[Federal Register Volume 80, Number 194 (Wednesday, October 7, 2015)]
[Proposed Rules]
[Pages 60592-60601]
[FR Doc No: 2015-24921]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Parts 393 and 396

[Docket No. FMCSA-2015-0176]
RIN 2126-AB81

Parts and Accessories Necessary for Safe Operation; Inspection,
Repair, and Maintenance; General Amendments

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: FMCSA proposes to amend the regulations for ``Parts and
Accessories Necessary for Safe Operation,'' and ``Inspection, Repair
and Maintenance,'' of the Federal Motor Carrier Safety Regulations
(FMCSRs) in response to several petitions for rulemaking from the
Commercial Vehicle Safety Alliance (CVSA) and the American Trucking
Associations (ATA), and two safety recommendations from the National
Transportation Safety Board (NTSB). Specifically, the Agency proposes
to add a definition of ``major tread groove;'' revise the rear license
plate lamp requirement to provide an exception for truck tractors
registered in States that do not require tractors to have a rear
license plate; provide specific requirements regarding when violations
or defects noted on a roadside inspection report need to be corrected;
amend Appendix G to the FMCSRs, ``Minimum Periodic Inspection
Standards,'' to include provisions for the inspection of antilock
braking systems (ABS), automatic brake adjusters, and brake adjustment
indicators, speed-restricted tires, and motorcoach passenger seat
mounting anchorages; and amend the periodic inspection rules to
eliminate the option for motor carriers to use a violation--free
roadside inspection report as proof of completing a comprehensive
inspection at least once every 12 months. In addition, the Agency
proposes to eliminate introductory text from Appendix G to the FMCSRs
because the discussion of the differences between the North American
Standard Inspection out-of-service criteria and FMCSA's periodic
inspection criteria is unnecessary.

DATES: You must submit comments on or before December 7, 2015.

ADDRESSES: You may submit comments identified by docket number FMCSA-
2015-0176 using any one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
     Hand delivery: Same as mail address above, between 9 a.m.
and 5 p.m., e.t., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' heading under
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rule, call or email Mr. Mike Huntley, Vehicle and Roadside
Operations Division, Office of Bus and Truck Standards and Operations,
Federal Motor Carrier Safety Administration, telephone:<PHONE_NUMBER>;
<EMAIL_ADDRESS>If you have questions about viewing or
submitting material to the docket, call Ms. Barbara Hairston, Program
Manager, Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Executive Summary

    FMCSA is responsible for regulations to ensure that all commercial
motor vehicles (CMVs) are systematically inspected, repaired, and
maintained and that all parts and accessories necessary for the safe
operation of CMVs are in safe and proper operating condition at all
times. In response to several petitions for rulemaking from CVSA and
ATA and two safety recommendations from the NTSB, FMCSA proposes to
amend various provisions in parts 393 and 396 of the FMCSRs. The
proposed amendments generally do not involve the establishment of new
or more stringent requirements, but instead clarify existing
requirements to increase consistency of enforcement activities.
    Specifically, the Agency proposes to (1) add a definition of
``major tread groove'' in Sec.  393.5; (2) delete the requirement in
Table 1 of Sec.  393.11 for truck tractors to have a rear license plate
light when State law does not require the vehicle to have a rear
license plate; (3) clarify Sec.  396.9 regarding when violations or
defects noted on a roadside inspection report need to be corrected; (4)
amend Appendix G to the FMCSRs, ``Minimum Periodic Inspection
Standards,'' to include provisions for the inspection of (a) ABS,
automatic brake adjusters, and brake adjustment indicators, (b) speed-
restricted tires, and (c) motorcoach passenger seat mounting
anchorages; (5) amend Sec.  396.17(f) to eliminate references to
roadside inspections; and (6) amend Sec.  396.19(b) regarding inspector
qualifications as a result of the amendments to Sec.  396.17(f)
described above. In addition, the Agency proposes to eliminate as
unnecessary a portion of Appendix G to the FMCSRs that describes the
differences between the out-of-service criteria and FMCSA's annual
inspection.
    The Agency believes the potential economic impact of these changes
is negligible because the proposed amendments generally do not involve
new or more stringent requirements, but a clarification of existing
requirements.

Public Participation and Request for Comments

    FMCSA encourages you to participate in this rulemaking by
submitting comments and related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (FMCSA-2015-0176), indicate the heading of the specific
section of this document to which each comment applies, and provide a
reason for each suggestion or recommendation. 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 the Agency can contact you if it has
questions regarding your submission.
    To submit your comment online, go to www.regulations.gov, type the
docket number, ``FMCSA-2015-0176'' in the ``Keyword'' box, and click
``Search.'' When the new screen appears, click the ``Comment Now!''
button and type your comment into the text box in the following screen.
Choose whether you are submitting your comment as an

individual or on behalf of a third party, and click ''Submit.''
    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.
    FMCSA will consider all comments and material received during the
comment period and may change this proposed rule based on your
comments. FMCSA may issue a final rule at any time after the close of
the comment period.

Viewing Comments and Documents

    To view comments and as well as any documents mentioned in this
preamble as being available in the docket, go to www.regulations.gov,
insert the docket number, ``FMCSA-2015-0176'' in the ``Keyword'' box,
and click ``Search.'' Next, click the ``Open Docket Folder'' button and
choose the document listed to review. If you do not have access to the
Internet, you may view the docket online by visiting the Docket
Services in Room W12-140 on the ground floor of the DOT West Building,
1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5
p.m. ET, Monday through Friday, except Federal holidays.

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 www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

Legal Basis for the Rulemaking

    This rulemaking is based on the authority of the Motor Carrier Act
of 1935 [1935 Act] and the Motor Carrier Safety Act of 1984 [1984 Act].
    The 1935 Act, as amended, provides that ``[t]he Secretary of
Transportation may prescribe requirements for--(1) qualifications and
maximum hours of service of employees of, and safety of operation and
equipment of, a motor carrier; and (2) qualifications and maximum hours
of service of employees of, and standards of equipment of, a private
motor carrier, when needed to promote safety of operation'' (49 U.S.C.
31502(b)).
    This NPRM would amend the FMCSRs to respond to several petitions
for rulemaking. The adoption and enforcement of such rules is
specifically authorized by the 1935 Act. This proposed rulemaking rests
squarely on that authority.
    The 1984 Act provides concurrent authority to regulate drivers,
motor carriers, and vehicle equipment. It requires the Secretary to
``prescribe regulations on commercial motor vehicle safety.'' The
regulations shall prescribe minimum safety standards for CMVs. At a
minimum, the regulations shall ensure that: (1) CMVs are maintained,
equipped, loaded, and operated safely; (2) the responsibilities imposed
on operators of CMVs do not impair their ability to operate the
vehicles safely; (3) the physical condition of operators of CMVs is
adequate to enable them to operate vehicles safely; (4) the operation
of CMVs does not have a deleterious effect on the physical condition of
the operators; and (5) that drivers are not coerced by motor carriers,
shippers, receivers, or transportation intermediaries to operate a
vehicle in violation of a regulation promulgated under 49 U.S.C. 31136
(which is the basis for much of the FMCSRs) or 49 U.S.C. chapters 51 or
313 (49 U.S.C. 31136(a)).
    This proposed rule concerns (1) parts and accessories necessary for
the safe operation of CMVs, and (2) the inspection, repair, and
maintenance of CMVs. It is based primarily on section 31136(a)(1) and
(2), and secondarily on section 31136(a)(4). This rulemaking would
ensure that CMVs are maintained, equipped, loaded, and operated safely
by requiring certain vehicle components, systems, and equipment to meet
minimum standards such that the mechanical condition of the vehicle is
not likely to cause a crash or breakdown. Section 31136(a)(3) is not
applicable because this rulemaking does not deal with driver
qualification standards. Because the amendments proposed by this rule
are primarily technical changes that clarify existing requirements and
improve enforcement consistency, FMCSA believes they will be welcomed
by motor carriers and drivers alike and that coercion to violate them
will not be an issue.
    Before prescribing any such regulations, FMCSA must consider the
``costs and benefits'' of any proposal (49 U.S.C. 31136(c)(2)(A) and
31502(d)). As discussed in greater detail in the ``Regulatory
Analyses'' section, FMCSA has determined that this proposed rule is not
a significant regulatory action. The Agency believes the potential
economic impact is negligible because the proposed amendments generally
do not involve the adoption of new or more stringent requirements, but
rather the clarification of existing requirements. As such, the costs
of the rule would not approach the $100 million annual threshold for
economic significance.

