[Federal Register Volume 77, Number 166 (Monday, August 27, 2012)]
[Rules and Regulations]
[Pages 51701-51705]
[FR Doc No: 2012-21032]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 85, 86, 600, 1033, 1036, 1037, 1039, 1065, 1066, and
1068

[EPA-HQ-OAR-2010-0162; FRL-9720-9]

EPA's Denial of the Petition To Reconsider the Greenhouse Gas
Emissions Standards and Fuel Efficiency Standards for Medium- and
Heavy-Duty Engines and Vehicles

AGENCY: Environmental Protection Agency (EPA).

ACTION: Denial of petition to reconsider.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) is denying
the petition of Plant Oil Powered Diesel Fuel Systems, Inc. (``POP
Diesel'') to reconsider the final rules establishing emissions
standards to reduce greenhouse gas emissions from on-road heavy-duty
vehicles.

DATES: This denial is effective August 27, 2012.

ADDRESSES: EPA's docket for this action is Docket ID No. EPA-HQ-OAR-
2010-0162. All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., confidential business
information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at
EPA's Docket Center, Public Reading Room, EPA West Building, Room 3334,
1301 Constitution Avenue NW., Washington, DC 20004. This Docket
Facility 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<PHONE_NUMBER>, and the telephone number for the Air Docket is
(202) 566-1742.

FOR FURTHER INFORMATION CONTACT: Steven Silverman, Office of General
Counsel, Environmental Protection Agency, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Acronyms and Abbreviations. The following acronyms and
abbreviations are used in this Decision.

CAA Clean Air Act
CO2 carbon dioxide
EV electric vehicle

EPA Environmental Protection Agency
FR Federal Register
FCV fuel cell vehicle
GHG greenhouse gas
GVWR gross vehicle weight rating
HD heavy-duty
N2O nitrous oxide
NHTSA National Highway Traffic Safety Administration
POP Diesel Plant Oil Powered Diesel Fuel Systems, Inc.
PHEV plug-in hybrid electric vehicle
RFS Renewable Fuel Standard
RIN Renewable Identification Number
VMT vehicle miles travelled

I. Introduction

    On September 15, 2011, the EPA issued final rules establishing
standards limiting emissions of CO2, methane, nitrous oxide
(N2O) and hydrofluorocarbons (greenhouse gases or GHGs) from
on-road heavy-duty vehicles, including combination tractors, heavy-duty
pickup trucks and vans, and vocational vehicles. 76 FR 57106 (September
15, 2011). In this joint rulemaking the National Highway Traffic Safety
Administration (NHTSA), on behalf of the Department of Transportation,
issued rules for fuel consumption from these vehicles at the same time.
Together these rules comprise a coordinated and comprehensive Heavy-
Duty (HD) National Program designed to address the urgent and closely
intertwined challenges of reduction of dependence on oil, achievement
of energy security, and amelioration of global climate change.
    POP Diesel petitioned EPA to reconsider its greenhouse standards.
Because the petition does not state grounds which satisfy the
requirements of section 307(d)(7)(B) of the Act, and does not provide
substantial support for the argument that the promulgated regulation
should be revised, EPA is denying the petition.

II. Standard for Reconsideration

    Section 307(d)(7)(B) of the Clean Air Act (CAA) states that: ``Only
an objection to a rule or procedure which was raised with reasonable
specificity during the period for public comment (including any public
hearing) may be raised during judicial review. If the person raising an
objection can demonstrate to the Administrator that it was
impracticable to raise such objection within such time or if the
grounds for such objection arose after the period for public comment
(but within the time specified for judicial review) and if such
objection is of central relevance to the outcome of the rule, the
Administrator shall convene a proceeding for reconsideration of the
rule and provide the same procedural rights as would have been afforded
had the information been available at the time the rule was proposed.
If the Administrator refuses to convene such a proceeding, such person
may seek review of such refusal in the United States court of appeals
for the appropriate circuit. Such reconsideration shall not postpone
the effectiveness of the rule. The effectiveness of the rule may be
stayed pending such reconsideration, however, by the Administrator or
the court for a period not to exceed three months.''
    Thus, for reconsideration to be mandated, a petition for
reconsideration must show why the objection or claim could not have
been presented during the comment period--either because it was
impracticable to raise the objection during that time or because the
grounds for raising the objection arose after the period for public
comment but within 60 days of publication of the final action (i.e.
``the time specified for judicial review''). To be of central relevance
to the outcome of a rule, an objection must provide substantial support
for the argument that the promulgated regulation should be revised. See
76 FR 28318 (May 17, 2011) and other actions there cited.
    Because all of the objections or claims raised in POP Diesel's
petition could have been presented to EPA during the rulemaking, EPA is
denying the request for reconsideration. EPA also finds that the
petitioner has not provided substantial support for the argument that
the promulgated regulation should be revised and is denying the request
for reconsideration for that reason as well.

III. POP Diesel's Petition for Reconsideration

    POP Diesel filed a petition for reconsideration with EPA on
November 14, 2011 and supplemented this petition on February 12, 2012.
The company produces equipment intended to be installed after-market on
diesel engines to permit the engines to operate on 100 percent
untransestrified plant oil. February 12 Petition p. 12. The engine
starts and shuts down on diesel from an original fuel tank during
startup and shutoff but at all other times would run on 100 percent
plant oil coming from an auxiliary tank. Id POP Diesel states that
engines operated on vegetable oils with its systems incur ``only a
modest fuel consumption penalty'' but would have superior GHG
performance if evaluated on a full lifecycle basis. November 14,
Petition p. 13; February 12 Petition p. 22.
    The objection raised in POP Diesel's petitions is that EPA failed
to adequately consider the so-called rebound effect during the
rulemaking. POP Diesel maintains that ``[t]he GHG standards will have
the effect of making diesel engines less expensive to operate on
petroleum fuel, which may, in fact, spur demand and have the result of
increasing overall energy consumption and likely, consumption of fossil
fuels.'' November 14, 2011 Petition p. 15. In its supplement to its
original petition, POP Diesel elaborated on this objection, maintaining
that the rules would increase GHG emissions from heavy-duty vehicles
due to aspects of the rebound effect not accounted for in EPA's
analysis. Specifically, POP Diesel maintains that EPA underestimated
the direct rebound effect and that a revised estimate of the direct
rebound effect would result in an increase in greenhouse gas emissions
Also, POP Diesel maintains that there are indirect, ``embedded energy''
(increased energy use as a result of additional goods and services
produced) and ``frontier'' (creation of new, energy-intense products)
rebound effects which EPA failed to examine, instead only analyzing
direct effects in the form of estimated increase in vehicle miles
travelled (and increases in GHG and criteria pollutant emissions
associated with that increase). February 12, 2012 Supplemental Petition
p. 12. These objections are accompanied by a supporting declaration of
Dr. Harry Duston Saunders (a published researcher in energy economics)
likewise dated February 12, 2012.
    POP Diesel does not address why this objection could not have been
raised during the public comment period, as required by section
307(d)(7)(B). EPA discussed the rebound effect at length in the
proposed rule. See 75 FR 74152, 74316-20 (November 30, 2010). The
proposal included specific discussions of factors affecting the
magnitude of the rebound effect, options for quantifying the effect
(including aggregate estimates, sector-specific estimates, econometric
estimates, and other modeling approaches), as well as quantified
estimates of the effect which EPA thereupon applied in estimating the
proposed rules' impacts on GHG emissions, criteria pollutant emissions,
as well as overall costs and benefits of the proposed program. Id. and
75 FR at 74290, 74313; see also Regulatory Impact Analysis: Final
Rulemaking to Establish Greenhouse Gas Emissions Standards and Fuel
Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles,
Docket EPA-HQ-OAR-2010-0162-3634, pages 9-9 through 9-18. EPA
received comments

