[Federal Register Volume 77, Number 150 (Friday, August 3, 2012)]
[Proposed Rules]
[Pages 46352-46361]
[FR Doc No: 2012-19017]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2010-1014; FRL-9708-7]

Approval and Promulgation of Implementation Plans; Kentucky;
110(a)(1) and (2) Infrastructure Requirements for the 1997 Annual and
2006 24-hour Fine Particulate Matter National Ambient Air Quality
Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve in part, and conditionally approve
in part, the State Implementation Plan (SIP) revisions, submitted by
the Commonwealth of Kentucky through the Kentucky Energy and
Environment Cabinet, Division for Air Quality (DAQ), as demonstrating
that the Commonwealth meets the requirements of sections 110(a)(1) and
(2) of the Clean Air Act (CAA or Act) for the 1997 annual and 2006 24-
hour fine particulate matter (PM2.5) national ambient air
quality standards (NAAQS). Kentucky certified that the Kentucky SIP
contains provisions that ensure the 1997 annual and 2006 24-hour
PM2.5 NAAQS are implemented, enforced, and maintained in
Kentucky (hereafter referred to as ``infrastructure submission''). EPA
is now taking three related actions on Kentucky DAQ's infrastructure
submissions for the Commonwealth. First, EPA is proposing to determine
that Kentucky DAQ's infrastructure submissions, provided to EPA on
August 26, 2008, and July 17, 2012, satisfy certain required
infrastructure elements for the 1997

annual and 2006 24-hour PM2.5 NAAQS. Second, EPA is
proposing to approve several Kentucky Revised Statutes (KRS) into the
SIP to address element 110(a)(2)(E)(ii), that relates to state board
requirements. Third, with respect to sections 110(a)(2)(C) and
110(a)(2)(J) as they relate to PSD requirements, EPA is proposing to
conditionally approve the SIP submissions as meeting these
requirements.

DATES: Written comments must be received on or before September 4,
2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2010-1014, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2010-1014,'' Regulatory Development Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Chief, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW., Atlanta, Georgia 30303-8960. 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 federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2010-1014. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through www.regulations.gov or
email, information that you consider to be CBI or otherwise protected.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., 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 in www.regulations.gov or
in hard copy at the Regulatory Development Section, Air Planning
Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person 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 to 4:30, excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Sean Lakeman, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404)
562-9043. Mr. Lakeman can be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. What elements are required under sections 110(a)(1) and (2)?
III. Scope of Infrastructure SIPs
IV. What is EPA's analysis of how Kentucky addressed the elements of
sections 110(a)(1) and (2) ``infrastructure'' provisions?
V. Proposed Action
VI. Statutory and Executive Order Reviews

I. Background

    On July 18, 1997 (62 FR 38652), EPA established an annual
PM2.5 NAAQS at 15.0 micrograms per cubic meter ([mu]g/m\3\)
based on a 3-year average of annual mean PM2.5
concentrations. At that time, EPA also established a 24-hour NAAQS of
65 [mu]g/m\3\. See 40 CFR 50.7. On October 17, 2006 (71 FR 61144), EPA
retained the 1997 annual PM2.5 NAAQS at 15.0 [mu]g/m\3\
based on a 3-year average of annual mean PM2.5
concentrations, and promulgated a new 24-hour NAAQS of 35 [mu]g/m\3\
based on a 3-year average of the 98th percentile of 24-hour
concentrations. By statute, SIPs meeting the requirements of sections
110(a)(1) and (2) are to be submitted by states within three years
after promulgation of a new or revised NAAQS. Sections 110(a)(1) and
(2) require states to address basic SIP requirements, including
emissions inventories, monitoring, and modeling to assure attainment
and maintenance of the NAAQS. States were required to submit such SIPs
to EPA no later than July 2000 for the 1997 annual PM2.5
NAAQS, no later than October 2009 for the 2006 24-hour PM2.5
NAAQS.
    On March 4, 2004, Earthjustice submitted a notice of intent to sue
related to EPA's failure to issue findings of failure to submit related
to the ``infrastructure'' requirements for the 1997 annual
PM2.5 NAAQS. On March 10, 2005, EPA entered into a consent
decree with Earthjustice which required EPA, among other things, to
complete a Federal Register notice announcing EPA's determinations
pursuant to section 110(k)(1)(B) as to whether each state had made
complete submissions to meet the requirements of section 110(a)(2) for
the 1997 PM2.5 NAAQS by October 5, 2008. In accordance with
the consent decree, EPA made completeness findings for each state based
upon what the Agency received from each state for the 1997
PM2.5 NAAQS as of October 3, 2008.
    On October 22, 2008, EPA published a final rulemaking entitled
``Completeness Findings for Section 110(a) State Implementation Plans
Pertaining to the Fine Particulate Matter (PM2.5) NAAQS''
making a finding that each state had submitted or failed to submit a
complete SIP that provided the basic program elements of section
110(a)(2) necessary to implement the 1997 PM2.5 NAAQS (see
73 FR 62902). For those states that did receive findings, the findings
of failure to submit for all or a portion of a state's implementation
plan established a 24-month deadline for EPA to promulgate a federal
implementation plan to

address the outstanding SIP elements unless, prior to that time, the
affected states submitted, and EPA approved, the required SIPs. The
findings that all or portions of a state's submission are complete
established a 12-month deadline for EPA to take action upon the
complete SIP elements in accordance with section 110(k).
    Kentucky's infrastructure submissions were received by EPA on
August 26, 2008, for the 1997 annual PM2.5 NAAQS, and on
July 17, 2012,\1\ for the 2006 24-hour PM2.5 NAAQS. The
August 26, 2008, submission was determined to be complete on February
26, 2009. Kentucky was among other states that did not receive findings
of failure to submit because it had provided a complete submission to
EPA to address the infrastructure elements for the 1997
PM2.5 NAAQS by October 3, 2008.
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    \1\ On July 17, 2012, Kentucky withdrew its September 8, 2009,
110(a)(1)-(2) infrastructure submission addressing the 8-hour ozone,
PM2.5 and Lead NAAQS. Kentucky replaced its September 8,
2009, 110(a)(1)-(2) infrastructure submission with a submission
provided on July 17, 2012.
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    On July 6, 2011, WildEarth Guardians and Sierra Club filed an
amended complaint related to EPA's failure to take action on the SIP
revision related to the ``infrastructure'' requirements for the 2006
24-hour PM2.5 NAAQS. On October 20, 2011, EPA entered into a
consent decree with WildEarth Guardians and Sierra Club which required
EPA, among other things, to complete a Federal Register notice of the
Agency's final action either approving, disapproving, or approving in
part and disapproving in part the Kentucky 2006 24-hour
PM2.5 NAAQS Infrastructure SIP revision addressing the
applicable requirements of sections 110(a)(2)(A)-(H), (J)-(M), except
for section 110(a)(2)(C) the nonattainment area requirements and
section 110(a)(2)(D)(i)(II) visibility requirements, by September 30,
2012. On July 20, 2011, EPA published a final rulemaking disapproving
the interstate transport requirements for section 110(a)(2)(D)(i) for
the 2006 24-hour PM2.5 NAAQS for Kentucky. See 76 FR 43136.
    Today's proposal addresses three related actions. First, EPA is
proposing to determine that, as described in its infrastructure
submissions, Kentucky's SIP meets the section 110(a)(2) infrastructure
requirements for both the 1997 annual and 2006 24-hour PM2.5
NAAQS with the exception of elements 110(a)(2)(C) respecting
nonattainment area and PSD requirements, 110(a)(2)(D)(i) respecting
interstate transport, and 110(a)(2)(J) respecting PSD requirements. For
the infrastructure elements except for 110(a)(2)(C), 110(a)(2)(D)(i)
and 110(a)(2)(J), as noted above, EPA is proposing to determine that
Kentucky's already approved SIP meets certain CAA requirements. Second,
EPA is proposing to approve Kentucky's July 17, 2012, submission
requesting approval of KRS Chapters 11A.020, 11A.030, 11A.040 224.10-
020 and 224.10-100 into the SIP to address element 110(a)(2)(E)(ii).
Third, with respect to elements 110(a)(2)(C) and 110(a)(2)(J) as they
both relate to PSD requirements, EPA is proposing to conditionally
approve these sub-elements.\2\
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    \2\ As discussed below in Section IV of this proposed rule,
EPA's proposed action to approve infrastructure elements
110(a)(2)(C) and 110(a)(2)(J) respecting PSD requirements, is
contingent upon final approval of Kentucky's PM2.5 NSR
program.
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II. What elements are required under sections 110(a)(1) and (2)?

