[Federal Register: January 11, 2007 (Volume 72, Number 7)]
[Rules and Regulations]
[Page 1292-1296]
[DOCID:fr11ja07-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R05-OAR-2006-0399; FRL-8267-9]

Determination of Attainment, Approval and Promulgation of
Implementation Plans and Designation of Areas for Air Quality Planning
Purposes; Indiana; Redesignation of the Allen County 8-hour Ozone
Nonattainment Area to Attainment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: On May 30, 2006, the Indiana Department of Environmental
Management (IDEM), submitted a request to redesignate the Allen County,
Indiana, (Fort Wayne) nonattainment area to attainment of the 8-hour
ozone National Ambient Air Quality Standard (NAAQS). In this submittal,
IDEM also requested EPA approval of an Indiana State Implementation
Plan (SIP) revision containing a 14-year maintenance plan for Allen
County. EPA is making a determination that the Allen County, Indiana
ozone nonattainment area has attained the 8-hour ozone NAAQS. This
determination is based on three years of complete, quality-assured
ambient air quality monitoring data for the 2003-2005 ozone seasons
that demonstrate that the 8-hour ozone NAAQS has been attained in the
area. Quality-assured monitoring data for 2006 show that the area
continues to attain the standard. EPA is also approving the request to
redesignate the area to attainment for the 8-hour ozone standard. EPA's
approval of the 8-hour ozone redesignation request is based on its
determination that Allen County, Indiana has met the criteria for
redesignation to attainment specified in the Clean Air Act (CAA). EPA
is also approving as a SIP revision the State's maintenance plan for
the area. Further, EPA is approving, for purposes of transportation
conformity, the motor vehicle emission budgets (MVEBs) for the year
2020 that are contained in the 14-year, 8-hour ozone maintenance plan
for Allen County.

DATES: This final rule is effective on February 12, 2007.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2006-0399. All documents in the docket are listed on
the http://www.regulations.gov Web site. Although listed in the index, some

information is not publicly available,

i.e., Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through http://www.regulations.gov
 or in hard copy at the Environmental Protection

Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays.
We recommend that you telephone Steven Rosenthal, Environmental
Engineer, at<PHONE_NUMBER> before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Steven Rosenthal, Environmental
Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J),
U.S. Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,(312) 886-6052,
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: In the following, whenever ``we,'' ``us,''
or ``our'' are used, we mean the United States Environmental Protection
Agency.

Table of Contents

I. What Is the Background for This Rule?
II. What Comments Did We Receive on the Proposed Action?
III. What Are Our Final Actions?
IV. Statutory and Executive Order Review

I. What Is the Background for This Rule?

    Ground-level ozone is not emitted directly by sources. Rather,
emissions of nitrogen oxides (NOX) and volatile organic
compounds (VOC) react in the presence of sunlight to form ground-level
ozone. NOX and VOC are referred to as precursors of ozone.
    The CAA requires EPA to designate as nonattainment any area that is
violating the 8-hour ozone NAAQS based on three consecutive years of
air quality monitoring data. EPA designated Allen County as a
nonattainment area in a Federal Register notice published on April 30,
2004, (69 FR 23857). The CAA contains two sets of provisions--subpart 1
and subpart 2--that address planning and control requirements for
nonattainment areas. (Both are found in title I, part D.) Subpart 1
(which EPA refers to as ``basic'' nonattainment) contains general, less
prescriptive, requirements for nonattainment areas for any pollutant--
including ozone--governed by a NAAQS. Subpart 2 (which EPA refers to as
``classified'' nonattainment) provides more specific requirements for
ozone nonattainment areas. Some areas are subject only to the
provisions of subpart 1. Other areas are also subject to the provisions
of subpart 2. Under EPA's 8-hour ozone implementation rule, signed on
April 15, 2004, an area was classified under subpart 2 based on its 8-
hour ozone design value (i.e., the 3-year average annual fourth-highest
daily maximum 8-hour average ozone concentration), if it had a 1-hour
design value at or above 0.121 ppm (the lowest 1-hour design value in
Table 1 of subpart 2). All other areas are covered under subpart 1,
based upon their 8-hour design values. Allen County was originally
designated as an 8-hour ozone nonattainment area by EPA on April 30,
2004, (69 FR 23857). At the same time EPA classified Allen County as a
subpart 1 8-hour ozone nonattainment area, based on air quality
monitoring data from 2001-2003.
    Under EPA regulations at 40 CFR part 50, the 8-hour ozone standard
is attained when the 3-year average of the annual fourth-highest daily
maximum 8-hour average ozone concentrations (i.e., 0.084 ppm) is less
than or equal to 0.08 ppm. (See 69 FR 23857 (April 30, 2004) for
further information). The data completeness requirement is met when the
average percent of days with valid ambient monitoring data is greater
than 90%, and no single year has less than 75% data completeness as
determined in Appendix I of Part 50.
    On May 30, 2006, Indiana submitted a request for redesignation of
Allen County to attainment for the 8-hour ozone standard. The
redesignation request included three years of complete, quality-assured
data for the period of 2003 through 2005, indicating the 8-hour NAAQS
for ozone had been achieved. The data satisfy the CAA requirements when
the 3-year average of the annual fourth-highest daily maximum 8-hour
average ozone concentration is less than or equal to 0.08 ppm. Under
the CAA, nonattainment areas may be redesignated to attainment if
sufficient complete, quality-assured data are available for the
Administrator to determine that the area has attained the standard and
the area meets the other CAA redesignation requirements in section
107(d)(3)(E).

