[Federal Register Volume 83, Number 56 (Thursday, March 22, 2018)]
[Notices]
[Pages 12630-12633]
[FR Doc No: 2018-05793]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82890; File No. SR-ICEEU-2018-002]

Self-Regulatory Organizations; ICE Clear Europe Limited; Order
Granting Accelerated Approval of Proposed Rule Change Relating to the
ICE Clear Europe Limited CDS Procedures, CDS Risk Policy, and CDS Risk
Model Description

March 16, 2018.

I. Introduction

    On February 6, 2018 ICE Clear Europe Limited (``ICE Clear Europe'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ a proposed rule change (SR-
ICEEU-2018-002) to revise: (i) Its CDS Procedures to support the
clearing of a new transaction type; and (ii) its CDS Risk Policy, and
CDS Risk Model Description document to incorporate certain
modifications to its risk management methodology.\3\ The proposed rule
change was published for comment in the Federal Register on February
15, 2018.\4\ The Commission did not receive comments on the proposed
rule change. For the reasons discussed below, the Commission is
approving the proposed rule change on an accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Capitalized terms used in this order, but not defined
herein, have the same meaning as in the ICE Clear Europe Rules, CDS
Procedures, CDS Risk Policy, or CDS Risk Model Description.
    \4\ Securities Exchange Act Release No. 34-82678 (February 9,
2018), 83 FR 6909 (February 15, 2018) (SR-ICEEU-2018-002)
(``Notice'').
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II. Description of the Proposed Rule Change

    ICE Clear Europe proposed revisions to its CDS Procedures, CDS Risk
Policy, and Risk Model Description document in order to provide for the
clearing of a new transaction type, the Standard European Senior Non-
Preferred Financial Corporate, and to provide for revised risk
management practices.

A. Changes to ICE Clear Europe CDS Procedures

    ICE Clear Europe proposed amending Paragraph 4.3(c)(ii) of its CDS
Procedures, which sets forth the requirements for Trade Particulars for
CDS that are submitted for Clearing, to reference the Standard European
Senior Non-Preferred Financial Corporate transaction type.\5\
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    \5\ Notice, 83 FR at 6909.
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    ICE Clear Europe also proposed amending Paragraph 11.3(i) to revise
the definition of ``Non-STEC Single Name Contract'' to include the
Standard European Senior Non-Preferred Financial Corporate transaction
type in the list of Reference Entities eligible to be cleared by ICE
Clear Europe, and also proposed amending Paragraph 11.3(j) to remove a
requirement providing that the relevant obligation must be ``Senior
Level'' and replace it with a requirement that the relevant obligation
be of the ``applicable seniority level.'' \6\
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    \6\ Id. at 6909-10.
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B. Changes to ICE Clear Europe's Risk Model Description

    As currently constructed, ICE Clear Europe's risk management
methodology takes into consideration the potential losses associated
with idiosyncratic credit events, which ICE Clear Europe refers to as
``Loss-Given Default'' or ``LGD.'' ICE Clear Europe deems each Single
Name (``SN'') reference entity a Risk Factor, and each combination of
definition, doc-clause, tier, and currency for a given SN Risk Factor
as a SN Risk Sub-Factor. ICE Clear Europe currently measures losses
associated with credit events through a stress-based approach
incorporating three recovery rate scenarios: a minimum recovery rate,
an expected recovery rate, and maximum recovery rate. ICE Clear Europe
combines exposures for Outright and index-derived Risk Sub-Factors at
each recovery rate scenario.\7\
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    \7\ Id. at 6910.
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    ICE Clear Europe currently uses the results from the recovery rate
scenarios as an input into the Profit/Loss-Given-Default (``P/LGD'')
calculations at both the Risk Sub-Factor and Risk Factor levels. For
each Risk Sub-Factor, ICE Clear Europe calculates the P/LGD as the
worst credit event outcome, and for each Risk Factor, ICE Clear Europe
calculates the P/LGD as the sum of the worst credit outcomes per Risk
Sub-Factor. These final P/LGD results are used as part of the
determination of risk requirements.\8\
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    \8\ Id.
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    ICE Clear Europe proposed changes to its LGD framework at the Risk
Factor level with respect to the LGD calculation. Specifically, ICE
Clear Europe proposed a change to its approach by incorporating more
consistency in the calculation of the P/LGD by using the same recovery
rate scenarios applied to the different Risk Sub-Factors which are part
of the considered Risk Factor. For each Risk Factor, ICE Clear Europe
would continue to calculate an ``extreme outcome'' as the sum of the
worst Risk Sub-Factor P/LGDs across all scenarios and also would, for
each Risk Factor, calculate an ``expected outcome'' as the worst sum of
all the Risk Sub-Factors P/LGDs across all of the same scenarios. Under
the proposed changes, ICE Clear Europe would then combine the results
of the ``extreme outcome'' calculation and the ``expected outcome''
calculation to compute the total LGD for each Risk Factor.\9\ ICE Clear
Europe proposed to apply a weight of 25% to the extreme outcome
component in order to implement certain requirements of relevant
regulatory technical standards arising under the European Market
Infrastructure Regulation.\10\
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    \9\ Id.
    \10\ See Commission Delegated Regulation (EU) No 153/2013
supplementing Regulation (EU) No 648/2012 of the European Parliament
and of the Council with regard to regulatory technical standards on
requirements for central counterparties. ICE Clear Europe is
authorized as a central counterparty under the European Market
Infrastructure Regulation and is subject to the requirements
thereof.
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    ICE Clear Europe also proposed to expand its LGD analysis to
incorporate a new ``Risk Factor Group'' level. Under the proposed
changes, a set of related Risk Factors would form a Risk Factor Group
based on either (1) having a common majority parental sovereign
ownership (e.g. quasi-sovereigns and sovereigns), or (2) being a
majority owned subsidiary of a common parent entity according to the
Bloomberg Related Securities Analysis. ICE Clear Europe noted that a
Risk Factor Group could consist of only one Risk Factor.\11\
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    \11\ Notice, 83 FR at 6910.
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    Under the proposed revisions, ICE Clear Europe would calculate the
total quantity LGD on a Risk Factor Group level, and account for the
exposure due to credit events associated with the reference entities
within a given Risk Factor Group. Where a Risk Factor Group contains
only one Risk Factor, ICE Clear Europe would compute the LGD as the
risk exposure due to a credit event for a given underlying reference

