[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)]
[Notices]
[Pages 1363-1365]
[FR Doc No: 2018-00354]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0275]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Certification To
Accompany Drug, Biological Product, and Device Applications or
Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
February 12, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0616.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Certification To Accompany Drug, Biological Product, and Device
Applications or Submissions (Form FDA 3674)

OMB Control Number 0910-0616--Extension

    The information required under section 402(j)(5)(B) of the Public
Health Service Act (PHS Act) (42 U.S.C. 282(j)(5)(B)) is submitted in
the form of a certification, Form FDA 3674, which accompanies
applications and submissions currently submitted to FDA and already
approved by OMB. The OMB control numbers and expiration dates for those
applications and submissions are: 21 CFR parts 312 and 314 (human
drugs), OMB control number 0910-0014, expiring February 28, 2019, and
OMB control number 0910-0001, expiring December 31, 2017; 21 CFR parts
312 and 601 (biological products), OMB control number 0910-0014,
expiring February 28, 2019, and OMB control number 0910-0338, expiring
March 31, 2020; and 21 CFR parts 807 and 814 (devices), OMB control
number 0910-0120, expiring June 30, 2020, and OMB control number 0910-
0231, expiring March 31, 2020.
    Title VIII of the Food and Drug Administration Amendments Act of
2007 (Pub. L. 110-85) amended the PHS Act by adding section 402(j). The
provisions broadened the scope of clinical trials subject to submitting
information and required additional information to be submitted to the
clinical trials databank (https://clinicaltrials.gov) (FDA has verified
the website address, but FDA is not responsible for any subsequent
changes to the website after this document publishes in the Federal
Register) previously established by the National Institutes of Health
(NIH)/National Library of Medicine. This includes expanded information
on applicable clinical trials and summary information on the results of
certain clinical trials. The provisions include responsibilities for
FDA as well as several amendments to the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
    One provision, section 402(j)(5)(B) of the PHS Act, requires that a
certification accompany human drug, biological, and device product
submissions made to FDA. Specifically, at the time of submission of an
application under sections 505, 515, or 520(m) of the FD&C Act (21
U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (42
U.S.C. 262), or submission of a report under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)), such application or submission must be
accompanied by a certification, Form FDA 3674, that all applicable
requirements of section 402(j) of the PHS Act have been met. Where
available, such certification must include the appropriate National
Clinical Trial (NCT) numbers that are assigned upon submission of
required information to the NIH databank at https://clinicaltrials.gov.
    The proposed extension of the collection of information is
necessary to satisfy the previously mentioned statutory requirement.
The importance of obtaining these data relates to adherence to the
legal requirements for submissions to the clinical trials registry and
results databank, and ensuring that individuals and organizations
submitting applications or reports to FDA under the listed provisions
of the FD&C Act or the PHS Act adhere to the appropriate legal and
regulatory requirements for certifying to having complied with those
requirements. The failure to submit the certification required by
section 402(j)(5)(B) of the PHS Act, and the knowing submission of a
false certification, are both prohibited acts under section 301 of the
FD&C Act (21 U.S.C. 331). Violations are subject to civil money
penalties. The Form FDA 3674 provides a convenient mechanism for
sponsors/applicants/submitters to satisfy the certification
requirements of the statutory provision.
    To assist sponsors/applicants/submitters in understanding the
statutory requirements associated with Form FDA 3674, we have provided
a guidance available at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm. This guidance recommends the applications and
submissions FDA considers should be accompanied by the certification
form, Form FDA 3674. The applications and submissions identified in the
guidance are reflected in the burden analysis. In 2017, we updated the
guidance to include references to the NIH Final Rule implementing
402(j) of the PHS Act (42 U.S.C. 282(j)). The final rule, published on
September 21, 2016 (81 FR 64982) (42 CFR part 11), clarifies the
requirements for submission of clinical trial information to https://clinicaltrials.gov.
    Investigational New Drug Applications. FDA's Center for Drug
Evaluation and Research (CDER) received 1,669 investigational new drug
applications (INDs) and 15,285 clinical protocol IND amendments in
calendar year (CY) 2016. CDER anticipates that IND and clinical
protocol amendment submission rates will remain at or near this level
in the near future.
    FDA's Center for Biologics Evaluation and Research (CBER) received
381 new

