[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Rules and Regulations]
[Pages 9600-9603]
[FR Doc No: 2015-03692]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2014-N-1903]

Medical Devices; Physical Medicine Devices; Classification of the
Powered Exoskeleton

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
powered exoskeleton into class II (special controls). The special
controls that will apply to the device are identified in this order and
will be part of the codified language for the powered exoskeleton's
classification. The Agency is classifying the device into class II
(special controls) in order to provide a reasonable assurance of safety
and effectiveness of the device.

DATES: This order is effective March 26, 2015. The classification was
applicable on June 26, 2014.

FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1434, Silver Spring, MD 20993-0002, 301-
796-6476<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Public Law 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) of the FD&C Act and then a request
for classification under the first procedure, the person determines
that there is no legally marketed device upon which to base a
determination of substantial equivalence and requests a classification
under section 513(f)(2) of the FD&C Act. If the person submits a
request to classify the device under this second procedure, FDA may
decline to undertake the classification request if FDA identifies a
legally marketed device that could provide a reasonable basis for
review of substantial equivalence with the device or if FDA determines
that the device submitted is not of ``low-moderate risk'' or that
general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    On June 22, 2013, Argo Medical Technologies, Inc., submitted a
request for classification of the ReWalk under section 513(f)(2) of the
FD&C Act. The manufacturer recommended that the device be classified
into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on June 26, 2014, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 890.3480.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a powered
exoskeleton will need to comply with the special controls named in this
final order. The device is assigned the generic name powered
exoskeleton, and it is identified as a prescription device that is
composed of an external, powered, motorized orthosis used for medical
purposes that is placed over a person's paralyzed or weakened limbs for
the purpose of providing ambulation.
    FDA has identified the following risks to health associated
specifically with this type of device, as well as the measures required
to mitigate these risks in table 1.

       Table 1--Powered Exoskeleton Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Instability, falls, and associated       Clinical testing.
 injuries.
                                         Training.
                                         Software verification,
                                          validation, and hazard
                                          analysis.
                                         Wireless testing.
                                         Electromagnetic compatibility
                                          (EMC) and electromagnetic
                                          interference (EMI) testing.
                                         Electrical safety testing.
                                         Design characteristics.
                                         Non-clinical performance
                                          testing.
                                         Water/particle ingress testing.
                                         Durability testing.
                                         Battery testing.
                                         Labeling.
Bruising, skin abrasion, pressure        Clinical testing.
 sores, soft tissue injury.
                                         Training.
                                         Labeling.
Diastolic hypertension and changes in    Clinical testing.
 blood pressure, and heart rate.
                                         Training.
                                         Labeling.
Adverse tissue reaction................  Biocompatibility assessment.
Premature battery failure..............  Battery testing.
                                         Labeling.
Interference with other electrical       EMC/EMI testing.
 equipment/devices.
                                         Labeling.

Burns, electrical shock................  Electrical safety testing.
                                         Thermal testing.
                                         Labeling.
Device malfunction resulting in          Clinical testing.
 unanticipated operation (e.g., device
 stoppage, unintended movement).
                                         Non-clinical performance
                                          testing.
                                         Training.
                                         Software verification,
                                          validation, and hazard
                                          analysis.
                                         Electrical safety testing.
                                         Battery testing.
                                         Water/particle ingress testing.
                                         Wireless testing.
                                         EMC/EMI testing.
                                         Flammability testing.
                                         Labeling.
Use error..............................  Clinical testing.
                                         Training.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in combination
with the general controls, address these risks to health and provide
reasonable assurance of the safety and effectiveness:
     Elements of the device materials that may contact the
patient must be demonstrated to be biocompatible.
     Appropriate analysis/testing must validate electronic
compatibility/interference (EMC/EMI), electrical safety, thermal
safety, mechanical safety, battery performance and safety, and wireless
performance, if applicable.
     Appropriate software verification, validation, and hazard
analysis must be performed.
     Design characteristics must ensure geometry and materials
composition are consistent with intended use.
     Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use.
Performance testing must include:
    [cir] Mechanical bench testing (including durability testing) to
demonstrate that the device will withstand forces, conditions, and
environments encountered during use;
    [cir] simulated use testing (i.e., cyclic loading testing) to
demonstrate performance of device commands and safeguard under worst
case conditions and after durability testing;
    [cir] verification and validation of manual override controls are
necessary, if present;
    [cir] the accuracy of device features and safeguards; and
    [cir] device functionality in terms of flame retardant materials,
liquid/particle ingress prevention, sensor and actuator performance,
and motor performance.
     Clinical testing must demonstrate safe and effective use
and capture any adverse events observed during clinical use when used
under the proposed conditions of use, which must include considerations
for:
    [cir] Level of supervision necessary and
    [cir] environment of use (e.g., indoors and/or outdoors), including
obstacles and terrain representative of the intended use environment.
     A training program must be included with sufficient
educational elements so that upon completion of training program, the
clinician, user, and companion can:
    [cir] Identify the safe environments for device use,
    [cir] use all safety features of device, and
    [cir] operate the device in simulated or actual use environments
representative of indicated environments and use.
     Labeling for the Physician and User must include the
following:
    [cir] Appropriate instructions, warning, cautions, limitations, and
information related to the necessary safeguards of the device,
including warning against activities and environments that may put the
user at greater risk;
    [cir] specific instructions and the clinical training needed for
the safe use of the device, which includes:
    [ssquf] Instructions on assembling the device in all available
configurations;
    [ssquf] instructions on fitting the patient;
    [ssquf] instructions and explanations of all available programs and
how to program the device;
    [ssquf] instructions and explanation of all controls, input, and
outputs;
    [ssquf] instructions on all available modes or states of the
device;
    [ssquf] instructions on all safety features of the device; and
    [ssquf] instructions for properly maintaining the device;
    [cir] Information on the patient population for which the device
has been demonstrated to have a reasonable assurance of safety and
effectiveness;
    [cir] pertinent non-clinical testing information (e.g., EMC,
battery longevity); and
    [cir] a detailed summary of the clinical testing including:
    [ssquf] Adverse events encountered under use conditions,
    [ssquf] summary of study outcomes and endpoints, and
    [ssquf] information pertinent to use of the device including the
conditions under which the device was studied (e.g., level of
supervision or assistance, and environment of use (e.g., indoors and/or
outdoors) including obstacles and terrain).
    Powered exoskeleton devices are restricted to patient use only upon
the authorization of a practitioner licensed by law to administer or
use the device; see section 520(e) of the FD&C Act (21 U.S.C. 360j(e))
and 21 CFR 801.109 (Prescription devices). Prescription-use
restrictions are a type of general controls as defined in section
513(a)(1)(A)(i) of the FD&C Act.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device

must submit to FDA a premarket notification, prior to marketing the
device, which contains information about the powered exoskeleton they
intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, and the collections
of information in 21 CFR part 801, regarding labeling have been
approved under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov.

    1. K131798: De Novo Request per 513(f)(2) from Argo Medical
Technologies, Inc., dated June 22, 2013.

List of Subjects in 21 CFR Part 890

    Medical devices, Physical medicine devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
890 is amended as follows:

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for 21 CFR part 890 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  890.3480 to subpart D to read as follows:

Sec.  890.3480  Powered exoskeleton.

