[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18153-18156]
[FR Doc No: 2023-06291]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2021-D-1118 and FDA-2020-D-1138]

Transition Plan for Medical Devices That Fall Within Enforcement
Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public
Health Emergency; Guidance for Industry, Other Stakeholders, and Food
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Transition Plan for
Medical Devices That Fall Within Enforcement Policies Issued During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency.'' FDA
recognizes that it will take time for device manufacturers, device
distributors, healthcare facilities, healthcare providers, patients,
consumers, and FDA to adjust from policies adopted and operations
implemented during the COVID-19 public health emergency (PHE) to
``normal operations.'' To provide a clear policy for all stakeholders
and FDA staff, the Agency is issuing this guidance to describe FDA's
general recommendations for a phased transition process with respect to
devices that fall within certain enforcement policies issued during the
COVID-19 PHE declared by the Secretary of Health and Human Services
(the Secretary) under the Public Health Service Act (PHS Act),
including recommendations regarding submitting a marketing submission,
as applicable, and taking other actions with respect to these devices.
This guidance applies to devices that fall within enforcement policies
in guidances included in List 1 of this guidance. The phased transition
process outlined in this guidance will begin on the ``implementation
date.'' The implementation date is the day the PHE expires or 45 days
after the finalization of this guidance, whichever comes later. Because
the COVID-19 section 319 PHE declaration is anticipated to expire at
least 45 days after the finalization of this guidance, or May 11, 2023,
the implementation date is that date. The guidances in List 1 of this
guidance will no longer be in effect after the 180-day transition
period ends.

DATES: The announcement of the guidance is published in the Federal
Register on March 27, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

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-2021-D-1118 for ``Transition Plan for Medical Devices That Fall
Within Enforcement Policies Issued During the Coronavirus Disease 2019
(COVID-19) Public Health Emergency'' or the Docket No. FDA-2020-D-1138
for ``Center for Devices and Radiological Health (CDRH): COVID-19.''
Received comments 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,<PHONE_NUMBER>.
     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 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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Transition Plan for Medical Devices That Fall Within Enforcement
Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public
Health Emergency'' to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Ryan Ortega, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4618, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, the Secretary issued a declaration of a PHE
related to COVID-19 in accordance with section 319 of the PHS Act
(section 319PHE) (42 U.S.C. 247d) and mobilized the Operating Divisions
of the Department of Health and Human Services (HHS).\1\ FDA issued
various guidance documents that describe enforcement policies for
certain devices that are intended to support the emergency response to
the COVID-19 pandemic.
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    \1\ Secretary of HHS, Determination That a Public Health
Emergency Exists (hereinafter referred to as ``section 319 PHE
declaration'') (originally issued on January 31, 2020, and
subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. On February 9, 2023, the
Secretary renewed the section 319 PHE declaration related to COVID-
19, effective February 11, 2023. The section 319 PHE declaration
related to COVID-19 is anticipated to expire at the end of the day
on May 11, 2023. See the HHS ``Fact Sheet: COVID-19 Public Health
Emergency Transition Roadmap,'' (February 9, 2023), available at
https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html.
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    Given the magnitude of the response to the COVID-19 pandemic, FDA
recognizes that a phased approach may help to facilitate an orderly and
transparent transition to normal operations. The Agency is issuing this
guidance to describe FDA's general recommendations for a phased
transition process with respect to devices that fall within certain
enforcement policies issued during the COVID-19 PHE, including
recommendations regarding submitting a marketing submission, as
applicable, and taking other actions with respect to these devices.
This guidance applies to devices that fall within the enforcement
policies described in List 1 of the guidance. FDA is concurrently
issuing a companion transition guidance to describe FDA's
recommendations for devices issued Emergency Use Authorizations related
to COVID-19.
    As described in this guidance, a 180-day transition period will
begin on the implementation date. The implementation date is the date
the COVID-19 section 319 PHE expires or 45 days after the finalization
of this guidance, whichever comes later. Because the COVID-19 section
319 PHE declaration is anticipated to expire at least 45 days after the
finalization of this guidance, or on May 11, 2023, the implementation
date is that date. FDA believes the phased approach over the course of
180 days following the implementation date as set forth in this
guidance can help foster compliance with applicable legal requirements
once the relevant enforcement policies are no longer in effect.
    A notice of availability of the draft guidance appeared in the
Federal Register of December 23, 2021 (86 FR 72973). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including providing clarity on the recommendations
regarding physical and/or electronic copies of updated labeling, and
adding clarifications regarding use of real-world evidence in marketing
submissions, interactions with FDA, collaboration with stakeholders on
the transition process, and revisions to example scenarios.

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Transition Plan for Medical Devices That
Fall Within Enforcement Policies Issued During the Coronavirus Disease
2019 (COVID-19) Public Health Emergency.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Guidances Identified in List 1 of This Guidance

