[Federal Register Volume 88, Number 65 (Wednesday, April 5, 2023)]
[Notices]
[Pages 20209-20210]
[FR Doc No: 2023-07102]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[PHMSA-2019-0098]

Lithium Battery Air Safety Advisory Committee; Notice of Public
Meeting

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
U.S. Department of Transportation (DOT).

ACTION: Notice of public meeting.

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SUMMARY: This notice announces a meeting of the Lithium Battery Air
Safety Advisory Committee (Committee).

DATES: The meeting will be held on April 20, 2023, from 9 a.m. to 5:30
p.m. EDT. Requests to attend the meeting must be sent by April 5, 2023,
to the point of contact identified in the FOR FURTHER INFORMATION
CONTACT section. Persons requesting to speak during the meeting must
submit a written copy of their remarks to DOT by April 5, 2023.
Requests to submit written materials to be reviewed during the meeting
must be received no later than April 5, 2023.

ADDRESSES: The meeting will be held at DOT Headquarters, West Building,
1200 New Jersey Avenue SE, Washington, DC 20590-0001. A remote
participation option will also be available and the meeting will be
webcast. Specific details on location and access to this meeting will
be posted on the Committee website located at: https://www.phmsa.dot.gov/hazmat/rulemakings/lithium-battery-safety-advisory-committee. The E-Gov website is located at https://www.regulations.gov.
Mailed written comments intended for the Committee should be sent to
Docket Management Facility, U.S. Department of Transportation (DOT),
1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC
20590-0001.

FOR FURTHER INFORMATION CONTACT: Steven Webb or Aaron Wiener, PHMSA,
U.S. Department of Transportation.

Telephone:<PHONE_NUMBER>. Email: [email protected]. Any
committee-related request should be sent to the email address listed in
this section.

SUPPLEMENTARY INFORMATION:

I. Background

    The Lithium Battery Air Safety Advisory Committee was created under
the Federal Advisory Committee Act (FACA, Pub. L. 92-463), in
accordance with Section 333(d) of the FAA Reauthorization Act of 2018
(Pub. L. 115-254).

II. Agenda

    The meeting agenda will address the following duties of the
Committee as specifically outlined in Section 333(d) of the FAA
Reauthorization Act of 2018:
    (a) Facilitate communication among manufacturers of lithium
batteries and products containing lithium batteries, air carriers, and
the federal government.
    (b) Discuss the effectiveness and the economic and social impacts
of lithium battery transportation regulations.
    (c) Provide the Secretary with information regarding new
technologies and transportation safety practices.
    (d) Provide a forum to discuss Departmental activities related to
lithium battery transportation safety.
    (e) Advise and recommend activities to improve the global
enforcement of U.S. regulations and the International Civil Aviation
Organization (ICAO) Technical Instructions relevant to air
transportation of lithium batteries, and the effectiveness of those
regulations.
    (f) Provide a forum for feedback on potential positions to be taken
by the U.S. at international forums.
    (g) Guide activities to increase awareness of relevant
requirements.
    (h) Review methods to decrease the risk posed by undeclared
hazardous materials.
    A final agenda will be posted on the Lithium Battery Air Safety
Advisory Committee website at least 15 days in advance of the meeting.

III. Public Participation

    The meeting will be open to the public. DOT is committed to
providing equal access to this meeting for all participants. If you
need alternative formats or services because of a disability, such as
sign language, interpretation, or other ancillary aids, please contact
the person listed in the FOR FURTHER INFORMATION CONTACT section no
later than April 5, 2023. To accommodate as many speakers as possible,
time for each commenter may be limited. There will be five minutes
allotted for oral comments from members of the public joining the
meeting. Individuals wishing to reserve speaking time during the
meeting must submit a request at the time of registration, as well as
the name, address, and organizational affiliation of the proposed
speaker. If the number of registrants requesting to make statements is
greater than can be reasonably accommodated during the meeting, PHMSA
may conduct a lottery to determine the speakers. Speakers are requested
to submit a written copy of their prepared remarks for inclusion in the
meeting records and for circulation to Lithium Battery Air Safety
Advisory Committee members. All prepared remarks submitted on time will
be accepted and considered as part of the record. Any member of the
public may present a written statement to the committee at any time.
Copies of the meeting minutes and committee presentations will be
available on the Lithium Battery Air Safety Advisory Committee website.
Presentations will also be posted on the E-Gov website in docket number
[PHMSA-2019-0098], within 30 days following the meeting.
    Written comments: Persons who wish to submit written comments on
the meetings may submit them to docket [PHMSA-2019-0098] in the
following ways:
    1. E-Gov Website: This site allows the public to enter comments on
any Federal Register notice issued by any agency.
    2. Mail: Dockets Management System; U.S. Department of
Transportation, Dockets Operations, M-30, Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC 20590- 0001.
    Instructions: Identify the docket number [PHMSA-2019-0098] at the
beginning of your comments. Note that all comments received will be
posted without change to the E-Gov website, including any personal
information provided. Anyone can search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). Therefore, consider
reviewing DOT's complete Privacy Act Statement in the Federal Register
published on April 11, 2000, (65 FR 19477), or view the Privacy Notice
on the E-Gov website before submitting comments.
    Docket: For docket access or to read background documents or
comments, go to the E-Gov website at any time or visit the DOT dockets
facility listed in the ADDRESSES category, between 9:00 a.m. and 5:00
p.m., Monday through Friday, except federal holidays.
    If you wish to receive confirmation of receipt of your written
comments, please include a self-addressed, stamped postcard with the
following statement: ``Comments on [PHMSA-2019-0098].'' The docket
clerk will date stamp the postcard prior to returning it to you via
U.S. mail.

Privacy Act Statement

    DOT may solicit comments from the public regarding certain general
notices. DOT posts these comments, without edit, including any personal
information the commenter provides, to the E-Gov website, as described
in the system of records notice (DOT/ALL-14 FDMS).

    Issued in Washington, DC, on March 31, 2023.
William S. Schoonover,
Associate Administrator for Hazardous Materials Safety, Pipeline and
Hazardous Materials Safety Administration.
[FR Doc. 2023-07102 Filed 4-4-23; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: June 10, 2010 (Volume 75, Number 111)]
[Notices]
[Page 32933-32934]
[DOCID:fr10jn10-43]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 2

May 25, 2010.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP09-1051-002.
    Applicants: Texas Gas Transmission, LLC.
    Description: Texas Gas Transmission, LLC submits the Seventh
Revised Sheet 99A to Gas Tariff, Third Revised Volume 1.
    Filed Date: 05/18/2010.
    Accession Number: 20100518-0216.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 1, 2010.

    Docket Numbers: RP10-699-001.
    Applicants: Equitrans, L.P.
    Description: Equitrans, LP submits pagination errata filing.
    Filed Date: 05/18/2010.
    Accession Number: 20100518-0215.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 1, 2010.

    Docket Numbers: RP99-106-016.
    Applicants: TransColorado Gas Transmission Company LLC
    Description: TransColorado Gas Transmission Company LLC submits its
annual revenue sharing report.
    Filed Date: 05/18/2010.
    Accession Number: 20100518-5044.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 1, 2010.

    Docket Numbers: RP09-447-006.
    Applicants: Monroe Gas Storage Company, LLC.
    Description: Monroe Gas Storage Company, LLC submits FERC Gas
Tariff Compliance Filing.
    Filed Date: 05/19/2010.
    Accession Number: 20100520-0204.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 1, 2010.

    Docket Numbers: RP10-726-001.
    Applicants: TransColorado Gas Transmission Company LLC.
    Description: TransColorado Gas Transmission Company LLC submits
tariff filing per 154.203: Compliance Filing of Baseline Filing to be
effective 5/12/2010.
    Filed Date: 05/21/2010.
    Accession Number: 20100521-5114.

    Comment Date: 5 p.m. Eastern Time on Wednesday, June 2, 2010.