    (a) Identification. A powered exoskeleton is a prescription device
that is composed of an external, powered, motorized orthosis used for
medical purposes that is placed over a person's paralyzed or weakened
limbs for the purpose of providing ambulation.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Elements of the device materials that may contact the patient
must be demonstrated to be biocompatible.
    (2) Appropriate analysis/testing must validate electromagnetic
compatibility/interference (EMC/EMI), electrical safety, thermal
safety, mechanical safety, battery performance and safety, and wireless
performance, if applicable.
    (3) Appropriate software verification, validation, and hazard
analysis must be performed.
    (4) Design characteristics must ensure geometry and materials
composition are consistent with intended use.
    (5) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use.
Performance testing must include:
    (i) Mechanical bench testing (including durability testing) to
demonstrate that the device will withstand forces, conditions, and
environments encountered during use;
    (ii) Simulated use testing (i.e., cyclic loading testing) to
demonstrate performance of device commands and safeguard under worst
case conditions and after durability testing;
    (iii) Verification and validation of manual override controls are
necessary, if present;
    (iv) The accuracy of device features and safeguards; and
    (v) Device functionality in terms of flame retardant materials,
liquid/particle ingress prevention, sensor and actuator performance,
and motor performance.
    (6) Clinical testing must demonstrate safe and effective use and
capture any adverse events observed during clinical use when used under
the proposed conditions of use, which must include considerations for:
    (i) Level of supervision necessary, and
    (ii) Environment of use (e.g., indoors and/or outdoors) including
obstacles and terrain representative of the intended use environment.
    (7) A training program must be included with sufficient educational
elements so that upon completion of training program, the clinician,
user, and companion can:
    (i) Identify the safe environments for device use,
    (ii) Use all safety features of device, and
    (iii) Operate the device in simulated or actual use environments
representative of indicated environments and use.
    (8) Labeling for the Physician and User must include the following:
    (i) Appropriate instructions, warning, cautions, limitations, and
information related to the necessary safeguards of the device,
including warning against activities and environments that may put the
user at greater risk.
    (ii) Specific instructions and the clinical training needed for the
safe use of the device, which includes:
    (A) Instructions on assembling the device in all available
configurations;
    (B) Instructions on fitting the patient;
    (C) Instructions and explanations of all available programs and how
to program the device;
    (D) Instructions and explanation of all controls, input, and
outputs;
    (E) Instructions on all available modes or states of the device;
    (F) Instructions on all safety features of the device; and
    (G) Instructions for properly maintaining the device.
    (iii) Information on the patient population for which the device
has been demonstrated to have a reasonable assurance of safety and
effectiveness.
    (iv) Pertinent non-clinical testing information (e.g., EMC, battery
longevity).
    (v) A detailed summary of the clinical testing including:
    (A) Adverse events encountered under use conditions,
    (B) Summary of study outcomes and endpoints, and
    (C) Information pertinent to use of the device including the
conditions under which the device was studied (e.g., level of
supervision or assistance, and environment of use (e.g., indoors and/or
outdoors) including obstacles and terrain).

    Dated: February 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03692 Filed 2-23-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 142 (Wednesday, July 24, 2019)]
[Proposed Rules]
[Pages 35582-35585]
[FR Doc No: 2019-15604]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2019-0382; FRL-9996-83-Region 1]

Air Plan Approval; Rhode Island; Prevention of Significant
Deterioration; PM10, PM2.5 and NOX

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the State of Rhode Island's State Implementation
Plan (SIP) relating to the regulation of fine particulate matter (that
is, particles with an aerodynamic diameter less than or equal to a
nominal 2.5 micrometers, generally referred to as
``PM2.5''), PM10 (particles with an aerodynamic
diameter less than or equal to a nominal 10 micrometers), and nitrogen
oxides (NOX) within the context of Rhode Island's Prevention
of Significant Deterioration (PSD) permitting program. The EPA is also
proposing to take action on other minor changes to Rhode Island's PSD
permitting program. In addition, EPA is proposing to convert several
conditionally approved infrastructure SIP elements to fully approved
elements in relation to the 2008 ozone, 2008 lead, 2010 nitrogen
dioxide and the 1997 and 2006 PM2.5 National Ambient Air
Quality Standards (NAAQS). These actions are being taken in accordance
with the Clean Air Act (CAA).

DATES: Written comments must be received on or before August 23, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OAR-2019-0382 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www.epa.gov/dockets/commenting-epa-dockets. Publicly
available docket materials are available at https://www.regulations.gov
or at the U.S. Environmental Protection Agency, EPA Region 1 Regional
Office, Air and Radiation Division, 5 Post Office Square--Suite 100,
Boston, MA. The EPA requests that if at all possible, you contact the
contact listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
legal holidays.

FOR FURTHER INFORMATION CONTACT: Donald Dahl, Air Permits, Toxics, and
Indoor Programs Branch, EPA Region 1 Regional Office, 5 Post Office
Square--Suite 100, Mail Code 5-02, Boston, MA 02109-3912, tel. (617)
918-1657, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

Table of Contents

I. Background and Purpose
II. Analysis of Rhode Island's SIP Revision
III. Proposed Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Background and Purpose

    The State of Rhode Island's PSD permitting program is established
in Title 250--Rhode Island Department of Environmental Management,
Chapter 120--Air Resources, Subchapter 05--Air Pollution Control, Part
9--Air Pollution Control Permits (Part 9). Revisions to the PSD program
were last approved into the Rhode Island SIP on October 24, 2013 (78 FR
63383). Rhode Island has authority to issue and enforce PSD permits
under its SIP-approved PSD program.

    On March 26, 2018, the Rhode Island Department of Environmental
Management (RI DEM) submitted to the EPA a formal revision to its SIP.
On February 6, 2019, RI DEM submitted to the EPA a letter clarifying
its intent to only incorporate certain elements of its March 2018
submittal for inclusion into the Rhode Island SIP. The RI DEM SIP
submittal, and subsequent clarification letter, were submitted to
address PM2.5 and PM10 in PSD permitting
regulations, to specifically address NOX as a precursor for
ozone, and to revise other minor changes to Rhode Island's PSD
permitting program. This submittal also sought to satisfy an April 20,
2016 conditional approval (81 FR 23175) for the 2008 ozone, 2008 lead,
2010 nitrogen dioxide and the 1997 and 2006 PM2.5 NAAQS
infrastructure SIPs (I-SIPs) only as it relates to the aspects of the
PSD program pertaining to NOX as a precursor for ozone and
changes made to 40 CFR part 51.166 in the EPA's October 20, 2010
rulemaking (75 FR 64864) concerning emissions of PM2.5.
    In the EPA's April 20, 2016 conditional approval, we cite a
February 18, 2016 letter from RI DEM which commits to making the
necessary changes to address the deficiencies in the Rhode Island SIP.
RI DEM's March 2018 SIP submittal and February 2019 clarification
letter satisfy the State's earlier commitment.