II. What Comments Did We Receive on the Proposed Action?

    EPA provided a 30-day review and comment period on the direct final
approval and proposal that were published in the Federal Register on
August 30, 2006. The direct final approval was withdrawn as a result of
comments received on September 4, 2006. Comments from a second
commenter were received well after the close of the comment period, but
are considered here. These comments, and EPA's responses, follow:
    (1) Comment: More information is needed to determine if the air
quality and enforceable emission reductions meet the requirements for
redesignation. Preliminary summer 2006 data is now available. It cannot
be determined from the data presented if enforceable emission
reductions have taken place in Allen County.
    Response: The Allen County redesignation is based upon air quality
monitoring data for 2003-2005 that clearly establishes that the 8-hour
ozone standard is being achieved. This air quality monitoring data is
described in EPA's August 30, 2006 proposal at 71 FR 51491. Also,
quality-assured 2006 data show continuing attainment. Using this 2006
data, the average of the 4th high values for the Leo and Ft. Wayne
monitoring sites are 0.077 and 0.072 ppm, respectively. This is well
below the violating level of 0.085 ppm.
    As discussed in the direct final approval, EPA believes that
Indiana has demonstrated that the observed air quality improvement in
Allen County is due to permanent and enforceable emission reductions
resulting from implementation of the SIP, Federal measures, and other
state-adopted measures. See the discussion at 71 FR 51493-51494 and
Tables 2 and 3. These include Statewide reasonably available control
technology (RACT) rules, the Indiana NOX SIP and acid rain
control, tier 2 emission standards for vehicles and gasoline sulfur
standards, and rules for both on and off-road diesel engines. Indiana
has documented both reductions in VOC (4.88 tons/day) and
NOX (3.81 tons/day) emissions in Allen County between 2002
(a nonattainment year) and 2004 (an attainment year), and also that
enforceable emission control requirements have been implemented in
Allen County. These controls have contributed to the documented
emission reductions. Therefore, we believe that they have caused and
contributed to the observed air quality improvement. Finally, as noted
above, 2006 data show continued attainment in Allen County.
    (2) Comment: It appears that cold and wet summers caused the
improvement in air quality. Doesn't the Cox/Chu model show that 2003-
2005 was an unusual met period?
    Response: EPA's redesignation policy requires the use of three
years of air quality data to compensate for the variation in
meteorological conditions and their effect on ozone levels. EPA

did not consider the Cox/Chu model or any other model to account for
year-to-year meteorological deviations. Consideration of such modeling
is not required by EPA's redesignation policy.
    (3) Comment: At the Leo site, 2003-2005 is the first period in the
entire site's monitoring history that it did not violate the standard.
However, it did have 8 exceedances over 84 ppb. This is more
exceedances than 10 of its 17-year history. We know from the met
analysis that was done that 2004 was an extremely unusual year with
rain and the seventh coldest August on record.
    Response: As discussed in detail in the Direct Final Notice, an
area is considered to be in attainment of the 8-hour ozone standard if
the 3-year average of the 4th high 8-hour ozone value, for each of the
three years, is 84 ppb or lower. Therefore, to determine compliance
with the standard, only the 4th high 8-hour ozone values are
considered, not the number of exceedances. Also, three years of air
quality data are used to allow for year-to-year variations in
meteorology. The commenter provides no data supporting the contention
that the ``lower'' ozone concentrations of 2004 completely dominated
the 2003-2005 average or that the 2003-2005 period as a whole had ozone
averages atypically influenced by meteorology compared to other three-
year periods.
    (4) Comment: EPA should delay redesignation until after the 2005-
2007 air quality data is collected and enforceable reduction(s) are
made.
    Response: Delay of the redesignation is not necessary because Allen
County is in attainment of the 8-hour ozone standard for 2003-2005.
Quality-assured 2004-2006 data shows continued attainment and both the
(ozone precursor) VOC and NOX emissions will continue to
decline through 2020, further decreasing peak ozone levels and
maintaining ozone attainment. As discussed previously, EPA believes
that Indiana has demonstrated that the observed air quality improvement
in Allen County is due to permanent and enforceable emission reductions
resulting from implementation of the SIP, Federal measures and other
state-adopted measures.
    (5) Comment: The commenter quotes John Stafford, Director,
Community Research Institute, Indiana University Purdue University,
Fort Wayne as saying: ``From an employment perspective, it appears that
northeast Indiana hit the low point of the downturn in the last three
quarters of 2003 and the first quarter of 2004. In 2006, northeast
Indiana should expect to see continued job growth, likely at a pace
reflective of that for Indiana statewide. On the conservative end,
additional 2,000 to 2,500 jobs to the Fort Wayne-Huntington-Auburn CSA
should be very achievable.'' The commenter concludes that it appears
that reductions came from activity changes and not enforceable
reductions.
    Response: Documentation was neither submitted supporting the above
employment projections, nor their potential impact on emissions. As set
forth above, EPA believes that the improvement in air quality was due
to permanent and enforceable emission reductions. Furthermore, Indiana
in its maintenance plan considered population and source growth when
making its future year emission projections which show decreasing VOC
and NOX emissions, and continued attainment throughout the
maintenance period. It should also be noted that Indiana's and 21 other
states' electric generating unit NOX emission control rules
stemming from EPA's NOX SIP Call have already been
implemented, with additional NOX emission reductions
expected through 2007. More specifically for Indiana, Table 3 in the
withdrawn direct final notice (at 71 FR 51494) shows that
NOX emissions have declined substantially from 1999 through
2005 from its electric generating units. Further, Tables 4 and 5 in the
withdrawn direct final notice show that VOC and NOX
emissions in Allen County will continue to decline through 2020. In
addition, the Clean Air Interstate Rule, to be implemented beginning in
2006, will further lower NOX emissions in upwind areas,
resulting in decreased ozone and ozone precursor transport into Allen
County--also supporting maintenance of the ozone standard in Allen
County.
    (6) Comment: Another commenter asked EPA to reconsider the adequacy
of the 8-hour ozone standard. The commenter stated her belief that the
current standard was inadequate to protect Allen County's citizens. (It
should be noted that EPA received this comment on October 30, 2006,
well after the comment period closed on September 29, 2006.)
    Response: The adequacy of the ozone standard is not at issue in
this rulemaking, which is an action to redesignate an area pursuant to
the current standard. EPA revised and promulgated the current ozone
standard (0.08 ppm, measured over an 8-hour period) on July 18, 1997
(62 FR 38856). This standard was promulgated to better protect public
health and is more stringent than the 1-hour ozone standard that was
previously in effect. This comment, which was not specific to the Allen
County redesignation request, would have more appropriately been
submitted in response to the proposal of the existing 8-hour standard;
it is not relevant with regard to whether Allen County is attaining the
current standard, which is the subject of this redesignation action.