INDs and 456 clinical protocol IND amendments in CY 2016. CBER
anticipates that IND and clinical protocol amendment submission rates
will remain at or near this level in the near future. The estimated
total number of submissions (new INDs and new protocol submissions)
subject to mandatory certification requirements under section
402(j)(5)(B) of the PHS Act is 16,954 for CDER plus 837 for CBER, or
17,791 submissions per year. The minutes per response is the estimated
number of minutes that a respondent would spend preparing the
information to be submitted to FDA under section 402(j)(5)(B) of the
PHS Act, including the time it takes to enter the necessary information
on the form.
    Based on its experience with current submissions, FDA estimates
that approximately 15 minutes on average would be needed per response
for certifications that accompany IND applications and clinical
protocol amendment submissions. It is assumed that most submissions to
investigational applications will reference only a few protocols for
which the sponsor/applicant/submitter has obtained an NCT number from
https://clinicaltrials.gov prior to making the submission to FDA. It is
also assumed that the sponsor/applicant/submitter has electronic
capabilities allowing them to retrieve the information necessary to
complete the form in an efficient manner.
    Marketing Applications/Submissions. In CY 2016, CDER and CBER
received 252 new drug applications (NDA)/biologics license applications
(BLA)/resubmissions and 1,067 NDA/BLA amendments for which
certifications are needed. CDER and CBER received 253 efficacy
supplements/resubmissions to previously approved NDAs/BLAs in CY 2016.
CDER and CBER anticipate that new drug/biologic applications/
resubmissions and efficacy supplement submission rates will remain at
or near this level in the near future.
    FDA's Center for Devices and Radiological Health (CDRH) received a
total of 330 new applications for premarket approvals (PMA), 510(k)
submissions containing clinical information, PMA supplements,
applications for humanitarian device exemptions (HDE) and amendments in
CY 2016. CDRH anticipates that application, amendment, supplement, and
annual report submission rates will remain at or near this level in the
near future.
    FDA's Office of Generic Drugs (OGD) received 1,036 abbreviated new
drug applications (ANDAs) in 2016. OGD received 698 bioequivalence
amendments/supplements in 2016. OGD anticipates that application,
amendment, and supplement submission rates will remain at or near this
level in the near future.
    Based on its experience reviewing NDAs, BLAs, PMAs, HDEs, 510(k)s,
and ANDAs and experience with current submissions of Form FDA 3674, FDA
estimates that approximately 45 minutes on average would be needed per
response for certifications that accompany NDA, BLA, PMA, HDE, 510(k),
and ANDA marketing applications and submissions. It is assumed that the
sponsor/applicant/submitter has electronic capabilities allowing them
to retrieve the information necessary to complete the form in an
efficient manner.
    In the Federal Register of September 22, 2017 (82 FR 44417), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                         Number of        Number of
                                        respondents      respondents      Number of     Total annual
        FDA Center/Activity          (investigational    (marketing     responses per     responses       Average burden per response       Total hours
                                       applications)    applications)    respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          CDER
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New Applications (IND).............            1,669   ..............               1           1,669  0.25 (15 minutes)................             417
Clinical Protocol Amendments (IND).           15,285   ..............               1          15,285  0.25 (15 minutes)................           3,821
New Marketing Applications/          ................             198               1             198  0.75 (45 minutes)................             149
 Resubmissions (NDA/BLA).
Clinical Amendments to Marketing     ................           1,067               1           1,067  0.75 (45 minutes)................             800
 Applications.
Efficacy Supplements/ Resubmissions  ................             219               1             219  0.75 (45 minutes)................             164
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                                                                          CBER
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New Applications (IND).............              381   ..............               1             381  0.25 (15 minutes)................              95
Clinical Protocol Amendments (IND).              456   ..............               1             456  0.25 (15 minutes)................             114
New Marketing Applications/          ................              54               1              54  0.75 (45 minutes)................              41
 Resubmissions (NDA/BLA).
Clinical Amendments to Marketing     ................               0               1               0  0.75 (45 minutes)................               0
 Applications.
Efficacy Supplements/ Resubmissions  ................              34               1              34  0.75 (45 minutes)................              26
 (BLA only).
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                                                                          CDRH
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New Marketing Applications           ................             330               1             330  0.75 (45 minutes)................             247
 (includes PMAs, HDEs, Supplements
 and 510(k)s expected to contain
 clinical data).
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                                                                           OGD
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Original Applications..............  ................           1,036               1  ..............  0.75 (45 minutes)................             777
Bioequivalence Supplements/          ................             698               1  ..............  0.75 (45 minutes)................             524
 Amendments.
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  ................  ..............  ..............  ..............  .................................           7,175
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: January 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00354 Filed 1-10-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 8, 2008 (Volume 73, Number 68)]
[Notices]
[Page 19135-19136]
[DOCID:fr08ap08-114]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2008-0062]

