[Federal Register: June 29, 2010 (Volume 75, Number 124)]
[Proposed Rules]
[Page 37343-37350]
[DOCID:fr29jn10-22]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 571

[Docket No. NHTSA-2010-0061]

Federal Motor Vehicle Safety Standards; Occupant Crash Protection

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Request for comments.

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

SUMMARY: This document requests public comments on a petition for
rulemaking submitted by Public Citizen and Advocates for Highway and
Auto Safety, to amend the Federal motor vehicle safety standard on
occupant crash protection to require automobile manufacturers to
install seat belt reminder systems for rear designated seating
positions in light passenger vehicles. The document discusses the
agency's research and findings as well as our knowledge of the
different types of rear seat belt reminder systems. In general, we are
encouraged by new methods to increase seat belt use. NHTSA requests
comments and information to assist the agency in determining whether to
grant or deny the petition.

DATES: Comments must be received on or before August 30, 2010.

ADDRESSES: You may submit comments (identified by the DOT Docket ID
Number above) by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m. ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Public
Participation heading of the SUPPLEMENTARY INFORMATION section of this
document. It is requested, but not required, that two copies of the
comment be provided. Note that all comments received will be posted
without change to http://www.regulations.gov, including any personal
information provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).

FOR FURTHER INFORMATION CONTACT:
    For Non-Legal Issues: Ms. Carla Rush, Office of Crashworthiness
Standards, National Highway Traffic Safety Administration, 1200 New
Jersey Ave., SE., Washington, DC 20590, Telephone:<PHONE_NUMBER>,
Facsimile:<PHONE_NUMBER>.
    For Legal Issues: Mr. J. Edward Glancy, Office of Chief Counsel,
National Highway Traffic Safety Administration, 1200 New Jersey Ave.,
SE., Washington, DC 20590, Telephone:<PHONE_NUMBER>, Facsimile: (202)
366-3820.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. Seat Belt Reminder Systems in the United States
    1. Regulatory History
    2. NHTSA Research and Consumer Information Programs
    B. Seat Belt Reminder Systems in Europe
    C. Seat Belt Reminder Systems in Japan
    D. Seat Belt Reminder Systems in Australia
II. Petition
III. Analysis
    A. Target Population
    B. Benefits
    C. Countermeasure Costs
    D. Summary
IV. Solicitation of Comments
V. Public Participation

I. Background

A. Seat Belt Reminder Systems in the United States

    Increasing seat belt use in the United States (U.S.) has been a
long-standing priority for the National Highway Traffic Safety
Administration (NHTSA). When used properly, NHTSA estimates that seat
belts (lap/shoulder belts) reduce the risk of fatal injury to front
seat passenger car occupants by 45 percent and the risk of moderate-to-
severe injury by 50 percent. Seat belts are even more effective for
light truck occupants, reducing the fatality risk by 60 percent and the
moderate-to-serious injury risk by 65 percent.\1\ For rear seat
passenger car occupants, seat belts reduce the risk of fatal injury by
44 percent. For rear seat passenger van and sport utility vehicle
occupants, seat belts reduce the risk of fatal injury by 73 percent.\2\
During the 5-year period from 2004 to 2008, seat belts saved over
75,000 lives.\3\ Historically, NHTSA has pursued two strategic
approaches for increasing seat belt use: Behavioral programs and
vehicle-based technologies.
---------------------------------------------------------------------------

    \1\ Traffic Safety Facts: Occupant Protection, 2006 Data. DOT HS
810 807. Washington, DC: National Highway Traffic Safety
Administration.
    \2\ Morgan, Christina. ``Effectiveness of Lap/Shoulder Belts in
the Back Outboard Seating Positions,'' DOT HS 808 945, NHTSA
Technical Report, 1999.
    \3\ Traffic Safety Facts: Crash Stats: Lives Saved in 2008 by
Restraint Use. DOT HS 811 153. Washington, DC: National Highway
Traffic Safety Administration.
---------------------------------------------------------------------------

    Behavioral programs aimed at increasing seat belt use have included
providing educational and technical assistance to the public, policy-
makers and intermediaries on the benefits of seat belt use and the
effectiveness of primary seat belt use laws and strengthening existing
laws. NHTSA has also worked with the States to encourage high
visibility seat belt use enforcement through programs such as safety
checkpoints and associated media campaigns. The agency has also worked
on national communication plans directed towards media opportunities to
support seat belt use mobilization efforts, as well as initiatives that
partner with employers and the insurance industry.
    In parallel with our behavioral strategies, the agency has also
pursued vehicle-based technologies for increasing seat belt use. These
include sensors in the seat belt system that can detect seat belt non-
use and provide audio/visual warnings or other incentives to encourage
unbelted occupants to fasten their seat belts. In this notice we will
discuss four different types of vehicle-based technologies: Driver seat
belt warning systems, seat belt interlocks, rear seat belt reminder
systems (SBRSs) and enhanced SBRSs.\4\ For the purposes of this notice,
the term rear SBRS does not necessarily limit the system to the
requirements of the driver seat belt warning systems that are regulated
by Federal Motor Vehicle Safety Standard (FMVSS) No. 208, ``Occupant
crash protection,'' which will be discussed in the following section.
However, as further discussed below, there are statutory limitations
with respect to our ability to require some types of enhanced SBRSs.
---------------------------------------------------------------------------

    \4\ For the purposes of this notice an ``enhanced SBRS'' is a
seat belt warning system that goes beyond the specifications of the
driver seat belt warning system that are set forth in S7.3 of FMVSS
No. 208.
---------------------------------------------------------------------------

1. Regulatory History
    Early driver seat belt warning systems and seat belt interlocks
date back to the 1970s, when seat belt use was only 12 to 15
percent.\5\ In 1971, NHTSA sought to increase seat belt use by adopting
occupant protection options for vehicles manufactured after 1972 that
required the use of a SBRS for the front outboard seating positions (36
FR 4600).\6\ Then in 1972, NHTSA adopted an occupant protection option
for passenger cars manufactured between August 15, 1973 and August 15,
1975, that required an interlock system which would prevent a vehicle
from starting if any of the front seat belts were not fastened (37 FR
3911).\7\
---------------------------------------------------------------------------

    \5\ ``Buckling Up, Technologies to Increase Seat Belt Use,''
Special Report 278, Committee for the Safety Belt Technology Study,
http://www.TRB.org, 2003, page 4. Haseltine, P.W. 2001. Seat Belt
Use in Motor Vehicles: The U.S. Experience. In 2001 Seat Belt
Summit, Automotive Coalition for Traffic Safety, Inc., Jan. 11-13.
    \6\ NHTSA Docket No. 69-7; Notice 9.
    \7\ NHTSA Docket No. 69-7; Notice 16.
---------------------------------------------------------------------------

    Contrary to the agency's expectations, the initial vehicle
introduction of these systems in the early 1970s was not well received
by the public. In particular, continuous buzzers and ignition
interlocks annoyed many consumers to the point of disabling or
circumventing the systems.\8\ As a result of the negative consumer
reaction, Congress adopted a provision, as part of the Motor Vehicle
and School Bus Safety Amendments of 1974, prohibiting the agency from
prescribing a motor vehicle safety standard that requires, or permits
as a compliance option, either ignition interlocks designed to prevent
starting or operating a motor vehicle if an occupant is not using a
seat belt, or a buzzer designed to indicate a seat belt is not in use
for a period of more than eight (8) seconds after the ignition was
turned to the ``start'' or ``on'' position (49 U.S.C. 30124).\9\
---------------------------------------------------------------------------

    \8\ Kratzke, S.R. 1995. Regulatory History of Automatic Crash
Protection in FMVSS 208. SAE Technical Paper 950865. International
Congress and Exposition, Society of Automotive Engineers, Detroit,
Mich., Feb. 27-March 2.
    \9\ There is no statutory requirement that the warning system be
limited to the driver's seating position.
---------------------------------------------------------------------------

    FMVSS No. 208 was ultimately amended to only require that the
driver's seating position be equipped with a seat belt warning system
that activates, under circumstances when the driver's seat belt is not
buckled, a continuous or intermittent audible signal for a period of
not less than 4 seconds and not more than 8 seconds, and a continuous
or flashing warning light for not less than 60 seconds after the
ignition switch is turned on (39 FR 42692).\10\ This provision was more
readily accepted by the public and has remained a part of the standard
for vehicles manufactured since 1974. Likewise, the Congressional
statutory provision of 1974 is still in effect today (49 U.S.C. 30124).
---------------------------------------------------------------------------