on its approach to the rebound effect and responded to them as part of
the rulemaking. 76 FR at 57326-30; see also Response to Comments
Document at 14-24. It is therefore apparent that POP Diesel had the
opportunity to present all of its objections regarding the rebound
effect during the rulemaking. Indeed, POP Diesel properly acknowledges
that its objections are ``belate[d]''. February Petition p. 4.
    A second reason that POP Diesel's objections do not require EPA to
reconsider the rule is that the declaration of Dr. Saunders is dated
February 12, 2012, outside of the period specified for judicial
review--i.e. November 11, 2011. Even if POP Diesel's objections could
not have been raised during the public comment period (which is not the
case), the grounds for objection did not arise ``during the time
specified for judicial review'', as required by section 307(d)(7)(B).
    POP Diesel also reiterates a number of arguments it already
presented to EPA in its comments to the proposed rule. Specifically,
the petition maintains that EPA should have evaluated all emission
control technologies on a lifecycle basis (``[i]n considering only
tailpipe emissions, rather than the full lifecycle GHG emissions of a
technology and fuel that would result from a wells-to-wheels analysis,
the Regulations arbitrarily favor and disfavor some alternatives over
others'', February amended petition p. 7). EPA addressed these issues
during the rulemaking. See 75 FR at 74198, 255-56 (proposal); 76 FR at
57246-47 (final rule) and Response to Comment Document at 16-157. EPA's
proposal likewise addressed the issues of whether compliance with the
standards should be measured on a tailpipe or lifecycle basis, and what
if any incentives were appropriate for advanced technologies and
alternative fuel vehicles. See 75 FR at 74198, 255-56. Consequently,
these are not issues which EPA is compelled to reconsider under section
307(d)(7)(B), since these objections could have been and were raised
during the public comment period on the proposed rule. EPA also rejects
the substance of the arguments raised in the petitions.\1\
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    \1\ EPA may permissibly respond to a request for reconsideration
without triggering additional notice and comment opportunities for a
petitioner or other entities. Coalition for Responsible Regulation
v. EPA, No. 09-1322 (D.C. Cir. June 26, 2012) slip op. p. 39.
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A. Direct Rebound Effect

    POP Diesel first maintains that EPA underestimated the extent of
the direct rebound effect, and that assigning different estimates of
rebound effects to different heavy-duty vehicle classes (medium-duty
pickups and vans, vocational vehicles, and combination tractors) was
arbitrary. Saunders Affidavit paras. 35-36.\2\ EPA explained its
rationale for selecting VMT rebound values for these three categories
of vehicles in both the proposed and final rules. In short, the values
for vocational vehicles and combination tractors fall within the range
of estimates presented in two available analyses of the HD rebound
effect.\3\ See 76 FR 57326-330. For medium-duty pickups and vans, EPA
applied the light-duty VMT rebound effect estimate from the final rule
establishing GHG standards for MYs 2012-2016 light-duty vehicles. Id.
at 57329. EPA reasonably did so since there were no estimates of the
direct rebound effect for medium-duty pickup trucks and vans (class 2b
and 3) cited in the literature, and these classes of vehicles are used
for purposes more similar to large light-duty vehicles than the other
heavy-duty vehicle categories.
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    \2\ Dr. Saunders cites Knittel, Automobiles on Steroids, for the
proposition that ``in the personal transportation sector of the
United States, a rebound effect of 75% between 1980 and 2006
existing because most of the technical engine efficiency gains were
offset by consumers choosing to take improvements in engine
efficiency in the form of increased vehicle weight and substantial
increases in average horsepower.'' Saunders Affidavit para. 14. The
Knittel study does not attribute any fleet shifts to a rebound
effect, and also discusses the light-duty vehicle sector
exclusively. The study therefore has no apparent relevance to the
heavy-duty GHG rulemaking, or to a discussion of rebound effects.
    \3\ The first analysis, from Cambridge Systematics, Inc., was
commissioned by the National Academy of Sciences and uses a range of
freight elasticities in the literature combined with technology cost
and fuel saving scenarios to estimate the potential magnitude of the
HD rebound effect. See 76 FR 74328. The second analysis, conducted
by NHTSA, is an econometric analysis that estimates short-run and
long-run elasticities of annual VMT with respect to fuel cost per
mile driven using data on national and state VMT and a variety of
other variables such as GDP, the volume of imports and exports, and
factors affecting the price of trucking services (e.g., driver
wages). Id. at 57329.
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    These values are based on the best available data and econometric
methods \4\ and reflect many of the components of the VMT rebound
effect that POP Diesel alleges (mistakenly) that EPA ignored (e.g.,
shifts of freight shipments from other transportation modes to
trucking). At proposal, we explicitly requested, but did not receive,
comment on all of the rebound estimates and assumptions in our proposed
rule. 75 FR at 74320. EPA continues to believe that its estimate of
direct VMT rebound effect in the final rule is reasonable.
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    \4\ The ``Saunders study'' discussed in the Saunders affidavit
(Saunders Affidavit para. 31-36) was not presented to EPA during the
public comment period, it reflects no expert peer review and, as Dr.
Saunders acknowledges, examines the entire transportation sector
rather than the medium- and heavy-duty vehicle sector covered under
EPA's rule.
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B. Indirect Rebound Effects

    POP Diesel also maintains that EPA should account for the energy
and GHG emissions impact associated with the so-called ``indirect''
rebound effects (distinct from the ``direct'' rebound effect). These
effects could arise from the decline in fuel costs as a result of the
rule, which could make goods and services transported by the U.S.
trucking industry less expensive. In turn, less expensive goods and
services could result in increased consumption of goods and service in
the overall economy. Producing extra goods and services requires that
more energy be used. This extra energy use can be thought of as
``embodied'' in the extra goods and services. Hence the term for this
type of indirect rebound effect is the ``embodied energy'' rebound
effect. The increased energy use from this type of indirect rebound
effect could result in increased greenhouse gas emissions. Saunders
Affidavit para. 46 Appendix A. A further indirect rebound effect
unaccounted for, according to the petition, is the ``frontier'' rebound
effect whereby energy efficiency gains enable creation of completely
new products which are themselves energy intensive. Id. para. 26.\5\
POP Diesel maintains that these assorted indirect effects are of such
magnitude as to create a ``backfire'' condition, negating all of the
emission benefits of the rule.
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    \5\ The Saunders declaration does not provide any examples of
potential ``frontier'' rebound effects from the heavy-duty GHG rule,
besides ``the rise of internet shopping'' that allows people to buy
products from distant locations instead of purchasing products
locally. Increased internet shopping is a well established market
trend, so we do not see how it could be reasonably attributed to the
modest increase in truck fuel efficiency that our standards will
bring about. Furthermore, there are many factors that have
contributed to increased internet shopping, most notably the
widespread use of computers and advances in internet applications,
which took place and would likely continue to take place in the
absence of any improvements in truck efficiency.
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    EPA is not aware of any data to indicate that the magnitude of
indirect rebound effects, if any, would be significant for this rule.
Research on indirect rebound effects is nascent. The magnitude of
effects from our rule postulated in the Saunders affidavit has no
support in the literature,\6\ reflects no

