After FDA approval of an initial plan, a supplement to the approved
plan should be submitted to FDA and approved before making changes to
the random and equal display or distribution of required warning
statements on packages or the quarterly rotation of required warning
statements in advertisements. For a new brand, a new plan or a
supplement to an FDA-approved plan would be required to be submitted
and approved before displaying or distributing packages and
advertisements for that new brand.
    However, in lieu of a supplement to an FDA-approved plan for a new
brand, manufacturers may reference in their initial plan all brands in
their product listing(s) under section 905(i) of the FD&C Act and
incorporate any new brands into their approved plan, so long as no
other changes are made to the plan. For retailer-generated advertising,
retailers may list ``all brands'' in their plan, which would cover
future brands, so long as the plan provides for the same schedule for
quarterly rotation of the required warning statements for all brands.
    FDA intends to allow electronic submissions, via FDA's Electronic
Submissions Gateway, and written submissions. FDA strongly encourages
electronic submission to facilitate efficiency and timeliness of
submission and processing.
    For each brand of cigarettes, the plan for packaging should explain
how: Each of the warnings will be randomly displayed during each 12-
month period on each brand; each of the warnings will be displayed in
as equal a number of times as possible on each brand of the product;
and product packages will be randomly and equally distributed in all
areas of the United States in which the product is marketed. FDA
expects that a plan for random and equal display and distribution of
warnings on packages will ordinarily be based on the date of
manufacture or shipment of the product. For each cigarette brand, the
plan for advertising should explain how the required warning statements
will be rotated quarterly in advertisements and how the quarterly
rotations will occur in alternating sequence. Among other things, the
plan should specify the initial rotation timeframe on which quarterly
rotation is based and, if the rotation timeframe varies for different
types/forms of advertising, specify the different quarterly timeframes
associated with the different types/forms of advertising, and describe
the quarterly schedule for rotating each of the required warnings for
each cigarette

brand. FDA would not consider a plan that merely restated the
regulatory requirements to be sufficiently detailed to enable FDA to
approve the plan.
    FDA's review of a plan would only be for determining compliance
with the regulatory criteria for approval of a plan, as set forth in
proposed Sec.  1140.10(g)(1) and (2). FDA requests that plans submitted
for review include representative samples of packages and
advertisements with each of the required warning statements. Such
samples would place the plan in context and, therefore, facilitate
FDA's review of the plan, not a review of the content of the package
labels and advertisements. Approval of a plan does not represent a
determination by FDA that any package or advertisement complies with
any of the other requirements regarding the placement, font type, size,
and color of the warnings found in section 4 of the FCLAA and proposed
part 1141, or any other requirements under the FD&C Act and its
implementing regulations. FDA intends to communicate the approval of a
plan with a letter to the submitter. After FDA approval of an initial
plan, a supplement to the approved plan would need to be submitted to
FDA for review and approved before making changes to the display or
distribution of required warnings on packages or the rotation of
required warning statements in advertisements. For a new brand, a new
plan or a supplement to an approved plan would need to be submitted and
approved before displaying or distributing packages and advertisements
for that new brand. However, in lieu of a supplement to an approved
plan for a new brand, manufacturers may reference in their initial plan
all brands in their product listing(s) under section 905(i) of the FD&C
Act and incorporate any new brands into their approved plan, so long as
no other changes are made to the plan. For retailer-generated
advertising, retailers may list ``all brands'' in their plan, which
would cover future brands, so long as the plan provides for the same
schedule for quarterly rotation of the required warning statements for
all brands.

                                Table 5--Estimated One-Time Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
          Type of plan               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Initial Plans...................              59               1              59             150           8,850
Supplements.....................              30               1              30              75           2,250
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          11,100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimates are based on FDA's experience with information
collections for other tobacco product plans (i.e., smokeless OMB
control number 0910-0671 and cigars OMB control number 0910-0768) and
2017 Treasury Alcohol and Tobacco Tax and Trade Bureau (TTB) data.
    As discussed in the preliminary regulatory impact analysis (see
section XII; Ref. 220), based on 2017 TTB data FDA estimates 59
entities will be affected by the rule. We estimate these 59 entities
will submit a one-time initial plan, and it will take an average of 150
hours per respondent to prepare and submit a plan for packaging and
advertising for a total of 8,850 hours. We estimate that about half of
respondents will submit a supplement. If a supplement to an approved
plan is submitted, FDA estimates it will take half the time per
response. We estimate receiving 30 supplements at 75 hours per response
for a total of 2,250 hours. FDA estimates that the total hours for
submitting initial plans and supplements will be 11,100.
    Proposed Sec.  1141.10(g)(4) would establish that each tobacco
product manufacturer required to randomly and equally display and
distribute warnings on packaging or quarterly rotate warnings on
advertisements in accordance with an FDA-approved plan under section 4
of the FCLAA and this proposed part must maintain a copy of the FDA-
approved plan (approved under proposed Sec.  1141.10(g)(3)). This copy
(or record) of such FDA-approved plan must be available for inspection
and copying by officers or employees of FDA. This proposed subsection
would require that the record(s) be retained for a period of not less
than 4 years from the date of FDA's approval of the plan.