    \10\ NHTSA Docket No. 74-39; Notice 3.
---------------------------------------------------------------------------

2. NHTSA Research and Consumer Information Programs
    As seat belt use increased to 73 percent in calendar year 2001,\11\
Congress directed NHTSA to study the potential benefits of technologies
designed to increase seat belt use (through contract with the
Transportation Research Board of the National Academy of Sciences
(NAS)).\12\ The study aimed to determine how current drivers might
accept technologies designed to increase seat belt use, and consider
whether legislative or regulatory actions were

necessary to enable their installation on passenger vehicles.
---------------------------------------------------------------------------

    \11\ Glassbrenner, Donna, Safety Belt and Helmet Use in 2002--
Overall Results. DOT HS 809 500. September 2002.
    \12\ House of Representatives Report 107-108 Department of
Transportation and Related Agencies Appropriation Bill, 2002, June
22, 2001.
---------------------------------------------------------------------------

    The study found that enhanced SBRSs that went beyond the required
FMVSS No. 208 driver seat belt warning system showed promise for
increasing seat belt use. It concluded that the data available at that
time provided ``strongly converging evidence in support of both the
potential effectiveness and consumer acceptance of many new seat belt
use technologies, particularly enhanced belt reminder systems.''
    The study also made eight recommendations for the continued
development of these technologies. One of the recommendations stated
that Congress should amend the statute regarding seat belt reminder
systems by lifting the restrictions on systems with visual and audible
signals that stay activated beyond the initial 8 seconds. It further
stated that amending the statute would provide NHTSA more flexibility
and the authority to require effective seat belt reminder
technologies.\13\ It also recommended that if voluntary efforts to
install effective SBRSs did not produce sufficient results, NHTSA
should mandate the most effective acceptable systems as determined by
the current data. In addition, the study recommended that Congress
provide NHTSA funding to support a multi-year program of research on
the effectiveness of different enhanced SBRSs, because the findings of
such research could help establish the scientific basis for regulation
should regulation be needed.
---------------------------------------------------------------------------

    \13\ ``Buckling Up, Technologies to Increase Seat Belt Use,''
Special Report 278, Committee for the Safety Belt Technology Study,
http://www.TRB.org, 2003.
---------------------------------------------------------------------------

    Concurrent with the NAS study, NHTSA's Administrator sent letters
to vehicle manufacturers in 2002, and again in 2003, encouraging them
to enhance their driver seat belt warning systems beyond the minimum
required by FMVSS No. 208. In addition, the agency explained through a
series of legal interpretations the attributes of various specific
enhanced SBRS designs contemplated by vehicle manufacturers that would
enable them to comply with FMVSS No. 208.\14\
---------------------------------------------------------------------------

    \14\ These interpretation letters can be found at http://
www.regulations.gov (Docket Nos.: NHTSA-2001-9899, NHTSA-2002-13379,
NHTSA-2003-14742, NHTSA-2003-15006, and NHTSA-2003-15156). In
general, the interpretation letters indicate that if manufacturers
want to provide a voluntary signal that goes beyond what is
specified in FMVSS No. 208, S7.3, they may do so, but that they must
provide a means for differentiating the voluntarily provided signal
from the required signal.
---------------------------------------------------------------------------

    Based on the number of vehicle manufacturer responses, we were
pleased that many manufacturers were voluntarily moving in the
direction of installing enhanced SBRSs.\15\ However, we found that
there was a spectrum of enhanced SBRS types that were being introduced
into the fleet. Some of the more rudimentary systems had a visual
signal that stayed activated until the belt was buckled, some had
audible signals that activated beyond the initial 8 seconds, and others
had visual signals that stay activated beyond the initial 60 seconds.
Some even had audible and visual signals that stay activated for
several minutes.
---------------------------------------------------------------------------

    \15\ See Docket No. NHTSA-2002-13226 at http://regulations.gov/.
---------------------------------------------------------------------------

    For the most part, these enhanced SBRSs were directed at front seat
applications. For the driver position, enhanced SBRSs primarily relied
on sensors found in the seat belt buckle and latch assemblies, since
the presence of a driver could be assumed. For front seat passengers,
some of the more advanced SBRSs relied on the use of existing sensors
in the seat, used for one of the advanced air bag compliance options.
These could include pressure-sensitive or capacitive sensors in the
seat cushions, for example, that were already installed for ensuring
the proper deployment or suppression of advanced air bags as required
by FMVSS No. 208.
    In September 2002, NHTSA also chartered an integrated project team
(IPT) to strategically identify innovative solutions and recommend
effective strategies in increasing seat belt use. The IPT recommended
several strategies for consideration.\16\ These included: Continued
work on encouraging vehicle manufacturers to voluntarily install
enhanced SBRSs, providing consumer information on vehicles equipped
with enhanced SBRSs as part of the New Car Assessment Program (NCAP),
and continued monitoring and assessment of the effectiveness and
acceptability of enhanced SBRSs through research.
---------------------------------------------------------------------------

    \16\ U.S. Department of Transportation, National Highway Traffic
Safety Administration, Initiatives to Address Safety Belt Use, July
2003, http://www.nhtsa.dot.gov/people/injury/SafetyBelt/OPIPT_
FinalRpt_07-17-03.html (September 30, 2003).
---------------------------------------------------------------------------

    In 2004, NHTSA started making enhanced SBRS information available
to consumers through the NCAP http://www.safercar.gov Web site. The
consumer information explained the functionality of enhanced SBRSs and
documented the availability of enhanced SBRS for each vehicle model on
the http://www.safercar.gov Web site. We have continued to collect and
disseminate the information in the years since. Currently in the U.S.,
479 vehicle models out of 493 were reported by their manufacturers as
having a SBRS that went beyond the minimum performance requirements of
FMVSS No. 208 according to the model year (MY) 2010 Buying a Safer Car
information. Currently the agency requests information about the
seating positions that have SBRSs and if the SBRS signal time exceeds
that required by FMVSS No. 208. It was reported that 372 of the 493
vehicle models have a SBRS for the right front passenger seat, and 416
of the 493 vehicle models have a SBRS signal (audio/visual/or both)
that stays active beyond the FMVSS No. 208 requirement. As Volvo
started introducing rear SBRSs in the U.S. in 2009, NHTSA expanded its
data collection efforts to include vehicle models with rear SBRS data.
In the MY 2010 Buying a Safer Car information, Volvo remains the only
vehicle manufacturer that offers rear SBRSs; furthermore, they have
become standard equipment in the majority of Volvo's 2010 model year
vehicles.\17\
---------------------------------------------------------------------------

    \17\ The Volvo models with rear SBRSs included: The XC60, XC70,
C30, C70, S40, S80, V50, and V70.
---------------------------------------------------------------------------

    In 2005, the Safe, Accountable, Flexible, and Efficient
Transportation Equity Act--Legacy for Users (SAFETEA-LU) \18\
legislation required that NHTSA evaluate the effectiveness and
acceptability of several different types of enhanced SBRSs being
offered by a number of manufacturers. In response, the agency initiated
a four-phase research study, which is partially completed.
---------------------------------------------------------------------------

    \18\ Safe, Accountable, Flexible, Efficient Transportation
Equity Act, Public Law No. 109-59, Sec.  10306 (2005).
---------------------------------------------------------------------------

    The first phase included an observational study of actual vehicles
in the field in which the front seat belt use rates in vehicles with
the enhanced SBRSs were compared to rates in comparable vehicles with
only the driver seat belt warning required by FMVSS No. 208. The study
looked at 20 different enhanced SBRSs systems as well as baseline
systems that did not exceed the FMVSS No. 208 requirements. Nine of the
20 enhanced SBRSs were driver only systems. The enhanced systems
studied had a variety of enhanced features; some enhancements were
related to the visual feedback, i.e., icons and/or text, and others
were related to auditory feedback. Similar systems were combined into
groups when determining effectiveness. Combining all the effective
estimates for all the enhanced SBRSs studied, it was estimated that
these systems were associated with increased front seat belt usage of
about 3-4 percentage points

above front seat belt usage rates for vehicles without enhanced
SBRSs.\19\
---------------------------------------------------------------------------

    \19\ Freedman, M., Levi, S., Zador, P., Lopdell, J., and
Bergeron, E., ``The effectiveness of enhanced seat belt reminder
systems--Observational field data collection methodology and
findings,'' Report : DOT HS 810 844, December 2007.
---------------------------------------------------------------------------