Notice of Receipt of Petition for Decision That Nonconforming
2005 Jeep Liberty Multipurpose Passenger Vehicles Are Eligible for
Importation

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice of receipt of petition for decision that nonconforming
2005 Jeep Liberty multipurpose passenger vehicles are eligible for
importation.

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SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
2005 Jeep Liberty multipurpose passenger vehicles that were not
originally manufactured to comply with all applicable Federal motor
vehicle safety standards (FMVSS) are eligible for importation into the
United States because (1) they are substantially similar to vehicles
that were originally manufactured for sale in the United States and
that were certified by their manufacturer as complying with the safety
standards, and (2) they are capable of being readily altered to conform
to the standards.

DATES: The closing date for comments on the petition is May 8, 2008.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted 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., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. 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).
    How to Read Comments Submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at http://
www.regulations.gov. Follow the online instructions for accessing the
dockets. The docket ID number and title of this notice are shown at the
heading of this document notice. Please note that even after the

comment closing date, we will continue to file relevant information in
the Docket as it becomes available. Further, some people may submit
late comments. Accordingly, we recommend that you periodically search
the Docket for new material.

FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for sale in the United States, certified under
49 U.S.C. 30115, and of the same model year as the model of the motor
vehicle to be compared, and is capable of being readily altered to
conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR Part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    J.K. Technologies, LLC, of Baltimore, Maryland (JK)(Registered
Importer 90-006) has petitioned NHTSA to decide whether nonconforming
2005 Jeep Liberty multipurpose passenger vehicles are eligible for
importation into the United States. The vehicles which JK believes are
substantially similar are 2005 Jeep Liberty multipurpose passenger
vehicles that were manufactured for sale in the United States and
certified by their manufacturer as conforming to all applicable FMVSS.
    The petitioner claims that it carefully compared non-U.S. certified
2005 Jeep Liberty multipurpose passenger vehicles to their U.S.-
certified counterparts, and found the vehicles to be substantially
similar with respect to compliance with most FMVSS.
    JK submitted information with its petition intended to demonstrate
that non-U.S. certified 2005 Jeep Liberty multipurpose passenger
vehicles, as originally manufactured, conform to many FMVSS in the same
manner as their U.S. certified counterparts, or are capable of being
readily altered to conform to those standards.
    Specifically, the petitioner claims that non-U.S. certified 2005
Jeep Liberty multipurpose passenger vehicles are identical to their
U.S.-certified counterparts with respect to compliance with Standard
Nos. 102 Transmission Shift Lever Sequence, Starter Interlock, and
Transmission Braking Effect, 103 Windshield Defrosting and Defogging
Systems, 104 Windshield Wiping and Washing Systems, 106 Brake Hoses,
108 Lamps, Reflective Devices and Associated Equipment, 111 Rearview
Mirrors, 113 Hood Latch System, 114 Theft Protection, 116 Motor Vehicle
Brake Fluids, 118 Power-Operated Window, Partition, and Roof Panel
Systems, 119 New Pneumatic Tires for Vehicles Other than Passenger
Cars, 124 Accelerator Control Systems, 135 Passenger Car Brake Systems,
201 Occupant Protection in Interior Impact, 202 Head Restraints, 204
Steering Control Rearward Displacement, 205 Glazing Materials, 206 Door
Locks and Door Retention Components, 207 Seating Systems, 209 Seat Belt
Assemblies, 210 Seat Belt Assembly Anchorages, 212 Windshield Mounting,
214 Side Impact Protection, 216 Roof Crush Resistance, 219 Windshield
Zone Intrusion, 301 Fuel System Integrity, and 302 Flammability of
Interior Materials.
    Petitioner states that the vehicle is equipped with a vehicle
identification number plate that complies with the requirements of 49
CFR Part 565.
    Petitioner also observes that the vehicle complies with the Theft
Prevention Standard found in 49 CFR part 541.
    Petitioner also contends that the vehicle is capable of being
readily altered to meet the following standards, in the manner
indicated:
    Standard No. 101 Controls and Displays: installation of a U.S.-
model instrument cluster.
    Standard No. 120 Tire Selection and Rims for Motor Vehicles Other
than Passenger Cars: installation of a tire information placard.
    Standard No. 208 Occupant Crash Protection: inspection of all
vehicles and replacement of any non U.S.-model seat belts, air bag
control units, air bags, and sensors with U.S.-model components on
vehicles that are not already so equipped.
    Petitioner states that the vehicle's restraint system components
include airbags, knee bolsters and combination lap and shoulder belts
at the front outboard designated seating positions and combination lap
and shoulder belts at the rear outboard designated seating positions.
    Standard No. 225 Child Restraint Anchorage Systems, inspection of
all vehicles and installation, on vehicles that are not already so
equipped, of U.S.-model components to meet the requirements of this
standard.
    The petitioner additionally states that a vehicle identification
plate must be affixed to the vehicles near the left windshield post to
meet the requirements of 49 CFR Part 565.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority: 49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8;
delegations of authority at 49 CFR 1.50 and 501.8.