    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed on or before 5 p.m. Eastern time on the specified comment
date. Anyone filing a protest must serve a copy of that document on all
the parties to the proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons
unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-13917 Filed 6-9-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 6, 2010 (Volume 75, Number 128)]
[Notices]
[Page 38802-38803]
[DOCID:fr06jy10-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR10-42-000]

DCP Raptor Pipeline, LLC; Notice of Baseline Filing

June 28, 2010.
    Take notice that on June 22, 2010, DCP Raptor Pipeline, LLC
submitted a baseline filing of its Statement of Operating Conditions
for services provided under section 311 of the Natural Gas Policy Act
of 1978 (NGPA).
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Comment Date: 5 p.m. Eastern time on Monday, July 12, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-16287 Filed 7-2-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 5, 2006 (Volume 71, Number 65)]
[Notices]
[Page 17084]
[DOCID:fr05ap06-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP99-301-140]

ANR Pipeline Company; Notice of Negotiated Rate Filing

March 28, 2006.
    Take notice that on March 20, 2006, ANR Pipeline Company (ANR)
tendered for filing and acceptance six copies of a negotiated rate
arrangement between ANR and various shippers who have subscribed for
capacity to be created by ANR's Wisconsin 2006 Expansion. ANR requests
that the negotiated rate arrangements become effective pursuant to each
agreement's respective term provision.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

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

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

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-4871 Filed 4-4-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 8 (Wednesday, January 13, 2021)]
[Proposed Rules]
[Page 2615]
[FR Doc No: C1-2020-28117]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0053; FRL-10016-93]

Receipt of Several Pesticide Petitions Filed for Residues of
Pesticide Chemicals in or on Various Commodities (October 2020)

Correction

    In proposed rule document 2020-28117 appearing on pages 82998
through 83000 in the issue of Monday, December 21, 2020, make the
following correction:
    (1) On page 82998, in the second column, in the DATES section,
change ``January 20, 2021'' to read ``January 21, 2021.''

[FR Doc. C1-2020-28117 Filed 1-12-21; 8:45 am]
BILLING CODE 1301-00-D


[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Rules and Regulations]
[Pages 64761-64763]
[FR Doc No: 2016-22709]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2016-N-2562]

Medical Devices; General and Plastic Surgery Devices;
Classification of the Magnetic Surgical Instrument System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

DATES: This order is effective September 21, 2016. The classification
was applicable on June 13, 2016.

FOR FURTHER INFORMATION CONTACT: Varun Pattani, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G452, Silver Spring, MD, 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require

premarket approval, unless and until the device is classified or
reclassified into class I or II, or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i), to a predicate device that does not require premarket approval.
The Agency determines whether new devices are substantially equivalent
to predicate devices by means of premarket notification procedures in
section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR
part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1) of
the FD&C Act. Under the first procedure, the person submits a premarket
notification under section 510(k) of the FD&C Act for a device that has
not previously been classified and, within 30 days of receiving an
order classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person requests a classification under section
513(f)(2). Under the second procedure, rather than first submitting a
premarket notification under section 510(k) of the FD&C Act and then a
request for classification under the first procedure, the person
determines that there is no legally marketed device upon which to base
a determination of substantial equivalence and requests a
classification under section 513(f)(2) of the FD&C Act. If the person
submits a request to classify the device under this second procedure,
FDA may decline to undertake the classification request if FDA
identifies a legally marketed device that could provide a reasonable
basis for review of substantial equivalence with the device or if FDA
determines that the device submitted is not of ``low-moderate risk'' or
that general controls would be inadequate to control the risks and
special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    On February 9, 2015, Levita Magnetics International Corp.,
submitted a request for classification of the Levita Magnetic Surgical
System under section 513(f)(2) of the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the request, FDA determined that the device
can be classified into class II with the establishment of special
controls. FDA believes these special controls, in addition to general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on June 13, 2016, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 878.4815.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a magnetic
surgical instrument system will need to comply with the special
controls named in this final order. The device is assigned the generic
name magnetic surgical instrument system, and it is identified as a
prescription device used in laparoscopic surgical procedures consisting
of several components, such as surgical instruments, and a magnetic
controller. The magnetic controller is provided separately from the
surgical instrument and is used outside the patient. The external
magnetic controller is magnetically coupled with the internal surgical
instrument(s) at the surgical site to grasp, hold, retract, mobilize,
or manipulate soft tissue and organs.
    FDA has identified the following risks to health associated
specifically with this type of device, as well as the mitigation
measures required to mitigate these risks in table 1.

    Table 1--Magnetic Surgical Instrument System Risks and Mitigation
                                Measures
------------------------------------------------------------------------
               Identified risk                    Mitigation measures
------------------------------------------------------------------------
Tissue Damage................................  In vivo Performance
                                                Testing.
                                               Human Factors Testing and
                                                Analysis.
                                               Training.
                                               Labeling.
Need for Extended or Additional Surgery:       In vivo Performance
 Inability to couple the external       Testing.
 magnet with the internal surgical instrument  Non-clinical Performance
 Inability to retrieve or maneuver      Testing.
 device                                        Human Factors Testing and
 Inability to visualize critical        Analysis.
 anatomical structures                         Training.
                                               Labeling.
Abdominal Wall Injury........................  In vivo Performance
                                                Testing.
                                               Human Factors Testing and
                                                Analysis.
                                               Labeling.
Electromagnetic Field Incompatibility or       Non-clinical Performance
 Interference (including ferromagnetic          Testing.
 implants in users and patients,
 electrosurgical devices, etc.).
                                               Human Factors Testing and
                                                Analysis.
                                               Training.
                                               Labeling.
Adverse Tissue Reaction......................  Biocompatibility
                                                Evaluation.
Infection....................................  Sterilization Validation.
                                               Reprocessing Validation.
                                               Shelf Life Validation.
                                               Labeling.
------------------------------------------------------------------------

    FDA believes that the special controls, in addition to the general
controls, address these risks to health and provide reasonable
assurance of the safety and effectiveness.
    A magnetic surgical instrument system device is not safe for use
except under the supervision of a practitioner licensed by law to
direct the use of the device. As such, the device is a prescription
device and must satisfy prescription labeling requirements (see 21 CFR
801.109, Prescription devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the magnetic surgical instrument
system they intend to market.

II. Environmental Impact

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

III. Paperwork Reduction Act of 1995

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

List of Subjects in 21 CFR Part 878

    Medical devices.

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

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

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

0
2. Add Sec.  878.4815 to subpart E to read as follows:

Sec.  878.4815  Magnetic surgical instrument system.

    (a) Identification. A magnetic surgical instrument system is a
prescription device used in laparoscopic surgical procedures consisting
of several components, such as surgical instruments, and a magnetic
controller. The magnetic controller is provided separately from the
surgical instrument and is used outside the patient. The external
magnetic controller is magnetically coupled with the internal surgical
instrument(s) at the surgical site to grasp, hold, retract, mobilize,
or manipulate soft tissue and organs.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) In vivo performance data must demonstrate that the device
performs as intended under anticipated conditions of use. Testing must
demonstrate the ability of the device to grasp, hold, retract,
mobilize, or manipulate soft tissue and organs.
    (2) Non-clinical performance data must demonstrate that the system
performs as intended under anticipated conditions of use. The following
performance characteristics must be tested:
    (i) Magnetic field strength testing characterization to identify
the distances from the magnet that are safe for patients and users with
ferromagnetic implants, devices, or objects.
    (ii) Ability of the internal surgical instrument(s) to be coupled,
de-coupled, and re-coupled with the external magnet over the external
magnet use life.
    (3) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device
components that are patient-contacting.
    (5) Methods and instructions for reprocessing reusable components
must be validated.
    (6) Performance data must support shelf life by demonstrating
continued sterility of the device or the sterile components and device
functionality over the labeled shelf life.
    (7) Training must be developed and validated by human factors
testing and analysis to ensure users can follow the instructions for
use to allow safe use of the device.
    (8) Labeling must include:
    (i) Magnetic field safe zones.
    (ii) Instructions for proper device use.
    (iii) A screening checklist to ensure that all patients and
operating staff are screened from bringing ferromagnetic implants,
devices, or objects near the external magnet.
    (iv) Reprocessing instructions for any reusable components.
    (v) Shelf life.
    (vi) Use life.