    The second phase examined which seat belt reminder characteristics
(e.g., visual, auditory, etc.) most influenced effectiveness and
acceptance for drivers. This phase found that all of the enhanced SBRSs
were perceived to be more effective in encouraging seat belt use than
the driver seat belt warning system required by FMVSS No. 208. The
study found a strong positive correlation between subjective
effectiveness and annoyance. Systems with more aggressive reminder
displays and more frequent repetition patterns were perceived to be the
most effective. However, no clear consensus existed regarding which
systems or displays were most acceptable and the degree to which
annoyance was an important attribute of an effective system.\20\
---------------------------------------------------------------------------

    \20\ Lerner, N., Singer, J., Huey, R., and Jenness, J.,
``Acceptability and Potential Effectiveness of Enhanced Seat Belt
Reminder System Features,'' Report : DOT HS 810 848,
December 2007.
---------------------------------------------------------------------------

    The third phase of our research study further analyzed the results
of the first and second phases, as well as focused on optimizing the
effectiveness and acceptance of enhanced SBRSs. The study found that
there is good agreement between the two studies on the association of a
greater likelihood of seat belt use with enhanced SBRSs and the
importance of including an auditory component to the system. Based on
the findings of this phase, a set of recommended system characteristics
were presented as part of the report, as well as a proposed rating
system for enhanced SBRSs.\21\
---------------------------------------------------------------------------

    \21\ Freedman, M., Lerner, N., Zador, P., Singer, J., and Levi,
S. Effectiveness and Acceptance of Enhanced Seat Belt Reminder
Systems: Characteristics of Optimal Reminder Systems. Report
: DOT HS 811 097, February 2009.
---------------------------------------------------------------------------

    The final phase, expected to be completed by mid-2010, is focused
on the effectiveness and acceptance of enhanced SBRSs in teen drivers
and passengers.

B. Seat Belt Reminder Systems in Europe

    In April 2008, a seat belt reminder system for the driver's seat
was incorporated into ECE R.16, ``Uniform provisions concerning the
approval of: safety belts, restraint systems, child restraint systems
and ISOFIX child restraint systems for occupants of power-driven
vehicles and vehicles equipped with safety belts, restraint systems,
child restraint systems and ISOFIX child restraint systems.'' The
requirements include two levels of warning signals for seat belt non-
use. The first level is a visual warning that is at least 4 seconds
long that activates when the driver's seat belt is unbuckled and the
ignition switch is engaged. An optional audible signal can be added.
The second level is a visual and audible signal that is at least 30
seconds long that activates when a driver operates a vehicle with his
or her seat belt unbuckled.
    Many passenger vehicles in Europe have enhanced SBRSs beyond the
minimum required by the European standards. Since 2002, the consumer
crash protection program in Europe, the European New Car Assessment
Programme (Euro NCAP), has awarded points to a vehicle if it is
voluntarily equipped with enhanced SBRSs that fully comply with their
protocol requirements.\22\
---------------------------------------------------------------------------

    \22\ Specifically, the awarded points are applied toward a
vehicle's Safety Assist rating, which in turn is used in the overall
rating for the vehicle. From February 2009, Euro NCAP will publish a
new overall rating for every vehicle that will cover Adult Occupant
Protection, Child Occupant Protection, Pedestrian Protection and a
new area of assessment: Safety Assist.
---------------------------------------------------------------------------

    In the Euro NCAP SBRS protocol requirements, seat belt use must be
identified for all seating positions at the start of a trip. However,
it does not require occupant detection sensors to determine whether a
passenger is actually occupying the seat. Separate points are given for
the driver, front passenger, and rear passenger seating positions.
    For front seats, an audiovisual signal must start when a front seat
occupant is unbelted and one of the following events takes place: The
engine has been running for 60 seconds, the vehicle has been in forward
motion for 60 seconds or 500 meters, or the vehicle has reached a
forward speed of 25 km/hr. The signal must be at least 90 seconds long.
    For rear seats, a visual signal must start within five seconds of
the engine starting or the start of forward motion. The visual signal
must be at least 30 seconds long and it must indicate the number of
rear seat belts that are in use. For rear seats with occupancy
detection, they must meet the same signal requirements as those without
occupancy detection except that no signal is required if there are no
occupants in the rear passenger seats or if all rear seat occupants are
belted. The system may allow the driver to acknowledge the signal for
rear seats and switch it off.
    Furthermore, when a seat belt experiences a change of status (from
buckled to unbuckled), an audiovisual signal is required for front and
rear seats.

C. Seat Belt Reminder Systems in Japan

    Japan's National Agency for Automobile Safety and Victim's Aid and
Japan's Ministry of Land, Infrastructure and Transport (JMLIT) has
initiated a two phase program as part of Japan's New Car Assessment
Program (JNCAP) to promote the introduction of enhanced SBRSs for
passenger seats. The first phase will identify which vehicles
voluntarily meet their enhanced SBRS requirements and make the
information available to consumers through their JNCAP pamphlet and
website.
    The requirements for enhanced SBRSs are similar to that of Euro
NCAP. The front seat occupant enhanced SBRS must have a 30 second
audible or visual signal that initiates when a front seat occupant is
unbelted and one of the following events takes place: The engine has
been running for 60 seconds, the vehicle has been in forward motion for
500 meters, or the vehicle has reached a forward speed between 10-25
km/h.
    The rear SBRS must have at least a 30 second audible or visual
reminder that is directed toward the driver or the unbuckled passenger.
The rear SBRS must also indicate to the driver the number of seat belts
that are in use. They do not require the rear SBRS to be equipped with
occupant detection technology.
    The second phase of the program will establish new enhanced SBRSs
requirements for JNCAP based on the findings of a study that is
currently underway to evaluate human factors and the effectiveness of
different types of visual and audible warning signals.

D. Seat Belt Reminder Systems in Australia

    In 1996, Australia's Department of Transport (now the Department of
Transport and Regional Services) introduced a new Australian Design
Rule (ADR) 69 that required manufacturers to meet certain crash
performance criteria in a dynamic full frontal crash. This ADR also
adopted a requirement for a driver SBRS that is currently still in
place. The driver SBRS comprises of a visual signal that must remain
activated for no less than four seconds after the ignition was switched
on, or before one of the following events takes place: The engine has
been running for 60 seconds, the vehicle has been in forward motion for
500 meters, or the vehicle has reached a forward speed between 25 km/h.
The ADR does

not require the system to operate if the driver's seat belt is buckled
or is withdrawn more than 10 cm from the retractor. The ADR also states
that if the system complies with the U.S. FMVSS No. 208, S7.3 that it
is deemed compliant with the ADR requirements.
    The Australasian New Car Assessment Program (ANCAP) conducts
assessments of seat belt reminders in accordance with the protocol
issued by Euro NCAP. ANCAP prepared a questionnaire to assist in the
assessment of seat belt reminder systems. Manufacturers may submit a
completed questionnaire to obtain a provisional assessment of reminder
systems by ANCAP. In addition to the Euro NCAP requirements, ANCAP
prefers that if the system does not implement occupant detection that a
positive indicator, such as a green light, be displayed for each rear
seat belt that is being used and that no display lights be shown for
unused seat belts. Furthermore, for systems with occupant detection,
ANCAP prefers a negative indicator, such as a red light for any seating
position that has an occupant that is unbuckled.\23\ ANCAP also began
applying Euro NCAP's change of status signal requirements for rear
seats after January 2008.
---------------------------------------------------------------------------

    \23\ ANCAP, Notes on the assessment protocol, Version 4.8,
October 29, 2007.
---------------------------------------------------------------------------

II. Petition

    On November 21, 2007, Public Citizen and Advocates for Highway and
Auto Safety (henceforth referred to as the petitioner) petitioned NHTSA
to amend FMVSS No. 208, to require automobile manufacturers to install
a SBRS for rear seats of passenger cars and multipurpose passenger
vehicles with a gross vehicle weight rating (GVWR) of 4,536 kg (10,000
lbs.) or less.\24\
---------------------------------------------------------------------------

    \24\ See docket to this notice for a copy of the petition.
---------------------------------------------------------------------------

    The petitioner stated that SBRSs for rear seats would save hundreds
of lives each year and that a large percentage of the lives saved would
be children. The petitioner suggested that if rear seat belt usage
matched the level of front seats, about 289 lives would be saved each
year, and 78 of those would be children between 5 and 18-years-old. The
petitioner noted that primary enforcement laws typically do not cover
rear seat occupants and claimed that studies have proven that SBRSs for
rear seats significantly increase rear passenger seat belt use. The
petitioner also stated that requiring SBRSs for rear seats is
consistent with former NHTSA administrator, Dr. Jeffrey Runge's,
statements on enhanced SBRSs as well as NHTSA's study on the
effectiveness of enhanced SBRSs for front seats, and the SAFETEA-LU
requirements to increase belt use for all passengers. The petitioner
further stated that SBRSs for rear seats are technologically feasible
and that they would be less costly if they were required in all
vehicles. Lastly, the petitioner stated that the American public
desires SBRSs for rear seats.