entity. Moreover, under the proposed approach, ICE Clear Europe would
sum the P/LGDs for each Risk Factor in a given Risk Factor Group, with
limited offsets in the event the Risk Factors exhibit positive P/LGD.
Using the results of the above calculation, ICE Clear Europe would
obtain the Risk Factor Group level LGD. The proposed approach would
also include a calculation which allows for the Risk Factor Group level
LGD to be attributed to each Risk Factor within the considered Risk
Factor Group.\12\
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    \12\ Id.
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    In addition to these changes, ICE Clear Europe also proposed
changes to the ``Loss Given Default Risk Analysis'' section of its Risk
Model Description document to incorporate the Risk Factor and Risk
Factor Group LGD calculation changes described above, as well as to
incorporate certain conforming changes to other sections of the Risk
Model Description document to reflect the proposed Risk Factor Group
analysis.\13\
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    \13\ Id.
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    ICE Clear Europe also proposed further changes with respect to the
``Idiosyncratic Jump-to-Default Requirements'' section of the Risk
Model Description document. As currently constructed, the portfolio
jump-to-default approach collateralizes the worst uncollateralized LGD
(``ULGD'') exposure among all Risk Factors. Under the proposed changes,
the portfolio jump-to-default (``JTD'') approach would collateralize,
through the portfolio JTD initial margin requirement that accounts for
the Risk Factor Group-specific LGD collateralization, the worst ULGD
exposure among all Risk Factor Groups. The ULGD exposure for a given
Risk Factor Group would be calculated as a sum of the associated Risk
Factor ULGDs.\14\
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    \14\ Id.
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    ICE Clear Europe also proposed certain minor edits to the Specific
Wrong-Way Risk and General Wrong Way Risk sections of the Risk Model
Description document to update language and calculation descriptions to
accommodate the introduction of the Risk Factor Group to the
``Idiosyncratic Jump-to-Default Requirements'' section.\15\
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    \15\ Id.
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    In addition, ICE Clear Europe proposed changes to the ``Guaranty
Fund Methodology'' section of the Risk Model Description document. ICE
Clear Europe's current guaranty fund methodology includes, among other
things, the assumption that up to three credit events, different from
the ones associated with Clearing Members, occur during the considered
risk horizon. ICE Clear Europe proposed expanding this approach to the
Risk Factor Group level by assuming that credit events associated with
up to three Risk Factor Groups, different from the ones associated with
the Clearing Members and the Risk Factors that are in the Risk Factor
Groups as the Clearing Participants, occur during the considered risk
horizon.\16\
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    \16\ Id.
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    Additional amendments to ICE Clear Europe's Risk Model Description
document include minor typographical and technical corrections and
clarifications.\17\
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    \17\ Id. at 6911.
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C. Changes to ICE Clear Europe's CDS Risk Policy

    ICE Clear Europe proposed conforming edits to its CDS Risk Policy
in order to incorporate the changes described above. Specifically, ICE
Clear Europe proposed to amend the definition of Risk Sub-Factor, as
set forth in the CDS Risk Policy, so that it is defined as a particular
combination of single-name reference, tier, currency, and documentation
clause.\18\ In addition, ICE Clear Europe proposed to amend the CDS
Risk Policy to provide that the worst LGD associated with a Risk Factor
Group will be used to determine the JTD requirement, instead of the
worst single-name LGD, and also proposed amendments that would clarify
that a Risk Factor Group would consist of a set of Risk Factors related
by a common parental ownership.\19\
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    \18\ Id.
    \19\ Id.
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III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act directs the Commission to approve a
proposed rule change of a self-regulatory organization if it finds that
such proposed rule change is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to such
organization.\20\ For the reasons given below, the Commission finds
that the proposal is consistent with Section 17A(b)(3)(F) of the Act,
and Rules 17Ad-22(b)(2), (b)(3), (e)(4)(ii), and (e)(6)(i).
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    \20\ 15 U.S.C. 78s(b)(2)(C).
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A. Consistency With Section 17A(b)(3)(F) of the Act

    Section 17A(b)(3)(F) of the Act requires, among other things, that
the rules of a registered clearing agency be designed to promote the
prompt and accurate clearance and settlement of securities transactions
and, to the extent applicable, derivative agreements, contracts, and
transactions, to assure the safeguarding of securities and funds which
are in the custody or control of the clearing agency or for which it is
responsible and, in general, to protect investors and the public
interest.\21\ The proposed rule change will provide for the clearance
and settlement of the Standard European Senior Non-Preferred Financial
Corporate, a new type of transaction that is similar to contracts
already cleared by ICE Clear Europe.
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    \21\ 15 U.S.C. 78q-1(b)(3)(F).
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    Separately, as described above, the proposed rule change would also
provide for certain revisions to ICE Clear Europe's risk management
methodology with respect to its LGD methodology. These changes entail
(i) incorporating a more consistent approach with respect to ICE Clear
Europe's recovery rate scenarios through the application of the same
recovery rate scenarios to risk factors that form part of the same Risk
Factor Group, (ii) combining the results of the ``expected'' and
``extreme'' P/LGD outcomes in order to calculate the total LGD for each
Risk Factor, (iii) expanding ICE Clear Europe's LGD analysis to a new
Risk Factor Group level, (iv) revising the calculation of the
Uncollateralized Loss Given Default to incorporate the Risk Factor
Group level LGD approach, and (v) modifying ICE Clear Europe's Guaranty
Fund Methodology to expand the credit event analysis to include the
Risk Factor Group approach.
    Based on a review of the Notice, the Commission believes that the
Standard European Senior Non-Preferred Financial Corporate transaction
type is substantially similar to other contracts cleared by ICE Clear
Europe. As such, the Commission believes that ICE Clear Europe's
existing clearing arrangements, and related financial safeguards
(including as further modified by the proposed rule change),
protections and risk management procedures will apply to this new
product on a substantially similar basis to the other contracts
currently cleared by ICE Clear Europe.
    Moreover, the Commission believes that the proposed changes to ICE
Clear Europe's risk management framework described above will enhance
the manner by which ICE Clear Europe considers and manages the risks
particular to the range of contracts it clears, including the new
Standard European Senior Non-Preferred Financial Corporate contract,
because such changes will enable ICE Clear

Europe to more accurately consider the particular risks of each type of
product it clears, including security-based swap products. Therefore,
the Commission finds that the proposed rule change is intended to
promote the prompt and accurate clearance and settlement of securities
transactions and derivatives agreements, contracts, and transactions,
as well as to assure the safeguarding of securities and funds which are
in the custody or control of the clearing agency or for which it is
responsible and, in general, to protect investors and the public
interest, and is therefore consistent with Section 17A(b)(3)(F) of the
Act.\22\
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    \22\ Id.
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B. Consistency With Rules 17Ad-22(b)(2) and (e)(6)(i)

    The Commission further finds that the proposed rule change is
consistent with Rules 17Ad-22(b)(2) and (e)(6)(i). Rule 17Ad-22(b)(2)
requires, in relevant part, a registered clearing agency that performs
central counterparty services to establish, implement, maintain and
enforce written policies and procedures reasonably designed to use
margin requirements to limit the registered clearing agency's credit
exposures to participants under normal market conditions and use risk-
based models and parameters to set margin requirements.\23\ Rule 17A-
d22(e)(6)(i) requires, in relevant part, that a covered clearing agency
that provides central counterparty services establish, implement,
maintain and enforce written policies and procedures reasonably
designed to cover its credit exposures to its participants by
establishing a risk-based margin system that, at a minimum, considers,
and produces margin levels commensurate with, the risks and particular
attributes of each relevant product, portfolio, and market.\24\
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    \23\ 17 CFR 240.17Ad-22(b)(2).
    \24\ 17 CFR 240.17Ad-22(e)(6)(i).
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    As described above, the proposed changes would (i) amend the manner
in which ICE Clear Europe calculates its Risk Factor-level LGD, (ii)
expand the LGD analysis to the Risk Factor Group level, and (iii) amend
the approach to calculating the Uncollateralized LGD to incorporate the
Risk Factor Group level approach. Specifically, ICE Clear Europe would
calculate, for each Risk Factor, an extreme outcome as the sum of the
worst Risk Sub-factor P/LGDs across all scenarios, and an expected
outcome as the worst sum of all Risk Sub-factor P/LGDs using the same
scenarios, and then add the two components to determine the total LGD
for each Risk Factor.
    The LGD analysis would also be modified to group individual Risk
Factors into Risk Factor Groups, and would result in the total LGD
being the sum of the P/LGDs for each Risk Factor within the Risk Factor
Group. The Commission believes that by making these changes, ICE Clear
Europe will augment its ability to more accurately consider the risks
associated with the products it clears, including the Standard European
Senior Non-Preferred Financial Corporate transaction type.
    As a result, the Commission believes that the proposed rule change
will facilitate the establishment of a risk-based margin system that
considers, and produces margin levels commensurate with, the risks and
particular attributes of the relevant product, portfolio, and market,
and will also enable ICE Clear Europe to more accurately determine and
collect the amount of resources necessary to limit its credit exposures
under normal market conditions, including credit exposures resulting
from clearing the new transaction type, through the use of risk-based
models. Therefore the Commission finds that the proposed rule change is
consistent with Rules 17Ad-22(b)(2) and (e)(6).\25\
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    \25\ 17 CFR 240.17Ad-22(b)(2) and (e)(6)(i).
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C. Consistency With Rules 17Ad-22(b)(3) and (e)(4)(ii)

