[Federal Register Volume 84, Number 198 (Friday, October 11, 2019)]
[Rules and Regulations]
[Pages 54785-54790]
[FR Doc No: 2019-22108]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2018-0621, FRL-10000-91-Region 2]

Approval of Source-Specific Air Quality Implementation Plans; New
Jersey

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving the
source-specific revisions to the New Jersey State Implementation Plan
(SIP) for 8-hour ozone for Paulsboro Refining, Buckeye Port Reading
Terminal, Buckeye Pennsauken Terminal, and Phillips 66 Company's Linden
facility. The current source-specific SIP revision addresses the
Reasonably Available Control Technology for volatile organic compounds
(VOC) for external floating roof tanks. The intended effect of this
revision is to address the Federal and state regulatory obligations for
external floating roof tanks that store VOC with vapor pressure three
(3) or more pounds per square inch absolute to be equipped with a domed
roof.

DATES: This final rule is effective on November 12, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID Number EPA-R02-OAR-2018-0621. All documents in the docket are
listed on the http://www.regulations.gov website. 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 electronically through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Linda Longo, Air Programs Branch,
Environmental Protection Agency, Region 2 Office, 290 Broadway, 25th
Floor, New York, New York 10007-1866,<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. The EPA's Evaluation of New Jersey's Submittals
III. Comments Received in Response to EPA's Proposed Action
IV. Summary of EPA Final Action
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. Background

    The EPA is approving the revision to the New Jersey SIP for
attainment and maintenance of the 8-hour ozone National Ambient Air
Quality Standards (NAAQS) for the following major VOC facilities:
Paulsboro Refining, Buckeye Port Reading Terminal, Buckeye Pennsauken
Terminal, and Phillips 66 Company's Linden facility. Specifically,
under New Jersey Administrative Code (NJAC), Title 7, Chapter 27,
Subchapter 16 (``Control and Prohibition of Air Pollution by Volatile
Organic Compounds''), Section 2 (``VOC Stationary Storage Tanks''), all
external floating roof tanks (EFRT) in Range III with vapor pressure
three (3) or more pounds per square inch absolute (psia) and that were
in existence on May 18, 2009 must be equipped with a domed roof the
first time the tank is degassed after May 19, 2009, and by no later
than May 1, 2020. See NJAC 7:27-16.2(l)(4). However, NJAC 7:27-16.17(a-
q) sets forth procedures and standards for establishing alternative and
facility-specific VOC control requirements for situations in which,
among other things, a facility can demonstrate that the control
requirements pursuant to NJAC 7:27-16.2 are not economically or
technologically feasible as applied to its operations. The EPA approved
NJAC 7:27-16.17(a-q) into the New Jersey SIP in 2010 (See 75 FR 45483
(August 3, 2010)) and is utilizing its functions in this current
action.
    As was discussed in EPA's October 29, 2018 (83 FR 54300) proposal,
the EPA reviewed the four facilities' alternative VOC control plans and
Reasonably Available Control Technology (RACT) analyses submitted with
New Jersey's SIP revision. The New Jersey Department of Environmental
Protection (NJDEP) concluded and the RACT analyses concluded that: (1)
Installing domes on 25 out of the 51 EFRT currently lacking them in
accordance with the proposed schedule which identifies the doming dates
for some tanks beyond the 2020 compliance date as authorized under NJAC
7:27-16.17, is economically and technologically feasible and therefore
RACT and (2) doming the remaining 26 EFRT currently without domes is
not

economically and technologically feasible and therefore not RACT. A
full summary, including RACT requirements, is included in the technical
support document (TSD) that is contained in the EPA's docket assigned
to this Federal Register document.

II. The EPA's Evaluation of New Jersey's Submittals

    The four facilities' source-specific SIP revisions found that the
doming of the total inventory of EFRT was not RACT, but the doming of
25 out of 51 EFRT on a delayed proposed schedule was technologically
and economically feasible pursuant to the New Jersey SIP and found that
doming the remaining 26 was not economically feasible. The EPA has
determined that the economic analyses regarding doming identified in
the source-specific SIP revisions are consistent with the NJDEP's VOC
RACT regulation and the EPA's rules and guidance. A detailed discussion
of the doming requirements, schedules and EPA's evaluation can be found
in the October 29, 2018 proposal and will not be restated here. See 83
FR 54300 (October 29, 2018).