III. Analysis

    In analyzing the petition to require SBRSs for rear seats, it
became readily apparent that the limiting factor in our benefits
estimate is the unknown effectiveness of rear SBRSs. Without this
information, the agency cannot make an accurate assessment of how many
lives would be saved and injuries reduced by requiring rear SBRSs, and
the cost-effectiveness of such systems. In the sections that follow, we
preliminarily identify the potential target population, discuss the
limitations of our effectiveness estimates, and the potential costs of
various rear SBRS technologies. However, as discussed further in this
notice, we are seeking comment and information from the public on each
aspect of our analysis.

A. Target Population

    The agency made some preliminary target population estimates in
analyzing the petition using the 2008 calendar year as a baseline. In
that year, front seat belt usage was 83 percent and rear seat belt
usage was 74 percent.\25\ According to the Fatality Analysis Reporting
System (FARS) data, there were 2,163 rear seat occupants killed that
year in motor vehicle crashes. According to the National Automotive
Sampling System (NASS) General Estimates System (GES) data, there were
another 266,163 MAIS \26\ 1-5 rear seat occupant injuries that
resulted.\27\ Of those, 1,442 fatalities and 28,075 MAIS 1-5 injuries
were to unrestrained rear seat occupants.\28\ These unrestrained
occupants are the target population any potential rulemaking on rear
SBRS would seek to address.
---------------------------------------------------------------------------

    \25\ Traffic Safety Facts: Seat Belt Use in Rear Seats in 2008.
DOT HS 811 133. Washington, DC: National Highway Traffic Safety
Administration, May 2009.
    \26\ The Maximum Abbreviated Injury Score (MAIS) is an
anatomical scoring system that provides a way of ranking the
severity of injury. The higher the score, the more severe the
injury.
    \27\ MAIS 1-5 injury benefits were further adjusted by a
universal exaggeration factor of 1.369 to address the over reporting
of safety belt use in injuries. (Fatality Reduction by Safety Belts
for Front-Seat occupants of Cars and Light Trucks, December 2000,
DOT HS 809 199).
    \28\ Injuries with unknown restraint usage were distributed
proportionately to those with known usage.
---------------------------------------------------------------------------

B. Benefits

    As previously mentioned, the agency lacks sufficient information on
the effectiveness of rear SBRSs. We are not aware of studies that show
how effective a warning sent to the driver (and/or front seat
passenger) would be in encouraging rear seat occupants to fasten their
seat belts. Depending upon the type of rear SBRS implemented, repeated
false alarms, for example, could be an annoyance to drivers and
consequently reduce its effectiveness. On the other hand, less
aggressive systems may not change an occupant's behavior.
    In the petitioner's benefits calculations, three hypothetical
outcomes were presented that could occur from requiring rear SBRSs:
    1. Increased rear seat belt usage to the level of front seat belt
usage;
    2. Increased rear seat belt usage by 9.1% in light trucks and 12.9%
in cars; and
    3. Increased rear seat belt usage to 85-90%.

    However, for the first outcome to occur, rear seat belt usage would
need to increase from 74 to 83 percent to be equivalent to front seat
belt usage (based on our 2008 baseline). This would require an increase
in rear seat belt usage of 9 percentage points, although front seat
enhanced SBRSs are preliminarily estimated to increase front seat belt
use by only 3-4 percent.\29\ The other two scenarios are more unlikely
since they assume higher effectiveness rates for rear SBRSs than are
currently achieved for front seat SBRSs. Finally, the petitioner also
suggested that benefits would be accrued to front seat occupants if
rear seat passengers were buckled up. While we agree, in principle,
that front seat occupant risk would be reduced by having rear seat
passengers restrained, we have evidence to suggest that these benefits
would be small and not a significant proportion of the benefits gained
from increases in rear seat belt usage.\30\
---------------------------------------------------------------------------

    \29\ We do not have data concerning the effectiveness of a basic
front seat belt reminder system. The closest data we have are from
the enhanced systems being implemented recently, which are over and
above the basic system.
    \30\ Bean, James D., et al., ``Fatalities in frontal crashes
despite seat belts and air bags,'' NHTSA technical report, DOT HS
811 202, September 2009. (This report documents a review of 122
cases where a frontal fatality occurred to a belted driver or right-
front passenger in a MY 2000 or newer vehicle in the CDS through
calendar year 2007. Of these 122 cases, only one fatality was
attributed to what the agency characterized as a ``back-seat
bullet.'')

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

    Generally, we are encouraged by the potential that enhanced SBRSs
have in increasing seat belt use, but the agency would like more
information prior to deciding whether to undertake a rulemaking action
for rear SBRSs. We invite the public to share its information and views
on rear SBRSs effectiveness in order to assist the agency in evaluating
these systems and their merit.

C. Countermeasure Costs

    In deciding whether to pursue a rulemaking action, the agency must
also consider the associated costs involved. The petitioner suggested
that rear SBRSs provide an effective strategy for saving lives ``at a
minimal additional cost to manufacturers and consumers.'' It suggested
that the following components would be needed: A seat sensor that
detects occupancy, a sensor in the seat belt buckle, and a control unit
that features a flashing light and audible sound. No costs for these
components were provided.
    In the NAS study, it was found that enhanced SBRSs for rear seats
are more costly than front-seat systems because the majority of
vehicles already have some type of front passenger occupancy sensor and
central processing unit installed for advanced air bag system purposes.
Occupancy detection technology is not readily-equipped in rear seats,
and those passenger vehicles equipped with large numbers of rear seat
occupant positions (e.g., 8-passenger sport utility vehicles, minivans,
and 15-passenger vans) would have to be equipped with sensors at each
rear seating position. The NAS study cited low rear seat occupancy
rates as another reason it did not consider the installation of rear
seat occupancy sensors to be cost-effective in its findings. NHTSA
estimates that rear seat occupants were 11 percent of the passenger
vehicle occupants involved in police-reported crashes in 2007.\31\
---------------------------------------------------------------------------

    \31\ In 2007 there were 13,613,000 passenger vehicle occupants
involved in police-reported crashes. The source of this data is both
the FARS and the NASS GES. Passenger vehicle occupant involvement in
fatal crashes comes from FARS and involvement in injury and property
damage only crashes comes from GES.
---------------------------------------------------------------------------