III. What Are Our Final Actions?

    EPA is taking several related actions. EPA is making a
determination that the Allen County nonattainment area has attained the
8-hour ozone standard. EPA is also approving the State's request to
change the legal designation of the Allen County area from
nonattainment to attainment for the 8-hour ozone NAAQS. EPA is also
approving Indiana's maintenance plan SIP revision for Allen County
(such approval being one of the CAA criteria for redesignation to
attainment status). The maintenance plan is designed to keep Allen
County in attainment for ozone for the next 14 years, through 2020. In
addition, and supported by and consistent with the ozone maintenance
plan, EPA is approving the 2020 VOC and NOX MVEBs for Allen
County for transportation conformity purposes.

IV. Statutory and Executive Order Review

Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and, therefore, is
not subject to review by the Office of Management and Budget.

Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    Because it is not a ``significant regulatory action'' under
Executive Order 12866 or a ``significant energy action,'' this action
is also not subject to Executive Order 13211, ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001).

Regulatory Flexibility Act

    This action merely approves state law as meeting Federal
requirements and imposes no additional requirements beyond those
imposed by state law. Redesignation of an area to attainment under
section 107(d)(3)(E) of the Clean Air Act does not impose any new
requirements on small entities. Redesignation is an action that affects
the status of a geographical area and does not impose any new
regulatory

requirements on sources. Accordingly, the Administrator certifies that
this rule will not have a significant economic impact on a substantial
number of small entities under the Regulatory Flexibility Act (5 U.S.C.
601 et seq.).

Unfunded Mandates Reform Act

    Because this rule approves pre-existing requirements under state
law and does not impose any additional enforceable duty beyond that
required by state law, it does not contain any unfunded mandate or
significantly or uniquely affect small governments, as described in the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

Executive Order 13175: Consultation and Coordination With Indian Tribal
Governments

    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000).

Executive Order 13132: Federalism

    This action also does not have federalism implications because it
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, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). Redesignation is an action that merely affects the status of
a geographical area, and does not impose any new requirements on
sources, or allows a state to avoid adopting or implementing additional
requirements, and does not alter the relationship or distribution of
power and responsibilities established in the Clean Air Act.

Executive Order 13045: Protection of Children From Environmental Health
and Safety Risks

    This rule also is not subject to Executive Order 13045 ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), because it is not economically significant.

National Technology Transfer Advancement Act

    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
state to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Redesignation is an
action that affects the status of a geographical area but does not
impose any new requirements on sources. Thus, the requirements of
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply.

Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).

Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under Section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by March 12, 2007. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review, nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to force its requirements. (See Section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Nitrogen dioxide, Ozone, Particulate matter, Volatile
organic compounds.

40 CFR Part 81

    Air pollution control, Environmental protection, National parks,
Wilderness areas.

    Dated: January 3, 2007.
Bharat Mathur,
Acting Regional Administrator, Region 5.

0
Parts 52 and 81, chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--[AMENDED]

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

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

Subpart P--Indiana

0
2. Section 52.777 is amended by adding paragraph (ff) to read as
follows:

Sec.  52.777  Control strategy: Photochemical oxidants (hydrocarbons).

* * * * *
    (ff) Approval--On May 30, 2006, Indiana submitted a request to
redesignate Allen County to attainment of the 8-hour ozone National
Ambient Air Quality Standard. As part of the redesignation request, the
State submitted a maintenance plan as required by section 175A of the
Clean Air Act. Elements of the section 175 maintenance plan include a
contingency plan and an obligation to submit a subsequent maintenance
plan revision in eight years as required by the Clean Air Act. Also
included were motor vehicle emission budgets to determine
transportation conformity in Allen County. The 2020 motor vehicle
emission budgets are 6.5 tons per day for VOC and 7.0 tons per day for
NOX.

PART 81--[AMENDED]

0
1. The authority citation for part 81 continues to read as follows:

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

0
2. Section 81.315 is amended by revising the entry for Fort Wayne, IN:
Allen County in the table entitled ``Indiana Ozone (8-Hour Standard)''
to read as follows:

Sec.  81.315  Indiana.

* * * * *

                                                  Indiana Ozone
                                                [8-Hour standard]
----------------------------------------------------------------------------------------------------------------
                                                Designation \a\                          Classification
         Designated area         -------------------------------------------------------------------------------
                                       Date\1\                 Type                  Date              Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Fort Wayne, IN: Allen County....            2/12/07  Attainment

                                                 * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is June 15, 2004, unless otherwise noted.