    As part of FDA's commitment to support continuity and response
efforts to the COVID-19 pandemic, the transition plan outlined in this
guidance takes into account that the guidances in List 1 of this
guidance will no longer be in effect after the 180-day transition
period ends, or after November 7, 2023.
    Generally, the guidances that set forth COVID-19-related
enforcement policies for certain devices initially stated that they
were intended to remain in effect only for the duration of the section
319 PHE declaration. As FDA announced in the Federal Register on March
13, 2023,\2\ many of these guidance documents--the guidances in List
1--have been revised to state that they are intended to continue in
effect for 180 days after the section 319 PHE declaration expires
unless a different intended duration is set forth in the finalized
version of this guidance. A different intended duration is not being
set forth in this guidance. The implementation date is the date the
section 319 PHE declaration expires, and the guidances are intended to
continue in effect for 180 days after that date.
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    \2\ See ``Guidance Documents Related to Coronavirus Disease 2019
(COVID-19)'' (88 FR 15417), available at https://www.federalregister.gov/documents/2023/03/13/2023-05094/guidance-documents-related-to-coronavirus-disease-2019-covid-19.
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    In finalizing this guidance, FDA added the following guidances to
List 1: ``Enforcement Policy for Viral Transport Media During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)''
\3\ and ``Enforcement Policy for Face Shields, Surgical Masks, and
Respirators During the Coronavirus Disease (COVID-19) Public Health
Emergency.'' \4\ These guidances were added to help facilitate an
appropriate transition period for these devices away from the policies
adopted and operations implemented during the COVID-19 PHE to normal
operations. FDA removed the following guidances from List 1:
``Enforcement Policy for the Quality Standards of the Mammography
Quality Standards Act During the COVID-19 Public Health Emergency,''
\5\ ``Enforcement Policy for Non-Invasive Remote Monitoring Devices
Used to Support Patient Monitoring During the Coronavirus Disease 2019
(COVID-19) Public Health Emergency (Revised),'' \6\ ``Enforcement
Policy for Face Masks and Barrier Face Coverings During the Coronavirus
Disease 2019 (COVID-19) Public Health Emergency,'' 7 8 and
``Enforcement Policy for Clinical Electronic Thermometers During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency.'' \9\ FDA
has removed these guidances from List 1 because: (1) the policy in the
guidance should not continue in effect beyond the expiration of the
COVID-19 PHE or (2) the guidance was extended beyond the expiration of
the COVID-19 PHE and FDA intends to retain the policy with appropriate
changes. See the Federal Register notice entitled ``Guidance Documents
Related to Coronavirus Disease 2019 (COVID-19).'' \10\
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    \3\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-viral-transport-media-during-coronavirus-disease-2019-covid-19-public-health.
    \4\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-shields-surgical-masks-and-respirators-during-coronavirus-disease-covid-19.
Bifurcation of the ``Enforcement Policy for Face Masks, Barrier Face
Coverings, Face Shields, Surgical Masks, and Respirators During the
COVID-19 Public Health Emergency (Revised)'' guidance was announced
in the Federal Register notice on March 13, 2023. The guidance
relating to face shields, surgical masks, and respirators is on List
1, and the guidance related to face masks and barrier face
coverings, as noted below, is outside the scope of this guidance.
    \5\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-quality-standards-mammography-quality-standards-act-during-covid-19-public-health.
    \6\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-non-invasive-remote-monitoring-devices-used-support-patient-monitoring-during.
    \7\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public.
    \8\ See footnote 4.
    \9\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-clinical-electronic-thermometers-during-coronavirus-disease-2019-covid-19-public.
    \10\ See footnote 2.
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III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Transition Plan for Medical Devices
That Fall Within Enforcement Policies Issued During the Coronavirus
Disease 2019 (COVID-19) Public Health Emergency'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document number GUI00021011 and complete
title to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
Office of Management and Budget (OMB) under the Paperwork Reduction Act
(PRA). The collections of information in the following FDA regulations
and guidance have been approved by OMB as listed in the table below.
    This guidance also contains new collections of information not
approved under a current collection. These new collections of
information have been granted a PHE waiver from the PRA by HHS on March
19, 2020, under section 319(f) of the PHS Act. Information concerning
the PHE PRA waiver can be found on the HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

----------------------------------------------------------------------------------------------------------------
                                        Another guidance referenced in    OMB control    New collection covered
              21 CFR part                        this guidance                No.           by PHE PRA waiver
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                                        ``Emergency Use Authorization        0910-0595
                                         of Medical Products and
                                         Related Authorities; Guidance
                                         for Industry and Other
                                         Stakeholders''.
                                        ``Requests for Feedback and          0910-0756
                                         Meetings for Medical Device
                                         Submissions: The Q-Submission
                                         Program Guidance for Industry
                                         and Food and Drug
                                         Administration Staff''.
800, 801, and 809.....................  ..............................       0910-0485
803...................................  ..............................       0910-0437
806...................................  ..............................       0910-0359
807, subparts A through D.............  ..............................       0910-0625
807, subpart E........................  ..............................       0910-0120
812...................................  ..............................       0910-0078
814, subparts A through E.............  ..............................       0910-0231
814, subpart H........................  ..............................       0910-0332
820...................................  ..............................       0910-0073
830 and 801.20........................  ..............................       0910-0720
860, subpart D........................  ..............................       0910-0844
                                                                                Notification of Intent.
                                                                                Transition
                                                                                Implementation Plan.
                                                                                Labeling Mitigation for
                                                                                Certain Reusable
                                                                                Devices.
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    Dated: March 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06291 Filed 3-24-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: February 12, 2007 (Volume 72, Number 28)]
[Notices]
[Page 6551-6552]
[DOCID:fr12fe07-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP99-176-125]

Natural Gas Pipeline Company of America; Notice of Negotiated
Rates

February 2, 2007.
    Take notice that on January 31, 2007, Natural Gas Pipeline Company
of America (Natural) tendered for filing as part of its FERC Gas
Tariff, Sixth Revised Volume No. 1, to effective April 1, 2007:

Third Revised Sheet No. 26E,
Fourth Revised Sheet No. 414A.01.

    Natural states that copies of the filing are being mailed to all
parties set out on the Commission's official service list.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the

appropriate action to be taken, but will not serve to make protestants
parties to the proceeding. Any person wishing to become a party must
file a notice of intervention or motion to intervene, as appropriate.
Such notices, motions, or protests must be filed in accordance with the
provisions of Section 154.210 of the Commission's regulations (18 CFR
154.210). Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E7-2256 Filed 2-9-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: April 22, 2009 (Volume 74, Number 76)]
[Rules and Regulations]
[Page 18298-18302]
[DOCID:fr22ap09-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2007-0528; FRL-8895-3]

Approval and Promulgation of Air Quality Implementation Plans;
Texas; Reasonable Further Progress Plan, Motor Vehicle Emissions
Budgets, and 2002 Base Year Emissions Inventory; Houston-Galveston-
Brazoria 1997 8-Hour Ozone Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a
revision to the Texas State Implementation Plan (SIP) to meet the
Reasonable Further Progress (RFP) and Emissions Inventory requirements
of the Clean Air Act (CAA) for the Houston-Galveston-Brazoria (HGB)
moderate 1997 8-hour ozone nonattainment area. EPA is also approving
the RFP motor vehicle emissions budgets (MVEBs) associated with the
revision. EPA is approving the SIP revision because it satisfies the
RFP and Emissions Inventory requirements for 1997 8-hour ozone
nonattainment areas classified as moderate and demonstrates the
required progress in reducing ozone precursors. EPA is approving the
revision pursuant to section 110 and part D of the CAA and EPA's
regulations.

