[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Rules and Regulations]
[Pages 58243-58245]
[FR Doc No: 2014-23042]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2014-0737; Special Conditions No. 25-570-SC]

Special Conditions: Boeing, Model 767-200/-300 Series Airplane,
as Modified by Avionics Support Group; Installed Rechargeable Lithium
Batteries and Battery Systems

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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SUMMARY: These special conditions are issued for the Boeing, Model 767-
200/-300 series airplanes. These airplanes, as modified by Avionics
Support Group, will have a novel or unusual design feature when
compared to the state of technology envisioned in the airworthiness
standards for transport category airplanes. This design feature is an
ePhone handset for use with the ICS SATCOM System that will use
rechargeable lithium batteries and battery systems. The applicable
airworthiness regulations do not contain adequate or appropriate safety
standards for this design feature. These special conditions contain the
additional safety standards that the Administrator considers necessary
to establish a level of safety equivalent to that established by the
existing airworthiness standards.

DATES: The effective date of these special conditions is September 29,
2014. We must receive your comments by November 13, 2014.

ADDRESSES: Send comments identified by docket number FAA-2014-0737
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http:// DocketsInfo.dot.gov/.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Nazih Khaouly, FAA, Airplane and
Flight Crew Interface Branch, ANM-111, Transport Airplane Directorate,
Aircraft Certification Service, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The FAA has determined that notice of, and
opportunity for prior public comment on, these special conditions is
impracticable because these procedures would significantly delay
issuance of the design approval and thus delivery of the affected
aircraft. In addition, the substance of these special conditions has
been subject to the public comment process in several prior instances
with no substantive comments received. The FAA therefore finds that
good cause exists for making these special conditions effective upon
publication in the Federal Register.

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We may change these special conditions based on the comments
we receive.

Background

    On March 3, 2014, Avionics Support Group applied for a supplemental
type certificate (STC) for the installation of an ePhone handset for
use with the ICG ICS-120A/220A SATCOM System that will use rechargeable
lithium batteries and battery systems. The Model 767-200/-300 series
airplanes are transport category airplanes powered by two turbo-fan
engines.
    Rechargeable lithium batteries are a novel or unusual design
feature in transport category airplanes. This type of battery has
certain failure, operational, and maintenance characteristics that
differ significantly from those of the nickel-cadmium and lead-acid
rechargeable batteries currently approved for installation on transport
category airplanes.

Type Certification Basis

    Under the provisions of 14 CFR 21.101, Avionics Support Group must
show that the Model 767-200/-300, as changed, continues to meet the
applicable provisions of the regulations incorporated by reference in
Type Certificate No. A1NM or the applicable regulations in effect on
the date of application for the change. The regulations incorporated by
reference in the type certificate are commonly referred to as the
``original type certification basis.''
    In addition, if the regulations incorporated by reference do not
provide adequate standards regarding the change, the applicant must
comply with certain regulations in effect on the date of application
for the change.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Model 767-200/-300 series
airplanes because of a novel or unusual design feature, special
conditions are prescribed under the provisions of 14 CFR 21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the applicant apply for an STC to modify any
other model included on the same type certificate to incorporate the
same novel or unusual design feature, the special conditions would also
apply to the other model.
    In addition to the applicable airworthiness regulations and special
conditions, the Model 767-200/-300 series airplanes must comply with
the fuel vent and exhaust emission requirements of 14 CFR part 34 and
the noise certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under 14 CFR 21.101.

Novel or Unusual Design Features

    The Model 767-200/-300 series airplanes will incorporate the
following novel or unusual design feature: The installation of an
ePhone handset for use with the ICG ICS-120A/220A SATCOM System that
will use rechargeable lithium batteries and battery system.

Discussion

    The current regulations governing installation of batteries in
large transport-category airplanes were derived from Civil Air
Regulations (CAR) part 4b.625(d) as part of the re-codification of CAR
4b that established 14 CFR part 25 in February 1965. The new battery
requirements, Sec.  25.1353(c)(1) through (c)(4), basically reworded
the CAR requirements.
    Increased use of nickel-cadmium batteries in small airplanes
resulted in increased incidents of battery fires and failures that led
to additional rulemaking affecting large transport category airplanes
as well as small airplanes. On September 1, 1977, and March 1, 1978,
the FAA issued Sec.  25.1353(c)(5) and (c)(6), respectively, governing
nickel-cadmium battery installations on large transport-category
airplanes.
    The proposed use of rechargeable lithium batteries for equipment
and systems on the Model 767-200/-300 series airplanes prompted the FAA
to review the adequacy of these existing regulations. Our review
indicates that the existing regulations do not adequately address
several failure, operational, and maintenance characteristics of
rechargeable lithium batteries that could affect the safety and
reliability of the lithium battery installations.
    At present, there is limited experience with the use of
rechargeable lithium batteries and battery systems in applications
involving commercial aviation. However, other users of this technology,
ranging from wireless telephone manufacturers to the electric-vehicle
industry, have noted safety problems with rechargeable lithium
batteries. These problems include overcharging, over-discharging, and
flammability of cell components.

1. Overcharging

    In general, lithium batteries are significantly more susceptible to
internal failures that can result in self-sustaining increases in
temperature and pressure (i.e., thermal runaway) than their nickel-
cadmium or lead-acid counterparts. This condition is especially true
for overcharging, which causes heating and destabilization of the
components of the cell, leading to the formation (by plating) of highly
unstable metallic lithium. The metallic lithium can ignite, resulting
in a self-sustaining fire or explosion. Finally, the severity of
thermal runaway, due to overcharging, increases with increasing battery
capacity due to the higher amount of electrolyte in large batteries.

2. Over-Discharging

    Discharge of some types of lithium battery cells beyond a certain
voltage (typically 2.4 volts), can cause corrosion of the electrodes of
the cell, resulting in loss of battery capacity that cannot be reversed
by recharging. This loss of capacity may not be detected by the simple
voltage measurements commonly available to flightcrews as a means of
checking battery status--a problem shared with nickel-cadmium
batteries.

3. Flammability of Cell Components

    Unlike nickel-cadmium and lead-acid batteries, some types of
lithium batteries use liquid electrolytes that are flammable. The
electrolyte can serve as a source of fuel for an external fire, if
there is a breach of the battery container.
    These problems experienced by users of lithium batteries raise
concern about the use of these batteries in commercial aviation. The
intent of the special conditions are to establish appropriate
airworthiness standards for lithium battery installations in the Model
767-200/-300 series airplanes and to ensure, as required by Sec. Sec.
25.1309 and 25.601, that these batteries are not hazardous or
unreliable.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    As discussed above, these special conditions are applicable to
Boeing Model 767-200/-300 series airplanes. Should Avionics Support
Group apply at a later date for a supplemental type certificate to
modify any other model included on Type Certificate No. A1NM to
incorporate the same novel or unusual design feature, the special
conditions would apply to that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on two airplane model series. It is not a rule of general applicability
and affects only the applicant who applied to the FAA for approval of
these features on the airplane.
    The substance of these special conditions has been subjected to the
notice and comment period in several prior instances and has been
derived without substantive change from those previously issued. It is
unlikely that prior public comment would result in a significant change
from the substance contained herein. Therefore, because a delay would
significantly affect the certification of the airplane, which is
imminent, the FAA has determined that prior public notice and comment
are unnecessary and impracticable, and good cause exists for adopting
these special conditions upon publication in the Federal Register. The
FAA is requesting comments to allow interested persons to submit views
that may not have been submitted in response to the prior opportunities
for comment described above.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Boeing Model 767-200/-300 series
airplanes modified by Avionics Support Group.

Installed Rechargeable Lithium Batteries and Battery Systems.

