[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7191-7192]
[FR Doc No: 2018-03345]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-1891]

Determination of Regulatory Review Period for Purposes of Patent
Extension; PORTRAZZA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
23, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 20, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 23, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-E-1891 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; PORTRAZZA.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase

begins. The approval phase starts with the initial submission of an
application to market the human biological product and continues until
FDA grants permission to market the biological product. Although only a
portion of a regulatory review period may count toward the actual
amount of extension that the Director of USPTO may award (for example,
half the testing phase must be subtracted as well as any time that may
have occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a human biological product
will include all of the testing phase and approval phase as specified
in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product PORTRAZZA
(necitumumab). PORTRAZZA is indicated, in combination with gemcitabine
and cisplatin, for first-line treatment of patients with metastatic
squamous non-small cell lung cancer. Subsequent to this approval, the
USPTO received a patent term restoration application for PORTRAZZA
(U.S. Patent No. 7,598,350) from Eli Lilly and Company, and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated August 30, 2016, FDA advised
the USPTO that this human biological product had undergone a regulatory
review period and that the approval of PORTRAZZA represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
PORTRAZZA is 2,533 days. Of this time, 2,175 days occurred during the
testing phase of the regulatory review period, while 358 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: December
19, 2008. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on December
19, 2008.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): December 2, 2014. The applicant claims
October 22, 2014, as the date the biologics license application (BLA)
for PORTRAZZA (BLA 125547) was initially submitted. However, FDA
records indicate that BLA 125547 was submitted on December 2, 2014.
    3. The date the application was approved: November 24, 2015. FDA
has verified the applicant's claim that BLA 125547 was approved on
November 24, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,321 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03345 Filed 2-16-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 9, 2010 (Volume 75, Number 45)]
[Proposed Rules]
[Page 10740-10753]
[DOCID:fr09mr10-25]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 575

[Docket No. NHTSA-2010-0025]
RIN 2127-AK51

New Car Assessment Program (NCAP); Safety Labeling

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: Since September 2007, new passenger vehicles have been
required to be labeled with safety rating information published by the
National Highway Traffic Safety Administration (NHTSA) under its New
Car Assessment Program (NCAP). This information is required to be part
of the Monroney (automobile price sticker) label. In July 2008, NHTSA
announced a decision to enhance the NCAP ratings program. In this
document, the agency is proposing to upgrade its regulation on vehicle
labeling of safety rating information to reflect the enhanced NCAP
ratings program. NHTSA is proposing, among other things, to include a
new overall vehicle score on the Monroney label.

DATES: Comments should be submitted early enough to ensure that they
are received no later than April 8, 2010.

ADDRESSES: Comments should refer to the docket number above and be
submitted by one of the following methods:
     Federal Rulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Please note, if
you are submitting comments electronically as a PDF (Adobe) file, we
ask that the documents submitted be scanned using an Optical Character
Recognition (OCR) process, thus allowing the agency to search and copy
certain portions of your submissions.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC between 9 a.m. and 5 p.m.
ET, Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the agency name and
docket number. 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. All comments received will be posted without change to http:/
/www.regulations.gov, including any personal information provided.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of NHTSA's dockets by the name of the individual
submitting the comments (or signing the comments, 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) or you may
visit http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For non-legal issues, you may contact
Ms. Jennifer N. Dang, Office of Crashworthiness Standards (Telephone:
202-493-0598). For legal issues, you may contact Ms. Dorothy Nakama,
Office of the Chief Counsel (Telephone:<PHONE_NUMBER>). You may send
mail to both of these officials at the National Highway Traffic Safety
Administration, 1200 New Jersey Avenue, SE., West Building, Washington,
DC 20590-0001.

SUPPLEMENTARY INFORMATION:

I. Background on the Monroney Label

    Most new vehicle buyers are probably familiar with the label
affixed to the side window showing the price of the vehicle and the
options installed on that vehicle. This label is required by Federal
law. The Automobile Information Disclosure Act (15 U.S.C. 1231-1233)
was enacted into law in 1958, and is also called the ``Monroney Act,''
after its sponsor, Senator Monroney of Oklahoma. The Monroney Act
requires all new light vehicles to have a window sticker affixed that
shows, among other things:
     Vehicle make.
     Vehicle model.
     Vehicle identification number.
     The final assembly point.
     The name and location of the dealer to whom the vehicle is
to be delivered.
     The manufacturer's suggested retail price (MSRP) of the
base vehicle.

     The MSRP of the optional equipment installed on the
particular vehicle.
     The transportation charges for delivery of the vehicle
from the manufacturer to the dealer, and
     The total MSRP of all of the above.
    Beginning with the 1959 model year, this information was provided
on the window label. Beginning in 1962, some manufacturers began
providing information not just on the options installed on the vehicle,
but on standard items as well.
    The information required to be labeled on the window by the
Monroney Act remained unchanged from its passage in 1958 until 2005. In
2005, Congress enacted SAFETEA-LU (Pub. L. 109-59), which expanded the
window label requirement to include the safety ratings assigned by
NHTSA under its New Car Assessment Program (NCAP), or a statement that
the vehicle was not assigned safety ratings under NCAP. The 2005 law
also added size and visibility requirements for the safety ratings
information (15 U.S.C. 1232(g) and (h)).
    In addition to the MSRP and safety ratings information, Congress
has also permitted the information from two other Federal programs to
appear on the Monroney label on the window of new vehicles. 49 U.S.C.
32908(b) requires that the Environmental Protection Agency (EPA) issue
regulations requiring vehicle manufacturers to attach a label in a
prominent place of the vehicle that provides information on:
     The vehicle's fuel economy.
     The estimated annual fuel cost of operating the vehicle.
     The range of fuel economy of comparable vehicles by all
manufacturers, and
     A statement that a booklet is available from the dealer to
compare the fuel economy of other vehicles manufactured by all
manufacturers for the model year.
    49 U.S.C. 32908(b)(2) expressly provides that the EPA ``may allow a
manufacturer to comply with this subsection by disclosing the
information on the label required under * * * the Automobile
Information Disclosure Act (15 U.S.C. 1232).''
    In addition to the fuel economy information, Congress has expressly
permitted one other type of required Federal information to appear on
the Monroney label. 49 U.S.C. 32304 requires that passenger motor
vehicle country of origin labeling be provided on new vehicles, and 49
U.S.C. 32304(g) provides that NHTSA ``shall permit a manufacturer to
comply with this section by allowing the manufacturer to disclose the
information * * * on the label required under * * * the Automobile
Information Disclosure Act (15 U.S.C. 1232).''
    We are not aware of instances other than the fuel economy labeling
and domestic content labeling where Congress has granted a Federal
agency permission to specify that other information be provided on the
Monroney label. Below is an example of a Monroney label as it appears
in a new vehicle window.