    The Commission further finds that the proposed rule change is
consistent with Rules 17Ad-22(b)(3) and (e)(4)(ii). Rule 17Ad-22(b)(3)
requires, in relevant part, a registered clearing agency that performs
central counterparty services to establish, implement, maintain and
enforce written policies and procedures that are reasonably designed to
maintain sufficient financial resources to withstand, at a minimum, a
default by the two participant families to which it has the largest
exposures in extreme but plausible market conditions.\26\ Rule 17Ad-
22(e)(4)(ii) requires, in relevant part, that a covered clearing agency
establish, implement, maintain and enforce written policies and
procedures reasonably designed to effectively identify, measure,
monitor, and manage its credit exposures to participants and those
arising from its payment, clearing, and settlement processes, including
by, for covered clearing agencies that are clearing agencies involved
in activities with a more complex risk profile, maintaining additional
financial resources at the minimum to enable it to cover a wide range
of foreseeable stress scenarios that include, but are not limited to,
the default of the two participant families that would potentially
cause the largest aggregate credit exposure for the covered clearing
agency in extreme but plausible market conditions.\27\
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    \26\ 17 CFR 240.17Ad-22(b)(3).
    \27\ 17 CFR 240.17Ad-22(e)(4)(ii).
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    As described above, the proposed rule change would amend certain
assumptions in ICE Clear Europe's Guaranty Fund Methodology, and the
calculation of the Specific Wrong Way Risk component of its guaranty
fund, by incorporating the new Risk Factor Group level analysis.
Specifically, ICE Clear Europe would expand its current approach to
assume that credit events used in the guaranty fund analysis occur at
the Risk Factor Group level, and would also base the specific wrong-way
risk component of its Guaranty Fund Methodology on the Risk Factor
Group approach.
    As with the changes to the LGD approach, the Commission believes
that the proposed changes to ICE Clear Europe's Guaranty Fund
Methodology will permit ICE Clear Europe to more accurately consider
the particular risks associated with the products it clears, including
the Standard European Senior Non-Preferred Financial Corporate
transaction type, that will be cleared as a result of the proposed
changes to ICE Clear Europe's CDS Procedures described above. As a
result, the Commission believes that the proposed changes will enable
ICE Clear Europe to more accurately measure the risks of associated
with the products it clears and thereby improve ICE Clear Europe's
ability to collect and maintain the level of financial resources
necessary to cover a wide range of foreseeable stress scenarios that
include, but are not limited to, the default of the two participant
families that would potentially cause the largest aggregate credit
exposure under extreme but plausible market conditions. Therefore, the
Commission finds that the proposed rule change is consistent with Rules
17Ad-22(b)(3) and (e)(4)(ii).\28\
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    \28\ 17 CFR 240.17Ad-22(b)(3) and (e)(4)(ii).
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    Section 19(b)(2)(C)(iii) of the Act allows the Commission to
approve a proposed rule change earlier than 30 days after the date of
publication of the notice of the proposed rule change where the
Commission finds good cause for so doing and publishes the reason for
the finding.\29\ The Commission finds good cause, pursuant to Section
19(b)(2)(C)(iii) of the Act, for approving the proposed rule change on
an accelerated basis prior to the 30th day

after the date of publication of the notice in the Federal Register in
order to facilitate the clearing of the Standard European Senior Non-
Preferred Financial Corporate transaction type, which the Commission
understands market participants will commence trading beginning on
March 20, 2018 \30\ and which are tied to European capital and
resolution regulations.
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    \29\ 15 U.S.C. 78s(b)(2)(C)(iii).
    \30\ See IHS Markit iTraxx Europe Rule Announcement, February 6,
2018 (stating that for iTraxx Europe Series 29, for French bank
OpCos that qualify for inclusion in the index, the senior non-
preferred reference obligations will be selected if available).
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IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change is consistent with the requirements of the Act and
in particular with the requirements of Section 17A of the Act,\31\ and
Rules 17Ad-22(b)(2), (b)((3), (e)(4)(ii), and (e)(6)(i) thereunder.\32\
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    \31\ 15 U.S.C. 78q-1.
    \32\ 17 CFR 240.17Ad-22(b)(2), (b)(3), (e)(4)(ii) and (e)(6)(i).
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    It Is Therefore Ordered pursuant to Section 19(b)(2) of the Act
\33\ that the proposed rule change (SR-ICEEU-2018-002) be, and hereby
is, approved on an accelerated basis.\34\
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    \33\ 15 U.S.C. 78s(b)(2).
    \34\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).
    \35\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\35\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-05793 Filed 3-21-18; 8:45 am]
 BILLING CODE 8011-01-P


--------------------------------------------------------------------------------
 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
--------------------------------------------------------------------------------
REGION 8
--------------------------------------------------------------------------------
1595 Wynkoop Street
--------------------------------------------------------------------------------
Denver, CO   80202-1129
--------------------------------------------------------------------------------
Phone<PHONE_NUMBER>
--------------------------------------------------------------------------------
		www.epa.gov/region8

Ref: 8ARD-PM

Thomas H. Gibbons
HES Professional
MPLX
1515 Arapahoe Street, Tower 1, Suite 1600
Denver, Colorado  80202

Re: 	MPLX, LP, Chapita, Wonsits Valley and Coyote Wash Compressor Station Minor Modifications to Operating Permits

Dear Mr. Gibbons:

This letter is regarding the minor permit modifications to the initial 40 CFR part 71 operating permits (Part 71 permits), permit numbers:

      Chapita Compressor Station, V-UO-000012-2018.01
      Wonsits Valley Compressor Station, V-UO-000005-2018.00
      Coyote Wash Compressor Station, V-UO-000015-2018.00

On July 23, 2021, the U.S. Environmental Protection Agency, Department of Justice and MPLX, LP agreed to modify the terms of surviving Paragraph 23 of a Consent Decree (United States v. Questar Gas
Management Co., Case No. 2:09-CV-00167-TS-PMV) to effect the following change: MPLX may use Test Method 320 of 40 CFR part 63, appendix A (Method 320) in lieu of Method 7E of 40 CFR part 60 (Method 7E) and Method 10 of 40 CFR part 60 (Method 10) for the measurement of nitrogen oxides and carbon monoxide, respectively, at its facilities (i.e., Chapita Compressor Station, Coyote Wash Compressor Station and Wonsits Valley Compressor Station).

Therefore, we are concurrently issuing the revised Title V permits to accurately describe and permit the correct engine test methods approved at the Chapita Compressor Station, Coyote Wash Compressor Station and Wonsits Valley Compressor Station. We also modified Wonsits Valley Compressor Station and Coyote Wash Compressor Station to show the ability to submit reports via the Compliance and Emissions Data Reporting Interface (CEDRI). We have determined that the modifications can be classified as a minor permit modification in accordance with 40 CFR 71.7(e)(1) and have revised the Title V permits accordingly. Permit amendments and revisions are not subject to public participation requirements.