    Furthermore, whether contemplating sophisticated occupancy sensors
or simpler belt use sensor technology, there are additional potential
practicability concerns that rear seats present over front seats,
including compatibility with removable seats (e.g., Stow-n-Go, Flip and
Fold). Additionally, occupancy detection complexities, such as
inanimate cargo (groceries or heavy objects) or pets that are often
transported in the rear seat present additional technical challenges in
mitigating false alarms. In consideration of these factors, the agency
believes that requiring that each rear seating position be equipped
with SBRS technology may be costly. We are therefore seeking comment on
this issue.
    Specifically, we would like to receive information on the range of
technologies, and related costs, that could be used in rear SBRS
strategies. For example, one system could include rear seat occupant
detection technology, rear seat belt use sensors, and a warning system
with visual and audible components. This system would likely provide a
high amount of reliability in detecting seat belt non-use and alerting
the driver, yet it would likely be the most costly to implement. It
also most closely resembles the petitioner's recommended
countermeasure. This system could activate an audible and visual signal
whenever there is an unbuckled rear seat passenger. Occupant detection
sensors would be used to identify the presence of rear passengers and
mitigate false alarms when there is no passenger in the seat and the
seat belt is unbuckled. While NHTSA is aware of the technology being
available for such a system, we are not aware of any such systems in
production.
    There are also lower cost rear SBRSs that are more comparable to
production systems designed to meet Euro NCAP requirements. Such a
system could incorporate rear seat belt use sensors and audible/visual
alarms, but would not include occupant detection capabilities.
Additionally, unlike the previously mentioned system, this enhanced
SBRS visually reports the number of belted rear passengers to the
driver, rather than notifying the driver of rear seat belt non-use.
Hence, this type of system relies on the driver (or the human factor)
to know how many rear seat occupants there are, and if that number
equals the number of seat belts that are reported by the enhanced SBRS
as being buckled. Notification to the driver would be conducted by
having a visual display on the console (either displaying a number, or
icons of each belted seating position) to alert the driver of the
number of rear seat belts in use. It could also provide an audible
alarm in the event the status of the seat belt buckle changes during
the course of the trip, as required by Euro NCAP. While the main
limitation of such a system is its reliance on the driver to know the
number of rear seat passengers and compare it to the visual reporting
of the rear SBRS, such a system could also be easier to ignore and may
not be as effective as an audible warning system that alerts the driver
of unbelted passengers at the start of a trip. Therefore, we are
seeking comment and information on the effectiveness of such a system.
    We also note that both of the aforementioned rear SBRSs lack a
means of detecting a child seat attached to a LATCH-equipped seating
position. The first system could potentially use the occupant detection
sensors to identify the presence of a child seat (e.g., in the same
manner that advanced air bag systems detect child seats in the front
passenger seat), but it would lack the sophistication of detecting
whether that child seat is actually attached to the LATCH anchorages.
Some type of LATCH anchorage detection sensor would also be needed.
While parents and caregivers could attach the child seat with the seat
belt at such seating positions in addition to using the LATCH
anchorages to minimize the audible/visual warnings to the driver, some
are of the opinion that using both seat belts and LATCH could be
considered a misuse condition. Alternatively, the consumer could attach
the seat belt and then place the child seat on top of it, attaching the
child seat with LATCH, or a seat belt detection system could also
encourage them to revert back to not using the LATCH anchorages at all,
and only restrain child seats using seat belts. The agency does not
consider one method of child seat installation safer than the other;
however, we have observed that child seats installed with LATCH are
more likely to be installed securely than child seats installed with
seat belts.\32\
---------------------------------------------------------------------------

    \32\ Decina, L.E.; Lococo, K.H.; and Doyle, C.T. 2006. Child
restraint use survey: LATCH use and misuse. Report no. DOT HS-810-
679. Washington, DC: National Highway Traffic Safety Administration,
Page 26.
---------------------------------------------------------------------------

    On the other hand, the second system mentioned above (e.g., the
lower cost technology) would simply consider the seating position with
the child seat attached by LATCH anchorages to be an unbuckled seating
position. A driver using this system would need to take this fact into
account when comparing the number of rear seat occupants against the
number reported by the rear SBRS. Or, like the first system, parents
and caregivers could buckle the seat belt, in addition to using LATCH,
to enable the system to count it as a belted seating position. However,
again, this could encourage them to revert to not using LATCH at all or
could encourage them to keep the belt buckled to mislead the system.

    Therefore, the agency is additionally seeking comment on how LATCH
would interact with a rear SBRSs. Would LATCH detection be a necessary
requirement of a rear SBRS so that when LATCH anchorages are used at a
LATCH-equipped seating position, the seating position would be
displayed as belted?

D. Summary

    The agency would like more information about the effectiveness of
the rear SBRSs discussed above, systems under development, and other
potential alternatives, to assist it in deciding whether to grant or
deny the petition. We have concerns that the estimated costs for some
technologies could be high and have technical complexities with
removable seats to overcome. Other lower cost systems may not be robust
enough to attain the benefits that we would hope to attain with such a
system.

IV. Solicitation of Comments

    To assist the agency in determining whether to grant or deny the
petition, NHTSA is soliciting comments and data in this notice. For
easy reference, the questions that follow are numbered consecutively.
NHTSA encourages commenters to provide specific responses for each
question for which they have information or views. In order to
facilitate tabulation of the written comments in sequence, please
identify the number of each question to which you are responding. NHTSA
requests that the rationale for positions taken by commenters be
specific and supported by data, including any analysis of safety
consequences. We encourage commenters to provide scientific analysis
and data relating to system designs, testing, and field experience as
well as arguments or views they believe are relevant to this topic.
    In providing information in response to the questions, NHTSA
invites commenters to address different kinds of potential rear SBRS,
including basic ones as well as enhanced systems. However, as noted
earlier, there are statutory limitations on the kinds of enhanced
systems that the agency could require by regulation. See 49 U.S.C.
30124. The petitioner stated that if the agency receives permission
from Congress to required enhanced performance reminders, the new
enhanced reminder requirement should also apply to the rear seat. While
we do not intend to limit commenters from identifying potential
regulatory requirements that they believe would be best, we ask that to
the extent any commenters recommend requirements that would not be
consistent with the existing statutory limitations that they also
provide recommendations as to what regulatory actions the agency should
take, if any, given those limitations.

Effectiveness

    1. What studies have been conducted (or are underway) on the
effectiveness of rear SBRSs in increasing rear seat belt use?
    2. What are the most important characteristics of a highly
effective rear SBRS? And what are the minimum characteristics?
    3. The agency's crash data show that a large percentage of unbelted
rear seat fatalities were in vehicles with drivers who were belted.\33\
What studies have been conducted (or are underway) on the effectiveness
of rear SBRSs in influencing belted drivers if they are reminded (by a
rear SBRS) that their rear passengers (especially child passengers) are
being afforded less protection than they are providing for themselves?
---------------------------------------------------------------------------

    \33\ See docket to this notice.
---------------------------------------------------------------------------

    4. How effective are visual reminders that provide the driver with
the number of belted rear passengers, and rely on the driver to know
how many rear seat occupants are in the vehicle, i.e., a system that
does not incorporate occupant sensors?
    5. How would LATCH interact with a rear SBRS?
    6. What studies have been conducted (or are underway) to study how
having a LATCH detection sensor would improve the rear SBRS's
effectiveness?

Consumer Acceptance

    7. What studies have been conducted (or are underway) on the
consumer acceptance of rear SBRSs?
    8. What characteristics should a rear SBRS have to maintain a high
level of effectiveness while maximizing consumer acceptance?
    9. What types of comments/complaints have vehicle manufacturers
received on their rear SBRSs?
    10. What are the ``lessons learned'' regarding the installation,
use, and acceptance of existing rear SBRSs?
    11. What are the types of rear SBRSs that are likely to cause some
consumers to disarm or purchase vehicles without a rear SBRS?

Technology and Costs

    12. What types of rear SBRSs are vehicle manufacturers installing
(or planning to install) in the U.S. or in other countries?
    13. What technologies would be necessary to overcome the
installation obstacles for rear seat occupant detection (e.g.,
removable seats, folding seats, rotating seats, etc.) and what are
their expected per vehicle costs? Are there similar concerns with the
installation of rear seat belt use sensors?

Regulation

    14. Should rear SBRSs be a mandatory requirement, or only regulated
if optionally provided?
    If so, what characteristics should they exhibit?
    a. Should the system be capable of detecting an occupant?
    b. Should the system have a visual-only signal or a visual and
audible signal?
    c. Should change of belt status be monitored?
    15. Are there better approaches to increase rear seat belt use
other than requiring or regulating rear SBRSs?
    a. Should NHTSA just continue to rely on its education and outreach
programs in supporting rear seat belt use laws?
    b. Should NHTSA take an approach similar to Euro NCAP and provide
ratings for rear SBRSs?

V. Public Participation

How Do I Prepare and Submit Comments?

    Your comments must be written and in English. To ensure that your
comments are correctly filed in the Docket, please include the docket
number of this document in your comments. Your comments must not be
more than 15 pages long.\34\ We established this limit to encourage you
to write your primary comments in a concise fashion. However, you may
attach necessary additional documents to your comments. There is no
limit on the length of the attachments. If you are submitting comments
electronically as a PDF (Adobe) file, we ask that the documents
submitted be scanned using the Optical Character Recognition (OCR)
process, thus allowing the agency to search and copy certain portions
of your submissions.\35\ Please note that pursuant to the Data Quality
Act, in order for substantive data to be relied upon and used by the
agency, it must meet the information quality standards set forth in the
OMB and DOT Data Quality Act guidelines.
---------------------------------------------------------------------------

    \34\ See 49 CFR 553.21.
    \35\ Optical Character Recognition (OCR) is the process of
converting an image of text, such as a scanned paper document or
electronic fax file, into computer-editable text.
---------------------------------------------------------------------------

    Accordingly, we encourage you to consult the guidelines in
preparing your comments. OMB's guidelines may be

accessed at: http://www.whitehouse.gov/omb/fedreg/reproducible.html.
DOT's guidelines may be accessed at: http://dmses.dot.gov/submit/
DataQualityGuidelines.pdf.