[GRAPHIC] [TIFF OMITTED] TR09MR10.000

II. Overview of This Proposal

    Section 10307 of the Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for Users (SAFETEA-LU), Public Law
109-59 (August 10, 2005; 119 Stat. 1144), requires new passenger
vehicles to be labeled with safety ratings from the National Highway
Traffic Safety Administration's (NHTSA) New Car Assessment Program
(NCAP).
    Pursuant to SAFETEA-LU, the agency published in the Federal
Register (71 FR 53572) on September 12, 2006 a final rule \1\ requiring
manufacturers by September 1, 2007, to incorporate a distinct safety
rating label into the Monroney (automobile price sticker) label
required by the Automobile Information Disclosure Act (AIDA), 15 U.S.C.
1231-1233. The September 12, 2006 final rule required that the safety
rating label:
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    \1\ 49 CFR part 575, Docket No. NHTSA-2006-25772, RIN 2127-A576,
``New Car Assessment Program; Safety Labeling'', Final Rule.
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     Have the title ``Government Safety Ratings'' along its
top,
     Be either 4\1/2\ inches wide by 3\1/2\ inches high or 8
percent of the area of the Monroney label, whichever is larger, and
     Include frontal crash (driver and passenger), side crash
(front seat and rear seat) and rollover safety ratings that have been
generated under NCAP or display the term ``Not Rated'' or ``To Be
Rated'' in any areas of the safety rating label where ratings have not
been developed. (Vehicles for which no safety ratings at all have been
developed may use a smaller safety rating label [4\1/2\ inches wide by
1\1/2\ inches high] indicating that the vehicle has not been rated by
the government.)
    The rule also required explanatory language for each of the areas
of safety ratings and, near the bottom of the label, language briefly
explaining the use of stars to communicate safety ratings (ratings are
from 1 to 5 stars with 5 stars being the highest rating). Finally, the
safety rating label must have ``http://www.safercar.gov or 1-888-327-
4236'' along the bottom of the label to alert consumers as to where
they may obtain further information.
    On July 11, 2008, the agency published a final decision notice

announcing enhancements to the NCAP programs. These enhancements
include:
     For the frontal crash program--modifying the frontal NCAP
rating system to reflect updated test dummies, expanded injury
criteria, and the inclusion of all body regions that are covered by
Federal Motor Vehicle Safety Standard (FMVSS) No. 208;
     For the side crash program--modifying the side NCAP rating
system to reflect new side impact test dummies, new injury criteria,
the inclusion of nearly all of the body regions that are covered by
FMVSS No. 214, as well as a new pole test using a small female crash
test dummy;
     A new overall vehicle score that will be based on frontal
crash, side crash, and rollover resistance test results; and
     A new program that will provide consumers with information
concerning the availability of advanced crash avoidance technologies.
    The final decision notice did not announce any changes to NCAP
rollover resistance testing.
    Beginning with model year 2011,\2\ safety ratings for new passenger
vehicles that must be in the safety rating label will be based on the
updated approaches to frontal and side crash testing and ratings
criteria.
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    \2\ On December 24, 2008, the agency published a notice
announcing a postponement (for one model year) in the implementation
of the new enhancements to the NCAP crash testing and safety rating
program in Docket No. NHTSA-2006-26555. The agency will begin
applying the enhanced NCAP testing and safety rating criteria to
model year 2011 vehicles.
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    Section 10307 of SAFETEA-LU specifies a number of detailed
requirements for the safety rating label, including content, size,
location, and applicability. The agency's September 2006 final rule was
consistent with those requirements, and included a number of detailed
requirements including ones related to format.
    In today's document, we are proposing to revise our regulation on
vehicle labeling of safety rating information to reflect the
enhancements to the NCAP programs listed above. Under this proposal:
    (1) Beginning with model year 2011, safety rating labels on new
passenger vehicles that are manufactured on or after September 1, 2010,
would be required to include, as the first item of safety information
in the safety rating label, an overall vehicle score based on a
vehicle's frontal crash, side crash, and rollover resistance ratings.
The agency would allow early compliance for model year 2011 vehicles
that are manufactured before September 1, 2010.\3\
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    \3\ In other words, manufacturers would have the option to place
the proposed safety rating labels on model year 2011 vehicles that
are manufactured before September 1, 2010.
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    (2) Language describing the nature and meaning of the NCAP test
data used to generate vehicle safety ratings and a reference to http://
www.safercar.gov for additional vehicle safety information in the
safety rating label would be revised slightly and, in some cases,
relocated in the safety rating label; and
    (3) Safety concerns identified as a result of NCAP testing would
need to be displayed in the overall vehicle score area of the safety
rating label in addition to the appropriate area of the safety rating
label to which the safety concern applies (frontal, side, or rollover).

III. Application

Vehicle Weight

    In 2005, Congress modified the Automobile Information Disclosure
Act (AIDA), 15 U.S.C. 1231-1233, which requires a Monroney label on all
passenger vehicles, to require that passenger vehicles with a Gross
Vehicle Weight Rating (GVWR) of 10,000 pounds or less, manufactured on
or after September 1, 2007, include on their Monroney labels safety
information developed as part of NHTSA's New Car Assessment Program
(NCAP). As a result, all changes to the safety rating label proposed in
this notice would apply to safety rating labels in the Monroney labels
of passenger vehicles with a Gross Vehicle Weight Rating (GVWR) of
10,000 pounds or less. Vehicles that have a Monroney label and that
have been rated in at least one area under NCAP would need to display
those ratings as described in this notice. Vehicles that display a
Monroney label and that have not been rated under NCAP would be
required to include in their Monroney label the smaller vehicle safety
rating label, which indicates that the vehicle has not been rated.

IV. Proposed New Requirements for the Safety Rating Label

A. Content and Graphic Details

    The agency is proposing to modify the safety rating label to add a
new area of the label for the overall vehicle score. This area would be
located immediately below the heading area and would be the first item
of safety information. Persons who are interested in the details
concerning the new overall vehicle score are encouraged to read the
July 2008 final decision notice announcing enhancements to the NCAP
programs.
    The format of the remainder of the safety rating label would be
very similar to the current safety rating label, except that language
explaining the five star rating system and other language indicating
that NHTSA is the source of the safety information contained in the
safety rating label would now be incorporated into the footer area of
the label, rather than be displayed in its own area of the label,
currently referred to as the general information area. Some minor
modifications in other language would also occur.
    The result would be that the modified safety rating label would
consist of six sections, the same number of sections in the current
safety rating label. The modified safety rating label would be
subdivided into--the heading area, a new overall vehicle score area,
the frontal crash area, the side crash area, the rollover area, and the
footer area. The position of these areas, running from the top to the
bottom of the label, would be as follows: heading area at the top,
followed by the overall vehicle score area, the frontal area, the side
area, the rollover area, and the footer area.
    As is currently the case, the areas of the label whose background
is light in color--overall vehicle score, frontal, side, and rollover--
would continue to be required to be separated from each other by a dark
line that is a minimum of 3 points in width. Also as is currently
required, the entire safety rating label would be required to be
surrounded by a solid dark line that is a minimum of 3 points in width.
The format of each area of the safety rating label is described below.
Heading Area
    The agency is proposing to change the language in the heading area
to read ``Government 5-Star Safety Ratings'' rather than the existing
heading ``Government Safety Ratings'', as a result of consumer research
conducted by NHTSA.\4\ When asked which heading is most appropriate for
the Federal Government motor vehicle safety rating system (which is
based on a 5-Star rating system), approximately two-thirds of the
interviewees preferred ``Government 5-Star Safety Ratings''.
Approximately two-thirds of the participants in the survey were aware
that the Government posts safety ratings on a new vehicle's window
sticker (the Monroney label), and the majority preferred the
``Government 5-Star Safety Ratings'' heading. Since it is critical that
the heading area be easily recognizable