The modified operating permits and all other supporting documents are accessible for your review at https://www.epa.gov/caa-permitting/caa-permits-issued-epa-region-8 or in their respective dockets at https://www.regulations.gov:

      Chapita Compressor Station, EPA-R08-OAR-2018-0346
      Wonsits Valley Compressor Station, EPA-R08-OAR-2018-0349
      Coyote Wash Compressor Station, EPA-R08-OAR-2019-0196

The modified Title V permits are being issued with the following permit numbers:

      Chapita Compressor Station, V-UO-000012-2018.02
      Wonsits Valley Compressor Station, V-UO-000005-2018.01
      Coyote Wash Compressor Station, V-UO-000015-2018.01

Please note that these modified Title V permit issuances will not change the originally issued permit expiration dates.

If you have any questions concerning the final modified permits, please contact Colin Schwartz, of my staff, at<PHONE_NUMBER> or at<EMAIL_ADDRESS>

                                    Sincerely,

							Carl Daly
                                    Acting Director
							Air and Radiation Division

cc:	Mike Natchees, Director, Air Quality Program, Ute Indian Tribe


[Federal Register: June 29, 2009 (Volume 74, Number 123)]
[Proposed Rules]
[Page 30993-30996]
[DOCID:fr29jn09-20]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 571

[Docket No. NHTSA-2001-8876]

Federal Motor Vehicle Safety Standard No. 108; Lamp, Reflective
Devices and Associated Equipment

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

ACTION: Denial of petition for rulemaking.

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SUMMARY: This document denies a petition for rulemaking submitted by
General Motors on December 20, 2001. The petitioner requested that the
agency amend the Federal motor vehicle safety standard (FMVSS) on
lamps, reflective devices, and associated equipment to require the
installation of daytime running lamps on passenger cars, multipurpose
passenger vehicles, trucks, and buses that have a gross vehicle weight
rating under 4,536 kilograms (10,000 lbs). NHTSA has reviewed the
petition and performed an extensive analysis of real world crash data.
Based on the results of our study we were unable to find solid evidence
of an overall safety benefit associated with daytime running lamps and
are therefore denying the petition for rulemaking. The agency maintains
its neutral position with respect to the safety benefits from the use
of daytime running lamps.

FOR FURTHER INFORMATION CONTACT: For non-legal issues, you may call Mr.
Markus Price, Office of Crash Avoidance Standards (Phone:<PHONE_NUMBER>;
FAX:<PHONE_NUMBER>).
    For legal issues, you may call Mr. Ari Scott, Office of the Chief
Counsel (Phone:<PHONE_NUMBER>; FAX:<PHONE_NUMBER>).
    You may send mail to these officials at: National Highway Traffic
Safety Administration, 1200 New Jersey Avenue, SE., Washington, DC
20590.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Summary
II. Background
III. Petition
IV. Agency Analysis and Decision
    a. NHTSA Studies and Comparison
    b. Differences in Statistical Methodology
V. Conclusion

I. Summary

    This document denies a 2001 petition from General Motors (GM)
requesting that the National Highway Traffic Safety Administration
(NHTSA) mandate the installation of daytime running lamps (DRLs) on all
vehicles with a gross vehicle weight rating (GVWR) under 4,536
kilograms (10,000 lbs). The rationale for denying the petition is that,
overall, studies of the effectiveness of DRLs have not indicated that
they are an effective means of preventing crashes. While GM presented
studies that appear to indicate a degree of effectiveness, NHTSA's own
studies contradict that finding. Furthermore, for reasons described in
detail below, a careful analysis of the various studies of DRL
effectiveness indicates flaws in the studies GM cites and that NHTSA
should place greater weight on its own studies. Given the information
currently available, the agency has been unable to determine if there
are any demonstrable safety benefits associated with mandating DRLs,
and therefore has decided that leaving them as a manufacturer option is
the best course of action.

II. Background

    Federal Motor Vehicle Safety Standard (FMVSS) No. 108; Lamps,
reflective devices, and associated equipment, establishes lighting
requirements for motor vehicles. Daytime Running Lamps (DRLs) are
steady burning lamps that illuminate when the regular headlamps are not
required for driving. While FMVSS No. 108 does not require DRLs, it
does specify requirements that they must meet if a vehicle manufacturer
voluntarily decides to install them.\1\
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    \1\ See 49 CFR 571.108, S7.10.1, Table I-a.
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    The requirements for DRLs were first established on January 11,
1993 in

response to a petition from General Motors (GM) that asked the agency
to facilitate the introduction of DRLs on motor vehicles. At that time,
GM's view was that an amendment ``would allow manufacturers to install
DRLs on new vehicles without being in violation of the multitude of
State laws'' which at that time had ``the unintended effect of
prohibiting them.'' Also, GM did not believe that there was
justification for mandating DRLs as standard equipment because there
was not yet evidence of a ``national safety need'' in the United
States. As a result of GM's petition, FMVSS No. 108 was amended to
permit, but not require, DRLs that comply with various marking and
performance requirements.\2\
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    \2\ See 59 FR 3501 January 11, 1993.
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III. Petition

    On December 20, 2001, GM petitioned the agency requesting that DRLs
be made required equipment on passenger vehicles, trucks and buses that
have a gross vehicle weight rating under 4,536 kilograms (10,000 lbs).
In support of its petition, GM provided information from a study that
reported a 5 percent decrease in daytime multiple vehicle crashes and a
9 percent reduction in vehicle to pedestrian crashes.\3\ GM claimed
that this report ``demonstrates that DRLs are preventing crashes and
injuries, and saving lives.'' The data supporting this study were
collected in 12 States from the years 1994 to 1997, using vehicle
registration as a measure of exposure, and the ratio of crash rates
estimated by the Poisson regression statistical method (described in
detail below).
---------------------------------------------------------------------------

    \3\ Docket No. NHTSA-2001-8876-11.
---------------------------------------------------------------------------

    As an update to the 2000 study, GM most recently sponsored a study
written by Steffey, Lau, and Ray of Exponent, Inc in 2008.\4\ This
study examined vehicles manufactured by GM, Saab, Toyota, Subaru,
Volkswagen and Volvo. Crash data were analyzed from 18 States between
the years 1996 and 2005. This study used two mathematical methods to
determine if there was a link between DRLs and crash rates, the ratio
of odds ratio method and the ratio of crash rates. This study reported
the impact of DRLs on various types of vehicle crashes including head-
on, rural area, highway, rain/fog, angle, urban area, sideswipe,
pedestrian, and motorcycle.
---------------------------------------------------------------------------

    \4\ Docket No. NHTSA-2001-8876-15.
---------------------------------------------------------------------------

    The Steffey et al. (2008) study reported a statistically
significant reduction in crashes associated with DRLs. For passenger
cars, it reported a reduction in daytime head-on multi-vehicle crashes
of 12.35 percent using the ratio of crash rates method. This study also
reported a significant reduction in rural area daytime multi-vehicle
crashes of 9.1 percent for passenger cars using this method.\5\ Similar
results were reported for light trucks. Similar to the 2001 GM study,
this study reported a 5 percent decrease in daytime multiple vehicle
crashes, but contrary to the 2001 study, a non-significant increase in
vehicle to pedestrian crashes of 2.5 was observed. No statistically
significant results were found for fatal crashes.
---------------------------------------------------------------------------

    \5\ Docket No. NHTSA-2001-8876-15 Steffey et al., p. 21.
---------------------------------------------------------------------------