    Dated: September 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22709 Filed 9-20-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 12010-12011]
[FR Doc No: 2015-05017]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Clinical Outcomes Assessment Development and Implementation:
Opportunities and Challenges; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

    The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Clinical Outcomes Assessment Development and
Implementation: Opportunities and Challenges.'' The purpose of the
public workshop is to provide updates on accomplishments, challenges,
and ongoing efforts in the use of clinical outcome assessments (COAs),
and plan for the future of COA development and utilization in drug
development programs, including how to incorporate the patient voice in
drug development using well-defined and reliable patient-centered
outcome measures. The public workshop will also discuss standards for
COA use and collaborative processes for COA development and
dissemination.
    Date and Time: The public workshop will be held on April 1, 2015,
from 8:30 a.m. to 5 p.m. Participants are encouraged to arrive early to
ensure time for parking and routine security checks before the
workshop.
    Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, The
Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the
public workshop participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking
and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Attendees are responsible for their own accommodations.
    The public workshop will also be available to be viewed online via
Webcast at https://collaboration.fda.gov/COApublicworkshop2015. Persons
interested in participating by Webcast must register online by March
27, 2015.
    Contact Person: Michelle Campbell, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
22, Rm. 6471, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Registration: Registration is free for the public workshop.
Interested parties are encouraged to register early because space is
limited to 150 attendees. Workshop space will be filled in order of
receipt of registration. Those accepted in to the workshop will receive
confirmation. Registration will close after the workshop is filled.
Registration at the site is not guaranteed but may be possible on a
space available basis on the day of the public workshop beginning at
7:30 a.m. If registration is filled, attendance to the workshop will be
available only through the Webcast.
    To register, visit http://www.fda.gov/Drugs/NewsEvents/ucm431040.htm. For those without Internet access, please call Michelle
Campbell (See Contact Person) to register.
    If you need special accommodations due to a disability, please
contact Michelle Campbell (See Contact Person) at least 7 days in
advance.

SUPPLEMENTARY INFORMATION: The Center for Drug Evaluation and Research
(CDER) reviews COAs, including patient-reported outcome measures,
clinician-reported outcome measures, and observer-reported outcome
measures, when submitted with an investigational new drug application,
a new drug application, or a biologics licensing application. CDER also
reviews a COA when submitted for qualification as a drug development
tool. Qualification of a COA is a regulatory determination that the COA
is well-suited for a specific context of use in drug development.
Following a public announcement of the qualification decision by FDA,
the COA will be publicly available for use in any appropriate drug
development program.
    This workshop will focus on current challenges and opportunities in
COA development and use, including establishing appropriate standards
for use; current efforts to encourage inclusion of well-defined and
reliable patient-centered outcome measures in drug development; use of
collaborative efforts in developing and utilizing COAs through various
partnerships; and future efforts to address challenges and gaps of COA
development and use for patient-centered drug development and medical
product labeling.
    For more information on this public workshop, visit http://www.fda.gov/Drugs/NewsEvents/ucm431040.htm.
    The Agency encourages patient advocates, health care providers,
researchers, regulators, individuals from academia, industry, and other
interested persons to attend this public workshop.

    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20857.
A transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857. Transcripts will also be available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm431040.htm approximately 45 days after
the workshop.

    Dated: February 27, 2015.
Leslie Kux,
 Associate Commissioner for Policy.
[FR Doc. 2015-05017 Filed 3-4-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Rules and Regulations]
[Pages 14681-14689]
[FR Doc No: 2013-05352]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2012-0700; FRL-9788-6]

Approval and Promulgation of Implementation Plans; Kentucky;
110(a)(1) and (2) Infrastructure Requirements for the 2008 8-Hour Ozone
National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is taking final action to approve in part, conditionally
approve in part, and disapprove in part, the July 17, 2012, State
Implementation Plan (SIP) submission provided by the Commonwealth of
Kentucky, through the Division of Air Quality (DAQ) of the Kentucky
Energy and Environment Cabinet. Kentucky DAQ submitted the July 17,
2012, SIP submission as a replacement to its original September 8,
2009, SIP submission. Specifically, this final rulemaking pertains to
the Clean Air Act (CAA or Act) requirements for the 2008 8-hour ozone
national ambient air quality standards (NAAQS) infrastructure SIP. The
CAA requires that each state adopt and submit a SIP for the
implementation, maintenance, and enforcement of each NAAQS promulgated
by EPA, which is commonly referred to as an ``infrastructure'' SIP.
Kentucky DAQ made a SIP submission demonstrating that the Kentucky SIP
contains provisions that ensure the 2008 8-hour ozone NAAQS are
implemented, enforced, and maintained in the Commonwealth (hereafter
referred to as ``infrastructure submission''). EPA is now taking final
action on three related actions on Kentucky DAQ's infrastructure SIP
submission. First, EPA is taking action to approve Kentucky DAQ's
infrastructure submission provided to EPA on July 17, 2012, as meeting
certain required infrastructure elements for the 2008 8-hour ozone
NAAQS. Second, with respect to the infrastructure elements related to
specific prevention of significant deterioration (PSD) requirements,
EPA is taking final action to approve, in part and conditionally
approve in part, the infrastructure SIP submission based on a December
19, 2012, commitment from Kentucky DAQ to submit specific enforceable
measures for approval into the SIP to address specific PSD program
deficiencies. Third, EPA is taking final action to disapprove Kentucky
DAQ's infrastructure SIP submission with respect to certain interstate
transport requirements for the 2008 8-hour ozone NAAQS because the
submission does not address the statutory provisions with respect to
the relevant NAAQS and thus does not satisfy the criteria for approval.
The CAA requires EPA to act on this portion of the SIP submission even
though under a recent court decision, Kentucky DAQ was not yet required
to submit a SIP submission to address these interstate transport
requirements. Moreover, under that same court decision, this
disapproval does not trigger an obligation for EPA to promulgate a
Federal Implementation Plan (FIP) to address these interstate transport
requirements.

DATES: This rule will be effective April 8, 2013.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2012-0700. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information 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 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 a.m. to 4:30 p.m. excluding
federal holidays.

FOR FURTHER INFORMATION CONTACT: Nacosta C. Ward, 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<PHONE_NUMBER>. Ms. Ward can be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Response to Comments
III. This Action
IV. Final Action
V. Statutory and Executive Order Reviews

I. Background

    Upon promulgation of a new or revised NAAQS, sections 110(a)(1) and
(2) of the CAA require states to address basic structural SIP
requirements, including emissions inventories, monitoring, and modeling
to assure attainment and maintenance for that new NAAQS.
    Section 110(a) of the CAA generally requires states to make a SIP
submission to meet applicable requirements in order 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. These SIP submissions are
commonly referred to as ``infrastructure'' SIP submissions. Section
110(a) imposes the obligation upon states to make an infrastructure 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 infrastructure SIP for a new or revised
NAAQS affect the content of the submission. The contents of such
infrastructure SIP submissions may also vary depending upon what
provisions the state's existing SIP already contains. In the case of
the 2008 8-hour ozone NAAQS, states typically have met the basic
program elements required in section 110(a)(2) through earlier SIP
submissions in connection with previous ozone NAAQS.
    More specifically, 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 basic structural SIP requirements such as modeling, monitoring,
and emissions inventories that are designed to assure attainment and
maintenance of the NAAQS. The applicable infrastructure SIP
requirements that are the subject of this rulemaking are listed
below.\1\
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    \1\ 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 other provisions of the CAA
for submission of SIP revisions specifically applicable for
attainment planning purposes. 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 final rulemaking does not address
infrastructure elements related to section 110(a)(2)(I) or the
nonattainment planning requirements of 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.\2\
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    \2\ This rulemaking only addresses requirements for this element
as they relate to attainment areas.
---------------------------------------------------------------------------

     110(a)(2)(D)(i): Interstate transport.\3\
---------------------------------------------------------------------------

    \3\ Section 110(a)(2)(D)(i) includes four requirements referred
to as prongs 1 through 4. Prongs 1 and 2 are provided at section
110(a)(2)(D)(i)(I); prongs 3 and 4 are provided at section
110(a)(2)(D)(i)(II). At this time, pursuant to a recent decision of
the U.S. Court of Appeals for the DC Circuit, the SIP submission
from Kentucky DAQ to meet section 110(a)(2)(D)(i)(I) is not a
required SIP submission. The portions of the SIP submission relating
to 110(a)(2)(D)(i)(II) and 110(a)(2)(D)(ii), in contrast, are
required. Although prongs 1 and 2 are not required, EPA is acting
today to disapprove Kentucky's submittal related to these prongs for
the reasons described in the proposed rule associated with this
rulemaking. See 78 FR 3867. Further information regarding EPA's
disapproval of prongs 1 and 2 is also provided below in section II.
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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.\4\
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    \4\ This requirement as mentioned above is not relevant to
today's final rulemaking.
---------------------------------------------------------------------------