DATES: This direct final rule will be effective June 22, 2009 without
further notice unless EPA receives relevant adverse comments by May 22,
2009. If adverse comments are received, EPA will publish a timely
withdrawal of the direct final rule in the Federal Register informing
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2007-0528, by one of the following methods:
     Federal e-Rulemaking Portal: http://www.regulations.gov.
     Follow the online instructions for submitting comments.
     EPA Region 6 ``Contact Us'' Web site: http://epa.gov/
region6/r6coment.htm. Please click on ``6PD (Multimedia)'' and select
``Air'' before submitting comments.
     E-mail: Mr. Guy Donaldson at<EMAIL_ADDRESS>Please
also send a copy by e-mail to the person listed in the FOR FURTHER
INFORMATION CONTACT section below.
     Fax: Mr. Guy Donaldson, Chief, Air Planning Section (6PD-
L), at fax number<PHONE_NUMBER>.
     Mail: Mr. Guy Donaldson, Chief, Air Planning Section (6PD-
L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200,
Dallas, Texas 75202-2733.
     Hand or Courier Delivery: Mr. Guy Donaldson, Chief, Air
Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross
Avenue, Suite 1200, Dallas, Texas 75202-2733. Such deliveries are
accepted only between the hours of 8 a.m. and 4 p.m. weekdays, and not
on legal holidays. Special arrangements should be made for deliveries
of boxed information.
    Instructions: Direct your comments to Docket No. EPA-R06-OAR-2007-
0528. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.gov
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Air Planning Section
(6PD-L), Environmental Protection Agency, 1445 Ross Avenue, Suite 700,
Dallas, Texas 75202-2733. The file will be made available by
appointment for public inspection in the Region 6 FOIA Review Room
between the hours of 8:30 a.m. and 4:30 p.m. weekdays except for legal
holidays. Contact the person listed in the FOR FURTHER INFORMATION
CONTACT paragraph below or Mr. Bill Deese at<PHONE_NUMBER> to make an
appointment. If possible, please make the appointment at least two
working days in advance of your visit. There will be a 15 cent per page
fee for making photocopies of documents. On the day of the visit,
please check in at the EPA Region 6 reception area at 1445 Ross Avenue,
Suite 700, Dallas, Texas.
    The State submittal is also available for public inspection during
official business hours, by appointment, at the Texas Commission on
Environmental Quality, Office of Air Quality, 12124 Park 35 Circle,
Austin, Texas 78753.

FOR FURTHER INFORMATION CONTACT: Emad Shahin, Air Planning Section
(6PD-L), Environmental Protection Agency, Region 6, 1445 Ross Avenue,
Suite 700, Dallas, Texas 75202-2733, telephone<PHONE_NUMBER>; fax number
214-665-7263; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we'',
``us'', or ``our'' is used, we mean the EPA.

Outline

I. What Action Is EPA Taking?
II. What Is a SIP?
III. What Is the Background for This Action?
IV. What Is EPA's Evaluation of the Revision?
V. Statutory and Executive Order Reviews

I. What Action Is EPA Taking?

    We are approving a revision to the Texas SIP, submitted to meet the
Emissions Inventory and RFP requirements of the CAA for the HGB
moderate 1997 8-hour ozone nonattainment area. The revision was adopted
by the State of Texas on May 23, 2007 and submitted to EPA on May 30,
2007. We are approving the 2002 Base Year Emissions Inventory, the 15%
RFP plan, and the RFP 2008 MVEBs. The RFP plan demonstrates that oxides
of nitrogen (NOX) emissions will be

reduced at least 15 percent for the period of 2002 through 2008. The
volatile organic compound (VOC) MVEB is 86.77 tons per day (tpd), and
the NOX emissions budget is 186.13 tpd. We are approving the
SIP revision because it satisfies the Emissions Inventory and RFP
requirements for 1997 8-hour ozone nonattainment areas classified as
moderate, and demonstrates the necessary further progress in reducing
ozone precursors.\1\ We are approving the MVEBs included in this plan
because these levels of motor vehicle emissions have been shown to be
consistent with meeting the RFP requirements. We are approving the
revision pursuant to section 110 and part D of the CAA and EPA's
regulations.
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    \1\ We reclassified the HGB nonattainment area too severe on
October 1, 2008 (73 FR 56983). As a result of the reclassification,
a revised RFP SIP is required in addition to the RFP SIP that we are
acting on today.
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    EPA is publishing this rule without prior proposal because we view
this as a noncontroversial amendment and anticipate no relevant adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the SIP revision if relevant adverse
comments are received. This rule will be effective on June 22, 2009
without further notice unless we receive relevant adverse comment by
May 22, 2009. If we receive relevant adverse comments, we will publish
a timely withdrawal in the Federal Register informing the public that
the rule will not take effect. We will address all public comments in a
subsequent final rule based on the proposed rule. We will not institute
a second comment period on this action. Any parties interested in
commenting must do so now. Please note that if we receive adverse
comment on an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, we may adopt
as final those provisions of the rule that are not the subject of an
adverse comment.

II. What Is a SIP?

    Section 110 of the CAA requires states to develop air pollution
regulations and control strategies to ensure that air quality meets the
national ambient air quality standards (NAAQS) established by EPA.
NAAQS are established under section 109 of the CAA and currently
address six criteria pollutants: carbon monoxide, nitrogen dioxide,
ozone, lead, particulate matter, and sulfur dioxide.
    A SIP is a set of air pollution regulations, control strategies,
other means or techniques, and technical analyses developed by the
state, to ensure that the state meets the NAAQS. It is required by
section 110 and other provisions of the CAA. A SIP protects air quality
primarily by addressing air pollution at its point of origin. A SIP can
be extensive, containing state regulations or other enforceable
documents, and supporting information such as emissions inventories,
monitoring networks, and modeling demonstrations. Each state must
submit regulations and control strategies to EPA for approval and
incorporation into the federally enforceable SIP.

III. What Is the Background for This Action?

    Inhaling even low levels of ozone, a key component of urban smog,
can trigger a variety of health problems including chest pains,
coughing, nausea, throat irritation, and congestion. It can also worsen
bronchitis and asthma, and reduce lung capacity. VOC and NOX
are known as ``ozone precursors'', as VOCs react with NOX,
oxygen, and sunlight to form ozone. The CAA requires that areas not
meeting the NAAQS for ozone demonstrate RFP in reducing emissions of
ozone precursors.
    EPA promulgated, on July 18, 1997, a revised 8-hour ozone standard
of 0.08 parts per million (ppm), which is more protective than the
previous 1-hour ozone standard (62 FR 38855).\2\ On April 30, 2004, EPA
published designations and classifications for the revised 1997 8-hour
ozone standard (69 FR 23936). HGB was classified as a moderate
nonattainment area under the 1997 8-hour ozone standard on June 15,
2004. The HGB 1997 8-hour nonattainment area consists of Brazoria,
Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery, and Waller
counties. On November 29, 2005 (70 FR 71612), as revised on June 8,
2007 (72 FR 31727), EPA published the Phase 2 final rule for
implementation of the 8-hour standard that addressed, among other
things, the RFP control and planning obligations as they apply to areas
designated nonattainment for the 1997 8-hour ozone NAAQS. In the Phase
1 Rule, RFP was defined in Sec.  51.900(p) as meaning for the purposes
of the 1997 8-hour NAAQS, the progress reductions required under
sections 172(c)(2), 182(b)(1), 182(c)(2)(B) and 182(c)(2)(C) of the
CAA. In section 51.900(q), rate of progress (ROP), was defined as
meaning for purposes of the 1-hour NAAQS, the progress reductions
required under sections 172(c)(2), 182(b)(1), 182(c)(2)(B), and
182(c)(2)(C) of the CAA (see 69 FR 23997).
---------------------------------------------------------------------------

    \2\ EPA issued a revised 8-hour ozone standard on March 27, 2008
(73 FR 16436). The designation and implementation process for that
standard is just starting and does not affect EPA's action here.
---------------------------------------------------------------------------

