[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Rules and Regulations]
[Pages 34850-34852]
[FR Doc No: 2017-15786]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2017-N-1916]

Medical Devices; Cardiovascular Devices; Classification of the
Balloon Aortic Valvuloplasty Catheter

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the balloon aortic valvuloplasty catheter into class II
(special controls). The special controls that will apply to the device
are identified in this order and will be part of the codified language
for the balloon aortic valvuloplasty catheter's classification. The
Agency is classifying the device into class II (special controls) to
provide a reasonable assurance of safety and effectiveness of the
device.

DATES: This order is effective July 27, 2017. The classification was
applicable on June 11, 2012.

FOR FURTHER INFORMATION CONTACT: Nicole Ibrahim, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1232, Silver Spring, MD, 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA

rulemaking process. These devices remain in class III and require
premarket approval unless and until the device is classified or
reclassified into class I or II, or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, also known as De Novo
classification, as amended by section 607 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144), provides
two procedures by which a person may request FDA to classify a device
under the criteria set forth in section 513(a)(1). Under the first
procedure, the person submits a premarket notification under section
510(k) of the FD&C Act for a device that has not previously been
classified and, within 30 days of receiving an order classifying the
device into class III under section 513(f)(1) of the FD&C Act, the
person requests a classification under section 513(f)(2). Under the
second procedure, rather than first submitting a premarket notification
under section 510(k) of the FD&C Act and then a request for
classification under the first procedure, the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence and requests a classification under section
513(f)(2) of the FD&C Act. If the person submits a request to classify
the device under this second procedure, FDA may decline to undertake
the classification request if FDA identifies a legally marketed device
that could provide a reasonable basis for review of substantial
equivalence with the device or if FDA determines that the device
submitted is not of ``low-moderate risk'' or that general controls
would be inadequate to control the risks and special controls to
mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device. In
accordance with section 513(f)(1) of the FD&C Act, FDA issued an order
on December 3, 2008, classifying the NuCLEUS-X Percutaneous
Transluminal Valvuloplasty Catheter into class III, because it was not
substantially equivalent to a device that was introduced or delivered
for introduction into interstate commerce for commercial distribution
before May 28, 1976, or a device which was subsequently reclassified
into class I or class II.
    On December 23, 2008, NuMED, Inc. submitted a request for
classification of the NuCLEUS-X Percutaneous Transluminal Valvuloplasty
Catheter under section 513(f)(2) of the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on June 11, 2012, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 870.1255.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a balloon
aortic valvuloplasty catheter will need to comply with the special
controls named in this final order. A De Novo classification decreases
regulatory burdens. When FDA classifies a device type as class I or II
via the De Novo pathway, other manufacturers do not have to submit a De
Novo request or premarket approval application to market the same type
of device, unless the device has a new intended use or technological
characteristics that raise different questions of safety or
effectiveness. Instead, manufacturers can use the less burdensome
pathway of 510(k), when necessary, to market their device, and the
device that was the subject of the original De Novo classification can
serve as a predicate device for additional 510(k)s from other
manufacturers.
    The device is assigned the generic name balloon aortic
valvuloplasty catheter, and it is identified as a catheter with a
balloon at the distal end of the shaft that is intended to treat
stenosis in the aortic valve when the balloon is expanded.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1:

                  Table 1--Balloon Aortic Valvuloplasty Catheter Risks and Mitigation Measures
----------------------------------------------------------------------------------------------------------------
              Identified risks                                       Mitigation measures
----------------------------------------------------------------------------------------------------------------
Adverse tissue reaction....................  Biocompatibility testing.
                                             Labeling.
Infection..................................  Sterility.
                                             Shelf life testing.
User error.................................  Labeling.
Valve leaflet perforation..................  Non-clinical performance evaluation.
                                             In Vivo evaluation.
                                             Labeling.
Perforation of vascular or cardiac tissue..  Non-clinical performance evaluation.
                                             In Vivo evaluation.
                                             Labeling.
Procedural complications, including          Non-clinical performance evaluation.
 bleeding, cardiac tamponade, calcium        In Vivo evaluation.
 embolic events, valvular regurgitation,     Labeling.
 and death.
Balloon burst..............................  Non-clinical performance evaluation.
                                             In Vivo evaluation.
                                             Labeling.

Inability for balloon deflation............  Non-clinical performance evaluation.
                                             In Vivo evaluation.
Increased balloon inflation and deflation    Non-clinical performance evaluation.
 times.                                      In Vivo evaluation.
                                             Labeling.
Inability to steer towards valve of          Non-clinical performance evaluation.
 interest.                                   In Vivo evaluation.
----------------------------------------------------------------------------------------------------------------

    FDA believes that special controls, in combination with the general
controls, address these risks to health and provide reasonable
assurance of safety and effectiveness.
    Balloon aortic valvuloplasty catheters are not safe for use except
under the supervision of a practitioner licensed by law to direct the
use of the device. As such, the device is a prescription device and
must satisfy prescription labeling requirements (see 21 CFR 801.109,
Prescription devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k), if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of the device. Therefore, this device type is not
exempt from premarket notification requirements. Persons who intend to
market this type of device must submit to FDA a premarket notification
(510(k)), prior to marketing the device, which contains information
about the balloon aortic valvuloplasty catheter they intend to market.

II. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. 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. 3501-3520). The collections of information in
part 807, subpart E, regarding premarket notification submissions, have
been approved under OMB control number 0910-0120, and the collections
of information in 21 CFR part 801, regarding labeling have been
approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for part 870 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  870.1255 to subpart B to read as follows:

Sec.  870.1255   Balloon aortic valvuloplasty catheter.

    (a) Identification. A balloon aortic valvuloplasty catheter is a
catheter with a balloon at the distal end of the shaft, which is
intended to treat stenosis in the aortic valve when the balloon is
expanded.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The device must be demonstrated to be biocompatible.
    (2) Sterility and shelf life testing must demonstrate the sterility
of patient-contacting components and the shelf life of these
components.
    (3) Non-clinical performance evaluation must demonstrate that the
device performs as intended under anticipated conditions of use,
including device delivery, inflation, deflation, and removal.
    (4) In vivo evaluation of the device must demonstrate device
performance, including the ability of the device to treat aortic
stenosis.
    (5) Labeling must include a detailed summary of the device-related
and procedure-related complications pertinent to the use of the device.

    Dated: July 21, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15786 Filed 7-26-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Proposed Rules]
[Pages 16981-16987]
[FR Doc No: 2012-6911]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 51

[EPA-HQ-OAR-2007-0089; FRL-9650-9]
RIN 2060-AO17

Air Quality: Revision to Definition of Volatile Organic
Compounds--Exclusion of a Group of Four Hydrofluoropolyethers (HFPEs)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The EPA is proposing to revise the agency's definition of
volatile organic compounds (VOCs) for purposes of preparing State
Implementation Plans (SIPs) to attain the national ambient air quality
standard (NAAQS) for ozone under Title I of the Clean Air Act (CAA).
This proposed revision would add four chemical compounds to the list of
compounds excluded from the definition of VOC on the basis that each of
these compounds makes a negligible contribution to tropospheric ozone
formation. These compounds consist of four hydrofluoropolyethers
(HFPEs) which are identified as HCF2OCF2H (also
known as HFE-134), HCF2OCF2OCF2H (also
known as HFE-236cal2),
HCF2OCF2CF2OCF2H (also
known as HFE-338pcc13), and

HCF2OCF2OCF2CF2OCF2
H (also known as H-Galden 1040X or H-Galden ZT 130 (or 150 or 180)). In
addition, the EPA is proposing to make certain technical corrections to
the current list of exempt compounds at 40 CFR 51.100(s)(1).