Background

    The fundamental purpose of 49 CFR part 393, ``Parts and Accessories
Necessary for Safe Operation,'' is to ensure that no employer operates
a CMV or causes or permits it to be operated, unless it is equipped in
accordance with the requirements and specifications of that part.
However, nothing contained in part 393 may be construed to prohibit the
use of additional equipment and accessories, not inconsistent with or
prohibited by part 393, provided such equipment and accessories do not
decrease the safety of operation of the motor vehicles on which they
are used. Compliance with the rules concerning parts and accessories is
necessary to ensure vehicles are equipped with the specified safety
devices and equipment.
    On August 15, 2005, FMCSA published a final rule amending part 393
of the FMCSRs to remove obsolete and redundant regulations; respond to
several petitions for rulemaking; provide improved definitions of
vehicle types, systems, and components; resolve inconsistencies between
part 393 and the National Highway Traffic Safety Administration's
(NHTSA) Federal Motor Vehicle Safety Standards (49 CFR part 571); and
codify certain FMCSA regulatory guidance concerning the requirements of
part 393 (70 FR 48008).
    Since publication of the 2005 final rule, FMCSA has received
petitions for rulemaking to amend part 393 from CVSA, requesting that
Sec.  393.5 be amended to include a definition of ``major tread
groove,'' and from ATA, requesting that Table 1 to Sec.  393.11 be
amended to delete the requirement for operable rear license plate
lights on truck tractors registered in States that do not require a
rear license plate to be displayed. In addition, FMCSA received a
separate petition from CVSA requesting that the Agency amend Appendix G
to the FMCSRs, ``Minimum Periodic Inspection Standards,'' to include
provisions for the inspection of ABS. Like the revisions made in the
August 2005 final rule, the amendments requested by CVSA and ATA would
simply clarify existing requirements.
    Proper inspection, repair, and maintenance of CMVs are essential to
the safety of motor carrier operations. The purpose of 49 CFR part 396,
``Inspection, Repair, and Maintenance,'' is to ensure that every motor
carrier (1) systematically inspects, repairs, and

maintains all motor vehicles subject to its control to ensure that all
parts and accessories are in safe and proper operating condition at all
times, and (2) maintains records of these inspections, repairs, and
maintenance. Generally, systematic means a regular or scheduled program
to keep vehicles in a safe operating condition. Part 396 does not
specify inspection, repair, or maintenance intervals because such
intervals are fleet specific, and in some instances, vehicle specific.
The inspection, repair, and maintenance intervals are to be determined
by the motor carrier. The requirements in part 396 concerning driver
pre- and post-trip inspections and periodic (annual) inspections are in
addition to the systematic inspection, repair, and maintenance
requirements.
    FMCSA has also received several petitions from CVSA seeking
amendments to part 396. First, while Sec.  396.9(d)(2) requires
violations or defects noted on roadside inspection reports to be
``corrected,'' CVSA requested that the Agency clarify when such vehicle
and driver violations or defects must be corrected. Second, CVSA
requested that the Agency remove the words ``or roadside'' from the
existing regulatory language of Sec.  396.17 to separate the roadside
inspection program conducted by law enforcement officials from the
periodic (annual) inspection requirements of Sec.  396.17. Third, CVSA
asked that Sec.  396.19 be amended to delete the references to the
``random roadside inspection program.'' Finally, CVSA requested that
FMCSA amend Appendix G to the FMCSRs by deleting the ``Comparison of
Appendix G, and the new North American Uniform Driver-Vehicle
Inspection Procedure (North American Commercial Vehicle Critical Safety
Inspection Items and Out-of-Service Criteria.)'' As with the proposed
amendments to part 393, the proposed revisions to part 396 merely
clarify existing requirements.
    In addition to the CVSA and ATA petitions for rulemaking, the NTSB
issued two safety recommendations to FMCSA relating to Appendix G of
the FMCSRs as a result of its investigation of an October 13, 2003,
crash in Tallulah, Louisiana, involving a motorcoach and a tractor
semitrailer combination. First, investigators discovered that the
motorcoach had been equipped with speed-restricted tires. While the
tires were designed for speeds not to exceed 55 mph, and to provide
high-load capacity and durability for inner city transit-bus-type
vehicles (which typically do not exceed speeds of 55 mph), the
motorcoach was being operated on the interstate at speeds exceeding 55
mph at the time of the crash. The NTSB noted that if a speed-restricted
tire is used in service above its rated speed for extended periods, a
catastrophic failure can result. The NTSB concluded that because the
CMV inspection criteria used by FMCSA and others do not address the
identification and appropriate use of speed-restricted tires, they
overlook an important vehicle safety factor and can result in CMVs
intended for highway use being operated with tires not suited for
highway speeds. The NTSB issued Safety Recommendation H-05-03 to FMCSA,
recommending that the Agency revise Appendix G ``to include inspection
criteria and specific language to address a tire's speed rating to
ensure that it is appropriate for a vehicle's intended use.''
    Second, investigators found that during the crash sequence, many
passenger seats did not remain in their original positions because they
had been improperly secured to the floor of the vehicle. The NTSB
concluded that improperly secured motorcoach passenger seats are not
likely to be identified during CMV inspections because no criteria or
procedures are available for the inspection of motorcoach seating
anchorage systems. The NTSB issued Safety Recommendation H-05-05 to
FMCSA, recommending that the Agency (1) develop a method for inspecting
motorcoach passenger seat mounting anchorages, and (2) revise Appendix
G of the FMCSRs to require inspection of these anchorages.

Discussion of Proposed Rulemaking

    Section 393.5, Definition of ``Major tread groove.'' Section 393.75
of the FMCSRs specifies the requirements for tires on CMVs operated in
interstate commerce. Paragraph (b) states that ``Any tire on the front
wheels of a bus, truck, or truck tractor shall have a tread groove
pattern depth of at least \4/32\ of an inch when measured at any point
on a major tread groove. The measurements shall not be made where tie
bars, humps, or fillets are located'' [emphasis added]. In addition,
Sec.  393.75(c) states that, ``Except as provided in paragraph (b) of
this section, tires shall have a tread groove pattern depth of at least
\2/32\ of an inch when measured in a major tread groove. The
measurement shall not be made where tie bars, humps or fillets are
located'' [emphasis added].
    In its petition, CVSA stated:

    The absence of a definition for what constitutes a major tread
groove leads to confusion for both enforcement and industry. There
are several grooves in a tire and not all of them are necessarily
major tread grooves. Dependent on where the tire is worn and what
the person understands to be a major tread groove is the important
and costly decision on whether or not the tire is required to be
replaced. A clear definition will reduce unnecessary disposal of
tires due to improper tread depth measurements, as well as reduce
improper violations/citations related to Sec.  393.75.

    CVSA contacted ATA's Technology & Maintenance Council (TMC) S.2
Tire & Wheel Study Group Task Force and asked them to (1) review the
regulatory language in Sec.  393.75(b) and (c), and (2) develop a
definition for ``major tread groove.'' The TMC Task Force recommended
that a major tread groove be defined as ``The space between two
adjacent tread ribs or lugs on a tire that contains a tread wear
indicator or wear bar. (In most cases, the locations of tread wear
indicators are designated on the upper sidewall/shoulder of the tire on
original tread tires.)''
    CVSA contends that it ``is imperative that measurements for tire
wear are taken in consistent locations to help promote uniformity and
consistency in both enforcement and maintenance.'' The proposed
definition of ``major tread groove'' was submitted to, reviewed, and
approved by CVSA's Vehicle Committee (consisting of enforcement,
government, and industry representatives) prior to the development and
submission of the petition for rulemaking to FMCSA. The petition
requests that Sec.  393.5 be amended to include the TMC Task Force's
suggested definition of ``major tread groove.''
    FMCSA agrees that uniformity and consistency in enforcement and
maintenance are critical. By including a definition of ``major tread
groove'' in Sec.  393.5--a term that is currently included in the
regulatory text of Sec.  393.75(b) and (c), but not specifically
defined--the Agency expects increased consistency in the application
and citation of Sec.  393.75 during roadside inspections.
    FMCSA proposes to amend Sec.  393.5 to include a definition for
``major tread groove'' that is consistent with the definition as
proposed by the TMC Task Force. In addition, the following illustration
will be added to Sec.  393.75, where the arrows indicate the location
of tread wear indicators or a wear bars signifying a major tread
groove:

[GRAPHIC] [TIFF OMITTED] TP07OC15.201

    Table 1 to Sec.  393.11, License Plate Lights. Federal Motor
Vehicle Safety Standard (FMVSS) No. 108, ``Lamps, reflective devices,
and associated equipment,'' requires all newly-manufactured passenger
cars, multipurpose passenger vehicles (MPVs), trucks, and buses to be
equipped with a single white license plate light, located at the rear,
to illuminate the license plate from the top or sides. The light must
be steady burning, and must be activated when the headlamps are
activated in a steady burning state or when the parking lamps on
passenger cars and MPVs, trucks, and buses are activated. Similarly,
Sec.  393.11(a)(1) of the FMCSRs requires all CMVs operated in
interstate commerce and manufactured on or after December 25, 1968, to
meet at least the minimum applicable requirements of FMVSS No. 108 in
effect at the time of manufacture of the vehicle. Footnote 11 to Table
1 of Sec.  393.11 requires that the license plate light ``be
illuminated when tractor headlamps are illuminated.''
    In its petition, ATA states:

    The purpose of the rear license plate lamp is ``to illuminate
the license plate from the top or sides.'' ATA believes that if
there is no license plate, there is no need and therefore should be
no regulatory requirement for a functioning rear license plate lamp.
As simple and commonsensical as this seems, roadside inspectors in
some [States] have issued citations to motor carriers when the rear
license plate holder is empty and the tractor license plate lamp is
either missing or not working. In surveying the 50 U.S. states and
the District of Columbia, ATA found that 35 states and the District
require only one license plate on a tractor, and it is to be placed
on the front. Only 14 states require two license plates, one each on
the front and back of the tractor. Therefore, the change we are
seeking in the application of the regulation would apply to a
significant number of commercial trucks with state-issued plates . .
. These changes to the existing regulatory requirements to exempt
commercial vehicles with no rear license plates will not adversely
impact safety and will help eliminate further unnecessary
enforcement actions by roadside inspectors.

    ATA's petition requests that FMCSA amend the license plate lamp
requirement in Table 1 to Sec.  393.11 to read ``At rear license plate
to illuminate the plate from the top or sides, except that no license
plate lamp is required where state law does not require a license plate
to be present.''
    As noted in both FMVSS No. 108 and the FMCSRs, the only function of
the rear license plate lamp is to illuminate the rear license plate.
FMCSA agrees with ATA that if a truck tractor is not required to
display a rear license plate, then there is no corresponding safety
need for a functioning rear license plate light. Uniformity and
consistency in enforcement are critical.
    FMCSA proposes to amend Footnote 11 to Table 1 of Sec.  393.11 to
indicate that no rear license plate lamp is required on truck tractors
registered in States that do not require tractors to display a rear
license plate.''
    Appendix G to the FMCSRs--ABS. Section 210 of the Motor Carrier
Safety Act of 1984 required the Secretary of Transportation to
establish standards for the annual (i.e., periodic) or more frequent
inspection of all CMVs engaged in interstate or foreign commerce. In
response, the Federal Highway Administration (FHWA) published a final
rule on December 7, 1988, adopting Sec.  396.17, which requires all
CMVs to be inspected at least once every 12 months (53 FR 49402, as
amended on December 8, 1989 (54 FR 50722)). In establishing specific
criteria for the newly required annual inspection, FHWA looked to
inspection criteria that had been developed based on the specifications
in part 393, notably (1) the CVSA vehicle out-of-service criteria and
(2) the vehicle portion of the FHWA National Uniform Driver-Vehicle
Inspection Procedure (NUD-VIP). FHWA decided to use the vehicle portion
of the NUD-VIP as the criteria for successful completion of the annual
inspection, and in the December 1988 rule, established Appendix G to
the FMCSRs as the minimum periodic inspection standards for Sec.
396.17. FHWA noted that utilization of the NUD-VIP would (1) provide
the necessary inspection-related pass/fail criteria for the periodic
inspection at a more stringent level than the vehicle out-of-service
criteria, and (2) provide the proper level of Federal oversight in
establishing and revising the criteria.
    NHTSA did not require medium and heavy vehicles to be equipped with
an ABS to improve lateral stability and steering control during braking
until 1995, when it published a final rule amending FMVSS No. 105,
``Hydraulic Brake Systems,'' and FMVSS No. 121, ``Air Brake Systems''
(60 FR 13216, March 10, 1995). In addition to requiring ABS on medium
and heavy vehicles, the 1995 rule also required all powered vehicles to
be equipped with an in-cab lamp to indicate ABS malfunctions. Truck
tractors and other trucks equipped to tow air-braked trailers are
required to have two separate in-cab lamps: One indicating malfunctions
in the towing vehicle ABS and the other in the trailer ABS.
    Part 393 of the FMCSRs was amended in 1998 to require carriers to
maintain ABS installed on truck tractors, single unit trucks, buses,
trailers, and converter dollies (63 FR 24454, May 4, 1998). Although
the final rule clearly placed on interstate motor carriers the
responsibility to maintain the ABS in operable condition at all times,
it did not add provisions regarding the periodic inspection of the ABS/
ABS malfunction indicator to the minimum periodic inspection standards
in Appendix G. This means that a vehicle could pass the periodic
inspection with an inoperable ABS/ABS malfunction indicator. However,
the operation of the vehicle with the inoperable ABS/ABS malfunction
indicator would be a violation of the FMCSRs and would preclude the
vehicle from receiving a roadside inspection decal.
    In its petition, CVSA requested that the Agency amend Appendix G to
include specific language regarding the inspection of the ABS system/
malfunction indicator during periodic/annual inspections. CVSA stated:

    While we realize that 49 CFR part 393--Parts and Accessories
Necessary for Safe Operation has requirements relating to ABS in
Sec.  393.55, periodic inspections are typically conducted using
Appendix G as a guide (and not Part 393) and as such, ABS
operational status is frequently neglected since it is not part of
Appendix G. Furthermore, many versions of the preprinted forms used
by personnel who conduct periodic inspections do not mention or list
ABS as an inspection item.
    The failure of some motor carriers to check ABS as a part of
their preventative maintenance programs is found by roadside
inspectors while conducting random roadside inspections. Inspectors
are frequently finding commercial motor vehicles with missing or
inoperative ABS malfunction indicators or indicators that are
constantly illuminated indicating a fault in the ABS. A study was
conducted by the Battelle Memorial Institute for FMCSA to assess the
status of the ABS warning system on in-service air-braked commercial
vehicles. Data from approximately 1,000 CMVs were collected in
California, Ohio, Pennsylvania, and Washington, by enforcement
personnel who had been specifically trained to inspect the ABS
warning lamp. With an ABS lamp check problem defined as falling into
one of

three categories; no lamp, lamp inoperative, or lamp on (thus
indicating an active ABS system fault), a snapshot of this aspect of
the CMV population was created. Results indicated that about one in
six power units manufactured after March 1, 1997 showed some problem
with their ABS warning lamp system. One in three trailers
manufactured after March 1, 1998 showed a problem. Furthermore, the
study indicated that ABS problems increased with vehicle age so the
percentages would likely be higher if the study was repeated today
since there are now older vehicles on the road with ABS.

    FMCSA agrees that the failure of a motor carrier to properly
maintain an important safety technology such as ABS should result in
the vehicle failing the periodic inspection. And although CVSA did not
mention automatic brake adjusters and brake adjustment indicators in
its petition, FMCSA believes these brake components should also be
included in Appendix G to ensure that vehicles cannot pass the periodic
inspection without this important safety equipment. FMCSA amended 49
CFR part 393 on September 6, 1995 (60 FR 46245) to require that
interstate motor carriers maintain these devices, but as with the ABS
final rule, the Agency did not include automatic brake adjusters and
brake adjustment indicators in Appendix G.
    ABS and automatic brake adjusters and brake adjustment indicator
requirements have been included in part 393 for approximately 20 years.
Therefore, FMCSA believes that it is reasonable to assume that the vast
majority of motor carriers currently include a review of these devices
and systems in their annual inspection programs despite the fact that
there are no explicit requirements in Appendix G to do so. As such, the
Agency believes that amending Appendix G to include a review of ABS and
automatic brake adjusters and brake adjustment indicators simply
maintains consistency between part 393 and Appendix G, and will result
in a de minimis added burden to motor carriers.
    Section 396.9, Inspection of motor vehicles and intermodal
equipment in operation. Section 396.9 of the FMCSRs authorizes special
agents of FMCSA, as defined in Appendix B to the FMCSRs, to enter upon
and perform inspections of a motor carrier's vehicles in operation,
i.e., to perform roadside inspections. Drivers receiving reports from
such inspections are required to provide a copy of the report to the
motor carrier or intermodal equipment provider (1) upon his/her arrival
at the next terminal or facility, or (2) immediately via mail, fax, or
other means if the driver is not scheduled to arrive at a terminal or
at a facility of the intermodal equipment provider within 24 hours.
Section 396.9(d)(2) requires that ``Motor carriers and intermodal
equipment providers shall examine the report. Violations or defects
noted thereon shall be corrected. Repairs of items of intermodal
equipment placed out-of-service are also to be documented in the
maintenance records for such equipment.'' However, Sec.  396.9(d)(2)
does not expressly state when such violations or defects need to be
remedied.
    CVSA asked FMCSA to amend Sec.  396.9(d)(2) to specifically require
that violations or defects noted in a roadside inspection report ``be
corrected prior to redispatching the driver and/or vehicle.'' In
support of its petition, CVSA stated:

    Upon review of the North American Standard Level I Inspection
(Part ``A''--Driver) training materials, it was noted that the
regulatory language ``prior to redispatch'' does not currently exist
in the Federal Motor Carrier Safety Regulations (FMCSRs). The
language has been used exclusively in the North American Standard
Out-of-Service Criteria (OOSC) and in the Appendix since the early
beginnings of the North American Standard Inspection Program. By
adding the regulatory language, it will provide enforcement and
industry with a clear understanding of the regulatory intent of when
vehicle and driver violations or defects must be corrected.

    Every driver is required to prepare a driver vehicle inspection
report (DVIR) in writing at the completion of each day's work on each
that he or she vehicle operated that lists ``any defect or deficiency
discovered by or reported to the driver which would affect the safety
of operation of the vehicle or result in its mechanical breakdown''
(Sec.  396.11(a)(2) [emphasis added]). Any defects or violations noted
during a roadside inspection conducted during that work day, and
documented in a report provided to the driver by an inspection
official, must be included in the DVIR prepared by the driver at the
end of the work day. In addition, Sec.  396.11(a)(3) specifies that
prior to requiring or permitting a driver to operate a vehicle, every
motor carrier or its agent shall (1) repair any defect or deficiency
listed on the DVIR which would be likely to affect the safety of
operation of the vehicle (Sec.  396.11(a)(3)(i)), and (2) certify on
the original DVIR that all defects or deficiencies have been repaired
or that repair is unnecessary before the vehicle is operated again
(Sec.  396.11(a)(3)(ii)).
    Section 396.11(a)(3) makes it clear that all defects and
deficiencies discovered by or reported to a driver--including those
identified during a roadside inspection conducted under the authority
of Sec.  396.9--must be corrected (or a certification provided stating
that repair is unnecessary) before a vehicle is operated each day.
However, the Agency agrees that the language of Sec.  396.9(d)(2) is
not as explicit as it could be, and could lead to uncertainty and/or
inconsistency in both the enforcement community and the motor carrier
industry regarding when violations and defects noted on roadside
inspection reports need to be corrected.
    While CVSA suggested inclusion of language that would require
violations or defects to be corrected ``prior to redispatching the
driver and/or vehicle,'' the Agency believes that use of the term
``redispatching'' could be troublesome in some operations, for example
in long-haul, multi-day cross country trips where a vehicle may be
``dispatched'' only at the trip's point of origin. On such trips, a
driver is required under Sec.  396.11 to ensure--at the beginning of
each day--that any defects or deficiencies discovered by or reported to
the driver on the previous day have been satisfactorily addressed
according to Sec.  396.11(a)(3)(i) and (ii). FMCSA is concerned that
amending Sec.  396.9(d)(2) using CVSA's recommended ``prior to
redispatch'' language could improperly imply that repairs are not
required each day on multi-day trips where the vehicle is not
``redispatched'' every day.
    Instead, to clarify the intent of Sec.  396.9(d)(2) as discussed
above, FMCSA proposes to amend that section by including a specific
cross reference to Sec.  396.11(a)(3).
    The Motor Carrier Safety Act of 1990 required that violations found
during inspections funded under the Motor Carrier Safety Assistance
Program (MCSAP) be corrected in a timely manner, and that States
participating in the MCSAP adopt a verification program to ensure that
CMVs and operators thereof found in violation of safety requirements
have subsequently been brought into compliance. [Sec. 15(d), Pub. L.
101-500, Nov. 3, 1990, 104 Stat. 1219]. Section 396.9(d)(3) requires
motor carriers and intermodal equipment providers, within 15 days, to
(1) certify that all violations noted have been corrected by completing
the ``Signature of Carrier/Intermodal Equipment Provider Official,
Title, and Date Signed'' portions of the roadside inspection form, (2)
return the completed roadside inspection form to the issuing agency,
and (3) retain a copy of the completed form for 12 months from the date
of the inspection.

    In a final rule implementing revisions to the MCSAP published on
September 8, 1992, the FHWA noted that the ATA had asked ``that
carriers be given more time to return inspection reports and file a
report at the terminal where the vehicle is maintained.'' Specifically,
the ATA requested that the carrier be allowed 60 days to file a copy of
each roadside inspection report. FHWA declined to adopt ATA's request,
stating ``Currently, Sec.  396.9 allows 15 days for the motor carrier
to certify correction of defects found in inspections. The FHWA
believes that this is sufficient time and, moreover, that these reports
on safety violations found on trucks and buses operating on the
highways require immediate attention and follow-up by the motor
carrier'' (57 FR 40946, 40951, Sept. 8, 1992). FMCSA requests comments
regarding whether the existing 15-day requirement in Sec.  396.9(d)(3)
remains appropriate, or whether a different time period should be
considered.
    Section 396.17, Periodic Inspection. Section 396.17(f) states that
``Vehicles passing roadside or periodic inspections performed under the
auspices of any State government or equivalent jurisdiction or the
FMCSA, meeting the minimum standards contained in appendix G of this
subchapter, will be considered to have met the requirements of an
annual inspection for a period of 12 months commencing from the last
day of the month in which the inspection was performed. If a vehicle is
subject to a mandatory State inspection program, as provided in Sec.
396.23(b)(1), a roadside inspection may only be considered equivalent
if it complies with the requirements of that program.''
    In its petition, CVSA recommended that Sec.  396.17(f) be amended
by removing the words ``roadside or'' from the current regulatory
language. CVSA stated:

    It is our strong belief that the roadside inspection program and
the annual/periodic inspection program need to be decoupled from
each other. The roadside inspection program and the North American
Standard Out-of-Service Criteria (OOSC) are not equivalent to a
``government mandated maintenance standard'' for annual or periodic
inspections. The North American Standard Inspection Program and
North American Standard Out-of-Service Criteria have been in place
for more than two decades and were never intended to serve this
purpose . . .
    The roadside inspection is the ``last line of defense'' for
highway safety. When a driver or vehicle is placed out of service
during a roadside inspection it is indicative that the motor carrier
likely has a failing or defective preventative maintenance and/or
driver trip inspection program . . .
    Far too many drivers, roadside inspectors, mechanics, company
safety professionals and owner operators reference the OOSC as the
``DOT'' standard. In our judgment it is a mistake and a misuse of
the intent of the OOSC. The OOSC serves as a uniform set of
guidelines for law enforcement officials when determining whether a
driver and/or vehicle are an imminent hazard. The Policy Statement
under Part II of the OOSC states ``These criteria are neither suited
nor intended to serve as vehicle maintenance or performance
standards.''