    On December 22, 2006, the U.S. Court of Appeals for the District of
Columbia Circuit vacated EPA's Phase 1 Rule in South Coast Air Quality
Management Dist. v. EPA, 472 F.3d 882 (DC Cir. 2006). On June 8, 2007,
in response to several petitions for rehearing, the court modified the
scope of vacatur of the Phase 1 Rule. See 489 F.3d 1245 (DC Cir. 2007),
cert. denied, 128 S.Ct. 1065 (2008). The court vacated those portions
of the Phase 1 Rule that provide for regulation of the 1997 8-hour
ozone NAAQS in some nonattainment areas under subpart 1 in lieu of
subpart 2. The decision held that EPA must retain the following 1-hour
ozone NAAQS measures: New source review, section 185 penalties, and
contingency plans for failure to meet RFP and attainment milestones.
The decision does not affect the requirements for areas classified
under subpart 2, such as the HGB area, to submit a reasonable further
progress plan for the 1997 8-hour ozone NAAQS. Litigation on the Phase
2 Rule is pending before the DC Circuit Court of Appeals.
    Section 182 of the CAA and EPA's 1997 8-hour ozone regulations \3\
require a state, for each 1997 8-hour ozone nonattainment area that is
classified as moderate, to submit an emissions inventory and a RFP plan
to show how the state will reduce emissions of ozone precursors. The
HGB moderate 1997 8-hour ozone nonattainment area has a maximum
attainment date of June 15, 2010, that is beyond five years after
designation. In addition, the HGB area has an approved 15% VOC Rate of
Progress plan under the 1-hour ozone standard (November 14, 2001, 66 FR
57160). (Rate of Progress refers to reasonable further progress for the
1-hour ozone standard.) For a moderate area with an attainment date of
more than five years after designation, the RFP plan must obtain a 15%
reduction in ozone precursor emissions for the first six years after
the baseline year (2002 through 2008).
---------------------------------------------------------------------------

    \3\ Reasonable further progress regulations are at 40 CFR
51.910, and emissions inventory regulations are at 40 CFR 51.915.
---------------------------------------------------------------------------

    Pursuant to CAA section 172(c)(9), RFP plans must include
contingency measures that will take effect without further action by
the state or EPA, which includes additional controls that would be
implemented if the area fails to reach the RFP milestones. While the
CAA does not specify the type of measures or quantity of emissions

reductions required, EPA provided guidance interpreting the CAA that
implementation of these contingency measures would provide additional
emissions reductions of up to 3% of the adjusted base year inventory
(or a lesser percentage that will make up the identified shortfall) in
the year following the RFP milestone year. For more information on
contingency measures, please, see the April 16, 1992 General Preamble
(57 FR 13498, 13510) and the November 29, 2005 Phase 2 8-hour ozone
standard implementation rule (70 FR 71612, 71650). RFP plans must also
include MVEBs, which are the allowable on-road mobile emissions an area
can produce and continue to demonstrate RFP.
    On May 23, 2007 Texas adopted as a SIP revision the RFP plan for
the HGB area and submitted it to us on May 30, 2007. The plan documents
a 15% NOX emission reduction in the HGB nonattainment area
for the period between 2002 and 2008, and includes a 2002 baseline
emissions inventory, MVEBs for 2008, and contingency measures. On June
15, 2007, we received a request from Governor Perry seeking voluntary
reclassification of the HGB area. The Governor requested that we
reclassify the HGB area from a moderate nonattainment area to a severe
nonattainment area under the 8-hour ozone standard. We reclassified the
area to severe on October 1, 2008 (73 FR 56983). Reclassification of
the area to severe will require Texas to develop and submit a revised
RFP SIP. For an area classified as severe, the required emissions
reductions for VOC and/or NOX are 18% for the six-year
period following the baseline emissions inventory year (2002), and an
average of 3% per year for all remaining three-year periods after the
first six-year period out to the area's attainment date (40 CFR
51.910(a)(1)(B)). The reclassification to severe set a new attainment
date as expeditiously as practicable, but no later than June 15, 2019.
Therefore, the revised RFP plan will have to address the years post
2008. Today's action addresses the plan for moderate ozone
nonattainment area requirements for the years 2002 to 2008.

IV. What Is EPA's Evaluation of the Revision?

    EPA has reviewed the revision for consistency with the requirements
of EPA regulations. A summary of EPA's analysis is provided below. For
a full discussion of our evaluation, please see our TSD.

A. Texas Has an Approvable Base Year Emissions Inventory

    CAA sections 172(c)(3) and 182(a)(1) require an inventory of actual
emissions from all sources of relevant pollutants in the nonattainment
area. Texas has developed a 2002 base year emissions inventory for the
HGB nonattainment area. The 2002 base year emissions inventory includes
all point, area, non-road mobile, and on-road mobile source emissions.
EPA reviewed the emission inventory and determined that it is
approvable because it was developed in accordance with EPA guidance on
emission inventory preparation. Table 1 lists the 2002 base year
emissions inventory for the HGB area. For more detail on how emissions
inventories were estimated, see the TSD.

           Table 1--HGB 2002 RFP Base Year Emissions Inventory
------------------------------------------------------------------------
                  2002 Base year inventory  (tons/day)
-------------------------------------------------------------------------
                  Source type                       NOX          VOC
------------------------------------------------------------------------
Point.........................................       339.48       297.12
Area..........................................        40.15       219.51
On-road Mobile................................       283.20       114.30
Non-road Mobile...............................       167.74       112.37
                                               -------------------------
    Total.....................................       830.57       743.30
------------------------------------------------------------------------

B. Adjusted Base Year Inventory and 2008 RFP Target Levels

    The 2002 base year emissions inventory referenced above is the
starting point for calculating RFP. Next, CAA section 182(b)(2)(C)
explains that the baseline from which emission reductions are
calculated should be determined as outlined pursuant to section
182(b)(1)(B). Section 182(b)(1)(B) and 40 CFR 51.910 require that the
base year inventory must be adjusted to exclude certain emissions
specified in section 182(b)(1)(D). This requires that the baseline
exclude emission reductions due to Federal Motor Vehicle Control
Programs (FMVCP) promulgated by the Administrator by January 1, 1990,
and emission reductions due to the regulation of Reid Vapor Pressure
promulgated by the Administrator prior to the enactment of the Clean
Air Act Amendments of 1990. These measures are not creditable.
    The result (after the adjustment) is the ``adjusted base year
inventory.'' The required RFP 15% reduction is calculated by
multiplying the adjusted base year inventory by 0.15. This figure is
subtracted from the adjusted base year inventory, resulting in the
target level of emissions for the milestone year (2008). Table 2
features a summary of the adjusted base year inventory (row c),
required 15% reductions (row d), and 2008 target level of emissions
(row e), as described above. Texas relied on reductions of
NOX emissions to demonstrate RFP.