III. Comments Received in Response to EPA's Proposed Action

    In response to EPA's October 29, 2018 proposed approval of the
source-specific revisions to the New Jersey State Implementation Plan
(SIP) for 8-hour ozone for Paulsboro Refining, Buckeye Port Reading
Terminal, Buckeye Pennsauken Terminal, and Phillips 66 Company's Linden
facility, the EPA received public comments from five Commenters during
the 30-day public comment period. After reviewing the comments, the EPA
has determined that two Commenters provided feedback that is outside
the scope of our proposed action or fails to identify any material
issue necessitating a response. The comments do not raise issues
relevant to the EPA's proposed action, therefore, the EPA will not
provide a specific response to these comments. The EPA did, however,
receive comments from three Commenters that are relevant and
significant to the EPA's proposed action, warranting a response from
the EPA. The relevant comments are summarized below and followed by an
EPA response. All comments submitted may be viewed under Docket ID
Number EPA-R02-OAR-2018-0621 on the http://www.regulations.gov website.
    Comment: According to the Paulsboro RACT analysis the cost estimate
to dome all 21 of the facility's ERFTs is in the range of $19,000-
149,000 per ton VOC reduced. The lower limit of $19,000 is within the
State's definition of what is economically feasible. The EPA should
reverse the NJDEP's decision to allow this facility not to dome eleven
of its 21 EFRT, furthermore, the EFRT should be domed six months ahead
of what is expected under the source-specific SIP revision.
    Response: The EPA disagrees that the cost of doming Paulsboro's
total inventory of 21 ERFT is economically feasible and that the
timeline for completing the doming requirement should be six months
sooner than in the source-specific SIP revision. EPA disagrees $19,000
is within New Jersey's range of economically feasible RACT control. The
commenter did not provide any documentation to support the statement
that the lower limit of $19,000 is within the State's definition of
what is economically feasible. On the contrary, New Jersey's SIP
revision specifically states the Paulsboro RACT analysis estimates the
cost to dome all 21 of the facility's ERFTs is in the range of $19,000-
149,000 per ton VOC reduced, and that this is not cost-effective for
meeting RACT. Therefore, as authorized in the New Jersey SIP, the
facility developed a cost-effective alternative plan to reduce VOC
emissions (i.e., the alternative VOC control plan).
    As for doming considered to be RACT, the EPA recognizes the doming
provision in NJAC 7:27-16.2 is intended to cover situations in which
doming an EFRT is RACT (that is, when implementation of the action is
both economically and technologically feasible) and that facilities are
allowed, under NJAC 7:27-16.17 to submit an alternative VOC control
plan where implementation of the prescribed RACT is demonstrated by the
facilities to be economically or technologically infeasible as applied
to their specific operations. This alternative VOC control plan
provision is intended to cover case-by-case circumstances for
facilities to explore cost effective options for VOC emission reduction
techniques. The EPA also takes notice of the fact that the facilities'
calculated lower limit of $19,000 per ton VOC emission reduced, is well
above what EPA has historically defined as economically feasible (i.e.,
$160-1300).\1\ Furthermore, contrary to the statement by the comment,
the 2007 New Jersey RACT Plan (i.e., State RACT rules) approved by the
EPA and discussed in the EPA's October 29, 2018 (83 FR 54300) proposal,
do not include a specific dollar amount. Thus, the four facilities
submitted an alternative VOC control plan and NJDEP has approved,
pursuant to the New Jersey ozone SIP, which is the subject of this
rulemaking.
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    \1\ EPA guidance in 1994 indicated States should consider in
their RACT determinations technologies that achieve 30-50 percent
reduction within a cost range of $160-1300 per ton of NOX
emissions reduced. See 70 FR 71652.
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    Paulsboro, and the other facilities under this rulemaking,
considered the Federal and state RACT requirements, determining that
the cost of doming the total inventory of EFRT by the compliance
deadline is beyond the range of what traditionally EPA and the State
would consider RACT. The intent of the alternative VOC control plan, as
authorized under NJAC 7:27-16.17, is to create an alternative to the
requirement to dome the facility's total inventory of EFRT that are
subject to the doming requirement under NJAC 7:27-16.2 (``doming
requirement''), because the facility has demonstrated that doming the
tanks by the compliance date is not economically feasible under the
State's RACT Plan. Under the alternative VOC control plan, the facility
will follow an alternative implementation schedule (``Alternative
Implementation Schedule'') in complying with the doming requirement on
the identified tanks, as authorized under NJAC 7:27-16.17(d)(2)(x).
Under NJAC 7:27-16.2(p)(2)(ii), the facility can submit a facility-wide
VOC control plan with an implementation schedule that, among other
requirements, ``shall be consistent with the facility's schedule for
tank removal from service for normal inspection and maintenance.'' The
facility's Alternative Implementation Schedule, as set forth in its
alternative VOC control plan, is based on the facility's 15-20-year
maintenance schedule for removing tanks from service for inspection and
maintenance; the Alternative Implementation Schedule will allow the
facility to achieve compliance in a cost reasonable manner. See
www.regulations.gov EPA-R02-OAR-2018-0621, Final TSD Paulsboro Buckeye
Phillips. According to the facility's RACT analysis cost table, (see
www.regulations.gov EPA-R02-OAR-2018-0621, Paulsboro SIP revision EFRT
domes 12 10 2015, Enclosure 7, Attachment 1), doming the set of tanks
that are designated for compliance by the 2020 compliance date is
economically feasible for those tanks because the annualized costs of
installation and maintenance of the domes are within the State's RACT
Plan considering the facility's business model. By contrast, the
annualized costs of installation and maintenance of the domes for tanks
that are following the Alternative Implementation Schedule to comply
after the default 2020 compliance date are beyond RACT