DATES: Comments must be received on or before April 23, 2012. Public
Hearing: If anyone contacts us requesting us to hold a public hearing
by April 9, 2012, we will hold a public hearing.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2007-0089, by one of the following methods:
     www.regulations.gov. Follow the on-line instructions for
submitting comments.
     Email: Comments may be sent by electronic mail (email) to
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-OAR-2007-0089.
     Fax: Fax your comments to:<PHONE_NUMBER>, Attention Docket
ID No. EPA-HQ-OAR-2007-0089.
     Mail: Send your comments to: Air and Radiation Docket and
Information Center, U.S. Environmental Protection Agency, Mail Code:
2822T, 1301 Constitution Ave. NW., Washington, DC 20460, Attention
Docket ID No. EPA-HQ-OAR-2007-0089.
     Hand Delivery: U.S. Environmental Protection Agency, EPA
West (Air Docket), 1301 Constitution Avenue NW., Room 3334, Washington,
DC 20004. Attention: Docket ID No. EPA-HQ-OAR-2007-0089. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2007-0089. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at 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 as CBI or otherwise protected information through
www.regulations.gov, or email. The www.regulations.gov Web site is an
``anonymous access'' system, which means that the EPA will not know
your identity or contact information unless you provide it in the body
of your comment. If you send an email comment directly to the EPA
without going through www.regulations.gov, your email 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, the 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 the EPA cannot read your comment due
to technical difficulties and cannot contact you for clarification, the
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 http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Office of Air and
Radiation Docket and Information Center, EPA West, Room 3334, 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 legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the Office of Air and Radiation
Docket and Information Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: David Sanders, Office of Air Quality
Planning and Standards, Air Quality Policy Division, State and Local
Programs Group, Mail Code (C539-01), Environmental Protection Agency,
Research Triangle Park, NC 27711; telephone<PHONE_NUMBER> or fax (919)
541-0824; and email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    Entities potentially affected by this proposed rule include, but
are not necessarily limited to, states (typically state air pollution
control agencies) that control VOCs, and industries listed in the
following table involved in the manufacture or use of fire suppressants
and specialized refrigerants in secondary loop refrigeration systems
for heat transfer.
    This proposed rule is applicable to all manufacturers,
distributors, and users of these chemical compounds.

------------------------------------------------------------------------
           Industry group                  SIC \a\          NAICS \b\
------------------------------------------------------------------------
Fire Suppression....................              2899    325998, 423990
Refrigerants........................        2869, 3585    238220, 336111
------------------------------------------------------------------------
\a\ Standard Industrial Classification.
\b\ North American Industry Classification System.

B. What should I consider as I prepare my comments for the EPA?

    Submitting CBI: Do not submit this information to the EPA through
www.regulations.gov or email. 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 the 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.

C. How can I find information about a possible public hearing?

    To request a public hearing or information pertaining to a public
hearing on this document, contact Ms. Pamela S. Long, Air Quality
Policy Division, Mail code C504-01, U.S. Environmental Protection
Agency, Research Triangle Park, NC 27711, telephone<PHONE_NUMBER>,
facsimile number<PHONE_NUMBER>, electronic email address:
<EMAIL_ADDRESS>

D. How is this preamble organized?

    The information presented in this preamble is organized as follows:

I. General Information
    A. Does this action apply to me?
    B. What should I consider as I prepare my comments for the EPA?
    C. How can I find information about a possible public hearing?
    D. How is this preamble organized?
II. Background
    A. VOC Exemptions
    B. Petitioned Compounds to List as Negligibly Reactive:
HCF2OCF2H (HFE 134),
HCF2OCF2OCF2H (HFE-236cal2),
HCF2OCF2CF2OCF2H (HFE-
338pcc13), and
HCF2OCF2OCF2CF2OCF2
H (H-Galden 1040X and H-Galden ZT 130 (or 150 or 180))
III. The EPA Response to the Petition
    A. Contribution to Tropospheric Ozone
    B. Likelihood of Risk to Human Health or the Environment
    C. Conclusion
IV. Proposed Action
V. Statutory and Executive Orders Reviews
    A. Executive Order 12866: Regulatory Planning and Executive
Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations

II. Background

A. VOC Exemptions

    Tropospheric ozone, commonly known as smog, is formed when VOCs and
nitrogen oxides (NOX) react in the atmosphere in the
presence of sunlight. Because of the harmful health effects of ozone,
the EPA and state governments limit the amount of VOCs that can be
released into the atmosphere. VOCs are those organic compounds of
carbon which form ozone through atmospheric photochemical reactions.
Different VOCs have different levels of reactivity--that is, they do
not react to form ozone at the same speed or do not form ozone to the
same extent. Some VOCs react slowly, or form less ozone; therefore,
changes in their emissions have limited effects on local or regional
ozone pollution episodes. It has been the EPA's policy that organic
compounds with a negligible level of reactivity should be excluded from
the regulatory definition of VOC so as to focus VOC control efforts on
compounds that do significantly increase ozone concentrations. The EPA
also believes that exempting such compounds creates an incentive for
industry to use negligibly reactive compounds in place of more highly
reactive compounds that are regulated as VOCs. The EPA lists these
negligibly reactive compounds in its regulations (at 40 CFR 51.100(s))
and excludes them from the definition of VOC.
    The CAA requires the regulation of VOCs for various purposes.
Section 302(s) of the CAA specifies that the EPA has the authority to
define what this term means, and hence what compounds shall be treated
as VOCs for regulatory purposes. The policy of excluding negligibly
reactive compounds from the VOC definition was first set forth in the
``Recommended Policy on Control of Volatile Organic Compounds'' (42 FR
35314, July 8, 1977) and was supplemented most recently with the
``Interim Guidance on Control of Volatile Organic Compounds in Ozone
State Implementation Plans'' (Interim Guidance) (70 FR 54046, September
13, 2005). The EPA uses the reactivity of ethane as the threshold for
determining whether a compound has negligible reactivity. Compounds
that are less reactive than, or equally reactive to, ethane under
certain assumed conditions may be deemed negligibly reactive and
therefore suitable for exemption from the regulatory definition of VOC.
Compounds that are more reactive than ethane continue to be considered
VOCs for regulatory purposes and therefore subject to control
requirements. The selection of ethane as the threshold compound was
based on a series of smog chamber experiments that underlay the 1977
policy.
    The EPA has used three different metrics to compare the reactivity
of a specific compound to that of ethane: (i) The reaction rate
constant (known as kOH) with the hydroxyl radical (OH); (ii)
the maximum incremental reactivities (MIR) of ethane and the compound
in question expressed on a reactivity per mass basis; and (iii) the MIR
of ethane and the compound in question expressed on a reactivity per
mole basis. Differences between these three metrics are discussed
below.
    The kOH is the reaction rate constant of the compound
with the OH radical in the air. This reaction is typically the first
step in a series of chemical reactions by which a compound breaks down
in the air and participates in the ozone-forming process. If this step
is slow, the compound will likely not form ozone at a very fast rate.
The kOH values have long been used by the EPA as a measure
of photochemical reactivity and ozone-forming activity, and they have
been the basis for most of the EPA's previous exclusions of negligibly
reactive compounds. The kOH metric is inherently a molar
comparison, i.e., it measures the rate at which molecules react.
    The MIR values, both by mole and by mass, are a more recently
developed measure of photochemical reactivity derived from a computer-
based photochemical model. This measurement considers the complete
ozone forming activity of a compound, not merely the first reaction
step. Further explanation of the MIR metric can be found in: W. P. L.
Carter, ``Development of Ozone Reactivity Scales for Volatile Organic
Compositions,'' Journal of the Air & Waste Management Association, Vol.
44, 881-899, July 1994.
    The MIR values for compounds are typically expressed as grams of
ozone formed per gram of VOC (mass basis), but may also be expressed as
grams of ozone formed per mole of VOC (molar basis). For comparing the
reactivities of two compounds, using the molar MIR values considers an
equal number of molecules of the two compounds. Alternatively, using
the mass MIR values compares an equal mass of the two compounds, which
will involve different numbers of molecules, depending on the relative
molecular weights. The molar MIR comparison is consistent with the
original smog chamber experiments that underlie the original selection
of ethane as the threshold compound and compared equal molar
concentrations of individual VOCs. It is also consistent with previous
reactivity determinations based on inherently molar kOH
values. By contrast, the mass MIR comparison is more consistent with
how MIR values and other reactivity metrics have been applied in
reactivity-based emission limits, such as the national VOC emissions
standards for aerosol coatings (73 FR 15604). Many other VOC
regulations contain limits based upon a weight of VOC per volume of
product, such as the EPA's regulations for limiting VOC emissions from
architectural and industrial maintenance coatings (65 FR 7736).
However, the fact that regulations are structured to measure VOC
content by weight for ease of implementation and enforcement does not
necessarily control whether VOC exemption