II. Analysis of Rhode Island's SIP Revision

    The EPA performed a review of Rhode Island's proposed revisions and
has determined that they are consistent with EPA's PSD program
regulations and also rectify the deficiencies indicated in our April
20, 2016 conditional approvals.
    Since the EPA's last approval of amendments to RI DEM's Part 9, the
State has undertaken a new codification system that results in
different citations between the current state regulations and the Rhode
Island SIP. Due to the State's new codification system, there are
instances where the state regulation being submitted for approval into
the SIP at this time does not mesh precisely within the existing
codification structure of the Rhode Island SIP. As a matter of
substantive legal requirements, however, the regulations approved into
the Rhode Island SIP, including those we are approving today, are
harmonious and clear.
    Below, we describe exactly how each definition and provision within
Part 9, as adopted by Rhode Island and in effect on April 5, 2018, and
that we are approving into Rhode Island's SIP through this notice, is
consistent with the EPA's regulations and how it will be incorporated
into the SIP. In most instances, the proposed amendments to the SIP are
straightforward, aligning with existing provisions in EPA's PSD
regulations at 40 CFR part 51.166 and thus need no detailed explanation
other than clarification as to how the proposed amendments will mesh
with the existing SIP's structure and codification. Our analysis of
each proposed amendment is provided below:
    1. Amendment to the definition of ``Baseline concentration'' in
Section 9.5.C.2., which corresponds to Section 9.5.l(b) in the
currently approved Rhode Island SIP. This amendment restructures the
definition and is consistent with the definition of ``Baseline
concentration'' in 40 CFR 51.166(b)(13).
    2. Amendment to the definition of ``Increment'' in Section
9.5.C.3., which corresponds to Section 9.5.1(d) in the currently
approved Rhode Island SIP. This amendment adds Class II increment
values for both annual and 24-hr maximum PM10 and
PM2.5. The State's new Class II increments are consistent
with the increment values for these pollutants in 40 CFR 51.166(c).
    3. Amendment to the definition of ``Major Source Baseline Date'' in
Section 9.5.C.4., which corresponds to Section 9.5.l(e) in the
currently approved Rhode Island SIP. This amendment adds a major source
baseline date for PM10 and PM2.5 consistent with
40 CFR 51.166(b)(14)(i) and adds language for establishing the baseline
date consistent with 40 CFR 51.166(b)(14)(iii).
    4. Amendment to the definition of ``Major Stationary Source'' in
Section 9.5.C.6., which corresponds to Section 9.5.l(g) in the
currently approved Rhode Island SIP. This amendment adds language
stating that a source that is major for NOX is also major
for ozone, which is consistent with 40 CFR 51.166(b)(1)(ii).
    5. Amendment to the definition of ``Minor Source Baseline Date'' in
Section 9.5.C.5., which corresponds to Section 9.5.l(f) in the
currently approved Rhode Island SIP. This amendment adds a specific
minor source baseline date for PM2.5 and is consistent with
40 CFR 51.166(b)(14)(ii)(c).
    RI DEM's PSD regulations are structured in a way that uses actual
specific dates based on submission of a first complete PSD application
to set the minor source baseline date for a particular pollutant. The
approach contained in EPA's regulations is somewhat different in the
sense that instead of using actual specific dates, EPA articulates the
concept of a first complete PSD application as the minor source
baseline date after a specified trigger date and does not reference any
one specific date. The minor source baseline date for PM2.5
in RI DEM's regulations is explicitly stated as March 29, 2016, which
corresponds to the date when the RI DEM received the first complete PSD
permit application that was significant for PM2.5.
Additionally, there can only be one minor source baseline date
statewide since Rhode Island's SIP defines the baseline area as the
entire State.
    6. Amendment to the definition of ``Regulated NSR Pollutant'' in
Section 9.5.A.36., which corresponds to Section 9.1.36 in the currently
approved Rhode Island SIP. This amendment adds the gaseous form of
PM10 and PM2.5 emissions, that condense into
particulates at ambient temperatures, as direct emissions of
PM10 and PM2.5. This amendment is consistent with
40 CFR 51.166(b)(49)(i)(a).
    7. Amendment to the definition ``Subject to Regulation'' in Section
9.5.A.41., which corresponds to Section 9.1.41 in the currently
approved Rhode Island SIP. This amendment removes sources, referred to
as ``step 2'' sources of greenhouse gases (GHG), from having to obtain
a PSD permit solely due to its GHG emissions and is consistent with 40
CFR 51.166(b)(48)(iv).
    In Step 2 of the GHG Tailoring Rule, which applied as of July 1,
2011, the PSD and title V permitting program requirements applied to
some sources that were classified as major sources based solely on
their GHG emissions or potential to emit GHGs. Step 2 also applied PSD
permitting requirements to modifications of otherwise major sources
that would increase only GHG emissions above the level in the EPA
regulations. The EPA generally described the sources covered by PSD
during Step 2 of the GHG Tailoring Rule as ``Step 2 sources'' or ``GHG-
only sources.'' The United States Supreme Court invalidated the EPA's
regulation of Step 2 sources in Utility Air Regulatory Group (UARG) v.
EPA, 134 S. Ct. 2427 (2014). In accordance with that decision, the
United States Court of Appeals for the District of Columbia Circuit
vacated the federal regulations that implemented Step 2 of the GHG
Tailoring Rule. See Coalition for Responsible Regulation, Inc. v. EPA,
606 Fed. Appx. 6, 7 (D.C. Cir. 2015). Subsequently, the EPA removed the
vacated elements from its rules. See 80 FR 50199 (August 19, 2015). The
EPA therefore has the authority to approve a state's request to remove
Step 2 sources from the SIP. EPA finds that removing Step 2 sources
from the SIP is also

consistent with Section 110(l) of the CAA, which states that the EPA
shall not approve a revision to the SIP if the revision would interfere
with any applicable requirement concerning attainment (of the NAAQS)
and reasonable further progress (as defined in CAA section 7501) or any
other requirement of the CAA.
    8. Elimination of the restriction on increment consumption in
Section 9.9.2 which corresponds to Section 9.5.3(a) in the currently
approved Rhode Island SIP. This amendment allows a new major stationary
source or a major modification to a stationary source to consume all
available increment. This amendment is consistent with 40 CFR
51.166(k)(1)(ii).
    The removal of the restriction on increment consumption is also
consistent with Section 110(l) of the CAA, which states that the EPA
shall not approve a revision to the SIP if the revision would interfere
with any applicable requirement concerning attainment (of the NAAQS)
and reasonable further progress (as defined in CAA section 7501) or any
other requirement of the CAA. Prior to this amendment, the Rhode Island
SIP limited the amount of increment that a new major stationary source
or major modification could consume to 75% of the remaining 24-hr
increment and 25% of the remaining annual increment. Although the
State's amendment removes these limits on the amount of available
increment that can be consumed, the amendment does not allow a source
to consume more increment than is available. See Subchapter 05, Part 9,
Section 9.9.1.A.2.a(2) of Rhode Island's Air Resources Regulations.
    9. Amendment to the provisions in Section 9.9.2.A.5.e(3), which
corresponds to Section 9.5.3(c)(5)c in the currently approved Rhode
Island SIP. This amendment prohibits emissions from temporary sources
of sulfur dioxide, nitrogen oxides, and particulate matter to be
excluded from increment consumption if the temporary emissions would
impact a Class I area. The State's amended regulation is consistent
with 40 CFR 51.166(f)(4)(iii)(a).
    10. Amendment to the table in Section 9.9.4.A., which corresponds
to the table at Section 5.5 in the currently approved Rhode Island SIP.
This amendment adds thresholds for annual and 24-hr PM2.5
emissions that, if exceeded, requires a new major stationary source or
a source making a major modification to comply with nonattainment new
source review requirements. This amendment is consistent with and, in
certain respects, more stringent than 40 CFR 51.165(b)(2).

III. Proposed Action

    Based on our analysis, the EPA is proposing to approve the Rhode
Island SIP revision, submitted by RI DEM to EPA on March 26, 2018 and
clarified by a letter dated February 6, 2019. The EPA is also proposing
to convert its April 20, 2016 conditional approval to a full approval
for the 2008 ozone, 2008 lead, 2010 nitrogen dioxide and the 1997 and
2006 PM2.5 NAAQS I-SIPs as it relates to the aspects of the
PSD program pertaining to NOX as a precursor for ozone and
changes made to 40 CFR part 51.166 in the EPA's October 20, 2010
rulemaking concerning emissions of PM2.5.
    The EPA is soliciting public comments on the issues discussed in
this notice or on other relevant matters. These comments will be
considered before taking final action. Interested parties may
participate in the Federal rulemaking procedure by submitting written
comments to this proposed rule by following the instructions listed in
the ADDRESSES section of this Federal Register.

IV. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the Rhode Island rules regarding definitions and permitting
requirements discussed in section II of this preamble. The EPA has
made, and will continue to make, these documents generally available
through https://www.regulations.gov and at the EPA Region 1 Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

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, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed 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 proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not expected to be an Executive Order 13771 regulatory
action because this action is not significant under Executive Order
12866;
     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 the 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, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

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

    Dated: July 16, 2019.
Deborah Szaro,
Acting Regional Administrator, EPA Region 1.
[FR Doc. 2019-15604 Filed 7-23-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Notices]
[Page 45586]
[FR Doc No: 2015-18670]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. DOT-NHTSA-2015-0072]

Federal Interagency Committee on Emergency Medical Services
Meeting

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

ACTION: Meeting notice--Federal Interagency Committee on Emergency
Medical Services.