expert peer review, and in the end is speculative. It appears highly
improbable that all of the GHG emissions benefits of this rule would be
negated by putative indirect rebound effects. As discussed in the
proposed and final rules, all of the fuel costs savings will not
necessarily be passed through to the consumer in terms of cheaper goods
and services. First, there may be market barriers that impede trucking
companies from passing along the fuel cost savings from the rule in the
form of lower rates; see 75 FR at 74320 and 76 FR at 57329-30. Second,
there are upfront vehicle costs (and potentially transaction or
transition costs associated with the adoption of new technologies) that
would partially offset some of the fuel cost savings from our rule,
thereby limiting the magnitude of the impact on prices of final goods
and services. Furthermore, there are additional benefits to consumers
associated with increased consumption of goods and services, which
would be important to consider if we were assessing the overall costs
and benefits associated with potential indirect rebound effects from
our rule. EPA thus does not accept this speculative assessment.
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    \6\ Dr. Saunders cited only one published study quantifying
indirect rebound effects (Druckman et al., 2011). Saunders affidavit
para. 16. Although this UK-based study could offer insights into how
to estimate indirect rebound effects in some contexts, the method
may not be appropriate here for many reasons. First, the U.S.
economy and consumer behavior is likely to differ from other
countries (e.g., Americans have different product and service
preferences and our products and services have different levels of
embedded energy). Similar data and models may not exist to replicate
the UK study in a U.S.-context. Second, the study is designed to
examine behavioral strategies (e.g., lowering thermostats, reducing
food waste, and biking instead of using a car) rather than improving
technology. Among other things, the study does not consider capital
expenditures associated with energy savings that could dampen any
increase in consumption of additional goods and services (e.g., our
rule increases the cost of new vehicles, which offsets the fuel cost
savings that trucking firms may pass along to shippers, which in
turn, would dampen any decrease in product prices that shippers pass
along to consumers). Third, the study does not consider the
potential for economic restructuring in response to decreased energy
consumption (i.e., it does not consider ``general equilibrium''
effects), which could lead to either lower or higher energy
consumption as a result of our rule. Fourth, the authors recognize
that there is a major limitation of the study: they have only a very
small number of expenditure categories in their model and there is
considerable disparity in GHG intensities of commodities within each
category (p. 3578). Fifth, the study does not directly explore the
market mechanism through which our rule could influence the amount
of goods and services consumed since it focuses on energy efficiency
improvements that more directly increase consumers' disposable
income rather than the more complex and indirect pathway where
greater truck fuel efficiency may result in lower-priced goods and
services. Finally, the authors do not attempt to quantify the
additional benefits to consumers associated with increased
consumption of goods and services, which would be important to
consider if we were assessing the overall costs and benefits
associated with potential indirect rebound effects from our rule.
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C. Fuel-Based Rule Rather Than a Vehicle-Based Rule

    POP Diesel requests EPA to re-evaluate the weight given to various
alternative technologies and fuels according to a lifecycle approach,
and to decouple fuel efficiency policy from GHG emissions policy.
February 12 Petition p. 2. In setting emissions standards for heavy-
duty vehicles, EPA reasonably chose to consider the impact on GHG
emissions of the fuels used by the different types of vehicles by
measuring the tailpipe emissions of vehicles, including alternative
fuel vehicles (which normally emit less GHG emissions than gasoline or
diesel-powered vehicles).\7\ In a separate program, the Congressionally
mandated Renewable Fuels Standard (RFS) program, there are strong
incentives for use of renewable diesel fuels and other renewable fuels.
See 76 FR at 57124. This program is specifically designed to mandate
increasing volumes of renewable fuel use in transportation fuels,
including renewable fuel used in heavy-duty diesel vehicles. The
definition of renewable fuel includes thresholds for reductions in
lifecycle greenhouse gas emissions, compared to petroleum fuel. For
example, specified volumes of biomass-based diesel fuel must be used in
the diesel transportation sector, and biomass-based diesel is defined
in part as a diesel fuel that achieves a 50 percent reduction in
lifecycle greenhouse emissions compared to baseline petroleum diesel
fuel. POP Diesel points out that its product is not presently eligible
to receive Renewable Identification Number (RIN) credits under that
program, but this is an issue which is properly considered under the
RFS program, which contains the mechanisms for determining whether a
diesel fuel qualifies as a renewable fuel.
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    \7\ POP Diesel's statement that the rules arbitrarily assign
zero emissions and zero fuel consumption to electric vehicles
(February revised petition, p. 6) is also misplaced. In fact,
compliance with the standards is measured identically for all
medium- and heavy-duty vehicles and engines: at the tailpipe. See 76
FR at 57247. Electric vehicles have zero GHG emissions measured at
the tailpipe. POP Diesel states further that the standards are
arbitrary in the GHG-reducing weight given to some alternative
technologies and fuels. POP Diesel's complaint (February amended
petition p. 6) that the rule provides incentives for use of certain
advanced technologies such as hybrid electrification and hydrogen
fuel cells questions legitimate policy choices unrelated to the
issue of fuel use.
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    EPA also does not accept the major premise of POP Diesel's
reconsideration petition and rulemaking comments. The company argues
that it is arbitrary that EPA has not established greenhouse gas
emission standards for heavy-duty vehicles premised on use of their
technology and its fuel. Under such a standard, the GHG level of a
vehicle using POP Diesel would be tailpipe emissions adjusted by a
factor reflecting the claimed reduction in lifecycle GHG emissions to
produce the POP Diesel fuel. See, e.g., November 14, 2011 Petition for
Reconsideration pp. 1-2 (``If the Regulations did consider this
technology, they could mandate much steeper reductions in greenhouse
gas * * * emissions by requiring every engine and vehicle manufacturer
of medium- and heavy-duty engines and vehicles to comply with a
corporate average for such emissions'').
    The heavy-duty vehicle and engine GHG standards are fuel neutral in
that they do not themselves require or assume that a vehicle or engine
will be operated on a particular type of fuel. If POP Diesel's
technology helps manufacturers reduce tailpipe GHG emissions, then it
will have the same opportunities as any other technology that
manufacturers will use to meet the standards. Moreover, POP Diesel has
not correctly characterized the agencies' consideration of the
interaction between the RFS program and the heavy-duty GHG standards.
As explained in the final rule, the tailpipe performance measurement of
alternative fuels provides sufficient incentives for their use. While
the agencies noted that incentives in the RFS pointed to a lack of a
need for further incentives, the rule's treatment of alternative fuels
was not premised on each alternative fuel being covered by the RFS
Standard.\8\ Indeed, other alternative fuels are similarly not covered
by the RFS standard, such as liquefied natural gas, compressed natural
gas, propane, hydrogen and electricity.
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    \8\ See 76 FR 57124.
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    Only where the vehicle or engine technology inherently demands a
certain type of fuel do the standards account for that fuel use, by
specifying the calculation procedure used to determine tailpipe
emissions. This is the case with electric vehicles (EV), plug-in hybrid
electric vehicles (PHEV), and hydrogen fuel cell vehicles, where the
technology itself necessitates use of electricity rather than
petroleum-based fuels.\9\ Unlike EVs, PHEVs, or FCVs,