    Issued on: April 1, 2008.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. E8-7388 Filed 4-7-08; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 231 (Thursday, December 1, 2016)]
[Proposed Rules]
[Pages 86684-86687]
[FR Doc No: 2016-28126]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 571

[Docket No. NHTSA-2016-0054]

Federal Motor Vehicle Safety Standards

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Denial of petition for rulemaking.

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SUMMARY: This document denies a petition for rulemaking, submitted by
Ms. Scheryn Bennett, requesting that the National Traffic Safety
Administration (NHTSA) require every vehicle to be equipped with an
emergency glass breaking tool. The data available to the agency shows
there is a great deal of uncertainty surrounding the actual number of
occupants that may have died due solely to drowning while trapped in an
immersed vehicle. The potential effectiveness of such a tool to
successfully aid an occupant's safe exit from an immersed vehicle is
also not known. In the absence of a requirement that each vehicle have
a glass breaking tool, nothing prevents vehicle manufacturers from
providing a tool or other means to allow vehicle evacuation during
immersion. Additionally, consumers can purchase their own tool and
locate it in the vehicle where they would be likely to access it in an
emergency.

DATES: This denial is effective as of December 1, 2016.

ADDRESSES: Office of Crashworthiness Standards, National Highway
Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington,
DC 20590.

FOR FURTHER INFORMATION CONTACT:
    For Non-Legal Issues: Mr. James Myers, Office of Crashworthiness
Standards, National Highway Traffic Safety Administration, 1200 New
Jersey Avenue SE., Washington, DC 20590, Telephone:<PHONE_NUMBER>,
Facsimile:<PHONE_NUMBER>.
    For Legal Issues: Ms. Rebecca Yoon, Office of Chief Counsel,
National Highway Traffic Safety Administration, 1200 New Jersey Avenue
SE., Washington, DC 20590, Telephone:<PHONE_NUMBER>.

SUPPLEMENTAL INFORMATION:

Table of Contents

I. Background
II. Petition
III. Analysis of Petition
    A. Preliminary Analysis of Real World Data
    B. Potential Effectiveness of Tool
    C. Costs Effectiveness
    D. Response to Standard Equipment Statement
IV. Conclusion

I. Background

    The National Traffic and Motor Vehicle Safety Act (``Safety Act,''
49 U.S.C. 30101 et seq.) authorizes NHTSA to issue safety standards for
new motor vehicles and new items of motor vehicle equipment. The
prescribed motor vehicle safety standards must be practicable, meet the
need for motor vehicle safety, and be stated in objective terms. NHTSA
does not endorse any vehicles or items of equipment. Further, NHTSA
does not approve or certify vehicles or equipment. Instead, the Safety
Act establishes a ``self-certification'' process under which each
manufacturer is responsible for certifying that its products meet all
applicable safety standards. NHTSA has not established any standards
pertaining to an emergency glass breaking tool, nor has the agency ever
established a requirement that they must be provided with any vehicle.