     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.
    On January 17, 2013, EPA proposed to approve Kentucky's July 17,
2012, infrastructure SIP submission and proposed to conditionally
approve in part sections 110(a)(2)(C), prong 3 of (D)(i), and (J), and
disapprove in part section 110(a)(2)(D)(i) for the 2008 8-hour ozone
NAAQS. See 78 FR 3867.
    EPA proposed conditional approval in part for sections
110(a)(2)(C), prong 3 of (D)(i),\5\ and (J) because, while the
Commonwealth's SIP does not currently contain provisions to address the
structural PSD requirements of the PSD and Nonattainment New Source
Review (NNSR) requirements related to the implementation of the NSR
PM2.5 Rule and the PM2.5 PSD Increment-SILs-SMC
Rule (only as it relates to PM2.5 Increments), Kentucky DAQ
committed in a letter dated December 19, 2012, to submit, within one
year, specific enforceable measures to EPA for incorporation into the
SIP to address these requirements. See 78 FR 3867. This commitment
letter meets the requirements of section 110(k)(4) of the CAA. Kentucky
DAQ's December 19, 2012, letter can be accessed at www.regulations.gov
using Docket ID No. EPA-R04-OAR-2012-0700.
---------------------------------------------------------------------------

    \5\ Section 110(a)(2)(D)(i) includes four requirements referred
to as prongs 1 through 4. Prongs 1 and 2 are provided at section
110(a)(2)(D)(i)(I); prongs 3 and 4 are provided at section
110(a)(2)(D)(i)(II). Today's conditional approval only relates to
the structural PSD requirements of section 110(a)(2)(D)(i)(II), also
known as prong 3 as noted above in footnote 3.
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    With respect to section 110(a)(2)(D)(i)(I),\6\ for the 2008 8-hour
ozone NAAQS, EPA published a proposal to disapprove Kentucky DAQ's July
17, 2012, SIP revision. EPA proposed disapproval of these elements
because the infrastructure SIP submission asserted that the
requirements of 110(a)(2)(D)(i)(I) with respect to the 2008 8-hour
ozone NAAQS were satisfied by the Commonwealth's approved regulations
to meet the Clean Air Interstate Rule (CAIR) requirements. CAIR,
however, was promulgated before the 2008 8-hour ozone NAAQS were
promulgated, and CAIR did not, in any way, address interstate transport
requirements related to the 2008 8-hour ozone NAAQS. See 78 FR 3867.
---------------------------------------------------------------------------

    \6\ Section 110(a)(2)(D)(i)(I) includes two distinct
requirements referred to as prongs 1 and 2. Prong 1 requires states
to prohibit emissions that significantly contribute to nonattainment
of the NAAQS in another state and prong 2 request states to prohibit
emissions that interfere with maintenance of the NAAQS in another
state.
---------------------------------------------------------------------------

    Finally, EPA notes that this final action on Kentucky's
infrastructure SIP submission for the 2008 8-hour ozone NAAQS is
required not only by section 110(k), but also by order issued by the
U.S. District Court for the Northern District of California in
WildEarth Guardians v. Jackson, Case No. 11-CV-5651 YGR. In an October
17, 2012, order granting partial summary judgment in the case, as
modified in a December 7, 2012, order granting in part EPA's motion for
an amended order, that court directed EPA to take final action upon the
infrastructure SIP at issue in this action by March 4, 2013. With
respect to Kentucky, the court specifically ordered EPA to act upon the
infrastructure SIP submission made by the Commonwealth on September 8,
2009, as revised on July 17, 2012. As explained in more detail in
response to relevant comments, EPA is addressing the requirements of
section 110(a)(2)(D)(i)(I) consistent with the opinion of the DC
Circuit Court's opinion in EPA Homer City Generation v. EPA, 696 F.3d 7
(DC Cir. 2012).

II. Response to Comments

    EPA received five sets of comments on the January 17, 2013,
proposed rulemaking to approve in part, conditionally approve in part,
and disapprove in part, Kentucky DAQ's infrastructure SIP submission
intended to meet the CAA requirements for the 2008 8-hour ozone NAAQS.
A summary of the comments and EPA's responses are provided below.
    Comment 1: One commenter contends that EPA cannot approve the
section 110(a)(2)(A) portion of Kentucky DAQ's infrastructure SIP
submission because certain counties in the Commonwealth have air
quality monitors with data that suggest such areas are not attaining
the 2008 8-hour ozone NAAQS. Specifically, the Commenter cites air
monitoring reports for Jefferson and Oldham counties indicating
violations of the NAAQS based on 2009-2011 design values. The Commenter
further contends that, based on available data for 2010-2012, 10
Kentucky counties will violate the 2008 8-hour ozone NAAQS based on
2010-2012 design values. According to the Commenter, if a designated
attainment area violates the NAAQS, then this means that the state must
necessarily lack adequate emissions limits in its infrastructure SIP
submission to attain and maintain that NAAQS.
    Response 1: EPA disagrees with the Commenter's contention that
Kentucky DAQ's 2008 8-hour ozone infrastructure SIP submission is not
approvable with respect to section 110(a)(2)(A) because of the monitor
design values noted by the Commenter. While EPA shares the Commenter's
concern regarding counties monitoring exceedances of the

2008 8-hour ozone NAAQS based upon 2009-2011 design values, such
concerns are outside the scope of what is germane to an evaluation of
section 110(a)(2)(A) of an infrastructure SIP.\7\
---------------------------------------------------------------------------

    \7\ EPA also notes that the Commenter relies upon preliminary
data to suggest that certain areas are violating the 2008 8-hour
ozone NAAQS based upon 2010-2012 data. This data has not yet been
certified, and as such, is not yet finalized. Regardless, for the
reasons discussed in Response 1, EPA does not believe that such
data, were it certified and final, would provide an appropriate
basis upon which to disapprove Kentucky's infrastructure SIP as it
relates to section 110(a)(2)(A) requirements.
---------------------------------------------------------------------------

    Pursuant to section 110(a)(2)(A), an infrastructure SIP submission
must include enforceable emission limitations and other control
measures, means, or techniques (including economic incentives such as
fees, marketable permits, and auctions of emissions rights), as well as
schedules and timetables for compliance, as may be necessary or
appropriate to meet the applicable requirements of the Act. The
Commenter, however, seems to believe that in the context of an
infrastructure SIP submission, section 110(a)(2)(A) requires that a
state must monitor attainment of the NAAQS at all monitors throughout
the state in order to demonstrate that the SIP contains the requisite
emissions limitations and other control measures, means or techniques
prescribed by the Act. EPA does not believe that this is a reasonable
interpretation of the provision with respect to infrastructure SIP
submissions. Rather, EPA believes that the proper inquiry at this
juncture is whether the state has met the basic structural SIP
requirements appropriate at the point in time EPA is acting upon it.
The Act provides states and EPA with other tools to address concerns
that arise with respect to violations of the NAAQS in a designated
attainment area, such as the authority to redesignate areas pursuant to
section 107(d)(3), the authority to issue a ``SIP Call'' pursuant to
section 110(k)(5), or the general authority to approve SIP revisions
that can address such violations of the NAAQS through other appropriate
measures. As stated in EPA's proposed approval for this rule, to meet
section 110(a)(2)(A), Kentucky submitted a list of existing emission
reduction measures in the SIP that control emissions of volatile
organic compounds and nitrogen oxides (NOx) in order to address ambient
ozone levels. EPA believes that this is sufficient for purposes of
infrastructure SIP submission.
    Comment 2: The Commenter contends that EPA must disapprove
Kentucky's infrastructure SIP submission as it relates to section
110(a)(2)(A) because the submittal fails to contain enforceable ozone
precursor limits and schedules/timetables for compliance to ensure
attainment and maintenance of the NAAQS. Specifically, the Commenter
contends that Kentucky has failed to identify how it will address the
violations for those counties monitoring violations of the NAAQS.
    Response 2: EPA disagrees with the Commenter's contention that
Kentucky should be required to submit the emissions limitations and
other control measures associated with a nonattainment plan in order to
satisfy section 110(a)(2)(A) requirements. This would be beyond the
scope of what is required per section 110(a)(2)(A) in the context of an
infrastructure SIP submission. Nonattainment area plans are due on a
different schedule from the section 110 infrastructure elements, and
such plans, if required, are reviewed and acted upon through a separate
process. Here, the most of the counties cited by the Commenter are not
designated nonattainment,\8\ and as such, the nonattainment plan
requirements referenced by the Commenter are not currently due. As
noted above, EPA shares the Commenter's concern regarding areas that
are monitoring exceedances of the 2008 8-hour ozone NAAQS and will work
appropriately with state and local agencies to address such
exceedances. Further, in approving Kentucky's infrastructure SIP, EPA
is affirming that Kentucky has sufficient authority to take the types
of actions required by the CAA in order to bring such areas back into
attainment.
---------------------------------------------------------------------------