there is nothing inherent in a diesel engine that compels use of the
POP Diesel product. Therefore, a standard premised on that product's
use would presuppose or require a market outcome which need not occur
and would be infeasible and arbitrary.
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    \9\ Even so, the standards for medium- and heavy-duty EVs and
PHEVs measure performance based on tailpipe emissions exclusively.
See 76 FR at 57247. The MYs 2012-2016 standards for light-duty EVs
and PHEVs do account for greenhouse gas emissions attributable to
upstream electricity generation after a designated number of EVs and
PHEVs are sold, but this upstream factor does not reflect a single
means of generating electricity and so differs from POP Diesel's
desired outcome, which is fuel specific. See 75 FR 25326, 25436-37
(May 7, 2010).
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    Even if EPA were to assume that POP Diesel's claim of lifecycle
emissions reductions are valid, and considered setting a vehicle
emissions standard that assumed or required use of the POP Diesel
technology and fuel, POP Diesel admits this would in fact lead to an
increase in the actual GHG emissions from the vehicle. The only
decrease in emissions would come from the claimed reduction in
lifecycle GHG emissions that POP Diesel says would occur with use of
their fuel. That would amount to adopting a vehicle emissions standard
to promote a vehicle technology that does not reduce but instead
increases the GHG emissions of the vehicle. The vehicle emissions
standard would take that approach solely as a mechanism to mandate the
use of a certain diesel fuel, based on emissions impacts associated
with the fuel, not the vehicle. This would dramatically distort the
purpose and structure of the vehicle emissions standard program,
largely turning it into a de facto fuel program. There is no good
reason to consider such a result here, especially where there already
is a separate fuel based program, the RFS program, that is directly
aimed at achieving the result POP Diesel seeks--a fuel program that
achieves a reduction in lifecycle GHG emissions associated with the
diesel fuel used by motor vehicles, through a mandate to use certain
renewable diesel fuels.
    A further reason this heavy-duty rule does not regulate GHG
emissions from a lifecycle perspective, or include explicit
consideration of plant-based fuels like the one utilized by POP
Diesel's technology, is that it would no longer be possible to
establish harmonized, performance-based tailpipe GHG emissions
standards (EPA) and fuel efficiency standards (NHTSA). As discussed
throughout the final rule, close coordination in this first heavy-duty
rule enabled EPA and NHTSA to promulgate complementary standards that
appropriately allow manufacturers to build one set of vehicles to
comply with both agencies' regulations. See, e.g., 76 FR at 57107-108.
This coordination was advocated by the President, id., widely supported
by stakeholders, and provides benefits for industry, government, and
taxpayers by increasing regulatory efficiency and reducing compliance
burdens.

D. Fleet-Wide Average Standards

    Finally, the petition maintains that EPA should impose corporate
fleet averages for GHG emissions, asserting that EPA did so only for
medium-duty engines and vehicles. Id. p. 23. In fact, the standards are
effectively corporate averages. See EPA, Heavy-Duty Diesel Greenhouse
Gas Response to Comment Document at p. 16-149--explaining that the rule
allows averaging, banking, and trading of credits within the same
``averaging set'', which means a manufacturer can comply through
averaging across (for example) all of its vocational vehicles under
19,501 pounds GVWR; or all of its Class 6 and 7 vocational vehicles and
tractors (that is, between all vehicles above 19,500 pounds GVWR and
less than 33,001 pounds GVWR); or between all vehicles with GVWR
greater than 33,000 pounds; or within the engine averaging sets (spark
ignition engines, compression-ignition light heavy-duty engines,
compression-ignition medium heavy-duty engines, and compression-
ignition heavy heavy-duty engines). See sections 1036.740(a) and
1037.740(a). In any case, this issue again was one which was presented
at proposal and addressed in the final rule. See 75 FR at 74250-54
(proposal) and 76 FR at 57238-240 (final). Consequently, POP Diesel has
again failed to show why its objection can be raised outside the period
for public comment, and in any case is mistaken. CAA section
307(d)(7)(B).
    Accordingly, because POP Diesel has not stated grounds requiring or
justifying reconsideration under section 307(d)(7)(B) EPA is denying
its petition.

    Dated: August 17, 2012.
Lisa P. Jackson,
Administrator.
[FR Doc. 2012-21032 Filed 8-24-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 92 (Thursday, May 12, 2022)]
[Notices]
[Pages 29155-29156]
[FR Doc No: 2022-10188]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2022-0116; FRL-9412-14-OCSPP]

Certain New Chemicals or Significant New Uses; Statements of
Findings for February 2022

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Toxic Substances Control Act (TSCA) requires EPA to
publish in the Federal Register a statement of its findings after its
review of certain TSCA notices when EPA makes a finding that a new
chemical substance or significant new use is not likely to present an
unreasonable risk of injury to health or the environment. Such
statements apply to premanufacture notices (PMNs), microbial commercial
activity notices (MCANs), and significant new use notices (SNUNs)
submitted to EPA under TSCA. This document presents statements of
findings made by EPA on such submissions during the period from
February 1, 2022 to February 28, 2022.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Rebecca Edelstein, Chemical Control Division (7405M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 202-
564-1667 email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. As such, the
Agency has not attempted to describe the specific entities that this
action may apply to. Although others may be affected, this action
applies directly to the submitters of the PMNs addressed in this
action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPPT-2022-0116, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics
Docket (OPPT Docket), Environmental Protection Agency Docket Center
(EPA/DC), West William Jefferson Clinton Bldg., Rm. 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 OPPT Docket is (202) 566-
0280. For the latest information on EPA/DC services and docket access,
visit https://www.epa.gov/dockets.

II. What action is the Agency taking?

    This document lists the statements of findings made by EPA after
review of notices submitted under TSCA section 5(a) that certain new
chemical substances or significant new uses are not likely to present
an unreasonable risk of injury to health or the

environment. This document presents statements of findings made by EPA
during the period from February 1, 2022 to February 28, 2022.

III. What is the Agency's authority for taking this action?

    TSCA section 5(a)(3) requires EPA to review a TSCA section 5(a)
notice and make one of the following specific findings:
     The chemical substance or significant new use presents an
unreasonable risk of injury to health or the environment;
     The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects of the
chemical substance or significant new use;
     The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects and the
chemical substance or significant new use may present an unreasonable
risk of injury to health or the environment;
     The chemical substance is or will be produced in
substantial quantities, and such substance either enters or may
reasonably be anticipated to enter the environment in substantial
quantities or there is or may be significant or substantial human
exposure to the substance; or
     The chemical substance or significant new use is not
likely to present an unreasonable risk of injury to health or the
environment.
    Unreasonable risk findings must be made without consideration of
costs or other non-risk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified as relevant
under the conditions of use. The term ``conditions of use'' is defined
in TSCA section 3 to mean ``the circumstances, as determined by the
Administrator, under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of.''
    EPA is required under TSCA section 5(g) to publish in the Federal
Register a statement of its findings after its review of a TSCA section
5(a) notice when EPA makes a finding that a new chemical substance or
significant new use is not likely to present an unreasonable risk of
injury to health or the environment. Such statements apply to PMNs,
MCANs, and SNUNs submitted to EPA under TSCA section 5.
    Anyone who plans to manufacture (which includes import) a new
chemical substance for a non-exempt commercial purpose and any
manufacturer or processor wishing to engage in a use of a chemical
substance designated by EPA as a significant new use must submit a
notice to EPA at least 90 days before commencing manufacture of the new
chemical substance or before engaging in the significant new use.
    The submitter of a notice to EPA for which EPA has made a finding
of ``not likely to present an unreasonable risk of injury to health or
the environment'' may commence manufacture of the chemical substance or
manufacture or processing for the significant new use notwithstanding
any remaining portion of the applicable review period.

IV. Statements of Administrator Findings Under TSCA Section 5(a)(3)(C)

    In this unit, EPA provides the following information (to the extent
that such information is not claimed as Confidential Business
Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this
period, EPA has made findings under TSCA section 5(a)(3)(C) that the
new chemical substances or significant new uses are not likely to
present an unreasonable risk of injury to health or the environment:
     EPA case number assigned to the TSCA section 5(a) notice.
     Chemical identity (generic name if the specific name is
claimed as CBI).
     Website link to EPA's decision document describing the
basis of the ``not likely to present an unreasonable risk'' finding
made by EPA under TSCA section 5(a)(3)(C).

------------------------------------------------------------------------
       EPA case No.         Chemical identity         Website link
------------------------------------------------------------------------
J-22-0008................  Modified Yeast       https://www.epa.gov/
                            (generic).           system/files/documents/
                                                 2022-03/j-22-
                                                 0008_determination_non-
                                                 cbi_final.pdf.
------------------------------------------------------------------------

(Authority: 15 U.S.C. 2601 et seq.)