    FMCSA emphasizes that under the existing regulatory language, only
roadside inspections ``meeting the minimum standards contained in
appendix G'' may be considered to be equivalent to a periodic/annual
inspection. This distinction was clearly and extensively discussed in
the December 1988 FHWA final rule discussed earlier that established
the periodic/annual inspection requirements of Sec.  396.17. In that
rule, FHWA stated:

    As noted in the NPRM, the commenters pointed out the differences
between random critical element roadside inspections and what they
perceived as the intent of Sec.  210 of the [1984] Act. They
indicated that a random roadside inspection was basically concerned
with ensuring that the vehicle did not pose an imminent danger on
the roadway. The focus is on checking the more critical components
such as brakes, headlights, brake lights, and steering and
suspension systems. In contrast, a periodic inspection should be
more concerned with the general overall safety condition of the
vehicle, including those parts, which if defective, worn, or missing
do not pose an immediate danger but nevertheless should be corrected
as soon as possible. Therefore, the rule requires that roadside
inspections meet the minimum standards contained in Appendix G in
order to meet the periodic inspection requirements . . .
    The current inspection standards associated with the CVSA or
NUD-VIP focus on random roadside inspections and examine certain key
components of a vehicle to detect those defects most often
identified as causing or contributing to the severity of commercial
motor vehicle accidents. The CVSA or NUD-VIP standards, by their
very nature, do not require disassembly of parts to effect a
thorough inspection. The FHWA believes that the criteria on which to
judge whether or not the vehicle passes the [periodic] inspection
should be more thorough than that used during roadside inspections .
. .
    Vehicles subjected to random roadside vehicle checks which
inspect vehicles using the criteria included in Appendix G will be
considered to have met the requirements of this rule if they pass
the inspection. Note that the current CVSA out-of-service criteria,
while very similar to that contained in Appendix G, are not
identical. The fact that a vehicle is subjected to and passes
roadside inspection (e.g., receiving a CVSA decal) does not
necessarily satisfy the requirements of the periodic inspection
under this rule. In order to meet the requirements for a periodic
inspection, the inspection must be performed using, as a minimum,
the criteria contained in Appendix G of this subchapter [emphasis
added in all].

    FMCSA emphasizes that the purpose of the periodic inspection rule
was to have motor carriers take full responsibility for having a
qualified mechanic do a thorough inspection of the vehicles the carrier
controls. FMCSA does not believe it is appropriate to continue to allow
carriers relief from this responsibility by using a roadside inspection
conducted by enforcement officials. Motor carriers are responsible for
having the means of ensuring the completion of a periodic inspection
irrespective of whether a roadside inspection is performed and this
rulemaking would require them to do so at least once every 12 months,
irrespective of whether a roadside inspection is performed during that
period.
    For the reasons explained above, FMCSA proposes to amend Sec.
396.17(f) to remove the words ``roadside or'' from the current
regulatory text as suggested by CVSA in its petition. This proposed
amendment would eliminate any uncertainties and make clear that a
roadside inspection is not equivalent to the periodic/annual inspection
required under Sec.  396.17, even if it is conducted in accordance with
the provisions of Appendix G.
    In addition, CVSA requested that FMCSA remove the section at the
end of Appendix G titled ``Comparison of Appendix G, and the new North
American Uniform Driver-Vehicle Inspection Procedure (North American
Commercial Vehicle Critical Safety Inspection Items and Out-Of-Service
Criteria). In light of the proposed amendments to Sec.  396.17(f)
described above, and to further decrease the possibility of confusion
regarding differing requirements of the roadside inspection program and
the periodic/annual inspection program, FMCSA proposes to delete the
section as suggested by CVSA.
    Section 396.19, Inspector Qualifications. Section 396.19 of the
FMCSRs prescribes the minimum qualifications for individuals performing
periodic/annual inspections under Sec.  396.17(d). Specifically, Sec.
396.19(b) states that ``Motor carriers and intermodal equipment
providers must retain evidence of that individual's qualifications
under this section. They must retain this evidence for the period
during which that individual is performing annual motor vehicle

inspections for the motor carrier or intermodal equipment provider, and
for one year thereafter. However, motor carriers and intermodal
equipment providers do not have to maintain documentation of inspector
qualifications for those inspections performed either as part of a
State periodic inspection program or at the roadside as part of a
random roadside inspection program.''
    Consistent with the proposed amendments to Sec.  396.17 discussed
above, CVSA's petition recommended that FMCSA delete the language
regarding ``a random roadside inspection program'' in Sec.  396.19(b).
    FMCSA agrees and proposes to amend Sec.  396.19(b) as suggested by
CVSA.
    NTSB Recommendations, Speed-restricted tires and motorcoach seat
anchorage strength in Appendix G.
    Speed-restricted tires. After investigating a 2003 motorcoach
crash, NTSB recommended that the Agency revise Appendix G ``to include
inspection criteria and specific language to address a tire's speed
rating to ensure that it is appropriate for a vehicle's intended use.''
    FMVSS No. 119, ``New pneumatic tires for motor vehicles with a GVWR
[Gross Vehicle Weight Rating] of more than 4,536 kilograms (10,000
pounds) and motorcycles,'' requires certain information to be marked on
the tire sidewall. S6.5(d) of the standard requires that each tire's
maximum load rating for single and dual applications and the
corresponding inflation pressure be labeled on the sidewall, which
provides information to the vehicle operator to ensure proper selection
and use of tires.
    However, a tire's maximum speed rating is not required to be
labeled on the sidewall, except for tires that are speed-restricted to
90 km/h (55 mph) or below.\1\ For speed-restricted tires, S6.5(e) of
the standard requires that the label on the sidewall be as follows:
``Max Speed _km/h (_mph).'' \2\ For tires that are not speed-
restricted, inspection officials have no way to determine from the
sidewall labeling the design maximum speed capability of the tire for
the specified maximum load rating and corresponding inflation pressure.
---------------------------------------------------------------------------

    \1\ NHTSA published an NPRM on September 29, 2010 proposing to
upgrade FMVSS No. 119 (75 FR 60036) to require a maximum speed
rating label for radial truck tires with load ranges F and above. No
final rule has been published to date.
    \2\ With respect to the tires on the motorcoach in the Tallulah,
LA crash, the NTSB Highway Accident Report notes ``The restricted
speed information was embossed on each tire's outer sidewall and was
clearly visible.''
---------------------------------------------------------------------------

    FMCSA agrees that speed-restricted tires should not be used on CMVs
operating on highways in excess of 55 mph for extended periods of time.
However, the adoption of a requirement regarding a tire's speed rating
in Appendix G, as recommended by the NTSB in Safety Recommendation H-
05-03, absent a regulatory requirement for tires to be so marked, would
result in inconsistent enforcement. As an alternative, FMCSA proposes
to add language to section 10 of Appendix G that will prohibit the use
of speed-restricted tires on CMVs subject to the FMCSRs unless the use
of such tires is specifically designated by the motor carrier.
    Motorcoach seat anchorage strength. Investigators found that during
the Tallulah crash sequence, many passenger seats did not remain
securely attached to the floor. The NTSB recommended that the Agency
(1) develop a method for inspecting motorcoach passenger seat mounting
anchorages, and (2) revise Appendix G of the FMCSRs to require
inspection of these anchorages.
    Section 393.93(a)(3) requires buses manufactured on or after
January 1, 1972, to conform to the requirements of FMVSS No. 207,
``Seating systems.'' FMVSS No. 207 establishes requirements for seats,
their attachment assemblies, and their installation to minimize the
possibility of their failure by forces acting on them as a result of
vehicle impact. For most vehicles required by FMVSS No. 208, ``Occupant
crash protection,'' to have seat belts, the seat belt anchorages must
be certified to the strength requirements of FMVSS No. 210, ``Seat belt
assembly anchorages,'' and the seats must be certified to FMVSS No.
207. Part of the FMVSS No. 207 requirements tests the forward strength
of the seat attachment to the vehicle replicating the load that would
be applied through the seat center of gravity by inertia in a 20 g
vehicle deceleration.
    However, FMVSS No. 207 specifically exempts (at S.4.2) all bus
passenger seats, including motorcoaches, except for small school bus
passenger seats. As such, there are no performance standards in place
in the FMVSSs specifically for motorcoach seat anchorages. Following
its investigation of the Tallulah crash, NTSB issued Safety
Recommendation H-05-01 to NHTSA to ``develop performance standards for
passenger seat anchorages in motorcoaches.''
    On November 25, 2013, NHTSA published a final rule requiring lap/
shoulder belts to be installed for each passenger seating position on
(1) all over-the-road buses \3\ manufactured on or after November 28,
2016, and (2) all buses other than over-the-road buses manufactured on
or after November 28, 2016, with a GVWR greater than 26,000 pounds,
with certain exclusions (78 FR 70416). This rule requires the seat belt
anchorages, both torso and lap, on passenger seats to be integrated
into the seat structure, and these seat belt anchorages to meet the
performance requirements of FMVSS No. 210. Testing performed by NHTSA
demonstrated that the FMVSS No. 210 requirement ensures that restraints
integrated into seats are tested adequately and that the seat
attachment is robust. Thus, NHTSA determined that additional FMVSS No.
207 requirements for motorcoach passenger seats are not needed. In
consideration of the above, NTSB reclassified Safety Recommendation H-
05-01 as ``Closed--Acceptable Alternative Action'' on July 22, 2014.
---------------------------------------------------------------------------

    \3\ The final rule defines over-the-road bus as ``A bus
characterized by an elevated passenger deck located over a baggage
compartment, except a school bus.''
---------------------------------------------------------------------------

    As noted in the NTSB's report following the Tallulah crash, ``Many
different seating system designs are used in motorcoaches operating in
the United States; each manufacturer uses its own hardware and
anchorage designs . . .'' The NTSB also noted that it had examined the
issue of motorcoach seat anchorage failure in six previous crash
investigations. The NTSB stated ``Several different seat anchorage
system designs were used in the motorcoaches involved in these
accidents. Even when properly installed and maintained, some seat
anchorage systems failed, while others did not, even in similar
accident scenarios.''
    Given the wide range of seat anchorage designs, coupled with the
lack of testing requirements specifically for seat anchorage strength
in the FMVSSs, it is not practicable for FMCSA to develop a detailed
methodology for the inspection of motorcoach passenger seat mounting
anchorages. However, FMCSA proposes to add a new section to Appendix G
that will require an examination of motorcoach seats during the conduct
of a periodic inspection in accordance with Sec.  396.17 to ensure that
they are securely attached to the vehicle structure.