    Section 110(a) of the CAA requires states to submit SIPs to provide
for the implementation, maintenance, and enforcement of a new or
revised NAAQS within three years following the promulgation of such
NAAQS, or within such shorter period as EPA may prescribe. Section
110(a) imposes the obligation upon states to make a SIP submission to
EPA for a new or revised NAAQS, but the contents of that submission may
vary depending upon the facts and circumstances. In particular, the
data and analytical tools available at the time the state develops and
submits the SIP for a new or revised NAAQS affects the content of the
submission. The contents of such SIP submissions may also vary
depending upon what provisions the state's existing SIP already
contains. In the case of the 1997 annual and 2006 24-hour
PM2.5 NAAQS, some states may need to adopt language specific
to the PM2.5 NAAQS to ensure that they have adequate SIP
provisions to implement the PM2.5 NAAQS.
    Section 110(a)(1) provides the procedural and timing requirements
for SIPs. Section 110(a)(2) lists specific elements that states must
meet for ``infrastructure'' SIP requirements related to a newly
established or revised NAAQS. As mentioned above, these requirements
include SIP infrastructure elements such as modeling, monitoring, and
emissions inventories that are designed to assure attainment and
maintenance of the NAAQS. The requirements that are the subject of this
proposed rulemaking are listed below \3\ and in EPA's October 2, 2007,
memorandum entitled ``Guidance on SIP Elements Required Under Section
110(a)(1) and (2) for the 1997 8-Hour Ozone and PM2.5
National Ambient Air Quality Standards'' and September 25, 2009,
memorandum entitled ``Guidance on SIP Elements Required Under Section
110(a)(1) and (2) for the 2006 24-Hour Fine Particle (PM2.5)
National Ambient Air Quality Standards.''
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    \3\ Two elements identified in section 110(a)(2) are not
governed by the three year submission deadline of section 110(a)(1)
because SIPs incorporating necessary local nonattainment area
controls are not due within three years after promulgation of a new
or revised NAAQS, but rather due at the time the nonattainment area
plan requirements are due pursuant to section 172. These
requirements are: (1) submissions required by section 110(a)(2)(C)
to the extent that subsection refers to a permit program as required
in part D Title I of the CAA, and (2) submissions required by
section 110(a)(2)(I) which pertain to the nonattainment planning
requirements of part D, Title I of the CAA. Today's proposed
rulemaking does not address infrastructure elements related to
section 110(a)(2)(I) but does provide detail on how Kentucky's SIP
addresses 110(a)(2)(C).
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     110(a)(2)(A): Emission limits and other control measures.
     110(a)(2)(B): Ambient air quality monitoring/data system.
     110(a)(2)(C): Program for enforcement of control
measures.\4\
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    \4\ This rulemaking only addresses requirements for this element
as they relate to attainment areas.
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     110(a)(2)(D): Interstate transport.\5\
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    \5\ Today's proposed rule does not address element
110(a)(2)(D)(i) (Interstate Transport) for the 1997 and 2006
PM2.5 NAAQS. Interstate transport requirements were
formerly addressed by Kentucky consistent with the Clean Air
Interstate Rule (CAIR). On December 23, 2008, CAIR was remanded by
the DC Circuit Court of Appeals, without vacatur, back to EPA. See
North Carolina v. EPA, 531 F.3d 896 (DC Cir. 2008). Prior to this
remand, EPA took final action to approve Kentucky SIP revision,
which was submitted to comply with CAIR. See 72 FR 56623 (October 4,
2007). In so doing, Kentucky CAIR SIP revision addressed the
interstate transport provisions in section 110(a)(2)(D)(i) for the
1997 PM2.5 NAAQS. In response to the remand of CAIR, EPA
has recently finalized a new rule to address the interstate
transport of nitrogen oxides and sulfur oxides in the eastern United
States. See 76 FR 48208 (August 8, 2011) (Transport Rule). That rule
was recently stayed by the DC Circuit Court of Appeals. EPA's action
on element 110(a)(2)(D)(i) will be addressed in a separate action.
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     110(a)(2)(E): Adequate resources.
     110(a)(2)(F): Stationary source monitoring system.
     110(a)(2)(G): Emergency power.
     110(a)(2)(H): Future SIP revisions.
     110(a)(2)(I): Areas designated nonattainment and meet the
applicable requirements of part D.\6\
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    \6\ This requirement was inadvertently omitted from EPA's
October 2, 2007, memorandum entitled ``Guidance on SIP Elements
Required Under Section 110(a)(1) and (2) for the 1997 8-Hour Ozone
and PM2.5 National Ambient Air Quality Standards,'' and
the September 25, 2009, memorandum entitled ``Guidance on SIP
Elements Required Under Section 110(a)(1) and (2) for the 2006 Fine
Particle (PM2.5) National Ambient Air Quality
Standards,'' but as mentioned above is not relevant to today's
proposed rulemaking.
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     110(a)(2)(J): Consultation with government officials;
public

notification; and PSD and visibility protection.
     110(a)(2)(K): Air quality modeling/data.
     110(a)(2)(L): Permitting fees.
     110(a)(2)(M): Consultation/participation by affected local
entities.

III. Scope of Infrastructure SIPs

    EPA is currently acting upon SIPs that address the infrastructure
requirements of CAA section 110(a)(1) and (2) for ozone and
PM2.5 NAAQS for various states across the country.
Commenters on EPA's recent proposals for some states raised concerns
about EPA statements that it was not addressing certain substantive
issues in the context of acting on those infrastructure SIP
submissions.\7\ Those Commenters specifically raised concerns involving
provisions in existing SIPs and with EPA's statements in other
proposals that it would address two issues separately and not as part
of actions on the infrastructure SIP submissions: (i) Existing
provisions related to excess emissions during periods of start-up,
shutdown, or malfunction (SSM) at sources, that may be contrary to the
CAA and EPA's policies addressing such excess emissions; and (ii)
existing provisions related to ``director's variance'' or ``director's
discretion'' that purport to permit revisions to SIP approved emissions
limits with limited public process or without requiring further
approval by EPA, that may be contrary to the CAA (director's
discretion). EPA notes that there are two other substantive issues for
which EPA likewise stated in other proposals that it would address
separately: (i) Existing provisions for minor source NSR programs that
may be inconsistent with the requirements of the CAA and EPA's
regulations that pertain to such programs (minor source NSR); and (ii)
existing provisions for PSD programs that may be inconsistent with
current requirements of EPA's ``Final NSR Improvement Rule,'' 67 FR
80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007)
(NSR Reform). In light of the comments, EPA believes that its
statements in various proposed actions on infrastructure SIPs with
respect to these four individual issues should be explained in greater
depth. It is important to emphasize that EPA is taking the same
position with respect to these four substantive issues in this action
on the infrastructure SIPs for the 1997 and 2006 PM2.5 NAAQS
from Kentucky.
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    \7\ See Comments of Midwest Environmental Defense Center, dated
May 31, 2011. Docket EPA-R05-OAR-2007-1179 (adverse
comments on proposals for three states in Region 5). EPA notes that
these public comments on another proposal are not relevant to this
rulemaking and do not have to be directly addressed in this
rulemaking. EPA will respond to these comments in the appropriate
rulemaking action to which they apply.
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    EPA intended the statements in the other proposals concerning these
four issues merely to be informational and to provide general notice of
the potential existence of provisions within the existing SIPs of some
states that might require future corrective action. EPA did not want
states, regulated entities, or members of the public to be under the
misconception that the Agency's approval of the infrastructure SIP
submission of a given state should be interpreted as a re-approval of
certain types of provisions that might exist buried in the larger
existing SIP for such state. Thus, for example, EPA explicitly noted
that the Agency believes that some states may have existing SIP
approved SSM provisions that are contrary to the CAA and EPA policy,
but that ``in this rulemaking, EPA is not proposing to approve or
disapprove any existing state provisions with regard to excess
emissions during SSM of operations at facilities.'' EPA further
explained, for informational purposes, that ``EPA plans to address such
State regulations in the future.'' EPA made similar statements, for
similar reasons, with respect to the director's discretion, minor
source NSR, and NSR Reform issues. EPA's objective was to make clear
that approval of an infrastructure SIP for these ozone and
PM2.5 NAAQS should not be construed as explicit or implicit
re-approval of any existing provisions that relate to these four
substantive issues. EPA is reiterating that position in this action on
the infrastructure SIP for Kentucky.
    Unfortunately, the Commenters and others evidently interpreted
these statements to mean that EPA considered action upon the SSM
provisions and the other three substantive issues to be integral parts
of acting on an infrastructure SIP submission, and therefore that EPA
was merely postponing taking final action on the issues in the context
of the infrastructure SIPs. This was not EPA's intention. To the
contrary, EPA only meant to convey its awareness of the potential for
certain types of deficiencies in existing SIPs and to prevent any
misunderstanding that it was reapproving any such existing provisions.
EPA's intention was to convey its position that the statute does not
require that infrastructure SIPs address these specific substantive
issues in existing SIPs and that these issues may be dealt with
separately, outside the context of acting on the infrastructure SIP
submission of a state. To be clear, EPA did not mean to imply that it
was not taking a full final agency action on the infrastructure SIP
submission with respect to any substantive issue that EPA considers to
be a required part of acting on such submissions under section 110(k)
or under section 110(c). Given the confusion evidently resulting from
EPA's statements in those other proposals, however, we want to explain
more fully the Agency's reasons for concluding that these four
potential substantive issues in existing SIPs may be addressed
separately from actions on infrastructure SIP submissions.
    The requirement for the SIP submissions at issue arises out of CAA
section 110(a)(1). That provision requires that states must make a SIP
submission ``within 3 years (or such shorter period as the
Administrator may prescribe) after the promulgation of a national
primary ambient air quality standard (or any revision thereof)'' and
that these SIPs are to provide for the ``implementation, maintenance,
and enforcement'' of such NAAQS. Section 110(a)(2) includes a list of
specific elements that ``[e]ach such plan'' submission must meet. EPA
has historically referred to these particular submissions that states
must make after the promulgation of a new or revised NAAQS as
``infrastructure SIPs.'' This specific term does not appear in the
statute, but EPA uses the term to distinguish this particular type of
SIP submission designed to address basic structural requirements of a
SIP from other types of SIP submissions designed to address other
different requirements, such as ``nonattainment SIP'' submissions
required to address the nonattainment planning requirements of part D,
``regional haze SIP'' submissions required to address the visibility
protection requirements of CAA section 169A, NSR permitting program
submissions required to address the requirements of part D, and a host
of other specific types of SIP submissions that address other specific
matters.
    Although section 110(a)(1) addresses the timing and general
requirements for these infrastructure SIPs, and section 110(a)(2)
provides more details concerning the required contents of these
infrastructure SIPs, EPA believes that many of the specific statutory
provisions are facially ambiguous. In particular, the list of required
elements provided in section 110(a)(2) contains a wide variety of
disparate provisions, some of which pertain to required legal
authority, some of which pertain to required substantive provisions,
and some of which pertain to requirements