    Dated: May 6, 2022.
Madison Le,
Director, New Chemicals Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2022-10188 Filed 5-11-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 3 (Wednesday, January 5, 2011)]
[Notices]
[Pages 569-570]
[FR Doc No: 2010-33292]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0634]

Draft Guidance for Industry and Food and Drug Administration
Staff; Establishing the Performance Characteristics of Nucleic Acid-
Based In Vitro Diagnostic Devices for the Detection and Differentiation
of Methicillin-Resistant Staphylococcus aureus and Staphylococcus
aureus; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Establishing the
Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic
Devices for the Detection and Differentiation of Methicillin-Resistant
Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA).'' The
draft guidance document provides industry and Agency staff with updated
recommendations for studies to establish the analytical and clinical
performance of nucleic acid-based in vitro diagnostic devices (IVDs)
intended for the detection and differentiation of methicillin-resistant
Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA). This draft
guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 5, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Establishing the Performance
Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for
the Detection and Differentiation of Methicillin-Resistant
Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA)'' to the
Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to 301-847-
8149. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Li Li, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5558, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing the draft guidance to provide industry and Agency
staff with recommendations for studies to establish the analytical and
clinical performance of nucleic acid-based IVDs intended for the
detection and differentiation of MRSA and SA. These devices are used to
aid in the prevention and control of MRSA/SA infections in healthcare
settings. This document is limited to studies intended to establish the
performance characteristics of devices that detect the MRSA/SA genome
(nucleic acid). It does not address detection of MRSA/SA antigens or
serological response from the host to the MRSA/SA antigens, nor does it
address establishing performance of non-MRSA/SA components of multi-
analyte or multiplex devices.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on establishing
the performance characteristics of nucleic acid-based IVDs for the
detection and differentiation of MRSA and SA. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Establishing the Performance Characteristics of Nucleic Acid-Based In
vitro Diagnostic Devices for the Detection and Differentiation of
Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus
aureus (SA),'' you may either send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number 1722 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of
information found in FDA regulations and guidance documents. 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 21 CFR part
807, subpart E have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR part 812 have been approved
under OMB control number 0910-0078; the collections of information in
21 CFR 50.23 have been approved under OMB control number 0910-0586; and
the collections of information in 21 CFR 56.115 have been approved
under OMB control number 0910-0130.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-33292 Filed 1-4-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 12 (Thursday, January 21, 2021)]
[Rules and Regulations]
[Pages 6247-6249]
[FR Doc No: 2021-01084]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2020-0459]
RIN 1625-AA00

Safety Zone; Tanapag Harbor, Saipan, CNMI

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is establishing a annually recurring safety
zone for navigable waters within Tanapag Harbor, Saipan. This safety
zone will encompass the designated swim course for the Escape from
Managaha swim event in the waters of Tanapag Harbor, Saipan,
Commonwealth of the Northern Mariana Islands. This action is necessary
to protect all persons and vessels participating in this marine event
from potential safety hazards associated with vessel traffic in the
area. Race participants, chase boats, and organizers of the event will
be exempt from the safety zone. Entry of persons or vessels into the
safety zone is prohibited unless authorized by the Captain of the Port
(COTP) Guam.

DATES: This rule is effective February 22, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2020-0459 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Chief Petty Officer Robert Davis, Sector Guam, U.S. Coast
Guard, by telephone at<PHONE_NUMBER>, or email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    The purpose of this rule is to ensure the safety of the
participants and the navigable waters in the safety zone before,
during, and after the scheduled swim event. In response, on November
20, 2020, the Coast Guard published a notice of proposed rulemaking
(NPRM) titled Safety Zone; Tanapag Harbor, Saipan, CNMI (85 FR 74304-
74306). There we stated why we issued the NPRM, and invited comments on
our proposed regulatory action related to this safety zone. During the
comment period that ended December 21, 2020, we received no comments.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under its authority in 46
U.S.C 70034 (previously 33 U.S.C. 1231). The Captain of the Port (COTP)
Guam has determined that potential hazards exist, and the purpose of
this rule is to protect all persons and vessels participating in this
marine event from potential safety hazards associated with vessel
traffic in the area.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no comments on our NPRM published
November 20, 2020. There are no changes in the regulatory text of this
rule from the proposed rule in the NPRM.
    This rule establishes a annual recurring safety zone from 5:00 a.m.
until 8:30 a.m. on a Saturday or Sunday between February and April. The
safety zone will cover all navigable waters within 100-yard radius of
race participants in Tanapag Harbor, Saipan. This rulemaking would
prohibit persons and vessels not involved in the event from being in
the safety zone unless authorized by the COTP or a designated
representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is

necessary, to select regulatory approaches that maximize net benefits.
Executive Order 13771 directs agencies to control regulatory costs
through a budgeting process. This rule has not been designated a
``significant regulatory action,'' under Executive Order 12866.
Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
will be able to safely transit around this safety zone, which will
impact a small designated area of Tanapag Harbor for 3.5 hours.
Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via
VHF-FM marine channel 16 about the zone, and the rule allows vessels to
seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received 00 comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of
1969(42 U.S.C. 4321-4370f), and have determined that this action is one
of a category of actions that do not individually or cumulatively have
a significant effect on the human environment. This rule involves a
safety zone lasting 3.5 hours that will prohibit entry within 100-yards
of swim participants. It is categorically excluded from further review
under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual
023-01-001-01, Rev. 1. A Record of Environmental Consideration
supporting this determination is available in the docket. For
instructions on locating the docket, see the ADDRESSES section of this
preamble.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--SAFETY ZONE; TANAPAG HARBOR, SAIPAN, CNMI

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

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.1417 to read as follows:

165.1417   Safety Zone; Tanapag Harbor, Saipan, CNMI.

    (a) Location. The following area, within the Guam Captain of the
Port (COTP) Zone (See 33 CFR 3.70-15), all navigable waters within a
100-yard radius of race participants for Escape for Managaha Swim in
Tanapag Harbor, Saipan. Race participants, chase boats, and organizers
of the event will be exempt from the safety zone.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a

Federal, State, and local officer designated by or assisting the
Captain of the Port (COTP) Sector Guam in the enforcement of the safety
zone.
    (c) Regulations. (1) In accordance with the general regulations in
section Sec.  165.23, entry into, transiting, or anchoring within this
safety zone is prohibited unless authorized by the COTP or a designated
on-scene representative.
    (2) This safety zone is closed to all persons and vessel traffic,
except as may be permitted by the COTP or a designated on-scene
representative.
    (3) The ``on-scene representative'' of the COTP is any Coast Guard
commissioned, warrant, or petty officer who has been designated by the
COTP to act on his or her behalf.
    (4) Persons and Vessel operators desiring to enter or operate
within the safety zone must contact the COTP or an on-scene
representative to obtain permission to do so. The COTP or an on-scene
representative may be contacted via VHF Channel 16. Vessel operators
given permission to enter or operate in the safety zone must comply
with all directions given to them by the COTP or an on-scene
representative.
    (d) Enforcement period. This safety zone will be enforced at a
specified date between February and April. The Coast Guard will provide
advance notice of enforcement and a broadcast notice to mariners to
inform public of specific date.

    Dated: January 12, 2021.
Christopher M. Chase,
Captain, U.S. Coast Guard, Captain of the Port, Guam.
[FR Doc. 2021-01084 Filed 1-19-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 23 (Thursday, February 3, 2011)]
[Notices]
[Pages 6144-6146]
[FR Doc No: 2011-2313]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0060]

Positron Emission Tomography; Notice of Public Meeting; Request
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to assist applicants in preparing new drug applications (NDAs)
or abbreviated new drug applications (ANDAs) for fludeoxyglucose (FDG)
18 injection, ammonia N 13 injection, and sodium fluoride F 18
injection used in positron emission tomography (PET) imaging. By
December 12, 2011, FDA expects all producers of PET drugs in commercial
clinical use to submit applications for marketing approval. FDA
recognizes that many PET drug producers are unfamiliar with the drug
approval process. Accordingly, FDA is holding this public meeting to
discuss the drug approval process and FDA's general inspection process.
Elsewhere in this issue of the Federal Register, FDA is announcing the
availability of a revised draft guidance for industry entitled ``PET
Drug Applications--Content and Format for NDAs and ANDAs'' that will be
used at the meeting to explain the drug approval process.