[FR Doc. E7-255 Filed 1-10-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 35 (Tuesday, February 22, 2011)]
[Notices]
[Pages 9817-9819]
[FR Doc No: 2011-3874]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2011-0008]

Standard on Commercial Diving Operations; Extension of the Office
of Management and Budget's (OMB) Approval of Information Collection
(Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its proposal to
extend OMB approval of the information collection requirements
specified in the Commercial Diving Operations Standard (29 CFR part
1910, subpart T).

DATES: Comments must be submitted (postmarked, sent, or received) by
April 25, 2011.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit your comments and attachments
to the OSHA Docket Office, Docket No. OSHA-2011-0008, U.S. Department
of Labor, Room N-2625, 200 Constitution Avenue, NW., Washington, DC
20210. Deliveries (hand, express mail, messenger, and courier service)
are accepted during the Department of Labor's and Docket Office's
normal business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the Information Collection Request (ICR) (OSHA-2011-
0008). All comments, including any personal information you provide,
are placed in the public docket without change, and may be made
available online at http://www.regulations.gov. For further information
on submitting comments see the ``Public Participation'' heading in the
section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You also may contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney, Directorate of Standards
and Guidance, OSHA, U.S. Department of Labor, Room N-3609, 200
Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of efforts in
obtaining information (29 U.S.C. 657). Subpart T applies to diving and
related support operations conducted by employers involved in general
industry, construction, ship repairing, shipbuilding, shipbreaking, and
longshoring, and specifies equipment and procedures that prevent injury
and death among workers exposed to hazards associated with diving and
diving support operations.
    Subpart T contains a number of paperwork requirements. The
following paragraphs describe these requirements.
    Section 1910.401(b). Allows employers to deviate from the
requirements of the Subpart to the extent necessary to prevent or
minimize a situation that is likely to cause death, serious physical
harm, or major environmental damage (but not situations in which purely
economic or property damage is likely to occur). They must notify the
OSHA Area Director within 48 hours of taking such action; this
notification must describe the situation responsible for the deviation
and the extent of the deviation from the requirements. On request of
the Area Director, employers must submit this information in writing.
    Sections 1910.410(a)(3) and (a)(4). Paragraph (a)(3) requires
employers to train all dive team members in cardiopulmonary
resuscitation and first aid (i.e., the American Red Cross

standard course or equivalent), while paragraph (a)(4) specifies that
employers train dive team members exposed to hyperbaric conditions, or
who control exposure of other employees to such conditions, in diving-
related physics and physiology.
    Sections 1910.420(a). Under paragraph (a), employers must develop
and maintain a safe practices manual and make it available to each dive
team member at the dive location. In addition, for each diving mode
used at the dive location, the manual must contain: Safety procedures
and checklists for diving operations; assignments and responsibilities
of the dive team members; equipment procedures and checklists; and
emergency procedures for fire, equipment failures, adverse
environmental conditions, and medical illness and injury.
    Section 1910.421(b). Under this provision, employers are to keep at
the dive location a list of telephone or call numbers for the following
emergency facilities and services: An operational decompression chamber
(if such a chamber is not at the dive location); accessible hospitals;
available physicians and means of emergency transportation; and the
nearest U.S. Coast Guard Rescue Coordination Center.
    Section 1910.421(f). Requires employers to brief dive team members
on the diving-related tasks they are to perform, safety procedures for
the diving mode used at the dive location, any unusual hazards or
environmental conditions likely to affect the safety of the diving
operation, and any modifications to operating procedures necessitated
by the specific diving operation. Before assigning diving-related
tasks, employers must ask each dive team member about their current
state of physical fitness, and inform the member about the procedure
for reporting physical problems or adverse physiological effects during
and after the dive.
    Section 1910.421(h). If the diving operation occurs in an area
capable of supporting marine traffic and occurs from a surface other
than a vessel, employers are to display a rigid replica of the
international code flag ``A'' that is at least one meter in height so
that it is visible from any direction; the employer must illuminate the
flag during night diving operations.
    Section 1910.422(e). Employers must develop and maintain a depth-
time profile for each diver that includes, as appropriate, any
breathing gas changes or decompression.
    Sections 1910.423(b)(1)(ii) through (b)(2). Requires the employer
to: Instruct the diver to report any physical symptoms or adverse
physiological effects, including symptoms of decompression sickness
(DCS); advise the diver of the location of a decompression chamber that
is ready for use; and alert the diver to the potential hazards of
flying after diving. For any dive outside the no-decompression limits,
deeper than 100 feet, or that uses mixed gas in the breathing mixture,
the employer must also inform the diver to remain awake and in the
vicinity of the decompression chamber that is at the dive location for
at least one hour after the dive or any decompression or treatment
associated with the dive.
    Section 1910.423(d). Paragraph (d)(1) specifies that employers are
to record and maintain the following information for each diving
operation: The names of dive-team members; date, time, and location;
diving modes used; general description of the tasks performed; an
estimate of the underwater and surface conditions; and the maximum
depth and bottom time for each diver. In addition, for each dive
outside the no-decompression limits, deeper than 100 feet, or that uses
mixed gas in the breathing mixture, paragraph (d)(2) requires the
employer to record and maintain the following information for each
diver: Depth-time and breathing gas profiles; decompression table
designation (including any modifications); and elapsed time since the
last pressure exposure if less than 24 hours or the repetitive dive
designation. Under paragraph (d)(3), if the dive results in DCS
symptoms, or the employer suspects that a diver has DCS, the employer
must record and maintain a description of the DCS symptoms (including
the depth and time of symptom onset) and the results of treatment.
    Section 1910.423(e). Requires employers to assess each DCS incident
by: Investigating and evaluating it based on the recorded information,
consideration of the past performance of the decompression profile
used, and the diver's individual susceptibility to DCS; taking
appropriate corrective action to reduce the probability of a DCS
recurrence; and, within 45 days of the DCS incident, preparing a
written evaluation of this assessment, including any corrective action
taken.
    Sections 1910.430(a), (b)(4), (c)(1)(ii), (c)(3)(i), (f)(3)(ii),
and (g)(2). Description of the requirements. Paragraph (a) contains a
general requirement that employers must record by means of tagging or a
logging system any work performed on equipment, including any
modifications, repairs, tests, calibrations, or maintenance performed
on the equipment. This record is to include a description of the work,
the name or initials of the individual who performed the work, and the
date they completed the work.
    Paragraphs (b)(4) and (c)(1)(iii) require employers to test two
specific types of equipment, including, respectively: The output of air
compressor systems used to supply breathing air to divers for air
purity every six months by means of samples taken at the connection to
the distribution system; and breathing-gas hoses at least annually at
one and one-half times their working pressure. Under paragraph
(c)(3)(i), employers must mark each umbilical (i.e., separate lines
supplying air and communications to a diver, as well as a safety line,
tied together in a bundle), beginning at the diver's end, in 10-foot
increments for 100 feet, then in 50-foot increments. Paragraph
(f)(3)(ii) mandates that employers regularly inspect and maintain
mufflers located in intake and exhaust lines on decompression chambers.
According to paragraph (g)(2), employers are to test depth gauges using
dead-weight testing, or calibrate the gauges against a master reference
gauge; such testing or calibration is to occur every six months or if
the employer finds a discrepancy larger than two percent of the full
scale between any two equivalent gauges. Employers must make a record
of the tests, calibrations, inspections, and maintenance performed on
the equipment specified by these paragraphs in accordance with section
1910.430(a).
    Sections 1910.440(a)(2) and (b). Under paragraph (a)(2) of this
provision, employers must record any diving-related injuries or
illnesses that result in a dive-team member remaining in hospital for
at least 24 hours. This record is to describe the circumstances of the
incident and the extent of any injuries or illnesses.
    Paragraph (b) of this provision regulates the availability of the
records required by the Subpart, including who has access to these
records, the retention periods for various records, and, in some cases,
the final disposition of the records. Under paragraph (b)(1), employers
must make any record required by the subpart available, on request, for
inspection and copying to an OSHA compliance officer or to a
representative of the National Institute for Occupational Safety and
Health (NIOSH). Paragraph (b)(2) specifies that employers are to
provide workers, their designated representatives, and OSHA compliance
officers with exposure and