    These special conditions require that (1) all characteristics of
the rechargeable lithium batteries and battery installation that could
affect safe operation of the Model 767-200/-300 series airplanes are
addressed; and (2) appropriate instructions for continued
airworthiness, which include maintenance requirements, are established
to ensure the availability of electrical power, when needed, from the
batteries.
    In lieu of the requirements of Title 14, Code of Federal
Regulations (14 CFR) 25.1353(b)(1) through (b)(4) at Amendment 25-123,
all rechargeable lithium batteries and battery systems on Model 767-
200/-300 series airplanes, modified by Avionics Support Group, must be
designed and installed as follows:
    1. Safe cell temperatures and pressures must be maintained during
any foreseeable charging or discharging

condition and during any failure of the charging or battery monitoring
system not shown to be extremely remote. The rechargeable lithium
battery installation must preclude explosion in the event of those
failures.
    2. Design of the rechargeable lithium batteries must preclude the
occurrence of self-sustaining, uncontrolled increases in temperature or
pressure.
    3. No explosive or toxic gases emitted by any rechargeable lithium
battery in normal operation, or as the result of any failure of the
battery charging system, monitoring system, or battery installation
which is not shown to be extremely remote, may accumulate in hazardous
quantities within the airplane.
    4. Installations of rechargeable lithium batteries must meet the
requirements of Sec.  25.863(a) through (d).
    5. No corrosive fluids or gases that may escape from any
rechargeable lithium battery may damage surrounding structure or any
adjacent systems, equipment, or electrical wiring of the airplane in
such a way as to cause a major or more severe failure condition, in
accordance with Sec.  25.1309(b) and applicable regulatory guidance.
    6. Each rechargeable lithium battery installation must have
provisions to prevent any hazardous effect on structure or essential
systems caused by the maximum amount of heat the battery can generate
during a short circuit of the battery or of its individual cells.
    7. Rechargeable lithium battery installations must have a system to
control the charging rate of the battery automatically, so as to
prevent battery overheating or overcharging, and,
    a. A battery temperature sensing and over-temperature warning
system with a means for automatically disconnecting the battery from
its charging source in the event of an over-temperature condition, or,
    b. A battery failure sensing and warning system with a means for
automatically disconnecting the battery from its charging source in the
event of battery failure.
    8. Any rechargeable lithium battery installation, the function of
which is required for safe operation of the airplane, must incorporate
a monitoring and warning feature that will provide an indication to the
appropriate flight crewmembers whenever the state-of-charge of the
batteries has fallen below levels considered acceptable for dispatch of
the airplane.
    9. The instructions for continued airworthiness required by Sec.
25.1529 must contain maintenance requirements to assure that the
battery is sufficiently charged at appropriate intervals specified by
the battery manufacturer and the equipment manufacturer that contain
the rechargeable lithium battery or rechargeable lithium battery
system. This is required to ensure that lithium rechargeable batteries
and lithium rechargeable battery systems will not degrade below
specified ampere-hour levels sufficient to power the airplane systems
for intended applications. The instructions for continued airworthiness
must also contain procedures for the maintenance of batteries in spares
storage to prevent the replacement of batteries with batteries that
have experienced degraded charge retention ability or other damage due
to prolonged storage at a low state of charge. Replacement batteries
must be of the same manufacturer and part number as approved by the
FAA. Precautions should be included in the instructions for continued
airworthiness maintenance instructions to prevent mishandling of the
rechargeable lithium battery and rechargeable lithium battery systems,
which could result in short-circuit or other unintentional impact
damage caused by dropping or other destructive means that could result
in personal injury or property damage.

    Note 1:  The term ``sufficiently charged'' means that the
battery will retain enough of a charge, expressed in ampere-hours,
to ensure that the battery cells will not be damaged. A battery cell
may be damaged by lowering the charge below a point where the
battery experiences a reduction in the ability to charge and retain
a full charge. This reduction would be greater than the reduction
that may result from normal operational degradation.

    Note 2: These special conditions are not intended to replace
Sec.  25.1353(b) in the certification basis of airplane Model 767-
200/-300 series airplanes. These special conditions apply only to
rechargeable lithium batteries and lithium battery systems and their
installations. The requirements of Sec.  25.1353(b) remain in effect
for batteries and battery installations on Model 767-200/-300 series
airplanes that do not use lithium batteries.

    Issued in Renton, Washington, on September 19, 2014.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-23042 Filed 9-26-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 110 (Thursday, June 7, 2012)]
[Notices]
[Pages 33733-33735]
[FR Doc No: 2012-13823]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2011-0893; FRL-9680-9]

Regulation of Fuel and Fuel Additives: Modification to Octamix
Waiver (TXCeed)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has reconsidered a portion
of a fuel waiver that was granted to the Texas Methanol Corporation
(Texas Methanol) under the Clean Air Act on February 8, 1988. This
waiver was previously reconsidered and modified on October 28, 1988, in
a Federal Register publication titled ``Fuel and Fuel Additives;
Modification of a Fuel Waiver Granted to the Texas Methanol
Corporation.'' Today's notice approves the use of an alternative
corrosion inhibitor, TXCeed, in Texas Methanol's gasoline-alcohol fuel,
OCTAMIX.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-HQ-OAR-2011-0893. All documents and public comments in the
docket are listed on the http://www.regulations.gov Web site.
Publically available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at
the Air Docket, EPA Headquarters Library, Mail Code: 2822T, EPA West
Building, 1301 Constitution Ave. NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding holidays. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
facsimile number for the Air Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For information regarding this notice
contact, Joseph R. Sopata, U.S. Environmental Protection Agency, Office
of Air and Radiation, Office of Transportation and Air Quality, (202)
343-9034, fax number,<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 211(f)(1) of the Clean Air Act (CAA or the Act) makes it
unlawful for any manufacturer of any fuel or fuel additive to first
introduce into commerce, or to increase the concentration in use of,
any fuel or fuel additive for use by any person in motor vehicles
manufactured after model year 1974, which is not substantially similar
to any fuel or fuel additive utilized in the certification of any model
year 1975, or subsequent model year, vehicle or engine under section
206 of the Act. The Environmental Protection Agency (EPA or the Agency)
last issued an interpretive rule on the phrase ``substantially
similar'' at 73 FR 22281 (April 25, 2008). Generally speaking, this
interpretive rule describes the types of unleaded gasoline that are
likely to be considered ``substantially similar'' to the unleaded
gasoline utilized in EPA's certification program by placing limits on a
gasoline's chemical composition as well as its physical properties,
including the amount of alcohols and ethers (oxygenates) that may be
added to gasoline. Fuels that are found to be ``substantially similar''
to EPA's certification fuels may be registered and introduced into
commerce. The current ``substantially similar'' interpretive rule for
unleaded gasoline allows no more than 2.7 percent oxygen by weight for
certain ethers and alcohols.
    Section 211(f)(4) of the Act provides that upon application of any
fuel or fuel additive manufacturer, the Administrator may waive the
prohibitions of section 211(f)(1) if the Administrator determines that
the applicant has established that the fuel or fuel additive, or a
specified concentration thereof, will not cause or contribute to a
failure of any emission control device or system (over the useful life
of the motor vehicle, motor vehicle engine, nonroad engine or nonroad
vehicle in which such device or system is used) to achieve compliance
by the vehicle or engine with the emission standards to which it has
been certified pursuant to sections 206 and 213(a) of the Act. The
statute requires that the Administrator shall take final action to
grant or deny an application after public notice and comment, within
270 days of receipt of the application.
    The Texas Methanol Corporation received a waiver under CAA section
211(f)(4) for a gasoline-alcohol fuel