   Table 2--Calculation of HGB Required NOX Target Level of Emissions
------------------------------------------------------------------------
                                                            NOX  (tons/
                       Description                             day)
------------------------------------------------------------------------
a. 2002 Emission Inventory..............................          830.57
b. Non-creditable Reductions, 2002-2008.................           42.20
c. 2002 Adjusted to 2008 (a-b)..........................          788.37
d. 15% Reductions (c x 0.15)............................          118.26
e. 2008 Target (c-d)....................................          670.11
------------------------------------------------------------------------

C. The 2008 Projected Emissions Inventories and How the Total Required
15% Reductions Are Achieved

    Next, section 182(b)(1)(A) requires that states need to provide
sufficient control measures in their RFP plans to offset any emissions
growth. To do this the state must estimate the amount of growth that
will occur between 2002 and the end of 2008. The state uses population
and economic forecasts to estimate how emissions will change in the
future. Generally, Texas followed our standard guidelines in estimating
the growth in emissions. EPA's MOBILE 6.2.03 model was used to develop
the 2008 on-road inventory. For more detail on how emissions growth was
estimated, see the TSD. Texas terms the projections of growth as the
RFP 2008 Uncontrolled Inventories.
    Texas then estimates the projected emission reductions from the
control measures in place between 2002 and the end of 2008 and applies
these to the RFP 2008 Uncontrolled Inventories; the results are the RFP
2008 Controlled Inventories. The total amount of NOX
emissions in the RFP 2008 Controlled Inventories must be equal to or
less than the 2008 target inventories (listed at row e in Table 2
above). The RFP plan relies on a number of state and federal control
measures intended to reduce NOX emissions. The control
measures address emissions from point, area, mobile non-road, and
mobile on-road sources.
    The majority of point source NOX reductions are from the
mass emissions cap and trade (MECT) program for utility boilers,
turbines, duct burners, heaters and furnaces, IC engines, and
industrial boilers. The HGB area did not rely upon any area source
controls for NOX reductions.

    Non-road emission reductions are from federal controls on non-road
engines. The mobile non-road emission reductions were estimated using
the NONROAD 2005 model, with customized data files to reflect emissions
generated by non-road mobile equipment in Texas. Emissions from
locomotives, aircraft and support equipment, and commercial marine
vessels were calculated outside of the NONROAD 2005 model using EPA
approved methodologies. EPA finds that Texas' projected emissions and
emission reductions for these three non-road mobile sources are
acceptable.
    Reductions in mobile on-road emissions resulted from the post-1990
FMVCP, reformulated gasoline, Texas' inspection and maintenance
program, and the Texas low emission diesel program. Each of the State
measures relied upon in this plan have been approved in separate
actions. See the TSD for more details.
    As a result, for NOX the target level of emissions is
670.11 tpd, and the 2008 projected emissions inventory (after RFP
reductions are applied) is 553.96 tpd. Since all reductions are
accomplished with NOX reductions, there is no VOC reduction
requirement for the area. As illustrated in Table 3, the 2008
projection inventory after RFP reductions is less than the target level
of emissions. Therefore, the control measures included in the 2008
projected emissions are adequate to meet the 15% RFP requirement.

              Table 3--Summary of RFP Demonstration for HGB
------------------------------------------------------------------------
                 Inventory                         NOX  (tons/day)
------------------------------------------------------------------------
2008 Target................................  670.11.
2008 Uncontrolled Emissions................  1026.63.
2008 RFP Emission Reductions...............  472.67.
2008 Projected Emissions after RFP           553.96.
 Reductions.
RFP Met?...................................  Yes.
------------------------------------------------------------------------

D. The Reasonable Further Progress Plan Includes Acceptable RFP
Contingency Measures

    The 1997 8-hour ozone RFP plan for a moderate nonattainment area
must include contingency measures, which are additional controls to be
implemented if the area fails to make reasonable further progress.
Contingency measures are intended to achieve reductions over and beyond
those relied on in the RFP demonstration and could include federal and
state measures already scheduled for implementation. The CAA does not
preclude a state from implementing such measures before they are
triggered. EPA interprets the CAA to require sufficient contingency
measures in the RFP submittal, so that upon implementation of such
measures, additional emission reductions of up to 3% of the adjusted
base year inventory (or a lesser percentage that will make up the
identified shortfall) would be achieved between the milestone year of
2008 and the next calendar year, i.e., 2009.
    Texas used federal and state measures currently being implemented
to meet the contingency measure requirement for the HGB RFP SIP. These
measures, which are the same measures used for RFP, provide reductions
that are in excess of those needed for RFP. As shown in Table 4, the
excess reductions are greater than 3% of the adjusted base year
inventory. Therefore these reductions are sufficient as contingency
measures.

     Table 4--RFP Contingency Measure Demonstration for HGB RFP SIP
------------------------------------------------------------------------
                Description                        NOX  (tons/day)
------------------------------------------------------------------------
a. Adjusted Base Year Inventory (from Table  788.37.
 2).
b. 3% Needed for Contingency (a x 0.03)....  23.65.
c. Excess Reductions Used for Contingency..  47.25.
d. Contingency Met?........................  Yes.
------------------------------------------------------------------------

E. The RFP Milestone 2008 MVEBs Are Approvable

    The 1997 8-hour ozone RFP plan must include MVEBs for
transportation conformity purposes. The MVEB is the mechanism to
determine if the future transportation plans conform to the SIP.
Conformity to a SIP means that transportation activities will not
produce new air quality violations, worsen existing violations, delay
reaching reasonable further progress milestones, or delay timely
attainment of the NAAQS. A MVEB is the maximum amount of emissions
allowed in the SIP for on-road motor vehicles. The MVEB establishes an
emissions ceiling for the regional transportation network. The HGB RFP
SIP contains VOC and NOX MVEBs for the RFP milestone year
2008. The emissions budget for VOC is 86.77 tpd, and the NOx emissions
budget is 186.13 tpd. On-road emissions must be shown in future
transportation plans to be less than the MVEBs for 2008 and subsequent
years. The VOC and NOX RFP emissions budgets are acceptable:
when added to the other components of the 2008 emissions inventory
(including non-road, stationary source, and area source emissions), the
total level of emissions is below the 2008 RFP emissions target level.
We found the RFP MVEBs (also termed transportation conformity budgets)
adequate, and on June 28, 2007, the availability of these budgets was
posted on our Web site for the purpose of soliciting public comments.
The comment period closed on July 30, 2007, and we received no
comments. On March 21, 2008, we published the Notice of Adequacy
Determination for these RFP MVEBs (73 FR 15152). Once determined
adequate, these RFP budgets must be used in future HGB transportation
conformity determinations. The adequacy determination represents a
preliminary finding by EPA of the acceptability of the MVEBs. Today, we
are finding the MVEBs are fully consistent with RFP, and the RFP plan
is fully approvable, as it sets the allowable on-road mobile emissions
the HGB area can produce and continue to demonstrate RFP.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);

     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by June 22, 2009. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen oxides, Ozone,
Volatile organic compounds.

