[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Notices]
[Pages 22941-22942]
[FR Doc No: 2013-08958]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2007-28927; Notice 2]

Sidump'r Trailer Company, Inc., Grant of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Grant of petition.

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SUMMARY: Sidump'r Trailer Company, Inc. (Sidump'r) has determined that
the rear impact guards on certain trailers that it manufactured between
January 10, 2006 and April 13, 2007 do not comply with paragraph S5.1
of 49 CFR 571.224, Federal Motor Vehicle Safety Standard (FMVSS) No.
224, Rear Impact Protection. Sidump'r has filed an appropriate report
pursuant to 49 CFR Part 573, Defect and Noncompliance Responsibility
and Reports, dated April 20, 2007.
    Pursuant to 49 U.S.C. 30118 (d) and 30120 (h) and the rule
implementing those provisions at 49 CFR Part 556, Sidump'r has
petitioned for an exemption from the notification and remedy
requirements of 49 U.S.C. Chapter 301 on the basis that this
noncompliance is inconsequential to motor vehicle safety. Notice of
receipt of a petition was published, with a 30-day public comment
period, on August 16, 2007, in the Federal Register (72 FR 46127). The
National Highway Traffic Safety Administration (NHTSA) received no
comments. To view the petition and all supporting documents log onto
the Federal Docket Management System (FDMS) Web site at: http://www.regulations.gov/. Then follow the online search instructions to
locate docket number ``NHTSA-2007-28927.''
    For further information on this decision, contact Mr. Luis
Figueroa, Office of Vehicle Safety Compliance, NHTSA, telephone (202)
366-5298, facsimile<PHONE_NUMBER>.
    Trailers Involved: Affected are approximately 416 model 223, 325
and 425 side dump bulk material hauling trailers manufactured by
Sidump'r between January 10, 2006 and April 13, 2007.
    Summary of Sidump'r's Analysis and Arguments: Sidump'r first became
aware of the noncompliance of these trailers when Sidump'r received a
customer inquiry on or about February 27, 2007 regarding the rear
impact guards installed on the subject trailers. As a result of this
inquiry, Sidump'r stated that it commenced a thorough engineering
evaluation of the rear end of the subject trailers to determine whether
they meet the requirements of FMVSS No. 224. Following this engineering
evaluation and after consultation with its counsel, Sidump'r determined
that the trailers do not comply with FMVSS No. 224.
    Specifically, Sidump'r has determined that the location of those
guards does not meet the requirements of paragraph S5.1.3 of FMVSS No.
224 because there is a ``push block'' located at the rear of the
trailer chassis extending 23.62 inches (600 mm) to the rear of the rear
impact guard. Sidump'r stated that it considered the ``push blocks'' to
be the ``rear extremities'' of the subject trailers. Therefore, it
concluded that the rearmost surface of the horizontal members of the
rear impact guards are located 11.62 inches (295 mm) too far forward of
the ``rear extremity'' of the trailers to conform with the requirements
of paragraph S5.1.3.
    Sidump'r also examined the possibility of the ``push block'' itself
serving as the rear impact guard. It determined that the ``push block''
itself does not constitute a compliant rear impact guard as originally
installed because it exceeds the maximum ground clearance of 22 inches
(560 mm) allowed by paragraph S5.1.2 of FMVSS No. 224 by 1.5 inches (38
mm).
    Sidump'r stated that it has corrected the problem that caused the
noncompliance in the trailers they produced after April 20, 2007 by
modifying the design of the trailers to incorporate an additional
horizontal member mounted to the underside of the ``push block''
assembly.
    Sidump'r also stated that it believes this noncompliance is
inconsequential to motor vehicle safety and that no further corrective
action is warranted due to the geometric characteristics of the
trailers and the nature of their field usage. Specifically, Sidump'r
makes the arguments that the overall level of safety of the subject
trailers is equivalent to a compliant trailer because their ``push
block'' is equipped with a guard-like structure that is comparable to a
compliant rear impact guard based on dimensional considerations, and on
a simulation of the guard performance \1\ when subjected to the loads
required under FMVSS No. 223. Sidump'r additionally supported its
position that the overall level of safety of the noncompliant trailers
is equivalent to comparable trailers by comparing them to road
construction controlled horizontal discharge trailers and by citing
several previous decisions where NHTSA granted temporary exemptions
from compliance with FMVSS No. 224 as the result of petitions filed
under 49 CFR Part 555 Temporary Exemption From Motor Vehicle Safety and
Bumper Standards for noncompliances that it considers similar in
consequence to those covered in this petition.
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    \1\ Fred P. Smith, P.E., CSP, Under Ride Report (Alpine
Engineering and Design, Inc., 2007). Supplemental petition data as
submitted on May 14, 2008 to docket number NHTSA-2007-28927.
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Discussion