Amendments to Existing Regulatory Guidance

    If the proposed regulatory amendments are adopted, FMCSA will amend
existing regulatory guidance

questions/answers as necessary to maintain consistency with the amended
regulatory language.

Regulatory Analyses

Executive Order 12866 (Regulatory Planning and Review and DOT
Regulatory Policies and Procedures as Supplemented by E.O. 13563)

    FMCSA has determined that this proposed rule is not a significant
regulatory action within the meaning of Executive Order (E.O.) 12866,
as supplemented by E.O. 13563 (76 FR 3821, January 21, 2011), or within
the meaning of DOT regulatory policies and procedures (DOT Order 2100.5
dated May 22, 1980; 44 FR 11034, February 2, 1979). The Agency believes
the potential economic impact is nominal because the proposed
amendments generally do not involve the adoption of new or more
stringent requirements, but rather the clarification of existing
requirements. As such, the costs of the rule would not approach the
$100 million annual threshold for economic significance. Moreover, the
Agency does not expect the rule to generate substantial congressional
or public interest. This proposed rule therefore has not been formally
reviewed by the Office of Management and Budget (OMB).

Regulatory Flexibility Act

    The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.)
requires Federal agencies to consider the effects of their regulatory
actions on small business and other small entities and to minimize any
significant economic impact. The term ``small entities'' encompasses
small businesses and 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.\4\
Accordingly, DOT policy requires an analysis of the impact of all
regulations on small entities and mandates that agencies strive to
lessen any adverse effects on these businesses.
---------------------------------------------------------------------------

    \4\ Regulatory Flexibility Act (5 U.S.C. 601 et seq.), see
National Archives at http://www.archives.gov/federal-register/laws/regulatory-flexibility/601.html.
---------------------------------------------------------------------------

    Under the Regulatory Flexibility Act, as amended by the Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (Title
II, Pub. L. 104-121, 110 Stat. 857, March 29, 1996), the proposed rule
is not expected to have a significant economic impact on a substantial
number of small entities because the proposed amendments generally do
not involve the adoption of new or more stringent requirements, but,
instead, the clarification of existing requirements. Therefore, there
is no disproportionate burden to small entities.
    Consequently, I certify that the proposed action will not have a
significant economic impact on a substantial number of small entities.
FMCSA invites comment from members of the public who believe there will
be a significant impact either on small businesses or on governmental
jurisdictions with a population of less than 50,000.

Assistance for Small Entities

    In accordance with section 213(a) of the SBREFA, FMCSA wants to
assist small entities in understanding this proposed rule so that they
can better evaluate its effects on themselves and participate in the
rulemaking initiative. If the proposed rule would affect your small
business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
consult the FMCSA point of contact, Mike Huntley, listed in the FOR
FURTHER INFORMATION CONTACT section of the proposed rule.
    Small businesses may send comments on the actions of Federal
employees who enforce or otherwise determine compliance with Federal
regulations to the Small Business Administration's 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 FMCSA, call
1-888-REG-FAIR (1-888-734-3247). DOT has a policy ensuring the rights
of small entities to regulatory enforcement fairness and an explicit
policy against retaliation for exercising these rights.

Unfunded Mandates Reform Act of 1995

    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,
taken together, or by the private sector of $155 million (which is the
value equivalent of $100 million in 1995, adjusted for inflation to
2014 levels) or more in any 1 year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

Paperwork Reduction Act

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

Executive Order 13132 (Federalism)

    A rule has implications for Federalism under Section 1(a) of
Executive Order 13132 if it has ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' FMCSA has determined that this proposal
would not have substantial direct costs on or for States, nor would it
limit the policymaking discretion of States. Nothing in this document
preempts any State law or regulation.

Executive Order 12988 (Civil Justice Reform)

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

Executive Order 13045 (Protection of Children)

    E.O. 13045, Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, Apr. 23, 1997), requires agencies
issuing ``economically significant'' rules, if the regulation also
concerns an environmental health or safety risk that an agency has
reason to believe may disproportionately affect children, to include an
evaluation of the regulation's environmental health and safety effects
on children. The Agency determined this proposed rule is not
economically significant. Therefore, no analysis of the impacts on
children is required. In any event, this regulatory action could not
present an environmental or safety risk that would disproportionately
affect children.

Executive Order 12630 (Taking of Private Property)

    FMCSA reviewed this notice of proposed rulemaking in accordance
with Executive Order 12630, Governmental Actions and Interference with
Constitutionally Protected Property Rights, and has determined it will
not effect a taking of private property or otherwise have taking
implications.

Privacy

    The Consolidated Appropriations Act, 2005 (Pub. L. 108-447, 118
Stat. 2809, 3268, 5 U.S.C. 552a note), requires the

Agency to conduct a privacy impact assessment (PIA) of a regulation
that will affect the privacy of individuals. This proposed rule does
not require the collection of personally identifiable information
(PII).
    The E-Government Act of 2002, Public Law 107-347, section 208, 116
Stat. 2899, 2921 (Dec. 17, 2002), requires Federal agencies to conduct
a privacy impact assessment for new or substantially changed technology
that collects, maintains, or disseminates information in an
identifiable form. No new or substantially changed technology would
collect, maintain, or disseminate information as a result of this rule.
Accordingly, FMCSA has not conducted a privacy impact assessment.

Executive Order 12372 (Intergovernmental Review)

    The regulations implementing Executive Order 12372 regarding
intergovernmental consultation on Federal programs and activities do
not apply to this program.

Executive Order 13211 (Energy Supply, Distribution, or Use)

    FMCSA has analyzed this proposed rule under E.O. 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. The Agency has determined that it is not a
``significant energy action'' under that order because it is not a
``significant regulatory action'' likely to have a significant adverse
effect on the supply, distribution, or use of energy. Therefore, it
does not require a Statement of Energy Effects under E.O. 13211.

Executive Order 13175 (Indian Tribal Governments)

    This rule does not have tribal implications under E.O. 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.

National Technology Transfer and Advancement Act

    The National Technology Transfer and Advancement Act (15 U.S.C. 272
note) directs agencies to use voluntary consensus standards in their
regulatory activities unless the agency provides Congress, through OMB,
with an explanation of why using these standards would be inconsistent
with applicable law or otherwise impractical. Voluntary consensus
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) are standards that are developed or adopted by
voluntary consensus standards bodies. This proposed rule does not use
technical standards. Therefore, we did not consider the use of
voluntary consensus standards.

