T3 helicopters are not certificated by the FAA and
are not included on the U.S. type certificate data sheet except where
the U.S. type certificate data sheet explains that the Model EC635T2+
helicopter having serial number 0858 was converted from Model EC635T2+
to Model EC135T2+; this proposed AD therefore does not include Model
EC635 P2+, EC635 P3, EC635 T1, EC635 T2+, and EC635 T3 helicopters in
the applicability.
    This AD was prompted by a hard landing of an Airbus Helicopters
Model

EC135 helicopter and the discovery of a ruptured and displaced tie bar
inside the piston of the longitudinal single-axis actuator of the MRA.
The FAA is issuing this AD to address a ruptured and displaced tie bar
inside the piston of the longitudinal single-axis actuator of the MRA,
which could result in reduced control of the helicopter and could
result in a forced landing with consequent damage to the helicopter and
injury to occupants. See the MCAI for additional background
information.

Explanation of Retained Requirements

    Although this AD does not explicitly restate the requirements of AD
2019-17-02, this AD retains certain requirements of AD 2019-17-02.
Those requirements are referenced in EASA AD 2020-0105, which, in turn,
is referenced in paragraph (g) of this AD.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0105 describes procedures for an initial inspection of
the affected single-axis actuators for corrosion, reporting inspection
findings, and replacing affected single-axis actuators that have
corrosion. EASA AD 2020-0105 also describes procedures for an option
for repetitive replacement or repetitive inspection for corrosion (and
repair if necessary) of the tie bar located in an affected single-axis
actuator. This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination

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

Requirements of This AD

    This AD requires accomplishing the actions specified in EASA AD
2020-0105, described previously, as incorporated by reference, except
for any differences identified as exceptions in the regulatory text of
this AD and except as discussed under ``Differences Between this AD and
the MCAI.''

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2020-0105
will be incorporated by reference in the FAA final rule. This AD would,
therefore, require compliance with EASA AD 2020-0105 in its entirety,
through that incorporation, except for any differences identified as
exceptions in the regulatory text of this AD. Using common terms that
are the same as the heading of a particular section in the EASA AD does
not mean that operators need comply only with that section. For
example, where the AD requirement refers to ``all required actions and
compliance times,'' compliance with this AD requirement is not limited
to the section titled ``Required Action(s) and Compliance Time(s)'' in
the EASA AD. Service information specified in EASA AD 2020-0105 that is
required for compliance with EASA AD 2020-0105 is available on the
internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-0317.

Differences Between This AD and the MCAI

    Where paragraph (4) of EASA AD 2020-0105 provides an option to do
repetitive inspections of an affected part, this AD would provide an
option to do repetitive repairs in lieu of the repetitive inspections
and would require that the repetitive repairs be done using a method
approved by the Manager, International Validation Branch, FAA.

FAA's Justification for Immediate Adoption and Determination of the
Effective Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies foregoing notice and comment prior to adoption of this rule
because a ruptured and displaced tie bar inside the piston of a
longitudinal, collective, or lateral single-axis actuator of the MRA
could result in reduced control of the helicopter, which could result
in a forced landing with consequent damage to the helicopter and injury
to occupants. In addition, the compliance time for the initial
inspection of each affected part is within 14 days after the effective
date of this AD, which is shorter than the time necessary for the
public to comment and for publication of the final rule. Therefore,
notice and opportunity for prior public comment are impracticable and
contrary to public interest pursuant to 5 U.S.C. 553(b)(3)(B). In
addition, the FAA finds that good cause exists pursuant to 5 U.S.C.
553(d) for making this amendment effective in less than 30 days, for
the same reasons the FAA found good cause to forgo notice and comment.

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2021-0317; Project Identifier MCAI-
2021-00175-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the AD, explain the reason for
any recommended change, and include supporting data. The FAA will
consider all comments received by the closing date and may amend this
AD because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this AD.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt

from public disclosure. If your comments responsive to this AD contain
commercial or financial information that is customarily treated as
private, that you actually treat as private, and that is relevant or
responsive to this AD, it is important that you clearly designate the
submitted comments as CBI. Please mark each page of your submission
containing CBI as ``PROPIN.'' The FAA will treat such marked
submissions as confidential under the FOIA, and they will not be placed
in the public docket of this AD. Submissions containing CBI should be
sent to Hal Jensen, Aerospace Engineer, Operational Safety Branch,
Compliance & Airworthiness Division, FAA, 950 L'Enfant Plaza N SW,
Washington, DC 20024; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Any commentary that the FAA receives that is not specifically
designated as CBI will be placed in the public docket for this
rulemaking.

Regulatory Flexibility Act (RFA)

    The requirements of the RFA do not apply when an agency finds good
cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and
comment. Because the FAA has determined that it has good cause to adopt
this rule without notice and comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 337 helicopters of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                     Estimated Costs for Required Actions *
----------------------------------------------------------------------------------------------------------------
               Labor cost                   Parts cost         Cost per product         Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
2 work-hours x $85 per hour = $170, per               $0  $170, per inspection cycle  $57,290, per inspection
 inspection cycle.                                                                     cycle.
----------------------------------------------------------------------------------------------------------------
* Table does not include estimated costs for reporting.