How Can I Be Sure That My Comments Were Received?

    If you submit your comments by mail and wish Docket Management to
notify you upon its receipt of your comments, enclose a self-addressed,
stamped postcard in the envelope containing your comments. Upon
receiving your comments, Docket Management will return the postcard by
mail.

How Do I Submit Confidential Business Information?

    If you wish to submit any information under a claim of
confidentiality, you should submit three copies of your complete
submission, including the information you claim to be confidential
business information, to the Chief Counsel, NHTSA, at the address given
above under FOR FURTHER INFORMATION CONTACT. When you send a comment
containing information claimed to be confidential business information,
you should include a cover letter setting forth the information
specified in our confidential business information regulation.\36\ In
addition, you should submit a copy, from which you have deleted the
claimed confidential business information, to the Docket by one of the
methods set forth above.
---------------------------------------------------------------------------

    \36\ See 49 CFR 512.
---------------------------------------------------------------------------

Will the Agency Consider Late Comments?

    We will consider all comments received before the close of business
on the comment closing date indicated above under DATES. To the extent
possible, we will also consider comments received after that date.

How Can I Read the Comments Submitted by Other People?

    You may read the materials placed in the docket for this document
(e.g., the comments submitted in response to this document by other
interested persons) at any time by going to http://www.regulations.gov.
Follow the online instructions for accessing the dockets. You may also
read the materials at the Docket Management Facility by going to the
street address given above under ADDRESSES. The Docket Management
Facility is open between 9 am and 5 pm Eastern Time, Monday through
Friday, except Federal holidays.
    Please note that even after the comment closing date, we will
continue to file relevant information on the docket as it becomes
available. Further, some people may submit late comments. Accordingly,
we recommend that you periodically check the docket for new material.

    Authority:  49 U.S.C. 322, 30111, 30115, 30117 and 30166;
delegation of authority at 49 CFR 1.50.

    Issued on: June 24, 2010.
Nathaniel Beuse,
Director, Office of Crash Avoidance Standards.
[FR Doc. 2010-15773 Filed 6-28-10; 8:45 am]
BILLING CODE P


[Federal Register Volume 87, Number 72 (Thursday, April 14, 2022)]
[Notices]
[Pages 22206-22207]
[FR Doc No: 2022-07984]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP21-44-000]

LA Storage, LLC; Notice of Availability of the Final
Environmental Impact Statement for the Proposed Hackberry Storage
Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a final environmental impact statement (EIS)
for the Hackberry Storage Project (Project), proposed by LA Storage,
LLC (LA Storage) in the above-referenced docket. LA Storage requests
authorization to construct and operate natural gas storage and
transmission facilities in Louisiana. The Project is designed to
provide 20.03 billion cubic feet of working gas storage capacity and
1.5 billion cubic feet per day of gas deliverability and injectability,
and interconnecting with the Cameron Interstate Pipeline (CIP)
facilities operated by Cameron Interstate Pipeline, LLC and the Port
Arthur Pipeline Louisiana Connector (PAPLC) facilities to be operated
by Port Arthur Pipeline, LLC.
    The final EIS assesses the potential environmental effects of the
construction and operation of the Project in accordance with the
requirements of the National Environmental Policy Act. FERC staff
concludes that approval of the proposed Project, with the mitigation
measures recommended in the EIS, would result in some adverse
environmental impacts; however, with the exception of climate change
impacts, those impacts would not be significant. The EIS does not
characterize the Project's greenhouse gas emissions as significant or
insignificant because the Commission is conducting a generic proceeding
to determine whether and how the Commission will conduct climate change
significance determinations going forward.\1\
---------------------------------------------------------------------------

    \1\ Consideration of Greenhouse Gas Emissions in Natural Gas
Infrastructure Project Reviews, 178 FERC ] 61,108 (2022); 178 FERC ]
61,197 (2022).
---------------------------------------------------------------------------

    The final EIS addresses the potential environmental effects of the
construction and operation of the following Project facilities: The
Project would involve the conversion of three existing salt dome
caverns to natural gas storage service and the development of one new
salt dome cavern for additional natural gas storage service, all within
a permanent natural gas storage facility on a 160-acre tract of land
owned by LA Storage in Cameron Parish, Louisiana. In addition to the
storage caverns, LA Storage would construct and operate on-site
compression facilities (Pelican Compressor Station) and up to six
solution mining water supply wells at the storage facility on LA
Storage's property. LA Storage would also construct and operate the
following natural gas facilities in Cameron and Calcasieu Parishes,
Louisiana: The Hackberry Pipeline, consisting of approximately 11.1
miles of 42-inch-diameter natural gas pipeline connecting the
certificated PAPLC pipeline (CP18-7) to the natural gas storage
caverns; the CIP Lateral, an approximately 4.9-mile-long, 42-inch-
diameter natural gas pipeline extending from the existing CIP to the
planned natural gas storage caverns; metering and regulating at the CIP
and PAPLC interconnects; and an approximately 6.2-mile-long, 16-inch-
diameter brine disposal pipeline that would transport brine from the
caverns to four saltwater disposal wells located on two new pads north
of the facility.
    The Commission mailed a copy of the Notice of Availability of the
Final Environmental Impact Statement for the Proposed Hackberry Storage
Project to federal, state, and local government representatives and
agencies; local libraries; newspapers; elected officials; Native
American Tribes; and other interested parties. The final EIS is only
available in electronic format. It may be viewed and downloaded from
the FERC's website (www.ferc.gov), on the natural gas environmental
documents page (https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents). In addition, the final EIS may be
accessed by using the eLibrary link on the FERC's website. Click on the
eLibrary link (https://elibrary.ferc.gov/eLibrary/search) select
``General Search'' and enter the docket number in the ``Docket Number''
field (i.e., CP21-44-000). Be sure you have selected an appropriate
date range. For assistance, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
    Additional information about the Project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC

website (www.ferc.gov) using the eLibrary link. The eLibrary link also
provides access to the texts of all formal documents issued by the
Commission, such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to https://www.ferc.gov/ferc-online/overview to
register for eSubscription.

    Dated: April 8, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-07984 Filed 4-13-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53927-53928]
[FR Doc No: 2011-22178]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4013-DR; Docket ID FEMA-2011-0001]

Nebraska; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Nebraska (FEMA-4013-DR), dated August 12,
2011, and related determinations.

DATES: Effective Date: August 12, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 12, 2011, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of Nebraska resulting from flooding during the period of May 24 to
August 1, 2011, is of sufficient severity and magnitude to warrant a
major disaster declaration under the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''). Therefore, I declare that such a major disaster
exists in the State of Nebraska.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance and Public
Assistance in the designated areas, and Hazard Mitigation throughout
the State. Consistent with the requirement that Federal assistance
is supplemental, any Federal funds provided under the Stafford Act
for Public Assistance, Hazard Mitigation, and Other Needs Assistance
will be limited to 75 percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Michael L. Parker, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Nebraska have been designated
as adversely affected by this major disaster:

    Boyd, Burt, Cass, Dakota, Dixon, Douglas, Knox, Sarpy, and
Washington Counties for Individual Assistance.
    Nemaha and Richardson Counties for emergency protective measures
(Category B) under the Public Assistance program.
    Burt, Cass, Dakota, Douglas, Garden, Knox, Lincoln, Otoe, Sarpy,
Scotts Bluff, Thurston, and Washington Counties for Public
Assistance.
    All counties within the State of Nebraska are eligible to apply
for assistance under the Hazard Mitigation Grant Program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-22178 Filed 8-29-11; 8:45 am]
BILLING CODE 9111-23-P


1 of 4 DRAFT 3/ 16/ 06 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY HUMAN STUDIES REVIEW BOARD ( HSRB) PUBLIC MEETING Tuesday, April 4, 2006 Holiday Inn   Rosslyn at Key Bridge 1900 North Fort Myer Drive Arlington, VA 22209 703 807 2000 HSRB WEB SITE http:// www. epa. gov/ osa/ hsrb/ Docket Telephone: ( 202) 566 1752 Docket Number: EPA HQ ORD 2006 0187 C 8: 30 AM Introduction and Identification of Board Members   HSRB Chair C 8: 45 AM Welcome   George Gray, Ph. D. ( EPA Science Advisor)

C 9: 00 AM Opening Remarks   Ms. Susan Hazen ( Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances, EPA)

C 9: 15 AM Meeting Administrative Procedures  Paul Lewis, Ph. D. ( Designated Federal Officer, HSRB, EPA)