medical records generated under the Subpart in accordance with Sec.
1910.1020 (``Access to employee exposure and medical records''); these
records include safe practices manuals, depth-time profiles, diving
records, DCS incident assessments, and hospitalization records. This
paragraph also mandates that employers make equipment inspection and
testing records available to employees and their designated
representative on request.
    According to paragraph (b)(3), employers must retain these records
for the following periods: Safe practices manuals, current document
only; depth-time profiles, until completing the diving record or the
DCS incident assessment; diving records, one year, except five years if
a DCS incident occurred during the dive; DCS incident assessments, five
years; hospitalization records, five years; and equipment inspections
and testing records, current tag or log entry until the employer
removes the equipment from service. Paragraphs (b)(4) and (b)(5)
specify the requirements for disposing of these records. Under
paragraph (b)(4), employers are to forward any record with an expired
five-year retention period to NIOSH. Paragraph (b)(5) states that
employers who cease to do business must transfer records without
unexpired retention dates to the successor employer who will retain
them for the required period; however, if the employers cease to do
business without a successor employer, they must transfer the records
to NIOSH.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions to
protect workers, including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the information
collection requirements contained in the Standard on Commercial Diving
Operations (29 CFR part 1910, subpart T). The Agency is requesting a
1,774 decrease in burden hours from the current level of 205,397 hours
to 203,623 hours. This request is being made due to an overall decrease
in the number of facilities affected by the Standard.
    Type of Review: Extension of a currently approved collection.
    Title: Standard on Commercial Diving Operations (29 CFR part 1910,
subpart T).
    OMB Number: 1218-0069.
    Affected Public: Business or other for-profits; Not-for-profit
institutions; Federal Government; State, Local or Tribal Governments.
    Number of Respondents: 2,500.
    Frequency: On Occasion; Annually.
    Total Responses: 3,969,219.
    Average Time per Response: Varies from 3 minutes (.05 hour) to
replace the safe practices manual to 1 hour to develop a new manual.
    Estimated Total Burden Hours: 203,623.
    Estimated Cost (Operation and Maintenance): $2,480.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile; or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for this ICR (Docket No. OSHA-2011-0008).
You may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or a facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and docket number so the Agency can attach them to
your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger or courier service, please contact the OSHA
Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
Information on using the http://www.regulations.gov Web site to submit
comments and access the docket is available at the Web site's ``User
Tips'' link. Contact the OSHA Docket Office for information about
materials not available through the Web site, and for assistance in
using the Internet to locate docket submissions.

V. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 4-2010
(75 FR 55355).

    Signed at Washington, DC on February 16, 2011.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2011-3874 Filed 2-18-11; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Rules and Regulations]
[Pages 61168-61169]
[FR Doc No: 2017-27854]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2017-N-6531]

Medical Devices; Neurological Devices; Classification of the
External Vagal Nerve Stimulator for Headache

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the external vagal nerve stimulator for headache into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the external vagal nerve stimulator for headache's classification. We
are taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices, in part by reducing regulatory burdens.

DATES: This order is effective December 27, 2017. The classification
was applicable on April 14, 2017.