decisions should be made on a weight basis as well.
    The choice of the molar basis versus the mass basis for the ethane
comparison can be significant. Given the relatively low molecular
weight of ethane, use of the mass basis tends to result in more VOCs
being classified as ``negligibly reactive'' than in the case of the
molar basis. In some cases, a compound might be considered less
reactive than ethane and eligible for VOC exemption under the mass
basis but not under the molar basis.
    In this proposed action, the EPA relies on the kOH
metric because of the availability of relevant data. No reported
calculations of MIR values on a molar or mass basis were found for
these compounds. Thus, the EPA relies on the kOH metric.
    The EPA's 2005 Interim Guidance also notes that concerns have
sometimes been raised about the potential impact of a VOC exemption on
environmental endpoints other than ozone concentrations, including fine
particle formation, air toxics exposures, stratospheric ozone
depletion, and climate change. The EPA has recognized, however, that
there are existing regulatory and non-regulatory programs that are
specifically designed to address these issues, and the agency continues
to believe that the impacts of VOC exemptions on environmental
endpoints other than ozone formation will be adequately addressed by
these programs. The VOC exemption policy is intended to facilitate
attainment of the ozone NAAQS, and questions have been raised as to
whether the agency has authority to use its VOC policy to address
concerns that are unrelated to ground-level ozone. Thus, in general,
VOC exemption decisions will continue to be based solely on
consideration of a compound's contribution to ozone formation. However,
if the agency determines that a particular VOC exemption is likely to
result in a significant increase in the use of a compound and that the
increased use would pose a significant risk to human health or the
environment that would not be addressed adequately by existing programs
or policies, the EPA reserves the right to exercise its judgment in
deciding whether to grant an exemption.
    In this case, the agency has examined available information on the
risks to human health and the environment and applicability of other
regulatory programs; that information for the four compounds considered
here is discussed further in Section III.

B. Petitioned Compounds To List as Negligibly Reactive:
HCF2OCF2H (HFE 134),
HCF2OCF2OCF2H (HFE-236cal2),
HCF2OCF2CF2OCF2H (HFE-
338pcc13), and
HCF2OCF2OCF2CF2OCF2
H (H-Galden 1040X and H-Galden ZT 130 (or 150 or 180))

    On February 10, 2005, Solvay Solexis, Incorporated submitted to the
EPA a petition requesting that four compounds in the family of products
known by the trade name H-Galden be added to the list of compounds that
are considered to be negligibly reactive in the definition of VOC at 40
CFR 51.100(s). These four compounds--HCF2OCF2H
(HFE-134), HCF2OCF2OCF2H (HFE-
236cal2), HCF2OCF2CF2OCF2H
(HFE-338pcc13), and
HCF2OCF2OCF2CF2OCF2
H (H-Galden 1040X and H-Galden ZT 130 (or 150 or 180))--can be used in
some heat transfer applications (as refrigerants) and as fire
suppressants.
    In both the refrigeration and fire suppressant end uses, these
HFPEs would be used as substitutes for ozone-depleting substances (ODS)
and thus have either undergone or would need to undergo review by the
EPA's Significant New Alternatives Policy (SNAP) Program. The SNAP
Program is EPA's program to evaluate and regulate substitutes for the
ozone-depleting chemicals that are being phased out under the
stratospheric ozone protection provisions of the CAA. In Section 612(c)
of the CAA, the agency is authorized to identify and publish lists of
acceptable and unacceptable substitutes for class I or class II ozone-
depleting substances.\1\ The EPA's SNAP program has evaluated the use
of H-Galden HFPEs and found acceptable their use as fire suppressants
in non-residential applications, in place of Halon 1211 (68 FR 4004,
January 27, 2003). However, the SNAP program has not approved H-Galden
HFPEs for certain other uses (i.e., solvent, aerosol propellant, foam
blowing, and refrigeration). There currently is no submission pending
review to list these substances as substitutes in other uses. Thus, at
this time, it would be a violation of the CAA and the SNAP program
regulations for any person to introduce H-Galden HFPEs into interstate
commerce for use in other end uses regulated by the SNAP program. H-
Galden HFPEs may be used in non-mechanical heat transfer as a secondary
refrigerant in secondary-loop refrigeration systems without approval
from SNAP; the EPA does not list, and does not currently require
notification for, compounds that are used only as a secondary fluid in
secondary-loop refrigeration systems (62 FR 10702; March 10, 1997).
---------------------------------------------------------------------------

    \1\ Information on the SNAP program can be found on the
following Web page: www.epa.gov/ozone/snap.
---------------------------------------------------------------------------