blend, known as OCTAMIX,\1\ provided that the resultant fuel is
composed of a maximum of 3.7 percent by weight oxygen, a maximum of 5
percent by volume methanol, a minimum of 2.5 percent by volume co-
solvents \2\ and 42.7 milligrams per liter (mg/l) of Petrolite TOLAD
MFA-10 corrosion inhibitor \3\. In the OCTAMIX waiver, the Agency
invited other corrosion inhibitor manufacturers to submit test data to
establish, on a case-by-case basis, whether their fuel additive
formulations are acceptable as alternatives to TOLAD MFA-10.\4\
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    \1\ OCTAMIX waiver decision, 53 FR 3636 (February 8, 1988).
    \2\ The co-solvents are any one or a mixture of ethanol,
propanols, butanols, pentanols, hexanols, heptanols and octanols
with the following constraints: the ethanol, propanols and butanols
or mixtures thereof must compose a minimum of 60 percent by weight
of the co-solvent mixture; a maximum limit of 40 percent by weight
of the co-solvents mixture is placed on the pentanols, hexanols,
heptanols and octanols; and the heptanols and octanols are limited
to 5 percent by weight of the co-solvent mixture.
    \3\ Additional conditions were the final fuel must meet ASTM
volatility specifications contained in ASTM D439-85a, as well as
phase separation conditions specified in ASTM D-2 Proposal P-176 and
Texas Methanol alcohol purity specifications.
    \4\ 53 FR 3637.
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    On March 23, 2011, Spirit of 21st Century LLC requested EPA allow
the use of its alternative corrosion inhibitor, TXCeed, in the OCTAMIX
gasoline-alcohol fuel blend which otherwise would not be allowed under
the waiver.\5\ Spirit of 21st Century LLC subsequently followed up its
March 23 request with additional information on May 17, 2011, July 6,
2011 and August 15, 2011.6 7 8 TXCeed is a fuel additive
formulation consisting of a corrosion inhibitor.
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    \5\ EPA-HQ-OAR-2011-0893-03.
    \6\ EPA-HQ-OAR-2011-0893-004.
    \7\ EPA-HQ-OAR-2011-0893-006.
    \8\ EPA-HQ-OAR-2011-0893-005.
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    On December 14, 2011, EPA published a notice in the Federal
Register (76 FR 77828) announcing receipt of Spirit of 21st Century
LLC's request and inviting comment on it. The comment period closed on
January 13, 2012. There were no public comments submitted to the Agency
in response to the notice published on December 14, 2011.

II. Discussion

    One of the major areas of concern to EPA in reviewing any waiver
request is the problem of materials compatibility. Materials
compatibility data could show a potential failure of fuel systems,
emissions related parts and emission control parts from use of the fuel
or fuel additive. Any failure could result in greater emissions that
would cause or contribute to the engines or vehicles exceeding their
emissions standards. Initially, Texas Methanol requested the use of
TOLAD MFA-10 or an appropriate concentration of any other corrosion
inhibitor such that the fuel will pass the National Association of
Corrosion Engineer's TM-01-72 (NACE RUST TEST). However, EPA concluded
that compliance with the NACE Rust Test alone was not adequate in
determining suitability of a corrosion inhibitor for use under the
OCTAMIX waiver.\9\ The Agency decided, therefore, to look at corrosion
inhibitors on a case-by-case basis to establish whether each
formulation would be acceptable as an alternative to the formulation of
the original corrosion inhibitor, TOLAD MFA-10, used in the OCTAMIX
waiver.\10\
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    \9\ 53 FR 3637.
    \10\ 53 FR 3637.
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    In order to determine whether the OCTAMIX waiver would meet the
criteria of section 211(f) if TXCeed were to be used as an alternative
corrosion inhibitor, EPA reviewed all data submitted with or referenced
by the Spirit of 21st Century LLC application. Spirit of 21st Century
LLC provided data showing their corrosion inhibitor, TXCeed, met ASTM
\11\ and NACE \12\ corrosion test results, as well as physical property
information.
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    \11\ ASTM D130-04e\1\ and ASTM D4814-10a.
    \12\ NACE Standard TM0172-2001.
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    TXCeed is a fuel additive mixture of naturally occurring
triglyceride oils and terpenes that purports to eliminate the corrosion
tendencies of alcohols. While both TOLAD MFA-10 and DMA-67 were only
evaluated with respect to their corrosion inhibitor efficacy under the
NACE corrosion test, TXCeed was evaluated and passed the most current
NACE corrosion test and two additional corrosion tests, the ASTM silver
and copper corrosion tests.\13\ Moreover, TXCeed was evaluated on the
most aggressive fuel formulation of alcohols allowed under the OCTAMIX
waiver,\14\ which is an OCTAMIX fuel formulation that included only
methanol at 5 volume percent and ethanol at 2.5 volume percent. The use
of higher molecular weight cosolvent alcohols, such as propanols or
butanols, would tend to be less corrosive. Since TXCeed passed the most
current NACE corrosion test and the ASTM silver and copper corrosion
tests using the most aggressive fuel formulation allowed under the
OCTAMIX waiver, the Agency believes that Spirit of 21st Century LLC has
met the burden of showing that it is an effective corrosion inhibitor
for use under the OCTAMIX waiver.
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    \13\ See EPA-HQ-OAR-2011-0893-0003.
    \14\ The co-solvents are any one or a mixture of ethanol,
propanols, butanols, pentanols, hexanols, heptanols and octanols
with the following constraints: the ethanol, propanols and butanols
or mixtures thereof must compose a minimum of 60 percent by weight
of the co-solvent mixture; a maximum limit of 40 percent by weight
of the co-solvents mixture is placed on the pentanols, hexanols,
heptanols and octanols; and the heptanols and octanols are limited
to 5 percent by weight of the co-solvent mixture.
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    With regard to the question of the emissions impacts of TXCeed,
Table 1 compares the physical properties (including the treat rate) of
TXCeed to a previously approved corrosion inhibitor under the OCTAMIX
waiver, DMA-67. Normally we would compare the physical properties of
the new corrosion inhibitor (TXCeed) to the physical properties of the
corrosion inhibitor previously approved under the waiver (TOLAD MFA-
10). In this instance, the physical property information for TOLAD MFA-
10 is no longer available, so we are comparing the physical properties
of TXCeed with the physical properties of an alternative corrosion
inhibitor previously approved under the OCTAMIX waiver, DMA-67. TXCeed
is added at about 30 times more than that of DMA-67, has a similar
specific gravity, and a much improved ash content performance. Although
TXCeed's flash point and viscosity are larger than DMA-67, TXCeed's
chemical composition and treat rate of less than 0.1 mass percent by
weight is such that it is a fuel additive falling under the baseline
gasoline fuel grouping category \15\ under our fuel and fuel additive
registration regulations. In addition, TXCeed's chemical composition
and treat rate is such that it meets our substantially similar
definition \16\. Given that TXCeed is a fuel additive that is both
substantially similar to the fuel additives used in our certification
program and a fuel additive falling under the baseline gasoline fuel
category, one would not expect significant emissions changes from the
use of TXCeed compared to other fuel additives that fall under the
baseline gasoline fuel category, which also includes TOLAD MFA-10 and
DMA-67. Therefore, as long as the other conditions of the OCTAMIX
waiver are met, which include applicable gasoline volatility
specifications,\17\ gasoline

phase separation specifications \18\ and alcohol purity conditions,\19\
the Agency believes that the use of TXCeed in place of TOLAD MFA-10
will allow engines and vehicles to remain compliant with their
emissions standards when using fuels made as approved under the
original conditions granted for the OCTAMIX waiver.
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    \15\ See 40 CFR 79.56(e)(3)(i).
    \16\ For our most recent substantially similar gasoline
interpretative rule, please see: http://www.epa.gov/fedrgstr/EPA-AIR/2008/April/Day-25/a8944.pdf.
    \17\ See 40 CFR 80.27 for applicable volatility specifications
for conventional gasoline, or 40 CFR part 80 subpart D for
reformulated gasoline requirements, or any applicable state
implementation plan approved by EPA that includes low RVP fuel.
    \18\ See American Society for Testing and Materials (ASTM) D4814
for applicable gasoline phase separation conditions.
    \19\ Additional conditions were the final fuel must meet ASTM
volatility specifications contained in ASTM D439-85a, as well as
phase separation conditions specified in ASTM D-2 Proposal P-176 and
Texas Methanol alcohol purity specifications. Since the time that
the OCTAMIX waiver was granted, ASTM D4814 has superceded ASTM
volatility specifications contained in ASTM D439-85a and the phase
separation conditions specified in ASTM D-2 Proposal P-176.