FOR FURTHER INFORMATION CONTACT: William Heetderks, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2682, Silver Spring, MD 20993-0002, 240-
402-5360, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the external vagal nerve
stimulator for headache as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On October 16, 2015, electroCore, LLC, submitted a request for De
Novo classification of the gammaCore Non-invasive Vagus Nerve
Stimulator. FDA reviewed the request in order to classify the device
under the criteria for classification set forth in section 513(a)(1) of
the FD&C Act.
    We classify 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 that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.

    Therefore, on April 14, 2017, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 882.5892. We have named
the generic type of device external vagal nerve stimulator for
headache, and it is identified as a prescription device used to apply
an electrical current to a patient's vagus nerve through electrodes
placed on the skin for the treatment of headache.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

     Table 1--External Vagal Nerve Stimulator for Headache Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction resulting from   Biocompatibility evaluation and
 patient contacting components.           Labeling.
Electrical shock injury from device      Electrical safety, thermal, and
 failure.                                 mechanical testing; Software
                                          verification, validation, and
                                          hazard analysis; and Labeling.
Incorrect stimulation resulting from     Electromagnetic compatibility
 interference from other electrical       testing.
 devices.
Stimulation side effects such as the     Labeling.
 following.
     Seizure
     Cardiac side effects
     Worsening of headache.
Ineffective therapeutic response due to  Non-clinical performance
 device failure.                          testing; Software
                                          verification, validation, and
                                          hazard analysis; and Labeling.
User error.............................  Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, external vagal nerve stimulators for
headache are for prescription use only. Prescription devices are exempt
from the requirement for adequate directions for use for the layperson
under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21
CFR 801.5, as long as the conditions of 21 CFR 801.109 are met
(referring to 21 U.S.C. 352(f)(1)).

III. Analysis of 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.

IV. 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
the guidance document ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' have been approved under OMB control
number 0910-0844; the collections of information in 21 CFR part 814,
subparts A through E, regarding premarket approval, have been approved
under OMB control number 0910-0231; 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.

List of Subjects in 21 CFR Part 882

    Medical devices, Neurological devices.

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

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

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

0
2. Add Sec.  882.5892 to subpart F to read as follows:

Sec.  882.5892  External vagal nerve stimulator for headache.

    (a) Identification. An external vagal nerve stimulator for headache
is a prescription device used to apply an electrical current to a
patient's vagus nerve through electrodes placed on the skin for the
treatment of headache.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The technical parameters of the device, including waveform,
output modes, maximum output voltage and current (with 500, 2,000, and
10,000 ohm loads), pulse duration, frequency, net charge ([mu]C) per
pulse, maximum phase charge at 500 ohms, maximum current density (mA/
cm\2\, r.m.s.), maximum average current (mA), maximum average power
density (W/cm\2\), and the type of impedance monitoring system shall be
fully characterized through non-clinical performance testing.
    (2) Software verification, validation, and hazard analysis shall be
performed.
    (3) Biocompatibility evaluation of the patient-contacting
components of the device shall be performed.
    (4) The device shall be tested for electrical, thermal, and
mechanical safety, and for electromagnetic compatibility (EMC).
    (5) The labeling must include:
    (i) Instructions for proper use of the device, including placement
of the device on the patient; and
    (ii) Instructions on care and cleaning of the device.

    Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27854 Filed 12-26-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 26 (Thursday, February 7, 2013)]
[Notices]
[Pages 9076-9078]
[FR Doc No: 2013-02705]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68800; File No. SR-CBOE-2013-012]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend CBSX Rule 52.4 Relating to the Clearly
Erroneous Policy

February 1, 2013.
    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 January 29, 2013, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I and II below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to extend a pilot program related to CBOE
Stock Exchange (``CBSX'') Rule 52.4, entitled ``Clearly Erroneous
Policy.'' The Exchange also proposes to adopt new paragraph (i) to CBSX
Rule 52.4 in connection with the upcoming operation of the Plan to
Address Extraordinary Market Volatility Pursuant to Rule 608 of
Regulation NMS under the Securities and Exchange Act of 1934 (the
``Limit Up-Limit Down Plan'' or ``Plan'').\3\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (the ``Limit Up-Limit Down
Release'').

(additions are in italics; deletions are [bracketed])
* * * * *

Chicago Board Options Exchange, Incorporated

Rules

* * * * *

Rule 52.4 Clearly Erroneous Policy

    The provisions of paragraphs (c), (e)(2), (f), and (g) of this
Rule, as amended on September 10, 2010, and the provisions of
paragraph (i), shall be in effect during a pilot period set to end
on [February 4]September 30, 2013. If the pilot is not either
extended, replaced or approved permanent by September 30, 2013, the
prior versions of paragraphs (c), (e)(2), (f), and (g) shall be in
effect, and the provisions of paragraph (i) shall be null and void.
* * * * *
    (i) Securities Subject to Limit Up-Limit Down Plan. For purposes
of this paragraph, the phrase ``Limit Up-Limit Down Plan'' or
``Plan'' shall mean the Plan to Address Extraordinary Market
Volatility Pursuant to Rule 608 of Regulation NMS under the Act. The
provisions of paragraphs (a) through (h) above shall govern all CBSX
transactions, including transactions in securities subject to the
Plan, other than as set forth in this paragraph (i). If as a result
of CBSX technology or systems issue any transaction occurs outside
of the applicable price bands disseminated pursuant to the Plan, an
Official or senior level employee designee, acting on his or her own
motion or at the request of a third party, shall review and declare
any such trades null and void. Absent extraordinary circumstances,
any such action of the Official or other senior level employee
designee shall be taken in a timely fashion, generally within thirty
(30) minutes of the detection of the erroneous transaction. When
extraordinary circumstances exist, any such action of the Official
or other senior level employee designee must be taken by no later
than the start of CBSX Regular Trading Hours on the trading day
following the date on which the execution(s) under review occurred.
Each CBSX Trader involved in the transaction shall be notified as
soon as practicable by CBSX, and the party aggrieved by the action
may appeal such action in accordance with the provisions of
paragraph (e)(2) above. In the event that a single plan processor
experiences a technology or systems issue that prevents the
dissemination of price bands, CBSX will make the determination of
whether to nullify transactions based on paragraphs (a) through (h)
above.
* * * * *
    The text of the proposed rule change is also available on the
Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission.