    The FAA estimates that it takes about 1 work-hour per product to
comply with the reporting requirement in this AD. The average labor
rate is $85 per hour. Based on these figures, the FAA estimates the
cost of reporting the inspection results on U.S. operators to be
$28,645, or $85 per product.
    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of any
required actions. The FAA has no way of determining the number of
helicopters that might need these on-condition actions:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
           Labor cost                 Parts cost       Cost per product
------------------------------------------------------------------------
6 work-hours x $85 per hour =     Up to $346,802....  Up to $347,312.
 $510.
------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. The FAA does not control warranty coverage for
affected individuals. As a result, the FAA has included all known costs
in the cost estimate.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to
Information Collection Clearance Officer, Federal Aviation
Administration, 10101 Hillwood Pkwy., Fort Worth, TX 76177-1524.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

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:
0
a. Removing Airworthiness Directive (AD) 2019-17-02, Amendment 39-19722
(84 FR 47410, September 10, 2019); and
0
b. Adding the following new AD:

2021-09-07 Airbus Helicopters Deutschland GmbH: Amendment 39-21520;
Docket No. FAA-2021-0317; Project Identifier MCAI-2021-00175-T.

(a) Effective Date

    This airworthiness directive (AD) becomes effective May 10,
2021.

(b) Affected ADs

    This AD replaces AD 2019-17-02, Amendment 39-19722 (84 FR 47410,
September 10, 2019) (AD 2019-17-02).

(c) Applicability

    This AD applies to Airbus Helicopters Deutschland GmbH Model
EC135P1, EC135P2, EC135P2+, EC135P3, EC135T1, EC135T2, EC135T2+, and
EC135T3 helicopters, certificated in any category, with any of the
part numbers specified in paragraphs (c)(1) through (3) of this AD
installed.
    (1) Longitudinal single-axis actuator part number (P/N)
L673M20A1008 or P/N L673M30A2111.
    (2) Collective single[hyphen]axis actuator P/N L673M20A1012, P/N
L673M30A1211, or P/N E673M30A1201.
    (3) Lateral single[hyphen]axis actuator P/N L673M20A1011 or P/N
L673M30A2311.

(d) Subject

    Joint Aircraft System Component (JASC) Code 67000, Rotorcraft
Flight Control.

(e) Reason

    This AD was prompted by a hard landing of an Airbus Helicopters
Deutschland GmbH Model EC135 helicopter and discovery of a ruptured
and displaced tie bar inside the piston of the longitudinal single-
axis actuator of the main rotor actuator (MRA). The FAA is issuing
this AD to address a ruptured and displaced tie bar inside the
piston of a longitudinal, collective, or lateral single-axis
actuator of the MRA, which could result in reduced control of the
helicopter and could result in a forced landing with consequent
damage to the helicopter and injury to occupants.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2020-0105, dated May 11, 2020 (EASA AD 2020-0105).

(h) Exceptions to EASA AD 2020-0105

    (1) Where EASA AD 2020-0105 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where paragraph (4) of EASA AD 2020-0105 refers to Table 1
of that AD for applicable compliance times, for this AD, use Table 1
to paragraph (h)(2) of this AD.
[GRAPHIC] [TIFF OMITTED] TR23AP21.098

    (3) Where the ``part calendar age (A)'' and ``part calendar age
(B)'' definitions of EASA AD 2020-0105 refer to March 29, 2019
``(ASB [alert service bulletin] reference date)'' and to April 26,
2019 ``(the effective date of EASA AD 2019-0087-E, dated April 24,
2019),'' this AD requires using April 23, 2019.
    (4) The ``Remarks'' section of EASA AD 2020-0105 does not apply
to this AD.
    (5) Where the service information referenced in EASA AD 2020-
0105 specifies to replace a certain part, this AD requires removing
that part from service or repairing using a method approved by the
Manager, International Validation Branch, FAA. For a repair method
to be approved by the Manager, International Validation Branch, as
required by this paragraph, the Manager's approval letter must
specifically refer to this AD.
    (6) Paragraph (2) of EASA AD 2020-0105 specifies to report
inspection results to Airbus Helicopters within a certain compliance
time. For this AD, report all inspection results at the applicable
time specified in paragraph (6)(i) or (ii) of this AD.
    (i) If the inspection was done on or after the effective date of
this AD: Submit the report within 7 days after the inspection.
    (ii) If the inspection was done before the effective date of
this AD: Submit the report within 7 days after the effective date of
this AD.
    (7) Where paragraph (4) of EASA AD 2020-0105 provides an option
to do repetitive replacements or repetitive inspections of an
affected part, this AD does not allow the option to do repetitive
inspections. However, this AD does allow repetitive repairs as an
option to the repetitive replacements specified in paragraph (4) of
EASA AD 2020-0105. The repetitive repairs must be done using a
method approved by the Manager, International Validation Branch,
FAA. For a repair method to be approved by the Manager,
International Validation Branch, as required by this paragraph, the
Manager's approval letter must specifically refer to this AD.

    (8) Where Note 1 of paragraph (4) of EASA AD 2020-0105 permits a
non-cumulative tolerance of 6 months to be applied to the interval
for the repetitive replacement or inspection of the affected part,
this AD requires the repetitive replacement or repair of the
affected part at intervals not exceeding 5 years 6 months.