            Table 1--Physical Properties of DMA-67 and TXCeed
------------------------------------------------------------------------

------------------------------------------------------------------------
Physical Properties............  DMA-67.............  TXCeed
Treat Rate (mg/liter)..........  31.4...............  987.6
Physical Form..................  Clear Amber Liquid.  Liquid \20\
Specific Gravity 60/60 [deg]F..  0.93...............  0.9662
Flash Point, PMCC, [deg]F......  64 [deg]F..........  230 [deg]F
Ash Content, weight percent....  <0.1...............  <0.0001
Viscosity, cSt @0 [deg]F.......  663................  19210
Viscosity, cSt @32 [deg]F......  180................  3220
Viscosity, cST @100 [deg]F.....  30.................  151
------------------------------------------------------------------------
\20\ According to Spirit of 21st Century LLC, the color of the liquid is
  dependent on the clarity of the chemical components comprised in fuel
  additive formulation of TXCeed.

III. Finding and Conclusion

    Based on the information submitted by Spirit of 21st Century LLC in
its application, I conclude that the performance of TXCeed in OCTAMIX
would be comparable to TOLAD MFA-10 and DMA-67. Therefore, I am
modifying condition (3) of the OCTAMIX waiver to read as follows:
    (3) Any one of the following three corrosion inhibitors must be
included:
    (a) Petrolite's corrosion inhibitor formulation, TOLAD MFA-10,
blended in the final fuel at 42.7 mg/l;
    OR
    (b) DuPont's corrosion inhibitor formulation, DMA-67, blended in
the final fuel at 31.4 mg/l;
    OR
    (c) Spirit of 21st Century LLC's corrosion inhibitor formulation,
TXCeed, blended in the final fuel at 3.9 ml/gal (987.6 mg/l).
    This action should provide additional flexibility to any
manufacturer wishing to produce the OCTAMIX blend. At the same time,
any manufacturer wishing to use a corrosion inhibitor other than the
three permitted by the OCTAMIX waiver must apply for a further
modification of the waiver. Since EPA is still unaware of any basis for
extrapolating findings in the emissions impact of one inhibitor to
other inhibitors, the Agency will continue to examine the emissions
impact of specific corrosion inhibitor formulations on a case-by-case
basis.

IV. Miscellaneous

    This waiver modification decision is final agency action of
national applicability for purposes of section 307(b)(1) of the Act.
Pursuant to CAA section 307(b)(1), judicial review of this final agency
action may be sought only in the United States Court of Appeals for the
District of Columbia Circuit. Petitions for review must be filed by
August 6, 2012. Judicial review of this final agency action may not be
obtained in subsequent proceedings, pursuant to CAA section 307(b)(2).
This action is not a rulemaking and is not subject to the various
statutory and other provisions applicable to a rulemaking.

    Dated: May 31, 2012.
Lisa P. Jackson,
Administrator.
[FR Doc. 2012-13823 Filed 6-6-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Rules and Regulations]
[Pages 70000-70003]
[FR Doc No: 2021-26543]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0688; Project Identifier 2019-SW-025-AD; Amendment
39-21781; AD 2021-22-08]
RIN 2120-AA64

Airworthiness Directives; H[eacute]licopt[egrave]res Guimbal
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
H[eacute]licopt[egrave]res Guimbal (HG) Model Cabri G2 helicopters.
This AD was prompted by the determination that certain parts need life
limits and certification maintenance requirement (CMR) tasks. This AD
requires establishing life limits and CMR tasks for various parts and
removing any parts from service that have reached or exceeded their
life limits. Depending on the results of the CMR tasks, this AD
requires corrective action. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective January 13, 2022.
    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in this AD as of January 13,
2022.

ADDRESSES: For service information identified in this final rule,
contact H[eacute]licopt[egrave]res Guimbal, 1070, rue du Lieutenant
Parayre, A[eacute]rodrome d'Aix-en-Provence, 13290 Les Milles, France;
telephone 33-04-42-39-10-88; email [email protected]; or at https://www.guimbal.com. You may view the referenced 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>. It is
also available at https://www.regulations.gov by searching for and
locating Docket No. FAA-2021-0688.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0688; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
European Aviation Safety Agency (now European Union Aviation Safety
Agency) (EASA) AD, any comments received, and other information. The
street address for Docket Operations is U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Andrea Jimenez, Aerospace Engineer,
COS Program Management Section, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to
H[eacute]licopt[egrave]res Guimbal (HG) Model Cabri G2 helicopters. The
NPRM published in the Federal Register on August 23, 2021 (86 FR
47038). In the NPRM, the FAA proposed to require before further flight,
removing from service certain part-numbered cooling fan front flanges
and engine pulley ball bearings that have accumulated or exceeded their
life limit. The NPRM also proposed to require establishing recurring
CMR tasks for certain part-numbered cooling fan front flanges.
Depending on the results of the CMR tasks, the NPRM proposed to require
corrective action. Additionally, the NPRM proposed to require painting
certain part-numbered tail booms with glossy white paint.
    The NPRM was prompted by a series of EASA ADs beginning with EASA
AD 2016-0032, dated February 24, 2016 (EASA AD 2016-0032), issued by
EASA, which is the Technical Agent for the Member States of the
European Union, to correct an unsafe condition for HG Model Cabri G2
helicopters. EASA AD 2016-0032 states HG has revised the airworthiness
limitations and maintenance tasks specified in the existing maintenance
manual. EASA further advised the revisions include new and more
restrictive applicable life limits and compliance times for applicable
tasks. Accordingly, EASA 2016-0032 required replacing each affected
part before exceeding its life limit, accomplishing all applicable
maintenance tasks within the defined intervals as described in revised
maintenance manual and if discrepancies were found accomplishing the
corrective actions in accordance with the applicable maintenance
instructions or contacting HG. EASA AD 2016-0032 also required revising
the existing Aircraft Maintenance Program (AMP) for your helicopter by
incorporating the actions specified in the revised maintenance. After
EASA issued EASA AD 2016-0032, HG again revised the airworthiness
limitations and maintenance tasks.
    Accordingly, EASA superseded EASA AD 2016-0032 with EASA AD 2019-
0025, dated February 4, 2019 (EASA AD 2019-0025). EASA advises new and
more restrictive life limits have been established for cooling fan part
number (P/N) G52-00-001, and P/N G52-00-002, which have been identified
as mandatory for continued airworthiness in H[eacute]licopt[egrave]res
Guimbal Cabri G2 Maintenance Manual (MM) No. J70-002 Issue 06, dated
December 6, 2018, Section C, Airworthiness Limitations (the ALS). In
addition to the new life limits, EASA advises of new and more
restrictive inspection intervals identified in the ALS for cooling fan
P/N G52-00-001 with a certain mounted cooling fan front flange P/N G52-
02-200, or P/N G52-02-201. EASA further advises that the ALS revised
the tail structure paint to include certain part-numbered tail booms
and an additional figure. This condition, if not addressed, could
result in parts remaining in service beyond their fatigue life and
failure of a part, which could result in loss of control of the
helicopter.
    Accordingly, EASA AD 2019-0025 retains the requirements of EASA AD
2016-0032 and requires replacing each affected part before exceeding
its life limit, accomplishing all applicable maintenance tasks within
the defined intervals as described in the ALS, and if discrepancies are
found accomplishing the corrective actions in accordance with the
applicable maintenance instructions or contacting HG. EASA AD 2019-0025
also requires revising the tail structure paint scheme to include
certain part-numbered tail booms and an additional figure. EASA AD
2019-0025 requires revising the existing AMP for your helicopter by
incorporating the actions specified in the ALS.