    With respect to the photochemical reactivity of the H-Galden
compounds, Solvay Solexis, Incorporated provided information on the
photochemical reactivity of its chemical compounds as measured by each
compound's kOH rate constant. Measurements of the reaction
rate of HCF2OCF2H (HFE-134) with OH have been
estimated at 298 K to be 2.9x10-15 (cm\3\/molecule-sec).
This rate constant is highly temperature dependent and decreases at
lower temperatures. The calculated reaction rates for the three
additional HFPEs submitted by Solvay Solexis are 2.4x10-15
(cm\3\/molecule-sec) for HFE-236cal2, 4.7x10-15 (cm\3\/molecule-sec)
for HFE-338pcc13, and 4.9x10-15 (cm\3\/molecule-sec) for H-
Galden 1040X. The kOH values for these four HFPEs are
significantly lower than the reaction rate for ethane which has a
kOH value of 2.4x10-13 (cm\3\/molecule-sec) at
298 K.
    The scientific information that the petitioner submitted in support
of the petition has been added to the docket for this rulemaking. This
docketed information includes journal articles where the rate constant
values can be found. Solvay Solexis, Incorporated submitted the
following articles in support of its petition: (1) ``Tropospheric
Degradation Products of Novel Hydrofluoropolyethers,'' Tuazon,
Environmental Science & Technology, University of California,
Riverside, May 1997; (2) ``Hydrofluoropolyethers,'' Marchionni,
Silvani, Fontana, Malinverno, Visca, Journal of Fluorine Chemistry,
Ausimont SpA, R & D Centre, 1999; and (3) ``Toxicological Profile of
Hydrofluoropolyethers,'' Malinverno, Colombo, Visca, Regulatory
Toxicology and Pharmacology, December, 2004.
    Information in the Solvay Solexis, Incorporated petition and its
reference material indicates that the four HFPEs have low acute
toxicity, no irritation or skin sensitization, and no detectable
genotoxic activity in vitro or in vivo. The HFPEs show a similarly low
potential for developmental toxicity. This toxicity information has
been placed in the docket for this rulemaking.

III. The EPA Response to the Petition

    Consistent with the Interim Guidance, the EPA's proposed response
to the petition is based on a consideration of the contribution that
each chemical makes to tropospheric ozone formation based on a
comparison of reactivity metrics, and our assessment that existing
programs or policies already adequately address the possibility that

granting the petition would pose a significant risk to human health or
the environment. Information on these topics is given below.

A. Contribution to Tropospheric Ozone

    Table 1 summarizes the information provided by the petitioner
regarding the photochemical reactivity of the compounds under
consideration. The data submitted by the petitioner support the
contention that the reactivity of these compounds, with respect to
reaction with the OH radical in the atmosphere, is lower than that of
ethane.

           Table 1--Summary of Reaction Rates With OH (kOH) Reaction Rate Constant Compared to Ethane
----------------------------------------------------------------------------------------------------------------
                                                                                kOH (cm\3\/        kOH ratio
          Chemical formula                CAS No.               Name           (molecule-sec))     relative to
                                                                                \1\             ethane
----------------------------------------------------------------------------------------------------------------
C2H6...............................           74-84-0  ethane...............         2.4x10-13              1.00
HCF2OCF2H..........................         1691-17-4  HFE-134..............         2.3x10-15              0.01
HCF2OCF2OCF2H......................        78522-47-1  HFE-236ca12..........         2.4x10-15              0.01
HCF2OCF2CF2OCF2H...................       188690-78-0  HFE-338pcc13.........         4.7x10-15              0.02
HCF2OCF2OCF2CF2OCF2H...............       188690-77-9  H-Galden 1040X.......         4.9x10-15              0.02
----------------------------------------------------------------------------------------------------------------
Note: \1\ K Tokuhashi et al., Journal of Physical Chemistry A, 104, 1165 (2000).

B. Likelihood of Risk to Human Health or the Environment

    Additionally, we examined and present available information on the
likelihood of risk to human health or the environment from increased
use of the chemicals considered here. We believe that current
regulation of these compounds under other EPA programs adequately
protects human health and the environment.
    The EPA's SNAP program has reviewed the potential impacts of the H-
Galden HFPEs on human health and the environment, including
stratospheric ozone depletion and global warming potential (GWP). From
a human health standpoint, use of HFPEs as a streaming agent fire
suppressant in non-residential applications does not pose a significant
risk as compared to other available substitutes with the same end use.
Because HFPEs do not contain chlorine or bromine, these compounds do
not contribute to the depletion of the ozone layer and have ozone
depletion potential values of zero. These HFPEs have significant GWPs,
comparable to those for hydrofluorocarbons also used as fire
suppressants. The SNAP program listed H-Galden HFPEs as acceptable
substitutes for Halon 1211 subject to narrowed use limits (for use only
in non-residential applications) because they reduce overall risk to
human health and the environment in the listed end use and application
(68 FR 4004, January 27, 2003).
    Table 2 shows the 20 and 100 year GWPs of these four compounds
relative to carbon dioxide (CO2) as reported by the
Intergovernmental Panel on Climate Change. These GWP-100 levels are
comparable to mid-range levels associated with some chemical compounds
that have previously been exempted from the VOC definition, which range
from 23 to 12,000. We invite the public to submit comments and
additional information relevant to this issue and whether such
information should be considered in connection with the decision to
grant an exemption from the regulatory definition of VOC.

Table 2--Summary of Global Warming Potentials Relative to CO2 Over 20 and 100 Years for the Four Compounds Being
                                          Considered for VOC Exemptions
----------------------------------------------------------------------------------------------------------------
                                                                               GWP relative to
          Chemical formula                CAS No.               Name           CO2  (20 years)   GWP relative to
                                                                                \1\        CO2  (100 years)
----------------------------------------------------------------------------------------------------------------
HCF2OCF2H..........................         1691-17-4  HFE-134..............             12200              6320
HCF2OCF2OCF2H......................        78522-47-1  HFE-236ca12..........              8000              2800
HCF2OCF2CF2OCF2H...................       188690-78-0  HFE-338pcc13.........              5100              1500
HCF2OCF2OCF2CF2OCF2H...............       188690-77-9  H-Galden 1040X.......              6320              1870
CO2................................          124-38-9  Carbon dioxide.......                 1                 1
----------------------------------------------------------------------------------------------------------------
Note: \1\ Forster, P., V. Ramaswamy, P. Artaxo, T. Berntsen, R. Betts, D.W. Fahey, J. Haywood, J. Lean, DC Lowe,
  G. Myhre, J. Nganga, R. Prinn, G. Raga, M. Schulz and R. Van Dorland, 2007: Changes in Atmospheric
  Constituents and in Radiative Forcing. In: Climate Change 2007: The Physical Science Basis. Contribution of
  Working Group I to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change [Solomon, S.,
  D. Qin, M. Manning, Z. Chen, M. Marquis, K.B. Averyt, M. Tignor and H.L. Miller (eds.)]. Cambridge University
  Press, Cambridge, United Kingdom and New York, NY, USA.

C. Conclusion

    In summary, for all four compounds, the EPA believes that (a) these
chemicals qualify as negligibly reactive with respect to their
contribution to tropospheric ozone formation, and (b) any non-
tropospheric ozone-related risks associated with potential increased
use are adequately addressed by other existing programs and policies.
We invite the public to submit comments and additional information
relevant to the issue of these compounds' overall risks and benefits to
human health and the environment, and on whether such information
should be considered in connection with the decision to grant an
exemption from the regulatory definition of VOC.