    Dated: April 10, 2009.
Lawrence E. Starfield,
Acting Regional Administrator, Region 6.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart SS--Texas

0
2. The second table in Sec.  52.2270(e) entitled ``EPA Approved
Nonregulatory Provisions and Quasi-Regulatory Measures in the Texas
SIP'' is amended by adding two new entries to the end of the table for
``Approval of the 1997 8-hour Ozone 15% Reasonable Further Progress
Plan, and 2008 RFP Motor Vehicle Emission Budgets'' and ``2002 Base
Year Emissions Inventory'', for the Houston-Galveston-Brazoria, TX
area. The additions read as follows:

Sec.  52.2270  Identification of plan.

* * * * *
    (e) * * *

                                    EPA-Approved Nonregulatory Provisions and
                                   Quasi-Regulatory Measures in the Texas SIP
----------------------------------------------------------------------------------------------------------------
                                        Applicable           State
      Name of SIP provision           geographic or       submittal/     EPA approval date         Comments
                                    nonattainment area  effective date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Approval of the 1997 8-hour Ozone  Houston-Galveston-         05/23/07  04/22/09 [Insert FR  ...................
 15% Reasonable Further Progress    Brazoria, TX.                        page number where
 Plan, and 2008 RFP Motor Vehicle                                        document begins].
 Emission Budgets.
2002 Base Year Emissions           Houston-Galveston-         05/23/07  04/22/09 [Insert FR  ...................
 Inventory.                         Brazoria, TX.                        page number where
                                                                         document begins].
----------------------------------------------------------------------------------------------------------------

[FR Doc. E9-9216 Filed 4-21-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 128 (Tuesday, July 3, 2012)]
[Notices]
[Pages 39564-39567]
[FR Doc No: 2012-16271]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2012-0086]

Group Lotus Plc, Receipt of Petition for Temporary Exemption From
an Advanced Air Bag Requirement of FMVSS No. 208

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

ACTION: Notice of receipt of a petition for a temporary exemption from
a provision of Federal Motor Vehicle Safety Standard (FMVSS) No. 208,
Occupant Crash Protection.

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

SUMMARY: In accordance with the procedures in 49 CFR part 555, Group
Lotus Plc has petitioned the agency for a temporary exemption from one
advanced air bag requirement of FMVSS No. 208, the higher maximum speed
(56 km/h (35 mph)) belted test requirement using 5th percentile adult
female dummies for its Evora model. The basis for the application is
that the petitioner avers compliance would cause it substantial
economic hardship and that it has tried in good faith to comply with
the standard.\1\ This notice of receipt of an application for a
temporary exemption is published in accordance with statutory and
administrative provisions. NHTSA has made no judgment on the merits of
the application.
---------------------------------------------------------------------------

    \1\ To view the application, go to http://www.regulations.gov
and enter the docket number set forth in the heading of this
document.

---------------------------------------------------------------------------
DATES: You should submit your comments not later than August 2, 2012.

FOR FURTHER INFORMATION CONTACT: David Jasinski, Office of the Chief
Counsel, NCC-112, National Highway Traffic Safety Administration, 1200
New Jersey Avenue SE., West Building 4th Floor, Room W41-213,
Washington, DC 20590. Telephone:<PHONE_NUMBER>; Fax:<PHONE_NUMBER>.

ADDRESSES: We invite you to submit comments on the application
described above. You may submit comments identified by docket number in
the heading of this notice by any of the following methods:
     Web Site: http://www.regulations.gov. Follow the
instructions for submitting comments on the electronic docket site by
clicking on ``Help and Information'' or ``Help/Info.''
     Fax: 1-202-493-2251.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, Room W12-140, 1200 New Jersey Avenue SE., Washington,
DC 20590.
     Hand Delivery: 1200 New Jersey Avenue SE., West Building
Ground Floor, Room W12-140, Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Instructions: All submissions must include the agency name and
docket number. Note that all comments received will be posted without
change to http://www.regulations.gov, including any personal
information provided. Please see the Privacy Act discussion below. We
will consider all comments received before the close of business on the
comment closing date indicated

above. To the extent possible, we will also consider comments filed
after the closing date.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov at any time or to
1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays. Telephone:<PHONE_NUMBER>.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://www.dot.gov/privacy.html.
    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 under FOR FURTHER INFORMATION CONTACT. In
addition, you should submit two copies, from which you have deleted the
claimed confidential business information, to Docket Management at the
address given above. 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 (49 CFR Part 512).

SUPPLEMENTARY INFORMATION:

I. Advanced Air Bag Requirements and Small Volume Manufacturers

    In 2000, NHTSA upgraded the requirements for air bags in passenger
cars and light trucks, requiring what are commonly known as ``advanced
air bags.'' \2\ The upgrade was designed to meet the twin goals of
improving protection for occupants of all sizes, belted and unbelted,
in moderate-to-high-speed crashes, and of minimizing the risks posed by
air bags to infants, children, and other occupants, especially in low-
speed crashes. Prior to this rule, crash tests under FMVSS No. 208 used
only one size dummy, a 50th percentile adult male dummy. However, the
advanced air bag rule specified the use of both 50th percentile adult
male and 5th percentile adult female dummies for the standard's crash
tests.
---------------------------------------------------------------------------

    \2\ See 65 FR 30680 (May 12, 2000).
---------------------------------------------------------------------------

    The requirements for the vehicle performance in an unbelted 32 km/h
(20 mph) to 40 km/h (25 mph) rigid barrier crash test and the belted
rigid barrier crash test with a maximum test speed of 48 km/h (30 mph)
for both the 50th percentile male dummy and the 5th percentile female
dummy were phased in beginning with the 2004 model year. Small volume
manufacturers were not subject to these advanced air bag requirements
until the end of the phase-in period, which was September 1, 2006.
    A second phase-in period required vehicles to be certified as
passing the belted rigid barrier test requirements at speeds up to 56
km/h (35 mph) using the 50th percentile adult male dummy. This
requirement was phased in beginning with the 2008 model year. Small
volume manufacturers were not subject to this requirement until the end
of the phase-in period, which was September 1, 2010.
    The 2000 final rule did not include a higher speed belted rigid
barrier test for a 5th percentile adult female dummy. Instead, NHTSA
initiated testing to examine the practicability of imposing such a
requirement.\3\
---------------------------------------------------------------------------

    \3\ See 65 FR 30690.
---------------------------------------------------------------------------