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

SUMMARY: NHTSA announces a meeting of the Federal Interagency Committee
on Emergency Medical Services (FICEMS) to be held in the Washington, DC
area. This notice announces the date, time, and location of the
meeting, which will be open to the public. Pre-registration is
encouraged.

DATES: The meeting will be held on August 12, 2015, from 10:00 a.m. EDT
to 1:00 p.m. EDT.

ADDRESSES: The meeting will be held at the Thomas ``Tip'' O'Neill
Building, 200 C Street SW. (Corner of 3rd Street and C SW.--huge glass
building on the corner), Washington, DC, 20201. Lower Level/Willow
Conference Room.

FOR FURTHER INFORMATION CONTACT: Drew Dawson, Director, Office of
Emergency Medical Services, National Highway Traffic Safety
Administration, 1200 New Jersey Avenue SE., NTI-140, Washington, DC
20590, Telephone number<PHONE_NUMBER>; Email<EMAIL_ADDRESS>    Registration Information: This meeting will be open to the general
public; however, pre-registration is highly encouraged to comply with
security procedures. Members of the public wishing to attend should
register online at http://events.SignUp4.com/FICEMS Mtg August 2015 no
later than August 10, 2015. Please note that the information collected
for registration, including full name, place of business, telephone #
and email address, will be used solely for the purposes of providing
registrants with access to the meeting site and to provide meeting
materials to registrants via email when they become available.
    A picture I.D. must be provided to enter the Thomas O'Neill
Building. For Non-Govt. Badge persons, they will need to be signed in
and leave their Drivers' License at Security and Pick up when they
leave. It is suggested that visitors arrive 30 minutes early in order
to facilitate entry. Attendees who are not United States citizens must
produce a valid passport to enter the building. Please be aware that
visitors to the Thomas O'Neill Building are subject to search and must
pass through a magnetometer. Weapons of any kind are strictly forbidden
in the building unless authorized through the performance of the
official duties of your employment (i.e. law enforcement officer).
Federal staff will be in the lobby beginning at 9:30 a.m. EDT on the
day of the meeting to escort members of the public to the meeting room.

SUPPLEMENTARY INFORMATION: Section 10202 of the Safe, Accountable,
Flexible, Efficient Transportation Equity Act: A Legacy For Users
(SAFETEA-LU), Pub. L. 109-59, provides that the FICEMS consist of
several officials from Federal agencies as well as a State emergency
medical services director appointed by the Secretary of Transportation.
    Tentative Agenda: This meeting of the FICEMS will focus on
addressing the requirements of SAFETEA-LU and the opportunities for
collaboration among the key Federal agencies involved in emergency
medical services. The tentative agenda includes:
     Report from the National EMS Advisory Council (NEMSAC)
     Presentation on ``Bystanders: The Nation's Immediate
Responders''
     Discussion of EMS Active Shooter Response
     Update on Opioid Overdoses and the Use of Narcan by EMS
Systems
     Reports on Progress Related to Four Priority Areas of the
Strategic Plan
    o EMS Preparedness
    o EMS Data Standardization & Exchange
    o Evidence-Based Guidelines Development and Implementation
    o Military Veteran Credentialing, including Considering of a
Position Statement on the Topic
     Reports, updates, and recommendations from FICEMS members
     A public comment period
    There will not be a call-in number provided for this FICEMS
meeting; however, minutes of the meeting will be available to the
public online at www.EMS.gov. A final agenda and other meeting
materials will be posted at www.EMS.gov/FICEMS.htm prior to the
meeting.

Jeffrey P. Michael,
Associate Administrator, Research and Program Development.
[FR Doc. 2015-18670 Filed 7-29-15; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 23 (Thursday, February 4, 2016)]
[Rules and Regulations]
[Pages 5937-5942]
[FR Doc No: 2016-02101]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 501

[Docket No. NHTSA-2015-0129]
RIN 2127-AL46

Organization and Delegation of Duties

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

ACTION: Final rule.

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

SUMMARY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT) is updating its regulations
governing the organization of NHTSA and delegations of authority from
the Administrator to Agency officials, to provide for a reorganization
of the Agency's internal structure. These changes will enable NHTSA to
achieve its mission more effectively and efficiently.

DATES: This rule is effective February 4, 2016.

FOR FURTHER INFORMATION CONTACT: Mr. Russell Krupen, Office of the
Chief Counsel, National Highway Traffic Safety Administration, 1200 New
Jersey Avenue SE., Washington, DC 20590. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This final rule amends 49 CFR part 501, the chapter of the Code of
Federal Regulations (CFR) that sets forth the organization of the
National Highway Traffic Safety Administration (NHTSA) and delegations
of authority from the NHTSA Administrator to other Agency officials, to
reflect a reorganization of the Agency's internal structure, to update
out-of-date information, and to improve accuracy and clarity. In
addition, this rule amends the succession to the Administrator to
conform to the new organizational structure. These changes will enable
the Agency to achieve its mission more effectively and efficiently.
    In particular, NHTSA is eliminating the Senior Associate
Administrator positions that were created in 2002 (67 FR 44083) from
its internal organization and adding the Executive Director and the
Chief Financial Officer positions, as well as their functions and
responsibilities. Conforming changes to the regulations, including
descriptions of the Associate Administrator positions, succession to
the Administrator, and delegations of authority, are included.
Additional changes have been made to improve formatting and consistency
throughout part 501.
    The amendments in this final rule relate solely to changes in the
organizational structure and the placement of the delegations of
authority for various functions within the agency. This final rule does
not impose substantive requirements on the public. It is ministerial in
nature and relates only to Agency management, organization, procedure,
and practice. Therefore, the Agency has determined that notice and
comment are unnecessary and that the rule is exempt from prior notice
and comment requirements under 5 U.S.C. 553(b)(3)(A). As these changes
will not have a substantive impact on the public, the Agency does not
expect to receive significant comments on the substance of the rule.
Therefore, the Agency finds that there is good cause under 5 U.S.C.
553(d)(3) to make this rule effective less than 30 days after
publication in the Federal Register.

II. Regulatory Analyses and Notices

Executive Order 12866 (Regulatory Planning and Review) and DOT
Regulatory Policies and Procedures

    NHTSA has determined that this final rule is not a significant
regulatory action under Executive Order 12866 and DOT Regulatory
Policies and Procedures (44 FR 11034). It was not reviewed by the
Office of Management and Budget. There are no costs associated with
this rule.

Executive Order 13132 (Federalism)

    This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13132 (``Federalism''). This
final rule does not have substantial direct effects on the States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government. Therefore, the consultation requirements of Executive
Order 13132 do not apply.

Executive Order 13175 (Consultation and Coordination With Indian Tribal
Governments)

    This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13175 (``Consultation and
Coordination with Indian Tribal Governments''). Because this final rule
does not significantly or uniquely affect the communities of the Indian
tribal governments and does not impose substantial direct compliance
costs, the

funding and consultation requirements of Executive Order 13175 do not
apply.

Regulatory Flexibility Act

    Because no notice of proposed rulemaking is required for this rule
under the Administrative Procedure Act, 5 U.S.C. 553, the provisions of
the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply.
This rule will not impose any costs on small entities because it is
merely organizational in nature and will not have a substantive impact
on the public. I hereby certify that this final rule will not have a
significant economic impact on a substantial number of small entities.

Paperwork Reduction Act

    This rule contains no information collection requirements under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) does
not require a written statement for this final rule because the rule
does not include a Federal mandate that may result in the expenditure
in any one year by State, local, and tribal governments, or the private
sector, exceeding the threshold set forth in 2 U.S.C. 1532(a).

List of Subjects in 49 CFR Part 501

    Authority delegations (Government agencies), Organization and
functions (Government agencies).