because it is not economically feasible to dome them by compliance
date. Doming these tanks would be too costly and unreasonable to dome
tanks that are not out-of-service. According to the facility's RACT
analysis cost table, generally, the group of tanks following the
Alternative Implementation Schedule has higher total costs (i.e.,
maintenance, administrative, and annualized) than the tanks being domed
by the default compliance date, a difference of approximately $119,000
more. The facility's costs for doming are based on the EPA Control Cost
Manual (see https://www.epa.gov/economic-and-cost-analysis-air-pollution-regulations/cost-reports-and-guidance-air-pollution) using a
7% interest over a 20-year useful life for each dome. The proposed
Alternative Implementation Schedule in the alternative VOC control plan
allows for the facility to spread the cost of installing and
maintaining the domes over a more reasonable timeline; this phased
approach allows the facility to minimize interference with normal
operation while achieving sufficient VOC emission reductions to support
the State's Ozone NAAQS attainment goals.
    With respect to the comment to require doming on the EFRT to be
completed six months ahead of the proposed dates, EPA believes this is
unwarranted. Installing the domes on a schedule earlier than what the
facilities provided in their analyses is not economically feasible and
therefore not RACT. Ideally, domes should be installed after the tank
is completely empty and out of service with ideal environmental weather
conditions, which makes timing important. The schedules outlined in the
facilities' alternative VOC control plans allow them flexibility to
schedule installation of the domes during ideal conditions and allow
for continuation of normal operating procedures. New Jersey has
exercised its authority under NJAC 7:27-16.17(d) and has considered the
facilities' proposed schedule for completion as a criterion in
determining that the alternative control plans are sufficient.
    Comment: The EPA cannot approve the EFRT dome deadline extensions
as they exceed the regulatory and statutory mandate that RACT must be
implemented ``as expeditiously as practicable but no later than 3
years.'' Title 40 CFR 51.1112(a)(3) requires ``The state shall provide
for implementation of RACT as expeditiously as practicable but no later
than January 1 of the 5th year after the effective date of designation
for the 2008 ozone NAAQS.''
    Response: The current action is approval of a source-specific SIP,
not the overall State RACT SIP. Given that, the overall State 2008 RACT
effective date is March 12, 2008, and the EPA approved the overall
State's RACT SIP revision to address the 2008 8-hour ozone NAAQS on May
15, 2009, within the statutory 24-month deadline for implementing RACT
40 CFR 51.1112(a)(3) applies to the overall implementation of the
State's RACT SIP. RACT compliance for a source-specific RACT
determination submitted as a SIP revision, as we have in this rule
making, is largely based on when the State submits and EPA acts on the
SIP revision.
    As stated in the previous response, installing the domes on a
schedule earlier than what the facilities provided in their analyses is
not economically feasible and therefore not RACT. Therefore,
installation of the domes by 2017 for the 2008 Ozone NAAQS and earlier
for the 1997 Ozone NAAQS, as the commenter suggests, would not be RACT
because it is not economically feasible.
    Comment: The EPA cannot approve this source-specific SIP revision
because New Jersey failed to provide an anti-backsliding analysis as
required under sections 110 and 172 of the CAA. As the Subchapter 16 is
approved into the ozone SIP and requires all EFRT in Range III to be
domed by no later than 2020, any exemption to this rule must consider
anti-backsliding. Furthermore, New Jersey is part of both the New York
non-attainment area and the ozone transport area where VOCs from tanks
like these can impede area's ability to attain the ozone standard.
    Response: The EPA recognizes the applicability of section 110(l) of
the CAA for source-specific SIP revisions, but in this instance, EPA
disagrees there is a cause for disapproval. Section 110(l) of the CAA
prohibits the EPA from approving revisions to a SIP if the revision
would interfere with any applicable requirement concerning attainment
and reasonable further progress, or any other requirement of the CAA.
In a circumstance such as that presented here, where approval of the
RACT alternative (i.e., the source-specific determination) would impact
air quality in a nonattainment area that is required to have an
attainment demonstration, any attainment demonstration for the area
must account for the source-specific RACT, and may do so: (1) By
showing that the attainment demonstration, in fact, accounts for the
source-specific RACT alternative; or (2) where the attainment
demonstration has not yet been approved, by showing (e.g., by
presenting information to be included in a forthcoming attainment
demonstration) that the attainment demonstration will be able to
properly account for emissions attributable to the proposed RACT
alternative. For example, the information could show that the
forthcoming attainment demonstration will not rely on emission
reductions for the source category as a whole, or that it will reduce
the emissions decreases credited to the source category by the
estimated amount of increases associated with source-specific RACT
determinations.
    The EPA has determined that this SIP revision does not interfere
with any applicable New Jersey ozone plan concerning attainment and
reasonable further progress of the NAAQS, or any applicable requirement
of the CAA. The ``applicable New Jersey ozone plan concerning
attainment and reasonable further progress'' for purposes of this SIP
revision is New Jersey's attainment demonstration SIP for the 2008
ozone standard. Two of the four facilities addressed in this SIP
revision are located in the northern portion of the State as part of
the New York-Northern New Jersey-Long Island, NY-NJ-CT (also referred
to as the New York Metropolitan Area or NYMA) moderate nonattainment
area. The comment is correct that Subchapter 16 (NJAC 7:27-16.2) is
approved into the New Jersey ozone SIP and the requirement for all EFRT
in Range III to be domed by 2020 is part of the SIP. While projected
emission controls in the New Jersey 2008 ozone attainment modeling \2\
included ozone projections to 2017 for bulk petroleum storage
degassing, cleaning, landing, and slotted guide poles, the emission
controls for placing domes on EFRT were not part of the modeling and no
VOC emission reduction credits (neither for all of the EFRT being domed
nor a percentage of them being domed) were relied upon for attainment
nor reasonable further progress of the ozone NAAQS. The ozone
attainment date for 1997 and 2008 ozone NAAQS for the NYMA are June 15,
2010 and June 20, 2018, respectively, but the doming requirement under
NJAC 7:27-16 has a future compliance date that is beyond this current
action, and beyond the attainment date for both the 1997 and 2008 ozone
NAAQS. New Jersey

recognized that (1) requiring doming of EFRT is an aggressive VOC
emission reduction requirement, and (2) when promulgating these
aggressive VOC emission reduction requirements to require doming of
EFRT, individual facilities may demonstrate, consistent with the SIP
approved provisions of NJAC 7:27-16.2 and 16.17, that these
requirements are not technologically and economically feasible or RACT
as applied to their operations, and therefore, New Jersey did not rely
on the maximum benefit of all, nor a percentage of the EFRT being domed
in the applicable New Jersey ozone attainment plan. There can be no
threat of backsliding of the NAAQS for these two source-specific SIP
revisions.
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    \2\ NJDEP State Implementation Plan Revision for Attainment and
Maintenance of the 75 ppb and 85 ppb Ozone National Ambient Air
Quality Standards, Ozone Attainment Demonstrations for the Northern
New Jersey-New York-Connecticut Nonattainment Area, https://www.state.nj.us/dep/baqp/ozoneppb.html.
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    The other two facilities addressed in this revision are located in
the southern area of the State, Paulsboro and Pennsauken, and part of
the Philadelphia-Wilmington-Atlantic City (PA-NJ-MD-DE) ozone
nonattainment area that is classified as marginal nonattainment for
both the 2008 and 2015 ozone NAAQS so the State has no requirement to
conduct attainment modeling nor to submit an attainment or reasonable
further progress plan. Therefore, a comparison of the VOC emissions
from the combined 12 EFRT (11 EFRT in Paulsboro and 1 EFRT in
Pennsauken) not being domed to the EPA approved 2011 VOC emissions
(See, 82 FR 44099 (September 21, 2017)) for the New Jersey portion of
Philadelphia-Wilmington-Atlantic City ozone nonattainment area to show
that the difference in emissions between the presumptive RACT and
source-specific RACT is so small that it should not interfere with
attainment or maintenance of the NAAQS or any other applicable
requirement. The combined VOC emissions by not doming the 12 EFRT is
approximately 14.98 tons per year (see the TSD for this action) or
0.041 tons per day compared to the total VOC emissions for the PA-NJ-
MD-DE area of 199.09 tons per day which correlates to approximately
0.021 percentage change in VOC emissions. Based on this minimal VOC
emissions change, EPA has determined there to be no threat of
backsliding of the NAAQS for these two source-specific SIP revisions.
    EPA also notes that New Jersey will have to account for the air
quality benefits achieved from the doming of any EFRT in any future
applicable ozone attainment or reasonable further progress plans where
the planning milestones (i.e., attainment date or projection year
emissions inventory) are beyond the applicable compliance date for
doming the EFRT. Specifically, New Jersey will have to account for the
doming of any EFRT in the ozone attainment plan for the 2008 serious
nonattainment NYMA area which is due August 3, 2020 and must show
attainment by July 20, 2021. See 84 FR 44238, August 23, 2019.
    Lastly, section 172(e) of the CAA provides that when the
Administrator relaxes a NAAQS, the EPA must ensure that all areas which
have not attained that NAAQS maintain ``controls which are no less
stringent than the controls applicable to areas designated
nonattainment before such relaxation.'' Although section 172(e) has
never applied directly to EPA's ozone standards, because those ozone
standards have only increased in stringency over time, the EPA has
applied the principles of section 172(e) to develop anti-backsliding
regulations following revocation of the 1-hour and 1997 ozone
standards. For this action, the procedure for approving alternatives
pursuant to NJAC 7:27-16.2 and 16.17 has already been approved by the
EPA (See, 75 FR 45483 (August 3, 2010)) and is in the New Jersey SIP,
so for the purposes of 172(e) the EPA is not altering the RACT
provision and is executing it as approved.