    \8\ As noted below, a portion of Campbell County, Kentucky is
designated nonattainment for the 2008 8-hour ozone NAAQS in
association with the Cincinnati-Hamilton nonattainment area.
---------------------------------------------------------------------------

    Comment 3: A number of Commenters disagreed with EPA's position
that disapproval of the Kentucky's infrastructure SIP, as it relates to
section 110(a)(2)(D)(i)(I) requirements, would not trigger a mandatory
duty for EPA to promulgate a FIP to address these requirements.
Specifically, the Commenters contend that the plain language of the CAA
requires EPA to issue a FIP within two years of a disapproval action.
In addition, the Commenters contend that the decision in EME Homer City
Generation v. EPA, 696 F.3d 7 (DC Cir. 2012) (EME Homer City), was
incorrectly decided and is inconsistent with previous decisions by the
DC Circuit Court of Appeals. The Commenters suggest that EPA should not
voluntarily follow the incorrectly decided EME Homer City opinion,
particularly in the context of an infrastructure action that only
impacts sources in Kentucky, a state under the jurisdiction of the
Sixth Circuit Court of Appeals rather than the DC Circuit Court of
Appeals.
    Response 3: EPA has historically adopted the interpretation
suggested by the Commenters that disapproval of section
110(a)(2)(D)(i)(I) would trigger an obligation for the Agency to
promulgate a FIP within two years if the state did not correct the SIP
deficiency within that time. EPA continues to agree that the plain
language of the statute establishes these obligations, and for those
reasons, we asked the U.S. Court of Appeals for the DC Circuit to grant
rehearing en banc of the decision in EME Homer City. That petition,
however, was denied on January 24, 2012, and the mandate was issued to
EPA on February 4, 2012. The deadline for any party to file a petition
for certiorari with the Supreme Court has not passed \9\ and the United
States has not yet decided whether to pursue further appeals. In the
meantime, EPA intends to act in accordance with the EME Homer City
opinion in which the court concluded that states have no obligation to
make a SIP submission to address section 110(a)(2)(D)(i)(I) for a new
or revised NAAQS until EPA has first defined a state's obligations
pursuant to that section. As described in the proposed rulemaking for
today's action, Kentucky did make such a submittal, and consistent with
section 110(k) of the CAA, EPA is required to act upon that submittal.
Because CAIR does not, in any way, address transport with respect to
the 2008 8-hour ozone NAAQS, it cannot be relied upon to satisfy the
requirements of 110(a)(2)(D)(i)(I) for that NAAQS. For this reason, the
Agency proposed to disapprove this portion of the infrastructure SIP
submission. However, because this portion of the infrastructure SIP
submission is not currently required for the 2008 8-hour ozone NAAQS
per the EME Homer City opinion, EPA's disapproval action today does not
presently trigger a FIP obligation.
---------------------------------------------------------------------------

    \9\ Pursuant to Rule 13 of the Supreme Court Rules, a petition
for certiorari must be filed within 90 days of the date of denial of
rehearing. The court may extend this deadline for good cause by up
to 60 days.
---------------------------------------------------------------------------

    EPA also disagrees with the Commenters' suggestion that the Agency
need not follow the DC Circuit's decision in EME Homer City in the
context of an infrastructure action for Kentucky. The EPA rule reviewed
by the court in EME Homer City--``Federal Implementation Plans:
Interstate Transport of Fine Particulate Matter and

Ozone and Correction of SIP Approvals,'' 76 FR 48207 (August 8, 2011)
also known as the Cross State Air Pollution Rule (CSAPR)--was
designated by EPA as a ``nationally applicable'' rule within the
meaning of section 307(b)(1) of the CAA. See id. at 48352. Accordingly,
all petitions for review of the CSAPR had to be filed in the U.S. Court
Appeals for the DC Circuit and could not be filed in any other federal
court. 42 U.S.C. 7607(b)(1). Accordingly, EPA believes the DC Circuit's
decision in EME Homer City vacating this rule is also nationally
applicable. As such, EPA does not intend to take any actions, even if
they are only reviewable in another federal Circuit Court of Appeals,
that are inconsistent with the decision of the DC Circuit.
    Comment 4: A number of states commented that Kentucky contributes
significantly to ozone nonattainment in other states. Specifically, the
Maryland Department of the Environment commented that it has performed
modeling to demonstrate that Maryland will continue to violate the 2008
8-hour ozone NAAQS even if all anthropogenic emissions in Maryland are
eliminated. It contends that corrective actions in states like Kentucky
that contribute to Maryland's nonattainment are necessary in order for
the state to meet the NAAQS. The Delaware Department of Natural
Resources and Environmental Control commented that modeling from the
CSAPR demonstrated that Kentucky emissions significantly contribute to
Delaware's ozone pollution by as much as 4.3 percent of the 2008 8-hour
ozone NAAQS in 2012 and that Delaware has done its fair share to
address ozone, and it expects EPA to ensure that upwind contributing
states fully address their contribution to downwind nonattainment.
Finally, the Connecticut Department of Energy & Environmental
Protection commented that CSAPR modeling demonstrates that Kentucky
emissions significantly contribute to Connecticut's ozone pollution by
as much as 3.4 percent of the 2008 8-hour ozone NAAQS in 2012, and that
Connecticut has done its fair share to address ozone emissions in the
state, and it now expects EPA to ensure that upwind contributing states
fully address their contribution to downwind nonattainment.
    Response 4: EPA acknowledges the Commenters' concern that
interstate transport of ozone and ozone precursors from upwind states
to downwind states may have adverse consequences on the ability of
downwind areas to attain the NAAQS in a timely fashion. It is for this
reason that EPA attempted, through CSAPR, to address emissions found to
significantly contribute to nonattainment of or interfere with
maintenance of the 1997 8-hour ozone NAAQS. The modeling done for
CSAPR, however, did not address the 2008 8-hour ozone NAAQS and EPA did
not draw any conclusions with respect to the 2008 8-hour ozone NAAQS
which did not exist when CAIR was promulgated. Moreover, the DC
Circuit, in its decision vacating the CSAPR, held that states are not
required to submit SIPs addressing the requirements of section
110(a)(2)(D)(i)(I) until EPA has quantified their obligation under that
provision. See EME Homer City, 696 F.3d at 37. The EME Homer City
opinion was issued in August of 2012, and on January 24, 2013, the
court denied all petitions for rehearing. As noted in the responses
above, the deadline for asking the Supreme Court to review the DC
Circuit's decision has not passed and the United States has not yet
decided whether to seek further appeal. In the meantime, and unless the
EME Homer City Generation decision is reversed or otherwise modified,
EPA intends to act in accordance with the DC Circuit's opinion. Under
this opinion, EPA has no authority to promulgate a FIP for section
110(a)(2)(D)(i)(I) until such time as the Agency quantifies States'
obligations under this section.
    Comment 5: One Commenter contended even if EPA chose to follow the
EME Homer City Generation decision, EPA should acknowledge that the
disapproval starts a FIP clock and then move expeditiously to provide
Kentucky with the information the EME Homer City court said EPA must
provide. The Commenter contended that EPA should be able to quantify
Kentucky's obligations under section 110(a)(2)(D)(i)(I) within six
months, thereby providing the Commonwealth with 18 months to submit a
new SIP to address this requirements.
    Response 5: EPA disagrees. As discussed above in the response to
comment 3, unless the D.C. Circuit's decision in EME Homer City is
reversed or otherwise modified, disapproval Kentucky DAQ's 2008
infrastructure SIP as it relates to section 110(a)(2)(i)(I) does not
give EPA authority, much less obligate it, to promulgate a FIP for
Kentucky. EPA intends to move forward expeditiously to address the
interstate transport requirements of the CAA in accordance with all
applicable court decisions.
    Comment 6: A number of Commenters contend that EPA's disapproval
section 110(a)(2)(D)(i)(I) triggers a section 110(k)(5) obligation to
initiate a ``SIP Call'' to revise Kentucky's inadequate infrastructure
SIP related to interstate transport requirements.
    Response 6: EPA disagrees. Section 110(k)(5) of the CAA provides a
mechanism (i.e., a ``SIP Call'') for correcting SIPs that the
Administrator finds to be substantially inadequate to meet CAA
requirements. As discussed above, EPA has historically interpreted
section 110(a)(1) of the CAA as establishing the required submittal
date for SIPs addressing all of the ``interstate transport''
requirements in section 110(a)(2)(D) including the provisions in
section 110(a)(2)(D)(i)(I) regarding significant contribution to
nonattainment and interference with maintenance. The D.C. Circuit's
recent opinion in EME Homer City, however, concluded that a SIP cannot
be deemed to lack a required submission or deemed deficient for failure
to meet the 110(a)(2)(D)(i)(I) obligation until EPA first quantifies
that obligation. As such, and consistent with the EME Homer City
opinion, EPA does not at this time believe that disapproval of section
110(a)(2)(D)(i)(I) requirements for Kentucky's 2008 8-hour ozone
infrastructure SIP constitutes a substantial inadequacy in the Kentucky
SIP because EPA has yet to quantify the Commonwealth's obligation under
this requirement. EPA intends to move forward expeditiously to
implement the interstate transport requirements of the CAA.
    Comment 7: One Commenter contends that EPA should disapprove
Kentucky's 2008 8-hour ozone infrastructure SIP submission with regard
to the visibility component of 110(a)(2)(D)(i)(II) until such time that
Kentucky imposes best available retrofit technology (BART) for nitrogen
oxides (NOx) and sulfur dioxides for electric generating units. The
Commenter asserts that the substitution of the CAIR for BART is not
permanent and enforceable and references the previous litigation
related to CAIR. The Commenter provides a number of comments in
relation to EPA's ``better than BART'' approach and reliance on CAIR to
support an approval action for the visibility components of Kentucky's
2008 8-hour ozone infrastructure submission.
    Response 7: EPA disagrees. As explained in detail in EPA's proposed
rulemaking related to today's action, EPA believes that in light of the
D.C. Circuit court's decision to vacate CSAPR, also known as the
Transport Rule (see EME Homer City, 696 F.3d 7), and the court's order
for EPA to ``continue administering CAIR pending the promulgation of a
valid replacement,'' it is appropriate for EPA