Session 1: Introduction C 9: 20 AM Session 1 Overview   Mr. William Jordan ( Office of Pesticide Programs [ OPP], EPA)

C 9: 25 AM Summary of EPA's Protections for Subjects of Human Research  Mr. William Jordan ( OPP, EPA)

C 10: 05 AM Break C 10: 20 AM EPA, OPP Assessment of Ethical Conduct of Human Studies   Mr. John Carley ( OPP, EPA)

C 10: 45 AM EPA, OPP Approach to Assessing Human Health Risks of Pesticides Using Data From Human Studies   Mr. Michael Metzger ( OPP, EPA)

C 11: 05 AM EPA, OPP Assessment of Individual Human Studies   Ray Kent, Ph. D. ( OPP, EPA)

C 11: 35 AM EPA, OPP Policy on " The Use of Data on Cholinesterase Inhibition for Risk Assessment of Organophosphorous and Carbamate Pesticides"   Anna Lowit, Ph. D. ( OPP, EPA)

C 12: 00 PM Lunch 2 of 4 Session 2: Carbamate Pesticides C 1: 00 PM Session 2 Overview   Anna Lowit, Ph. D. ( OPP, EPA)

C 1: 05 PM Science and Ethics of Aldicarb Human Studies  Linda Taylor, Ph. D. ( OPP, EPA) and Mr. John Carley ( OPP, EPA)

C 1: 30 PM Science and Ethics of Methomyl Human Studies   Elissa Reaves, Ph. D. ( OPP, EPA) and Mr. John Carley ( OPP, EPA)

C 2: 00 PM Science and Ethics of Oxamyl Human Studies   Elissa Reaves, Ph. D. ( OPP, EPA) and Mr. John Carley ( OPP, EPA)

C 2: 45 PM Break C 3: 00 PM Public Comments on Session 2 C 4: 15 PM HSRB Writing Session C 5: 15 PM Adjourn 3 of 4 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY HUMAN STUDIES REVIEW BOARD ( HSRB) PUBLIC MEETING Wednesday, April 5, 2006 Holiday Inn   Rosslyn at Key Bridge 1900 North Fort Myer Drive Arlington, VA 22209 703 807 2000 HSRB WEB SITE http:// www. epa. gov/ osa/ hsrb/ ORD Docket Telephone: ( 202) 564 1752 ORD Docket Number: EPA HQ ORD 2006 0187 C 8: 30 AM Convene Meeting   HSRB Chair C 8: 40 AM Followup From Previous Day's Discussion   Mr. William Jordan ( OPP, EPA)

C 8: 50 AM Board Discussion C 10: 15 PM Break Session 3: Organophosphate Pesticides C 10: 30 PM Session 3 Overview   Ray Kent, Ph. D. ( OPP, EPA)

C 10: 35 AM Science and Ethics of AZM Human Studies   John Doherty, Ph. D. ( OPP, EPA) and Mr. John Carley ( OPP, EPA)

C 11: 00 AM Science and Ethics of DDVP Human Studies   Ray Kent, Ph. D. ( OPP, EPA) and Mr. John Carley ( OPP, EPA)

C 11: 45 PM Lunch C 12: 45 PM Public Comments on Session 3 C 2: 00 PM Board Discussion C 3: 15 PM Break Session 4: Other Pesticides C 3: 30 PM Session Overview   Ray Kent, Ph. D. ( OPP, EPA)

C 3: 35 PM Science and Ethics of Ethephon  Ray Kent, Ph. D. ( OPP, EPA) and Mr. John Carley ( OPP, EPA)

C 4: 00 PM Science and Ethics of Amitraz Human Studies   John Liccione, Ph. D. ( OPP, EPA) and Mr. John Carley ( OPP, EPA)

C 4: 30 PM HSRB Writing Session C 5: 30 PM Adjournment 4 of 4 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY HUMAN STUDIES REVIEW BOARD ( HSRB) PUBLIC MEETING Thursday, April 6, 2006 Holiday Inn   Rosslyn at Key Bridge 1900 North Fort Myer Drive Arlington, VA 22209 703 807 2000 HSRB WEB SITE http:// www. epa. gov/ osa/ hsrb/ ORD Docket Telephone: ( 202) 564 1752 ORD Docket Number: EPA HQ ORD 2006 0187 C 8: 30 AM Convene Meeting   HSRB Chair C 8: 45 AM Followup From Previous Day's Discussion   Mr. William Jordan ( OPP, EPA)

C 9: 00 PM Science and Ethics of Sodium Cyanide Human Studies   William Dykstra, Ph. D. ( OPP, EPA) and Mr. John Carley ( OPP, EPA)

C 9: 30 AM Public Comments on Session 4 C 10: 30 AM Break C 10: 45 AM Board Discussion C 12: 00 PM Lunch C 1: 00 PM HSRB Writing Session C 4: 30 PM Adjournment Please be advised that agenda times are approximate. For further information, please contact the Designated Federal Officer for this meeting, Paul Lewis via telephone: ( 202) 564 8381 or email: lewis. paul@ epa. gov


[Federal Register: November 30, 2007 (Volume 72, Number 230)]
[Notices]
[Page 67781-67782]
[DOCID:fr30no07-107]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) received a request for a waiver of compliance with certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

SMS Lines

[Waiver Petition Docket Number FRA-2007-0007]

    The SMS Lines (SMS), a Class III railroad, seeks a waiver of
compliance from the requirements of Title 49 Code of Federal
Regulations (CFR) Sec.  223.11 Requirements for existing locomotives.
SMS has operated within the Pureland Industrial Park in Bridgeport,
Gloucester County, New Jersey since June, 1994. The petitioner proposes
to use three switching type locomotives numbers 102, 308, and 309 on a
limited reserve basis for yard and local switching service.
    SMS Locomotives Number 102, model DS 4-4-750 was built in 1951, 308
model S-12 was built in 1953, and 309 model S-12 was built in 1952, by
the Baldwin Locomotive Works (BLW). They would operate over
approximately 5 miles of track with four grade crossings within the
Industrial Park at Bridgeport, New Jersey, and one grade crossing at
the Valery Refinery in Paulsboro, New Jersey. Current operations
average 1 train per day, 6 days per week, year-round at each location
operating at restricted speed, as all track is FRA Class I (10 mph).
    The petitioner believes that this locomotive can be safely operated
throughout the industrial park and refinery with the current non-
compliant safety-type glazing. The cost to the SMS for installation of
all new window frames and compliant FRA Types I and II glazing is
significant, with only a

marginal increase in safety due to the low speed. Historically,
railroad glazing has not been vandalized within the Pureland Industrial
Park or the Valero Refinery, and there are no overhead bridges or
tunnels.
    All three locomotives are in reserve status, and only used when the
regularly assigned locomotives are unavailable due to inspection or
repair. SMS plans to upgrade the glazing in all three locomotives to
compliant FRA Types I and II material as they are overhauled and
repainted.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (i.e., Waiver Petition Docket Number FRA-
2007-0007) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online

instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http: //http://www.regulations.gov.

    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC, on November 26, 2007.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. E7-23200 Filed 11-29-07; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Rules and Regulations]
[Pages 30722-30724]
[FR Doc No: 2014-12297]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2014-N-0430]

Medical Devices; Gastroenterology-Urology Devices; Classification
of Pancreatic Drainage Stent and Delivery System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the
pancreatic drainage stent and delivery system into class II (special
controls). The special controls that will apply to the device are
identified in this order, and will be part of the codified language for
the pancreatic drainage stent and delivery system classification. The
Agency is classifying the device into class II (special controls) in
order to provide a reasonable assurance of safety and effectiveness of
the device.

DATES: This order is effective June 30, 2014. The classification was
applicable beginning December 18, 2013.