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA reviewed the relevant
data and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these helicopters. Except for minor editorial changes,
this AD is adopted as proposed in the NPRM. Changes include clarifying
the name of and the specific portions of Guimbal France
H[eacute]licopt[egrave]res Guimbal Cabri G2 Maintenance Manual and
Instructions for Continued Airworthiness, J70-002--Issue 06, dated
December 6, 2018 (MM J70-002 Issue 06) that are required to accomplish
this final rule. MM J70-002 Issue 06 also refers to a flashlight as a
torchlight; accordingly, changes have been made in this final rule to
clarify that where MM J70-002 Issue 06 specifies to use a torchlight,
to use a flashlight instead. This final rule also removes the
requirements of accomplishing sub section 52-A-10 Cooling Fan
Inspection, paragraph d), of MM J70-002 Issue 06 because it is
unnecessary, this final rule already provides requirements pertaining
to what to do if there is a crack.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed page C-6 of Section C, Airworthiness Limitations,
and page E-5-53 of Section E, Maintenance Instructions, of MM J70-002
Issue 06. This service information specifies airworthiness life limits,
inspection intervals, and CMR requirements for parts installed on Cabri
G2 helicopters. MM J70-002 Issue 06 also establishes life limits for
certain part-numbered cooling fan front flanges, and engine pulley ball
bearings and CMR requirements for certain cooling fan front flanges.
    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.

Differences Between This AD and EASA 2019-0025

    EASA AD 2019-0025 requires contacting H[eacute]licopt[egrave]res
Guimbal for corrective actions when a discrepancy is

found, whereas this AD requires removing the part from service. EASA AD
2019-0025 requires accomplishing the actions specified in the ALS,
whereas this AD requires establishing a life limit for certain part-
numbered cooling fan front flanges and certain part-numbered engine
pulley ball bearings and removing any part from service accordingly
instead. EASA AD 2019-0025 requires revising the AMP with the actions
specified in the ALS, whereas this AD does not.

Costs of Compliance

    The FAA estimates that this AD affects 32 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD.
    Replacing a cooling fan front flange takes about 16 work-hours and
parts cost about $4,500 for an estimated cost of $5,860 per helicopter
and $187,520 for the U.S. fleet, per replacement cycle.
    Replacing an engine pulley ball bearing takes about 12 work-hours
and parts cost about $250 for an estimated cost of $1,270 per
helicopter and $40,640 for the U.S. fleet, per replacement cycle.
    The FAA has no way of determining the estimated costs to do
allowable repairs based on the results of the CMR tasks. If required,
replacing a cracked cooling fan front flange takes about 16 work-hours
and parts cost about $4,500 for an estimated cost of $5,860.
    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected operators.

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 helicopters identified in this rulemaking action.

Regulatory Findings

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

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 adding the following new airworthiness
directive:

2021-22-08 H[eacute]licopt[egrave]res Guimbal: Amendment 39-21781;
Docket No. FAA-2021-0688; Project Identifier 2019-SW-025-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective January 13, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to H[eacute]licopt[egrave]res Guimbal (HG) Model
Cabri G2 helicopters, certificated in any category.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 7100, Powerplant
System.

(e) Unsafe Condition

    This AD was prompted by a notification of certain parts
remaining in service beyond their fatigue life or beyond maintenance
intervals required by the certification maintenance requirements
(CMRs) of the Instructions for Continued Airworthiness. The FAA is
issuing this AD to prevent failure of a part, which could result in
loss of control of the helicopter.

(f) Compliance

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

(g) Required Actions

    (1) Before further flight after the effective date of this AD,
remove from service any part that has reached or exceeded its life
limit, as specified in paragraphs (g)(1)(i) through (iii) of this
AD, and thereafter remove from service any part on or before each
part reaches its life limit:
    (i) The life limit for cooling fan front flange part number (P/
N) G52-02-200 mounted on pulley (12 screws) P/N G52-10-100 or G52-
10-101; and cooling fan front flange P/N G52-02-201 mounted or
having been mounted on pulley (12 screws) P/N G52-10-100 or G52-10-
101, installed on cooling fan P/N G52-00-001 or G52-00-002; is 2,200
total hours time-in-service (TIS).
    (ii) The life limit for cooling fan front flange P/N G52-02-201
mounted on pulley (24 screws) P/N G52-10-102 and having never been
mounted on pulley (12 screws) P/N G52-10-100 or G52-10-101,
installed on cooling fan P/N G52-00-001 or G52-00-002, is 4,400
total hours TIS.
    (iii) The life limit for engine pulley ball bearing P/N HG61-
0790 and HG61-1944, installed on engine pulley assembly P/N G51-14-
1XX, is 2,200 total hours TIS.
    (2) Perform the following CMR tasks as follows:
    (i) Cooling fan front flange P/N G52-02-200 mounted on pulley
(12 screws) P/N G52-10-100 or G52-10-101; and cooling fan front
flange P/N G52-02-201 mounted or having been mounted on pulley (12
screws) P/N G52-10-100 or G52-10-101, installed on cooling fan P/N
G52-00-001, and with 500 or more total hours TIS since new as of the
effective date of this AD: Within 5 hours TIS after the effective
date of this AD and thereafter at intervals not to exceed 50 hours
TIS, or 70 engine start-stop cycles, whichever occurs first, inspect
the cooling fan front flange for a crack in accordance with Section
E, Maintenance Instructions, sub section 52-A-10 Cooling Fan
Inspection, paragraph c), on page E-5-53, of Guimbal France
H[eacute]licopt[egrave]res Guimbal Cabri G2 Maintenance Manual (MM)
and Instructions for Continued Airworthiness, J70-002--Issue 06,
dated December 6, 2018 (MM J70-002 Issue 06), except where MM J70-
002 Issue 06 specifies to use a torchlight, use a flashlight. If any
crack is found, before further flight, remove the cooling fan front
flange from service.
    (ii) Cooling fan front flange P/N G52-02-200 mounted on pulley
(12 screws) P/N G52-10-100 or G52-10-101; and cooling fan front
flange P/N G52-02-201 mounted or having been mounted on pulley (12
screws) P/N G52-10-100 or G52-10-101, installed on cooling fan P/N
G52-00-001, and with less than 500 total hours TIS since new as of
the effective date of this AD: Before

accumulating 500 total hours TIS since new and thereafter at
intervals not to exceed 50 hours TIS, or 70 engine start-stop
cycles, whichever occurs first, inspect the cooling fan front flange
for a crack in accordance with Section E, Maintenance Instructions,
sub section 52-A-10 Cooling Fan Inspection, paragraph c), on page E-
5-53, of MM J70-002 Issue 06, except where MM J70-002 Issue 06
specifies to use a torchlight, use a flashlight. If any crack is
found, before further flight, remove the cooling fan front flange
from service.
    (iii) Cooling fan front flange P/N G52-02-201 mounted on pulley
(24 screws) P/N G52-10-102 and having never been mounted on pulley
(12 screws) P/N G52-10-100 or G52-10-101, installed on cooling fan
P/N G52-00-002: Before accumulating 500 total hours TIS since new
and thereafter at intervals not to exceed 100 hours TIS, inspect the
cooling fan front flange for a crack in accordance with Section E,
Maintenance Instructions, sub section 52-A-10 Cooling Fan
Inspection, paragraph c), on page E-5-53, of MM J70-002 Issue 06,
except where MM J70-002 Issue 06 specifies to use a torchlight, use
a flashlight. If any crack is found, before further flight, remove
the cooling fan front flange from service.
    (iv) For helicopters with tail boom P/N G65-00-101, G65-00-102
or G65-00-103 and subsequent installed: Before further flight after
the effective date of this AD, paint or verify the tail boom upper
surface in accordance with Section C, Airworthiness Limitations, sub
section C-23 Tail Structure Paint, on page C-6, of MM J70-002 Issue
06, as applicable to your helicopter.