Environment (National Environmental Policy Act, Clean Air Act,
Environmental Justice)

    FMCSA analyzed this NPRM for the purpose of the National
Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and
determined this action is categorically excluded from further analysis
and documentation in an environmental assessment or environmental
impact statement under FMCSA Order 5610.1 (69 FR 9680, March 1, 2004),
Appendix 2, paragraphs 6(z)(aa) and 6(z)(bb). The Categorical Exclusion
(CE) in paragraph 6(z)(aa) covers regulations requiring motor carriers,
their officers, drivers, agents, representatives, and employees
directly in control of CMVs to inspect, repair, and provide maintenance
for every CMV used on a public road. The CE in paragraph 6(z)(bb)
covers regulations concerning vehicle operation safety standards (e.g.,
regulations requiring: Certain motor carriers to use approved equipment
which is required to be installed such as an ignition cut-off switch,
or carried on board, such as a fire extinguisher, and/or stricter blood
alcohol concentration (BAC) standards for drivers, etc.), equipment
approval, and/or equipment carriage requirements (e.g. fire
extinguishers and flares). The CE determination is available for
inspection or copying in the Regulations.gov Web site listed under
ADDRESSES.
    FMCSA also analyzed this rule under the Clean Air Act, as amended
(CAA), section 176(c) (42 U.S.C. 7401 et seq.), and implementing
regulations promulgated by the Environmental Protection Agency.
Approval of this action is exempt from the CAA's general conformity
requirement since it does not affect direct or indirect emissions of
criteria pollutants.
    Under E.O. 12898 (Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations), each Federal
agency must identify and address, as appropriate, ``disproportionately
high and adverse human health or environmental effects of its programs,
policies, and activities on minority populations and low-income
populations'' in the United States, its possessions, and territories.
FMCSA has determined that this proposed rule would have no
environmental justice effects, nor would its promulgation have any
collective environmental impact.

List of Subjects

49 CFR Part 393

    Highway safety, Motor carriers, Motor vehicle safety, Reporting and
recordkeeping requirements.

49 CFR Part 396

    Highways and roads. Motor carriers, Motor vehicle equipment, Motor
vehicle safety.

    For the reasons stated above, FMCSA proposes to amend 49 CFR
chapter III, subchapter B, as follows:

PART 393--PARTS AND ACCESSORIES NECESSARY FOR SAFE OPERATION

0
1. The authority citation for part 393 continues to read as follows:

    Authority:  49 U.S.C. 31136, 31151, and 31502; sec. 1041(b) of
Pub. L. 102-240, 105 Stat. 1914, 1993 (1991); and 49 CFR 1.87.

0
2. Amend Sec.  393.5 to add a definition for ``Major tread groove'' in
alphabetical order to read as follows:

Sec.  393.5  Definitions.

* * * * *
    Major tread groove is the space between two adjacent tread ribs or
lugs on a tire that contains a tread wear indicator or wear bar. (In
most cases, the locations of tread wear indicators are designated on
the upper sidewall/shoulder of the tire on original tread tires.)
* * * * *
0
3. In Sec.  393.11, revise Footnote 11 of Table 1 to read as follows:

Sec.  393.11  Lamps and reflective devices.

* * * * *
Table 1 of Sec.  393.11--Required Lamps and Reflectors on Commercial
Motor Vehicles
* * * * *
    Footnote--11 To be illuminated when tractor headlamps are
illuminated. No rear license plate lamp is required on truck tractors
registered in States that do not require tractors to display a rear
license plate.
* * * * *

PART 396--INSPECTION, REPAIR, AND MAINTENANCE

0
4. The authority citation for part 396 continues to read as follows:

    Authority: 49 U.S.C. 504, 31133, 31136, 31151, and 31502; sec.
32934, Pub. L. 112-141, 126 Stat. 405, 830; and 49 CFR 1.87.

0
5. Revise Sec.  396.9(d)(2) to read as follows:

Sec.  396.9  Inspection of motor vehicles and intermodal equipment in
operation.

* * * * *
    (d) * * *
    (2) Motor carriers and intermodal equipment providers shall examine
the report. Violations or defects noted thereon shall be corrected in
accordance with Sec.  396.11(a)(3). Repairs of items of intermodal
equipment placed out-of-service are also to be documented in the
maintenance records for such equipment.
* * * * *
0
6. Revise Sec.  396.17(f) to read as follows:

Sec.  396.17  Periodic inspection.

* * * * *
    (f) Vehicles passing periodic inspections performed under the
auspices of any State government or equivalent jurisdiction or the
FMCSA, meeting the minimum standards contained in appendix G of this
subchapter, will be considered to have met the requirements of an
annual inspection for a period of 12 months commencing from the last
day of the month in which the inspection was performed.
* * * * *
0
7. Revise Sec.  396.19(b) to read as follows:

Sec.  396.19  Inspector qualifications.

* * * * *
    (b) Motor carriers and intermodal equipment providers must retain
evidence of that individual's qualifications under this section. They
must retain this evidence for the period during which that individual
is performing annual motor vehicle inspections for the motor carrier or
intermodal equipment provider, and for one year thereafter. However,
motor carriers and intermodal equipment providers do not have to
maintain documentation of inspector qualifications for those
inspections performed as part of a State periodic inspection program.
0
8. Amend Appendix G to Subchapter B of Chapter III by:
0
a. Adding Section 1.l;
0
b. Revising Section 10.c;
0
c. Adding Section 14; and
0
d. Removing ``Comparison of Appendix G, and the New North American
Uniform Driver Vehicle Inspection Procedure (North American Commercial
Vehicle Critical Safety Inspection Items and Out-Of-Service
Criteria)'', including the introductory text and paragraphs 1.--13.
    The additions and revision read as follows:

Appendix G to Subchapter B of Chapter III--Minimum Periodic Inspection
Standards

* * * * *

1. Brake System

* * * * *

l. Antilock Brake System \1\
---------------------------------------------------------------------------

    \1\ This section is applicable to tractors with air brakes built
on or after March 1, 1997, and all other vehicles with air brakes
built on or after March 1, 1998. This section is also applicable to
vehicles over 10,000 lbs. GVWR with hydraulic brakes built on or
after March 1, 1999.
---------------------------------------------------------------------------

    (1) Missing ABS malfunction indicator components (bulb, wiring,
etc.).
    (2) ABS malfunction indicator that does not illuminate when
power is first applied to the ABS controller (ECU).
    (3) ABS malfunction indicator that stays illuminated while power
is continuously applied to the ABS controller (ECU).
    (4) Other missing or inoperative ABS components.
* * * * *

10. Tires

* * * * *
c. Installation of speed-restricted tires (unless specifically
designated by motor carrier)
* * * * *

14. Motorcoach Seats

    a. Any passenger seat that is not securely fastened to the
vehicle structure.

    Issued under the authority of delegation in 49 CFR 1.87 on:
September 24, 2015.
T. F. Scott Darling, III,
Acting Administrator.
[FR Doc. 2015-24921 Filed 10-6-15; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 85, Number 105 (Monday, June 1, 2020)]
[Notices]
[Pages 33165-33167]
[FR Doc No: 2020-11683]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1069]

Approved Drug Products With Therapeutic Equivalence Evaluations
(the ``Orange Book''); Establishment of a Public Docket; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the establishment of a public docket to solicit comments on FDA's
publication entitled ``Approved Drug Products With Therapeutic
Equivalence Evaluations'' (commonly known as the ``Orange Book''). The
Orange Book identifies drug products approved by FDA under the Federal
Food, Drug, and Cosmetic Act (FD&C Act) and includes related
information. As part of FDA's Drug Competition Action Plan and our
continued effort to improve transparency and provide useful information
to regulated industry and the public, we are seeking comments on how
stakeholders and the public use the Orange Book and whether it can be
improved.

DATES: Submit either electronic or written comments by August 31, 2020.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-1069 for ``Approved Drug Products With Therapeutic
Equivalence Evaluations (the 'Orange Book'); Establishment of a Public
Docket; Request for Comments.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be