    This study also analyzed the data using the ratio of odds ratio
technique. GM stated that this methodology produced findings that
correlated DRLs with a reduction in certain crash types. However,
NHTSA's analysis found, with regard to the overall crash rates
experienced by vehicles equipped with DRLs, the Steffey et al. study's
analysis using the ratio of odds ratios method did not produce a
statistically significant decrease in the crash rates of those
vehicles.\6\
---------------------------------------------------------------------------

    \6\ Docket No. NHTSA-2001-8876-15 Steffey et al. page 38.
---------------------------------------------------------------------------

IV. Discussion and Analysis

    After carefully reviewing the data in GM's petition, NHTSA has come
to the conclusion that the evidence linking DRLs to lower incidents of
crashes is not persuasive. To begin, NHTSA believes that one of the
statistical techniques used in the two GM studies, the ratio of crash
rates method, is less effective in this case than the ratio of odds
ratio method used in the three NHTSA studies (to be fair, this
methodology was also employed in the Steffey et al. study).
Additionally, certain correlations in the GM study raise questions as
to the validity of its findings. Contrary to this, NHTSA's studies do
not show that DRLs are an effective means of crash avoidance. Given
these issues, NHTSA does not believe that the case has been made to
incorporate a change to require DRLs.

A. NHTSA Studies and Comparison

    In 2000, NHTSA published a study that examined the effectiveness of
DRLs installed on passenger cars manufactured in the 1990s.\7\ In that
study, no statistically significant results were found using the ratio
of odds ratio method. In 2004, NHTSA again reported on the
effectiveness of DRLs on crashes within the U.S.\8\ Again, using a
broader data set and a different control group, no results using the
ratio of odds ratio method produced statistical significance.
---------------------------------------------------------------------------

    \7\ DOT HS 808 645 Table 24 & 25 Available at http://
www.nhtsa.dot.gov/people/ncsa/pdf/DRL7_RPT.pdf.
    \8\ DOT HS 809 760 Appendix B Available at http://www-
nrd.nhtsa.dot.gov/Pubs/809760.PDF.
---------------------------------------------------------------------------

    In 2008, NHTSA completed a new study on the effectiveness of
DRLs.\9\ The data source is FARS (2000-2005), and State data from 9
States (2000-2005). The results of this NHTSA study (2008) are
inconclusive regarding overall DRL effectiveness. When both light truck
and cars are evaluated together, the result of DRL installation is a
non-statistically significant decrease in two vehicle, all severity
crashes of 0.3 percent (-2.5-3.1, 0.95 confidence). A statistically
significant decrease of 5.7 percent (0.7-10.7, 0.95 confidence) in two
vehicle type crashes for light trucks is somewhat offset by a non-
significant 2 percent (-5.4-1.4, 0.95 confidence) increase in passenger
car crashes of the same type and severity. Further complicating
attempts to find a definitive pattern of safety impact that DRLs have,
this study finds a non-significant increase of 12.2 percent (-50.1-
25.7, 0.95 confidence) in light truck-motorcycle crashes. Contrarily,
it also reports that a non-significant decrease of 1.2 percent (-18.5-
20.9, 0.95 confidence) is observed for passenger cars of the same crash
type. Continuing, this study was also unable to find a clear pattern of
effectiveness between States. An overview of the results finds some
positive and some negative results depending on crash type and crash
severity. When all crashes are considered, a non-significant decrease
of 0.1 percent is observed, demonstrating the overall safety benefits
of DRLs in this study are inconclusive.
---------------------------------------------------------------------------

    \9\ HS 811 029.
---------------------------------------------------------------------------

    The agency is aware of some groups' concerns that DRLs may have a
detrimental impact on motorcycle safety. The concern is that as
motorcycles have historically been the only class of vehicles using
DRLs, as other vehicle classes begin to use DRLs the unique conspicuity
provided to motorcycles by DRLs will be diminished. Neither the GM, nor
the agency's studies are able to establish new evidence with respect to
this concern. Therefore, the potential ``masking effect'' is still
unknown and was not considered in this denial notice analysis.
    The agency believes that the result derived based on the ratio of
odds ratios are more plausible and defendable than those based on crash
rates used in GM's study. The Steffey et al. study found a

4.28 percent decrease in nighttime multi-party car crashes as a result
of DRL installation. It also found a 3.67 percent decrease in single
vehicle light truck crashes. Additionally, the report found that DRLs
would reduce nighttime fatal crashes by 11.4 percent for passenger cars
and daytime single-vehicle crashes by 9.4 percent for light trucks.\10\
These results cast doubt on the validity of the GM study because we do
not believe these crash types are plausibly affected by DRL
installation. The authors claim these numbers ``serve as useful control
groups and benchmarks for comparison.'' \11\ The agency respectfully
disagrees, and believes this may demonstrate the lack of control for
changes that may have occurred during the study period. Another
limitation regarding this GM study is the different time period for
which vehicle registration was recorded compared to the times that the
crashes occurred. The registration numbers were recorded as a snapshot
in time on July first, but the crashes occurred throughout the entire
year. This time difference may cause inaccuracies in the number of
vehicles in the exposure group.
---------------------------------------------------------------------------

    \10\ Docket No. NHTSA-2001-8876-15 Steffey et al., p. 24-25.
    \11\ Docket No. NHTSA-2001-8876-15 Steffey et al. p. 20.
---------------------------------------------------------------------------

B. Differences in Statistical Methodology

    As discussed above, numerous studies exist that attempt to quantify
the crash risk relative to the installation of DRLs. Among these
studies, various statistical techniques have been used for determining
the effectiveness in real world crashes, including the ratio of odds
ratios method (used in the NHTSA studies), and the ratio of crash rates
method (used in the GM studies). NHTSA believes that the ratio of odds
ratios is the most effective means for the analysis in these studies.
    The primary statistical technique used in the studies submitted by
GM in support of its petition is the ratio of crash rates method. This
was used in the 2001 GM study, and was also used in certain parts of
the 2008 Steffey et al. study. This technique compared the ratio of
crashes to the number of vehicles of that type registered. This
collision rate is calculated and compared for both vehicles with DRLs
and for vehicles without DRLs. This comparison reportedly represents
the effectiveness of the DRL. This is mathematically represented as
follows:
[GRAPHIC] [TIFF OMITTED] TP29JN09.011

    Continuing, this expression is modeled using a Poisson regression
model to estimate the overall DRL effect across all model pairs.
Because this method uses vehicle registration as the measure of
exposure, it may not reflect the actual on-road exposure of vehicles in
use that, in actuality, may be involved in a crash. For example, this
methodology would assign equal weight to a vehicle driven five miles
per day as to a vehicle driven 25 miles per day, despite the fact that
the latter vehicle is far more exposed to the risk of a crash.
    The ratio of odds ratios method, which was used in NHTSA's studies
and in some parts of the Steffey et al. study, avoids using vehicle
registration as a method of exposure. This method compares the ratio of
target crashes in the daytime with control crashes in the daytime. It
continues by calculating the ratio of target crashes at night compared
to the control crashes at night. The ratio of these ratios is then
considered the odds of a vehicle becoming involved in a DRL relevant
crash. This ratio is calculated for both a group of DRL-equipped
vehicles, and for a group of vehicles which do not have DRLs installed.
A comparison of the two groups' odds then determines the effectiveness
of the DRL. This method is demonstrated as follows:

                          DRL-Equipped Vehicles
------------------------------------------------------------------------
         Light condition            Target crashes      Control crashes
------------------------------------------------------------------------
Daytime.........................  N1................  N2.
Nighttime.......................  N3................  N4.
------------------------------------------------------------------------