Requirement Background

    Paragraph S5.1.3 Guard Rear Surface of FMVSS No. 224 requires:

At any height 560 mm or more above the ground, the rearmost surface
of the horizontal member of the guard shall be located as close as
practical to a transverse vertical plane tangent to the rear
extremity of the vehicle, but no more than 305 mm forward of that

plane. Notwithstanding this requirement, the horizontal member may
extend rearward of the plane, and guards with rounded corners may
curve forward within 255 mm of the longitudinal vertical planes that
are tangent to side extremities of the vehicle.

    Paragraph S5.1.2 Guard Height of FMVSS No. 224 requires:

The vertical distance between the bottom edge of the horizontal
member of the guard and the ground shall not exceed 560 mm at any
point across the full width of the member. Notwithstanding this
requirement, guards with rounded corners may curve upward within 255
mm of the longitudinal vertical planes that are tangent to the side
extremities of the vehicle.

    Sidump'r states that NHTSA has granted temporary exemptions based
on: Infrequent highway use (69 FR 30989, 68 FR 7406 and 64 FR 49049),
as well as small production quantities of vehicles (66 FR 22069, 63 FR
16857, 66 FR 20028 and 68 FR 7406). Those temporary exemptions were
granted based on petitions submitted by vehicle manufacturers under 49
CFR Part 555, Temporary Exemption from Motor Vehicle Safety and Bumper
Standards. The statutory provision (49 U.S.C. 30113) that permits
manufacturers to file petitions for a determination of exemption allows
NHTSA to temporarily exempt manufacturers from specific FMVSS or bumper
standard requirements. This provision applies to vehicles that have not
yet been passed from the manufacturer to an owner, purchaser, or
dealer, which is not the case for the subject trailers. Exemptions are
available under this provision to permit vehicles to be built without
complying with the standards based on certain specific criteria,
including the petitioner's economic hardship. Under each of the
criteria, the number of vehicles produced is a specific consideration.
See, e.g., 49 CFR 555.6(a)(2)(v). The primary basis for NHTSA granting
the temporary exemptions cited above was because the petitioners had
met the burden of persuasion that compliance would have caused
substantial economic hardship. Economic hardship is not a consideration
in the evaluation process for inconsequentiality petitions. See 49 CFR
Part 556. Accordingly, NHTSA does not find those decisions under Part
555 relevant here.
    NHTSA agrees with Sidump'r's assessment that the rear impact guards
on the subject trailers do not conform to the requirements of S5.1.3 of
49 CFR 571.224 because they are mounted too far forward of the rear
extremities of the trailers.
    Also, NHTSA agrees with Sidump'r's assessment that if a guard-like
structure under the push block complies with the dimensional and
performance requirements of FMVSS No. 223 and FMVSS No. 224 that the
guard-like structure can serve as a rear impact guard.\2\ Sidump'r used
a finite element model analysis \3\ to make a determination that the
guard like structure would meet the performance requirements. Finite
element modeling is a mature science and appropriately accurate for
modeling the rudimentary force deflection characteristics of the guard-
like structure under the push block. Based on that analysis, which
Sidump'r submitted to the docket, the guard-like structure appears to
meet the loads and energy absorption requirement under FMVSS No. 223.
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    \2\ NHTSA's Chief Counsel interpretation letter to Jason Backs
(CPS Trailers, May 28, 1998).
    \3\ Finite element analysis can be used as a basis for
establishing certification to performance requirements of a
standard.
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    In addition, based on the drawings provided by Sidump'r, NHTSA
agrees that the guard-like structure meets all of FMVSS No. 224
configuration requirements except for guard height. While the maximum
height requirement was exceeded by an inch and a half, NHTSA does not
consider the difference significant in this particular instance. Using
NCAP (2003-2009) test data OVSC selected compact and subcompact
vehicles to determine the part of the frame structure that would most
likely engage the bumper of a trailer and the height of that structure
in the car. We determined that the area most likely to be engaged by
the rear impact guard would be the area of the unibody where the front
shock absorbers (struts) are attached. We also looked at the height of
the engine block in those cars. The shock absorber height and the top
of the engine block height are data points measured as part of the NCAP
frontal impact evaluation of vehicles. The average shock absorber
height was 838 mm (33 in) with a minimum of 566 mm (22 in) and a
maximum of 972 mm (38 in). The average engine block height was 836 mm
(33 in) with a minimum of 748 mm (29 in) and a maximum of 935 mm (37
in). In addition, we asked laboratory personnel to measure the depth of
the engine block cover of several vehicles to be crash tested. The
average depth was between 2 and 4 in. This depth was used to assess
shearing of the engine block cover during a crash and possible impact.
Based on this NCAP data we believe the car's frontal structure will
effectively engage the rear impact guard during a crash incident and
that Sidump'r's guard placement of 1 in (38 mm) over the required FMVSS
No. 224 guard height is inconsequential to vehicle safety based on the
particular facts in this case.
    NHTSA Decision: In consideration of the foregoing, NHTSA has
decided that Sidump'r has met its burden of persuasion that the
dimensional noncompliance described in Sidump'r's Noncompliance
Information Report is inconsequential to motor vehicle safety.
Accordingly, Sidump'r's petition is granted, and the Sidump'r is
exempted from the obligation of providing notification of, and a remedy
for, the noncompliances under 49 U.S.C. 30118 and 30120.
    Authority: 49 U.S.C. 30118, 30120; delegations of authority at 49
CFR 1.50 and 501.8.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 3120, respectively, to
notify owners, purchasers, and dealers of a defect or noncompliance and
to remedy the defect or noncompliance. Therefore, this decision only
applies to the trailers that Sidump'r no longer controlled at the time
that it determined that a noncompliance existed in the subject
vehicles.