                               Table 6--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
          Plan records               Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Records.........................              59             1.5              89               3             267
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             267
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that 59 recordkeepers will keep a total of about 89
records at 2 hours per record for a total of 267 hours. As stated
previously, these estimates are based on FDA's experience with
information collections for other tobacco product plans (i.e.,
smokeless OMB control number 0910-0671 and cigars OMB control number
0910-0768). Based on our estimates for the submission of initial plans
and supplements (that all respondents will submit initial plans and
about half of respondents will submit supplements), we estimate that
each recordkeeper will keep an average of 1.5 records.
    FDA estimates that the total burden for this information collection
is 11,367 hours (11,100 reporting + 267 recordkeeping).
    FDA believes that the proposed required warnings for cigarette
packages and cigarette advertisements in proposed Sec.  1141.10 are not
subject to

review by OMB under the PRA because they do not constitute a
``collection of information'' under that statute (44 U.S.C. 3501-3520).
Rather, these labeling statements are a ``public disclosure'' of
information originally supplied by the Federal Government to the
recipient for the purpose of ``disclosure to the public'' (5 CFR
1320.3(c)(2)).
    To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB or emailed to<EMAIL_ADDRESS>(see ADDRESSES). All comments should be identified with the title of
the information collection.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), the Agency has submitted the information collection
provisions of this proposed rule to OMB for review. These requirements
will not be effective until FDA obtains OMB approval. FDA will publish
a notice concerning OMB approval of these requirements in the Federal
Register.

XV. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132 and seek input from State
and local officials on potential federalism impacts of the proposed
regulation. Section 4(a) of the Executive Order requires agencies to
``construe . . . a Federal statute to preempt State law only where the
statute contains an express preemption provision or there is some other
clear evidence that the Congress intended preemption of State law, or
where the exercise of State authority conflicts with the exercise of
Federal authority under the Federal statute.'' This rule is being
proposed under section 4 of the FCLAA, as amended by the Tobacco
Control Act, and sections 701, 704, 903, 905(g), and 909 of the FD&C
Act, as amended by the Tobacco Control Act. Federal law includes an
express preemption provision that preempts any requirement, except
pursuant to the Tobacco Control Act, for a ``statement relating to
smoking and health, other than the statement required by section 4 of
[FCLAA], . . . on any cigarette package.'' Section 5(a) of the FCLAA.
It also includes an express preemption provision that preempts any
``requirement or prohibition based on smoking and health . . . imposed
under State law with respect to the advertising or promotion of any
cigarettes the packages of which are labeled in conformity with the
provisions of [FCLAA],'' which includes section 4 of the FCLAA. Section
5(b) of the FCLAA. However, section 5(b) of the FCLAA does not preempt
any State or local statutes and regulations based on smoking and
health, that take effect after June 22, 2009, imposing specific bans or
restrictions on the time, place, and manner, but not content, of the
advertising or promotion of any cigarettes. Section 5(c) of the FCLAA.
    In addition, section 916(a)(2) of the FD&C Act (21 U.S.C. 387p)
expressly preempts any state or local requirement which is different
from, or in addition to, any requirement under Chapter IX of the FD&C
Act relating to, among other things, misbranding and labeling. This
express preemption provision, however, does not apply to requirements
relating to among other things the sale, distribution, access to, or
the advertising and promotion of tobacco products.

XVI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.

XVII. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

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List of Subjects in 21 CFR Part 1141

    Advertising, Incorporation by reference, Labeling, Packaging and
containers, Tobacco, Smoking.