to help consumers identify the NHTSA safety information on the Monroney
label, the agency is proposing to require the words ``Government 5-Star
Safety Ratings'' in centered boldface, light capital letters against a
dark background.
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    \4\ The full study report is available at http://
www.regulations.gov in Docket No. NHTSA-2006-25772.
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Overall Vehicle Score Area
    In NHTSA's July 11, 2008 final decision notice (which discusses how
the agency plans to enhance its existing NCAP programs), the overall
vehicle score is referred to as the Vehicle Safety Score. NHTSA's
research found that most participants preferred the term ``Overall
Vehicle Score'' as compared to ``Vehicle Safety Score'' to convey the
overall safety rating of a vehicle.\5\ Therefore, the agency is
proposing that ``Overall Vehicle Score'' be used to describe the
section of the safety rating label in which stars reflecting the
overall vehicle score will be displayed.
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    \5\ The full study report is available at http://
www.regulation.gov in Docket No. NHTSA-2006-25772.
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    NHTSA is also proposing to require the statement ``Based on the
combined ratings of frontal, side and rollover.'' at the bottom of this
area of the safety rating label to explain to consumers how the overall
vehicle score is determined. The words ``Star rating,'' which are
currently included in similar statements in other areas of the safety
rating label, would be excluded from this statement. The agency
believes consumers will readily understand that a star rating is
involved because of the obvious use of stars in the safety rating
label. (In other sections of this document, the agency is proposing to
drop the use of the words ``Star rating'' from the other areas of the
safety rating label where they are currently used.)
    Finally, the agency is proposing that the words, ``Should ONLY be
compared to other vehicles of similar weight class.'' appear at the
bottom of the overall vehicle score area of the safety rating label as
well. The current safety rating label is required to include the
statement, ``Frontal ratings should ONLY be compared to other vehicles
of similar weight class.'' at the bottom of the Frontal Crash area of
the safety rating label. (As explained elsewhere in this notice, the
agency is proposing to eliminate the words ``Frontal ratings'' so that
the statement required in the Frontal Crash area would be identical to
the one proposed above for the overall vehicle score area.) Since the
overall vehicle score is based in part on the frontal crash rating, the
agency believes it is appropriate to propose the same language for both
the Frontal Crash area and the Overall Vehicle Score area.
Frontal Area
    In the current NCAP frontal crash test program, NHTSA provides
consumers with frontal crash ratings for two seating positions, the
driver and the right front passenger. The current rating for each
seating position is based on the combined chance of serious injury to
the head and chest. As mentioned previously, the new frontal program
will include all of the FMVSS No. 208 body regions (head, neck, chest,
and femur). The new program will also use a different crash test dummy
in the right front passenger seating position. The seating positions
will remain the same. Hence, the new frontal crash rating for each
seating position will be based on the combined chance of serious injury
to the head, neck, chest, and femur.
    Nearly three-fourths of the participants in NHTSA's consumer
research preferred a rating for each frontal seating position over an
overall frontal rating.\6\ NHTSA understands consumers' preference for
having crash rating information by seating position readily available
at the point of sale. Thus, the agency proposes to continue reporting
frontal crash ratings on the Monroney label by seating position on the
revised safety rating label. It is proposed that the term ``Frontal
Crash'' continue to be used to refer to frontal crash test ratings and
``Driver'' and ``Passenger'' still be used to refer to the seating
positions and the applicable star rating.
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    \6\ The full study report is available at http://
www.regulations.gov in Docket No. NHTSA-2006-25772.
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    Currently the statement, ``Star ratings based on the risk of injury
in a frontal impact.'' is required at the bottom of the Frontal Crash
area of the safety rating label. NHTSA is proposing that this statement
be shortened to ``Based on the risk of injury in a frontal impact.'' As
explained previously, the term ``Star ratings,'' would be excluded from
this statement because the term ``Government 5[dash]Star Safety
Ratings'' would appear in the heading area of the modified safety
rating label and should make clear to consumers that the stars in any
area of the safety rating label reflect safety ratings. This generic
statement would continue to provide the agency with the flexibility to
update the ratings (due to additional injury criteria, an update to
FMVSS No. 208, etc.) without conducting further rulemaking to update
the label.
    As explained above under Overall Vehicle Score Area, the statement,
``Frontal ratings should ONLY be compared to other vehicles of similar
weight class.'' is currently required at the bottom of the Frontal
Crash area of the safety rating label. NHTSA is proposing that this
statement be shortened to ``Should ONLY be compared to other vehicles
of similar weight class.'' This shortened statement would be required,
as the longer statement is currently required, at the bottom of the
frontal crash area of the safety rating label. The words ``Frontal
ratings'' would be deleted because we believe consumers would realize
that the statement refers to Frontal ratings since the statement would
appear in the Frontal Crash area of the safety rating label.
Side Area
    In the current side NCAP program, NHTSA conducts side impact tests
that provide consumers with side ratings for the first and second
seating rows of a vehicle, specifically for the driver seating position
and the rear outboard seating passenger position. In the current
program, a moving deformable barrier (MDB) test is used to assess side
impact protection. Currently, side impact ratings for each seating
position are based on chest injury only.
    Changes to the side NCAP program include (1) new test dummies for
the two seating positions in the MDB test, (2) a new oblique pole test
with a small female crash test dummy in the driver position, and (3)
additional injury criteria for both the MDB and the new oblique pole
tests. As previously mentioned, the enhanced side NCAP program will
include nearly all of the FMVSS No. 214 body regions (except for the
lower spine acceleration for the small female crash test dummy) for the
calculation of the side NCAP rating. In other words, the new side
program will include, for the MDB test, head, chest, abdomen, and
pelvic injury criteria in the driver seating position and head and
pelvic injury criteria in the rear passenger seating position. The new
oblique pole test will include head and pelvic injury criteria in the
driver seating position. In summary, ratings for the new side program
will be based on (1) for the driver seating position, a combined chance
of serious injury to the head, chest, abdomen, and pelvis in an MDB
test as well as a combined chance of injury to the head and pelvis in a
side oblique pole or narrow object test, and (2) for the rear passenger
seating position, a combined chance of serious injury to the head and
pelvis in an MDB test.
    As discussed previously, an overwhelming proportion of

interviewees in a NHTSA consumer survey preferred that NHTSA provide
crash test ratings by seating position on the revised safety rating
label. Therefore, as with frontal crash ratings, it is proposed that
side crash ratings continue to be presented by seating position.
    ``Side Crash'' would still be used to describe the side crash test
ratings, and ``Front Seat'' and ``Rear Seat'' would still be used to
describe the seating positions and applicable star ratings for those
seating positions. Furthermore, as in the Frontal Crash area, NHTSA is
also proposing to shorten the statement required at the bottom of the
Side Crash area to ``Based on the risk of injury in side impact
tests.'' The words ``Star ratings'' currently required at the beginning
of this statement would be excluded for the same reason these words
would be excluded from a similar statement in the Frontal Crash area.
Also, this generic statement would allow the agency the flexibility to
update the ratings (i.e., due to additional injury criteria, an update
to FMVSS No. 214, etc.) on the label without conducting further
rulemaking.
Rollover Area
    As discussed in the July 11, 2008 final decision notice, the agency
decided to not change its current rollover test program, which uses a
vehicle's Static Stability Factor (SSF) and the results of a dynamic
rollover ``fishhook'' test, to determine the chance that a vehicle will
roll over in a single-vehicle crash and the rollover resistance rating
that results. It is proposed the term ``Rollover'' for the area of the
safety rating label for the rollover rating remain the same in the
revised safety rating label since the program is unchanged. However,
NHTSA is proposing to shorten the statement required at the bottom of
the rollover area to ``Based on the risk of rollover in a single
vehicle crash.'' As with the Frontal Crash and Side Crash areas of the
safety rating label, we are proposing to exclude the words ``Star
rating'' from this statement for the same reason given for excluding
these words from those two areas of the label.
Footer Area
    The agency has required the phrase ``Star ratings range from 1 to 5
stars ([starf][starf][starf][starf][starf]) with 5 being the highest.''
in the current general information area of the safety rating label.\7\
This statement is used not only to remind consumers that the maximum
rating is 5 stars but also to fulfill the Congressional requirement
that the graphic depiction of the vehicle rating be displayed in a
clearly differentiated fashion while also indicating the maximum
possible rating. Additionally, the text ``Source: National Highway
Traffic Safety Administration (NHTSA)'' is required to appear as the
last line in the general information area of the existing safety rating
label. This statement is used to inform consumers that the ratings are
from a government agency.
---------------------------------------------------------------------------