II. Petition

    On January 22, 2014, Ms. Scheryn Bennett, (henceforth referred to
as Ms. Bennett), requested that NHTSA require every vehicle to be
equipped with an ``emergency window breaker.'' Ms. Bennett cited the
drowning deaths of a mother and her two minor children during an August
2011 flash flood in Pittsburgh, PA, and wrote that ``evidence showed
they [the victims] attempted to kick out the windows in their
minivan.'' Ms. Bennett expressed a concern for vehicle occupants to
exit a passenger vehicle via a window after the vehicle has become
trapped in water such that the water interrupts the vehicle electrical
system, rendering the power windows inoperable. Additionally, Ms.
Bennett contended that ``[j]ust as a spare tire and jack are standard
in all vehicles so should an emergency window breaker.''

III. Analysis of Petition

    As a general matter, any proposed safety standard issued by NHTSA
must meet the need for motor vehicle safety. Typically, we assess
whether a standard would meet the need for motor vehicle safety by
analyzing the real-world safety problem (which is the ``safety need''),
and then analyzing how well the safety problem can be addressed by the
standard we are proposing (whether the safety need is met by the
standard). It is challenging for the agency to justify a new regulation
based only on an

assumption that a particular vehicle safety feature or piece of
equipment has potential for reducing injury or death in some crash
scenarios.

A. Preliminary Analysis of Real World Data

    Ms. Bennett provided a newspaper article reporting on the death of
a mother and her two children that drowned in their minivan during a
severe flash flood event. We searched for additional data that could
support the existence of a safety need which could be addressed by an
emergency window breaking tool. NHTSA's data review for this petition
examined the information available in the agency's Fatality Analysis
Reporting System (FARS) and Not-in-Traffic Surveillance (NiTS)
databases. We also examined vehicle related cataclysmic drowning
incident information available from the National Oceanic and
Atmospheric Administration (NOAA) Web site.
    NHTSA's FARS database is a nationwide census of yearly data
regarding fatal injuries suffered in motor vehicle traffic crashes.
However, it does not capture fatalities that occur directly as a result
of a cataclysm, such as flooding. An example of this would be a motor
vehicle swept away while a bridge the vehicle was crossing is washed
out during a hurricane or flood. Accidents related to a cataclysm, but
occurring after the cataclysm has ended, would be traffic crashes and
would be in FARS. Such an example could be where a motor vehicle is
driven into water after a hurricane or flood where a bridge was washed
out.
    In the 2011 technical paper Drowning Deaths in Motor Vehicle
Traffic Accidents,\1\ NHTSA reviewed data available in FARS and linked
it to Multiple Cause of Death (MCoD) data from the Centers for Disease
Control and Prevention (CDC). The information indicated that drowning
was involved in approximately 1 percent of the average annual motor
vehicle occupant traffic fatalities for the time period reviewed for
the paper (or 384 motor vehicle occupant traffic fatalities annually).
NHTSA further analyzed the data for indications of possible occupant
trauma that would indicate the fatally injured occupant(s) could have
been unable to self-evacuate from their vehicle because of their
physical condition at the time of the vehicle immersion. These included
potentially incapacitating crash scenarios such as vehicle rollovers,
impacts with fixed objects, alcohol levels at or above the legal limit,
and occupant ejection cases. Removing incidents involving vehicle
rollovers and alcohol/drug usage from the above 384 fatalities yielded
an annual average of 81 crash fatalities involving accidental drowning.
We further excluded events in which the vehicle struck a fixed object
prior to entering the water. Based upon this analysis, there were 28
drowning fatalities that were caused by crashes where vehicle immersion
or unknown factors were the first harmful event.\2\ These 28
individuals are the group most likely to have been in a position to
self-evacuate from their immersed vehicle. However, the database
details are insufficient to conclusively determine which of these
fatalities occurred solely due to drowning and not factors such as
physical trauma, seat belt issues, confusion, or other unknown issues,
and thus may have survived if an emergency glass breaking tool had been
available in the vehicle.
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    \1\ ``Drowning Deaths In Motor Vehicle Traffic Accidents''; Rory
Austin; National Highway Traffic Safety Administration; 22nd
Experimental Safety of Vehicles Conference, Washington, DC, Paper
Number 11-0170, 2011. (http://www-esv.nhtsa.dot.gov/Proceedings/22/files/22ESV-000170.pdf)
    \2\ Ibid, Table 7 records an annual average of 106 fatalities
for immersion events with no rollover. Per FARS database inquiry, 25
of these fatalities had BAC .08 or higher (105 minus 25 equals 81).
Of the remaining fatalities, 53 were from incidents where the
vehicle collided with a fixed object prior to entering the water.
This leaves 28 average annual crash fatalities possibly due solely
to drowning.
---------------------------------------------------------------------------