IV. Proposed Action

    The EPA hereby proposes to amend its definition of VOC at 40 CFR
51.100(s) to exclude a group of four HFPE's identified as
HCF2OCF2H (known as HFE-134),
HCF2OCF2OCF2H (known as HFE-236cal2),
HCF2OCF2CF2OCF2H (known as
HFE-338pcc13), and
HCF2OCF2OCF2CF2OCF2
H (known as H-Galden 1040X and also H-Galden ZT 130 (or 150 or 180)) as
VOCs for ozone SIP and ozone control purposes. If an entity uses or
produces any of these four HFPE compounds and is subject to the

EPA regulations limiting the use of VOC in a product, limiting the VOC
emissions from a facility, or otherwise controlling the use of VOC for
purposes related to attaining the ozone NAAQS, then the compound will
not be counted as a VOC in determining whether these regulatory
obligations have been met. This action may also affect whether any of
these four HFPE compounds are considered as VOCs for state regulatory
purposes to reduce ozone formation, if a state relies on the EPA's
definition of VOC. States are not obligated to exclude from control as
a VOC those compounds that the EPA has found to be negligibly reactive.
However, if this action is made final, states may not take credit for
controlling these compounds in their ozone control strategies.
    The EPA is also proposing to make certain technical corrections to
the current list of exempt compounds at 40 CFR 51.100(s)(1) by
replacing several commas separating individual compounds with
semicolons and by removing the erroneous ``(1)'' notation in ``(1)
1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-trifluoromethyl-pentane
(HFE-7300)'' so that it reads ``1,1,1,2,2,3,4,5,5,5-decafluoro-3-
methoxy-4-trifluoromethyl-pentane (HFE-7300)''.

V. Statutory and Executive Order Reviews

A. Executive Orders 12866: Regulatory Planning and Executive Order
13563: Improving Regulation and Regulatory Review

    Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993),
this action is a ``significant regulatory action'' because it raises
novel legal or policy issues arising out of legal mandates.
Accordingly, the EPA submitted this action to the Office of Management
and Budget (OMB) for review under Executive Orders 12866 and 13563 (76
FR 3821, January 21, 2011) and any changes made in response to OMB
recommendations have been documented in the docket for this action.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320.3(b). It does not contain any
recordkeeping or reporting requirement.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
proposed rule will not have a significant economic impact on a
substantial number of small entities. Small entities include small
businesses, small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of this proposed rule on
small entities, small entity is defined as: (1) A small business that
is a small industrial entity as defined in the U.S. Small Business
Administration (SBA) size standards. (See 13 CFR 121.); (2) A
governmental jurisdiction that is a government of a city, county, town,
school district, or special district with a population of less than
50,000; and (3) A small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field.
    After considering the economic impacts of this proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This
proposed rule will not impose any requirements on small entities.
    We continue to be interested in the potential impacts of the
proposed rule on small entities and welcome comments on issues related
to such impacts.

D. Unfunded Mandates Reform Act

    This action contains no federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for state, local, or tribal governments or the private
sector. The action imposes no enforceable duty on any state, local or
tribal governments or the private sector. Therefore, this action is not
subject to the requirements of sections 202 and 205 of the UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will 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. This proposed action addresses the
exemption of a set of chemical compounds from the VOC definition. Thus,
Executive Order 13132 does not apply to this rule. In the spirit of
Executive Order 13132, and consistent with the EPA policy to promote
communications between the EPA and state and local governments, the EPA
specifically solicits comment on this proposed rule from state and
local officials.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have
substantial direct effects on tribal governments, 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 in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule. In the spirit
of Executive Order 13175, and consistent with the EPA policy to promote
communications between the EPA and Tribal governments, the EPA
specifically solicits additional comment on this proposed rule from
tribal officials.

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

    This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not economically significant as defined
in EO 12866. While this proposed rule is not subject to the Executive
Order, the EPA has reason to believe that ozone has a disproportionate
effect on active children who play outdoors (62 FR 38856-38859, July
18, 1997). The EPA has not identified any specific studies on whether
or to what extent the chemical compound may affect children's health.
The EPA has placed the available data regarding the health effects of
this chemical compound in Docket No. EPA-HQ-OAR-2007-0089.
    The public is invited to submit comments or identify peer-reviewed
studies and data, of which the EPA may not be aware, that assess
results of early life exposure to the chemical compounds herein.

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

    This proposed rule is not a ``significant energy action'' as
defined in Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May

22, 2001) because it is not likely to have a significant adverse effect
on the supply, distribution, or use of energy. This action proposes to
revise the EPA's definition of VOCs for purposes of preparing SIPs to
attain the NAAQS for ozone under title I of the CAA.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer Advancement Act
of 1995 (``NTTAA''), Public Law 104-113, section 12(d), (15 U.S.C. 272
note) directs the EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs the
EPA to provide Congress, through OMB, with explanations when the agency
decides not to use available and applicable voluntary consensus
standards.
    This proposed rulemaking does not involve technical standards.
Therefore, the EPA is not considering the use of any voluntary
consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, Feb. 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    The EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it will not
affect the level of protection provided to human health or the
environment.

List of Subjects in 40 CFR Part 51

    Environmental protection, Administrative practice and procedure,
Air pollution control, Ozone, Reporting and recordkeeping requirements,
Volatile organic compounds.

    Dated: March 15, 2012.
Lisa P. Jackson,
Administrator.

    For reasons set forth in the preamble, part 51 of chapter I of
title 40 of the Code of Federal Regulations is proposed to be amended
as follows:

PART 51--REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF
IMPLEMENTATION PLANS

    1. The authority citation for part 51 continues to read as follows:

    Authority: 23 U.S.C. 101; 42 U.S.C. 7401-7671q.

Sec.  51.100  [Amended]

    2. In Sec.  51.100 in paragraph (s)(1) introductory text, remove
the words ``methyl acetate, 1,1,1,2,2,3,3-heptafluoro-3-methoxy-propane
(n-C3F7OCH3, HFE-7000), 3-ethoxy- 1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-
2- (trifluoromethyl) hexane (HFE-7500), 1,1,1,2,3,3,3-
heptafluoropropane (HFC 227ea), methyl formate (HCOOCH3), (1)
1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy- 4-trifluoromethyl-pentane
(HFE-7300); propylene carbonate; dimethyl carbonate; and
perfluorocarbon compounds which fall into these classes:'' and add in
their place the words ``methyl acetate; 1,1,1,2,2,3,3-heptafluoro-3-
methoxy-propane (n-C3F7OCH3, HFE-7000); 3-ethoxy-
1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-(trifluoromethyl) hexane (HFE-
7500); 1,1,1,2,3,3,3-heptafluoropropane (HFC 227ea); methyl formate
(HCOOCH3); 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy- 4-trifluoromethyl-
pentane (HFE-7300); propylene carbonate; dimethyl carbonate;
HCF2OCF2H (HFE134);
HCF2OCF2OCF2H (HFE-236cal2);
HCF2OCF2CF2OCF2H (HFE-
338pcc13);
HCF2OCF2OCF2CF2OCF2
H (H-Galden 1040x or H-Galden ZT 130 (or 150 or 180)); and
perfluorocarbon compounds which fall into these classes:''

[FR Doc. 2012-6911 Filed 3-22-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 195 (Wednesday, October 11, 2017)]
[Notices]
[Pages 47288-47289]
[FR Doc No: 2017-21880]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice Suspending Implementation of the Environmental Impact
Statement and Record of Decision for the Philadelphia International
Airport Capacity Enhancement Program

AGENCY: Federal Aviation Administration (FAA) DOT.