    For the reasons stated in the preamble, NHTSA revises 49 CFR part
501 to read as follows:

PART 501--ORGANIZATION AND DELEGATION OF POWERS AND DUTIES

Sec.
501.1 Purpose.
501.2 General.
501.3 Organization and general responsibilities.
501.4 Succession to Administrator.
501.5 Exercise of authority.
501.6 Secretary's reservations of authority.
501.7 Administrator's reservations of authority.
501.8 Delegations.

    Authority: 49 U.S.C. 105 and 322, and delegations of authority
at 49 CFR 1.81 and 1.95.

Sec.  501.1  Purpose.

    This part describes the organization of the National Highway
Traffic Safety Administration (NHTSA), an operating administration
within the U.S. Department of Transportation, and provides for the
performance of duties imposed on, and the exercise of powers vested in,
the Administrator of NHTSA.

Sec.  501.2  General.

    The responsibilities and authorities delegated to NHTSA and the
Administrator are set forth in Sec. Sec.  1.81, 1.94, and 1.95 of this
title.

Sec.  501.3  Organization and general responsibilities.

    NHTSA consists of a headquarters organization located in
Washington, DC, a unified field organization consisting of ten
geographic regions with a Regional Office located in each region, the
Vehicle Research and Test Center located in East Liberty, Ohio, and the
Uniform Tire Quality Grading Test Facility located in San Angelo,
Texas. The organization of, and general spheres of responsibility
within, NHTSA are as follows:
    (a) Office of the Administrator--(1) Administrator. (i) Represents
the Department and is the principal advisor to the Secretary in all
matters related to 49 U.S.C. chapters 301, 303, 321, 323, 325, 327, 329
and 331; 23 U.S.C. chapter 4, except section 409; 23 U.S.C. 153, 154,
158, 161, 163, 164 and 313 (with respect to matters within the primary
responsibility of NHTSA); and such other responsibilities and
authorities as are delegated by the Secretary of Transportation (49 CFR
1.94 and 1.95);
    (ii) Establishes NHTSA program policies, objectives, and priorities
and directs the development of action plans to accomplish the NHTSA
mission;
    (iii) Directs, controls, and evaluates the organization, program
activities, performance of NHTSA staff, program and field offices;
    (iv) Approves broad legislative, budgetary, fiscal and program
proposals and plans; and
    (v) Takes management actions of major significance, such as those
relating to changes in basic organizational structure, appointment of
key personnel, allocation of resources, and matters of special
political or public interest or sensitivity.
    (2) Deputy Administrator. Assists the Administrator in discharging
responsibilities. Directs and coordinates the Administration's
management and operational programs, and related policies and
procedures at headquarters and in the field.
    (3) Executive Director. As the principal advisor to the
Administrator and Deputy Administrator, provides direction on internal
management and mission support programs. Provides executive direction
over the Associate Administrators, Chief Financial Officer, and Chief
Information Officer.
    (4) Director, Office of Civil Rights. As the principal advisor to
the Administrator and Deputy Administrator on all matters pertaining to
civil rights, serves as Director of Equal Employment Opportunity and of
Title VI Compliance (Civil Rights Act of 1964, as amended, and related
regulations). Assures agency compliance with Section 504 of the
Rehabilitation Act of 1973, the Americans with Disabilities Act (ADA),
and other nondiscrimination statutes, regulations, Executive Orders,
and policies. Periodically reviews and evaluates the civil rights
programs of State Department of Motor Vehicles and Highway Safety
Offices to ensure that recipients of NHTSA financial assistance meet
applicable Federal civil rights requirements. Monitors the
implementation of and compliance with civil rights requirements,
investigates complaints of discrimination, conducts compliance reviews,
provides technical assistance to recipients of NHTSA financial
assistance and stakeholders, and provides assistance to the Office of
the Secretary in investigating and adjudicating formal complaints of
discrimination.
    (5) Director, Office of Governmental Affairs, Policy & Strategic
Planning. As the principal advisor to the Administrator and Deputy
Administrator on all intergovernmental matters, including
communications with Congress, communicates agency policy and serves as
coordinator on legislative affairs. Also, serves as coordinator of
agency policy discussions and activities and communicates with other
operating administrations and the Office of Secretary on strategic
planning efforts.
    (6) Director of Communications. As the principal advisor to the
Administrator and Deputy Administrator on external communications and
information dissemination, serves as coordinator on public affairs.
    (b) Chief Counsel. As chief legal officer for the Administrator and
the Administration, provides general legal services and legal services
related to legislative activities; prepares litigation and issues
subpoenas; and effects rulemaking actions.
    (c) Associate Administrators, Chief Financial Officer, and Chief
Information Officer--(1) Associate Administrator for Administration.
Administers and conducts NHTSA's personnel management activities;
initiates and oversees a comprehensive program of administrative
support services to meet agency requirements, including development,
maintenance, and operation of NHTSA's manuals, notices, and orders,
property management, and the purchase, delivery, and

administration of a range of supplies, equipment, and other support
services; is responsible for administrative operational expenses and
working capital fund operations; serves as the agency's technical
expert for all administrative activities; and administers an executive
correspondence program and maintains policy files for the Administrator
and Deputy Administrator.
    (2) Associate Administrator for Communications and Consumer
Information. Represents NHTSA to the general public and others;
provides reliable, timely, and accurate traffic safety information to
the general public, consumers, partner organizations, and citizens
groups through media and public education efforts; and provides
scheduling and speechwriting support for the Administrator.
    (3) Associate Administrator for Enforcement. Directs matters
related to the enforcement of motor vehicle safety, fuel economy, theft
prevention, damageability, consumer information, and odometer laws and
regulations; conducts testing, inspection, and investigation necessary
for the identification and correction of safety-related defects in
motor vehicles and motor vehicle equipment; and ensures recalls of
noncomplying and defective vehicles and motor vehicle equipment are
effective and are conducted in accordance with Federal law and
regulations.
    (4) Associate Administrator for National Center for Statistics and
Analysis. Provides the data, analysis, and evaluation to support
determination of the nature, causes, and injury outcomes of motor
vehicle traffic crashes, the strategies and interventions that will
reduce crashes and their consequences, and the potential impact, costs,
and benefits of highway safety programs and regulatory activities;
targets the collection and analysis of data and the dissemination of
information to identify potential highway safety problems, evaluate
expected program and regulatory impact and actual goal achievement, and
support data driven decisions; and identifies, advances, and promotes
new methodologies, technologies, systems, and procedures that improve
the completeness, accuracy, timeliness, and accessibility of data
collection, analysis, and evaluation.
    (5) Associate Administrator for Regional Operations and Program
Delivery. Directs the management of State and community highway safety
programs; administers and coordinates all Regional activities,
including activities having a headquarters-regional interface;
develops, reviews, implements, and coordinates related programs,
policies, and procedures; and coordinates with the Federal Highway
Administration, the Federal Motor Carrier Safety Administration, and
other Federal agencies on traffic safety programs, as appropriate.
    (6) Associate Administrator for Research and Program Development.
Administers traffic safety programs and provides national leadership
and technical assistance to States, local communities, national
organizations, and other partners in the identification, research,
planning, development, demonstration, implementation, evaluation, and
dissemination of highway safety programs designed to prevent or reduce
traffic-related crashes and the resulting deaths, injuries, property
damage, and associated costs. Coordinates with the Federal Highway
Administration, the Federal Motor Carrier Safety Administration, and
other Federal agencies on traffic safety programs, as appropriate.
    (7) Associate Administrator for Rulemaking. Develops and
promulgates Federal standards dealing with motor vehicle safety, theft
prevention, consumer information, the National Driver Register, and
fuel economy, and directs programs relating to bumper standards, safety
performance standards, and other regulations for new and used motor
vehicles and equipment, including tires. Develops and conducts the New
Car Assessment Program.
    (8) Associate Administrator for Vehicle Safety Research. Develops
and conducts research, development, test, and evaluation programs and
projects necessary to support consumer information programs,
guidelines, industry voluntary standards, and Federal motor vehicle
regulations; manages the facilities and programs related to these
activities; and conducts crash data analyses in defining safety
problems.
    (9) Chief Financial Officer. Administers the agency planning and
budget activities in coordination with the Department of
Transportation, the Office of Management and Budget, and Congress;
assures the appropriate development of budget requests and the
subsequent execution of operating budgets within the agency to meet all
programmatic requirements; conducts all necessary accounting
transactions to assure full and accurate accountability for all
financial resources of the agency; initiates and oversees a
comprehensive program of acquisition support for agency buying and
supplier requirements, including acquisition planning, purchasing,
payments, and administration; facilitates, coordinates, tracks, and
monitors all external audits, reviews, and other oversight activities
of agency programs, finances, transactions, or activities--working
closely with responsible program and operational officials; facilitates
and oversees the agency travel program, including the administration
and operation of the travel management system, the travel card program,
and the provision of travel management advice and guidance; and serves
as the agency's technical expert for all financial management
activities.
    (10) Chief Information Officer. Administers all NHTSA Information
Technology functions and needs to ensure that IT resources are
effectively acquired and managed to maximize mission performance and
return on IT investments.