    NHTSA also examined the information available in our NiTS database.
The NiTS database tracks nontraffic crashes which occur off of public
roads in locations such as private roads, driveways, parking lots, and
undeveloped areas. Unfortunately, the system does not have any linked
mortality data, which prevents a similar analysis to the one for
traffic fatalities using FARS. Furthermore, while the database can list
a most harmful event of immersion when applicable, the results
previously presented above from the technical paper Drowning Deaths in
Motor Vehicle Traffic Accidents \3\ indicate that this variable does
not provide a good proxy for counting drowning deaths. Additionally,
the event details available are insufficient to determine if the
individuals died inside or outside of their vehicles. Thus, this
database could not provide data supporting a safety need for this
petition.
---------------------------------------------------------------------------

    \3\ Ibid., page 7.
---------------------------------------------------------------------------

    NHTSA also researched flood related fatality information available
on the NOAA Web site. The NOAA Web site uses data obtained from the
CDC. Reviewing the listed event circumstances for only fatalities in
which the persons died inside \4\ a motor vehicle, there were on
average 34 people annually that died inside their vehicles for the
years 2010-2014.\5\ The information available on the NOAA Web site does
not permit an evaluation into possible escape methods that may have
benefitted these individuals, which makes it difficult to use this
information to establish a safety need. It is further not possible to
determine the extent to which there is an overlap in the fatality count
between the 28 FARS fatalities and the 34 NOAA fatalities of people
dying each year inside their vehicles during motor vehicle water
immersion incidents. Neither is it possible to determine whether these
people had compromised physical conditions due to event induced trauma
or whether unknown physical barriers such as event damaged vehicle
systems prevented them from escaping their vehicle interiors prior to
drowning. NHTSA's review of the available information did not provide
data to support the safety need listed in Ms. Bennett's petition. The
information does not reveal whether the people died in these accidents
due solely to drowning or from some other cause. Because it cannot be
determined exactly how these people died, it is challenging to develop
specific safety recommendations that could prevent this type of
fatality.
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    \4\ The NOAA data lists fatalities for people that escaped their
trapped vehicle as a vehicle related fatality. The NOAA data also
lists ATV and horse and buggy in the vehicle related category. These
fatalities were excluded from our analysis since an emergency glass
breaking tool would likely not have helped these people.
    \5\ The NOAA information lists the following in-vehicle
fatalities for vehicles trapped in floodwaters: 2010 44 fatalities;
2011 60 fatalities; 2012 9 fatalities; 2013 31 fatalities; and 2014
24 fatalities.
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B. Potential Effectiveness of Tool

    Multiple types of glass breaking tools are commercially available
for consumers to purchase. The tools can be attached to a key chain,
attached to a seat belt, mounted in the vehicle interior, or stored in
a convenient location within the vehicle interior. These tools are
intended to quickly and efficiently break the tempered glass \6\
material of a passenger vehicle's side window in order to create a
vehicle emergency egress location. Currently-available glass breaking
tools may be