to rely at this time on CAIR to support approval of Kentucky's 2008 8-
hour ozone infrastructure submission as it relates to visibility. EPA
has been ordered by the court to develop a new rule, and to continue
implementing CAIR in the meantime. While EPA had filed a petition for
rehearing of the court's decision on the Transport Rule, this petition
was later denied on January 24, 2013. The deadline for any party to
file a petition for certiorari with the Supreme Court has not passed,
and the United States has not yet decided whether to pursue further
appeals. In the meantime, EPA does not intend to act in a manner
inconsistent with the decision of the D.C. Circuit. Based on the
current direction from the court to continue administering CAIR, EPA
believes that it is appropriate to rely on CAIR emission reductions for
purposes of assessing the adequacy of Kentucky's infrastructure SIP
with respect to prong 4 of section 110(a)(2)(D)(i)(II) while a valid
replacement rule is developed and until implementation plans complying
with any such new rule are submitted by the states and acted upon by
EPA or until the EME Homer City case is resolved in a way that provides
different direction regarding CAIR and CSAPR.
    Furthermore, as neither the Commonwealth nor EPA has taken any
action to remove CAIR from the Kentucky SIP, CAIR remains part of the
federally-approved SIP and can be considered in determining whether the
SIP as a whole meets the requirement of prong 4 of 110(a)(2)(D)(i)(II).
EPA is taking final action to approve the infrastructure SIP submission
with respect to prong 4 because Kentucky's regional haze SIP, which EPA
has given a limited approval in combination with its SIP provisions to
implement CAIR adequately, prevents sources in Kentucky from
interfering with measures adopted by other states to protect visibility
during the first planning period. While EPA is not at this time
proposing to change the March 30, 2012, limited approval and limited
disapproval of Kentucky's regional haze SIP, EPA expects to propose an
appropriate action regarding Kentucky's regional haze SIP if necessary
upon final resolution of the EME Homer City litigation. More detailed
rationale to support EPA's approval of prong 4 for Kentucky's 2008 8-
hour ozone infrastructure submission can be found in EPA's proposed
rulemaking for today's final action. See 78 FR 3867.
    Comment 8: One Commenter states that EPA should disapprove the
visibility prong of Kentucky's 2008 8-hour ozone infrastructure
submission because the Commenter asserts that Kentucky has failed to
conduct its 5-year progress review for its regional haze SIP by the
required date.
    Response 8: EPA does not agree that Kentucky has missed its
deadline to submit its 5-year progress review SIP related to regional
haze. Kentucky's initial regional haze SIP was submitted on June 25,
2008, so the Commonwealth's 5-year regional haze progress review SIP is
not due until June 25, 2013. Even assuming, however, that the deadline
for the Commonwealth's submittal of its progress review SIP had passed,
this alone would not warrant the disapproval of Kentucky's 2008 8-hour
ozone infrastructure SIP submission as it relates to visibility.
    Comment 9: One Commenter states ``[n]ow that en banc review of
Homer has been denied, EPA should promptly propose and promulgate a
full approval of KY's regional haze SIP.'' The Commenter also asserts
that, ``[t]his prospective action should also apply to the other
elements of the KY SIP that address reasonable progress and the long
term strategy for visibility.''
    Response 9: This comment is outside of the scope of today's action.
As explained in EPA's proposal notice related to today's action, EPA
has already taken final action on Kentucky's regional haze SIP. See 77
FR 19098 (March 30, 2012). EPA's proposal notice related to today's
action did not involve a reconsideration of the Agency's March 30,
2012, final action on the Commonwealth's regional haze SIP. While EPA's
proposal notice did note the litigation related to the Transport Rule
and also noted that based on the EME Homer City court's decision on the
Transport Rule that it would be appropriate to propose to rescind its
limited disapproval of Kentucky's regional haze SIP and propose a full
approval, EPA did not take such action because the Agency was awaiting
a decision related to the possibility that the court would grant EPA's
petition for an en banc review. EPA mentioned in that proposal notice
that an en banc review of the court's decision could have a different
outcome that could bear on such action on the regional haze SIP. Since
the time of EPA's proposal for Kentucky's 2008 8-hour ozone
infrastructure SIP, the court has denied EPA's petition for en banc
review. As noted above, on January 24, 2013, EPA's petition was denied
and the mandate was issued to EPA on February 4, 2013. The deadline for
any party to file a petition for certiorari with the Supreme Court has
not passed and the United States has not yet decided whether to pursue
further appeals. In the meantime, EPA does not intend to act in a
manner inconsistent with the decision of the D.C. Circuit. However, EPA
does not think it is appropriate in today's action to rescind its
limited disapproval of Kentucky's regional haze SIP. Notably, as
explained in EPA's proposal notice related to Kentucky's 2008 8-hour
ozone infrastructure action, EPA does not believe that rescinding the
Agency's previous limited disapproval of Kentucky's regional haze SIP
is necessary to support a full approval of the visibility components of
110(a)(2)(D)(i)(I) and 110(a)(2)(J) for Kentucky's 2008 8-hour ozone
infrastructure SIP. Moreover, EPA has not proposed to rescind the
Agency's previous limited disapproval, which would be an appropriate
procedural step prior to rescinding that disapproval.
    Comment 10: One Commenter contends that ``EPA must disapprove the
infrastructure SIP because it does not contain the 2008 ozone NAAQS.''
In support of this contention, the Commenter points to a table codified
at 401 KAR 53:010, as evidence that Kentucky's ozone limits ``remain at
levels set in 1997.''
    Response 10: EPA does not agree with the Commenter's assertion that
Kentucky's 2008 8-hour ozone infrastructure SIP should be disapproved
because ``it does not contain the 2008 8-hour ozone NAAQS.'' In
response to this comment, EPA has investigated the facts concerning the
table in question. EPA acknowledges that the table in Appendix A to 401
KAR 53:010 pointed to by the Commenter currently does not list the 2008
8-hour ozone NAAQS. However, EPA does not believe that the out-of-date
table indicates that the Kentucky SIP does not adequately address
infrastructure requirements for the 2008 8-hour ozone NAAQS.
    The Commonwealth's infrastructure SIP submission explicitly stated
that it was submitted to address the 2008 8-hour ozone NAAQS. Within
that submission, the Commonwealth indicated that its existing
provisions are appropriate for purposes of the 2008 8-hour ozone NAAQS.
EPA considers this to be accurate, based upon the specific contents of
the infrastructure SIP submission for various elements of section
110(a)(2). For example, Kentucky's applicable permitting regulations
define a ``regulated NSR pollutant'' as ``[a] pollutant for which a
national ambient air quality standard has been promulgated* * *.'' 401
KAR 51:001(207). In assessing permits issued by the Commonwealth, EPA
routinely interprets the ``for which a national