(h) Credit for Previous Actions

    This paragraph provides credit for the actions specified in
paragraphs (g)(2)(i) through (iii) of this AD, if those actions were
performed before the effective date of this AD using Section E,
Maintenance Instructions, sub section 52-A-10 Cooling Fan
Inspection, paragraphs (c) and (d), of Guimbal France
H[eacute]licopt[egrave]res Guimbal Cabri G2 MM and Instructions for
Continued Airworthiness, J70-002 Issue--05.1, dated October 30,
2015.

(i) 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 (j)(1) of
this AD. Information may be emailed to: [email protected].
    (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.

(j) Related Information

    (1) For more information about this AD, contact Andrea Jimenez,
Aerospace Engineer, COS Program Management Section, Operational
Safety Branch, Compliance & Airworthiness Division, FAA, 1600
Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-
7330; email [email protected].
    (2) Service information identified in this AD that is not
incorporated by reference is available at the contact information
specified in paragraphs (k)(3) and (4) of this AD.
    (3) The subject of this AD is addressed in European Aviation
Safety Agency (now European Union Aviation Safety Agency (EASA) AD
2019-0025, dated February 4, 2019. You may view the EASA AD on the
internet at https://www.regulations.gov in Docket No. FAA-2021-0688.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Page C-6 of Section C, Airworthiness Limitations, of Guimbal
France H[eacute]licopt[egrave]res Guimbal Cabri G2 Maintenance
Manual and Instructions for Continued Airworthiness, J70-002--Issue
06, dated December 6, 2018.
    (ii) Page E-5-53 of Section E, Maintenance Instructions, of
Guimbal France H[eacute]licopt[egrave]res Guimbal Cabri G2
Maintenance Manual and Instructions for Continued Airworthiness,
J70-002--Issue 06, dated December 6, 2018.
    (3) For service information identified in this AD, contact
H[eacute]licopt[egrave]res Guimbal, 1070, rue du Lieutenant Parayre,
A[eacute]rodrome d'Aix-en-Provence, 13290 Les Milles, France;
telephone 33-04-42-39-10-88; email [email protected]; or at
https://www.guimbal.com.
    (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>.
    (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, email: [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on October 14, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-26543 Filed 12-8-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 191 (Thursday, October 1, 2020)]
[Notices]
[Pages 61953-61955]
[FR Doc No: 2020-21652]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1517]

The Use of Physiologically Based Pharmacokinetic Analyses--
Biopharmaceutics Applications for Oral Drug Product Development,
Manufacturing Changes, and Controls; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``The Use of
Physiologically Based Pharmacokinetic Analyses--Biopharmaceutics
Applications for Oral Drug Product Development, Manufacturing Changes,
and Controls.'' This guidance provides general recommendations
regarding the development, evaluation, and use of physiologically based
pharmacokinetic (PBPK) analyses for biopharmaceutics applications
employed by sponsors of investigational new drug applications, new drug
applications, or abbreviated new drug applications, and supplements to
these applications, for oral drug product development, manufacturing
changes, and controls. The guidance covers how to develop, evaluate,
and apply PBPK models for biopharmaceutics-related uses, such as
establishing clinically relevant dissolution specifications and quality
risk assessment for postapproval manufacturing changes.

DATES: Submit either electronic or written comments on the draft
guidance by November 30, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1517] for ``The Use of Physiologically Based Pharmacokinetic
Analyses--Biopharmaceutics Applications for Oral Drug Product
Development, Manufacturing Changes, and Controls.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Paul Seo, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 21, Rm. 1628, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``The Use of Physiologically Based Pharmacokinetic Analyses--
Biopharmaceutics Applications for Oral Drug Product Development,
Manufacturing Changes, and Controls.'' This draft guidance provides
general recommendations regarding the development, evaluation, and use
of PBPK analyses for biopharmaceutics applications employed by sponsors
of investigational new drug applications, new drug applications, or
abbreviated new drug applications, and supplements to these
applications, for oral drug product development, manufacturing changes,
and controls. PBPK analyses use models and simulations that combine
physiology, population, and drug characteristics to mechanistically
describe the pharmacokinetic and/or pharmacodynamic behaviors of a drug
product.
    Submission of these analyses to FDA is discussed in the guidance
for industry entitled ``Physiologically Based Pharmacokinetic
Analyses--Format and Content'' (available at https://www.fda.gov/media/101469/download). However, the application of PBPK modeling in support
of drug product development is an evolving field. FDA recognizes this
challenge and encourages the development and use of new tools and
approaches for linking pharmaceutical quality to clinical performance.
    Advances in modeling and simulation have enabled the integration of
factors such as the physicochemical properties of the active
pharmaceutical ingredient, dissolution data, and the physiology of the
gastrointestinal tract into the development of PBPK models. As such,
PBPK modeling has become a promising tool in predicting systemic drug
exposure of oral drug products.
    PBPK analyses for biopharmaceutics applications combine dissolution
modeling, biopredictive dissolution profiles, or other in vitro testing
inputs with PBPK modeling strategies to quantitatively describe the
differential and potential interactions of formulation variants with
the body and their effect on drug exposure.
    This guidance describes recommended PBPK model structure, which
provides a mechanistic framework of drug oral absorption by
representing the in vivo drug absorption process and accounting for the
relevant

product quality attributes that affect drug dissolution and absorption,
and discusses how to capture and present model assumptions and
parameters. Model validation and refinement are also discussed.
    In addition, the guidance discusses the major regulatory uses of
PBPK modeling for biopharmaceutics applications with respect to
supporting product quality. Factors regarding the development of
clinically relevant dissolution specifications to aid in biopredictive
dissolution method development and to support clinically relevant
dissolution acceptance criteria are presented, as well as
considerations for conducting virtual bioequivalence studies.
    PBPK modeling for biopharmaceutics applications also can be used to
establish clinically relevant drug product quality specifications other
than dissolution, which can be used to ensure bioequivalence of batches
within the specification limits, to the pivotal clinical/
bioavailability batches, or to the reference listed drug for generic
drugs. Finally, the guidance discusses the use of PBPK analyses for
biopharmaceutics applications as an advanced tool for quality risk
assessment and management in both the pre- and postapproval stages.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``The Use of
Physiologically Based Pharmacokinetic Analyses-- Biopharmaceutics
Applications for Oral Drug Product Development, Manufacturing Changes,
and Controls.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved FDA collections
of information. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of
information in 21 CFR part 314 have been approved under OMB control
number 0910-0001.