(i) Special Flight Permit

    Special flight permits, as described in 14 CFR 21.197 and
21.199, are prohibited.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (k) 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.

(k) Related Information

    For more information about this AD, contact Hal Jensen,
Aerospace Engineer, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 950 L'Enfant Plaza N SW, Washington, DC
20024; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2020-0105,
dated May 11, 2020.
    (ii) [Reserved]
    (3) For EASA AD 2020-0105, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2021-0317.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on April 15, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-08574 Filed 4-21-21; 11:15 am]
BILLING CODE 4910-13-P


                          eNOI Data Processing Steps

Data from EPA's eNOI system was downloaded in August 2012 in order to analyze MSGP DMR records. The data from separate eNOI tables were combined into an Access database for processing (see MS Access file: eReporting_8-27-2012.mdb). Most of the processing/analysis of the data was performed in a separate MS Access file (see MS Access file: eReporting Analysis, r00.accdb) with some supporting steps performed using MS Excel (see QBM Analysis, rev 01.xlsx). We followed the below steps in processing the data. A more detailed description is provided in the MS Word file, $Documentation.docx.
Initial Data Processing Steps
   1) Data from the following eNOI tables were queried for the purposes of this analysis: PT_STATUS, RPT_FACILITY RPT_MONITORING, ERPT_DISCHARGE_LOCATION_ID, and RPT_DISCHARGE. We started with 42,351 (485 facilities) monitoring records.
   2) The following initial steps were performed to remove un-needed data records, leaving 23,835 records (385 facilities):
      i) Deleted records where the parameter name was not provided.
      ii) Deleted facilities that were not "Active".
      iii) Deleted monitoring data not associated with the benchmark monitoring program and/or effluent guideline monitoring program.
      iv) Deleted monitoring results identified as "not applicable".
Benchmark Monitoring Data Processing Steps
   1) It was determined that the eNOI program had allowed users to enter the parameter name in an open format approach. Using the data from the initial processing steps, those inconsistencies were resolved with simplifications. For example, it was determined to treat parameters reported as "Lead", "Total Lead", and "Total Recoverable Lead" as the same. Numerous miss-spellings were also addressed.
   2) Metals with hardness-specific benchmarks processing steps
         a. Select records from step 1 associated with the benchmark monitoring program for the six metals with hardness-specific benchmarks (n=6,155).
         b. Records with missing hardness data were eliminated (n=4,973).
         c. Records with non-standard quarterly reporting periods were eliminated (n=4479).
         d. Records with missing or zero concentrations reported as `detected' or as `detected but below QL' were eliminated (n=4371, 3539 detected observations, 148 facilities).
         e. As per the permit requirements for computing yearly averages, the concentrations for `non-detects' was recoded to zero and concentrations for `detected but below QL' was recoded to one-half the quantitation limit.
   3) Other parameter processing steps
         a. Select records from step 1 associated with parameters that have constant benchmarks (n=14,734).
         b. Records with non-standard quarterly reporting periods were eliminated (n=13,591).
         c. Records with missing or zero concentrations reported as `detected' or as `detected but below QL' were eliminated (n=12,288 w/ 9943 detected observations, 355 facilities).
         d. As per the permit requirements for computing yearly averages, the concentrations for `non-detects' was recoded to zero and concentrations for `detected but below QL' was recoded to one-half the quantitation limit.
   4) The resulting data were sorted by permit, outfall, parameter, and reporting sequence (i.e., ERPT_MONITOR_EVENT_ID). The reporting sequence was used to sort reporting data periods into an approximate chronological order. Using this order, sequential observations from the same reporting period were averaged to a single value for a given reporting period.
   5) Yearly averages were then computed whenever the four consecutive records included data from each of the standard quarterly reporting periods. (Each record could only be used in one yearly average, i.e., no sliding yearly window.) Based on the available data, one facility could have from 1-3 yearly averages for a given outfall/parameter combination.
         a. There were 1,334 yearly averages meeting the above requirements.
   6) The resulting yearly averages were combined with the benchmark monitoring requirements at the subsector level, compared to their corresponding benchmark values, and results summarized to the sector level.
         a. For example, PRR05BH95 is associated with subsectors C.1, C.2, C.3, and C.4. The requirements for these subsectors are listed below. The analysis for PRR05BH95 would then include the results for iron, lead, nitrate+nitrite, phosphorus, zinc, aluminum in Sector C without duplication (i.e., even though zinc is listed under three separate subsectors, the zinc results for PRR05BH95 is only analyzed once)
Subsector
Simplified Parameter Names
C.1
Iron, Lead,  Nitrate + Nitrite, Phosphorus,  Zinc
C.2
Aluminum, Iron, Nitrate + Nitrite
C.3
Nitrate + nitrite, Zinc
C.4
Zinc
         b. In another example, MAR05CW65 is associated with subsectors L.1 and O.1 with a monitoring requirement of TSS and iron, respectively. In this case, the TSS results for MAR05CW65 are included under Sector L and the iron results are included under Sector O, only.
         c. An overall table is provided that analyzes all the data regardless of the facility's monitoring requirements.