for both authority and substantive provisions.\8\ Some of the elements
of section 110(a)(2) are relatively straightforward, but others clearly
require interpretation by EPA through rulemaking, or recommendations
through guidance, in order to give specific meaning for a particular
NAAQS.\9\
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    \8\ For example, section 110(a)(2)(E) provides that states must
provide assurances that they have adequate legal authority under
state and local law to carry out the SIP; section 110(a)(2)(C)
provides that states must have a substantive program to address
certain sources as required by part C of the CAA; section
110(a)(2)(G) provides that states must have both legal authority to
address emergencies and substantive contingency plans in the event
of such an emergency.
    \9\ For example, section 110(a)(2)(D)(i) requires EPA to be sure
that each state's implementation plan contains adequate provisions
to prevent significant contribution to nonattainment of the NAAQS in
other states. This provision contains numerous terms that require
substantial rulemaking by EPA in order to determine such basic
points as what constitutes significant contribution. See ``Rule To
Reduce Interstate Transport of Fine Particulate Matter and Ozone
(Clean Air Interstate Rule); Revisions to Acid Rain Program;
Revisions to the NOX SIP Call; Final Rule,'' 70 FR 25162
(May 12, 2005) (defining, among other things, the phrase
``contribute significantly to nonattainment'').
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    Notwithstanding that section 110(a)(2) provides that ``each'' SIP
submission must meet the list of requirements therein, EPA has long
noted that this literal reading of the statute is internally
inconsistent, insofar as section 110(a)(2)(I) pertains to nonattainment
SIP requirements that could not be met on the schedule provided for
these SIP submissions in section 110(a)(1).\10\ This illustrates that
EPA must determine which provisions of section 110(a)(2) may be
applicable for a given infrastructure SIP submission. Similarly, EPA
has previously decided that it could take action on different parts of
the larger, general ``infrastructure SIP'' for a given NAAQS without
concurrent action on all subsections, such as section 110(a)(2)(D)(i),
because the Agency bifurcated the action on these latter ``interstate
transport'' provisions within section 110(a)(2) and worked with states
to address each of the four prongs of section 110(a)(2)(D)(i) with
substantive administrative actions proceeding on different tracks with
different schedules.\11\ This illustrates that EPA may conclude that
subdividing the applicable requirements of section 110(a)(2) into
separate SIP actions may sometimes be appropriate for a given NAAQS
where a specific substantive action is necessitated, beyond a mere
submission addressing basic structural aspects of the state's
implementation plans. Finally, EPA notes that not every element of
section 110(a)(2) would be relevant, or as relevant, or relevant in the
same way, for each new or revised NAAQS and the attendant
infrastructure SIP submission for that NAAQS. For example, the
monitoring requirements that might be necessary for purposes of section
110(a)(2)(B) for one NAAQS could be very different than what might be
necessary for a different pollutant. Thus, the content of an
infrastructure SIP submission to meet this element from a state might
be very different for an entirely new NAAQS, versus a minor revision to
an existing NAAQS.\12\
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    \10\ See Id., 70 FR 25162, at 63-65 (May 12, 2005) (explaining
relationship between timing requirement of section 110(a)(2)(D)
versus section 110(a)(2)(I)).
    \11\ EPA issued separate guidance to states with respect to SIP
submissions to meet section 110(a)(2)(D)(i) for the 1997 ozone and
1997 PM2.5 NAAQS. See ``Guidance for State Implementation
Plan (SIP) Submissions to Meet Current Outstanding Obligations Under
Section 110(a)(2)(D)(i) for the 8-Hour Ozone and PM2.5
National Ambient Air Quality Standards,'' from William T. Harnett,
Director Air Quality Policy Division OAQPS, to Regional Air Division
Director, Regions I-X, dated August 15, 2006.
    \12\ For example, implementation of the 1997 PM2.5
NAAQS required the deployment of a system of new monitors to measure
ambient levels of that new indicator species for the new NAAQS.
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    Similarly, EPA notes that other types of SIP submissions required
under the statute also must meet the requirements of section 110(a)(2),
and this also demonstrates the need to identify the applicable elements
for other SIP submissions. For example, nonattainment SIPs required by
part D likewise have to meet the relevant subsections of section
110(a)(2) such as section 110(a)(2)(A) or (E). By contrast, it is clear
that nonattainment SIPs would not need to meet the portion of section
110(a)(2)(C) that pertains to part C, i.e., the PSD requirements
applicable in attainment areas. Nonattainment SIPs required by part D
also would not need to address the requirements of section 110(a)(2)(G)
with respect to emergency episodes, as such requirements would not be
limited to nonattainment areas. As this example illustrates, each type
of SIP submission may implicate some subsections of section 110(a)(2)
and not others.
    Given the potential for ambiguity of the statutory language of
section 110(a)(1) and (2), EPA believes that it is appropriate for EPA
to interpret that language in the context of acting on the
infrastructure SIPs for a given NAAQS. Because of the inherent
ambiguity of the list of requirements in section 110(a)(2), EPA has
adopted an approach in which it reviews infrastructure SIPs against
this list of elements ``as applicable.'' In other words, EPA assumes
that Congress could not have intended that each and every SIP
submission, regardless of the purpose of the submission or the NAAQS in
question, would meet each of the requirements, or meet each of them in
the same way. EPA elected to use guidance to make recommendations for
infrastructure SIPs for these ozone and PM2.5 NAAQS.
    On October 2, 2007, EPA issued guidance making recommendations for
the infrastructure SIP submissions for both the 1997 8-hour ozone NAAQS
and the 1997 PM2.5 NAAQS.\13\ Within this guidance document,
EPA described the duty of states to make these submissions to meet what
the Agency characterized as the ``infrastructure'' elements for SIPs,
which it further described as the ``basic SIP requirements, including
emissions inventories, monitoring, and modeling to assure attainment
and maintenance of the standards.'' \14\ As further identification of
these basic structural SIP requirements, ``attachment A'' to the
guidance document included a short description of the various elements
of section 110(a)(2) and additional information about the types of
issues that EPA considered germane in the context of such
infrastructure SIPs. EPA emphasized that the description of the basic
requirements listed on attachment A was not intended ``to constitute an
interpretation of'' the requirements, and was merely a ``brief
description of the required elements.'' \15\ EPA also stated its belief
that with one exception, these requirements were ``relatively self
explanatory, and past experience with SIPs for other NAAQS should
enable States to meet these requirements with assistance from EPA
Regions.'' \16\ However, for the one exception to that general
assumption (i.e., how states should proceed with respect to the
requirements of section 110(a)(2)(G) for the 1997 PM2.5
NAAQS), EPA gave much more specific recommendations. But for other
infrastructure SIP submittals, and for certain elements of the
submittals for the 1997 PM2.5 NAAQS, EPA assumed that each
state

would work with its corresponding EPA regional office to refine the
scope of a state's submittal based on an assessment of how the
requirements of section 110(a)(2) should reasonably apply to the basic
structure of the state's implementation plans for the NAAQS in
question.
---------------------------------------------------------------------------

    \13\ See ``Guidance on SIP Elements Required Under Section
110(a)(1) and (2) for the 1997 8-hour Ozone and PM2.5
National Ambient Air Quality Standards,'' from William T. Harnett,
Director Air Quality Policy Division, to Air Division Directors,
Regions I--X, dated October 2, 2007 (the ``2007 Guidance'').
    \14\ Id., at page 2.
    \15\ Id., at attachment A, page 1.
    \16\ Id., at page 4. In retrospect, the concerns raised by the
Commenters with respect to EPA's approach to some substantive issues
indicates that the statute is not so ``self explanatory,'' and
indeed is sufficiently ambiguous that EPA needs to interpret it in
order to explain why these substantive issues do not need to be
addressed in the context of infrastructure SIPs and may be addressed
at other times and by other means.
---------------------------------------------------------------------------