    On August 31, 2006, NHTSA published a final rule that increased the
maximum test speed for the belted rigid barrier test using the 5th
percentile adult female test dummy from 48 km/h (30 mph) to 56 km/h (35
mph).\4\ This new requirement was phased in beginning with the 2010
model year. Small manufacturers are not subject to this requirement
until the completion of the phase in period, which is September 1,
2012.
---------------------------------------------------------------------------

    \4\ See 71 FR 51768.
---------------------------------------------------------------------------

    In recent years, NHTSA has addressed a number of petitions for
exemption from some of the initial advanced air bag requirements of
FMVSS No. 208. The majority of these requests came from small
manufacturers, each of which petitioned on the basis that compliance
would cause it substantial economic hardship and that it has tried in
good faith to comply with the standard. In recognition of the more
limited resources and capabilities of small manufacturers, authority to
grant exemptions based on substantial economic hardship and good faith
efforts was added to the Vehicle Safety Act in 1972 to enable the
agency to give those manufacturers additional time to comply with the
Federal safety standards.
    NHTSA granted a number of these petitions, usually in situations in
which the manufacturer was supplying standard air bags in lieu of
advanced air bags.\5\ In addressing these petitions, NHTSA has
recognized that small manufacturers may face particular difficulties in
acquiring or developing advanced air bag systems.
---------------------------------------------------------------------------

    \5\ See, e.g., grant of petition to Panoz, 72 FR 28759 (May 22,
2007), or grant of petition to Koenigsegg, 72 FR 17608 (April 9,
2007).
---------------------------------------------------------------------------

    Notwithstanding those previous grants of exemption, NHTSA has
considered two key issues--
    (1) whether it is in the public interest to continue to grant such
petitions, particularly in the same manner as in the past, given the
number of years these requirements have now been in effect and the
benefits of advanced air bags, and
    (2) to the extent such petitions are granted, what plans and
countermeasures to protect child and infant occupants, short of
compliance with the advanced air bags, should be expected.
    While the exemption authority was created to address the problems
of small manufacturers and the agency wishes to be appropriately
attentive to those problems, it was not anticipated by the agency that
use of this authority would result in small manufacturers being given
much more than relatively short term exemptions from recently
implemented safety standards, especially those addressing particularly
significant safety problems.
    Given the passage of time since the advanced air bag requirements
were established and implemented, and in light of the benefits of
advanced air bags, NHTSA has determined that it is not in the public
interest to continue to grant exemptions from these requirements under
the same terms as in the past.\6\ The costs of compliance with the
advanced air bag requirements of FMVSS No. 208 are costs that all
entrants to the U.S. automobile marketplace should expect to bear.
Furthermore, NHTSA understands that, in contrast to the initial years
after the advanced air bag requirements went into effect, low volume
manufacturers now have access to advanced air bag technology.
Accordingly, NHTSA has concluded that the expense of advanced air bag
technology is not now sufficient, in and of itself, to justify the
grant of a petition for a hardship exemption from the advanced air bag
requirements.\7\
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    \6\ See denial of petition of Pagani Automobili SpA, 76 FR
47641-42 (Aug. 5, 2011).
    \7\ See id.
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    NHTSA further notes that the granting of hardship exemptions from
motor

vehicle safety standards is subject to the agency's finding that the
petitioning manufacturer has ``tried to comply with the standard in
good faith.'' \8\ In response to prior petitions, NHTSA has granted
temporary exemptions from the advanced air bag requirements as a means
of affording eligible manufacturers an additional transition period to
comply with the exempted standard. In deciding whether to grant an
exemption based on substantial economic hardship and good faith
efforts, NHTSA considers the steps that the manufacturer has already
taken to achieve compliance, as well as the future steps the
manufacturer plans to take during the exemption period and the
estimated date by which full compliance will be achieved.\9\
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    \8\ 49 U.S.C. 30113(b)(3)(B)(i)
    \9\ 49 CFR 555.6(a)(2)
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    NHTSA invites comment on how these considerations relate to Lotus's
petition for an exemption from the higher speed belted rigid barrier
test using the 5th percentile adult female test dummy. In this respect,
Lotus notes that it seeks exemption from only a single test performance
requirement rather than all of the advanced air bag requirements.

II. Statutory Authority for Temporary Exemptions

    The National Traffic and Motor Vehicle Safety Act (Safety Act),
codified as 49 U.S.C. Chapter 301, provides the Secretary of
Transportation authority to exempt, on a temporary basis and under
specified circumstances, motor vehicles from a motor vehicle safety
standard or bumper standard. This authority is set forth at 49 U.S.C.
30113. The Secretary has delegated the authority for implementing this
section to NHTSA.
    The Act authorizes the Secretary to grant a temporary exemption to
a manufacturer of not more than 10,000 motor vehicles annually, on such
terms as he deems appropriate, if he finds that the exemption would be
consistent with the public interest and the Safety Act and if he also
finds that ``compliance with the standard would cause substantial
economic hardship to a manufacturer that has tried to comply with the
standard in good faith.''
    NHTSA established Part 555, Temporary Exemption from Motor Vehicle
Safety and Bumper Standards, to implement the statutory provisions
concerning temporary exemptions. Under Part 555, a petitioner must
provide specified information in submitting a petition for exemption.
These requirements are specified in 49 CFR 555.5, and include a number
of items. Foremost among them are that the petitioner must set forth
the basis of the application under Sec.  555.6, and the reasons why the
exemption would be in the public interest and consistent with the
objectives of 49 U.S.C. Chapter 301.
    A manufacturer is eligible to apply for a hardship exemption if its
total motor vehicle production in its most recent year of production
did not exceed 10,000 vehicles, as determined by the NHTSA
Administrator (49 U.S.C. 30113).
    In determining whether a manufacturer of a vehicle meets that
criterion, NHTSA considers whether a second vehicle manufacturer also
might be deemed the manufacturer of that vehicle. The statutory
provisions governing motor vehicle safety (49 U.S.C. Chapter 301) do
not state that a manufacturer has substantial responsibility as
manufacturer of a vehicle simply because it owns or controls a second
manufacturer that assembled that vehicle. However, the agency considers
the statutory definition of ``manufacturer'' (49 U.S.C. 30102) to be
sufficiently broad to include sponsors, depending on the circumstances.
Thus, NHTSA has stated that a manufacturer may be deemed to be a
sponsor and thus a manufacturer of a vehicle assembled by a second
manufacturer if the first manufacturer had a substantial role in the
development and manufacturing process of that vehicle.
    While 49 U.S.C. 30113(b) states that exemptions from a Safety Act
standard are to be granted on a ``temporary basis,'' \10\ the statute
also expressly provides for renewal of an exemption on reapplication.
Manufacturers are nevertheless cautioned that the agency's decision to
grant an initial petition in no way predetermines that the agency will
repeatedly grant renewal petitions, thereby imparting semi-permanent
status to an exemption from a safety standard. Exempted manufacturers
seeking renewal must bear in mind that the agency is directed to
consider financial hardship as but one factor, along with the
manufacturer's ongoing good faith efforts to comply with the
regulation, the public interest, consistency with the Safety Act,
generally, as well as other such matters provided in the statute.
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    \10\ 49 U.S.C. 30113(b)(1).
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III. Overview of Petition