Sec.  501.4  Succession to Administrator.

    (a) The Deputy Administrator is the ``first assistant'' to the
Administrator for purposes of the Federal Vacancies Reform Act of 1998
(5 U.S.C. 3345-3349d) and shall, in the event the Administrator dies,
resigns, or is otherwise unable to perform the functions and duties of
the office, serve as the Acting Administrator, subject to the
limitations established by law.
    (b) In the event both the Administrator and the Deputy
Administrator die, resign, and/or are otherwise unable to perform the
functions and duties of their respective offices, or in the event that
both positions are vacant, the following officials, subject to
paragraph (c) and in the order indicated, shall serve as Acting Deputy
Administrator and shall perform the functions and duties of the
Administrator, except for any non-delegable statutory and/or regulatory
functions and duties:
    (1) The Chief Counsel;
    (2) The Executive Director;
    (3) Further officials as may be designated in an internal order on
succession.
    (c) In order to qualify for the line of succession, officials must
be encumbered in their position on a permanent basis.

Sec.  501.5  Exercise of authority.

    (a) All authorities lawfully vested in and reserved to the
Administrator in this title, part, or other NHTSA regulation or
directive may be exercised by the Deputy Administrator and, in the
absence or disability of both officials, by the Chief Counsel, unless
specifically prohibited by statute, regulation, or order.

    (b) In exercising the powers and performing the duties delegated by
this part, officers of NHTSA and their delegates are governed by
applicable laws, executive orders, regulations, and other directives,
and by policies, objectives, plans, standards, procedures, and
limitations as may be issued from time to time by or on behalf of the
Secretary of Transportation, the Administrator, the Deputy
Administrator, the Chief Counsel, and the Executive Director or, with
respect to matters under their jurisdiction, by or on behalf of the
Associate Administrators, the Regional Administrators, and the
Directors of Staff Offices.
    (c) Each officer to whom authority is delegated by this part may
redelegate and authorize successive redelegations of that authority
subject to any conditions the officer prescribes.
    (d) Each officer to whom authority is delegated will administer and
perform the functions described in the officer's respective functional
statements.

Sec.  501.6  Secretary's reservations of authority.

    The authorities reserved to the Secretary of Transportation are set
forth in Sec.  1.21 of this title.

Sec.  501.7  Administrator's reservations of authority.

    The delegations of authority in this part do not extend to the
following authority, which is reserved to the Administrator, except
when exercised pursuant to Sec. Sec.  501.4 and 501.5(a):
    (a) The authority under 23 U.S.C. chapter 4 (except section 403)
and any uncodified provision of law to apportion authorization amounts
and distribute obligation limitations or award grants to States for
highway safety programs or other highway safety purposes;
    (b) The authority to issue, amend, or revoke uniform State highway
safety guidelines and rules identifying highly effective highway safety
programs under 23 U.S.C. 402;
    (c) The authority to fix the rate of compensation for non-
government members of agency sponsored committees which are entitled to
compensation.
    (d) The authority under 49 U.S.C. chapter 301 to:
    (1) Issue, amend, or revoke final Federal motor vehicle safety
standards and regulations;
    (2) Make final decisions concerning alleged safety-related defects
and noncompliances with Federal motor vehicle safety standards;
    (3) Grant or renew temporary exemptions from Federal motor vehicle
safety standards; and
    (4) Grant or deny appeals from determinations upon a manufacturer's
petition for decision of inconsequential defect or noncompliance and
exemption from the notification and remedy requirements of 49 U.S.C.
chapter 301 in connection with a defect or noncompliance.
    (e) The authority under 49 U.S.C. chapters 303, 321, 323, 325, and
329 (except section 32916(b)) to:
    (1) Issue, amend, or revoke final rules and regulations; and
    (2) Assess civil penalties and approve manufacturer fuel economy
credit plans under chapter 329.
    (f) The authority to carry out, in coordination with the Federal
Motor Carrier Safety Administrator, the authority vested in the
Secretary by 49 U.S.C. chapter 311 subchapter III, to promulgate safety
standards for commercial motor vehicles and equipment subsequent to
initial manufacture when the standards are based upon and similar to a
Federal Motor Vehicle Safety Standard promulgated, either
simultaneously or previously, under 49 U.S.C. chapter 301.

Sec.  501.8  Delegations.

    (a) Deputy Administrator. The Deputy Administrator is delegated
authority to act for the Administrator, except where specifically
limited by law, order, regulation, or instructions of the
Administrator. The Deputy Administrator is delegated authority to
assist the Administrator in providing executive direction to all
organizational elements of NHTSA.
    (b) Executive Director. The Executive Director is delegated line
authority for executive direction over the Associate Administrators,
the Chief Financial Officer, and the Chief Information Officer.
    (c) Director, Office of Civil Rights. The Director, Office of Civil
Rights is delegated authority to:
    (1) Serve as the Director of Equal Employment Opportunity.
    (2) Serve as the compliance coordinator for:
    (i) Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et
seq.), as amended, and related regulations;
    (ii) Section 504 of the Rehabilitation Act of 1973;
    (iii) The Americans with Disabilities Act (ADA); and
    (iv) Other nondiscrimination statutes, regulations, Executive
Orders, and policies.
    (3) Investigate complaints of civil rights discrimination, conduct
compliance reviews, and provide technical assistance to recipients of
NHTSA financial assistance and stakeholders.
    (4) Review and evaluate the civil rights programs of State
Department of Motor Vehicles and Highway Safety Offices to ensure that
recipients of NHTSA financial assistance meet applicable Federal civil
rights requirements.
    (d) Chief Counsel. The Chief Counsel is delegated authority to:
    (1) Exercise the powers and perform the duties of the Administrator
with respect to:
    (i) Issuing odometer regulations authorized under 49 U.S.C. chapter
327.
    (ii) Providing technical assistance and granting extensions of time
to the states under 49 U.S.C. 32705.
    (iii) Granting or denying petitions for approval of alternate motor
vehicle mileage disclosure requirements under 49 U.S.C. 32705.
    (2) Establish the legal sufficiency of all investigations and
enforcement actions conducted under the authority of 49 U.S.C. chapters
301, 303, 321, 323, 325, 327, 329 and 331; to make an initial penalty
demand based on a violations of any of these chapters; and to
compromise:
    (i) Any civil penalty imposed under 49 U.S.C. 30165 in an amount of
$1,000,000 or less.
    (ii) Any civil penalty or monetary settlement other than those
imposed under 49 U.S.C. 30165 in an amount of $100,000 or less.
    (3) Exercise the powers of the Administrator under 49 U.S.C.
30166(c), (g), (h), (i), and (k).
    (4) Issue subpoenas, after notice to the Administrator, for the
attendance of witnesses and production of documents pursuant to 49
U.S.C. chapters 301, 321, 323, 325, 327, 329 and 331.
    (5) Issue authoritative interpretations of the statutes
administered by NHTSA and the regulations issued by the agency.
    (6) Administer 5 U.S.C. 552 (FOIA) and 49 CFR part 7 (Public
Availability of Information) in connection with the records of NHTSA.
    (7) Administer the Privacy Act of 1974, 5 U.S.C. 552a, and 49 CFR
part 10 (Maintenance of and Access to Records Pertaining to
Individuals) in connection with the records of NHTSA.
    (8) Carry out the functions and exercise the authority vested in
the Secretary for 23 U.S.C. 313 (Buy America), with respect to matters
within the primary responsibility of NHTSA.
    (e) Associate Administrator for Administration. The Associate
Administrator for Administration is