ELG Data Processing
   1) It was determined that the eNOI program had allowed users to enter the parameter name in an open format approach. Using the data from the initial processing steps, those inconsistencies were resolved with simplifications. For example, it was determined to treat parameters reported as "Arsenic", "Total Arsenic", and "Total Recoverable Arsenic" as the same. Numerous miss-spellings were also addressed.
   2) Select measurements associated with the ELG monitoring program (n=3,299).  (Unlike the benchmark monitoring program, we were only interested in whether reported results for detected observations exceeded the ELG concentrations. Thus, no screening for sampling quarter, hardness, or presence of concentrations was considered.)
   3) ELG concentrations were extracted from the MSGP permit by sector. For some combinations of sector and parameter, there were multiple ELG concentrations, typically for the monthly average values and daily maximums. We chose to reduce this to the daily maximum for consistency with the collected measurements.
   4) Some facilities belong to more than one sector. As a result when the 3,299 records from above are joined to the Sector-Facility lookup table, we get 5,327 records for analysis.


[Federal Register Volume 81, Number 166 (Friday, August 26, 2016)]
[Rules and Regulations]
[Pages 58823-58826]
[FR Doc No: 2016-20381]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-3696; Directorate Identifier 2015-NM-113-AD;
Amendment 39-18625; AD 2016-17-12]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Airbus Model A318 and A319 series airplanes, Model A320-211, -212, -
214, -231, -232, and -233 airplanes, and Model A321 series airplanes.
This AD was prompted by a report of a partial loss of the no-back brake
(NBB) efficiency during endurance qualification tests on the trimmable
horizontal stabilizer actuator (THSA). This AD requires inspecting
certain THSAs to determine the number of total flight cycles the THSA
has accumulated, and replacing the THSA if necessary. We are issuing
this AD to prevent premature wear of the carbon friction disks on the
NBB of the THSA, which could lead to reduced braking efficiency in
certain load conditions, and, in conjunction with the inability of the
power gear train to keep the ball screw in its last commanded position,
could result in uncommanded movements of the trimmable horizontal
stabilizer and loss of control of the airplane.

DATES: This AD is effective September 30, 2016.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September
30, 2016.

ADDRESSES: For service information identified in this final rule,
contact Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 44 51; email<EMAIL_ADDRESS>Internet
http://www.airbus.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
3696.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
3696; 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 street address for the Docket Office (telephone
800-647-5527) is Docket 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: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all Airbus Model A318 and
A319 series airplanes, Model A320-211, -212, -214, -231, -232, and -233
airplanes, and Model A321 series airplanes. The NPRM published in the
Federal Register on February 17, 2016 (81 FR 8023) (``the NPRM'').
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2015-0080, dated May 7, 2015 (referred to after
this as the Mandatory Continuing Airworthiness Information, or ``the
MCAI''), to correct an unsafe condition for all Airbus Model A318 and
A319 series airplanes, Model A320-211, -212, -214, -231, -232, and -233
airplanes, and Model A321 series airplanes. The MCAI states:

    During endurance qualification tests on A380 Trimmable
Horizontal Stabilizer Actuator (THSA), a partial loss of the no-back
brake (NBB) efficiency was experienced. Investigation results
concluded that this particular malfunction was due to an ageing/
endurance issue of the surfaces of the NBB carbon friction disks,
leading to a partial loss of braking efficiency in some specific
aerodynamic load conditions.
    Due to design similarity on A320 family fleet, the same tests
were initiated by the THSA manufacturer on certain SA [single-aisle]
type THSA, sampled from the field. Subject tests confirmed that THSA
Part Number (P/N) 47145 series, as installed on A320 family
aeroplanes, are also affected by this partial loss of NBB
efficiency.
    This condition, if not detected and corrected, and in
conjunction with the power gear train not able to keep the ball
screw in its last commanded position, could lead to an uncommanded
movement of the THS, possibly resulting in loss of control of the
aeroplane.
    For the reasons described above, this [EASA] AD requires
[inspecting certain THSAs to determine the number of total flight
cycles the THSA has accumulated and replacing THSAs having certain
total flight cycles] . . . .

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
3696.

Comments

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

Request To Refer to the Latest Service Information

    Airbus requested that we refer to the latest service information:
Airbus Service Bulletin A320-27-1242, Revision 01, dated February 4,
2016 (we referred to Airbus Service Bulletin A320-27-1242, dated
February 9, 2015, as the appropriate source of service information for
accomplishing the replacement specified in the NPRM). Airbus also
requested that we provide credit for previous actions done per Airbus
Service Bulletin A320-27-1242, dated February 9, 2015.
    We agree with the request to refer to the latest service
information. Airbus Service Bulletin A320-27-1242, Revision 01, dated
February 4, 2016, includes updated information and specifies that no
additional work is necessary for airplanes modified by the previous
issue. We have revised paragraphs (h)(1) and (h)(2) of this AD to refer
to Airbus Service Bulletin A320-27-1242, Revision 01, dated February 4,
2016. We have also added new paragraph (k) to this AD (and redesignated
subsequent paragraphs accordingly) to provide credit for actions done
as specified in Airbus Service Bulletin A320-27-1242, dated February 9,
2015.