ambient air quality standard has been promulgated'' language in the
Kentucky SIP as referring to the current federally-promulgated NAAQS.
EPA notes that in practice the Commonwealth is also addressing the 2008
8-hour ozone NAAQS.\10\
---------------------------------------------------------------------------

    \10\ For example, EPA is currently reviewing the Suncoke Energy
PSD Application (PSD-KY-265), which was submitted to DAQ on December
7, 2012, and received by EPA for review February 7, 2013. The terms
of this application reflect the 2008 8-hour ozone standard as the
applicable NAAQS.
---------------------------------------------------------------------------

    Finally, EPA understands that the Commonwealth has initiated action
to update the out-of-date table cited by the Commenter to eliminate any
ambiguity or confusion regarding this point. In consultation with the
Commonwealth, EPA's understanding is that the Commonwealth is in the
process of updating the table to reflect the current NAAQS. EPA
believes that, with correction of the table, there should be no
misunderstandings concerning the fact that the Commonwealth's SIP is
designed to address the 2008 8-hour ozone NAAQS in accordance with the
requirements of section 110(a)(1) and (2). As such, EPA does not agree
that Kentucky's infrastructure SIP submission must be disapproved as a
result of the out-of-date table cited by the Commenter.
    Comment 11: One Commenter contends that EPA cannot determine that
the Kentucky SIP provides the necessary assurances required by section
110(a)(2)(E)(i) that the Commonwealth will have adequate personnel,
funding and authority under state law to carry out its implementation
plan given (in the Commenter's opinion) that Kentucky's infrastructure
SIP fails to adequately address the significant and important
requirements of element (D)(i).
    Response 11: EPA does not agree. Section 110(a)(2)(E)(i) requires
that the SIP provide ``necessary assurances that the State * * * will
have adequate personnel, funding, and authority under State * * * law
to carry our such implementation plan * * *.'' As described in the
proposal for today's action, Kentucky has submitted information to
demonstrate that DAQ 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. In addition, EPA noted the March 14, 2012, Agency
letter to DAQ outlining the current status of grant commitments for
2011, each of which have since been finalized. Finally, the proposed
rule for today's action described that Kentucky's personnel, funding,
and legal authority to carry out the Commonwealth's implementation plan
is included with all prehearings and final SIP submittals to EPA. Based
upon this information EPA proposed to approve Kentucky's infrastructure
submission for purposes of the 2008 8-hour ozone NAAQS. The Commenter
does not refute these facts.
    While the Commenter is correct in asserting that Kentucky's
infrastructure SIP presently fails to address section
110(a)(2)(D)(i)(I) for the 2008 8-hour ozone NAAQS, it is incorrect to
conclude that such failure must result in a disapproval of section
110(a)(2)(E)(i). EPA does not view the satisfaction of section
110(a)(2)(D)(i)(I) requirements as germane to an evaluation of whether
a state has met its obligations under section 110(a)(2)(E)(i). Rather,
EPA interprets section 110(a)(2)(E)(i) as requiring that the state have
adequate authority under statutes, rules, and regulations to carry out
applicable SIP obligations with respect to the relevant NAAQS. See 40
CFR Part 51, Subparts L and O.
    As described above, EPA's disapproval of the Kentucky
infrastructure SIP as it relates to the section 110(a)(2)(D)(i)(I)
transport requirements is based upon the Commonwealth's reliance upon
CAIR to satisfy the interstate transport obligations of a NAAQS which
CAIR did not address. The fact that this portion of the SIP cannot be
approved, however, does not in any way demonstrate a deficiency in the
underlying authority of the Kentucky DAQ to promulgate rules and
regulations to address these requirements. The Commenter provided no
information to suggest that Kentucky lacks the personnel, authority to
address the interstate transport requirements.
    Comment 12: One Commenter asserts that EPA must disapprove
Kentucky's infrastructure SIP related to section 110(a)(2)(J) (127
public notice requirements) because in the Commenter's opinion Kentucky
does not provide public notification of 2008 8-hour ozone NAAQS
violations in areas beyond Oldham and Jefferson counties. Specifically,
the Commenter indicates that the state agency does not notify the
public of 2008 8-hour ozone violations in counties that are currently
designated attainment for the 1-hour and 1997 8-hour standards (i.e.,
all counties but Jefferson and Oldham).
    Response 12: EPA does not agree with the Commenter's assertion that
EPA must disapprove Kentucky's infrastructure SIP submission as it
relates to the section 110(a)(2)(J) requirements for public
notification because the SIP does not provide for public notification
of 2008 8-hour ozone NAAQS violations.
    First the Commenter fails to note the distinction between exceeding
the ozone NAAQS and violating the ozone NAAQS. Under the CAA, there is
a clear distinction between a violation and an exceedance of an ambient
air quality standard.\11\ Pursuant to the public notification
requirements of section 110(a)(2)(J), states are not required to notify
the public of NAAQS violations as suggested by the Commenter. Instead,
states are required ``to notify the public during any calendar [year]
on a regular basis of instances or areas in which any national primary
ambient air quality standard is exceeded or was exceeded during any
portion of the preceding calendar year * * *'' (emphasis added). See 42
U.S.C. 7427.
---------------------------------------------------------------------------

    \11\ An exceedance occurs when monitored ozone concentrations
exceed the NAAQS. Ozone is collected as an hourly average of
continuous data and, in the context of the 2008 8-hour ozone NAAQS
is then used to determine the daily 8-hour average value. An ozone
exceedance occurs when a monitor records an 8-hour averaged ambient
level of ozone above the standard, in this case, above 0.075 parts
per million (ppm). A violation of an ozone standard (as opposed to
an exceedance) is based on 3-year averages of data. Violations of
the 8-hour standard are determined using the annual 4th-highest
daily maximum 8-hour ozone value at each monitor. A violation
requires a 3-year average of the annual 4th-highest daily maximum 8-
hour value that is greater than 0.075 ppm.
---------------------------------------------------------------------------

    Second, the Commenter is mistaken because the Commonwealth does
notify the public regarding ambient air quality in Kentucky, including
exceedances of the standard. As described in the proposal for today's
action, notification to the public regarding exceedances is
accomplished through Kentucky DAQ's Web site at http://air.ky.gov/Pages/AirQualityIndexMonitoring.aspx, which provides real time
monitoring data for all of the Commonwealth's ozone monitors and
provides access to Air Quality Index (AQI) information.\12\ In
addition, Kentucky's Web site also provides information related to
health considerations based on the concentration of the pollutants in
the air and information related to ways the public can help reduce air
pollution. EPA has determined that that this method of notify the
public of ambient quality is sufficient to meet Kentucky's
infrastructure SIP obligations described at section 110(a)(2)(J)
regarding public notification.
---------------------------------------------------------------------------

    \12\ EPA notes that Kentucky provides this information for
monitors through the Commonwealth, and that the locations of the
monitors are included in the Commonwealth's approved network
monitoring plan. Thus this information is available for appropriate
locations throughout the state.
---------------------------------------------------------------------------

    Finally, EPA also notes that this comment presupposes that there
have

been violations of the 2008 ozone NAAQS based on 2010 to 2012 design
values which have yet to be certified. Although the Kentucky DAQ
maintains the above-referenced Web site with real time monitoring data
for the Commonwealth's ozone monitors, Kentucky is not required to
certify each year's data until April 1, 2013. As such, until the 2012
data referenced by the Commenter is certified, it remains preliminary
and EPA does not view a NAAQS violation as having occurred.
Consequently, the Commenter's reference to data not-yet-certified is
premature.\13\
---------------------------------------------------------------------------