    Therefore, under the Federal Cigarette Labeling and Advertising
Act, the Federal Food, Drug, and Cosmetic Act, and under authority
delegated to the Commissioner of Food and Drugs, the Food and Drug
Administration proposes to revise 21 CFR part 1141 to read as follows:

PART 1141--REQUIRED WARNINGS FOR CIGARETTE PACKAGES AND
ADVERTISEMENTS

Subpart A--General Provisions
Sec.
1141.1 Scope.
1141.3 Definitions.
1141.5 Incorporation by reference.
Subpart B--Required Warnings for Cigarette Packages and Advertisements
1141.10 Required warnings.
1141.12 Misbranding of cigarettes.

    Authority: 15 U.S.C. 1333; 21 U.S.C. 371, 374, 387c, 387e, 387i;
Secs. 201 and 202, Pub. L. 111-31, 123 Stat. 1776.

Subpart A--General Provisions

Sec.  1141.1  Scope.

    (a) This part sets forth the requirements for the display of
required warnings on cigarette packages and in advertisements for
cigarettes.
    (b) The requirements of this part do not apply to manufacturers or
distributors of cigarettes that do not manufacture, package, or import
cigarettes for sale or distribution within the United States.
    (c) A cigarette retailer will not be in violation of Sec.  1141.10
for packaging that:
    (1) Contains a warning;
    (2) Is supplied to the retailer by a license- or permit-holding
tobacco product manufacturer, or distributor; and
    (3) Is not altered by the retailer in a way that is material to the
requirements of section 4 of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1333) or this part.
    (d) Section 1141.10(d) applies to a cigarette retailer only if that
retailer is responsible for or directs the warnings required under
Sec.  1141.10 for advertising. However, this paragraph (d) does not
relieve a retailer of liability if the retailer displays, in a location
open to the public, an advertisement that does not contain a warning or
has been altered by the retailer in a way that is material to the
requirements of section 4 of the Federal Cigarette Labeling and
Advertising Act or this part.

Sec.  1141.3  Definitions.

    For purposes of this part:
    Cigarette means--
    (1) Any roll of tobacco wrapped in paper or in any substance not
containing tobacco; and
    (2) Any roll of tobacco wrapped in any substance containing tobacco
which, because of its appearance, the type of tobacco used in the
filler, or its packaging and labeling, is likely to be offered to, or
purchased by, consumers as a cigarette described in paragraph (1) of
this definition.
    Commerce means:
    (1) Commerce between any State, the District of Columbia, the
Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa,
Wake Island, Midway Islands, Kingman Reef, or Johnston Island and any
place outside thereof;
    (2) Commerce between points in any State, the District of Columbia,
the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American
Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island,
but through any place outside thereof; or
    (3) Commerce wholly within the District of Columbia, Guam, the
Virgin Islands, American Samoa, Wake Island, Midway Island, Kingman
Reef, or Johnston Island.
    Distributor means any person who furthers the distribution of
cigarettes, whether domestic or imported, at any point from the
original place of manufacture to the person who sells or distributes
the product to individuals for personal consumption. Common carriers
are not considered distributors for the purposes of this part.
    Front panel and rear panel mean the two largest sides or surfaces
of the package.
    Manufacturer means any person, including any repacker or relabeler,
who manufactures, fabricates, assembles, processes, or labels a
finished cigarette product; or imports any cigarette that is intended
for sale or distribution to consumers in the United States.
    Package or packaging means a pack, box, carton, or container of any
kind in which cigarettes are offered for sale, sold, or otherwise
distributed to consumers.
    Person means an individual, partnership, corporation, or any other
business or legal entity.
    Retailer means any person who sells cigarettes to individuals for
personal consumption, or who operates a facility where vending machines
or self-service displays of cigarettes are permitted.
    United States, when used in a geographical sense, includes the
several States, the District of Columbia, the Commonwealth of Puerto
Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway
Islands, Kingman Reef, and Johnston Island. The term ``State'' includes
any political division of any State.

Sec.  1141.5  Incorporation by reference.

    (a) Certain material titled ``Required Cigarette Health Warnings,''
appearing in Sec.  1141.10, is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1

CFR part 51. All approved material is available for inspection at U.S.
Food and Drug Administration, Division of Dockets Management, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available from the
source listed in paragraph (b) of this section. It is also available
for inspection at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    (b) Center for Tobacco Products, U.S. Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993; 1-888-463-6332.
    (1) ``Required Cigarette Health Warnings''
    (2) [Reserved]

Subpart B--Required Warnings for Cigarette Packages and
Advertisements

Sec.  1141.10  Required warnings.