FOR FURTHER INFORMATION CONTACT: Jeffrey Cooper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G228, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144, July 9, 2012, 126 Stat. 1054), provides two procedures by which a
person may request FDA to classify a device under the criteria set
forth in section 513(a)(1). Under the first procedure, the person
submits a premarket notification under section 510(k) of the FD&C Act
for a device that has not previously been classified and, within 30
days of receiving an order classifying the device into class III under
section 513(f)(1) of the FD&C Act, the person requests a classification
under section 513(f)(2). Under the second procedure, rather than first
submitting a premarket notification under section 510(k) of the FD&C
Act and then a request for classification under the first procedure,
the person determines that there is no legally marketed device upon
which to base a determination of substantial equivalence and requests a
classification under section 513(f)(2) of the FD&C Act. If the person
submits a request to classify the device under this second procedure,
FDA may decline to undertake the classification request if FDA
identifies a legally marketed device that could provide a reasonable
basis for review of substantial equivalence with the device or if FDA
determines that the device submitted is not of ``low-moderate risk'' or
that general controls would be inadequate to control the risks and
special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    On February 15, 2013, Xlumena, Inc., submitted a request for
classification of the AXIOS Stent and Delivery System under section
513(f)(2) of the FD&C Act. The manufacturer recommended that the device
be classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the de novo request, FDA determined that the
device can be classified into class II with the establishment of
special controls. FDA believes these special controls, in addition to
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on December 18, 2013, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding Sec.  876.5015.
    Following the effective date of this final classification
administrative order, any firm submitting a premarket notification
(510(k)) for a pancreatic drainage stent and delivery system will need
to comply with the special controls named in the final administrative
order.
    The device is assigned the generic name pancreatic drainage stent
and delivery system, and it is identified as a prescription device that
consists of a self-expanding, covered, metallic stent, intended for
placement to facilitate transmural endoscopic drainage of pancreatic
pseudocysts. This stent is intended to be removed upon confirmation of
pseudocyst resolution. This device may also include a delivery system.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks
in table 1:

    Table 1--Pancreatic Drainage Stent and Delivery System Risks and
                           Mitigation Measures
------------------------------------------------------------------------
           Identified risk                     Mitigation measure
------------------------------------------------------------------------
Adverse tissue reaction or infection.  Biocompatibility testing.
                                       Sterility testing.
                                       Labeling.
Partial expansion of stent...........  Clinical experience.
                                       In-vitro (bench) testing.
                                       Labeling.

Failure to deliver stent.............  Clinical experience.
                                       In-vitro (bench) testing.
                                       Labeling.
Stent occlusion......................  Clinical experience.
                                       Labeling.
Stent ingrowth/failure to remove       Clinical experience.
 stent.                                Labeling.
Stent migration (passive dislocation)  Clinical experience.
                                       In-vitro (bench) testing.
                                       Labeling.
Stent dislodgement (active             Clinical experience.
 dislocation).                         In-vitro (bench) testing.
                                       Labeling.
Tissue ulceration....................  Clinical experience.
                                       In-vitro (bench) testing.
                                       Labeling.
Procedural complications.............  Clinical experience.
                                       Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to
the general controls, address these risks to health and provide
reasonable assurance of safety and effectiveness:
    1. The device and elements of the delivery device that may contact
the patient must be demonstrated to be biocompatible.
    2. Performance data must demonstrate the sterility of patient-
contacting components of the device.
    3. Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the requested shelf life.
    4. Non-clinical testing data must demonstrate that the stent and
delivery system perform as intended under anticipated conditions of
use. The following performance characteristics must be tested:
     Deployment testing of the stent and delivery system must
be conducted under simulated use conditions.
     Removal force testing must be conducted. The removal force
testing must demonstrate that the stent can be safely removed, and that
the stent will remain in place when subjected to forces encountered
during use.
     Expansion force testing must be conducted. The expansion
force must demonstrate that the forces exerted by the stent will not
damage the tissue surrounding the stent.
     Compression force testing must be conducted. The
compression force must demonstrate that the stent will withstand the
forces encountered during use.
     Dimensional verification testing must be conducted.
     Tensile testing of joints and materials must be conducted.
The minimum acceptance criteria must be adequate for its intended use.
     Fatigue testing must be conducted. Material strength must
demonstrate that the stent will withstand forces encountered during
use.
     Corrosion testing must be conducted. Corrosion resistance
must demonstrate that the stent will withstand conditions encountered
during use.
    5. Non-clinical testing must evaluate the compatibility of the
stent in a magnetic resonance environment.
    6. Well-documented clinical experience must demonstrate safe and
effective use, and capture any adverse events observed during clinical
use.
    7. Labeling must include the following:
     Appropriate instructions, warnings, cautions, limitations,
and information related to the safe use of the device, including
deployment of the device, maintenance of the drainage lumen, and
removal of the device.
     A warning that the safety and patency of the stent has not
been established beyond the duration of the documented clinical
experience.
     Specific instructions and the qualifications and clinical
training needed for the safe use of the device, including deployment of
the device, maintenance of the drainage lumen, and removal of the
device.
     Information on the patient population for which the device
has been demonstrated to be effective.
     A detailed summary of the clinical experience pertinent to
use of the device.
     A detailed summary of the device technical parameters.
     A detailed summary of the device- and procedure-related
complications pertinent to use of the device.
     An expiration date/shelf life.
    Pancreatic drainage stents and delivery systems are prescription
devices restricted to patient use only upon the authorization of a
practitioner licensed by law to administer or use the device. (Proposed
Sec.  876.5015(a); see section 520(e) of the FD&C Act (21 U.S.C.
360j(e)) and 21 CFR 801.109 (Prescription devices).) Prescription-use
restrictions are a type of general controls as defined in section
513(a)(1)(A)(i) of the FD&C Act.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification prior to marketing the device,
which contains information about the pancreatic drainage stent and
delivery system they intend to market.

II. Environmental Impact

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

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously approved collections of information found in other
FDA regulations. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120, and
the collections of information in 21 CFR part 801, regarding labeling,
have been approved under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov.

    1. K123250: De Novo Request per section 513(f)(2) of the Federal
Food, Drug, and Cosmetic Act From Xlumena, Inc., dated February 15,
2013.

List of Subjects in 21 CFR Part 876

    Medical devices.

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

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for 21 CFR part 876 continues to read as
follows:

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

0
2. Add Sec.  876.5015 to subpart F to read as follows:

Sec.  876.5015  Pancreatic drainage stent and delivery system.

    (a) Identification. A pancreatic drainage stent is a prescription
device that consists of a self-expanding, covered, metallic stent,
intended for placement to facilitate transmural endoscopic drainage of
pancreatic pseudocysts. This stent is intended to be removed upon
confirmation of pseudocyst resolution. This device may also include a
delivery system.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The device and elements of the delivery device that may contact
the patient must be demonstrated to be biocompatible.
    (2) Performance data must demonstrate the sterility of patient-
contacting components of the device.
    (3) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the requested shelf life.
    (4) Non-clinical testing data must demonstrate that the stent and
delivery system perform as intended under anticipated conditions of
use. The following performance characteristics must be tested:
    (i) Deployment testing of the stent and delivery system must be
conducted under simulated use conditions.
    (ii) Removal force testing must be conducted. The removal force
testing must demonstrate that the stent can be safely removed, and that
the stent will remain in place when subjected to forces encountered
during use.
    (iii) Expansion force testing must be conducted. The expansion
force must demonstrate that the forces exerted by the stent will not
damage the tissue surrounding the stent.
    (iv) Compression force testing must be conducted. The compression
force must demonstrate that the stent will withstand the forces
encountered during use.
    (v) Dimensional verification testing must be conducted.
    (vi) Tensile testing of joints and materials must be conducted. The
minimum acceptance criteria must be adequate for its intended use.
    (vii) Fatigue testing must be conducted. Material strength must
demonstrate that the stent will withstand forces encountered during
use.
    (viii) Corrosion testing must be conducted. Corrosion resistance
must demonstrate that the stent will withstand conditions encountered
during use.
    (5) Non-clinical testing must evaluate the compatibility of the
stent in a magnetic resonance (MR) environment.
    (6) Well-documented clinical experience must demonstrate safe and
effective use, and capture any adverse events observed during clinical
use.
    (7) Labeling must include the following:
    (i) Appropriate instructions, warnings, cautions, limitations, and
information related to the safe use of the device, including deployment
of the device, maintenance of the drainage lumen, and removal of the
device.
    (ii) A warning that the safety and patency of the stent has not
been established beyond the duration of the documented clinical
experience.
    (iii) Specific instructions and the qualifications and clinical
training needed for the safe use of the device, including deployment of
the device, maintenance of the drainage lumen, and removal of the
device.
    (iv) Information on the patient population for which the device has
been demonstrated to be effective.
    (v) A detailed summary of the clinical experience pertinent to use
of the device.
    (vi) A detailed summary of the device technical parameters.
    (vii) A detailed summary of the device- and procedure-related
complications pertinent to use of the device.
    (viii) An expiration date/shelf life.

    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12297 Filed 5-28-14; 8:45 am]
BILLING CODE 4160-01-P