    On September 25, 2009, EPA issued guidance to make recommendations
to states with respect to the infrastructure SIPs for the 2006
PM2.5 NAAQS.\17\ In the 2009 Guidance, EPA addressed a
number of additional issues that were not germane to the infrastructure
SIPs for the 1997 8-hour ozone and 1997 PM2.5 NAAQS, but
were germane to these SIP submissions for the 2006 PM2.5
NAAQS (e.g., the requirements of section 110(a)(2)(D)(i) that EPA had
bifurcated from the other infrastructure elements for those specific
1997 ozone and PM2.5 NAAQS). Significantly, neither the 2007
Guidance nor the 2009 Guidance explicitly referred to the SSM,
director's discretion, minor source NSR, or NSR Reform issues as among
specific substantive issues EPA expected states to address in the
context of the infrastructure SIPs, nor did EPA give any more specific
recommendations with respect to how states might address such issues
even if they elected to do so. The SSM and director's discretion issues
implicate section 110(a)(2)(A), and the minor source NSR and NSR Reform
issues implicate section 110(a)(2)(C). In the 2007 Guidance and the
2009 Guidance, however, EPA did not indicate to states that it intended
to interpret these provisions as requiring a substantive submission to
address these specific issues in existing SIP provisions in the context
of the infrastructure SIPs for these NAAQS. Instead, EPA's 2007
Guidance merely indicated its belief that the states should make
submissions in which they established that they have the basic SIP
structure necessary to implement, maintain, and enforce the NAAQS. EPA
believes that states can establish that they have the basic SIP
structure, notwithstanding that there may be potential deficiencies
within the existing SIP. Thus, EPA's proposals for other states
mentioned these issues not because the Agency considers them issues
that must be addressed in the context of an infrastructure SIP as
required by section 110(a)(1) and (2), but rather because EPA wanted to
be clear that it considers these potential existing SIP problems as
separate from the pending infrastructure SIP actions. The same holds
true for this action on the infrastructure SIPs for Kentucky.
---------------------------------------------------------------------------

    \17\ See ``Guidance on SIP Elements Required Under Sections
110(a)(1) and (2) for the 2006 24-Hour Fine Particle
(PM2.5) National Ambient Air Quality Standards (NAAQS),''
from William T, Harnett, Director Air Quality Policy Division, to
Regional Air Division Directors, Regions I--X, dated September 25,
2009 (the ``2009 Guidance'').
---------------------------------------------------------------------------

    EPA believes that this approach to the infrastructure SIP
requirement is reasonable because it would not be feasible to read
section 110(a)(1) and (2) to require a top to bottom, stem to stern,
review of each and every provision of an existing SIP merely for
purposes of assuring that the state in question has the basic
structural elements for a functioning SIP for a new or revised NAAQS.
Because SIPs have grown by accretion over the decades as statutory and
regulatory requirements under the CAA have evolved, they may include
some outmoded provisions and historical artifacts that, while not fully
up to date, nevertheless may not pose a significant problem for the
purposes of ``implementation, maintenance, and enforcement'' of a new
or revised NAAQS when EPA considers the overall effectiveness of the
SIP. To the contrary, EPA believes that a better approach is for EPA to
determine which specific SIP elements from section 110(a)(2) are
applicable to an infrastructure SIP for a given NAAQS, and to focus
attention on those elements that are most likely to need a specific SIP
revision in light of the new or revised NAAQS. Thus, for example, EPA's
2007 Guidance specifically directed states to focus on the requirements
of section 110(a)(2)(G) for the 1997 PM2.5 NAAQS because of
the absence of underlying EPA regulations for emergency episodes for
this NAAQS and an anticipated absence of relevant provisions in
existing SIPs.
    Finally, EPA believes that its approach is a reasonable reading of
section 110(a)(1) and (2) because the statute provides other avenues
and mechanisms to address specific substantive deficiencies in existing
SIPs. These other statutory tools allow the Agency to take appropriate
tailored action, depending upon the nature and severity of the alleged
SIP deficiency. Section 110(k)(5) authorizes EPA to issue a ``SIP
call'' whenever the Agency determines that a state's SIP is
substantially inadequate to attain or maintain the NAAQS, to mitigate
interstate transport, or otherwise to comply with the CAA.\18\ Section
110(k)(6) authorizes EPA to correct errors in past actions, such as
past approvals of SIP submissions.\19\ Significantly, EPA's
determination that an action on the infrastructure SIP is not the
appropriate time and place to address all potential existing SIP
problems does not preclude the Agency's subsequent reliance on
provisions in section 110(a)(2) as part of the basis for action at a
later time. For example, although it may not be appropriate to require
a state to eliminate all existing inappropriate director's discretion
provisions in the course of acting on the infrastructure SIP, EPA
believes that section 110(a)(2)(A) may be among the statutory bases
that the Agency cites in the course of addressing the issue in a
subsequent action.\20\
---------------------------------------------------------------------------

    \18\ EPA has recently issued a SIP call to rectify a specific
SIP deficiency related to the SSM issue. See, ``Finding of
Substantial Inadequacy of Implementation Plan; Call for Utah State
Implementation Plan Revision,'' 74 FR 21639 (April 18, 2011).
    \19\ EPA has recently utilized this authority to correct errors
in past actions on SIP submissions related to PSD programs. See
``Limitation of Approval of Prevention of Significant Deterioration
Provisions Concerning Greenhouse Gas Emitting-Sources in State
Implementation Plans; Final Rule,'' 75 FR 82536 (December 30, 2010).
EPA has previously used its authority under CAA 110(k)(6) to remove
numerous other SIP provisions that the Agency determined it had
approved in error. See 61 FR 38664 (July 25, 1996) and 62 FR 34641
(June 27, 1997) (corrections to American Samoa, Arizona, California,
Hawaii, and Nevada SIPs); 69 FR 67062 (November 16, 2004)
(corrections to California SIP); and 74 FR 57051 (November 3, 2009)
(corrections to Arizona and Nevada SIPs).
    \20\ EPA has recently disapproved a SIP submission from Colorado
on the grounds that it would have included a director's discretion
provision inconsistent with CAA requirements, including section
110(a)(2)(A). See 75 FR 42342, 42344 (July 21, 2010) (proposed
disapproval of director's discretion provisions); 76 FR 4540
(January 26, 2011) (final disapproval of such provisions).
---------------------------------------------------------------------------

IV. What is EPA's analysis of how Kentucky addressed the elements of
sections 110(a)(1) and (2) ``infrastructure'' provisions?

    Kentucky's infrastructure submissions address the provisions of
sections 110(a)(1) and (2) as described below.
    1. 110(a)(2)(A): Emission limits and other control measures:
Kentucky's infrastructure submissions provide an overview of the
provisions of the Kentucky Air Regulations relevant to air quality
control regulations. Chapter 50--General Administrative Procedures, of
the Kentucky Air Regulations generally authorizes the Kentucky
Environmental and Public Protection Cabinet to adopt rules for the
control of air pollution, including those necessary to obtain EPA
approval under section 110 of the CAA and details the authority and
means with which DAQ can require testing and emissions verification.
Chapter 51--Attainment and Maintenance of the National Ambient Air
Quality Standards, also includes references to rules adopted by
Kentucky to control air pollution. Chapter 53--