IV. Summary of EPA's Final Action

    The NJDEP determined that the four facilities discussed above could
avoid doming 26 EFRT, because requiring the four facilities' total
inventory of 51 EFRT to be domed by the default compliance date under
NJAC 7:27-16 would be economically infeasible and not RACT.
Specifically, the EPA is approving the NJDEP SIP revisions for 8-hour
ozone to allow the Paulsboro facility not to dome eleven EFRT; the
Buckeye facilities not to dome five EFRT; and the Phillips 66 Company
facility not to dome ten EFRT. The EPA is also approving the
requirement to dome the remaining 25 EFRT in accordance with the
schedule set out in the facilities' alternative control plan. This SIP
revision would require the facilities to dome eight of the 25 EFRT on a
delayed timeline due to the economic infeasibility of doming the tanks
by 2020 (and convert one EFRT to an internal floating roof tank).
    As stated in EPA's October 29, 2018 proposal, NJAC 7:27-16.17
establishes procedures and standards for alternative, facility-specific
VOC control requirements. Under NJAC 7:27-16.17(l)(2), a source seeking
approval for facility-specific controls must modify its Title V
operating permit to incorporate the approved alternative control plan
and comply with the plan's requirements in order to comply with NJAC
7:27-16.

V. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
provisions described above in Section IV. Final Action. EPA has made,
and will continue to make, these materials generally available through
http://www.regulations.gov and at the EPA Region 2 Office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information). Therefore, these
materials have been approved by EPA for inclusion in the State
Implementation Plan, have been incorporated by reference by EPA into
that plan, are fully federally enforceable under sections 110 and 113
of the Clean Air Act as of the effective date of the final rulemaking
of EPA's approval, and will be incorporated by reference in the next
update to the SIP compilation. See 62 FR 27968 (May 22, 1997).

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided they meet the criteria of the CAA. Accordingly, this action
merely approves state law as meeting Federal requirements and does not
impose additional requirements beyond those imposed by state law. For
that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described

in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4);
     does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175, because the SIP is not approved to
apply in Indian country located in the state, and the EPA notes that it
will not impose substantial direct costs on tribal governments or
preempt tribal law. Thus, Executive Order 13175 does not apply to this
action.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by December 10, 2019. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

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

    Dated: September 23, 2019.
Peter D. Lopez,
Regional Administrator, Region 2.

    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart FF--New Jersey

0
2. Section 52.1570(d) is amended by adding entries for ``Paulsboro
Refinery,'' ``Buckeye Port Reading Terminal,'' ``Buckeye Pennsauken
Terminal,'' and ``Phillips 66 Company Linden'' to the end of the table
to read as follows:

Sec.  52.1570   Identification of plan.

* * * * *
    (d) * * *

                               EPA--Approved New Jersey Source-Specific Provisions
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                                                          State
         Name of source              Identifier No.     effective    EPA approval date           Comments
                                                           date
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                                                  * * * * * * *
Paulsboro Refinery..............  PI 55829; BOP          6/26/2018  10/11/2019, [Insert  The External floating
                                   180002 U900.                      citation of          roof tanks (EFRTs)
                                                                     publication].        that are not being
                                                                                domed include tank
                                                                                numbers 725, 802,
                                                                                1023, 1027, 2869,
                                                                                2940, 2941, 3174, S8O,
                                                                                S8I, and S82. The
                                                                                EFRTs that may
                                                                                complete doming after
                                                                                the regulatory
                                                                                deadline include tank
                                                                                numbers 1063, 1116,
                                                                                1320, 1065, and 1066.
Buckeye Port Reading Terminal...  PI 17996, BOP          6/13/2018  10/11/2019, [Insert  The EFRTs that are not
                                   160001 U8.                        citation of          being domed include
                                                                     publication].        tank numbers 7930,
                                                                                7934, 7937, and 7945.
                                                                                The EFRTs that may
                                                                                complete doming after
                                                                                the regulatory
                                                                                deadline include tank
                                                                                numbers 1219 and 1178.
Buckeye Pennsauken Terminal.....  PI 51606, BOP          8/21/2014  10/11/2019, [Insert  The EFRT that are not
                                   130002 U1.                        citation of          being domed include
                                                                     publication].        tank number 2018.
Phillips 66 Company Linden......  PI 41805, BOP          1/26/2018  10/11/2019, [Insert  The EFRTs that are not
                                   170004 U16.                       citation of          being domed include
                                                                     publication].        tank numbers T52,
                                                                                T105, T119, T134,
                                                                                T244, T349, T350,
                                                                                T354, T355, and T356.
                                                                                The EFRT that may
                                                                                complete doming after
                                                                                the regulatory
                                                                                deadline include tank
                                                                                number T234.
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 2019-22108 Filed 10-10-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 12, 2009 (Volume 74, Number 7)]
[Proposed Rules]
[Page 1164-1166]
[DOCID:fr12ja09-14]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-1361; Directorate Identifier 2008-NM-140-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier Model DHC-8-102, -103, and -
106 Airplanes and DHC-8-200, -300, and -400 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    A fuselage spoiler cable disconnect sensing device was installed
in production on later DHC-8 Series 100/200/300 aircraft, and on all
DHC-8 Series 400 aircraft. On earlier DHC-8 Series 100/200/300
aircraft, its installation was mandated by [Canadian] Airworthiness
Directive CF-2006-13 [which corresponds to FAA AD 2007-21-16].
    However, several incorrectly assembled spoiler cable disconnect
sensing devices have recently been discovered on in-service
aircraft. A pulley and plastic spacer had been inadvertently
interchanged during assembly of the device in production, resulting
in the spoiler cable sliding on the spacer rather than on the
pulley, as designed.
    Continued operation with an incorrectly assembled spoiler cable
disconnect sensing device could result in impaired operation of the
sensing device and/or an eventual fuselage spoiler cable disconnect,
with possible reduced controllability of the aircraft.