DATES: The meeting will be held on March 2, 2011, from 8:30 p.m. to 5
p.m. See section IV of this document for information on how to register
for and attend the meeting. Submit either electronic or written
comments on this document by March 7, 2011.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, rm. 1503, Silver Spring, MD 20993-
0002.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Giaquinto, Food and Drug Administration, Center for Drug
Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, rm. 6164,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, President Clinton signed the Food and Drug
Administration Modernization Act of 1997 (Pub. L. 105-115) (FDAMA) into
law. Section 121(c) of FDAMA directs FDA to regulate PET drugs. Section
121 requires FDA to develop appropriate procedures for the approval of
PET drugs as well as current good manufacturing practice (CGMP)
requirements for such drugs; to consult with patient advocacy groups,
professional associations, manufacturers, and persons licensed to make
or use PET drugs in the process of establishing these procedures and
requirements; and to not require the submission of NDAs or ANDAs for
compounded PET drugs that are not adulterated as described in the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) for a period of 4
years after the date of enactment of FDAMA or 2 years after the date
FDA adopts special approval procedures and CGMP

requirements for PET drugs, whichever is longer.
    Beginning in 1997, FDA took a series of actions to regulate PET
drugs.
     The Agency conducted several public meetings with various
representatives of an industry trade association, the Academy for
Molecular Imaging (formerly the Institute for Clinical PET (ICP)), and
other interested persons to discuss FDA proposals for PET drug approval
procedures and CGMP requirements. Because certain PET drugs have been
used clinically for a number of years, FDA conducted its own review of
the published literature \1\ to evaluate the safety and effectiveness
of the PET drugs in widespread use for certain indications to
facilitate the process of submitting applications for these products.
---------------------------------------------------------------------------

    \1\ As stated in FDA guidance for industry entitled ``Providing
Clinical Evidence of Effectiveness for Human Drugs and Biological
Products,'' FDA may, in certain circumstances, rely on published
literature alone to support the approval of a new drug product under
section 505 of the FD&C Act (21 U.S.C. 355).
---------------------------------------------------------------------------

     The Agency discussed its preliminary findings on the
safety and effectiveness of FDG F 18 injection (for the assessment of
malignancy as well as left ventricular myocardial viability) and
ammonia N 13 injection (for assessing myocardial perfusion) with the
ICP and other interested persons at public meetings on November 17,
1998, and February 18 and 19, 1999.
     On June 28 and 29, 1999, the Agency presented its findings
to its Medical Imaging Drugs Advisory Committee (Advisory Committee).
The Advisory Committee concluded that FDG F 18 injection and ammonia N
13 injection can be considered safe and effective for the indications
noted previously, although it recommended some revisions to the wording
of the indications proposed by FDA.
     In a notice published in the Federal Register of March 10,
2000 (65 FR 12999), FDA presented its findings of safety and
effectiveness for the PET drugs studied for certain indications and
described the types of applications that can be submitted for FDG F 18
injection, ammonia N 13 injection, and sodium fluoride F 18 injection
used in PET imaging. These findings fulfill the requirement to develop
appropriate approval procedures for these PET drugs.
     In the Federal Register of April 1, 2002, FDA published a
preliminary draft proposed CGMP regulation (67 FR 15344) and a draft
guidance on CGMP requirements (67 FR 15404) for public comment; in the
Federal Register of September 20, 2005, FDA published a proposed rule
(70 FR 55038) and revised draft guidance (70 FR 55145), to solicit
additional public input; in the Federal Register of December 10, 2009
(74 FR 65409), after carefully considering all public input, FDA
published a final CGMP regulation, triggering the 2-year time period
for PET drug producers to submit an NDA or ANDA for any PET drug used
clinically.
    FDA is in the process of establishing a time line for completion of
the review of PET drug applications and approval determinations. PET
drug application submissions must be received by the Agency on or
before December 12, 2011. Applicants may continue to use a PET drug
during the time of our NDA or ANDA review. FDA intends to exercise
enforcement discretion regarding unapproved PET drugs while submissions
are reviewed. However, FDA expects that by December 9, 2015, all PET
drugs in commercial clinical use (i.e., not used under a Radioactive
Drug Research Committee or an investigational new drug application
(IND)) will be used under approved applications and does not intend to
exercise enforcement discretion beyond that date.

II. PET Guidances

    Elsewhere in this issue of the Federal Register, FDA is making
available a revised draft guidance for industry entitled ``PET Drug
Applications--Content and Format for NDAs and ANDAs.'' The draft
guidance provides background information on the regulation of PET
drugs; makes recommendations to help producers decide whether to submit
an NDA or ANDA for their PET drug; includes a description of the
content and format for both an NDA and an ANDA; and provides text that
may be used in the applications.
    More information on CGMP requirements for PET drugs may be found in
the guidance for industry entitled ``PET Drugs--Current Good
Manufacturing Practice (CGMP)'' issued December 2009, available at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070306.pdf.

III. Purpose and Scope of the Meeting

    The purpose of this meeting is to assist applicants in preparing
NDA and ANDA submissions for specific PET drugs: FDG F 18 injection,
ammonia N 13 injection, and sodium fluoride F 18 injection. FDA will
present information designed to assist PET drug producers with the
entire application process. FDA expects to discuss the following topics
at the public meeting:
     Whether to submit an NDA or ANDA,
     Preparing and submitting an NDA,
     Preparing and submitting an ANDA,
     Bioequivalence requirements,
     Labeling,
     User fees,
     Drug Master Files,
     Compliance with CGMPs, and
     INDs.
    The Office of Critical Path Programs is preparing a separate
training session on electronic submission of applications and
electronic drug registration and listing for PET drug producers. The
training will be offered via webinar and will be made available at
several different times. Therefore, these topics will not be addressed
at the March 2, 2011, meeting. For more information on this training
and its availability, please contact Elizabeth Giaquinto (see FOR
FURTHER INFORMATION CONTACT).

IV. Registration and Attendance

    The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating, therefore early
arrival is encouraged. Attendance is free and will be on a first-come,
first-served basis. For more information on meeting registration,
contact Elizabeth Giaquinto (see FOR FURTHER INFORMATION CONTACT).
    If you need special accommodations because of a disability, please
contact Elizabeth Giaquinto (see FOR FURTHER INFORMATION CONTACT) at
least 7 days before the meeting.
    A live Web cast of this meeting will be available on the Agency's
Web site at https://collaboration.fda.gov/petdrugs/ on the day of the
meeting. For more information on the Web cast and Connect Pro meeting,
please contact Elizabeth Giaquinto (see FOR FURTHER INFORMATION
CONTACT).

V. Comments

    Regardless of attendance at the public meeting, interested persons
may submit to the Division of Docket Managements (see ADDRESSES) either
electronic or written comments on the topics discussed in this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m. Monday through Friday.

VI. Transcripts

    Please be advised that as soon as a transcript is available, it
will be

accessible at http://www.regulations.gov. It may be viewed at the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be
available in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. Written requests are to be sent to
Division of Freedom of Information (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857.