quite capable of vacating tempered glass from a window opening.
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    \6\ Per ANSI/SAE Z26.1-1996 the term ``tempered glass'' means a
single piece of specially treated sheet, plate, or float glass
possessing mechanical strength substantially higher than annealed
glass. When broken at any point the entire piece breaks into small
pieces that have relatively dull edges as compared to those of
broken pieces of annealed glass.
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    However, the glass breaking tools will not quickly and efficiently
break those passenger vehicle side windows constructed with laminated
glass \7\ material.\8\ The capability of glass breaking tools to break
plastic glazing materials permitted for use in motor vehicles by FMVSS
No. 205 is also unknown. Information on the percentage of passenger
vehicles with side or rear windows constructed of laminated glass or
plastic glazing materials is not collected by the agency. An
examination of information available from the Enhanced Protective Glass
Automotive Association indicates at least four dozen passenger vehicle
models may have laminated glass material at vehicle locations other
than the front windshield.\9\ These vehicles tend to be lower volume,
luxury models. Even in vehicles with laminated glass in side windows,
there may be other windows with tempered glass, such as the rear window
or potentially a sunroof. Drivers and occupants would need to not only
know which windows are breakable by the emergency glass breaking tool
and which are not, but would also need to be prepared to respond
accordingly as their vehicle is filling with water.
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    \7\ Per ANSI/SAE Z26.1-1996 the term ``laminated glass'' means
two or more pieces of sheet, plate, or float glass bonded together
by an intervening layer or layers of plastic material. It will crack
or break under sufficient impact, but the pieces of glass tend to
adhere to the plastic. If a hole is produced, the edges are likely
to be less jagged than would be the case with ordinary annealed
glass.
    \8\ ``Type of Glass in Your Car's Windows Could Change Escape
Plan''; Deanna Dewberry, News 5 NBCDFW.com; May 6, 2013 (2014 NBC
Universal Media, LLC.) http://www.nbcdfw.com/investigations/Type-of-Glass-in-Your-Cars-Windows-Could-Change-Escape-Plan-206353031.html;
last accessed May 15, 2015.
    \9\ ``Enhanced Protective Glass Applications''; Enhanced
Protective Glass Automotive Association; http://www.epgaa.com/?page_id=1673; last accessed May 15, 2015.
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    There are other concerns related to the potential effectiveness of
a requirement for such a tool beyond knowing which vehicle windows can
or cannot be broken with the tool. First, it is not clear to the agency
that a vehicle driver or passenger would be aware of the existence of
such a device, its location, or how and when it should be used without
additional information being provided. It is unclear whether
information in the owner's manual would be sufficient to properly
educate the vehicle occupants as to the existence of the device and its
use. It is reasonable to assume the device would need to be located
within the occupant compartment. However, the agency questions how
likely it would be for the tool to be used if the tool was hidden away
in the glove compartment or other non-visible location, or whether the
tool would need to always be visible and within reach for it to be used
when needed. The answer to that question may be tied to the success of
the educational information referred to above.
    There are many situationally dependent, time critical decisions
that conscious occupants may face if their vehicle becomes immersed in
water, particularly if it is caught in a flash flood. Do the occupants
need to leave the vehicle interior to avoid drowning and how quickly
should that happen? What is the best way to safely exit the vehicle?
What is the fastest, most survivable path to exit the flood waters?
What special considerations are needed to help children get out of the
vehicle if only one adult is present? All of these decisions and many
more must be made within a few seconds once such a life threatening
event begins. Once a vehicle becomes completely submerged, the
occupants will face a reduced chance of survival.\10\
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    \10\ Gordon G. Giesbrecht, ``My Car Is Sinking: Automobile
Submersion, Lessons in Vehicle Escape,'' Aviation, Space, and
Environmental Medicine, Volume 81, Issue 8, August 2010.
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    All of the above issues are open questions that will affect the
real world effectiveness of a requirement to provide an emergency glass
breaking tool. Based on the information available to NHTSA about the
apparent size of the safety problem (i.e., the number of people who die
each year from drowning in their vehicle because they could not open
the window and were not otherwise incapacitated) and the lack of
information available about how well emergency glass breaking tools
might address that safety problem, the agency is unable to say with
confidence that a requirements for an emergency window breaking tool
would meet the need for safety, as required by the Safety Act.