The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by February 11,
2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet http://www.bombardier.com.
You may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dan Parrillo, Aerospace Engineer,
Airframe and Propulsion Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-1361;
Directorate Identifier 2008-NM-140-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

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2008-28, dated July 10, 2008 (referred to after this as ``the MCAI''),
to correct an unsafe condition for the specified products. The MCAI
states:

    A fuselage spoiler cable disconnect sensing device was installed
in production on later DHC-8 Series 100/200/300 aircraft, and on all
DHC-8 Series 400 aircraft. On earlier DHC-8 Series 100/200/300
aircraft, its installation was mandated by [Canadian] Airworthiness
Directive CF-2006-13 [which corresponds to FAA AD 2007-21-16].
    However, several incorrectly assembled spoiler cable disconnect
sensing devices have recently been discovered on in-service
aircraft. A pulley and plastic spacer had been inadvertently
interchanged during assembly of the device in production, resulting
in the spoiler cable sliding on the spacer rather than on the
pulley, as designed.
    Continued operation with an incorrectly assembled spoiler cable
disconnect sensing device could result in impaired operation of the
sensing device and/or an eventual fuselage spoiler cable disconnect,
with possible reduced controllability of the aircraft.

Required actions include inspecting the fuselage spoiler cable
disconnect sensing device and, if necessary, inspecting components for
wear and damage, replacing worn or damaged components, and correctly
re-assembling the sensing device. You may obtain further information by
examining the MCAI in the AD docket.

Relevant Service Information

    Bombardier has issued Service Bulletins 84-27-34, dated October 3,
2007, and 8-27-107, dated October 16, 2007. The actions described in
this service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    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 pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 145 products of U.S. registry. We also estimate that
it would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $11,600, or $80 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this 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); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Bombardier, Inc. (Formerly de Havilland, Inc.): Docket No. FAA-2008-
1361; Directorate Identifier 2008-NM-140-AD.

Comments Due Date

    (a) We must receive comments by February 11, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to the following Bombardier Model DHC-8
airplanes, certificated in any category.
    (1) Model DHC-8-102, -103, -106, -201, -202, -301, -311, and -
315 airplanes, serial numbers 003 through 644 inclusive.
    (2) Model DHC-8-400, -401 and -402 airplanes, serial numbers
4003, 4004, 4006, and 4008 through 4164 inclusive.

Subject

    (d) Air Transport Association (ATA) of America Code 27: Flight
controls.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    A fuselage spoiler cable disconnect sensing device was installed
in production on later DHC-8 Series 100/200/300 aircraft, and on all
DHC-8 Series 400 aircraft. On earlier DHC-8 Series 100/200/300
aircraft, its installation was mandated by [Canadian] Airworthiness
Directive CF-2006-13 [which corresponds to FAA AD 2007-21-16].
    However, several incorrectly assembled spoiler cable disconnect
sensing devices have recently been discovered on in-service
aircraft. A pulley and plastic spacer had been inadvertently
interchanged during assembly of the device in production, resulting
in the spoiler cable sliding on the spacer rather than on the
pulley, as designed.
    Continued operation with an incorrectly assembled spoiler cable
disconnect sensing device could result in impaired operation of the
sensing device and/or an eventual fuselage spoiler cable disconnect,
with possible reduced controllability of the aircraft.

Required actions include inspecting the fuselage spoiler cable
disconnect sensing device and, if necessary, inspecting components
for wear and damage, replacing worn or damaged components, and
correctly re-assembling the sensing device.

Actions and Compliance

    (f) Unless already done, do the following.
    (1) For Bombardier Model DHC-8-102, -103, -106, -201, -202, -
301, -311, and -315 airplanes, serial numbers 003 through 561
inclusive: Do the actions required by paragraph (f)(1)(i) or
(f)(1)(ii) of this AD, as applicable, in accordance with paragraph
3.B., Part A, of Bombardier Service Bulletin 8-27-107, dated October
16, 2007.
    (i) For airplanes on which fuselage spoiler cable disconnect
sensing device, Modsum 8Q100898, has been installed as of the
effective date of this AD: Within 1,000 flight hours after the
effective date of this AD, inspect the fuselage spoiler cable
disconnect sensing device for correct assembly.
    (ii) For airplanes on which fuselage spoiler cable disconnect
sensing device, Modsum 8Q100898, has not been installed as of the
effective date of this AD: Concurrently with

the installation of Modsum 8Q100898, inspect the fuselage spoiler
cable disconnect sensing device for correct assembly.

    Note 1: AD 2007-21-16 requires the installation of Modsum
8Q100898.

    (2) For Bombardier Model -102, -103, -106, -201, -202, -301, -
311, and -315 airplanes, serial numbers 562 through 644 inclusive:
Within 1,000 flight hours after the effective date of this AD,
inspect the fuselage spoiler cable disconnect sensing device for
correct assembly in accordance with paragraph 3.B., Part A, of
Bombardier Service Bulletin 8-27-107, dated October 16, 2007.

    Note 2: The fuselage spoiler cable disconnect sensing device was
installed in production on the airplanes identified in paragraph
(f)(2) of this AD.

    (3) For Bombardier Model DHC 8-400, -401, and -402 airplanes,
serial numbers 4003, 4004, 4006, and 4008 through 4164 inclusive:
Within 1,000 flight hours after the effective date of this AD,
inspect the fuselage spoiler cable disconnect sensing device for
correct assembly in accordance with paragraph 3.B., Part A, of
Bombardier Service Bulletin 84-27-34 dated October 3, 2007.

    Note 3: The fuselage spoiler cable disconnect sensing device was
installed in production on the airplanes identified in paragraph
(f)(3) of this AD.

    (4) For all airplanes: If an incorrectly assembled sensing
device is detected during any inspection required by paragraphs
(f)(1), (f)(2), or (f)(3) of this AD, before further flight, inspect
the components, replace worn or damaged components, and correctly
re-assemble the sensing device. Do the actions in accordance with
paragraph 3.B., Part B, of Bombardier Service Bulletin 8-27-107,
dated October 16, 2007; or Bombardier Service Bulletin 84-27-34,
dated October 3, 2007; as applicable.