ACTION: Suspending implementation of the Environmental Impact Statement
(EIS) and Record of Decision (ROD) for the Philadelphia International
Airport (PHL) Capacity Enhancement Program (CEP).

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

SUMMARY: The FAA is suspending further implementation of the December
2010 ROD for the Philadelphia International Airport (PHL) CEP. Due to
unforeseen changes in operations at PHL, several of the airfield
capacity enhancing components identified in the CEP ROD are not needed
at this time. When the CEP ROD was issued, operations at PHL were
forecasted to reach 555,112 in 2016 and 699,799 in 2025. PHL was
consistently ranked as one of the most delayed airports in the nation.
Delays at PHL contributed to delays throughout the region and across
the nation and were resulting in substantial costs in time and money
for passengers and airlines. However, unforeseen changes in the
aviation industry and aircraft activity have resulted in considerably
less activity at PHL. Actual operations at PHL in 2016 were 394,022,
nearly thirty percent lower than originally forecasted. PHL is no
longer experiencing severe congestion or significant delays. Over
recent years, there has been no indication or reason to believe that
forecasted operations and associated delays at PHL will reach the level
experienced at the time FAA approved the CEP ROD. Since there is no
longer

a foreseeable need for additional capacity at PHL, the airport sponsor,
the City of Philadelphia, has elected to postpone several of the major
components of CEP, including construction of the new southern runway
and the extension of Runway 8/26. In support of this decision, the FAA
is suspending the ROD for the PHL CEP. Projects currently underway will
continue to completion. As circumstances change and new projects are
proposed, environmental analyses for those projects will be conducted
in accordance with the National Environmental Policy Act (NEPA).

DATES: Applicable upon publication in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Susan L. McDonald, Environmental
Protection Specialist, Federal Aviation Administration, Harrisburg
Airports District Office, 3905 Hartzdale Drive, Suite 508, Harrisburg,
PA 17011.

SUPPLEMENTARY INFORMATION: In 2003, the City of Philadelphia, the
airport sponsor, who owns and operates PHL, asked FAA to consider ways
to accommodate existing and forecasted aviation demands. PHL was one of
the airports contributing to delays throughout the national airspace
system, with delays approaching 20 minutes per average annual
operation. Operations (aircraft takeoffs and landings) at PHL were
increasing and forecasted to reach 555,112 in 2016 and 699,799 in 2025.
Delays at PHL were attributed to airfield configuration deficiencies
and operational constraints; particularly in poor weather conditions.
The purpose of the CEP was to enhance airport capacity in order to
accommodate current and future aviation demand in the Philadelphia
Metropolitan Area during all weather conditions. The FAA signed the ROD
for the CEP on December 30, 2010.
    The CEP was designed to provide PHL with five runways connected by
a redesigned and more efficient taxiway system. Under CEP, Runway 17/35
would remain as a 6,500-foot-long crosswind runway. Runway 8/26 would
be extended 2,000 feet to the east, for a total length of 7,000 feet
with an Engineered Materials Arresting System (EMAS) constructed at the
east end of the runway. Runway 9L/27R would remain at its current
length (9,500 feet) and location. Runway 9R/27L would be extended to
the east by 1,500 feet, to a total length of 12,000 feet, and would be
renamed Runway 9C/27C. A new 9,103-foot-long runway, Runway 9R/27L,
would be constructed 1,600 feet south of Runway 9C/27C (existing 9R/
27L). All existing navigational aids would be relocated as necessary,
or new navigational aids installed as required to meet the approach
criteria for the particular runway end. The CEP included upgrades and
reconfigurations to the existing terminal complex, and the addition of
a new commuter terminal east of Runway 17/35. An automated people mover
(APM) was to be constructed to transport passengers between terminals
and parking facilities. The CEP would also have required the relocation
or expansion of many of the other airport facilities, including cargo,
general aviation (corporate), maintenance, fuel, training facilities,
and deicing facilities. The FAA's Air Traffic Control Tower (ATCT) was
also to be relocated. In order to accommodate the CEP, several off-
airport facilities and properties needed to be acquired or, in some
cases, relocated.
    The City of Philadelphia has actively worked to implement the
various components of the CEP since 2010. To date, the City has
acquired several parcels of land, constructed taxiway improvements, and
begun work on extending Runway 9R/27L. During this period, changes in
both the aviation industry and aviation activity have resulted in
reductions in the number of operations at PHL. Although enplanements at
PHL have remained steady, the number of aircraft takeoffs and landings
has decreased. In 2016, annual operations at PHL were 394,022; nearly
30 percent lower than forecasted. This decrease in operations is
attributed to airlines using larger planes that can seat more
passengers, general aviation activity shifting to other regional
airports, and consolidations within the airline industry, such as the
merger of US Airways and American Airlines. This unforeseen drop in
operations has resulted in the airport sponsor realigning its capital
improvement program to address more immediate needs at the airport, and
indefinitely deferring the construction of the southern runway and the
Runway 8/26 extension. For these reasons, implementation of the ROD for
the PHL CEP is being suspended. Projects currently underway at PHL will
continue to completion. As circumstances change and new projects are
proposed, environmental analyses for the projects will be conducted in
accordance with NEPA.

FOR FURTHER INFORMATION CONTACT: Susan McDonald, Environmental
Protection Specialist, Federal Aviation Administration, Harrisburg
Airports District Office, 3905 Hartzdale Drive, Suite 508, Camp Hill,
PA 17011, Telephone<PHONE_NUMBER>.

    Issued in Camp Hill, Pennsylvania, October 3, 2017.
Lori Pagnanelli,
Manager, Harrisburg Airports District Office.
[FR Doc. 2017-21880 Filed 10-10-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 139 (Thursday, July 21, 2022)]
[Notices]
[Page 43595]
[FR Doc No: 2022-15524]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Termination of the Preparation of an Air Tour Management Plan at
Everglades National Park, Florida

AGENCY: Federal Aviation Administration.

ACTION: Notice of Termination of the Preparation of Air Tour Management
Plan.

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

SUMMARY: The Federal Aviation Administration (FAA), in cooperation with
the National Park Service (NPS) (together, the agencies), announces
that it has discontinued its preparation of the Air Tour Management
Plan (ATMP) for commercial air tour operations over Everglades National
Park in Florida because the sole air tour operator with interim
operating authority (IOA) for the park voluntarily surrendered its Part
135 operating certificate and is no longer authorized to conduct tours
over the park. In addition, the voluntary agreements between the
operator and the agencies for Biscayne National Park and Big Cypress
National Preserve have been terminated and the operator will be deleted
from the FAA's records of authorized commercial air tour operators.