    Dated: January 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2313 Filed 2-2-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Proposed Rules]
[Pages 50047-50050]
[FR Doc No: 2018-21455]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0806; Product Identifier 2018-NM-056-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede Airworthiness Directive (AD) 2015-12-
08, which applies to all Airbus SAS Model A318 and A319 series
airplanes and all Model A320-211, A320-212, A320-214, A320-231, A320-
232, A320-233, A321-111, A321-112, A321-131, A321-211, A321-212, A321-
213, A321-231, and A321-232 airplanes. AD 2015-12-08 requires an
inspection to determine the batch number or installation date of the
oxygen pipe assembly that is installed at the end of the right-hand
crew distribution line, and replacement of the pipe if necessary. Since
we issued AD 2015-12-08, further investigation determined that affected
oxygen pipes may have been installed on more airplanes than initially
identified. This proposed AD would revise the applicability to include
additional airplane models and additional pipes to be replaced if
necessary. We are proposing this AD to address the unsafe condition on
these products.

DATES: We must receive comments on this proposed AD by November 19,
2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Airbus
SAS, Airworthiness Office--EIAS, Rond-Point Emile Dewoitine No: 2,
31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email [email protected]; internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0806; 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 NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (phone 800-647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0806;
Product Identifier 2018-NM-056-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this proposed AD. We will consider
all comments received by the closing date and may amend this proposed
AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We issued AD 2015-12-08, Amendment 39-18182 (80 FR 34262, June 16,
2015) (``AD 2015-12-08''), for all Airbus SAS Model A318-111, A318-112,
A318-121, A318-122, A319-111, A319-112, A319-113, A319-114, A319-115,
A319-131, A319-132, A319-133, A320-211, A320-212, A320-214, A320-231,
A320-232, A320-233, A321-111, A320-112, A320-131, A320-211, A320-212,
A320-213, A320-231, and A320-232 airplanes. AD 2015-12-08 requires an
inspection to determine the batch number or installation date of the
oxygen pipe assembly that is installed at the end of the right-hand
crew distribution line, and replacement of the pipe if necessary. AD
2015-12-08 resulted from a report of corrosion found during the
manufacturing process for some oxygen pipe assemblies that are used to
supply oxygen to the flight crew. We issued AD 2015-12-08 to address
corrosion of the oxygen pipe assemblies, which could lead to blocked or
reduced oxygen supply to a flight crew in case of decompression or
smoke/fire in the flight deck. In addition, the presence of particles
in oxygen lines, under certain conditions, increases the risk of fire
in the flight deck.

Actions Since AD 2015-12-08 Was Issued

    Since we issued AD 2015-12-08, we have determined that additional
airplane models may be subject to the identified unsafe condition.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2018-0060R1, dated July 19, 2018 (referred to

after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Airbus SAS Model
A318 and A319 series airplanes; all Model A320-211, A320-212, A320-214,
A320-215, A320-216, A320-231, A320-232, A320-233, A321-111, A321-112,
A321-131, A321-211, A321-212, A321-213, A321-231, and A321-232
airplanes; and certain Model A320-251N, A320-271N, and A321-271N
airplanes. The MCAI states:

    Some oxygen pipe assemblies were found corroded during
manufacturing at supplier level. The affected pipe assembly was
installed at the end of the right hand (RH) crew distribution line,
just upstream of the First Officer and RH Observer oxygen mask
boxes.
    The investigation showed that the affected pipes had been heat
treated just 4 weeks before the summer factory closure and were only
cleaned after re-opening of the factory. During this interruption,
corrosion developed in these pipes.
    This condition, if not detected and corrected, could lead to
blocked or reduced oxygen supply to a flight crew member in case of
decompression or smoke/fire in the cockpit. In addition, the
presence of particles in oxygen lines, under certain conditions,
increases the risk of fire in the cockpit.
    The parts manufacturer identified the batch numbers of the
potentially affected pipes that were manufactured in a specific
period in 2011. Based on that information, Airbus identified the
aeroplanes on which those pipes were installed on the production
line and issued SB A320-35-1069, containing instructions to remove
the affected pipes from service.
    Consequently, EASA issued AD 2013-0278 [which corresponds to FAA
AD 2015-12-08, Amendment 39-18182 (80 FR 34262, June 16, 2015) (``AD
2015-12-08'')] to require the identification and replacement of the
affected oxygen pipes. That [EASA] AD also prohibited installation
of any affected pipe on other aeroplanes.
    After EASA AD 2013-0278 was issued, further investigation
determined that affected oxygen pipes may have been installed on
more aeroplanes than initially identified. Consequently, Airbus
revised SB A320-35-1069 and EASA issued AD 2017-0150, retaining the
requirements of EASA AD 2013-0278, which was superseded, and
requiring the same actions on these additional aeroplanes.
    After EASA AD 2017-0150 was issued, it was determined that five
A320 and A321 NEO aeroplanes had been delivered with a configuration
which potentially allows the installation of an affected oxygen
pipe.
    Consequently, EASA issued AD 2018-0060, retaining the
requirements of EASA AD 2017-0150, which was superseded, expanding
the Applicability to include the five A320 and A321 NEO aeroplanes,
and correcting the Table in Appendix 1 by removing MSN [manufacturer
serial number] 5091 which belongs to Group 2.
    Since that AD was issued, several operator requests were
received to clarify the required actions for Group 3 and Group 4
aeroplanes. It was determined that, as per Airbus configuration
control, the EASA AD No.: 2018-0060R1 affected parts have been
identified as being potentially installed in production only on
Group 1 and Group 2 aeroplanes. However, it is possible that those
parts migrated to other aeroplanes during maintenance; for that
reason, Group 3 and 4 aeroplanes need to be considered. This AD is
revised accordingly.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0806.

Model A320-216 Airplanes

    The Airbus SAS Model A320-216 was type certificated on December 19,
2016. Before that date, any EASA AD that affected Model A320-216
airplanes was included on the Required Airworthiness Action List
(RAAL). Model A320-216 airplanes have subsequently been placed on the
U.S. Register, and will now be included in FAA AD actions. For Airbus
SAS Model A320-216 airplanes, the requirements that correspond to AD
2015-12-08 were mandated by the MCAI via the RAAL. Although that RAAL
requirement is still in effect, for continuity and clarity we have
identified Airbus SAS Model A320-216 airplanes in paragraph (c) of this
proposed AD; the restated requirements of paragraphs (g), (h), and (i)
of this proposed AD would therefore apply to those airplanes.

Related Service Information Under 1 CFR Part 51

    Airbus SAS has issued Service Bulletin A320-35-1069, Revision 3,
dated December 8, 2017. The service information describes an inspection
to determine the batch number or installation date of the oxygen pipe
assembly that is installed at the end of the right hand crew
distribution line, and replacement of the pipe. 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.

Explanation of Revised Service Information

    AD 2015-10-08 required using Airbus Service Bulletin A320-35-1069,
dated April 26, 2013, for an inspection to determine the batch number
or installation date of the oxygen pipe assembly that is installed at
the end of the right-hand crew distribution line, and replacement of
the pipe if necessary. We have determined that Airbus Service Bulletin
A320-35-1069, Revision 3, December 8, 2017, adds additional airplane
models to the applicability, but adds no new actions.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop on other
products of the same type design.

Proposed Requirements of This NPRM

    This proposed AD would retain all requirements of AD 2015-12-08,
and would revise the applicability to include additional airplane
models and additional pipes to be replaced if necessary.

Costs of Compliance

    We estimate that this proposed AD affects 50 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
2 work-hours x $85 per hour = $170...........................              $0             $170           $8,500
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the proposed inspection.
We have no way of determining the number of aircraft that might need
these replacements:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
5 work-hours x $85 per hour = $425....              $0             $425
------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. We do not control warranty coverage for
affected individuals. As a result, we have included all known costs in
our cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes to the Director of the System Oversight
Division.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2015-12-08, Amendment 39-18182 (80 FR 34262, June 16, 2015), and adding
the following new AD:

Airbus SAS: Docket No. FAA-2018-0806; Product Identifier 2018-NM-
056-AD.