    (a) A required warning must include the following:
    (1) One of the following textual warning label statements:
    (i) WARNING: Tobacco smoke can harm your children.
    (ii) WARNING: Tobacco smoke causes fatal lung disease in
nonsmokers.
    (iii) WARNING: Smoking causes age-related macular degeneration,
which can lead to blindness.
    (iv) WARNING: Smoking causes type 2 diabetes, which raises blood
sugar.
    (v) WARNING: Smoking reduces blood flow to the limbs, which can
require amputation.
    (vi) WARNING: Smoking causes cataracts, which can lead to
blindness.
    (vii) WARNING: Smoking causes bladder cancer, which can lead to
bloody urine.
    (viii) WARNING: Smoking reduces blood flow, which can cause
erectile dysfunction.
    (ix) WARNING: Smoking causes head and neck cancer.
    (x) WARNING: Smoking can cause heart disease and strokes by
clogging arteries.
    (xi) WARNING: Smoking during pregnancy stunts fetal growth.
    (xii) WARNING: Smoking causes COPD, a lung disease that can be
fatal.
    (2) A color graphic to accompany the textual warning label
statement.
    (b) Each required warning, comprising a combination of a textual
warning label statement and its accompanying color graphic, must be
obtained and accurately reproduced as specified from the electronic
files contained in ``Required Cigarette Health Warnings,'' which is
incorporated by reference at Sec.  1141.5.
    (c) It is unlawful for any person to manufacture, package, sell,
offer to sell, distribute, or import for sale or distribution within
the United States any cigarettes unless the package of which bears a
required warning in accordance with section 4 of the Federal Cigarette
Labeling and Advertising Act and this part.
    (1) The required warning must appear directly on the package and
must be clearly visible underneath any cellophane or other clear
wrapping.
    (2) The required warning must comprise at least the top 50 percent
of the front and rear panels; provided, however, that on cigarette
cartons, the required warning must be located on the left side of the
front and rear panels of the carton and must comprise at least the left
50 percent of these panels.
    (3) The required warning must be positioned such that the text of
the required warning and the other information on that panel of the
package have the same orientation.
    (d) It is unlawful for any manufacturer, distributor, or retailer
of cigarettes to advertise or cause to be advertised within the United
States any cigarette unless each advertisement bears a required warning
in accordance with section 4 of the Federal Cigarette Labeling and
Advertising Act and this part.
    (1) For print advertisements and other advertisements with a visual
component (including, for example, advertisements on signs, retail
displays, internet web pages, digital platforms, mobile applications,
and email correspondence), the required warning must appear directly on
the advertisement.
    (2) The required warning must comprise at least 20 percent of the
area of the advertisement in a conspicuous and prominent format and
location at the top of each advertisement within the trim area, if any.
    (3) The text in each required warning must be in the English
language, except as follows:
    (i) In the case of an advertisement that appears in a non-English
medium, the text in the required warning must appear in the predominant
language of the medium whether or not the advertisement is in English;
and
    (ii) In the case of an advertisement that appears in an English
language medium but that is not in English, the text in the required
warning must appear in the same language as that principally used in
the advertisement.
    (4) For English-language and Spanish-language warnings, each
required warning must be obtained from the electronic files contained
in ``Required Cigarette Health Warnings,'' which is incorporated by
reference at Sec.  1141.5, and must be accurately reproduced as
specified in ``Required Cigarette Health Warnings.''
    (5) For non-English-language warnings, other than Spanish-language
warnings, each required warning must be obtained from the electronic
files contained in ``Required Cigarette Health Warnings,'' which is
incorporated by reference at Sec.  1141.5, and must be accurately
reproduced as specified in ``Required Cigarette Health Warnings,''
including the substitution and insertion of a true and accurate
translation of the textual warning label statement in place of the
English language version. The inserted textual warning label statement
must comply with the requirements of section 4 of the Federal Cigarette
Labeling and Advertising Act, including area and other formatting
requirements, and this part.
    (e) The required warnings must be indelibly printed on or
permanently affixed to the package or advertisement. These warnings,
for example, must not be printed or placed on a label affixed to a
clear outer wrapper that is likely to be removed to access the product
within the package.
    (f) No person may manufacture, package, sell, offer for sale,
distribute, or import for sale or distribution within the United States
cigarettes whose packages or advertisements are not in compliance with
section 4 of the Federal Cigarette Labeling and Advertising Act and
this part, except as provided by Sec.  1141.1(c) and (d).
    (g)(1) Random display. The required warnings for packages specified
in paragraph (a) of this section must be randomly displayed in each 12-
month period, in as equal a number of times as is possible on each
brand of the product and be randomly distributed in all areas of the
United States in which the product is marketed in accordance with a
plan submitted by the tobacco product manufacturer, distributor, or
retailer to, and approved by, the Food and Drug Administration.
    (2) Rotation. The required warnings for advertisements specified in
paragraph (a) of this section must be rotated quarterly in alternating
sequence in advertisements for each brand of cigarettes in accordance
with a plan submitted by the tobacco product manufacturer, distributer,
retailer to, and approved by, the Food and Drug Administration.
    (3) Review. The Food and Drug Administration will review each plan