    \7\ The current regulatory text has a comma between the
``parenthesis'' and the word ``with'' whereas the text in the sample
label does not. The agency is proposing to revise the text as stated
in this notice to reflect the text shown in the sample label.
---------------------------------------------------------------------------

    Also on the existing safety rating label, the text
``www.safercar.gov or 1-888-327-4236'' is required to be placed in the
footer area. This information is provided not only to help consumers
identify the agency's Web site, where additional NHTSA safety
information can be found, but also to fulfill the mandate from Congress
that the safety rating label contain a reference to http://
www.safercar.gov and additional vehicle safety resources.
    Due to the proposed addition of an overall vehicle score area in
the modified safety rating label, the agency believes that for the
label to be presented in a legible, visible, and prominent fashion that
covers at least 8 percent of the total area of the Monroney label or an
area with a minimum of 4\1/2\ inches in length and 3\1/2\ inches in
height on the Monroney label, only the required rating information
should be provided in designated relevant areas (i.e., overall vehicle
score area, frontal crash area, side crash area, and rollover area). In
other words, the agency is proposing that the texts ``Star ratings
range from 1 to 5 stars ([starf][starf][starf][starf][starf]) with 5
being the highest.'' and ``Source: National Highway Traffic Safety
Administration (NHTSA)'' \8\ be shown in the footer area (instead of in
the current general information area) along with the agency's Web site
information.\9\
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    \8\ The current regulatory text does not include a period at the
end of the Source text whereas the text in the sample labels does.
The agency is proposing to revise the text shown in the sample
labels to reflect the text stated in the regulation.
    \9\ The Web site information ``http://www.safercar.gov'' will
not be shown italicized to reflect the sample label.
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    More than half of the respondents who participated in NHTSA's
consumer survey preferred that the agency's Web address, hotline
number, and source information be included in the footer area.\10\
Under this proposal, the general information area where this
information is currently displayed would be eliminated as a separate
area of the safety rating label.
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    \10\ The full study report is available at http://
www.regulations.gov in Docket No. NHTSA-2006-25772.
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Safety Concerns
    For vehicle tests for which NHTSA reports a safety concern as part
of the star rating, the regulation currently requires a symbol
consisting of an exclamation point inside a triangle (safety concern
symbol) to be depicted as a superscript to the star rating, and the
same symbol to be depicted at the bottom of the relevant area along
with the words ``Safety Concern: Visit http://www.safercar.gov or call
1-888-327-4236 for more details.'' Examples of such safety concerns are
high likelihoods of thigh injury, pelvic injury, or head injury; fuel
leakage; and door openings.
    NHTSA believes the inclusion of all of the FMVSS No. 208 body
regions in the calculation of the frontal NCAP rating and nearly all of
the FMVSS No. 214 body regions (except for the lower spine acceleration
for the small female crash test dummy) in the calculation of the side
NCAP rating will lead to more robust ratings and significantly reduce
the need to use the safety concern symbol to highlight injury related
occurrences during testing. For those injury related safety concerns
and safety concerns relating to the physical structure of a vehicle
(i.e., fuel leakage, door openings, etc.) that continue to arise, the
agency would continue to require depiction of the symbol and related
statement in the appropriate area of the safety rating label.
    We are proposing to also require, whenever a safety concern arises
in any rating category, that the safety concern symbol and related
statement be included in the overall vehicle score area of the safety
rating label as well. We believe that to not require the symbol in this
location as well as in the location containing the rating for the
testing in which the safety concern arose could diminish the effect of
having the symbol in the applicable rating category by suggesting that
the safety concern was not sufficient to have an impact on the overall
safety of the vehicle. The agency's view is that any safety concern
that arises during NCAP testing is a necessary part of the overall
picture of a vehicle's relative safety, even though the concern does
not have an impact on the rating derived from the specific testing in
which the concern arose. Since the overall vehicle score is based on
the combined ratings of the frontal crash, side crash, and rollover
tests, the agency believes that a safety concern relating to one of
these NCAP

tests should be noted in the area where the overall vehicle score is
displayed.
    NHTSA continues to believe that the types of events that trigger a
safety concern and the use of the safety concern symbol are significant
and should be communicated to consumers. Agency consumer research
indicates that consumers welcome having this information so that they
may use it in making vehicle purchasing decisions. Depiction of the
safety symbol to flag safety concerns is therefore consistent with the
overall goal of NCAP, which is to create market forces to drive
manufacturers to continually enhance the safety of the vehicles they
produce. Furthermore, the agency believes it would be inconsistent and
misleading to consumers to have a safety concern for a vehicle noted on
the agency Web site, http://www.safercar.gov, and not on the vehicle
safety label in the Monroney label.
    The agency is seeking comments and plans to conduct consumer
research into the extent to which consumers understand this approach,
or other approaches, to communicating safety concerns. Since consumers
may rely on some or all of the sections of the Monroney label to make
purchasing decisions, we seek comment on whether NHTSA's planned
follow-up consumer testing for the safety section of the label should
include all four items that might appear on the Monroney label (price,
safety, fuel economy, and domestic content) to help the agency better
understand any potential tradeoffs consumers may make among those items
and whether the amount of space dedicated to each of the four items
affects the attention consumers give the items. NHTSA also solicits
public comments on the benefits the public would receive from a
coordinated approach to any revisions of the Monroney label among the
three agencies with authority over the different sections (the
Department of Justice for price information, the Environmental
Protection Agency for fuel economy, and NHTSA for safety and domestic
content), and whether those benefits would outweigh any delays that
might occur to achieve comprehensive and coordinated revisions to parts
of the Monroney label.
    The agency is currently developing communications materials to
educate consumers about the safety ratings label, including detailed
explanations of the individual safety ratings and how those ratings
indicate the percent chance of serious injury to the occupant(s)
traveling in a vehicle that is involved in a crash. However, the agency
is seeking comments on key components of effective approaches of
communicating the safety ratings to consumers. NHTSA is particularly
interested in data to substantiate the effectiveness of recommended
approaches. The agency is also seeking comments on the current consumer
understanding of the NCAP star safety ratings and the difference
between those ratings, which range from 1 to 5 stars, and whether other
presentation formats could more effectively communicate that
information to consumers. As above, NHTSA is especially interested in
reviewing the data to support commenters' suggested alternative
approaches.

B. Crash Avoidance Technologies

    Enhancements to the existing NCAP testing programs also include the
establishment of a crash avoidance technology information program under
which the agency will indicate on the http://www.safercar.gov Web site
those vehicles equipped with certain technologies either available or
as standard equipment. To be so noted, the crash avoidance technology
of the vehicle will need to meet NHTSA performance requirements for the
technology involved.
    The agency selected three technologies that are mature enough to
include in a crash avoidance ratings program at this time. The three
technologies are electronic stability control (ESC), forward collision
warning (FCW), and lane departure warning (LDW). The agency plans to
use text and simple graphics on http://www.safercar.gov to communicate
(1) the fact that ESC, LDW, and/or FCW is available as optional or
standard equipment on vehicles and (2) that the equipment involved
meets the appropriate agency performance requirements.
    The agency has decided at this time to not include advanced
technology information in the safety rating label for the following
reasons:
     Including advanced crash avoidance technologies in the
safety rating label of the Monroney label would require that the agency
conduct a rulemaking to update the safety rating label each time that
the list of crash avoidance technologies changed.
     Available Monroney label space is limited. If information
on crash avoidance technologies were included in the new safety rating
label, the information on the safety rating label as a whole might not
be legible.
    The agency is seeking comments from the public on the approach the
agency is taking to communicate the availability of these advanced
technologies and on how these and other technologies that may arise
should be communicated in the future.