FOR FURTHER INFORMATION CONTACT: Keith Lusk, Program Manager, AWP-1SP,
Federal Aviation Administration, Western-Pacific Region, 777 South
Aviation Boulevard, Suite 150, El Segundo, California 90245. Telephone:
(424) 405-7017.

SUPPLEMENTARY INFORMATION: In a September 3, 2020 Federal Register
notice (85 FR 55060), the FAA in cooperation with the National Park
Service (NPS) provided notice of its intent to complete Air Tour
Management Plans (ATMPs) for 23 National Park System units. The
agencies began developing ATMPs for these parks, including Everglades
National Park, pursuant to the National Parks Air Tour Management Act
of 2000 (Pub. L. 106-181) and its implementing regulations contained in
14 CFR part 136, subpart B, National Parks Air Tour Management.
    In a July 29, 2021 Federal Register notice (86 FR 40897), the FAA,
in cooperation with the NPS, announced public meetings and the
availability of proposed ATMPs for four National Park System units,
including Everglades National Park. The agencies posted the draft ATMP
for Everglades National Park on their respective websites and took
comments over a 30-day period on the NPS Planning, Environment, and
Public Comment System website. The agencies conducted a public meeting
for the proposed ATMP for Everglades National Park on August 19, 2021.
    On April 13, 2022, the sole operator with interim operating
authority (IOA) for Everglades National Park voluntarily surrendered
its Part 135 certificate. This certificate is required by the FAA for
an operator that provides air transportation of persons or property for
compensation or hire. Upon surrender of a Part 135 certificate, all
authorizations given to an operator through its Operations
Specifications are cancelled, including IOA to conduct commercial air
tours over a park. In this case, the operator also had IOA for Biscayne
National Park, Big Cypress National Preserve and Dry Tortugas National
Park. Given that the operator is no longer authorized to conduct air
tours over any of these parks, the operator will be deleted from the
FAA's records of authorized commercial air tour operators.
    As the sole operator conducting commercial air tours over
Everglades National Park has voluntarily surrendered its operating
certificate and no longer has the authority to conduct air tours over
the park, an ATMP is no longer required or needed at this time. 49
U.S.C. 40128(b)(1)(A). Therefore, the FAA, in cooperation with the NPS,
has discontinued its preparation of an ATMP for Everglades National
Park.
    The FAA and the NPS had also previously entered into voluntary
agreements for the conduct of commercial air tours over Big Cypress
National Preserve and Biscayne National Park with this same operator
under 49 U.S.C. 40128(b)(7). This notice also announces that both of
these voluntary agreements have been terminated due to the operator's
voluntary surrender of its operating certificate and with it, its
authority to conduct air tours over both Big Cypress National Preserve
and Biscayne National Park.

    Issued in El Segundo, California, on July 15, 2022.
Keith Lusk,
Program Manager, Special Programs Staff, Western-Pacific Region.
[FR Doc. 2022-15524 Filed 7-20-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: February 1, 2006 (Volume 71, Number 21)]
[Notices]
[Page 5304]
[DOCID:fr01fe06-56]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-178-000]

Mojave Pipeline Company; Notice of Proposed Changes in FERC Gas
Tariff

January 25, 2006.
    Take notice that on January 20, 2006, Mojave Pipeline Company
(Mojave) tendered for filing as part of its FERC Gas Tariff, Second
Revised Volume No. 1, tariff sheets listed in the Appendix to the
filing, to become effective on February 20, 2006.
    Mojave states that it is filing to update its Tariff to provide for
commonly used contract provisions such as pressure commitments and
evergreen clauses as well as to modify its Pro Forma Service Agreements
to provide for circumstances where a shipper requests varying contract
quantities, different service points or rates, or where precedent
conditions are required for expansions. In addition, Mojave is adding
provisions to the Tariff to specify the types of discounts that it may
offer as well as to request negotiated rate authority.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-1257 Filed 1-31-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 73 (Thursday, April 16, 2015)]
[Rules and Regulations]
[Pages 20414-20416]
[FR Doc No: 2015-08758]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2015-0185]
RIN 1625-AA08

Special Local Regulation; Glass City Scrimmage; Maumee River,
Toledo, OH

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary Special Local
Regulation on the Maumee River, Toledo, Ohio. This Special Local
Regulation is necessary to protect race participants from other vessel
traffic. This temporary Special Local Regulation is intended to
restrict vessels from a portion of the Maumee River during the Glass
City Scrimmage.

DATES: This rule will be effective from 6 a.m. until 1 p.m. on April
18, 2015.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2015-0185. To view documents
mentioned in this preamble as being available in the docket, go to
http://www.regulations.gov, inserting USCG-2015-0185 in the ``Keyword''
box, and then clicking ``search.'' They are also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary final rule, contact or email MST1 Brett A. Kreigh, U.S. Coast
Guard Marine Safety Unit Toledo, at<PHONE_NUMBER> or
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Barbara Hairston, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
TFR Temporary Final Rule

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing an NPRM with respect to this rule
because doing so would be impracticable. Additional details regarding
this emergent event were received from the event sponsor after the
annual permitting process but not received in sufficient time for the
Coast Guard to publish an NPRM and solicit public comments before the
occurrence of the event. Thus, waiting for a notice and comment period
to run would inhibit the Coast Guard from protecting the public and
vessels from hazards associated with the event.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this temporary rule effective less than 30 days after
publication in the Federal Register. For the same reasons discussed in
the preceding paragraph, waiting for a 30 day notice period to run
would be impracticable and contrary to the public interest.

B. Basis and Purpose

    On Saturday, April 18, 2015, from 6 a.m. to 1 p.m. an organized
racing event will take place on the Maumee River where participants
will row shell boats from the Craig Memorial Bridge at River Mile 3.30
to the Martin Luther King Jr. Memorial Bridge at River Mile 4.30 on the
Maumee River in Toledo, OH. The Captain of the Port Detroit has
determined that this boat race, due to its close proximity to
watercraft and being in the shipping channel, poses extra and unusual
hazards to public safety and property, including potential collisions,
allisions, and individuals falling into the water. Establishing a
special local regulated area is necessary to protect persons and
property at these events and help minimize the associated risks.