(a) Comments Due Date

    We must receive comments by November 19, 2018.

(b) Affected ADs

    This AD replaces AD 2015-12-08, Amendment 39-18182 (80 FR 34262,
June 16, 2015) (``AD 2015-12-08'').

(c) Applicability

    This AD applies to the Airbus SAS airplanes identified in
paragraphs (c)(1) through (c)(5) of this AD, certificated in any
category.
    (1) Model A318-111, -112, -121, and -122 airplanes, all
manufacturer serial numbers.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes, all manufacturer serial numbers.
    (3) Model A320-211, -212, -214, -216, -231, -232, and -233
airplanes, all manufacturer serial numbers.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, and -232
airplanes, all manufacturer serial numbers.
    (5) Model A320-251N, A320-271N, and A321-271N airplanes,
manufacturer serial numbers 6101, 6286, 6419, 6642, and 6673.

(d) Subject

    Air Transport Association (ATA) of America Code 35, Oxygen.

(e) Reason

    This AD was prompted by a report of corrosion found during the
manufacturing process for some oxygen pipe assemblies that are used
to supply oxygen to the flight crew. We are issuing this AD to
address corrosion of the oxygen pipe assemblies, which could lead to
blocked or reduced oxygen supply to a flight crew in case of
decompression or smoke/fire in the flight deck. In addition, the
presence of particles in oxygen lines, under certain conditions,
increases the risk of fire in the flight deck.

(f) Compliance

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

(g) Retained Inspection for Batch Numbers and Replacement, With New
Service Information

    This paragraph restates the requirements of paragraph (g) of AD
2015-12-08, with new service information. For airplanes identified
in paragraph 1.A. of Airbus Service Bulletin A320-35-1069, dated
April 26, 2013: Within 7,500 flight hours or 26 months, whichever
occurs first after July 21, 2015 (the effective date of AD 2015-12-
08), inspect the crew oxygen pipe, having part number (P/N)
D3511032000640, to determine the batch number of that pipe, in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A320-35-1069, dated April 26, 2013; or Airbus Service
Bulletin A320-35-1069, Revision 03, dated December 8, 2017. A review
of airplane maintenance records is acceptable in lieu of this
inspection if the batch number of the pipe can be conclusively
determined from that review. If the batch number of the oxygen pipe
is 19356252, 40008586, 40076689, 40187414, 40292749, 40405164,
40649383, 40724994, 40820410, or 40911832: Within 7,500 flight hours
or 26 months, whichever occurs first after July 21, 2015, replace
the oxygen pipe with a serviceable part, in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A320-35-1069,
dated April 26, 2013; or Airbus Service Bulletin A320-35-1069,
Revision 03, dated December 8, 2017. After the effective date of
this AD, only Airbus Service Bulletin A320-35-1069, Revision 3,
dated December 8, 2017, may be used to do the actions required by
this paragraph.

(h) Retained Inspection for Part Number and Installation Date of Crew
Oxygen Pipe, With No Changes

    This paragraph restates the requirements of paragraph (h) of AD
2015-12-08, with no changes. For airplanes identified in paragraphs
(c)(1) through (c)(4) of this AD that are not identified in
paragraph 1.A. of Airbus Service Bulletin A320-35-1069, dated April
26, 2013: Within 7,500 flight hours or 26 months, whichever occurs
first after July 21, 2015 (the effective date of AD 2015-12-08),
inspect the crew oxygen pipe to determine whether P/N D3511032000640
was installed after June 2011. A review of airplane maintenance
records is acceptable in lieu of this inspection if the part number
and installation date of the pipe can be conclusively determined
from that review. If the pipe was installed after June 2011, or the
date cannot be conclusively determined, before further flight, do
the actions required in paragraph (g) of this AD.

(i) Retained Parts Installation Prohibition, With No Changes

    This paragraph restates the requirements of paragraph (i) of AD
2015-12-08, with no changes. For airplanes identified in paragraphs
(c)(1) through (c)(4) of this AD, except for Model A320-216
airplanes: As of July 21, 2015 (the effective date of AD 2015-12-
08), do not install, on any airplane, a crew oxygen pipe P/N
D3511032000640, that is identified as belonging to batch number
19356252, 40008586, 40076689, 40187414, 40292749, 40405164,
40649383, 40724994, 40820410, or 40911832.

(j) New Requirement of This AD: Inspection for Batch Numbers and
Replacement for Certain Airplanes

    For airplanes identified in paragraph (c)(5) of this AD and for
Model A320-216 airplanes: Within 7,500 flight hours or 26 months,
whichever occurs first after the effective date of this AD, inspect
the crew oxygen pipe, having P/N D3511032000640, to determine the
batch number of that pipe, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A320-35-1069, Revision 03,
dated December 8, 2017. A review of airplane maintenance records is
acceptable in lieu of this inspection if the batch number of the
pipe can be conclusively determined from that review. If the batch
number of the oxygen pipe is 19356252, 40008586, 40076689, 40187414,
40292749, 40405164, 40649383, 40724994, 40820410, or 40911832:
Within 7,500 flight hours or 26 months, whichever occurs first after
the effective date of this AD, replace the oxygen pipe with a
serviceable part, in accordance with the Accomplishment Instructions
of Airbus Service Bulletin A320-35-1069, Revision 03, dated December
8, 2017.

(k) New Parts Installation Prohibition for Certain Airplanes

    For airplanes identified in paragraph (c)(5) of this AD and for
Model A320-216 airplanes: As of the effective date of this AD, do
not install, on any airplane, a crew oxygen pipe P/N D3511032000640,
that is identified as belonging to batch number 19356252, 40008586,
40076689, 40187414, 40292749, 40405164, 40649383, 40724994,
40820410, or 40911832.

(l) Credit for Previous Actions

    (1) For the airplanes identified in paragraph (g) of this AD:
This paragraph provides credit for actions required by paragraph (g)
of this AD, if those actions were performed before July 21, 2015
(the effective date of AD 2015-12-08) using a service bulletin
identified in paragraph (l)(1)(i) or (l)(1)(ii) of this AD.
    (i) Airbus Service Bulletin A320-35-1069, Revision 01, dated
March 24, 2014.
    (ii) Airbus Service Bulletin A320-35-1069, Revision 02, dated
October 26, 2016.
    (2) For airplanes identified in paragraph (j) of this AD: This
paragraph provides credit for actions required by paragraph (j) of
this AD, if those actions were performed before the effective date
of this AD using a service bulletin identified in paragraph
(l)(2)(i), (l)(2)(ii), or (l)(2)(iii) of this AD.
    (i) Airbus Service Bulletin A320-35-1069, dated April 26, 2013.
    (ii) Airbus Service Bulletin A320-35-1069, Revision 01, dated
March 24, 2014.
    (iii) Airbus Service Bulletin A320-35-1069, Revision 02, dated
October 26, 2016.

(m) Other FAA AD Provisions

    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards 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 International Section, send it to the attention of
the person identified in paragraph (n)(2) of this AD. Information
may be emailed to: [email protected]. 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.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Section, Transport Standards
Branch, FAA; or the European Aviation Safety Agency (EASA); or
Airbus SAS's EASA Design Organization Approval (DOA). If approved by
the DOA, the approval must include the DOA-authorized signature.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2018-0060R1, dated July 19, 2018, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0806.
    (2) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAL, Rond-Point Emile Dewoitine
No: 2, 31700 Blagnac Cedex, France; phone: +33 5 61 93 36 96; fax:
+33 5 61 93 45 80; email: [email protected];
internet: http://www.airbus.com. You may view this service
information at the FAA, Transport Standards Branch, 2200 South 216th
St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on September 23, 2018.
John P. Piccola,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-21455 Filed 10-3-18; 8:45 am]
 BILLING CODE 4910-13-P