Request To Extend the Compliance Times

    United Airlines (UAL) requested that we extend the compliance times
proposed in the NPRM. UAL stated that U.S. operators receive less time
to prepare and plan compared to their counterparts in Europe who follow
EASA AD 2015-0080, dated May 7, 2015. UAL noted that the large amount
of THSAs that need to be replaced will cause cancellations, spare
shortages, and interruptions to its operation. UAL recommended a later
compliance time than proposed in paragraph (g)(2) of the proposed AD.
    We disagree with the request to extend the compliance time. UAL did
not provide data to substantiate that an extension to the compliance
time will provide an acceptable level of safety. We determine AD
compliance times primarily on our assessment of the safety risk. Some
safety issues are more time-sensitive than others, so we consider the
overall risk to the fleet, including the severity of the failure and
the likelihood of the failure's occurrence.
    We and our colleagues in the foreign civil airworthiness
authorities (in this case, EASA) work closely with manufacturers to
ensure that all appropriate actions are taken at appropriate times to
mitigate risks to the fleet and address identified unsafe conditions.
In addition, U.S. operators have the same opportunity as their European
counterparts to prepare and plan by reviewing and providing comments to
EASA's proposed airworthiness directives (PADs). An EASA PAD is a
rulemaking document similar to the FAA's NPRM. In most cases, the FAA
follows the intent of the AD issued by the state of design; therefore,
we encourage U.S. operators to provide feedback to EASA PADs, which are
accessible at the following link: http://ad.easa.europa.eu.
    For this AD, we determined that accomplishing the replacements
before specific dates, as stated in the MCAI, are necessary in order to
address the identified unsafe condition in a timely manner. Therefore,
we have not changed this AD in this regard. However, under the
provisions of paragraph (l)(1) of this AD, we may approve requests for
adjustments to the compliance time if data are submitted to
substantiate that such an adjustment would provide an acceptable level
of safety.

Request To Remove Replacement Requirement

    UAL requested that we remove the replacement requirement specified
by paragraph (h)(2) of the proposed AD. UAL stated that the
requirements in paragraphs (h)(1) and (h)(2) of the proposed AD are
contradictory. UAL noted that operators will not be able to predict the
future number of flight cycles. UAL stated, as an example, that a THSA
having accumulated 38,000 total flight cycles on the effective date
would be out of compliance with paragraph (h)(2) of the proposed AD
when the AD becomes effective, since the THSA has exceeded 36,000 total
flight cycles.
    We disagree with the request to remove paragraph (h)(2) of this AD.
However, we do find it necessary to clarify the requirements. After
accomplishing each inspection required by paragraph (g) of this AD,
operators must comply with paragraph (h)(1) of this AD, which mandates
the first requirement for THSA replacement after each inspection of the
THSAs if any part number 47145-(XXX) is found and the THSA has exceeded
the corresponding flight-cycle limits specified in

paragraphs (g)(1) through (g)(5) of this AD.
    Paragraph (h)(2) of this AD establishes the life limit of the THSA
as of each date specified in paragraphs (g)(1) through (g)(5) of this
AD and mandates replacement before the corresponding flight-cycle
limit. The flight-cycle limit varies on each date specified in
paragraphs (g)(1) through (g)(5) of this AD. Paragraphs (h)(1) and
(h)(2) of this AD are separate requirements that do not conflict.
    For example, if the THSA has accumulated 38,000 total flight cycles
as of the effective date of this AD, then paragraph (h)(1) of this AD
does not require replacement immediately (on the effective date of this
AD) since the THSA has fewer than 40,000 total flight cycles (which is
the flight-cycle limit specified in paragraph (g)(1) of this AD). That
THSA would be subject to the compliance time of paragraph (h)(2) of
this AD, which requires that, as of the effective date of this AD, the
THSA must be replaced before exceeding 40,000 total flight cycles until
the next inspection is done before December 31, 2016. The new flight-
cycle limit as of that date is 36,000 total flight cycles (which is the
flight-cycle limit specified in paragraph (g)(2) of this AD).
    Each U.S. operator has unique fleet utilization data that can
assist in predicting the number of flight cycles accumulated on the
THSA and therefore can estimate when a THSA must be replaced. However,
under the provisions of paragraph (l)(1) of this AD, we may approve
requests for adjustments to the compliance time for replacing the THSA
if data are submitted to substantiate that such an adjustment would
provide an acceptable level of safety. We have not changed this AD in
this regard.

Change to Paragraph (j) of This AD

    We made minor changes to the language in paragraph (j) of this AD
to clarify the parts installation limitation.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

    We reviewed Airbus Service Bulletin A320-27-1242, Revision 01,
dated February 4, 2016. The service information describes procedures
for replacing the THSA with a serviceable THSA. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 959 airplanes of U.S. registry.
    We also estimate that it would take about 1 work-hour per product
to comply with the basic requirements of this AD. The average labor
rate is $85 per work-hour. Based on these figures, we estimate the cost
of this AD on U.S. operators to be $81,515, or $85 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 21 work-hours and require parts costing $26,500, for a cost
of $28,285 per product. We have no way of determining the number of
aircraft that might need this action.

Authority for This Rulemaking

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

Regulatory Findings

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

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):

2016-17-12 Airbus: Amendment 39-18625; Docket No. FAA-2016-3696;
Directorate Identifier 2015-NM-113-AD.

(a) Effective Date

    This AD is effective September 30, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus airplanes, certificated in any
category, identified in paragraphs (c)(1), (c)(2), (c)(3), and
(c)(4) of this AD, all manufacturer serial numbers.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model A320-211, -212, -214, -231, -232, and -233 airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, and -232
airplanes.