                            Non-DRL Vehicles
------------------------------------------------------------------------
         Light condition            Target crashes      Control crashes
------------------------------------------------------------------------
Daytime.........................  N5................  N6.
Nighttime.......................  N7................  N8.
------------------------------------------------------------------------

                                                      [GRAPHIC] [TIFF OMITTED] TP29JN09.012

    The value of R represents the relative odds of daytime target
crashes involvements between DRL-equipped vehicles and non-DRL
vehicles. The agency believes the ratio of odds ratio is the optimal
method because it has a strong confounding-factor-control ability. With
regard to the previous example, the ratio of odds ratios would factor
in a higher expected crash rate for the vehicle driven 25 miles per day
than the vehicle driven five.
    The ratio of odds ratios avoids using crash rates because the true
exposure data generally do not exist. In GM's case, with regard to the
portion of the study that utilized the ratio of crash rates method,
vehicle registrations were used as the exposure data. However,
registration data do not differentiate driving between DRL and non-DRL
vehicles. They do not separate daytime and nighttime driving.
Consequently, vehicle registrations are not considered to be an
appropriate exposure measure for a DRL study. The contradicting results
from the GM study demonstrate this. In contrast, the ratio of odds
ratios method compares the ratio of target crashes (DRL-relevant) to
control crashes (non DRL-relevant) in the daytime.
    The Steffey et al. study incorporated both of the methodologies in
arriving at its conclusions. Using the ratio of crash rates method, the
study found an overall decrease in crash rates of 4.61 percent, which
was noted as statistically significant.\12\ However, using the ratio of
odds ratios method, the same report found a non-significant decrease in
the crash rates of 1.36 percent.\13\ Given the significant divergence
in results from the different methodologies, we feel that the results
from the ratio of crash rates methodology should be assigned less
weight in NHTSA's analysis of the safety effect of DRLs.
---------------------------------------------------------------------------

    \12\ Steffey et al., p. 34.
    \13\ Steffey et al., p. 38.
---------------------------------------------------------------------------

V. Conclusion

    The agency's 2008 DRL study is a more robust study than previous
attempts by the agency to quantify the effectiveness of DRLs. This
newest study was unable to find solid evidence of overall safety
benefits associated with DRLs installed on passenger vehicles using the
ratio of odds ratio statistical technique. While DRLs may be beneficial
for certain scenarios, the agency has been unable to document overall
safety benefits due to DRL installation which could serve as a basis
for mandating them. NHTSA is therefore denying this petition from GM.
However, the agency is willing to re-examine the DRL issue if
additional data is presented demonstrating overall safety benefits. Any
such study should consider using the ratio of odds ratios technique as
used in the latest NHTSA study, or provide compelling evidence that an
alternative technique is superior at predicting the effectiveness of
DRLs. In the meantime, the agency remains neutral with respect to a
policy regarding the inclusion of DRLs in vehicles. Although we do not
find data that provides a definitive safety benefit that justifies
Federal regulation, we are not making recommendations that vehicle
manufacturers should change their policies regarding DRLs.
Manufacturers should continue to make individual decisions regarding
DRLs in their vehicles.

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

    Issued: June 23, 2009.
Nathaniel Beuse,
Director, Office of Crash Avoidance Standards.
[FR Doc. E9-15314 Filed 6-26-09; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register: October 17, 2007 (Volume 72, Number 200)]
[Notices]
[Page 58929-58936]
[DOCID:fr17oc07-129]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2007-28055]

Demonstration Project on NAFTA Trucking Provisions

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice; request for public comment.

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

SUMMARY: The FMCSA announces and requests public comment on data and
information concerning the Pre-Authority Safety Audits (PASAs) for
motor carriers that have applied to participate in the Agency's project
to demonstrate the ability of Mexico-domiciled motor carriers to
operate safely in the United States beyond the commercial zones along
the U.S.-Mexico border. This action is required by the ``U.S. Troop
Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability
Appropriations Act, 2007.''

DATES: Comments must be received on or before November 1, 2007.

ADDRESSES: You may submit comments identified by FDMS Docket ID Number
FMCSA-2007-28055 by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the online instructions for submitting

comments.
    Alternatively, you can file comments using the following methods:
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., Room W12-140, Washington,
DC 20590.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Request for
Comments heading of the Supplementary Information section of this
document. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information

provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov. Follow the online

instructions for accessing the dockets.

FOR FURTHER INFORMATION CONTACT: Mr. Milt Schmidt, Division Chief,
North American Borders Division, Telephone<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Background

    On May 25, 2007, the President signed into law the U.S. Troop
Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability
Appropriations Act, 2007 (the Act), (Public Law 110-28). Section 6901
of the Act requires that certain actions be

taken by the Department of Transportation (the Department) as a
condition of obligating or expending appropriated funds to grant
authority to Mexico-domiciled motor carriers to operate beyond United
States municipalities and commercial zones on the United States-Mexico
border (border commercial zones).
    Section 6901(b)(2)(B)(i) of the Act requires FMCSA to publish
comprehensive data and information on the pre-authorization safety
audits (PASAs) conducted before and after the date of enactment of the
Act of motor carriers domiciled in Mexico that are granted authority to
operate beyond the border commercial zones. As of October 9, 2007, five
carriers have been granted authority to operate beyond the border
commercial zones as part of this demonstration project. However, FMCSA
has chosen to publish for public comment data and information relating
to all PASAs conducted as of October 9, 2007.
    On June 8, 2007, FMCSA published PASA data for all motor carriers
that had applied to participate in the demonstration project, based on
information available as of May 31, 2007. The FMCSA announces that the
following Mexico-domiciled motor carriers in Table 1 have successfully
completed their PASAs since the publication of the June 8 notice:

                                 Table 1
------------------------------------------------------------------------
   Row number in tables 2
 through 4 of the Appendix         Name of carrier         USDOT  number
     to today's notice
------------------------------------------------------------------------
3..........................  ARTEMIO GUERRERO ZAVALA....          555995
6..........................  GUADALUPE OCON & RUFUGIO             557217
                              ROMO SAUCEDO.
12.........................  JOSE DAVID RUVALCABA ADAME.          563815
13.........................  TRINITY INDUSTRIES DE                610385
                              MEXICO, S. DE R.L. DE C.V..
15.........................  GCC TRANSPORTE, S.A. DE              650155
                              C.V..
18.........................  MOISES ALVAREZ PEREZ.......          677516
22.........................  VERONICA GONZALEZ &                  736405
                              GILBERTO GONZALEZ NUNO.
24.........................  NOE BASILIO MONTIEL........          786826
25.........................  QNW DE BAJA SA DE CV.......          791091
31.........................  EDS INTERNACIONAL SA DE CV.          924559
32.........................  OSCAR HILARIO MARTINEZ.....          947058
34.........................  FIDEPAL S DE RL DE IP Y CV.          975522
44.........................  AVOMEX INTERNACIONAL SA DE          1142107
                              CV.
45.........................  AGUIRRE RAMOS JORGE LUIS...         1286830
47.........................  TRANSPORTES SELG SA DE CV..         1658656
------------------------------------------------------------------------