C. Notification

Current Process
    In May/June of each year, NHTSA collects information from vehicle
manufacturers to help the agency identify new vehicle models,
redesigned vehicles, and models whose design will carry-over from the
previous model year.\11\ Once the agency analyzes the information
provided, the carry-over models, new and redesigned models not being
tested, and new and redesigned models to be tested are posted on the
agency's Web site, http://www.safercar.gov.\12\
---------------------------------------------------------------------------

    \11\ Carry-over models are vehicles that have been tested under
the NCAP in previous years, and whose design has not changed,
therefore retaining the previous safety rating.
    \12\ Through carry-over and new testing, NCAP provides ratings
for approximately 85 percent of the vehicle fleet each year.
---------------------------------------------------------------------------

    At about the same time, the agency sends a letter to officially
inform each vehicle manufacturer which models the agency has determined
to be carry-over vehicles and their respective NCAP star rating(s).
NHTSA provides these letters to manufacturers as soon as a
determination is made regarding the status of the vehicles (carryover
or non-carryover) to ensure that manufacturers have the opportunity to
place NCAP star ratings on the Monroney labels of these models as soon
as they begin the new year of production.
    The agency also sends a separate letter to each vehicle
manufacturer indicating which models have been selected for NCAP
testing. Once a selected vehicle has been tested and NHTSA completes
the process of thoroughly reviewing the data generated during NCAP
testing, the agency sends a letter informing the manufacturer of the
rating(s) of the tested vehicle. The letter also informs the
manufacturer which vehicle trim lines and corporate twins will be rated
based on the results from the tested vehicle.
    Vehicles for which ratings have not been provided in one or more of
the ratings areas must have ``Not Rated'' in those areas of the safety
rating label. Vehicles that have not been tested in any of the ratings
areas and therefore do not have ratings in any ratings area may use a
smaller safety rating label described in 49 CFR 575.301. Vehicles that
are slated to be tested by NHTSA, but have not yet been tested may have
``To Be Rated'' in the various ratings areas of the safety rating label
for which testing is slated.

Model Year 2011 Process
    Due to the enhancements to the NCAP frontal and side crash test
programs, no frontal and side safety ratings of the current NCAP crash
test programs will carry-over to model year 2011 vehicles. To help
address this, the agency plans to modify its current notification
process for 2011 model year vehicles. NHTSA began collecting basic
model year 2011 vehicle information from vehicle manufacturers in
September 2009. Based on information provided by the manufacturers, the
agency will devise a preliminary model year 2011 testing schedule.
NHTSA also plans to contact vehicle manufacturers again in March 2010
and in June 2010 to help the agency to continue to identify and verify
vehicles to be tested with the upgraded frontal and side crash tests
and to ensure that initial projections of vehicle availability provided
by manufacturers still align with the agency's testing schedule.
    Once NHTSA has determined that a 2011 model year vehicle will be
tested, which could occur as early as after the initial contact with
manufacturers or as late as the last contact with manufacturers, the
agency will send a letter to officially inform each vehicle
manufacturer which 2011 model year vehicles the agency has selected for
the updated tests. Additional letters may be required to notify vehicle
manufacturers of vehicles selected for NCAP testing later in the
vehicle selection process. Once vehicles have been tested and the data
generated during the NCAP tests has been thoroughly reviewed, the
agency will send letters to manufacturers of the tested vehicles
informing them of the ratings achieved by those vehicles. As with the
current process, the letter will also inform manufacturers which trim
lines and corporate twins will get the same ratings as the vehicle
actually tested. Additionally, the ratings will be announced in a press
release and posted on the agency's Web site http://www.safercar.gov.
    The rollover NCAP program has not changed. Therefore, rollover
resistance ratings for some model year 2010 vehicles will carryover to
model year 2011 vehicles. Carryover rollover resistance ratings for
vehicles slated to be crash tested under the revised NCAP will be
posted on http://www.safercar.gov as soon as they are confirmed as
carryover ratings. This will allow consumers to continue to have access
to this information while the revised NCAP crash testing and rating
program is being rolled out. Official notification of carryover
rollover resistance ratings for these vehicles, as well as notification
of the rollover resistance ratings for non-carryover vehicles that are
selected for rollover testing, will occur at the same time
manufacturers are notified of crash ratings under the revised NCAP
crash program.
    Once the first year of testing using the revised frontal and side
crash tests is completed, the agency will resume the notification
process that the agency has followed prior to the implementation of the
enhanced crash test programs. Specifically, the vehicle information
collection process will again begin in May/June of each year. The
agency will continue to send letters to each vehicle manufacturer
indicating which models have been selected for the NCAP crash test and
other programs. The agency will send a separate letter to officially
inform each manufacturer which models the agency has determined to be
carry-over vehicles and the safety ratings that apply to those
vehicles. Letters informing manufacturers of the ratings assigned to
vehicles tested will be sent when testing and quality control of test
data has been completed.
    Since the frontal and side safety ratings of the current NCAP crash
test programs will not be carried-over to model year 2011 vehicles and
beyond, manufacturers will be required to either post ``Not Rated'' on
the Monroney label for the frontal and side crash categories until the
agency informs the manufacturer of the rating(s) that apply or post
``To Be Rated'' if the vehicle involved is slated to be tested. If
NHTSA has not released a safety rating for any category for a vehicle
and will not be performing any NCAP tests on the vehicle, the
manufacturer may use a smaller safety rating label as illustrated in
Figure 2.

D. Timing

    As in the current labeling program, the agency will require vehicle
manufacturers to place the new Government 5-Star safety ratings on the
safety rating label of the Monroney label of new vehicles manufactured
30 days after receiving from NHTSA notification of the test results.
The agency does not and will not require manufacturers to reprint
Monroney labels for vehicles that were produced prior to the agency's
notification.\13\ However, manufacturers are allowed to voluntarily re-
label vehicles, should they choose, by replacing the entire Monroney
label (not just the safety rating label with the NCAP information).
---------------------------------------------------------------------------

    \13\ The vehicle manufacturing date will be used to determine
which vehicles will be required to have the new NCAP star rating(s).
---------------------------------------------------------------------------

E. Consumer Education

    As discussed previously, new model year 2011 and later vehicles
will be subjected to the enhanced NCAP program. NHTSA realizes that
consumers could misinterpret or be confused by differences between
ratings for model year 2010 and 2011 vehicles. Even when model year
2010 and 2011 vehicles achieve the same rating, consumers may not fully
understand what this means. To address this, the agency plans to
develop an educational toolkit and work with various partners to
educate consumers about its new Government 5-Star Safety Ratings
program.

F. Compliance Date

    Under our proposal, beginning with model year 2011, passenger
vehicles that are manufactured on or after September 1, 2010, would be
required to have the new safety rating labels. The agency would allow
early compliance for model year 2011 vehicles that are manufactured
before September 1, 2010, provided the ratings placed on the safety
rating label were derived from vehicle testing conducted by the
National Highway Traffic Safety Administration that is appropriate for
model year 2011 or later vehicles.
    Some model year 2010 vehicles may continue to be manufactured after
September 1, 2010. The requirements of the existing regulation would
apply to these vehicles.
    Under our proposal, the new regulation that would apply to model
year 2011 and later vehicles manufactured on or after September 1, 2010
would be designated as Sec.  575.302. The existing regulation, with
minor conforming amendments, would continue to be at Sec.  575.301.