(d) Subject

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

(e) Reason

    This AD was prompted by a report of a partial loss of the no-
back brake (NBB) efficiency during endurance qualification tests on
the trimmable horizontal stabilizer

actuator (THSA). We are issuing this AD to prevent premature wear of
the carbon friction disks on the NBB of the THSA, which could lead
to reduced braking efficiency in certain load conditions, and, in
conjunction with the inability of the power gear train to keep the
ball screw in its last commanded position, could result in
uncommanded movements of the trimmable horizontal stabilizer and
loss of control of the airplane.

(f) Compliance

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

(g) Inspection To Determine THSA Part Number and Accumulated Total
Flight Cycles

    No later than each date specified in paragraphs (g)(1) through
(g)(5) of this AD: Inspect the THSA to determine if it has a part
number (P/N) 47145-(XXX), and, if any THSA P/N 47145-(XXX) is found,
determine the total number of flight cycles accumulated since the
THSA's first installation on an airplane, or since the most recent
NBB replacement, whichever is later. A review of airplane delivery
or maintenance records is acceptable in lieu of this inspection if
the part number of the THSA can be conclusively determined from that
review. In case maintenance records concerning the most recent NBB
disk replacement are unavailable or incomplete, the total flight
cycles accumulated since first installation of the THSA on an
airplane apply.
    (1) As of the effective date of this AD: The THSA flight-cycle
limit (since first installation on an airplane, or since the most
recent NBB replacement, whichever is later) is 40,000 total flight
cycles.
    (2) As of December 31, 2016: The THSA flight-cycle limit (since
first installation on an airplane, or since the most recent NBB
replacement, whichever is later) is 36,000 total flight cycles.
    (3) As of December 31, 2017: The THSA flight-cycle limit (since
first installation on an airplane, or since the most recent NBB
replacement, whichever is later) is 33,600 total flight cycles.
    (4) As of December 31, 2018: The THSA flight-cycle limit (since
first installation on an airplane, or since the most recent NBB
replacement, whichever is later) is 31,600 total flight cycles.
    (5) As of December 31, 2019: The THSA flight-cycle limit (since
first installation on an airplane, or since the most recent NBB
replacement, whichever is later) is 30,000 total flight cycles.

(h) Replacements

    For airplanes with any THSA P/N 47145-(XXX): Do the replacements
required by paragraphs (h)(1) and (h)(2) of this AD.
    (1) No later than each date specified in paragraphs (g)(1)
through (g)(5) of this AD, replace all THSA that have reached or
exceeded on each date the corresponding number of flight cycles
specified in paragraphs (g)(1) through (g)(5) of this AD. Do the
replacement in accordance with the Accomplishment Instructions of
Airbus Service Bulletin A320-27-1242, Revision 01, dated February 4,
2016. Affected THSAs must be replaced with serviceable THSAs.
    (2) As of each date specified in paragraphs (g)(1) through
(g)(5) of this AD, and before exceeding the flight cycle limit
corresponding to each date, as applicable: Replace each THSA with a
serviceable THSA, in accordance with the Accomplishment Instructions
of Airbus Service Bulletin A320-27-1242, Revision 01, dated February
4, 2016.

(i) Definition of Serviceable THSA

    For the purposes of this AD: A serviceable THSA is a THSA that
has not exceeded the applicable flight-cycle limits, as specified
paragraphs (g)(1) through (g)(5) of this AD, since first
installation of the THSA on an airplane or since last NBB
replacement, whichever is later.

    Note 1 to paragraph (i) of this AD: Guidance for NBB disc
replacement can be found in UTC Aerospace Systems Service Bulletin
47145-27-17, Revision 1, dated July 21, 2015.

(j) Parts Installation Limitation

    As of each date specified in paragraphs (g)(1) through (g)(5) of
this AD, as applicable, only installation of a serviceable THSA P/N
47145-(XXX) is allowed on an airplane.

(k) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(h) of this AD, if those actions were performed before the effective
date of this AD using Airbus Service Bulletin A320-27-1242, dated
February 9, 2015.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (3) Required for Compliance (RC): If any service information
contains procedures or tests that are identified as RC, those
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(m) Special Flight Permits

    Special flight permits, as described in Section 21.197 and
Section 21.199 of the Federal Aviation Regulations (14 CFR 21.197
and 21.199), are not allowed.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2015-0080, dated May 7, 2015,
for related information. This MCAI may be found in the AD docket on
the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2016-3696.
    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (o)(3) and (o)(4) of this AD.

(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus Service Bulletin A320-27-1242, Revision 01, dated
February 4, 2016.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
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 August 18, 2016.
Dorr M. Anderson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-20381 Filed 8-25-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 140 (Monday, July 24, 2023)]
[Proposed Rules]
[Pages 47413-47414]
[FR Doc No: 2023-15290]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2022-0673; FRL-10900-01-R5]

Air Plan Approval; Illinois; NAAQS Update

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
Illinois Environmental Protection Agency (IEPA or Illinois). The
revision, submitted on July 8, 2022, incorporates revisions to the
Illinois air pollution control rules entitled ``Part 243--Ambient Air
Quality Standards'' and also updates the ``List of Designated Reference
and Equivalent Methods'' in response to EPA rulemakings and changes to
the National Ambient Air Quality Standards (NAAQS) that EPA adopted in
2021.