Ambient Air Quality Standards, serves to establish the requirements for
the prevention, abatement and control of air pollution. EPA has made
the preliminary determination that the provisions contained in these
regulations and Kentucky's practices are adequate to protect the
PM2.5 annual and 24-hour NAAQS in Kentucky.
    In this action, EPA is not proposing to approve or disapprove any
existing state provisions with regard to excess emissions during SSM of
operations at a facility. EPA believes that a number of states have SSM
provisions which are contrary to the CAA and existing EPA guidance,
``State Implementation Plans: Policy Regarding Excess Emissions During
Malfunctions, Startup, and Shutdown'' (September 20, 1999), and the
Agency plans to address such state regulations in the future. In the
meantime, EPA encourages any state having deficient SSM provisions to
take steps to correct it as soon as possible.
    Additionally, in this action, EPA is not proposing to approve or
disapprove any existing state rules with regard to director's
discretion or variance provisions. EPA believes that a number of states
have such provisions which are contrary to the CAA and existing EPA
guidance (52 FR 45109 (November 24, 1987)), and the Agency plans to
take action in the future to address such state regulations. In the
meantime, EPA encourages any state having a director's discretion or
variance provision which is contrary to the CAA and EPA guidance to
take steps to correct the deficiency as soon as possible.
    2. 110(a)(2)(B) Ambient air quality monitoring/data system: Chapter
50--General Administrative Procedures, and Chapter 53--Ambient Air
Quality Standards, along with the Commonwealth's Network Description
and Ambient Air Monitoring Network Plan, provide for an ambient air
quality monitoring system in the State. Annually, EPA approves the
ambient air monitoring network plan for the state agencies. On July 1,
2011, the Commonwealth of Kentucky submitted its plan to EPA. On
October 20, 2011, EPA approved Kentucky's monitoring network plan.
Kentucky's approved monitoring network plan can be accessed at
www.regulations.gov using Docket ID No. EPA-R04-OAR-2010-1014. EPA has
made the preliminary determination that Kentucky's SIP and practices
are adequate for the ambient air quality monitoring and data systems
related to the 1997 annual and 2006 24-hour PM2.5 NAAQS.
    3. 110(a)(2)(C) Program for enforcement of control measures
including review of proposed new sources: Chapter 51--Attainment and
Maintenance of the National Ambient Air Quality Standards, describes
the permit requirements for new major sources or major modifications of
existing sources in areas classified as attainment or unclassifiable
under section 107(d)(1)(A)(ii) or (iii) of the CAA. This ensures that
sources in areas attaining the NAAQS at the time of designations
prevent any significant deterioration in air quality. Chapter 51 also
sets the permitting requirements for areas in or around nonattainment
areas. On July 3, 2012, Kentucky submitted a letter to EPA to provide
the schedule to address outstanding requirements promulgated in the NSR
PM2.5 Rule related to the PM2.5 standard for
their PSD program and committing to providing the necessary SIP
revision to address these NSR PM2.5 Rule requirements.
    Based on Kentucky's commitment, EPA is proposing to conditionally
approve Kentucky's 110(a)(2)(C) infrastructure SIP consistent with
section 110(k)(4) of the Act. EPA intends to move forward with
finalizing the conditional approval consistent with section 110(k)(4)
of the Act.
    In this action, EPA is proposing to conditionally approve
Kentucky's infrastructure SIP for the 1997 annual and 2006 24-hour
PM2.5 NAAQS with respect to the general requirement in
section 110(a)(2)(C) to include a program in the SIP that regulates the
modification and construction of any stationary source as necessary to
assure that the NAAQS are achieved. EPA is not proposing to approve or
disapprove the Commonwealth's existing minor NSR program itself to the
extent that it is inconsistent with EPA's regulations governing this
program. EPA believes that a number of states may have minor NSR
provisions that are contrary to the existing EPA regulations for this
program. EPA intends to work with states to reconcile state minor NSR
programs with EPA's regulatory provisions for the program. The
statutory requirements of section 110(a)(2)(C) provide for considerable
flexibility in designing minor NSR programs, and EPA believes it may be
time to revisit the regulatory requirements for this program to give
the states an appropriate level of flexibility to design a program that
meets their particular air quality concerns, while assuring reasonable
consistency across the country in protecting the NAAQS with respect to
new and modified minor sources.
    EPA is proposing to conditionally approve element 110(a)(2)(C)
based on the commitment of the Commonwealth to submit SIP revisions to
address the PM2.5 NSR requirements.
    4. 110(a)(2)(D)(ii) Interstate and International transport
provisions: In Chapter 51:017--Prevention of Significant Deterioration
of air quality, Kentucky outlines how it will notify neighboring states
of potential impacts from new or modified sources. Kentucky does not
have any pending obligation under sections 115 and 126 of the CAA. EPA
has made the preliminary determination that Kentucky's SIP and
practices are adequate for insuring compliance with the applicable
requirements relating to interstate and international pollution
abatement for the 1997 annual and 2006 24-hour PM2.5 NAAQS.
    5. 110(a)(2)(E) Adequate resources: Section 110(a)(2)(E) requires
that each implementation plan provide (i) necessary assurances that the
State will have adequate personnel, funding, and authority under state
law to carry out its implementation plan, (ii) that the State comply
with the requirements respecting State Boards pursuant to section 128
of the Act, and (iii) necessary assurances that, where the State has
relied on a local or regional government, agency, or instrumentality
for the implementation of any plan provision, the State has
responsibility for ensuring adequate implementation of such plan
provisions. EPA is proposing to approve Kentucky's SIP as meeting the
requirements of sub-elements 110(a)(2)(E)(i), (ii) and (iii).
    In support of EPA's proposal to approve elements 110(a)(2)(E)(i)
and (iii), Kentucky DAQ's infrastructure submissions demonstrate that
it is responsible for promulgating rules and regulations for the NAAQS,
emissions standards general policies, a system of permits, fee
schedules for the review of plans, and other planning needs. As
evidence of the adequacy of Kentucky DAQ's resources with respect to
sub-elements (i) and (iii), EPA submitted a letter to Kentucky on March
14, 2012, outlining 105 grant commitments and current status of these
commitments for fiscal year 2011. The letter EPA submitted to Kentucky
can be accessed at www.regulations.gov using Docket ID No. EPA-R04-OAR-
2010-1014. Annually, states update these grant commitments based on
current SIP requirements, air quality planning, and applicable
requirements related to the NAAQS. There were no outstanding issues in
relation to the SIP for fiscal year 2011, therefore, Kentucky's grants
were finalized and closed out. EPA has made the preliminary
determination that Kentucky has adequate resources for implementation
of the 1997 annual

and 2006 24-hour PM2.5 NAAQS. In addition, the requirements
of 110(a)(2)(E)(i) and (iii) are met when EPA performs a completeness
determination for each SIP submittal. This determination ensures that
each submittal provides evidence that adequate personnel, funding, and
legal authority under State Law has been used to carry out the state's
implementation plan and related issues. Kentucky's authority is
included in all prehearings and final SIP submittal packages for
approval by EPA. EPA has made the preliminary determination that
Kentucky has adequate resources for implementation of the 1997 annual
and 2006 24-hour PM2.5 NAAQS.
    Section 110(a)(2)(E)(ii) requires that the Commonwealth comply with
section 128 of the CAA. Section 128 requires that: (1) The majority of
members of the state board or body which approves permits or
enforcement orders represent the public interest and do not derive any
significant portion of their income from persons subject to permitting
or enforcement orders under the CAA; and (2) any potential conflicts of
interest by such board or body, or the head of an executive agency with
similar, powers be adequately disclosed. Kentucky's July 17, 2012,
submission adequately demonstrated that Kentucky's SIP meets the
applicable section 128 requirements pursuant to section
110(a)(2)(E)(ii). For purposes of section 128(a)(1), Kentucky has no
boards or bodies with authority over air pollution permits or
enforcement actions. Such matters are instead handled by the Director
of Division for Air Quality. As such, a ``board or body'' is not
responsible for approving permits or enforcement orders in Kentucky,
and the requirements of section 128(a)(1) are not applicable. Regarding
section 128(a)(2) (also applicable to the infrastructure SIP pursuant
to section 110(a)(2)(E)(ii)), EPA is, through this notice, proposing to
approve Kentucky's July 17, 2012, SIP revision requesting incorporation
of KRS Chapters 11A.020, 11A.030, 11A.040 and Chapters 224.10-020 and
224.10-100 into the SIP to address sub-element 110(a)(2)(E)(ii). KRS
Chapters:

11A.020. Public servant prohibited from certain conduct--Exception--
Disclosure of personal or private interest;
11A.030. Considerations in determination to abstain from action on
official decision--Advisory opinion,
11A.030. Acts prohibited for public servant or officer--exception;
224.10-020. Department within the cabinet--Offices and divisions
within the departments-Appointments, and
224.10-100. Powers and duties of cabinet,