C. Discussion of Rule

    This rule will be enforced 6 a.m. until 1 p.m. on April 18, 2015.
The Coast Guard requires that all vessels transiting the area proceed
at a no-wake speed and maintain extra vigilance at all times.
    Vessel traffic may proceed down the West side of the river at a no
wake speed during racing. The races will stop for oncoming freighter or
commercial traffic. The on-scene representative or event sponsor
representatives may permit vessels to transit the area when no race
activity is occurring. The on-scene representative may be present on
any Coast Guard, state or local law enforcement vessel assigned to
patrol the event.
    This temporary Special Local Regulation will encompass all U.S.
waters on the Maumee River, Toledo, OH from the Craig Memorial Bridge
at River Mile 3.30 to the Martin Luther King Jr. Memorial Bridge at
River Mile 4.30.
    The Captain of the Port will notify the affected segments of the
public of the enforcement of this Special Local Regulation by all
appropriate means, including a Broadcast Notice to Mariners and Local
Notice to Mariners.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This temporary final rule is not a significant regulatory action
under section 3(f) of Executive Order 12866, Regulatory Planning and
Review, as supplemented by Executive Order 13563, Improving Regulation
and Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under that Order. We conclude that this
temporary final rule is not a significant regulatory action because we
anticipate that it will have minimal impact on the economy, will not
interfere with other agencies, will not adversely alter the budget of
any

grant or loan recipients, and will not raise any novel legal or policy
issues. The temporary Special Local Regulation will be relatively small
and be enforced for a relatively short time. Thus, restrictions on
vessel movement within that particular area are expected to be minimal.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
temporary final rule will not have a significant economic impact on a
substantial number of small entities.
    This temporary final rule will affect the following entities, some
of which might be small entities: The owners or operators of vessels
intending to transit or anchor in the portion of the Maumee River
discussed above from 6 a.m. until 1 p.m. on April 18, 2015.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against entities
that question or complain about this rule or any policy or action of
the Coast Guard.

4. Collection of Information

    This temporary final rule will call for no new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

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

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children From Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves the establishment of a special local regulation issued in
conjunction with a regatta or marine parade and therefore is
categorically excluded under figure 2-1, paragraph (34)(h), of the
Instruction. During the annual permitting process for this boat racing
event an environmental analysis was conducted to include the effects of
this special local regulation.

List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233.

0
2. Add temporary Sec.  100.35T-0185 to read as follows:

Sec.  100.35T-0185  Special Local Regulation, Glass City Scrimmage,
Toledo, OH.

    (a) Location. The regulated area includes all U.S. navigable waters
of the Maumee River, Toledo, OH, from the Craig Memorial Bridge at
River Mile 3.30 to the Martin Luther King Jr. Memorial Bridge at River
Mile 4.30.
    (b) Enforcement period. This section will be enforced from 6 a.m.
until 1 p.m. on April 18, 2015.
    (c) Regulations. (1) Consistent with Sec.  100.901 of this part,
vessels transiting within the regulated area shall travel at a no-wake
speed and remain vigilant at all times. Additionally, vessels within
the regulated area must yield right-of-way for event participants and
event safety craft. Commercial vessels will have right-of-way over
event participants, and event safety craft.
    (2) The ``on-scene representative'' of the Captain of the Port,
Sector Detroit is any Coast Guard commissioned, warrant, or petty
officer who has been designated by the Captain of the Port, Sector
Detroit to act on his behalf. The on-scene representative of the
Captain of the Port, Sector Detroit will be aboard either a Coast Guard
or Coast Guard Auxiliary vessel. The Captain of the Port, Sector
Detroit or his designated on scene representative may be contacted via
VHF Channel 16.
    (3) Vessel operators entering or operating in the special local
regulated area must comply with all directions given to them by the
Captain of the Port, Sector Detroit or his on-scene representative.

    Dated: March 31, 2015.
Scott B. Lemasters,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2015-08758 Filed 4-15-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Rules and Regulations]
[Pages 56755-56756]
[FR Doc No: 2012-21531]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0338; Directorate Identifier 2009-SW-51-AD;
Amendment 39-17172; AD 2012-17-09]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for
Eurocopter France Model SA341G helicopters. This AD requires replacing
any rotating star with more than 12,000 hours TIS. This AD was prompted
by an analysis and tests performed by the manufacturer that indicate
that the life limit of the rotating star should be 12,000 hours time-
in-service (TIS). The actions of this AD are intended to prevent
failure of the rotating star and subsequent loss of control of the
helicopter.

DATES: This AD is effective October 19, 2012.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, any incorporated-by-reference
service information, the economic evaluation, any comments received,
and other information. The street address for the Docket Operations
Office (phone:<PHONE_NUMBER>) is U.S. Department of Transportation,
Docket Operations Office, M-30, West Building Ground Floor, Room W12-
140, 1200 New Jersey Avenue SE., Washington, DC 20590.

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

Discussion

    On March 29, 2012, at 77 FR 18965, the Federal Register published
our notice of proposed rulemaking (NPRM), which proposed to amend 14
CFR part 39 to include an AD that would apply to Eurocopter France
Model SA341G helicopters, with rotating star, part number (P/N)
341A31.4116.21 installed. That NPRM proposed to require replacing any
rotating star with 12,000 or more hours TIS with an airworthy rotating
star with less than 12,000 hours TIS. The NPRM also proposed to revise
the Airworthiness Limitations section of the Instructions for Continued
Airworthiness by reducing the service life of the main rotor rotating
star from unlimited hours to 12,000 hours TIS. The proposed
requirements were intended to prevent failure of the rotating star and
subsequent loss of control of the helicopter.
    The Direction Generale de l'Aviation Civile (DGAC), which is the
aviation authority for France, has issued DGAC AD No. F-2004-070, dated
May 26, 2004, to correct an unsafe condition for Eurocopter France
Model SA 341/342 helicopters. The DGAC advises that they issued the AD
to require a new service life limit of 12,000 flight hours for the

rotating star, part number (P/N) 341A31.4116.21, installed on Model
SA341G helicopters.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we did not receive any comments on the NPRM.

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, DGAC, its technical
representative, has notified us of the unsafe condition described in
the DGAC AD. We are issuing this AD because we evaluated all
information provided by DGAC and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of the same type
designs and that air safety and the public interest require adopting
the AD requirements as proposed.

Costs of Compliance

    We estimate that this AD will affect 21 helicopters of U.S.
registry and the actions will take approximately 6 work hours per
helicopter to accomplish at an average labor rate of $85 per work hour.
Required parts will cost approximately $6,000. Based on these figures,
we estimate the total cost impact of this AD on U.S. operators to be
$6,510 to replace the rotating star on each helicopter, or $136,710 for
the entire U.S. fleet.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2012-17-09 Eurocopter France: Amendment 39-17172; Docket No. FAA-
2012-0338; Directorate Identifier 2009-SW-51-AD.

(a) Applicability

    This AD applies to Model SA341G helicopters, with rotating star,
part number (P/N) 341A31.4116.21 installed, certificated in any
category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a reduced service life
of the rotating star. This condition could result in failure of the
rotating star and subsequent loss of control of the helicopter.

(c) Effective Date

    This AD becomes effective October 19, 2012.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless accomplished
previously.

(e) Required Actions

    (1) Before further flight, remove any rotating star, P/N
341A31.4116.21, with 12,000 or more hours time-in-service (TIS), and
replace it with an airworthy rotating star with less than 12,000
hours TIS.
    (2) Revise the Airworthiness Limitations section of the
Instructions for Continued Airworthiness by reducing the service
life of the main rotor rotating star from unlimited hours TIS to
12,000 hours TIS.

(f) Alternative Methods of Compliance (AMOCs)

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

(g) Additional Information

    The subject of this AD is addressed in Direction Generale de
l'Aviation Civile (France) AD No. F-2004-070, dated May 26, 2004.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6220: Main Rotor
Head.

    Issued in Fort Worth, Texas, on August 21, 2012.
Lance T. Gant,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2012-21531 Filed 9-13-12; 8:45 am]
BILLING CODE 4910-13-P