submitted under this section and approve it if the plan:
    (i) Will provide for the equal distribution and display on
packaging and the rotation required in advertising under this
subsection; and
    (ii) Assures that all of the labels required under this section
will be displayed by the tobacco product manufacturer, distributor, or
retailer at the same time.
    (4) Record retention. Each tobacco product manufacturer required to
randomly and equally display and distribute warnings on packaging or
rotate warnings in advertisements in accordance with an FDA-approved
plan under section 4 of the Federal Cigarette Labeling and Advertising
Act and this part must maintain a copy of such FDA-approved plan and
make it available for inspection and copying by officers or employees
duly designated by the Secretary of Health and Human Services. The FDA-
approved plan must be retained while in effect and for a period of not
less than 4 years from the date it was last in effect.

Sec.  1141.12  Misbranding of Cigarettes.

    (a) A cigarette will be deemed to be misbranded under section
903(a)(1) of the Federal Food, Drug, and Cosmetic Act if its package
does not bear one of the required warnings in accordance with section 4
of the Federal Cigarette Labeling and Advertising Act and this part. A
cigarette will be deemed to be misbranded under section 903(a)(7)(A) of
the Federal Food, Drug, and Cosmetic Act if its advertising does not
bear one of the required warnings in accordance with section 4 of the
Federal Cigarette Labeling and Advertising Act and this part.
    (b) A cigarette advertisement and other descriptive printed matter
issued or caused to be issued by the manufacturer, packer, or
distributor will be deemed to include a brief statement of relevant
warnings for the purposes of section 903(a)(8) of the Federal Food,
Drug, and Cosmetic Act if it bears one of the required warnings in
accordance with section 4 of the Federal Cigarette Labeling and
Advertising Act and this part. A cigarette distributed or offered for
sale in any State shall be deemed to be misbranded under section
903(a)(8) of the Federal Food, Drug, and Cosmetic Act unless the
manufacturer, packer, or distributor includes in all advertisements and
other descriptive printed matter issued or caused to be issued by the
manufacturer, packer, or distributor with respect to the cigarette one
of the required warnings in accordance with section 4 of the Federal
Cigarette Labeling and Advertising Act and this part.

    Dated: July 24, 2019.
Norman E. Sharpless,
Acting Commissioner of Food and Drugs.
    Dated: August 9, 2019.
Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services.
[FR Doc. 2019-17481 Filed 8-15-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 19, 2010 (Volume 75, Number 74)]
[Notices]
[Page 20423-20425]
[DOCID:fr19ap10-108]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2010-0041; Notice 1]

Fuji Heavy Industries USA, Inc., Receipt of Petition for Decision
of Inconsequential Noncompliance

    Fuji Heavy Industries USA, Inc. (Fuji), on behalf of Subaru of
America, Inc.,

and Fuji Heavy Industries, Ltd., has determined that the front
passenger airbag suppression status telltale in some 2010 Subaru Legacy
passenger car and Outback multipurpose vehicle models, manufactured
from the start of their 2010 model year production \1\ through June 30,
2009, did not comply with paragraph S19.2.2 of 49 CFR 571.208, Federal
Motor Vehicle Safety Standard (FMVSS) No. 208, Occupant Crash
Protection. Fuji estimates that less than 1 percent (0.8%) or about 27
out of a total of 3,405 vehicles potentially involved have the
noncompliance.\2\ Fuji has filed an appropriate report pursuant to 49
CFR Part 573, Defect and Noncompliance Responsibility and Reports.
---------------------------------------------------------------------------