require adequate disclosure of any potential conflicts of interest and
meets the requirements of section 128(a)(2) of the Act. EPA has made
the preliminary determination that, following final approval of these
chapters in the SIP, Kentucky will have adequate resources for
implementation of the 1997 annual and 2006 24-hour PM2.5
NAAQS.
    6. 110(a)(2)(F) Stationary source monitoring system: Chapter 50--
General Administrative Procedures of the Kentucky Air Regulations
describes how the major source and minor source emission inventory
programs collect emission data throughout the Commonwealth and ensure
the quality of such data. Additionally, Kentucky is required to submit
emissions data to EPA for purposes of the National Emissions Inventory
(NEI). The NEI is EPA's central repository for air emissions data. EPA
published the Air Emissions Reporting Rule (AERR) on December 5, 2008,
which modified the requirements for collecting and reporting air
emissions data (73 FR 76539). The AERR shortened the time states had to
report emissions data from 17 to 12 months, giving states one calendar
year to submit emissions data. All states are required to submit a
comprehensive emissions inventory every three years and report
emissions for certain larger sources annually through EPA's online
Emissions Inventory System. States report emissions data for the six
criteria pollutants and the precursors that form them--nitrogen oxides,
sulfur dioxide, ammonia, lead, carbon monoxide, particulate matter, and
volatile organic compounds. Many states also voluntarily report
emissions of hazardous air pollutants. Kentucky made its latest update
to the NEI on March 14, 2012. EPA compiles the emissions data,
supplementing it where necessary, and releases it to the general public
through the Web site http://www.epa.gov/ttn/chief/eiinformation.html.
EPA has made the preliminary determination that Kentucky's SIP and
practices are adequate for the stationary source monitoring systems
related to the 1997 annual and 2006 24-hour PM2.5 NAAQS.
    7. 110(a)(2)(G) Emergency power: Chapter 55--Emergency Episodes
contains provisions for the identification of air pollution emergency
episodes. Episode criteria and emissions reduction plans are also
covered in this regulation. These criteria have previously been
approved by EPA. On September 25, 2009, EPA released the guidance
entitled ``Guidance on SIP Elements Required Under Sections 110(a)(1)
and (2) for the 2006 24-Hour Fine Particulate (PM2.5)
National Ambient Air Quality Standards (NAAQS).'' This guidance
clarified that ``to address the section 110(a)(2)(G) element, states
with air quality control regions identified as either Priority I, IA,
or Priority II by the `Prevention of Air Pollution Emergency Episodes'
rule at 40 CFR 51.150, must develop emergency episode contingency
plans.'' EPA's September 25, 2009, guidance also states that ``until
the Agency finalized changes to the emergency episode regulation to
establish for PM2.5 specific levels for classifying areas as
Priority I, IA, or II for PM2.5, and to establish a
significant harm level (SHL) * * *,'' it recommends that states with a
24-Hour PM2.5 concentration above 140 [micro]g/m\3\ (using
the most recent three years of data) develop an emergency episode plan.
For states where this level has not been exceeded, the state can
certify that it has appropriate general emergency powers to address
PM2.5 related episodes, and that no specific emergency
episode plans are needed at this time. On September 19, 2008, KYDAQ
submitted a letter to EPA verifying that it is a Class III Priority
Area and is exempt from adopting emergency episode plan for
PM2.5 NAAQS. Kentucky had not previously public noticed its
certification submissions (including the September 19, 2008, letter)
with regard to 110(a)(2)(G) for the PM2.5 NAAQS. In May
2012, Kentucky public noticed its certification, and on July 17, 2012,
submitted the public-noticed certification as a supplement to its
original certification for element 110(a)(2)(G) for the
PM2.5 NAAQS. EPA has made the preliminary determination that
Kentucky's SIP and practices are adequate for emergency powers related
to the 1997 annual and 2006 24-hour PM2.5 NAAQS.
    8. 110(a)(2)(H) Future SIP revisions: As previously discussed, DAQ
is responsible for adopting air quality rules and revising SIPs as
needed to attain or maintain the NAAQS. Kentucky has the ability and
authority to respond to calls for SIP revisions, and has provided a
number of SIP revisions over the years for implementation of the PM
NAAQS. Specific to the 1997 annual and 2006 24-hour PM2.5
NAAQS, Kentucky's submissions have included:
     December 3, 2008, Louisville, Huntington-Ashland and
Cincinnati PM2.5 Attainment Demonstrations;
     February 8, 2012, Huntington-Ashland 1997 Annual
PM2.5 Redesignation Request and Maintenance Plan;

     March 5, 2012, Louisville 1997 Annual PM2.5
Redesignation Request and Maintenance Plan; and,

EPA has made the preliminary determination that Kentucky's SIP and
practices adequately demonstrate a commitment to provide future SIP
revisions related to the 1997 annual and 2006 24-hour PM2.5
NAAQS when necessary.
    9. 110(a)(2)(J) (121 consultation) Consultation with government
officials: Kentucky Air Regulations Chapter 50--General Administrative
Procedures of the Kentucky Air Regulations and Chapter 51--Attainment
and Maintenance of the National Ambient Air Quality Standards are
responsible for consultation with government officials whose
jurisdictions might be affected by SIP development activities. More
specifically, Kentucky adopted state-wide consultation procedures for
the implementation of transportation conformity which includes the
consideration of the development of mobile inventories for SIP
development. Required partners covered by Kentucky's consultation
procedures include federal, state and local transportation and air
quality agency officials. EPA approved Kentucky's consultation
procedures on September 15, 2010 (75 FR 55988). Additionally, DAQ
submitted a regional haze plan which outlines its consultation
practices with Federal Land Managers. EPA has made the preliminary
determination that Kentucky's SIP and practices adequately demonstrate
consultation with government officials related to the 1997 annual and
2006 24-hour PM2.5 NAAQS when necessary.
    10. 110(a)(2)(J) (127 public notification) Public notification: The
Commonwealth's emergency episode provisions provide for notification to
the public when the NAAQS, including the PM NAAQS, are exceeded.
Additionally, the Commonwealth reports daily air quality information on
its state Web site at: http://air.ky.gov/Pages/AirQualityIndexMonitoring.aspx to inform the public on the existing air
quality within the Commonwealth. EPA has made the preliminary
determination that Kentucky's SIP and practices adequately demonstrate
the Commonwealth's ability to provide public notification related to
the 1997 annual and 2006 24-hour PM2.5 NAAQS when necessary.
    11. 110(a)(2)(J) (PSD)PSD and visibility protection: Kentucky
demonstrates its authority to regulate new and modified sources of PM
to assist in the protection of air quality in Kentucky. Chapter 51--
Attainment and Maintenance of the National Ambient Air Quality
Standards, describes the permit requirements for new major sources or
major modifications of existing sources in areas classified as
attainment or unclassifiable under section 107(d)(1)(A)(ii) or (iii) of
the CAA. This ensures that sources in areas attaining the NAAQS at the
time of designations prevent any significant deterioration in air
quality. Chapter 51 also sets the permitting requirements for areas in
or around nonattainment areas. As with infrastructure element
110(a)(2)(C), infrastructure element 110(a)(2)(J) Kentucky's SIP does
not include provisions to meet all the requirements for NSR/PSD related
to the PM2.5 standard. As noted above on July 3, 2012,
Kentucky submitted a letter to EPA providing a schedule to address
outstanding requirements promulgated in the NSR PM2.5 Rule
related to the PM2.5 standard for their PSD program and
committing to providing the necessary SIP revision to address its NSR
PM2.5 Rule SIP deficiencies. As a result, EPA is proposing
to conditionally approve Kentucky's infrastructure SIP with respect to
element 110(a)(2)(J) in accordance with section 110(k)(4) of the Act.
EPA intends to move forward with finalizing the conditional approval
consistent with section 110(k)(4) of the Act.
    With regard to the applicable requirements for visibility
protection, EPA recognizes that states are subject to visibility and
regional haze program requirements under part C of the Act (which
includes sections 169A and 169B). In the event of the establishment of
a new NAAQS, however, the visibility and regional haze program
requirements under part C do not change. Thus, EPA finds that there is
no new visibility obligation ``triggered'' under section 110(a)(2)(J)
when a new NAAQS becomes effective. This would be the case even in the
event a secondary PM2.5 NAAQS for visibility is established,
because this NAAQS would not affect visibility requirements under part
C. EPA has made the preliminary determination that Kentucky's SIP and
practices adequately demonstrate the Commonwealth's ability to
implement PSD programs and to provide for visibility protection related
to the 1997 annual and 2006 24-hour PM2.5 NAAQS when
necessary.
    12. 110(a)(2)(K) Air quality and modeling/data: Kentucky Air
Regulations Chapter 50--General Administrative Procedures, provides
Kentucky with the authority to conduct air quality modeling and report
the results of such modeling to EPA. This regulation demonstrates that
Kentucky has the authority to provide relevant data for the purpose of
predicting the effect on ambient air quality of the 1997 annual and
2006 24-hour PM2.5 NAAQS. EPA has made the preliminary
determination that Kentucky's SIP and practices adequately demonstrate
the Commonwealth's ability to provide for air quality and modeling,
along with analysis of the associated data, related to the 1997 annual
and 2006 24-hour PM2.5 NAAQS when necessary.
    13. 110(a)(2)(L) Permitting fees: Kentucky addresses the review of
construction permits as previously discussed in 110(a)(2)(C) above.
Permitting fees are collected through the Commonwealth's title V fees
program, which has been federally approved. EPA has made the
preliminary determination that Kentucky's SIP and practices adequately
provide for permitting fees related to the 1997 annual and 2006 24-hour
PM2.5 NAAQS when necessary.
    14. 110(a)(2)(M) Consultation/participation by affected local
entities: DAQ coordinates with local governments affected by the SIP.
Kentucky's SIP also includes a description of the public participation
process for SIP development. Kentucky has consulted with local entities
for the development of transportation conformity and has worked with
the Federal Land Managers as a requirement of its regional haze rule.
More specifically, Kentucky adopted State-wide consultation procedures
for the implementation of transportation conformity which includes the
development of mobile inventories for SIP development and the
requirements that link transportation planning and air quality planning
in nonattainment and maintenance areas. The state and local
transportation agency officials are most directly impacted by
transportation conformity requirements and have a requirement to have
public involvement for their activities including the analysis which
shows how they meet transportation conformity requirements. EPA
approved Kentucky's consultation procedures in Chapter 50:066--
Conformity of transportation plans, programs, and projects (Amendment),
on April 21, 2010 (75 FR 20180). EPA has made the preliminary
determination that Kentucky's SIP and practices adequately demonstrate
consultation with affected local entities related to the 1997 annual
and 2006 24-hour PM2.5 NAAQS when necessary.