delegated authority to administer and conduct NHTSA's personnel
management activities; conduct administrative and management services
in support of NHTSA missions and programs; and administer an executive
correspondence program.
    (f) Associate Administrator for Communications and Consumer
Information. The Associate Administrator for Communications and
Consumer Information is delegated authority to manage and coordinate
market research, planning coordination, development, and promotion of
public education campaigns for both paid media and unpaid public
services to support program efforts; develop overall agency messaging
and communications strategies in support of program initiatives; and
develop agency policies on messaging and communications procedures and
processes.
    (g) Associate Administrator for Enforcement. The Associate
Administrator for Enforcement is delegated authority to administer the
NHTSA enforcement program for all laws, standards, and regulations
pertinent to vehicle safety, fuel economy, theft prevention,
damageability, consumer information, and odometers, authorized under 49
U.S.C. chapters 301, 323, 325, 327, 329, and 331; conduct testing,
inspection, and investigation necessary for the identification and
correction of safety-related defects in motor vehicles and motor
vehicle equipment and noncompliances with Federal motor vehicle safety
standards; make initial decisions concerning alleged safety-related
defects and noncompliances with Federal motor vehicle safety standards;
grant or deny a manufacturer's petition for decision of inconsequential
defect or noncompliance and exemption from the notification and remedy
requirements of 49 U.S.C. chapter 301 in connection with a defect or
noncompliance; issue regulations relating to the importation of motor
vehicles under 49 U.S.C. 30141-30147; and grant and deny petitions for
import eligibility determinations submitted to NHTSA by motor vehicle
manufacturers and registered importers under 49 U.S.C. 30141.
    (h) Associate Administrator for National Center for Statistics and
Analysis. The Associate Administrator for National Center for
Statistics and Analysis is delegated authority to provide the data,
analysis, and evaluation and create and maintain information systems
necessary to support the purposes of 49 U.S.C. chapters 301, 303, 323,
325, 327, 329, and 331, 23 U.S.C. chapter 4, any uncodified provisions
of law related to such issues, and any cross-cutting safety
initiatives; to develop, maintain, and operate the National Driver
Register and a nationwide clearinghouse of problem drivers; and to
support State integrated highway and traffic records safety information
systems.
    (i) Associate Administrator for Regional Operations and Program
Delivery. The Associate Administrator for Regional Operations and
Program Delivery is delegated authority, except for authority reserved
to the Administrator, to exercise the powers and perform the duties of
the Administrator with respect to grants to States for highway safety
programs or other State programs under 23 U.S.C. chapter 4 (except
section 403) and uncodified provisions of law, including approval and
disapproval of State highway safety plans and vouchers, in accordance
with the procedural requirements of the Administration. The Associate
Administrator for Regional Operations and Program Delivery is also
delegated authority over programs with respect to the authority vested
by section 210(2) of the Clean Air Act, as amended (42 U.S.C. 7544(2));
the authority vested by 49 U.S.C. 20134(a) with respect to laws
administered by NHTSA pertaining to highway, traffic, and motor vehicle
safety, in coordination with the Associate Administrator for Research
and Program Development; the authority vested by 23 U.S.C. 153, 154,
158, 161, 163, and 164, in coordination with the Federal Highway
Administrator as appropriate; and the authority vested by 23 U.S.C.
404, in coordination with the Associate Administrator for
Communications and Consumer Information.
    (j) Associate Administrator for Research and Program Development.
The Associate Administrator for Research and Program Development is
delegated authority to develop and conduct research and development
programs and projects necessary to support the purposes of 23 U.S.C.
chapter 4, any uncodified provisions of law related to that chapter,
and cross-cutting safety initiatives; conduct research and development
activities described or specifically enumerated in 23 U.S.C. 403; carry
out the functions and exercise the authority vested in the Secretary
and Administrator under section 10202 of the Safe, Accountable,
Flexible, Efficient Transportation Equity Act: A Legacy for Users,
Public Law 109-59 [42 U.S.C. 300d-4], as amended by section 31108 of
the Moving Ahead for Progress in the 21st Century Act, Public Law 112-
141, relating to emergency medical services, except for authority
reserved to the Secretary under Sec.  1.21 or the Administrator under
Sec.  501.7; and exercise the authority vested by 49 U.S.C. 20134(a)
with respect to laws administered by NHTSA pertaining to highway,
traffic, and motor vehicle safety, in coordination with the Associate
Administrator for Regional Operations and Program Delivery.
    (k) Associate Administrator for Rulemaking. The Associate
Administrator for Rulemaking is delegated authority, except for
authority reserved to the Administrator or delegated to the Chief
Counsel, to exercise the powers and perform the duties of the
Administrator with respect to the setting of motor vehicle safety and
theft prevention standards, fuel economy standards, procedural
regulations, the National Driver Register, and the development of
consumer information and odometer regulations authorized under 49
U.S.C. chapters 301, 303, 321, 323, 325, 327, 329, and 331, and any
uncodified provisions of law related to such issues. The Associate
Administrator for rulemaking is also delegated authority to perform
activities that support the development of these regulations and
standards; extend comment periods (both self-initiated and in response
to a petition or request for extension of time) for noncontroversial
rulemakings; make technical amendments or corrections to a final rule;
extend the effective date of a noncontroversial final rule; and develop
and conduct the New Car Assessment Program.
    (l) Associate Administrator for Vehicle Safety Research. The
Associate Administrator for Vehicle Safety Research is delegated
authority to develop and conduct research, development, test, and
evaluation programs and projects necessary to support the purposes of
49 U.S.C. chapters 301, 323, 325, 327, 329, and 331, any uncodified
provisions of law related to such issues, and any cross-cutting safety
initiatives.
    (m) Chief Financial Officer. The Chief Financial Officer is
delegated authority to direct the NHTSA planning and evaluation system
in conjunction with Departmental requirements and planning goals;
coordinate the development of the Administrator's plans, budgets, and
programs, and analyses of their expected impact; exercise procurement
authority with respect to NHTSA requirements; administer NHTSA
financial management programs, including systems of funds control and
accounts of all financial transactions; and enter into inter- and
intra-departmental reimbursable agreements other than

with the head of another Department or agency, provided that this
authority to enter into such agreements may be redelegated only to
Office Directors and Contracting Officers.
    (n) Chief Information Officer. The Chief Information Officer is
delegated authority to formulate IT policy, guidance, procedures,
security, and best practices; implement an IT capital planning program,
an integrated Enterprise Architecture program, and a mission
information protection program that ensures privacy, security, and
critical infrastructure protection for NHTSA systems and data; and
provide for other NHTSA IT functions to support the agency's mission,
performance goals, and objectives.

    Issued in Washington, DC, under authority delegated in 49 CFR
1.81 and 1.95.
Mark R. Rosekind,
Administrator.
[FR Doc. 2016-02101 Filed 2-3-16; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 74, Number 102 (Friday, May 29, 2009)]
[Notices]
[Pages 25787-25789]
[FR Doc No: E9-12445]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59963; File No. SR-BATS-2009-012]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
BATS Rules To Offer an After Hours Trading Session

May 21, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 20, 2009, BATS Exchange, Inc. (``BATS'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).