FAA AD Differences

    Note 4: This AD differs from the MCAI and/or service information
as follows: No difference.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. Send information to ATTN: Dan Parrillo, Aerospace
Engineer, Airframe and Propulsion Branch, ANE-171, FAA, New York
Aircraft Certification Office, 1600 Stewart Avenue, Suite 410,
Westbury, New York 11590; telephone<PHONE_NUMBER>; fax (516) 794-
5531. Before using any approved AMOC on any airplane to which the
AMOC applies, notify your appropriate principal inspector (PI) in
the FAA Flight Standards District Office (FSDO), or lacking a PI,
your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI Canadian Airworthiness Directive CF-2008-28,
dated July 10, 2008; Bombardier Service Bulletin 84-27-34, dated
October 3, 2007; and Bombardier Service Bulletin 8-27-107 dated
October 16, 2007; for related information.

    Issued in Renton, Washington, on December 18, 2008.
Stephen P. Boyd,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.

[FR Doc. E9-323 Filed 1-9-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Notices]
[Pages 8721-8723]
[FR Doc No: 2016-03542]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0934]

Determination of Regulatory Review Period for Purposes of Patent
Extension; SUPERA PERIPHERAL STENT SYSTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for SUPERA PERIPHERAL STENT SYSTEM and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of an application
to the Director of the U.S. Patent and Trademark Office (USPTO),
Department of Commerce, for the extension of a patent which claims that
medical device.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
22, 2016. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 22, 2016.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-E-0934 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; SUPERA PERIPHERAL STENT SYSTEM''.
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at

http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device SUPERA PERIPHERAL
STENT SYSTEM. SUPERA PERIPHERAL STENT SYSTEM is indicated to improve
luminal diameter in the treatment of patients with symptomatic de novo
or restenotic native lesions or occlusions of the superficial femoral
artery and/or popliteal artery with reference vessel diameters of 4.0
to 6.5 millimeters (mm) and lesion lengths up to 140 mm. Subsequent to
this approval, the USPTO received a patent term restoration application
for SUPERA PERIPHERAL STENT SYSTEM (U.S. Patent No. 8,419,788) from
IDEV Technologies Inc., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated March 19, 2015, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of SUPERA PERIPHERAL STENT SYSTEM represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
SUPERA PERIPHERAL STENT SYSTEM is 1,894 days. Of this time, 1,396 days
occurred during the testing phase of the regulatory review period,
while 498 days occurred during the approval phase. These periods of
time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: January 21, 2009. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the FD&C act for human tests to
begin became effective January 21, 2009.
    2. The date an application was initially submitted with respect to
the device under section 515 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e): November 16, 2012. The applicant claims November
9, 2012, as the date the premarket approval application (PMA) for
SUPERA PERIPHERAL STENT SYSTEM (PMA P120020) was initially submitted.
However, FDA records indicate that PMA P120020 was submitted on
November 16, 2012.
    3. The date the application was approved: March 28, 2014. FDA has
verified the applicant's claim that PMA P120020 was approved on March
28, 2014.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 158 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Petitions that have not been made publicly available on http://

www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03542 Filed 2-19-16; 8:45 am]
 BILLING CODE 4164-01-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Laura Nollen,<PHONE_NUMBER>

Interregional Research Project Number 4 (IR-4)

Petition Number (PP# 0E7779)

	EPA has received a pesticide petition, PP# 0E7779, from IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of dicamba (3,6-dichloro-o-anisic and its metabolite 3,6-dichloro-5-hydroxy-o-anisic acid (5-OH dicamba) in or on the raw agricultural commodity teff, forage at 90.0 parts per million (ppm); teff, grain at 6.0 ppm; teff, straw at 30.0 ppm; and teff, hay at 40.0 ppm.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The nature of dicamba residues in dicamba is adequately understood.  The primary route of metabolism of dicamba is by demethylation to form DCSA and subsequent hydroxylation to form the minor metabolite DCGA (3,6-dichlorogentisic acid).  DCSA and its glucose conjugates are the major metabolites from both pre and postemergence applications of dicamba.   Parent dicamba can be expected to comprise a significant portion of the residue in both teff forage and hay for postemergence applications.  DCGA and its conjugates can be expected to be present only at low levels in teff forage and hay.  EPA has previously determined that the dicamba residues of concern  are dicamba, DCSA, and 5-OH dicamba. Based on the results of  metabolism studies, the current tolerance expression is adequate for teff forage and hay.

	2. Analytical method. Adequate enforcement methods are available for the analysis of residues of dicamba and its relevant metabolites in or on plant and livestock commodities. Pesticide Analytical Manual (PAM) Vol. II lists appropriate analytical methods, based on gas chromatography (GC) with electron capture detection (GC/ECD), that are sufficient to provide for the enforcement of proposed dicamba tolerances in teff forage, grain, straw and hay.

	3. Magnitude of residues. The proposed tolerances are based on a US EPA ChemSAC decision.  IR-4 received a request (PR 10195) for the use of dicamba on teff.  Teff is a small grain grown as a warm season cereal crop and the cultural practices are similar to other small grains such as wheat, barley, rye and oats.  Given that teff and other cereal grains have similar morphological, cultural practices, taxonomical characteristics, and share similar pest problems, IR-4 proposed extrapolating the tolerances for wheat and other grains to tolerances for teff.  IR-4 also stated that crop group 15 is scheduled to be included in a 2011 crop group submission to the EPA, which was confirmed by Bernie Schneider.  Bernie stated that currently most of the teff is grown in ID and MT.  Considering the low acreage grown in the US and the similarity to other cereal grains, the ChemSAC concurred with the IR-4 proposal for the use of dicamba  on teff. In addition, the proposed tolerances for dicamba in teff forage and hay will not result in secondary residues in meat and milk above the tolerances already published at 40 CFR 180.227.

B. Toxicological Profile EPA has previously evaluated available toxicology data on dicamba and concluded the data are of sufficient quality and reliability to merit reregistration.  EPA also found the available data to be adequate to characterize the toxicity of dicamba as it relates to human health including variability and sensitivity of major subgroups of consumers including infants and children.  The nature of dicamba toxicity is discussed in the 2006 Registration Eligibility Decision (RED) and as part of a recent action to establish tolerances on sweet corn commodities (Federal Register: April 2, 2008, Vol. 73, No. 64, p. 17914-18; Petition No. 0E6209; Decision: 304187; EPA-HQ-OPP-2007-0325).