V. Proposed Action

    As described above, DAQ has addressed the elements of the CAA
110(a)(1) and (2) SIP requirements pursuant to EPA's October 2, 2007,
and

September 25, 2009, guidance to ensure that the 1997 annual and 2006
24-hour PM2.5 NAAQS are implemented, enforced, and
maintained in Kentucky. EPA is proposing to determine that Kentucky's
infrastructure submissions, provided to EPA on August 26, 2008, and on
July 17, 2012, addressed the required infrastructure elements for the
1997 annual and 2006 24-hour PM2.5 NAAQS with the exceptions
of elements (C) and (J) (as related to the PSD requirements of this
element).
    With respect to element 110(a)(2)(E)(ii), EPA is today proposing to
determine that Kentucky's SIP satisfies this infrastructure element
contingent upon EPA taking final action to approve Kentucky's July 17,
2012, submission requesting approval of KRS Chapters 11A.020, 11A.030,
11A.040, 224.10-020 and 224.10-100 into the SIP to address sub-element
110(a)(2)(E)(ii). Today's action is also proposing approval of KRS
Chapters 11A.020, 11A.030, 11A.040, 224.10-020 and 224.10-100 into the
SIP.
    With respect to elements 110(a)(2)(C) and 110(a)(2)(J) relating to
the PSD requirements, EPA is proposing to conditionally approve these
requirements based upon the commitment made by Kentucky to submit the
requisite SIP revision to address the Commonwealth's current NSR
PM2.5 Rule SIP deficiencies. Consistent with section
110(k)(4) of the CAA, if the Commonwealth fails to comply with its
commitment, this proposed condition approval would automatically be
treated as a disapproval of these elements.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. 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 Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the Commonwealth, and EPA notes that it will not impose substantial
direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Nitrogen dioxide, Particulate matter, Reporting and
recordkeeping requirements, Volatile organic compounds.

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

    Dated: July 20, 2012.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 2012-19017 Filed 8-2-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40402-40403]
[FR Doc No: 2019-17394]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Number: PR19-70-000.
    Applicants: Columbia Gas of Ohio, Inc.
    Description: Tariff filing per 284.123(b),(e)/: COH Rates effective
July 31 2019 to be effective 7/31/2019.
    Filed Date: 8/7/19.
    Accession Number:<PHONE_NUMBER>09.
    Comments/Protests Due: 5 p.m. ET 8/28/19.

    Docket Numbers: CP19-496-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Abbreviated Application for the Abandonment of Service
under Rate Schedule X-234 of Transcontinental Gas Pipe Line Company,
LLC under CP19-496.
    Filed Date: 8/2/19.
    Accession Number: 20190802-5187.
    Comments Due: 5 p.m. ET 8/23/19.

    Docket Numbers: RP19-1060-001.
    Applicants: WBI Energy Transmission, Inc.
    Description: Compliance filing 2019 Compliance Filing on 7-29-19
Order on Filings in with Order No. 587-Y to be effective 8/1/2019.
    Filed Date: 8/6/19.
    Accession Number: 20190806-5118.
    Comments Due: 5 p.m. ET 8/19/19

    Docket Numbers: RP19-1457-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 080619 Negotiated Rates--
Spotlight Energy, LLC R-7725-05 to be effective 10/1/2019.
    Filed Date: 8/6/19.
    Accession Number: 20190806-5033.
    Comments Due: 5 p.m. ET 8/19/19.

    Docket Numbers: RP19-1458-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 080619 Negotiated Rates--
Castleton Commodities Merchant Trading L.P. R-4010-18 to be effective
10/1/2019
    Filed Date: 8/6/19.
    Accession Number: 20190806-5034.
    Comments Due: 5 p.m. ET 8/19/19.

    Docket Numbers: RP19-1459-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 080619 Negotiated Rates--
Castleton Commodities Merchant Trading L.P. R-4010-19 to be effective
10/1/2019.
    Filed Date: 8/6/19.
    Accession Number: 20190806-5035.
    Comments Due: 5 p.m. ET 8/19/19.

    Docket Numbers: RP19-1088-001.
    Applicants: Enable Gas Transmission, LLC.
    Description: Compliance filing NAESB 3.1 Compliance Filing to be
effective 8/1/2019.
    Filed Date: 8/7/19.
    Accession Number: 20190807-5104.
    Comments Due: 5 p.m. ET 8/19/19.

    Docket Numbers: RP19-1095-001.
    Applicants: Enable Mississippi River Transmission, LLC.
    Description: Compliance filing MRT--NAESB 3.1 Complianec Filing to
be effective 8/1/2019.
    Filed Date: 8/7/19.
    Accession Number: 20190807-5106.
    Comments Due: 5 p.m. ET 8/19/19.

    Docket Numbers: RP19-1460-000.
    Applicants: WBI Energy Transmission, Inc.
    Description: Sec.  4(d) Rate Filing: 2019 Non Conforming and
Negotiated SA's FT-1517 and IT-838 to be effective 9/13/2019.
    Filed Date: 8/7/19.
    Accession Number: 20190807-5027.
    Comments Due: 5 p.m. ET 8/19/19.

    Docket Numbers: RP19-1461-000.
    Applicants: Anadarko Energy Services Company, Pacific Summit Energy
LLC.
    Description: Joint Petition for Temporary Waiver of Commission
Policies, Capacity Release Regulations and Policies, et al. of Anadarko
Energy Services Company, et al. under RP19-1461.
    Filed Date: 8/7/19.
    Accession Number: 20190807-5030.
    Comments Due: 5 p.m. ET 8/19/19.

    Docket Numbers: RP19-1462-000.
    Applicants: Anadarko Energy Services Company,Sequent Energy
Management, L.P.
    Description: Joint Petition for Temporary Waiver of Commission
Policies, Capacity Release Regulations and Policies, et al. of Anadarko
Energy Services Company, et al. under RP19-1462.
    Filed Date: 8/7/19.
    Accession Number: 20190807-5031.
    Comments Due: 5 p.m. ET 8/19/19.

    Docket Numbers: RP19-915-001.
    Applicants: SG Resources Mississippi, L.L.C.
    Description: Compliance filing SG Resources Mississippi, L.L.C.--
Order No. 587-Y Compliance, Directed Changes to be effective 8/1/2019.
    Filed Date: 8/7/19.
    Accession Number: 20190807-5028.
    Comments Due: 5 p.m. ET 8/19/19.

    Docket Numbers: RP19-917-001.
    Applicants: Pine Prairie Energy Center, LLC.
    Description: Compliance filing Pine Prairie Energy Center, LLC--
Order No. 587-Y Compliance, Directed Changes to be effective 8/1/2019.
    Filed Date: 8/7/19.
    Accession Number: 20190807-5026.
    Comments Due: 5 p.m. ET 8/19/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings

can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: August 8, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-17394 Filed 8-13-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 8 (Wednesday, January 13, 2016)]
[Notices]
[Pages 1665-1666]
[FR Doc No: 2016-00591]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of DC Brands International Inc., Order of
Suspension of Trading

January 11, 2016.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
DC Brands International Inc. (``DC Brands'') because DC Brands has not
filed any periodic reports since it filed a Form 10-Q for the period
ended June 30, 2014. Specifically, DC Brands is over a year delinquent
in its periodic reporting and it has not submitted the following
required filings:
     Form 10-Q for the quarter ended September 30, 2014 (due
November 15, 2014)
     Form 10-K for the fiscal year ended December 31, 2014 (due
March 31, 2015)
     Form 10-Q for the quarter ended March 31, 2015 (due May
15, 2015)
     Form 10-Q for the quarter ended June 30, 2015 (due August
15, 2015)
     Form 10-Q for the quarter ended September 30, 2015 (due
November 15, 2015)
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company.

    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed company is suspended for the period from 9:30 a.m. EST on
January 11, 2016, through 11:59 p.m. EST on January 25, 2016.

    By the Commission.
Brent J. Fields,
Secretary.
[FR Doc. 2016-00591 Filed 1-11-16; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register: October 21, 2009 (Volume 74, Number 202)]
[Notices]
[Page 54053-54055]
[DOCID:fr21oc09-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0503]

Draft Guidances for Industry and Food and Drug Administration
Staff; Computer-Assisted Detection Devices Applied to Radiology Images
and Radiology Device Data--Premarket Notification [510(k)] Submissions
and Clinical Performance Assessment: Considerations for Computer-
Assisted Detection Devices Applied to Radiology Images and Radiology
Device Data--Premarket Approval (PMA) and Premarket Notification
[510(k)] Submissions; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of two related draft guidance documents. One is a draft
guidance entitled, ``Computer-Assisted Detection Devices Applied to
Radiology Images and Radiology Device Data--Premarket Notification
[510(k)] Submissions'' (``CADe 510(k) draft guidance''). This draft
guidance provides recommendations regarding premarket notification
(510(k)) submissions of certain computer-assisted detection (CADe)
devices applied to radiology images and radiology device data. The
second draft guidance is entitled, ``Clinical Performance Assessment:
Considerations for Computer-Assisted Detection Devices Applied to
Radiology Images and Radiology Device Data--Premarket Approval (PMA)
and Premarket Notification [510(k)] Submissions'' (``CADe clinical
performance assessment draft guidance''). This draft guidance provides
recommendations on how to design and conduct clinical performance
studies for CADe devices applied to radiology images and radiology
device data. These studies may be part of a premarket submission to
FDA, whether it is a 510(k) submission, an application for premarket
approval (PMA), an application for a humanitarian device exemption
(HDE), or an application for an investigational device exemption (IDE).
These draft guidances are not final nor are they in effect at this
time.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
these draft guidances before it begins work on the final versions of
these guidances, submit written or electronic comments on the draft
guidances by January 19, 2010.