    In accordance with 49 U.S.C. 30113 and the procedures in 49 CFR
part 555, Group Lotus Plc (Lotus) has submitted a petition asking the
agency for a temporary exemption from one advanced air bag requirement
of FMVSS No. 208 for its Evora model. Specifically, the petition
requests an exemption from the advanced air bag requirement in S14.7,
which requires vehicles manufactured on or after September 1, 2012, to
meet the higher maximum speed (56 km/h (35 mph)) belted test
requirement using the 5th percentile adult female dummy.\11\ Lotus
requests this exemption only for the front passenger seat. The basis
for the application is that compliance would cause the petitioner
substantial economic hardship and that the petitioner has tried in good
faith to comply with the standard. Lotus has requested an exemption for
a period of 31 months from September 1, 2012 to March 31, 2015.
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    \11\ In its petition, Lotus asks for exemption from S15.1(b) and
S16.1(a)(2) as well. However, those provisions apply to only those
vehicles certified as complying with S14.6 or S14.7. If an exemption
is granted, the vehicle would not be required to be certified to
S14.7. S14.6 is the phase in for the higher speed 5th percentile
adult female belted barrier test requirement that is not applicable
to Lotus. In that instance, neither provision would apply to the
exempted vehicles. Furthermore, S16.1(a)(2) is the test procedure
for conducting the rigid barrier test using 5th percentile adult
female dummies. This test procedure contains no substantive
requirements for which Lotus would need exemption.
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    Lotus is a United Kingdom corporation. In the year prior to the
filing of its petition, Lotus produced a total of 3,115 vehicles.\12\
Lotus states that, since its inception, it has never manufactured more
than 10,000 vehicles in a year. Lotus states further that, although it
is owned by the Malaysian automobile manufacturer Proton, Proton is not
a ``sponsor'' of Lotus and its production should not be (and
historically has not been) aggregated with Lotus's production for the
purpose of determining eligibility for a temporary exemption. Lotus
anticipates that the number of exempted vehicles imported to the U.S.
if this petition is granted would be approximately 800.
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    \12\ This total includes 690 vehicles that were assembled for
Tesla Motors, Inc.
---------------------------------------------------------------------------

    Lotus previously obtained an exemption from the advanced air bag
requirements for its Elise model.\13\ In its petition for exemption
from the advanced air bag requirements for the Elise, Lotus committed
to equipping its next model, the Evora, with compliant advanced air
bags. Lotus states that, since its introduction to the U.S. market in
2010, the Evora has been fully compliant with FMVSS No. 208. However,
Lotus states that its sales have been lower than projected because of

Lotus's financial hardship, exacerbated by the global recession;
emergence of competition in its market segment; and the withdrawal of
the Elise from the U.S. market. Furthermore, Lotus states the Evora's
advanced air bag system will not comply with the higher speed 5th
percentile female belted occupant (passenger side, fully forward seat
position) barrier crash test without sourcing new components and
conducting a complete revalidation of the system. Lotus previously
believed that Evora sales would have been augmented by a new product
using substantially the same platform, upon which compliance with the
higher speed 5th percentile female belted requirements would have been
developed. However, Lotus states that it stopped that development
program due to poor Evora sales and repositioning of its business
(moving from the entry level premium segment to the high performance,
luxury sports car segment).
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    \13\ See 71 FR 52851, 52859-62 (Docket No. NHTSA-2006-25324).
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    Lotus states that the Evora cannot meet the higher speed 5th
percentile female belted test requirements because the Evora's air bag
electronic control unit (ECU) does not have the capability to monitor
whether the seat belt is buckled and its seat belt supplier does not
have a suitable buckle switch. A buckle switch would allow the ECU to
fire only the first stage of the air bag inflator for buckled occupants
while firing two stages for unbuckled occupants, allowing the stiffness
of the air bag to be different for belted and unbelted occupants. In
order to incorporate a buckle switch in the Evora, Lotus states that a
new air bag ECU would need to be sourced, calibrated, and validated; a
new seat belt system would need to be sourced; and a complete series of
development tests would need to be conducted.
    Lotus expects that this development would cost over $4 million.
Lotus states that it does not have sufficient financial resources to
complete this development. Lotus's financial statements show that from
the period between April 2007 and March 2010, the company experienced
losses of approximately $40 million. With an exemption, Lotus predicts
that it would make a profit of approximately $24 million between April
2010 and March 2014. Without an exemption, Lotus predicts its profit in
the same period would be reduced to $13 million. However, Lotus
contends that the financial impact would be greater because, without
the exemption, Lotus would withdraw from the U.S. market and lose its
market share, resulting in intangible losses such as loss of brand
image, complication of reentry into the U.S. market in the future, and
job losses.
    Lotus states that it has considered alternative means of
compliance, but these alternatives have been found to be incapable of
providing a solution. Lotus states that it could not use a seat belt
buckle sensor from its current seat belt supplier because the switch is
inadequate and there is not a suitable ECU. Lotus states that it
considered moving the passenger seat rearward, but concluded it would
have to reevaluate compliance with the 50th percentile male tests in
both the belted and unbelted conditions which would result in similar
costs to those described above. Lotus also states that it considered
fixing the passenger seat in the mid-position, but concluded that
occupant ingress/egress would be adversely affected and it would
prevent a 95th percentile occupant from fitting in the passenger seat.
    Lotus states that, while an exemption is in effect, it will provide
advice and warnings in its owners' manual identifying the risks
associated with correct positioning of the seat belt and sitting too
close to the air bag.

IV. Completeness and Comment Period

    Upon receiving a petition, NHTSA conducts an initial review of the
petition with respect to whether the petition is complete and whether
the petitioner appears to be eligible to apply for the requested
exemption. The agency has tentatively concluded that the petition from
Lotus is complete and that Lotus is eligible to apply for a temporary
exemption. The agency has not made any judgment on the merits of the
application, and is placing a non-confidential copy of the petition in
the docket.
    The agency seeks comment from the public on the merits of Lotus's
application for a temporary exemption from the higher speed 5th
percentile adult female belted barrier crash test in S14.7 of FMVSS No.
208. We are providing a 30-day comment period. After considering public
comments and other available information, we will publish a notice of
final action on the application in the Federal Register.

    Issued on: June 26, 2012.
Nathaniel Beuse,
Director, Office of Crash Avoidance Standards.
[FR Doc. 2012-16271 Filed 7-2-12; 8:45 am]
BILLING CODE 4910-59-P