	1. Acute toxicity.  As noted in Dicamba RED, 2006 and Decision 304187.

	2. Genotoxicity. As noted in Dicamba RED, 2006 and Decision 304187.

	3. Reproductive and developmental toxicity. As noted in Dicamba RED, 2006 and Decision 304187.

	4. Subchronic toxicity. As noted in Dicamba RED, 2006 and Decision 304187.

	5. Chronic toxicity. As noted in Dicamba RED, 2006 and Decision 304187.

	6. Animal metabolism. As noted in Dicamba RED, 2006 and Decision 304187.

	7. Metabolite toxicology. Toxicity studies on DCSA and DCGA have been conducted to further characterize their toxicity. Overall, only a few minor quantitative and qualitative differences in toxicity were observed when comparing DCSA, DCGA and dicamba. These data demonstrate that the overall toxicity profiles of dicamba and its metabolites, DCSA and DCGA, are substantially similar and that neither DCSA nor DCGA present any new or unusual toxicity concerns beyond what has already been considered for parent dicamba.  Therefore, existing dicamba toxicity endpoints are sufficient to assess potential health risks from exposure to DCSA and DCGA metabolites.

	8. Endocrine disruption. Dicamba does not belong to a class of chemicals known for having adverse effects on the endocrine system. No effects indicative of endocrine disruption have been observed in the various short- and long-term studies conducted with various mammalian species.

C. Aggregate Exposure

	1. Dietary exposure. Existing tolerances for dicamba residues in meat and milk are adequate to support the proposed tolerances of dicamba in teff forage, grain, straw and hay. In addition, the proposed new use that supports the teff forage, grain, straw and hay tolerances does not result in an increase in estimated drinking water exposure beyond what has already been evaluated by EPA. Consequently, no incremental dietary (food plus water) exposure to dicamba is anticipated from the proposed tolerances, and the most recent EPA dietary exposure assessment supporting dicamba tolerances for sweet corn commodities (Federal Register: April 2, 2008, Vol. 73, No. 64, p. 17914-18; Petition No. 0E6209; Decision: 304187) is adequate to support the proposed tolerances on teff,  forage, grain, straw and hay.

	i. Food. In support of the proposed tolerances for sweet corn commodities, a highly conservative acute dietary assessment was conducted for all dicamba food exposures assuming 100% of crop and livestock food commodities contain tolerance level residues.  Acute dietary (food plus water) exposure (95[th] percentile) was conservatively estimated to be 0.044 mg/kg bw/day for the general population and 0.109 mg/kg bw/day  for the most highly exposed subpopulation of infants < 1year old.  A Tier I chronic dietary assessment was also conducted and chronic dietary exposure was conservatively estimated to be 0.012 mg/kg bw/day for the general population and 0.030 mg/kg bw/day for the most highly exposed subpopulation of children aged 1-2 years old.

	ii. Drinking water. EPA estimated concentrations of dicamba and DCSA in groundwater and surface water using the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models. Combined estimated environmental concentrations (EECs) of dicamba and DCSA for acute exposures are estimated to be 367 parts per billion (ppb) for surface water and 0.016 ppb for ground water.  The combined EECs for chronic exposures are estimated to be 13.8 ppb for surface water and 0.016 ppb for ground water.  Estimates of exposure from drinking water were combined with the food exposures reported above.

	2. Non-dietary exposure. Dicamba is currently registered for use on residential sites, including home lawns and golf courses. Residential handlers are likely to be exposed to dicamba residues via dermal and inhalation routes during handling, mixing, loading and applying activities.  Post application exposure to dicamba also exists for adults and children who reenter a treated area.  EPA assessed non-dietary exposure (residential handler and residential post application)  to dicamba in support of the proposed tolerances for sweet corn commodities (Federal Register: April 2, 2008, Vol. 73, No. 64, p. 17914-18; Petition No. 0E6209; Decision: 304187).  Non-dietary exposure to dicamba did not exceed the Agency's level of concern.

D. Cumulative Effects

	EPA has not made a common mechanism of toxicity finding for dicamba.

E. Safety Determination

	1. U.S. population. The proposed dicamba tolerances for teff forage, grain, straw and hay do not pose any incremental dietary exposure to the general US population beyond that which has been previously considered by EPA as part of previous regulatory actions.  A conservative dietary exposure analysis (food plus water) was conducted for dicamba in support of the proposed tolerances for sweet corn commodities (Federal Register: April 2, 2008, Vol. 73, No. 64, pages 17914-18; Petition No. 0E6209; Decision No. 304187).  Dietary exposure from all registered uses of dicamba combined utilized only 4.4% aPAD and 2.6% cPAD for the general US population. Considering the completeness of the overall toxicity database supporting this petition, there is reasonable certainty that no harm will result from aggregate exposure arising from current and proposed dicamba uses including all anticipated dietary and non-occupational exposures.

	2. Infants and children. The proposed dicamba tolerances for teff forage, grain, straw and  hay do not pose any incremental dietary exposure to infants and children beyond that which has been previously considered by EPA.  A conservative dietary exposure analysis (food plus water) showed that exposure from all registered dicamba uses contributes only 11% aPAD for the most highly exposed population subgroup of infants less than one year old for acute exposure, and 6.7% cPAD for the most highly exposed population subgroup of children 1-2 years old for chronic exposure. Considering the completeness of the overall toxicity database supporting this petition, there is reasonable certainty that no harm will result from aggregate exposure arising from current and proposed dicamba uses including all anticipated dietary and non-occupational exposures.

F. International Tolerances

	There currently are no CODEX, Canadian or Mexican maximum residue limits (MRLs) for residues of dicamba on teff forage, grain, straw or hay.


[Federal Register Volume 83, Number 79 (Tuesday, April 24, 2018)]
[Notices]
[Pages 17879-17880]
[FR Doc No: 2018-08508]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2018-0051]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of applications for exemption; request for comments.

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SUMMARY: FMCSA announces receipt of applications from eight individuals
for an exemption from the prohibition in the Federal Motor Carrier
Safety Regulations (FMCSRs) against persons with a clinical diagnosis
of epilepsy or any other condition that is likely to cause a loss of
consciousness or any loss of ability to control a commercial motor
vehicle (CMV) to drive in interstate commerce. If granted, the
exemptions would enable these individuals who have had one or more
seizures and are taking anti-seizure medication to operate CMVs in
interstate commerce.