III. Electronic Access

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

    Dated: September 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21652 Filed 9-30-20; 8:45 am]
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[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Notices]
[Page 6722]
[FR Doc No: 2023-02089]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 11286-028]

City of Abbeville; Notice of Intent To File License Application,
Filing of Pre-Application Document, and Approving Use of the
Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process (TLP).
    b. Project No.: 11286-028.
    c. Dated Filed: November 29, 2022.
    d. Submitted By: City of Abbeville.
    e. Name of Project: Abbeville Hydroelectric Project.
    f. Location: On the Rocky River in Abbeville and Anderson Counties,
South Carolina. No federal lands are occupied by the project works or
located within the project boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Applicant Contact: Tim Hall, Director of Public Utilities, City
of Abbeville, 306 Cambridge Street, Abbeville, SC 29620; Phone: (864)
366-5058, Email: [email protected].
    i. FERC Contact: Kristine Sillett at<PHONE_NUMBER> or
[email protected].
    j. The City of Abbeville filed its request to use the TLP on
November 29, 2022. The City of Abbeville provided public notice of its
request on November 30, 2022. In a letter dated January 26, 2023, the
Director of the Division of Hydropower Licensing approved the City of
Abbeville's request to use the TLP.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and/or NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, Part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the South Carolina State Historic Preservation
Officer, as required by section 106, National Historic Preservation
Act, and the implementing regulations of the Advisory Council on
Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating the City of Abbeville as
the Commission's non-federal representative for carrying out informal
consultation, pursuant to section 7 of the Endangered Species Act and
section 305(b) of the Magnuson-Stevens Fishery Conservation and
Management Act; and consultation pursuant to section 106 of the
National Historic Preservation Act.
    m. The City of Abbeville filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD may be viewed on the Commission's website
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY).
    o. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 11286. Pursuant to 18 CFR
16.8, 16.9, and 16.10 each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by November 30,
2025.
    p. Register online at https://ferconline.ferc.gov/eSubscription.aspx to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: January 26, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-02089 Filed 1-31-23; 8:45 am]
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[Federal Register: June 1, 2006 (Volume 71, Number 105)]
[Rules and Regulations]
[Page 31097-31100]
[DOCID:fr01jn06-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2006-0052; FRL-8177-8]

Approval and Promulgation of Maintenance Plan Revisions; Ohio:
Carbon Monoxide Maintenance Plan Updates; Limited Maintenance Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving an
October 20, 2005, request from Ohio for a State Implementation Plan
(SIP) revision of the Cuyahoga County carbon monoxide (CO) maintenance
plan. The CO maintenance plan revision is an update to the current
approved maintenance plan and continues to demonstrate maintenance of
the CO National Ambient Air Quality Standard (NAAQS) for an additional
10 years. The maintenance plan revision is submitted as a limited
maintenance plan for the Cuyahoga County, Ohio carbon monoxide area.

DATES: This rule is effective on July 31, 2006, unless EPA receives
adverse written comments by July 3, 2006. If EPA receives adverse
comments, EPA will publish a timely withdrawal of the rule in the
Federal Register and inform the public that the rule will not take
effect at that time.

ADDRESSES: Submit comments, identified by Docket ID No. EPA-R05-OAR-
2006-0052 by one of the following methods:
     http://www.regulations.gov. Follow the on-line

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: John M. Mooney, Chief, Criteria Pollutant Section,
(AR-18J), Air Programs Branch, Air and Radiation Division, U.S.
Environmental Protection Agency, 77 West Jackson Boulevard, Chicago,
Illinois 60604.
     Hand delivery: John M. Mooney, Chief, Criteria Pollutant
Section, (AR-18J), Air Programs Branch, Air and Radiation Division,
U.S. Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, 18th floor, Chicago, Illinois 60604.
    Such deliveries are only accepted during the Regional Office's
normal hours of operation. The Regional Office's official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding
Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2006-0052. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov, or e-mail. The http://www.regulations.gov Web site

is an ``anonymous access'' systems, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional instructions on submitting
comments, go to Section I of the SUPPLEMENTARY INFORMATION section of
this document.
    Docket: All documents in the docket are listed in the http://www.regulations.gov
 index. Although listed in the index, some

information is

not publicly available, e.g., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically in
http://www.regulations.gov or in hard copy at Environmental Protection

Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This Facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. We
recommend that you telephone Patricia Morris, Environmental Scientist,
at<PHONE_NUMBER> before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Patricia Morris, Environmental
Scientist, Criteria Pollutant Section, Air Programs Branch (AR-18J),
U.S. Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What Should I Consider as I Prepare My Comments for EPA?
II. What Is the Background of This SIP?
III. What Is a Limited Maintenance Plan?
IV. What Does This Mean for Transportation Conformity?
V. What Action Is EPA Taking Today?
VI. Statutory and Executive Order Reviews

I. What Should I Consider as I Prepare My Comments for EPA?

    A. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of

the information that you claim to be CBI. For CBI information in a disk
or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
as CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    B. Tips for Preparing Your Comments. When submitting comments,
remember to:
    1. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    2. Follow directions--The EPA may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

II. What Is the Background of This SIP?

    On October 20, 2005, the Ohio Environmental Protection Agency
(OEPA), submitted the final public hearing documentation for a SIP
revision request for the Cuyahoga County, Ohio carbon monoxide area.
The revision consists of a second follow-on ten year carbon monoxide
maintenance plan, and a request for a limited CO maintenance plan
designation. A public hearing was held on March 10, 2005, in Cleveland,
Ohio and a transcript from the public hearing was submitted.
    In 1991, EPA designated Cuyahoga County, Ohio as a CO nonattainment
area (see 56 FR 56694 November 6, 1991). The State of Ohio developed
state implementation plans to control CO emissions through a number of
federally mandated control programs, as well as State initiated control
programs. These control measures resulted in the attainment of the
NAAQS for carbon monoxide in Cuyahoga County, Ohio. The area was
redesignated to attainment effective March 7, 1994, (59 FR 5332).
    Section 175A of the CAA sets forth the elements of a maintenance
plan for areas seeking redesignation from nonattainment to attainment.
The plan must demonstrate continued attainment of the applicable NAAQS
for at least ten years after the EPA Administrator approves a
redesignation to attainment. Eight years after the redesignation, the
state must submit a revised maintenance plan which demonstrates
attainment for the ten years following the initial ten-year period. The
SIP submittal has been submitted by Ohio to meet the second maintenance
plan requirement of the CAA. This second maintenance plan supplements,
and does not replace, the original approved maintenance plan. The
commitments in the approved maintenance plan continue to apply for the
second 10 year timeframe.
    Ohio originally submitted the emissions projections and SIP
revision request on December 24, 2003. However, the state did not
conduct a public hearing on the proposed SIP revision at that time. The
EPA wrote a letter to Ohio dated January 28, 2004, noting that the
public hearing requirements needed to be met. Ohio has now conducted
the appropriate public hearing and has submitted the public hearing
materials with the SIP revision request.

III. What Is a Limited Maintenance Plan?

    EPA detailed the limited maintenance plan approach in a memorandum
entitled ``Limited Maintenance Plan Option for Nonclassifiable CO
Nonattainment Areas'' from Joseph Paisie, Group Leader, Integrated
Policy and Strategies Group, Office of Air Quality Planning and
Standards (OAQPS), dated October 6, 1995. Pursuant to this approach,
EPA will consider the maintenance demonstration satisfied for ``not
classified'' areas if the monitoring data show the design value is at
or below, 7.65 parts per million (ppm), or 85 percent of the level of
the 8-hour CO NAAQS. The design value must be based on eight
consecutive quarters of data. For such areas, there is no requirement
to project emissions of air quality over the maintenance period. EPA
believes that if the area begins the maintenance period at, or below,
85 percent of the CO 8 hour NAAQS, then the applicability of Prevention
of Significant Deterioration (PSD) requirements, the control measures
already in the SIP, and Federal measures, should provide adequate
assurance of maintenance over the 10-year maintenance period.
    In addition, the design value for the area must continue to be at
or below 7.65 ppm until the time of final EPA action.
    Current 2005 and 2006 8-hour CO design values for the Cuyahoga
County area meet the requirements for a limited maintenance plan. The 8
hour values from the Airdata reports were examined for Cuyahoga County
and have not exceeded the 7.65 ppm level for the time frame of 2001 to
2005. Because Cuyahoga County is an attainment/unclassifiable area and
meets the monitored CO levels, the area qualifies

for the limited maintenance plan option. The Ohio EPA will continue to
maintain a continuous CO monitoring network, meeting the requirements
of 40 CFR Part 58, that provides adequate coverage to verify continued
compliance with the CO NAAQS.