C. Cost Effectiveness

    Anecdotal market research on commercially available tempered glass
breaking tools shows that there are a variety of tools marketed as
emergency window glass breaking tools. They are generally either a type
of hammer or a spring loaded punch. Some of the available tools are
intended solely for breaking glass. Other tools provide additional
functionality such as seat belt cutters, flashlights, or even tire
pressure gauges. Purchase costs for these tools range from
approximately $3.50 to $20.00 each.
    In addition to the preliminary nature of the above cost estimates,
there are several other barriers to making a reasonable estimate of the
cost effectiveness of a potential requirement for this tool. First, as
previously discussed, the available motor vehicle crash information
suggests that the number of people that might be expected to require a
means of escaping an immersed vehicle through a window opening may be
on the order of 28 persons annually. However, as also outlined above,
there is a great deal of uncertainty surrounding any estimate, as the
data does not permit a conclusive determination on the number of
fatalities due solely to drowning, even when immersion is the first
harmful event. Second, the potential effectiveness of the tool measured
by an occupant's ability to safely exit a vehicle is not known.
Although the glass breaking tool is expected to easily shatter tempered
glass when used, there are other factors that are very likely to reduce
the effectiveness of the tool. High among these would be a lack of
knowledge of the existence of the tool and finding it as a vehicle
becomes immersed. Thus, the uncertainty in the population of vehicle
occupants that require the tool and in its potential effectiveness
results in a highly uncertain assessment of potential benefits. Any
resulting cost effectiveness estimate would be tenuous.

D. Response to Standard Equipment Statement

    Ms. Bennett wrote that spare tires and jacks are ``standard'' on
all vehicles. This is not correct; NHTSA has issued no standard or
regulation which requires vehicles to be provisioned with a spare tire
and tools for changing tires. Many vehicles do not have a spare tire
and jack, but rather other means of facilitating the temporary driving
of a vehicle after a tire becomes flat, such as an inflator and sealant
kit or run-flat tires.\11\
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    \11\ Your next car may not have a spare tire; Jim Travers;
Consumer Reports.Org article; Published August 16, 2014; last
accessed May 15, 2015; http://www.consumerreports.org/cro/news/2014/08/your-next-car-may-not-have-a-spare-tire/index.htm.
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    The vehicle original equipment manufacturers (OEMs) may offer
consumers the option to purchase motor vehicle equipment that provides
safety benefits beyond the minimum requirements of the various FMVSS.
Just as several OEMs sell optional first aid and road side assistance
kits for their vehicles, they could sell an appropriate

glass breaking tool with recommended procedures for usage during an
emergency.
    Consumers also have the option to equip their vehicles with
emergency safety equipment. Items such as fire extinguishers,
automotive tool kits, aftermarket vehicle jacks and lug wrenches,
battery jumper cables, first aid kits, winter emergency survival kits,
survival kits for desert travel, and vehicle break down kits are items
available for consumers to purchase for emergency preparedness.
Consumers who do purchase safety items for their vehicles may be more
likely to know where these items are stored in their vehicles and how
to use the equipment. All vehicle operators are strongly encouraged to
understand their vehicle's capabilities and safety features, their
expected driving environment, and to be prepared for possible emergency
situations.

IV. Conclusion

    NHTSA shares Ms. Bennett's desire to prevent deaths in motor
vehicles. However, at this time there are several substantial obstacles
to proposing an objective motor vehicle safety standard to assist
vehicle occupants in evacuating a passenger vehicle that has become
immersed in water.
    First, as previously explained, the data available to the agency
shows there is a great deal of uncertainty surrounding any estimate of
occupants requiring the use of the glass breaking tool. Second, the
potential effectiveness of the tool to provide drivers and occupants
with a method to safely exit a vehicle during an immersion event is not
known. Due to the uncertainty surrounding whether the glass breaking
tool would successfully aid all occupants in all vehicles during a
vehicle immersion situation, NHTSA cannot justify a mandate for such a
tool.
    Even without a requirement that each vehicle have a glass breaking
tool, there is nothing to keep vehicle manufacturers from providing it
or other means to allow vehicle evacuation during immersion. In
addition, consumers can purchase their own tool and locate it in the
vehicle where they would be likely to access it in an emergency. Those
consumers who do this may be more aware of the existence of the tool
when the need to use it arises than would occupants of a vehicle where
the tool has been provided as standard equipment.
    In accordance with 49 CFR part 552, NHTSA hereby denies Ms. Scheryn
Bennett's January 22, 2014, petition to require every vehicle to be
equipped with ``an emergency window breaker.''

    Authority: 49 U.S.C. 322, 30111, 30115, 30117, and 30162;
delegation of authority at 49 CFR 1.95.

    Issued in Washington, DC, under authority delegated in 49 CFR
1.95.
Raymond R. Posten,
Associate Administrator for Rulemaking.
[FR Doc. 2016-28126 Filed 11-30-16; 8:45 am]
 BILLING CODE 4910-59-P