DATES: Comments must be received on or before May 24, 2018.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2018-0051 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
e.t., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number(s) for this notice. Note that all comments received will
be posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments online.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., e.t.,
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Docket
Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the FMCSRs for a five-year period if it finds ``such exemption
would likely achieve a level of safety that is equivalent to or greater
than the level that would be achieved absent such exemption.'' The
statute also allows the Agency to renew exemptions at the end of the
five-year period. FMCSA grants exemptions from the FMCSRs for a two-
year period to align with the maximum duration of a driver's medical
certification.
    The eight individuals listed in this notice have requested an
exemption from the epilepsy and seizure disorders prohibition in 49 CFR
391.41(b)(8). Accordingly, the Agency will evaluate the qualifications
of each applicant to determine whether granting the exemption will
achieve the required level of safety mandated by statute.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist Medical Examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--MEDICAL
ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8), paragraphs
3, 4, and 5.]
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    \1\ See http://www.ecfr.gov/cgi-bin/text-idx?SID=e47b48a9ea42dd67d999246e23d97970&mc=true&node=pt49.5.391&rgn=div5#ap49.5.391_171.a and https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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    The advisory criteria states the following:
    If an individual has had a sudden episode of a non-epileptic
seizure or loss of consciousness of unknown cause that did not require
anti-seizure medication, the decision whether that person's condition
is likely to cause the loss of consciousness or loss of ability to
control a CMV should be made on an individual basis by the Medical
Examiner in consultation with the treating physician. Before
certification is considered, it is suggested that a six-month waiting
period elapse from the time of the episode. Following the waiting
period, it is suggested that the individual have a complete
neurological examination. If the results of the examination are
negative and anti-seizure medication is not required, then the driver
may be qualified.
    In those individual cases where a driver had a seizure or an
episode of loss of consciousness that resulted from a known medical
condition (e.g., drug reaction, high temperature, acute infectious
disease, dehydration, or acute metabolic disturbance), certification
should be deferred until the driver has recovered fully from that
condition, has no existing residual complications, and is not taking
anti-seizure medication.
    Drivers who have a history of epilepsy/seizures, off anti-seizure
medication and seizure-free for 10 years, may be qualified to operate a
CMV in interstate commerce. Interstate drivers with a history of a
single unprovoked seizure may be qualified to drive a CMV in interstate
commerce if seizure-free and off anti-seizure medication for a five-
year period or more.
    As a result of Medical Examiners misinterpreting advisory criteria
as regulation, numerous drivers have been prohibited from operating a
CMV in interstate commerce based on the fact that they have had one or
more seizures and are taking anti-seizure medication,

rather than an individual analysis of their circumstances by a
qualified Medical Examiner based on the physical qualification
standards and medical best practices.
    On January 15, 2013, FMCSA announced in a Notice of Final
Disposition titled, Qualification of Drivers; Exemption Applications;
Epilepsy and Seizure Disorders, (78 FR 3069), its decision to grant
requests from 22 individuals for exemptions from the regulatory
requirement that interstate CMV drivers have ``no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause loss of consciousness or any loss of ability to
control a CMV.'' Since the January 15, 2013 notice, the Agency has
published additional notices granting requests from individuals for
exemptions from the regulatory requirement regarding epilepsy found in
49 CFR 391.41(b)(8).
    To be considered for an exemption from the epilepsy and seizure
disorders prohibition in 49 CFR 391.41(b)(8), applicants must meet the
criteria in the 2007 recommendations of the Agency's Medical Expert
Panel (MEP) (78 FR 3069).

II. Qualifications of Applicants

Steven H. Ford

    Mr. Ford is a 59-year-old Class D driver in Wisconsin. He has a
history of epilepsy and has been seizure free since 1995. He takes
anti-seizure medication, with the dosage and frequency remaining the
same since 1995. His physician states that he is supportive of Mr. Ford
receiving an exemption.

Scott Habeck

    Mr. Habeck is a 55-year-old Class A3 driver in South Dakota. He has
a history of epilepsy and has been seizure free since 2006. He takes
anti-seizure medication, with the dosage and frequency remaining the
same since 2006. His physician states that he is supportive of Mr.
Habeck receiving an exemption.

Nathan E. Kanouff

    Mr. Kanouff is a 37-year-old Class AM driver in Georgia. He has a
history of epilepsy and has been seizure free since 2009. He takes
anti-seizure medication, with the dosage and frequency remaining the
same since 2013. His physician states that he is supportive of Mr.
Kanouff receiving an exemption.

Richard L. Kienel, Jr.

    Mr. Kienel is a 36-year-old Class C driver in Georgia. He has a
history of a seizure disorder and has been seizure free since 1999. He
takes anti-seizure medication, with the dosage and frequency remaining
the same since 2013. His physician states that he is supportive of Mr.
Kienel receiving an exemption.

Joe L. King, Jr.

    Mr. King is a 49-year-old Class C driver in North Carolina. He has
a history of a single provoked seizure and has been seizure free since
2017. He stopped taking anti-seizure medication in 2017. His physician
states that he is supportive of Mr. King receiving an exemption.

Daniel L. Martin

    Mr. Martin is a 39-year-old Class B driver in Iowa. He has a
history of a single unprovoked seizure and has been seizure free since
1994. He stopped taking anti-seizure medication in 1997. His physician
states that he is supportive of Mr. Martin receiving an exemption.

Phillip Moore

    Mr. Moore is a 57-year-old Class A driver in Connecticut. He has a
history of a single unprovoked seizure and has been seizure free since
2013. He takes anti-seizure medication, with the dosage and frequency
remaining the same since 2013. His physician states that he is
supportive of Mr. Moore receiving an exemption.

Joshua Thomas

    Mr. Thomas is a 29-year-old Class D driver in Minnesota. He has a
history of a seizure disorder and has been seizure free since 2010. He
takes anti-seizure medication, with the dosage and frequency remaining
the same since 2012. His physician states that he is supportive of Mr.
Thomas receiving an exemption.

III. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated in the dates
section of the notice.

IV. Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket number FMCSA-2018-0051 and click
the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. If you submit your comments by mail or
hand delivery, submit them in an unbound format, no larger than 8\1/2\
by 11 inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the facility,
please enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and materials received during the
comment period. FMCSA may issue a final determination at any time after
the close of the comment period.

V. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, go to http://www.regulations.gov and in the search box insert
the docket number FMCSA-2018-0051 and click ``Search.'' Next, click
``Open Docket Folder'' and you will find all documents and comments
related to this notice.

    Issued on: April 18, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-08508 Filed 4-23-18; 8:45 am]
 BILLING CODE 4910-EX-P