V. Rulemaking Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

    NHTSA has considered the impact of this proposed rule under
Executive Order 12866 and the Department of Transportation's regulatory
policies and procedures. This proposed rulemaking document was not
reviewed under E.O. 12866, ``Regulatory Planning and Review.'' This
action has been determined to be ``non-significant'' under the
Department of Transportation's regulatory policies and procedures. The
agency concludes that if this rule were made final, the impacts of the
amendments would be so minimal that preparation of a full

regulatory evaluation would not be required.
    This NPRM proposes to require vehicle manufacturers to add to the
existing safety rating label the new overall vehicle score rating the
agency has added to the NCAP program, and to make minor modifications
to the safety rating label. The agency has considered and concluded
that the one-time redesign cost and the cost of redesign to replace
``Not Rated'' or ``To Be Rated'' with stars each time a vehicle is
rated, all to be minor. The cost of the existing label is estimated to
be less than $0.15 per vehicle, and, under our proposal, the label
would remain the same size. Given these considerations, any effects on
costs would be trivial.

B. Regulatory Flexibility Act

    Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.,
as amended by the Small Business Regulatory Enforcement Fairness Act
(SBREFA) of 1996), whenever an agency is required to publish a notice
of rulemaking for any proposed or final rule, it must prepare and make
available for public comment a regulatory flexibility analysis that
describes the effect of the rule on small entities (i.e., small
businesses, small organizations, and small governmental jurisdictions).
The Small Business Administration's regulations at 13 CFR part 121
define a small business, in part, as a business entity ``which operates
primarily within the United States.'' (13 CFR 121.105(a)). No
regulatory flexibility analysis is required if the head of an agency
certifies the rule will not have a significant economic impact on a
substantial number of small entities. SBREFA amended the Regulatory
Flexibility Act to require Federal agencies to provide a statement of
the factual basis for certifying that a rule will not have a
significant economic impact on a substantial number of small entities.
    NHTSA has considered the effects of this proposed rule under the
Regulatory Flexibility Act. There are four small motor vehicle
manufacturers in the United States building vehicles that would be
affected by this rule. I certify that this proposed rule would not have
a significant economic impact on a substantial number of small
entities. The rationale for this certification is that the agency does
not believe that this proposal adds a significant economic cost to a
motor vehicle. The cost of the existing label is estimated to be less
than $0.15 per vehicle. The requirements proposed by today's document
would result in minor costs, as it would merely require redesign of
that label.

C. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.)
(PRA), a person is not required to respond to a collection of
information by a Federal agency unless the collection displays a valid
Office of Management and Budget (OMB) control number. For the following
reasons, NHTSA concludes that if made final, this rulemaking would not
impose any new collection of information requirements for which a 5 CFR
part 1320 clearance must be obtained. As described previously, this
rule, if made final, would require vehicle manufacturers to include on
the existing safety rating labels, the overall vehicle score rating
information by NCAP. This NPRM proposes how NHTSA will describe the
appearance of the label, and specify to the vehicle manufacturers, in
both individual letters to the manufacturers and on the NHTSA's
5[dash]Star safety ratings Web site (http://www.safercar.gov), the
information specific to a particular motor vehicle make and model that
the vehicle manufacturer must place on the Monroney label.
    Because, if this rule is made final, NHTSA will specify the format
of the safety rating label, and the information each vehicle
manufacturer must include on the label, this ``collection of
information'' falls within the exception described in 5 CFR
1320.3(c)(2) which states in part: ``The public disclosure of
information originally supplied by the Federal government to the
recipient for the purpose of disclosure to the public is not included
within this definition.''
    The Government 5[dash]Star safety ratings are created by NHTSA.
This rule, if made final, would require vehicle manufacturers to take
the Government 5[dash]Star safety ratings (which NHTSA will provide to
each manufacturer) and report them on the Monroney labels, thus
disclosing them to potential customers (i.e., the public). For this
reason, this proposed rule, if made final, would impose a ``collection
of information'' requirement for which 5 CFR part 1320 approval need
not be obtained.

D. National Environmental Policy Act

    NHTSA has analyzed this proposed rule for the purposes of the
National Environmental Policy Act and has determined that if made
final, the rule will not have any significant impact on the quality of
the human environment.

E. Executive Order 13132 (Federalism)

    The agency has analyzed this proposed rule in accordance with the
principles and criteria contained in Executive Order 13132 and has
determined that it does not have sufficient federalism implications to
warrant consultation with State and local officials or the preparation
of a federalism summary impact statement. If made final, this rule will
have no substantial effects on the States, on the current Federal-State
relationship, or on the current distribution of power and
responsibilities among the various local officials.

F. Civil Justice Reform

    This proposed rule would not have any retroactive effect. Parties
are not required to exhaust administrative remedies before filing suit
in court.

G. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272)
directs NHTSA to use voluntary consensus standards in regulatory
activities unless doing so would be inconsistent with applicable law or
would otherwise be impractical. Voluntary consensus standards are
technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies, such as the Society of
Automotive Engineers (SAE). The agency searched for, but did not find
any voluntary consensus standards relevant to this proposed rule.

H. Unfunded Mandates Reform Act

    This proposed rule will not impose any unfunded mandates under the
Unfunded Mandates Reform Act (UMRA) of 1995. This rule will not result
in costs of $100 million or more to either State, local, or tribal
governments, in the aggregate, or to the private sector. Thus, this
rule is not subject to the requirements of sections 202 and 205 of the
UMRA.

I. Plain Language

    Executive Order 12866 requires each agency to write all rules in
plain language. Application of the principles of plain language
includes consideration of the following questions:
     Have we organized the material to suit the public's needs?
     Are the requirements in the rule clearly stated?
     Does the rule contain technical language or jargon that is
not clear?

     Would a different format (grouping and order of sections,
use of headings, paragraphing) make the rule easier to understand?
     Would more (but shorter) sections be better?
     Could we improve clarity by adding tables, lists, or
diagrams?
     What else could we do to make this rulemaking easier to
understand?
    If you have any responses to these questions, please include them
in your comments on this NPRM.

J. Privacy Act Statement

    Anyone is able to search the electronic form of all comments or
petitions 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) or
you may visit http://www.regulations.gov.

VI. Public Participation

    We invite comments on today's proposal. We are providing a 30-day
comment period. We are not providing a longer period because there is a
need to complete rulemaking in time to allow manufacturers to make any
necessary changes in the labels for MY 2011 vehicles manufactured on or
after September 1, 2010. Moreover, we believe 30 days is sufficient,
given that the rulemaking addresses changes in an existing label to
reflect already announced changes in the NCAP Program.

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.\14\ 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.
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    \14\ See 49 CFR 553.21.
---------------------------------------------------------------------------

    Please submit your comments 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, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. Eastern
Time, Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    If you are submitting comments electronically as a PDF (Adobe)
file, we ask that the documents submitted be scanned using Optical
Character Recognition (OCR) process, thus allowing the agency to search
and copy certain portions of your submissions.\15\
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    \15\ 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.
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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.\16\
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    \16\ See 49 CFR 512.
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    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.

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. If a
comment is received too late for us to consider in developing a final
rule (assuming that one is issued), we will consider that comment as an
informal suggestion for future rulemaking action.