    \1\ On April 8, 2010, Fuji provided the actual start of
production dates. The start of production for the subject Subaru
Legacy passenger cars was June 1, 2009, and the start of production
date for the subject Outback multipurpose passenger vehicles was
June 15, 2009.
    \2\ The estimate of a less than one percent frequency rate for
the noncompliance was based on Fuji's inspection of approximately
5,400 vehicles on July 2-10, 2009, at their Subaru Automotive
Indiana plant after the noncompliance was discovered. Of this total,
the Company found 45 models with the noncompliance, or about 0.8% of
the inspected vehicles.
---------------------------------------------------------------------------

    Pursuant to 49 U.S.C. 30118(d) and 30120(h), Fuji has petitioned
for an exemption from the notification and remedy requirements of 49
U.S.C. Chapter 301 on the basis that this noncompliance is
inconsequential to motor vehicle safety.
    This notice of receipt of Fuji's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    Fuji estimated that 3,405 \3\ 2010 Legacy passenger cars and
Outback multipurpose passenger vehicles, produced at the Company's
Subaru Automotive Indiana plant between the start of model year 2010
production through June 30, 2009, are involved. Fuji also estimated
that 0.8% of those 3,405 have the subject noncompliance.
---------------------------------------------------------------------------

    \3\ Fuji's petition, which was filed under 49 CFR Part 556,
requests an agency decision to exempt Fuji as importer from the
notification and recall responsibilities of 49 CFR Part 573 for
3,405 vehicles manufactured prior to July 1, 2009. However, the
agency cannot relieve Fuji distributors of the prohibitions on the
sale, offer for sale, or introduction or delivery for introduction
into interstate commerce of any of the subject vehicles under their
control after Fuji recognized that the subject noncompliance
existed. Those vehicles must be brought into conformance, exported,
or destroyed.
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    Paragraph S19.2.2 of FMVSS No. 208 requires:

    S19.2.2 The vehicle shall be equipped with at least one telltale
which emits light whenever the passenger air bag system is
deactivated and does not emit light whenever the passenger air bag
system is activated, except that the telltale(s) need not illuminate
when the passenger seat is unoccupied. Each telltale:
    (a) Shall emit yellow light;
    (b) Shall have the identifying words ``PASSENGER AIR BAG OFF''
or ``PASS AIR BAG OFF'' on the telltale or within 25 mm (1.0 in) of
the telltale; and
    (c) Shall not be combined with the readiness indicator required
by S4.5.2 of this standard.
    (d) Shall be located within the interior of the vehicle and
forward of and above the design H-point of both the driver's and the
right front passenger's seat in their forwardmost seating positions
and shall not be located on or adjacent to a surface that can be
used for temporary or permanent storage of objects that could
obscure the telltale from either the driver's or right front
passenger's view, or located where the telltale would be obscured
from the driver's view if a rear-facing child restraint listed in
appendix A or A-1, as appropriate, is installed in the right front
passenger's seat.
    (e) Shall be visible and recognizable to a driver and right
front passenger during night and day when the occupants have adapted
to the ambient light roadway conditions.
    (f) Telltales need not be visible or recognizable when not
activated.
    (g) Means shall be provided for making telltales visible and
recognizable to the driver and right front passenger under all
driving conditions. The means for providing the required visibility
may be adjustable manually or automatically, except that the
telltales may not be adjustable under any driving conditions to a
level that they become invisible or not recognizable to the driver
and right front passenger.
    (h) The telltale must not emit light except when the passenger
air bag is turned off or during a bulb check upon vehicle starting.