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 aspects of such
statements.

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

1. Purpose
    The purpose of this filing is to extend the effectiveness of CBSX's
current rule ``Clearly Erroneous Policy'' and to adopt new paragraph
(i) to CBSX Rule 52.4 in connection with upcoming operation of the
Limit Up-Limit Down Plan.
Proposal To Extend Pilot
    Portions of Rule 52.4, explained in further detail below, are
currently operating as a pilot program set to expire on February 4,
2013.\4\ The Exchange proposes to extend the pilot program to September
30, 2013.
---------------------------------------------------------------------------

    \4\ Securities Exchange Act Release No. 67575 (August 2, 2012),
77 FR 47478 (August 8, 2012) (SR-CBOE-2012-070).
---------------------------------------------------------------------------

    On September 10, 2010, the Commission approved, on a pilot basis,
changes to CBSX Rule 52.4 to provide for uniform treatment: (1) Of
clearly erroneous execution reviews in multi-stock events involving
twenty or more securities; and (2) in the event transactions occur that
result in the issuance of an individual stock trading pause by the
primary market and subsequent transactions that occur before the
trading pause is in effect on CBSX.\5\ The Exchange also adopted
additional changes to CBSX Rule 52.4 that reduced the ability of CBSX
to deviate from the objective standards set forth in Rule 52.4.\6\ The
Exchange believes the benefits to market participants from the more
objective clearly erroneous executions rule should continue on a pilot
basis through

September 30, 2013, which is the date that the Exchange anticipates
that the phased implementation of the Limit Up-Limit Down Plan will be
complete. As explained in further detail below, although the Limit Up-
Limit Down Plan is intended to prevent executions that would need to be
nullified as clearly erroneous, the Exchange believes that certain
protections should be maintained while the industry gains initial
experience operating with the Limit Up-Limit Down Plan, including the
provisions of Rule 52.4 that currently operate as a pilot.
---------------------------------------------------------------------------

    \5\ Securities Exchange Act Release No. 62886 (September 10,
2010), 75 FR 56613 (September 16, 2010) (SR-CBOE-2010-056).
    \6\ Id.
---------------------------------------------------------------------------

Proposed Limit Up-Limit Down Provision to Rule 52.4
    The Exchange proposes to adopt new paragraph (i) to Rule 52.4, to
provide that the existing provisions of CBSX Rule 52.4 will continue to
apply to all CBSX transactions, including transactions in securities
subject to the Plan, other than as set forth in proposed paragraph (i).
Accordingly, other than as proposed below, the Exchange proposes to
maintain and continue to apply the Clearly Erroneous Policy standards
in the same way that it does today. Notably, this means that CBSX might
nullify transactions that occur within the price bands disseminated
pursuant to the Limit Up-Limit Down Plan to the extent such
transactions qualify as clearly erroneous under existing criteria. As
an example, assume that a Tier 1 security pursuant to the Plan has a
reference price pursuant to both the Plan and Rule 52.4 of $100.00. The
lower pricing band under the Plan would be $95.00 and the upper pricing
band under the Plan would be $105.00. An execution could occur on CBSX
in this security at $96.00, as this is within the Plan's pricing bands.
However, if subjected to review as potentially clearly erroneous, CBSX
would nullify an execution at $96.00 as clearly erroneous because it
exceeds the 3% threshold that is in place pursuant to Rule 52.4(c)(1)
for securities priced above $50.00 (i.e., with a reference price of
$100.00, any transactions at or below $97.00 or above $103.00 could be
nullified as clearly erroneous). Accordingly, this proposal maintains
the status quo with respect to reviews of clearly erroneous executions
and the application of objective numerical guidelines by CBSX. The
proposal does not increase the discretion afforded to CBSX in
connection with reviews of clearly erroneous executions.
    The Limit Up-Limit Down Plan is designed to prevent executions from
occurring outside of dynamic price bands disseminated to the public by
the single plan processor as defined in the Limit Up-Limit Down
Plan.\7\ The possibility remains that CBSX could experience a
technology or systems problem with respect to the implementation of the
price bands disseminated pursuant to the Plan. To address such
possibilities, CBSX proposes to adopt language to make clear that if a
CBSX technology or systems issue results in any transaction occurring
outside of the price bands disseminated pursuant to the Plan, an
Official or senior level employee designee, acting on his or her own
motion or at the request of a third party, shall review and declare any
such trades null and void. Absent extraordinary circumstances, any such
action of the Official or other senior level employee designee shall be
taken in a timely fashion, generally within thirty (30) minutes of the
detection of the erroneous transaction. When extraordinary
circumstances exist, any such action of the Official or other senior
level employee designee must be taken by no later than the start of
CBSX Regular Trading Hours \8\ on the trading day following the date on
which the execution(s) under review occurred. Although CBSX will act as
promptly as possible and the proposed objective standard (i.e., whether
an execution occurred outside the band) should make it feasible to
quickly make a determination, there may be circumstances in which
additional time may be needed for verification of facts or coordination
with outside parties, including the single plan processor responsible
for disseminating the price bands and other market centers.
Accordingly, CBSX believes it necessary to maintain some flexibility to
make a determination outside of the thirty (30) minute guideline. In
addition, CBSX proposes that a transaction that is nullified pursuant
to new paragraph (i) would be appealable in accordance with the
provisions of Rule 52.4(e)(2). In addition, CBSX proposes to make clear
that in the event that a single plan processor experiences a technology
or systems problem that prevents the dissemination of price bands, CBSX
would make the determination of whether to nullify transactions based
on Rule 52.4(a)-(h).
---------------------------------------------------------------------------