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 a.m. and 5 p.m. Eastern Time, Monday through
Friday, except Federal holidays.
    Please note that even after the comment closing date, we will
continue to file relevant information in the Docket as it becomes
available. Furthermore, some people may submit late comments. Thus, we
recommend that you periodically check the Docket for new material.

List of Subjects in 49 CFR Part 575

    Consumer protection, Motor vehicle safety, Reporting and
recordkeeping requirements.

    In consideration of the foregoing, NHTSA proposes to amend 49 CFR
part 575 as set forth below:

PART 575--CONSUMER INFORMATION

    1. The authority citation for part 575 continues to read as
follows:

    Authority:  49 U.S.C. 32302, 30111, 30115, 30117, 30166 and
30168, Pub. L. 104-414, 114 Stat. 1800, Pub. L. 109-59, Stat. 1144,
15 U.S.C. 1232(g); delegation of authority at 49 CFR 1.50.

    2. Section 575.301 is amended by revising the section heading and
paragraph (b) to read as follows:

Sec.  575.301  Vehicle labeling of safety rating information
(applicable unless a vehicle is subject to Sec.  575.302).

* * * * *
    (b) Application. This section applies to automobiles with a GVWR of
10,000 pounds or less, manufactured on or after September 1, 2007, that
are required by the Automobile Information Disclosure Act, 15 U.S.C.
1231-1233, to have price sticker labels (Monroney labels), e.g.
passenger vehicles, station wagons, passenger vans, and sport utility
vehicles, except for vehicles that are subject to Sec.  575.302. Model
Year 2011 or later vehicles manufactured prior to September 1, 2010
may, at the manufacturer's option, be labeled according to the
provisions of Sec.  575.302

instead of this section provided the ratings placed on the safety
rating label are derived from vehicle testing conducted by the National
Highway Traffic Safety Administration that is appropriate for Model
Year 2011 or later vehicles.
* * * * *
    3. Section 575.302 is added to read as follows:

Sec.  575.302  Vehicle labeling of safety rating information
(compliance required for model year 2011 and later vehicles
manufactured on or after September 1, 2010).

    (a) Purpose and Scope. The purpose of this section is to aid
potential purchasers in the selection of new passenger motor vehicles
by providing them with safety rating information developed by NHTSA in
its New Car Assessment Program (NCAP) testing. Manufacturers of
passenger motor vehicles described in paragraph (b) of this section are
required to include this information on the Monroney label. Although
NHTSA also makes the information available through means such as
postings at http://www.safercar.gov and http://www.nhtsa.dot.gov, the
additional Monroney label information is intended to provide consumers
with relevant information at the point of sale.
    (b) Application. This section applies to automobiles with a GVWR of
10,000 pounds or less, manufactured on or after September 1, 2010 that
are declared by their manufacturer to be model year 2011 or later
vehicles and that are required by the Automobile Information Disclosure
Act, 15 U.S.C. 1231-1233, to have price sticker labels (Monroney
labels), e.g. passenger vehicles, station wagons, passenger vans, and
sport utility vehicles. Model Year 2011 or later vehicles manufactured
prior to September 1, 2010 may, at the manufacturer's option, be
labeled according to the provisions of this Sec.  575.302 provided the
ratings placed on the safety rating label are derived from vehicle
testing conducted by the National Highway Traffic Safety Administration
that is appropriate for Model Year 2011 or later vehicles.
    (c) Definitions--(1) Monroney label means the label placed on new
automobiles with the manufacturer's suggested retail price and other
consumer information, as specified at 15 U.S.C. 1231-1233.
    (2) Safety rating label means the label with NCAP safety rating
information, as specified at 15 U.S.C. 1232(g). The safety rating label
is part of the Monroney label.
    (d) Required Label--(1) Except as specified in paragraph (f) of
this section, each vehicle must have a safety rating label that is part
of its Monroney label, meets the requirements specified in paragraph
(e) of this section, and conforms in content, format and sequence to
the sample label depicted in Figure 1 of this section. If NHTSA has not
provided a safety rating for any category of vehicle performance for a
vehicle, the manufacturer may use the smaller label specified in
paragraph (f) of this section.
    (2) The label must depict the star ratings for that vehicle as
reported to the vehicle manufacturer by NHTSA.
    (3) Whenever NHTSA informs a manufacturer in writing of a new
safety rating for a specified vehicle or the continued applicability of
an existing safety rating for a new model year, including any safety
concerns, the manufacturer shall include the new or continued safety
rating on vehicles manufactured on or after the date 30 calendar days
after receipt by the manufacturer of the information.
    (4) If, for a vehicle that has an existing safety rating for a
category, NHTSA informs the manufacturer in writing that it has
approved an optional NCAP test that will cover that category, the
manufacturer may depict vehicles manufactured on or after the date of
receipt of the information as ``Not Rated'' or ``To Be Rated'' for that
category.
    (5) The text ``Overall Vehicle Score,'' ``Frontal Crash,'' ``Side
Crash,'' ``Rollover,'' ``Driver,'' ``Passenger,'' ``Front Seat,''
``Rear Seat'' and where applicable, ``Not Rated'' or ``To Be Rated,''
the star graphic indicating each rating, as well as any text in the
header and footer areas of the label, must have a minimum font size of
12 point. All remaining text and symbols on the label (including the
star graphic specified in paragraph (e)(9)(i)(A) of this section), must
have a minimum font size of 8 point.
    (e) Required Information and Format--(1) Safety Rating Label
Border. The safety rating label must be surrounded by a solid dark line
that is a minimum of 3 points in width.
    (2) Safety Rating Label Size and Legibility. The safety rating
label must be presented in a legible, visible, and prominent fashion
that covers at least 8 percent of the total area of the Monroney label
(i.e., including the safety rating label) or an area with a minimum of
4\1/2\ inches in length and 3\1/2\ inches in height on the Monroney
label, whichever is larger.
    (3) Heading Area. The words ``Government 5-Star Safety Ratings''
must be in boldface, capital letters that are light in color and
centered The background must be dark.
    (4) Overall Vehicle Score Area. (i) The overall vehicle score area
must be placed immediately below the heading area and must have dark
text and a light background. The overall vehicle score rating must be
displayed with the maximum star rating achieved.
    (ii) The words ``Overall Vehicle Score'' must be in boldface
aligned to the left side of the label. The achieved star rating must be
on the same line, aligned to the right side of the label.
    (iii) The words ``Based on the combined ratings of frontal, side
and rollover.'', followed (on the next line) by the statement ``Should
ONLY be compared to other vehicles of similar weight class.'' must be
placed at the bottom of the overall vehicle score area.
    (iv) If NHTSA has not released the star rating for the ``Frontal
Crash,'' ``Side Crash,'' or ``Rollover'' area, the text ``Not Rated''
must be used in boldface. However, as an alternative, the words ``To Be
Rated'' (in boldface) may be used if the manufacturer has received
written notification from NHTSA that the vehicle has been chosen for
the NCAP frontal, side, and/or rollover testing such that there will be
ratings in all three areas.
    (5) Frontal Crash Area. (i) The frontal crash area must be placed
immediately below the overall vehicle score area, separated by a dark
line that is a minimum of three points in width. The text must be dark
against a light background. Both the driver and the right front seat
passenger frontal crash test ratings must be displayed with the maximum
star ratings achieved.
    (ii) The words ``Frontal Crash'' must be in boldface, cover two
lines, and be aligned to the left side of the label.
    (iii) The word ``Driver'' must be on the same line as the word
``Frontal'' in ``Frontal Crash,'' and be left justified, horizontally
centered and vertically aligned at the top of the label. The achieved
star rating for ``Driver'' must be on the same line, left justified,
and aligned to the right side of the label.
    (iv) If NHTSA has not released the star rating for the ``Driver''
position, the text ``Not Rated'' must be used in boldface. However, as
an alternative, the words ``To Be Rated'' (in boldface) may be used if
the manufacturer has received written notification from NHTSA that the
vehicle has been chosen for NCAP testing. Both texts must be on the
same line as the text ``Driver'', left justified, and aligned to the
right side of the label.
    (v) The word ``Passenger'' must be on the same line as the word
``Crash'' in ``Frontal Crash,'' below the word ``Driver,'' and be left
justified, horizontally centered and vertically aligned at the top of
the label. The