DATES: Comments must be received on or before August 23, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2022-0673 at https://www.regulations.gov, or via email to
[email protected]. For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Daphne Onsay, Life Scientist, Control
Strategies Section, Air Programs Branch (AR-18J), Environmental
Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago,
Illinois 60604,<PHONE_NUMBER>, [email protected]. The EPA Region 5
office is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal holidays and facility closures due to COVID-19.

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

I. What are the State rule revisions?

    On July 8, 2022, IEPA submitted a request to EPA to incorporate
revisions to the Illinois air pollution control rules in Title 35 of
the Illinois Administrative Code, Part 243--Air Quality Standards. The
submission updates sections 243.108 and 243.122. Part 243 includes
Illinois' adoption of ambient air quality standards related to the
NAAQS.

II. What is EPA's analysis of the State's submittal?

    Illinois revised Part 243 to reflect amendments to EPA's ``List of
Designated References and Equivalent Methods'' used to determine
compliance with the NAAQS (fine particulate matter (PM2.5)
and coarse particulate matter (PM10), SO2, carbon
monoxide (CO), lead (Pb), oxides of nitrogen (NOX), and
ozone (O3)). In addition to these changes, Illinois updated
existing rule language to address EPA's revocation of the 1971 primary,
24-hour, and annual average NAAQS for SO2.
    Other revisions to Part 243 include a range of administrative
changes, such as making grammatical corrections, removing the
unnecessary version date from the Code of Federal Regulations (CFR)
citations, and updating the CFR citations to the latest version
available.
    EPA is proposing to approve the revisions to Part 243 which are
described below:
    Section 243.108 Incorporation by Reference--incorporates by
reference EPA's ``List of Designated Reference and Equivalent Methods''
for measuring ambient concentrations to demonstrate compliance with the
NAAQS (PM2.5 and PM10, SO2, CO, Pb,
NOX, and O3).
    EPA designated one new Federal reference monitoring method on March
4, 2021 (86 FR 12682) for SO2 in ambient air. On December
15, 2021, EPA updated the ``List of Designated Reference and Equivalent
Methods'' to include the new Federal reference monitoring method for
SO2. The proposed SIP revision would update section 243.108
to incorporate the changes based on EPA's action dated December 15,
2021.
    Section 243.122 Sulfur Oxides (Sulfur Dioxide)--the sulfur oxide
(as SO2) primary and secondary standards and measurement
methods, respectively, in subsections 243.122(a) and (b). EPA removed
the 1971 primary, 24 hour, and annual standard on April 30, 2022. IEPA
has removed (subsection 243.122(a) to be consistent with EPA's actions.
IEPA has updated its SO2 standard (section 243.122) to
reflect updates at the Federal level.

III. Section 110(l) Analysis of the State's Submittal

    EPA is proposing to approve the revisions to Part 243 discussed
above because the revisions meet all applicable requirements under
section 110(k)(3) the Clean Air Act (CAA). Furthermore, Illinois has
shown that the revisions to Part 243 do not interfere with any
applicable requirement concerning attainment and reasonable further
progress or any other applicable CAA requirement, consistent with
section 110(l) of the CAA.
    Under section 110(l) of the CAA, EPA shall not approve a SIP
revision if it would interfere with any applicable requirement
concerning attainment and reasonable further progress (as defined in
section 171 of the CAA) or any other applicable requirement of the CAA.
The proposed SIP revision would not interfere with any applicable CAA
requirements based on technical analysis submitted by Illinois. Part
243 contains the state's ambient air quality standards, which are now
consistent with the NAAQS. The changes to the ambient air quality
standards in Part 243 rules will have no effect on actual or allowable
emissions as they only update references to the NAAQS in the Illinois
SIP. Illinois has shown there is no impact of revising Part 243 that

would hinder Illinois' ability to maintain and meet the NAAQS for
NO2, O3, Pb, PM2.5, PM10,
SO2, and CO. Therefore, these revisions to sections 243.108
and 243.122 are approvable as they update sections 243.108 and 243.122
to be consistent with EPA's promulgated NAAQS. The revisions will not
increase any emissions to the atmosphere because they do not impact on
any source applicability or emissions.

IV. What action is EPA taking?

    EPA is proposing to approve a revision to the Illinois SIP. The
submittal updates revisions to the Illinois regulations at Title 35 of
the Illinois Administrative Code, Part 243--Air Quality Standards (Part
243). Specifically, the updates made to the following rules in Part
243: Sections 243.108 and 243.122 to be ``identical in substance'' to
and consistent with updates to the list of designated Federal
equivalent and reference methods and updates to the NAAQS adopted by
EPA. IEPA's revisions mirror EPA's reference method for the 2010 1-hour
SO2 standard. IEPA removed the 1971 primary, 24 hour and
annual SO2 standard reflecting EPA's action at the Federal
level.