IV. What Does This Mean for Transportation Conformity?

    Section 176(c) of the CAA defines transportation conformity as
conformity to the SIP's purpose of eliminating or reducing the severity
and number of violations of the NAAQS and achieving expeditious
attainment of such standards. The CAA further defines transportation
conformity to mean that no Federal transportation activity will: (1)
Cause or contribute to any new violation of any standard in any area;
(2) increase the frequency or severity of any existing violation of any
standard in any area; or (3) delay timely attainment of any standard or
any required interim emission reductions or other milestones in any
area. The Federal Transportation Conformity Rule, 40 CFR part 93
subpart A, sets forth the criteria and procedures for demonstrating and
assuring conformity of transportation plans, programs and projects
which are developed, funded or approved by the U.S. Department of
Transportation, and by metropolitan planning organizations or other
recipients of funds under title 23 U.S.C. or the Federal Transit Laws
(49 U.S.C. chapter 53). The transportation conformity rule applies
within all nonattainment and maintenance areas. As prescribed by the
transportation conformity rule, once an area has an applicable State
Implementation Plan with motor vehicle emissions budgets, the expected
emissions from planned transportation activities must be consistent
with (''conform to'') such established budgets for that area.
    In the case of the Cuyahoga County, Ohio, CO limited maintenance
plan area, however, the emissions budgets may be treated as essentially
not constraining for the length of the second maintenance period as
long as the area continues to meet the limited maintenance criteria.
There is no reason to expect that this area will experience so much
growth in that period that a violation of the CO NAAQS would result.
The OEPA submittal includes projections of point, area, and mobile
source emissions out to the year 2015. During this timeframe, CO
emissions are projected to decrease from 248,801 tons per year in 2002
to 154,102 tons per year in 2015. The on-road mobile source emissions
are estimated at 219,912 tons per year in 2002 and are expected to
decrease to 120,267 tons per year in 2015. In other words, emissions
from on-road transportation sources need not be capped for the
maintenance period because, based on the available data, it is
unreasonable to believe that emissions from such sources would increase
to a level that would threaten the air quality in this area for the
duration of this maintenance plan. Therefore, for the limited
maintenance plan CO maintenance area, all Federal actions that require
conformity determinations under the transportation conformity rule are
considered to satisfy the regional emissions analysis and ``budget
test'' requirements in 40 CFR 93.118 of the rule.
    Since limited maintenance plan areas are still maintenance areas,
however, transportation conformity determinations are still required
for transportation plans, programs and projects. Specifically, for such
determinations, transportation plans, transportation improvement
programs and projects must still demonstrate that they are fiscally
constrained (40 CFR part 108) and must meet the criteria for
consultation and Transportation Control Measure (TCM) implementation in
the conformity rule (40 CFR 93.112 and 40 CFR 93.113, respectively). In
addition, projects in limited maintenance areas will still be required
to meet the criteria for CO hot spot analyses to satisfy ``project
level'' conformity determinations (40 CFR 93.116 and 40 CFR 93.123)
which must incorporate the latest planning assumptions and models that
are available. All aspects of transportation conformity (with the
exception of satisfying the emissions budget test) will still be
required.
    If one of the carbon monoxide attainment areas monitors carbon
monoxide concentrations at or above the limited maintenance eligibility
criteria of 7.65 parts per million then that maintenance area would no
longer qualify for a limited maintenance plan and would revert to a
full maintenance plan. In this event, the limited maintenance plan
would remain applicable for conformity purposes only until the full
maintenance plan is submitted and EPA has found its motor vehicle
emissions budgets adequate for conformity purposes or EPA approves the
full maintenance plan SIP revision.

V. What Action Is EPA Taking Today?

    EPA is approving a SIP revision request submitted by the State of
Ohio. This SIP revision meets the requirement for a second 10 year
maintenance plan for Cuyahoga County, Ohio. The SIP revision
supplements the current approved CO maintenance plan and establishes a
limited maintenance plan with an unlimited budget for regional motor
vehicle emissions for the Cuyahoga County, Ohio CO maintenance area.
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the state plan in the event that
relevant adverse written comments are filed. This rule will be
effective July 31, 2006 without further notice unless we receive
relevant adverse written comments by July 31, 2006. If we receive such
comments, we will withdraw this action before the effective date by
publishing a subsequent document that will withdraw the final action.
All public comments received will then be addressed in a subsequent
final rule based on the proposed action. The EPA will not institute a
second comment period. Any parties interested in commenting on this
action should do so at this time. If we do not receive any comments,
this action will be effective July 31, 2006.

VI. Statutory and Executive Order Reviews

Executive Order 12866; Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget.

Executive Order 13211: Actions That Significantly Affect Energy Supply,
Distribution, or Use

    Because it is not a ``significant regulatory action'' under
Executive Order 12866 or a ``significant energy action,'' this action
is also not subject to Executive Order 13211, ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001).

Regulatory Flexibility Act

    This action merely approves state law as meeting Federal
requirements and imposes no additional requirements beyond those
imposed by state law. Accordingly, the Administrator certifies that
this rule will not have a significant economic impact on a substantial
number of small entities under the Regulatory Flexibility Act (5 U.S.C.
601 et seq.).

Unfunded Mandates Reform Act

    Because this rule approves pre-existing requirements under state
law and does not impose any additional enforceable duty beyond that
required by state law, it 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).

Executive Order 13175 Consultation and Coordination With Indian Tribal
Governments

    This rule also does not have tribal implications because it will
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, as specified by Executive Order 13175 (59
FR 22951, November 9, 2000).

Executive Order 13132 Federalism

    This action also does not have Federalism implications because it
does not have substantial direct effects 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, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). This action merely approves a state rule implementing a
Federal standard, and does not alter the relationship or the
distribution of power and responsibilities established in the Clean Air
Act.

Executive Order 13045 Protection of Children From Environmental Health
and Safety Risks

    This rule also is not subject to Executive Order 13045 ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), because it is not economically significant.

National Technology Transfer Advancement Act

    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
state to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply.

Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).

Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
section 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 31, 2006. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Intergovernmental relations.

    Dated: May 19, 2006.
Norman Niedergang,
Acting Regional Administrator, Region 5.

0
For the reasons stated in the preamble, part 52, chapter I, of title 40
of the Code of Federal Regulations is amended as follows:

PART 52--[AMENDED]

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

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

Subpart KK--Ohio

0
2. Section 52.1887 is amended by adding paragraph (e) to read as
follows:

Sec.  52.1887  Control strategy: Carbon monoxide.

* * * * *
    (e) Approval--On October 20, 2005, Ohio submitted a State
Implementation Plan (SIP) revision of the Cuyahoga County carbon
monoxide (CO) maintenance plan. The CO maintenance plan revision is an
update to the current approved maintenance plan and continues to
demonstrate maintenance of the CO National Ambient Air Quality Standard
(NAAQS) for an additional 10 years. The maintenance plan revision is
submitted as a limited maintenance plan for the Cuyahoga County, Ohio
carbon monoxide area and provides an unlimited motor vehicle emissions
budget as long as the ambient CO levels remain below the 7.65 parts per
million design value specified as the criterion for the limited
maintenance plan.

[FR Doc. 06-5013 Filed 5-31-06; 8:45 am]

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