achieved star rating for ``Passenger'' must be on the same line, left
justified, and aligned to the right side of the label.
    (vi) If NHTSA has not released the star rating for ``Passenger,''
the words ``Not Rated'' must be used in boldface. However, as an
alternative, the words ``To Be Rated'' (in boldface) may be used if the
manufacturer has received written notification from NHTSA that the
vehicle has been chosen for NCAP testing. Both texts must be on the
same line as the text ``Passenger'', left justified, and aligned to the
right side of the label.
    (vii) The words ``Based on the risk of injury in a frontal
impact.'', followed (on the next line) by the statement ``Should ONLY
be compared to other vehicles of similar weight class.'' must be placed
at the bottom of the frontal crash area.
    (6) Side Crash Area. (i) The side crash area must be immediately
below the frontal crash area, separated by a dark line that is a
minimum of three points in width. The text must be dark against a light
background. Both the driver and the rear seat passenger side crash test
rating must be displayed with the maximum star rating achieved.
    (ii) The words ``Side Crash'' must cover two lines, and be aligned
to the left side of the label in boldface.
    (iii) The words ``Front seat'' must be on the same line as the word
``Side'' in ``Side Crash'' and be left justified, horizontally centered
and vertically aligned in the middle of the label. The achieved star
rating for ``Front seat'' must be on the same line, left justified, and
aligned to the right side of the label.
    (iv) If NHTSA has not released the star rating for ``Front Seat,''
the words ``Not Rated'' must be used in boldface. However, as an
alternative, the words ``To Be Rated'' (in boldface) may be used if the
manufacturer has received written notification from NHTSA that the
vehicle has been chosen for NCAP testing. Both texts must be on the
same line as the text ``Front seat'', left justified, and aligned to
the right side of the label.
    (v) The words ``Rear seat'' must be on the same line as the word
``Crash'' in ``Side Crash,'' below the word ``Front seat,'' and be left
justified, horizontally centered and vertically aligned in the middle
of the label. The achieved star rating for ``Rear seat'' must be on the
same line, left justified, and aligned to the right side of the label.
    (vi) If NHTSA has not released the star rating for ``Rear Seat,''
the text ``Not Rated'' must be used in boldface. However, as an
alternative, the text ``To Be Rated'' (in boldface) may be used if the
manufacturer has received written notification from NHTSA that the
vehicle has been chosen for NCAP testing. Both texts must be on the
same line as the text ``Rear seat'', left justified, and aligned to the
right side of the label.
    (vii) The words ``Based on the risk of injury in side impact
tests.'' must be placed at the bottom of the side crash area.
    (7) Rollover Area. (i) The rollover area must be immediately below
the side crash area, separated by a dark line that is a minimum of
three points in width. The text must be dark against a light
background. The rollover test rating must be displayed with the maximum
star rating achieved.
    (ii) The word ``Rollover'' must be aligned to the left side of the
label in boldface. The achieved star rating must be on the same line,
aligned to the right side of the label.
    (iii) If NHTSA has not tested the vehicle, the words ``Not Rated''
must be used in boldface. However, as an alternative, the words ``To Be
Rated'' (in boldface) may be used if the manufacturer has received
written notification from NHTSA that the vehicle has been chosen for
NCAP testing. Both texts must be on the same line as the text
``Rollover'', left justified, and aligned to the right side of the
label.
    (iv) The words ``Based on the risk of rollover in a single vehicle
crash.'' must be placed at the bottom of the rollover area.
    (8) Graphics. The star graphic is depicted in Figure 3 and the
safety concern graphic is depicted in Figure 4.
    (9) Footer Area. The footer area must be placed at the bottom of
the label; the text must be in boldface letters that are light in
color, and be centered. The background must be dark. The text must
state the following, in the specified order, on separate lines:
    (i) '' Star ratings range from 1 to 5 stars
([starf][starf][starf][starf][starf]) with 5 being the highest.''
    (ii) ``Source: National Highway Traffic Safety Administration
(NHTSA)''
    (iii) ``www.safercar.gov or 1-888-327-4236''
    (10) Safety Concern. For vehicle tests for which NHTSA reports a
safety concern as part of the safety rating, and for overall vehicle
scores that are derived from vehicle tests for at least one of which
NHTSA reports a safety concern as part of the safety rating, the label
must:
    (i) Depict, as a superscript to the star rating, the related
symbol, as depicted in Figure 4 of this section, at \2/3\ the font size
of the base star, and
    (ii) Include at the bottom of the relevant area (i.e., overall
vehicle score area, frontal crash area, side crash area, rollover area)
as the last line of that area, in no smaller than 8 point type, the
related symbol, as depicted in Figure 4 of this section, as a
superscript of the rest of the line, and the text ``Safety Concern:
Visit http://www.safercar.gov or call 1-888-327-4236 for more
details.''
    (11) No additional information may be provided in the safety rating
label area. The specified information provided in a language other than
English is not considered to be additional information.
    (f) Smaller Safety Rating Label for Vehicles With No Ratings. (1)
If NHTSA has not released a safety rating for any category for a
vehicle, the manufacturer may use a smaller safety rating label that
meets paragraphs (f)(2) through (f)(5) of this section. A sample label
is depicted in Figure 2.
    (2) The label must be at least 4\1/2\ inches in width and 1\1/2\
inches in height, and must be surrounded by a solid dark line that is a
minimum of 3 points in width.
    (3) Heading Area. The text must read ``Government 5-Star Safety
Ratings'' and be in 14-point boldface, capital letters that are light
in color, and be centered. The background must be dark.
    (4) General Information. The general information area must be below
the header area. The text must be dark and the background must be
light. The text must state the following, in at least 12-point font, be
left-justified, and aligned to the left side of the label: ``This
vehicle has not been rated by the government for overall vehicle score,
frontal crash, side crash, or rollover risk.''
    (5) Footer Area. The footer area must be placed at the bottom of
the label; the text must be in 12-point boldface letters that are light
in color, and be centered. The background must be dark. The text must
state the following, in the specified order, on separate lines:
    (i) ``Source: National Highway Traffic Safety Administration
(NHTSA)'' and
    (ii) ``http://www.safercar.gov or 1-888-327-4236''.
    (6) No additional information may be provided in the smaller safety
rating label area. The specified information provided in a language
other than English is not considered to be additional information.
    (g) Labels for alterers. (1) If, pursuant to 49 CFR 567.7, a person
is required to affix a certification label to a vehicle, and the
vehicle has a safety rating label with one or more safety ratings, the
alterer must also place another label on that vehicle as specified in
this paragraph.
    (2) The additional label (which does not replace the one required
by 49 CFR 567.7) must read: ``This vehicle has been altered. The stated
star ratings on the safety rating label may no longer be applicable.''

    (3) The label must be placed adjacent to the Monroney label or as
close to it as physically possible.
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    Issued on: March 3, 2010.
Stephen R. Kratzke,
Associate Administrator For Rulemaking.
[FR Doc. 2010-4867 Filed 3-8-10; 8:45 am]
BILLING CODE 4910-59-P