ADDRESSES:  Submit written requests for single copies of the draft
guidance document entitled ``Computer-Assisted Detection Devices
Applied to Radiology Images and Radiology Device Data--Premarket
Notification [510(k)] Submissions'' or the draft guidance document
entitled ``Clinical Performance Assessment: Considerations for
Computer-Assisted Detection Devices Applied to Radiology Images and
Radiology Device Data--Premarket Approval (PMA) and Premarket
Notification [510(k)] Submissions'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., WO66-4613, Silver Spring, MD 20993. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to these draft
guidances.
    Submit written comments concerning either of these draft guidances
and the questions found in the supplementary information to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. Identify comments with the
docket number found in brackets in the heading of this document. Please
include your rationale and/or scientific justification with your
comments.

FOR FURTHER INFORMATION CONTACT: Nicholas Petrick, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., White Oak Bldg. 62, rm. 4116, Silver Spring, MD 20993,
301-796-2563, and Joyce Whang, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., White
Oak Bldg. 66, rm. G318, Silver Spring, MD 20993.

SUPPLEMENTARY INFORMATION:

I. Background

    CADe devices are computerized systems that incorporate pattern
recognition and data analysis capabilities (i.e., combine values,
measurements, or features extracted from the patient radiological data)
intended to identify, mark, highlight, or in any other manner direct
attention to portions of an image, or aspects of radiology device data,
that may reveal abnormalities during interpretation of

patient radiology images or patient radiology device data by the
intended user (i.e., a physician or other health care professional). In
drafting these documents, we considered the recommendations made during
the Radiological Devices Panel on March 4 through 5, 2008. Further
information on this public advisory committee meeting, including panel
transcripts, can be found at: http://www.fda.gov/ohrms/dockets/ac/
cdrh08.html#radiology.
    The CADe 510(k) draft guidance provides recommendations on
documentation and performance testing to be part of a 510(k) submission
for Class II CADe devices applied to radiology images and radiology
device data. The CADe clinical performance assessment draft guidance
provides recommendations regarding clinical performance studies for
both Class II and Class III CADe devices applied to radiology images
and radiology device data.

II. Frequently Asked Questions

    The agency anticipates including a section containing frequently
asked questions (FAQs) in each of the guidances to further clarify the
agency's recommendations regarding premarket notification (510(k))
submissions of certain computer-assisted detection (CADe) devices
applied to radiology images and radiology, and on how to design and
conduct clinical performance studies for CADe devices applied to
radiology images and radiology device data. The agency is requesting
public comment on the proposed sample questions provided in this
document. Suggestions for additional questions and answers that are not
included below but that may be helpful in understanding the guidances
are also encouraged. The public comments will allow the agency to
further refine the guidance and develop a FAQ section to communicate
the recommended level of evidence for different premarket submissions.
The agency also wants to ensure that these guidances adequately address
these anticipated questions. The agency may adjust, add or delete
questions based on received comments.
    The first group of draft sample questions (Q1-Q7) has been
developed to provide context to the principles discussed in the CADe
510(k) draft guidance. They may help in preparing a Premarket
Notification [510(k)] Submission for your CADe device. Please comment
on the following questions and what you believe would be the
expectation of the agency based on the issues presented in the CADe
510(k) draft guidance.
    Q1: Our CT CADe device is intended to be used on a variety of CT
devices. Should any clinical trials we perform include every unit with
which the CT CADe device is intended to be used?
    Q2: Our CADe device is designed to detect lung nodules. Should we
power our standalone performance assessment so that statistically
significant results can be obtained for the clinically relevant
subgroups of lesions, for example, nodules near the mediastinum versus
the peripheral lung fields?
    Q3: We have an already cleared CADe device and have updated one of
its algorithms. Should we perform another clinical performance
assessment (i.e., a reader study)?
    Q4: We have a new CADe device and have done standalone testing
comparing it to an already cleared CADe device. Our new CADe identified
additional cancers and had fewer false positive marks than the cleared
device but ours missed some of the cancers detected by the cleared
device. Should we perform a clinical performance assessment?
    Q5: We have an already cleared CADe device and have changed the
prompt format (e.g., masses are now marked with a circle rather than an
arrow). Should we perform another clinical performance assessment?
    Q6: In a 510(k), can I reuse the test dataset that supported
clearance of the predicate CADe device and if so what are the
constraints on this reuse?
    Q7: Our colon CADe device can be used for both 2D and 3D
interpretation. Should we perform clinical tests using both
interpretation modes?
    The second set of draft sample questions (Q8-Q11) has been
developed to provide context to the principles discussed in the CADe
clinical performance assessment draft guidance. They may help in
developing and conducting a clinical performance assessment of your
CADe device to support clearance or approval. Again, please comment on
these questions and what you believe would be the expectation of the
agency based on the issues presented in the CADe clinical performance
assessment draft guidance.
    Q8: The guidance calls for the trial readers to be ``representative
of the intended population of clinical users.'' Can you give some
examples and should the number of readers in each of the subgroups be
proportional to the numbers in the population of clinical users?
    Q9: We have a new breast CADe device and would like to market it
for use with all legally marketed Full Field Digital Mammography
(FFDM). Should we perform reader studies with each legally marketed
FFDM?
    Q10: We have a breast CADe device approved for use with a specific
legally marketed Full Field Digital Mammography (FFDM) based on a
robust MRMC study. We would like to market it for use with an
additional legally marketed FFDM. Should we perform a clinical
performance assessment (i.e., reader study) to assess the CADe for use
with the new FFDM or is standalone performance data enough to
demonstrate comparable results based on the specifications of the
device?
    Q11: We have improved our legally marketed CADe device and will be
submitting a new 510(k) for the upgraded version. Is image reading
without CADe a suitable control arm against which to compare the
upgraded CADe device?
    The agency is seeking input to the previous sample questions and
suggestions on additional questions so that it can further refine the
guidance and develop a FAQ section to communicate the recommended level
of evidence for different premarket submissions. Your input would allow
us to consider multiple viewpoints of what is the adequacy of evidence
for these devices.

III. Significance of Guidance

    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidances,
when finalized, will represent, respectively, the agency's current
thinking on `` Computer-Assisted Detection Devices Applied to Radiology
Images and Radiology Device Data--Premarket Notification [510(k)]
Submissions'' and on ``Clinical Performance Assessment: Considerations
for Computer-Assisted Detection Devices Applied to Radiology Images and
Radiology Device Data--Premarket Approval (PMA) and Premarket
Notification [510(k)] Submissions.'' The guidance documents do not
create or confer any rights for or on any person and do not operate to
bind FDA or the public. Alternative approaches may be used if such
approaches satisfy the requirements of the applicable statute and
regulations.

IV. Electronic Access

    Persons interested in obtaining a copy of either draft guidance may
do so by using the Internet. To receive ``Computer-Assisted Detection
Devices Applied to Radiology Images and Radiology Device Data--
Premarket Notification [510(k)] Submissions,'' you may either send an
e-mail request to<EMAIL_ADDRESS>to receive an electronic copy of
the document or send

a fax request to<PHONE_NUMBER> to receive a hard copy. Please use the
document number 1697 to identify the draft guidance you are requesting.
To receive ``Clinical Performance Assessment: Considerations for
Computer-Assisted Detection Devices Applied to Radiology Images and
Radiology Device Data--Premarket Approval (PMA) and Premarket
Notification [510(k)] Submissions,'' you may either send an e-mail
request to<EMAIL_ADDRESS>to receive an electronic copy of the
document or send a fax request to<PHONE_NUMBER> to receive a hard copy.
Please use the document number 1698 to identify the draft guidance you
are requesting.
    CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, mammography matters, and other device-oriented
information. The CDRH web site may be accessed at http://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available at http://www.regulations.gov.

V. Paperwork Reduction Act of 1995

    These draft guidances contain information collection provisions
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 USC 3501-3520) (the PRA).
The collections of information addressed in these draft guidance
documents have been approved by OMB in accordance with the PRA under
the regulations governing premarket notification submissions (21 CFR
part 807, subpart E, OMB No. 0910-0120), premarket approval
applications (21 CFR part 814, OMB No. 0910-0231), investigational
device exemptions (21 CFR part 812, OMB No. 0910-0078), and
humanitarian use devices (21 CFR part 814, OMB No. 0910-0332). The
labeling provisions addressed in the ``Computer-Assisted Detection
Devices Applied to Radiology Images and Radiology Device Data--
Premarket Notification [510(k)] Submissions'' draft guidance have been
approved by OMB under OMB No. 0910-0485.

VI. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.

    Dated: October 15, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25233 Filed 10-20-09; 8:45 am]

BILLING CODE 4160-01-S