    The FMCSA includes as an appendix to this Federal Register notice,
data and information on the PASAs for which the motor carrier
successfully completed the process before the enactment of the Act, and
any completed since then. See Tables 2, 3, and 4 in the appendix. The
appendix also includes information about carriers that failed the PASA
in Table 5. Although failure to successfully complete the PASA
precludes their participation in the project and the Act only requires
publication of data for carriers receiving operating authority, FMCSA
is publishing this information to show that an additional 20 motor
carriers, in addition to the six motor carriers published on June 8,
have failed to meet U.S. safety standards. A narrative description of
each column heading contained within the appendix's Tables 2, 3, and 4,
``Successful Pre-Authority Safety Audit (PASA) Information as of
October 9, 2007'' as well as in Table 5 ``Failed Pre-Authority Safety
Audit (PASA) Information as of October 9, 2007,'' is provided below:
    A. Row Number in the Appendix: The line in the table on which all
the PASA information concerning the motor carrier is presented.
    B. Name of Carrier: The legal name of the Mexico-domiciled motor
carrier that applied for authority to operate in the United States
(U.S.) beyond the border commercial zones and was considered for
participation in the cross border demonstration project.
    C. U.S. DOT Number: The identification number assigned to the
Mexico-domiciled motor carrier and required to be displayed on each
side of the power unit. If granted provisional operating authority, the
Mexico domiciled motor carrier will be required to add the suffix ``X''
to the ending of its assigned U.S. DOT Number.
    D. PASA Scheduled: The date the Pre-Authorization Safety Audit
(PASA) was scheduled to be initiated.
    E. PASA Completed: The date the PASA was completed.
    F. PASA Results: The results upon completion of the PASA. The PASA
receives a quality assurance review before approval. The quality
assurance process involves a dual review by the FMCSA Division Office
Supervisor of the Auditor assigned to conduct the PASA and the FMCSA
Service Center New Entrant Specialist designated for the specific FMCSA
Division Office. The dual review ensures the successfully completed
PASA was conducted in accordance with FMCSA policy, procedures and
guidance. Upon approval, the PASA results are uploaded into the FMCSA
Motor Carrier Management Information System (MCMIS). The PASA
information and results are then recorded in the Mexico-domiciled motor
carrier's safety performance record in MCMIS.
    G. FMCSA Register: The date the FMCSA published notice of a
successfully completed PASA in the FMCSA Register. The FMCSA Register
notice advises interested parties that the application has been
preliminarily granted and that protests to the application must be
filed within 10 days of the publication date. Protests are filed with
FMCSA Headquarters in Washington, DC. The notice in the FMCSA Register
lists the following information:
    a. Current registration number (e.g., MX-123456);
    b. Date the notice was published in the FMCSA Register;
    c. The applicant's name and address; and
    d. Representative or contact information for the applicant.
    H. U.S. Drivers: The total number of drivers the motor carrier
intends to use in the United States.

    I. U.S. Vehicles: The total number of power units the motor carrier
intends to operate in the United States.
    J. Passed Verification 5 Elements (Yes/No): A Mexico-domiciled
motor carrier will not be granted provisional operating authority if
FMCSA cannot verify all of the following five mandatory elements. FMCSA
must:
    a. Verify a controlled substances and alcohol testing program
consistent with 49 CFR Part 40.
    b. Verify a system of compliance with hours-of-service rules of 49
CFR Part 395, including recordkeeping and retention;
    c. Verify proof of financial responsibility;
    d. Verify records of periodic vehicle inspections; and
    e. Verify the qualifications of each driver the carrier intends to
use under such authority, as required by 49 CFR Parts 383 and 391,
including confirming the validity of each driver's Licencia Federal de
Conductor.
    K. If No, Which Element Failed: If FMCSA could not verify one or
more of the five mandatory elements outlined in 49 CFR Part 365,
Appendix A, Section III, this column will specify which mandatory
element(s) could not be verified.
    Please note that for items L through P below, during the PASA,
after verifying the five mandatory elements discussed in item G above,
FMCSA will gather information by reviewing a motor carrier's compliance
with ``acute and critical'' regulations of the Federal Motor Carrier
Safety Regulations (FMCSRs) and Hazardous Materials Regulations (HMRs).
Acute regulations are those where noncompliance is so severe as to
require immediate corrective actions by a motor carrier regardless of
the overall basic safety management controls of the motor carrier.
Critical regulations are those where noncompliance relates to
management and/or operational controls. These are indicative of
breakdowns in a carrier's management controls. A list of acute and
critical regulations is included in 49 CFR Part 385, Appendix B,
Section VII.
    Parts of the FMCSRs and HMRs having similar characteristics are
combined together into six regulatory areas called ``factors.'' The
regulatory factors are intended to evaluate the adequacy of a carrier's
management controls.
    Factor 5 relates to the transportation of hazardous materials and
was omitted below, as Mexico-domiciled motor carriers that transport
hazardous materials are not permitted to participate in the cross-
border demonstration project.
    L. Passed Phase 1, Factor 1: A ``yes'' in this column indicates the
carrier has successfully met Factor 1 (listed in Part 365, Subpart E,
Appendix A, Section IV(f)). Factor 1 includes the General Requirements
outlined in Parts 387 (Minimum Levels of Financial Responsibility for
Motor Carriers) and 390 (Federal Motor Carrier Safety Regulations-
General).
    M. Passed Phase 1, Factor 2: A ``yes'' in this column indicates the
carrier has successfully met Factor 2, which includes the Driver
Requirements outlined in Parts 382 (Controlled Substances and Alcohol
Use and Testing), 383 (Commercial Driver's License Standards;
Requirements and Penalties) and 391 (Qualifications of Drivers and
Longer Combination Vehicle (LCV) Driver Instructors).
    N. Passed Phase 1, Factor 3: A ``yes'' in this column indicates the
carrier has successfully met Factor 3, which includes the Operational
Requirements outlined in Parts 392 (Driving of Commercial Motor
Vehicles) and 395 (Hours of Service of Drivers).
    O. Passed Phase 1, Factor 4: A ``yes'' in this column indicates the
carrier has successfully met Factor 4, which includes the Vehicle
Requirements outlined in Parts 393 (Parts and Accessories Necessary for
Safe Operation) and 396 (Inspection, Repair and Maintenance) and
vehicle inspection and out-of-service data for the last 12 months.
    P. Passed Phase 1, Factor 6: A ``yes'' in this column indicates the
carrier has successfully met Factor 6, which includes Accident History.
This factor is the recordable accident rate during the past 12 months.
A recordable ``accident'' is defined in 49 CFR 390.5, and means an
accident involving a commercial motor vehicle operating on a public
road in interstate or intrastate commerce which results in: a fatality;
a bodily injury to a person who, as a result of the injury, immediately
received medical treatment away from the scene of the accident; or one
or more motor vehicles incurring disabling damage as a result of the
accident requiring the motor vehicle to be transported away from the
scene by a tow truck or other motor vehicle.
    Q. Number U.S. Vehicles Inspected: The total number of vehicles
(power units and trailers) the motor carrier intends to operate in the
United States that received a vehicle inspection during the PASA.
During a PASA, FMCSA inspected all vehicles that did not display a
current Commercial Vehicle Safety Alliance (CVSA) inspection decal.
This number reflects the vehicles that were inspected, irrespective of
whether the vehicle received a CVSA inspection decal as a result of a
passed inspection.
    R. Number U.S. Vehicles Issued CVSA Decal: The total number of
inspected vehicles (power units and trailers) the motor carrier intends
to operate in the United States that received a CVSA inspection decal
as a result of an inspection during the PASA.
    S. Number U.S. Vehicles with Current CVSA Decal: The total number
of vehicles (power units and trailers) the motor carrier intends to
operate in the United States that displayed a current CVSA inspection
decal at the time of the PASA.
    T. Controlled Substances Collection: Refers to the applicability
and/or country of origin of the controlled substance and alcohol
collection facility that will be used by a motor carrier who has
successfully completed the PASA.
    a. ``US'' means the controlled substance and alcohol collection
facility is based in the United States.
    b. ``MX'' means the controlled substance and alcohol collection
facility is based in Mexico.
    c. ``Non-CDL'' means that during the PASA, FMCSA verified that the
motor carrier is not utilizing commercial motor vehicles subject to the
commercial driver's license requirements as defined in 49 CFR 383.5
(Definition of Commercial Motor Vehicle). Any motor carrier that does
not operate commercial motor vehicles as defined in Sec.  383.5 is not
subject to DOT controlled substance and alcohol testing requirements.
    U. Name of Controlled Substances and Alcohol Collection Facility:
Shows the name and location of the U.S. controlled substances and
alcohol collection facility that will be used by a Mexico-domiciled
motor carrier who has successfully completed the PASA.