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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is proposing to amend BATS Rules in order to begin
offering a trading session after the close of Regular Trading Hours \5\
(the ``After Hours Trading Session'') that will last from 4 to 5 p.m.
Eastern Time.
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    \5\ As defined in current BATS Rule 1.5(v), which the Exchange
proposes to re-number as BATS Rule 1.5(w).
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    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange currently allows trading during a Pre-Opening Session
that lasts from 8 a.m. to 9:30 a.m. Eastern Time, with Regular Trading
Hours lasting from 9:30 a.m. to 4 p.m. Eastern Time. The purpose of the
proposed rule change is to amend BATS Rules in order to allow trading
on the Exchange during an After Hours Trading Session that will last
from 4 to 5 p.m. Eastern Time. Thus, in addition to adding a definition
to BATS Rule 1.5 for the ``After Hours Trading Session,'' the Exchange
has proposed to add a reference to the After Hours Trading Session to
Exchange Rules that address trading outside of Regular Trading Hours
(currently only through the Pre-Opening Session). The Exchange has also
proposed modifications to the Time-in-Force section of BATS Rule 11.9
to indicate that a Good 'til Day Order, for which a User must indicate
an expiration time, can last until the close of the After Hours Trading
Session, and to add a new Time-in-Force parameter called a Good 'til
Extended Day Order (``GTX''). As defined in proposed BATS Rule
11.9(c)(5), a limit order with a Time-in-Force of GTX will be cancelled
by the close of the After Hours Trading Session, if not executed
earlier.
    Market Makers registered with the Exchange are required to satisfy
certain obligations, including the requirement to maintain continuous
two-sided quotations in securities in which they are registered.
Pursuant to BATS Rule 11.8(b), a Market Maker's obligations apply
during Regular Trading Hours on days that the Exchange is open for
business. The Exchange has proposed language to clarify that to the
extent a Market Maker chooses to act as a Market Maker outside of
Regular Trading Hours, such Market Maker must comply, while its quotes
are open, with all applicable Exchange Rules.
    Trading outside of Regular Trading Hours involves potential risks,
including the possibility of less information regarding indicative
values, lower liquidity, higher volatility, changing prices, unlinked
markets with the possibility of trade-throughs, and wider spreads.
Moreover, trades executed during extended hours sessions may receive
executions at inferior prices when compared to the high/low of the day.
Exchange Rule 14.1(c)(2) presently requires the Exchange to distribute
an information circular to its Members in connection with any UTP
Derivative Security \6\ traded on the Exchange that includes a section
advising the Member of the risks of trading such security during the
Pre-Opening Session. The Exchange has proposed to amend BATS Rule 14.1
to also include reference to the After Hours Trading Session in
paragraph (c)(2), and thus, will provide information to its Members
regarding trading of any UTP Derivative Security during the After Hours
Trading Session in future information circulars.
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    \6\ As defined in BATS Rule 14.1(c).
---------------------------------------------------------------------------

    In addition, and in light of the risks described above, the
Exchange has proposed adding new BATS Rule 3.21 that will require
Exchange Members that execute trades on behalf of customers during
either extended hours session offered by the Exchange to provide such
customers with notice regarding the risks of trading during extended
hours. In order to reduce additional compliance burdens with respect to
this disclosure requirement, the Exchange has based BATS Rule 3.21 on
the rules of other self-regulatory organizations,\7\ and thus, believes
that many or all Exchange Members to which proposed BATS Rule 3.21 will
apply are already required to provide such disclosures to their
customers.
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    \7\ See, e.g., NASDAQ Rule 4631, NYSE Arca Equities Rule
7.34(e), and ISE Rule 2102, Interpretation and Policy .04 and .05.
---------------------------------------------------------------------------

    The information circular requirement applicable to the Exchange and
the customer disclosure requirement applicable to Members, along with
all other equity rules and trading surveillance that currently apply to
trading on the Exchange during the Pre-Opening Session and Regular
Trading Hours will apply to the After Hours Trading Session. As it
currently does with trades executed during the Pre-Opening Session, the
Exchange will designate all trades executed during the After Hours
Trading Session appropriately when reporting such trades through any
consolidated transaction reporting system.
    The Exchange has also proposed adding new Interpretation and Policy
.01 to BATS Rule 14.1, which explains the circumstances under which the
Exchange will halt trading during the Pre-Opening and After Hours
Trading Sessions. Specifically, as permitted pursuant to the rules of
other national securities exchanges,\8\ the Exchange may continue
trading of a UTP Derivative Security (as defined in BATS Rule 14.1(c))
during the Pre-Opening Session if that security commenced trading
during that session notwithstanding an interruption in the calculation
or wide dissemination of the Intraday Indicative Value (``IIV'') or
value of the underlying index, as applicable. If the IIV or value of an
underlying index for a UTP Derivative Security is not calculated or
available after the close of Regular Trading Hours on the Exchange, the
Exchange will only trade that UTP Derivative Security to the extent the
listing market traded the security until the close of its regular
trading session without a halt. If the IIV or value of an underlying
index for a UTP Derivative Security is still unavailable or is not
being calculated as of the beginning of the Pre-Opening Session on the
next business day, the Exchange will not commence trading of that
security during the Pre-Opening Session, and will resume trading of the
UTP Derivative Security only if the IIV or value of an underlying index
for that UTP Derivative Security is again being calculated or widely
disseminated, or if the listing market resumes trading.
---------------------------------------------------------------------------

    \8\ See, e.g., NYSE Arca Equities Rule 7.34(a)(4); ISE Rule
2102(e).

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    In addition to the proposed changes described above, the Exchange
is proposing to make certain non-substantive changes to Interpretation
and Policy .01 of Exchange Rule 8.15 to update and correct cross-
references to other Exchange Rules.
2. Statutory Basis
    The rule change proposed in this submission is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\9\ Specifically, the
proposed change is consistent with Section 6(b)(5) of the Act,\10\
because it would promote just and equitable principles of trade, remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system, and, in general, protect investors and
the public interest. In particular, the proposed rule change will allow
the Exchange to provide a competitive marketplace for Exchange Users to
trade securities until 5 p.m. Eastern Time.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement of Burden on Competition

    The Exchange does not believe that the proposed rule change imposes
any burden on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing rule change does not: (1) Significantly
affect the protection of investors or the public interest; (2) impose
any significant burden on competition; and (3) become operative for 30
days after the date of this filing, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and Rule 19b-4(f)(6) thereunder.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally may
not become operative prior to 30 days after the date of filing.\13\
However, Rule 19b-4(f)(6)(iii) \14\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay. The Commission notes that
BATS' proposal is substantially similar to the rules of other national
securities exchanges and does not raise any new substantive issues.\15\
BATS expects to have operational and technological changes in place to
support the proposed rule change on May 26, 2009.\16\ In addition, BATS
states that the proposal does not require significant programming
efforts by BATS Users or other market participants that would
necessitate a delay.\17\ Based on the foregoing, the Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest and hereby designates
the proposal operative upon filing.\18\
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    \13\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
the Commission written notice of its intent to file the proposed
rule change, along with a brief description and text of the proposed
rule change, at least five business days prior to the date of filing
of the proposed rule change, or such shorter time as designated by
the Commission. The Exchange has satisfied this notice requirement.
    \14\ Id.
    \15\ See supra note 7.
    \16\ See SR-BATS-2009-012, Item 7.
    \17\ Id.
    \18\ For the purposes only of waiving the 30-day operative
delay, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of such proposed rule
change the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors or otherwise in
furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-BATS-2009-012 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File No. SR-BATS-2009-012. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of BATS. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File No. SR-BATS-2009-012 and should be
submitted on or before June 19, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Florence E. Harmon,
Deputy Secretary.
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    \19\ 17 CFR 200.30-3(a)(12).
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[FR Doc. E9-12445 Filed 5-28-09; 8:45 am]
BILLING CODE 8010-01-P