    \7\ See Limit Up-Limit Down Release, supra note 3.
    \8\ Regular Trading Hours commence at 9:30 a.m. Eastern Time.
See CBSX Rule 51.2(a).
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    The Exchange believes that cancelling trades that occur outside of
the price bands disseminated pursuant to the Plan is consistent with
the purpose and intent of the Plan, as such transactions are not
intended to occur in the first place. If transactions do occur outside
of the price bands and no exception applies--which necessarily would be
caused by a technology or systems issue--then the Exchange believes the
appropriate result is to nullify such transactions.
 2. Statutory Basis
    The Exchange believes that its proposal 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\ In particular, the
proposal 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. The Exchange believes that the pilot
program promotes just and equitable principles of trade in that it
promotes transparency and uniformity across markets concerning review
of transactions as clearly erroneous. More specifically, the Exchange
believes that the extension of the pilot would help assure that the
determination of whether a clearly erroneous trade has occurred will be
based on clear and objective criteria, and that the resolution of the
incident will occur promptly through a transparent process. The
proposed rule change would also help assure consistent results in
handling erroneous trades across the U.S. markets, thus furthering fair
and orderly markets, the protection of investors and the public
interest. Although the Limit Up-Limit Down Plan will be operational
during the same time period as the proposed extended pilot, the
Exchange believes that maintaining the pilot for at least through the
phased implementation of the Plan is operational will help to protect
against unanticipated consequences. To that end, the extension will
allow the Exchange to determine whether Rule 52.4 is necessary once the
Plan is operational and, if so, whether improvements can be made.
Further, the Exchange believes it consistent with the protection of
investors and the public interest to adopt objective criteria to
nullify transactions that occur outside of the Plan's price bands when
such transactions should not have been executed but were due to a
systems or technology issue.
---------------------------------------------------------------------------

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

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

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. To the contrary, the Exchange
believes that the Financial Industry Regulatory Authority (``FINRA'')
and other national securities exchanges are also filing similar
proposals, and thus, that the proposal will help to ensure consistent
rules across market centers.

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

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

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

    Because the proposed rule change does not (i) Significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \11\ and Rule 19b-
4(f)(6)(iii) thereunder.\12\
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6)(iii). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the 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.
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    A proposed rule change filed under Rule 19b-4(f)(6) \13\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii) \14\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing.
---------------------------------------------------------------------------

    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest, as
it will allow the pilot program to continue uninterrupted, thereby
avoiding the investor confusion that could result from a temporary
interruption in the pilot program. For this reason, the Commission
designates the proposed rule change to be operative upon filing.\15\
---------------------------------------------------------------------------

    \15\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend 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 email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2013-012 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 Number SR-CBOE-2013-012. This file
number should be included on the subject line if email 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. 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 Number SR-CBOE-2013-012 and should be
submitted on or before February 28, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-02705 Filed 2-6-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: February 15, 2008 (Volume 73, Number 32)]
[Proposed Rules]
[Page 8837-8838]
[DOCID:fr15fe08-20]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2006-0641; A-1-FRL-8527-4]

Approval and Promulgation of Air Quality Implementation Plans;
Massachusetts; Certification of Tunnel Ventilation Systems in the
Metropolitan Boston Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The EPA is proposing to approve a State Implementation Plan
(SIP) revision submitted by the State of Massachusetts. The SIP
revision consists of technical revisions to Massachusetts regulation
310 CMR 7.38, ``Certification of Tunnel Ventilation Systems in the
Metropolitan Boston Air Pollution Control District.'' The amendments
better define the emissions monitoring techniques for various types of
tunnel ventilation systems, and provide flexibility in emission
monitoring requirements. This action is being taken in accordance with
the Clean Air Act.

DATES: Written comments must be received on or before March 17, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OAR-2006-0641 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R01-OAR-2006-0641,'' Anne Arnold, U.S. Environmental
Protection Agency, EPA New England Regional Office, One Congress
Street, Suite 1100 (mail code CAQ), Boston, MA 02114-2023.
    5. Hand Delivery or Courier. Deliver your comments to: Anne Arnold,
Manager, Air Quality Planning Unit, Office of Ecosystem Protection,
U.S. Environmental Protection Agency, EPA New England Regional Office,
One Congress Street, 11th floor, (CAQ), Boston, MA 02114-2023. Such
deliveries are only accepted during the Regional Office's normal hours
of operation. The Regional Office's official hours of business are
Monday through Friday, 8:30 to 4:30, excluding legal holidays.
    Please see the direct final rule which is located in the Rules
Section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Donald O. Cooke, Air Quality Unit,
U.S. Environmental Protection Agency, EPA New England Regional Office,
One Congress Street, Suite 1100 (CAQ), Boston, MA 02114-2023, telephone
number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.

Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.
    For additional information, see the direct final rule which is
located in the Rules section of this Federal Register.

    Dated: February 1, 2008.
Ira W. Leighton,
Acting Regional Administrator, EPA New England.
[FR Doc. E8-2746 Filed 2-14-08; 8:45 am]

BILLING CODE 6560-50-P