Request for Comments

    In accordance with the U.S. Troop Readiness, Veterans' Care,
Katrina Recovery, and Iraq Accountability Appropriations Act, 2007,
FMCSA requests public comment from all interested persons on the PASA
information presented in the appendix to this notice. All comments
received before the close of business on the comment closing date
indicated at the beginning of this notice will be considered and will
be available for examination in the docket at the location listed under
the address section of this notice. Comments received after the comment
closing date will be filed in the public docket and will be considered
to the extent practicable. In

addition to late comments, the FMCSA will also continue to file, in the
public docket, relevant information that becomes available after the
comment closing date. Interested persons should continue to examine the
public docket for new material.

    Issued on: October 11, 2007.
John H. Hill,
Administrator.

Appendix

BILLING CODE 4910-EX-P

[GRAPHIC] [TIFF OMITTED] TN17OC07.027

[GRAPHIC] [TIFF OMITTED] TN17OC07.028

[GRAPHIC] [TIFF OMITTED] TN17OC07.029

[GRAPHIC] [TIFF OMITTED] TN17OC07.030

[FR Doc. 07-5134 Filed 10-16-07; 8:45 am]

BILLING CODE 4910-EX-C


[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)]
[Notices]
[Pages 42514-42515]
[FR Doc No: 2018-18081]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2999]

Determination That DANOCRINE (Danazol) Capsules, 50 Milligrams,
100 Milligrams, and 200 Milligrams, Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness Except the Indication of Fibrocystic
Breast Disease, Which Was Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that DANOCRINE (danazol) Capsules, 50 milligrams (mg), 100
mg, and 200 mg, were not withdrawn from sale for reasons of safety or
effectiveness, except with respect to the indication of fibrocystic
breast disease that was withdrawn for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to suspend approval of abbreviated new drug applications
(ANDAs) that refer to this drug product and have removed the indication
for fibrocystic breast disease. This determination also will allow FDA
to continue to approve ANDAs that refer to this drug as long as they
meet relevant legal and regulatory requirements. However, the Agency
will not accept or approve ANDAs for DANOCRINE (danazol) Capsules, 50
mg, 100 mg, and 200 mg that include fibrocystic breast disease as an
indication.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    Under Sec.  314.161(a)(2), the Agency must also determine whether a
listed drug was withdrawn from sale for reasons of safety or
effectiveness if ANDAs that referred to the listed drug have already
been approved prior to its market withdrawal. If the Agency determines
that a listed drug was withdrawn from sale for reasons of safety or
effectiveness, and there are approved ANDAs that reference that listed
drug, FDA will initiate a proceeding to determine whether the
suspension of the ANDAs is also required (Sec.  314.161(d)).
    DANOCRINE (danazol) Capsules, 50 mg, 100 mg, and 200 mg, is the
subject of NDA 017557 held by Sanofi-Aventis, and initially approved on
June 21, 1976. DANOCRINE is indicated for the treatment of
endometriosis amenable to hormonal management, prevention of attacks of
angioedema of all types (cutaneous, abdominal, and laryngeal) in males
and females, and fibrocystic breast disease. Specifically, with respect
to fibrocystic breast disease, the labeling states ``Most cases of
fibrocystic breast disease may be treated by simple

measures (e.g., padded brassieres and analgesics). In infrequent
patients, symptoms of pain and tenderness may be severe enough to
warrant treatment by suppression of ovarian function. DANOCRINE is
usually effective in decreasing nodularity, pain, and tenderness. It
should be stressed to the patient that this treatment is not innocuous
in that it involves considerable alterations of hormone levels and that
recurrence of symptoms is very common after cessation of therapy.''
    DANOCRINE (danazol) Capsules, 50 mg, 100 mg, and 200 mg, were
discontinued from sale in December 2004. FDA moved the product to the
``Discontinued Drug Product List'' section of the Orange Book at that
time. In a letter dated October 17, 2011, Sanofi-Aventis requested the
withdrawal of the DANOCRINE application. On July 19, 2013, the Agency
issued a Federal Register notice withdrawing NDA 017557, the
application for DANOCRINE, effective August 19, 2013.
    After reviewing our records and based on the information we have at
this time, FDA has determined that under Sec.  314.161 DANOCRINE
(danazol) Capsules, 50 mg, 100 mg, and 200 mg, were not withdrawn from
sale for reasons of safety or effectiveness, except with respect to the
indication for fibrocystic breast disease. Fibrocystic breast disease
refers to mastalgia or breast pain caused by benign proliferative
breast tissue. The term fibrocystic breast disease is no longer used,
in part because it is not accurate to describe the condition as a
disease when it is in fact the result of normal physiologic changes.
    DANOCRINE (danazol) has been associated with two serious adverse
reactions: hepatocellular injury (i.e., hepatocellular injury,
hepatocellular jaundice, and hepatic failure) and an increased risk of
rhabdomyolysis in patients taking danazol and statins. These two
adverse reactions were not yet recognized when DANOCRINE (danazol) was
originally approved for fibrocystic breast disease in 1980. Both of
these adverse reactions were added to the safety labeling for the
product several years after the product was initially approved. In
addition, androgenic adverse effects and a contraindication for use in
women who are pregnant or attempting to become pregnant limit the
utility of DANOCRINE (danazol) for the fibrocystic breast disease
indication.
    The Agency conducted a review of the benefit-risk profile for each
indication of DANOCRINE (danazol). For the treatment of fibrocystic
breast disease, the Agency concluded that the benefit-risk profile of
the product is unfavorable given the risk of potentially serious
adverse reactions and that the condition is a benign, non-disease
state. In addition, many other treatment options exist for this
condition, including dietary measures, use of supportive undergarments
and pain relievers such as acetaminophen or non-steroidal anti-
inflammatory drug products. Many of these treatment options present a
very low risk of adverse reactions. For the indications of treatment of
endometriosis amenable to hormone management and prevention of attacks
of angioedema of all types (cutaneous, abdominal, and laryngeal) in
males and females, the Agency has determined that DANOCRINE (danazol)
continues to have a favorable benefit-risk profile.
    Accordingly, the Agency will continue to list DANOCRINE (danazol)
Capsules, 50 mg, 100 mg, and 200 mg, in the ``Discontinued Drug Product
List'' section of the Orange Book. All approved ANDAs have removed the
fibrocystic breast disease indication from their labeling. In addition,
FDA will continue to approve ANDAs that refer to DANOCRINE (danazol)
Capsules as long as they meet relevant legal and regulatory
requirements, but FDA will not accept or approve ANDAs that refer to
this drug product and propose to include the fibrocystic breast disease
indication.

    Dated: August 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18081 Filed 8-21-18; 8:45 am]
 BILLING CODE 4164-01-P