made publicly available, submit your comments only as a written/paper
submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lisa Bercu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1672, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    As its core function, the Orange Book identifies drug products
approved by FDA under the FD&C Act and includes patent and exclusivity
information related to those drug products. The main criteria for the
inclusion of a drug product in the Orange Book are that the drug
product is the subject of an approved application and that FDA has not
determined the drug product to have been withdrawn for safety or
efficacy reasons. The Orange Book includes drug products approved prior
to the 1962 amendments to the FD&C Act on the basis of safety and found
to be effective through the Drug Efficacy Study Implementation process.
However, pre-1938 drug products not subject to the premarket approval
authorities of the FD&C Act are excluded from the Orange Book. In
addition, drug products that were not marketed at the time of the first
publication of the Orange Book or were discontinued between 1980 and
1987, prior to the identification of discontinued products, are also
not included in the list.
    The Orange Book also contains therapeutic equivalence evaluations
for approved multisource prescription drug products. Therapeutic
equivalents are approved drug products that FDA has determined are
pharmaceutical equivalents for which bioequivalence has been
demonstrated, and can be expected to have the same clinical effect and
safety profile when administered to patients under the conditions
specified in the labeling (Sec.  314.3(b) (21 CFR 314.3(b))). The
therapeutic equivalence evaluations in the Orange Book serve as public
information available to prescribers, pharmacists, Federal and State
health agencies, and private formularies, among others, to promote
public education in the area of drug product selection and to foster
the containment of health care costs. Therapeutic equivalence
evaluations in the Orange Book are not official FDA actions affecting
the legal status of products under the FD&C Act.
    The Orange Book is composed of four main parts: (1) The
Prescription Drug Product List, which is a list of approved marketed
prescription drug products with therapeutic equivalence evaluations;
(2) the OTC Drug Product List, which is a list of marketed over-the-
counter (OTC) drug products that have been approved in new drug
applications (NDAs) or abbreviated new drug applications (ANDAs); (3)
the Drug Products with Approval under section 505 of the FD&C Act (21
U.S.C. 355) administered by the Center for Biologics Evaluation and
Research List; and (4) the Discontinued Drug Product List, which is a
cumulative list of approved drug products that have never been
marketed, are for exportation, are for military use, are not
commercially distributed by a Federal or State government entity, have
been discontinued from marketing and FDA has not determined that they
were withdrawn from sale for safety or effectiveness reasons, or have
had their approvals withdrawn for other than safety or efficacy reasons
subsequent to being discontinued from marketing. The Orange Book also
includes indices of prescription and OTC drug products by proprietary
name (brand name or trade name) or, if no proprietary name exists,
established name of the active ingredient and by applicant name, which
have been abbreviated for this publication. The Addendum to the Orange
Book provides patent information for certain listed drugs, and
identifies drugs that qualify under the FD&C Act for periods of
exclusivity, as described in detail below.
    The Orange Book was first published on October 31, 1980. On
September 24, 1984, the President signed into law the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(Hatch-Waxman Amendments), which required that FDA make publicly
available a list of approved drug products with monthly supplements
(section 505(j)(7)(A) of the FD&C Act). The Orange Book and its monthly
Cumulative Supplements satisfy this requirement.
    Since that time, the Orange Book has played an essential
administrative role in FDA's implementation of the FD&C Act. For
example, the FD&C Act requires NDA holders to submit the patent number
and expiration date of any patent which claims the drug or a method of
using such drug and for which a claim of patent infringement could
reasonably be asserted against a person engaged in the unlicensed
manufacture, use, or sale of the drug (see section 505(b)(1) and
505(c)(2) of the FD&C Act; see also 21 CFR 314.50(h), 314.53, and
314.70(f)). The FD&C Act requires FDA to publish this patent
information (see section 505(b)(1) and 505(c)(2) of the FD&C Act). This
patent information submitted by NDA holders is listed in the Orange
Book.
    In addition, section 505(j)(7)(A)(i)(III) of the FD&C Act requires
that FDA publish and make publicly available information to show
whether in vitro or in vivo bioequivalence studies, or both studies,
are required for ANDAs that refer to an NDA, and FDA has determined
that the therapeutic equivalence codes for multisource products in the
Orange Book satisfy this requirement.
    The Orange Book also identifies drugs that qualify under the FD&C
Act for periods of exclusivity. An NDA or ANDA holder is eligible for
exclusivity if statutory and regulatory requirements are met.
Exclusivities under the FD&C Act include pediatric exclusivity,
Generating Antibiotic Incentives Now or GAIN exclusivity, 180-day
exclusivity, competitive generic therapy exclusivity, new chemical
entity exclusivity, 3-year exclusivity, and orphan drug exclusivity
(see sections 505(c)(3)(E), 505(j)(5)(B)(iv), 505(j)(5)(B)(v),

505(j)(5)(F), 505A (21 U.S.C. 355a), 505E (21 U.S.C. 355f), 506H (21
U.S.C. 356h), and 527 (21 U.S.C. 360cc) of the FD&C Act; see also 21
CFR 314.108, 316.31, 316.34). The exclusivities identified above are
set forth on a product-specific basis in the Orange Book. This
information is used by a wide range of stakeholders, including
applicants of ANDAs and 505(b)(2) applications, in planning product
development.
    The Orange Book also plays an essential administrative role in
FDA's implementation of recent statutory provisions related to drug
product regulation. For example, section 505(j)(12) of the FD&C Act,
added by the FDA Reauthorization Act of 2017 (Pub. L. 115-52) (FDARA),
requires FDA to publish on its website and update at least every 6
months a list of approved NDA products that are off-patent and off-
exclusivity, and for which FDA has not approved an ANDA referencing
that NDA drug product, and FDA uses the Orange Book to populate this
list. Section 506I of the FD&C Act requires NDA and ANDA holders to
provide a written notification to FDA 180 days prior to withdrawing an
approved drug from sale, to provide written notification to FDA within
180 days of the date of approval of a drug if that drug will not be
available for sale within 180 days of the date of approval, and to have
reviewed information in the Orange Book and submitted a one-time
marketing status report. This information is used by FDA to move drugs
that are not available for sale from the ``Prescription Drug Product
List'' to the ``Discontinued Drug Product List'' in the Orange Book
(see section 506I(e) of the FD&C Act).
    FDA has historically sought to update and enhance the Orange Book
to make it more accessible and useful to regulated industry and the
public. Below are examples of updates FDA has made to the publication:
     In 1985, FDA added to the Orange Book a list of OTC drug
products that have been approved in NDAs or ANDAs.
     In 1997, FDA published the Orange Book on the internet.
     In 2003, FDA started publishing an indicator as to whether
a listed patent contains drug substance and/or drug product claims.
     In 2005, FDA made the Orange Book available for download
off the Agency's website.
     In 2005, FDA switched from publishing patent listings in a
public docket to publishing them daily in the Orange Book.
     In 2005, FDA switched from publishing generic drug
approvals monthly to publishing them daily.
     In 2015, FDA launched a mobile application, ``Orange Book
Express,'' to put timely information in the hands of those using
smartphones and tablets.
     In 2016, FDA redesigned the Orange Book website to include
commonly used features on the home page and to allow users to better
navigate the Orange Book and customize their search.
     In 2017, FDA revised the Orange Book so that drug listings
now clarify which listed drugs are RLDs and which are reference
standards (see Sec.  314.3(b)), as well as to clarify which products in
the ``Discontinued Drug Product List'' may be referred to as an RLD.
     In 2017, FDA revised the Orange Book to include listed
patent submission dates, when available.
     In 2017, FDA added the patent disputes list to the Orange
Book website, which informs stakeholders which patents have been
disputed by an outside party to FDA.
     In 2018, FDA updated the Orange Book to include
descriptions indicating which indication(s) are protected by orphan
drug exclusivity.
    As part of FDA's Drug Competition Action Plan \1\ and our continued
effort to provide more accessible and useful information in the Orange
Book, FDA is considering whether there are other opportunities to
enhance the publication. The Drug Competition Action Plan aims to
facilitate more generic competition, promote patient access, and
improve the economics of developing generic medicines. Soliciting
public comment on this topic will help guide the Agency's priorities as
we consider enhancing the Orange Book.
---------------------------------------------------------------------------

    \1\ Available at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan.
---------------------------------------------------------------------------

II. Establishment of a Public Docket and Request for Comments

    FDA is establishing a public docket to solicit input from a broad
group of stakeholders, including patients, health care providers, drug
manufacturers, public policy makers (e.g., Federal and State health
agencies), individuals involved in patent litigation (e.g., patent
counsel), and any other interested parties, on whether and how the
Orange Book can be improved. (To note, FDA intends to publish a
separate Federal Register notice seeking public input specifically on
patent listings in the Orange Book in the near future, and thus is not
soliciting comment on that topic now.) In addition to general comments,
FDA is interested in responses to the following questions:
     What types of people or entities use the Orange Book?
     What sections of the Orange Book do these different types
of people or entities use?
     For what reasons do these people or entities use the
Orange Book? What additional information or features (e.g., additional
search functions) could be incorporated into the Orange Book to make it
more useful?
     Is the information in the Orange Book regarding
therapeutic equivalence generally useful?
    [cir] How useful is the second letter of a therapeutic equivalence
evaluation code?
    [cir] How could the therapeutic equivalence information be made
more user-friendly or otherwise be tailored to meet the needs of people
or entities that use the Orange Book (e.g., the therapeutic equivalence
evaluation code)?
    [cir] If you use the information regarding therapeutic equivalence,
how do you use it?
    [cir] Does the information regarding therapeutic equivalence
promote drug competition? And if so, how?
     Is there any other information regarding the Orange Book
that would be useful for FDA to consider?

    Dated: May 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11683 Filed 5-29-20; 8:45 am]
BILLING CODE 4164-01-P