    Issued On: April 11, 2013.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2013-08958 Filed 4-16-13; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: November 5, 2009 (Volume 74, Number 213)]
[Notices]
[Page 57319]
[DOCID:fr05no09-60]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0322]

Draft Guidance for Industry on Dosage Delivery Devices for Over-
The-Counter Liquid Drug Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry titled ``Dosage Delivery
Devices for OTC Liquid Drug Products.'' FDA is issuing this guidance
because of ongoing concerns about potentially serious accidental drug
overdoses that can result from the use of dosage delivery devices with
markings inconsistent or incompatible with the labeled dosage
directions for over-the-counter (OTC) liquid drug products.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by February 3, 2010.

ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the guidance to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Spencer Salis, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, rm. 5216 Silver Spring, MD 20993-0002, 301-
796-3327.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
titled ``Dosage Delivery Devices for OTC Liquid Drug Products.'' This
document is intended to provide guidance to firms that are
manufacturing, marketing, or distributing OTC liquid drug products
packaged with dosage delivery devices (e.g., calibrated cups, droppers,
syringes, or spoons). The Agency has determined that many OTC liquid
drug products in the marketplace are packaged with dosage delivery
devices that bear markings that are inconsistent with the labeled
dosage directions, contain superfluous markings, or are missing
necessary markings. FDA is issuing this guidance because of ongoing
concerns about potentially serious accidental drug overdoses that can
result from the use of dosage delivery devices with markings that are
inconsistent or incompatible with the labeled dosage directions for OTC
drug products. FDA recommends that dosage delivery devices be included
for all OTC drug products that are liquid formulations; they should
bear markings that are consistent with the labeled dosage directions;
and they should be labeled in a manner that attempts to ensure that
they are used only with the products with which they are included.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). When finalized the
guidance will represent the agency's current thinking on ``Dosage
Delivery Devices for OTC Liquid Drug Products.'' It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
www.regulations.gov.

    Dated: October 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26531 Filed 11-04-09; 8:45 am]

BILLING CODE 4160-01-S