V. Incorporation by Reference

    In this rule, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference Illinois rules 243.108 and 243.122, effective May 18, 2022,
discussed in section II of this preamble. EPA has made, and will
continue to make, these documents generally available through
www.regulations.gov and at the EPA Region 5 Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 CAA. 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 Orders 12866 (58
FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);
     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
on 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 subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it approves a state program;
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001); and
     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 CAA.
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rulemaking 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).
    Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
February 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' EPA further defines the term fair treatment to mean that
``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.''
    IEPA did not evaluate environmental justice considerations as part
of its SIP submittal; the CAA and applicable implementing regulations
neither prohibit nor require such an evaluation. EPA did not perform an
EJ analysis and did not consider EJ in this action. Consideration of EJ
is not required as part of this action, and there is no information in
the record inconsistent with the stated goal of E.O. 12898 of achieving
environmental justice for people of color, low-income populations, and
Indigenous peoples.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Ozone,
Particulate matter, Sulfur oxides, Volatile organic compounds.

    Dated: July 13, 2023.
Debra Shore,
Regional Administrator, Region 5.
[FR Doc. 2023-15290 Filed 7-21-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Rules and Regulations]
[Pages 65132-65134]
[FR Doc No: 2023-20396]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0712]
RIN 1625-AA00

Safety Zone, Allegheny River, Mile Markers 15.5 to 16.5,
Allegheny County, PA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
the waters of the Allegheny River on September 22, 2023, at mile marker
15.5 to 16.5 from 7:30 through 9 a.m. This action is necessary to
provide for the safety of life on these navigable waters during an on-
land demolition. This rulemaking prohibits persons and vessels from
being in the safety zone unless authorized by the Captain of the Port
Pittsburgh or a designated representative.

DATES: This rule is effective from 7:30 through 9 a.m. on September 22,
2023.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2023-0712 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LTJG Eyobe Mills, Marine Safety Unit Pittsburgh, U.S.
Coast Guard, at telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable and contrary to
the public interest. This safety zone must be established by September
22, 2023, to provide for the safety of life on the navigable waters
during a demolition, and we lack sufficient time to provide a
reasonable comment period and then consider those comments before
issuing this rule. The NPRM process would delay the establishment of
the safety zone until after the date of the demolition. Vessels or
people inside the safety zone have to potential of getting hit with
debris.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impractical and contrary to the public interest
because this action is necessary to ensure the safety of vessels and
persons during the demolition event on September 22, 2023.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Pittsburgh (COTP) has determined that
potential hazards associated with the land-based demolition on
September 22, 2023, will be a safety concern for anyone on the
Allegheny River at mile marker 15.5 to 16.5. This rule is needed to
protect personnel, vessels, and the marine environment in the navigable
waters within the temporary safety zone.

IV. Discussion of the Rule

    This rule establishes a safety zone from 7:30 until 9 a.m. on
September 22, 2023. The safety zone will cover all navigable waters on
Allegheny River, within mile marker 15.5 to 16.5. The duration of the
zone is intended to protect personnel, vessels, and the marine
environment in these navigable waters during a land-based demolition.
    No vessel or person is permitted to enter the safety zone without
obtaining permission from the COTP or a designated representative of
the COTP. A designated representative is a commissioned, warrant, or
petty officer of the Coast Guard assigned to units under the
operational control of the COTP. To seek permission to enter, contact
the COTP or a designated representative via VHF-FM channel 16. Persons
and vessels permitted to enter the safety zone must comply with all
lawful orders or directions issued by the COTP or designated
representative. The COTP or a designated representative will inform the
public of the effective period for the safety zone as well as any
changes in the dates and times of enforcement through Broadcast Notices
to Mariners or Marine Safety Information Bulletins, as appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866, as amended by
Executive Order 14094 (Modernizing Regulatory Review). Accordingly,
this rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, and duration of the temporary safety zone. This safety zone
only impacts a 1-mile

stretch of the Allegheny River for one and a half hours on September
22, 2023. Moreover, the Coast Guard will issue LNMs, MSIBs, and/or BNMs
via VHF-FM marine channel 16 about the zone and the rule allows vessels
to seek permission from the COTP to transit the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or Tribal Government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone that only impacts 1-mile stretch of the Allegheny River for
one and a half hours on September 22, 2023, on the Allegheny River. It
is categorically excluded from further review under paragraph L60(A) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
Record of Environmental Consideration supporting this determination is
available in the docket. For instructions on locating the docket, see
the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T08-0712 to read as follows:

Sec.  165.T08-0712  Safety Zone; Allegheny River, Mile Markers 15.5 to
16.5, Allegheny County, PA.

    (a) Safety zone. The following area is a safety zone: All waters of
the Allegheny River, from surface to bottom, between mile markers 15.5
to 16.5.
    (b) Definitions. As used in this section, Designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port Pittsburgh (COTP) in the enforcement of the
regulations in this section.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you are prohibited from entering, transiting
through, anchoring in, or remaining within the regulated area described
in paragraph (a) of this section unless authorized by the COTP or their
designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by VHF Channel 16. Those in the regulated area must
comply with all lawful orders or directions given to them by the COTP
or the designated representative.
    (3) The COTP will provide notice of the regulated area through
advanced

notice via broadcast notice to mariners and by on-scene designated
representatives.
    (d) Enforcement period. This section will be enforced from 7:30 to
9 a.m. on September 22, 2023.

Eric J. Velez,
Commander, U.S. Coast Guard, Captain of the Port Pittsburgh.
[FR Doc. 2023-20396 Filed 9-20-23; 8:45 am]
BILLING CODE 9110-04-P