    Fuji explained that the noncompliance is that front passenger
airbag suppression status telltale lamp did not illuminate as required
by paragraph S19.2.2 of FMVSS No. 208. Fuji expressed the belief that
the cause of the noncompliance is an open circuit in the power supply
to the lamp. The Company said that ``installation of the wiring harness
to the multifunction display and passenger airbag suppression status
telltale was routed at the instrument panel subsupplier such that
tension was put on the wiring harness connector'' which can cause it to
come loose. To correct this problem, the Company has re-routed the
wiring harness to ``push'' rather than ``pull'' on the wiring harness
connector in vehicles manufactured after July 10, 2009.
    The noncompliance was discovered on July 1, 2009, at the Company's
Subaru Indiana plant during a quality inspection process that revealed
a number of multi-function displays that did not illuminate and further
inspection revealed that this also affected the front passenger airbag
suppression status telltale.\4\
---------------------------------------------------------------------------

    \4\ The 2010 Subaru Legacy and Outback models' telltale has both
an air bag suppression status indicator for ON and OFF. Thus, either
ON or OFF on the telltale should be illuminated whenever the
ignition is on.
---------------------------------------------------------------------------

    On July 10, 2009, Fuji completed the inspection of 5,400 of its
vehicles awaiting shipment and corrected the noncompliance of 45
vehicles by ``pushing tight'' the harness connector. In addition,
Subaru of America, Inc. notified its U.S. dealers and distributors on
July 16, 2009, and included complete repair instructions for vehicles
in their inventory which had not been inspected or repaired prior to
shipment from the Company.
    Fuji believes that the noncompliance is inconsequential to motor
vehicle safety. Fuji argues that:

    Based on the inspection of approximately 5,400 vehicles still at
Subaru Automotive Indiana and a finding that the wiring harness
connector to the front passenger airbag suppression status telltale
or other multi-function display had been loose on 45 vehicles,
Subaru has determined that the expected occurrence rate is about
0.8% [less than one percent].
    [Subaru] * * * has determined that 3,405 vehicles were shipped
to dealers prior to the discovery of this problem. Using the above
frequency rate,
    * * * [the Company] expect that only about 27 vehicles will have
a noncompliance with FMVSS 208.
    All other aspects of the front passenger advanced airbag
suppression system will continue to function properly.
    Since Subaru has both an OFF and ON indication in the
suppression telltale, a complete absence of illumination is a
warning that the lamp is not functioning. Since power to the
telltale is also power to the multi-function display, the owner will
have a clear indication to quickly report a problem to a Subaru
dealer.
    Vibration bench testing in Japan by the [Company's] supplier
revealed that no disengagement of a wiring harness connector that
originally worked properly will occur during the use of vehicle.
    Dealers will receive a TSB with repair instructions on July 16,
2009 for any vehicles in their inventory, which had not been
inspected or repaired prior to shipment to dealers or for vehicles
where the owner reports a telltale/multi-function display problem.
Dealers will also be instructed to check both the telltale and
display at the first scheduled service (at 3,750 or 7,000 miles
depending on variant).

    In summary, Fuji/Subaru states that it believes the noncompliance
is inconsequential to motor vehicle safety because the expected
occurrence rate for the noncompliance is less than one percent (about
0.8%); a complete absence of illumination on the telltale gives a clear
indication to the vehicle

owner to quickly report a problem to the Subaru dealer; the Company's
vibration testing supports the conclusion that this noncompliance is
not likely to later occur in vehicles that were produced without the
noncompliance; and Dealers will also be instructed to check both the
telltale and display at the first scheduled service (at 3,750 or 7,000
miles depending on variant) and will receive a technical service
bulletin (TSB) with repair instructions for any vehicles in their
inventory, which had not been inspected or repaired prior to shipment
to dealers or for vehicles where the owner reports a telltale/multi-
function display problem.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance.
    Interested persons are invited to submit written data, views, and
arguments on this petition. Comments must refer to the docket and
notice number cited at the beginning of this notice and be submitted by
any of the following methods:
    a. By mail addressed to: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
    b. By hand delivery to U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590. The Docket Section is open on
weekdays from 10 a.m. to 5 p.m. except Federal Holidays.
    c. Electronically: by logging onto the Federal Docket Management
System (FDMS) Web site at http://www.regulations.gov/. Follow the
online instructions for submitting comments. Comments may also be faxed
to 1-202-493-2251.
    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.
    Documents submitted to a docket may be viewed by anyone at the
address and times given above. The documents may also be viewed on the
Internet at http:// www.regulations.gov by following the online
instructions for accessing the dockets. DOT's complete Privacy Act
Statement is available for review in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.
    Comment closing date: May 19, 2010.

    Authority: (49 U.S.C. 30118, 30120: delegations of authority at
CFR 1.50 and 501.8)

Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2010-8981 Filed 4-16-10; 8:45 am]
BILLING CODE P