    \13\ EPA also wishes to clarify that Commenter incorrectly
indicates that all counties aside from Jefferson and Oldham are
designated attainment for the 2008 8-hour ozone NAAQS. There are
also three partial counties in Northern Kentucky (i.e., Boone,
Campbell and Kenton) are designated nonattainment for the 2008 8-
hour ozone NAAQS as part of the Cincinnati-Hamilton Nonattainment
Area. The Campbell County monitor referred to by the Commenter is
included in the 2008 8-hour ozone nonattainment area and is not in
area designated attainment as suggested by one Commenter. See 77 FR
30088.
---------------------------------------------------------------------------

III. This Action

    In this rulemaking, EPA is taking final action to approve Kentucky
DAQ's infrastructure submission as demonstrating that the Commonwealth
meets the applicable requirements of sections 110(a)(1) and (2) of the
CAA for the 2008 8-hour ozone NAAQS, with the exception of section
110(a)(2)(D)(i)(I) concerning interstate transport, and sections
110(a)(2)(C), prong 3 of 110(a)(2)(D)(i), and 110(a)(2)(J) pertaining
to structural PSD requirements.
    With respect to section 110(a)(2)(D)(i)(I), which pertains to
interstate transport, EPA is taking final action to disapprove this
portion of Kentucky DAQ's infrastructure SIP for the 2008 8-hour ozone
NAAQS.
    With respect to sections 110(a)(2)(C), prong 3 of 110(a)(2)(D)(i),
and 110(a)(2)(J), EPA is finalizing conditional approval for this
portion of Kentucky DAQ's infrastructure SIP for the 2008 8-hour ozone
NAAQS. Today's final action to conditionally approve of these portions
of sections 110(a)(2)(C), prong 3 of 110(a)(2)(D)(i), and 110(a)(2)(J)
specifically related to the structural PSD requirements is based upon a
December 19, 2012, commitment letter submitted by Kentucky DAQ to EPA.
The Commonwealth's December 19, 2012, letter can be accessed at
www.regulations.gov using Docket ID No. EPA-R04-OAR-2012-0700. Through
this letter, Kentucky DAQ, committed to adopt specific enforceable
measures to address current deficiencies in its SIP related to the
structural PSD requirements of the PSD and NNSR requirements related to
the implementation of the NSR PM2.5 Rule and the
PM2.5 PSD Increment-SILs-SMC Rule (only as it relates to
PM2.5 Increments). This commitment letter meets the
requirements of section 110(k)(4) of the CAA, and as such, EPA is
relying upon this commitment to conditionally approve sections
110(a)(2)(C), prong 3 of 110(a)(2)(D)(i), and 110(a)(2)(J). For more
information, see EPA's proposal for today's rulemaking. See 78 FR 3867.
    Accordingly, for purposes of today's conditional approval sections
110(a)(2)(C), prong 3 of 110(a)(2)(D)(i), and 110(a)(2)(J) as it
relates to the structural PSD requirements, Kentucky DAQ must submit to
EPA by March 10, 2014, a SIP revision adopting the specific enforceable
measures as described in the Commonwealth's commitment letter described
above. If the Commonwealth fails to actually submit this revision by
March 10, 2014, today's conditional approval will automatically become
a disapproval for the 2008 8-hour ozone NAAQS.

IV. Final Action

    EPA is taking final action to approve most elements contained in
Kentucky DAQ's infrastructure SIP submission made by the Commonwealth
on September 8, 2009, as revised on July 17, 2012, because it addresses
the required infrastructure elements for the 2008 8-hour ozone NAAQS
with exception of sections 110(a)(2)(C), prong 3 of 110(a)(2)(D)(i),
and 110(a)(2)(J) as they relate to structural PSD requirements, and
section 110(a)(2)(D)(i)(I) as it relates to interstate transport. With
the exceptions noted above Kentucky DAQ has addressed the elements of
the CAA 110(a)(1) and (2) SIP requirements pursuant to section 110 of
the CAA to ensure that the 2008 8-hour ozone NAAQS are implemented,
enforced, and maintained in Kentucky.
    With respect to section 110(a)(2)(D)(i)(I) specifically pertaining
interstate transport, EPA is finalizing disapproval for this portion of
Kentucky DAQ's infrastructure SIP for the 2008 8-hour ozone NAAQS.
    With respect to sections 110(a)(2)(C), prong 3 of 110(a)(2)(D)(i),
and 110(a)(2)(J) as they relate to the structural PSD requirements of
the PSD and NNSR requirements related to the implementation of the NSR
PM2.5 Rule and the PM2.5 PSD Increment-SILs-SMC
Rule (only as it relates to PM2.5 Increments), EPA is taking
final action to conditionally approve the Commonwealth's infrastructure
SIP in part, based on an December 19, 2012, commitment that Kentucky
DAQ will adopt specific enforceable measures related to the structural
PSD requirements detailed above into its SIP and submit these revisions
to EPA by March 10, 2014. If the Commonwealth fails to actually submit
these revisions by the applicable dates described above, today's
conditional approval(s) will automatically be disapproved on that date.

V. 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. 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
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the 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 rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by May 6, 2013. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: March 1, 2013.
A. Stanley Meiburg
Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart S--Kentucky

0
2. Section 52.919 is amended by designating the existing undesignated
paragraph as paragraph (a) and adding paragraph (b) to read as follows:

Sec.  52.919  Identification of plan-conditional approval.

    (a) * * *
    (b) Conditional Approval--Submittal from the Commonwealth of
Kentucky, through the Division of Air Quality (DAQ) of the Kentucky
Energy and Environment Cabinet, dated December 19, 2012, to address the
Clean Air Act (CAA) sections 110(a)(2)(C), prong 3 of 110(a)(2)(D)(i),
and 110(a)(2)(J) for the 2008 8-hour Ozone National Ambient Air Quality
Standards. With respect to CAA sections 110(a)(2)(C), prong 3 of
110(a)(2)(D)(i), and 110(a)(2)(J), the Commonwealth must submit to EPA
by March 10, 2014, SIP revisions adopting specific enforceable measures
related the structural PSD requirements of the PSD and NNSR
requirements related to the implementation of the NSR PM2.5
Rule and the PM2.5 PSD Increment-SILs-SMC Rule (only as it
relates to PM2.5 Increments) as described in the
Commonwealth's commitment letter.

0
3. In Sec.  52.920, the table in paragraph (e) is amended by adding a
new entry ``110(a)(1) and (2) Infrastructure Requirements for the 2008
8-Hour Ozone National Ambient Air Quality Standards'' at the end of the
table to read as follows:

Sec.  52.920  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Kentucky Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                     Applicable      State submittal
   Name of non-regulatory SIP       geographic or     date/effective   EPA approval date       Explanations
           provision             nonattainment area        date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
110(a)(1) and (2)                Commonwealth of          7/17/2012   3/7/2013..........  With the exception of
 Infrastructure Requirements      Kentucky.                           [Insert citation     section
 for the 2008 8-Hour Ozone                                             of publication].    110(a)(2)(D)(i)(I)
 National Ambient Air Quality                                                              concerning interstate
 Standards.                                                                                transport which is
                                                                                being disapproved
                                                                                and, the portions of
                                                                                sections
                                                                                110(a)(2)(C), prong 3
                                                                                of 110(a)(2)(D)(i),
                                                                                and 110(a)(2)(J)
                                                                                related to structural
                                                                                PSD requirements,
                                                                                which are being
                                                                                conditionally
                                                                                approved.
----------------------------------------------------------------------------------------------------------------

0
4. Section 52.930 is amended by adding paragraph (l) to read as
follows:

Sec.  52.930  Control strategy: Ozone.

* * * * *
    (l) Disapproval. EPA is disapproving in part, the Commonwealth of
Kentucky's Infrastructure SIP for the 2008 8-hour Ozone National
Ambient Air Quality Standards addressing section 110(a)(2)(D)(i)(I)
concerning interstate transport requirements, submitted July 17, 2012.

[FR Doc. 2013-05352 Filed 3-6-13; 8:45 am]
BILLING CODE 6560-50-P